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TCT-697 Comparison of Outcomes of Transcatheter Aortic Valve Replacement plus Percutaneous Coronary Intervention versus Transcatheter Aortic Valve Replacement Alone in the United States
B282
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
SAVR (n[8) GSH S1, meanSD (nmol/mg
P value
4.020.52
TAVR (n[16)
P value
3.490.45
protein) GSH S2, meanSD (nmol/mg
3.820.46
0.14
3.510.69
0.55
3.400.52
0.03
3.650.56
0.78
protein) GSH S3, meanSD (nmol/mg protein) FRAP S1, meanSD (mmol/L)
285.5144.95
FRAP S2, meanSD (mmol/L)
304.5379.77
0.12
337.1975.89
0.02
FRAP S3, meanSD (mmol/L)
264.13569.18
0.80
316.46105.56
0.19
289.9866.93
CONCLUSION The present study confirmed the classic oxidative response observed after SAVR and showed that TAVR did not significantly induce oxidative stress response. The increase in FRAP observed in the TAVR group suggests that TAVR might improve antioxidant status, even in higher risk patients. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-697 Comparison of Outcomes of Transcatheter Aortic Valve Replacement plus Percutaneous Coronary Intervention versus Transcatheter Aortic Valve Replacement Alone in the United States Vikas Singh,1 Badal Thakkar,2 Alexis Rodriguez,3 Nileshkumar Patel,4 Apurva Badheka,5 Carlos Alfonso,6 Mauricio Cohen,7 Igor Palacios,8 Ignacio Inglessis,9 Sammy Elmariah,10 William O’Neill11 1 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States; 2Rutgers New Jersey Medical School, Newark, New Jersey, United States; 3university of miami miller school of medicine, Miami, Florida, United States; 4University of Miami, Miami, Florida, United States; 5Yale university, New Haven, Connecticut, United States; 6University of Miami Miller School of Medicine, Miami, Florida, United States; 7University of Miami Hospital, Miami, Florida, United States; 8Massachusetts General Hospital, Boston, Massachusetts, United States; 9Massachusetts General Hospital, Boston, Massachusetts; 10Massachusetts General Hospital, Boston, Massachusetts, United States; 11Henry Ford Hospital, Detroit, Michigan, United States BACKGROUND Transcatheter aortic valve replacement (TAVR) in combination with percutaneous coronary intervention (PCI) has emerged as a less invasive and feasible therapeutic option for this high surgical risk patient population with AS and CAD. The aim of this study is to determine the outcomes of TAVR when performed along with PCI during the same hospitalization from the largest publically available inpatient database in the United States. METHODS We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. Procedural complications were identified by Patient Safety Indicators. Propensity-scoring method was used by establishing matched cohorts to control for imbalances of patients’ and hospitals’ characteristics between the two groups (TAVR + PCI versus TAVR on the same hospitalization). RESULTS A total of 22,344 (weighted) TAVRs were performed between 2011 through 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Amongst the TAVR + PCI group, 69.7% of the patients had single vessel, 22.2% two vessels and 1.6% had three vessels PCI. Of these, 59.8% had one and 34.4% had 2 stents deployed. Drug eluting stents were more commonly used compared to bare metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%, p<0.001) and complications: vascular injury requiring surgery (8.2% vs. 4.2, p<0.001), cardiac (25.4% vs. 18.6%, p<0.001), respiratory (24.6% vs. 16.1%, p<0.001) and infectious (10.7% vs. 3.3%, p<0.001) when compared to the TAVR group. The mean length of hospital stay and cost of hospitalization was also significantly higher in the TAVR + PCI group. The propensity score matched analysis yielded similar results. CONCLUSION Performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications and cost when compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR. The ideal time gap between PCI and TAVR is yet to be determined. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-698 Comparison of the fully repositionable and retrievable Lotus Valve and Direct Flow Medical Valve for the treatment of severe aortic stenosis: a high-volume single center experience Francesco Giannini,1 Azeem Latib,2 Matteo Montorfano,3 Neil Ruparelia,4 Matteo Longoni,5 Andrea Aurelio,6 Richard Jabbour,7 Damiano Regazzoli,8 Luca Angelo Ferri,9 Antonio Mangieri,10 Marco Ancona,11 Akihito Tanaka,12 Eustachio Agricola,13 Alaide Chieffo,14 Ottavio Alfieri,15 Antonio Colombo16 1 Interventional Cardiology institute San Raffaele Hospital, Soverato, Reggio Calabria, Italy; 2EMO-GVM Centro Cuore Columbus, Milan, Italy; 3San Raffaele Hospital, Milan, Italy; 4Hammersmith Hospital, London, United Kingdom; 5Arrowhead Regional Medical Center, Milan, Milan, Italy; 6San Raffaele Hospital - Milan, Taranto, Bari, Italy; 7 Unknown, London, United Kingdom; 8San Raffaele Hospital; 9San Raffaele Hospital / Vita-Salute University, Milan, Milan, Italy; 10San Raffaele Hospital, Milan, Milan, Italy; 11San Raffaele Scientific Insitute, milan, Milan, Italy; 12San Raffaele Scientific Institute, Milan, Italy; 13 San Raffaele Hospital; 14San Raffaele Scientific Institute, Milan, Italy; 15 San Raffaele Hospital, Milan, Italy; 16San Raffaele Scientific Institute, Milan, Italy BACKGROUND A limitation of first generation transcatheter aortic valve replacement (TAVR) devices was the occurrence of paravalvular leak (PVL) that when greater than mild has been demonstrated to a predictor of mortality. Second generation devices have been designed to reduce this. One technological advance has been the ability to reposition devices to facilitate optimal implantation depth to reduce the likelihood of PVL. In this study we compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-criteria following TAVI with the fully repositionable and retrievable Lotus and Direct Flow Medical (DFM) devices. METHODS Baseline characteristics, procedural and follow-up data from consecutive patients with severe aortic stenosis (AS) who underwent transfemoral (TF) TAVR with Lotus valve and DFM valve at a highly experienced high-volume center between March 2012 and May 2016 were retrospectively analyzed. Severe AS was defined by echocardiographic criteria including an aortic valve area (AVA) of <1 cm2 or an indexed AVA of <0.6 cm2/m2 in combination with clinical symptoms. Patients treated for aortic regurgitation or for bioprosthesis failure were excluded. RESULTS A total of 175 patients with severe AS underwent TF TAVR with the Lotus (n¼60) and DFM (n¼115) valves. Baseline characteristics and perimeter derived annulus diameters did not differ between the two groups. Device success rates (95% vs 96.5%, p¼0.63) and VARC-defined combined safety (90% vs 93%, p¼0.48) and clinical efficacy (86.7% vs 90.4%, p¼0.45) endpoints 30 days were similar between Lotus and DFM groups. There was no severe cases of PVL; one patient in the Lotus group and two patients in the DFM developed moderate PVL. The rate of mild PVL was low in both groups (10% in Lotus and 15% in DFM group, p¼0.46). The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3% vs. 11.2%, p<0.001) and a lower mean aortic gradient (9.45 vs 12.35, p<0.001) at 30-days compared to the DFM valve. CONCLUSION In this single-center, retrospective analysis, both Lotus and DFM devices showed excellent device success, safety and efficacy at 30 day follow-up. The DFM valve was associated with higher transvalvular gradients but lower new pacemaker implantation rate when compared to the Lotus valve. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-699 Anatomic Deployment Index: A Novel Measure of SAPIEN 3 Transcatheter Heart Valve Performance Rebecca Hahn,1 Maria Alu,2 Jonathon Leipsic,3 Pamela Douglas,4 Wael Jaber,5 Neil Weissman,6 Omar Khalique,7 Philipp Blanke,8 Rupa Parvataneni,9 Susheel Kodali,10 Vinod Thourani,11 Philippe Pibarot12 1 New York-Presbyterian Hospital, New York, New York, United States; 2 Columbia University Medical Center, Wilson, North Carolina, United States; 3St. Paul’s Hospital, Vancouver, British Columbia, Canada; 4 Duke Clinical Research Institute, Durham, North Carolina, United States; 5MUW; 6MedStar Health Research Institute, Washington, District of Columbia, United States; 7New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 8St. Paul’s Hospital, Vancouver, British Columbia,
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
SAVR (n[8) GSH S1, meanSD (nmol/mg
P value
4.020.52
TAVR (n[16)
P value
3.490.45
protein) GSH S2, meanSD (nmol/mg
3.820.46
0.14
3.510.69
0.55
3.400.52
0.03
3.650.56
0.78
protein) GSH S3, meanSD (nmol/mg protein) FRAP S1, meanSD (mmol/L)
285.5144.95
FRAP S2, meanSD (mmol/L)
304.5379.77
0.12
337.1975.89
0.02
FRAP S3, meanSD (mmol/L)
264.13569.18
0.80
316.46105.56
0.19
289.9866.93
CONCLUSION The present study confirmed the classic oxidative response observed after SAVR and showed that TAVR did not significantly induce oxidative stress response. The increase in FRAP observed in the TAVR group suggests that TAVR might improve antioxidant status, even in higher risk patients. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-697 Comparison of Outcomes of Transcatheter Aortic Valve Replacement plus Percutaneous Coronary Intervention versus Transcatheter Aortic Valve Replacement Alone in the United States Vikas Singh,1 Badal Thakkar,2 Alexis Rodriguez,3 Nileshkumar Patel,4 Apurva Badheka,5 Carlos Alfonso,6 Mauricio Cohen,7 Igor Palacios,8 Ignacio Inglessis,9 Sammy Elmariah,10 William O’Neill11 1 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States; 2Rutgers New Jersey Medical School, Newark, New Jersey, United States; 3university of miami miller school of medicine, Miami, Florida, United States; 4University of Miami, Miami, Florida, United States; 5Yale university, New Haven, Connecticut, United States; 6University of Miami Miller School of Medicine, Miami, Florida, United States; 7University of Miami Hospital, Miami, Florida, United States; 8Massachusetts General Hospital, Boston, Massachusetts, United States; 9Massachusetts General Hospital, Boston, Massachusetts; 10Massachusetts General Hospital, Boston, Massachusetts, United States; 11Henry Ford Hospital, Detroit, Michigan, United States BACKGROUND Transcatheter aortic valve replacement (TAVR) in combination with percutaneous coronary intervention (PCI) has emerged as a less invasive and feasible therapeutic option for this high surgical risk patient population with AS and CAD. The aim of this study is to determine the outcomes of TAVR when performed along with PCI during the same hospitalization from the largest publically available inpatient database in the United States. METHODS We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. Procedural complications were identified by Patient Safety Indicators. Propensity-scoring method was used by establishing matched cohorts to control for imbalances of patients’ and hospitals’ characteristics between the two groups (TAVR + PCI versus TAVR on the same hospitalization). RESULTS A total of 22,344 (weighted) TAVRs were performed between 2011 through 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Amongst the TAVR + PCI group, 69.7% of the patients had single vessel, 22.2% two vessels and 1.6% had three vessels PCI. Of these, 59.8% had one and 34.4% had 2 stents deployed. Drug eluting stents were more commonly used compared to bare metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%, p<0.001) and complications: vascular injury requiring surgery (8.2% vs. 4.2, p<0.001), cardiac (25.4% vs. 18.6%, p<0.001), respiratory (24.6% vs. 16.1%, p<0.001) and infectious (10.7% vs. 3.3%, p<0.001) when compared to the TAVR group. The mean length of hospital stay and cost of hospitalization was also significantly higher in the TAVR + PCI group. The propensity score matched analysis yielded similar results. CONCLUSION Performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications and cost when compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR. The ideal time gap between PCI and TAVR is yet to be determined. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-698 Comparison of the fully repositionable and retrievable Lotus Valve and Direct Flow Medical Valve for the treatment of severe aortic stenosis: a high-volume single center experience Francesco Giannini,1 Azeem Latib,2 Matteo Montorfano,3 Neil Ruparelia,4 Matteo Longoni,5 Andrea Aurelio,6 Richard Jabbour,7 Damiano Regazzoli,8 Luca Angelo Ferri,9 Antonio Mangieri,10 Marco Ancona,11 Akihito Tanaka,12 Eustachio Agricola,13 Alaide Chieffo,14 Ottavio Alfieri,15 Antonio Colombo16 1 Interventional Cardiology institute San Raffaele Hospital, Soverato, Reggio Calabria, Italy; 2EMO-GVM Centro Cuore Columbus, Milan, Italy; 3San Raffaele Hospital, Milan, Italy; 4Hammersmith Hospital, London, United Kingdom; 5Arrowhead Regional Medical Center, Milan, Milan, Italy; 6San Raffaele Hospital - Milan, Taranto, Bari, Italy; 7 Unknown, London, United Kingdom; 8San Raffaele Hospital; 9San Raffaele Hospital / Vita-Salute University, Milan, Milan, Italy; 10San Raffaele Hospital, Milan, Milan, Italy; 11San Raffaele Scientific Insitute, milan, Milan, Italy; 12San Raffaele Scientific Institute, Milan, Italy; 13 San Raffaele Hospital; 14San Raffaele Scientific Institute, Milan, Italy; 15 San Raffaele Hospital, Milan, Italy; 16San Raffaele Scientific Institute, Milan, Italy BACKGROUND A limitation of first generation transcatheter aortic valve replacement (TAVR) devices was the occurrence of paravalvular leak (PVL) that when greater than mild has been demonstrated to a predictor of mortality. Second generation devices have been designed to reduce this. One technological advance has been the ability to reposition devices to facilitate optimal implantation depth to reduce the likelihood of PVL. In this study we compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-criteria following TAVI with the fully repositionable and retrievable Lotus and Direct Flow Medical (DFM) devices. METHODS Baseline characteristics, procedural and follow-up data from consecutive patients with severe aortic stenosis (AS) who underwent transfemoral (TF) TAVR with Lotus valve and DFM valve at a highly experienced high-volume center between March 2012 and May 2016 were retrospectively analyzed. Severe AS was defined by echocardiographic criteria including an aortic valve area (AVA) of <1 cm2 or an indexed AVA of <0.6 cm2/m2 in combination with clinical symptoms. Patients treated for aortic regurgitation or for bioprosthesis failure were excluded. RESULTS A total of 175 patients with severe AS underwent TF TAVR with the Lotus (n¼60) and DFM (n¼115) valves. Baseline characteristics and perimeter derived annulus diameters did not differ between the two groups. Device success rates (95% vs 96.5%, p¼0.63) and VARC-defined combined safety (90% vs 93%, p¼0.48) and clinical efficacy (86.7% vs 90.4%, p¼0.45) endpoints 30 days were similar between Lotus and DFM groups. There was no severe cases of PVL; one patient in the Lotus group and two patients in the DFM developed moderate PVL. The rate of mild PVL was low in both groups (10% in Lotus and 15% in DFM group, p¼0.46). The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3% vs. 11.2%, p<0.001) and a lower mean aortic gradient (9.45 vs 12.35, p<0.001) at 30-days compared to the DFM valve. CONCLUSION In this single-center, retrospective analysis, both Lotus and DFM devices showed excellent device success, safety and efficacy at 30 day follow-up. The DFM valve was associated with higher transvalvular gradients but lower new pacemaker implantation rate when compared to the Lotus valve. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-699 Anatomic Deployment Index: A Novel Measure of SAPIEN 3 Transcatheter Heart Valve Performance Rebecca Hahn,1 Maria Alu,2 Jonathon Leipsic,3 Pamela Douglas,4 Wael Jaber,5 Neil Weissman,6 Omar Khalique,7 Philipp Blanke,8 Rupa Parvataneni,9 Susheel Kodali,10 Vinod Thourani,11 Philippe Pibarot12 1 New York-Presbyterian Hospital, New York, New York, United States; 2 Columbia University Medical Center, Wilson, North Carolina, United States; 3St. Paul’s Hospital, Vancouver, British Columbia, Canada; 4 Duke Clinical Research Institute, Durham, North Carolina, United States; 5MUW; 6MedStar Health Research Institute, Washington, District of Columbia, United States; 7New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 8St. Paul’s Hospital, Vancouver, British Columbia,