Cryoballoon Pulmonary Vein Isolation Research Articles

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.

NT-pro-BNP as a Predictor for Recurrence of Atrial Fibrillation after Primary Cryoballoon Pulmonary Vein Isolation.

NT-pro-BNP is produced in the cardiac atria and ventricles in response to increased wall stress. It may be a marker of both AF disease progression and co-morbidities that affect success after pulmonary vein isolation (PVI). This single-center retrospective study analyzed the association between pre-procedural NT-pro-BNP serum levels and the long-term outcome after a first-ever PVI in cryo-technique. Patients were followed by searching the hospital information system and conducting structured telephone interviews. Treatment failure was defined as any relapse of atrial fibrillation (AF) occurring 90 days after the index PVI at the earliest. Kaplan-Meier survival curves and Cox proportional hazards models were computed to assess the impact of NT-pro-BNP on AF recurrence. Following 374 patients over a median of 3.8 years (range: 0.25-9.4 years), baseline NT-pro-BNP was associated with the combined endpoint in univariate analysis (HR 1.04 per 100 pg/mL increase, 95% CI: 1.02-1.07, p &lt; 0.001). Results were virtually unchanged in the multivariate model or if the data were log-transformed. Intraprocedural left atrial pressure correlated positively with log NT-pro-BNP. NT-pro-BNP was associated with AF relapse during a long-term follow-up after first-ever cryo-PVI in our cohort of patients with predominantly normal left ventricular function. This lab parameter is easy to obtain and has significant potential to guide treatment decisions.

Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter

ObjectiveWe aimed to compare cryoballoon pulmonary vein isolation (PVI) with standard radiofrequency cavotricuspid isthmus (CTI) ablation as first-line treatment for typical atrial flutter (AFL).MethodsCryoballoon Pulmonary Vein Isolation as First-Line Treatment...

Abstract 10330: Do Radiofrequency and Cryoballoon Pulmonary Vein Isolation Induce Similar Rates of Pericardial Inflammation?

Introduction: Pericardial inflammation/irritation (P I/I ) is a known occurrence after Radiofrequency (RF) and Cryoballoon (CB) pulmonary vein isolation (PVI) for pts with AF. We hypothesized that any new pericardial effusions (PE) or ECG evidence of pericarditis were clinical manifestations of P I/I post-PVI. Data comparing the incidence and clinical significance of P I/I between the 2 treatment modalities are limited. Methods: Retrospective analysis of post-PVI P I/I in pts undergoing either CB or RF ablation for AF. We included any degree of new PE or ECG changes consistent with pericarditis seen post-procedure as a surrogate for P I/I . Results: A total of 224 pts (70 CB and 154 RF) with AF undergoing their first PVI were studied. Compared to RF, CB pts tended to be female (47.1% vs 31.2%, P=0.021), were less likely to receive concurrent cavotricuspid-isthmus (CTI) ablation (4.29% vs 61.0%, P&lt;0.01), and were less likely to receive post-PVI NSAIDs (17.1% vs 56.5%, P&lt;0.01). Despite differences in baseline characteristics, the incidence of post-PVI P I/I between CB and RF was similar (17.1% vs 20.8%, P=0.469). No episode of P I/I led to any hemodynamic instability or required intervention. Pts with P I/I were more likely to be female (52.3% vs 32.4%, P=0.014) and had lower BMIs (28.7kg/m 2 vs 31.2kg/m 2 , P=0.012). Characteristics of pts in each treatment group as well as pts with and without P I/I were summarized in Table 1. Conclusions: In contrast with prior studies that demonstrated lower rates of P I/I with CB, we demonstrate similar rates of P I/I with CB and RF. The occurrence of P I/I was not associated with increased incidence of early AF recurrence. P I/I was more likely to develop in female pts with lower BMI. Although NSAIDs are often used post-PVI, we found no association between NSAID use and development of P I/I .

Abstract 13319: Cryoaballoon Ablation in Patients With Atrial Fibrillation and Heart Failure - Insights From Ongoing POLAR-HF Trial

Background Atrial Fibrillation (AF) and heart failure (HF) often co-exist and increase cardiovascular mortality. Radiofrequency ablation is safe and effective in patients with AF and HF. There is evidence for a reduction in mortality in treated patients (CASTLE, NEJM 2019), and the European Society of Cardiology recommends catheter ablation (class 1A), particularly in patients with tachycardiomyopathy. However, there is no large-scale prospective study evaluating efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) in patients with AF and HF. Objective Prospective comparison of cryoPVI in patients with and without HF (defined as LVEF ≤ 40%) regarding efficacy and safety. Methods POLAR-HF trial is an investigator-initiated, single-center, prospective, non-inferiority, interventional study. Follow-up was performed at 3, 6 and 12, 18 and 24 months after ablation. Endpoints were: symptomatic AF recurrence for efficacy and bleeding, stroke or death for safety. Periprocedural parameters were observed. Results: We analyzed 668 consecutive patients who underwent cryoPVI. Of these 581 had normal LVEF (age 69±10 years, CHA2DS2-VASc Score 2.7±1.5, 54% male) while 87 patients (13%) suffered from HF (age 70±10 years, CHA2DS2-VASc Score 3.3±1.4, 70% male). After 24 months primary efficacy endpoint occurrence was similar in normal LVEF and HF group (34.1 % vs. 35.6%, P=0.66, Figure). Safety endpoint occurred in form of pericardial effusion or transient phrenic nerve injury in six patients with normal LVEF (1.2%) and none in HF group. No deaths or strokes were observed in either group. Conclusion The interim results of the POLAR-HF study suggest that cryoPVI is a safe and effective ablation method for patients with atrial fibrillation and heart failure.

Assessment of sex-related differences and outcome in patients who underwent cryoballoon pulmonary vein isolation for atrial fibrillation: an observational cohort study

ObjectivesPulmonary vein isolation (PVI) is widely accepted as an effective and safe treatment for symptomatic atrial fibrillation (AF). However, data on sex-related differences and associations with clinical outcome and safety...

Real-time magnetic resonance-guided right atrial flutter ablation after cryo-balloon pulmonary vein isolation.

Real-time magnetic resonance-guided right atrial flutter ablation after cryo-balloon pulmonary vein isolation.

Persistent Atrial Fibrillation in Elderly Patients: Limited Efficacy of Pulmonary Vein Isolation.

(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3–24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan–Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

Using the pre-freezing technique results in a wider area of antral isolation during cryoballoon pulmonary vein isolation in patients with atrial fibrillation.

The "pre-freezing" technique was a method in which a fully inflated balloon after the start of freezing was pressed against the pulmonary vein (PV) during cryoballoon ablation and has been applied especially in large-size PVs. Of 556 patients who underwent cryoballoon ablation for atrial fibrillation (AF), the pre-freezing technique was applied to 48 patients. The resulting 2:1 propensity score-matched data set included 120 patients. Using the pre-freezing technique, all left-superior PVs, all left-inferior PVs, and 95% of right-superior PVs were successfully isolated. In most right-inferior PVs, complete sealing using the pre-freezing technique was challenging, and this technique was not applied. Procedure time was similar between the two groups. In the pre-freezing group, the percentage of the left atrial posterior wall isolated was larger (47.6 ± 10.3 vs. 42.8 ± 15.7%, P = 0.006), and the postoperative reduction of diaphragmatic compound motor action potentials tended to occur less frequently (2.5 vs. 12.5%, P = 0.07), and the reduction of the cross-sectional LSPV area was smaller (17.5 ± 12.2 vs. 27.2 ± 19.8%, P = 0.03) than the conventional group. The AF-free rate of the two groups was similar between the two groups (P = 0.15). The pre-freezing technique was a simple method that can isolate a wider surface area during cryoballoon PV isolation. While the postoperative AF recurrence was comparable, the postoperative reduction in the cross-sectional PV area was less than that of the conventional method, which may reduce the risk of PV stenosis.

Absence of atrial fibrillation in the blanking period following cryoballoon pulmonary vein isolation – does it always portend a good prognosis?

Abstract Background Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted method for ablation in patients with paroxysmal and persistent atrial fibrillation (PAF, PeAF). Freedom from AF in the blanking period (BP), conventionally defined as the first 3-months post-PVI, has been associated with the best long-term outcomes. However, the influence of antiarrhythmic drugs (AADs) during the BP on long-term outcomes is not well understood. Objective To compare long-term outcomes between patients who were and were not on an AAD prior to ablation and remained free from AF during the 3-month BP post CB PVI. Methods We enrolled consecutive AF patients undergoing CB PVI; all pts had an implantable loop recorder (ILR). No patient had any AF in the first 90 days post CB PVI. We divided the patients into three groups: (1) never had exposure to an AAD; (2) were intolerant to/failed AAD and thus were not taking an AAD at time of ablation; and (3) were on AAD at time of ablation. In the latter group, every effort was made to stop the AAD before the end of the BP. Results The cohort included 96 pts (66±10 years; 60 [63%] male; 55 [57%] PAF; CHA2DS2-VASc 2.5±1.4). There were 23 (24%) patients in group 1, 13 (14%) patients in group 2, and 60 (63%) pts in group 3. Patients in group 3 were more likely to have PeAF; AADs were stopped at a median of 36 days IQR (27, 91) in this group. Patients were followed for 1-year during which time 28 (29%) patients had recurrent AF (despite having no AF during the BP). The best outcome was seen in patients who never used an AAD; the worst outcome was seen in patients who were on an AAD at time of ablation (Figure 1). Conclusion Our data show that absence of AF during a 3-month post CB PVI BP alone does not guarantee good-long term outcome, unless the patient was never treated with an AAD. In contrast, in patients ablated while taking an AAD, recurrent AF was observed in 37% even though they were completely AF-free during the BP. Funding Acknowledgement Type of funding sources: None.

Cryoballoon ablation in obese patients: it is worth it, let us work it

Abstract Background Obesity is a major risk factor for atrial fibrillation (AF) development and of increasing prevalence in western countries. Safe and effective treatment methods for obese patients with AF are therefore important. Cryoballoon pulmonary vein isolation (CryoPVI) is a well-established therapy for symptomatic AF but data regarding obese patients are lacking. Objective To prospectively compare efficacy, safety and periprocedural parameters of CPVI in normal-weight and obese (Body-Mass-Index (BMI) ≥30kg/m2) patients. Methods We analyzed consecutive patients who underwent CryoPVI in a single-center cohort between 2018 and 2020. CryoPVI was performed in a standardized fashion. Follow-up was performed at 3, 6, 12, 18 and 24 months after CryoPVI. Endpoints were: symptomatic AF relapse for efficacy and bleeding, phrenic nerve injury, stroke or death for safety. Periprocedureal parameters were observed. Results We included 464 patients into the analysis, of these 331 patients had normal BMI (mean BMI 25.5±2.8 kg/m2, age 70±10 years, CHA2DS2-VASc 2.7±1.5, 56% male) while 133 patients (28.7%) suffered from obesity (mean BMI 33.2 kg/m2, age 67±9 years, CHA2DS2-VASc 2.7±1.4, 55% male). After 24 months freedom from AF relapse was similar for normal-weight and obese patients (58.8% vs. 61%, P=0.78, Figure 1A). Primary safety end point occurred in form of pericardial effusion or phrenic nerve injury in five patients with normal BMI (1.5%) and none obesity group. No deaths or strokes were observed in either group. Compared with control left-atrial dwell time (39.7±14.6 min vs. 44.8±18.7 min, P=0.002, fluoroscopy time (7.3±3.6 min vs. 8.3±4.1 min, P=0.013), contrast dye use (64.6±34.3 ml vs. 74.5±39.5 ml, P=0.009), and radiation dose (224.8±164.2 cGy·cm2 vs. 533.3±655.6 cGy·cm2, P&amp;lt;0.001) were significantly higher in obese patients (Figure 1B–E). Conclusion CryoPVI is safe and effective in obese patients but achievement of PVI is associated with longer procedure times, higher radiation exposure and contrast dye use. Funding Acknowledgement Type of funding sources: None.

A Single Center Experience of Atrial Fibrillation Ablation with Cryoballon

Background: Electrical isolation of the pulmonary veins is known as the fundamental of for atrial fibrillation (AF) treatment invasively, and thus, has been suggested as the first-line therapy in AF curation. In this study, we presented our single center pulmonary vein isolation (PVI) experience and long-term clinical outcome. &#x0D; Methods: One hundred and six symptomatic AF patients resistant to medical therapy underwent cryoablation of the pulmonary veins. Participants were divided into two groups regarding AF categorization as persistent or paroxysmal. Recurrence and peri-procedural complications were evaluated after the treatment.&#x0D; Results: A 106 patients, 67 males (63.2%), with mean age of 51.8 ±13.1 years, underwent cryoablation. While the paroxysmal AF group was composed of 90 patients (84.9%); the persistent AF group consisted of 16 patients (15.1%). The procedure mean time was 115,9±9,1 minute while the fluoroscopy mean time was 29,2±5,6 minutes. A total of 8 (7.5%) non-fatal complications were experienced. A total of 18 recurrences (17%) were observed during mean duration of 25.2 months follow-up period. The survival rates without AF were 85.6% and 61.8 % in in the paroxysmal and persistent groups, respectively.&#x0D; Conclusion: The cryoballoon PVI seems to be a successful and reliable method of treating AF and may be preferred as a primary procedure even in patients with persistent AF.

Incidence of Long-Term Pulmonary Vein Reconnection after a 2-Minute Cryoballoon Freeze for Pulmonary Vein Isolation—Invasive Insights of TTI-Dependent Cryoenergy Titration

Introduction: The optimal freeze duration in cryoballoon pulmonary vein isolation (PVI) is unknown. TTI-based titration of cryoenergy allows individualized freeze duration and has emerged as a favorable ablation strategy in PV cryoablation. In a recent study, we demonstrated that omission of a bonus freeze and reduction in freeze duration to a minimum of 2 min in the case of short TTI led to comparable arrhythmia recurrence rates. Whereas clinical outcome seems to be comparable to fixed freeze duration, evidence of long-term PV reconnection rates in patients undergoing TTI-based cryoballoon ablation is sparse. Aim of the study: To evaluate the procedural efficacy of a single 2-min freeze for PVI, we assessed PV conduction recovery after cryoballoon PVI with a TTI-guided titration of freeze duration compared to a fixed ablation protocol. Methods and Results: We included consecutive patients with atrial fibrillation (AF) recurrence undergoing a second ablation procedure after the initial cryoballoon procedure. The second AF ablation procedure was performed by the 3D-mapping system and radiofrequency ablation technique. A total of 219 patients (age: 66.2 ± 10.8 years, 53% female, paroxysmal AF: 53%) treated with the TTI-guided protocol (174 patients, 685 PV) or fixed protocol (45 patients, 179 PV) showed comparable total reconnection rates (TTI: 36.9% vs. fixed: 31.8%, p = 0.21). The PV reconnection rate was not statistically different for PVs treated with a 2-min freeze in case of short TTI, compared to longer freeze duration. Interestingly, the PV reconnection rate was lower in LIPVs treated with the fixed protocol (13% vs. 31%, p = 0.029). In the TTI group, 17 out of 127 patients (15%) had durable isolation of all PVs, whereas in 8 out of 40 patients (20%) in the fixed group, all PVs were still isolated (p = 0.31). Conclusions: overall reconnection rate was not different using a TTI-guided ablation protocol compared to a fixed ablation protocol, whereas the LIPV reconnection rate was significantly lower in patients treated with a fixed ablation protocol.

Process optimization for atrial fibrillation ablation.

In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity by either adding electrophysiology laboratory resources or optimizing process management. In order to optimize process management, we applied "Lean Six Sigma" method to a single ablation center. We compared procedural parameters, acute efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) before and after modifications. Patients (n = 713) undergoing cryoPVI (108 before and 605 after process optimization) were analysed. Within 3 years of process optimization, electrophysiology laboratory occupancy time (150.7 ± 44.4 vs. 94 ± 22.1 min, P < 0.001), procedure time (84.5 ± 21-47.4 ± 12 min, P < 0.001), left-atrial dwell time (53.9 ± 18.4-31.9 ± 9.9 min, P < 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8 min, P < 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15 mL, P < 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249 cGy cm2, P < 0.001) were reduced by ∼77 and ∼72%, respectively. There was no difference in safety endpoint occurrence (3.7 vs. 1.5%, P = 0.11). The process optimization of cryoPVI for AF therapy using the 'Lean Six Sigma' method significantly increases efficiency without compromising patient safety.

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).

A novel alternating second-generation cryoballoon or contact-force guided radiofrequency catheter ablation strategy for redo-ablation in patients with recurrent atrial fibrillation: a single-center experience.

Pulmonary vein (PV) reconnection after radiofrequency (RFC) or cryoballoon (CB) pulmonary vein isolation (PVI) is common. We report a single-center experience of 156 patients who underwent a redo procedure-ablation strategy for recurrent atrial fibrillation (AF) in a reverse sequence after a failed index RFC or CB PVI. A total of 60 patients after index CB PVI underwent RFC-redo ablation (CB-RFC redo), and 96 patients after index RFC PVI underwent CB-redo ablation (RFC-CB redo). During the redo procedure, the proportion of patients with PV reconnection was lower after index CB PVI procedure compared with the proportion of patients after index RFC PVI (88.3% versus 98.9%, p = 0.01). Additionally, a mean number of 1.50 ± 0.8 PVs/patient were reconnected after index CB PVI, compared with 3.36 ± 0.9 PVs/patient after index RFC PVI (p = 0.001). Patients after index RFC PVI frequently presented with ≥ 3 reconnected PVs, compared with index CB PVI (70.8% vs 10%, p < 0.001). At a 2-year follow-up, 43 patients (27.6%) developed recurrence after redo ablation, with a similar AF-free outcome (CB-RFC redo:73.3% vs RFC-CB redo: 71.9%, p = 0.873). In the multivariate analysis, persistent AF (HR = 2.107, 95% CI: 1.085-4.091, p = 0.028) and early AF recurrence after the initial ablation (HR = 2.431, 95% CI: 1.279-4.618, p = 0.007) were independent predictors of AF recurrence. The extent and distribution of PV reconnections were different after index RFC and CB PVI procedures. Alternating CB or RFC ablation technique strategy is effective with a similar long-term outcome, and it may be an appropriate option for repeated AF ablation.

Efficacy and safety of cryoballoon pulmonary vein isolation for paroxysmal and persistent atrial fibrillation: A comparison with radiofrequency ablation

BackgroundCryoballoon ablation was established as an effective and safe modality to achieve pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). However, its role in persistent atrial fibrillation (PersAF) remains unclear.ObjectiveThis study aimed to evaluate the efficacy and safety of cryoballoon PVI in PAF and PersAF comparing conventional radiofrequency catheter ablation (RFCA).MethodsTwo hundred patients undergoing cryoballoon ablation for symptomatic AF were consecutively enrolled in this retrospective study. For comparison, 210 patients undergoing RFCA in the same period were included. The primary outcome was a recurrence of any atrial tachyarrhythmias (ATas) after the index ablation. 12-lead ECG and 24-hour Holter monitoring were obtained at 1,3,6 and 9–12 months.ResultsPVI by cryoablation alone was achieved in 197 patients (98.5%). ATas-free survival at 12 months post-ablation was 72.7% in the cryoablation and 80.6% in the RFCA group (P = 0.123), respectively. The cryoablation showed comparable efficacy maintaining sinus rhythm compared with RFCA in PAF (P = 0.539), whereas in PersAF, ATas-free survival was significantly lower in cryoablation (P = 0.039). PV reconnection was observed in the majority of patients (14/16, 87.5%) who receive redo RFCA. Complications were encountered in 10 patients, including femoral arteriovenous fistula (n = 1), transient phrenic nerve palsy (n = 8), and minimal amount pericardial effusion (n = 1).ConclusionThe efficacy of cryoballoon PVI is comparable with conventional RFCA in PAF, whereas PVI alone using cryoballoon may not be insufficient to maintaining sinus rhythm in PersAF. The safety of cryoballlon PVI is tolerable.

Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial

BackgroundTransseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with the initial advancement into the left atrium. We compared the effectiveness of a radiofrequency needle-based transseptal system versus conventional needle for transseptal access.MethodsThis prospective controlled trial randomized 161 patients with symptomatic paroxysmal atrial fibrillation undergoing cryoballoon pulmonary vein isolation to transseptal access with a commercially available transseptal system (radiofrequency needle plus stiff pigtail wire; RF + Pigtail group) versus conventional transseptal access (standard group). The primary outcome was time required for left atrial access. Secondary outcomes included failure of the assigned transseptal system, radiation exposure, and complications.ResultsThe median transseptal puncture time was significantly shorter using the radiofrequency needle plus stiff pigtail wire transseptal system compared with conventional transseptal (840 ± 323 vs. 956 ± 407 s, P = 0.0489). Compared to conventional transseptal puncture, fewer transseptal attempts were required (1.0 ± 0.5 RF applications vs. 1.3 ± 0.8 mechanical punctures, P = 0.0123) and the fluoroscopy time was significantly shorter (72.0 [IQR 48.0, 129.0] vs. 93.0 [IQR 60.0, 171.0] s, P = 0.0490) with the radiofrequency needle plus stiff pigtail wire transseptal system. Failure to achieve transseptal LA access with the assigned system was rarely observed (1.3% vs. 5.7%, P = 0.2192). There were no procedural complications observed with either system.ConclusionsThe use of a radiofrequency needle plus stiff pigtail wire resulted in shorter time to left atrial access and reduced fluoroscopy time compared to left atrial access using conventional transseptal equipment.Trial registrationClinicalTrials.gov identifier NCT03199703.

Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.

Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF. Consecutive patients (n = 22, mean age 60 ± 11 years, 59.1% of males) who were treated with a stand-alone FIRM-guided ablation were included in this retrospective single-center study. Procedural data and arrhythmia-free survival at 12 months were compared with n = 86 consecutive patients (mean age 62 ± 13 years, 62.4% of males) who received de-novo CB2-PVI. Median procedure duration was significantly longer in the FIRM group than in the CB2-PVI group (152 [IQR 120-176] minutes vs. 122 [110-145] minutes; p = .031). One patient (1.2%) in the CB2-PVI group and five patients (22.7%) in the FIRM group had vascular access complications. Atrial tachyarrhythmias recurred in 15 patients in the FIRM group and 11 in the CB2-PVI group. Kaplan-Meier estimation of single-procedure arrhythmia-free survival at 12 months was 25% (95% confidence interval [CI] 6%-44%) in the FIRM group and 87% (95% CI 78%-96%) in the CB2-PVI group (p < .001). Repeat ablations were performed in 14/20 (70.0%) patients in the FIRM group and in 12/85 (14.1%) in the CB2-PVI group (p < .001). De novo ablation of AF using FIRM-guided AF ablation results in shorter arrhythmia-free survival after 12 months compared to CB2-PVI and a need for repeat ablation in the majority of patients to achieve stable sinus rhythm.

An automatic single beat algorithm to discriminate farfield from nearfield bipolar voltage electrograms from the pulmonary veins

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): “Stiftung für Herzschrittmacher und Elektrophysiologie” Basel, Switzerland Background Confirmation of pulmonary vein (PV) isolation (PVI) during ablation of atrial fibrillation can be challenging due to superimposition of nearfield (NF) PV and farfield (FF) atrial bipolar voltage electrograms (BVE). Purpose To develop an automatic algorithm allowing to discriminate PV nearfield (PV-NF) from atrial farfield (atrial-FF) BVE from a circular mapping catheter during cryoballoon (CB) PVI based on a single-heartbeat analysis. Methods BVEs from a decapolar inner-lumen diagnostic catheter (Achieve, Medtronic) during CB PVI were manually classified as PV-NF, atrial-FF and combined FF-NF signal based on the characteristics and disappearance of the PV signal during isolation (Figure, upper row). BVE power spectra were computed using the fast Fourier transform (FFT) and the automatic classification of PV-NF, atrial-FF and combined FF-NF signals was performed using the power in different frequency bands (Figure, lower row). Support vector machine classifier was used to identify PV-NF BVE due to its highest predictive accuracy for the two classes PV-NF+ (PV-NF only and combined FF-NF) and PV-NF- (atrial-FF only). Validation of the approach was performed by comparison of a subset of 80 random samples, which were classified in addition by five experienced electrophysiologists. Results We analysed a dataset of 355 BVEs from 57 patients. The examples were balanced between the two classes PV-NF+ and PV-NF-. The mean duration (95% CI) of the BVE was 58 ms (26 to 86), 70 ms (50 to 100) and 94 ms (71 to 139) for PV NF, atrial-FF and combined FF-NF, respectively. The overall balanced accuracy including BVE from all PVs was 82.7% (95% CI: 80.3% to 85.1%). The analysis on individual PVs showed an accuracy of 96.6%, 85.2%, 80.8%, and 76.9% for the right inferior, right superior, left inferior and left superior PV, respectively. Validation of the algorithm in the subset of 80 patients showed a comparable accuracy, sensitivity and specificity in PV-NF detection between the automatic algorithm and the experienced electrophysiologists (82.8%, 89.2%, and 76.3%, compared to 85.2%, 91.9%, and 78.5%, respectively). Conclusion A reliable automatic based classification algorithm to identify PV-NF BVE could be developed based on a single-beat analysis. Real-time applications as well as using other electrode configurations may improve local signal interpretation.