Balloon Ablation Research Articles

Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.

A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched. Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360days following ablation including 48-h Holter ECGs. A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm2. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433). RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90days predicts later AF recurrence.

Anatomical-guided third-generation laser balloon ablation for the treatment of paroxysmal atrial fibrillation assessed by continuous rhythm monitoring: results from a multicentre prospective study.

The third-generation laser balloon (LB3) is an established ablation device for pulmonary vein isolation (PVI) that allows direct visualization of the anatomical target. Equipped with an automatic circumferential laser delivery modality, it aims at continuous circumferential PVI, improving both acute and clinical outcomes. We sought to evaluate the clinical efficacy of LB3 ablation using an anatomical-based approach without verifying electrical isolation. Among 257 paroxysmal AF patients undergoing LB3 ablation across four Italian centres, 204 (72% male, mean age 60.4 ± 11.1 years) were included. The primary endpoint was freedom from any atrial tachyarrhythmia (ATa) recurrence after the blanking period (BP), assessed with implantable cardiac monitors (ICMs). All pulmonary veins (PVs) were targeted using the LB3, with the RAPID mode used on an average of 96 ± 8, 86 ± 19, 98 ± 11, and 84 ± 15% for the left superior, left inferior, right superior, right inferior PV, and left common ostium, respectively. Freedom from arrhythmia recurrences was 84.8% at 1, 80.4% at 2, and 76.0% at 3 years. An ATa burden ≥ 5% was documented in 2.5, 4.4, and 5.4% at 1, 2, and 3 years, respectively. Relapses during the BP [hazard ratio (HR) = 2.182, P = 0.032] and left atrial dilation (HR = 1.964, P = 0.048) were independent predictors of recurrences. Anatomical-guided LB3 ablation for paroxysmal AF is a safe and effective approach, providing excellent clinical outcomes as assessed by ICM over nearly 3 years of follow-up.

Efficacy and Safety of Laser Balloon Versus Irrigated Radiofrequency Ablation as Initial Therapies for Atrial Fibrillation: A Meta-Analysis.

Catheter ablation (CA) is an effective therapy for atrial fibrillation (AF) and, although radiofrequency ablation (RFA) is the standard treatment for pulmonary vein isolation (PVI), it is complex and time-consuming. Laser balloon ablation (LBA) has been introduced to simplify the conventional RFA; however, results of studies comparing LBA and RFA remain controversial. As such, this investigation aimed to comprehensively evaluate the efficacy and safety of LBA versus RFA. The PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched for relevant studies. The primary endpoints were the freedom from atrial tachyarrhythmia (ATA) and procedure-related complications. Twelve studies including 1274 subjects were included. LBA and RFA yielded similar rates of freedom from ATA (72.5% vs. 68.7%, odds ratio [OR] = 1.26, 95% confidence interval [CI] 1.0-1.7, p = 0.11) and procedure-related complications (7.7% vs. 6.5%, OR = 1.17, 95% CI 0.72-1.90, p = 0.536). LBA with the second- and third-generation laser balloons (LB2/3) yielded remarkably higher rates of freedom from ATA than RFA using contact-force technology (RFA-CF) (OR = 1.91, p = 0.013). Significantly lower pulmonary vein (PV) reconnection rates (OR = 0.51, p = 0.021), but higher phrenic nerve palsy (PNP) rates (OR = 3.42, p = 0.023) were observed in the LBA group. LBA had comparable procedure (weighted mean difference [WMD] = 8.43 min, p = 0.337) and fluoroscopy times (WMD = 3.09 min, p = 0.174), but a longer ablation time (WMD = 12.57 min, p = 0.00) than those for RFA. LBA and RFA treatments were comparable in terms of freedom from ATA and postprocedural complications in patients with AF. Compared with RFA, LBA was associated with significantly lower PV reconnection rates, but a higher incidence of PNP and longer ablation time.

Impact of different energy sources on coagulation biomarkers and silent cerebral events in balloon-based ablation for atrial fibrillation

BackgroundDifferent energy sources of balloon-based ablation for pulmonary vein isolation (PVI) cause different kinds of endothelial damage and coagulation responses associated with thromboembolic risk. ObjectivesTo compare the impact of different balloon-based ablation, cryo-balloon ablation (CBA) and laser balloon ablation (LBA), on coagulation/fibrinolysis biomarkers and silent cerebral events (SCEs) in paroxysmal atrial fibrillation (PAF). MethodsPAF patients who underwent PVI using either CBA (n=52) or LBA (n=53) without radiofrequency touch-up ablation were eligible. Time-course (day-0 [before ablation], day-1, day-2, and day-28) of myocardial enzymes and inflammatory and coagulation/fibrinolysis biomarkers was evaluated during the perioperative period. Brain MRI was performed within 2 days after the procedure to evaluate SCEs. ResultsThere was no difference in patient characteristics between CBA and LBA.CBA had greater myocardial injury (troponin-I and creatine kinase MB) and lower inflammatory reaction (WBC and neutrophil/lymphocyte ratio) than LBA. The coagulation biomarkers maximally increased by day-2 and then decreased in both groups. In day-28, the serum prothrombin fragment 1+2 and D-dimer levels in LBA were significantly higher than the values in CBA. The fibrinolysis biomarker (plasmin-α2 plasmin inhibitor complex) did not increase after the procedure in either group. The incidence of SCEs was comparable between CBA and LBA (11% vs. 15%, p=0.591). No thromboembolic event was observed. ConclusionCBA and LBA had different effects on myocardial injury, inflammatory reaction, and coagulation activity but did not affect the incidence of thromboembolic events. LBA had significantly higher coagulation activity in day-28 and may require more careful post-procedural anticoagulation than CBA.

Ultra-high density mapping for the evaluation of the antral scar extension after ablation with a radiofrequency balloon catheter in atrial fibrillation patients

Abstract Background The Heliostar radiofrequency (RF) balloon ablation catheter enables one-shot pulmonary veins isolation (PVI). The RF balloon by occluding the PV ostia creates an antral scar. Purpose We sought to investigate the extension of the antral scar by mean of ultra-high density mapping. Methods Paroxysmal and persistent atrial fibrillation (AF) patients undergoing first PVI ablation with the Heliostar catheter across 4 European centers were enrolled. Ultra-high density mapping of left atrium was performed with the Octaray catheter, a octa-spline mapping catheter before and after the ablation. All maps were acquired in sinus rhythm, patients in AF underwent electrical cardioversion before mapping. The bipolar voltage maps from each patients were analysed: the left atrial area < 0.2 mV was considered scar and was calculated before and after the ablation and the distance between left and right antral lesions at upper and inferior posterior wall were also calculated. Results Overall, 49 patients were enrolled, 82% were male, the mean age was 60±9 years, 66% had paroxysmal AF. PVI was achieved in 100% patients. The mean left atrial area was 209±44 cm2, the scar after the ablation was 9±4.6 %, with 49±11% of the posterior wall still viable (bipolar voltage > 0.5mV). The distance between left and right antral lesions at the upper posterior wall was 26.57 mm whereas at the inferior aspect was 29.59 mm. Conclusions The RF balloon catheter creates a wide antral scar during AF ablation although without compromising the integrity of the posterior wall.

Radiofrequency balloon ablation: 1-year outcomes of the AURORA registry

Abstract Background and Objectives A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into 3D mapping system was recently launched. Methods Patients ablated for paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (persAF) at two German high-volume electrophysiology centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180 and 360 days following ablation including 24h Holter ECGs. Results A total of 101 patients were enrolled (50 from centre A, 51 from centre B) and 86 patients (48% male, 65 ± 11 years, 55% PAF, 59 ± 7% left ventricular ejection fraction (LVEF)) completed the follow-up. Mean ablation and procedure times were 26 ± 13 min and 71 ± 20 min, respectively. Dose area product was 1501 ± 1634 mGycm2. Acute PVI was achieved in 100%. Atrial fibrillation (AF) free survival after a mean FU of 361 (219-375) days was 78.4% for PAF and 75.4% for persAF. (p= 0.828). A multiple regression analysis did not reveal any clinical or procedural predictors of AF recurrence among sex, age, BMI, left atrial diameter, LVEF, ablation time, procedure time and single shot PVI. However, early recurrence of atrial tachyarrhythmia (ERAT) was an independent predictor for AF recurrence at 1-year (Hazard Ratio [HR]: 3.198; 95% confidence interval [95% CI]: 1.036 - 10.32, p value = 0.0433). Primary adverse events occurred in 3.5% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke or phrenic nerve paralysis were observed. Conclusions RFB-based PVI is clinically effective and safe. ERAT at the first follow-up visit is an independent predictor of late AF recurrence.

One shot "fire & ice"

Abstract Introduction Pulmonary vein isolation (PVI) is the best and first strategies during ablation of atrial fibrillation (1-4). Short- and long-term effectivity as well as procedure time are important parameters during PVI-ablation. New efforts are made to find longer effectivity, low risk of the procedure and shorter procedure. Purpose The aim of our study is to compare the two "balloon - one shot" methods (radiofrequency balloon "RFB" and cryoballoon "CB") in terms of speed, efficacy and safety. Methods Prospective, randomized, pilot single-center trial including 74 consecutive patients with paroxysmal, persistent or long lasting persistent atrial fibrillation who undergo for the first time PVI-ablation between December 2022 and October 2023. Patient were randomized 1:1 according type of AF, Sex, Hypertension, left ventricular ejection fraction e left atrial volume in a multi-electrode radiofrequency balloon catheter Heliostar ablation or in cryoballoon system ablation. Both groups had comparable clinical characteristics. Results Median Age of the population was 64 year (iq range 57-70), 19 were female (25,7%), 31 patients (42%) had paroxysmal atrial fibrillation, median EF was 60% (iq range 55-65) and median left atrial volume 36 ml/mq (iq 28-40). 37 patients undergo cryoballoon PVI and 37 patients undergo RF balloon Ablation. Compared with the RFB group, the CB group showed a shorter procedure time [65 minutes (55-75) vs. 75 minutes (65-90) (P < 0.008)]. The DAP (dose area product) was lower in RFB Group [7 Gy*cm2 ( 5-10) vs CB Group 11 ( 7-18), p<0,001]. First-pass isolation was comparable. We had 5 complications in RFB group (1 pericardial effusion without pericardiocentesis, 3 transitory ST-elevation on ECG due to air embolism, 1 transient phrenic nerve palsy) and 3 complications in CB group (3 transient phrenic nerve palsy) P=ns. During the procedures in 3 cases of RF group and in 1 case of CB group (p=ns) we had to change the balloon due to technical issues. Conclusion The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. CB has shorter procedural times but with a higher X-Ray exposure.Figure 1Figure 2

Hysteroscopic Partial Endometrial Resection Versus Thermal Balloon Ablation for Treatment of Heavy Menstrual Bleeding in Premenopausal Women

Hysteroscopic Partial Endometrial Resection Versus Thermal Balloon Ablation for Treatment of Heavy Menstrual Bleeding in Premenopausal Women

Quantitative comparison of the isolation lesions between conventional- and larger-sized visually guided laser balloon ablation.

The importance of a wider circumferential isolation of the pulmonary veins (PV), which includes a large portion of the left atrial posterior wall (LAPW), has been suggested in several studies. However, the extended isolation area using a larger inflated visually guided laser balloon (VGLB) ablation remains to be elucidated. Seventy-eight patients with atrial fibrillation (AF) who underwent VGLB ablation were enrolled in this prospective study. An electroanatomic map of the left atrium was obtained before and after PV isolation (PVI) using a conventional-sized VGLB. The isolation areas were extended by the largest-sized VGLB ablation and remapped in the same manner. After the ablation, isolation areas were calculated with CARTO-3 system.The one-year atrial arrhythmia (Ata) recurrence was assessed. RESULTS: The largest-sized VGLB ablation yielded statistically greater areas of isolation in left-sided PV antrum (PVA) (11.5 ± 2.3 cm2 vs. 15.9 ± 3.5 cm2, P < .001) and right-sided PVA (14.2 ± 3.3 cm2 vs. 20.6 ± 4.4 cm2, P < .001) than the conventional-sized VGLB. Further, non-ablated LAPW (12.3 ± 4.4 cm2 vs. 7.8 ± 3.9 cm2, P < .001) was significantly reduced after largest-sized VGLB ablation, compared to the conventional-sized VGLB ablation.The one-year Ata freedom was 83.7% in patients with paroxysmal AF and 96.4% in those with persistent AF. The largest-sized VGLB ablation technique can create a significantly wider isolation area of PVA and debulk a large amount of LAPW than the conventional-sized VGLB ablation.The one-year outcome was similarly high in paroxysmal and persistent AF.

Current Balloon Devices for Ablation of Atrial Fibrillation.

Balloon-based catheter ablation is a valuable option for the treatment of atrial fibrillation (AF) because contiguous lesions can be created to achieve pulmonary vein isolation (PVI), and the method is less dependent than traditional ablation methods on the operator's skill and experience. Cryoballoon ablation is used universally worldwide, with its efficacy and safety being comparable to the efficacy and safety of standard radiofrequency ablation, and the procedure can be completed in a relatively short time. Hot balloon ablation was developed in Japan. The balloon maintains its compliance even during the energy delivery, and a large areal ablation lesion is created. Furthermore, the hot balloon system is the only system for which oesophageal cooling is a standard feature. Laser balloon ablation, which is performed under direct endoscopic vision, has proven to be effective and safe for achieving a PVI. The laser balloon system provides an improved field of view and automated circumferential ablation for a rapid and effective PVI. The authors have reviewed the currently available balloon systems as used for AF ablation, i.e., PVI, and have provided detailed insight and perspectives on the currently available cryoballoon and hot balloon technologies, plus laser balloon technology.

Phrenic nerve injury after atrial fibrillation ablation: different recovery courses among cryoballoon, laser balloon, and radiofrequency ablation.

Phrenic nerve injury (PNI) is one of the common complications in atrial fibrillation (AF) ablation, which often recovers spontaneously. However, the course of its recovery has not been examined fully, especially in regard to the different ablation methods. We sought to compare the recovery course of PNI in cryoballoon, laser balloon, and radiofrequency ablation. This multicenter retrospective study analyzed 355 patients who suffered from PNI during AF ablation. PNI occurred during cryoballoon ablation (CB group) and laser balloon ablation (LB group) for a pulmonary vein isolation in 288 and 20 patients, and radiofrequency ablation for a superior vena cava (SVC) isolation (RF-SVC group) in 47 patients, respectively RESULTS: There was a significant difference in the estimated probability of PNI recovery after the procedure between the methods (p = 0.01). PNI recovered significantly earlier in the CB group, especially within 24h and 3months post-procedure (the percentage of the recovery within 24h and 3months: 49.7% and 71.5% in the CB group, 15.0% and 22.2% in the LB group, and 23.4% and 41.9% in the RF-SVC group, respectively). Persistent PNI after 12months was observed in only seven patients in the CB group, one in the LB group, and four in the RF-SVC group, respectively. PNI rarely persists over 12months after AF ablation; however, there is a difference in the timing of its recovery. PNI recovers quicker with cryoballoon ablation than with laser balloon ablation or radiofrequency ablation of the SVC.

Cryoballoon vs. laser balloon ablation for atrial fibrillation: a meta-analysis.

Cryoballoon ablation (CBA) and laser balloon ablation (LBA) are two innovative ways for the treatment of atrial fibrillation (AF). This study aimed to evaluate the efficacy and safety of cryoballoon ablation and laser balloon ablation in patients with AF. We searched Pubmed, Embase, Ovid, Web of Science and other databases for comparative trials comparing CB and LB ablation in the treatment of AF, from establishment of database to August, 2023. A total of 13 studies and 3,582 patients were included (CBA, n = 2,308; LBA, n = 1,274). There was no difference between CBA and LBA in acute PVI rate per vein, 12-months recurrence rate of AF, 12-months recurrence rate of atrial arrhythmia, occurrence rate of pericardial tamponade, occurrence rate of inguinal complications. LBA presented a lower acute PVI rate per patients (CBA 97.0% vs. LBA 93.4%, RR = 1.04, 95%CI: 1.01-1.07). Transient nerve palsy was more likely to occur after CBA (CBA 2.7% vs. LBA 0.7%, RR = 4.25, 95%CI: 2.06-8.76). However, the occurrence of persistent nerve palsy between CBA and LBA groups were similar (CB 1.4% vs. LB 1.0%, RR = 1.09, 95%CI: 0.55-2.14). In terms of procedural duration, the procedural time of CBA was shorter than that of LBA (WMD = -26.58, 95%CI: -36.71-16.46). Compared with LBA, CBA had a shorter procedural duration. There was a higher incidence of transient but not persistent phrenic nerve palsy after CBA. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=272607 Identifier (CRD42021272607).

Pulmonary Vein Stenosis After Catheter Ablation of Atrial Fibrillation Using a Cryoballoon, Hot Balloon, or Laser Balloon.

Pulmonary vein stenosis (PVS) after PV isolation (PVI) for atrial fibrillation (AF) is a severe complication that requires angioplasty. This study aimed to compare the reduction of the cross-sectional PV area (PVA) and the incidence of PVS after cryoballoon (CB)-PVI, hot balloon (HB)-PVI, or laser balloon (LB)-PVI. A total of 320 patients who underwent an initial catheter ablation procedure for AF using a CB, HB, or LB in 2 hospitals were included. They underwent contrast-enhanced multidetector CT before and 3 months after the procedure. In all 4 PVs, the reduction in PVA was more significant in the LB group than in the CB or HB groups, respectively. Moderate (50-75%) and severe (>75%) PVS were observed in 5.3% and 0.5% of the PVs, respectively. Although moderate PVS was more frequently observed in the LB group than in the CB or HB groups (8.2%, 3.8%, and 5.0%; P=0.03), the incidence of severe PVS was similar in the LB, CB, and HB groups (0.3%, 0.5%, and 1.0%; P=0.46). Symptomatic PVS requiring intervention occurred in 1 (0.3%) patient. Although the reduction in cross-sectional PVA and the incidence of moderate PVS after LB-PVI was more significant than after CB-PVI or HB-PVI, it rarely led to severe PVS. Symptomatic PVS requiring intervention was rare after the balloon ablation of AF.

Long-term success rates of a stable, low pressure cryo balloon for the treatment of paroxysmal atrial fibrillation - results of the prospective, international, multicenter POLAR-ICE study

Abstract Background/Introduction Pulmonary vein isolation (PVI) using a cryo balloon is well-established for the treatment of paroxysmal atrial fibrillation (PAF). Compared to other available technologies, the usage of a stable, low pressure cryo balloon (POLARx, Boston Scientific) has demonstrated lower nadir temperatures and longer thawing times. However, long term efficacy and safety still needs to be proven. Purpose The aim of the POLAR-ICE Study was to evaluate long-term efficacy and safety outcome of cryo balloon ablation in patients with paroxysmal atrial fibrillation. Methods POLAR ICE, a prospective, non-randomized, international, multicenter study, enrolled 399 patients across 19 centers, between Aug 2020 and May 2021. Patients with paroxysmal atrial fibrillation undergoing de novo PVI were included into the study. During the index procedure, procedural characteristics, such as time to isolation (TTI), cryoablations per pulmonary vein, balloon nadir temperature, and occlusion grade were recorded. Procedural success was defined as successful isolation of each vein proven by entrance block. Follow up visits were at 3, 6, and 12 months. Recurrence is defined as any documented (ECG/Holter) episode of atrial fibrillation / atrial tachycardia longer than 30sec. after a blanking period of 3 months. Results 399 patients (mean age 61 years, 36% female) were included into the study. After 12 months, freedom from any arrhythmia was 83.5% and freedom from atrial fibrillation 88.1% (Figure 1). Procedure/ablation related Serious adverse events occurred in 8.7% of patients, and included access complications (2.6%), cardiac tamponade (0.5%), air embolism (0.3%), AV block (0.3%), effusion (0.3%) phrenic nerve palsy (0.3%), stroke (0.3%), transient ischemic attack (0.3%). Redo procedures have been conducted in 19 patients. In 14/19 pts reconnection of at least one PV could be identified (RSPV n=8, RIPV n=12, LSPV n=9, LIPV n=11). Freedom from any arrhythmia was associated with lower nadir temperature (p=0.008) and longer time to thaw (p=0.05) during the index procedure. Conclusions In this prospective, non-randomized, international, multicenter study, isolation of the pulmonary veins using a stable, low pressure cryo balloon was highly effective and safe in patients treated for paroxysmal atrial fibrillation. Lower nadir temperatures and a longer thawing time were predictors of clinical success.

Temporal trends in the utilization, referral patterns, and complications of catheter ablation for atrial fibrillation in the Netherlands, 2013-2021

Abstract Background Over the past decade, atrial fibrillation (AF) ablation technologies have evolved, operator experience has improved, and indications for referral to AF ablation has expanded. A recent population-level assessment is warranted to assess the impact of these changes on trends in the utilization, referrals, and adverse events (AEs) of AF ablation. Purpose Our aim was to describe temporal trends in the population-level incidence, patients referred, and AEs of AF ablation in the Netherlands from 2013 to 2021. Methods Temporal trend analyses were conducted using the AF ablation population in the Netherlands Heart Registration and included all consecutive patients treated with catheter ablation for AF between 2013 and 2021 at 16 hospitals in the Netherlands. Annual crude, sex- and age-standardized incidence rates of AF ablation were calculated. Poisson regression models with robust variances were used to evaluate trends in the incidence of AF ablation. Trends in patient characteristics, AEs, and repeat ablations over the study period were evaluated with ANOVA tests. Results Between 2013 and 2021, 37,538 AF ablations were performed in the Netherlands, of which 27,027 (72.0%) were index ablations. Repeat ablations (10,511 procedures) were performed within a median time to repeat ablation of 1 (IQR 1-2) year. AF ablation patients were a median age 63 (IQR 56-69) years, 32.8% women, 70.7% had paroxysmal AF, and median CHA2DS2-VASC score was 1 (IQR 1-2). Most patients underwent radiofrequency ablation (55.4%), followed by cryoballoon (33.4%), PVAC (0.6%), pulse-field (0.3%), laser balloon ablation (0.1%), and other (0.1%) (10.1% missing). Over the 9-year period, there was a statistically significant increase in index [incidence rate ratio (IRR) 1.07 (95% CI 1.05-1.08)] and repeat [IRR 1.09 (95% CI 1.05-1.12)] ablations from 2013 to 2021 (Figure 1). The annual sex-standardized incidence rates of AF ablations were approximately double for men compared to women throughout follow-up (Figure 2). In recent years, AF ablation patients had more persistent AF, higher CHA2DS2-VASC scores, and lower LVEF (p&amp;lt;0.05 for all). Minor vascular AEs within 30 days were the most frequent AE of AF ablation (1.1%), followed by phrenic nerve paralysis (0.6%), in-hospital bleeding (0.6%), cardiac tamponade (0.5%), thrombosis (0.3%), major vascular AEs (0.2%) and all-cause mortality (0.1%). Incidence of most AEs remained stable over time (p&amp;gt;0.05 for all). CONCLUSION In the Netherlands, the utilization of AF ablation increased by 7% from 2013 to 2021. In recent years, populations referred for AF ablation were increasingly older, had more persistent AF, higher CHA2DS2-VASC scores, and lower LVEF; however, men remained twice as likely to undergo AF ablation compared to women. Reasons for the lower rate of AF ablation among women requires further investigation.

Efficacy and safety of visually guided laser balloon versus cryoballoon ablation for paroxysmal atrial fibrillation: a systematic review and meta-analysis.

Newly developed catheter ablation (CA) techniques, such as laser balloon ablation (LBA) and cryoballoon ablation (CBA), have been introduced in recent years and emerged as valuable alternatives to conventional radiofrequency CA strategies for paroxysmal atrial fibrillation (PAF) patients. However, evidence comparing LBA and CBA remain controversial. Thus, we conducted this meta-analysis to assess the efficacy and safety between these two techniques. Scientific databases (PubMed, Embase) and relevant websites (the Cochrane Library, ClinicalTrials.gov) were systematically searched from inception to March 2023. The primary outcomes of interest were the AF recurrence and the procedure-related complications. Secondary outcomes included procedural time, fluoroscopy time, and left atrial (LA) dwell time. Seven clinical trials with a total of 637 patients were finally enrolled. No significant differences were found between LBA and CBA in terms of AF recurrence [16.3% vs. 22.7%, odds ratio (OR) = 0.66, 95% confidence interval (CI): 0.42-1.05, p = 0.078] or total procedural-related complications (8.4% vs. 6.4%, OR = 1.33, 95% CI: 0.71-2.51, p = 0.371). LBA had a significantly longer procedural time [weighted mean difference (WMD) = 38.03 min, 95% CI: 13.48-62.58 min, p = 0.002] and LA dwell time (WMD = 46.67 min, 95% CI: 14.63-78.72 min, p = 0.004) than CBA, but tended to have shorter fluoroscopy time. LBA and CBA treatment have comparable efficacy and safety for PAF patients. LBA was associated with longer procedural and LA dwell times compared with CBA. Further large-scale studies are warranted to compare these two techniques with the newest generations.Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=426513, identifier (CRD42023426513).

Bayesian network meta-analysis comparing hot balloon, laser balloon and cryoballoon ablation as initial therapies for atrial fibrillation.

Balloon-based catheter ablation (CA) technologies, including hot balloon ablation (HBA), laser balloon ablation (LBA) and cryoballoon ablation (CBA) have been introduced in recent years as alternatives to conventional radiofrequency ablation therapy for atrial fibrillation (AF). However, the results remain controversial concerning the optimal approach. Thus, we conducted a network meta-analysis (NMA) to comprehensively evaluate the efficacy and safety of HBA, LBA and CBA. Clinical trials comparing the efficacy and safety of HBA, LBA and CBA were identified through a systematic search up to October 2022. The primary outcomes of interest were the recurrence of AF and procedure-related complications. Twenty clinical trials with a total of 1,995 patients were included in the meta-analysis. The NMA results demonstrated that HBA, LBA and CBA had comparable AF recurrence rates (HBA vs. CBA: odds ratio OR = 0.88, 95% credible interval CrI: 0.56-1.4; LBA vs. CBA: OR = 1.1, 95% CrI: 0.75-1.5; LBA vs. HBA: OR = 1.2, 95% CrI: 0.70-2.0) and procedure-related complications (HBA vs. CBA: OR = 0.93, 95% CrI: 0.46-2.3; LBA vs. CBA: OR = 1.1, 95% CrI: 0.63-2.1; LBA vs. HBA: OR = 1.2, 95% CrI: 0.44-2.8). The surface under the cumulative ranking curve (SUCRA) suggested that HBA may be the optimal approach concerning the primary outcomes (SUCRA = 74.4%; 61.1%, respectively). However, HBA (40.1%) had a significantly higher incidence of touch-up ablation (TUA) than LBA (8.5%, OR = 2.8, 95% CrI: 1.1-7.1) and CBA (11.9%, OR = 3.7, 95% CrI: 1.9-7.5). LBA required more procedure time than CBA [mean difference (MD = 32.0 min, 95% CrI: 19.0-45.0 min)] and HBA (MD = 26.0 min, 95% CrI: 5.6-45.0 min), but less fluoroscopy time than HBA (MD = -9.4 min, 95% CrI: -17.0--2.4 min). HBA, LBA and CBA had comparable efficacy and safety as initial treatments for AF. HBA ranked highest in the primary outcomes, but at the cost of a higher incidence of TUA and longer fluoroscopy time. www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022381954, identifier: CRD42022381954.

Endometrium Ablation using a Foley catheter with a cost-effective technique in a hospital environment.

Objective: To evaluate the effectiveness of employing Foley’s catheter and modified thermal balloon ablation to treat heavy menstrual bleeding (HMB). Study Design: Prospective Interventional Randomized Control study. Setting: Departments of Gynecological of Three Semi Government Hospitals of the City. Period: January 2021 to September 2022. Material &amp; Methods: In the study, 12 patients between the ages of 42 and 50 who complained of menorrhagia and who had not responded to treatment for at least 6 months were recruited. Pre-ablation endometrial curettage was performed on each patient. A 30-50 ml latex covered Foley’s Catheter was evaluated after being introduced into uterine cavity, inflated as much as the cavity would allow under moderate pressure, and changed every two minutes with fresh boiling saline for eight minutes. Following that, hysteroscopic examination and a 6-month follow-up were performed to look for endometrial scarring. Results: Significantly shorter hospital stays, shorter recovery times following surgery, and quicker return to normal daily and sexual activities. Regarding problems, menstrual alterations, amenorrhea rate, and failure rate during the course of follow-up, there was no discernible difference between patients. This method has a success rate of almost 88%. Conclusion: In situations with limited resources, improved thermal balloon ablation with a Foley’s catheter can be a potential treatment for HMB. It is a more affordable option that the preliminary endometrial ablation approaches.

Clinical introduction of ultrasound-guided vascular access in catheter ablation of left atrial arrhythmias

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Vascular complications are a common occurrence during atrial fibrillation ablation. Observational studies show that the incidence of vascular complications can be reduced by using ultrasound (US)-guided puncture, however its routine use is not established in many centers. Purpose To compare the rate of vascular complications between ultrasound-guided and conventional anatomic landmark-guided vascular access during catheter ablation of left atrial arrhythmias. Methods Patients undergoing catheter ablation for atrial fibrillation were included sequentially. All patients receiving US-guided puncture were prospectively enrolled group A, while patients who underwent the procedure with standard puncture technique served as control group B. The primary endpoint were periprocedural vascular complications requiring intervention within 30 days of the procedure Results 599 patients (average age: 68 ± 11 years, 63,1% male) were analyzed, 299 in group A and 300 in group B. Demographic and clinical baseline characteristics were comparable between the two groups, except higher prevalence of pre-existing Diabetes mellitus in group A (14,7% vs. group B: 8,7%, p=0.022). The majority of patients were treated with radiofrequency ablation (51,5%), followed by pulsed-field ablation (20,4%) and cryoballoon (18,7%). Other ablation techniques were laserballoon and radiofrequency balloon ablation. The overall rate of vascular complications was lower with the ultrasound-guided puncture than the anatomic landmark-guided puncture (14/299 4,7% vs. 27/300 9%, p=0.036). The ultrasound-guided puncture resulted in a significantly reduced rate of false aneurysms (3/299 1% vs. 12/300 4%, p=0.019). In addition, arteriovenous fistula (2/0,7% vs. 4/1,3%, p=0.414) and hematoma requiring treatment (9/299 3% vs. 11/300 3,7%, p=0.655) were also lower in group A. Conclusion The use of ultrasound-guided vascular access for catheter ablation resulted in a significant reduction of the overall vascular complication rate.

Pulmonary vein stenosis post cryo AF ablation using single shot 4-minute freeze technique

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Magdi Yacoub foundation Introduction Cryo balloon ablation is widely used for AF ablation. Cryo ablation techniques include regular 2 shots per vein Vs single shot freeze technique. Studies showed that the single shot freeze technique is as effective as the double freezing shot, thus becoming the standard technique (1). There is a debate on whether the single shot freeze should be 3 minutes or 4 minutes. Some data suggest similar efficacy while other data suggest more durable PV isolation with the 4-minute technique (2). Severe pulmonary vein (PV) stenosis is a rare but a serious complication. The only available data on iatrogenic PV stenosis are from studies on the single 3-minute freeze technique (3). Purpose Assessment of the incidence of PVs stenosis using single shot 4-minute freeze technique. Methods We conducted a single center prospective study where we recruited 28 consecutive patients with 102 PVs scheduled for cryo AF ablation using 2nd generation cryo balloon using single shot 4-minute freeze technique as the standard technique. All patients had cardiac CT before ablation and at least 3 months post ablation where each PV’s cross-sectional area was measured. Measurements were validated by a single experienced operator. PV stenosis was classified to minimal, mild, moderate, and severe if the PV’s area decreased by 25%, 25-50%, 50-75% and more than 75% respectively. All patients were assessed regarding the presence of any symptom suggesting PV stenosis or other complications. Results Of the studied 102 PVs, only one vein (0.98%) had severe stenosis (asymptomatic) and one vein (0.98%) had moderate stenosis. Both were left superior pulmonary vein (LSPV). 13 veins (12.7%) developed mild stenosis, 74 veins (72%) showed minimal stenosis and 13 veins had no change in area. None of the studied patients developed phrenic nerve palsy or esophageal injury peri-procedure. Discussion Our results suggest low risk of developing severe PV stenosis using the 4-minute single shot freeze technique (0.98%). However, minimal, and mild pulmonary vein stenosis occurred in 84.7% of the patients denoting that this change is expected with the procedure. Tokutake et al studied the effect of using the single shot 3-minute freeze technique on PV area 3 months post cryo AF ablation and reported mild, moderate and severe (&amp;gt;75%) PV stenosis in 24.6%, 3.8% and 1.3% of PVs respectively (3). This shows that using the 4-minute freeze technique has a similarly low incidence of severe PV stenosis to the published data on the 3-minute technique. It appears that the LSPV is the most liable for this complication and this goes in line with the previous studies. Conclusion Using the 4-minute single shot freeze technique in cryo AF ablation appears to have a comparable low incidence of severe PV stenosis to the published data for the 3-minute freeze technique. The overall risk of severe PV stenosis is low. It appears that the LSPV is the most liable for this complication.