Arturo Giordano1, Nicola Corcione1, Paolo Ferraro2, Alberto Morello1, Sirio Conte2, Luca Testa3, Alessandro Iadanza4, Gennaro Sardella5, Massimo Mancone5, Sergio Berti6, Anna S Petronio7, Enrico Romagnoli8, Martino Pepe9, Giacomo Frati10,11, Giuseppe Biondi-Zoccai12,13. 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. Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University, Rome, Italy - giuseppe.biondizoccai@uniroma.it. 13. Mediterranea Cardiocentro, Naples, Italy.
Abstract
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.
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.
Authors: Claudio Montalto; Andrea Raffaele Munafò; Luca Arzuffi; Francesco Soriano; Antonio Mangieri; Stefano Nava; Giovanni Luigi De Maria; Francesco Burzotta; Fabrizio D'Ascenzo; Antonio Colombo; Azeem Latib; Jacopo Andrea Oreglia; Adrian P Banning; Italo Porto; Gabriele Crimi Journal: Eur Heart J Open Date: 2022-08-18
Authors: Sergio Berti; Francesco Bedogni; Arturo Giordano; Anna S Petronio; Alessandro Iadanza; Antonio L Bartorelli; Bernard Reimers; Carmen Spaccarotella; Carlo Trani; Tiziana Attisano; Angela Marella Cenname; Gennaro Sardella; Roberto Bonmassari; Massimo Medda; Fabrizio Tomai; Giuseppe Tarantini; Eliano P Navarese Journal: J Am Heart Assoc Date: 2020-10-24 Impact factor: 5.501