Procedural outcome & risk prediction in young patients undergoing transvenous lead extraction-a GALLERY subgroup analysis.

Background: The prevalence of young patients with cardiac implantable electronic devices (CIED) is steadily increasing, accompanied by a rise in the occurrence of complications related to CIEDs. Consequently, transvenous lead extraction (TLE) has become a crucial treatment approach for such individuals. Objective: The purpose of this study was to examine the characteristics and procedural outcomes of young patients who undergo TLE, with a specific focus on identifying independent risk factors associated with adverse events. Methods: All patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) were categorized into two groups based on their age at the time of enrollment: 45 years or younger, and over 45 years. A subgroup analysis was conducted specifically for the younger population. In this analysis, predictor variables for all-cause mortality, procedural complications, and procedural failure were evaluated using multivariable analyses. Results: We identified 160 patients aged 45 years or younger with a mean age of 35.3 ± 7.6 years and 42.5% (n = 68) female patients. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2 ± 1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. The all-cause in-hospital mortality rate was 2.5%, with septic shock identified as the primary cause of mortality. Multivariable analysis revealed CKD (OR: 19.0; 95% CI: 1.84-194.9; p = 0.018) and systemic infection (OR: 12.7; 95% CI: 1.14-142.8; p = 0.039) as independent predictor for all-cause mortality. Lead age ≥ 10 years (OR: 14.58, 95% CI: 1.36-156.2; p = 0.027) was identified as sole independent risk factor for procedural complication. Conclusion: TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.

Impact of a time-to-effect-guided ablation protocol in cryoballoon ablation on the durability of pulmonary vein isolation.

BACKGROUND: Cryoballoon (CB)-based pulmonary vein isolation (PVI) has proven to be as effective as radiofrequency-based ablation. Different ablation protocols took the individual time-to-isolation (TTI) into account aiming at shorter but equally or even more effective freeze cycles. The current study sought to assess the impact of the TTI on PVI durability in patients undergoing a repeat procedure for recurrence of atrial tachyarrhythmia (ATA). METHODS AND RESULTS: In 205 patients with ATA recurrence after previous CB-based PVI, a total of 806 pulmonary veins (PVs) were identified. A total of 126 out of 806 PVs (16%) were previously treated with a TTI-guided ablation (Protocol #1; TTI + 120 s), in 92/806 (11%) PVs TTI was only monitored (m) but fixed freeze cycles were applied (Protocol #2; mTTI) and in 588/806 (73%) a fixed freeze cycle was applied without mTTI. There was no difference in the PV-reconduction rate between the groups (p = .23). The right inferior pulmonary vein (RIPV) showed overall significantly higher reconduction rates compared to the other PVs (RIPV-left inferior PV p < .003, -left superior PV p < .001, -right superior PV p < .013). Twenty-one patients (10%) were demonstrated to have only electrical reconduction of the RIPV, while all other PVs were still electrically isolated. CONCLUSIONS: The TTI-based CB ablation protocol did not show significant differences regarding PV-reconduction rates compared to the other ablation protocols.

Performance and outcome of the subcutaneous implantable cardioverter-defibrillator after transvenous lead extraction.

AIMS: The subcutaneous cardioverter-defibrillator (S-ICD) may be a valuable option in patients after successful transvenous lead extraction (TLE) without indication for pacemaker therapy and persistent risk of sudden cardiac death. The aim of this study was to evaluate device performance, postoperative outcome, and safety in patients who received a S-ICD after TLE compared to patients who underwent de-novo S-ICD implantation. METHODS: A retrospective analysis of all patients included into our institution's S-ICD database between September 2010 and May 2019 was conducted.The patients were divided in two groups, depending on whether they had received their S-ICD after TLE (n = 31) or de-novo (n = 113). RESULTS: The TLE group was significantly older with a mean age of 54.3 ± 15.7 versus 46.7 ± 14.4 years; p = .007. Leading S-ICD indication in the TLE group was previous infection (50%), whereas in the de-novo group the S-ICD was primarily chosen due to young patient age (74.6%). Median duration of follow-up was 527.0 versus 472.5 days, respectively; p = .576. Most common complication during follow-up was inappropriate ICD therapy (12.9% vs. 13.3%); p = 1.000. Pocket erosion/infection occurred in 3.2% versus 3.5% with no reported cases of systemic (re-)infection in either group; p = 1.000. All-cause mortality was low (6.2% vs. 2.7%) and entirely unrelated to S-ICD implantation or the device itself; p = .293. CONCLUSION: The S-ICD is a safe and effective alternative for patients after TLE with very similar results regarding device performance and postoperative outcome, when compared to patients who underwent de-novo S-ICD implantation.

Reconduction After Second-Generation Cryoballoon-Based Pulmonary Vein Isolation　- Impact of Different Ablation Strategies.

BACKGROUND: The second-generation cryoballoon (CB2) has demonstrated high procedural efficacy and convincing clinical success rates for pulmonary vein isolation (PVI). Nevertheless, data on the impact of different ablations protocols on durability are limited. The aim was to comparing the durability of PVI following 3 different ablation strategies in patients with recurrence of atrial fibrillation or atrial tachycardia undergoing repeat procedures.Methods and Results:In 192 patients, a total of 751 PVs were identified. All PVs were successfully isolated during index PVI. Thirty-one out of 192 (16%) patients were treated with a bonus-freeze protocol (group 1), 67/192 (35%) patients with a no bonus-freeze protocol (group 2), and 94/192 (49%) patients with a time-to-effect-guided protocol (group 3). Persistent PVI was documented in 419/751 (55.8%) PVs, and in 41/192 (21%) patients, all PVs were persistently isolated. The total rate of PV reconnection was not significantly different between the groups (P=0.134) and the comparison of individual PVs revealed no differences (P-values for RSPV: 0.424, RIPV: 0.541, LSPV: 0.788, LIPV: 0.346, LCPV: 0.865). The procedure times were significantly reduced by omitting the bonus-freeze and applying individualized application times (group 1: 123.4±31.5 min, group 2: 112.9±39.8 min, group 3: 86.67±28.4 min, P<0.001). CONCLUSIONS: Comparing 3 common ablation protocols, no differences for durable PVI were detected. Procedure times were significantly reduced by omitting the bonus-freeze cycle and by applying individualized application times.

Positive impact of pulmonary vein isolation on biventricular pacing in nonresponders to cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is less effective in patients with atrial fibrillation (AF) because of impaired ventricular CRT capture. OBJECTIVE: We investigated the effects of catheter ablation in patients with AF and previous nonresponse to CRT. METHODS: Consecutive patients with AF and CRT nonresponse who underwent catheter ablation for AF were analyzed. CRT nonresponse was defined as one of the following: (1) reduced biventricular capture <95% due to rapidly conducted AF, (2) <1 point improvement in New York Heart Association (NYHA) class after CRT implantation, or (3) insufficient increase in left ventricular ejection fraction (LVEF; ≤5%) after CRT implantation. RESULTS: Thirty-eight patients (8 women [21%]; mean age 68 ± 10 years; LVEF 30% ± 7%, biventricular capture 88.0% [25th, 75th percentile 75.3%, 98.5%]) underwent catheter ablation. One major and 1 minor complication occurred (1 lethal atrioesophageal fistula and 1 hemodynamically nonrelevant pericardial effusion). The Kaplan-Meier estimates for arrhythmia-free survival after single and multiple ablation procedures were 29% (95% confidence interval 16%-51%) and 67% (95% confidence interval 53%-86%) after 24 months. After a median follow-up of 817 days (25th, 75th percentile 179, 1741 days), biventricular capture and LVEF were significantly higher (median [25th, 75th percentile] 99% [96%, 99%], difference 8% [0.2%, 3.75%], P < .0001; mean 32.1% ± 9.1%, difference 2.2% ± 7.1%, P = .0225) and patients had a significantly lower functional NYHA class (28 of 37 patients with improvement of at least 1 point; P < .0001). CONCLUSION: Catheter ablation of AF significantly improves CRT response in patients with heart failure and concomitant AF in terms of increased biventricular capture and LVEF and improved functional NYHA class.

Is less more? Impact of different ablation protocols on periprocedural complications in second-generation cryoballoon based pulmonary vein isolation.

Aims: Second-generation cryoballoon (CB2) based pulmonary vein isolation (PVI) has emerged as an effective treatment option for symptomatic atrial fibrillation (AF). The current study sought to assess the impact of different ablation protocols on the incidence and characteristics of procedural complications in a large patient cohort. Methods and results: A total of 563 consecutive patients with symptomatic AF who underwent CB2-based ablation between July 2012 and January 2016, were assessed. Three different ablation protocols were applied and characterized by (#1) a bonus-freeze following PVI, (#2) no bonus-freeze after PVI, and (#3) a 'time-to-effect'-guided strategy. Major complications occurred in 30/563 patients (5.3%) with phrenic nerve palsy (PNP) as the most frequent complication occurring in 2.7% of the cases. The overall incidence of complications was significantly lower in patients treated with a 'time-to-effect' guided ablation strategy compared with the other ablation protocols (8.1% [17/211] (protocol #1+#2) vs. 3.7% [13/352] (protocol #3), respectively; P = 0.026). The 'time-to-effect' guided ablation protocol was associated with less applied freeze-cycles and shorter freeze-cycle durations. Additionally, shorter procedure times, radiation exposures and lower volumes of contrast medium needed were assessed for the 'time-to-effect' guided protocol as compared with the other ablation protocols. Conclusion: The overall incidence of complications was 5.3% in our analysis. The most frequent complication was PNP. The use of a time-to-effect guided ablation protocol was associated with a lower incidence of major complications compared with a bonus-freeze and no bonus-freeze protocol.

Direct Comparison of Point-by-Point and Rapid Ultra-High-Resolution Electroanatomical Mapping in Patients Scheduled for Ablation of Atrial Fibrillation.

INTRODUCTION: Three-dimensional electroanatomical mapping (EAM) is an established tool facilitating catheter ablation. In this context, the novel Rhythmia system sets a new bar in fast high-resolution mapping. The aim of this study was to directly compare point-by-point versus rapid ultra-high-resolution EAM in patients scheduled for ablation of atrial fibrillation (AF) with focus on procedural data, acute success, and midterm clinical outcome. METHODS AND RESULTS: A total number of 74 consecutive patients (48/74 male) with symptomatic AF were scheduled to undergo pulmonary vein isolation (PVI) using either Carto or Rhythmia. The Carto-guided procedures were performed using point-by-point acquisition according to our routine approach, whereas for Rhythmia, fast anatomical mapping was utilized. Comparing Rhythmia- versus Carto-guided ablation approaches, we observed a significantly longer total mapping time (P = 0.001), longer total fluoroscopy time (P = 0.001), more delivered RF-applications (P = 0.019), and longer total RF-duration (P = 0.002). There was no difference regarding total ablation time (P = 0.707), total procedure duration (P = 0.99), and acute procedural success. During follow-up, 84.8% of patients remained free from any AF/AT-recurrence using Carto versus 88.2% when using Rhythmia (P = 0.53). From Kaplan-Meier analysis, the event rate estimations were 15% versus 13.5%, respectively. CONCLUSION: The present study reports our first clinical experience using Rhythmia in direct comparison with the established Carto system for AF ablation. Our data clearly demonstrate that Rhythmia was proved to be effective and well applicable but more data will be mandatory before final conclusions can be drawn.