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Comparative analysis of regional outcomes and adverse events after continuous-flow left ventricular assist device implantation: An IMACS analysis.

Published on May 16, 2020in Journal of Heart and Lung Transplantation8.578
· DOI :10.1016/J.HEALUN.2020.05.001
K.K. Mirza2
Estimated H-index: 2
,
Rongbing Xie7
Estimated H-index: 7
(UAB: University of Alabama at Birmingham)
+ 5 AuthorsDaniel J. Goldstein21
Estimated H-index: 21
(Montefiore Medical Center)
Abstract
INTRODUCTION Regional outcomes after implantation of continuous-flow left ventricular assist devices (LVADs) have not been described. We examined differences in patient selection, survival, and adverse events across 3 geographic regions of the world: the Americas, Asia-Pacific, and Europe. METHODS Using data from The International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support registry, all adult patients implanted with a continuous-flow LVADs were included in this International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support analysis (n = 15,560), of whom, 9,988 (64%) received axial-flow devices and 5,572 (36%) received centrifugal-flow devices. RESULTS There were significant interregional differences in the rate of implantation of patients aged >70 years (Americas: 14%, Asia-Pacific: 1%, Europe: 5%; p CONCLUSION There are marked global differences in LVAD recipient characteristics, device utilization, and post-operative care. These heterogeneities along with differences in patient management and transplantation rates may impact long-term survival. Regional differences in adverse event incidence warrant further investigation.
  • References (28)
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References28
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#1Mandeep R Mehra Mdfacc (Harvard University)H-Index: 66
#2Nir Uriel (U of C: University of Chicago)H-Index: 36
Last. Daniel J. GoldsteinH-Index: 30
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Abstract Background In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device ...
34 CitationsSource
#1Daniel J. Goldstein (Montefiore Medical Center)H-Index: 21
#2Bart Meyns (Katholieke Universiteit Leuven)H-Index: 35
Last. James K. Kirklin (UAB: University of Alabama at Birmingham)H-Index: 67
view all 10 authors...
BACKGROUND The IMACS Registry compiles and analyzes worldwide data from patients undergoing implantation of durable left ventricular assist devices. METHODS Data encompassing 16,286 LVAD recipients from 4 collectives and 24 individual hospitals was collected and analyzed. In this 3rd annual report we compare and contrast outcomes, adverse events and risks factors between axial flow and centrifugal flow device recipients. RESULTS Significant differences were found in the baseline characteristics ...
5 CitationsSource
#1F. Gustaffson (UCPH: University of Copenhagen)H-Index: 44
#2Steven M. Shaw (University of Manchester)H-Index: 12
Last. Jens Garbade (Leipzig University)H-Index: 25
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Aims: The ELEVATE registry was planned to study post-approval outcomes with HeartMate 3™ (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD). Methods and results: A total of 482 patients provided consent to participate in ELEVATE (enrolled cohort). Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. An additional 58 patients we...
10 CitationsSource
Left ventricular assist devices (LVADs) are emerging as the treatment of choice for advanced heart failure due to the dearth of healthy donor hearts for cardiac transplantation. The HeartMate 3 LVAD is a novel centrifugal pump which was developed to provide hemodynamic support in heart failure patients, either as a bridge to transplant (BTT), myocardial recovery, or as destination therapy (DT). Technological and clinical advancements have led to optimized hemocompatibility and development of les...
1 CitationsSource
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 hosp...
25 CitationsSource
#2Luis Almenar-Bonet (IPN: Instituto Politécnico Nacional)H-Index: 12
Last. María G. Crespo LeiroH-Index: 32
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Background In Spain, listing for high-urgent heart transplantation is allowed for critically ill candidates not weanable from temporary mechanical circulatory support (T-MCS). We sought to analyse the clinical outcomes of this strategy. Methods and results We conducted a case-by-case, retrospective review of clinical records of 291 adult patients listed for high-urgent heart transplantation under temporary devices from 2010 to 2015 in 16 Spanish institutions. Survival after listing and adverse c...
21 CitationsSource
#1Jennifer Cowger (St Vincent Hospital)H-Index: 23
#2Yoshifumi Naka (Columbia University)H-Index: 68
Last. Ulrich P. JordeH-Index: 40
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The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrant...
11 CitationsSource
#1Takeshi NakataniH-Index: 30
#2Kazuhiro Sase (Juntendo University)H-Index: 18
Last. Soichro KitamuraH-Index: 56
view all 17 authors...
Background In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public–private partnership in collaborat...
18 CitationsSource
Source
#1James K. Kirklin (UAB: University of Alabama at Birmingham)H-Index: 67
#2Francis D. Pagani (UM: University of Michigan)H-Index: 68
Last. David C. Naftel (UAB: University of Alabama at Birmingham)H-Index: 64
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Background The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals. Methods The eighth annual report of INTERMACS updates the first decade of patient enrollment. Results In the current era, >95% of implants are continuous flow devices. Overall survival continues to remain >80% at 1 year and 70% at 2 years. Review of major adverse events shows minimal advantage for patients with ambulatory heart failure pre-impl...
272 CitationsSource
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