01 junio 2014

JACC. Significant Mitral Regurgitation Left Untreated at the Time of Aortic Valve Replacement. A Comprehensive Review of a Frequent Entity in the Transcatheter Aortic Valve Replacement Era

Luis Nombela-Franco, MD∗; Henrique Barbosa Ribeiro, MD∗; Marina Urena, MD∗; Ricardo Allende, MD∗; Ignacio Amat-Santos, MD∗; Robert DeLarochellière, MD∗; Eric Dumont, MD∗; Daniel Doyle, MD∗; Hugo DeLarochellière, MS∗; Jerôme Laflamme, MS∗; Louis Laflamme, MS∗; Eulogio García, MD†; Carlos Macaya, MD, PhD†; Pilar Jiménez-Quevedo, MD†; Mélanie Côté, MSc∗; Sebastien Bergeron, MD∗; Jonathan Beaudoin, MD∗; Philippe Pibarot, PhD∗; Josep Rodés-Cabau, MD∗

Abstract: Significant mitral regurgitation (MR) is frequent in patients with severe aortic stenosis (AS). In these cases, concomitant mitral valve repair or replacement is usually performed at the time of surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) has recently been considered as an alternative for patients at high or prohibitive surgical risk. However, concomitant significant MR in this setting is typically left untreated. Moderate to severe MR after aortic valve replacement is therefore a relevant entity in the TAVR era. The purpose of this review is to present the current knowledge on the clinical impact and post-procedural evolution of concomitant significant MR in patients with severe AS who have undergone aortic valve replacement (SAVR and TAVR). This information could contribute to improving both the clinical decision-making process in and management of this challenging group of patients.

01 junio 2014

JACC. Insights Into Echo-Attenuated Plaques, Echolucent Plaques, and Plaques With Spotty Calcification. Novel Findings From Comparisons Among Intravascular Ultrasound, Near-Infrared Spectroscopy, and Pathological Histology in 2,294 Human Coronary Artery Segments

Jun Pu, MD∗; Gary S. Mintz, MD†; Sinan Biro, MSc†; Jin-Bae Lee, MD∗; Stephen T. Sum, PhD§; Sean P. Madden, PhD§; Allen P. Burke, MD||; Pei Zhang, PhD||; Ben He, MD‡; James A. Goldstein, MD#; Gregg W. Stone, MD∗; James E. Muller, MD§; Renu Virmani, MD¶; Akiko Maehara, MD∗

Objectives: Three intravascular ultrasound (IVUS) signatures have been associated with coronary artery disease instability: echo attenuation, an intraplaque echolucent zone, and spotty calcification. The aim of this study was to investigate the substrates responsible for these IVUS signatures in a relatively large series of post-mortem human coronary samples.

01 septiembre 2015

JACC: CARDIOVASCULAR INTERVENTIONS. Clinical Impact of Aortic Regurgitation After Transcatheter Aortic Valve Replacement. Insights Into the Degree and Acuteness of Presentation

Miguel Jerez-Valero, MD∗; Marina Urena, MD∗; John G. Webb, MD†; Corrado Tamburino, MD‡; Antonio J. Munoz-Garcia, MD, PhD§; Asim Cheema, MD‖; Antonio E. Dager, MD¶; Vicenç Serra, MD#; Ignacio J. Amat-Santos, MD∗∗; Marco Barbanti, MD†; Sebastiano Immè, MD‡; Juan H. Alonso Briales, MD§; Hatim Al Lawati, MD‖; Luis Miguel Benitez, MD¶; Angela Maria Cucalon, MD¶; Bruno Garcia del Blanco, MD#; Ana Revilla, MD, PhD∗∗; Eric Dumont, MD∗; Henrique Barbosa Ribeiro, MD∗; Luis Nombela-Franco, MD∗; Sébastien Bergeron, MD∗; Philippe Pibarot, PhD∗; Josep Rodés-Cabau, MD∗

Objectives: The aim of this study was to determine the impact of the degree of residual aortic regurgitation (AR) and acuteness of presentation of AR after transcatheter aortic valve replacement (TAVR) on outcomes.

01 septiembre 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Periprocedural Intracardiac Echocardiography for Left Atrial Appendage Closure. A Dual-Center Experience

Sergio Berti, MD∗; Umberto Paradossi, MD∗; Francesco Meucci, MD†; Giuseppe Trianni, MD∗; Apostolos Tzikas, MD‡; Marco Rezzaghi, MD∗; Miroslava Stolkova, MD†; Cataldo Palmieri, MD∗; Fabio Mori, MD†; Gennaro Santoro, MD†

Objectives: This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation.

01 septiembre 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Radiation Dose Benchmarks During Cardiac Catheterization for Congenital Heart Disease in the United States

Sunil J. Ghelani, MD∗; Andrew C. Glatz, MD, MSCE†; Sthuthi David, BS∗; Ryan Leahy, MD, MS‡; Russel Hirsch, MD§; Laurie B. Armsby, MD‖; Sara M. Trucco, MD¶; Ralf J. Holzer, MD, MSc#; Lisa Bergersen, MD, MPH∗

Objectives: The aim of this study was to define age-stratified, procedure-specific benchmark radiation dose levels during interventional catheterization for congenital heart disease.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Comparison of Transfemoral Transcatheter Aortic Valve Replacement Performed in the Catheterization Laboratory (Minimalist Approach) Versus Hybrid Operating Room (Standard Approach). Outcomes and Cost Analysis

Vasilis Babaliaros, MD∗; Chandan Devireddy, MD∗; Stamatios Lerakis, MD∗; Robert Leonardi, MD∗; Sebastian A. Iturra, MD†; Kreton Mavromatis, MD∗; Bradley G. Leshnower, MD†; Robert A. Guyton, MD†; Mihir Kanitkar, MD∗; Patricia Keegan, NP∗; Amy Simone, PA†; James P. Stewart, MD∗; Nima Ghasemzadeh, MD∗; Peter Block, MD∗; Vinod H. Thourani, MD†

Objectives: The aim of this study was to compare transfemoral transcatheter aortic valve replacement (TF TAVR) performed in a catheterization laboratory (minimalist approach [MA]) with TF TAVR performed in a hybrid operating room (standard approach [SA]).

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Results of the U.S. Food and Drug Administration Continued Access Clinical Trial of the GORE HELEX Septal Occluder for Secundum Atrial Septal Defect

Alexander J. Javois, MD∗; Jonathan J. Rome, MD‡; Thomas K. Jones, MD§; Evan M. Zahn, MD‖; Craig E. Fleishman, MD¶; Ricardo H. Pignatelli, MD#; Larry A. Latson, MD∗∗

Objectives: This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial septal defect.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Predictors of Recurrent Events in Patients With Cryptogenic Stroke and Patent Foramen Ovale Within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) Trial

Sammy Elmariah, MD, MPH∗; Anthony J. Furlan, MD‡; Mark Reisman, MD§; David Burke, MD†; Moshe Vardi, MD†; Neil J. Wimmer, MD‖; Shuqiong Ling, MS†; Xiaohua Chen, MA†; David M. Kent, MD, MSc¶; Joseph Massaro, PhD†; Laura Mauri, MD, MSc†

Objectives: This study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Quantity and Location of Aortic Valve Complex Calcification Predicts Severity and Location of Paravalvular Regurgitation and Frequency of Post-Dilation After Balloon-Expandable Transcatheter Aortic Valve Replacement

Omar K. Khalique, MD∗; Rebecca T. Hahn, MD∗; Hemal Gada, MD∗; Tamim M. Nazif, MD∗; Torsten P. Vahl, MD∗; Isaac George, MD∗; Bindu Kalesan, PhD, MPH∗; Molly Forster, BA∗; Mathew B. Williams, MD∗; Martin B. Leon, MD∗; Andrew J. Einstein, MD, PhD∗; Todd C. Pulerwitz, MD∗; Gregory D.N. Pearson, MD, PhD∗; Susheel K. Kodali, MD∗

Objectives: This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR).

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Survival of Transcatheter Mitral Valve Repair Compared With Surgical and Conservative Treatment in High-Surgical-Risk Patients

Martin J. Swaans, MD∗; Annelies L.M. Bakker, MD∗; Arash Alipour, MD, PhD∗; Martijn C. Post, MD, PhD∗; Johannes C. Kelder, MD, PhD∗; Thom L. de Kroon, MD†; Frank D. Eefting, MD∗; Benno J.W.M. Rensing, MD, PhD∗; Jan A.S. Van der Heyden, MD, PhD∗

Objectives: The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR).

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Intravascular Ultrasound-Derived Minimal Lumen Area Criteria for Functionally Significant Left Main Coronary Artery Stenosis

Seung-Jung Park, MD, PhD∗; Jung-Min Ahn, MD∗; Soo-Jin Kang, MD∗; Sung-Han Yoon, MD∗; Bon-Kwon Koo, MD†; Jong-Young Lee, MD∗; Won-Jang Kim, MD∗; Duk-Woo Park, MD∗; Seung-Whan Lee, MD∗; Young-Hak Kim, MD∗; Cheol Whan Lee, MD∗; Seong-Wook Park, MD, PhD∗

Objectives: This study sought to evaluate the intravascular ultrasound (IVUS) minimal lumen area (MLA) for functionally significant left main coronary artery (LMCA) stenosis using fractional flow reserve (FFR) as the standard.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches in Women Undergoing Percutaneous Coronary Intervention. The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) Trial

Sunil V. Rao, MD∗; Connie N. Hess, MD, MHS∗; Britt Barham, BA∗; Laura H. Aberle, BSPH∗; Kevin J. Anstrom, PhD∗; Tejan B. Patel, MD†; Jesse P. Jorgensen, MD‡; Ernest L. Mazzaferri, Jr., MD§; Sanjit S. Jolly, MD‖; Alice Jacobs, MD¶; L. Kristin Newby, MD∗; C. Michael Gibson, MD#; David F. Kong, MD∗; Roxana Mehran, MD∗∗; Ron Waksman, MD††; Ian C. Gilchrist, MD‡‡; Brian J. McCourt∗; John C. Messenger, MD§§; Eric D. Peterson, MD, MPH∗; Robert A. Harrington, MD‖‖; Mitchell W. Krucoff, MD∗

Objectives: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Randomized Comparison of Everolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With ST Elevation Myocardial Infarction. RACES-MI Trial

Emilio Di Lorenzo, MD, PhD∗; Rosario Sauro, MD∗; Attilio Varricchio, MD, PhD∗; Michele Capasso, MD∗; Tonino Lanzillo, MD∗; Fiore Manganelli, MD∗; Giannignazio Carbone, MD∗; Francesca Lanni, MD∗; Maria Rosaria Pagliuca, MD∗; Giovanni Stanco, MD∗; Giuseppe Rosato, MD∗; Harry Suryapranata, MD, PhD†; Giuseppe De Luca, MD, PhD‡

Objectives: The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty.

01 agosto 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

Lisette Okkels Jensen, MD, DMSci, PhD∗; Per Thayssen, MD, DMSci∗; Michael Maeng, MD, PhD†; Evald Høj Christiansen, MD, PhD†; Jan Ravkilde, MD, DMSci‡; Knud Nørregaard Hansen, MD∗; Anne Kaltoft, MD, PhD†; Hans Henrik Tilsted, MD‡; Morten Madsen, MSc§; Jens Flensted Lassen, MD, PhD†

Equal unrestricted grants were received from Abbott Vascular, Boston Scientific, Cordis, and Johnson & Johnson. These companies did not have a role in study design, data collection, data analysis, or interpretation of results. They also did not have access to the clinical trial database or an opportunity to review the manuscript. Dr. Jensen has received honoraria from Abbott Vascular and Cordis and an unrestricted grant from Terumo to her institution. Dr. Thayssen has received unrestricted grants from Abbott Vascular and Cordis to his institution. Dr. Ravkilde has received honoraria from Abbott Vascular and unrestricted grants from Abbott Vascular, Boston Scientific, Cordis Johnson & Johnson, Medtronic, Biosensors, and Terumo to his institution. Dr. Lassen has received unrestricted grants from Abbott Vascular, Boston Scientific, Cordis Johnson & Johnson, Medtronic, Biosensors, Terumo, and St. Jude Medical to his institution. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

01 julio 2014

JACC: CARDIOVASCULAR INTERVENTIONS. Futility, Benefit, and Transcatheter Aortic Valve Replacement

Brian R. Lindman, MD, MSCI∗; Karen P. Alexander, MD†; Patrick T. O´Gara, MD‡; Jonathan Afilalo, MD, MSc

Transcatheter aortic valve replacement (TAVR) is a transformative innovation that provides treatment for high or prohibitive surgical risk patients with symptomatic severe aortic stenosis who either were previously not referred for or were denied operative intervention. Trials have demonstrated improvements in survival and symptoms after TAVR versus medical therapy; however, there remains a sizable group of patients who die or lack improvement in quality of life soon after TAVR. This raises important questions about the need to identify and acknowledge the possibility of futility in some patients considered for TAVR. In this very elderly population, a number of factors in addition to traditional risk stratification need to be considered including multimorbidity, disability, frailty, and cognition in order to assess the anticipated benefit of TAVR. Consideration by a multidisciplinary heart valve team with broad areas of expertise is critical for assessing likely benefit from TAVR. Moreover, these complicated decisions should take place with clear communication around desired health outcomes on behalf of the patient and provider. The decision that treatment with TAVR is futile should include alternative plans to optimize the patient´s health state or, in some cases, discussions related to end-of-life care. We review issues to be considered when making and communicating these difficult decisions.