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Valvular Heart Disease
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Valvular Heart Disease Exhibit Halls A and B Monday, October 17, 2005, 9:00 am - 5:00 pm (Abstract Nos. 236-240) TCT-236 Predictive Value of EuroScore for In-Hospital and Follow-Up Mortality after Balloon Aortic Valvuloplasty Annapoorna S. Kini, Tirumalesh Venkatesh, Robert Pyo, Mary-Beth Duffy, Pedro R. Moreno, Samin K. Sharma Mount Sinai Hospital, New York, NY Background: Balloon aortic valvuloplasty (BAV) is currently performed in pts with severe aortic stenosis (AS) who either have prohibitive surgical risk for aortic valve replacement or have limited life expectancy. EuroScore is a simple risk stratification tool, derived from multiple baseline factors and is predictive of in-hospital mortality after bypass surgery and has been validated in the surgical literature. It is not known whether EuroScore can be utilized to predict short- or long-term mortality after BAV. Methods and Results: A total of 202 high-risk inoperable patients with symptomatic severe AS underwent BAV at Mount Sinai Hospital from January 2001 to December 2003. All pts were followed for in-hospital events and follow-up mortality at median of 2.5 years (Table). Logistic EuroScore on average over-estimated death risk by absolute 26% (predicted surgical mortality of 34% vs. actual BAV in-hospital mortality of 8%) [95% CI 3% 20%; p <0.001]. Logistic EuroScore is useful in predicting BAV in-hospital mortality (p = 0.029) but the predictive value is modest (ROC of 0.66 with c-statistic). Cutoff of significant mortality occurs at EuroScore of 10. Conclusion: Present analysis suggests the use of Euroscore as a simple risk stratification tool in predicting in-hospital mortality after BAV. Also, AS pts with EuroScore >10 may be most appropriate candidates for percutaneous aortic valve replacement. Table. Euroscore ≤5 6-10 10-15 >15 P
N 6 70 89 37
Predicted surgical mortality (%) 4 12 36 58
In-hospital BAV mortality (%) 0 4.3 10.1 16.2 0.029
Follow-up BAV mortality (%) 16.7 27.5 37.2 40.1 0.05
TCT-237 Percutaneous Aortic Valve Implantation: A Large Annulus Prosthesis John G. Webb1, Mann Chandavimol1, Samuel J. McClure1, Donald R. Ricci2, Ronald G. Carere1, Christopher R. Thompson1 1 St. Paul’s Hospital, Vancouver, BC, Canada2Vancouver General Hospital, Vancouver, BC, Canada Objectives. We describe the initial clinical experience with a new large (26mm) annulus Cribier-Edwards percutaneous aortic valve (PAV). Background. The Cribier-Edwards PAV (Edwards LifeSciences Inc., Irvine, CA) is a trileaflet equine pericardial valve mounted within a tubular slotted stainless steel stent. Previous implants have employed a 23 mm outer diameter PAV. Although initial results have been encouraging, valve embolization at the time of implantation and paravalvular regurgitation have occurred. The ideal relationship between annulus size and prosthesis size is unknown. Methods. Implantation of 26 mm Cribier-Edwards PAVs was undertaken in five patients with symptomatic severe aortic valve stenosis. Patients were 82 + 5 years with median additive EuroScore of 11 and 23.0% predicted operative mortality rate. Results. The PAVs were successfully implanted in all 5 patients via the
retrograde trans-arterial femoral approach. Mean aortic gradient decreased from 48 to 18 mm Hg with valve area increased from 0.7 to 1.6 cm2. PHV embolization did not occur. There were no major procedural related complications. At 40 + 16 days, all patients remain alive and out of hospital. Aortic annulus by echo (mm) Valve area pre (cm²) Valve area post (cm²) Paravalvular regurgitation post (mean, range) Valve embolization
23 mm (N=8) 22.0 ± 1.4 0.6 ± 0.1 1.3 ± 0.5 Mild: 2+ (0-3) 2
26 mm (N=5) 23.7± 1.5 0.7 ± 0.2 1.6 ± 0.2 Trivial: 1+ (1-2) 0
Conclusion. We have demonstrated the feasibility of PAV implantation via the retrograde trans-arterial approach using a new large annulus prosthesis. In selected patients a larger diameter device may be associated with a lower risk of PAV embolization and post-implantation paravalvular aortic regurgitation. TCT-238 Clinical Outcome of PMV-Associated Moderate or Severe MR Sung Hea Kim, Je Sang Kim, Seung Woo Park, Sang Hoon Lee, Kyung Pyo Hong, Jung-Don Seo, Sang-Chol Lee Department of Medicine, Sungkyunkwan University School of Medicine, Cardiac and Vascular Center, Seoul, Republic of Korea Background: Mitral regurgitation(MR) is a significant complication after percutaneous mitral valvuloplasty(PMV). We sought to investigate the natural history of moderate or severe MR after PMV. Methods: PMV was performed in 183 consecutive patients with severe mitral stenosis. Baseline and follow-up echocardiographic and clinical data of 29 patients who developed moderate or severe MR after PMV were reviewed retrospectively. Results: Among the 29 patients, 19 developed moderate and 10 severe regurgitation. Their mean age was 42±9 years. Mean follow-up period was 4.0±2.4 years. Excluding 2 patients who underwent emergency surgery immediately after PMV and 1 patient who refused follow up, baseline post-procedural echocardiography was performed in 26 patients 1 day after PMV. MR grade improved in 35%(2/8 in severe, 6/18 in moderate MR) after 1 year. Among these improved subjects, however, the grade of MR re-progressed in 27% on 3-year and in an additional 36% on 5year follow-up. The overall progression rate for initial moderate MR (n=18) was 15% and 53% in 3 and 5 years after PMV, respectively. Left atrial size also showed a significant increase with time (p=0.02). A total of 8 cases of major clinical events occurred during follow-up, with a 5year event rate of 32%. The events were; 2 cases of elective operation, 2 cases of new atrial fibrillation, 1 case of heart failure and 1 case of stroke. Conclusion: PMV-associated moderate or severe MR shows relatively rapid progression and frequent clinical events on follow-up. Special attention is required in these patients including detailed history taking and annual echocardiographic examination TCT-239 Mitral Valvuloplasty in the Pediatric Age Group: Immediate and Long Term Follow-Up Results Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta, Praveen Singh, Ramesh Arora, Sanjay Tyagi G B Pant Hospital and Maulana Azad Medical College, New Delhi, India Background: Mitral balloon valvuloplasty (BV) is effective therapeutic option but there is paucity of data on immediate/ long-term efficacy of BV in pediatric age group (≤ 15 years). Methods: Hospital data between October 1987-December 2004 were analyzed to determine immediate/longterm results of BV. 603/6870 (8.7%)
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
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P O S T E R A B S T R A C T S
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) ≤ 15 years were studied. Age range was 6-15 (mean 11.3 ± 2.8 years) mean height (142.2 ±11.8 cms); mean body surface area (BSA) (1.2 ± 0.2); male to female ratio 1.2:1. All had sinus rhythm. Preprocedure mitral valve area (MVA) by echocardiography ranged from 0.4-1cm2; Wilkins score ≤ 8 in majority (n=547, 90.8%). Mitral regurgitation (MR) was mild in 112/603 (18.5%), moderate in 28 (4.6%), severe in 20 (3.3%). Inoue balloon (Toray, Japan) was used for BV in 542 patients (89.8%) and double balloon (Mansfield Scientific Inc) in rest (21-22 mm/m2 BSA). Severe pulmonary arterial hypertension (mean PA pressure ≥ 50 mm Hg) was present in 406 (67.3%) Successful procedure was defined as (MVA > 1cm2/m2 BSA or mean gradient < 5 mm Hg in absence of complication) and restenosis (MVA ≤ 0.8cm2/m2 BSA or > 50% gain loss). Results: 592 (98.2%) patient had successful BV. MVA increased from 0.73 ± 0.16 cm2 to 1.88 ± 0.32 cm2 (p< 0.0001) and mean PA pressure fell from 68 ± 15.4 to 27.6 ± 10.4 mm Hg (p< 0.001), transmitral gradient reduced from 18.6 ± 6.12 to 3.6 ± 3.20 mm Hg; (p<0.001). 6 (0.9%) developed severe MR (4 required mitral valve replacement). One had cardiac tamponade (expired);4 had suboptimal result. All with preexisting severe MR had successful BV, symptomatic improvement. 18 showed reduction in severity of MR on followup (mild MR-4, moderate MR-14) only 2 required MVR. Over followup of 96.4 ± 38.2 months (range 5-195 months), 74 patients (12.2%) developed restenosis, of whom 58 (9.6%) with class III/IV symptoms underwent successful redilatation and 6 (0.9%) underwent successful third dilatation. No deaths occurred during followup. Conclusion: MV provides excellent long-term palliation in pediatric patients preserving native valve and avoiding complications of valve replacement. Concomitant severe MR should not be considered an absolute contraindication in this age group. TCT-240 Percutaneous Aortic Valve Replacement Utilizing Novel Inflatable Fabric Cuff Supported Tissue Valve in Ovine Model Reginald Low1, Jason Rogers1, Gordon Bishop2, Randy Lashinski2 1 U.C. Davis, Sacramento, CA;2Direct Flow Medical Inc., Santa Rosa, CA
P O S T E R A B S T R A C T S
Background: Advances in percutaneous therapeutic vascular procedures are being applied to nonsurgical percutaneous valve replacement and repair. The feasibility of percutaneous transcatheter aortic valve replacement via antegrade and retrograde approach utilizing a metallic stent based tissue valve has been demonstrated. A novel inflatable fabric cuff supported tissue valve has been developed for percutaneous delivery which permits accurate positioning, repositioning, tight sealing to annulus and if necessary, retrieval. Method: A new percutaneously delivered valve prosthesis has been developed (Direct Flow Medical Inc.) using pericardial tissue mounted to a fabric inflatable cuff similar to a surgical valve. The valve is delivered retrograde via catheter and unsheathed just below the aortic annulus. The fabric cuff supported valve is then expanded by inflating with contrast and positioned at the annulus. Once proper positioning and function are confirmed, a solidifying polymer is injected to replace the contrast followed by release of the connecting tubing from the prosthesis. This next generation valve has been implanted in a series of ovine models and positioning and function are assessed radiographically, hemodynamically and by intracardiac echo. Results: This inflatable fabric cuff supported tissue valve has been acutely deployed successfully in healthy sheep with position and valve function assessed by angiography, hemodynamics and intracardiac echo.Valve retention was confirmed with epinephrine challenge. Clinical data will be presented. Conclusion: This novel fabric cuff pericardial valve represents the next generation transcatheter delivered aortic valve. Potential advantages include accurate positioning, repositioning, excellent conformability to the annulus to reduce perivalvular leak and retrieval, if necessary.
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The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
N 6 70 89 37
Predicted surgical mortality (%) 4 12 36 58
In-hospital BAV mortality (%) 0 4.3 10.1 16.2 0.029
Follow-up BAV mortality (%) 16.7 27.5 37.2 40.1 0.05
TCT-237 Percutaneous Aortic Valve Implantation: A Large Annulus Prosthesis John G. Webb1, Mann Chandavimol1, Samuel J. McClure1, Donald R. Ricci2, Ronald G. Carere1, Christopher R. Thompson1 1 St. Paul’s Hospital, Vancouver, BC, Canada2Vancouver General Hospital, Vancouver, BC, Canada Objectives. We describe the initial clinical experience with a new large (26mm) annulus Cribier-Edwards percutaneous aortic valve (PAV). Background. The Cribier-Edwards PAV (Edwards LifeSciences Inc., Irvine, CA) is a trileaflet equine pericardial valve mounted within a tubular slotted stainless steel stent. Previous implants have employed a 23 mm outer diameter PAV. Although initial results have been encouraging, valve embolization at the time of implantation and paravalvular regurgitation have occurred. The ideal relationship between annulus size and prosthesis size is unknown. Methods. Implantation of 26 mm Cribier-Edwards PAVs was undertaken in five patients with symptomatic severe aortic valve stenosis. Patients were 82 + 5 years with median additive EuroScore of 11 and 23.0% predicted operative mortality rate. Results. The PAVs were successfully implanted in all 5 patients via the
retrograde trans-arterial femoral approach. Mean aortic gradient decreased from 48 to 18 mm Hg with valve area increased from 0.7 to 1.6 cm2. PHV embolization did not occur. There were no major procedural related complications. At 40 + 16 days, all patients remain alive and out of hospital. Aortic annulus by echo (mm) Valve area pre (cm²) Valve area post (cm²) Paravalvular regurgitation post (mean, range) Valve embolization
23 mm (N=8) 22.0 ± 1.4 0.6 ± 0.1 1.3 ± 0.5 Mild: 2+ (0-3) 2
26 mm (N=5) 23.7± 1.5 0.7 ± 0.2 1.6 ± 0.2 Trivial: 1+ (1-2) 0
Conclusion. We have demonstrated the feasibility of PAV implantation via the retrograde trans-arterial approach using a new large annulus prosthesis. In selected patients a larger diameter device may be associated with a lower risk of PAV embolization and post-implantation paravalvular aortic regurgitation. TCT-238 Clinical Outcome of PMV-Associated Moderate or Severe MR Sung Hea Kim, Je Sang Kim, Seung Woo Park, Sang Hoon Lee, Kyung Pyo Hong, Jung-Don Seo, Sang-Chol Lee Department of Medicine, Sungkyunkwan University School of Medicine, Cardiac and Vascular Center, Seoul, Republic of Korea Background: Mitral regurgitation(MR) is a significant complication after percutaneous mitral valvuloplasty(PMV). We sought to investigate the natural history of moderate or severe MR after PMV. Methods: PMV was performed in 183 consecutive patients with severe mitral stenosis. Baseline and follow-up echocardiographic and clinical data of 29 patients who developed moderate or severe MR after PMV were reviewed retrospectively. Results: Among the 29 patients, 19 developed moderate and 10 severe regurgitation. Their mean age was 42±9 years. Mean follow-up period was 4.0±2.4 years. Excluding 2 patients who underwent emergency surgery immediately after PMV and 1 patient who refused follow up, baseline post-procedural echocardiography was performed in 26 patients 1 day after PMV. MR grade improved in 35%(2/8 in severe, 6/18 in moderate MR) after 1 year. Among these improved subjects, however, the grade of MR re-progressed in 27% on 3-year and in an additional 36% on 5year follow-up. The overall progression rate for initial moderate MR (n=18) was 15% and 53% in 3 and 5 years after PMV, respectively. Left atrial size also showed a significant increase with time (p=0.02). A total of 8 cases of major clinical events occurred during follow-up, with a 5year event rate of 32%. The events were; 2 cases of elective operation, 2 cases of new atrial fibrillation, 1 case of heart failure and 1 case of stroke. Conclusion: PMV-associated moderate or severe MR shows relatively rapid progression and frequent clinical events on follow-up. Special attention is required in these patients including detailed history taking and annual echocardiographic examination TCT-239 Mitral Valvuloplasty in the Pediatric Age Group: Immediate and Long Term Follow-Up Results Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta, Praveen Singh, Ramesh Arora, Sanjay Tyagi G B Pant Hospital and Maulana Azad Medical College, New Delhi, India Background: Mitral balloon valvuloplasty (BV) is effective therapeutic option but there is paucity of data on immediate/ long-term efficacy of BV in pediatric age group (≤ 15 years). Methods: Hospital data between October 1987-December 2004 were analyzed to determine immediate/longterm results of BV. 603/6870 (8.7%)
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
99H
P O S T E R A B S T R A C T S
MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) ≤ 15 years were studied. Age range was 6-15 (mean 11.3 ± 2.8 years) mean height (142.2 ±11.8 cms); mean body surface area (BSA) (1.2 ± 0.2); male to female ratio 1.2:1. All had sinus rhythm. Preprocedure mitral valve area (MVA) by echocardiography ranged from 0.4-1cm2; Wilkins score ≤ 8 in majority (n=547, 90.8%). Mitral regurgitation (MR) was mild in 112/603 (18.5%), moderate in 28 (4.6%), severe in 20 (3.3%). Inoue balloon (Toray, Japan) was used for BV in 542 patients (89.8%) and double balloon (Mansfield Scientific Inc) in rest (21-22 mm/m2 BSA). Severe pulmonary arterial hypertension (mean PA pressure ≥ 50 mm Hg) was present in 406 (67.3%) Successful procedure was defined as (MVA > 1cm2/m2 BSA or mean gradient < 5 mm Hg in absence of complication) and restenosis (MVA ≤ 0.8cm2/m2 BSA or > 50% gain loss). Results: 592 (98.2%) patient had successful BV. MVA increased from 0.73 ± 0.16 cm2 to 1.88 ± 0.32 cm2 (p< 0.0001) and mean PA pressure fell from 68 ± 15.4 to 27.6 ± 10.4 mm Hg (p< 0.001), transmitral gradient reduced from 18.6 ± 6.12 to 3.6 ± 3.20 mm Hg; (p<0.001). 6 (0.9%) developed severe MR (4 required mitral valve replacement). One had cardiac tamponade (expired);4 had suboptimal result. All with preexisting severe MR had successful BV, symptomatic improvement. 18 showed reduction in severity of MR on followup (mild MR-4, moderate MR-14) only 2 required MVR. Over followup of 96.4 ± 38.2 months (range 5-195 months), 74 patients (12.2%) developed restenosis, of whom 58 (9.6%) with class III/IV symptoms underwent successful redilatation and 6 (0.9%) underwent successful third dilatation. No deaths occurred during followup. Conclusion: MV provides excellent long-term palliation in pediatric patients preserving native valve and avoiding complications of valve replacement. Concomitant severe MR should not be considered an absolute contraindication in this age group. TCT-240 Percutaneous Aortic Valve Replacement Utilizing Novel Inflatable Fabric Cuff Supported Tissue Valve in Ovine Model Reginald Low1, Jason Rogers1, Gordon Bishop2, Randy Lashinski2 1 U.C. Davis, Sacramento, CA;2Direct Flow Medical Inc., Santa Rosa, CA
P O S T E R A B S T R A C T S
Background: Advances in percutaneous therapeutic vascular procedures are being applied to nonsurgical percutaneous valve replacement and repair. The feasibility of percutaneous transcatheter aortic valve replacement via antegrade and retrograde approach utilizing a metallic stent based tissue valve has been demonstrated. A novel inflatable fabric cuff supported tissue valve has been developed for percutaneous delivery which permits accurate positioning, repositioning, tight sealing to annulus and if necessary, retrieval. Method: A new percutaneously delivered valve prosthesis has been developed (Direct Flow Medical Inc.) using pericardial tissue mounted to a fabric inflatable cuff similar to a surgical valve. The valve is delivered retrograde via catheter and unsheathed just below the aortic annulus. The fabric cuff supported valve is then expanded by inflating with contrast and positioned at the annulus. Once proper positioning and function are confirmed, a solidifying polymer is injected to replace the contrast followed by release of the connecting tubing from the prosthesis. This next generation valve has been implanted in a series of ovine models and positioning and function are assessed radiographically, hemodynamically and by intracardiac echo. Results: This inflatable fabric cuff supported tissue valve has been acutely deployed successfully in healthy sheep with position and valve function assessed by angiography, hemodynamics and intracardiac echo.Valve retention was confirmed with epinephrine challenge. Clinical data will be presented. Conclusion: This novel fabric cuff pericardial valve represents the next generation transcatheter delivered aortic valve. Potential advantages include accurate positioning, repositioning, excellent conformability to the annulus to reduce perivalvular leak and retrieval, if necessary.
100H
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster