title: Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project.
abstract: BACKGROUND
  Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA.
  
  
  METHODS
  A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated.
  
  
  RESULTS
  Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred.
  
  
  CONCLUSIONS
  This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times.
  
  
  BACKGROUND
  clinicaltrials.gov (NCT01007474).
authors.affiliation: University of Florence, Firenze, Italy.|IRCCS Multimedica, Milano, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Padeletti
authors.affiliation: Azienza Ospedaliera Spedali Civili, Brescia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Curnis
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, IRCCS, University of Milan, Milano, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.affiliation: Ospedale Niguarda Ca' Granda, Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Lunati
authors.affiliation: Clinica San Carlo, Paderno Dugnano, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Porcellini
authors.affiliation: ULSS 15 Alta Padovana, Camposampiero, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Verlato
authors.affiliation: Policlinico Casilino, Roma, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Sciarra
authors.affiliation: Presidio Ospedaliero Riunito, Ciriè, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Senatore
authors.affiliation: A.O. Santa Maria Del Carmine, Rovereto, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Catanzariti
authors.affiliation: Azienda Ospedaliera di Padova, Padova, Italy.
authors.forename: Loira
authors.initials: L
authors.lastname: Leoni
authors.affiliation: Azienda Ospedaliera ´Ospedale Maggiore´ di Crema, Crema, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.affiliation: Ospedale Civile di Conegliano, Conegliano Veneto, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Delise
authors.affiliation: GVM Care & Research Group, Cotingola, Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: Iacopino
authors.affiliation: Azienda Ospedaliera Careggi, Firenze, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pieragnoli
authors.affiliation: Nuovo Ospedale delle Apuane, Massa, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Arena
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000453:epidemiology* / Q000601:surgery*; D017115:Catheter Ablation / Q000706:statistics & numerical data*; D015984:Causality; D015331:Cohort Studies; D015897:Comorbidity; D017679:Cryotherapy / Q000706:statistics & numerical data*; D005240:Feasibility Studies; D005260:Female; D006329:Heart Conduction System / Q000601:surgery; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology* / Q000517:prevention & control; D015995:Prevalence; D011667:Pulmonary Veins / Q000601:surgery*; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000706:statistics & numerical data; D055815:Young Adult
keywords: atrial fibrillation; catheter ablation; cryoablation; cryoballoon catheter; pulmonary vein isolation