Safety of SDD following Cryoballoon Ablation
SDD has been previously evaluated in other sections of cardiology and
demonstrated cost benefits.2 Importantly, in any SDD
procedure, the rate of intraprocedural and post-procedural complications
must remain low for patient safety and economic benefit(s). In this
analysis, the complication rate in SDD and ONS cohorts was not different
from each other and comparable to previous reports. A systematic review
of 192 studies by Gupta et al . determined the overall incidence
of complications associated with catheter ablation of AF was
2.9%,11 which is similar to the rate of patients who
stayed overnight in this analysis. The systematic review did not mention
the method of discharge in the literature search; however, given the
fact that it included all studies prior to 2012, it is likely that most
of these patients were kept overnight.11 A worldwide
survey on safety of AF ablation agnostic of ablation modality collected
from 182 centers reported a slightly higher complication rate of
4.5%.12 The reasons for higher rate in the global
survey may include that it incorporated earlier catheter technology and
techniques and centers with a wide range of volume and experience. By
contrast, this study included patients from three high volume centers
with experienced operators. The overall complication rate in the SDD
group was numerically lower than the ONS group. This might be explained
by a selection bias by the operator. As represented in the baseline
characteristics, the operators most likely chose younger and healthier
patients to be discharged the same day while patients with more
comorbidities where observed overnight following the cryoballoon
ablation.
Hematoma or vascular complication were the most common complication
observed in our study, consistent with other reports.1,
11, 12 The rate of hematoma has been reported between 1.2-1.4%;
however, the rate of hematoma in our study was slightly lower at
0.67-0.93%. Ultrasound guidance to obtain vascular access may have
contributed to the low rate of vascular complications in our
trial.13 The risk of stroke in previous studies has
been reported between 0.23-0.30%, which is slightly higher than
observed in our study.11, 12 Uninterrupted
anticoagulation with warfarin or DOAC facilitated early ambulation on
continued anticoagulation, which may have contributed to a low risk of
stroke complications. Most pericardial effusion and tamponade events
generally occur during the procedure or are observed immediately after
the procedure.1 In our study, all transseptal
punctures were performed under intracardiac echocardiographic guidance.
The presence or absence of pericardial effusion was examined via imaging
(e.g. fluoroscopy and ultrasound) both during the case and after
the catheter ablation procedure. Furthermore, due to serious
consequences of these complications, some of the participating centers
performed a transthoracic echocardiogram before discharge. These
additional precautions may safeguard against undetected pericardial
complications in the SDD population.