TY - JOUR
T1 - Identifying patients at risk
T2 - multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
AU - Numan, Lieke
AU - Zimpfer, Daniel
AU - Zadok, Osnat Itzhaki Ben
AU - Aarts, Emmeke
AU - Morshuis, Michiel
AU - Guenther, Sabina P. W.
AU - Riebandt, Julia
AU - Wiedemann, Dominik
AU - Ramjankhan, Faiz Z.
AU - Oppelaar, Anne-Marie
AU - Ben-Gal, Tuvia
AU - Ben-Avraham, Binyamin
AU - Asselbergs, Folkert W.
AU - Schramm, Rene
AU - van Laake, Linda W.
N1 - Funding Information: L. N., O. I. B. Z, E. A., M. M, S. P. W. G., J. R., F. R., A.‐M. O., T. B.‐G., B. B.‐A., F. W. A., and R. S. have no conflict of interest. The UMCU, which employs L. W. L. received consultancy fees from Medtronic, Abbott, Vifor, and Novartis, outside the submitted work. MedUni Vienna, which employs D. Z. reports grants, personal fees, and non‐financial support from Medtronic and Abbott, and D. W. reports personal fees from Abbott and Xenios/Fresenius, outside the submitted work. Funding Information: The collaboration project is co-funded by the PPP Allowance made available by Health-Holland, Top Sector Life Sciences & Health, to stimulate public–private partnerships (LVAD–LVAD, LSHM19035). Publisher Copyright: © 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2023/6
Y1 - 2023/6
N2 - 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.
AB - 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.
KW - Centrifugal continuous flow pump
KW - End-stage heart failure
KW - LVAD
KW - Left ventricular assist device
KW - Mechanical circulatory support
UR - http://www.scopus.com/inward/record.url?scp=85148444163&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ehf2.14308
DO - https://doi.org/10.1002/ehf2.14308
M3 - Article
C2 - 36798028
SN - 2055-5822
VL - 10
SP - 1656
EP - 1665
JO - ESC heart failure
JF - ESC heart failure
IS - 3
ER -