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ESTUDIOS


15 septiembre 2021

Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI

Mohamed El Farissi, Richard Good, Thomas Engstrøm, Keith G. Oldroyd, Grigoris V. Karamasis, Pieter J. Vlaar, Jacob T. Lønborg, Koen Teeuwen, Thomas R. Keeble, Kenneth Mangion, Bernard De Bruyne, Ole Fröbert, Annemiek De Vos, Bastiaan Zwart, Roel J.R. Snijder, Guus R.G. Brueren, Pieter-Jan Palmers, Inge F. Wijnbergen, Colin Berry, Pim A.L. Tonino, Luuk C. Otterspoor, and Nico H.J. Pijls

Objectives The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI).

15 septiembre 2021

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement

Jason H. Rogers, Paul Sorajja, Vinod H. Thourani, Rahul Prakash Sharma, Bassem Chehab, Jennifer Cowger, David Heimansohn, Vinay Badhwar, Mayra Guerrero, and Gorav Ailawadi

Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.

15 septiembre 2021

Machine Learning Identifies Clinical Parameters to Predict Mortality in Patients Undergoing Transcatheter Mitral Valve Repair

Elric Zweck, Maximilian Spieker, Patrick Horn, Christos Iliadis, Clemens Metze, Refik Kavsur, Vedat Tiyerili, Georg Nickenig, Stephan Baldus, Malte Kelm, Marc Ulrich Becher, Roman Pfister, and Ralf Westenfeld

Objectives The aim of this study was to develop a machine learning (ML)–based risk stratification tool for 1-year mortality in transcatheter mitral valve repair (TMVR) patients incorporating metabolic and hemodynamic parameters.

15 septiembre 2021

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry

Tsuyoshi Kaneko, Sameer Hirji, Syed Zaid, Rudiger Lange, Jörg Kempfert, Lenard Conradi, Christian Hagl, Michael A. Borger, Maurizio Taramasso, Tom C. Nguyen, Gorav Ailawadi, Ashish S. Shah, Robert L. Smith, Amedeo Anselmi, Matthew A. Romano, Walid Ben Ali, Basel Ramlawi, Kendra J. Grubb, Newell B. Robinson, Luigi Pirelli, Michael W.A. Chu, Martin Andreas, Jean-Francois Obadia, Marco Gennari, Andrea Garatti, Didier Tchetche, Tamim M. Nazif, Vinayak N. Bapat, Thomas Modine, Paolo Denti, Gilbert H.L. Tang, and on behalf of CUTTING-EDGE Investigators

The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).

15 septiembre 2021

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

Santiago Garcia, Robert J. Cubeddu, Rebecca T. Hahn, Julien Ternacle, Samir R. Kapadia, Susheel K. Kodali, Vinod H. Thourani, Wael A. Jaber, Craig R. Asher, Sammy Elmariah, Raj Makkar, John G. Webb, Howard C. Herrmann, Michael Lu, Chandan M. Devireddy, S. Chris Malaisrie, Craig R. Smith, Michael J. Mack, Paul Sorajja, João L. Cavalcante, Mario Goessl, Gautam R. Shroff, Martin B. Leon, and Philippe Pibarot

Objectives The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).

15 septiembre 2021

Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry

Vinayak N. Bapat, Syed Zaid, Shinichi Fukuhara, Shekhar Saha, Keti Vitanova, Philipp Kiefer, John J. Squiers, Pierre Voisine, Luigi Pirelli, Moritz Wyler von Ballmoos, Michael W.A. Chu, Josep Rodés-Cabau, J. Michael DiMaio, Michael A. Borger, Rudiger Lange, Christian Hagl, Paolo Denti, Thomas Modine, Tsuyoshi Kaneko, Gilbert H.L. Tang, and on behalf of EXPLANT-TAVR Investigators

Objectives The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation.

15 septiembre 2021

Stent Expansion Indexes to Predict Clinical Outcomes: An IVUS Substudy From ADAPT-DES

Tatsuhiro Fujimura, Mitsuaki Matsumura, Bernhard Witzenbichler, D. Christopher Metzger, Michael J. Rinaldi, Peter L. Duffy, Giora Weisz, Thomas D. Stuckey, Ziad A. Ali, Zhipeng Zhou, Gary S. Mintz, Gregg W. Stone, and Akiko Maehara

Objectives The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes.

15 agosto 2021

Antithrombotic Therapy After Transcatheter Aortic Valve Replacement

Davide Capodanno, Jean-Philippe Collet, George Dangas, Gilles Montalescot, Jurrien M. ten Berg, Stephan Windecker, and Dominick J. Angiolillo

Transcatheter aortic valve replacement (TAVR) is a treatment option for symptomatic patients with severe aortic stenosis who are candidates for a bioprosthesis across the entire spectrum of risk. However, TAVR carries a risk for thrombotic and bleeding events, underscoring the importance of defining the optimal adjuvant antithrombotic regimen. Antithrombotic considerations are convoluted by the fact that many patients undergoing TAVR are generally elderly and present with multiple comorbidities, including conditions that may require long-term oral anticoagulation (OAC) (eg, atrial fibrillation) and antiplatelet therapy (eg, coronary artery disease). After TAVR among patients without baseline indications for OAC, recent data suggest dual-antiplatelet therapy to be associated with an increased risk for bleeding events, particularly early postprocedure, compared with single-antiplatelet therapy with aspirin. Concerns surrounding the potential for thrombotic complications have raised the hypothesis of adjunctive use of OAC for patients with no baseline indications for anticoagulation. Although effective in modulating thrombus formation at the valve level, the bleeding hazard has shown to be unacceptably high, and the net benefit of combining antiplatelet and OAC therapy is unproven. For patients with indications for the use of long-term OAC, such as those with atrial fibrillation, the adjunctive use of antiplatelet therapy increases bleeding. Whether direct oral anticoagulant agents achieve better outcomes than vitamin K antagonists remains under investigation. Overall, single-antiplatelet therapy and OAC appear to be reasonable strategies in patients without and with indications for concurrent anticoagulation. The aim of the present review is to appraise the current published research and recommendations surrounding the management of antithrombotic therapy after TAVR, with perspectives on evolving paradigms and ongoing trials.

15 septiembre 2021

TAVR Patients Requiring Anticoagulation: Direct Oral Anticoagulant or Vitamin K Antagonist?

Romain Didier, Thibault Lhermusier, Vincent Auffret, Hélène Eltchaninoff, Herve Le Breton, Guillaume Cayla, Philippe Commeau, Jean Philippe Collet, Thomas Cuisset, Nicolas Dumonteil, Jean Philippe Verhoye, Sylvain Beurtheret, Thierry Lefèvre, Emmanuel Teiger, Didier Carrié, Dominique Himbert, Bernard Albat, Alain Cribier, Arnaud Sudre, Didier Blanchard, Olivier Bar, Gilles Rioufol, Frederic Collet, Remi Houel, Louis Labrousse, Nicolas Meneveau, Said Ghostine, Thibaut Manigold, Philippe Guyon, Stephane Delepine, Xavier Favereau, Geraud Souteyrand, Patrick Ohlmann, Vincent Doisy, Farzin Beygui, Antoine Gommeaux, Jean-Philippe Claudel, Francois Bourlon, Bernard Bertrand, Bernard Iung, Martine Gilard, and on behalf of STOP-AS and France-TAVI

Objectives Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs).

15 agosto 2021

Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services

Edward D. Percy, Morgan T. Harloff, Sameer Hirji, Siobhan McGurk, Farhang Yazdchi, Paige Newell, Alexandra Malarczyk, Ashraf Sabe, Uri Landes, John Webb, Michael J. Reardon, Vinod H. Thourani, Gilbert H.L. Tang, Vinayak Bapat, Deepak Bhatt, Patrick O’Gara, Thomas Gleason, Pinak Shah, and Tsuyoshi Kaneko

Objectives The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database.

15 agosto 2021

Coronary Physiological Assessment in a Patient With Atrial Fibrillation: The Importance of Rhythm

Mark T. Mills, Andreas L. Kyriacou, Paul D. Morris, and Julian P. Gunn

A 55-year-old man presented with a 4-month history of progressive dyspnea and exertional chest tightness (Canadian Cardiovascular Society class III). His background included persistent atrial fibrillation (AF) with pulmonary vein isolation 2 years previously. Invasive coronary angiography 3 years previously revealed a left anterior descending coronary artery (LAD) artery stenosis, treated conservatively. Echocardiography during AF demonstrated a left ventricular ejection fraction of 15%. (Written consent for submission and publication of this case, including images and text, was obtained from the patient.) To determine the relative contribution of the arrythmia and the coronary stenosis to the patient’s symptoms, we performed invasive coronary angiography and redo AF catheter ablation in a single sitting, under general anesthesia. Angiography confirmed progression of the proximal LAD stenosis (Figure 1). Coronary physiological assessment with a PressureWire X (Abbott) and Coroventis software measured FFR, coronary flow reserve, and index of microvascular resistance under baseline and adenosine-induced hyperemia. Measurements were assessed in AF (patient’s intrinsic rate), sinus rhythm (SR; following direct-current cardioversion [DCCV]), and an atrial-paced rhythm via a decapolar catheter in the coronary sinus, at an identical ventricular rate to AF.

15 agosto 2021

Infarction at a Distance: Simultaneous Acute Myocardial Infarction Due to Non–Infarct-Related Chronic Artery Occlusion

Sayaka Funabashi, Masashi Fujino, Yoshiaki Morita, and Teruo Noguchi

The presence of chronic total occlusion (CTO) in a non–infarct-related artery (IRA) in patients with acute myocardial infarction (AMI) is associated with poor prognosis. Severe stenosis or CTO in a non–IRA might cause ischemia in a region remote from the infarct. This phenomenon is known as ischemia at a distance (1). We encountered a patient who experienced MI in a remote region supplied by an artery with CTO.

15 agosto 2021

Recapture of the Sapien-3 Delivery System After Transversal Balloon Rupture Using a Whole Percutaneous Femoral Approach

Antonio Giulio Bruno, Nevio Taglieri, Francesco Saia, Rodolfo Pini, Enrico Gallitto, Gabriele Ghetti, Mateusz Orzalkiewicz, Cinzia Marrozzini, Gianluca Faggioli, Mauro Gargiulo, Alessandro Leone, Carlo Savini, Davide Pacini, Nazzareno Galié, and Tullio Palmerini

A 57-year-old man with severe aortic valve stenosis at high surgical risk underwent transcatheter valve replacement with a 29-mm Edwards Sapien-3 valve (Edwards Lifesciences). The valve was successfully implanted using the right femoral access, but at the end of the deployment the balloon ruptured (Videos 1 and 2) and could not be retrieved from the e-Sheath. The Commander delivery system was then readvanced in the aorta over the wire (Video 3), which was snared and externalized using a 25-mm AndraSnare (Andramed GmbH) inserted through the left femoral artery using a 25-cm-long 22-F Cook sheath (Cook Medical) (Figure 1). Then, the Commander was pushed over the wire, across the aortic bifurcation, making the ruptured balloon get into the Cook sheath (Figure 2). The Commander was then truncated (Figure 3), and the ruptured balloon proximal part attached to the pusher/balloon catheter unit was retrieved through the eSheath (Figure 4). Then, the ruptured balloon distal part attached to the inner balloon shaft was pushed forward such that it could be externalized through the left femoral sheath, cut (Figure 5), and finally pulled back with the wire through the eSheath (Figure 6).

15 agosto 2021

Interventional Snare Procedure to Lift a Balloon-Expandable TAVR Impeding a Mechanical Bi-Leaflet Mitral Valve

Leo Nicolai, Michael Näbauer, Sebastian Sadoni, Hans Theiss, Martin Orban, Christian Hagl, Steffen Massberg, Jörg Hausleiter, and Daniel Braun

An 82-year-old man presented with progressive dyspnea (New York Heart Association functional class III) caused by severe aortic stenosis. Heart team assessment revealed high operative risk because of patient age and previous surgical mitral valve replacement (Sorin Bicarbon bileaflet 27 mm) 28 years ago (STS Score 4.2%). Therefore, the patient was scheduled for transcatheter aortic valve replacement (TAVR) using a balloon-expandable Edwards Sapien-3 29-mm prosthesis, which was performed under conscious sedation without obvious complications. Post-interventional transthoracic echocardiography showed an increased transmitral inflow gradient (dPmean 12 mm Hg) compared with baseline (dPmean 4 mm Hg). Fluoroscopy revealed an overlap of the proximal stent struts with the anterior part of the mitral prosthesis preventing opening movement of the anterior disc (Figure 1, Video 1). We discussed the treatment options in our interdisciplinary heart team. Because overlap with the prosthesis appeared to be minimal, it was decided to attempt pulling the Sapien valve cranially using a snare. First, a 0.35-mm wire was placed through the distal stent struts on the side of the contact with the mechanical prosthesis using an internal mammy artery catheter via right brachial arterial access. This wire was then snared in the ascending aorta via a right femoral access. A safari wire was placed in the left ventricle to secure access through the Sapien valve in case of aortic embolization during traction on the snare.

15 agosto 2021

Post MI Ventricular Septal Defect Treated by Percutaneous Implantation of Figulla Flex ASD Occluder

Tomáš Kovárník, Jan Bělohlávek, David Zemánek, and Lukáš Lambert

A 69-year-old woman was admitted with subacute anterior myocardial infarction complicated by ventricular septal defect (Figure 1, Videos 1 and 2). Stenoses in the left anterior descending coronary artery and in the left circumflex artery were found (Video 3). Impella CP (Abiomed, Danvers, Massachusetts) was inserted to stabilize the patient for cardiogenic shock with ejection fraction 35% (Figure 2). Because of extremely high risk for cardiac surgery caused by poor hemodynamic status, and significant comorbidities (systemic scleroderma), we decided for percutaneous closure on the third day. Venoarterial extracorporeal membrane oxygenation (RotaFlow, Maquet, Hirrlingen, Germany) was inserted for risk of hemodynamic collapse during the planned procedure (Video 4). Using a pigtail catheter, we introduced a hydrophilic Terumo wire through ventricular septal defect into the right ventricle, and to the superior vena cava. We then snared it using a Multi-Snare micro 15 mm (Pfm Medical Carlsbad, California) and externalized it (via femoral vein) (Figure 3, Video 5). Repetitive ventricular tachycardia, with full dependency on extracorporeal membrane oxygenation, occurred during this maneuver. We chose an atrial septal defect Figula Flex 16 occluder (Occlutech, Jena, Germany) because of its high flexibility (Figure 4, Video 6). A final ventriculography revealed the incomplete occlusion of ventricular septal defect (Video 7). We performed percutaneous coronary intervention with a 3.5 × 20 mm Cre8 stent (Alvimedica, Istanbul, Turkey) to the left anterior descending coronary artery, a 2.5 × 24 mm Synergy stent (Boston Scientific, Natick, Massachusetts) to the mid-left circumflex artery, and a 3.5 × 31 mm Cre8 stent from the left main to the proximal left circumflex artery (Video 8). The procedure was finished by extracorporeal membrane oxygenation extraction, and a percutaneous closure of the arterial site by 2 ProGlide (Abbott, Abbott Park, Illinois) sutures.

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