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Minerva Cardioangiologica 2019 December;67(6):443-9

DOI: 10.23736/S0026-4725.19.05071-0

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

Comparison of ProGlide vs. Prostar in patients undergoing transcatheter aortic valve implantation

Arturo GIORDANO 1, Nicola CORCIONE 1, Paolo FERRARO 2, Alberto MORELLO 1, Sirio CONTE 2, Luca TESTA 3, Alessandro IADANZA 4, Gennaro SARDELLA 5, Massimo MANCONE 5, Sergio BERTI 6, Anna S. PETRONIO 7, Enrico ROMAGNOLI 8, Martino PEPE 9, Giacomo FRATI 10, 11, Giuseppe BIONDI-ZOCCAI 10, 12 , on behalf of the Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea (RISPEVA) Study Investigators

1 Unit of Cardiovascular Interventional Medicine, Pineta Grande Hospital, Castel Volturno, Caserta, Italy; 2 Unit of Hemodynamics, Santa Lucia Hospital, San Giuseppe Vesuviano, Naples, Italy; 3 Department of Cardiology, San Donato Polyclinic IRCCS, San Donato Milanese, Milan, Italy; 4 Unit of Hemodynamics, Department of Cardiac, Thoracic and Vascular Sciences, Santa Maria alle Scotte Polyclinic, Siena, Italy; 5 Department of Cardiovascular, Respiratory, Nephrological, Anaesthetic and Geriatric Sciences, Umberto I Polyclinic, Sapienza University, Rome, Italy; 6 G. Monasterio C.N.R. Foundation, Ospedale del Cuore, Massa, Italy; 7 Department of Cardiology, AOUP Cisanello, University Hospital of Pisa, Pisa, Italy; 8 Institute of Cardiology, A. Gemelli University Polyclinic, IRCCS and Foundation, Sacred Heart Catholic University, Rome, Italy; 9 Division of Cardiology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy; 10 Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University, Rome, Italy; 11 IRCCS NEUROMED, Pozzili, Isernia, Italy; 12 Mediterranea Cardiocentro, Naples, Italy



BACKGROUND: Expanding indications to transcatheter aortic valve implantation (TAVI) warrant meticolous vascular management and minimization of access site complications. Two leading vascular closure devices (VCD) are currently used for TAVI, ProGlide vs. Prostar, but their comparative effectiveness and safety are debated. We aimed at comparing acute and 1-month outcomes of patients undergoing TAVI using as VCD either ProGlide (Perclose) or Prostar (XL).
METHODS: The prospective RISPEVA database was queried for baseline, procedural, and outcome details of patients undergoing TAVI and in whom either ProGlide or Prostar had been used as VCD. Outcomes of interest were death, vascular complication, and bleeding, distinguishing specific subtypes. Outcomes were adjudicated according to current Valve Academic Research Consortium definitions.
RESULTS: A total of 1987 subjects were included, 913 (46.0%) receiving ProGlide, and 1074 receiving Prostar (54.0%). Several baseline and procedural differences were evident, including surgical risk, concomitant coronary artery disease, sheath size, use of predilation, and chosen TAVI device (all P<0.05). Periprocedurally, despite similar rates of device success (P=0.262), Prostar was associated with a lower risk of vascular stenosis (P=0.005), but a higher rate of device malfunction (P=0.028). Unadjusted analysis for 1-month outcomes suggested higher rates of major adverse events, any bleeding, major bleeding, and renal failure in patients receiving Prostar (all P<0.05). However, propensity score-adjusted analysis did not confirm any significant differences, suggesting that confounding factors mostly drove unadjusted differences.
CONCLUSIONS: Use of ProGlide and Prostar as VCD of choice for TAVI appears similarly safe and effective, despite some potential benefits associated with ProGlide. Further randomized trials are warranted to confirm or disprove these findings.


KEY WORDS: Transcatheter aortic valve replacement; Vascular closure devices; Cardiovascular surgical procedures

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