Outcomes of adjunct posterior wall isolation in atrial fibrillation patients with cardiac implantable electronic devices.

BACKGROUND: Although pulmonary vein isolation (PVI) remains the cornerstone of catheter ablation of atrial fibrillation (AF), several studies have illustrated clinical benefits associated with PVI with posterior wall isolation (PWI). METHODS: This retrospective study investigated the outcomes of PVI alone versus PVI+PWI performed using the cryoballoon in patients with cardiac implantable electronic devices (CIEDs) and paroxysmal AF (PAF) or persistent AF (PersAF). RESULTS: Acute PVI was achieved in all patients using cryoballoon ablation. Compared to PVI alone, PVI+PWI was associated with longer cryoablation, fluoroscopy, and total procedure times. Adjunct radiofrequency was required to complete PWI in 29/77 patients (37.7%). Adverse events were similar with PVI alone versus PVI+PWI. But at 24 ± 7 months of follow-up, not only cryoballoon PVI+PWI was associated with improved freedom from recurrent AF (74.3% vs. 46.0%, P = .007) and all atrial tachyarrhythmias (71.4% vs. 38.1%, P = .001) in patients with PersAF, cryoballoon PVI+PWI also yielded greater freedom from AF (88.1% vs. 63.7%, P = .003) and all atrial tachyarrhythmias (83.3% vs. 60.8%, P = .008) in those with PAF. Additionally, PVI+PWI was associated with higher reductions in atrial tachyarrhythmia burden (97.9% vs. 91.6%, P < .001), need for cardioversion (5.2% vs. 23.6%, P < .001) and repeat catheter ablation (10.4% vs. 26.1%, P = .005), and a longer time-to-arrhythmia recurrence (16 ± 6 months vs. 8 ± 5 months, P < .001) in both PersAF and PAF patients. CONCLUSION: In CIED patients with PersAF or PAF, cryoballoon PVI+PWI is associated with a greater freedom from recurrent AF and atrial tachyarrhythmias, as compared to PVI alone during long-term follow-up.

Pulmonary Vein Isolation With and Without Posterior Wall Isolation in Paroxysmal Atrial Fibrillation: IMPPROVE-PAF Trial.

BACKGROUND: Prior studies have demonstrated clinical benefits associated with cryoballoon pulmonary vein isolation (PVI) and concomitant posterior wall isolation (PWI) in patients with persistent atrial fibrillation (AF). However, the role for this approach in patients with paroxysmal atrial fibrillation (PAF) remains unclear. OBJECTIVES: This study investigated the acute and long-term outcomes of PVI vs PVI+PWI using cryoballoon in patients with symptomatic PAF. METHODS: This retrospective study (NCT05296824) examined the outcomes of cryoballoon PVI (n = 1,342) vs cryoballoon PVI+PWI (n = 442) in patients with symptomatic PAF during long-term follow-up. Using the nearest-neighbor method, a 1:1 matched sample of patients receiving PVI alone and PVI+PWI was created. RESULTS: The matched cohort consisted of 320 patients (PVI: n = 160; PVI+PWI: n = 160). PVI+PWI was associated with longer cryoablation (23 ± 10 minutes vs 42 ± 11 minutes; P < 0.001) and procedure times (103 ± 24 minutes vs 127 ± 14 minutes; P < 0.001). In 39 (24.4%) of 160 patients, adjunct radiofrequency ablation was required for PVI+PWI. Adverse event rates were similar (PVI 3.8% vs PVI+PWI 1.9%; P = 0.31). Though there were no differences at 12 months, freedom from all atrial arrhythmias (67.5% vs 45.0%; P < 0.001) and AF (75.6% vs 55.0%; P < 0.001) were significantly greater with PVI+PWI vs PVI alone at 39 ± 9 months of follow-up. PVI+PWI was also associated with reduced long-term need for cardioversion (16.9% vs 27.5%; P = 0.02) and repeat catheter ablation (11.9% vs 26.3%; P = 0.001), and emerged as the only significant predictor of freedom from recurrent AF (HR: 2.79; 95% CI: 1.64-4.74; P < 0.001). CONCLUSIONS: Compared with cryoballoon PVI, cryoballoon PVI+PWI appears to be associated with greater freedom from recurrent atrial arrhythmias and AF in patients with PAF during long-term follow-up >3 years.

Concomitant Pulmonary Vein and Posterior Wall Isolation Using Cryoballoon With Adjunct Radiofrequency in Persistent Atrial Fibrillation.

OBJECTIVES: The aim of this multicenter, randomized, single-blind study was to prospectively evaluate the short-and long-term outcomes of pulmonary vein isolation (PVI) versus PVI with concomitant left atrial posterior wall isolation (PWI) using the cryoballoon in patients with symptomatic persistent/long-standing persistent atrial fibrillation (P/LSP-AF). BACKGROUND: Some studies have suggested a clinical benefit associated with PVI+PWI in patients with P/LSP-AF. However, there are limited safety and efficacy data on this approach using cryoballoon ablation. METHODS: The immediate and long-term outcomes in patients with P/LSP-AF randomized to PVI (n = 55) versus PVI+PWI (n = 55) using the cryoballoon were prospectively examined. RESULTS: Baseline characteristics were similar. PVI was achieved in all patients (21 ± 11 min). PWI was attained using 23 ± 8 min of cryoablation. Adjunct radiofrequency ablation was required in 4 of 110 patients (7.3%) to complete PVI (3 ± 2 min) and in 25 of 55 patients (45.5%) to complete PWI (4 ± 6 min). Although left atrial dwell time (113 ± 31 min vs. 75 ± 32 min; p < 0.001) and total procedure time (168 ± 34 min vs. 127 ± 40 min; p < 0.001) were longer with PVI+PWI, this cohort required fewer intraprocedural cardioversions (89.1% vs. 96.4%; p = 0.04). Adverse events occurred in 5.5% in each group (p = 1.00). However, the incidence of recurrent atrial fibrillation at 12 months was significantly lower with PVI+PWI (25.5% vs. 45.5%; p = 0.028). Additionally, in a multivariate analysis, PVI+PWI emerged as a significant predictor of freedom from recurrent atrial fibrillation (odds ratio: 3.67; 95% confidence interval: 1.44 to 9.34; p = 0.006). CONCLUSIONS: In patients with P/LSP-AF, PVI+PWI using the cryoballoon is associated with a significant reduction in atrial fibrillation recurrence, but similar safety, as compared with PVI alone.

Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design.

BACKGROUND: There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. OBJECTIVE: The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. METHODS: The PIVoTAL is a prospective, randomized controlled study ( ClinicalTrials.gov : NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I-IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7-14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation. CONCLUSION: The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.

Impact of irrigation flow rate and intrapericardial fluid on cooled-tip epicardial radiofrequency ablation.

BACKGROUND: The optimal irrigation flow rate (IFR) during epicardial radiofrequency (RF) ablation has not been established. OBJECTIVE: This study specifically examined the impact of IFR and intrapericardial fluid (IPF) accumulation during epicardial RF ablation. METHODS: Altogether, 452 ex vivo RF applications (10 g for 60 seconds) delivered to the epicardial surface of bovine myocardium using 3 open-irrigated ablation catheters (ThermoCool SmartTouch, ThermoCool SmartTouch-SF, and FlexAbility) and 50 in vivo RF applications delivered (ThermoCool SmartTouch-SF) in 4 healthy adult swine in the presence or absence of IPF were examined. Ex vivo, RF was delivered at low (≤3 mL/min), reduced (5-7 mL/min), and high (≥10 mL/min) IFRs using intermediate (25-35 W) and high (35-45 W) power. In vivo, applications were delivered (at 9.3 ± 2.2 g for 60 seconds at 39 W) using reduced (5 mL/min) and high (15 mL/min) IFRs. RESULTS: Ex vivo, surface lesion diameter inversely correlated with IFR, whereas maximum lesion diameter and depth did not differ. While steam pops occurred more frequently at low IFR using high power (ThermoCool SmartTouch and ThermoCool SmartTouch-SF), tissue disruption was rare and did not vary with IFR. In vivo, charring/steam pop was not detected. Although there were no discernible differences in lesion size with IFR, surface lesion diameter, maximum diameter, depth, and volume were all smaller in the presence of IPF at both IFRs. CONCLUSION: Cooled-tip epicardial RF ablation created using reduced IFRs (5-7 mL/min) yields lesion sizes similar to those created using high IFRs (≥10 mL/min) without an increase in steam pop/tissue disruption, whereas the presence of IPF significantly reduces the lesion size.

Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization.

BACKGROUND: Surgical exclusion of the left atrial appendage (LAA) can frequently yield incomplete closure. OBJECTIVE: We evaluated the ischemic stroke/systemic embolization (SSE) risk in patients with atrial fibrillation (AF) and complete LAA closure (cLAA) vs incompletely surgically ligated LAA (ISLL) and LAA stump after surgical suture ligation. METHODS: Seventy-two patients (CHA2DS2-VASc score 4.1 ± 1.9) underwent surgical LAA ligation in conjunction with mitral valve/AF surgery and postoperative LAA evaluation using computerized tomographic angiography. RESULTS: Overall, cLAA was detected in 46 of 72 patients (64%), ISLL in 17 patients (24%), and LAA stump in 9 patients (12%). The incidences of oral anticoagulation (OAC) and recurrent AF were similar among the 3 groups during 44 ± 19 months of follow-up. SSE occurred in 2% of patients with cLAA vs 24% with ISLL and 0% with LAA stump (P = .006). None of the patients with SSE were receiving OAC, and all had recurrent AF during follow-up. Additionally, patients with SSE exhibited a significantly smaller ISLL neck diameter (2.8 ± 1.0 vs 7.1 ± 2.1 mm; P = .002). The annualized SSE risk was 1.9% (entire cohort), 6.5% (ISLL patients), 14.4% (ISLL patients not receiving OAC), and 19.0% (ISLL neck diameter ≤5.0 mm) per 100 patient-years of follow-up. The latter risk was nearly 5 times greater than predicted by conventional risk-stratification schemes. Moreover, ISLL emerged as an independent predictor of SSE in univariate analyses and as the sole predictor of SSE in a multivariate analysis. CONCLUSION: In patients with AF, ISLL is a predictor of SSE, independent of conventional risk stratification schemes. Consequently, OAC should be strongly considered in this high-risk cohort.