Underwent Cryoballoon Pulmonary Vein Isolation Research Articles

Cryoballoon Pulmonary Vein Isolation With Versus Without Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation: The CRALAL Randomized Clinical Trial.

Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with those with paroxysmal AF. We investigate whether additional linear ablation from the superior vena cava to the right atrial septum and cavotricuspid isthmus ablation improves the rhythm outcome of patients with persistent AF undergoing cryoballoon PVI (Cryo-PVI). In this investigator-initiated, multicenter, randomized clinical trial, 289 patients with persistent AF refractory to antiarrhythmic drug therapy were randomized 1:1 to either Cryo-PVI with additional right atrium (RA) linear ablation or Cryo-PVI alone. The primary end point was any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period after ablation. The secondary end points were atrial arrhythmia recurrence or antiarrhythmic drug use after a 3-month blanking period, complications, and total procedure time. During the median follow-up of 24 months (median age, 63 years; 23.9% women), the atrial arrhythmia recurrence was less frequent in the additional RA ablation group (n=50, 37.5%) than in the Cryo-PVI alone group (n=69, 53.1%; absolute difference, -15.6% [95% CI, -27.9% to -3.4%]; hazard ratio, 0.66 [95% CI, 0.46-0.94]). Antiarrhythmic drugs were prescribed after the 3-month period to 72 (49.3%) patients in the additional RA ablation group and 79 (55.2%) patients in the Cryo-PVI alone group. No difference was found in complication rate between the 2 groups. Total procedure time was longer in the additional RA ablation group (median, 88 versus 72 minutes; P<0.001). Additional RA linear ablation beyond Cryo-PVI improved the ablation outcome compared with that of PVI alone in persistent AF patients.

Impact of obesity and early recurrence of atrial fibrillation on very late recurrence following cryoballoon pulmonary vein isolation

Abstract Background Obesity and early recurrence of atrial fibrillation (ERAF) post cryoballoon (CB) pulmonary vein isolation (PVI) both portend a lower 1-year success rate of ablation. Even after an initial successful ablation, about 1/3 of patients develop a very late recurrence (VLR) of AF, defined as the first AF recurrence more than a year after ablation (excluding an initial 90 day blanking period [BP]). The impact of obesity and ERAF on VLR is still unknown. Purpose To evaluate the impact of obesity and ERAF on VLR following CB PVI. Methods We enrolled consecutive patients with symptomatic AF who underwent CB PVI and had an implantable loop recorder for long-term ECG monitoring. We identified patients who had no AF recurrence (outside the BP) in the first-year post ablation. ERAF was defined as any episode of AF recorded in the first 90 days post ablation. Patients were grouped as either obese (BMI ≥ 30 kg/m2) or non-obese (BMI &amp;lt;30 kg/ m2). AF recurrences after 1-year post-ablation were ascertained using the loop recorder. Results From the initial cohort of 210 patients, 109 (52%) patients (64 ± 10 years; 75 [68%] male; 64 [59%] PAF; CHA2DS2-VASc 2.3 ± 1.4, 38 [35%] with obesity and 41 [38%] had ERAF) were AF-free during the first year. During a follow-up of 961 ± 196 days, 51 (47%) patients had VLR. Non-obese patients without ERAF had the best outcome (Figure). In multivariate analysis, obesity and ERAF were the only significant predictors of VLR (Table). As compared to non-obese patients without ERAF, obese patients with ERAF had a 4-fold greater likelihood of VLR. Conclusions About 50% of patients have no AF recurrence in the first year after CB PVI. Non-obese patients have the best outcome regardless of ERAF occurrence. On the other hand, obese patients with ERAF almost always have VLR.

Weight change does not impact long-term outcomes following cryoballoon pulmonary vein isolation

Abstract Background Weight loss has been suggested to reduce frequency and burden of atrial fibrillation (AF) in overweight patients (pts). However, there are limited data on weight loss impact on outcomes in pts with AF who have undergone pulmonary vein isolation (PVI). Purpose To understand the impact of weight change on long-term outcomes, as assessed by freedom from recurrent AF in pts undergoing cryoballoon (CB) PVI. Methods We enrolled consecutive pts with AF who underwent CB PVI; all had implantable loop recorders (ILR) for long-term ECG monitoring. The cohort was divided into 4 groups based on weight change 1-year post ablation: (1) optimal weight loss (OWL) – weight decrease ≥ 10%; (2) minimal weight loss (MWL) - weight loss (WL) 3-9% weight decrease; (3) no weight change (NWC) - weight change &amp;lt; 3%, (4) weight gain (WG) ≥ 3% weight increase. We assessed for AF recurrence after excluding a 3-month post-ablation blanking period. Results Out of a total of 322 pts who underwent ablation, 241 (75%) pts (69 ± 10 years; 159 (66%) male; 133 (55%) PAF; CHA2DS2-VASc 2.7 ± 1.5; BMI 30 ± 5) had weight information available at ablation and last follow-up. All were off antiarrhythmics by 1 year. There were no differences in the 4 cohorts with respect to baseline characteristics. During the first year, about ¼ of pts were able to lose ≥ 3% of weight but only 8 pts (3%) were able to lose ≥ 10%. AF recurred in 153 (63%); they were older, more likely to have persistent AF (PeAF), and a higher CHA2DS2-VASc score. However, weight change did not impact outcome (Figure). In a multivariate Cox Regression hazards analysis, PAF vs. PeAF at ablation was the only factor associated with any recurrence at follow-up (Figure). Conclusions Post CB PVI only about ¼ of pts are able to lose weight. Weight changes in the first-year post ablation in obese pts did not alter outcomes with respect to likelihood of recurrent AF. These data should be taken into account when considering catheter ablation.

Impact of early atrial arrhythmia recurrence on long-term CryoPVI success

Abstract Background According to current guidelines, the occurrence of atrial fibrillation (AF) recurrence within the first 90 days after pulmonary vein isolation (PVI) should not indicate re-do procedures. Accordingly, a 90-day blanking period is usually accepted. However, data suggests that early atrial arrhythmia relapses during the blanking period have an impact on the efficacy. The optimal period for indicating a re-ablation therefore remains unclear. Methods We prospectively analyzed consecutive AF patients who underwent cryoballoon PVI (CryoPVI) in a single-center cohort between 2018 and 2023. We divided patients into four groups according to arrhythmia recurrence (recurrence between 0-30 days, recurrence between 30-60 days, recurrence between 60-90 days and no recurrence within the first 90 days). CryoPVI was performed in a standardized procedure. At 3, 6, 12, 18, 24 and 36 months after CryoPVI follow up was performed. Efficacy endpoint was the occurrence of symptomatic atrial arrhythmia relapse. Results During the study period 1179 patients underwent a first CryoPVI. Of these, 84 patients (7.1%) had atrial arrhythmia relapse between 0-30 days, 38 patients (3.2%) had atrial arrhythmia relapse between 30-60 days, and 38 patients (3.2%) had a relapse between 60-90 days. Overall, 1019 (86.4%) patients didn’t have an atrial arrhythmia relapse between 0-90 days after CryoPVI. Primary efficacy endpoint incidence after 36 months was significantly higher in patients who experienced atrial arrhythmia relapse within the first 90 days (between 0-30 days 62.5% vs. between 30-60 days 70.1% vs. between 60-90 days 77.9% vs. no recurrence ≤ 90 days 41.6%, p&amp;lt;0.0001). Conclusion Atrial arrhythmia relapse within the first 90 days is associated with a reduced long-term efficacy of CryoPVI. Re-ablation should be indicated regardless of the time of recurrence.

Weight change does not impact the long-term outcomes following pulmonary vein isolation in obese patients with atrial fibrillation

Abstract Background Weight loss has been shown to reduce the burden of atrial fibrillation (AF) in obese patients. However, there are limited data on the impact of weight loss on long-term outcomes in patients with atrial fibrillation (AF) who undergo pulmonary vein isolation (PVI). Objective To understand the impact of weight change, as assessed by freedom from recurrent AF, in obese patients undergoing cryoballoon (CB) PVI. Methods We enrolled consecutive obese (BMI ≥ 30 kg/m2) patients with AF who underwent CB PVI; all patients had an implantable loop recorder (ILR) for long-term ECG monitoring. The cohort was divided into 3 groups based on their weight change 1-year after ablation: (1) weight loss (WL) &amp;gt; 3% weight decrease; (2) no weight change (NWC) - weight change &amp;lt; 3%, (3) weight gain (WG) &amp;gt; 3% weight increase. We assessed long-term AF recurrences, after excluding an initial 3-month post-ablation blanking period. Results Out of total of 137 pts with obesity, 61 pts had weight available at the ablation and at 1-year follow-up (65 ± 9 years; 41 [67%] male; 23 [38%] PAF; CHA2DS2-VASc 2.9 ± 1.7). There were no differences in baseline characteristics. At follow-up, 24 (39%), 26 (43%), and 11 (18%) pts lost, had no change, or gained weight, respectively. Of the 24 pts who lost weight, 3 pts lost &amp;gt; 10% body weight. During a follow-up of 964 ± 512 days, 41 (67%) pts had recurrent AF; the change in weight did not impact outcomes (Figure), including those who lost &amp;gt; 10% body weight. Conclusions During 3-years of follow-up, 2/3 of obese patients had objective evidence of AF recurrence following CB PVI. Weight change in the first-year post ablation did not alter long-term outcomes. Other strategies may be needed in these patients to improve outcomes.

Impact of obesity and pattern of atrial fibrillation on long-term outcome following cryoballoon pulmonary vein isolation

Abstract Background Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted method for treatment of paroxysmal and persistent atrial fibrillation (PAF, PeAF). Obese and PeAF patients do worse following ablation. However, there are limited data on the impact of both variables on outcomes. Objective To understand the impact of obesity and AF pattern on long-term outcomes following CB PVI. Methods We enrolled consecutive AF patients undergoing CB PVI; all patients had an implantable loop recorder (ILR) for long term continuous monitoring. Obesity (O) was defined as a BMI ≥ 30 kg/m2. The cohort was divided into 4 groups based on presence of obesity and type of AF at the initial ablation: (1) N-O (non-obese) and PAF, (2) O and PAF, (3) N-O and PeAF, and (4) O and PeAF. We assessed long-term AF recurrences, after excluding an initial 3-month post-ablation blanking period. Results The cohort included 322 patients (67 ± 9 years; 209 [65%] male; 177 [55%] PAF; CHA2DS2-VASc 2.7 ± 1.6, 137 [43%] O). Obese patients were younger and more likely to have hypertension and diabetes. During a follow-up of 931 ± 599 days, 211 (66%) patients had recurrent AF. The best outcome was seen in N-O obese patients with PAF; all other groups fared similarly (Figure). Group 1 had significantly lower AF recurrence compared to all 3 other groups (Figure). In multivariate analysis, obesity/AF type was the only significant predictor of AF recurrence (Table). As compared to N-O PAF pts, O PeAF patients had a 2-fold greater likelihood of AF recurrence. Conclusions During almost 3-years of objective follow-up, we found that CB PVI performs best in non-obese pts with PAF. Once obesity occurs, PAF pts respond as poorly to PVI as pts with PeAF, irrespective of obesity status. Additional strategies are needed in these patients.

Balloon technologies for pulmonary vein isolation-12-month outcome and comparison of the novel radiofrequency balloon with the cryoballoon in patients with paroxysmal atrial fibrillation.

The cryoballoon (CB) has become a standard tool for pulmonary vein isolation (PVI), but the technology is limited in certain ways. A novel RF-balloon (Heliostar™, Biosense Webster, CA, USA) promises the advantages of a balloon technology in combination with 3D mapping. To assess procedural data and outcome, all patients undergoing RF-balloon PVI were included and compared with data from consecutive patients undergoing CB PVI for paroxysmal AF. A total of 254 patients (63 ± 13years, 54% male) were included: 30 patients undergoing RF-balloon and 224 patients CB PVI. Baseline parameters were comparable. Procedure duration (104.3 ± 35.3min vs. 69.9 ± 23.1min; p ≤ 0.001) and fluoroscopy time (16.3 ± 7.1min vs. 11.6 ± 4.9min; p ≤ 0.001) were longer using the RF-balloon; ablation time (43.5 ± 17.9 vs. 36.4 ± 15.6; p = 0.08) did not differ, and time-to-isolation (TTI) was shorter (18.2 ± 7.0s vs. 62.8 ± 35.1s; p ≤ 0.001). Second-generation RF-balloon cases showed shorter ablation time and TTI at comparable procedure duration and fluoroscopy time. One pericardial effusion occurred with the RF-balloon due to complicated transseptal access. During CB PVI in 4/224 patients (1.8%), a phrenic nerve palsy was observed. After 12months, 78% of patients after RF-balloon and 81% of patients after CB PVI (p = 0.5) were free from atrial arrhythmias. The RF-balloon was safe and effective. Compared with the CB, TTI was shorter, but procedure durations and fluoroscopy times were longer. This can be attributed to a learning curve and the initial necessity for separate 3D map preparation. Considering the results with the second-generation RF-balloon, more experience is needed to determine the potential benefits.

Best Practice Guide for Cryoballoon Ablation in Atrial Fibrillation: The Compilation Experience of More than 1000 Procedures

Nowadays, the cryoballoon (CB) constitutes an established alternative to radio frequency (RF) ablation for pulmonary vein isolation (PVI), which offers the possibility to isolate the PVs with a single application. Since the introduction of the second-generation CB, we prospectively collected our data to optimize the procedure on >1000 consecutive patients who underwent CB PVI performed in our center. It is expected that subsequent guidelines will suggest first-line PVI through CB in patients with paroxysmal AF with a class I indication. Indeed, in the long-term follow-up (36 months) of the EARLY-AF trial, CB had a lower incidence of persistent atrial fibrillation episodes compared to the anti-arrhythmic drugs group. We now review the current best practices in an effort to drive consistent outcomes and minimize complications. PV isolation through CB is the most studied single-shot technique for atrial fibrillation ablation, having shown the potential to alter the natural history of the arrhythmia. Several procedural tips and tricks can improve procedural flow and effectiveness. In the present article we provided not only technical details but measurable biophysical parameters that can reliably guide the operator into achieving the best outcome for his patients.

Albumin as a Prognostic Marker for Atrial Fibrillation Recurrence following Cryoballoon Ablation of Pulmonary Venous.

Introduction: Atrial fibrillation (AF) recurrence following pulmonary vein isolation (PVI) ablation has clinical significance. Identifying risk factors for AF recurrence is important. We investigated serum albumin (SA) levels (g/dL) as a prognostic factor for the recurrence of AF following cryoballoon PVI ablation. Methods: We included patients who underwent cryoballoon PVI ablation at our institution between the years 2013 and 2018. The primary outcome was recurrence of AF during follow up. Results: Our cohort consisted of 126 patients (67% males, mean age 61.8 ± 10.0 years). The pattern of AF amongst the cohort was paroxysmal in 62.5%, persistent in 25.4%, and longstanding persistent in 6.3%. Those with lower SA levels had a mean AF duration significantly less than those with higher SA levels (2.81 years, 7.34 years, and 6.37 years for SA levels of <3.8, 3.8−4.1, and ≥4.1, respectively; p = 0.003). Patients with lower SA levels were significantly more likely to have had more previous cardioversions and a larger left atrial area and volume. The mean follow-up was 380 days, in which the AF recurrence rate was 20.6%. Patients with lower SA level had significantly more AF recurrences (47.4%, 16.7%, and 2.2% for SA levels of <3.8, 3.8−4.1, and ≥4.1, respectively; p < 0.001). Upon multivariate analysis, an SA level < 3.8 was associated with a higher risk of AF recurrence (OR = 5.422 95% CI 1.134; 25.910; p < 0.001). Conclusion: SA levels were found to be a strong independent marker for AF recurrence following PVI ablation.

ECG-I phenotyping of persistent AF based on driver burden and distribution to predict response to pulmonary vein isolation (PHENOTYPE-AF).

This prospective trial sought to phenotype persistent atrial fibrillation (AF) based on AF mechanisms using electrocardiographic imaging(ECGI) mapping to determine whether this would predict long-term freedom from arrhythmia after pulmonary vein isolation (PVI). Patients with persistent AF of <2 years duration underwent cryoballoon PVI. ECGI mapping was performed before PVIto determine potential drivers (PDs) defined as rotational activations completing ≥1.5 revolutions or focal activations. The coprimary endpoint was the association between (1) PD burden (defined as the number of PD occurrences) and (2) PD distribution (defined as the number of segments on an 18-segment model of the atria harboring PDs) with freedom from arrhythmia at 1-year follow up. Of 100 patients, 97 completed follow up and 52 (53.6%) remained in sinus rhythm off antiarrhythmic drugs. Neither PD burden nor PD distribution predicted freedom from arrhythmia (hazard ratio [HR]: 1.01, 95% confidence interval [CI]: 0.99-1.03, p = .164; and HR: 1.04, 95% CI: 0.91-1.17, p = .591, respectively). Otherwise, the burden of rotational PDs, rotational stability, and the burden of PDs occurring at the pulmonary veins and posterior wall all failed to predict arrhythmia recurrence (all p > .10). AF mechanisms as determined using ECGI mapping do not predict outcomes after PVI for persistent AF. Further studies using different methodologies to characterize AF mechanisms are warranted(NCT03394404).

Is there clinical utility to replacement of an implantable loop recorder in patients who have previously undergone cryoballoon pulmonary vein isolation?

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable loop recorders (ILRs) are used for long-term ECG monitoring following catheter ablation in patients (pts) with atrial fibrillation (AF) to guide clinical management. However, little is known about what do when the ILR reaches end of service (EOS). Purpose To identify pts who underwent replacement of their ILR and determine the diagnostic yield and clinical utility of the replacement device. Methods We enrolled 222 consecutive pts with AF who underwent cryoballoon pulmonary vein isolation (CB PVI) and had an ILR. We identified pts who subsequently underwent ILR replacement. The diagnostic and clinical utility of the newly replaced ILR was determined. Results The cohort included 56 pts (64 + 9 years; 35 [63%] male; 27 [48%] PAF; CHA2DS2-VASc 2.3 ± 1.5) in whom the initial ILR reached EOS. They were followed for 3.7 ± 2.1 years. Recurrent AF was observed in 41 (73%) of these pts; this triggered an intervention in 17 (41%) pts (Figure). Of the other 15 (27%) pts without any documented AF, anticoagulation was withheld in 13 [87%] pts. Following ILR replacement, 33 (80%) of the 41 pts had more AF (n=11 [33%] required an intervention) and 5 additional pts had AF for the first time. Conclusions Our data show that after CB PVI, ILRs help guide decisions regarding rhythm management and oral anticoagulation. When the initial ILR was replaced by a second ILR, AF was detected (often for the first time) in some patients; the findings were used to guide clinical decision making in the entire cohort. Thus, at this time, it remains undefined when ECG monitoring of these pts can be stopped because it is no longer clinical meaningful.

Yearly incidence and pattern of very late recurrence of atrial fibrillation as detected by continuous electrocardiographic monitoring using an implantable loop recorder

Abstract Funding Acknowledgements Type of funding sources: None. Background A very late recurrence (VLR) of atrial fibrillation (AF) is considered present when patients have their first recurrence of AF &amp;gt; 12 months post-ablation. Little is known about the yearly rates and patterns of VLR AF recurrence. Objective To assess the yearly incidence and pattern of VLR in pts with AF who underwent cryoballoon (CB) pulmonary vein isolation (PVI). Methods We prospectively enrolled consecutive patients with AF who underwent CB PVI and had an implantable loop recorder (ILR) inserted up to 3 months post-ablation. Patients were followed for recurrent AF (excluding a 3-month post-ablation blanking period). Results Our cohort included 222 patients (66 ± 9 years; 143 [64%] male; 120 [54%] paroxysmal AF; CHA2DS2-VASc 2.6 ± 1.6). At 1-year, 111 (50%) patients remained free of AF. Two-year follow-up was available in 95 of these patients; 62 (65%) remained in sinus. Three-year follow-up was available in 42 of these patients; 36 (86%) remained in sinus (Figure). Of the 39 patients who developed AF after initially being free of AF for at least 1-year post ablation, 24 (62%) patients had either a frequent or persistent pattern of AF. Conclusions Our data show that the greatest likelihood of failure following a CB PVI occurs in the first year of ablation. The rate of failure becomes lower year by year. These data suggest that long term outcome may be driven more by the initial ablation as opposed to progressive evolution of the patient’s substrate

Evaluation of cryoballoon pulmonary vein isolation lesions during the acute and chronic phases using a high-resolution mapping system.

An acute cryothermal ablation lesion contains both reversible and irreversible elements. However, differences in lesions created with cryoballoon pulmonary vein isolation (PVI) between the acute and chronic phases have not been fully elucidated. We retrospectively analyzed 23 consecutive patients with atrial fibrillation who underwent cryoballoon PVI during the initial procedure followed by a second ablation procedure. In all patients, cryoballoon PVI lesions were evaluated with high-resolution voltage mapping just after PVI (acute phase) and during the second session (chronic phase). We compared the area and width of the non-isolated left atrial posterior wall (NI-LAPW) with voltage ≥ 0.5mV during both sessions. PVI was successfully achieved in all patients. Cryoballoon PVI lesions were re-evaluated at 11 [2-17] months post-procedure. During the chronic phase, NI-LAPW width became significantly larger at the level of the roof (change, 5.8 ± 5.5mm; p < 0.001) and at the level of the carina (change, 3.3 ± 7.0mm; p < 0.05), and NI-LAPW area became significantly larger (change, 1.5 ± 1.9 cm2; p < 0.001) compared with the acute phase. Eight patients without any PV reconnections also had larger NI-LAPW areas (change, 1.3 ± 1.2 cm2; p < 0.05) during the chronic phase. Conduction resumption confined to the right carina was observed in 1 (4.3%) patient who presented with circumferential PVI that included the carina during the first session. Acute cryoballoon PVI lesions significantly regressed during the chronic phase. PV reconnections and the isolation area should be carefully re-evaluated during the second procedure.

Transesophageal echocardiography guided transseptal puncture and nadir temperatures in cryoballoon pulmonary vein isolation.

IntroductionCryoballoon (CB) guided pulmonary vein isolation (PVI) is an established procedure in the treatment of atrial fibrillation (AF). Transseptal access is an indispensable step during PVI and may be associated with severe complications. For specific interventions, specific puncture sites of the fossa ovalis are advantageous. Here, we analyzed the potential impact of a transesophageal echocardiography (TOE) guided transseptal puncture on nadir temperatures in CB PVI.Methods and ResultsWe retrospectively analyzed 209 patients undergoing CB PVI in our hospital. The use of TOE had been at the operator’s discretion. No TOE‐related complications such as perforation of the pharynx or esophagus or loss of teeth were noted. Concerning the applied freezes, we found significantly lower nadir temperatures in all PVs in the TOE group than in the non‐TOE group. Procedure time and fluoroscopy time and complications were similar in both groups.ConclusionTOE‐guided TSP in CB PVI is safe and feasible. Our study found significantly lower nadir temperatures of CB freezes after TOE‐guided TSP which potentially underscores the value of a more infero‐anterior puncture site.

Cryoballoon Ablation Strategy in Persistent Atrial Fibrillation.

Background: Cryoballoon ablation is established for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). The objective was to evaluate CBA strategy in consecutive patients with persistent AF in the initial AF ablation procedure.Material and Methods: Prospectively, patients with symptomatic persistent AF scheduled for AF ablation all underwent cryoballoon PVI. Technical enhancements, laboratory management, safety, single-procedure outcome, predictors of recurrence, and durability of PVI were evaluated.Results: From 2007 to 2020, a total of 1,140 patients with persistent AF, median age 68 years, underwent cryoballoon ablation (CBA). Median left atrial (LA) diameter was 45 mm (interquantile range, IQR, 8), and Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke or TIA or thromboembolism (doubled), Vascular disease, Age 65 to 74 years, Sex category (CHA2DS2-VASc) score was 3. Acute isolation was achieved in 99.6% of the pulmonary veins by CBA. Median LA time and median dose area product decreased significantly over time (p < 0.001). Major complications occurred in 17 (1.5%) patients including 2 (0.2%) stroke/transitory ischemic attack (TIA), 1 (0.1%) tamponade, relevant groin complications, 1 (0.1%) significant ASD, and 4 (0.4%) persistent phrenic nerve palsy (PNP). Transient PNP occurred in 66 (5.5%) patients. No atrio-esophageal fistula was documented. Five deaths (0.4%), unrelated to the procedure, occurred very late during follow-up. After initial CBA, arrhythmia recurrences occurred in 46.6% of the patients. Freedom from atrial arrhythmias at 1-, and 2-year was 81.8 and 61.7%, respectively. Independent predictors of recurrence were LA diameter, female sex, and use of the first cryoballoon generation. Repeat ablations due to recurrences were performed in 268 (23.5%) of the 1,140 patients. No pulmonary vein (PV) reconduction was found in 49.6% of the patients and 73.5% of PVs. This rate increased to 66.4% of the patients and 88% of PVs if an advanced cryoballoon was used in the first AF ablation procedure.Conclusion: Cryoballoon ablation for symptomatic persistent AF is a reasonable strategy in the initial AF ablation procedure.

Results and Predictive Factors After One Cryoablation for Persistent Atrial Fibrillation

Cryoballoon pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) ablation is an increasingly used strategy. We aimed to determine the results and predictors of arrhythmia recurrence after a single procedure of cryoballoon PVI for patients with persistent and long-standing persistent AF. We included all consecutive patients who underwent cryoballoon PVI for the treatment of persistent symptomatic drug-refractory AF since 2012. All patients were prospectively followed to detect the recurrence of atrial tachyarrhythmia (ATa). Predictors of recurrence were assessed. Cryoballoon PVI was performed on 399 patients with persistent AF, among whom 52 (13%) had long-standing persistent AF. Patients with long-standing persistent AF had a significantly larger left atrium than those with persistent AF. A 28-mm cryoballoon was used for 322 patients (93%). In total, 359 patients (90%) completed the 12-month follow-up visit and the median follow-up was 24 months (interquartile range 43 to 13). The 2-year probability of freedom from ATa recurrence was 51% for persistent AF and 27% for long-standing persistent AF. Long-standing persistent AF and left atrial area/volume were independent predictors of ATa recurrence. Ten patients (2.5%) experienced phrenic nerve palsy, 1 tamponade (0.25%), 2 stroke (0.5%), 2 pericardial effusions (0.5%), and 5 vascular complications (1.25%). In conclusion, 2-year ATa-free survival rates were 51 and 27% for persistent and long-standing persistent AF patients, respectively. Complications were rare. Long-standing persistent AF and left-atrial area/volume were predictors of recurrence.

Clinical Effect of Adaptive Servo-Ventilation on Left Atrial Pressure During Catheter Ablation in Sedated Patients With Atrial Fibrillation.

Sedation during pulmonary vein isolation (PVI) for atrial fibrillation often provokes a decline in left atrial (LA) pressure (LAP) under atmospheric pressure and increases the risk of systemic air embolisms. This study aimed to investigate the efficacy of adaptive servo-ventilation (ASV) on the LAP in sedated patients.Methods and Results:Fifty-one consecutive patients undergoing cryoballoon PVI were enrolled. All patients underwent sedation using propofol throughout the procedure. After the transseptal puncture and the insertion of a long sheath into the LA, the LAP was measured. Then, the ASV treatment was started, and the LAP was re-measured. The LAP before and after the ASV support was investigated. Before ASV, the LAP during the inspiratory phase was significantly smaller than that during the expiratory phase (4.9±5.4 mmHg vs. 14.0±5.2 mmHg, P<0.01). The lowest LAP was -2.2±5.1 mmHg and was under 0 mmHg in 37 (73%) patients. After the ASV, the LAP during the inspiratory phase significantly increased to 8.9±4.1 mmHg (P<0.01), and lowest LAP increased to 4.7±5.9 mmHg (P<0.01). The negative lowest LAP value became positive in 30/37 (81%) patients. There were no statistical differences regarding obstructive sleep apnea (OSA), obesity, gender, or other comorbidities between patients with and without a negative lowest LAP after ASV support. ASV is effective for increasing the LAP above 0 mmHg and might prevent air embolisms during PVI.

Cryoballoon Ablation of Atrial Fibrillation Without Demonstration of Pulmonary Vein Occlusion-The Simplify Cryo Study.

Background: The demonstration of pulmonary vein (PV) occlusion is routinely performed and considered a prerequisite for successful cryoballoon (CB) ablation of atrial fibrillation (AF). The purpose of this study was to assess the feasibility and impact on procedural parameters and outcome of a standardized procedural protocol without demonstrating PV occlusion.Methods and Results: Consecutive patients undergoing CB pulmonary vein isolation (PVI) were studied. After cMRI assessment, patients treated by PVI using a novel no-contrast (NC) protocol without routine contrast injections to demonstrate PV occlusion (NC group) were compared to patients undergoing PVI with contrast injections to demonstrate PV occlusion (standard group). One hundred patients with paroxysmal or persistent AF (age 61 ± 10 years, ejection fraction 59 ± 11%, left atrial volume index 37.2 ± 2.0 mL/m2) were studied. The NC protocol was feasible in 72 of 75 patients (96%). Total procedure time and fluoroscopy time were 64.0 ± 14.1 min and 11.0 ± 4.6 min in the NC group and 92.0 ± 25.3 min and 18.0 ± 6.0 min in the standard group, respectively (all p < 0.001). Dose area product was 368 ± 362 cGy*cm2 in the NC group compared to 1928 ± 1541 cGy*cm2 in the standard group (p < 0.001). Forty-five of 75 patients (60%) in the NC group and 16 of 25 patients (64%) in the standard group remained in stable sinus rhythm after a single PVI and a 1-year follow-up (p = 0.815).Conclusions: Performing CB ablation without using contrast injections to demonstrate PV occlusion was feasible, resulted in reduced radiation exposure, and increased the efficiency of the procedure.

Pulmonary vein and left atrial posterior wall isolation for the treatment of atrial fibrillation: Comparable outcomes for adults with congenital heart disease.

Optimal treatment strategies for ACHD with AF are unknown. This study sought to assess outcomes of pulmonary vein isolation (PVI) ± left atrial (LA), posterior wall isolation (PWI) for adults with congenital heart disease (ACHD), and atrial fibrillation (AF). A retrospective review of all cryoballoon (CB) PVI ± PWI procedures at a single center over a 3-year period were performed. Clinical characteristics and outcomes for patients with and without ACHD were compared. The primary outcome was the occurrence of atrial tachyarrhythmia at 12-months postablation after a 90-day blanking period. Three-hundred and sixteen patients (mean: 63 ± 12 years, [63% male]) underwent CB PVI ± PWI during the study, including 31 (10%) ACHD (simple 35%, moderate 39%complex 26%; nonparoxysmal AF in 52%). ACHD was younger (51 vs. 64 years;p < .001) with a lower CHADS2 DS2 -VASc score (1.2 vs. 2.1;p = .001) but had a greater LA diameter (4.9 vs. 4.0 cm;p < .001) and a number of prior cardioversions (0.9 vs. 0.4;p < .001) versuscontrols. 12-month freedom from recurrent AF was similar for ACHD and controls (76% vs. 80%;p = .6) and remained nonsignificant in multivariate analysis (hazard ratio:1.8, 95% confidence interval:0.7-5.1; p = .22). At 12-months postablation, 75% of ACHD versus93% of control patients were off antiarrhythmic drug therapy (p = .07). This study demonstrates younger age and lower conventional stroke risk, yet clinically advanced AF for ACHD relative to controls. CB PVI ± PWI was an effective strategy for the treatment of AF among all forms of ACHD with similar 12-month outcomes as compared to controls.

Abstract 15934: Comparison of Atrial Fibrillation Burden Reduction in Patients With Paroxysmal and Persistent Atrial Fibrillation Undergoing Cryoballoon Pulmonary Vein Isolation

Background: Pulmonary vein isolation (PVI) is a cornerstone of atrial fibrillation (AF) ablation procedures to treat symptomatic AF. Ablation success is defined by absence of AF recurrence &gt;30 seconds. However, reduction in AF burden (AFB) is also an important endpoint. Whether patients with paroxysmal (PAF) and persistent AF (PeAF) have similar reduction in AFB post-ablation is unknown. Objective: To compare the decrease in AFB following cryoballoon (CB) PVI in patients with PAF and PeAF. Methods: We enrolled consecutive pts with an implantable loop recorder (ILR) who subsequently underwent CB PVI. All patients were followed prospectively for at least one year, or until repeat ablation; we compared AFB pre and post-ablation. Results: The cohort included had 47 patients (66 ± 10 years; 32 [68%] male; PAF [n=23, 49%]; CHA 2 DS 2 -VASc 2.7 ± 1.7, 34 [72%] on AAD at the time of ablation). A median of 136 days [IQR 280, 73; minimum of 30 days] of ILR data pre-ablation were available. The median AFB for PAF was 4.7% [IQR 0.9, 14.8] and PeAF was 6.8% [IQR 1.1, 40.4]. After excluding a 3-month post-ablation blanking period, recurrent AF occurred in 12 (52%) PAF and 11 (46%) PeAF patients. The median AFB post-ablation for PAF and PeAF cohorts was 0.03%, [IQR 0, 0.3] and 0.04%, [IQR 0, 1.1], respectively. This represents a &gt;99% reduction in AFB. Conclusion: Although 50% of patients undergoing CB PVI for PAF or PeAF had a recurrence of AF, there was &gt;99% reduction in AFB in both groups. These data highlight the importance of using AFB burden as a marker of therapeutic efficacy post-AF ablation.