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.

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.

Incidence of ventricular arrhythmias related to COVID infection and vaccination in patients with Brugada syndrome: Insights from a large Italian multicenter registry based on continuous rhythm monitoring.

INTRODUCTION: Brugada syndrome (BrS) has a dynamic ECG pattern that might be revealed by certain conditions such as fever. We evaluated the incidence and management of ventricular arrhythmias (VAs) related to COVID-19 infection and vaccination among BrS patients carriers of an implantable loop recorder (ILR) or implantable cardioverter-defibrillator (ICD) and followed by remote monitoring. METHODS: This was a multicenter retrospective study. Patients were carriers of devices with remote monitoring follow-up. We recorded VAs 6 months before COVID-19 infection or vaccination, during infection, at each vaccination, and up to 6-month post-COVID-19 or 1 month after the last vaccination. In ICD carriers, we documented any device intervention. RESULTS: We included 326 patients, 202 with an ICD and 124 with an ILR. One hundred and nine patients (33.4%) had COVID-19, 55% of whom developed fever. Hospitalization rate due to COVID-19 infection was 2.76%. After infection, we recorded only two ventricular tachycardias (VTs). After the first, second, and third vaccines, the incidence of non-sustained ventricular tachycardia (NSVT) was 1.5%, 2%, and 1%, respectively. The incidence of VT was 1% after the second dose. Six-month post-COVID-19 healing or 1 month after the last vaccine, we documented NSVT in 3.4%, VT in 0.5%, and ventricular fibrillation in 0.5% of patients. Overall, one patient received anti-tachycardia pacing and one a shock. ILR carriers had no VAs. No differences were found in VT before and after infection and before and after each vaccination. CONCLUSIONS: From this large multicenter study conducted in BrS patients, followed by remote monitoring, the overall incidence of sustained VAs after COVID-19 infection and vaccination is relatively low.

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.

Indications, evidence, and controversy in the closure of the left atrial appendage.

Closure of the left atrial appendage (LAAO) represents a valid option for the prevention of cardio-embolic stroke in patients with atrial fibrillation (AF) at high bleeding risk. Previous studies had shown that the atrial appendage represents the site of atrial thrombus formation in about 90% of cases in the presence of non-valvular AF. In all patients with AF and higher thromboembolic risk (in particular with CHA2DS2VASc score ≥2 in women and ≥1 in men) there is an indication for thromboembolic prophylaxis with AOC (oral anti-coagulants). The main guidelines and international consensus documents place the indication for the LAAO in patients with the need for thromboembolic prophylaxis who have contraindications to oral anticoagulant therapy (class of recommendation IIb).

Why can primary angioplastics be ineffective despite the precocity of the intervention?

Early coronary revascularization is a first choice therapeutic strategy in the case of acute myocardial infarction (MI). Despite an early coronary angioplasty, however, in some cases, there is a lower efficacy of revascularization, with less favourable clinical outcome in the short and long terms. Various elements participate in the distant prognosis after primary coronary angioplasty (PCI). Among the clinical risk factors that predispose to a recurrence of ischaemic cardiovascular events are advanced age, diabetes mellitus, chronic renal failure, peripheral vascular disease, atrial fibrillation and the multiplicity of cardiovascular risk factors, which identify a higher baseline risk profile. The risk factors associated with the percutaneous interventional procedure include the presence of diffuse or complex coronary lesions, the use of small diameter stents or a suboptimal post procedural thrombolysis in MI flow. The occurrence of procedural complications, such as no-reflow, is in fact associated with an increase in the infarct area and a worse prognosis, as it favours negative ventricular remodelling. The presence of concomitant right ventricular dysfunction, the high ventricular arrhythmic burden in the acute phase, the presence of risk factors for thrombosis or intra-stent restenosis also affect the outcome after primary PCI.

Prevention of ischaemic events in subjects with polydistrict vascular disease.

The incidence of new cardiovascular events in patients with chronic coronary syndrome remains high, particularly in the presence of concomitant high thrombotic risk factors (diabetes mellitus, renal failure, multivessel coronary artery disease, multiple district atherosclerosis, recurrent events, heart failure). The risk of such recurrent events can be reduced by implementing various strategies, which include careful individual stratification of ischaemic and haemorrhagic risk and the choice of the most appropriate antithrombotic therapy for the individual patient, also by combining aspirin with a second antiplatelet agent/a low-dose anticoagulant, in order to achieve the maximum net clinical benefit.

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.

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.

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.

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.

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.

Rate and nature of complications of conduction system pacing compared with right ventricular pacing: Results of a propensity score-matched analysis from a multicenter registry.

BACKGROUND: Conduction system pacing (CSP) using His bundle pacing (HBP) or left bundle branch area pacing (LBBAP) has emerged as an alternative to right ventricular pacing (RVP). Comparative data on the risk of complications between CSP and RVP are lacking. OBJECTIVE: This prospective, multicenter, observational study aimed to compare the long-term risk of device-related complications between CSP and RVP. METHODS: A total of 1029 consecutive patients undergoing pacemaker implantation with CSP (including HBP and LBBAP) or RVP were enrolled. Propensity score matching for baseline characteristics yielded 201 matched pairs. The rate and nature of device-related complications occurring during follow-up were prospectively collected and compared between the 2 groups. RESULTS: During a mean follow-up duration of 18 months, device-related complications were observed in 19 patients: 7 in RVP (3.5%) and 12 in CSP (6.0%) (P = .240). On dividing the matched cohort into 3 groups with similar baseline characteristics according to pacing modality (RVP, n = 201; HBP, n = 128; LBBAP, n = 73), patients with HBP showed a significantly higher rate of device-related complications than did patients with RVP (8.6% vs 3.5%; P = .047) and patients with LBBAP (8.6% vs 1.3%; P = .034). Patients with LBBAP showed a rate of device-related complications similar to that of patients with RVP (1.3% vs 3.5%; P = .358). Most of the complications observed in patients with HBP (63.6%) were lead related. CONCLUSION: Globally, CSP was associated with a risk of complications similar to that of RVP. Considering HBP and LBBAP separately, HBP showed a significantly higher risk of complications than did both RVP and LBBAP whereas LBBAP showed a risk of complications similar to that of RVP.

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.

Access Site Bleeding Complications with NOACs versus VKAs in Patients with Atrial Fibrillation Undergoing Cardiac Implantable Device Intervention.

There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group (p = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs (p = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs versus VKAs (HR 0.35, 95% CI 0.13-0.96, p = 0.042). Such NOACs benefit was confirmed versus patients on VKAs without peri-procedural bridging with low-molecular-weight heparin (HR 0.34, 95% CI 0.11-0.99, p = 0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events, and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. In conclusion, our data suggest that, among patients with AF undergoing implantable cardiac defibrillator or pacemaker intervention, the use of NOACs versus VKAs may be associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low-molecular-weight heparin in the VKA group. These results are hypothesis generating and need to be confirmed in a specific randomized study.

[Zero-fluoroscopy transcatheter ablation and CRT-D implantation: new frontiers of electroanatomical mapping systems]. / Ablazione transcatetere e contestuale impianto di CRT-D "zero-fluoroscopy": nuove frontiere del mappaggio elettroanatomico.

In cardiac resynchronization therapy (CRT) implantation procedures, contrast-induced nephropathy risk and ionizing radiation exposure can be eliminated using electroanatomical mapping system (EAMS). Under EAMS guidance, it is possible to place the left ventricular catheter in the branch of the coronary sinus that presents the latest activation. The use of EAMS allows for both arrhythmic ablation and CRT implantation to be obtained in a single, "zero fluoroscopy" procedure. Here we report two cases of successful arrhythmia ablation and CRT-D implantation with "zero fluoroscopy" in a single procedure.

Updated antithrombotic strategies to reduce the burden of cardiovascular recurrences in patients with chronic coronary syndrome.

Despite recent achievements in secondary cardiovascular prevention, the risk of further events in patients with chronic coronary syndromes (CCS) remains elevated. Highest risk is seen in patients with recurrent events, comorbidities or multisite atherosclerosis. Optimising antithrombotic strategies in this setting may significantly improve outcomes. The higher the baseline risk, the higher the absolute event reduction with approaches using combined antithrombotic treatments. Tailoring such strategies to the individual patient risk appears crucial to achieve net benefit (i.e., substantial ischaemic event prevention at a limited cost in terms of bleeding). This paper focuses on antithrombotic and non-pharmacological approaches to secondary cardiovascular disease prevention in CCS. In particular, we critically review current evidence on the use of dual antithrombotic therapy, including the newest approach of aspirin plus low-dose anticoagulation and its net clinical outcome according to baseline risk.