Dataset Information

The safety and efficacy of second-generation cryoballoon ablation plus catheter ablation for persistent atrial fibrillation: A systematic review and meta-analysis.

ABSTRACT:

Background

Growing evidence suggests that second-generation cryoballoon ablation (2G-CB) is effective in patients with persistent atrial fibrillation (PerAF). The cornerstone of atrial fibrillation (AF) ablation is pulmonary vein isolation (PVI). The purpose of this study was to summarize the available data on the safety and mid-term (≥ 12 months) effectiveness of a 'PVI-only' strategy vs. a 'PVI-plus' strategy using 2G-CB in patients with PerAF.

Methods

We searched the PubMed, EMBASE and Cochrane library databases for studies on 2G-CB for PerAF. Group analysis was based on the ablation approach: 'PVI-only' versus 'PVI-plus', the latter of which involved PVI plus other substrate modifications. Studies showing clinical success rates at a follow-up (FU) of ≥ 12 months were included. Complication rates were also assessed. Data were analyzed by applying a fixed effects model.

Results

A total of 879 patients from 5 studies were analyzed. After a mid-term FU of 27 months, the overall success rate of 2G-CB for PerAF was 66.1%. In the 'PVI-plus' group, the success rate was 73.8%. In the 'PVI-only' group, the success rate was 53.6%. No heterogeneity was noted among studies (I2 = 0.0%, P = 0.82). Complications occurred in 5.2% of patients (P = 0.93), and the rate of phrenic nerve (PN) injury was 2.8% (P = 0.14). Vascular assess complications were the most frequent at 1.6% (P = 0.33). No death or myocardial infarction was reported.

Conclusion

'PVI-plus' involving 2G-CB seems to be safe and effective for treating PerAF.

SUBMITTER: Shao M

PROVIDER: S-EPMC6201921 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionBoth radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency.MethodsIPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis.ResultsIn the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses.ConclusionRadiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times.

Project description:ObjectiveTo compare real-world clinical and economic outcomes among atrial fibrillation (AF) patients undergoing cardiac ablation with the contact force-sensing porous tip THERMOCOOL SMARTTOUCH SF (STSF) catheter versus the Arctic Front Advance Cryoballoon (AFA-CB) catheter.DesignRetrospective, observational cohort study.SettingPremier Healthcare Database (PHD), between 1 September 2016 and 30 June 2018.ParticipantsPatients with AF (≥18 years) were included if they had an index ablation procedure performed using the STSF catheter or AFA-CB catheter at a US hospital that consistently provided inpatient and outpatient data to PHD in the 12-month preindex period. Using 1:1 propensity score matching, patient groups were matched on study covariates.Primary and secondary outcome measuresCost, length of stay (LOS), readmissions, direct current cardioversion (DCCV) and reablation outcomes were compared between matched cohorts of STSF and AFA-CB patients.ResultsA total of 3015 patients with AF met the study criteria, of which 1720 had ablation using the STSF catheter and 1295 had ablation using the AFA-CB catheter. In the propensity-matched sample, patients receiving ablation with the STSF catheter had ~17% lower total costs (US$23 096 vs US$27 682, p≤0.0001) and ~27% lower supply costs (US$10 208 vs US$13 816, p≤0.0001) versus patients receiving ablation with the AFA-CB catheter. A significantly lower likelihood of 4-month to 6-month cardiovascular-related readmission (OR 0.460, 95% CI 0.220 to 0.959) was associated with the STSF catheter versus the AFA-CB catheter. No significant differences in LOS, room and board cost, 4-month to 6-month all-cause and AF-related readmissions, DCCV and reablation were observed among technologies. Sensitivity analysis restricting patient sample by provider ablation volume demonstrated similar results.ConclusionLower index ablation total and supply costs were observed among patients with AF undergoing cardiac catheter ablation using the STSF catheter versus the AFA-CB catheter.