Long‐term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure—two‐year results from the HeartMate 3 CE Mark Study

Schmitto, Jan D.; Pya, Yuriy; Zimpfer, Daniel; Krabatsch, Thomas; Garbade, Jens; Rao, Vivek; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Sood, Poornima; Damme, Laura; Netuka, Ivan

doi:10.1002/ejhf.1284

Cited by 80 publications

(65 citation statements)

References 39 publications

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“…The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial showed a bleeding complication rate of 43% in the HM3 population (bleeding requiring surgery: 12%; gastrointestinal bleeding: 27%) . This was further confirmed by the 2‐year results of the HM3 CE Mark study, which reported an incidence of bleeding events requiring surgery of 16% …”

Section: Preoperative Characteristics Of Patients Discharged With Andmentioning

confidence: 82%

Do we need aspirin in HeartMate 3 patients?

Consolo

Lucchetti

Tramontin

et al. 2019

European J of Heart Fail

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Section: Preoperative Characteristics Of Patients Discharged With Andmentioning

confidence: 82%

Do we need aspirin in HeartMate 3 patients?

Consolo

Lucchetti

Tramontin

et al. 2019

European J of Heart Fail

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“…Advances in long‐term mechanical circulatory support with left ventricular assist devices (LVADs) have significantly improved outcomes in this rapidly expanding population . However, several challenges in the clinical management of LVAD recipients remain and several opportunities exist to further optimize patient benefits, including combined device therapy with cardiac implantable electronic devices (CIEDs).…”

Section: Introductionmentioning

confidence: 99%

Cardiac implantable electronic devices with a defibrillator component and all‐cause mortality in left ventricular assist device carriers: results from the PCHF‐VAD registry

Čikeš

Jakuš

Claggett

et al. 2019

European J of Heart Fail

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Aims To compare characteristics of left ventricular assist device (LVAD) recipients receiving a cardiac implantable electronic device (CIED) with a defibrillator component (implantable cardioverter‐defibrillator and cardiac resynchronization therapy with defibrillation, CIED‐D) vs. those without one, and to assess whether carrying such a device contiguously with an LVAD is associated with outcomes. Methods and results Overall, 448 patients were analysed (mean age 52 ± 13 years, 82% male) in the multicentre European PCHF‐VAD registry. To account for all active CIED‐Ds during ongoing LVAD treatment, outcome analyses were performed by a time‐varying analysis with active CIED‐D status post‐LVAD as the time‐varying covariate. At the time of LVAD implantation, 235 patients (52%) had an active CIED‐D. Median time on LVAD support was 1.1 years (interquartile range 0.5–2.0 years). A reduction of 36% in the risk of all‐cause mortality was observed in patients with an active CIED‐D [hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.46–0.91; P = 0.012), increasing to 41% after adjustment for baseline covariates (HR 0.59, 95% CI 0.40–0.87; P = 0.008) and 39% after propensity score adjustment (HR 0.61, 95% CI 0.39–0.94; P = 0.027). Other than CIED‐D, age, LVAD implant as redo surgery, number of ventricular arrhythmia episodes and use of vasopressors pre‐LVAD were remaining significant risk factors of all‐cause mortality. Incident ventricular arrhythmias post‐LVAD portended a 2.4‐fold and 2.6‐fold increased risk of all‐cause and cardiovascular death, respectively; carrying an active CIED‐D remained associated with a 47% and 43% reduction in these events, respectively. Conclusions In an analysis accounting for all active CIED‐Ds, including those implanted during LVAD support, carrying such a device was associated with significantly better survival during LVAD support.

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“…pump-patient interface-related complications (acquired von Willebrand disease, infection, stroke, and pump thrombosis). [12][13][14] In the first 60 days after implantation, the most frequent complications are bleedings, infections, and arrhythmias, followed by respiratory and neurologic events, reoperations, and tamponade. Bleedings and arrhythmias tend to precipitate immediately after the intervention, while infections and neurologic events appear to have a gradual beginning.…”

Section: Lvad-related Complicationsmentioning

confidence: 99%

Left Ventricular Assist Device-Related Complications

Clément¹,

Anghel

Sascău

et al. 2020

Journal of Cardiovascular Emergencies

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Left ventricular assist device (LVAD) has emerged as a safe, durable, and revolutionary therapy for end-stage heart failure patients. Despite the appearance of newer-generation devices that have improved patient outcomes, the burden of adverse events remains significant. Although the survival rate for patients with LVAD is appreciated to be 81% at 1 year and 70% at 2 years, the incidence of adverse events is also high. Over time, both early and late postimplant complications have diminished in terms of prevalence and impact; however, complications, such as infections, bleeding, right heart failure, pump thrombosis, aortic insufficiency, or stroke, continue to represent a challenge for the practitioner. Therefore, the aim of this review is to highlight the most recent data regarding the current use of LVAD in the treatment of end-stage heart failure, with a specific focus on LVAD-related complications, in order to improve device-related outcomes. It will also revise how to mitigate the risk and how to approach specific adverse events. Withal, understanding the predisposing risk factors associated with postimplant complications, early recognition and appropriate treatment help to significantly improve the prognosis for patients with end-stage heart failure.

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Long‐term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure—two‐year results from the HeartMate 3 CE Mark Study

Cited by 80 publications

References 39 publications

Do we need aspirin in HeartMate 3 patients?

Do we need aspirin in HeartMate 3 patients?

Cardiac implantable electronic devices with a defibrillator component and all‐cause mortality in left ventricular assist device carriers: results from the PCHF‐VAD registry

Left Ventricular Assist Device-Related Complications

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