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TCT-662 Outcomes after TAVR in high-risk patients beyond 6 years
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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
procedural transient ischemic attacks, minor or major strokes occurred. Macroscopic material liberated during the TAVI procedure was captured in the device filter baskets in 13 pts (86.6%). The visible material captured was found in 1 or both filters, different sizes, maximum of 3 mm.
CATEGORIES STRUCTURAL: Valvular Disease: Aortic
CONCLUSION In our experience the use of dual filter–based cerebral embolic protection device system is feasible and safe. Embolic debris traveling to the brain and potentially conducive to cerebrovascular events was captured in 86.6% of TAVI procedures where a filter-based embolic protection device was used.
Magdalena Erlebach,1 Marcus-André Deutsch,2 Melchior Burri,3 Johannes Ziegelmueller,4 Domenico Mazzitelli,5 Hendrik Ruge,6 Markus Krane,7 Ruediger Lange,8 Sabine Bleiziffer9 1 German Heart Center Munich, Munich, Germany; 2Pharmacy, Jahangirnagar University, Dhaka, Bangladesh; 3German Heart Centre Munich, Munich, Germany; 4German Heart Center Munich, Munich, Germany; 5Complejo Hospitalario Universitario Albacete; 6Munich, Germany; 7Montefiore Medical Center; 8German Heart Center Munich; 9 German Heart Center Munich, Munich, Germany
CATEGORIES STRUCTURAL: Complications
TCT-661 The Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights from the PARTNER II SAPIEN 3 Cohort Yigal Abramowitz,1 Brian Lindman,2 Tarun Chakravarty,3 Hasanian Jilaihawi,4 Samir Kapadia,5 Wilson Szeto,6 Philippe Pibarot,7 Vasilis Babaliaros,8 Howard Herrmann,9 Richard Smalling,10 Lars Svensson,11 Torsten Vahl,12 Vinod Thourani,13 Susheel Kodali,14 Craig Smith,15 Yiran Zhang,16 Maria Alu,17 Michael Mack,18 Martin Leon,19 Raj Makkar20 1 Cedars-Sinai Medical Center, Los Angeles, California, United States; 2 Aurora St. Luke’s Hospital; 3Cedars Sinai Medical Center, Los Angeles, California, United States; 4Cedars Sinai Medical Center, Montreal, Quebec, Canada; 5Cleveland Clinic, Cleveland, Ohio, United States; 6 University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States; 7Quebec Heart and Lung Institute, Quebec City, Quebec, Canada; 8Emory University School of Medicine, Atlanta, Georgia, United States; 9Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States; 10UTHealth/Memorial Hermann Heart and Vascular Institute, Houston, Texas, United States; 11 Cleveland Clinic Foundation, Cleveland, Ohio, United States; 12 Columbia University Medical Center, New York, New York, United States; 13Emory University Hospital Midtown, Atlanta, Georgia, United States; 14NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 15NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 16University of Massachusetts Medical School; 17 Columbia University Medical Center, Wilson, North Carolina, United States; 18The Heart Hospital Baylor Plano, Plano, Texas, United States; 19 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 20Cedars-Sinai Medical Center, Los Angeles, California, United States BACKGROUND Diabetes mellitus (DM) adversely affects morbidity and mortality for cardiovascular diseases and procedures. There is limited data on the impact of DM on the prognosis of patients with severe aortic stenosis that undergo TAVR. In a sub-study of the PARTNER I trial, 1-year mortality was higher in patients without DM compared to patients with diabetes, although multivariable analysis was not performed. We aimed to evaluate the clinical characteristics and the early and 1-year outcomes after TAVR according to DM status. METHODS Among treated patients with severe symptomatic aortic stenosis at high or intermediate risk for surgery in the PARTNER II (Placement of AorticTranscatheter Valve) trial treated with a SAPIEN 3 (S3) valve, we examined outcomes stratified according to diabetes status. The primary outcome was all-cause mortality at 1 year. RESULTS Among 1,661 patients treated with an S3 valve, there were 558 (33.6%) patients with DM (156 insulin-treated and 402 oral/diet treated). Patients with DM were younger (mean age 79.77.2 vs.83.56.8; p<0.001) and had higher BMI (30.86.8 vs.27.45.7; p<0.001). Patients with insulin-treated DM had a higher prevalence of COPD. At 30 days, overall mortality and major complications rates were similar between groups. At 1 year, overall mortality was similar between diabetics and non-diabetics but insulin-treated patiants had significantly higher mortality compared to non-insulin treated diabetics (13.0% vs. 7.1%; p¼0.03). In a multivariable model, compared to non-diabetic patients, insulin-treated DM and non-insulin treated DM were not significantly associated with mortality (HR 1.40; 95% CI: 0.81-2.43; p¼0.23 and HR 0.68: 95% CI:0.42-1.09; p¼0.11, respectively). Stroke rates at 1-year were also similar between groups. CONCLUSION DM is not associated with early or 1-year mortality or major complications in intermediate or high-risk patients undergoing TAVR with an S3 valve, although insulin-treated diabetics have increased 1-year mortality compared to non-insulin treated diabetics.
TCT-662 Outcomes after TAVR in high-risk patients beyond 6 years
BACKGROUND We sought to describe the clinical and echocardiographic outcome of high-risk patients having undergone TAVR with a potential follow-up of more than 6 years. METHODS From a prospective registry, comprising a total of 1595 patients, all consecutive patients having undergone TAVR between June 2007 and September 2009, allowing for a minimum follow-up of 6 years, were analyzed. Kaplan-Meier and multivariate analysis were used for statistical analysis. RESULTS A total of 300 patients (age 80.96.5yrs, STS score 6.54.5, logEuroScore 21.213.3%) were included. A CoreValve (Medtronic, MN, USA) prosthesis was used in 215 patients (72%), a Sapien (Edwards, CA, USA) in 85 patients (28%). Access route was transfemoral in 65.7%, transapical in 28.7% (others in 5.6%). At 1, 5 and 7 years estimated survival was 76.0%, 40.2% and 23.4%. There was no significant difference between access routes. Of baseline, peri- and postprocedural factors cerebral artery disease (HR 2.2, 95%CI 1.1 to 4.7, p¼0.037), postoperative or chronic atrial fibrillation (HR 1.9, 95% CI 1.0 to 3.7, p¼0.047) and level of STS score (HR 1.2 per point increase, 95%CI 1.1 to 1.3, p<0.001) were independently associated with 5-year death. Freedom from NYHA class III, IV or death at 1, 5 and 7 years was 74.7%, 33.1% and 11.4%. At 5 years, 77.8% of surviving patients were in NYHA class I or II. Freedom from stroke at 1, 5 and 7 years was 90.4%, 81.3% and 77.1%. During follow-up 10/3.6% required reoperation for various reasons. Valve function remained stable (linearized mean pressure gradient (MPG) increase 0.02mmHg/ year (95% CI: 0.17 to -0.14mmHg, MPG at discharge: 11.9mmHg)). Freedom from structural valve dysfunction according to VARC-2 criteria (valvular AR>moderate and/or MPG20mmHg) at 1, 5 and 7 years was 88.5%, 80.9% and 76.0%. CONCLUSION After 7 years, 23.4% of high-risk patients having undergone TAVR with 1st generation devices were still alive. VARCcomplication rates during the study period remained low. Preexisting rather than procedure-related factors seem to independently influence long-term mortality. A high proportion of survivors maintain good clinical status and valve function in the long-term. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-663 Twelve months outcome in patients undergoing transfemoral aortic valve replacement (TAVR) with the repositionable and retrievable Boston Scientific Lotus valve compared with the balloonexpandable Edwards Sapien 3 device Julia Seeger,1 Birgid Gonska,2 Christoph Rodewald,3 Wolfgang Rottbauer,4 Jochen Wöhrle5 1 Ulm University, Ulm, Germany; 2University hospital Ulm, Ulm, Germany; 3Uniklinik Ulm, Ulm, Germany; 4University Hospital of Ulm, Ulm, Baden-Württemberg, Germany; 5University Hospital Ulm, Ulm, Germany BACKGROUND Residual aortic regurgitation was frequent with first generation TAVR devices. Innovations with new generation are aiming to optimize valve performance and improve clinical outcome. METHODS We compared 30 days and 12 months outcome of the new generation repositionable and retrievable Boston Scientific Lotus Valve and the balloon-expandable Edwards Sapien 3 valve. Outcomes were studied according to VARC-2 criteria. RESULTS Between 2014 and 2016 consecutive patients treated with the Boston Scientific Lotus Valve (N¼202) and the Edwards Sapien 3 (N¼335) were prospectively enrolled (clinicaltrials.gov NCT02162069). There was no moderate or severe AR with both new generation devices. AR was lowest with the Lotus valve. Rate of pacemaker
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
procedural transient ischemic attacks, minor or major strokes occurred. Macroscopic material liberated during the TAVI procedure was captured in the device filter baskets in 13 pts (86.6%). The visible material captured was found in 1 or both filters, different sizes, maximum of 3 mm.
CATEGORIES STRUCTURAL: Valvular Disease: Aortic
CONCLUSION In our experience the use of dual filter–based cerebral embolic protection device system is feasible and safe. Embolic debris traveling to the brain and potentially conducive to cerebrovascular events was captured in 86.6% of TAVI procedures where a filter-based embolic protection device was used.
Magdalena Erlebach,1 Marcus-André Deutsch,2 Melchior Burri,3 Johannes Ziegelmueller,4 Domenico Mazzitelli,5 Hendrik Ruge,6 Markus Krane,7 Ruediger Lange,8 Sabine Bleiziffer9 1 German Heart Center Munich, Munich, Germany; 2Pharmacy, Jahangirnagar University, Dhaka, Bangladesh; 3German Heart Centre Munich, Munich, Germany; 4German Heart Center Munich, Munich, Germany; 5Complejo Hospitalario Universitario Albacete; 6Munich, Germany; 7Montefiore Medical Center; 8German Heart Center Munich; 9 German Heart Center Munich, Munich, Germany
CATEGORIES STRUCTURAL: Complications
TCT-661 The Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights from the PARTNER II SAPIEN 3 Cohort Yigal Abramowitz,1 Brian Lindman,2 Tarun Chakravarty,3 Hasanian Jilaihawi,4 Samir Kapadia,5 Wilson Szeto,6 Philippe Pibarot,7 Vasilis Babaliaros,8 Howard Herrmann,9 Richard Smalling,10 Lars Svensson,11 Torsten Vahl,12 Vinod Thourani,13 Susheel Kodali,14 Craig Smith,15 Yiran Zhang,16 Maria Alu,17 Michael Mack,18 Martin Leon,19 Raj Makkar20 1 Cedars-Sinai Medical Center, Los Angeles, California, United States; 2 Aurora St. Luke’s Hospital; 3Cedars Sinai Medical Center, Los Angeles, California, United States; 4Cedars Sinai Medical Center, Montreal, Quebec, Canada; 5Cleveland Clinic, Cleveland, Ohio, United States; 6 University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States; 7Quebec Heart and Lung Institute, Quebec City, Quebec, Canada; 8Emory University School of Medicine, Atlanta, Georgia, United States; 9Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States; 10UTHealth/Memorial Hermann Heart and Vascular Institute, Houston, Texas, United States; 11 Cleveland Clinic Foundation, Cleveland, Ohio, United States; 12 Columbia University Medical Center, New York, New York, United States; 13Emory University Hospital Midtown, Atlanta, Georgia, United States; 14NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 15NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 16University of Massachusetts Medical School; 17 Columbia University Medical Center, Wilson, North Carolina, United States; 18The Heart Hospital Baylor Plano, Plano, Texas, United States; 19 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 20Cedars-Sinai Medical Center, Los Angeles, California, United States BACKGROUND Diabetes mellitus (DM) adversely affects morbidity and mortality for cardiovascular diseases and procedures. There is limited data on the impact of DM on the prognosis of patients with severe aortic stenosis that undergo TAVR. In a sub-study of the PARTNER I trial, 1-year mortality was higher in patients without DM compared to patients with diabetes, although multivariable analysis was not performed. We aimed to evaluate the clinical characteristics and the early and 1-year outcomes after TAVR according to DM status. METHODS Among treated patients with severe symptomatic aortic stenosis at high or intermediate risk for surgery in the PARTNER II (Placement of AorticTranscatheter Valve) trial treated with a SAPIEN 3 (S3) valve, we examined outcomes stratified according to diabetes status. The primary outcome was all-cause mortality at 1 year. RESULTS Among 1,661 patients treated with an S3 valve, there were 558 (33.6%) patients with DM (156 insulin-treated and 402 oral/diet treated). Patients with DM were younger (mean age 79.77.2 vs.83.56.8; p<0.001) and had higher BMI (30.86.8 vs.27.45.7; p<0.001). Patients with insulin-treated DM had a higher prevalence of COPD. At 30 days, overall mortality and major complications rates were similar between groups. At 1 year, overall mortality was similar between diabetics and non-diabetics but insulin-treated patiants had significantly higher mortality compared to non-insulin treated diabetics (13.0% vs. 7.1%; p¼0.03). In a multivariable model, compared to non-diabetic patients, insulin-treated DM and non-insulin treated DM were not significantly associated with mortality (HR 1.40; 95% CI: 0.81-2.43; p¼0.23 and HR 0.68: 95% CI:0.42-1.09; p¼0.11, respectively). Stroke rates at 1-year were also similar between groups. CONCLUSION DM is not associated with early or 1-year mortality or major complications in intermediate or high-risk patients undergoing TAVR with an S3 valve, although insulin-treated diabetics have increased 1-year mortality compared to non-insulin treated diabetics.
TCT-662 Outcomes after TAVR in high-risk patients beyond 6 years
BACKGROUND We sought to describe the clinical and echocardiographic outcome of high-risk patients having undergone TAVR with a potential follow-up of more than 6 years. METHODS From a prospective registry, comprising a total of 1595 patients, all consecutive patients having undergone TAVR between June 2007 and September 2009, allowing for a minimum follow-up of 6 years, were analyzed. Kaplan-Meier and multivariate analysis were used for statistical analysis. RESULTS A total of 300 patients (age 80.96.5yrs, STS score 6.54.5, logEuroScore 21.213.3%) were included. A CoreValve (Medtronic, MN, USA) prosthesis was used in 215 patients (72%), a Sapien (Edwards, CA, USA) in 85 patients (28%). Access route was transfemoral in 65.7%, transapical in 28.7% (others in 5.6%). At 1, 5 and 7 years estimated survival was 76.0%, 40.2% and 23.4%. There was no significant difference between access routes. Of baseline, peri- and postprocedural factors cerebral artery disease (HR 2.2, 95%CI 1.1 to 4.7, p¼0.037), postoperative or chronic atrial fibrillation (HR 1.9, 95% CI 1.0 to 3.7, p¼0.047) and level of STS score (HR 1.2 per point increase, 95%CI 1.1 to 1.3, p<0.001) were independently associated with 5-year death. Freedom from NYHA class III, IV or death at 1, 5 and 7 years was 74.7%, 33.1% and 11.4%. At 5 years, 77.8% of surviving patients were in NYHA class I or II. Freedom from stroke at 1, 5 and 7 years was 90.4%, 81.3% and 77.1%. During follow-up 10/3.6% required reoperation for various reasons. Valve function remained stable (linearized mean pressure gradient (MPG) increase 0.02mmHg/ year (95% CI: 0.17 to -0.14mmHg, MPG at discharge: 11.9mmHg)). Freedom from structural valve dysfunction according to VARC-2 criteria (valvular AR>moderate and/or MPG20mmHg) at 1, 5 and 7 years was 88.5%, 80.9% and 76.0%. CONCLUSION After 7 years, 23.4% of high-risk patients having undergone TAVR with 1st generation devices were still alive. VARCcomplication rates during the study period remained low. Preexisting rather than procedure-related factors seem to independently influence long-term mortality. A high proportion of survivors maintain good clinical status and valve function in the long-term. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-663 Twelve months outcome in patients undergoing transfemoral aortic valve replacement (TAVR) with the repositionable and retrievable Boston Scientific Lotus valve compared with the balloonexpandable Edwards Sapien 3 device Julia Seeger,1 Birgid Gonska,2 Christoph Rodewald,3 Wolfgang Rottbauer,4 Jochen Wöhrle5 1 Ulm University, Ulm, Germany; 2University hospital Ulm, Ulm, Germany; 3Uniklinik Ulm, Ulm, Germany; 4University Hospital of Ulm, Ulm, Baden-Württemberg, Germany; 5University Hospital Ulm, Ulm, Germany BACKGROUND Residual aortic regurgitation was frequent with first generation TAVR devices. Innovations with new generation are aiming to optimize valve performance and improve clinical outcome. METHODS We compared 30 days and 12 months outcome of the new generation repositionable and retrievable Boston Scientific Lotus Valve and the balloon-expandable Edwards Sapien 3 valve. Outcomes were studied according to VARC-2 criteria. RESULTS Between 2014 and 2016 consecutive patients treated with the Boston Scientific Lotus Valve (N¼202) and the Edwards Sapien 3 (N¼335) were prospectively enrolled (clinicaltrials.gov NCT02162069). There was no moderate or severe AR with both new generation devices. AR was lowest with the Lotus valve. Rate of pacemaker