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Identifying patients at risk: multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices.
Numan, Lieke; Zimpfer, Daniel; Zadok, Osnat Itzhaki Ben; Aarts, Emmeke; Morshuis, Michiel; Guenther, Sabina P W; Riebandt, Julia; Wiedemann, Dominik; Ramjankhan, Faiz Z; Oppelaar, Anne-Marie; Ben-Gal, Tuvia; Ben-Avraham, Binyamin; Asselbergs, Folkert W; Schramm, Rene; Van Laake, Linda W.
Affiliation
  • Numan L; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
  • Zimpfer D; Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
  • Zadok OIB; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
  • Aarts E; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
  • Morshuis M; Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.
  • Guenther SPW; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.
  • Riebandt J; Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.
  • Wiedemann D; Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
  • Ramjankhan FZ; Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
  • Oppelaar AM; Department of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.
  • Ben-Gal T; Department of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.
  • Ben-Avraham B; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
  • Asselbergs FW; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
  • Schramm R; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
  • Van Laake LW; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
ESC Heart Fail ; 10(3): 1656-1665, 2023 06.
Article in En | MEDLINE | ID: mdl-36798028
AIMS: Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. METHODS AND RESULTS: We performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14-1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant. CONCLUSIONS: HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thrombosis / Brain Ischemia / Heart-Assist Devices / Stroke / Heart Failure Type of study: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Female / Humans / Male / Middle aged Language: En Journal: ESC Heart Fail Year: 2023 Document type: Article Affiliation country: Netherlands Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thrombosis / Brain Ischemia / Heart-Assist Devices / Stroke / Heart Failure Type of study: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Female / Humans / Male / Middle aged Language: En Journal: ESC Heart Fail Year: 2023 Document type: Article Affiliation country: Netherlands Country of publication: United kingdom