844 results on '"Jeffrey J. Popma"'
Search Results
2. Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J‐TVT
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Tsuyoshi Kaneko, Sreekanth Vemulapalli, Shun Kohsaka, Kazuo Shimamura, Amanda Stebbins, Hiraku Kumamaru, Adam J. Nelson, Andrzej Kosinski, Koichi Maeda, Joseph E. Bavaria, Shigeru Saito, Michael J. Reardon, Toru Kuratani, Jeffrey J. Popma, Taku Inohara, Vinod H. Thourani, John D. Carroll, Hideyuki Shimizu, Morimasa Takayama, Martin B. Leon, Michael J. Mack, and Yoshiki Sawa
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aortic stenosis ,bioprosthetic aortic valve ,TAVR ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization‐by‐Doing) between the 2 countries. Methods and Results The patient‐level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J‐TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45–97) in the United States and 28 (interquartile range, 19–41) in Japan. Overall, patients in J‐TVT were older (United States: mean‐age, 80.1±8.7 versus Japan: 84.4±5.2; P
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- 2022
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3. Comparative utility of frailty to a general prognostic score in identifying patients at risk for poor outcomes after aortic valve replacement
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Sandra Shi, Natalia Festa, Jonathan Afilalo, Jeffrey J. Popma, Kamal R. Khabbaz, Roger J. Laham, Kimberly Guibone, and Dae Hyun Kim
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Aortic valve replacement ,Frailty ,Mortality ,Geriatric assessment ,Geriatrics ,RC952-954.6 - Abstract
Abstract Background Current guidelines recommend considering life expectancy before aortic valve replacement (AVR). We compared the performance of a general mortality index, the Lee index, to a frailty index. Methods We conducted a prospective cohort study of 246 older adults undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) at a single academic medical center. We compared performance of the Lee index to a deficit accumulation frailty index (FI). Logistic regression was used to assess the association of Lee index or FI with poor outcome, defined as death or functional decline with severe symptoms at 12 months. Discrimination was assessed using C-statistics. Results In the overall cohort, 44 experienced poor outcome (31 deaths, 13 functional decline with severe symptoms). The risk of poor outcome by Lee index quartiles was 6.8% (reference), 17.9% (odds ratio [OR], 3.0; 95% confidence interval, [0.9–10.2]), 20.0% (OR 3.4; [1.0–11.4]), and 34.0% (OR 7.1; [2.2–22.6]) (p-for-trend = 0.001). Risk of poor outcome by FI quartiles was 3.6% (reference), 10.3% (OR 3.1; [0.6–15.8]), 25.0% (OR 8.8; [1.9–41.0]), and 37.3% (OR 15.8; [3.5–71.1]) (p-for-trend
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- 2020
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4. Scaffold underexpansion and late lumen loss after bioresorbable scaffold implantation: Insights from ABSORB JAPAN trial
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Kozo Okada, Yasuhiro Honda, Hideki Kitahara, Masayasu Ikutomi, Ryo Kameda, M. Brooke Hollak, Paul G. Yock, Jeffrey J. Popma, Hajime Kusano, Wai-Fung Cheong, Krishnankutty Sudhir, Peter J. Fitzgerald, and Takeshi Kimura
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Absorb BVS ,Scaffold underexpansion ,Late lumen loss ,Late acquired ISA ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background: Device underexpansion is associated with late adverse outcomes after bioresorbable vascular scaffold (BVS) implantation. This study, representing official IVUS results of the ABSORB Japan trial, aimed to characterize IVUS findings, focusing specifically on acute device expansion, and to investigate its impact on late lumen loss (LLL) with Absorb-BVS compared with cobalt-chromium everolimus-eluting stents (CoCr-EES). Methods: ABSORB Japan enrolled 148 patients (2:1 randomization) in the IVUS cohort. Serial IVUS was prescheduled at post-procedure and 3 years. Acute device expansion was evaluated with respect to the degree and uniformity of the implanted device. Results: Overall, Absorb-BVS showed smaller and more nonuniform device expansion at post-procedure, compared with CoCr-EES, which was particularly prominent in small-vessel lesions. In serial analysis, Absorb-BVS showed unique associations of smaller device expansion (r = 0.40, p = 0.001) and more nonuniformity (r = 0.29, p = 0.007) at post-procedure with greater LLL at 3 years, primarily attributable to greater negative remodeling (r = 0.39, p = 0.006). In contrast, acute device expansion showed no relation with subsequent lumen change in CoCr-EES. In Absorb-BVS, ischemic-driven target lesion or vessel revascularization (ID-TLR or ID-TVR) at 3 years occurred more frequently in small- versus large-vessel lesions (12.5% vs. 0%, p = 0.04 for ID-TLR and 15.6% vs. 2.3%, p = 0.08 for ID-TVR). Conversely, Absorb BVS had no target lesion nor vessel failure, even in small-vessel lesions, when adequate device expansion was achieved at post-procedure. Conclusions: Unlike CoCr-EES, underexpansion was associated with greater negative remodeling and LLL in Absorb-BVS. This may in part account for the poorer outcomes of Absorb-BVS than CoCr-EES when under-expanded.
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- 2020
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5. Lower Blood Pressure After Transcatheter or Surgical Aortic Valve Replacement is Associated with Increased Mortality
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Brian R. Lindman, Kashish Goel, Javier Bermejo, Joshua Beckman, Jared O'Leary, Colin M. Barker, Clayton Kaiser, João L. Cavalcante, Sammy Elmariah, Jian Huang, Graeme L. Hickey, David H. Adams, Jeffrey J. Popma, and Michael J. Reardon
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aortic valve stenosis ,blood pressure ,mortality ,transcatheter aortic valve implantation ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Blood pressure (BP) guidelines for patients with aortic stenosis or a history of aortic stenosis treated with aortic valve replacement (AVR) match those in the general population, but this extrapolation may not be warranted. Methods and Results Among patients enrolled in the Medtronic intermediate, high, and extreme risk trials, we included those with a transcatheter AVR (n=1794) or surgical AVR (n=1103) who were alive at 30 days. The associations between early (average of discharge and 30 day post‐AVR) systolic BP (SBP) and diastolic BP (DBP) measurements and clinical outcomes between 30 days and 1 year were evaluated. Among 2897 patients, after adjustment, spline curves demonstrated an association between lower SBP (
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- 2019
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6. Aplicação clínica do ultra-som intracoronário
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Alexandre Abizaid, Gary S. Mintz, Andrea S. Abizaid, Lowell F. Satler, Jeffrey J. Popma, Augusto D. Pichard, Roxana Mehran, Kenneth M. Kent, and Martin B. Leon
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 1997
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7. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
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John K. Forrest, G. Michael Deeb, Steven J. Yakubov, Hemal Gada, Mubashir A. Mumtaz, Basel Ramlawi, Tanvir Bajwa, Paul S. Teirstein, Michael DeFrain, Murali Muppala, Bruce J. Rutkin, Atul Chawla, Bart Jenson, Stanley J. Chetcuti, Robert C. Stoler, Marie-France Poulin, Kamal Khabbaz, Melissa Levack, Kashish Goel, Didier Tchétché, Ka Yan Lam, Pim A.L. Tonino, Saki Ito, Jae K. Oh, Jian Huang, Jeffrey J. Popma, Neal Kleiman, Michael J. Reardon, Paul Sorajja, Timothy Byrne, Merick Kirshner, John Crouch, Joseph Coselli, Guilherme Silva, Robert Hebeler, Robert Stoler, Ashequl Islam, Anthony Rousou, Mark Bladergroen, Peter Fail, Donald Netherland, W.A.L. Tonino, Arnaud Sudre, Pierre Berthoumieu, Houman Khalili, G. Chad Hughes, J Kevin Harrison, Ajanta De, Pei Tsau, Nicolas M. van Mieghem, Robert Larbalestier, Gerald Yong, Shikhar Agarwal, William Martin, Steven Park, Michael Reardon, Siamak Mohammadi, Josep Rodes-Cabau, Jeffrey Sparling, C. Craig Elkins, Brian Ganzel, Ray V. Matthews, Vaughn A. Starnes, Kenji Ando, Bernard Chevalier, Arnaud Farge, William Combs, Rodrigo Bagur, Michael Chu, Gregory Fontana, Visha Dev, Ferdinand Leya, J. Michael Tuchek, Ignacio Inglessis, Arminder Jassar, Nicolo Piazza, Kevin Lacappelle, Daniel Steinberg, Marc Katz, John Wang, Joseph Kozina, Frank Slachman, Robert Merritt, Bart Jensen, Jorge Alvarez, Robert Gooley, Julian Smith, Reda Ibrahim, Raymond Cartier, Joshua Rovin, Tomoyuki Fujita, Bruce Rutkin, Steven Yakubov, Howard Song, Firas Zahr, Shigeru Miyagawa, Vivek Rajagopal, James Kauten, Mubashir Mumtaz, Ravinay Bhindi, Peter Brady, Sanjay Batra, Thomas Davis, Ayman Iskander, David Heimansohn, James Hermiller, Itaru Takamisawa, Thomas Haldis, Seiji Yamazaki, Paul Teirstein, Norio Tada, Shigeru Saito, William Merhi, Stephane Leung, David Muller, Robin Heijmen, George Petrossian, Newell Robinson, Peter Knight, Frederick Ling, Sam Radhakrishnan, Stephen Fremes, Eric Lehr, Sameer Gafoor, Thomas Noel, Antony Walton, Jon Resar, David Adams, Samin Sharma, Scott Lilly, Peter Tadros, George Zorn, Harold Dauerman, Frank Ittleman, Erik Horlick, Chris Feindel, Frederick Welt, Vikas Sharma, Alan Markowitz, John Carroll, David Fullerton, Bartley Griffith, Anuj Gupta, Eduardo de Marchena, Tomas Salerno, Stanley Chetcuti, Ibrahim Sultan, Sanjeevan Pasupati, Neal Kon, David Zhao, and John Forrest
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Cardiology and Cardiovascular Medicine - Published
- 2023
8. The Top Ten Clinical Trials in Patients Undergoing Transcatheter Aortic Valve Implantation
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Ying‐Hwa Chen, Diana Anghel, and Jeffrey J. Popma
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- 2023
9. Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps
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Howard C. Herrmann, Philippe Pibarot, Changfu Wu, Rebecca T. Hahn, Gilbert H.L. Tang, Amr E. Abbas, David Playford, Marc Ruel, Hasan Jilaihawi, Janarthanan Sathananthan, David A. Wood, Ruggero De Paulis, Jeroen J. Bax, Josep Rodes-Cabau, Duke E. Cameron, Tiffany Chen, Pedro J. Del Nido, Marc R. Dweck, Tsuyoshi Kaneko, Azeem Latib, Neil Moat, Thomas Modine, Jeffrey J. Popma, Jamie Raben, Robert L. Smith, Didier Tchetche, Martyn R. Thomas, Flavien Vincent, Ajit Yoganathan, Bram Zuckerman, Michael J. Mack, and Martin B. Leon
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Cardiology and Cardiovascular Medicine - Published
- 2022
10. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices
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William W, O'Neill, Mark, Anderson, Daniel, Burkhoff, Cindy L, Grines, Navin K, Kapur, Alexandra J, Lansky, Salvatore, Mannino, James M, McCabe, Khaldoon, Alaswad, Ramesh, Daggubati, David, Wohns, Perwaiz M, Meraj, Duane S, Pinto, Jeffrey J, Popma, Jeffrey W, Moses, Theodore L, Schreiber, and E, Magnus Ohman
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Percutaneous Coronary Intervention ,Treatment Outcome ,Myocardial Infarction ,Humans ,Coronary Artery Disease ,Prospective Studies ,Cardiology and Cardiovascular Medicine - Abstract
Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial.Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days.Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P.001) and prior myocardial infarction (40.7% vs 69.3%; P.001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P.001) and duration of support was longer (median 1.6 vs 1.3 hours; p0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P.001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P.001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P.001), as was procedural hypotension (2.2% vs 10.1%; P.001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P.001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048).The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.
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- 2022
11. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials
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Ryo Kameda, Masayasu Ikutomi, Absorb, M. Brooke Hollak, Yasuhiro Honda, Krishnankutty Sudhir, Jeffrey J. Popma, Paul G. Yock, Takeshi Kimura, Hajime Kusano, Stephen G. Ellis, Hideki Kitahara, Dean J. Kereiakes, Takeshi Nishi, Kozo Okada, Wai-Fung Cheong, Peter J. Fitzgerald, Shinji Imura, and Gregg W. Stone
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Target lesion ,medicine.medical_specialty ,Randomization ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Prosthesis Design ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Japan ,Internal medicine ,Absorbable Implants ,Intravascular ultrasound ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Ultrasonography, Interventional ,medicine.diagnostic_test ,business.industry ,Hazard ratio ,Drug-Eluting Stents ,medicine.disease ,Clinical trial ,Treatment Outcome ,Drug-eluting stent ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. Methods A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1–5.0] years. Results During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. Conclusions Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. Clinical trial registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).
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- 2021
12. Computed Tomography–Derived 3D Modeling to Guide Sizing and Planning of Transcatheter Mitral Valve Interventions
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Ricardo P.J. Budde, Gry Dahle, Ronak Rajani, Bernard Prendergast, Stephen H. Little, Alexander Hirsch, Dee Dee Wang, Simon Redwood, Joris F. Ooms, Michael L Chuang, Nicolas M. Van Mieghem, Magali Minet, Michael Pfeiffer, Jeffrey J. Popma, Peter P de Jaegere, Brinder Kanda, and William W. O'Neill
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Mitral annular calcification ,medicine.medical_specialty ,Cardiac anatomy ,medicine.medical_treatment ,Computed tomography ,030204 cardiovascular system & hematology ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Mitral valve ,Multidetector Computed Tomography ,Multidetector computed tomography ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Medical physics ,cardiovascular diseases ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Mitral valve replacement ,3D modeling ,Sizing ,medicine.anatomical_structure ,Heart Valve Prosthesis ,cardiovascular system ,Mitral Valve ,Cardiology and Cardiovascular Medicine ,business - Abstract
A plethora of catheter-based strategies have been developed to treat mitral valve disease. Evolving 3-dimensional (3D) multidetector computed tomography (MDCT) technology can accurately reconstruct the mitral valve by means of 3-dimensional computational modeling (3DCM) to allow virtual implantation of catheter-based devices. 3D printing complements computational modeling and offers implanting physician teams the opportunity to evaluate devices in life-size replicas of patient-specific cardiac anatomy. MDCT-derived 3D computational and 3D-printed modeling provides unprecedented insights to facilitate hands-on procedural planning, device training, and retrospective procedural evaluation. This overview summarizes current concepts and provides insight into the application of MDCT-derived 3DCM and 3D printing for the planning of transcatheter mitral valve replacement and closure of paravalvular leaks. Additionally, future directions in the development of 3DCM will be discussed.
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- 2021
13. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries
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Linda R. Valsdottir, Eric A. Secemsky, Robert W. Yeh, Issam Moussa, Charles A. Simonton, Hector Tamez, Yang Song, C. Michael Gibson, and Jeffrey J. Popma
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Hazard ratio ,Percutaneous coronary intervention ,medicine.disease ,Coronary artery disease ,Lesion ,Restenosis ,Internal medicine ,Conventional PCI ,medicine ,Cardiology ,cardiovascular diseases ,Myocardial infarction ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Stroke - Abstract
BACKGROUND In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood. AIMS This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR. METHODS National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009 to December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularisation including target vessel revascularisation (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI. RESULTS Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days-quartile 3: 1,379 days). The frequency of MACCE (55.6% vs 45.0%; p
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- 2021
14. Aortic valve replacement vs. balloon-expandable and self-expandable transcatheter implantation: A network meta-analysis
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Hans Gustav Hørsted Thyregod, Guglielmo Gallone, Giorgio Marengo, Ovidio De Filippo, Susanna Breviario, Pierluigi Omedè, Margherita Annaratone, Gabriele Crimi, Francesco Melillo, Luca Franchin, Jeffrey J. Popma, Susheel Kodali, Francesco Bruno, Michele La Torre, Gaetano M. De Ferrari, Stefano Salizzoni, Mauro Rinaldi, Luca Baldetti, Laura Marruncheddu, Federico Conrotto, Lars Søndergaard, Fabrizio D'Ascenzo, and Holger Thiele
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medicine.medical_specialty ,Network Meta-Analysis ,030204 cardiovascular system & hematology ,Prosthesis Design ,Surgical aortic valve implantation ,law.invention ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Aortic valve replacement ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Stroke ,Transcatheter aortic valve implantation ,business.industry ,Aortic stenosis ,Acute kidney injury ,Atrial fibrillation ,Aortic Valve Stenosis ,Self-expandable valves ,Balloon-expandable valves ,medicine.disease ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Meta-analysis ,Cardiology ,Observational study ,Cardiology and Cardiovascular Medicine ,business - Abstract
Introduction Recently, observational data have raised concerns about safety of selfexpandable (SE) compared to balloon-expandable (BE) valves in TAVI, although potentially limited by patient selection bias. Methods. All Randomized Controlled Trials (RCTs) comparing BE vs. SE TAVI or/and vs. aortic valve replacement (AVR) were included and compared through Network Meta Analysis (NMA). All-cause and cardiovascular (CV) mortality were the primary endpoints, stroke, rates of permanent pacemaker implantation (PPI), moderate/severe paravalvular leak (PVL) and reintervention were the secondary endpoints. Results We obtained data from 11 RCTs, encompassing 9752 patients. After one and two years, no significant differences for allcause and CV mortality were observed. Compared to surgical bioprostheses, both BE and SE TAVI reduced the risk of acute kidney injury (OR 0.42; CI 95% 0.30–0.60 and OR 0.44; CI 95% 0.32–0.60), new-onset atrial fibrillation (OR 0.24; CI 95% 0.14–0.42 and OR 0.21; CI 95% 0.13–0.34) and major bleedings (OR 0.32; CI 95% 0.16–0.65 and OR 0.47; CI 95% 0.25–0.89). The BE prostheses reduced the risk of moderate/severe PVL at 30-day (OR 0.31; CI 95% 0.17–0.55) and of PPI both at 30-day (OR 0.51; CI 95% 0.33–0.79) and 1 year (OR 0.40; CI 95% 0.30–0.55) as compared to SE TAVI. Conclusions A TAVI strategy, independently from BE or SE prostheses, offers a midterm survival comparable to AVR. The BE prostheses are associated with a reduction of PPI and PVL compared to SE prostheses without any differences in all-cause and CV mortality during two years of follow up. PROSPERO ID CRD42020182407.
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- 2021
15. Imaging strategies for safety surveillance after renal artery denervation
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Debbie L. Cohen, Sidney Cohen, Ido Weinberg, Alexandra Almonacid, Jeffrey J. Popma, Gail Hadley, Raymond R. Townsend, and Seth Uretsky
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Denervation ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Context (language use) ,General Medicine ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,medicine.disease ,Renal artery stenosis ,Magnetic resonance angiography ,Clinical trial ,03 medical and health sciences ,Stenosis ,0302 clinical medicine ,medicine.artery ,Internal medicine ,Cardiology ,Medicine ,030212 general & internal medicine ,Renal artery ,Cardiology and Cardiovascular Medicine ,business ,Computed tomography angiography - Abstract
Renal denervation has emerged as a safe and effective therapy to lower blood pressure in hypertensive patients. In addition to the main renal arteries, branch vessels are also denervated in more contemporary studies. Accurate and reliable imaging in renal denervation patients is critical for long-term safety surveillance due to the small risk of renal artery stenosis that may occur after the procedure. This review summarizes three common non-invasive imaging modalities: Doppler ultrasound (DUS), computed tomography angiography (CTA), and magnetic resonance angiography (MRA). DUS is the most widely used owing to cost considerations, ease of use, and the fact that it is less invasive, avoids ionizing radiation exposure, and requires no contrast media use. Renal angiography is used to determine if renal artery stenosis is present when non-invasive imaging suggests renal artery stenosis. We compiled data from prior renal denervation studies as well as the more recent SPYRAL-HTN OFF MED Study and show that DUS demonstrates both high sensitivity and specificity for detecting renal stenosis de novo and in longitudinal assessment of renal artery patency after interventions. In the context of clinical trials DUS has been shown, together with the use of the baseline angiogram, to be effective in identifying stenosis in branch and accessory arteries and merits consideration as the main screening imaging modality to detect clinically significant renal artery stenosis after renal denervation and this is consistent with guidelines from the recent European Consensus Statement on Renal Denervation.
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- 2021
16. COMPUTED TOMOGRAPHY TO ASSESS FEASIBILITY OF CORONARY ACCESS FOLLOWING BALLOON-EXPANDABLE VALVE IMPLANTATION WITHIN A SUPRA-ANNULAR TRANSCATHETER VALVE
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Toby Rogers, Julianne Spencer, Gilbert Hin-Lung Tang, Kendra Janel Grubb, Patrick Gleason, Hemal Gada, Paul D. Mahoney, Harold L. Dauerman, John K. Forrest, Michael J. Reardon, Mohamed Abdel-Wahab, Rishi Puri, Guilherme Attizzani, Michael Caskey, Christine Chung, Ying-Hwa Chen, Wah Wah Htun, Jorge Zhingre Sanchez, Greta Schwartz, Jeffrey J. Popma, and Janarthanan Sathananthan
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Cardiology and Cardiovascular Medicine - Published
- 2023
17. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk
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Daniel, O'Hair, Steven J, Yakubov, Kendra J, Grubb, Jae K, Oh, Saki, Ito, G Michael, Deeb, Nicolas M, Van Mieghem, David H, Adams, Tanvir, Bajwa, Neal S, Kleiman, Stanley, Chetcuti, Lars, Søndergaard, Hemal, Gada, Mubashir, Mumtaz, John, Heiser, William M, Merhi, George, Petrossian, Newell, Robinson, Gilbert H L, Tang, Joshua D, Rovin, Stephen H, Little, Renuka, Jain, Sarah, Verdoliva, Tim, Hanson, Shuzhen, Li, Jeffrey J, Popma, and Michael J, Reardon
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Cardiology and Cardiovascular Medicine - Abstract
ImportanceThe frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood.ObjectiveTo evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery.Design, Setting, and ParticipantsThis post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022.InterventionsPatients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies.Main Outcomes and MeasuresThe primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.ResultsOf 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis.Conclusions and RelevanceThis study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes.Trial RegistrationClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374
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- 2023
18. The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies
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Michael J. Mack, J. James Edelman, Sari D. Holmes, Piotr Suwalski, Susheel Kodali, John D. Carroll, Anson Cheung, Christopher Meduri, Jessica Forcillo, Vinod H. Thourani, Francis D. Ferdinand, Jeffrey J. Popma, Gregory P. Fontana, Michael A. Borger, Gilbert H.L. Tang, Tsuyoshi Kaneko, Niv Ad, Samir R. Kapadia, Michael J. Reardon, Tom C. Nguyen, Bob Kiaii, Husam H. Balkhy, Joerg Kempfert, and Martin B. Leon
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Consensus ,Statement (logic) ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Risk Assessment ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Aortic valve replacement ,Risk Factors ,medicine ,Humans ,030212 general & internal medicine ,Heart Valve Prosthesis Implantation ,business.industry ,Expert consensus ,Aortic Valve Stenosis ,General Medicine ,medicine.disease ,Surgery ,Stenosis ,Treatment Outcome ,Cardiothoracic surgery ,Aortic Valve ,Meta-analysis ,Cardiology and Cardiovascular Medicine ,Intermediate risk ,business - Abstract
Objective There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons. Methods Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year. Results Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, I2 = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, I2 = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios. Conclusions In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient’s aortic valve disease.
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- 2021
19. Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial)
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Hemal Gada, Carlos Sanchez, Shuzhen Li, Jeffrey J. Popma, Steven J. Yakubov, Stephan Windecker, Michael J. Reardon, Isaac George, Stanley Chetcuti, Nicolas M. Van Mieghem, Neal S. Kleiman, Patrick W. Serruys, Mubashir Mumtaz, Susheel Kodali, G. Michael Deeb, and Harold L. Dauerman
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Male ,medicine.medical_specialty ,Transcatheter aortic ,Population ,Hemodynamics ,030204 cardiovascular system & hematology ,Risk Assessment ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Aortic valve replacement ,Risk Factors ,Internal medicine ,Clinical endpoint ,Humans ,Medicine ,030212 general & internal medicine ,610 Medicine & health ,Propensity Score ,Symptomatic aortic stenosis ,education ,Stroke ,Aged ,Aged, 80 and over ,education.field_of_study ,business.industry ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Heart Valve Prosthesis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Intermediate risk - Abstract
The SURTAVI trial demonstrated the noninferiority of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. Most TAVI patients received an early generation device which is no longer commercially available. This analysis compares TAVI outcomes in patients that received the Evolut R valve to those of similar patients randomized to SAVR in the SURTAVI trial. The continued access study of SURTAVI (CAS) enrolled 290 patients. Of them, 252 were implanted with the 23, 26, or 29 mm Evolut R device. Propensity-score matching between this group and SURTAVI SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis. The primary end point for comparison was the rate of all-cause mortality or disabling stroke at 1-year. The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). At 1-year TAVI was numerically favored (4.1% vs 8.2%; p = 0.082). In conclusion, compared with SAVR, TAVI using Evolut R had a favorable 30-day safety profile, significantly better hemodynamic performance, and a comparable 1-year rate of all-cause mortality or disabling stroke, suggesting this may be a preferred treatment for patients with severe, symptomatic aortic stenosis at intermediate surgical risk.
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- 2020
20. Physical Performance and Risk of Postoperative Delirium in Older Adults Undergoing Aortic Valve Replacement
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Jeffrey J. Popma, Kimberly Guibone, Aarti Rao, Kamal R. Khabbaz, Dae Hyun Kim, Jonathan Afilalo, Roger J. Laham, Edward R. Marcantonio, and Sandra M. Shi
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,General Medicine ,Logistic regression ,medicine.disease ,Cardiac surgery ,03 medical and health sciences ,0302 clinical medicine ,Aortic valve replacement ,Valve replacement ,Internal medicine ,mental disorders ,medicine ,Cardiology ,Delirium ,030212 general & internal medicine ,Geriatrics and Gerontology ,medicine.symptom ,Risk factor ,Prospective cohort study ,business ,Stroke ,030217 neurology & neurosurgery - Abstract
Background Delirium is a major risk factor for poor recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). It is unclear whether preoperative physical performance tests improve delirium prediction. Objective To examine whether physical performance tests can predict delirium after SAVR and TAVR, and adapt an existing delirium prediction rule for cardiac surgery, which includes Mini-Mental State Examination (MMSE), depression, prior stroke, and albumin level. Design Prospective cohort, 2014-2017. Setting Single academic center. Subjects A total of 187 patients undergoing SAVR (n=77) or TAVR (n=110). Methods The Short Physical Performance Battery (SPPB) score was calculated based on gait speed, balance, and chair stands (range: 0-12 points, lower scores indicate poor performance). Delirium was assessed using the Confusion Assessment Method. We fitted logistic regression to predict delirium using SPPB components and risk factors of delirium. Results Delirium occurred in 35.8% (50.7% in SAVR and 25.5% in TAVR). The risk of delirium increased for lower SPPB scores: 10-12 (28.2%), 7-9 (34.5%), 4-6 (37.5%) and 0-3 (44.1%) (p-for-trend=0.001). A model that included gait speed
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- 2020
21. Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve
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Guilherme F. Attizzani, G. Michael Deeb, Jian Huang, Alan H. Markowitz, Luis Augusto Palma Dallan, Abeel A. Mangi, Michael J. Reardon, John K. Forrest, Steven J. Yakubov, and Jeffrey J. Popma
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Male ,medicine.medical_specialty ,Time Factors ,Transcatheter aortic ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Prosthesis Design ,Risk Assessment ,Severity of Illness Index ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Aortic valve replacement ,Risk Factors ,Multidetector Computed Tomography ,Multidetector computed tomography ,medicine ,Humans ,030212 general & internal medicine ,Symptomatic aortic stenosis ,Stroke ,Aged ,Randomized Controlled Trials as Topic ,Retrospective Studies ,Aged, 80 and over ,Self expandable ,business.industry ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Female ,Cardiology and Cardiovascular Medicine ,business ,Efficacy Study - Abstract
This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group).The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear.Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2.The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively).The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).
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- 2020
22. Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement
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Neel M. Butala, Robert W. Yeh, Dhruv S. Kazi, Linda R. Valsdottir, Kamil F. Faridi, Yuansong Zhao, Jeffrey J. Popma, Hector Tamez, Jordan B. Strom, J. Matthew Brennan, and Changyu Shen
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Male ,Aortic valve ,medicine.medical_specialty ,Transcatheter aortic ,medicine.medical_treatment ,Medicare ,law.invention ,Transcatheter Aortic Valve Replacement ,Randomized controlled trial ,Valve replacement ,law ,Physiology (medical) ,Outcome Assessment, Health Care ,medicine ,Humans ,Treatment effect ,Intensive care medicine ,Aged ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,business.industry ,Incidence ,United States ,Administrative claims ,Clinical trial ,medicine.anatomical_structure ,Health Care Surveys ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). Results: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial’s primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65–1.09]; P =0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66–1.11]; P =0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes ( P noninferiority P =0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73–1.41]; P =0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims ( P non inferiority Conclusions: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.
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- 2020
23. Frailty and Bleeding in Older Adults Undergoing TAVR or SAVR
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Sandra Lauck, Nicolas Noiseux, Yves Langlois, Giuseppe Martucci, Marino Labinaz, Dae Hyun Kim, John G. Webb, Rakesh C. Arora, Jonathan Afilalo, Andre Lamy, Louis P. Perrault, Thierry Lefèvre, Nathan Messas, Nicolo Piazza, Jeffrey J. Popma, Anita W. Asgar, Melissa Bendayan, and Mark D. Peterson
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Population ,Odds ratio ,030204 cardiovascular system & hematology ,medicine.disease ,Confidence interval ,3. Good health ,03 medical and health sciences ,0302 clinical medicine ,Aortic valve replacement ,Internal medicine ,Cohort ,medicine ,Clinical endpoint ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,Packed red blood cells ,education ,business ,Cohort study - Abstract
Objectives The aim of this study was to examine the value of frailty to predict in-hospital major bleeding and determine its impact on mid-term mortality following transcatheter (TAVR) or surgical (SAVR) aortic valve replacement. Background Bleeding complications are harbingers of mortality and major morbidity in patients undergoing TAVR or SAVR. Despite the high prevalence of frailty in this population, little is known about its effects on bleeding risk. Methods A post hoc analysis was performed of the multinational FRAILTY-AVR (Frailty Aortic Valve Replacement) cohort study, which prospectively enrolled older adults ≥70 years of age undergoing TAVR or SAVR. Trained researchers assessed frailty using a questionnaire and physical performance battery pre-procedure and ascertained clinical data from the electronic health record. The primary endpoint was major or life-threatening bleeding during the index hospitalization, and the secondary endpoint was units of packed red blood cells transfused. Results The cohort consisted of 1,195 patients with a mean age of 81.3 ± 6.0 years. The incidence of life-threatening bleeding, major bleeding with a clinically apparent source, and major bleeding without a clinically apparent source was, respectively, 3%, 6%, and 9% in the TAVR group and 8%, 10%, and 31% in the SAVR group. Frailty measured using the Essential Frailty Toolset was an independent predictor of major bleeding and packed red blood cell transfusions in both groups. Major bleeding was associated with a 3-fold increase in 1-year mortality following TAVR (odds ratio: 3.40; 95% confidence interval: 2.22 to 5.21) and SAVR (odds ratio: 2.79; 95% confidence interval: 1.25 to 6.21). Conclusions Frailty is associated with post-procedural major bleeding in older adults undergoing TAVR and SAVR, which is in turn associated with a higher risk for mid-term mortality.
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- 2020
24. Computed Tomography Annular Dimensions: A Novel Method to Compare Prosthetic Valve Hemodynamics
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Steven J. Yakubov, Michael J. Boulware, Mubashir Mumtaz, Michael J. Reardon, Thomas G. Gleason, Arie Pieter Kappetein, Hemal Gada, Jeffrey J. Popma, Stanley Chetcuti, Mathew R. Williams, Shuzhen Li, Jae K. Oh, G. Michael Deeb, and Cardiothoracic Surgery
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Pulmonary and Respiratory Medicine ,Hemodynamics ,Computed tomography ,030204 cardiovascular system & hematology ,Prosthesis Design ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Retrospective Studies ,Prosthetic heart ,Bioprosthesis ,Prosthetic valve ,medicine.diagnostic_test ,Task force ,business.industry ,Organ Size ,Surgical valves ,030228 respiratory system ,Aortic Valve ,Heart Valve Prosthesis ,Preoperative Period ,Surgery ,Tomography ,Tomography, X-Ray Computed ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine - Abstract
Background The Cardiac Surgical Societies Valve Labeling Task Force consensus document acknowledged inconsistent sizing and labeling of prosthetic heart valves. This study compared the labeled size, internal diameter, and hemodynamics of different surgical and transcatheter valve types implanted into the same size annulus, measured by preprocedural computed tomography (CT). Methods Patients were retrospectively sorted into 3 CT annular diameter size groups: small (less than 23 mm), medium (23 to less than 26 mm), and large (26 mm or greater). Surgical valves were sorted into 4 categories based on tissue and design: (stentless porcine, standard stented bovine, wraparound stented bovine, and stented porcine). Comparisons were made within the surgical types and with a transcatheter valve. Echocardiograms were independently assessed and CTs were centrally measured. Results We analyzed 726 surgical and 923 transcatheter valve paired data sets. Among the various valve types implanted into the same size CT annulus, there were significant differences regarding size, internal diameter, and hemodynamics within all 3 size groups. Root enlargement procedures occurred in 1.2% with no differences across valve types or size groups. Transcatheter valve hemodynamics were similar to stentless valves and were significantly better than all stented valves. There was no difference in hemodynamics between the 2 bovine stented valve types, and stented porcine valves were inferior to all valve types. Conclusions This study documents that prosthetic heart valve sizing and labeling inconsistencies exist. Use of preoperative CT annular dimensions is the most accurate method to compare size, internal diameter, and hemodynamics of bioprosthetic aortic valves because it compares values among various valve types implanted into the same size annulus.
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- 2020
25. Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: A post hoc analysis of the randomised SURTAVI trial
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Patrick W. Serruys, Mark Robbins, Nicolas M. Van Mieghem, Steven J. Yakubov, Peter S. Fail, Wen Cheng, Stephan Windecker, William Merhi, John Heiser, Edgar Feinberg, Jeffrey J. Popma, Robert Hebeler, Raj Makkar, Michael J. Reardon, Robert C. Stoler, and Cardiology
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Male ,medicine.medical_specialty ,Population ,030204 cardiovascular system & hematology ,law.invention ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Aortic valve replacement ,Randomized controlled trial ,law ,Risk Factors ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,education ,Stroke ,Body surface area ,Heart Valve Prosthesis Implantation ,education.field_of_study ,business.industry ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Clinical trial ,Stenosis ,Treatment Outcome ,Aortic Valve ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
AIMS: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial. METHODS AND RESULTS: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p
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- 2020
26. Three Generations of Self-Expanding Transcatheter Aortic Valves
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Gilbert H.L. Tang, Jeffrey J. Popma, Angie Zhang, Steven J. Yakubov, Ryan Kaple, Tamim Nazif, Michael J. Reardon, John K. Forrest, and Mathew R. Williams
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medicine.medical_specialty ,Thesaurus (information retrieval) ,Transcatheter aortic ,business.industry ,General surgery ,MEDLINE ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Medicine ,030212 general & internal medicine ,Paravalvular leak ,Three generations ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objectives The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. Background Over the past decade there have been r...
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- 2020
27. Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial
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Nicolas M. Van Mieghem, Jeffrey J. Popma, G. Michael Deeb, Steven J. Yakubov, Patrick W. Serruys, Stephan Windecker, Lars Søndergaard, Mubashir Mumtaz, Hemal Gada, Stanley Chetcuti, Neal S. Kleiman, Susheel Kodali, Isaac George, Patrick Teefy, Bob Kiaii, Jae K. Oh, Arie Pieter Kappetein, Yanping Chang, Andrew S. Mugglin, Michael J. Reardon, Paul Sorajja, Benjamin Sun, Himanshu Agarwal, Thomas Langdon, Peter den Heijer, Mohamed Bentala, Daniel O’Hair, Tanvir Bajwa, Timothy Byrne, Michael Caskey, Basil Paulus, Edward Garrett, Robert Stoler, Robert Hebeler, Kamal Khabbaz, David Scott Lim, Mark Bladergroen, Peter Fail, Edgar Feinberg, Michael Rinaldi, Eric Skipper, Atul Chawla, David Hockmuth, Raj Makkar, Wen Cheng, Janah Aji, Frank Bowen, Theodore Schreiber, Scott Henry, Christian Hengstenberg, Sabine Bleiziffer, J. Kevin Harrison, Chad Hughes, James Joye, Vincent Gaudiani, Vasilis Babaliaros, Vinod Thourani, Nicolas van Mieghem, A. Pieter Kappetein, Harold Dauerman, Joseph Schmoker, Kimberly Skelding, Alfred Casale, Jan Kovac, Tomasz Spyt, Puvi Seshiah, J. Michael Smith, Raymond McKay, Robert Hagberg, Ray Matthews, Vaughn Starnes, William O’Neill, Gaetano Paone, Jose Maria Hernandez García, Miguel Such, Cesar Morís de la Tassa, Juan Carlos Llosa Cortina, Thierry Carrel, Brian Whisenant, John Doty, Jon Resar, John Conte, Vicken Aharonian, Thomas Pfeffer, Andreas Rück, Matthias Corbascio, Daniel Blackman, Pankaj Kaul, Chad Kliger, Derek Brinster, Ferdinand Leya, Mamdouh Bakhos, Gurpreet Sandhu, Alberto Pochettino, Nicolo Piazza, Benoit de Varennes, Ad van Boven, Piet Boonstra, Ron Waksman, Ammar Bafi, Anita Asgar, Raymond Cartier, Robert Kipperman, John Brown, Lang Lin, Joshua Rovin, Samin Sharma, David Adams, Stanley Katz, Alan Hartman, Hasanian Al-Jilaihawi, Mathew Williams, Juan Crestanello, Scott Lilly, Mohammad Ghani, Robert Mark Bodenhamer, Vivek Rajagopal, James Kauten, Mumbashir Mumtaz, Williams Bachinsky, Georg Nickenig, Armin Welz, Peter Skov Olsen, Steven Yakubov, Daniel Watson, Adnan Chhatriwalla, Keith Allen, Paul Teirstein, Jeffrey Tyner, Paul Mahoney, Joseph Newton, William Merhi, John Keiser, Alan Yeung, Craig Miller, Jurriën ten Berg, Robin Heijmen, George Petrossian, Newell Robinson, Stephen Brecker, Marjan Jahangiri, Thomas Davis, Sanjay Batra, James Hermiller, David Heimansohn, Sam Radhakrishnan, Stephen Fremes, Brijeshwar Maini, Brian Bethea, David Brown, William Ryan, Michael Reardon, Neal Kleiman, Christian Spies, Jeffrey Lau, Howard Herrmann, Joseph Bavaria, Eric Horlick, Chris Feindel, Franz-Josef Neumann, Friedhelm Beyersdorf, Roland Binder, Francesco Maisano, Marco Costa, Alan Markowitz, Peter Tadros, George Zorn, Eduardo de Marchena, Tomas Salerno, Marino Labinz, Marc Ruel, Joon Sup Lee, Thomas Gleason, Frederick Ling, Peter Knight, Mark Robbins, Stephen Ball, John Giacomini, Thomas Burdon, Robert Applegate, Neal Kon, Richard Schwartz, Scott Schubach, John Forrest, Abeel Mangi, and Cardiology
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Male ,Time Factors ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Severity of Illness Index ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Valve replacement ,Risk Factors ,law ,Cause of Death ,Credible interval ,Clinical endpoint ,030212 general & internal medicine ,610 Medicine & health ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,Europe ,Stroke ,Treatment Outcome ,Aortic Valve ,transcatheter aortic valve replacement ,Female ,Cardiology and Cardiovascular Medicine ,surgical aortic valve replacement ,Canada ,medicine.medical_specialty ,Risk Assessment ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Frequentist inference ,medicine ,Humans ,Aged ,business.industry ,Hemodynamics ,aortic stenosis ,Bayes Theorem ,Aortic Valve Stenosis ,Recovery of Function ,randomized clinical trial ,medicine.disease ,Interim analysis ,United States ,Confidence interval ,Surgery ,Stenosis ,Quality of Life ,business - Abstract
Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.
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- 2020
28. Impact of Stroke Volume Index and Left Ventricular Ejection Fraction on Mortality After Aortic Valve Replacement
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Stephen H. Little, David H. Adams, Jae K. Oh, Vuyisile T. Nkomo, Michael J. Boulware, Saki Ito, João L. Cavalcante, Stanley J. Checuti, David A. Orsinelli, Sidney Cohen, G. Michael Deeb, Michael J. Reardon, Grace Lin, Jian Huang, and Jeffrey J. Popma
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medicine.medical_specialty ,Ejection fraction ,business.industry ,medicine.medical_treatment ,Retrospective cohort study ,General Medicine ,Stroke volume ,medicine.disease ,Stenosis ,Aortic valve replacement ,Valve replacement ,Internal medicine ,Severity of illness ,cardiovascular system ,medicine ,Cardiology ,In patient ,business - Abstract
Objective To assess the impact of stroke volume index (SVI) and left ventricular ejection fraction (LVEF) on prognosis in patients with severe aortic stenosis, comparing those undergoing transcatheter aortic valve replacement (TAVR) and those with surgical AVR (SAVR). Patients and Methods A total of 742 patients from the CoreValve US Pivotal High-Risk Trial randomized to TAVR (n=389) or SAVR (n=353) from February 2011 to September 2012 were stratified by an SVI of 35 mL/m2 and LVEF of 50% for comparing all-cause mortality at 1 year. Results The prevalence of an SVI of less than 35 mL/m2 in patients who underwent TAVR and SAVR was 35.8% (125 of 349) and 31.3% (96 of 307), respectively; LVEF of less than 50% was present in 18.1% (63 of 348) and 19.6% (60 of 306), respectively. Among patients with an SVI of less than 35 mL/m2, 1-year mortality was similar between patients with TAVR and SAVR (16.3% vs 22.2%; P=.25). However, in those with an SVI of 35 mL/m2 or greater, 1-year mortality was lower in those with TAVR than SAVR (10.3% vs 17.3%; P=.03). In patients with an LVEF of less than 50%, mortality was not affected by AVR approach (P>.05). In patients with an LVEF of 50% or higher, TAVR was associated with lower mortality than SAVR when SVI was preserved (9.8% vs 18.6%; P=.01). Mortality was not affected by SVI within the same AVR approach when LVEF was 50% or higher. Conclusion In patients with severe aortic stenosis at high risk, there is a significant interaction between AVR approach and the status of SVI and LVEF. When LVEF or SVI was reduced, prognosis was similar regardless of AVR approach. In those with preserved LVEF or SVI, TAVR was associated with a better prognosis than SAVR. Trial Registration clinicaltrials.gov Identifier: NCT01240902
- Published
- 2020
29. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent
- Author
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Yasuhiro Honda, Atsuo Namiki, Satoshi Yasuda, Jeffrey J. Popma, Richard Rapoza, Keiichi Igarashi Hanaoka, Charles A. Simonton, Gregg W. Stone, Hajime Kusano, Taku Asano, Kozo Okada, Kenji Ando, Jungo Furuya, Kengo Tanabe, Ken Kozuma, Takeshi Kimura, Hideki Kitahara, Yukio Ozaki, Hiroki Shiomi, Yoshinobu Onuma, Peter J. Fitzgerald, Takafumi Ueno, Masafumi Ono, and Patrick W. Serruys
- Subjects
medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Stent ,Percutaneous coronary intervention ,Context (language use) ,030204 cardiovascular system & hematology ,medicine.disease ,Thrombosis ,Confidence interval ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Angiography ,Intravascular ultrasound ,medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,Nuclear medicine ,business - Abstract
Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95% confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95% confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)
- Published
- 2020
30. Vascular Complications after Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis
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Zouhair Rahhab, Isabella Kardys, Nicolas M. Van Mieghem, Nahid El Faquir, Michael J. Reardon, Herbert Kroon, Peter de Jaegere, Joost Daemen, Jeffrey J. Popma, Francesca Ziviello, and Karan R.R. Ramdat Misier
- Subjects
medicine.medical_specialty ,Transcatheter aortic ,business.industry ,Meta-analysis ,medicine ,Cardiology and Cardiovascular Medicine ,business ,Surgery - Abstract
Background: Vascular complications (VCs) after transcatheter aortic valve implantation (TAVI) are associated with impaired outcome. We performed a meta-analysis to determine in-hospital/30-day majo...
- Published
- 2020
31. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption
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Steven O. Marx, Siok Hwee Tan, Marc Litt, Ameer Kabour, Stephen G. Ellis, Charles A. Simonton, Divine E. Ediebah, Jeffrey J. Popma, David G. Rizik, Annapoorna Kini, Paul S. Teirstein, Dean J. Kereiakes, Gregg W. Stone, Ronald P. Caputo, and D. Christopher Metzger
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medicine.medical_specialty ,Everolimus ,business.industry ,medicine.medical_treatment ,Five year follow up ,Percutaneous coronary intervention ,medicine.disease ,Resorption ,Surgery ,Coronary artery disease ,Physiology (medical) ,Drug delivery ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,Bioresorbable scaffold ,medicine.drug ,Bioresorbable vascular scaffold - Abstract
Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. Methods: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. Results: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55–1.24] versus 1.35 [95% CI, 1.02–1.78]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P int =0.056) compared with the 0- to 3-year time period. Conclusions: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01751906.
- Published
- 2019
32. Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial
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Sanjit S. Jolly, Justin E. Davies, Aditya Mandawat, Hussein R. Al-Khalidi, Jennifer A. Rymer, Ian C. Gilchrist, Mauricio G. Cohen, Jeffrey J. Popma, Mitchell W. Krucoff, David F. Kong, J. Dawn Abbott, and Sunil V. Rao
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Population ,Investigational device exemption ,030204 cardiovascular system & hematology ,Revascularization ,law.invention ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Humans ,Multicenter Studies as Topic ,Prospective Studies ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,education ,Aged ,Randomized Controlled Trials as Topic ,Sirolimus ,education.field_of_study ,business.industry ,Percutaneous coronary intervention ,Drug-Eluting Stents ,Middle Aged ,medicine.disease ,Clinical trial ,Treatment Outcome ,surgical procedures, operative ,Conventional PCI ,Emergency medicine ,ST Elevation Myocardial Infarction ,Cardiology and Cardiovascular Medicine ,business ,Immunosuppressive Agents - Abstract
Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio–guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio–guided complete revascularization versus infarct-related artery–only revascularization.
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- 2019
33. The Impact of Basal Septal Hypertrophy on Outcomes after Transcatheter Aortic Valve Replacement
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Jeffrey J. Popma, Kimberly Guibone, James Chang, Rebecca T. Hahn, Duane S. Pinto, Nicholas J. Kiefer, Gordon M. Burke, Jordan B. Strom, and Gregory C. Salber
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Male ,medicine.medical_specialty ,Transcatheter aortic ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Article ,030218 nuclear medicine & medical imaging ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Risk Factors ,Interquartile range ,Internal medicine ,Heart Septum ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,In patient ,Embolization ,Retrospective Studies ,Aged, 80 and over ,Left bundle branch block ,business.industry ,Aortic Valve Stenosis ,Odds ratio ,Cardiomyopathy, Hypertrophic ,medicine.disease ,Treatment Outcome ,Echocardiography ,Aortic Valve ,Heart Valve Prosthesis ,Cardiology ,Female ,Basal septal hypertrophy ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Background The role of basal septal hypertrophy (BSH) on preprocedural transthoracic echocardiography in transcatheter aortic valve replacement (TAVR) is unknown. Methods Medical charts and preprocedural transthoracic echocardiograms of 378 patients who underwent TAVR were examined. The association between BSH and the primary composite outcome of valve pop-out, recapture, embolization, aborted procedure, conversion to open procedure, new conduction disturbance, or need for permanent pacemaker ≤30 days after TAVR was evaluated. Patients with preexisting pacemakers were excluded. Sensitivity analyses were performed varying the definition of BSH. Results Of 296 TAVR patients (78.3%) with interpretable images, 55 (18.6%) had BSH at a median of 40 days (interquartile range, 19–62 days) before TAVR. Age and sex were similar among those with and without BSH. BSH patients received postdilation more frequently (BSH+ vs BSH−: 41.8% vs 29.9%, P = .04). A total of 50 individuals (16.9%) received pacemakers within 30 days, and 128 (43.2%) developed conduction disturbances (with left bundle branch block most common), without differences between groups. BSH was unrelated to the primary outcome on multivariate analysis (adjusted odds ratio BSH+ vs BSH−, 0.94; 95% CI, 0.42−2.11; P = .88). Conclusions In this convenience sample of TAVR recipients at a large academic medical center, patients with BSH were more likely to receive postdilation. BSH was not associated with procedural or conduction outcomes after TAVR in patients without preexisting pacemakers.
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- 2019
34. The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement
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George L. Zorn, Neal S. Kleiman, Jeffrey J. Popma, David R. Hockmuth, Mubashir Mumtaz, Shuzhen Li, Peter Tadros, Thomas G. Gleason, Michael J. Reardon, Moritz C. Wyler von Ballmoos, G. Michael Deeb, Atul Chawla, Nicolas M. Van Mieghem, and Cardiology
- Subjects
Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,030204 cardiovascular system & hematology ,Risk Assessment ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Aortic valve replacement ,Valve replacement ,Risk Factors ,Internal medicine ,Risk of mortality ,medicine ,Humans ,Risk factor ,education ,Aged ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,education.field_of_study ,Surrogate endpoint ,business.industry ,Proportional hazards model ,Hazard ratio ,medicine.disease ,030228 respiratory system ,Aortic Valve ,Cardiology ,Female ,Surgery ,Erythrocyte Transfusion ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: An increasing body of evidence suggests that packed red blood cell (PRBC) transfusion may be associated with increased morbidity and mortality after transcatheter and surgical aortic valve replacement. It remains unclear whether PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality after aortic valve replacement in different populations. Methods: The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial randomized 1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to transcatheter aortic valve replacement or surgical aortic valve replacement. Baseline characteristics and outcomes including all-cause and cardiovascular mortality at 30 days and thereafter were compared between participants with and participants without PRBC transfusion. Cox proportional hazards models with time-varying covariates were fitted to estimate the effect of PRBC transfusion on mortality after adjustment for comorbidities and procedural complications. Results: Patients receiving PRBC were older, more commonly female and frail, with more comorbidities. The Society of Thoracic Surgeons Predicted Risk of Mortality baseline score was higher in the transfused group. After adjustment for these differences, PRBC transfusion was associated with mortality at 30 days, but not thereafter. The effect of PRBC on mortality (hazard ratio 1.04; 95% confidence interval, 0.96 to 1.11; P = .304) at 30 days was not independent of procedural complications (hazard ratio 21.04; 95% CI, 7.26 to 60.95; P < .001). Conclusions: Poor health status, procedural complications, PRBC transfusion, and mortality are correlated with each other. Transfusion of PRBC did not independently increase risk for mortality. In this intermediate-risk population, transfusion appears to be a risk marker of chronic conditions and periprocedural complications as opposed to a risk factor for postprocedural mortality. (Clinical trial registration: www.clinicaltrials.gov NCT01586910.)
- Published
- 2021
35. Heart Team 2.0
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Michael J. Reardon, Michael J. Mack, Martin B. Leon, and Jeffrey J. Popma
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Patient Care Team ,business.industry ,Heart team ,Heart Valve Diseases ,Humans ,Medicine ,Coronary Artery Disease ,Medical emergency ,Cardiology and Cardiovascular Medicine ,business ,medicine.disease - Published
- 2019
36. Self-Expanding Valve System for Treatment of Native Aortic Regurgitation by Transcatheter Aortic Valve Implantation (from the STS/ACC TVT Registry)
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Wilson Y. Szeto, Jeffrey J. Popma, Howard C. Herrmann, Angie Q. Zhang, Michael J. Reardon, Paul Sorajja, Jay Giri, Nimesh D. Desai, Susheel Kodali, J. Eduardo Rame, Saif Anwaruddin, Gilbert H.L. Tang, James B. Hermiller, and Fenton H. McCarthy
- Subjects
Male ,medicine.medical_specialty ,Transcatheter aortic ,medicine.medical_treatment ,Aortic Valve Insufficiency ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,Prosthesis Design ,Risk Assessment ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Cause of Death ,Internal medicine ,Humans ,Medicine ,Hospital Mortality ,Registries ,030212 general & internal medicine ,Survival rate ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Cause of death ,Aged, 80 and over ,business.industry ,Proportional hazards model ,Hazard ratio ,Retrospective cohort study ,Prognosis ,Survival Rate ,Treatment Outcome ,Heart Valve Prosthesis ,Multivariate Analysis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p0.001), albumin3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.
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- 2019
37. Late‐term safety and effectiveness of everolimus‐eluting stents in chronic total coronary occlusion revascularization: Final 4‐year results from the evaluation of the XIENCE coronary stent, Per formance, and T echnique in C hronic T otal O cclusions (EXPERT CTO) multicenter trial
- Author
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Jin Wang, J. Aaron Grantham, Pradyumna E. Tummala, Robert McGreevy, Jeffrey J. Popma, David E. Kandzari, Weiying Zhao, Nicholas Lembo, Annapoorna Kini, Charles Orr, Dimitri Karmpaliotis, William J. Nicholson, William Lombardi, and Jeffrey W. Moses
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Stent ,General Medicine ,030204 cardiovascular system & hematology ,Revascularization ,03 medical and health sciences ,0302 clinical medicine ,Coronary occlusion ,Internal medicine ,Multicenter trial ,Conventional PCI ,Coronary stent ,medicine ,Cardiology ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,Mace - Abstract
Background Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. Methods Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. Results Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. Conclusions In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.
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- 2019
38. A Practical Two‐Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement
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Jeffrey J. Popma, Quinn P. Hosler, Kimberly Guibone, Sandra M. Shi, Roger J. Laham, Jonathan Afilalo, Dae Hyun Kim, Kamal R. Khabbaz, and Anthony J. Maltagliati
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Sensitivity and Specificity ,Article ,Cohort Studies ,03 medical and health sciences ,Grip strength ,0302 clinical medicine ,Valve replacement ,Aortic valve replacement ,Weight loss ,Internal medicine ,Outcome Assessment, Health Care ,Preoperative Care ,medicine ,Humans ,030212 general & internal medicine ,Prospective cohort study ,Geriatric Assessment ,Aged ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,Frailty ,business.industry ,Incidence (epidemiology) ,Aortic Valve Stenosis ,medicine.disease ,Cardiac surgery ,Aortic Valve ,Cohort ,Female ,Geriatrics and Gerontology ,medicine.symptom ,business - Abstract
OBJECTIVES Despite evidence, frailty is not routinely assessed before cardiac surgery. We compared five brief frailty tests for predicting poor outcomes after aortic valve replacement and evaluated a strategy of performing comprehensive geriatric assessment (CGA) in screen-positive patients. DESIGN Prospective cohort study. SETTING A single academic center. PARTICIPANTS Patients undergoing surgical aortic valve replacement (SAVR) (n = 91; mean age = 77.8 y) or transcatheter aortic valve replacement (TAVR) (n = 137; mean age = 84.5 y) from February 2014 to June 2017. MEASUREMENTS Brief frailty tests (Fatigue, Resistance, Ambulation, Illness, and Loss of weight [FRAIL] scale; Clinical Frailty Scale; grip strength; gait speed; and chair rise) and a deficit-accumulation frailty index based on CGA (CGA-FI) were measured at baseline. A composite of death or functional decline and severe symptoms at 6 months was assessed. RESULTS The outcome occurred in 8.8% (n = 8) after SAVR and 24.8% (n = 34) after TAVR. The chair rise test showed the highest discrimination in the SAVR (C statistic = .76) and TAVR cohorts (C statistic = .63). When the chair rise test was chosen as a screening test (≥17 s for SAVR and ≥23 s for TAVR), the incidence of outcome for screen-negative patients, screen-positive patients with CGA-FI of .34 or lower, and screen-positive patients with CGA-FI higher than .34 were 1.9% (n = 1/54), 5.3% (n = 1/19), and 33.3% (n = 6/18) after SAVR, respectively, and 15.0% (n = 9/60), 14.3% (n = 3/21), and 38.3% (n = 22/56) after TAVR, respectively. Compared with routinely performing CGA, targeting CGA to screen-positive patients would result in 54 fewer CGAs, without compromising sensitivity (routine vs targeted: .75 vs .75; P = 1.00) and specificity (.84 vs .86; P = 1.00) in the SAVR cohort; and 60 fewer CGAs with lower sensitivity (.82 vs.65; P = .03) and higher specificity (.50 vs .67; P
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- 2019
39. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients
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Joshua Rovin, Michael J. Reardon, David H. Adams, Judah Askew, P.S. Teirstein, Tanvir Bajwa, John Heiser, G. Michael Deeb, Newell Robinson, Thomas G. Gleason, Antony Walton, Paul Sorajja, Neal S. Kleiman, Hemal Gada, John K. Forrest, Jae K. Oh, Basel Ramlawi, Mubashir Mumtaz, Michael J. Boulware, Jon R. Resar, George Petrossian, Stanley Chetcuti, Andrew S. Mugglin, Nicolo Piazza, George L. Zorn, Steven J. Yakubov, Daniel O'Hair, William Merhi, Didier Tchetche, Hongyan Qiao, and Jeffrey J. Popma
- Subjects
Aortic valve ,medicine.medical_specialty ,Transcatheter aortic ,business.industry ,medicine.medical_treatment ,Atrial fibrillation ,General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,Surgery ,03 medical and health sciences ,Stenosis ,0302 clinical medicine ,medicine.anatomical_structure ,Valve replacement ,Aortic valve stenosis ,cardiovascular system ,medicine ,In patient ,030212 general & internal medicine ,business ,Stroke - Abstract
Background Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is know...
- Published
- 2019
40. Habitual Physical Activity in Older Adults Undergoing TAVR
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Dae Hyun Kim, Jeffrey J. Popma, Nicolas Noiseux, Anita W. Asgar, Nicolo Piazza, Andre Lamy, Sandra Lauck, Giuseppe Martucci, Jonathan Afilalo, John G. Webb, Rakesh C. Arora, Louis P. Perrault, Thierry Lefèvre, Marino Labinaz, Janarthanan Sathananthan, Philippe Généreux, and Mark D. Peterson
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,Stenosis ,0302 clinical medicine ,Valve replacement ,Aortic valve replacement ,Interquartile range ,Internal medicine ,Cohort ,Clinical endpoint ,Risk of mortality ,Medicine ,030212 general & internal medicine ,Risk factor ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objectives The authors sought to assess the distribution and prognostic significance of habitual physical activity (HPA) in older adults undergoing transcatheter aortic valve replacement (TAVR). Background Low HPA is associated with mortality and disability in community-dwelling older adults. In the setting of TAVR, it is unclear whether low HPA is a risk factor for downstream morbidity or a byproduct of severe aortic stenosis that improves following its correction. Methods Older adults undergoing TAVR in the prospective multicentre FRAILTY-AVR (Frailty in Aortic Valve Replacement) study were interviewed to quantify their HPA in kilocalories/week using a validated questionnaire at baseline and follow-up. The primary endpoint was all-cause mortality at 12 months. Results The cohort consisted of 755 patients with a median age of 84.0 years (interquartile range [IQR]: 80.0 to 87.0 years). At baseline, median HPA was 1,116 kcal/week (IQR: 227 to 2,715 kcal/week) with 73% of patients performing Conclusions Sedentary patients have a higher risk of mortality and functional decline following TAVR.
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- 2019
41. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement
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Jonathan Afilalo, Dae Hyun Kim, Edward R. Marcantonio, Minhee Sung, Jung Lee, Caroline A. Kim, Roger J. Laham, Lewis A. Lipsitz, Jeffrey J. Popma, Kamal R. Khabbaz, Sandra M. Shi, and Kimberly Guibone
- Subjects
Male ,medicine.medical_specialty ,Activities of daily living ,Transcatheter aortic ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Article ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Valve replacement ,Aortic valve replacement ,Risk Factors ,Internal medicine ,mental disorders ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Prospective cohort study ,Aged ,Aged, 80 and over ,Frailty ,business.industry ,Incidence ,Incidence (epidemiology) ,Delirium ,Recovery of Function ,medicine.disease ,Cardiology ,Female ,Functional status ,Geriatrics and Gerontology ,medicine.symptom ,business - Abstract
BACKGROUND Transcatheter aortic valve replacement (TAVR) may be associated with less delirium and allow faster recovery than surgical aortic valve replacement (SAVR). OBJECTIVE To examine the association of delirium and its severity with clinical and functional outcomes after SAVR and TAVR. DESIGN Prospective cohort study. SETTING An academic medical center. PARTICIPANTS A total of 187 patients, aged 70 years and older, undergoing SAVR (N = 77) and TAVR (N = 110) in 2014 to 2016. MEASUREMENTS Delirium was assessed daily using the Confusion Assessment Method (CAM), with severity measured by the CAM-Severity (CAM-S) score (range = 0-19). Outcomes were prolonged hospitalization (9 days or more); institutional discharge; and functional status, measured by ability to perform 22 daily activities and physical tasks over 12 months. RESULTS SAVR patients had a higher incidence of delirium than TAVR patients (50.7% vs 25.5%; P
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- 2019
42. Initial Feasibility Study of a New Transcatheter Mitral Prosthesis
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Gaetano Paone, Lowell F. Satler, Philipp Blanke, Thomas Modine, Darren L. Walters, David G. Rizik, Jeffrey J. Popma, Richard Bae, Neil Moat, Vinay Badhwar, Gry Dahle, Samir R. Kapadia, Vinod H. Thourani, Michael L Chuang, Jonathon Leipsic, Paul A. Grayburn, Paolo Denti, Vasilis C. Babaliaros, Paul Sorajja, Mubashir Mumtaz, David W.M. Muller, Brian Bethea, Francesco Bedogni, Mayra Guerrero, Nicolas Dumonteil, and Ajay Sinhal
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medicine.medical_specialty ,Mitral regurgitation ,Ejection fraction ,business.industry ,medicine.medical_treatment ,Mitral valve replacement ,medicine.disease ,Prosthesis ,Surgery ,Heart failure ,Cohort ,Risk of mortality ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,Stroke - Abstract
Background Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p Conclusions In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
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- 2019
43. Comparison of Local Versus General Anesthesia Following Transfemoral Transcatheter Self-Expanding Aortic Valve Implantation (from the Transcatheter Valve Therapeutics Registry)
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Michael J. Reardon, Sandeep M. Patel, Marco A. Costa, Paul Sorajja, Sharla Chenoweth, Guilherme F. Attizzani, George Dangas, Wilson Y. Szeto, Jeffrey J. Popma, and Susheel Kodali
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Male ,Aortic valve ,medicine.medical_treatment ,Anesthesia, General ,030204 cardiovascular system & hematology ,law.invention ,Cohort Studies ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Valve replacement ,law ,medicine ,Humans ,Local anesthesia ,In patient ,Hospital Mortality ,Registries ,030212 general & internal medicine ,Intraoperative Complications ,Stroke ,Aged, 80 and over ,Bioprosthesis ,business.industry ,Aortic Valve Stenosis ,Length of Stay ,medicine.disease ,Intensive care unit ,Intensive Care Units ,medicine.anatomical_structure ,Heart Valve Prosthesis ,Anesthesia ,Propensity score matching ,Female ,Cardiology and Cardiovascular Medicine ,business ,Anesthesia, Local ,Cohort study - Abstract
Transfemoral transcatheter aortic valve replacement (TF-TAVR) is mostly performed under general anesthesia (GA) in most US centers. We examined in-hospital and 30-day outcomes in patients who underwent TF-TAVR with a self-expanding bioprosthesis using local anesthesia (LA) or GA. Patients from the Transcatheter Valve Therapeutics Registry who underwent TF-TAVR from January 2014 to June 2016 with LA or GA were evaluated. Propensity matching was performed and procedural and clinical outcomes compared up to 30 days. A total of 11,006 patients were included (GA: 8,239 [74.9%] and LA: 2,767 [25.1%]). After propensity matching (n = 1,988 matched sets), device success was similar (94.5% vs 94.6%, p = 0.905). No differences in in-hospital stroke (2.7% vs 2.3%, p = 0.413) or paravalvular regurgitation grade (p = 0.113) were noted. Fewer LA patients were converted to open heart surgery (0.2% vs 0.6%, p = 0.076) or experienced an in-hospital major vascular complication (0.7% vs 1.4%, p = 0.026). Intensive care unit time (40.1 ± 58.4 vs 50.9 ± 72.1 hours, p0.001) and postprocedure length of stay (4.1 ± 3.6 vs 5.0 ± 4.5 days, p0.001) were significantly shorter with LA. In-hospital and 30-day all-cause mortality were lower in the LA cohort compared to the GA cohort ([1.1% vs 2.7%, p0.001] and [2.1% vs 3.9%, p = 0.001]). In conclusion, in the largest series of self-expanding bioprostheses for TF-TAVR, these propensity-matched cohorts demonstrate that LA is an acceptable alternative to GA with comparable success, lower safety outcomes, complications rates, and in-hospital and 30-day all-cause mortality.
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- 2019
44. Impact of calcification on percutaneous coronary intervention: MACE‐Trial 1‐year results
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Jeffrey J. Popma, Ryan W. Bolduan, Roxana Mehran, Talhat Azemi, Gregory R. Giugliano, Samin K. Sharma, Jon R. Resar, Manesh R. Patel, Brad J. Martinsen, Ron Waksman, and David Cohen
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Atherectomy, Coronary ,Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Severity of Illness Index ,Lesion ,Atherectomy ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Risk Factors ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Vascular Calcification ,Prospective cohort study ,Aged ,Aged, 80 and over ,business.industry ,Percutaneous coronary intervention ,Retrospective cohort study ,General Medicine ,Middle Aged ,medicine.disease ,United States ,Clinical trial ,Treatment Outcome ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Mace ,Calcification - Abstract
OBJECTIVES The Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE-Trial) was designed to provide further insight on the impact of calcification on procedural and long-term percutaneous coronary intervention outcomes. BACKGROUND Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation. METHODS The MACE-Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild [N = 133], moderate [N = 99], and severe [N = 114]). Endpoints were lesion success, procedural success, and 1-year major adverse cardiac events (MACEs). RESULTS Presence of severe calcification had significant impact on lesion success ([83.3%] versus none/mild calcification [94.7%, P = 0.006]) and procedural success ([86.8%] versus moderate [95.0%, P = 0.028], and none/mild [97.7%, P = 0.001]). 1-year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P
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- 2019
45. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk Results From the Randomized SURTAVI Trial
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Eberhard Grube, Isaac George, Mathew R. Williams, Steven J. Yakubov, Yanping Chang, Molly Schiltgen, Arie Pieter Kappetein, G. Michael Deeb, Nicolas M. Van Mieghem, Jeffrey J. Popma, Lars Søndergaard, Susheel Kodali, Thomas Engstrøm, Patrick W. Serruys, Michael J. Reardon, Cardiology, and Cardiothoracic Surgery
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medicine.medical_specialty ,Percutaneous ,Surgical approach ,business.industry ,medicine.medical_treatment ,medicine.disease ,Revascularization ,Surgical risk ,Surgery ,Coronary artery disease ,Stenosis ,Aortic valve replacement ,Physiology (medical) ,Aortic valve stenosis ,Medicine ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. Methods: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. Results: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P P P =0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5–14.7 versus 12.3%; 95% CI, 9.8–15.4; P =0.76). Conclusions: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01586910.
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- 2019
46. Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial
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Atul Chawla, Daniel R. Watson, Nicolas M. Van Mieghem, Newell Robinson, Shuzhen Li, Jeffrey J. Popma, Robin H. Heijmen, Neal S. Kleiman, John V. Conte, George Petrossian, Mathew R. Williams, Michael J. Reardon, Steven J. Yakubov, David Hockmuth, A. Pieter Kappetein, and Cardiology
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Risk Assessment ,law.invention ,Cohort Studies ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Coronary artery bypass surgery ,0302 clinical medicine ,Valve replacement ,Randomized controlled trial ,Aortic valve replacement ,law ,medicine ,Risk of mortality ,Humans ,030212 general & internal medicine ,Coronary Artery Bypass ,Aged ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,business.industry ,Brief Report ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Treatment Outcome ,Aortic valve stenosis ,Aortic Valve ,Cohort ,Female ,Cardiology and Cardiovascular Medicine ,business ,Cohort study - Abstract
IMPORTANCE: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. OBJECTIVE: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. DESIGN, SETTING, AND PARTICIPANTS: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. INTERVENTIONS: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. RESULTS: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P
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- 2019
47. Safety and efficacy of dedicated guidewire and microcatheter technology for chronic total coronary occlusion revascularization
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Jeffrey J. Popma, William Lombardi, Stephen Cook, William J. Nicholson, David E. Kandzari, Ashish Pershad, J A Grantham, Jeffrey W. Moses, and Dimitrios Karmpaliotis
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Male ,Cardiac Catheterization ,medicine.medical_specialty ,Time Factors ,Percutaneous ,medicine.medical_treatment ,Myocardial Infarction ,030204 cardiovascular system & hematology ,Coronary Angiography ,Revascularization ,Total occlusion ,Cardiac Catheters ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Risk Factors ,medicine ,Humans ,Hospital Mortality ,Prospective Studies ,030212 general & internal medicine ,Prospective cohort study ,Aged ,Miniaturization ,business.industry ,Equipment Design ,General Medicine ,Middle Aged ,United States ,Surgery ,Clinical trial ,Treatment Outcome ,Coronary Occlusion ,Multicenter study ,Coronary occlusion ,Chronic Disease ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Limited study has detailed the procedural outcomes and utilization of contemporary coronary guidewires and microcatheters designed for chronic total occlusion (CTO) percutaneous revascularization and with application of modern techniques.A prospective, multicenter, single-arm trial was conducted to evaluate procedural and in-hospital outcomes among 163 patients undergoing attempted CTO revascularization with specialized guidewires and microcatheters. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction, or repeat target vessel revascularization (major adverse cardiac events).The prevalence of diabetes was 42.9%; prior myocardial infarction, 41.1%; and previous bypass surgery, 36.8%. Average (mean±SD) CTO length was 41±29 mm, and mean Japanese CTO score was 2.6±1.3. A guidewire support catheter was used in 91.7% of cases, and the mean number of CTO-specific guidewires per procedure was 3.1±2.9. Overall, procedural success was observed in 73.0% of patients. The rate of successful guidewire recanalization was 89.0%, and absence of in-hospital major adverse cardiac event was 81.0%. Methods included antegrade (45.4%), retrograde (5.5%) and combined antegrade/retrograde techniques (49.1%). Total mean procedure time was 119±68 min; mean radiation dose, 2613±1881 mGy; and contrast utilization, 287±142 ml. Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 13 (8.0%) patients.In this multicenter, prospective registration trial representing contemporary technique, favorable procedural success and early clinical outcomes inform technique and strategy using dedicated CTO guidewires and microcatheters in a high lesion complexity patient population.
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- 2018
48. The Value of Claims-Based Nontraditional Risk Factors in Predicting Long-term Mortality After MitraClip Procedure
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Changyu Shen, Robert W. Yeh, Jeffrey J. Popma, Kamil F. Faridi, Duane S. Pinto, Linda R. Valsdottir, and Harun Kundi
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Male ,medicine.medical_specialty ,030204 cardiovascular system & hematology ,Medicare ,Risk Assessment ,Article ,03 medical and health sciences ,0302 clinical medicine ,Renal Dialysis ,Risk Factors ,Atrial Fibrillation ,Humans ,Medicine ,In patient ,030212 general & internal medicine ,Cardiac Surgical Procedures ,Cardiac risk ,Aged ,Heart Failure ,business.industry ,Proportional hazards model ,Liver Diseases ,MitraClip ,Mitral Valve Insufficiency ,Shock ,United States ,Integrated discrimination improvement ,Multivariate Analysis ,Emergency medicine ,Mitral Valve ,Female ,Transcatheter mitral valve repair ,Long term mortality ,Cardiology and Cardiovascular Medicine ,business ,Percutaneous Mitral Valve Repair ,Follow-Up Studies - Abstract
We sought to identify nontraditional risk factors coded in administrative claims data and evaluate their ability to improve prediction of long-term mortality in patients undergoing percutaneous mitral valve repair.Patients undergoing transcatheter mitral valve repair using MitraClip implantation between September 28, 2010, and September 30, 2015 were identified among Medicare fee-for-service beneficiaries. We used nested Cox regression models to identify claims codes predictive of long-term mortality. Four groups of variables were introduced sequentially: cardiac and noncardiac risk factors, presentation characteristics, and nontraditional risk factors.A total of 3782 patients from 280 clinical sites received treatment with MitraClip over the study period. During the follow-up period, 1114 (29.5%) patients died with a median follow-up time period of 13.6 (9.6 to 17.3) months. The discrimination of a model to predict long-term mortality including only cardiac risk factors was 0.58 (0.55 to 0.60). Model discrimination improved with the addition of noncardiac risk factors (c = 0.63, 0.61 to 0.65; integrated discrimination improvement [IDI] = 0.038, P0.001), and with the subsequent addition of presentation characteristics (c = 0.67, 0.65 to 0.69; IDI = 0.033, P0.001 compared with the second model). Finally, the addition of nontraditional risk factors significantly improved model discrimination (c = 0.70, 0.68 to 0.72; IDI = 0.019, P0.001, compared with the third model).Risk-prediction models, which include nontraditional risk factors as identified in claims data, can be used to predict long-term mortality risk more accurately in patients who have undergone MitraClip procedures.
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- 2018
49. 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients
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William Merhi, John V. Conte, Stan Chetcuti, Steven J. Yakubov, Newell Robinson, James B. Hermiller, George L. Zorn, G. Michael Deeb, Peter Tadros, CoreValve U.S. Pivotal High Risk Trial Clinical Investigators, Thomas G. Gleason, Jae K. Oh, J. Kevin Harrison, Jeffrey J. Popma, John Heiser, G. Chad Hughes, David H. Adams, Neal S. Kleiman, Joon S. Lee, Mubashir Mumtaz, Michael J. Reardon, George Petrossian, and Jian Huang
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Male ,Aortic valve ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Aortic Valve Insufficiency ,Self Expandable Metallic Stents ,030204 cardiovascular system & hematology ,law.invention ,Cohort Studies ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Valve replacement ,Aortic valve replacement ,Risk Factors ,law ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Mortality ,Stroke ,Aged ,Aged, 80 and over ,business.industry ,Mortality rate ,medicine.disease ,Surgery ,Stenosis ,Treatment Outcome ,medicine.anatomical_structure ,Aortic valve stenosis ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients. Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
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- 2018
50. Trends in Isolated Surgical Aortic Valve Replacement According to Hospital-Based Transcatheter Aortic Valve Replacement Volumes
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Robert W. Yeh, Changyu Shen, Jeffrey J. Popma, Sammy Elmariah, Linda R. Valsdottir, Harun Kundi, and Jordan B. Strom
- Subjects
medicine.medical_specialty ,Transcatheter aortic ,business.industry ,medicine.medical_treatment ,Medicare beneficiary ,Patient characteristics ,Hospital based ,030204 cardiovascular system & hematology ,medicine.disease ,Annual change ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Valve replacement ,Quartile ,Aortic valve replacement ,Medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business - Abstract
Objectives This study sought to evaluate the trends in isolated surgical aortic valve replacement (SAVR) procedures across hospitals with different transcatheter aortic valve replacement (TAVR) volumes among Medicare beneficiaries. Background The volume of TAVR has increased in the United States since its approval, now exceeding that of isolated SAVR. Methods Hospitalizations of adults (≥18 years) with International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes for SAVR (35.21 or 35.22) or TAVR (35.05 or 35.06) who were included in the Medicare Provider Analysis and Review database between January 1, 2011, and December 31, 2014, were included. Trends in isolated SAVR patient characteristics, procedural volumes, and outcomes by quartile (Q) of hospital-level TAVR use were assessed over the study period. Results A total of 37,705 isolated SAVR procedures were analyzed for the study. The annual volume of isolated SAVR procedures decreased in hospitals performing the largest number of TAVR procedures (Q3: 1,557 in 2011 to 1,391 in 2014; and Q4: 2,607 in 2011 to 1,791 in 2014). Thirty-day and 1-year mortality after SAVR also declined over the study period in hospitals with the largest TAVR volume (annual change rate in mortality for Q3: −16.4%, p Conclusions The advent of TAVR was associated with a reduction in isolated SAVR volumes, a decrease in comorbidities among patients undergoing SAVR, and corresponding reductions in observed short- and long-term SAVR mortality among hospitals performing the greatest number of TAVRs.
- Published
- 2018
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