Major Bleeding During HeartMate II Support

Bunte, Matthew C.; Blackstone, Eugene H.; Thuita, Lucy; Fowler, Jeffrey; Joseph, Lee; Ozaki, Aska; Starling, Randall C.; Smedira, Nicholas G.; Mountis, Maria

doi:10.1016/j.jacc.2013.05.089

Cited by 62 publications

(61 citation statements)

References 23 publications

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“…Another report found INR to be a poor predictor of bleeding when using the last INR measurement before a bleeding event. 23 Labile INR before implantation did not predict bleeding events in our analysis, although only 25% of patients were on warfarin before LVAD implantation. Thrombocytopenia was not assessed in our analysis.…”

Section: Discussionmentioning

confidence: 52%

HAS-BLED and CHA2DS2-VASc Scores as Predictors of Bleeding and Thrombotic Risk After Continuous-Flow Ventricular Assist Device Implantation

Koene

Win

Naksuk

et al. 2014

Journal of Cardiac Failure

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Section: Discussionmentioning

confidence: 52%

HAS-BLED and CHA2DS2-VASc Scores as Predictors of Bleeding and Thrombotic Risk After Continuous-Flow Ventricular Assist Device Implantation

Koene

Win

Naksuk

et al. 2014

Journal of Cardiac Failure

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“…A recent study of 139 HMII patients showed the greatest risk of bleeding was within the first 2 weeks post-operatively and early bleeding was associated with decreased survival. 26 Later gastrointestinal bleeding is reported with rates as high as 13% in the ADVANCE: HVAD BTT Trial CAP. 14 A single-center study of 86 HMII patients reported gastrointestinal bleeding as a frequent source of morbidity for patients but not a factor that significantly impacts survival.…”

Section: Resultsmentioning

confidence: 99%

Clinical Outcomes After Continuous-Flow Left Ventricular Assist Device

McIlvennan

Magid

Ambardekar

et al. 2014

Circ: Heart Failure

141

101

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Background Conveying the complex trade-offs of continuous-flow left ventricular assist devices (CF LVAD) is challenging, and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of CF LVAD. Methods and Results PubMed and Cochrane Library were searched from January 2007–December 2013, supplemented with manual review. Three reviewers independently assessed each study for saliency regarding patient-centered outcomes. Data were summarized in tabular form. Overall study characteristics encouraged inclusion of all indications (destination therapy and bridge to transplant) and prevented meta-analysis. The electronic search identified 465 abstracts, of which 50 met inclusion criteria; manual review added 2 articles in press. The articles included 10 industry-funded trials and registries, 10 multi-center reports, and the remainder single-center observational experiences. Estimated actuarial survival after CF LVAD ranged from 56–87% at 1-year, 43–84% at 2-years, and 47% at 4-years. Improvements in functional class and quality of life were reported, but missing data complicated interpretation. Adverse events were experienced by the majority of patients, but estimates for bleeding, stroke, infection, right heart failure, arrhythmias, and rehospitalizations varied greatly. Conclusions The totality of data for CF LVADs show consistent improvements in survival and quality of life counterbalanced by a range of common complications. While this summary should provide a practical resource for health care provider-led discussions with patients, it highlights the critical need for high-quality patient-centered data collected with standard definitions.

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“…This finding is again consistent with previous reports that cite bleeding as the most common perioperative event in these patients. 40 The 3rd leading cause of readmission was neurologic events, which occurred in 28 patients, or 13.3% of the LVAD-related admissions. Technological innovations designed to eliminate the driveline and to provide more biocompatible surfaces are clearly needed.…”

Section: Discussionmentioning

confidence: 99%

Present-Day Hospital Readmissions after Left Ventricular Assist Device Implantation: A Large Single-Center Study

Hernandez¹,

Singh²,

Hoang³

et al. 2015

Texas Heart Institute Journal

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A Large Single-Center StudyLeft ventricular assist device (LVAD) C irculatory support with left ventricular assist devices (LVADs) has emerged as a powerful therapy that can improve outcomes in patients who have advanced heart failure (HF) refractory to medical therapy.1-3 The scarcity of donor organs severely limits transplantation as an option for patients with advanced HF; moreover, transplant patients need lifelong immunosuppression, the medications for which can have their own serious side effects. The newest generation of LVADs comprises continuous-flow (CF) pumps, which use axial or centrifugal technology, deliver flows of up to 10 L/min, 2,4 and are smaller and more durable than previous models. Currently, these LVADs are implanted either as a bridge to transplantation (BTT) or as destination therapy (DT), which offers a permanent alternative to transplantation.Recently, patients with end-stage HF were given new options when the U.S. Food and Drug Administration (FDA) approved 2 continuous-flow LVADs: the HeartMate ® II (Thoratec Corporation; Pleasanton, Calif ) and the HeartWare ® Ventricular Assist System (HeartWare Inc.; Framingham, Mass). The HeartMate II was approved for BTT in 2008 and for DT in 2010, and the HeartWare was approved for BTT in 2012. These milestones initiated modern LVAD therapy, enabling this treatment to become available to a larger population of patients. [5][6][7][8][9] Consequently, LVAD use has dramatically increased throughout the world, particularly for DT, and growing numbers of medical centers are offering device therapy. [9][10][11] This trend has been bolstered by reports that LVAD use, in HF patients 70 years of age or older, is associated with

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Major Bleeding During HeartMate II Support

Abstract: The risk of bleeding peaks early after HMII implantation. Bleeding of thoracic and gastrointestinal sources dominates these events, although many patients undergo transfusions for anemia without an apparent source of hemolysis or bleeding.

Cited by 62 publications

References 23 publications

HAS-BLED and CHA2DS2-VASc Scores as Predictors of Bleeding and Thrombotic Risk After Continuous-Flow Ventricular Assist Device Implantation

HAS-BLED and CHA2DS2-VASc Scores as Predictors of Bleeding and Thrombotic Risk After Continuous-Flow Ventricular Assist Device Implantation

Clinical Outcomes After Continuous-Flow Left Ventricular Assist Device

Present-Day Hospital Readmissions after Left Ventricular Assist Device Implantation: A Large Single-Center Study

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