Initial Clinical Experience With the HeartWare Left Ventricular Assist System: A Single-Center Report

Dell’Aquila, Angelo M.; Schneider, Stefan R.B.; Schlarb, Dominik; Redwan, Bassam; Sindermann, Jürgen R.; Ellger, Björn; Stypmann, Jörg; Tjan, T. D. T.; Scheld, Hans H.; Hoffmeier, A.

doi:10.1016/j.athoracsur.2012.08.052

Cited by 30 publications

(12 citation statements)

References 17 publications

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“…Furthermore, most patients in this subpopulation underwent implantation of a pulsatile extracorporeal LVAD questioning comparability of the results. The incidence of postoperative ARF after CF-LVAD implantation reported previously ranges between 8.7% and 13% 4,6,16 and seems to be considerably lower than experienced in our study. The reason for this discrepancy might be the fact that the patients who were at high risk for postoperative complications, such as the patients on ECMO or other mechanical circulatory support, were not excluded in our study.…”

Section: Discussioncontrasting

confidence: 68%

“…4,6,9 However, unlike the other series, the patients who had been on ECMO, short- and even long-term mechanical circulatory support preoperatively were not excluded from this study for the purpose of evaluating the influence of previous mechanical support and the impact of the second surgery as possible risk factors on early mortality. Significantly, higher risk of bleeding and higher morbidity and mortality associated with the VAD exchange have been described previously.…”

Section: Discussionmentioning

confidence: 99%

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Outcomes and Predictors of Early Mortality After Continuous-Flow Left Ventricular Assist Device Implantation as a Bridge to Transplantation

Sabashnikov¹,

Mohite

Zych

et al. 2014

ASAIO Journal

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Left ventricular assist devices (LVADs) are fast becoming standard of care for patients with advanced heart failure. However, despite continuous improvement in VAD technology, there remains a significant early postoperative morbidity and mortality in this extreme patient group. The aim of the current study was to explore the short-term outcomes and predictors for 90 day mortality in the patients after implantation of continuous-flow LVAD. Perioperative clinical, echocardiographic, hemodynamic, and laboratory data of 90 day survivors and nonsurvivors were collected and compared retrospectively. Multivariate logistic regression analysis was performed on univariate predictors for 90 day mortality with an entry criterion of p < 0.1. Between July 2006 and May 2012, 117 patients underwent implantation of a continuous-flow LVAD as a bridge to transplantation: 71 (60.7%) HeartMate II (Thoratec Corp, Pleasanton, CA) and 46 (39.3%) HVAD (HeartWare International, Framingham, MA). All-cause 90 day mortality was 17.1%. Multivariate analysis revealed higher preoperative central venous pressure (odds ratio [OR], 1.18; 95% confidence interval [CI], 1.014–1.378; p = 0.033) and higher age (OR, 1.14; 95% CI, 1.01–1.38; p = 0.045) as the only independent predictors for 90 day mortality. Optimization of preoperative volume status, preload, and right heart function as well as age-based selection of candidates for LVAD support are the critical factors influencing early outcome after continuous-flow LVAD implantation.

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Section: Discussioncontrasting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Outcomes and Predictors of Early Mortality After Continuous-Flow Left Ventricular Assist Device Implantation as a Bridge to Transplantation

Sabashnikov¹,

Mohite

Zych

et al. 2014

ASAIO Journal

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“…(Ann Thorac Surg 2015;-:---) Ó 2015 by The Society of Thoracic Surgeons N owadays, new-generation left ventricular assist devices (VADs), in conjunction with more appropriate indications, offer the possibility to support patients for a notably long time [1,2]. In this context, besides concerns regarding the early postoperative period, long-term survival and the freedom from major complications, such as infections, are gaining increasing importance.…”

mentioning

confidence: 98%

Contributory Role of Fluorine 18-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the Diagnosis and Clinical Management of Infections in Patients Supported With a Continuous-Flow Left Ventricular Assist Device

Dell’Aquila

Mastrobuoni

Alles

et al. 2016

The Annals of Thoracic Surgery

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“…The reported rates of GI bleeding range from 15%[13] to as high as 40%,[14] with the majority of studies reporting rates in the range of 20–30% [15–20]. Loss of von Willebrand multimers due to high shear stress and decreased arterial pulsatility are believed to be the principle characteristics of CF-LVADs that cause GI bleeding [21–24].…”

Section: Discussionmentioning

confidence: 99%

Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure –1 year results from the Ce mark trial

Krabatsch

Netuka

Schmitto

et al. 2017

J Cardiothorac Surg

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BackgroundThe HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein.MethodsA prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days.ResultsFifty patients—54% bridge to transplant (BTT) and 46% destination therapy (DT)—were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2–4, with cardiac index 1.8 + 0.5 L/min/m2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006).ConclusionsThe 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient’s functional status and quality of life significantly improved over time.Trial registrationClinicaltrials.gov registration number: NCT02170363. Registered June 19, 2014.

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Initial Clinical Experience With the HeartWare Left Ventricular Assist System: A Single-Center Report

Cited by 30 publications

References 17 publications

Outcomes and Predictors of Early Mortality After Continuous-Flow Left Ventricular Assist Device Implantation as a Bridge to Transplantation

Outcomes and Predictors of Early Mortality After Continuous-Flow Left Ventricular Assist Device Implantation as a Bridge to Transplantation

Contributory Role of Fluorine 18-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the Diagnosis and Clinical Management of Infections in Patients Supported With a Continuous-Flow Left Ventricular Assist Device

Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure –1 year results from the Ce mark trial

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