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Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial
Συγγραφείς: Lorusso, Roberto, Ravaux, Justine M., Pollari, Francesco, Folliguet, Thierry A., Kappert, Utz, Meuris, Bart, Shrestha, Malakh L., Roselli, Eric E., Bonaros, Nikolaos, Fabre, Olivier, Corbi, Pierre, Troise, Giovanni, Andreas, Martin, Pinaud, Frederic, Pfeiffer, Steffen, Kueri, Sami, Tan, Erwin, Voisine, Pierre, Girdauskas, Evaldas, Rega, Filip, Garcia-Puente, Julio, Fischlein, Theodor
Πηγή: ISSN:1010-7940 ; ISSN:1873-734X ; European Journal Of Cardio-Thoracic Surgery, vol. 62 (4.
Στοιχεία εκδότη: Oxford University Press (OUP)
Έτος έκδοσης: 2022
Θεματικοί όροι: Science & Technology, Life Sciences & Biomedicine, Cardiac & Cardiovascular Systems, Respiratory System, Surgery, Cardiovascular System & Cardiology, Aortic valve replacement, Pacemaker, Sutureless valves, AORTIC-VALVE, CONDUCTION DISORDERS, PERMANENT PACEMAKER, RISK-FACTORS, REPLACEMENT, BIOPROSTHESIS, OUTCOMES, IMPACT, BLOCK, Aortic Valve, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Humans, Artificial, Prospective Studies, Prosthesis Design, Risk Factors, Treatment Outcome, on behalf the PERSIST-AVR Investigators, 1102 Cardiorespiratory Medicine and Haematology
Περιγραφή: OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697. ; sponsorship: This research project was funded by CORCYM S.r.l. (CORCYM S.r.l.) ; status: Published
Τύπος εγγράφου: article in journal/newspaper
Περιγραφή αρχείου: application/pdf
Γλώσσα: English
Relation: https://lirias.kuleuven.be/handle/20.500.12942/698595; https://doi.org/10.1093/ejcts/ezac164; https://pubmed.ncbi.nlm.nih.gov/35290444
DOI: 10.1093/ejcts/ezac164
Διαθεσιμότητα: https://lirias.kuleuven.be/handle/20.500.12942/698595
https://hdl.handle.net/20.500.12942/698595
https://lirias.kuleuven.be/retrieve/ea3b300a-1bd2-406c-ab9d-9e2c7b26be46
https://doi.org/10.1093/ejcts/ezac164
https://pubmed.ncbi.nlm.nih.gov/35290444
Rights: info:eu-repo/semantics/openAccess ; public ; All rights reserved
Αριθμός Καταχώρησης: edsbas.BBFAFE32
Βάση Δεδομένων: BASE
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  Data: Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial
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  Data: <i>ISSN:1010-7940 ; ISSN:1873-734X ; European Journal Of Cardio-Thoracic Surgery, vol. 62 (4</i>.
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  Data: 2022
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  Data: OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697. ; sponsorship: This research project was funded by CORCYM S.r.l. (CORCYM S.r.l.) ; status: Published
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  Data: https://lirias.kuleuven.be/handle/20.500.12942/698595; https://doi.org/10.1093/ejcts/ezac164; https://pubmed.ncbi.nlm.nih.gov/35290444
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      – SubjectFull: Aortic valve replacement
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      – SubjectFull: Pacemaker
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