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TCT-678 Incidence, Predictors and Clinical Outcomes of Coronary Obstruction Following Transcatheter Aortic Valve Implantation for Degenerative Bioprosthetic Surgical Valves: Insights from the VIVID Registry
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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
RESULTS Patient characteristics in both groups were comparable (inter alia comorbidities, BMI and time on dialysis), with patients in the TAVR group tending to be older (69 vs. 65.5 years; p¼0.06). Median duration of hospital stay in the TAVR group was 19 (11.5-21.75) days. Patients after SAVR had a significantly longer stay with 33 (2162) days (p¼0.002). After SAVR, there was a more pronounced SIRS (measured by CRP) and a higher incidence of acute graft failure (45% vs. 89.5%; p¼0.006). Graft losses occurred without exception in the SAVR group (n¼7). 30-day mortality was 10% in both groups. However, in-hospital mortality reached 25% after SAVR (TAVR 10%), indicating a more complicated course after open heart surgery. By Kaplan Meier estimation, 1-year survival tend to be better after TAVR (90% vs. 69%), while follow-up after 5 years was comparable in both group (TAVR 62% vs. SAVR 52%) (log-rank-test; p¼0.86). CONCLUSION In KTR with severe AS, TAVR can be performed with good mid-term results. Compared to SAVR, TAVR shows better short term results and, eminently important, leads to less graft loss. However, careful treatment planning and risk estimation in this special population is mandatory. Further studies evaluating best treatment in this specific population are warranted. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-678 Incidence, Predictors and Clinical Outcomes of Coronary Obstruction Following Transcatheter Aortic Valve Implantation for Degenerative Bioprosthetic Surgical Valves: Insights from the VIVID Registry
CONCLUSION Concomitant mitral/tricuspid valvular disease is common in TAVR patients. Improvement in the degree of valvular regurgitation post TAVR is more likely in the mitral position than in the tricuspid position. Patients with significant residual MR or TR that fails to improve, demonstrate a strong trend toward higher mortality after TAVR. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-677 Comparison of surgical versus interventional treatment of aortic valve stenosis in kidney transplant recipients Stefan Büttner,1 Helge Weiler,2 Carolin Zöller,3 Sammy Patyna,4 Jörg Honold,5 Nestoras Papadopoulos,6 Helmut Geiger,7 Ingeborg A. Hauser,8 Mariuca Vasa-Nicotera,9 Stephan Fichtlscherer10 1 Medical Clinic III – Department of Nephrology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany; 2 Experimental Radiology, Charité University Hospital, Berlin, Germany; 3Tufts Medical Center; 4Takase Cllinic; 5Mimihara General Hospital; 6General Hospital of Shenyang Military Region, Shenyang, China; 7International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; 8Institut de cardiologie Pitié salpêtrière; 9University Hospital Frankfurt; 10General Hospital of Shenyang Military Region, Shenyang, China BACKGROUND Surgical aortic valve replacement (SAVR) in kidney transplant recipients (KTR) with severe aortic stenosis (AS) is associated with high morbidity and mortality, especially due to cardiovascular and infectious complications, as well as an increased risk of postoperative kidney failure potentially leading to graft loss. Preliminary data from our center showed that transcatheter aortic valve implantation (TAVR) is safe in KTR requiring aortic valve replacement. However, long-term data on TAVR in KTR are still lacking. METHODS We retrospectively analyzed all 40 KTR, in which aortic valve replacement was performed at our center between 2005 and 2015. We compared the outcome and follow-up of TAVR (n¼20) versus SAVR (n¼20) with respect to patient and graft survival. Decision for each treatment strategy was determined for every single case within the interdisciplinary heart team.
Henrique Ribeiro,1 Josep Rodés-Cabau,2 Jong Kwan Park,3 Philipp Blanke,4 Jonathon Leipsic,5 Vinayak Bapat,6 Raj Makkar,7 Matheus Simonato dos Santos,8 Marco Barbanti,9 Joachim Schofer,10 Sabine Bleiziffer,11 Azeem Latib,12 David Hildick-Smith,13 Patrizia Presbitero,14 Stephan Windecker,15 Massimo Napodano,16 Alfredo Cerillo,17 Mohamed Abdel-Wahab,18 Didier Tchetche,19 Claudia Fiorina,20 Mauricio Cohen,21 Mayra Guerrero,22 Brian Whisenant,23 Fabian Nietlispach,24 Luis Nombela Franco,25 Fabio Brito,26 Pedro Lemos,27 John Webb,28 Danny Dvir29 1 Hopital Laval, Quebec City, Quebec, Canada; 2Quebec Heart and Lung Institute/Laval University, Quebec, Quebec, Canada; 3National Health Insurance Service Ilsan Hospital, Goyang, Korea, Republic of; 4St. Paul’s Hospital, Vancouver, British Columbia, Canada; 5St. Paul’s Hospital, Vancouver, British Columbia, Canada; 6Guy’s and St. Thomas’, London, United Kingdom; 7Cedars-Sinai Medical Center, Los Angeles, California, United States; 8Federal University of Sao Paulo, Vancouver, Brazil; 9Ferrarotto Hospital, University of Catania, Catania, Italy; 10Hamburg University Cardiovascular Center and Department for percutaneous treatment of structural hea, Hamburg, Germany; 11 German Heart Center Munich, Munich, Germany; 12EMO-GVM Centro Cuore Columbus, Milan, Italy; 13Sussex Cardiac Centre, Brighton, United Kingdom; 14Istituto Clinico Humanitas, Rozzano-Milan, Italy; 15 Swiss Cardiovascular Center Bern, Bern, Switzerland; 16Padova University Hospital, Padova, Italy; 17Fondazione Toscana G. Monasterio, Massa, Massa and Carrara, Italy; 18Heart Center, Segeberger Kliniken, Bad Segeberg, Germany; 19Clinique Pasteur, Toulouse, France; 20Brescia, Italy; 21University of Miami Hospital, Miami, Florida, United States; 22Evanston Hospital, Evanston, Illinois, United States; 23Intermountain Medical Center, Salt Lake City, Utah, United States; 24University Hospital Zurich; 25Hospital Clínico San Carlos, Madrid, Spain; 26University of Texas Health Science Center at San Antonio, Sao Paulo, São Paulo, Brazil; 27University of São Paulo Medical School, São Paulo, São Paulo, Brazil; 28St. Paul’s Hospital, Vancouver, British Columbia, Canada; 29St. Paul’s Hospital, Vancouver, British Columbia, Canada BACKGROUND There are limited data on coronary obstruction (CO) following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The present study includes a large cohort of patients undergoing ViV suffering this complication. METHODS A total of 34 patients with symptomatic CO following 1,508 aortic procedures from the Valve-in-Valve International Data (VIVID) registry were included (incidence of 2.25%). Pre-TAVI computed tomography (CT) data was available in 20 CO patients and in 90 controls, and data was subject to centralized blinded CoreLab analysis. The distance between a virtual transcatheter ring similar in size to the implanted device at the level of each coronary ostium (VTC) was determined. RESULTS Baseline clinical characteristics in the CO patients were similar to controls. CO was more common in stentless or stented bioprostheses with externally mounted leaflets than in stented
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
bioprostheses with internally mounted leaflets (6.1% vs. 3.7% vs. 0.8%, respectively; p<0.001). Balloon post-dilation was more frequently performed in CO group (24.2% vs. 12.7%, p¼0.05, respectively), and 30-day mortality was 52.9% vs. 3.9%, respectively (p<0.001). VTC distance was shorter in CO patients in relation to controls (3.242.22 vs. 6.302.34, respectively; p<0.001). Using multivariable analysis, the use of a stentless (OR 8.76, 95% CI: 3.5221.8, p<0.001) or stented bioprosthesis with externally mounted leaflets (Mitroflow [Sorin]; Trifecta [St. Jude Medical], OR 4.95, 95% CI: 1.88-13.1, p¼0.001) were independent predictors of CO. In addition, shorter VTC distance was independently associated with CO (p<0.01), with an optimal cutoff level of 4mm (AUC 0.895; p<0.001). CONCLUSION Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and those with shorter VTC distance. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-679 Diabetes and Clinical Outcomes in Intermediate Risk Patients Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: An Analysis of the PARTNER 2A Trial Brian Lindman,1 Yigal Abramowitz,2 Philippe Pibarot,3 Nishath Quader,4 Hersh Maniar,5 Alan Zajarias,6 Suzanne Arnold,7 Rebecca Hahn,8 Sammy Elmariah,9 Rakesh Suri,10 Torsten Vahl,11 Lars Svensson,12 Vinod Thourani,13 Claire Litherland,14 Maria Alu,15 Martin Leon,16 Raj Makkar17 1 Aurora St. Luke’s Hospital; 2Cedars-Sinai Medical Center, Los Angeles, California, United States; 3Quebec Heart and Lung Institute, Quebec City, Quebec, Canada; 4Sejong General Hospital; 5Washington University School of Medicine, St. Louis, Missouri, United States; 6Barnes Jewish Hospital, St. Louis, Missouri, United States; 7Saint Luke’s Hospital, Kansas City, Missouri, United States; 8New York-Presbyterian Hospital, New York, New York, United States; 9Massachusetts General Hospital, Boston, Massachusetts, United States; 10Cleveland Clinic; 11Columbia University Medical Center, New York, New York, United States; 12 Cleveland Clinic Foundation, Cleveland, Ohio, United States; 13Emory University Hospital Midtown, Atlanta, Georgia, United States; 14 Cardiovascular Research Foundation; 15Columbia University Medical Center, Wilson, North Carolina, United States; 16NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 17Cedars-Sinai Medical Center, Los Angeles, California, United States
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TCT-680 Impact of Annual Hospital Percutaneous Coronary Intervention Volume on Transcatheter Aortic-Valve Replacement Outcomes Nileshkumar Patel,1 Nish Patel,2 Shilpkumar Arora,3 Vikas Singh,4 Carlos Alfonso,5 Mauricio Cohen6 1 University of Miami, Miami, Florida, United States; 2University of Miami Miller School of Medicine, Miami, Florida, United States; 3Mount Sinai st luke’s roosevelt, New York, New York, United States; 4 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States; 5University of Miami Miller School of Medicine, Miami, Florida, United States; 6University of Miami Hospital, Miami, Florida, United States BACKGROUND The Centers for Medicare & Medicaid Services (CMS) requires maintaining 400 percutaneous coronary intervention (PCI) every year for hospital program with transcatheter aortic-valve replacement (TAVR) experience. However, it is uncertain whether or not a higher PCI volume is needed to optimize TAVR outcomes. METHODS We conducted an observational analysis from the Nationwide Inpatient Sample (NIS) database from January 2012 to December 2013. ICD-9-CM procedure codes were used to identify TAVR (35.05 and 35.06) and PCI (36.06 and 36.07). Annual hospital PCI volumes were calculated using unique identification numbers. We divided hospitals into two groups: <400 PCIs/year vs. 400 PCIs/year. The primary outcome was in-hospital mortality, and secondary outcomes were bleeding requiring transfusion, vascular injury, and stroke. Twolevel hierarchical multivariate mixed models were created to identify predictors of outcomes. RESULTS Of 21, 180 TAVRs, 7,654 TAVRs were performed in 258 hospitals in 2012, and 13, 526 TAVRs were performed in 312 hospitals in 2013. Mean age of the study population was 81.1 8.6 years (Mean SD), 49.2% were women. Most of the TAVRs were performed in hospitals performing 400 PCIs/year (71.5%). Overall in-hospital mortality was 4.9%. There was no statistical difference in adjusted inhospital mortality (5.2% vs. 4.7%; OR 0.98, CI 0.62-1.54, p-value 0.124) among hospitals performing <400 vs. 400 PCIs/year. Similarly, adjusted rates of secondary outcomes were also not significantly different between two groups (see figure).
BACKGROUND In the PARTNER IA trial with high-risk patients, a posthoc analysis demonstrated that diabetics had lower 1-year all-cause mortality when treated with TAVR compared to SAVR. Our objective was to examine whether diabetes altered outcomes based on treatment group in the PARTNER 2A intermediate risk trial, which demonstrated similar 1- and 2-year all-cause mortality after TAVR or SAVR. METHODS Among patients with severe symptomatic aortic stenosis at intermediate risk for surgery in the PARTNER 2A trial, we evaluated whether there was an interaction between diabetes status and treatment group with respect to all-cause mortality in Cox proportional hazards models. We also tested for an interaction with respect to 2year left ventricular (LV) mass index and LV ejection fraction. RESULTS Among 1938 patients in PARTNER 2A, 703 patients (36%) were diabetic, including 215 (11%) that were insulin dependent. There was no interaction between diabetes and treatment group (TAVR or SAVR) with respect to 1- or 2-year all-cause mortality (interaction p>0.05). The rates of all-cause death at 1 and 2 years were similar in the TAVR and SAVR treatment groups, respectively, among patients with insulin-dependent diabetes (1 year: 11.2% and 13.4%, p¼0.63; 2 years: 15.0% and 16.9%, p¼0.67), non-insulin-dependent diabetes (1 year: 11.6% and 8.5%, p¼0.25; 2 years: 14.7% and 15.0%, p¼0.97), and no diabetes (1 year: 11.9% and 14.6%, p¼0.12; 2 years: 16.8% and 19.1%, p¼0.24). Among those in the transfemoral-access cohort (n¼1482), these relationships were similar. In separate models, after adjustment for (1) baseline LV mass index or (2) baseline LV ejection fraction, SAVR was associated with lower LV mass index and higher LV ejection fraction at 2 years. Neither of these relationships was altered by diabetes status (interaction p>0.05). CONCLUSION Among intermediate risk patients, all-cause mortality was similar after TAVR or SAVR regardless of diabetes status. Diabetes also did not alter the association between SAVR and more favorable LV remodeling and function after valve replacement. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
CONCLUSION Our study demonstrated no association between hospital PCI volume and TAVR outcomes. The CMS requirement of 400 PCIs per year does not seem to be necessary to warrant optimal TAVR outcomes. The skillsets needed to perform PCI may not fully translate to TAVR, which is a very distinct procedure. Further studies are needed to confirm our finding. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-681 SOLACE AU Study: Interim results at one year of the Edwards SAPIEN XT TM Transcatheter Heart Valve in intermediate risk patients with severe aortic stenosis in Australia Darren Walters,1 Ajay Sinhal,2 Martin Ng,3 Gerald Yong,4 Nigel Jepson,5 Stephen Worthley,6 Ronen Gurvitch,7 Tony Walton,8 Robert Whitbourn9
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
RESULTS Patient characteristics in both groups were comparable (inter alia comorbidities, BMI and time on dialysis), with patients in the TAVR group tending to be older (69 vs. 65.5 years; p¼0.06). Median duration of hospital stay in the TAVR group was 19 (11.5-21.75) days. Patients after SAVR had a significantly longer stay with 33 (2162) days (p¼0.002). After SAVR, there was a more pronounced SIRS (measured by CRP) and a higher incidence of acute graft failure (45% vs. 89.5%; p¼0.006). Graft losses occurred without exception in the SAVR group (n¼7). 30-day mortality was 10% in both groups. However, in-hospital mortality reached 25% after SAVR (TAVR 10%), indicating a more complicated course after open heart surgery. By Kaplan Meier estimation, 1-year survival tend to be better after TAVR (90% vs. 69%), while follow-up after 5 years was comparable in both group (TAVR 62% vs. SAVR 52%) (log-rank-test; p¼0.86). CONCLUSION In KTR with severe AS, TAVR can be performed with good mid-term results. Compared to SAVR, TAVR shows better short term results and, eminently important, leads to less graft loss. However, careful treatment planning and risk estimation in this special population is mandatory. Further studies evaluating best treatment in this specific population are warranted. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-678 Incidence, Predictors and Clinical Outcomes of Coronary Obstruction Following Transcatheter Aortic Valve Implantation for Degenerative Bioprosthetic Surgical Valves: Insights from the VIVID Registry
CONCLUSION Concomitant mitral/tricuspid valvular disease is common in TAVR patients. Improvement in the degree of valvular regurgitation post TAVR is more likely in the mitral position than in the tricuspid position. Patients with significant residual MR or TR that fails to improve, demonstrate a strong trend toward higher mortality after TAVR. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-677 Comparison of surgical versus interventional treatment of aortic valve stenosis in kidney transplant recipients Stefan Büttner,1 Helge Weiler,2 Carolin Zöller,3 Sammy Patyna,4 Jörg Honold,5 Nestoras Papadopoulos,6 Helmut Geiger,7 Ingeborg A. Hauser,8 Mariuca Vasa-Nicotera,9 Stephan Fichtlscherer10 1 Medical Clinic III – Department of Nephrology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany; 2 Experimental Radiology, Charité University Hospital, Berlin, Germany; 3Tufts Medical Center; 4Takase Cllinic; 5Mimihara General Hospital; 6General Hospital of Shenyang Military Region, Shenyang, China; 7International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; 8Institut de cardiologie Pitié salpêtrière; 9University Hospital Frankfurt; 10General Hospital of Shenyang Military Region, Shenyang, China BACKGROUND Surgical aortic valve replacement (SAVR) in kidney transplant recipients (KTR) with severe aortic stenosis (AS) is associated with high morbidity and mortality, especially due to cardiovascular and infectious complications, as well as an increased risk of postoperative kidney failure potentially leading to graft loss. Preliminary data from our center showed that transcatheter aortic valve implantation (TAVR) is safe in KTR requiring aortic valve replacement. However, long-term data on TAVR in KTR are still lacking. METHODS We retrospectively analyzed all 40 KTR, in which aortic valve replacement was performed at our center between 2005 and 2015. We compared the outcome and follow-up of TAVR (n¼20) versus SAVR (n¼20) with respect to patient and graft survival. Decision for each treatment strategy was determined for every single case within the interdisciplinary heart team.
Henrique Ribeiro,1 Josep Rodés-Cabau,2 Jong Kwan Park,3 Philipp Blanke,4 Jonathon Leipsic,5 Vinayak Bapat,6 Raj Makkar,7 Matheus Simonato dos Santos,8 Marco Barbanti,9 Joachim Schofer,10 Sabine Bleiziffer,11 Azeem Latib,12 David Hildick-Smith,13 Patrizia Presbitero,14 Stephan Windecker,15 Massimo Napodano,16 Alfredo Cerillo,17 Mohamed Abdel-Wahab,18 Didier Tchetche,19 Claudia Fiorina,20 Mauricio Cohen,21 Mayra Guerrero,22 Brian Whisenant,23 Fabian Nietlispach,24 Luis Nombela Franco,25 Fabio Brito,26 Pedro Lemos,27 John Webb,28 Danny Dvir29 1 Hopital Laval, Quebec City, Quebec, Canada; 2Quebec Heart and Lung Institute/Laval University, Quebec, Quebec, Canada; 3National Health Insurance Service Ilsan Hospital, Goyang, Korea, Republic of; 4St. Paul’s Hospital, Vancouver, British Columbia, Canada; 5St. Paul’s Hospital, Vancouver, British Columbia, Canada; 6Guy’s and St. Thomas’, London, United Kingdom; 7Cedars-Sinai Medical Center, Los Angeles, California, United States; 8Federal University of Sao Paulo, Vancouver, Brazil; 9Ferrarotto Hospital, University of Catania, Catania, Italy; 10Hamburg University Cardiovascular Center and Department for percutaneous treatment of structural hea, Hamburg, Germany; 11 German Heart Center Munich, Munich, Germany; 12EMO-GVM Centro Cuore Columbus, Milan, Italy; 13Sussex Cardiac Centre, Brighton, United Kingdom; 14Istituto Clinico Humanitas, Rozzano-Milan, Italy; 15 Swiss Cardiovascular Center Bern, Bern, Switzerland; 16Padova University Hospital, Padova, Italy; 17Fondazione Toscana G. Monasterio, Massa, Massa and Carrara, Italy; 18Heart Center, Segeberger Kliniken, Bad Segeberg, Germany; 19Clinique Pasteur, Toulouse, France; 20Brescia, Italy; 21University of Miami Hospital, Miami, Florida, United States; 22Evanston Hospital, Evanston, Illinois, United States; 23Intermountain Medical Center, Salt Lake City, Utah, United States; 24University Hospital Zurich; 25Hospital Clínico San Carlos, Madrid, Spain; 26University of Texas Health Science Center at San Antonio, Sao Paulo, São Paulo, Brazil; 27University of São Paulo Medical School, São Paulo, São Paulo, Brazil; 28St. Paul’s Hospital, Vancouver, British Columbia, Canada; 29St. Paul’s Hospital, Vancouver, British Columbia, Canada BACKGROUND There are limited data on coronary obstruction (CO) following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The present study includes a large cohort of patients undergoing ViV suffering this complication. METHODS A total of 34 patients with symptomatic CO following 1,508 aortic procedures from the Valve-in-Valve International Data (VIVID) registry were included (incidence of 2.25%). Pre-TAVI computed tomography (CT) data was available in 20 CO patients and in 90 controls, and data was subject to centralized blinded CoreLab analysis. The distance between a virtual transcatheter ring similar in size to the implanted device at the level of each coronary ostium (VTC) was determined. RESULTS Baseline clinical characteristics in the CO patients were similar to controls. CO was more common in stentless or stented bioprostheses with externally mounted leaflets than in stented
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
bioprostheses with internally mounted leaflets (6.1% vs. 3.7% vs. 0.8%, respectively; p<0.001). Balloon post-dilation was more frequently performed in CO group (24.2% vs. 12.7%, p¼0.05, respectively), and 30-day mortality was 52.9% vs. 3.9%, respectively (p<0.001). VTC distance was shorter in CO patients in relation to controls (3.242.22 vs. 6.302.34, respectively; p<0.001). Using multivariable analysis, the use of a stentless (OR 8.76, 95% CI: 3.5221.8, p<0.001) or stented bioprosthesis with externally mounted leaflets (Mitroflow [Sorin]; Trifecta [St. Jude Medical], OR 4.95, 95% CI: 1.88-13.1, p¼0.001) were independent predictors of CO. In addition, shorter VTC distance was independently associated with CO (p<0.01), with an optimal cutoff level of 4mm (AUC 0.895; p<0.001). CONCLUSION Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and those with shorter VTC distance. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-679 Diabetes and Clinical Outcomes in Intermediate Risk Patients Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: An Analysis of the PARTNER 2A Trial Brian Lindman,1 Yigal Abramowitz,2 Philippe Pibarot,3 Nishath Quader,4 Hersh Maniar,5 Alan Zajarias,6 Suzanne Arnold,7 Rebecca Hahn,8 Sammy Elmariah,9 Rakesh Suri,10 Torsten Vahl,11 Lars Svensson,12 Vinod Thourani,13 Claire Litherland,14 Maria Alu,15 Martin Leon,16 Raj Makkar17 1 Aurora St. Luke’s Hospital; 2Cedars-Sinai Medical Center, Los Angeles, California, United States; 3Quebec Heart and Lung Institute, Quebec City, Quebec, Canada; 4Sejong General Hospital; 5Washington University School of Medicine, St. Louis, Missouri, United States; 6Barnes Jewish Hospital, St. Louis, Missouri, United States; 7Saint Luke’s Hospital, Kansas City, Missouri, United States; 8New York-Presbyterian Hospital, New York, New York, United States; 9Massachusetts General Hospital, Boston, Massachusetts, United States; 10Cleveland Clinic; 11Columbia University Medical Center, New York, New York, United States; 12 Cleveland Clinic Foundation, Cleveland, Ohio, United States; 13Emory University Hospital Midtown, Atlanta, Georgia, United States; 14 Cardiovascular Research Foundation; 15Columbia University Medical Center, Wilson, North Carolina, United States; 16NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 17Cedars-Sinai Medical Center, Los Angeles, California, United States
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TCT-680 Impact of Annual Hospital Percutaneous Coronary Intervention Volume on Transcatheter Aortic-Valve Replacement Outcomes Nileshkumar Patel,1 Nish Patel,2 Shilpkumar Arora,3 Vikas Singh,4 Carlos Alfonso,5 Mauricio Cohen6 1 University of Miami, Miami, Florida, United States; 2University of Miami Miller School of Medicine, Miami, Florida, United States; 3Mount Sinai st luke’s roosevelt, New York, New York, United States; 4 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States; 5University of Miami Miller School of Medicine, Miami, Florida, United States; 6University of Miami Hospital, Miami, Florida, United States BACKGROUND The Centers for Medicare & Medicaid Services (CMS) requires maintaining 400 percutaneous coronary intervention (PCI) every year for hospital program with transcatheter aortic-valve replacement (TAVR) experience. However, it is uncertain whether or not a higher PCI volume is needed to optimize TAVR outcomes. METHODS We conducted an observational analysis from the Nationwide Inpatient Sample (NIS) database from January 2012 to December 2013. ICD-9-CM procedure codes were used to identify TAVR (35.05 and 35.06) and PCI (36.06 and 36.07). Annual hospital PCI volumes were calculated using unique identification numbers. We divided hospitals into two groups: <400 PCIs/year vs. 400 PCIs/year. The primary outcome was in-hospital mortality, and secondary outcomes were bleeding requiring transfusion, vascular injury, and stroke. Twolevel hierarchical multivariate mixed models were created to identify predictors of outcomes. RESULTS Of 21, 180 TAVRs, 7,654 TAVRs were performed in 258 hospitals in 2012, and 13, 526 TAVRs were performed in 312 hospitals in 2013. Mean age of the study population was 81.1 8.6 years (Mean SD), 49.2% were women. Most of the TAVRs were performed in hospitals performing 400 PCIs/year (71.5%). Overall in-hospital mortality was 4.9%. There was no statistical difference in adjusted inhospital mortality (5.2% vs. 4.7%; OR 0.98, CI 0.62-1.54, p-value 0.124) among hospitals performing <400 vs. 400 PCIs/year. Similarly, adjusted rates of secondary outcomes were also not significantly different between two groups (see figure).
BACKGROUND In the PARTNER IA trial with high-risk patients, a posthoc analysis demonstrated that diabetics had lower 1-year all-cause mortality when treated with TAVR compared to SAVR. Our objective was to examine whether diabetes altered outcomes based on treatment group in the PARTNER 2A intermediate risk trial, which demonstrated similar 1- and 2-year all-cause mortality after TAVR or SAVR. METHODS Among patients with severe symptomatic aortic stenosis at intermediate risk for surgery in the PARTNER 2A trial, we evaluated whether there was an interaction between diabetes status and treatment group with respect to all-cause mortality in Cox proportional hazards models. We also tested for an interaction with respect to 2year left ventricular (LV) mass index and LV ejection fraction. RESULTS Among 1938 patients in PARTNER 2A, 703 patients (36%) were diabetic, including 215 (11%) that were insulin dependent. There was no interaction between diabetes and treatment group (TAVR or SAVR) with respect to 1- or 2-year all-cause mortality (interaction p>0.05). The rates of all-cause death at 1 and 2 years were similar in the TAVR and SAVR treatment groups, respectively, among patients with insulin-dependent diabetes (1 year: 11.2% and 13.4%, p¼0.63; 2 years: 15.0% and 16.9%, p¼0.67), non-insulin-dependent diabetes (1 year: 11.6% and 8.5%, p¼0.25; 2 years: 14.7% and 15.0%, p¼0.97), and no diabetes (1 year: 11.9% and 14.6%, p¼0.12; 2 years: 16.8% and 19.1%, p¼0.24). Among those in the transfemoral-access cohort (n¼1482), these relationships were similar. In separate models, after adjustment for (1) baseline LV mass index or (2) baseline LV ejection fraction, SAVR was associated with lower LV mass index and higher LV ejection fraction at 2 years. Neither of these relationships was altered by diabetes status (interaction p>0.05). CONCLUSION Among intermediate risk patients, all-cause mortality was similar after TAVR or SAVR regardless of diabetes status. Diabetes also did not alter the association between SAVR and more favorable LV remodeling and function after valve replacement. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
CONCLUSION Our study demonstrated no association between hospital PCI volume and TAVR outcomes. The CMS requirement of 400 PCIs per year does not seem to be necessary to warrant optimal TAVR outcomes. The skillsets needed to perform PCI may not fully translate to TAVR, which is a very distinct procedure. Further studies are needed to confirm our finding. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-681 SOLACE AU Study: Interim results at one year of the Edwards SAPIEN XT TM Transcatheter Heart Valve in intermediate risk patients with severe aortic stenosis in Australia Darren Walters,1 Ajay Sinhal,2 Martin Ng,3 Gerald Yong,4 Nigel Jepson,5 Stephen Worthley,6 Ronen Gurvitch,7 Tony Walton,8 Robert Whitbourn9