Wearable defibrillator to improve accuracy in selecting candidates to implantable defibrillator: A real-world experience.

AIMS: The indication for implantable cardioverter defibrillator (ICD) for sudden cardiac death (SCD) prevention relies mostly on left ventricular ejection fraction (LVEF) ≤ 35%. The use of a wearable cardioverter defibrillator (WCD) in the case of dynamic alterations of LVEF may help avoid an improper early ICD implant when a favourable evolution in the post-acute phase is observed and may help reduce costs. METHODS: This parallel cohort retrospective study included patients with heart failure with reduced ejection fraction (HFrEF) at high risk of arrhythmias recruited in the acute phase and divided into an early ICD cohort and a WCD cohort for primary prevention during the waiting period established by European Society of Cardiology guidelines. RESULTS: A total of 41 consecutive patients were enrolled: 26 in the WCD group and 15 in the early ICD group. Age, LVEF at baseline, causes of HFrEF and drug therapy in the two cohorts were similar. During the waiting period after the inclusion, three patients (11.5%) in the WCD cohort and four (26.7%) in the early ICD cohort developed relevant ventricular arrhythmias (P = 0.22); none of them had subsequent LVEF recovery. At the end of the waiting period, 13 patients (50%) in the WCD group and 7 (46.7%) in the early ICD group experienced LVEF recovery (P = 0.84). The average cost per patient at the end of the waiting period was €23 934 in the early ICD cohort versus €19 167 in the WCD cohort (-19.9%). This cost savings from WCD use appears even higher when projected over a 10 year period (-41.2%). CONCLUSIONS: WCD may represent a cost-effective strategy to more accurately select candidates for the primary prevention ICD implant among high-risk patients with HFrEF. ICD use provides effective protection from SCD and reduces costs compared with an extensive early ICD implant.

Closed loop stimulation in left bundle branch area pacing.

INTRODUCTION: Closed Loop Stimulation (CLS) is a rate-responsive algorithm that adjusts heart rate (HR) based on changes in intracardiac impedance measured from the right ventricle lead. However, the use of CLS in conduction system pacing has not been investigated. In this retrospective study, we aimed to assess whether CLS with left bundle branch area pacing (LBBAP) can generate an appropriate distribution of HR in daily life. METHODS AND RESULTS: Our study included 24 patients with CLS pacing and chronotropic incompetence, comparing them with 19 patients receiving DDD pacing, all with LBBAP. Cumulative HR distribution charts were generated using data from a single device interrogation with a minimum follow-up period of 30 days. In DDD-CLS mode, there was a higher percentage of atrial pacing compared to DDD mode (median 58% [interquartile range 29%-83%] vs. 13% [10%-26%], p = .001), and CLS-paced beats were present across all frequency bins. The distribution of beats between the groups was similar (p = .643), resulting in comparable mean HR (72 bpm [70-77] vs. 73 bpm [65-75], p = .615). CONCLUSIONS: In the context of LBBAP, CLS effectively modulates pacing rates over a wide frequency range. This lead position does not adversely affect the rate-responsive performance of the algorithm.

Left bundle branch area versus conventional pacing after transcatheter valve implant for aortic stenosis: the LATVIA study.

BACKGROUND: Atrioventricular block (AVB) is a frequent complication in patients undergoing transcatheter aortic valve implantation (TAVI). Right apex ventricular pacing (RVP) represents the standard treatment but may induce cardiomyopathy over the long term. Left bundle branch area pacing (LBBAP) is a promising alternative, minimizing the risk of desynchrony. However, available evidence with LBBAP after TAVI is still low. OBJECTIVE: To assess the feasibility and safety of LBBAP for AVB post-TAVI compared with RVP. METHODS: Consecutive patients developing AVB early after TAVI were enrolled between 1 January 2022 and 31 December 2022 at three high-volume hospitals and received LBBAP or RVP. Data on procedure and at short-term follow-up (at least 3 months) were collected. RESULTS: A total of 38 patients (61% men, mean age 83 ±â€Š6 years) were included; 20 patients (53%) received LBBAP. Procedural success was obtained in all patients according to chosen pacing strategy. Electrical pacing performance at implant and after a mean follow-up of 4.2 ±â€Š2.8 months was clinically equivalent for both pacing modalities. In the LBBAP group, procedural time was longer (70 ±â€Š17 versus 58 ±â€Š15 min in the RVP group, P  = 0.02) and paced QRS was shorter (120 ±â€Š19 versus 155 ±â€Š12 ms at implant, P  < 0.001; 119 ±â€Š18 versus 157 ±â€Š9 ms at follow-up, P  < 0.001). Complication rates did not differ between the two groups. CONCLUSION: In patients with AVB after TAVI, LBBAP is feasible and safe, resulting in a narrow QRS duration, either acutely and during the follow-up, compared with RVP. Further studies are needed to evaluate if LBBAP reduces pacing-induced cardiomyopathy in this clinical setting.

A real-world multicenter study on left atrial appendage occlusion: The Italian multi-device experience.

Background: Transcatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO. Methods: We retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies. Results: Among the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes. Conclusions: Our findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.

Complications of left bundle branch area pacing compared with biventricular pacing in candidates for resynchronization therapy: Results of a propensity score-matched analysis from a multicenter registry.

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is a well-established therapy in patients with reduced left ventricular ejection fraction, heart failure, and left bundle branch block. Left bundle branch area pacing (LBBAP) has recently been shown to be a feasible and effective alternative to BVP. Comparative data on the risk of complications between LBBAP and BVP among patients undergoing CRT are lacking. OBJECTIVE: The aim of this study was to compare the long-term risk of procedure-related complications between LBBAP and BVP in a cohort of patients undergoing CRT. METHODS: This prospective, multicenter, observational study enrolled 668 consecutive patients (mean age 71.2 ± 10.0 years; 52.2% male; 59.4% with New York Heart Association class III-IV heart failure symptoms) with left ventricular ejection fraction 33.4% ± 4.3% who underwent BVP (n = 561) or LBBAP (n = 107) for a class I or II indication for CRT. Propensity score matching for baseline characteristics yielded 93 matched pairs. The rate and nature of intraprocedural and long-term post-procedural complications occurring during follow-up were prospectively collected and compared between the 2 groups. RESULTS: During a mean follow-up of 18 months, procedure-related complications were observed in 16 patients: 12 in BVP (12.9%) and 4 in LBBAP (4.3%) (P = .036). Compared with patients who underwent LBBAP, those who underwent BVP showed a lower complication-free survival (P = .032). In multivariate analysis, BVP resulted an independent predictive factor associated with a higher risk of complications (hazard ratio 3.234; P = .042). Complications related to the coronary sinus lead were most frequently observed in patients who underwent BVP (50.0% of all complications). CONCLUSION: LBBAP was associated with a lower long-term risk of device-related complications compared with BVP in patients with an indication for CRT.

Early effects of left bundle branch area pacing on ventricular activation by speckle tracking echocardiography.

BACKGROUND: Left bundle branch area pacing (LBBAP) is an emerging cardiac pacing modality that preserves fast electrical activation of the ventricles and provides very good electrical measures. Little is known on mechanical ventricular activation during this pacing modality. METHODS: We prospectively enrolled patients receiving LBBAP. Electrocardiographic and electrical parameters were evaluated at implantation, < 24 h and 3 months. Transthoracic echocardiography with strain analysis was performed at baseline and after 3 months, when ventricular mechanical activation and synchrony were analyzed by time-to-peak standard deviation (TPSD) of strain curves for both ventricles. Intraventricular left ventricular (LV) dyssynchrony was investigated by LV TPSD and interventricular dyssynchrony by left ventricle-right ventricle TPSD (LV-RV TPSD). RESULTS: We screened 58 patients with permanent pacing indication who attempted LBBAP. Procedural success was obtained in 56 patients (97%). Strain data were available in 50 patients. QRS duration was 124.1 ± 30.7 ms at baseline, while paced QRS duration was 107.7 ± 13.6 ms (p < 0.001). At 3 months after LBBAP, left ventricular ejection fraction (LVEF) increased from 52.9 ± 10.6% at baseline to 56.9 ± 8.4% (p = 0.004) and both intraventricular LV dyssynchrony and interventricular dyssynchrony significantly improved (LV TPSD reduction from 38.2 (13.6-53.9) to 15.1 (8.3-31.5), p < 0.001; LV-RV TPSD from 27.9 (10.2-41.5) to 13.9 (4.3-28.7), p = 0.001). Ameliorations with LBBAP were consistent in all subgroups, irrespective of baseline QRS duration, types of intraventricular conduction abnormalities, and LVEF. CONCLUSIONS: Echocardiographic strain analysis shows that LBBAP determines a fast and synchronous biventricular contraction with a stereotype mechanical activation, regardless of baseline QRS duration, pattern, and LV function.

Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario.

BACKGROUND: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). RESEARCH DESIGN AND METHODS: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. RESULTS: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. CONCLUSIONS: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

Left bundle branch area pacing (LBBAP) Auto Threshold algorithms Evaluation for Conduction System Pacing: The LATECS pilot Trial.

BACKGROUND: Automated threshold measurements (ATM) and output adaptation improved safety and follow-up of cardiac implantable devices (CIED) in the last years. These algorithms were validated for conventional cardiac pacing; however, they were not suitable for permanent His Pacing. Left bundle branch area pacing (LBBAP) is an emerging technique to obtain physiologic cardiac stimulation; we tried to assess if ATM could be applied to this setting. METHODS: Consecutive patients receiving ATM-capable CIED and LBBAP in our hospital were enrolled in this prospective, observational trial; they were evaluated 3 months after implant, comparing pacing thresholds manually assessed and obtained via ATM. Subsequent remote follow-up was carried on when available. RESULTS: Forty-five patients were enrolled. ATM for LBBAP lead provided consistent results in all the patients and was therefore activated; mean value of manually obtained LBBAP capture threshold was 0.66 ± 0.19 V versus ATM of 0.64 ± 0.19 V. TOST analysis showed equivalence of the two measures (p = .66). At subsequent follow-up (mean follow up 7.7 ± 3.2 months), ATM was effective in assessing pacing thresholds and no clinical adverse event was observed. CONCLUSIONS: ATM algorithms proved equivalent to manual testing in determining capture threshold and were reliably employed in patients receiving LBBAP CIED.

Optimization of the atrioventricular delay in conduction system pacing.

INTRODUCTION: In patients receiving conduction system pacing (CSP), it is not well established how to program the sensed atrioventricular delay (sAVD), with respect to the type of capture obtained (selective, nonselective His-bundle [HB] capture or left bundle branch [LBB] capture). The aim of this study was to acutely assess the effectiveness of an electrophysiology (EP)-guided method for sAVD optimization by comparing it with the echocardiogram-guided optimization. METHODS AND RESULTS: Consecutive patients undergoing HB or LBB pacing were enrolled. The EP-guided sAVD was defined as the sAVD leading to a PR interval of 150 ms on surface electrocardiogram (ECG). In HB pacing patients, EP-guided sAVD was obtained subtracting the time from the onset of the P wave on ECG to the local atrial electrogram (EGM) recorded by the atrial lead (right atrial sensing latency, RASL) and the His-ventricular interval from 150 ms; in LBB pacing patients, subtracting RASL from 150 ms. Transmitral flow assessment by pulsed wave Doppler was used to find the echo-optimized sAVD by a modified iterative method. The discordance between the EP-guided and the echo-optimized sAVD was recorded. RESULTS: Seventy-one patients were enrolled: 12 with selective, 32 nonselective HB capture, and 27 LBB capture. Overall, the rate of concordance between the EP-guided and the echo-optimized sAVD was 71.8%, with no significant differences between the three groups. CONCLUSION: In CSP patients, an optimal sAVD can be programmed, in more than 70% of cases, considering only simple EGM intervals to obtain a physiological PR interval on surface ECG.