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Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy
Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
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Cardiovascular Revascularization Medicine
Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy☆ Hoyle L. Whiteside a,⁎, Supawat Ratanapo b, Albert Sey b, Abdullah Omar b, Deepak Kapoor b a b
Department of Internal Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA Department of Cardiology, Medical College of Georgia, Augusta University, Augusta, GA, USA
a r t i c l e
i n f o
Article history: Received 9 July 2017 Received in revised form 18 August 2017 Accepted 22 August 2017 Available online xxxx Keywords: Rotational atherectomy Percutaneous coronary intervention Coronary artery disease
a b s t r a c t Introduction: The efficacy of heparin based flush solutions in rotational atherectomy (RA) has not been validated. Recently, a single center study demonstrated the feasibility of an alternative flush solution with 10,000 U of unfractionated heparin (UFH) in 1 L of normal saline. We aimed to evaluate the safety and efficacy of an alternative flush solution intermittently utilized at our institution. Methods: We retrospectively identified 150 patients undergoing RA over a three year period. One hundred cases utilized an alternative flush solution containing 10,000 U UFH, 400mcg nitroglycerin, and 10 mg verapamil in 1 L normal saline and fifty cases utilized RotaGlide Lubricant (Boston Scientific) in addition to heparin and vasodilators in the same dose. The primary end point was to compare rates of procedural success. Secondary endpoints were to report procedural characteristics including the incidence of major adverse cardiac events (MACE) and minor periprocedural complications. Results: Procedural success was achieved in 98% (98/100) of cases utilizing the alternative Rota-Flush solution compared to 100% (50/50) in the Rota-Glide group (P = 0.553). A total of 292 lesions (200 Rota-Flush vs 92 Rota-Glide) were targeted for intervention. MACE occurred in 13 (13%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.425). Conclusion: Rotational atherectomy performed with the previously defined Rota-Flush or Rota-Glide solutions resulted in similar rates of procedural success. There were no significant disparities in incidence of MACE and minor periprocedural complications between the two groups. Heparin based rota-flush solutions can be effective alternatives to traditional solutions containing RotaGlide Lubricant. © 2017 Elsevier Inc. All rights reserved.
1. Introduction Coronary artery calcium is a marker of advanced coronary artery disease and is a predictor of adverse clinical outcomes including stroke and myocardial infarction [1–5]. Severely calcified coronary lesions increase the intricacy of percutaneous coronary intervention (PCI) and are associated with increased procedural risk and adverse clinical outcomes [6–11]. These lesions can be resistant to adequate predilatation, impair stent delivery and expansion, and lead to an increased rate of stent thrombosis and/or restenosis [1,12]. Current guidelines indicate that rotational atherectomy (RA) is a reasonable approach to heavily calcified lesions which cannot be crossed by a balloon catheter or adequately dilated before stent implantation [13]. RA is a technique which was introduced by Jerome Ritchie and David Auth and first utilized in human ☆ Disclosure statement: The authors report no financial relationships or conflicts of interest regarding the content herein. ⁎ Corresponding author at: Department of Internal Medicine, Augusta University, 1120 15th Street, Augusta, GA 30912, USA. E-mail address: [email protected] (H.L. Whiteside).
cases by Fourrier et al. in 1988 [14,15]. The technique relies on the principle of “orthogonal displacement of friction” and utilizes a rotating diamond shaped burr to modify calcified coronary lesions and reduce plaque burden [16]. The resulting luminal morphology of treated lesions is smooth and nonendothelialized, which differs from lesions treated with balloon angioplasty [17–21]. The Rotablator Rotational Atherectomy System (Boston Scientific, Marlborough, MA) is a device approved for percutaneous rotational coronary angioplasty. The system utilizes a pressurized flush solution to lubricate the drive shaft in order to reduce friction, heat generation, and sudden drops in revolutions per minute [22]. The standard flush solution includes vasodilators such as nitroglycerin and verapamil in addition to RotaGlide Lubricant (Boston Scientific Marlborough, MA) which contains olive oil, egg yolk, phospholipids, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and water [22]. Known clinical complications of rotational atherectomy are similar to those common to PCI and include the need for urgent coronary artery bypass graft surgery, myocardial infarction, stroke, and death. Angiographic complications include coronary vasospasm, dissection, side branch loss, and slow-flow/no-reflow phenomenon [16,18].
https://doi.org/10.1016/j.carrev.2017.08.013 1553-8389/© 2017 Elsevier Inc. All rights reserved.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
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H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
RotaGlide Lubricant has been studied in a small population of twenty patients following failed stent placement [23]. It was reported to facilitate stent delivery in complex lesions in addition to being safe and biocompatible with drug-eluting stents. The efficacy of alternative rotaflush solutions has not been thoroughly investigated. In a recent case series, Lee et al. evaluated the safety and feasibility of a heparin based rota-flush solution in the absence of vasodilators [24]. The authors report that the use of a heparin based rota-flush solution without vasodilators is a reasonable alternative to RotaGlide and vasodilators. These findings have not yet been validated. We sought to evaluate the safety and procedural success rate of an alternative rota-flush solution intermittently utilized at our institution and its potential impact on both major adverse cardiac events (MACE) and minor periprocedural complications. 2. Methods 2.1. Study population Following institutional review board approval, we identified all patients who underwent rotational atherectomy at the Medical College of Georgia/Augusta University Medical Center between January 1st 2014 and December 31st 2016, using an institutional database. One hundred and fifty patients met inclusion criteria and data was extracted from the electronic medical record system in accordance to the study protocol. 2.2. Procedural technique and medical intervention Patients underwent percutaneous coronary intervention (PCI) with rotational atherectomy performed by one of six operating physicians. Standard techniques were utilized to perform PCI via a transradial or transfemoral approach. Dual-antiplatelet therapy with a P2Y12 inhibitors and aspirin was administered prior to PCI. Unfractionated heparin was administered intravenously throughout the procedure to achieve an activated clotting time (ACT) N250 s. Intravascular ultrasound (IVUS) was utilized prior to intervention in all but one case and fractional flow reserve (FFR) was utilized to evaluate coronary lesions with 50– 70% stenosis. The selection of arterial access sheath, burr size, and stent type (bare-metal vs drug-eluting) was determined by the operating physician. In addition, the decision to utilize a temporary pacemaker and/or provide hemodynamic support with an intra-aortic balloon pump (IABP) or percutaneous left ventricular assist device (pLVAD) was operator dependent, based on patient and target lesion profile. Rotational atherectomy was performed using one of two rota-flush solutions based on operator preference. The “Rota-Glide” solution contained one 20cm 3 vial of RotaGlide Lubricant, 10 mg verapamil, 400 mcg nitroglycerin, and 10,000 U unfractionated heparin in 1 L of normal saline. The alternative “Rota-Flush” solution contained 10 mg verapamil, 400 mcg nitroglycerin, and 10,000 U unfractionated heparin in 1 L of normal saline. The target lesion was crossed using a 0.014″ work-horse wire followed by wire exchange for a 0.009”Rota-floppy wire (Boston Scientific, Marlborough, MA) via an over-the-wire balloon or microcatheter. A pressure bag infusion containing either Rota-Glide or the alternative Rota-Flush solution was utilized based on operator preference. The flush solution was started and the burr was advanced through the lesion using a pecking technique. The duration of each pass with the burr was less than or equal to 20 s. Following rotational atherectomy, the decision to proceed with coronary angioplasty and/ or stent placement was routinely guided by IVUS. All patients were treated with dual antiplatelet therapy following PCI. In addition, all patients were prescribed an angiotensinconverting enzyme inhibitor or angiotensin II receptor blocker, beta-blocker, and statin at the time of discharge unless clinically contraindicated.
2.3. Data extraction A detailed chart review was conducted to collect demographic data including cardiac risk factors, echocardiographic data, procedural characteristics, and the incidence of MACE and minor periprocedural complications. All physician notes were reviewed up until the time of discharge in order to extract both subjective and objective data such as the development of anginal symptoms or hematoma at arterial access site. All data was entered into a dedicated rotational atherectomy database. 2.4. Study endpoints The primary end point was procedural success defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 and residual stenosis ≤ 30% after final percutaneous transluminal coronary angioplasty (PTCA) and/or stent placement. If stent loss, death, or an indication for emergent PCI and/or coronary artery bypass graft surgery developed during the first 24 h, the procedure was considered a failure. Secondary endpoints were the development of major and minor periprocedural complications prior to hospital discharge. Major adverse cardiac events were defined as: bradycardia requiring transvenous pacing, hypotension requiring vasopressors or placement of mechanical hemodynamic support (IABP or pLVAD), sustained ventricular arrhythmia, need for target lesion revascularization, non-fatal myocardial infarction, stroke, and cardiac death. Target lesion revascularization was defined as the development of ischemia due to a stenosis of ≥50% of the luminal diameter either within the stent or within 5 mm of its borders which required surgical or percutaneous revascularization. Acute and subacute stent thrombosis was defined according to the Academic Research Consortium definition [25]. Myocardial infarction was defined as the development of new ST-segment elevation or an increase in cardiac biomarkers either ≥2× the upper limit of normal or above the previously documented value in addition to the development of ischemic symptoms. Death was to be considered cardiac in origin unless a non-cardiac origin was documented in the electronic medical record. Minor periprocedural complications were defined as: development of hematoma or pseudoaneurysm at the vascular access site or reported systemic blood loss from any source. 2.5. Statistical analysis Statistical analysis was performed with R© version 3.3.1 (2016-0621) -The R Foundation for Statistical Computing Platform. The difference between means for continuous variables was tested by two-tailed t-test. For categorical values, the Fishers exact test was utilized in testing the significance of dependent variables on independent variables. Pvalues b 0.05 were considered statistically significant. Descriptive statistics were used to analyze procedural characteristics. Continuous variables are reported as a mean and standard deviation while categorical variables are reported as a value and percentage. 3. Results 3.1. Population demographics and procedural characteristics Patient demographics and cardiac risk factors for both the RotaFlush and Rota-Glide groups are documented in Table 1. A total of 292 lesions (200 Rota-Flush vs 92 Rota-Glide) were targeted for intervention and the distribution of target lesions are listed in Table 2. Unprotected left main disease was targeted in 19 (19%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.095). A complete list of procedural characteristics including: burr size, number of stents utilized, type of stent deployed, and application of IVUS is provided in Table 3.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx Table 1 Population demographics.
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Table 3 Procedural characteristics. Rota-flush (N = 100)
Rota-glide (N = 50)
Demographics Age Gender (male) Diabetes mellitus Hypertension Hyperlipidemia History of stroke History of myocardial infarction History of coronary angioplasty History of coronary bypass
Result ± SD (%) 67.5 ± 9.8 64 (64) 61 (61) 88 (88) 82 (82) 8 (8) 34 (34) 39 (39) 34 (34)
Result ± SD (%) 69.8 ± 10.5 37 (74) 21 (42) 49 (98) 35 (70) 6 (12) 16 (32) 18 (36) 9 (18)
P P P P P P P P P
= = = = = = = = =
0.198 0.330 0.269 0.061 0.100 0.552 0.856 0.859 0.055
Echocardiograms Ejection fraction b30% 30% to 50% 50% or greater
N = 98 (98) 48.1 ± 14.8 15 (15) 32 (32) 51 (51)
N = 48 (96) 45.1 ± 16.7 11 (22) 12 (24) 25 (50)
P P P P
= = = =
0.294 0.288 0.505 0.908
3.2. Clinical outcomes The primary endpoint of procedural success was achieved in 98% (98/100) of cases utilizing the alternative Rota-Flush solution compared to a 100% (50/50) success rate in the Rota-Glide group (P = 0.553). In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication. Major adverse cardiac events occurred in 13 (13%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.425) and the incidence of each event is reported in Table 4. Hypotension requiring the addition of vasopressors and/or mechanical hemodynamic support (IABP or pLVAD) was the most common major complication (8% Rota-Flush vs 4% Rota-Glide). Prophlylactic hemodynamic support with either IABP or pLVAD was utilized in six patients (4% Rota-Flush vs 4% Rota-Glide). Five cases required intraoperative bail out hemodynamic support with either vasopressors (5) and/or IABP (3) (4% RotaFlush vs 2% Rota-Glide). In all cases of hypotension, procedural success was achieved and all patients left the catheterization laboratory with adequate blood pressure in the setting of vasopressors or mechanical hemodynamic support. Minor periprocedural complications occurred in 8 (8%) and 5 (10%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.76). This includes one case of guide wire entrapment which was not one of the prespecified minor periprocedural complications, but was included based on consensus agreement by the authors. The incidence of each minor periprocedural complication is documented in Table 4. Of one hundred and fifty cases included in our study, there were three documented deaths. Two patients were critically ill upon presentation and the third developed conduction abnormalities N 24 h
Procedural success IVUS Access Femoral Radial Burr size 1.25 1.5 1.75 2.0 2.15 2.25 Stents per case 0 1 2 3 4 5 Type of stent utilized by case DES BMS Sheath size (Fr) 6 7 8 6.5 sheathless guide Procedural Support Temporary pacemaker IABP LVAD (Impella)
Rota-flush (N = 100)
Rota-glide (N = 50)
Result ± SD (%)
Result ± SD (%)
98 (98) 100 (100)
50 (100) 49 (98)
96 (96) 4 (4) 1.79 ± 0.30 7 (7) 26 (26) 29 (29) 18 (18) 8 (8) 12 (12) 1.82 ± 1.10 13 (13) 24 (24) 38 (38) 19 (19) 5 (5) 1 (1) N = 87 80 (80) 7 (7)
46 (92) 4 (8) 1.58 ± 0.23 9 (18) 24 (48) 10 (20) 7 (14) 0 (0) 0 (0) 1.78 ± 0.89 1 (2) 22 (44) 15 (30) 11 (22) 1 (2) 0 (0) N = 49 48 (96) 1 (2)
33 (33) 30 (30) 37 (37) 0 (0)
13 (26) 14 (28) 22 (44) 1 (2)
3 (3) 5 (5) 5 (5)
11 (22) 5 (10) 2 (2)
Abbreviations: BMS: bare-metal stent; DES: drug-eluting stent; IABP: intra-aortic balloon pump; IVUS: Intravascular ultrasound; LVAD: left ventricular assist device.
postoperatively. Demographic data, procedural characteristics, and a brief summary of hospital course for these three cases are provided in (Supplementary materials: Table 1). The option for autopsy was declined in all three cases.
4. Discussion The primary end point of our study was to report the procedural success rate for rotational atherectomy performed with the previously defined alternative Rota-Flush solution. In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication.
Table 4 Major adverse cardiac events and periprocedural complications. Table 2 Distribution of target lesions. Lesion location
Rota-flush (N = 100)
Rota-glide (N = 50)
LM Unprotected LM Prox LAD Mid LAD Distal LAD Prox RCA Mid RCA Prox LCx Mid LCx PDA Ramus Total lesions
23 (23) 19 (19) 36 (36) 39 (39) 3 (3) 22 (22) 29 (29) 17 (17) 10 (10) 1 (1) 0 (0) N = 200
5 (10) 4 (8) 29 (58) 23 (46) 4 (8) 9 (18) 8 (16) 5 (10) 3 (6) 0 (0) 1 (2) N = 92
P P P P P P P P P P P
= = = = = = = = = = =
0.074 0.095 0.011 0.412 0.188 0.569 0.086 0.259 0.417 0.798 0.271
Abbreviations: LAD: left anterior descending artery; LCx: left circumflex artery; LM: left main; PDA: posterior descending artery; RCA: right coronary artery.
Major adverse cardiac events Hypotension Bradycardia Ventricular arrhythmia No reflow Tamponade Dissection Recurrent angina Minor complications Blood loss Pseudoaneurysm Hematoma Guide-wire entrapment⁎ Deaths
Rota-flush (N = 100)
Rota-glide (N = 50)
13 (13) 8 (8) 5 (5) 3 (3) 2 (2) 0 0 1 (1) 8 (8) 3 (3) 1 (1) 3 (3) 1 (1) 3 (3)
4 (8) 2 (4) 0 1 (2) 0 1 (2) 2 (4) 0 5 (10) 0 1 (2) 4 (8) 0 0
P P P P P P P P P P P P P P
= = = = = = = = = = = = = =
0.425 0.360 0.237 0.722 0.548 0.271 0.134 0.798 0.760 0.398 0.622 0.188 0.798 0.397
⁎ Not included in prespecified list of periprocedural complications.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
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H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
Procedural success was achieved in all but two cases. The first failed case, involved rotational atherectomy targeting the left main (unprotected), proximal, and middle left anterior descending (LAD) arteries. RA was performed without complication using a maximum burr size of 2.25 mm. In this case, the mid LAD stent could only be partially expanded due to hard underlying plaque and resulted in a residual 50% stenosis. There was good flow distal to the lesion and the stent remained patent at 7 months follow up. The second failed case involved a patient who developed recurrent angina following successful RA. Subsequent coronary angiogram revealed a 50% stenosis due to a soft plaque at the distal edge of a middle LAD stent which prompted additional intervention, which was successful. In a case series of 67 patients, Lee et al. examined the safety and procedural success rates of an alternative heparin based rota-flush solution and concluded that it is a reasonable alternative to standard flush solutions containing RotaGlide Lubricant [24]. Their work provides insight into the potential utility of alternative rota-flush solutions; however it is limited by a lack of comparison to standard flush solutions. In our study, we were able to retrospectively analyze and compare the procedural success and periprocedural complication rates of patients undergoing rotational atherectomy with a standard Rota-Glide solution and an alternative heparin based Rota-Flush solution utilized at our institution. Procedural success was achieved in all but two cases and the difference between the two groups was not statistically significant (98/100 vs 50/50 P = 0.553). This data provides additional evidence to validate the efficacy of alternative heparin based rota-flush solutions in rotational atherectomy. If evidence continues to suggest that the addition of Rota-Glide lubricant does not have a statistically meaningful impact on procedural success and periprocedural outcomes, then the theoretical benefit of performing rotational atherectomy in the absence of Rota-glide becomes multifactorial. First, Rota-Glide is a foreign substance with multiple components including olive oil and egg yolk phospholipids. While adverse reactions to these components are uncommon, the risk is not nonexistent and utilization of the solution is contraindicated in patients with known allergies. Second, there is a cost associated with the utilization of Rota-glide lubricant. At our institution, the cost is reported at $80.75 per vial. Although the cost of Rota-glide lubricant is minimal relative to total expense of PCI, in the absence of clearly defined impact on procedural success and outcomes, Rota-glide may represent an unnecessary expenditure. Third, all pharmaceutical products are regulated and subject to shortages, contamination, and expiration. Of note, IVUS was utilized in all but one case. It is possible that the use of IVUS prior to intervention can better delineate the morphology of the target lesion, increasing the precision of RA. If IVUS improves the precision of RA, it may mitigate the impact of lipid-based emulsion prior to stent deployment which was initially reported by Singh et al. [23]
Hypotension requiring vasopressors, insertion of IABP, or pLVAD was documented in 10 cases (8% vs 4%). Five patients met criteria for hypotension based on hemodynamic instability prior to intervention and/or utilization of prophylactic hemodynamic support. The decision to utilize prophylactic hemodynamic support was operator dependent and strongly influenced by hemodynamic instability, chronic comorbidities, and complexity of the target lesion. If these cases are excluded, five patients (4% vs 2%) were documented to develop periprocedural hypotension requiring additional hemodynamic support. The circumstances surrounding these five cases include: no reflow phenomenon (2), PEA arrest responsive to vasopressors (1), Ventricular tachycardia (1), and significant gastrointestinal blood loss (1). Five patients were reported to develop bradycardia (5% vs 0%) in the period surrounding rotational atherectomy. Of these five patients, two had documented bradycardia prior to arrival in the catheterization laboratory. Of the remaining patients, one developed intra-operative bradycardia in the setting of right coronary artery (RCA) intervention and no reflow phenomenon. The final two patients developed bradycardia within 48 h of intervention. In both cases, RA was performed to the LAD without intervention to the RCA or circumflex. It is unclear what role other underlying cardiac pathology may have contributed to these two cases. Furthermore, there is a disparity in the absolute utilization of preemptive transvenous pacemakers (TVP) (3% vs 22% P = 0.001) which may impact our ability to detect bradycardia. The decision to utilize preemptive TVP was an operator dependent decision. The personal practice habit of one of the operators, who does not utilize RotaGlide lubricant, is to rarely utilize preemptive TVP. This physician is a large volume operator whose patient population greatly contributed to the Rota-Flush group. For this reason, the authors feel that the disparity in utilization of TVP is representative of operator preference, not meaningful differences in patient comorbidities or lesion complexity. Two cases (2% vs 0% P = 0.548) were remarkable for a lack of immediate myocardial reperfusion “no reflow” following RA. Both cases involved significant intervention to the RCA with the placement of multiple drug-eluting stents. Coronary blood flow was responsive to intracoronary administration of nitroglycerin, verapamil, heparin, and tirofiban in both cases and angiogram demonstrated TIMI 3 flow prior to departure from the catheterization laboratory. In total, there were three deaths in our study population. Two of the three patients were critically ill upon presentation with a significant burden of ventricular tachycardia and hemodynamic instability. Both of these patients underwent rotational atherectomy with prophylactic hemodynamic support (IABP or pLVAD) due to overwhelming underlying cardiac pathology and imposed poor prognosis. Procedural success was achieved in both cases. Despite successful PCI, the patient's hemodynamic status continued to decline over the remainder of their hospitalization. The final patient tolerated RA well and left the catheterization laboratory in stable condition. However, the patient developed 2:1 AV block 40 h into the postoperative period which progressed to asystole. Autopsy was declined in all three cases.
4.1. Major adverse cardiac events and deaths 4.2. Study limitations Although the incidence of major adverse cardiac events was increased in the Rota-Flush group, the disparity between the two groups did not meet statistical significance. In addition, the incidence of MACE in the Rota-Flush group was strongly driven by the presence of pre-procedural instability, primarily; ischemia induced ventricular tachycardia and hypotension. In total, five patients in the Rota-Flush group met prespecified criteria for MACE prior to arrival in the catheterization laboratory. A sixth patient, who presented with a ST segment elevation myocardial infarction (STEMI) from an outside facility, would meet criteria shortly after arrival. With regards to individual endpoints, several differences in absolute incidence of MACE existed between the two groups. Although these differences did not meet statistical significance, the incidence of hypotension, bradyarrhythmia, and no reflow phenomenon warrant further discussion.
Our study is limited by the retrospective nature of the data collected. It is a non-randomized study and was conducted at a single center. Data was solely collected from the electronic medical record system at our institution. Our study is also limited by its small sample size and short follow up period. Validation of our findings in a larger group and/or a longer follow up period would be of benefit. 5. Conclusion Rotational atherectomy performed with the previously defined Rota-Flush or Rota-Glide solutions resulted in similar rates of procedural success. In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication. Limitations to
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
stent delivery and deployment were minimal as only one case was complicated by suboptimal stent expansion. The disparity in incidence of major adverse cardiac events was not significant between the two groups and was driven by pre-existing clinical instability prior to intervention. An alternative rota-flush solution containing 10,000 U unfractionated heparin, 400mcg nitroglycerin, and 10 mg verapamil in 1 L of normal saline can be an effective alternative to traditional rotaflush solutions containing RotaGlide Lubricant. Supplementary data to this article can be found online at https://doi. org/10.1016/j.carrev.2017.08.013. Acknowledgments No additional acknowledgements beyond the individuals listed as authors who meet the specified conditions for authorship. The authors have no financial relationships to disclose. References [1] Lee MS, Shah N. The impact and pathophysiologic consequences of coronary artery calcium deposition in percutaneous coronary interventions. J Invasive Cardiol 2016;28(4):160–7 [Epub 2015 Aug 25]. [2] Reifart N, Vandormael M, Krajcar M, Preusler W, Schwarz F, Storger H, et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer laser, rotational atherectomy, and balloon angioplasty comparison (ERBAC) study. Circulation 1997;96:91–8. [3] Dill T, Dietz U, Hamm CW, Kuchler R, Rupprecht HJ, Haude M. A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA study). Eur Heart J 2000;21(21):1759–66. [4] Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, et al. Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study. Eur Heart J 1998;19:1224–31. [5] Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, et al. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol 2005;96(9):1242–7. [6] Tian W, Lhermusier T, Minha S, Waksman R. Rational use of rotational atherectomy in calcified lesions in the drug-eluting stent era: review of the evidence and current practice. Cardiovasc Revasc Med 2015;16(2):78–83. [7] Sharma SK, Israel DH, Kamean JL, Bodian CA, Ambrose JA. Clinical, angiographic, and procedural determinants of major and minor coronary dissection during angioplasty. Am Heart J 1993;126(1):39–47. [8] Rathore S, Terashima M, Katoh O, Matsuo H, Tanaka N, Kinoshita Y, et al. Predictors of angiographic restenosis after drug eluting stents in the coronary arteries: contemporary practice in real world patients. EuroIntervention 2009;5(3):349–54.
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[9] Onuma Y, Tanimoto S, Ruygrok P, Neuzner J, Piek JJ, Seth A, et al. Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study. Catheter Cardiovasc Interv 2010;76(5):634–42. [10] Genereux P, Maehara A, Kirtane A, Brener S, Palmerini T, Lasalle L, et al. Impact of coronary calcification on one–year outcomes after PCI in STEMI and NSTEMI: pooled analysis from horizons and acuity trials. J Am Coll Cardiol 2013;61(10):E1716. [11] Lee MS, Yang T, Lasala J, Cox D. Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-elutingstents: two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program. Catheter Cardiovasc Interv 2016;88(6):891–7. https://doi.org/10.1002/ccd.26395 [Epub 2016 Jan 12]. [12] Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 2005;45(7):995–8. [13] Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, et al. 2011 ACCF/ AHA/SCAI guideline for percutaneous coronary intervention: executive summary. J Am Coll Cardiol 2011;58(24):2550–83. [14] Ritchie JL, Hansen DD, Intlekofer MJ, Hall M, Auth DC. Rotational approaches to atherectomy and thrombectomy. Z Kardiol 1987;76(Suppl. 6):59e65. [15] Fourrier JL, Bertrand ME, Auth DC, Lablanche J, Gommeaux A, Brunetaud JM. Percutaneous coronary rotational angioplasty in humans: preliminary report. J Am Coll Cardiol 1989;14(5):1278–82. [16] Cavusoglu E, Kini AS, Marmur JD, Sharma SK. Current status of rotational atherectomy. Catheter Cardiovasc Interv 2004;62(4):485–98. [17] Mintz GS, Potkin BN, Keren G, Satler LF, Pichard AD, Kent KM, et al. Intravascular ultrasound evaluation of the effect of rotational atherectomy in obstructive atherosclerotic coronary artery disease. Circulation 1992;86(5):1383–93. [18] Tomey MI, Kini AS, Sharma SK. Current status of rotational atherectomy. JACC Cardiovasc Interv 2014;7(4):345–53. [19] Farb A, Roberts DK, Pichard AD, Kent KM, Virmani R. Coronary artery morphologic features after coronary rotational atherectomy: insights into mechanisms of lumen enlargement and embolization. Am Heart J 1995;129:1058–67. [20] Jimenez-Valero S, Galeote G, Sanchez-Recalde A, Moreno R. Optical coherence tomography after rotational atherectomy. Rev Esp Cardiol 2009;62:585–6. [21] Kovach JA, Mintz GS, Pichard AD, Kent KM, Popma JJ, Satler LF, et al. Sequential intravascular ultrasound of the mechanisms of rotational atherectomy and adjunct balloon angioplasty. J Am Coll Cardiol 1993;22(4):1024–32. [22] Rotablator rotational atherectomy system reference guide. Accessed at https:// www.bostonscientific.com/content/dam/bostonscientific/Interventional% 20Cardiology/portfolio-group/Plaque-Modification/Rotablator-System-ReferenceGuide_IC-193906-AA.pdf, Accessed date: 18 January 2017. [23] Singh A, Awar M, Ahmed A, Fischman DL, Walinsky P, Savage MP. Facilitated stent delivery using applied topical lubrication. Catheter Cardiovasc Interv 2007;69(2):218–22. [24] Lee MS, Kim MH, Rha SW. Alternative rota-flush solution for patients with severe coronary artery calcification who undergo rotational atherect. J Invasive Cardiol 2017;29(1):25–8 [pii: JIC2016615-1 Epub 2016 Jun 15]. [25] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115(17):2344–51.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy☆ Hoyle L. Whiteside a,⁎, Supawat Ratanapo b, Albert Sey b, Abdullah Omar b, Deepak Kapoor b a b
Department of Internal Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA Department of Cardiology, Medical College of Georgia, Augusta University, Augusta, GA, USA
a r t i c l e
i n f o
Article history: Received 9 July 2017 Received in revised form 18 August 2017 Accepted 22 August 2017 Available online xxxx Keywords: Rotational atherectomy Percutaneous coronary intervention Coronary artery disease
a b s t r a c t Introduction: The efficacy of heparin based flush solutions in rotational atherectomy (RA) has not been validated. Recently, a single center study demonstrated the feasibility of an alternative flush solution with 10,000 U of unfractionated heparin (UFH) in 1 L of normal saline. We aimed to evaluate the safety and efficacy of an alternative flush solution intermittently utilized at our institution. Methods: We retrospectively identified 150 patients undergoing RA over a three year period. One hundred cases utilized an alternative flush solution containing 10,000 U UFH, 400mcg nitroglycerin, and 10 mg verapamil in 1 L normal saline and fifty cases utilized RotaGlide Lubricant (Boston Scientific) in addition to heparin and vasodilators in the same dose. The primary end point was to compare rates of procedural success. Secondary endpoints were to report procedural characteristics including the incidence of major adverse cardiac events (MACE) and minor periprocedural complications. Results: Procedural success was achieved in 98% (98/100) of cases utilizing the alternative Rota-Flush solution compared to 100% (50/50) in the Rota-Glide group (P = 0.553). A total of 292 lesions (200 Rota-Flush vs 92 Rota-Glide) were targeted for intervention. MACE occurred in 13 (13%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.425). Conclusion: Rotational atherectomy performed with the previously defined Rota-Flush or Rota-Glide solutions resulted in similar rates of procedural success. There were no significant disparities in incidence of MACE and minor periprocedural complications between the two groups. Heparin based rota-flush solutions can be effective alternatives to traditional solutions containing RotaGlide Lubricant. © 2017 Elsevier Inc. All rights reserved.
1. Introduction Coronary artery calcium is a marker of advanced coronary artery disease and is a predictor of adverse clinical outcomes including stroke and myocardial infarction [1–5]. Severely calcified coronary lesions increase the intricacy of percutaneous coronary intervention (PCI) and are associated with increased procedural risk and adverse clinical outcomes [6–11]. These lesions can be resistant to adequate predilatation, impair stent delivery and expansion, and lead to an increased rate of stent thrombosis and/or restenosis [1,12]. Current guidelines indicate that rotational atherectomy (RA) is a reasonable approach to heavily calcified lesions which cannot be crossed by a balloon catheter or adequately dilated before stent implantation [13]. RA is a technique which was introduced by Jerome Ritchie and David Auth and first utilized in human ☆ Disclosure statement: The authors report no financial relationships or conflicts of interest regarding the content herein. ⁎ Corresponding author at: Department of Internal Medicine, Augusta University, 1120 15th Street, Augusta, GA 30912, USA. E-mail address: [email protected] (H.L. Whiteside).
cases by Fourrier et al. in 1988 [14,15]. The technique relies on the principle of “orthogonal displacement of friction” and utilizes a rotating diamond shaped burr to modify calcified coronary lesions and reduce plaque burden [16]. The resulting luminal morphology of treated lesions is smooth and nonendothelialized, which differs from lesions treated with balloon angioplasty [17–21]. The Rotablator Rotational Atherectomy System (Boston Scientific, Marlborough, MA) is a device approved for percutaneous rotational coronary angioplasty. The system utilizes a pressurized flush solution to lubricate the drive shaft in order to reduce friction, heat generation, and sudden drops in revolutions per minute [22]. The standard flush solution includes vasodilators such as nitroglycerin and verapamil in addition to RotaGlide Lubricant (Boston Scientific Marlborough, MA) which contains olive oil, egg yolk, phospholipids, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and water [22]. Known clinical complications of rotational atherectomy are similar to those common to PCI and include the need for urgent coronary artery bypass graft surgery, myocardial infarction, stroke, and death. Angiographic complications include coronary vasospasm, dissection, side branch loss, and slow-flow/no-reflow phenomenon [16,18].
https://doi.org/10.1016/j.carrev.2017.08.013 1553-8389/© 2017 Elsevier Inc. All rights reserved.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
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H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
RotaGlide Lubricant has been studied in a small population of twenty patients following failed stent placement [23]. It was reported to facilitate stent delivery in complex lesions in addition to being safe and biocompatible with drug-eluting stents. The efficacy of alternative rotaflush solutions has not been thoroughly investigated. In a recent case series, Lee et al. evaluated the safety and feasibility of a heparin based rota-flush solution in the absence of vasodilators [24]. The authors report that the use of a heparin based rota-flush solution without vasodilators is a reasonable alternative to RotaGlide and vasodilators. These findings have not yet been validated. We sought to evaluate the safety and procedural success rate of an alternative rota-flush solution intermittently utilized at our institution and its potential impact on both major adverse cardiac events (MACE) and minor periprocedural complications. 2. Methods 2.1. Study population Following institutional review board approval, we identified all patients who underwent rotational atherectomy at the Medical College of Georgia/Augusta University Medical Center between January 1st 2014 and December 31st 2016, using an institutional database. One hundred and fifty patients met inclusion criteria and data was extracted from the electronic medical record system in accordance to the study protocol. 2.2. Procedural technique and medical intervention Patients underwent percutaneous coronary intervention (PCI) with rotational atherectomy performed by one of six operating physicians. Standard techniques were utilized to perform PCI via a transradial or transfemoral approach. Dual-antiplatelet therapy with a P2Y12 inhibitors and aspirin was administered prior to PCI. Unfractionated heparin was administered intravenously throughout the procedure to achieve an activated clotting time (ACT) N250 s. Intravascular ultrasound (IVUS) was utilized prior to intervention in all but one case and fractional flow reserve (FFR) was utilized to evaluate coronary lesions with 50– 70% stenosis. The selection of arterial access sheath, burr size, and stent type (bare-metal vs drug-eluting) was determined by the operating physician. In addition, the decision to utilize a temporary pacemaker and/or provide hemodynamic support with an intra-aortic balloon pump (IABP) or percutaneous left ventricular assist device (pLVAD) was operator dependent, based on patient and target lesion profile. Rotational atherectomy was performed using one of two rota-flush solutions based on operator preference. The “Rota-Glide” solution contained one 20cm 3 vial of RotaGlide Lubricant, 10 mg verapamil, 400 mcg nitroglycerin, and 10,000 U unfractionated heparin in 1 L of normal saline. The alternative “Rota-Flush” solution contained 10 mg verapamil, 400 mcg nitroglycerin, and 10,000 U unfractionated heparin in 1 L of normal saline. The target lesion was crossed using a 0.014″ work-horse wire followed by wire exchange for a 0.009”Rota-floppy wire (Boston Scientific, Marlborough, MA) via an over-the-wire balloon or microcatheter. A pressure bag infusion containing either Rota-Glide or the alternative Rota-Flush solution was utilized based on operator preference. The flush solution was started and the burr was advanced through the lesion using a pecking technique. The duration of each pass with the burr was less than or equal to 20 s. Following rotational atherectomy, the decision to proceed with coronary angioplasty and/ or stent placement was routinely guided by IVUS. All patients were treated with dual antiplatelet therapy following PCI. In addition, all patients were prescribed an angiotensinconverting enzyme inhibitor or angiotensin II receptor blocker, beta-blocker, and statin at the time of discharge unless clinically contraindicated.
2.3. Data extraction A detailed chart review was conducted to collect demographic data including cardiac risk factors, echocardiographic data, procedural characteristics, and the incidence of MACE and minor periprocedural complications. All physician notes were reviewed up until the time of discharge in order to extract both subjective and objective data such as the development of anginal symptoms or hematoma at arterial access site. All data was entered into a dedicated rotational atherectomy database. 2.4. Study endpoints The primary end point was procedural success defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 and residual stenosis ≤ 30% after final percutaneous transluminal coronary angioplasty (PTCA) and/or stent placement. If stent loss, death, or an indication for emergent PCI and/or coronary artery bypass graft surgery developed during the first 24 h, the procedure was considered a failure. Secondary endpoints were the development of major and minor periprocedural complications prior to hospital discharge. Major adverse cardiac events were defined as: bradycardia requiring transvenous pacing, hypotension requiring vasopressors or placement of mechanical hemodynamic support (IABP or pLVAD), sustained ventricular arrhythmia, need for target lesion revascularization, non-fatal myocardial infarction, stroke, and cardiac death. Target lesion revascularization was defined as the development of ischemia due to a stenosis of ≥50% of the luminal diameter either within the stent or within 5 mm of its borders which required surgical or percutaneous revascularization. Acute and subacute stent thrombosis was defined according to the Academic Research Consortium definition [25]. Myocardial infarction was defined as the development of new ST-segment elevation or an increase in cardiac biomarkers either ≥2× the upper limit of normal or above the previously documented value in addition to the development of ischemic symptoms. Death was to be considered cardiac in origin unless a non-cardiac origin was documented in the electronic medical record. Minor periprocedural complications were defined as: development of hematoma or pseudoaneurysm at the vascular access site or reported systemic blood loss from any source. 2.5. Statistical analysis Statistical analysis was performed with R© version 3.3.1 (2016-0621) -The R Foundation for Statistical Computing Platform. The difference between means for continuous variables was tested by two-tailed t-test. For categorical values, the Fishers exact test was utilized in testing the significance of dependent variables on independent variables. Pvalues b 0.05 were considered statistically significant. Descriptive statistics were used to analyze procedural characteristics. Continuous variables are reported as a mean and standard deviation while categorical variables are reported as a value and percentage. 3. Results 3.1. Population demographics and procedural characteristics Patient demographics and cardiac risk factors for both the RotaFlush and Rota-Glide groups are documented in Table 1. A total of 292 lesions (200 Rota-Flush vs 92 Rota-Glide) were targeted for intervention and the distribution of target lesions are listed in Table 2. Unprotected left main disease was targeted in 19 (19%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.095). A complete list of procedural characteristics including: burr size, number of stents utilized, type of stent deployed, and application of IVUS is provided in Table 3.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx Table 1 Population demographics.
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Table 3 Procedural characteristics. Rota-flush (N = 100)
Rota-glide (N = 50)
Demographics Age Gender (male) Diabetes mellitus Hypertension Hyperlipidemia History of stroke History of myocardial infarction History of coronary angioplasty History of coronary bypass
Result ± SD (%) 67.5 ± 9.8 64 (64) 61 (61) 88 (88) 82 (82) 8 (8) 34 (34) 39 (39) 34 (34)
Result ± SD (%) 69.8 ± 10.5 37 (74) 21 (42) 49 (98) 35 (70) 6 (12) 16 (32) 18 (36) 9 (18)
P P P P P P P P P
= = = = = = = = =
0.198 0.330 0.269 0.061 0.100 0.552 0.856 0.859 0.055
Echocardiograms Ejection fraction b30% 30% to 50% 50% or greater
N = 98 (98) 48.1 ± 14.8 15 (15) 32 (32) 51 (51)
N = 48 (96) 45.1 ± 16.7 11 (22) 12 (24) 25 (50)
P P P P
= = = =
0.294 0.288 0.505 0.908
3.2. Clinical outcomes The primary endpoint of procedural success was achieved in 98% (98/100) of cases utilizing the alternative Rota-Flush solution compared to a 100% (50/50) success rate in the Rota-Glide group (P = 0.553). In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication. Major adverse cardiac events occurred in 13 (13%) and 4 (8%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.425) and the incidence of each event is reported in Table 4. Hypotension requiring the addition of vasopressors and/or mechanical hemodynamic support (IABP or pLVAD) was the most common major complication (8% Rota-Flush vs 4% Rota-Glide). Prophlylactic hemodynamic support with either IABP or pLVAD was utilized in six patients (4% Rota-Flush vs 4% Rota-Glide). Five cases required intraoperative bail out hemodynamic support with either vasopressors (5) and/or IABP (3) (4% RotaFlush vs 2% Rota-Glide). In all cases of hypotension, procedural success was achieved and all patients left the catheterization laboratory with adequate blood pressure in the setting of vasopressors or mechanical hemodynamic support. Minor periprocedural complications occurred in 8 (8%) and 5 (10%) cases in the Rota-Flush and Rota-Glide groups, respectively (P = 0.76). This includes one case of guide wire entrapment which was not one of the prespecified minor periprocedural complications, but was included based on consensus agreement by the authors. The incidence of each minor periprocedural complication is documented in Table 4. Of one hundred and fifty cases included in our study, there were three documented deaths. Two patients were critically ill upon presentation and the third developed conduction abnormalities N 24 h
Procedural success IVUS Access Femoral Radial Burr size 1.25 1.5 1.75 2.0 2.15 2.25 Stents per case 0 1 2 3 4 5 Type of stent utilized by case DES BMS Sheath size (Fr) 6 7 8 6.5 sheathless guide Procedural Support Temporary pacemaker IABP LVAD (Impella)
Rota-flush (N = 100)
Rota-glide (N = 50)
Result ± SD (%)
Result ± SD (%)
98 (98) 100 (100)
50 (100) 49 (98)
96 (96) 4 (4) 1.79 ± 0.30 7 (7) 26 (26) 29 (29) 18 (18) 8 (8) 12 (12) 1.82 ± 1.10 13 (13) 24 (24) 38 (38) 19 (19) 5 (5) 1 (1) N = 87 80 (80) 7 (7)
46 (92) 4 (8) 1.58 ± 0.23 9 (18) 24 (48) 10 (20) 7 (14) 0 (0) 0 (0) 1.78 ± 0.89 1 (2) 22 (44) 15 (30) 11 (22) 1 (2) 0 (0) N = 49 48 (96) 1 (2)
33 (33) 30 (30) 37 (37) 0 (0)
13 (26) 14 (28) 22 (44) 1 (2)
3 (3) 5 (5) 5 (5)
11 (22) 5 (10) 2 (2)
Abbreviations: BMS: bare-metal stent; DES: drug-eluting stent; IABP: intra-aortic balloon pump; IVUS: Intravascular ultrasound; LVAD: left ventricular assist device.
postoperatively. Demographic data, procedural characteristics, and a brief summary of hospital course for these three cases are provided in (Supplementary materials: Table 1). The option for autopsy was declined in all three cases.
4. Discussion The primary end point of our study was to report the procedural success rate for rotational atherectomy performed with the previously defined alternative Rota-Flush solution. In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication.
Table 4 Major adverse cardiac events and periprocedural complications. Table 2 Distribution of target lesions. Lesion location
Rota-flush (N = 100)
Rota-glide (N = 50)
LM Unprotected LM Prox LAD Mid LAD Distal LAD Prox RCA Mid RCA Prox LCx Mid LCx PDA Ramus Total lesions
23 (23) 19 (19) 36 (36) 39 (39) 3 (3) 22 (22) 29 (29) 17 (17) 10 (10) 1 (1) 0 (0) N = 200
5 (10) 4 (8) 29 (58) 23 (46) 4 (8) 9 (18) 8 (16) 5 (10) 3 (6) 0 (0) 1 (2) N = 92
P P P P P P P P P P P
= = = = = = = = = = =
0.074 0.095 0.011 0.412 0.188 0.569 0.086 0.259 0.417 0.798 0.271
Abbreviations: LAD: left anterior descending artery; LCx: left circumflex artery; LM: left main; PDA: posterior descending artery; RCA: right coronary artery.
Major adverse cardiac events Hypotension Bradycardia Ventricular arrhythmia No reflow Tamponade Dissection Recurrent angina Minor complications Blood loss Pseudoaneurysm Hematoma Guide-wire entrapment⁎ Deaths
Rota-flush (N = 100)
Rota-glide (N = 50)
13 (13) 8 (8) 5 (5) 3 (3) 2 (2) 0 0 1 (1) 8 (8) 3 (3) 1 (1) 3 (3) 1 (1) 3 (3)
4 (8) 2 (4) 0 1 (2) 0 1 (2) 2 (4) 0 5 (10) 0 1 (2) 4 (8) 0 0
P P P P P P P P P P P P P P
= = = = = = = = = = = = = =
0.425 0.360 0.237 0.722 0.548 0.271 0.134 0.798 0.760 0.398 0.622 0.188 0.798 0.397
⁎ Not included in prespecified list of periprocedural complications.
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
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H.L. Whiteside et al. / Cardiovascular Revascularization Medicine xxx (2017) xxx–xxx
Procedural success was achieved in all but two cases. The first failed case, involved rotational atherectomy targeting the left main (unprotected), proximal, and middle left anterior descending (LAD) arteries. RA was performed without complication using a maximum burr size of 2.25 mm. In this case, the mid LAD stent could only be partially expanded due to hard underlying plaque and resulted in a residual 50% stenosis. There was good flow distal to the lesion and the stent remained patent at 7 months follow up. The second failed case involved a patient who developed recurrent angina following successful RA. Subsequent coronary angiogram revealed a 50% stenosis due to a soft plaque at the distal edge of a middle LAD stent which prompted additional intervention, which was successful. In a case series of 67 patients, Lee et al. examined the safety and procedural success rates of an alternative heparin based rota-flush solution and concluded that it is a reasonable alternative to standard flush solutions containing RotaGlide Lubricant [24]. Their work provides insight into the potential utility of alternative rota-flush solutions; however it is limited by a lack of comparison to standard flush solutions. In our study, we were able to retrospectively analyze and compare the procedural success and periprocedural complication rates of patients undergoing rotational atherectomy with a standard Rota-Glide solution and an alternative heparin based Rota-Flush solution utilized at our institution. Procedural success was achieved in all but two cases and the difference between the two groups was not statistically significant (98/100 vs 50/50 P = 0.553). This data provides additional evidence to validate the efficacy of alternative heparin based rota-flush solutions in rotational atherectomy. If evidence continues to suggest that the addition of Rota-Glide lubricant does not have a statistically meaningful impact on procedural success and periprocedural outcomes, then the theoretical benefit of performing rotational atherectomy in the absence of Rota-glide becomes multifactorial. First, Rota-Glide is a foreign substance with multiple components including olive oil and egg yolk phospholipids. While adverse reactions to these components are uncommon, the risk is not nonexistent and utilization of the solution is contraindicated in patients with known allergies. Second, there is a cost associated with the utilization of Rota-glide lubricant. At our institution, the cost is reported at $80.75 per vial. Although the cost of Rota-glide lubricant is minimal relative to total expense of PCI, in the absence of clearly defined impact on procedural success and outcomes, Rota-glide may represent an unnecessary expenditure. Third, all pharmaceutical products are regulated and subject to shortages, contamination, and expiration. Of note, IVUS was utilized in all but one case. It is possible that the use of IVUS prior to intervention can better delineate the morphology of the target lesion, increasing the precision of RA. If IVUS improves the precision of RA, it may mitigate the impact of lipid-based emulsion prior to stent deployment which was initially reported by Singh et al. [23]
Hypotension requiring vasopressors, insertion of IABP, or pLVAD was documented in 10 cases (8% vs 4%). Five patients met criteria for hypotension based on hemodynamic instability prior to intervention and/or utilization of prophylactic hemodynamic support. The decision to utilize prophylactic hemodynamic support was operator dependent and strongly influenced by hemodynamic instability, chronic comorbidities, and complexity of the target lesion. If these cases are excluded, five patients (4% vs 2%) were documented to develop periprocedural hypotension requiring additional hemodynamic support. The circumstances surrounding these five cases include: no reflow phenomenon (2), PEA arrest responsive to vasopressors (1), Ventricular tachycardia (1), and significant gastrointestinal blood loss (1). Five patients were reported to develop bradycardia (5% vs 0%) in the period surrounding rotational atherectomy. Of these five patients, two had documented bradycardia prior to arrival in the catheterization laboratory. Of the remaining patients, one developed intra-operative bradycardia in the setting of right coronary artery (RCA) intervention and no reflow phenomenon. The final two patients developed bradycardia within 48 h of intervention. In both cases, RA was performed to the LAD without intervention to the RCA or circumflex. It is unclear what role other underlying cardiac pathology may have contributed to these two cases. Furthermore, there is a disparity in the absolute utilization of preemptive transvenous pacemakers (TVP) (3% vs 22% P = 0.001) which may impact our ability to detect bradycardia. The decision to utilize preemptive TVP was an operator dependent decision. The personal practice habit of one of the operators, who does not utilize RotaGlide lubricant, is to rarely utilize preemptive TVP. This physician is a large volume operator whose patient population greatly contributed to the Rota-Flush group. For this reason, the authors feel that the disparity in utilization of TVP is representative of operator preference, not meaningful differences in patient comorbidities or lesion complexity. Two cases (2% vs 0% P = 0.548) were remarkable for a lack of immediate myocardial reperfusion “no reflow” following RA. Both cases involved significant intervention to the RCA with the placement of multiple drug-eluting stents. Coronary blood flow was responsive to intracoronary administration of nitroglycerin, verapamil, heparin, and tirofiban in both cases and angiogram demonstrated TIMI 3 flow prior to departure from the catheterization laboratory. In total, there were three deaths in our study population. Two of the three patients were critically ill upon presentation with a significant burden of ventricular tachycardia and hemodynamic instability. Both of these patients underwent rotational atherectomy with prophylactic hemodynamic support (IABP or pLVAD) due to overwhelming underlying cardiac pathology and imposed poor prognosis. Procedural success was achieved in both cases. Despite successful PCI, the patient's hemodynamic status continued to decline over the remainder of their hospitalization. The final patient tolerated RA well and left the catheterization laboratory in stable condition. However, the patient developed 2:1 AV block 40 h into the postoperative period which progressed to asystole. Autopsy was declined in all three cases.
4.1. Major adverse cardiac events and deaths 4.2. Study limitations Although the incidence of major adverse cardiac events was increased in the Rota-Flush group, the disparity between the two groups did not meet statistical significance. In addition, the incidence of MACE in the Rota-Flush group was strongly driven by the presence of pre-procedural instability, primarily; ischemia induced ventricular tachycardia and hypotension. In total, five patients in the Rota-Flush group met prespecified criteria for MACE prior to arrival in the catheterization laboratory. A sixth patient, who presented with a ST segment elevation myocardial infarction (STEMI) from an outside facility, would meet criteria shortly after arrival. With regards to individual endpoints, several differences in absolute incidence of MACE existed between the two groups. Although these differences did not meet statistical significance, the incidence of hypotension, bradyarrhythmia, and no reflow phenomenon warrant further discussion.
Our study is limited by the retrospective nature of the data collected. It is a non-randomized study and was conducted at a single center. Data was solely collected from the electronic medical record system at our institution. Our study is also limited by its small sample size and short follow up period. Validation of our findings in a larger group and/or a longer follow up period would be of benefit. 5. Conclusion Rotational atherectomy performed with the previously defined Rota-Flush or Rota-Glide solutions resulted in similar rates of procedural success. In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication. Limitations to
Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013
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Please cite this article as: Whiteside HL, et al, Efficacy of a heparin based rota-flush solution in patients undergoing rotational atherectomy, Cardiovasc Revasc Med (2017), https://doi.org/10.1016/j.carrev.2017.08.013