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Structural Heart Disease
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Structural Heart Disease Exhibit Halls A and B Monday, October 17, 2005, 9:00 am - 5:00 pm (Abstract Nos. 209-224) TCT-209 Acute Morphologic Differences between Alcohol Septal Ablation and Surgical Septal Myectomy Uma S Valeti1, Rick A Nishimura1, David R Holmes, Jr.1, Jerome F Breen1, Philip A Araoz1, Charanjit S Rihal1, Bernard J Gersh1, Hartzell A Schaff1, Barry J Maron2 1 Mayo Clinic, Rochester, MN;2Minneapolis Heart Institute Foundation, Minneapolis, MN Background: There is significant controversy regarding the different effects of surgical septal myectomy (SM) and alcohol septal ablation (ASA). Objective: To describe the acute morphologic differences that result from SM and ASA using cardiac MRI Methods and Results: Cine and contrast-enhanced MRI images were obtained in HCM patients before and after SM (n=14) and ASA (n=17). The location of the septal reduction, extent of myocardial necrosis and conduction system abnormalities were compared. With SM, there was a discrete area of resected tissue in the basal anterior ventricular septum and involved only the LV side of the septum in a non-transmural fashion. (Fig A). There was no evidence of post operative intramyocardial necrosis at the site of SM. In contrast, ASA produced a large transmural infarction, located more inferiorly in the basal septum and also extending into the inferior septum at the midventricular level (Fig. B). The area of infarction due ASA was substantial, 17 ± 7 gm, 3-fold greater than the average amount of tissue resected by SM (6 ± 5gm, p<0.0001). Left bundle branch block developed in 62% of SM patients and right bundle branch block developed in 47% of ASA patients. Conclusions: SM and ASA for severely symptomatic, drug refractory patients with obstructive HCM have substantially different effects on LV septal myocardium, in which only ASA produced a large intramyocardial scar. These findings have important implications for patient selection and management, as well as long term outcome.
TCT-210 Early Course of Hemodynamic and Morphologic Changes in Patients Undergoing Alcohol Septal Ablation for Obstructive Hypertrophic Cardiomyopathy is Influenced by Age of Patients Josef Veselka1, Radka Duchonova1, Sarka Prochazkova1, Ingrid Homolova1, David Zemanek1, Jana Palenickova1, David Tesar2 1 Dpt. of Cardiology, Prague 5, Czech Republic2Dpt. of Imaging Methods, Prague 5, Czech Republic Background: The hemodynamic and clinical benefit of alcohol septal
ablation (PTSMA) has been convincingly demonstrated in many studies up to now. The aim of this study was to compare the time course of both hemodynamic and morphological changes related to the age of treated patients. Methods: Forty-four patients (54 ± 13 years, range 24-81 years) with a symptomatic obstructive hypertrophic cardiomyopathy (HCM) receiving a maximum medical therapy were enrolled consecutively. The study population was divided into three groups according to their age; group A [14 pts. (24-48 years)], group B [14 pts. (49-60 years)] and group C [16 pts. (61-81 years)]. Clinical and echocardiographic data were obtained at the baseline and periodically up to 12 months after PTSMA. Results: At the baseline, there was a significant difference between septum thickness (IVS) in age-related groups (24 ± 5 mm vs 21 ± 3 mm vs 19 ± 3 mm for groups A vs B vs C; p<0.01 for group A vs groups B and C). A significant IVS reduction was identified in all age-related groups of patients (p<0.01). There was a significant correlation between IVS and age at the baseline and in the early postprocedural period. However, this correlation was not significant after IVS remodeling at 3 and 12-month examination. At the baseline, there were no significant differences between LV outflow gradient in all age-related groups (70 mmHg [40 - 108] vs 54 mmHg [40 - 89] vs 69 mmHg [37 - 97] for groups A vs B vs C). A significant outflow gradient reduction was identified in all age-related groups of patients (p<0.01). After multivariate adjustment, there was a significant influence of age (p<0.01) on course of LV outflow gradient decrease. Conclusion: PTSMA is an effective treatment option for patients with obstructive HCM irrespective of their age. Our study suggests that the younger patients are characterized by a thicker basal septum at the baseline and slower hemodynamic and morphologic improvement within the early postprocedural period. TCT-211 Percutaneous Closure of the Left Atrial Appendage to Prevent Stroke in Patients with Atrial Fibrillation - Current Results of the First USEuropean Multicenter Trial Evelyn Fischer1, Mark Reisman2, William Gray3, Heyder Omran4, Paul Kramer5, Antonio Bartorelli6, Paolo Della Bella6, Peter Block7, Carlo DiMario8, Ray Matthews9, Jeffery Moses10, Allan Skanes11, Bernhard Meier12, Athena Poppas13, David Williams14, Paul Teirstein15, Yves Bayard16, Stefan Ostermayer1, Thomas Trepels1, Kai Billinger1, Michaela Leetz1, Madlen Reschke1, Horst Sievert1 1 CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany2Swedish Cardiovascular Research Institute, Seattle, WA;3University of California, San Francisco, CA;4University of Bonn Medicine and Cardiology, Bonn, Germany5Shawnee Mission Medical Centre, Shawnee Mission, KS;6Centro Cardiologico S.p.A., Milan, Italy7Emory University Hospital, Atlanta, GA;8Ospedale San Raffaelle, Milan, Italy9Good Samaritan Hospital, Los Angeles, CA;10Lenox Hill Hospital, New York, NJ;11London Health Sciences Centre, London, ON, Canada12Swiss Cardiovascular Center Bern, Bern, Switzerland13Rhode Island Hospital, Providence, RI;14Lenox Hill Hospital, Providence, RI;15Scripps Clinic Medical Group, La Jolla, CA;16CardioVascular Center, Farnkfurt, Sankt Katharinen, Frankfurt, Germany Background: The left atrial appendage is the most important source of cardiogenic thrombi in patients with atrial fibrillation, causing major strokes. Closing the left atrial appendage (LAA) with the Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO) device may be an alternative for patients with contraindications for warfarin therapy. Methods: The device is a self-expanding nitinol cage covered with ePTFE. It is delivered through a 12 French transseptal sheath especially designed to access the LAA. 111 patients with a mean age of 71±9 years were enrolled in the PLAATO feasibility study and followed for a total of 168 patient years. Results: In three patients a device could not be implanted due to complications
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) when accessing the groin, a thrombus noted in the right atrium and cardiac tamponade, respectively. In all other patients the device was successfully implanted. During the procedure, cardiac tamponade occurred in 4 patients. One had to undergo surgery and three pericardiocentesis. During follow up, 9 patients died. Reasons for death were cerebral hemorrhage (1), multiorgan-failure (3), sudden cardiac death (1), renal failure (2), suicide (1) and brain tumor (1). None of these deaths were procedure or device related. In one patient, an echo-dense layer was found on the device surface at the 1 month and 6 month follow up, but was resolved at the 9 month follow up without sequelae. The expected annual risk of stroke of our patients based on the CHADS2 score was 6.3%. Six patients sustained a stroke during follow up, so that the annual stroke rate was 3.6%. That leads to a risk reduction by PLAATO of 43%. Conclusions: Follow up tests show, that LAA occlusion with the PLAATO device is a feasible and safe method to prevent stroke in high risk AF patients with contraindication for warfarin therapy. TCT-212 Cardiac Magnetic Resonance Imaging in Patients with Transcatheter Closure of Patent Foramen Ovale Thorsten Nusser1, Martin Höher2, Nico Merkle1, Olaf Grebe1, Jochen Spiess1, Hans A. Kestler1, Matthias Kochs1, Vinzenz Hombach1, Jochen Wöhrle1 1 University of Ulm, Ulm, Germany2Klinikum Bayreuth, Bayreuth, Germany
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Background: Cardiac magnetic resonance imaging (CMRI) is a powerful and non-invasive tool for detailed assessment of cardiac anatomy and function. The value of CMRI compared with transesophageal echocardiography (TEE) in patients undergoing transcatheter closure of patent foramen ovale (PFO) has not been settled so far. Methods: In patients with cryptogenic ischemic events and PFO CMRI was performed pre and post PFO closure. The intervention was done with fluoroscopy and TEE guidance using the Cardia Star™ device. CMRI was compared to TEE regarding the detection of atrial septal aneurysm (ASA) and contrast enhanced right-to-left shunting during Valsalva maneuver. In CMRI the atrial septum was scanned using highresolution short axis cine images with a turbo-field-echo sequence on a 1.5T whole body scanner. To determine provokable atrial rightto-left shunting in CMRI we performed contrast enhanced real-time perfusion analysis in two cine sequences, a short axis and a long axis 4-chamber view, using a bolus of 0.1mmol/kg body weight Gd-DTPA. Results: We analyzed 75 patients after cryptogenic ischemic events with CMRI pre and after transcatheter PFO closure and at 12 months (n=65). In high-resolution cine images ASA was seen in 28/75 (37%) compared with 63% (47/75) in TEE. We performed 211 CMRI studies with corresponding TEE. With contrast enhanced perfusion analysis, CMRI detected right-toleft shunting in 48/72 (67%) of moderate or severe shunts but only 6/32 (18%) of mild shunts in TEE. No shunt was present in 107 patients with both techniques. Volumetric and flow measurements revealed systemic shunts in 18/75 patients, which completely disappeared after closure. CMRI exlcuded anomalous venous returns in all and detected coronary anomaly in two patients. Conclusions: Present CMRI technique is inferior to TEE in detection of contrast enhanced right-to-left shunting and identification of ASA, but provides additional information regarding systemic shunts and cardiac anomalies. In patients not tolerating the TEE probe, CMRI provides valuable information on atrial septal morphology and cardiac shunting.
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TCT-213 Late Failure of Percutaneous PFO Closure: Mechanisms of Failure and Treatment Options Sherman G Sorensen1, James W Long2, Steven C Horton1, Peter J Casterella1, Laurie Raleigh3, Heather Aguilar3, Donald L Lappé1, Joseph B Muhlestein2 1 Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2LDS Hospital Cardiology, Salt Lake City, UT;3Utah Heart Clinic, Salt Lake City, UT BACKGROUND: Percutaneous catheter closure of patent foramen ovale (PFO) is an increasingly accepted treatment option for stroke prevention that has good procedural safety and early results. However, late results due to device failure are unknown. Differences of device design, device materials, implantation technique, healing effect, or PFO morphologic features may influence long-term outcomes. METHODS: From 2001-2005, 950 PFO closure procedures were performed with 261 CardioSEAL® (CS) and 689 Amplatzer® PFO (AMP) devices. Implant imaging used transesophageal echocardiography in 430 patients (pts) and intra-cardiac echocardiography in 520 pts. In our early experience with the CS device, pts with long PFO tunnel (> 10 mm) and large PFO with atrial septal aneurysm (ASA) were usually treated by the transeptal technique. Eleven (1.0%) pts (3 AMP, 8 CS) required evaluation and treatment for persistent or late failure of PFO closure (range: 9-26 months post closure). Evaluation of these pts was prompted by transient ischemic attack (TIA) in 4 pts, recurrent complex migraine (migraine with TIA symptoms) in 3 pts, and persistent severe shunt in 4 pts. RESULTS: There were 3 AMP pts that had severe persistent shunting. All had ASA, long tunnel, and closure with a 35 mm AMP device. Catheter treatment was not feasible and all were treated medically without event. Of the 8 CS pts, 5 developed progressive shunt worsening from implant to symptom presentation. All CS failure patients were closed by the transeptal technique, had a tunnel of 15-27 mm, had an ASA, and received a large device (40 mm= 4 pts, 33 mm= 4 pts). Device retraction and arm splay was defined by echocardiography in all and by surgical removal in 4 pts. There were 4 pts treated by second device placement (second device: AMP PFO= 2 pts, AMP SO= 2 pts). CONCLUSIONS: We conclude that 1) Late PFO closure failure is uncommon and is multi-factorial; 2) Healing retraction is related to transeptal placement and device type, but is treatable by second device placement; 3) AMP failure due to non incorporation is difficult to treat percutaneously; and 4) Complex PFO morphology may be better treated with devices resulting in better defect filling and device apposition. TCT-214 Incidence of Thrombus Formation on ASD and PFO Closure Devices Ilona Hofmann, Madlen Reschke, Hildegard Lißmann-Jensen, Horst Sievert CardioVascularCenter, Frankfurt/Main, Germany Purpose: A potential complication of transcatheter ASD and PFO closure is a thrombus formation on the device. We analyzed the incidence, morphology and clinical relevance of thrombus formation on these devices detected by transesophageal echocardiography. Methods: From August 1992 to April 2005, 1531 adult patients underwent transcatheter closure of a patent foramen ovale (n= 969) or an atrial septal defect (n=562). The transesophageal echocardiography was performed after 4 weeks and 6 months and on clinical indikation. Results: Thrombus formation was detected on the device in 19 (PFO: n=12, ASD: n=7) of 1531 patients (1,2%). The size of thrombus ranged from 3, 7 to 30 mm. Thrombus was attached on the left atrial side in 11 patients, on the right atrial side in 4 patients and on the
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) both in 3. In 1 case thrombus was diagnosed on the Eustachean tube. This was observed after 2-4 weeks in 14, after 6 months in 1, after 1 year in 2, after 4 years in 1 and after 5 years in 1patient. 12 patients with thrombus had a Starflex-Occluder, 3 patients an ASDOSOccluder, in each case 1 patient an Amplatzer, a Cardioseal and in 2 cases were used the Helex. Post procedure device arm fractures were found in 3 patients (16%) and atrial fibrillation in 2 patients (11%). 3 embolic events (3 minor strokes) occurred. In 16/19 patients the thrombus resolved following anticoagulation therapy (heparin, warfarin) or antiplatelet medication (aspirin, clopidogrel). In 3/19 patients the thrombus had to be removed surgically. Conclusion: The incidence of thrombus formation on closure devices is low. In most of the patients the thrombus resolved under anticoagulation therapy without clinical consequences. Significant predictors of thrombus were device arm fracture, atrial fibrillation, atrium septal aneurysm and specific occluder model. TCT-215 Transcatheter Closure of Perimembranous Ventricular Septal Defect by Amplatzer Devices: Immediate and Long-Term Follow-Up Results Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta, Manish Sharma, Dinesh Raj, Ramesh Arora, Sanjay Tyagi G B Pant Hospital and Maulana Azad Medical College, New Delhi, India Background: Transcatheter closure of perimembranous ventricular septal defect (PMVSD) is an evolving new therapeutic modality even for patients with restrictive defects. We report our single center experience with Amplatzer muscular ventricular septal occluder (AMSO) and Amplatzer asymmetric perimembranous occluder (ASPO) with long-term follow up results. Method: Between January1998 and December 2004, 82 patients (58 male, 24 female), aged 2-33 years (median 12 years) and weight 8-52 kg (median 24 kg) underwent closure of PMVSD (60 with AMSO and 22 with ASPO). Included were patients of PMVSD with (i) small band or rim of ≥ 5 mm from aortic valve (for ASPO defects with < 5 mm were also included). (ii) distance from center to insertion of right coronary cusp >50% of required device size (iii) aneurysm formation. Size of VSD assessed by echocardiography varied from 2.5 to 12mm (mean 5.2 ± 2.1mm). 36 patients had aneurysm formation and seven had left ventricle to right atrial communication. Pulmonary to systemic flow ratio was > 2:1 in 32 patients (39%). Device was delivered through transvenous route in all cases except one. Devices were deployed under fluoroscopic and transthoracic echocardiographic guidance (TTE)/ angiography and size of device chosen(4-14 mm) was 2mm larger than that determined by TTE but equal to stretched balloon diameter (34 patients). Results: AMSO could be positioned successfully in all (n=60) while ASPO had to be retrieved in 3 patients who developed acute AR with hemodynamic compromise (superior margin of defect < 3 mm from aortic valve in all) resulting in a procedural success rate of 96.4%. Incidence of residual shunt 24 hours after procedure was 3(0.03%). All had trivial shunts that disappeared within 1 month. New tricuspid stenosis was observed in 1 patient with AMSO that resolved with balloon dilatation. Patients were followed up by TTE and ECG at 24 hours,1,3 and 6 monthly thereafter. At 6-84 months (mean 38.2 ± 12.8) follow-up, there was no incidence of migration/fracture of device, infective endocarditis, aortic regurgitation, hemolysis or development of conduction defect. Conclusion: Closure of PMVSD with Amplatzer devices is safe and effective with low rate of complications.
TCT-216 Transcatheter Closure of Atrial Septal Defects and Patent Foramen Ovale Using the Helex Septal Occluder Stefan H U Ostermayer, Neil Wilson, Kai Billinger, Madlen Reschke, Yves Bayard, Franziska Buescheck, Evelyn Fischer, Michaela Leetz, Margaret Taaffe, Ralph Hein, Albrecht Roemer, Horst Sievert CardioVascular Center Frankfurt, Frankfurt, Germany Background: Transcatheter closure of atrial septal defects (ASD) and patent foramen ovale (PFO) has become a routine procedure in many centers. The Helex septal occluder (W.L. Gore and Associates, Flagstaff, AZ) is a twoumbrella device formed by one continuous nitinol wire which is covered by ePTFE (expanded polytetrafluoroethylene). It has a unique spiral shape which provides a very low profile and an atraumatic healing process after implantation. Methods: Between December 1999 and May 2005 percutaneous interatrial defect closure using the Helex septal occluder was attempted in 353 patients (51 ASD/ 302 PFO). Post procedure patients received clopidogrel (PFO only), aspirin and a subacute endocarditis prophylaxis for the first six months following the procedure. Transesophageal echocardiography, fluoroscopy and chest-X-ray were performed at one and six months. Thereafter, follow-up was performed clinically and by questionnaire (14.6 ± 14.2 months, 430 patient years). Results: Implantation of the Helex septal occluder was successful in 349 patients. In three patients the Helex occluder showed a suboptimal position during implantation and was therefore removed and exchanged for a different type of device. In three patients the occluder embolized immediately following implantation or during the initial hospital stay. In one of them a different device was implanted while two patients received a Helex occluder during a second attempt. In two further patients device embolization was noticed at the one and six months follow-up. Both received a different type of device during a second procedure. The stretched ASD diameter determined by balloon sizing was 13.0 ± 3.3 mm, the stretched PFO diameter was 9.2 ± 3.6 mm. Twelve patients received a second device: Two patients because of a second defect and ten patients because of a residual shunt of the first occluder. One hundred thirty-eight patients had an atrial septal aneurysm in additional to their ASD or PFO. Conclusion: Transcatheter closure of inter-atrial defects using the Helex septal occluder is a feasible and safe procedure even in defects with an associated atrial septal aneurysm. TCT-217 Migraine Induction by Brain Micro-Embolization During Contrast Transcranial Doppler Evaluation of Right-to-Left Shunt Sherman G Sorensen1, Deborah L Davis2, Laurie Raleigh2, Heather Aguilar2, Peter J Casterella1, Brianna S Ronnow3, Ali K Choucair4, Donald L Lappé1, Heidi Thomas3, Joseph B Muhlestein3 1 Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2Utah Heart Clinic, Salt Lake City, UT;3LDS Hospital Cardiology, Salt Lake City, UT;4LDS Hospital Neurology and Cardiology, Salt Lake City, UT BACKGROUND: Brain micro-embolization (mEMB) due to right-toleft shunt (RLS) has been described with contrast echocardiography, brain imaging (MRI) of divers with decompression illness, and while crossing a patent foramen ovale (PFO) during closure procedures. RLS occurs in 50% of migraine (MHA) patients (pts) with several reports describing migraine improvement or even resolution with PFO closure. We have observed severe MHA symptoms (MHA, A, visual loss, vertigo [MHA-SX]) induced by TCD suggesting that brain mEMB may be a trigger for MHA. METHODS: Of 490 pts undergoing percutaneous PFO closure for recurrent stroke, 176 (36%) reported active MHA before closure with 49 (28%) having aura (A). Pre- and 90 day post-procedural power M-mode transcranial
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Doppler (TCD) with rest (R) and calibrated valsalva (V) agitated saline contrast intra-venous injections were compared (N=148). Cerebral mEMB events were quantified by automatic embolic detection program (scale of 1-5). A separate group of 225 consecutive pts referred for diagnostic TCD were evaluated by questionnaire as to the onset of MHA-SX with TCD. Indications for diagnostic TCD: cerebrovascular accident (CVA)=22%, transient ischemic attack (TIA)=30%, MHA=49%, and abnormal MRI=69%. RESULTS: Responses to PFO closure pre- vs. 90-day post procedure included reduced incidence of active MHA: 176 vs. 23 pts (p=0.001), reduced TCD-R: 2.74+1.02 vs. 0.52+1.02 (p=0.0001), and TCD-V: 4.73+0.73 vs. 1.86+1.71 (p=0.0001). Migraine symptoms during TCD testing occurred in 23% of the 225 pts, and MHA-SX was associated with severe shunt (p=0.003). Of pts with severe shunting, 31% had MHA-SX. In the MHA pts, 49.6% had a grade 5 TCD-V, and 50% had MHA-SX during testing. Although, MHA-SX were induced in pts without prior history of MHA, MHA pts were 4 times as likely to have MHA-SX with TCD (p=0.01) than non-MHA pts. CONCLUSIONS: We postulate that: 1) Brain micro-embolization during contrast TCD may trigger migraine symptoms in pts with RLS, 2) Brain sensitization in migraine sufferers results in heightened response to mEMB, and 3) Spontaneous mEMB during daily life in pts with large RLS may trigger MHA or other neurologic symptoms. TCT-218 Is PFO Closure Effective in Reducing Migraine Symptoms? A Controlled Study Carey Kimmelstiel1, Christopher Gange1, Christopher Lyle2, David Thaler1 1 Tufts-New England Medical Center, Boston, MA;2Regulatory and Clinical Research Institute, Minneapolis, MN
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Background: Several studies suggest a reduction in migraine symptoms following percutaneous patent foramen ovale (PFO) closure. These studies have been limited by their lack of a control group. METHODS: We examined a database of all transesophageal echocardiograms (TEE) performed over 1 year at a single center. Three patient groups were identified: PFO undergoing endovascular closure (Closed PFO; n=41), PFO treated medically (Open PFO; n=63), and age and gender-matched subjects without PFO (controls; n=63). We interviewed all subjects to determine the presence and severity of migraine with or without aura. Headache frequency and severity were assessed retrospectively, examining time points 3 months pre and post closure (Closed PFO) or 3 months pre and post TEE performance (Open PFO and controls). Migraine frequency and severity were assessed utilizing a standardized questionnaire and the validated MIDAS migraine scoring system. RESULTS: Migraines were significantly more common in PFO patients than in controls - Closed PFO (24/41) 59%; Open PFO (26/63) 41%; Controls (10/63) 16% (p < 0.05 for both PFO groups compared to controls). In patients with migraine, endovascular closure had significant beneficial effects on migraine frequency and severity (see table). CONCLUSION: These controlled data suggest that migraine is significantly more frequent in subjects with PFO and that PFO closure is highly associated with a reduction in migraine symptoms. Randomized trials are necessary to validate these data. Change in migraine symptoms Migraine Frequency Migraine Severity Reduced Same More p* Reduced Same More 20 2 2 13 9 1
Closed PFO (n=24) Open PFO 0 25 1 (n=26) Controls 1 9 0 (n=10) * compared to Closed PFO group
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TCT-219 Initial Experience with Alcohol Septal Ablation Using a Novel Magnetic Navigation System John Buergler1, Neal Kleiman1, Jennifer Franklin1, Kelly Elliott2, Sherif Nagueh1 1 Baylor College of Medicine, Houston, TX;2Stereotaxis, St. Louis, MO Background: Alcohol septal ablation (ASA) is now an established therapy for the treatment of patients with hypertrophic obstructive cardiomyopathy (HOCM). However, there are a number of cases in which it is difficult to cannulate the target septal artery due to its small diameter and/or angulation at its origin from the LAD. In these cases, the procedure may be aborted altogether or carried out at the expense of a higher risk of arterial dissection. Recently, a magnetic assistance system (MAI), in which magnetic fields are used to guide and precisely position the wire to the desired site, was used to help navigate the angulation from the LAD into the target artery. We herein report on our initial experience with the use of the MAI system in ASA. Methods: From October 2004 through April 2005, 14 patients (5 women) with HOCM (septal thickness 1.9±0.3 cm), angina (mean angina class 2.6±0.9), and CHF (NYHA class 3.2±0.4) underwent ASA using the MAI system (Niobe® Stereotaxis, Inc. St. Louis, MO). The system is comprised of two magnets, one on each side of the patient, Windows® based software that allows dynamic magnetic field directional control, and a magnetically enabled 0.014 in. floppy tipped wire. Precise control of wire tip direction is controlled in-vivo by operator/software interactive control of the external magnetic field flux. A balloon is advanced over the Stereotaxis wire. Once placed in the target artery, the wire was removed and ethanol (2.2±1.1) ml was injected into 1.2±0.4 arteries with a peak CK leak of 1050±582 u/l. The pressure gradient was obtained at baseline and immediately after ASA via catheters in the aorta and left ventricle. Results: The pressure gradient was reduced from 60±35 at baseline to 5±8 mm Hg (p<0.001) immediately after ASA. Overall, the procedure success rate was 100% and there was no evidence of dissection or other complications related to the use of MAI. Complications included 1 patient requiring permanent pacing due to complete heart block. Conclusion: MAI has the potential to increase the success and safety of ASA in patients with HOCM. Additional studies are warranted to prove this hypothesis. TCT-220 Patent Foramen Ovale: A Domestic Swine Model with Prevalence, Structure, and Histopathology Comparable to Human Hearts Hidehiko Hara1, Krzysztof Karnicki2, MaryLou Stewart2, Jamie M. Pelzel1, Serge Rousselle3, Glen Smits3, Robert S. Schwartz1 1 Minneapolis Heart Institute Foundation, Minneapolis, MN;2Medical Laboratory Surgical Services, Rochester, MN;3Charles River Laboratory, Osceola, WI Backgrounds: Patent foramen ovale (PFO) is becoming increasingly important as multiple clinical syndromes are caused by this abnormality. Novel technologies to close PFO percutaneously are under development but lack an appropriate animal model for testing. We sought to evaluate the domestic swine as a model for PFO in both gross and histopathologic features. Methods: Experiments were performed using one hundred porcine hearts from necropsy of domestic swine (age 4 to 6 months). They were examined for PFO prevalence, appearance, size and occurrence of other atrial septal abnormalities. Results: PFO was found in 32 of the 100 porcine hearts (PFO prevalence 32%, Confidence: 24-42%). One porcine heart had an atrial septal defect (ASD) (ASD prevalence 1%, Confidence: 0-5%). Sixteen PFO were measured, and showed tunnel length (12.0 +/- 5.6 mm) compared with long axis from left to right atrium (4.7+/- 3.2 mm, 4.0 +/- 2.6 respectively, p=0.5). Multiple regression analysis was performed on the length of PFO. The long
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) axis length from left atrium was the only predictor (r2=0.404, p=0.034). Histopathologic comparison between human and porcine PFO demonstrated marked similarity in cellular and matrix composition (Figure. a). Conclusions: PFO prevalence in domestic swine is highly comparable to that in humans. The porcine PFO exhibits size, gross and microscopic structure virtually identical to that in humans. The domestic swine PFO model may find use in testing new technologies for interventional PFO closure.
TCT-221 MRI in Patients with Patent Foramen Ovale or with Residual Shunt after Percutaneous Occlusion Oliver K Mohrs1, Damir Erkapic1, Steffen E. Petersen2, Rainer Schraeder1, Bernd Nowak1, Hans-Ulrich Kauczor3, Thomas Voigtlaender1 1 Cardiovascular Center Bethanien (CCB), Frankfurt / Main, Germany2University of Oxford, Oxford, United Kingdom3German Cancer Research Center (DKFZ), Heidelberg, Germany Background: Patent foramen ovale (PFO) is a known cause of cerebral strokes or transient ischemic attacks due to paradoxical embolism. This study was designed to evaluate the feasibility of dynamic contrastenhanced MRI (ceMRI) to detect patent foramen ovale (PFO) or residual shunt after percutaneous transcatheter closure of PFO. Methods: We examined 25 patients (11 female, mean age 53 ±14), 19 patients with first diagnosis of PFO and 6 with residual shunt after percutaneous closure of PFO. Transesophageal echocardiography (TEE) served as the clinical reference. A dynamic contrast-enhanced (10cc followed by 20cc saline @ 6cc/sec Gd-DTPA) saturation-recovery-SSFP-sequence was performed during Valsalva maneuver at 1.5 Tesla. Besides a qualitative, visual analysis, the relative signal intensity (%) compared to baseline over time was calculated for the left atrium (LA) and the pulmonary vein (PV). Results: Visual analysis detected 23/25 cases by an early contrast enhancement in LA due to contrast flow through PFO. The two false negative results comprised one patient with first diagnosis of PFO and one patient with a residual shunt. Patients with a huge PFO on TEE presented with a bright enhancement in the entire LA and patients with a small PFO only a slight enhancement near the atrial septum. In 22/25 cases signal-to-time curves showed two signal-peaks in LA compared to baseline signal. The first peak in LA (mean 190±73% of the baseline signal) appeared 10±4 seconds earlier than the single signal-peak in PV (mean 534±159%). A second signal-peak in LA (mean 585±148%) followed immediately. The mean interval between the two signal peaks in LA was 10±3 seconds during which the signal decreased (mean 129±32%). Conclusion: This study demonstrates that dynamic ceMRI has the potential to reliably detect PFO and residual shunts after percutaneous closure of
PFO. Especially patients who cannot tolerate the transesophageal probe could benefit from a non-invasive MRI approach. TCT-222 Transcatheter Closure of Large Atrial Septal Defects under Transoesophageal Echocardiographic Guidance Without Balloon Sizing Maneuver Furong Zhang, Junzhu Chen, Qianmin Tao, Liangrong Zheng, Jianhua Zhu, Zhelan Zheng, Lei Yao, Yun Mu First Affiliated Hospital,Zhejiang University, Hangzhou,Zhejiang, China Background: The stretched balloon diameter(SBD) is supposed to the gold standard for selecting the size of device. However, the balloon sizing maneuver could overestimate the actual defect size, is time consuming, is difficult in some large ASD. The purpose of this study was to evaluate the feasibility of closure of ASD≥ 25 mm(range 25 to 32 mm) using transesophageal echocardiography (TEE) selecting the device size of Amplatzer Septal Occluder(ASO) without balloon sizing. Methods: Between Jan. 2000 and May 2003, large ASD closure with the ASO was performed in 36 adults (mean age 45± 14years,range 20~66years, 23 female). The patients were divided into two groups. In the study group, a closure of ASD was attempted using TEE without balloon sizing in the 18 patients. In the control group, ASD closure was performed using the SBD in the other 18 patients. In the control group, we implanted devices 2~4 mm larger than the SBD. In the study group, A device with a waist diameter 4~8 mm bigger than maximal TEE defect diameter was chosen. Results: In the study group, ASD median diameter is 26.8±1.9 mm under TEE; Devices ranging from 30 to 38 mm in diameter (33.3±2.4mm) were implanted. In the control group, ASD median diameter is 26.5±1.9mm under TEE and Devices ranging from 30 to 38 mm (33.7±2.2 mm),the SBD was 30.6±1.6 mm. There was no significant difference between the 2 Groups in age,sex ratio,weight,Qp/Qs, defect diameter and diameter of devices (P>0.05). An ASO was successfully implanted in all patients. Fluoroscopy times,TEE times and procedure times in the study group were significantly shorter than thoses in the control group (12.1±7.3 min vs. 19.4±6.7 min; P<0.01),(20.5±5.4 vs.29.2±6.8 min; P<0.01), (52.8±13.2 vs. 78.3±15.1 min; P<0.01). All of patients was no residual shunt found during 3~12 months follow-up. TTE and chest radiographs showed no displacementof the occluders. Conclusions: Transcatheter closure of large secundum ASD atrial septal defect using ASO without Balloon Sizing Maneuver is accepted treatment modality. TCT-223 PFO Closure Using Premiere: The CLOSE UP Trial Horst Sievert1, Franz Kleber2, Stephan Windecker3, Frank Uhlemann4, Christine Tiefenbacher5, Franziska Büscheck1, Dennis W. Wahr6 1 CardioVascular Center Frankfurt, Frankfurt, Germany2Unfallkrankenhau s, Berlin, Germany3Inselspital, Bern, Switzerland4Olgahospital, Stuttgart, Germany5Universitatsklinikum, Heidelberg, Germany6Velocimed, Inc., Maple Grove, MN Background: CLOSE UP was a prospective trial conducted to determine the safety and performance of the Premere PFO Closure System. Methods/Results: Seventy-three patients with a PFO and a history of stroke or TIA felt to be due to paradoxical emboli were enrolled at 5 sites; 67 patients were implanted with the device (54 study, 13 roll-in patients). Six patients did not receive the Premere device due to PFO and atrial anatomy (3 study, 3 roll-in). Atrial septal aneurysm was present in 18; average PFO diameter was 8.9 ±3.78 (range 1.9-19); 28 patients received the 15 mm and 39 the 20 mm device. Closure rates, defined as ≤5 bubbles on TEE Valsalva exam, are shown in Table 1; only those patients with an echo study at that time point are reported. For example, the single 20 mm
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) device patient open at 6 months did not have a study done at 3 months. At the start of the trial only the 15 mm device was available; closure rates appear better with the 20 mm device. There have been no events of death, hemo-pericardium, stroke or TIA. One patient (1.9%) was found to have visible thrombus on the left atrial anchor (TEE) at 3 months and received heparin/coumadin. Five patients had transient new arrhythmias: 4 were minor with no treatment; 1 with intermittent atrial fibrillation. Only the patient with AF was treated; all arrhythmias resolved prior to 6 month. Conclusion: The Premere device effectively closes PFO, and has a very low risk of adverse events.
Closure at 2 weeks Closure at 3 months Closure at 6 months
PFO Closure Rate with Premere All Study Patients 15 mm Device % (n) % (n) 67.3 (35/52) 47.6 (10/21) 89.8 (44/49) 75.0 (15/20) 92.9 (39/42) 90.5 (19/21)
20 mm Device % (n) 80.6 (25/31) 100.0 (29/29) 95.6 (22/23)
TCT-224 Patent Foramen Ovale Closures Improves Migraine Severity and Intensity Sabu J George, Malek Numeir, Nicholas Skiadas, John Grammes, Firas Alani, Grewal Rasveg, Benjamin Silverman, Juzer Lokandwala, Zeb Jahan, Nicole Bruno, Bruce Bowers, Ismail Dairywala, Jennifer Yanoschak, Carole Thomas, Daniel McCormick, Sheldon Goldberg Hahnemann University Hospital, Philadelphia, PA
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Background: Patients with cryptogenic stroke and PFO have a higher incidence of migraine. Recent data suggest that PFO closure results in improvement of symptoms. Methods: We reviewed all patients undergoing PFO closure for neurologic events from 2002 to 2004. Patients with migraines were identified using the International Headache Society Criteria. Follow up was obtained via a questionnaire using the MIDAS scale. Median follow up was 1.8 years. The MIDAS grades were compared pre-and post closure using the Wilcoxon test. Results: The files on 186 patients were reviewed. Follow up was obtained in 158/186 (85%). Of these 36/158 (23%) had migraines (26 female,10 male). The indications for PFO closure were CVA in 20/36(56%) and TIA in 16/36(44%). The pre-and post closure change in MIDAS grade is shown in Figure 1. There was a significant decrease in MIDAS grade after closure (p<0.001). Fifty six percent of patients (20/36) showed improvement of at least one MIDAS grade, eight of whom had complete relief. Fourty four percent of patients (16/36) had no change in MIDAS grade. A trend towards more Conclusion: There was objective improvement in migraine following PFO closure, especially in patients with more severe symptoms.
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TCT-210 Early Course of Hemodynamic and Morphologic Changes in Patients Undergoing Alcohol Septal Ablation for Obstructive Hypertrophic Cardiomyopathy is Influenced by Age of Patients Josef Veselka1, Radka Duchonova1, Sarka Prochazkova1, Ingrid Homolova1, David Zemanek1, Jana Palenickova1, David Tesar2 1 Dpt. of Cardiology, Prague 5, Czech Republic2Dpt. of Imaging Methods, Prague 5, Czech Republic Background: The hemodynamic and clinical benefit of alcohol septal
ablation (PTSMA) has been convincingly demonstrated in many studies up to now. The aim of this study was to compare the time course of both hemodynamic and morphological changes related to the age of treated patients. Methods: Forty-four patients (54 ± 13 years, range 24-81 years) with a symptomatic obstructive hypertrophic cardiomyopathy (HCM) receiving a maximum medical therapy were enrolled consecutively. The study population was divided into three groups according to their age; group A [14 pts. (24-48 years)], group B [14 pts. (49-60 years)] and group C [16 pts. (61-81 years)]. Clinical and echocardiographic data were obtained at the baseline and periodically up to 12 months after PTSMA. Results: At the baseline, there was a significant difference between septum thickness (IVS) in age-related groups (24 ± 5 mm vs 21 ± 3 mm vs 19 ± 3 mm for groups A vs B vs C; p<0.01 for group A vs groups B and C). A significant IVS reduction was identified in all age-related groups of patients (p<0.01). There was a significant correlation between IVS and age at the baseline and in the early postprocedural period. However, this correlation was not significant after IVS remodeling at 3 and 12-month examination. At the baseline, there were no significant differences between LV outflow gradient in all age-related groups (70 mmHg [40 - 108] vs 54 mmHg [40 - 89] vs 69 mmHg [37 - 97] for groups A vs B vs C). A significant outflow gradient reduction was identified in all age-related groups of patients (p<0.01). After multivariate adjustment, there was a significant influence of age (p<0.01) on course of LV outflow gradient decrease. Conclusion: PTSMA is an effective treatment option for patients with obstructive HCM irrespective of their age. Our study suggests that the younger patients are characterized by a thicker basal septum at the baseline and slower hemodynamic and morphologic improvement within the early postprocedural period. TCT-211 Percutaneous Closure of the Left Atrial Appendage to Prevent Stroke in Patients with Atrial Fibrillation - Current Results of the First USEuropean Multicenter Trial Evelyn Fischer1, Mark Reisman2, William Gray3, Heyder Omran4, Paul Kramer5, Antonio Bartorelli6, Paolo Della Bella6, Peter Block7, Carlo DiMario8, Ray Matthews9, Jeffery Moses10, Allan Skanes11, Bernhard Meier12, Athena Poppas13, David Williams14, Paul Teirstein15, Yves Bayard16, Stefan Ostermayer1, Thomas Trepels1, Kai Billinger1, Michaela Leetz1, Madlen Reschke1, Horst Sievert1 1 CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany2Swedish Cardiovascular Research Institute, Seattle, WA;3University of California, San Francisco, CA;4University of Bonn Medicine and Cardiology, Bonn, Germany5Shawnee Mission Medical Centre, Shawnee Mission, KS;6Centro Cardiologico S.p.A., Milan, Italy7Emory University Hospital, Atlanta, GA;8Ospedale San Raffaelle, Milan, Italy9Good Samaritan Hospital, Los Angeles, CA;10Lenox Hill Hospital, New York, NJ;11London Health Sciences Centre, London, ON, Canada12Swiss Cardiovascular Center Bern, Bern, Switzerland13Rhode Island Hospital, Providence, RI;14Lenox Hill Hospital, Providence, RI;15Scripps Clinic Medical Group, La Jolla, CA;16CardioVascular Center, Farnkfurt, Sankt Katharinen, Frankfurt, Germany Background: The left atrial appendage is the most important source of cardiogenic thrombi in patients with atrial fibrillation, causing major strokes. Closing the left atrial appendage (LAA) with the Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO) device may be an alternative for patients with contraindications for warfarin therapy. Methods: The device is a self-expanding nitinol cage covered with ePTFE. It is delivered through a 12 French transseptal sheath especially designed to access the LAA. 111 patients with a mean age of 71±9 years were enrolled in the PLAATO feasibility study and followed for a total of 168 patient years. Results: In three patients a device could not be implanted due to complications
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) when accessing the groin, a thrombus noted in the right atrium and cardiac tamponade, respectively. In all other patients the device was successfully implanted. During the procedure, cardiac tamponade occurred in 4 patients. One had to undergo surgery and three pericardiocentesis. During follow up, 9 patients died. Reasons for death were cerebral hemorrhage (1), multiorgan-failure (3), sudden cardiac death (1), renal failure (2), suicide (1) and brain tumor (1). None of these deaths were procedure or device related. In one patient, an echo-dense layer was found on the device surface at the 1 month and 6 month follow up, but was resolved at the 9 month follow up without sequelae. The expected annual risk of stroke of our patients based on the CHADS2 score was 6.3%. Six patients sustained a stroke during follow up, so that the annual stroke rate was 3.6%. That leads to a risk reduction by PLAATO of 43%. Conclusions: Follow up tests show, that LAA occlusion with the PLAATO device is a feasible and safe method to prevent stroke in high risk AF patients with contraindication for warfarin therapy. TCT-212 Cardiac Magnetic Resonance Imaging in Patients with Transcatheter Closure of Patent Foramen Ovale Thorsten Nusser1, Martin Höher2, Nico Merkle1, Olaf Grebe1, Jochen Spiess1, Hans A. Kestler1, Matthias Kochs1, Vinzenz Hombach1, Jochen Wöhrle1 1 University of Ulm, Ulm, Germany2Klinikum Bayreuth, Bayreuth, Germany
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Background: Cardiac magnetic resonance imaging (CMRI) is a powerful and non-invasive tool for detailed assessment of cardiac anatomy and function. The value of CMRI compared with transesophageal echocardiography (TEE) in patients undergoing transcatheter closure of patent foramen ovale (PFO) has not been settled so far. Methods: In patients with cryptogenic ischemic events and PFO CMRI was performed pre and post PFO closure. The intervention was done with fluoroscopy and TEE guidance using the Cardia Star™ device. CMRI was compared to TEE regarding the detection of atrial septal aneurysm (ASA) and contrast enhanced right-to-left shunting during Valsalva maneuver. In CMRI the atrial septum was scanned using highresolution short axis cine images with a turbo-field-echo sequence on a 1.5T whole body scanner. To determine provokable atrial rightto-left shunting in CMRI we performed contrast enhanced real-time perfusion analysis in two cine sequences, a short axis and a long axis 4-chamber view, using a bolus of 0.1mmol/kg body weight Gd-DTPA. Results: We analyzed 75 patients after cryptogenic ischemic events with CMRI pre and after transcatheter PFO closure and at 12 months (n=65). In high-resolution cine images ASA was seen in 28/75 (37%) compared with 63% (47/75) in TEE. We performed 211 CMRI studies with corresponding TEE. With contrast enhanced perfusion analysis, CMRI detected right-toleft shunting in 48/72 (67%) of moderate or severe shunts but only 6/32 (18%) of mild shunts in TEE. No shunt was present in 107 patients with both techniques. Volumetric and flow measurements revealed systemic shunts in 18/75 patients, which completely disappeared after closure. CMRI exlcuded anomalous venous returns in all and detected coronary anomaly in two patients. Conclusions: Present CMRI technique is inferior to TEE in detection of contrast enhanced right-to-left shunting and identification of ASA, but provides additional information regarding systemic shunts and cardiac anomalies. In patients not tolerating the TEE probe, CMRI provides valuable information on atrial septal morphology and cardiac shunting.
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TCT-213 Late Failure of Percutaneous PFO Closure: Mechanisms of Failure and Treatment Options Sherman G Sorensen1, James W Long2, Steven C Horton1, Peter J Casterella1, Laurie Raleigh3, Heather Aguilar3, Donald L Lappé1, Joseph B Muhlestein2 1 Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2LDS Hospital Cardiology, Salt Lake City, UT;3Utah Heart Clinic, Salt Lake City, UT BACKGROUND: Percutaneous catheter closure of patent foramen ovale (PFO) is an increasingly accepted treatment option for stroke prevention that has good procedural safety and early results. However, late results due to device failure are unknown. Differences of device design, device materials, implantation technique, healing effect, or PFO morphologic features may influence long-term outcomes. METHODS: From 2001-2005, 950 PFO closure procedures were performed with 261 CardioSEAL® (CS) and 689 Amplatzer® PFO (AMP) devices. Implant imaging used transesophageal echocardiography in 430 patients (pts) and intra-cardiac echocardiography in 520 pts. In our early experience with the CS device, pts with long PFO tunnel (> 10 mm) and large PFO with atrial septal aneurysm (ASA) were usually treated by the transeptal technique. Eleven (1.0%) pts (3 AMP, 8 CS) required evaluation and treatment for persistent or late failure of PFO closure (range: 9-26 months post closure). Evaluation of these pts was prompted by transient ischemic attack (TIA) in 4 pts, recurrent complex migraine (migraine with TIA symptoms) in 3 pts, and persistent severe shunt in 4 pts. RESULTS: There were 3 AMP pts that had severe persistent shunting. All had ASA, long tunnel, and closure with a 35 mm AMP device. Catheter treatment was not feasible and all were treated medically without event. Of the 8 CS pts, 5 developed progressive shunt worsening from implant to symptom presentation. All CS failure patients were closed by the transeptal technique, had a tunnel of 15-27 mm, had an ASA, and received a large device (40 mm= 4 pts, 33 mm= 4 pts). Device retraction and arm splay was defined by echocardiography in all and by surgical removal in 4 pts. There were 4 pts treated by second device placement (second device: AMP PFO= 2 pts, AMP SO= 2 pts). CONCLUSIONS: We conclude that 1) Late PFO closure failure is uncommon and is multi-factorial; 2) Healing retraction is related to transeptal placement and device type, but is treatable by second device placement; 3) AMP failure due to non incorporation is difficult to treat percutaneously; and 4) Complex PFO morphology may be better treated with devices resulting in better defect filling and device apposition. TCT-214 Incidence of Thrombus Formation on ASD and PFO Closure Devices Ilona Hofmann, Madlen Reschke, Hildegard Lißmann-Jensen, Horst Sievert CardioVascularCenter, Frankfurt/Main, Germany Purpose: A potential complication of transcatheter ASD and PFO closure is a thrombus formation on the device. We analyzed the incidence, morphology and clinical relevance of thrombus formation on these devices detected by transesophageal echocardiography. Methods: From August 1992 to April 2005, 1531 adult patients underwent transcatheter closure of a patent foramen ovale (n= 969) or an atrial septal defect (n=562). The transesophageal echocardiography was performed after 4 weeks and 6 months and on clinical indikation. Results: Thrombus formation was detected on the device in 19 (PFO: n=12, ASD: n=7) of 1531 patients (1,2%). The size of thrombus ranged from 3, 7 to 30 mm. Thrombus was attached on the left atrial side in 11 patients, on the right atrial side in 4 patients and on the
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) both in 3. In 1 case thrombus was diagnosed on the Eustachean tube. This was observed after 2-4 weeks in 14, after 6 months in 1, after 1 year in 2, after 4 years in 1 and after 5 years in 1patient. 12 patients with thrombus had a Starflex-Occluder, 3 patients an ASDOSOccluder, in each case 1 patient an Amplatzer, a Cardioseal and in 2 cases were used the Helex. Post procedure device arm fractures were found in 3 patients (16%) and atrial fibrillation in 2 patients (11%). 3 embolic events (3 minor strokes) occurred. In 16/19 patients the thrombus resolved following anticoagulation therapy (heparin, warfarin) or antiplatelet medication (aspirin, clopidogrel). In 3/19 patients the thrombus had to be removed surgically. Conclusion: The incidence of thrombus formation on closure devices is low. In most of the patients the thrombus resolved under anticoagulation therapy without clinical consequences. Significant predictors of thrombus were device arm fracture, atrial fibrillation, atrium septal aneurysm and specific occluder model. TCT-215 Transcatheter Closure of Perimembranous Ventricular Septal Defect by Amplatzer Devices: Immediate and Long-Term Follow-Up Results Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta, Manish Sharma, Dinesh Raj, Ramesh Arora, Sanjay Tyagi G B Pant Hospital and Maulana Azad Medical College, New Delhi, India Background: Transcatheter closure of perimembranous ventricular septal defect (PMVSD) is an evolving new therapeutic modality even for patients with restrictive defects. We report our single center experience with Amplatzer muscular ventricular septal occluder (AMSO) and Amplatzer asymmetric perimembranous occluder (ASPO) with long-term follow up results. Method: Between January1998 and December 2004, 82 patients (58 male, 24 female), aged 2-33 years (median 12 years) and weight 8-52 kg (median 24 kg) underwent closure of PMVSD (60 with AMSO and 22 with ASPO). Included were patients of PMVSD with (i) small band or rim of ≥ 5 mm from aortic valve (for ASPO defects with < 5 mm were also included). (ii) distance from center to insertion of right coronary cusp >50% of required device size (iii) aneurysm formation. Size of VSD assessed by echocardiography varied from 2.5 to 12mm (mean 5.2 ± 2.1mm). 36 patients had aneurysm formation and seven had left ventricle to right atrial communication. Pulmonary to systemic flow ratio was > 2:1 in 32 patients (39%). Device was delivered through transvenous route in all cases except one. Devices were deployed under fluoroscopic and transthoracic echocardiographic guidance (TTE)/ angiography and size of device chosen(4-14 mm) was 2mm larger than that determined by TTE but equal to stretched balloon diameter (34 patients). Results: AMSO could be positioned successfully in all (n=60) while ASPO had to be retrieved in 3 patients who developed acute AR with hemodynamic compromise (superior margin of defect < 3 mm from aortic valve in all) resulting in a procedural success rate of 96.4%. Incidence of residual shunt 24 hours after procedure was 3(0.03%). All had trivial shunts that disappeared within 1 month. New tricuspid stenosis was observed in 1 patient with AMSO that resolved with balloon dilatation. Patients were followed up by TTE and ECG at 24 hours,1,3 and 6 monthly thereafter. At 6-84 months (mean 38.2 ± 12.8) follow-up, there was no incidence of migration/fracture of device, infective endocarditis, aortic regurgitation, hemolysis or development of conduction defect. Conclusion: Closure of PMVSD with Amplatzer devices is safe and effective with low rate of complications.
TCT-216 Transcatheter Closure of Atrial Septal Defects and Patent Foramen Ovale Using the Helex Septal Occluder Stefan H U Ostermayer, Neil Wilson, Kai Billinger, Madlen Reschke, Yves Bayard, Franziska Buescheck, Evelyn Fischer, Michaela Leetz, Margaret Taaffe, Ralph Hein, Albrecht Roemer, Horst Sievert CardioVascular Center Frankfurt, Frankfurt, Germany Background: Transcatheter closure of atrial septal defects (ASD) and patent foramen ovale (PFO) has become a routine procedure in many centers. The Helex septal occluder (W.L. Gore and Associates, Flagstaff, AZ) is a twoumbrella device formed by one continuous nitinol wire which is covered by ePTFE (expanded polytetrafluoroethylene). It has a unique spiral shape which provides a very low profile and an atraumatic healing process after implantation. Methods: Between December 1999 and May 2005 percutaneous interatrial defect closure using the Helex septal occluder was attempted in 353 patients (51 ASD/ 302 PFO). Post procedure patients received clopidogrel (PFO only), aspirin and a subacute endocarditis prophylaxis for the first six months following the procedure. Transesophageal echocardiography, fluoroscopy and chest-X-ray were performed at one and six months. Thereafter, follow-up was performed clinically and by questionnaire (14.6 ± 14.2 months, 430 patient years). Results: Implantation of the Helex septal occluder was successful in 349 patients. In three patients the Helex occluder showed a suboptimal position during implantation and was therefore removed and exchanged for a different type of device. In three patients the occluder embolized immediately following implantation or during the initial hospital stay. In one of them a different device was implanted while two patients received a Helex occluder during a second attempt. In two further patients device embolization was noticed at the one and six months follow-up. Both received a different type of device during a second procedure. The stretched ASD diameter determined by balloon sizing was 13.0 ± 3.3 mm, the stretched PFO diameter was 9.2 ± 3.6 mm. Twelve patients received a second device: Two patients because of a second defect and ten patients because of a residual shunt of the first occluder. One hundred thirty-eight patients had an atrial septal aneurysm in additional to their ASD or PFO. Conclusion: Transcatheter closure of inter-atrial defects using the Helex septal occluder is a feasible and safe procedure even in defects with an associated atrial septal aneurysm. TCT-217 Migraine Induction by Brain Micro-Embolization During Contrast Transcranial Doppler Evaluation of Right-to-Left Shunt Sherman G Sorensen1, Deborah L Davis2, Laurie Raleigh2, Heather Aguilar2, Peter J Casterella1, Brianna S Ronnow3, Ali K Choucair4, Donald L Lappé1, Heidi Thomas3, Joseph B Muhlestein3 1 Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2Utah Heart Clinic, Salt Lake City, UT;3LDS Hospital Cardiology, Salt Lake City, UT;4LDS Hospital Neurology and Cardiology, Salt Lake City, UT BACKGROUND: Brain micro-embolization (mEMB) due to right-toleft shunt (RLS) has been described with contrast echocardiography, brain imaging (MRI) of divers with decompression illness, and while crossing a patent foramen ovale (PFO) during closure procedures. RLS occurs in 50% of migraine (MHA) patients (pts) with several reports describing migraine improvement or even resolution with PFO closure. We have observed severe MHA symptoms (MHA, A, visual loss, vertigo [MHA-SX]) induced by TCD suggesting that brain mEMB may be a trigger for MHA. METHODS: Of 490 pts undergoing percutaneous PFO closure for recurrent stroke, 176 (36%) reported active MHA before closure with 49 (28%) having aura (A). Pre- and 90 day post-procedural power M-mode transcranial
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Doppler (TCD) with rest (R) and calibrated valsalva (V) agitated saline contrast intra-venous injections were compared (N=148). Cerebral mEMB events were quantified by automatic embolic detection program (scale of 1-5). A separate group of 225 consecutive pts referred for diagnostic TCD were evaluated by questionnaire as to the onset of MHA-SX with TCD. Indications for diagnostic TCD: cerebrovascular accident (CVA)=22%, transient ischemic attack (TIA)=30%, MHA=49%, and abnormal MRI=69%. RESULTS: Responses to PFO closure pre- vs. 90-day post procedure included reduced incidence of active MHA: 176 vs. 23 pts (p=0.001), reduced TCD-R: 2.74+1.02 vs. 0.52+1.02 (p=0.0001), and TCD-V: 4.73+0.73 vs. 1.86+1.71 (p=0.0001). Migraine symptoms during TCD testing occurred in 23% of the 225 pts, and MHA-SX was associated with severe shunt (p=0.003). Of pts with severe shunting, 31% had MHA-SX. In the MHA pts, 49.6% had a grade 5 TCD-V, and 50% had MHA-SX during testing. Although, MHA-SX were induced in pts without prior history of MHA, MHA pts were 4 times as likely to have MHA-SX with TCD (p=0.01) than non-MHA pts. CONCLUSIONS: We postulate that: 1) Brain micro-embolization during contrast TCD may trigger migraine symptoms in pts with RLS, 2) Brain sensitization in migraine sufferers results in heightened response to mEMB, and 3) Spontaneous mEMB during daily life in pts with large RLS may trigger MHA or other neurologic symptoms. TCT-218 Is PFO Closure Effective in Reducing Migraine Symptoms? A Controlled Study Carey Kimmelstiel1, Christopher Gange1, Christopher Lyle2, David Thaler1 1 Tufts-New England Medical Center, Boston, MA;2Regulatory and Clinical Research Institute, Minneapolis, MN
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Background: Several studies suggest a reduction in migraine symptoms following percutaneous patent foramen ovale (PFO) closure. These studies have been limited by their lack of a control group. METHODS: We examined a database of all transesophageal echocardiograms (TEE) performed over 1 year at a single center. Three patient groups were identified: PFO undergoing endovascular closure (Closed PFO; n=41), PFO treated medically (Open PFO; n=63), and age and gender-matched subjects without PFO (controls; n=63). We interviewed all subjects to determine the presence and severity of migraine with or without aura. Headache frequency and severity were assessed retrospectively, examining time points 3 months pre and post closure (Closed PFO) or 3 months pre and post TEE performance (Open PFO and controls). Migraine frequency and severity were assessed utilizing a standardized questionnaire and the validated MIDAS migraine scoring system. RESULTS: Migraines were significantly more common in PFO patients than in controls - Closed PFO (24/41) 59%; Open PFO (26/63) 41%; Controls (10/63) 16% (p < 0.05 for both PFO groups compared to controls). In patients with migraine, endovascular closure had significant beneficial effects on migraine frequency and severity (see table). CONCLUSION: These controlled data suggest that migraine is significantly more frequent in subjects with PFO and that PFO closure is highly associated with a reduction in migraine symptoms. Randomized trials are necessary to validate these data. Change in migraine symptoms Migraine Frequency Migraine Severity Reduced Same More p* Reduced Same More 20 2 2 13 9 1
Closed PFO (n=24) Open PFO 0 25 1 (n=26) Controls 1 9 0 (n=10) * compared to Closed PFO group
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<0.0001
0
23
0
<0.0001
<0.0001
1
9
0
0.027
TCT-219 Initial Experience with Alcohol Septal Ablation Using a Novel Magnetic Navigation System John Buergler1, Neal Kleiman1, Jennifer Franklin1, Kelly Elliott2, Sherif Nagueh1 1 Baylor College of Medicine, Houston, TX;2Stereotaxis, St. Louis, MO Background: Alcohol septal ablation (ASA) is now an established therapy for the treatment of patients with hypertrophic obstructive cardiomyopathy (HOCM). However, there are a number of cases in which it is difficult to cannulate the target septal artery due to its small diameter and/or angulation at its origin from the LAD. In these cases, the procedure may be aborted altogether or carried out at the expense of a higher risk of arterial dissection. Recently, a magnetic assistance system (MAI), in which magnetic fields are used to guide and precisely position the wire to the desired site, was used to help navigate the angulation from the LAD into the target artery. We herein report on our initial experience with the use of the MAI system in ASA. Methods: From October 2004 through April 2005, 14 patients (5 women) with HOCM (septal thickness 1.9±0.3 cm), angina (mean angina class 2.6±0.9), and CHF (NYHA class 3.2±0.4) underwent ASA using the MAI system (Niobe® Stereotaxis, Inc. St. Louis, MO). The system is comprised of two magnets, one on each side of the patient, Windows® based software that allows dynamic magnetic field directional control, and a magnetically enabled 0.014 in. floppy tipped wire. Precise control of wire tip direction is controlled in-vivo by operator/software interactive control of the external magnetic field flux. A balloon is advanced over the Stereotaxis wire. Once placed in the target artery, the wire was removed and ethanol (2.2±1.1) ml was injected into 1.2±0.4 arteries with a peak CK leak of 1050±582 u/l. The pressure gradient was obtained at baseline and immediately after ASA via catheters in the aorta and left ventricle. Results: The pressure gradient was reduced from 60±35 at baseline to 5±8 mm Hg (p<0.001) immediately after ASA. Overall, the procedure success rate was 100% and there was no evidence of dissection or other complications related to the use of MAI. Complications included 1 patient requiring permanent pacing due to complete heart block. Conclusion: MAI has the potential to increase the success and safety of ASA in patients with HOCM. Additional studies are warranted to prove this hypothesis. TCT-220 Patent Foramen Ovale: A Domestic Swine Model with Prevalence, Structure, and Histopathology Comparable to Human Hearts Hidehiko Hara1, Krzysztof Karnicki2, MaryLou Stewart2, Jamie M. Pelzel1, Serge Rousselle3, Glen Smits3, Robert S. Schwartz1 1 Minneapolis Heart Institute Foundation, Minneapolis, MN;2Medical Laboratory Surgical Services, Rochester, MN;3Charles River Laboratory, Osceola, WI Backgrounds: Patent foramen ovale (PFO) is becoming increasingly important as multiple clinical syndromes are caused by this abnormality. Novel technologies to close PFO percutaneously are under development but lack an appropriate animal model for testing. We sought to evaluate the domestic swine as a model for PFO in both gross and histopathologic features. Methods: Experiments were performed using one hundred porcine hearts from necropsy of domestic swine (age 4 to 6 months). They were examined for PFO prevalence, appearance, size and occurrence of other atrial septal abnormalities. Results: PFO was found in 32 of the 100 porcine hearts (PFO prevalence 32%, Confidence: 24-42%). One porcine heart had an atrial septal defect (ASD) (ASD prevalence 1%, Confidence: 0-5%). Sixteen PFO were measured, and showed tunnel length (12.0 +/- 5.6 mm) compared with long axis from left to right atrium (4.7+/- 3.2 mm, 4.0 +/- 2.6 respectively, p=0.5). Multiple regression analysis was performed on the length of PFO. The long
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) axis length from left atrium was the only predictor (r2=0.404, p=0.034). Histopathologic comparison between human and porcine PFO demonstrated marked similarity in cellular and matrix composition (Figure. a). Conclusions: PFO prevalence in domestic swine is highly comparable to that in humans. The porcine PFO exhibits size, gross and microscopic structure virtually identical to that in humans. The domestic swine PFO model may find use in testing new technologies for interventional PFO closure.
TCT-221 MRI in Patients with Patent Foramen Ovale or with Residual Shunt after Percutaneous Occlusion Oliver K Mohrs1, Damir Erkapic1, Steffen E. Petersen2, Rainer Schraeder1, Bernd Nowak1, Hans-Ulrich Kauczor3, Thomas Voigtlaender1 1 Cardiovascular Center Bethanien (CCB), Frankfurt / Main, Germany2University of Oxford, Oxford, United Kingdom3German Cancer Research Center (DKFZ), Heidelberg, Germany Background: Patent foramen ovale (PFO) is a known cause of cerebral strokes or transient ischemic attacks due to paradoxical embolism. This study was designed to evaluate the feasibility of dynamic contrastenhanced MRI (ceMRI) to detect patent foramen ovale (PFO) or residual shunt after percutaneous transcatheter closure of PFO. Methods: We examined 25 patients (11 female, mean age 53 ±14), 19 patients with first diagnosis of PFO and 6 with residual shunt after percutaneous closure of PFO. Transesophageal echocardiography (TEE) served as the clinical reference. A dynamic contrast-enhanced (10cc followed by 20cc saline @ 6cc/sec Gd-DTPA) saturation-recovery-SSFP-sequence was performed during Valsalva maneuver at 1.5 Tesla. Besides a qualitative, visual analysis, the relative signal intensity (%) compared to baseline over time was calculated for the left atrium (LA) and the pulmonary vein (PV). Results: Visual analysis detected 23/25 cases by an early contrast enhancement in LA due to contrast flow through PFO. The two false negative results comprised one patient with first diagnosis of PFO and one patient with a residual shunt. Patients with a huge PFO on TEE presented with a bright enhancement in the entire LA and patients with a small PFO only a slight enhancement near the atrial septum. In 22/25 cases signal-to-time curves showed two signal-peaks in LA compared to baseline signal. The first peak in LA (mean 190±73% of the baseline signal) appeared 10±4 seconds earlier than the single signal-peak in PV (mean 534±159%). A second signal-peak in LA (mean 585±148%) followed immediately. The mean interval between the two signal peaks in LA was 10±3 seconds during which the signal decreased (mean 129±32%). Conclusion: This study demonstrates that dynamic ceMRI has the potential to reliably detect PFO and residual shunts after percutaneous closure of
PFO. Especially patients who cannot tolerate the transesophageal probe could benefit from a non-invasive MRI approach. TCT-222 Transcatheter Closure of Large Atrial Septal Defects under Transoesophageal Echocardiographic Guidance Without Balloon Sizing Maneuver Furong Zhang, Junzhu Chen, Qianmin Tao, Liangrong Zheng, Jianhua Zhu, Zhelan Zheng, Lei Yao, Yun Mu First Affiliated Hospital,Zhejiang University, Hangzhou,Zhejiang, China Background: The stretched balloon diameter(SBD) is supposed to the gold standard for selecting the size of device. However, the balloon sizing maneuver could overestimate the actual defect size, is time consuming, is difficult in some large ASD. The purpose of this study was to evaluate the feasibility of closure of ASD≥ 25 mm(range 25 to 32 mm) using transesophageal echocardiography (TEE) selecting the device size of Amplatzer Septal Occluder(ASO) without balloon sizing. Methods: Between Jan. 2000 and May 2003, large ASD closure with the ASO was performed in 36 adults (mean age 45± 14years,range 20~66years, 23 female). The patients were divided into two groups. In the study group, a closure of ASD was attempted using TEE without balloon sizing in the 18 patients. In the control group, ASD closure was performed using the SBD in the other 18 patients. In the control group, we implanted devices 2~4 mm larger than the SBD. In the study group, A device with a waist diameter 4~8 mm bigger than maximal TEE defect diameter was chosen. Results: In the study group, ASD median diameter is 26.8±1.9 mm under TEE; Devices ranging from 30 to 38 mm in diameter (33.3±2.4mm) were implanted. In the control group, ASD median diameter is 26.5±1.9mm under TEE and Devices ranging from 30 to 38 mm (33.7±2.2 mm),the SBD was 30.6±1.6 mm. There was no significant difference between the 2 Groups in age,sex ratio,weight,Qp/Qs, defect diameter and diameter of devices (P>0.05). An ASO was successfully implanted in all patients. Fluoroscopy times,TEE times and procedure times in the study group were significantly shorter than thoses in the control group (12.1±7.3 min vs. 19.4±6.7 min; P<0.01),(20.5±5.4 vs.29.2±6.8 min; P<0.01), (52.8±13.2 vs. 78.3±15.1 min; P<0.01). All of patients was no residual shunt found during 3~12 months follow-up. TTE and chest radiographs showed no displacementof the occluders. Conclusions: Transcatheter closure of large secundum ASD atrial septal defect using ASO without Balloon Sizing Maneuver is accepted treatment modality. TCT-223 PFO Closure Using Premiere: The CLOSE UP Trial Horst Sievert1, Franz Kleber2, Stephan Windecker3, Frank Uhlemann4, Christine Tiefenbacher5, Franziska Büscheck1, Dennis W. Wahr6 1 CardioVascular Center Frankfurt, Frankfurt, Germany2Unfallkrankenhau s, Berlin, Germany3Inselspital, Bern, Switzerland4Olgahospital, Stuttgart, Germany5Universitatsklinikum, Heidelberg, Germany6Velocimed, Inc., Maple Grove, MN Background: CLOSE UP was a prospective trial conducted to determine the safety and performance of the Premere PFO Closure System. Methods/Results: Seventy-three patients with a PFO and a history of stroke or TIA felt to be due to paradoxical emboli were enrolled at 5 sites; 67 patients were implanted with the device (54 study, 13 roll-in patients). Six patients did not receive the Premere device due to PFO and atrial anatomy (3 study, 3 roll-in). Atrial septal aneurysm was present in 18; average PFO diameter was 8.9 ±3.78 (range 1.9-19); 28 patients received the 15 mm and 39 the 20 mm device. Closure rates, defined as ≤5 bubbles on TEE Valsalva exam, are shown in Table 1; only those patients with an echo study at that time point are reported. For example, the single 20 mm
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) device patient open at 6 months did not have a study done at 3 months. At the start of the trial only the 15 mm device was available; closure rates appear better with the 20 mm device. There have been no events of death, hemo-pericardium, stroke or TIA. One patient (1.9%) was found to have visible thrombus on the left atrial anchor (TEE) at 3 months and received heparin/coumadin. Five patients had transient new arrhythmias: 4 were minor with no treatment; 1 with intermittent atrial fibrillation. Only the patient with AF was treated; all arrhythmias resolved prior to 6 month. Conclusion: The Premere device effectively closes PFO, and has a very low risk of adverse events.
Closure at 2 weeks Closure at 3 months Closure at 6 months
PFO Closure Rate with Premere All Study Patients 15 mm Device % (n) % (n) 67.3 (35/52) 47.6 (10/21) 89.8 (44/49) 75.0 (15/20) 92.9 (39/42) 90.5 (19/21)
20 mm Device % (n) 80.6 (25/31) 100.0 (29/29) 95.6 (22/23)
TCT-224 Patent Foramen Ovale Closures Improves Migraine Severity and Intensity Sabu J George, Malek Numeir, Nicholas Skiadas, John Grammes, Firas Alani, Grewal Rasveg, Benjamin Silverman, Juzer Lokandwala, Zeb Jahan, Nicole Bruno, Bruce Bowers, Ismail Dairywala, Jennifer Yanoschak, Carole Thomas, Daniel McCormick, Sheldon Goldberg Hahnemann University Hospital, Philadelphia, PA
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Background: Patients with cryptogenic stroke and PFO have a higher incidence of migraine. Recent data suggest that PFO closure results in improvement of symptoms. Methods: We reviewed all patients undergoing PFO closure for neurologic events from 2002 to 2004. Patients with migraines were identified using the International Headache Society Criteria. Follow up was obtained via a questionnaire using the MIDAS scale. Median follow up was 1.8 years. The MIDAS grades were compared pre-and post closure using the Wilcoxon test. Results: The files on 186 patients were reviewed. Follow up was obtained in 158/186 (85%). Of these 36/158 (23%) had migraines (26 female,10 male). The indications for PFO closure were CVA in 20/36(56%) and TIA in 16/36(44%). The pre-and post closure change in MIDAS grade is shown in Figure 1. There was a significant decrease in MIDAS grade after closure (p<0.001). Fifty six percent of patients (20/36) showed improvement of at least one MIDAS grade, eight of whom had complete relief. Fourty four percent of patients (16/36) had no change in MIDAS grade. A trend towards more Conclusion: There was objective improvement in migraine following PFO closure, especially in patients with more severe symptoms.
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