Expert review of medical devices · 2026
Routine microaxial left ventricular support during nonemergent high-risk PCI: an updated systematic review and meta-analysis with Bayesian and grade methodologies.
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Mohamed Ahmed Elmorsy, Abomohsen Mustafa, Almakadma Abdul Hakim, Kholeif Zeyad, Elalfy Aya, Idries Iyad, Abdelkhalek Ahmed M, Elkhayat Ibrahim, Ghannam Mohammed, AlQassab Osamah, Mojahedi Azad, Gadelmawla Ahmed Farid, Rashwan Rana, Farid Meena, Gunsburg Moshe, Chadow Hal L
Аннотация
INTRODUCTION: Microaxial left ventricular support (MLVS; Impella, Abiomed) is increasingly used during nonemergent high-risk percutaneous coronary intervention (HR-PCI), although randomized evidence remains limited and device-related complications are a concern.
METHODS: PubMed/MEDLINE, Scopus, Web of Science, and the Cochrane Library were searched from inception through March 2026 for randomized and comparative observational studies of MLVS versus control during nonemergent HR-PCI. Random-effects meta-analysis, subgroup and sensitivity analyses, Bayesian modeling, risk-of-bias assessment, and GRADE were performed.
RESULTS: Ten studies including 7,875 patients were analyzed. MLVS was not associated with lower all-cause mortality overall (RR 1.17, 95% CI 0.81-1.67; I2 = 82.1%). Exploratory analyses showed higher mortality estimates in randomized trials (RR 1.44, 95% CI 1.05-1.97) and studies of planned pre-PCI support (RR 1.52, 95% CI 1.17-1.97). Bayesian analysis yielded a median RR of 1.14 (95% CrI 0.80-1.65; Pr[RR >1]=77.2%). Myocardial infarction, stroke/cerebrovascular events, and MACE/MACCE were not significantly different, while major bleeding was increased (RR 1.92, 95% CI 1.14-3.23).
CONCLUSIONS: Current evidence does not support routine prophylactic MLVS during nonemergent HR-PCI. Selective use may remain appropriate, but further adequately powered randomized trials are needed.
PROTOCOL REGISTRATION: PROSPERO CRD420261358349.
METHODS: PubMed/MEDLINE, Scopus, Web of Science, and the Cochrane Library were searched from inception through March 2026 for randomized and comparative observational studies of MLVS versus control during nonemergent HR-PCI. Random-effects meta-analysis, subgroup and sensitivity analyses, Bayesian modeling, risk-of-bias assessment, and GRADE were performed.
RESULTS: Ten studies including 7,875 patients were analyzed. MLVS was not associated with lower all-cause mortality overall (RR 1.17, 95% CI 0.81-1.67; I2 = 82.1%). Exploratory analyses showed higher mortality estimates in randomized trials (RR 1.44, 95% CI 1.05-1.97) and studies of planned pre-PCI support (RR 1.52, 95% CI 1.17-1.97). Bayesian analysis yielded a median RR of 1.14 (95% CrI 0.80-1.65; Pr[RR >1]=77.2%). Myocardial infarction, stroke/cerebrovascular events, and MACE/MACCE were not significantly different, while major bleeding was increased (RR 1.92, 95% CI 1.14-3.23).
CONCLUSIONS: Current evidence does not support routine prophylactic MLVS during nonemergent HR-PCI. Selective use may remain appropriate, but further adequately powered randomized trials are needed.
PROTOCOL REGISTRATION: PROSPERO CRD420261358349.