Study Design and Patient Population
The main objective of this multicenter retrospective observational study
was to describe the safety outcomes following a cryoballoon ablation of
AF in a SDD cohort compared to patients discharged via a
standard-of-care route that encompassed an overnight hospitalization
(ONS) for patient observation. At each hospital, the SDD cohort was
comprised of consecutive patients discharged the same day as their
cryoballoon ablation, and the ONS cohort was a pair-matched collection
of patients at these centers (matching based on gender, age, BMI, and AF
classification). The study was completed at three different US centers
(Staten Island University Hospital a Northwell Health Hospital, Staten
Island, NY; Mercy General Hospital/Dignity Health Heart and Vascular
Institute, Sacramento, CA; and Spectrum Health Medical Center, Grand
Rapids, MI) from January 2014 to March 2019. Subject inclusion criteria
included any patient undergoing a cryoballoon ablation of atrial
fibrillation at the three hospitals and willingness to complete
in-office follow-up examinations. Patients who had a complication during
the procedure were excluded from the analysis, as the decision to
discharge home the same day was made by the operator after the procedure
and was then based on clinical standards-of-care at each hospital with
most patients not eligible for SDD. Institutional review board approval
was granted at each hospital, and all patients gave informed consent for
the data collection and the catheter ablation procedure. This project
and the data collection activities conformed with the principles
outlined in the Declaration of Helsinki. Data warehousing was hosted by
the Staten Island University Hospital using REDCap (project-redcap.org).
A subject-key system was used to de-identify patients which was not
shared between hospitals in order to maintain the privacy of protected
health information.