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Vascular access and complications
WEDNESDAY 9/25/02 9:00 –10:00
Vascular Access and Complications Wednesday, September 25, 2002 9:00 –10:00 AM 3:00 – 4:00 PM Main Lobby (Abstract nos. 428 – 450)
TCT-428 Randomized Comparison of Transradial Coronary Intervention with Transfemoral Access Combined with Arteriotomy Closure Devices: the EMPIRE Study. S.K. Chugh, N. Solankhi, J.G. Webb, C.E.H. Buller, L. Bussoli, M. Wilson, A. Dodek, R.G. Carere. Interventional Cardiology, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
P O S T E R A B S T R A C T S
Background: To enable rapid mobilization and promote patient comfort, both transradial catheterization and transfemoral catheterization with arterial closure have been advocated. Early generation arteriotomy closure devices (ACDs) had higher complications compared with manual compression but enable rapid mobilization. Transradial interventions have few complications but are technically more difficult to perform. There are few data comparing radial access with ACDs and no randomized study assesses patient preference. The objective of this study was to prospectively evaluate procedural success, technical difficulties, and complications as well as patient comfort. Methods: Patients considered suitable for same-day discharge were randomized to the radial or femoral approach. The latter were then randomized to Techstar (suture based) vs AngioSeal (collagen based) closure device. Access site complications, ease of procedure, and guide catheter performance and patient comfort were assessed. Follow-up was performed at 2 to 4 days. Results: Arterial access was easier and guide catheter performance better with femoral access, though overall procedure success was similar. Procedure (44 ⫾ 21 minutes vs 42 ⫾ 20 minutes, p ⫽ 0.004) and fluoroscopy (16 ⫾ 12 vs 10 ⫾ 7 minutes, p ⫽ 0.004) times were longer with the radial route. Bleeding (9% vs 29% vs 32%, p ⫽ 0.05) and hematomas (6% vs 43% vs 39%) were less with radial compared with femoral puncture combined with Angioseal or Techstar closure devices. No particular route was preferred by patients. Conclusion: Although the femoral approach was faster and considered easier, there were fewer access-site related complications with radial approach. There was no difference in patient comfort with either approach.
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aim of this study was to assess whether the new iterations of suturemediated closure devices, the Closer and Closer S 6Fr (Perclose, Redwood City, CA), resulted in a lower rate of bleeding complications. Methods: Between April 2001 and April 2002, we prospectively gathered data on all patients (n ⫽ 358) in whom closure after coronary and peripheral diagnostic (DX) or interventional (IX) catheterization was attempted with the new devices (Closer, n ⫽ 171 and Closer S, n ⫽ 187). Glycoprotein (GP) IIb/IIIa inhibitors were used in 71 (57.7%) coronary interventional procedures. Exclusion criteria included common femoral artery (CFA) lumen diameter ⬍5 mm; puncture at site other than CFA; and heavy calcification at CFA. Patients were evaluated for incidence of major complications, defined as hematoma ⬎6 cm; infection requiring intravenous antibiotics; pseudoaneurysm; retroperitoneal bleed; surgical repair; transfusion. Antegrade approach was performed in 11 patients (5.8%) receiving the Closer S. Results: Device success (defined as the ability to achieve hemostasis with the device only) was obtained in 343 (95.8%) patients. All device failures resulted in manual compression without incident. Complications occurred in 3 (0.84%) patients and consisted of 2 hematomas and 1 pseudoaneurysm. No complications resulted from use of the Closer S device in the antegrade approach. No complications occurred as a result of GP IIb/IIIa usage or elevated ACT levels. (Table.) Procedural Type
DX (n ⴝ 125)
IX (n ⴝ 233)
Total (n ⴝ 358)
GP IIb/IIIa use (n) Incidence of major complications (n) Rate of complication (%)
0 0 0
71 3 1.29
71 3 0.84
Conclusion: The use of new-generation suture closure devices after coronary and peripheral diagnostic or intervention procedures is associated with an acceptably low rate of vascular access site bleeding complication. Reliable hemostasis can be achieved regardless of GP IIb/IIIa use. Further randomized evaluation is necessary to determine whether the devices result in a reduction in complication when compared with standard compression methods.
TCT-430 Radial Artery Occlusion After Transradial Artery Coronary Procedures: An Ultrasonographic Analysis. J. Monse´gu, B. Bertrand, P. Schiano, P. Duriez, J.P. Ollivier. Val-de-Graˆce Military Hospital, Paris, France.
Background: Vascular access site complications with the early-generation suturing devices have been reported to be as high as 24.7%. The
Background: The transradial approach for coronary angiography or angioplasty has been shown to be effective and useful in routine. The aim of the study was to evaluate prospectively the incidence of radial artery occlusion by ultrasonography. Methods: From January to May 2002 we screened prospectively patients undergoing a transradial coronary intervention (TCI). Emergent patients were excluded. A catheterization laboratory nurse, after training, performed ultrasonography of the radial artery before and after the procedure with a Hitachi EUB 565. Two-dimensional vascular images and pulsed Doppler studies were performed using a 7.5-MHz transducer, measuring the luminal diameter and the flow velocity. Procedure-related variables including sheath size, procedure time, number of catheters used, and postprocedural complications were noted to define factors predictive of thrombosis. Results: In all, 183 patients undergoing a TCI were studied; there was a majority of men (80.8%). Radial failure was noted in 5 cases. The mean age was 64 ⫾ 10.9 years. There were 32 patients with diabetes, and there was a previous radial approach in 22.6% and an outcome TCI in 29%. Coronary angiography was performed in 122 patients, angioplasty in 26 cases, and both were performed in 29 cases. A 5Fr stent was used in 142 cases and a 6Fr stent in 35 patients. Radial spasm was
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TCT-429 Use of a New Suture Closure Device Is Associated with a Low Rate of Bleeding Complication. T. Shimshak. The Christ Hospital, Cincinnati, Ohio, USA.
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very infrequent (6%), and after procedure only 1 radial artery was clinically occluded with a negative flow and another patient had no flow but a palpable pulse. There was no occurrence of major postprocedure bleeding. Ultrasonography results are summarized in the Table.
Luminal diameter (mm) Mean flow velocity upstream (cm/sec) Mean flow velocity downstream (cm/sec)
Preprocedural
Postprocedural
p Value
3.67 ⫾ 0.8 30 ⫾ 9.6
3.52 ⫾ 0.8 29.5 ⫾ 11.4
NS NS
30 ⫾ 9.6
31.3 ⫾ 11.7
NS
Conclusion: With ⬍1% radial occlusion, these results showed the safety of the radial approach in terms of artery patency. Nevertheless, we are waiting for the late results (2 months) to conclude definitively that the radial approach is a choice approach for routine coronary intervention.
TCT-431 Anatomic Consideration of the Radial Artery for Transradial Coronary Procedures: Arterial Diameter, Branching Anomaly, and Vessel Tortuosity. B.S. Yoo, J.Y. Ko, J.Y. Kim, S.H. Lee, S.O. Hwang, K.H. Choe, J.H. Yoon. Wonju College of Medicine, Yonsei University, Wonju, Korea. Background: The radial artery is currently regarded as a useful vascular access site for coronary procedures. We wanted to evaluate the size of radial artery, and the incidence and clinical significance of anomalous branching patterns and tortuosity of the radial artery. Methods: Retrograde radial artery angiography was performed before the transradial coronary procedure in 1,191 cases. The inner diameter of the radial artery was measured before and after the procedure using a 10.5-MHZ transducer (ULTRAMARK9; ATL Inc., Bothell, WA) in the usual manner. Branching anomaly and tortuosity of the radial artery, procedure times and local vascular complications were analyzed. Results: The diameter of radial artery was 2.66 ⫾ 0.44 mm by 2-dimensional analysis. There was significant difference between men (1.72 ⫾ 0.14 m2) and women (1.53 ⫾ 0.14 m2) in BSA and radial artery size (men, 2.69 ⫾ 0.40 mm; women, 2.43 ⫾ 0.38 mm; p ⬍0.001). There was no statistical difference between the diameter of left and right radial artery. Anomalous radial arterial branching was found in 3.2%, and the most common anomaly was the high origin of the radial artery (2.4%). Tortuosity of the radial artery was found in 4.2%. Crossover to other arteries, radial artery occlusion, and perforation occurred in 24, 6, and 4 cases, respectively. Prolonged procedure times, crossovers to other arteries and radial artery perforation were related with tortuosity of the radial artery, but not with anomalous branching. Conclusion: In almost all patients, the diameter of radial artery was large enough for 6Fr or 7 Fr guiding catheters. The incidences of branching anomalies and tortuosity of the radial artery were low in our study. Radial artery tortuosity was associated with old age, prolonged procedure time, and radial artery perforation.
TCT-432 Angiography for Venous and Left Mammary Grafts Is Done Reliably and Safely via Right Radial Artery in Patients with the Preoperative Angiography Performed via the Same Right Radial Artery. K.S. Cha, S.G. Kim, M.H. Kim, Y.D. Kim, J.S. Kim. DongA University Medical Center, Pusan, South Korea. Background: The radial artery is accessed for angiography in patients with bypass grafts. The left radial artery is preferred because the left
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mammary graft is cannulated easily. However, the increased use of radial artery as a free bypass graft is another issue. It would be prudent to avoid the left radial access in patients with the preoperative angiography done via the right radial artery. We assessed the hypothesis that angiography for venous and left mammary grafts would be done reliably and safely via right radial artery in patients with a severely tortuous right subclavian-innominate artery not shown on preoperative angiography performed via the same artery. Methods: After right transradial coronary angiography, graft angiography was performed with Amplatz catheters for venous grafts and with JL-3.5 or modified Simmons catheters for the left mammary graft in 86 consecutive patients with bypass surgery. An exclusion criterion was the presence of severely tortuous right subclavian-innominate artery at the preoperative angiography. Results: Thirteen patients (15%) were excluded. Graft angiography via the right radial artery was completed without crossover to another arterial access in 71 patients (97%). In all, 132 (90%) venous bypass grafts were cannulated selectively and 15 (10%) grafts were not found due to not having ring markers. Nine (82%) of 11 left mammary grafts were visualized well with the nonselective technique of JL-3.5 catheter, and 56 (97%) of 58 mammary grafts were cannulated with selective technique of modified Simmons catheters. There were no procedurerelated complications. Conclusion: Angiography for venous grafts and left mammary graft is done reliably and safely via the right radial artery in patients with a severely tortuous right subclavian-innominate artery not shown on the preoperative angiography performed via the same artery. This helps to reserve the left radial artery for a future graft when femoral access is difficult or impossible for angiography.
TCT-433 Transradial Approach with 4 French Catheters for Coronary Angiography: A Pilot Study. F. Zampetakis, P. Ohlmann, S. Hassani, C. Haffner, P. Attali, J.M. Mossard Hopital Universitaire de Strasbourg, Strasbourg, France. Background: The use of the transradial approach has increased in the last few years. The advantages of this technique are (1) better comfort for the patient, (2) few local complications, and (3) shorter hospital stay and lower hospitalization costs. One major inconvenience of the transradial approach is the possibility of radial thrombosis that occurs in 5% of cases, even when asymptomatic. The radial thrombosis is related to the diameter of the sheath. Because of the minimal sheath size of the 4Fr catheter, we assume that 4Fr catheters would decrease the risk of radial thrombosis Methods: In this prospective study, we evaluated the feasibility of the transradial approach with the 4Fr Cordis Infiniti catheters. From March to May 2002, 100 consecutive patients were included. Exclusion criteria were negative Allen test and terminal renal insufficiency. All patients were treated with enoxaparin before and 1 day after the procedure. They received an additional bolus of 100 IU/kg of heparin during the procedure. Results: The success rate of 4Fr selective coronary catheterization was 97%. We observed 1 crossover to femoral approach because of puncture failure, and 2 crossovers from 4Fr to 5Fr or 6Fr catheters. The catheters used were JL4, JL 3.5 (92%), and AL2 (18%) for the left main, JR 3.5, JR 4, and AL2 for right coronary ostium. Ad hoc percutaneous coronary intervention (PCI) was attempted in 22 patients using a sheathless 5Fr approach with success. The clinical radial thrombosis rate study was 3% at 1 month on the overall population (lost of the radial pulse). Conclusion: This preliminary study suggests that coronary angiography is possible with 4Fr catheters via a transradial approach. PCI with a sheathless 5Fr catheter is also possible without complications. The rate of radial thrombosis seems to be decreased by using 4Fr diagnostic
SEPTEMBER 24, 2002
TCT ABSTRACTS/Poster
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WEDNESDAY 9/25/02 9:00 –10:00 catheter or 5Fr sheathless guidance. A larger study is necessary to confirm these results.
TCT-434 Suture-Mediated Arteriotomy Closure Is Associated with a Low Rate of Major Vascular Complications in High-Risk Post–Percutaneous Coronary Intervention Patient Subsets. T. Kerwin, S. Nathan, F.Q. Almeda, R.J. Snell, C. J. Kavinsky, G.L. Schaer. Section of Cardiology, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois, USA.
P O S T E R A B S T R A C T S
Background: Decreased time to ambulation has been demonstrated with arteriotomy closure devices after femoral arterial access. However, several studies have found higher rates of major vascular sequelae compared with manual compression. Few data exist evaluating the impact of the current generation of 6Fr suture-mediated closure (SMC) devices on vascular and hemorrhagic complications after femoral arterial access in high-risk post–percutaneous coronary intervention (PCI) patients. Methods: Data from 829 consecutive patients undergoing PCI were gathered from prospectively collected ACC/AHA-compliant angiographic databases at our institution. The patients were divided into 2 groups based on use of manual compression or SMC with the use of the 6Fr Closer device. Patient characteristics analyzed included age, sex, body surface area (BSA), sheath size, and glycoprotein (GP) IIb/IIIa antagonist use. Patient records were queried for occurrence of major vascular and hemorrhagic complications, which included documented retroperitoneal bleeding, pseudoaneurysm formation, and hematoma formation necessitating blood transfusion. Anatomic suitability for arteriotomy closure was confirmed angiographically in all patients who underwent closure. Results: Of 829 consecutive interventional procedures, hemostasis was achieved by manual compression in 84.1% and with the use of SMC in 15.9%. There were no significant differences between the 2 groups with regards to age, sex, and BSA. An 8Fr sheath was used in 38.3% of the manual compression group and 5.4% of the SMC group (p⬍0.01). A GP IIb/IIIa inhibitor was used in 51% of the manual compression cases and 68% of the SMC cases (p⬍0.01). Major vascular complications occurred in 1.3% of the manual compression cases and 0.7% of the SMC cases (p ⫽ 0.33). Conclusion: We found a very low rate of major vascular complications in patients undergoing PCI when hemostasis was achieved by either manual compression or deployment of the Closer 6Fr SMC device. Our overall complication rate of 1.2% is lower than the general 2% to 5% complication rate reported in the literature. The data show that in patients undergoing PCI, with a high rate of GP IIb/IIIa inhibitor use, deployment of the 6Fr Closer device is associated with a low rate of major vascular complications.
TCT-435 Dialysis Patients Undergoing Percutaneous Coronary Interventions Are at Increased Risk for Vascular Complications. R. Hajj-Ali1, M. Salem1, C. Park1, R. Ezzeddine2, D. Marchant1, B. Kaplan1, S. Green1, S. Katz1, L. Ong1. 1North Shore University Hospital; 2University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
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State reporting system. The primary end point was defined as a vascular complication requiring surgery. Results: Of 63 dialysis patients, 4 (6.3%) had vascular complications compared with 34 (0.3%) of 11,217 patients not on dialysis (p ⬍0.001). This association persisted after adjusting for potential confounders using logistic regression analysis (p ⬍0.001; odds ratio, 19.6). Conclusion: Renal failure requiring dialysis is an independent risk factor for major vascular complications in patients undergoing PCIs.
TCT-436 Repeated Arteriotomy Repair Using Suture Mediated Closure After Transfemoral Diagnostic and Therapeutic Intervention. M. Razminia, J. Molnar, B. Kunjummen, M. Elbzour, A. Trivedi, R. Manda, M. Guerrero, V. Vidyarthi, A. Ahmed, D. Lubell, S. Khosla. Mount Sinai Hospital, Chicago Medical School, Chicago, Illinois, USA. Background: To evaluate the safety and efficacy of repeated femoral arteriotomy repair using suture mediated closure after diagnostic or therapeutic coronary or peripheral vascular intervention. Methods: Retrospective analysis of 312 consecutive patients undergoing arteriotomy repair using suture mediated closure device (Perclose; Abbot), performed by a single high-volume operator. Results: Thirteen-month data on 312 patients (men, n ⫽ 147 [47%]; mean age, 62 ⫾ 13 years) was evaluated retrospectively. Patients were divided into 6 groups based on the number of times the same femoral arteriotomy was repaired. Group 1, once; Group 2, twice; Group 3, 3 times, etc. (Table).
Patients (n) Acute success rate* (%) Vascular complication‡ (%) Infectious complication (%) Anticoagulated (%)
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
232 99.6†
53 99
21 100
4 94
1 100
1 100
0.4
1
0
6
0
0
None
1§
15
30
None
None
None
None
33
45
60
80
*Acute success rate defined as achievement of immediate homeostasis without vascular surgery, blood transfusion, or death. † One patient required vascular surgery because of a misdirected perclose needle after diagnostic coronary angiogram. ‡ Need for urgent surgery or ⬎15% drop in HCT. § This complication required surgical vascular repair due to local abscess. The time interval between 2 perclose placements was 300 days. The overall vascular complication rate was 0.9%. The average time between each procedure in patients undergoing multiple closures was 44 ⫾ 61 days (median, 16 days; range, 1–300 days). Patient demographics of the 6 groups were similar regarding age, sex, prevalence of peripheral vascular disease, and diabetes. Conclusion: The femoral arteriotomy site can be safely and effectively repaired multiple times using a suture mediated closure device when performed by an experienced operator, even in fully anticoagulated patients.
Background: Patients with renal failure commonly have calcified vessels. The purpose of this study was to investigate whether dialysis patients undergoing percutaneous coronary interventions (PCI) are at increased risk for vascular complications. Methods: Patients (N ⫽ 11,280) underwent PCI at our institution between January 1, 1997 and March 31, 2001. Information regarding complications was collected prospectively as part of the New York
Thrombin Injection for Treatment of Iatrogenic Pseudoaneurysms: A Multicenter Experience. H. Sievert1, O.
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TCT-437 (withdrawn) TCT-438
TCT ABSTRACTS/Poster
WEDNESDAY 9/25/02 9:00 –10:00
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Pusankov1, R. Jacksch2, M. Kotzerke3, J. Selbach5, J. Demharter8, T. Dorsel9, T. Sto¨ rk4, P. Meyer6, A. Fach1, W. Knobloch2, E. Ko¨ hler7, W. Pfeil1. 1Cardiovascular Center Bethanien, Frankfurt, Germany; 2 St. Vincenz-Krankenhaus, Essen, Germany; 3Hegau-Klinikum, Singen, Germany; 4Karl-Olga Krankenhaus, Stuttgart, Germany; 5 Caritas-Krankenhaus, Bad Mergentheim, Germany; 6Kreisklinik Mindelheim, Mindelheim, Germany; 7Klinikum Meiningen, Meiningen, Germany; 8Zentralklinikum Augsburg, Augsburg, Germany; 9Josef Hospital WAF, Warendorf, Germany. Background: Iatrogenic pseudoaneurysms of the femoral artery are among the major vascular complications occurring after catheter interventions. Thrombin injection into the aneurysm is an alternative to surgery or duplex-guided compression therapy. We evaluated safety and efficacy in a multicenter study. Methods: In 165 patients (mean age, 68 ⫾ 11 years), a pseudoaneurysm of the femoral artery diagnosed 1 to 63 days (median, 2 days) after puncture of the femoral artery was treated with local injection of thrombin solution (1:1000; Thrombin Topical USP; Gen Trac Inc. Middleton, USA). In 32 of 165 patients, a previous attempt with ultrasound-guided compression was unsuccessful. The mean maximum diameter of the aneurysm was 2.7 ⫾ 1.1 cm. Thrombin solution 0.1 mL to 4 mL (mean, 0.6 ⫾ 0.6 mL) was slowly injected into the aneurysm under ultrasound guidance. Follow-up duplex ultrasound examinations were performed until absorption of the aneurysm. Patients were ambulated after 12 to 24 hours. Results: In all patients, thrombin injection led to immediate thrombus formation within the aneurysm. In 2 patients a second and in 3 patients a third thrombin injection was necessary. Three patients later needed surgery for removal of the resulting hematoma. In 1 patient surgery for recurrent bleeding was performed (uneventful). No other complications occurred. Conclusion: Iatrogenic pseudoaneurysms of the femoral artery can be treated effectively by direct thrombin injection. In this multicenter registry the complication rate was low. This therapy has become the method of choice in our institutions.
TCT-439 Does the Use of Vascular Closure Devices Decrease Vascular Complications in the Current Era of Percutaneous Coronary Intervention? M.C. Kim, A.S. Kini, P.C. Lee, C.A. Mitre, S.N. Doshi, S. Mukallam, S.K. Sharma. Cardiac Catheterization Laboratory, The Zena and Michael A. Wiener Cardiovascular Institute, The Mount Sinai School of Medicine, New York, New York, USA. Background: The role of vascular closure devices (VCD) in the current era of percutaneous coronary intervention (PCI) is controversial. Although early ambulation and improved patient comfort can be expected with VCD, there have been conflicting reports on the incidence of vascular complications after PCI. We analyzed the incidence of vascular complications and the overall hospital length of stay in patients who received VCD in the current era of PCI versus manual compression. Methods: We retrospectively analyzed 5,548 consecutive patients who underwent PCI in the current era of stents and glycoprotein IIb/IIIa inhibitors for the incidence of vascular complications using the International Review Board–approved Mount Sinai Interventional Cardiology Database. Results: There were 1,120 patients (20% of total) who received a VCD (73% Closer-S [Perclose Inc., Redwood, CA], 21% Duett [Vascular Solutions, St. Paul, MN], 6% Vasoseal [Datascope Inc., Montvale, NJ]) and 4,428 patients had manual compression. Compared with manual compression patients, those receiving VCD were less likely to have a history of peripheral vascular disease (7.7% vs 10.2%,
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p ⫽ 0.01) and chronic renal insufficiency (4.1% vs 5.9%, p ⫽ 0.02); glycoprotein IIb/IIIa inhibitors (84.8% VCD group vs 83.1%) and stent use (67.2% vs 61.5%) were similar. Aspirin and clopidogrel were used as post-stent therapy. The incidence of major vascular complications (major TIMI bleeding, pseudoaneurysms, and vascular surgery) was significantly lower in the VCD group versus manual compression (0.9% vs 1.9%, p ⫽ 0.009). There was no significant difference in other vascular complications, including small (⬍5 cm) hematomas (5.2% vs 6.1%), moderate to large (⬎5 cm and retroperitoneal) hematomas (1.7% vs 2.2%), bleeding requiring transfusion (1.5% vs 1.3%), and minor TIMI bleeding (2.8% vs 1.8%). Hospital length of stay was lower in the VCD group versus manual compression (2.1 ⫾ 3.4 vs 2.7 ⫾ 4.9 days, p ⫽ 0.0002). Conclusion: In the current era of PCI, the use of the more recent generation of vascular closure devices results in a lower incidence of major vascular complications when compared with manual compression. Hospital length of stay is decreased in properly selected patients receiving VCD, suggesting that there may be a cost-effective role in PCI.
TCT-440 The Economic Advantages of Femoral Closure Device Use: A Randomized Comparison of Suture-Mediated Closure Versus Compression. R. Prashad, P. Urban. Ocala Regional Medical Center, Ocala, Florida, USA. Background: Clinical studies have demonstrated that arterial closure devices minimize the need for routine sheath pulls and manual compression, leading to a reduced acuity of care, length of stay, and greater patient satisfaction. While clinical and other benefits of suture-based closure have been reported, the economic advantages have not been studied. The purpose of this study was to assess resource utilization and direct hospital costs associated with use of the Perclose suture-mediated closure device (Abbott Vascular Devices, Redwood City, CA) as compared with standard compression after routine diagnostic cardiac catheterization procedures. Methods: Patients (N ⫽ 100) were randomized in a 1:1 ratio to receive manual compression or suture closure of the arteriotomy after diagnostic catheterization. A card was blindly pulled at the end of each procedure to determine the method of closure. Once the patient was transferred to a postcare recovery area, every postprocedure task done for each patient was timed and documented to capture the total number of minutes spent caring for the patient, the type of function performed, and any supplies used as a result of the method of closure, including use of a hospital bed in the specified care unit. Primary end points included time to hospital discharge, incidence of major complication, and all associated postprocedural costs. An activity-based cost accounting system will be used to assign costs associated with each task performed relative to patient care, and supplies used will be calculated based on national averages as determined by The Redbook. Results: Preliminary results indicate improved resource utilization, fewer minutes spent managing the vascular access site, and an overall reduction in length of stay. No incidence of major complications was reported in either group. Conclusion: Data analysis is being performed to quantify the dollar value of the outcomes and will be available in time for presentation at the TCT meeting.
TCT-441 Clinical Experience Using a Novel Bioadhesive for Femoral Arteriotomy Closure After Angiography or Percutaneous Vascular Intervention. R.J. Whitbourn1, P.J. Mossop1, E. Feldman2, M. Cincotta1. 1Department of Cardiology, St. Vincent’s
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WEDNESDAY 9/25/02 9:00 –10:00 Hospital, Melbourne, Australia; 2Evanston Hospital, Chicago, Illinois, USA. Background: Coronary or peripheral angiograms and catheter-based revascularizations leave an arteriotomy needing closure. Sealing of this puncture site routinely requires manual compression. This investigation tested safety and efficacy of the NeoMend arterial closure device and biogel in closing femoral arteriotomies after percutaneous coronary and vascular procedures. Methods: Participants aged 40 to 77 years had scheduled angiography using a 6Fr sheath. Written informed consent was given, and accepted protocols were followed, including heparin and clopidogrel for interventions. The NeoMend device allowed injection of a 2-part polyethyleneglycol/human albumen complex via a specialized catheter exchanged for the femoral sheath after angiography. Manual pressure was applied for 5-minute increments for in situ gelation of the bioadhesive until hemostasis. Results: Data are given as the number of cases or mean ⫾ SEM (range) (Table).
P O S T E R A B S T R A C T S
Parameter
Diagnostic Group
Interventional Group
Participants Activated clotting time (sec) Hemostasis ⬍5 min. Hemostasis ⬍10 min. Hemostasis 10–25 min. Time to device removal (min) Time to standing (min) Time to ambulation (min) Eligible for discharge ⬍4 hr Acute hematoma ⬃2 mL
11 men, 7 women 167 ⫾ 6
5 men 264 ⫾ 49
23 189 ⫾ 13
7 15 3 21 ⫾ 3 152 ⫾ 9 (n ⫽ 17) 230 ⫾ 10 (n ⫽ 17) 17 3
0 4 1 80 ⫾ 15
7 19 4 34 ⫾ 6
5 2
22 5
All
Times are from femoral incision. Time from device insertion to removal was 1.9 ⫾ 0.2 minutes. Seventeen diagnostic cases were able to stand after 3 hours, walk after 4 hours, and were eligible for discharge after ⬍4 hours. One required coronary graft surgery. Three arteriotomies re-bled some hours after initial hemostasis and were treated with manual compression. At 1-week follow-up, 8 femoral sites showed bruising and 7 showed a small lump. Two interventional patients returned to hospital, 1 with femoral site inflammation requiring antibiotics and debridement and 1 with myocardial infarction (unrelated). There were no other adverse events. Hematomas had resolved and femoral arterial flow was normal at the 45-day follow-up. Conclusion: Hemostasis was achieved in ⬍10 minutes for 83% of cases. The NeoMend arterial closure device provided safe, convenient, and time-effective hemostasis of femoral arteriotomies, facilitating prompt ambulation and hospital discharge.
TCT-442 New Concepts in Vascular Closure: An Endovascular Surgeon’s Perspective on Manual Compression May Not Be Benign. D. Allie, M. Lirtzman, C. Wyatt, A. Keller, M. Khan, M. Khan, P. Fail, G. Chaisson, C. Hebert, S. Ellis, C. Walker. Cardiovascular Institute of the South, Lafayette, Opelousas, and Houma, Louisiana, USA; Medical Center of Southwest Louisiana, Lafayette, Louisiana, USA; Terrebonne General Medical Center, Houma, Louisiana, USA.
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(MC) is the “gold standard,” but there are few data regarding a method of action, short- or long-term local femoral artery (FA) effects, or safety and timing of reentry. Methods: Between January 1999 and May 2002, 75 FA were exposed intraoperatively for endovascular abdominal aneurysm exclusion and FA repair. At 1 to 30 days preoperatively, 70 FA underwent closure of a 6Fr diagnostic angiography site. VCD including sutureand staple-mediated collagen plugs (CP), thrombotic patch (P), and MC were used. More than 3,000 intraoperative photos were analyzed. FA pathology included VCD failure, infection, pseudoaneurysm, thrombosis, groin and retroperitoneal hematoma, arteriovenous fistula, “high sticks,” and perivascular scar fibrosis. A PS score (PSS) was objectively assigned (mild ⫽ 1, moderate ⫽ 2, severe ⫽ 3) and time of surgery (TTS) was recorded. Results: Results are shown in the Table.
Variables Infection Pseudoaneurysm Hematoma Thrombosis Fistula VCDF PFS (Total) PFS (Mean) TTS (Days) TTS (Mean)
MC
Suture Closure
Staple Closure
CP
P
N ⫽ 20 0 1 2 0 1 N/A 55 2.75 1–30 12.4
N ⫽ 30 1 1 2 1 0 2 80 2.66 1–30 14.5
N⫽2 0 0 0 0 0 0 N/A N/A ⬍1 ⬍1
N⫽8 0 0 1 1 0 1 18 2.25 1–21 10.4
N ⫽ 10 0 0 1 0 0 0 25 2.5 1–30 14
With MC ⬍7 days, FA revealed significant intramural ecchymosis and hematoma and the actual “stick site” appeared unhealed and the FA wall weakened. Conclusion: Significant perivascular scarring and fibrosis occur with all modes of FA closure. MC is not benign, and questions arise regarding risks and timing of FA reentry. A search must continue for the ideal VCD.
TCT-443 A Randomized Trial Comparing the QuickSeal Femoral Arterial Closure Device with Manual Control After Diagnostic and Interventional Catheterization Procedures. J.S. Yadav1, D. Moliterno1, S.L. Almany2, F. Castaneda3, T.M. Shimshak4, T.P. Davis5, J.F. Benenati6, A. DeFranco7, B.D. Rutherford8, M.W. Mewissen9. 1Cleveland Clinic Foundation, Cleveland, Ohio, USA; 2 William Beaumont Hospital, Royal Oak, Michigan, USA; 3OSF St. Francis Medical Center, Peoria, Illinios, USA; 4Ohio Heart Health Center, Cincinnati, Ohio, USA; 5St. John Hospital and Medical Center, Detroit, Michigan, USA; 6Miami Cardiac and Vascular Institute, Baptist Hospital of Miami, Miami, Florida, USA; 7McLaren Regional Heart and Vascular Center-Flint, Michigan, USA; 8MidAmerica Heart Institute, St. Lukes Hospital, Kansas City, Missouri, USA; 9Wisconsin Heart and Vascular Clinic, St. Lukes Medical Center, Milwaukee, Wisconsin, USA.
Background: Femoral artery access complications (FAC) remain a significant source of morbidity and costs. “Major” and “minor” FAC are reported in 0.9% to 11.8% of cases yet no standardization exists. Vascular closure devices (VCD) have not decreased FAC, have significant limitations, and create a new subset of FAC. Manual compression
Background: The safety and efficacy of the QuickSeal femoral arterial closure device (SUB-Q Inc., San Clemente, CA) was compared with manual compression. Unlike closure devices currently available, QuickSeal delivers an extravascular, porcine gelatin sponge (nonbovine and noncollagen) directly over the guidewire to achieve hemostasis of vascular puncture sites 8Fr and smaller. Methods: A prospective, multicenter, randomized, controlled trial involving 398 patients was conducted. A 3:2 device-to-control ratio was used, with randomization stratified by type of procedure (diagnos-
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tic or interventional). Primary end points included time to hemostasis, time to ambulation, and rate of major complications. Sheaths were removed when activated clotting times (ACT) were ⱕ250 seconds when glycoprotein (GP) IIb/IIIa platelet inhibitors were administered, ⱕ300 seconds without GP IIb/IIIa platelet inhibitors, and ⱕ180 seconds for manual compression. Time to hemostasis and time to ambulation were measured from the time the final angiography image was taken. Results: The rate of major complications, including vascular repair, bleeding requiring transfusion/intervention, and infection requiring extended hospitalization/intravenous antibiotics, was similar between the device (1.3%) and control (0.6%) arms. One patient in each arm required a transfusion and 2 patients in the device arm experienced a pseudoaneurysm that was resolved with a thrombin injection. The mean time to hemostasis (18.5 minutes for device vs 131.6 minutes for control), time to ambulation (5.1 hours vs 9.6 hours), and time to hospital discharge (26.2 hours vs 36.3 hours) were significantly shorter for the QuickSeal device than for manual compression. Conclusion: In this randomized trial, QuickSeal was found to be safe and effective in closing femoral artery access sites. It reduced time to hemostasis, time to ambulation, and time to eligibility for hospital discharge in diagnostic and interventional procedures, and reduced time to actual hospital discharge in diagnostic procedures.
TCT-444 Use of the AngioSeal Collagen-Based Vascular Closure Device. H. Eggebrecht, U. Woertgen, C. Naber, A. Schmermund, T. Bartel, M. Haude, R. Erbel, D. Baumgart. Department of Cardiology, University Clinic Essen, Essen, Germany. Background: Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in consecutive patients undergoing cardiac catheterization or coronary angioplasty. Methods: In a prospective study, we systematically used a collagen-based vascular closure device (AngioSeal, St. Jude Medical) in 1,317 consecutive patients (995 men, 322 women; mean age, 61.2 years) for closure of the femoral access site immediately after diagnostic or interventional coronary procedures independent of the coagulation status. Patients were monitored for 24 hours after the procedure. Results: Patients undergoing coronary angioplasty (n ⫽ 644) received more heparin than patients with diagnostic cardiac catheterization (n ⫽ 673) (9,675 IU ⫾ 1,144 IU vs 6,419 IU ⫾ 2,211 IU, p ⬍0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic versus interventional procedures (95.8% vs 96.7%, p ⫽ 0.46). Complete hemostasis immediately after deployment of the device was achieved in ⬎90% of all patients, but was lower in the interventional group (93.7% vs 90.6%, p ⫽ 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients with no differences between diagnostic or interventional patients (0.62% vs 0.45%, p ⫽ 0.953). Subgroup analysis revealed female sex as a predictor of access site complications. Conclusion: Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.
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TCT-445 Incidence of Deep Venous Thrombosis in Low-Risk Patients Early After Diagnostic Cardiac Catheterization. D. Paniagua1, R. Carrillo-Jimenez2, R. Ciccia-McLean2, J.C. London˜ o2, F. LopezJimenez3, W.K. Vaughn1, J. J. Ferguson1, Z. Krajcer1, N. Strickman1, R.D. Fish1. 1St. Luke’s Episcopal Hospital/Texas Heart Institute and Baylor College of Medicine, Texas, USA; 2Mt. Sinai Medical Center, Miami Beach, Florida, USA; 3Mayo Clinic, Rochester, Minnesota, USA. Background: Deep venous thrombosis (DVT) has been observed after diagnostic cardiac catheterization (DCC) and associated groin compression procedures. We hypothesized that DVT can be found in low-risk patients after DCC. Methods: We prospectively studied 77 low-risk patients referred for DCC in 2 academic medical centers. Patients with a history of DVT/pulmonary embolism, hypercoagulable state, malignancy, major surgery within the previous 6 months, current anticoagulation, recent use of thrombolysis, and those undergoing coronary intervention were excluded. Lower-extremity venous B-mode and color Doppler ultrasound (US) studies were obtained in all participants before DCC and within 24 hours after DCC. Results: The mean age was 57 ⫾ 13 years (range, 20 –90 years). There were 39 men and 38 women. In this cohort, 49% were hypertensive, 16% had diabetes, 14% were smokers, and 55% used aspirin. Among women, 21% were on estrogen therapy. Indications for DCC were suspected coronary artery disease in 84% and other (valvular heart disease, cardiomyopathy, and post– heart transplant evaluation) in 16%. Left-heart DCC was performed in 69%, and both right and left heart DCC in 31%. Manual and clamp groin compression were performed in 35% and 65% of patients, respectively (no closure devices were used). At follow-up US, 4 patients (3 women) developed DVT (5% incidence) in the ipsilateral ileofemoral vein only (asymptomatic in all cases). The Fisher exact test revealed no significant association between the presence of DVT and female sex (p ⫽ 0.35), current smoking (p ⫽ 0.09), diabetes mellitus (p ⫽ 0.50), right and left heart DCC (p ⫽ 0.65), and manual or clamp compression (p ⫽ 0.43). Analysis of variance showed no relation between the presence of DVT and patient age (p ⫽ 0.95), arterial time (p ⫽ 0.06), and compression time (p ⫽ 0.56). Conclusion: DVT is an under-recognized complication of DCC in low-risk patients. We found a 5% incidence of DVT within 24 hours after DCC. There was a suggestive trend that smokers and those with longer arterial time were more prone to develop DVT. Larger analytical prospective studies with serial US assessments are needed to confirm its incidence and predictors.
TCT-446 Safety and Efficiency of the New AngioSeal STS Device. P.L. Schwimmbeck, M. Pauschinger, B. Bigalke, B. Witzenbichler, H.-P. Schultheiss. Department of Internal Medicine/Cardiology, University Hospital Benjamin Franklin, Free University, Berlin, Germany. Background: A new version of the AngioSeal vascular closure device has been developed that incorporates a self-tightening slipknot. This allows the procedure to be completed on the catheterization laboratory table. We compared the performance of the new device (STS) with the previous model (Millenium platform) in prospective study. Methods: We studied 52 consecutive patients who received arterial closure of the puncture site in the groin after diagnostic or interventional cardiac catherization using the new STS device and 57 consecutive patients who were treated with the Millenium platform device as a control. All patients received a predeployment fluoroscopy to deter-
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WEDNESDAY 9/25/02 9:00 –10:00 mine suitability for closure using the device. Activated clotting time (ACT) values for interventional patients were measured; for diagnostic cases, a fixed dose of 5,000 U heparin was used. Results: Patient characteristics are given in the Table.
Patients (n) Male/female Diagnostic/interventional Mean interventional ACT (sec) GP IIb/IIIa inhibitor use
STS
Millenium
52 34/18 37/15 331 7/15
57 44/13 42/15 367 0/15
GP ⫽ glycoprotein. Immediate hemostasis was achieved using the STS device with only insignificant oozing in a few cases. For the STS device, the mean time to hemostasis was 87 seconds. Almost half of our patients receiving the STS device were mobilized within 10 minutes (diagnostic) and 2 hours (interventional) compared with our routine for the Millenium platform device with 4 hours (diagnostic) and 6 hours (interventional). There were no complications in either group. One STS device was successfully implanted into a Gore-Tex graft in the groin. Conclusion: In our group of patients, we found the hemostatic performance of the new device to be superior to the previous one, regardless of ACT value or use of glycoprotein IIb/IIIa inhibitor therapy (abciximab, tirofiban). Completion of the arterial closure in the catheterization laboratory is a most useful feature of the new device, as patients do not need to be tracked for suture cutting. Mobilization times could be safely reduced with no instances of the subsequent bleeding.
TCT-447
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In Vivo Evaluation of the 6Fr Perclose Closer and the 6Fr AngioSeal Millenium Device in the Canine Model. T. Ohki, N. Gargiulo, H. Kurvers, C. Santizo, R. De Graaf, F. Veith. Montefiore Medical Center and Albert Einstein College of Medicine, New York, New York, USA. Background: Complications associated with hemostatic closure devices have been reported. However, the intra- and extravascular effects of these devices have not been well studied. Our objective was to assess the performance as well as the healing characteristics of 2 US Food and Drug Association–approved devices in canines. Methods: Twelve adult male dogs were anesthetized and intubated before percutaneous access of both femoral arteries with a 6Fr sheath. All dogs were systemically heparinized to an activated clotting time ⬎350 sec. Duplex sonography (DS) was performed preoperatively to measure vessel diameter and flow velocity. Each device was randomly deployed into 1 of the femoral arteries. DS was performed immediately post deployment and at 28 days to measure changes in vessel diameter and flow velocity. At 28 days, angiography and DS was performed on both femoral arteries before being harvested for histologic evaluation. Time required to dissect each vessel was recorded. Results: Nine of 12 dogs were alive at 42 days. Three dogs died of hemorrhagic shock secondary to AngioSeal (St. Jude Medical, St. Paul, MN) device failure. The Table outlines various end points and results.
Hemostasis time (min) Change in vessel diameter (flow velocity, cm/sec) Pre/post deployment Pre/28-day deployment Intimal hyperplasia (intima/media ratio) Extravascular scarring (dissection time, min)
Perclose
AngioSeal
0*
39 ⫾ 7*
21.2 ⫾ 4.7 0 0.4 ⫾ 0.2 5 ⫾ 1*
28.2 ⫾ 6.9 47.0 ⫾ 8.3 0.5 ⫾ 0.3 20 ⫾ 3*
*p ⬍0.05.
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Conclusion: Use of the AngioSeal collagen plug closure device results in a prolonged hemostasis time. In addition, because of the use of an intra- and extravascular foreign body, Angioseal resulted in a tendency toward vessel narrowing as well as increased periadventitial inflammation resulting in a prolonged dissection time. Suture closure of the arteriotomy with the Perclose closure device (Abbott Vascular, Redwood City, CA) results in immediate hemostasis and minimal intraand extravascular reaction.
TCT-448 Reduced Vascular Complications After Percutaneous Coronary Interventions with a Nonmechanical Suture Device: Results from the Randomized Rapid Ambulation After Closure (RACE) Study. T.A. Sanborn1, J.D. Ogilby2, J. Ritter3, G.W. Stone4, B. Klugherz5, R. Fields6, C. White7, J. McGarvey8, D.L. Morris9, R. Wilensky10. 1Evanston Northwestern Healthcare, Chicago, Illinois, USA; 2Thomas Jefferson University, Philadelphia, Pennsylvania, USA; 3Christiana Care Health Services; 4Lenox Hill Hospital, New York, New York, USA; 5Abington Memorial Hospital; 6St. Mary Medical Center; 7Ochsner Clinic; 8Doylestown Hospital; 9Leigh Valley Hospital; 10Hospital University of Pennsylvania, Philadelphia, Pennsylvania, USA. Background: Current percutaneous vascular suture devices remain mechanically complex and expensive. We sought to evaluate the safety of a new nonmechanical percutaneous suture device, X-PRESS, after diagonistic catheterization and percutaneous coronary intervention (PCI) in the setting of glycoprotein (GP) IIb/IIIa use. Methods: A total of 392 patients undergoing diagnostic catheterization (n ⫽ 132) or PCI (n ⫽ 260) were randomized (2:1 ratio, device vs compression) in the multicenter, prospective RACE (Rapid Ambulation After Closure) study. GP IIb/IIIa inhibitors were used in 55% of PCI. The primary safety end point was the incidence of major vascular complications (surgical repair, transfusion, ultrasound-guided compression, infection requiring intravenous antibiotics). Results: Preliminary analysis indicates no significant difference in the overall incidence of major vascular complications between compression (n ⫽ 3, 2.3%) and device (n ⫽ 1, 0.4%) groups (p ⫽ 0.49). However, in the PCI subset, there was a significant reduction in the incidence of major vascular complications with the X-PRESS device (0 of 173; 0%) versus compression (3 of 87; 3.4%) (p ⫽ 0.037). Conclusion: A novel nonmechanical suture device was found to have fewer major vascular complications than compression after PCI with a high level of GP IIb/IIIa usage. Adjudicated results as well as primary efficacy results will be available for presentation.
TCT-449 Outpatient, Elective, Transradial Coronary Interventions Are Safe, Feasible, and Potentially Cost Saving. S.R. Mulukutla, H.A. Cohen. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. Background: Few studies have examined the feasibility of outpatient percutaneous coronary interventions (PCIs). Overnight observation is still standard after uncomplicated, elective PCI. In the United States, ⬎750,000 PCI are performed annually, the majority of which are performed via transfemoral access. Transradial PCI is an underutilized technique that has the benefits of lower morbidity and increased patient comfort when compared with the transfemoral technique. This retrospective study examines the feasibility of elective transradial interventions and examines the potential cost savings of outpatient PCI. Methods: A retrospective analysis was performed on 100 consecutive outpatients who had elective, uncomplicated, transradial coronary interventions and were admitted for routine observation. Patients with
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acute coronary syndrome, suboptimal results, and those receiving glycoprotein IIb/IIIa inhibitors were excluded from consideration. Of the 750,000 PCIs performed annually, ⱖ375,000 patients are outpatients. At least 75% of these patients may be eligible for transradial access, and of those 70% may be eligible for outpatient procedures. A monitored hospital bed is estimated to cost $1,400 per day. Results: A total of 105 vessels were intervened upon in the 100 patients. The average stenosis before PCI was 86%, and all lesions had 0% residual stenosis after PCI. All patients received clopidogrel. All patients were allowed to ambulate immediately post procedure. There were no major or minor complications associated with the procedure or access site. In all, 88 patients were discharged within 24 hours. Longer hospitalizations in the remaining 12 patients were unrelated to their procedure. Using conservative estimates, an outpatient strategy with transradial PCI could result in a cost-savings of $275 million to the US healthcare system. Conclusion: This analysis suggests that outpatient stenting is feasible, safe, and cost saving. With lower morbidity and increased comfort, the transradial approach is an attractive option for an outpatient stenting trial. Given the increasing cost of technology as it relates to PCI, new cost-saving strategies are crucial. This study suggests that an outpatient trial of transradial percutaneous coronary interventions is warranted.
TCT-450 Transradial Coronary Angioplasty in Acute Coronary Syndromes. Z. Ruzsa, I. Ungi, L. Rudas, A. Thury, R. Sepp, T. Horva´ th, Zs. Zimmermann, M. Csana´ dy. University of Szeged, Department of Cardiology, Szeged, Hungary. Background: Transradial (TR) access has been getting more and more popular for percutaneous coronary intervention (PCI) because of the patient’s comfort and the low complication rate. However, its suitability for emergency cases has been questioned in the literature. This study was performed to compare the outcome and complication rate after TR and transfemoral (TF) PCI for acute coronary syndromes (ACS) in a
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1-year patient population. TR angioplasty has been performed since 1999 in our department, and after the initial learning curve we started the TR access in ACS as well. Methods: The clinical and angiographic database of ACS treated by PCI in 2001 was reviewed and evaluated. All of the patients with ACS (n ⫽ 293) were assigned to TR (n ⫽ 69) or TF (n ⫽ 224) groups. Several parameters were applied to evaluate the potential advantages or drawbacks of TR access: (1) rate of access site complications, (2) outcome of PCI by BENESTENT criteria, (3) x-ray area dose, (4) fluoroscopy time, (5) consumption of angioplasty equipment, and (6) length of hospital stay. Selection of the access site was made by the operator’s preference. The need for intra-aortic balloon pump (IABP) was the only exclusion criterion for TR access; therefore, we excluded the IABP cases from the TF group, as well. The Student t test and z test were used for statistical analysis. Results: The TR and TF approaches were successful in all cases. The consumption of guiding catheters (1.2 per procedure) and balloon catheters (0.8 per procedure) proved to be the same for the 2 groups. Good angiographic results were reached in 62 patients in the TR group (90%) and 204 patients (91%) in the TF group by BENESTENT criteria. The mean x-ray dose was 11,429 cGy/cm2 in the TR and 11,549 cGy/cm2 in the TF groups (p ⫽ 0.018). The mean fluoroscopy time was 14.3 minutes in the TR group and 14.4 minutes in the TF group (p ⫽ 0.100). Major entry site complications were encountered in 7 patients (3.13%) in the transfemoral group. There was no major entry site complication in the transradial group. The 1-month major adverse coronary events rate was found to be 5% in the TF group and 1.6% in the TR group (p ⫽ 0.248). The hospital stay was 3.77 days after TR interventions and 3.79 days after TF interventions (p ⫽ 0.38). We used glycoprotein IIb/IIIa receptor blocking agents in 18 patients (26%) after TR interventions and in 89 patients (39%) after TF interventions (p ⫽ 0.068). Conclusion: Our results suggest that TR access is safe and effective for the treatment of ACS without the need of excess use of radiation or equipment. The lack of site-related complications in the TR group is extremely important in the ACS patient subset.
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TCT-428 Randomized Comparison of Transradial Coronary Intervention with Transfemoral Access Combined with Arteriotomy Closure Devices: the EMPIRE Study. S.K. Chugh, N. Solankhi, J.G. Webb, C.E.H. Buller, L. Bussoli, M. Wilson, A. Dodek, R.G. Carere. Interventional Cardiology, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
P O S T E R A B S T R A C T S
Background: To enable rapid mobilization and promote patient comfort, both transradial catheterization and transfemoral catheterization with arterial closure have been advocated. Early generation arteriotomy closure devices (ACDs) had higher complications compared with manual compression but enable rapid mobilization. Transradial interventions have few complications but are technically more difficult to perform. There are few data comparing radial access with ACDs and no randomized study assesses patient preference. The objective of this study was to prospectively evaluate procedural success, technical difficulties, and complications as well as patient comfort. Methods: Patients considered suitable for same-day discharge were randomized to the radial or femoral approach. The latter were then randomized to Techstar (suture based) vs AngioSeal (collagen based) closure device. Access site complications, ease of procedure, and guide catheter performance and patient comfort were assessed. Follow-up was performed at 2 to 4 days. Results: Arterial access was easier and guide catheter performance better with femoral access, though overall procedure success was similar. Procedure (44 ⫾ 21 minutes vs 42 ⫾ 20 minutes, p ⫽ 0.004) and fluoroscopy (16 ⫾ 12 vs 10 ⫾ 7 minutes, p ⫽ 0.004) times were longer with the radial route. Bleeding (9% vs 29% vs 32%, p ⫽ 0.05) and hematomas (6% vs 43% vs 39%) were less with radial compared with femoral puncture combined with Angioseal or Techstar closure devices. No particular route was preferred by patients. Conclusion: Although the femoral approach was faster and considered easier, there were fewer access-site related complications with radial approach. There was no difference in patient comfort with either approach.
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aim of this study was to assess whether the new iterations of suturemediated closure devices, the Closer and Closer S 6Fr (Perclose, Redwood City, CA), resulted in a lower rate of bleeding complications. Methods: Between April 2001 and April 2002, we prospectively gathered data on all patients (n ⫽ 358) in whom closure after coronary and peripheral diagnostic (DX) or interventional (IX) catheterization was attempted with the new devices (Closer, n ⫽ 171 and Closer S, n ⫽ 187). Glycoprotein (GP) IIb/IIIa inhibitors were used in 71 (57.7%) coronary interventional procedures. Exclusion criteria included common femoral artery (CFA) lumen diameter ⬍5 mm; puncture at site other than CFA; and heavy calcification at CFA. Patients were evaluated for incidence of major complications, defined as hematoma ⬎6 cm; infection requiring intravenous antibiotics; pseudoaneurysm; retroperitoneal bleed; surgical repair; transfusion. Antegrade approach was performed in 11 patients (5.8%) receiving the Closer S. Results: Device success (defined as the ability to achieve hemostasis with the device only) was obtained in 343 (95.8%) patients. All device failures resulted in manual compression without incident. Complications occurred in 3 (0.84%) patients and consisted of 2 hematomas and 1 pseudoaneurysm. No complications resulted from use of the Closer S device in the antegrade approach. No complications occurred as a result of GP IIb/IIIa usage or elevated ACT levels. (Table.) Procedural Type
DX (n ⴝ 125)
IX (n ⴝ 233)
Total (n ⴝ 358)
GP IIb/IIIa use (n) Incidence of major complications (n) Rate of complication (%)
0 0 0
71 3 1.29
71 3 0.84
Conclusion: The use of new-generation suture closure devices after coronary and peripheral diagnostic or intervention procedures is associated with an acceptably low rate of vascular access site bleeding complication. Reliable hemostasis can be achieved regardless of GP IIb/IIIa use. Further randomized evaluation is necessary to determine whether the devices result in a reduction in complication when compared with standard compression methods.
TCT-430 Radial Artery Occlusion After Transradial Artery Coronary Procedures: An Ultrasonographic Analysis. J. Monse´gu, B. Bertrand, P. Schiano, P. Duriez, J.P. Ollivier. Val-de-Graˆce Military Hospital, Paris, France.
Background: Vascular access site complications with the early-generation suturing devices have been reported to be as high as 24.7%. The
Background: The transradial approach for coronary angiography or angioplasty has been shown to be effective and useful in routine. The aim of the study was to evaluate prospectively the incidence of radial artery occlusion by ultrasonography. Methods: From January to May 2002 we screened prospectively patients undergoing a transradial coronary intervention (TCI). Emergent patients were excluded. A catheterization laboratory nurse, after training, performed ultrasonography of the radial artery before and after the procedure with a Hitachi EUB 565. Two-dimensional vascular images and pulsed Doppler studies were performed using a 7.5-MHz transducer, measuring the luminal diameter and the flow velocity. Procedure-related variables including sheath size, procedure time, number of catheters used, and postprocedural complications were noted to define factors predictive of thrombosis. Results: In all, 183 patients undergoing a TCI were studied; there was a majority of men (80.8%). Radial failure was noted in 5 cases. The mean age was 64 ⫾ 10.9 years. There were 32 patients with diabetes, and there was a previous radial approach in 22.6% and an outcome TCI in 29%. Coronary angiography was performed in 122 patients, angioplasty in 26 cases, and both were performed in 29 cases. A 5Fr stent was used in 142 cases and a 6Fr stent in 35 patients. Radial spasm was
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TCT-429 Use of a New Suture Closure Device Is Associated with a Low Rate of Bleeding Complication. T. Shimshak. The Christ Hospital, Cincinnati, Ohio, USA.
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very infrequent (6%), and after procedure only 1 radial artery was clinically occluded with a negative flow and another patient had no flow but a palpable pulse. There was no occurrence of major postprocedure bleeding. Ultrasonography results are summarized in the Table.
Luminal diameter (mm) Mean flow velocity upstream (cm/sec) Mean flow velocity downstream (cm/sec)
Preprocedural
Postprocedural
p Value
3.67 ⫾ 0.8 30 ⫾ 9.6
3.52 ⫾ 0.8 29.5 ⫾ 11.4
NS NS
30 ⫾ 9.6
31.3 ⫾ 11.7
NS
Conclusion: With ⬍1% radial occlusion, these results showed the safety of the radial approach in terms of artery patency. Nevertheless, we are waiting for the late results (2 months) to conclude definitively that the radial approach is a choice approach for routine coronary intervention.
TCT-431 Anatomic Consideration of the Radial Artery for Transradial Coronary Procedures: Arterial Diameter, Branching Anomaly, and Vessel Tortuosity. B.S. Yoo, J.Y. Ko, J.Y. Kim, S.H. Lee, S.O. Hwang, K.H. Choe, J.H. Yoon. Wonju College of Medicine, Yonsei University, Wonju, Korea. Background: The radial artery is currently regarded as a useful vascular access site for coronary procedures. We wanted to evaluate the size of radial artery, and the incidence and clinical significance of anomalous branching patterns and tortuosity of the radial artery. Methods: Retrograde radial artery angiography was performed before the transradial coronary procedure in 1,191 cases. The inner diameter of the radial artery was measured before and after the procedure using a 10.5-MHZ transducer (ULTRAMARK9; ATL Inc., Bothell, WA) in the usual manner. Branching anomaly and tortuosity of the radial artery, procedure times and local vascular complications were analyzed. Results: The diameter of radial artery was 2.66 ⫾ 0.44 mm by 2-dimensional analysis. There was significant difference between men (1.72 ⫾ 0.14 m2) and women (1.53 ⫾ 0.14 m2) in BSA and radial artery size (men, 2.69 ⫾ 0.40 mm; women, 2.43 ⫾ 0.38 mm; p ⬍0.001). There was no statistical difference between the diameter of left and right radial artery. Anomalous radial arterial branching was found in 3.2%, and the most common anomaly was the high origin of the radial artery (2.4%). Tortuosity of the radial artery was found in 4.2%. Crossover to other arteries, radial artery occlusion, and perforation occurred in 24, 6, and 4 cases, respectively. Prolonged procedure times, crossovers to other arteries and radial artery perforation were related with tortuosity of the radial artery, but not with anomalous branching. Conclusion: In almost all patients, the diameter of radial artery was large enough for 6Fr or 7 Fr guiding catheters. The incidences of branching anomalies and tortuosity of the radial artery were low in our study. Radial artery tortuosity was associated with old age, prolonged procedure time, and radial artery perforation.
TCT-432 Angiography for Venous and Left Mammary Grafts Is Done Reliably and Safely via Right Radial Artery in Patients with the Preoperative Angiography Performed via the Same Right Radial Artery. K.S. Cha, S.G. Kim, M.H. Kim, Y.D. Kim, J.S. Kim. DongA University Medical Center, Pusan, South Korea. Background: The radial artery is accessed for angiography in patients with bypass grafts. The left radial artery is preferred because the left
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mammary graft is cannulated easily. However, the increased use of radial artery as a free bypass graft is another issue. It would be prudent to avoid the left radial access in patients with the preoperative angiography done via the right radial artery. We assessed the hypothesis that angiography for venous and left mammary grafts would be done reliably and safely via right radial artery in patients with a severely tortuous right subclavian-innominate artery not shown on preoperative angiography performed via the same artery. Methods: After right transradial coronary angiography, graft angiography was performed with Amplatz catheters for venous grafts and with JL-3.5 or modified Simmons catheters for the left mammary graft in 86 consecutive patients with bypass surgery. An exclusion criterion was the presence of severely tortuous right subclavian-innominate artery at the preoperative angiography. Results: Thirteen patients (15%) were excluded. Graft angiography via the right radial artery was completed without crossover to another arterial access in 71 patients (97%). In all, 132 (90%) venous bypass grafts were cannulated selectively and 15 (10%) grafts were not found due to not having ring markers. Nine (82%) of 11 left mammary grafts were visualized well with the nonselective technique of JL-3.5 catheter, and 56 (97%) of 58 mammary grafts were cannulated with selective technique of modified Simmons catheters. There were no procedurerelated complications. Conclusion: Angiography for venous grafts and left mammary graft is done reliably and safely via the right radial artery in patients with a severely tortuous right subclavian-innominate artery not shown on the preoperative angiography performed via the same artery. This helps to reserve the left radial artery for a future graft when femoral access is difficult or impossible for angiography.
TCT-433 Transradial Approach with 4 French Catheters for Coronary Angiography: A Pilot Study. F. Zampetakis, P. Ohlmann, S. Hassani, C. Haffner, P. Attali, J.M. Mossard Hopital Universitaire de Strasbourg, Strasbourg, France. Background: The use of the transradial approach has increased in the last few years. The advantages of this technique are (1) better comfort for the patient, (2) few local complications, and (3) shorter hospital stay and lower hospitalization costs. One major inconvenience of the transradial approach is the possibility of radial thrombosis that occurs in 5% of cases, even when asymptomatic. The radial thrombosis is related to the diameter of the sheath. Because of the minimal sheath size of the 4Fr catheter, we assume that 4Fr catheters would decrease the risk of radial thrombosis Methods: In this prospective study, we evaluated the feasibility of the transradial approach with the 4Fr Cordis Infiniti catheters. From March to May 2002, 100 consecutive patients were included. Exclusion criteria were negative Allen test and terminal renal insufficiency. All patients were treated with enoxaparin before and 1 day after the procedure. They received an additional bolus of 100 IU/kg of heparin during the procedure. Results: The success rate of 4Fr selective coronary catheterization was 97%. We observed 1 crossover to femoral approach because of puncture failure, and 2 crossovers from 4Fr to 5Fr or 6Fr catheters. The catheters used were JL4, JL 3.5 (92%), and AL2 (18%) for the left main, JR 3.5, JR 4, and AL2 for right coronary ostium. Ad hoc percutaneous coronary intervention (PCI) was attempted in 22 patients using a sheathless 5Fr approach with success. The clinical radial thrombosis rate study was 3% at 1 month on the overall population (lost of the radial pulse). Conclusion: This preliminary study suggests that coronary angiography is possible with 4Fr catheters via a transradial approach. PCI with a sheathless 5Fr catheter is also possible without complications. The rate of radial thrombosis seems to be decreased by using 4Fr diagnostic
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WEDNESDAY 9/25/02 9:00 –10:00 catheter or 5Fr sheathless guidance. A larger study is necessary to confirm these results.
TCT-434 Suture-Mediated Arteriotomy Closure Is Associated with a Low Rate of Major Vascular Complications in High-Risk Post–Percutaneous Coronary Intervention Patient Subsets. T. Kerwin, S. Nathan, F.Q. Almeda, R.J. Snell, C. J. Kavinsky, G.L. Schaer. Section of Cardiology, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois, USA.
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Background: Decreased time to ambulation has been demonstrated with arteriotomy closure devices after femoral arterial access. However, several studies have found higher rates of major vascular sequelae compared with manual compression. Few data exist evaluating the impact of the current generation of 6Fr suture-mediated closure (SMC) devices on vascular and hemorrhagic complications after femoral arterial access in high-risk post–percutaneous coronary intervention (PCI) patients. Methods: Data from 829 consecutive patients undergoing PCI were gathered from prospectively collected ACC/AHA-compliant angiographic databases at our institution. The patients were divided into 2 groups based on use of manual compression or SMC with the use of the 6Fr Closer device. Patient characteristics analyzed included age, sex, body surface area (BSA), sheath size, and glycoprotein (GP) IIb/IIIa antagonist use. Patient records were queried for occurrence of major vascular and hemorrhagic complications, which included documented retroperitoneal bleeding, pseudoaneurysm formation, and hematoma formation necessitating blood transfusion. Anatomic suitability for arteriotomy closure was confirmed angiographically in all patients who underwent closure. Results: Of 829 consecutive interventional procedures, hemostasis was achieved by manual compression in 84.1% and with the use of SMC in 15.9%. There were no significant differences between the 2 groups with regards to age, sex, and BSA. An 8Fr sheath was used in 38.3% of the manual compression group and 5.4% of the SMC group (p⬍0.01). A GP IIb/IIIa inhibitor was used in 51% of the manual compression cases and 68% of the SMC cases (p⬍0.01). Major vascular complications occurred in 1.3% of the manual compression cases and 0.7% of the SMC cases (p ⫽ 0.33). Conclusion: We found a very low rate of major vascular complications in patients undergoing PCI when hemostasis was achieved by either manual compression or deployment of the Closer 6Fr SMC device. Our overall complication rate of 1.2% is lower than the general 2% to 5% complication rate reported in the literature. The data show that in patients undergoing PCI, with a high rate of GP IIb/IIIa inhibitor use, deployment of the 6Fr Closer device is associated with a low rate of major vascular complications.
TCT-435 Dialysis Patients Undergoing Percutaneous Coronary Interventions Are at Increased Risk for Vascular Complications. R. Hajj-Ali1, M. Salem1, C. Park1, R. Ezzeddine2, D. Marchant1, B. Kaplan1, S. Green1, S. Katz1, L. Ong1. 1North Shore University Hospital; 2University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
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State reporting system. The primary end point was defined as a vascular complication requiring surgery. Results: Of 63 dialysis patients, 4 (6.3%) had vascular complications compared with 34 (0.3%) of 11,217 patients not on dialysis (p ⬍0.001). This association persisted after adjusting for potential confounders using logistic regression analysis (p ⬍0.001; odds ratio, 19.6). Conclusion: Renal failure requiring dialysis is an independent risk factor for major vascular complications in patients undergoing PCIs.
TCT-436 Repeated Arteriotomy Repair Using Suture Mediated Closure After Transfemoral Diagnostic and Therapeutic Intervention. M. Razminia, J. Molnar, B. Kunjummen, M. Elbzour, A. Trivedi, R. Manda, M. Guerrero, V. Vidyarthi, A. Ahmed, D. Lubell, S. Khosla. Mount Sinai Hospital, Chicago Medical School, Chicago, Illinois, USA. Background: To evaluate the safety and efficacy of repeated femoral arteriotomy repair using suture mediated closure after diagnostic or therapeutic coronary or peripheral vascular intervention. Methods: Retrospective analysis of 312 consecutive patients undergoing arteriotomy repair using suture mediated closure device (Perclose; Abbot), performed by a single high-volume operator. Results: Thirteen-month data on 312 patients (men, n ⫽ 147 [47%]; mean age, 62 ⫾ 13 years) was evaluated retrospectively. Patients were divided into 6 groups based on the number of times the same femoral arteriotomy was repaired. Group 1, once; Group 2, twice; Group 3, 3 times, etc. (Table).
Patients (n) Acute success rate* (%) Vascular complication‡ (%) Infectious complication (%) Anticoagulated (%)
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
232 99.6†
53 99
21 100
4 94
1 100
1 100
0.4
1
0
6
0
0
None
1§
15
30
None
None
None
None
33
45
60
80
*Acute success rate defined as achievement of immediate homeostasis without vascular surgery, blood transfusion, or death. † One patient required vascular surgery because of a misdirected perclose needle after diagnostic coronary angiogram. ‡ Need for urgent surgery or ⬎15% drop in HCT. § This complication required surgical vascular repair due to local abscess. The time interval between 2 perclose placements was 300 days. The overall vascular complication rate was 0.9%. The average time between each procedure in patients undergoing multiple closures was 44 ⫾ 61 days (median, 16 days; range, 1–300 days). Patient demographics of the 6 groups were similar regarding age, sex, prevalence of peripheral vascular disease, and diabetes. Conclusion: The femoral arteriotomy site can be safely and effectively repaired multiple times using a suture mediated closure device when performed by an experienced operator, even in fully anticoagulated patients.
Background: Patients with renal failure commonly have calcified vessels. The purpose of this study was to investigate whether dialysis patients undergoing percutaneous coronary interventions (PCI) are at increased risk for vascular complications. Methods: Patients (N ⫽ 11,280) underwent PCI at our institution between January 1, 1997 and March 31, 2001. Information regarding complications was collected prospectively as part of the New York
Thrombin Injection for Treatment of Iatrogenic Pseudoaneurysms: A Multicenter Experience. H. Sievert1, O.
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Pusankov1, R. Jacksch2, M. Kotzerke3, J. Selbach5, J. Demharter8, T. Dorsel9, T. Sto¨ rk4, P. Meyer6, A. Fach1, W. Knobloch2, E. Ko¨ hler7, W. Pfeil1. 1Cardiovascular Center Bethanien, Frankfurt, Germany; 2 St. Vincenz-Krankenhaus, Essen, Germany; 3Hegau-Klinikum, Singen, Germany; 4Karl-Olga Krankenhaus, Stuttgart, Germany; 5 Caritas-Krankenhaus, Bad Mergentheim, Germany; 6Kreisklinik Mindelheim, Mindelheim, Germany; 7Klinikum Meiningen, Meiningen, Germany; 8Zentralklinikum Augsburg, Augsburg, Germany; 9Josef Hospital WAF, Warendorf, Germany. Background: Iatrogenic pseudoaneurysms of the femoral artery are among the major vascular complications occurring after catheter interventions. Thrombin injection into the aneurysm is an alternative to surgery or duplex-guided compression therapy. We evaluated safety and efficacy in a multicenter study. Methods: In 165 patients (mean age, 68 ⫾ 11 years), a pseudoaneurysm of the femoral artery diagnosed 1 to 63 days (median, 2 days) after puncture of the femoral artery was treated with local injection of thrombin solution (1:1000; Thrombin Topical USP; Gen Trac Inc. Middleton, USA). In 32 of 165 patients, a previous attempt with ultrasound-guided compression was unsuccessful. The mean maximum diameter of the aneurysm was 2.7 ⫾ 1.1 cm. Thrombin solution 0.1 mL to 4 mL (mean, 0.6 ⫾ 0.6 mL) was slowly injected into the aneurysm under ultrasound guidance. Follow-up duplex ultrasound examinations were performed until absorption of the aneurysm. Patients were ambulated after 12 to 24 hours. Results: In all patients, thrombin injection led to immediate thrombus formation within the aneurysm. In 2 patients a second and in 3 patients a third thrombin injection was necessary. Three patients later needed surgery for removal of the resulting hematoma. In 1 patient surgery for recurrent bleeding was performed (uneventful). No other complications occurred. Conclusion: Iatrogenic pseudoaneurysms of the femoral artery can be treated effectively by direct thrombin injection. In this multicenter registry the complication rate was low. This therapy has become the method of choice in our institutions.
TCT-439 Does the Use of Vascular Closure Devices Decrease Vascular Complications in the Current Era of Percutaneous Coronary Intervention? M.C. Kim, A.S. Kini, P.C. Lee, C.A. Mitre, S.N. Doshi, S. Mukallam, S.K. Sharma. Cardiac Catheterization Laboratory, The Zena and Michael A. Wiener Cardiovascular Institute, The Mount Sinai School of Medicine, New York, New York, USA. Background: The role of vascular closure devices (VCD) in the current era of percutaneous coronary intervention (PCI) is controversial. Although early ambulation and improved patient comfort can be expected with VCD, there have been conflicting reports on the incidence of vascular complications after PCI. We analyzed the incidence of vascular complications and the overall hospital length of stay in patients who received VCD in the current era of PCI versus manual compression. Methods: We retrospectively analyzed 5,548 consecutive patients who underwent PCI in the current era of stents and glycoprotein IIb/IIIa inhibitors for the incidence of vascular complications using the International Review Board–approved Mount Sinai Interventional Cardiology Database. Results: There were 1,120 patients (20% of total) who received a VCD (73% Closer-S [Perclose Inc., Redwood, CA], 21% Duett [Vascular Solutions, St. Paul, MN], 6% Vasoseal [Datascope Inc., Montvale, NJ]) and 4,428 patients had manual compression. Compared with manual compression patients, those receiving VCD were less likely to have a history of peripheral vascular disease (7.7% vs 10.2%,
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p ⫽ 0.01) and chronic renal insufficiency (4.1% vs 5.9%, p ⫽ 0.02); glycoprotein IIb/IIIa inhibitors (84.8% VCD group vs 83.1%) and stent use (67.2% vs 61.5%) were similar. Aspirin and clopidogrel were used as post-stent therapy. The incidence of major vascular complications (major TIMI bleeding, pseudoaneurysms, and vascular surgery) was significantly lower in the VCD group versus manual compression (0.9% vs 1.9%, p ⫽ 0.009). There was no significant difference in other vascular complications, including small (⬍5 cm) hematomas (5.2% vs 6.1%), moderate to large (⬎5 cm and retroperitoneal) hematomas (1.7% vs 2.2%), bleeding requiring transfusion (1.5% vs 1.3%), and minor TIMI bleeding (2.8% vs 1.8%). Hospital length of stay was lower in the VCD group versus manual compression (2.1 ⫾ 3.4 vs 2.7 ⫾ 4.9 days, p ⫽ 0.0002). Conclusion: In the current era of PCI, the use of the more recent generation of vascular closure devices results in a lower incidence of major vascular complications when compared with manual compression. Hospital length of stay is decreased in properly selected patients receiving VCD, suggesting that there may be a cost-effective role in PCI.
TCT-440 The Economic Advantages of Femoral Closure Device Use: A Randomized Comparison of Suture-Mediated Closure Versus Compression. R. Prashad, P. Urban. Ocala Regional Medical Center, Ocala, Florida, USA. Background: Clinical studies have demonstrated that arterial closure devices minimize the need for routine sheath pulls and manual compression, leading to a reduced acuity of care, length of stay, and greater patient satisfaction. While clinical and other benefits of suture-based closure have been reported, the economic advantages have not been studied. The purpose of this study was to assess resource utilization and direct hospital costs associated with use of the Perclose suture-mediated closure device (Abbott Vascular Devices, Redwood City, CA) as compared with standard compression after routine diagnostic cardiac catheterization procedures. Methods: Patients (N ⫽ 100) were randomized in a 1:1 ratio to receive manual compression or suture closure of the arteriotomy after diagnostic catheterization. A card was blindly pulled at the end of each procedure to determine the method of closure. Once the patient was transferred to a postcare recovery area, every postprocedure task done for each patient was timed and documented to capture the total number of minutes spent caring for the patient, the type of function performed, and any supplies used as a result of the method of closure, including use of a hospital bed in the specified care unit. Primary end points included time to hospital discharge, incidence of major complication, and all associated postprocedural costs. An activity-based cost accounting system will be used to assign costs associated with each task performed relative to patient care, and supplies used will be calculated based on national averages as determined by The Redbook. Results: Preliminary results indicate improved resource utilization, fewer minutes spent managing the vascular access site, and an overall reduction in length of stay. No incidence of major complications was reported in either group. Conclusion: Data analysis is being performed to quantify the dollar value of the outcomes and will be available in time for presentation at the TCT meeting.
TCT-441 Clinical Experience Using a Novel Bioadhesive for Femoral Arteriotomy Closure After Angiography or Percutaneous Vascular Intervention. R.J. Whitbourn1, P.J. Mossop1, E. Feldman2, M. Cincotta1. 1Department of Cardiology, St. Vincent’s
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WEDNESDAY 9/25/02 9:00 –10:00 Hospital, Melbourne, Australia; 2Evanston Hospital, Chicago, Illinois, USA. Background: Coronary or peripheral angiograms and catheter-based revascularizations leave an arteriotomy needing closure. Sealing of this puncture site routinely requires manual compression. This investigation tested safety and efficacy of the NeoMend arterial closure device and biogel in closing femoral arteriotomies after percutaneous coronary and vascular procedures. Methods: Participants aged 40 to 77 years had scheduled angiography using a 6Fr sheath. Written informed consent was given, and accepted protocols were followed, including heparin and clopidogrel for interventions. The NeoMend device allowed injection of a 2-part polyethyleneglycol/human albumen complex via a specialized catheter exchanged for the femoral sheath after angiography. Manual pressure was applied for 5-minute increments for in situ gelation of the bioadhesive until hemostasis. Results: Data are given as the number of cases or mean ⫾ SEM (range) (Table).
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Parameter
Diagnostic Group
Interventional Group
Participants Activated clotting time (sec) Hemostasis ⬍5 min. Hemostasis ⬍10 min. Hemostasis 10–25 min. Time to device removal (min) Time to standing (min) Time to ambulation (min) Eligible for discharge ⬍4 hr Acute hematoma ⬃2 mL
11 men, 7 women 167 ⫾ 6
5 men 264 ⫾ 49
23 189 ⫾ 13
7 15 3 21 ⫾ 3 152 ⫾ 9 (n ⫽ 17) 230 ⫾ 10 (n ⫽ 17) 17 3
0 4 1 80 ⫾ 15
7 19 4 34 ⫾ 6
5 2
22 5
All
Times are from femoral incision. Time from device insertion to removal was 1.9 ⫾ 0.2 minutes. Seventeen diagnostic cases were able to stand after 3 hours, walk after 4 hours, and were eligible for discharge after ⬍4 hours. One required coronary graft surgery. Three arteriotomies re-bled some hours after initial hemostasis and were treated with manual compression. At 1-week follow-up, 8 femoral sites showed bruising and 7 showed a small lump. Two interventional patients returned to hospital, 1 with femoral site inflammation requiring antibiotics and debridement and 1 with myocardial infarction (unrelated). There were no other adverse events. Hematomas had resolved and femoral arterial flow was normal at the 45-day follow-up. Conclusion: Hemostasis was achieved in ⬍10 minutes for 83% of cases. The NeoMend arterial closure device provided safe, convenient, and time-effective hemostasis of femoral arteriotomies, facilitating prompt ambulation and hospital discharge.
TCT-442 New Concepts in Vascular Closure: An Endovascular Surgeon’s Perspective on Manual Compression May Not Be Benign. D. Allie, M. Lirtzman, C. Wyatt, A. Keller, M. Khan, M. Khan, P. Fail, G. Chaisson, C. Hebert, S. Ellis, C. Walker. Cardiovascular Institute of the South, Lafayette, Opelousas, and Houma, Louisiana, USA; Medical Center of Southwest Louisiana, Lafayette, Louisiana, USA; Terrebonne General Medical Center, Houma, Louisiana, USA.
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(MC) is the “gold standard,” but there are few data regarding a method of action, short- or long-term local femoral artery (FA) effects, or safety and timing of reentry. Methods: Between January 1999 and May 2002, 75 FA were exposed intraoperatively for endovascular abdominal aneurysm exclusion and FA repair. At 1 to 30 days preoperatively, 70 FA underwent closure of a 6Fr diagnostic angiography site. VCD including sutureand staple-mediated collagen plugs (CP), thrombotic patch (P), and MC were used. More than 3,000 intraoperative photos were analyzed. FA pathology included VCD failure, infection, pseudoaneurysm, thrombosis, groin and retroperitoneal hematoma, arteriovenous fistula, “high sticks,” and perivascular scar fibrosis. A PS score (PSS) was objectively assigned (mild ⫽ 1, moderate ⫽ 2, severe ⫽ 3) and time of surgery (TTS) was recorded. Results: Results are shown in the Table.
Variables Infection Pseudoaneurysm Hematoma Thrombosis Fistula VCDF PFS (Total) PFS (Mean) TTS (Days) TTS (Mean)
MC
Suture Closure
Staple Closure
CP
P
N ⫽ 20 0 1 2 0 1 N/A 55 2.75 1–30 12.4
N ⫽ 30 1 1 2 1 0 2 80 2.66 1–30 14.5
N⫽2 0 0 0 0 0 0 N/A N/A ⬍1 ⬍1
N⫽8 0 0 1 1 0 1 18 2.25 1–21 10.4
N ⫽ 10 0 0 1 0 0 0 25 2.5 1–30 14
With MC ⬍7 days, FA revealed significant intramural ecchymosis and hematoma and the actual “stick site” appeared unhealed and the FA wall weakened. Conclusion: Significant perivascular scarring and fibrosis occur with all modes of FA closure. MC is not benign, and questions arise regarding risks and timing of FA reentry. A search must continue for the ideal VCD.
TCT-443 A Randomized Trial Comparing the QuickSeal Femoral Arterial Closure Device with Manual Control After Diagnostic and Interventional Catheterization Procedures. J.S. Yadav1, D. Moliterno1, S.L. Almany2, F. Castaneda3, T.M. Shimshak4, T.P. Davis5, J.F. Benenati6, A. DeFranco7, B.D. Rutherford8, M.W. Mewissen9. 1Cleveland Clinic Foundation, Cleveland, Ohio, USA; 2 William Beaumont Hospital, Royal Oak, Michigan, USA; 3OSF St. Francis Medical Center, Peoria, Illinios, USA; 4Ohio Heart Health Center, Cincinnati, Ohio, USA; 5St. John Hospital and Medical Center, Detroit, Michigan, USA; 6Miami Cardiac and Vascular Institute, Baptist Hospital of Miami, Miami, Florida, USA; 7McLaren Regional Heart and Vascular Center-Flint, Michigan, USA; 8MidAmerica Heart Institute, St. Lukes Hospital, Kansas City, Missouri, USA; 9Wisconsin Heart and Vascular Clinic, St. Lukes Medical Center, Milwaukee, Wisconsin, USA.
Background: Femoral artery access complications (FAC) remain a significant source of morbidity and costs. “Major” and “minor” FAC are reported in 0.9% to 11.8% of cases yet no standardization exists. Vascular closure devices (VCD) have not decreased FAC, have significant limitations, and create a new subset of FAC. Manual compression
Background: The safety and efficacy of the QuickSeal femoral arterial closure device (SUB-Q Inc., San Clemente, CA) was compared with manual compression. Unlike closure devices currently available, QuickSeal delivers an extravascular, porcine gelatin sponge (nonbovine and noncollagen) directly over the guidewire to achieve hemostasis of vascular puncture sites 8Fr and smaller. Methods: A prospective, multicenter, randomized, controlled trial involving 398 patients was conducted. A 3:2 device-to-control ratio was used, with randomization stratified by type of procedure (diagnos-
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tic or interventional). Primary end points included time to hemostasis, time to ambulation, and rate of major complications. Sheaths were removed when activated clotting times (ACT) were ⱕ250 seconds when glycoprotein (GP) IIb/IIIa platelet inhibitors were administered, ⱕ300 seconds without GP IIb/IIIa platelet inhibitors, and ⱕ180 seconds for manual compression. Time to hemostasis and time to ambulation were measured from the time the final angiography image was taken. Results: The rate of major complications, including vascular repair, bleeding requiring transfusion/intervention, and infection requiring extended hospitalization/intravenous antibiotics, was similar between the device (1.3%) and control (0.6%) arms. One patient in each arm required a transfusion and 2 patients in the device arm experienced a pseudoaneurysm that was resolved with a thrombin injection. The mean time to hemostasis (18.5 minutes for device vs 131.6 minutes for control), time to ambulation (5.1 hours vs 9.6 hours), and time to hospital discharge (26.2 hours vs 36.3 hours) were significantly shorter for the QuickSeal device than for manual compression. Conclusion: In this randomized trial, QuickSeal was found to be safe and effective in closing femoral artery access sites. It reduced time to hemostasis, time to ambulation, and time to eligibility for hospital discharge in diagnostic and interventional procedures, and reduced time to actual hospital discharge in diagnostic procedures.
TCT-444 Use of the AngioSeal Collagen-Based Vascular Closure Device. H. Eggebrecht, U. Woertgen, C. Naber, A. Schmermund, T. Bartel, M. Haude, R. Erbel, D. Baumgart. Department of Cardiology, University Clinic Essen, Essen, Germany. Background: Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in consecutive patients undergoing cardiac catheterization or coronary angioplasty. Methods: In a prospective study, we systematically used a collagen-based vascular closure device (AngioSeal, St. Jude Medical) in 1,317 consecutive patients (995 men, 322 women; mean age, 61.2 years) for closure of the femoral access site immediately after diagnostic or interventional coronary procedures independent of the coagulation status. Patients were monitored for 24 hours after the procedure. Results: Patients undergoing coronary angioplasty (n ⫽ 644) received more heparin than patients with diagnostic cardiac catheterization (n ⫽ 673) (9,675 IU ⫾ 1,144 IU vs 6,419 IU ⫾ 2,211 IU, p ⬍0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic versus interventional procedures (95.8% vs 96.7%, p ⫽ 0.46). Complete hemostasis immediately after deployment of the device was achieved in ⬎90% of all patients, but was lower in the interventional group (93.7% vs 90.6%, p ⫽ 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients with no differences between diagnostic or interventional patients (0.62% vs 0.45%, p ⫽ 0.953). Subgroup analysis revealed female sex as a predictor of access site complications. Conclusion: Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.
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TCT-445 Incidence of Deep Venous Thrombosis in Low-Risk Patients Early After Diagnostic Cardiac Catheterization. D. Paniagua1, R. Carrillo-Jimenez2, R. Ciccia-McLean2, J.C. London˜ o2, F. LopezJimenez3, W.K. Vaughn1, J. J. Ferguson1, Z. Krajcer1, N. Strickman1, R.D. Fish1. 1St. Luke’s Episcopal Hospital/Texas Heart Institute and Baylor College of Medicine, Texas, USA; 2Mt. Sinai Medical Center, Miami Beach, Florida, USA; 3Mayo Clinic, Rochester, Minnesota, USA. Background: Deep venous thrombosis (DVT) has been observed after diagnostic cardiac catheterization (DCC) and associated groin compression procedures. We hypothesized that DVT can be found in low-risk patients after DCC. Methods: We prospectively studied 77 low-risk patients referred for DCC in 2 academic medical centers. Patients with a history of DVT/pulmonary embolism, hypercoagulable state, malignancy, major surgery within the previous 6 months, current anticoagulation, recent use of thrombolysis, and those undergoing coronary intervention were excluded. Lower-extremity venous B-mode and color Doppler ultrasound (US) studies were obtained in all participants before DCC and within 24 hours after DCC. Results: The mean age was 57 ⫾ 13 years (range, 20 –90 years). There were 39 men and 38 women. In this cohort, 49% were hypertensive, 16% had diabetes, 14% were smokers, and 55% used aspirin. Among women, 21% were on estrogen therapy. Indications for DCC were suspected coronary artery disease in 84% and other (valvular heart disease, cardiomyopathy, and post– heart transplant evaluation) in 16%. Left-heart DCC was performed in 69%, and both right and left heart DCC in 31%. Manual and clamp groin compression were performed in 35% and 65% of patients, respectively (no closure devices were used). At follow-up US, 4 patients (3 women) developed DVT (5% incidence) in the ipsilateral ileofemoral vein only (asymptomatic in all cases). The Fisher exact test revealed no significant association between the presence of DVT and female sex (p ⫽ 0.35), current smoking (p ⫽ 0.09), diabetes mellitus (p ⫽ 0.50), right and left heart DCC (p ⫽ 0.65), and manual or clamp compression (p ⫽ 0.43). Analysis of variance showed no relation between the presence of DVT and patient age (p ⫽ 0.95), arterial time (p ⫽ 0.06), and compression time (p ⫽ 0.56). Conclusion: DVT is an under-recognized complication of DCC in low-risk patients. We found a 5% incidence of DVT within 24 hours after DCC. There was a suggestive trend that smokers and those with longer arterial time were more prone to develop DVT. Larger analytical prospective studies with serial US assessments are needed to confirm its incidence and predictors.
TCT-446 Safety and Efficiency of the New AngioSeal STS Device. P.L. Schwimmbeck, M. Pauschinger, B. Bigalke, B. Witzenbichler, H.-P. Schultheiss. Department of Internal Medicine/Cardiology, University Hospital Benjamin Franklin, Free University, Berlin, Germany. Background: A new version of the AngioSeal vascular closure device has been developed that incorporates a self-tightening slipknot. This allows the procedure to be completed on the catheterization laboratory table. We compared the performance of the new device (STS) with the previous model (Millenium platform) in prospective study. Methods: We studied 52 consecutive patients who received arterial closure of the puncture site in the groin after diagnostic or interventional cardiac catherization using the new STS device and 57 consecutive patients who were treated with the Millenium platform device as a control. All patients received a predeployment fluoroscopy to deter-
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WEDNESDAY 9/25/02 9:00 –10:00 mine suitability for closure using the device. Activated clotting time (ACT) values for interventional patients were measured; for diagnostic cases, a fixed dose of 5,000 U heparin was used. Results: Patient characteristics are given in the Table.
Patients (n) Male/female Diagnostic/interventional Mean interventional ACT (sec) GP IIb/IIIa inhibitor use
STS
Millenium
52 34/18 37/15 331 7/15
57 44/13 42/15 367 0/15
GP ⫽ glycoprotein. Immediate hemostasis was achieved using the STS device with only insignificant oozing in a few cases. For the STS device, the mean time to hemostasis was 87 seconds. Almost half of our patients receiving the STS device were mobilized within 10 minutes (diagnostic) and 2 hours (interventional) compared with our routine for the Millenium platform device with 4 hours (diagnostic) and 6 hours (interventional). There were no complications in either group. One STS device was successfully implanted into a Gore-Tex graft in the groin. Conclusion: In our group of patients, we found the hemostatic performance of the new device to be superior to the previous one, regardless of ACT value or use of glycoprotein IIb/IIIa inhibitor therapy (abciximab, tirofiban). Completion of the arterial closure in the catheterization laboratory is a most useful feature of the new device, as patients do not need to be tracked for suture cutting. Mobilization times could be safely reduced with no instances of the subsequent bleeding.
TCT-447
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In Vivo Evaluation of the 6Fr Perclose Closer and the 6Fr AngioSeal Millenium Device in the Canine Model. T. Ohki, N. Gargiulo, H. Kurvers, C. Santizo, R. De Graaf, F. Veith. Montefiore Medical Center and Albert Einstein College of Medicine, New York, New York, USA. Background: Complications associated with hemostatic closure devices have been reported. However, the intra- and extravascular effects of these devices have not been well studied. Our objective was to assess the performance as well as the healing characteristics of 2 US Food and Drug Association–approved devices in canines. Methods: Twelve adult male dogs were anesthetized and intubated before percutaneous access of both femoral arteries with a 6Fr sheath. All dogs were systemically heparinized to an activated clotting time ⬎350 sec. Duplex sonography (DS) was performed preoperatively to measure vessel diameter and flow velocity. Each device was randomly deployed into 1 of the femoral arteries. DS was performed immediately post deployment and at 28 days to measure changes in vessel diameter and flow velocity. At 28 days, angiography and DS was performed on both femoral arteries before being harvested for histologic evaluation. Time required to dissect each vessel was recorded. Results: Nine of 12 dogs were alive at 42 days. Three dogs died of hemorrhagic shock secondary to AngioSeal (St. Jude Medical, St. Paul, MN) device failure. The Table outlines various end points and results.
Hemostasis time (min) Change in vessel diameter (flow velocity, cm/sec) Pre/post deployment Pre/28-day deployment Intimal hyperplasia (intima/media ratio) Extravascular scarring (dissection time, min)
Perclose
AngioSeal
0*
39 ⫾ 7*
21.2 ⫾ 4.7 0 0.4 ⫾ 0.2 5 ⫾ 1*
28.2 ⫾ 6.9 47.0 ⫾ 8.3 0.5 ⫾ 0.3 20 ⫾ 3*
*p ⬍0.05.
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Conclusion: Use of the AngioSeal collagen plug closure device results in a prolonged hemostasis time. In addition, because of the use of an intra- and extravascular foreign body, Angioseal resulted in a tendency toward vessel narrowing as well as increased periadventitial inflammation resulting in a prolonged dissection time. Suture closure of the arteriotomy with the Perclose closure device (Abbott Vascular, Redwood City, CA) results in immediate hemostasis and minimal intraand extravascular reaction.
TCT-448 Reduced Vascular Complications After Percutaneous Coronary Interventions with a Nonmechanical Suture Device: Results from the Randomized Rapid Ambulation After Closure (RACE) Study. T.A. Sanborn1, J.D. Ogilby2, J. Ritter3, G.W. Stone4, B. Klugherz5, R. Fields6, C. White7, J. McGarvey8, D.L. Morris9, R. Wilensky10. 1Evanston Northwestern Healthcare, Chicago, Illinois, USA; 2Thomas Jefferson University, Philadelphia, Pennsylvania, USA; 3Christiana Care Health Services; 4Lenox Hill Hospital, New York, New York, USA; 5Abington Memorial Hospital; 6St. Mary Medical Center; 7Ochsner Clinic; 8Doylestown Hospital; 9Leigh Valley Hospital; 10Hospital University of Pennsylvania, Philadelphia, Pennsylvania, USA. Background: Current percutaneous vascular suture devices remain mechanically complex and expensive. We sought to evaluate the safety of a new nonmechanical percutaneous suture device, X-PRESS, after diagonistic catheterization and percutaneous coronary intervention (PCI) in the setting of glycoprotein (GP) IIb/IIIa use. Methods: A total of 392 patients undergoing diagnostic catheterization (n ⫽ 132) or PCI (n ⫽ 260) were randomized (2:1 ratio, device vs compression) in the multicenter, prospective RACE (Rapid Ambulation After Closure) study. GP IIb/IIIa inhibitors were used in 55% of PCI. The primary safety end point was the incidence of major vascular complications (surgical repair, transfusion, ultrasound-guided compression, infection requiring intravenous antibiotics). Results: Preliminary analysis indicates no significant difference in the overall incidence of major vascular complications between compression (n ⫽ 3, 2.3%) and device (n ⫽ 1, 0.4%) groups (p ⫽ 0.49). However, in the PCI subset, there was a significant reduction in the incidence of major vascular complications with the X-PRESS device (0 of 173; 0%) versus compression (3 of 87; 3.4%) (p ⫽ 0.037). Conclusion: A novel nonmechanical suture device was found to have fewer major vascular complications than compression after PCI with a high level of GP IIb/IIIa usage. Adjudicated results as well as primary efficacy results will be available for presentation.
TCT-449 Outpatient, Elective, Transradial Coronary Interventions Are Safe, Feasible, and Potentially Cost Saving. S.R. Mulukutla, H.A. Cohen. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. Background: Few studies have examined the feasibility of outpatient percutaneous coronary interventions (PCIs). Overnight observation is still standard after uncomplicated, elective PCI. In the United States, ⬎750,000 PCI are performed annually, the majority of which are performed via transfemoral access. Transradial PCI is an underutilized technique that has the benefits of lower morbidity and increased patient comfort when compared with the transfemoral technique. This retrospective study examines the feasibility of elective transradial interventions and examines the potential cost savings of outpatient PCI. Methods: A retrospective analysis was performed on 100 consecutive outpatients who had elective, uncomplicated, transradial coronary interventions and were admitted for routine observation. Patients with
SEPTEMBER 24, 2002
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acute coronary syndrome, suboptimal results, and those receiving glycoprotein IIb/IIIa inhibitors were excluded from consideration. Of the 750,000 PCIs performed annually, ⱖ375,000 patients are outpatients. At least 75% of these patients may be eligible for transradial access, and of those 70% may be eligible for outpatient procedures. A monitored hospital bed is estimated to cost $1,400 per day. Results: A total of 105 vessels were intervened upon in the 100 patients. The average stenosis before PCI was 86%, and all lesions had 0% residual stenosis after PCI. All patients received clopidogrel. All patients were allowed to ambulate immediately post procedure. There were no major or minor complications associated with the procedure or access site. In all, 88 patients were discharged within 24 hours. Longer hospitalizations in the remaining 12 patients were unrelated to their procedure. Using conservative estimates, an outpatient strategy with transradial PCI could result in a cost-savings of $275 million to the US healthcare system. Conclusion: This analysis suggests that outpatient stenting is feasible, safe, and cost saving. With lower morbidity and increased comfort, the transradial approach is an attractive option for an outpatient stenting trial. Given the increasing cost of technology as it relates to PCI, new cost-saving strategies are crucial. This study suggests that an outpatient trial of transradial percutaneous coronary interventions is warranted.
TCT-450 Transradial Coronary Angioplasty in Acute Coronary Syndromes. Z. Ruzsa, I. Ungi, L. Rudas, A. Thury, R. Sepp, T. Horva´ th, Zs. Zimmermann, M. Csana´ dy. University of Szeged, Department of Cardiology, Szeged, Hungary. Background: Transradial (TR) access has been getting more and more popular for percutaneous coronary intervention (PCI) because of the patient’s comfort and the low complication rate. However, its suitability for emergency cases has been questioned in the literature. This study was performed to compare the outcome and complication rate after TR and transfemoral (TF) PCI for acute coronary syndromes (ACS) in a
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1-year patient population. TR angioplasty has been performed since 1999 in our department, and after the initial learning curve we started the TR access in ACS as well. Methods: The clinical and angiographic database of ACS treated by PCI in 2001 was reviewed and evaluated. All of the patients with ACS (n ⫽ 293) were assigned to TR (n ⫽ 69) or TF (n ⫽ 224) groups. Several parameters were applied to evaluate the potential advantages or drawbacks of TR access: (1) rate of access site complications, (2) outcome of PCI by BENESTENT criteria, (3) x-ray area dose, (4) fluoroscopy time, (5) consumption of angioplasty equipment, and (6) length of hospital stay. Selection of the access site was made by the operator’s preference. The need for intra-aortic balloon pump (IABP) was the only exclusion criterion for TR access; therefore, we excluded the IABP cases from the TF group, as well. The Student t test and z test were used for statistical analysis. Results: The TR and TF approaches were successful in all cases. The consumption of guiding catheters (1.2 per procedure) and balloon catheters (0.8 per procedure) proved to be the same for the 2 groups. Good angiographic results were reached in 62 patients in the TR group (90%) and 204 patients (91%) in the TF group by BENESTENT criteria. The mean x-ray dose was 11,429 cGy/cm2 in the TR and 11,549 cGy/cm2 in the TF groups (p ⫽ 0.018). The mean fluoroscopy time was 14.3 minutes in the TR group and 14.4 minutes in the TF group (p ⫽ 0.100). Major entry site complications were encountered in 7 patients (3.13%) in the transfemoral group. There was no major entry site complication in the transradial group. The 1-month major adverse coronary events rate was found to be 5% in the TF group and 1.6% in the TR group (p ⫽ 0.248). The hospital stay was 3.77 days after TR interventions and 3.79 days after TF interventions (p ⫽ 0.38). We used glycoprotein IIb/IIIa receptor blocking agents in 18 patients (26%) after TR interventions and in 89 patients (39%) after TF interventions (p ⫽ 0.068). Conclusion: Our results suggest that TR access is safe and effective for the treatment of ACS without the need of excess use of radiation or equipment. The lack of site-related complications in the TR group is extremely important in the ACS patient subset.
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