Danilo Ricciardi1, Giuseppe Arena2, Roberto Verlato3, Saverio Iacopino4, Paolo Pieragnoli5, Giulio Molon6, Massimiliano Manfrin7, Giuseppe Allocca8, Giuseppe Cattafi9, Giusy Sirico10, Giovanni Rovaris11, Luigi Sciarra12, Daniele Nicolis13, Claudio Tondo14. 1. Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo 200, 00128, Rome, Italy. d.ricciardi@unicampus.it. 2. Nuovo Ospedale delle Apuane, Massa, Italy. 3. ULSS 6 Euganea, Camposampiero, Italy. 4. GVM Care & Research Group, Cotignola, Italy. 5. Careggi Hospital, Florence, Italy. 6. IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Italy. 7. Ospedale Centrale di Bolzano, Divisione di Cardiologia, Bolzano, Italy. 8. Ospedale Civile, Conegliano, Veneto, Italy. 9. ASST GOM, Niguarda, Milan, Italy. 10. Istituto Clinico Sant'Ambrogio, Milan, Italy. 11. Ospedale San Gerardo, Azienda Socio Sanitaria Territoriale, Monza, Italy. 12. Policlinico Casilino, Rome, Italy. 13. Azienda Ospedaliera Carlo Poma, Mantova, Italy. 14. Heart Rhythm Center at Monzino Cardiac Center, IRCC Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Abstract
PURPOSE: Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C. METHODS: Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C. RESULTS: From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA2DS2-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025). CONCLUSIONS: According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males. CLINICAL TRIAL REGISTRATION: NCT01007474.
PURPOSE: Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C. METHODS: Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C. RESULTS: From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA2DS2-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025). CONCLUSIONS: According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males. CLINICAL TRIAL REGISTRATION: NCT01007474.
Authors: Nikolaos Dagres; Robby Nieuwlaat; Panos E Vardas; Dietrich Andresen; Samuel Lévy; Stuart Cobbe; Dimitrios Th Kremastinos; Günter Breithardt; Dennis V Cokkinos; Harry J G M Crijns Journal: J Am Coll Cardiol Date: 2007-01-22 Impact factor: 24.094
Authors: Roy Beinart; Suhny Abbara; Andrew Blum; Maros Ferencik; Kevin Heist; Jeremy Ruskin; Moussa Mansour Journal: J Cardiovasc Electrophysiol Date: 2011-05-26
Authors: Donald M Lloyd-Jones; Thomas J Wang; Eric P Leip; Martin G Larson; Daniel Levy; Ramachandran S Vasan; Ralph B D'Agostino; Joseph M Massaro; Alexa Beiser; Philip A Wolf; Emelia J Benjamin Journal: Circulation Date: 2004-08-16 Impact factor: 29.690
Authors: Gaetano Paparella; Saverio Iacopino; Thiago Guimarães Osório; Juan Pablo Abugattas de Torres; Erwin Ströker; Juan Sieira; Hannes Vanacker; Bernard De Ruyter; Serge Boveda; Riccardo Maj; Gianluca Borio; Alessandro Rizzo; Alessio Galli; Pedro Brugada; Carlo de Asmundis; Gian-Battista Chierchia Journal: J Interv Card Electrophysiol Date: 2020-05-31 Impact factor: 1.900