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Mandeep R Mehra, Daniel J Goldstein, Nir Uriel, Joseph C Cleveland, Melana Yuzefpolskaya, Christopher Salerno, Mary N Walsh, Carmelo A Milano, Chetan B Patel, Gregory A Ewald, Akinobu Itoh, David Dean, Arun Krishnamoorthy, William G Cotts, Antone J Tatooles, Ulrich P Jorde, Brian A Bruckner, Jerry D Estep, Valluvan Jeevanandam, Gabriel Sayer, Douglas Horstmanshof, James W Long, Sanjeev Gulati, Eric R Skipper, John B O'Connell, Gerald Heatley, Poornima Sood, Yoshifumi Naka
Background In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. Methods In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy)...
March 11, 2018: New England Journal of Medicine
Jasmin S Hanke, Günes Dogan, Amelie Zoch, Marcel Ricklefs, Leonhard Wert, Christina Feldmann, Christoph Bara, Malakh Shrestha, Jochen Tillmanns, Tibor Kempf, Johann Bauersachs, Axel Haverich, Jan D Schmitto
BACKGROUND: The HeartMate 3 (HM3; Abbott Laboratories, Lake Forest, Ill) left ventricular assist device (LVAD) received its Conformité Européenne mark for Europe in October 2015 and is currently under investigation of the Food and Drug Administration to gain approval in the United States. Within this study, we present the first real-world experiences, 1-year outcomes, and adverse events of a single-center cohort treated with the HM3. METHODS: We prospectively studied midterm results of 27 consecutive patients receiving the HM3 at a single institution...
February 13, 2018: Journal of Thoracic and Cardiovascular Surgery
Seraina Anne Dual, Alissa Muller, Stefan Boës, Oliver Brinkmann, Séline Steffanoni, Volkmar Falk, Mirko Meboldt, Marianne Schmid Daners, Simon Sündermann
PURPOSE: Less invasive left ventricular assist device implantation became feasible with the development of smaller devices. This study evaluated a sutureless aortic anastomosis device to facilitate the implant procedure. DESCRIPTION: The novel anastomotic device deploys and anchors an acute-angled stent in the aortic wall to create a sutureless outflow graft anastomosis in the ascending aorta. Four aortic anastomoses were performed on the beating hearts of two pigs without cross-clamping or cardiopulmonary bypass...
March 9, 2018: Annals of Thoracic Surgery
Shawn M Shah, Nicholas R Teman, Eileen Dearth, Leora T Yarboro, John A Kern
Utilization of a left ventricular assist device (LVAD) as a bridge to myocardial recovery is an established therapy for acute systolic heart failure. However, device removal can present a technical challenge with no clear consensus on preferred method. In this case report, we describe a complex patient who underwent successful explantation of an LVAD using an intraoperatively constructed apical plug. This method utilizes inexpensive and easily accessible materials, minimizes ventricular distortion during device removal, and preserves the ventricular sewing ring for future reimplantation...
March 9, 2018: Annals of Thoracic Surgery
Thomas A Csepe, Ahmet Kilic
Cardiogenic shock (CS) continues to have high mortality and morbidity despite advances in pharmacological, mechanical, and reperfusion approaches to treatment. When CS is refractory to medical therapy, percutaneous mechanical circulatory support (MCS) should be considered. Acute MCS devices, ranging from intra-aortic balloon pumps (IABPs) to percutaneous temporary ventricular assist devices (VAD) to extracorporeal membrane oxygenation (ECMO), can aid, restore, or maintain appropriate tissue perfusion before the development of irreversible end-organ damage...
October 2017: Journal of Thoracic Disease
Michael P O'Neil, Rene Alie, Linrui Ray Guo, Mary-Lee Myers, John Murkin, Chris Ellis
BACKGROUND: Pulsatile perfusion may offer microcirculatory advantages over conventional non-pulsatile perfusion during cardiopulmonary bypass (CPB). Here we present direct visual evidence of microvascular perfusion and vasoreactivity between perfusion modalities. METHODS: A prospective, randomized cohort study of twenty high-risk cardiac surgical patients undergoing pulsatile (n=10) or non-pulsatile (n=10) flow during CPB. Changes in sublingual mucosal microcirculation were assessed using orthogonal polarization spectral imaging along with near-infrared spectroscopic indices of thenar muscle tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test at various time points: T0-baseline, T1-30min CPB, T2-90min CPB, T3-1hr post CPB, and T4-24hr post CPB...
January 29, 2018: Annals of Thoracic Surgery
Masashi Kawabori, Chitaru Kurihara, Tadahisa Sugiura, William E Cohn, Andrew B Civitello, O Howard Frazier, Jeffrey A Morgan
BACKGROUND: Having a preoperative small left ventricle (LV) has been associated with higher complication and mortality rates after left ventricular assist device (LVAD) implantation; however, the outcomes after continuous-flow LVAD implantation have not been well studied. This is the first large-scale analysis of long-term survival after continuous-flow LVAD implantation in patients with a preoperative small LV. METHODS: Our cohort comprised 511 patients who underwent primary implantation of a HeartMate II (n = 393 [Thoratec, Pleasanton, CA]) or HeartWare HVAD (n = 118 [HeartWare International, Framingham, MA]) at our institution between November 2003 and March 2016...
December 28, 2017: Annals of Thoracic Surgery
Keyur B Shah, Randall C Starling, Joseph G Rogers, Douglas A Horstmanshof, James W Long, Vigneshwar Kasirajan, Josef Stehlik, Joyce Chuang, David J Farrar, Jerry D Estep
BACKGROUND: The ROADMAP study showed survival with improved functional status was better with left ventricular assist device (LVAD) therapy compared with optimal medical management (OMM) in ambulatory, non-inotrope-dependent (INTERMACS [IM] Profile 4 to 7) patients. To study more balanced cohorts and better define which patients may benefit from implantation of an LVAD, we re-evaluated the patients enrolled in ROADMAP when stratified by INTERMACS profile (Profile 4 and Profiles 5 to 7)...
December 7, 2017: Journal of Heart and Lung Transplantation
Stefan Klotz, Antje Karluss, Sina Stock, Alex Frydrychowicz, Hans-Hinrich Sievers
We report the case of an HeartMate III left ventricular assist device (LVAD) thrombosis triggered by a shock from an automatic implantable cardioverter defibrillator, releasing a left ventricular thrombus sucked in the LVAD inflow cannula. With LVAD low flow only the increase in motor temperature gave a hint of the thrombosis and a computer tomography scan confirmed the diagnosis. Pump exchange was performed with an uneventful outcome.
December 2017: Annals of Thoracic Surgery
Francisco A Arabía, Carmelo A Milano, Claudius Mahr, Edwin C McGee, Nahush A Mokadam, J Eduardo Rame, Jaime D Moriguchi, Danny Ramzy, David C Naftel, Susan L Myers, James K Kirklin
BACKGROUND: The incidence of right ventricular dysfunction requiring right ventricular assist device after left ventricular assist device placement has been reported between 10% to 30%. The mortality rate is higher compared with patients who require left ventricular assist device only; the most effective and safest biventricular assist device remains unknown. We aimed to determine the survival outcomes and frequency of adverse events in patients with two durable, intracorporeal, continuous flow centrifugal pumps for support...
November 17, 2017: Annals of Thoracic Surgery
Sudeep Kuchibhotla, Michele L Esposito, Catalina Breton, Robert Pedicini, Andrew Mullin, Ryan O'Kelly, Mark Anderson, Dennis L Morris, George Batsides, Danny Ramzy, Mark Grise, Duc Thinh Pham, Navin K Kapur
BACKGROUND: Biventricular failure is associated with high in-hospital mortality. Limited data regarding the efficacy of biventricular Impella axial flow catheters (BiPella) support for biventricular failure exist. The aim of this study was to explore the clinical utility of percutaneously delivered BiPella as a novel acute mechanical support strategy for patients with cardiogenic shock complicated by biventricular failure. METHODS AND RESULTS: We retrospectively analyzed data from 20 patients receiving BiPella for biventricular failure from 5 tertiary-care hospitals in the United States...
October 20, 2017: Journal of the American Heart Association
Daniel J Goldstein, Mandeep R Mehra, Yoshifumi Naka, Christopher Salerno, Nir Uriel, David Dean, Akinobu Itoh, Francis D Pagani, Eric R Skipper, Geetha Bhat, Nirav Raval, Brian A Bruckner, Jerry D Estep, Rebecca Cogswell, Carmelo Milano, Lahn Fendelander, John B O'Connell, Joseph Cleveland
BACKGROUND: Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices...
January 2018: Journal of Heart and Lung Transplantation
Valluvan Jeevanandam, Tae Song, David Onsager, Takeyoshi Ota, Colleen Juricek LaBuhn, Thomas Lammy, Gabriel Sayer, Gene Kim, Sonna Patel-Raman, Nir Uriel
BACKGROUND: The intravascular ventricular assist system (iVAS) is a new, minimally invasive, ambulatory counterpulsation heart assist system delivered via the subclavian artery and powered by a portable driver. It is designed for recovery, bridge to transplantation (BTT) or for prolonging medical therapy. We report the first-in-human (FIH) experience with iVAS. METHODS: This is a prospective, non-randomized single arm, U.S. Food and Drug Administration (FDA)-approved early feasibility trial in patients listed for cardiac transplantation...
November 10, 2017: Journal of Heart and Lung Transplantation
Hiroki Kohno, Goro Matsumiya, Yoshiki Sawa, Minoru Ono, Yoshikatsu Saiki, Akira Shiose, Kenji Yamazaki, Yoshiro Matsui, Hiroshi Niinami, Hikaru Matsuda, Soichiro Kitamura, Takeshi Nakatani, Shunei Kyo
BACKGROUND: The Jarvik 2000 ventricular assist device features a miniaturized intraventricular pump and an intermittent low-speed function that facilitates aortic valve opening. Despite its long history, little is known about the Jarvik device with regard to post-implantation outcomes. METHODS: Prospectively collected data from 13 participating hospitals were extracted from the Japanese Registry for Mechanically Assisted Circulatory Support database to analyze mortality, morbidity and de-novo aortic regurgitation...
October 24, 2017: Journal of Heart and Lung Transplantation
Theo M M H de By, Paul Mohacsi, Brigitta Gahl, Armin Zittermann, Thomas Krabatsch, Finn Gustafsson, Pascal Leprince, Bart Meyns, Ivan Netuka, Kadir Caliskan, Evaristo Castedo, Francesco Musumeci, André Vincentelli, Roland Hetzer, Jan Gummert
OBJECTIVES: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was founded in Berlin, Germany. EUROMACS is supported fully by the European Association for Cardio-Thoracic Surgery (EACTS) and, since 2014, has functioned as a committee of the EACTS. The purpose of having the EUROMACS as a part of the EACTS is to accumulate clinical data related to long-term mechanical circulatory support for scientific purposes and to publish annual reports. METHODS: Participating hospitals contributed surgical and cardiological pre-, peri- and long-term postoperative data of mechanical circulatory support implants to the registry...
September 29, 2017: European Journal of Cardio-thoracic Surgery
Ioannis Dimarakis, Steven Shaw, Rajamiyer Venkateswaran
No abstract text is available yet for this article.
October 2014: Journal of Thoracic and Cardiovascular Surgery
Ramanan Umakanthan, Nicholas A Haglund, John M Stulak, Lyle D Joyce, Rashid Ahmad, Mary E Keebler, Simon Maltais
Advances in mechanical circulatory support have been critical in bridging patients awaiting heart transplantation. In addition, improvement in device durability has enabled left ventricular assist device therapy to be applied as destination therapy in those not felt to be transplant candidate. Because of the increasing complexity of patients, there continues to be a need for alternative strategies for device implantation to bridge high-risk patients awaiting heart transplantation, wherein the risks of numerous previous sternotomies may be prohibitive...
November 2013: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Robyn Basken, Charles M Bazzell, Richard Smith, Rajesh Janardhanan, Zain Khalpey
Device thrombosis is a devastating complication of left ventricular assist devices. The definitive treatment has been device exchange or explant. Evidence of increasing morbidity and mortality with device exchange has shifted strategies toward conservative management. In this report, we detail the use of thrombolytics as salvage therapy in a patient with an occlusive HeartWare ventricular assist device (HeartWare Inc., Framingham, MA) thrombus, resulting in long-term survival without further intervention.
July 2017: Journal of Cardiac Surgery
Giuseppe M Raffa, Giuseppe D'Ancona, Sergio Sciacca, Astrid Pietrosi, Cesar M Hernandez Baravoglia, Marco Turrisi, Giuseppe Romano, Alessandro Armaro, Vincenzo Stringi, Francesco Clemenza, Michele Pilato
Endoventricular thrombolytic procedure (ETP) has been used to treat continuous-flow left ventricle assist device (CF-LVAD) thrombosis. The study aims to investigate the occurrence of complications after ETP. Data were retrospectively reviewed and analyzed in a series of patients who underwent CF-LVAD followed by ETP. Since November 2010, 20 patients underwent HeartWare CF-LVAD implantation at our institute. Four patients (20%) developed pump thrombosis and underwent a total of nine ETPs with tissue plasminogen activator infused into the left ventricle...
June 2015: Artificial Organs
Robert L Kormos
No abstract text is available yet for this article.
September 23, 2017: Journal of Thoracic and Cardiovascular Surgery
2017-10-20 21:05:03
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