"Ablate and Pace" with Conduction System Pacing: Concomitant versus Delayed Atrioventricular Junction Ablation.

Objectives: Conduction system pacing (CSP) and atrioventricular junction ablation (AVJA) improve the outcomes in patients with symptomatic, refractory atrial fibrillation (AF). In this setting, AVJA can be performed simultaneously with implantation or in a second procedure a few weeks after implantation. Comparison data on these two alternative strategies are lacking. Methods: A prospective, multicentre, observational study enrolled consecutive patients with symptomatic, refractory AF undergoing CSP and AVJA performed in a single procedure or in two separate procedures. Data on the long-term outcomes and healthcare resource utilization were prospectively collected. Results: A total of 147 patients were enrolled: for 105 patients, CSP implantation and AVJA were performed simultaneously (concomitant AVJA); in 42, AVJA was performed in a second procedure, with a mean of 28.8 ± 19.3 days from implantation (delayed AVJA). After a mean follow-up of 12 months, the rate of procedure-related complications was similar in both groups (3.8% vs. 2.4%; p = 0.666). Concomitant AVJA was associated with a lower number of procedure-related hospitalizations per patient (1.0 ± 0.1 vs. 2.0 ± 0.3; p < 0.001) and with a lower number of hospital treatment days per patient (4.7 ± 1.8 vs. 7.4 ± 1.9; p < 0.001). Conclusions: Concomitant AVJA resulted as being as safe as delayed AVJA and was associated with a lower utilization of healthcare resources.

Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach.

AIMS: Conduction system pacing (CSP) and atrioventricular junction ablation (AVJA) improve outcomes in patients with symptomatic, refractory atrial fibrillation (AF). Superior approach (SA) from the pocket, via the axillary or subclavian vein, has been recently proposed as an alternative to the conventional femoral access (FA) to perform AVJA. In this study, we compare the impact of these alternative approaches on nurse workload (NWL) and patient satisfaction. METHODS AND RESULTS: This was a prospective, observational study enrolling consecutive patients undergoing simultaneous CSP and AVJA. Electrophysiology laboratory (EP Lab) NWL was calculated by using a self-developed model. Ward NWL was calculated using the MIDENF® validated scale. Patient satisfaction was collected using the Hospital Consumer Assessment of Healthcare Provider Systems questionnaire. A total of 119 patients were enrolled: in 50, AVJA was primarily attempted with SA, and in 69 with FA. Compared with FA, SA was associated with a lower EP Lab NWL (169.8 ± 26.7 vs. 202.7 ± 38.9 min; P < 0.001) and a lower Ward NWL (474.5 ± 184.8 vs. 808.6 ± 289.9 min; P < 0.001). Multivariate analysis identified SA as an independent predictor of lower EP Lab NWL [hazard ratio (HR) 4.60; P = 0.001] and of lower Ward NWL (HR 45.13; P < 0.001). Compared with FA, SA was associated with a higher patient-reported rating regarding their experience during hospital stay (P = 0.035) and the overall hospital evaluation (P = 0.026). CONCLUSION: In patients undergoing simultaneous CSP and AVJA, the use of an SA for ablation is a valid alternative to conventional FA. Compared with FA, this approach significantly reduces NWL and is associated with greater patient satisfaction. REGISTRATION: ClinicalTrials.gov: NCT03612635.

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.

Upgrade from leadless to transvenous pacemaker with left bundle branch area pacing: A case report.

An 80-years-old patient with permanent atrial fibrillation and symptomatic, paroxysmal atrioventricular blocks (AVBs) underwent leadless pacemaker (L-PM) implantation. Seven years after implantation, as a consequence of a progression of the AVB towards a persistent form, resulting in an increased need for pacing, he developed a pacing-induced cardiomyopathy. He then underwent a successful upgrade from L-PM to a transvenous pacemaker (T-PM) with left bundle branch area pacing (LBBAP). The L-PM did not interfere with the T-PM and was turned off and abandoned. One month after the upgrading the patient showed a significant improvement in cardiac function and functional capacity.

Paucisymptomatic post COVID-19 myocarditis in a young athlete during return to play workflow: possible usefulness of global longitudinal strain analysis.

A young competitive athlete undergoes the diagnostic investigations protocol before returning to competitive practice (return to play protocol) after COVID-19 infection. Despite the paucisymptomatic presentation of COVID-19 infection and the absence of relevant anomalies in standard first-level diagnostic investigations, echocardiographic examination findings especially speckle tracking analysis (global longitudinal strain) along with some clinical aspects suggested further second-level investigations eventually allowing the identification of inflammatory myocardial damage.

Catheter ablation in patients with paroxysmal atrial fibrillation and absence of structural heart disease: A meta-analysis of randomized trials.

Introduction: Rhythm control strategy in paroxysmal atrial fibrillation (AF) can be performed with antiarrhythmic drugs (AAD) or catheter ablation (CA). Nevertheless, a clear overview of the percentage of freedom from AF over time and complications is lacking. Therefore, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing CA versus AAD. Methods: We searched databases up to 5 May 2023 for RCTs focusing on CA versus AAD. The study endpoints were atrial tachyarrhythmia (AT) recurrence, progression to persistent AF, overall complications, stroke/TIA, bleedings, heart failure (HF) hospitalization and all-cause mortality. Results: Twelve RCTs enrolling 2393 patients were included. CA showed a significantly lower AT recurrence rate at one year [27.4 % vs 56.3 %; RR: 0.45; p < 0.00001], at two years [39.9 % vs 62.7 %; RR: 0.56; p = 0.0004] and at three years [45.7 % vs 80.9 %; RR: 0.54; p < 0.0001] compared to AAD. Furthermore, CA significantly reduced the progression to persistent AF [1.6 % vs 12.9 %; RR: 0.14; p < 0.00001] with no differences in overall complications [5.9 % vs 4.5 %; RR: 1.27; p = 0.22], stroke/TIA [0.6 % vs 0.6 %; RR: 1.10; p = 0.86], bleedings [0.4 % vs 0.6 %; RR: 0.90; p = 0.84], HF hospitalization [0,3% vs 0,7%; RR: 0.56; p = 0.37] and all-cause mortality [0,4% vs 0.5 %; RR: 0.78; p = 0.67]. Subgroup analysis between radiofrequency and cryo-ablation or considering RCTs with CA as first-line treatment showed no significant differences. Conclusion: CA demonstrated lower rates of AT recurrence over the time, as well as a significant reduction in the progression from paroxysmal to persistent AF, with no difference in terms of energy source, complications, and clinical outcomes.

Superior approach from the pocket for atrioventricular junction ablation performed at the time of conduction system pacing implantation.

BACKGROUND: Conduction system pacing (CSP) and atrioventricular junction ablation (AVJA) improve outcomes in patients with symptomatic, refractory atrial fibrillation (AF). Superior approach (SA) from the pocket via axillary or subclavian vein has been proposed as an alternative to the conventional femoral venous access (FA) to perform AVJA. OBJECTIVE: To assess the feasibility and safety of SA for AVJA performed simultaneously with CSP, and to compare this approach with FA. METHODS: A prospective, observational study, enrolling consecutive patients with symptomatic, refractory AF undergoing simultaneous CSP and AVJA. RESULTS: A total of 107 patients were enrolled: in 50, AVJA was primarily attempted with SA, in 69 from FA. AVJA with SA was successful in 38 patients (76.0%), while in 12 patients, a subsequent FA was required. AVJA from FA was successful in 68 patients (98.5%), while in one patient, a left-sided approach via femoral artery was required. Compared with FA, SA was associated with a significantly longer duration of ablation (238.0 ± 218.2 vs. 161.9 ± 181.9 s; p = .035), a significantly shorter procedure time (28.1 ± 19.8 vs. 19.8 ± 16.8 min; p = .018), an earlier ambulation (2.7 ± 3.2 vs. 19.8 ± 0.1 h; p < .001), and an earlier discharge from procedure completion (24.0 ± 2.7 vs. 27.1 ± 5.1 h; p < .001). After a median follow-up of 12 months, the rate of complications was similar in the two groups (2.0% in SA, 4.3% in FA; p = .483). CONCLUSION: Simultaneous CSP and AVJA with SA is feasible, with a safety profile similar to FA. Compared to FA, this approach reduces the procedure times and allows earlier ambulation and discharge.

Spontaneous Sinus Rhythm Restoration in Patients With Refractory, Permanent Atrial Fibrillation Who Underwent Conduction System Pacing and Atrioventricular Junction Ablation.

Ablate and pace (A&P) with conduction system pacing (CSP) improves outcomes in patients with symptomatic permanent atrial fibrillation (AF). Data on spontaneous sinus rhythm restoration (SSRR) in this setting are lacking. This study aimed to assess the incidence and the predictors of SSRR in a population of patients with permanent AF who underwent A&P with CSP. Prospective, observational study, enrolling consecutive patients with symptomatic permanent AF (of documented duration >6 months) and uncontrolled, drug-refractory high ventricular rate, who underwent A&P with CSP. The incidence and predictors of SSRR were prospectively assessed. A total of 107 patients (79.0 ± 9.1 years, 33.6% male, 74.8% with New York Heart Association class ≥III, 56.1% with ejection fraction <40%) were enrolled: 40 received His' bundle pacing, 67 left bundle branch area pacing. During a median follow-up of 12 months SSRR was observed in 14 patients (13.1%), occurring a median of 3 months after A&P (interquartile range 1 to 6; range 0 to 17). Multivariable analysis identified a duration of permanent AF <12 months (hazard ratio 7.7, p = 0.040) and a left atrial volume index <49 ml/m2 (hazard ratio 14.8, p = 0.008) as independent predictors of SSRR. In patients with coexistence of both predictors the incidence of SSRR was of 41.4%. In a population of patients with symptomatic, permanent AF, treated with A&P with CSP, SSRR was observed in 13% of patients during follow-up. A duration of permanent AF <12 months and a left atrial volume index <49 ml/m2 were independent predictors of this phenomenon.

High power short duration versus low power long duration ablation in patients with atrial fibrillation: A meta-analysis of randomized trials.

BACKGROUND: High-power-short-duration (HPSD) radiofrequency (RF) ablation is a viable alternative to low-power-long-duration (LPLD) RF for pulmonary vein isolation (PVI). Nevertheless, trials showed conflicting results regarding atrial fibrillation (AF) recurrences and few data concerning complications. Therefore, we conducted a meta-analysis of randomized trials comparing HPSD versus LPLD. METHODS: We systematically searched the electronic databases for studies published from inception to March 31, 2023 focusing on HPSD versus LPLD. The study endpoints were AF recurrence, procedural times and overall complications. RESULTS: Five studies enrolling 424 patients met the inclusion criteria (mean age 61.1 years; 54.3% paroxysmal AF; mean LVEF 58.2%). Compared to LPLD, HPSD showed a significantly lower AF recurrence rate [16.3% vs. 30,1%; RR: 0.54 (95% CI: 0.38-0.79); p = 0.001] at a mean 10.9 months follow-up. Moreover, HPSD led to a significant reduction in total procedural time [MD: -26.25 min (95%CI: -42.89 to -9.61); p = 0.002], PVI time [MD: -26.44 min (95%CI: -38.32 to -14.55); p < 0.0001], RF application time [MD: -8.69 min (95%CI: -11.37 to -6.01); p < 0.00001] and RF lesion number [MD: -7.60 (95%CI: -10.15 to -5.05); p < 0.00001]. No difference was found in either right [80.4% vs. 78.2%; RR: 1.04 (95% CI: 0.81-1.32); p = 0.77] or left [92.3% vs. 90.2%; RR: 1.02 (95% CI: 0.94-1.11); p = 0.58] first-pass isolation and overall complications [6% vs. 3.7%; RR: 1.45 (95%CI: 0.53-3.99); p = 0.47] between groups. CONCLUSION: In our metanalysis of randomized trials, HPSD ablation appeared to be associated to a significantly improved freedom from AF and shorter procedures, without increasing the risk of complications.

Ablate and pace: Comparison of outcomes between conduction system pacing and biventricular pacing.

BACKGROUND: Conduction system pacing (CSP), including His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP), have been proposed as alternatives to biventricular pacing (BVP) in patients scheduled for ablate and pace (A&P) strategy. The aim of this study was to compare the clinical outcomes, including the rate and nature of device-related complications, between BVP and CSP in a cohort of patients undergoing A&P. METHODS: Prospective, multicenter, observational study, enrolling consecutive patients undergoing A&P. The risk of device-related complications and of heart failure (HF) hospitalization was prospectively assessed. RESULTS: A total of 373 patients (75.3 ± 8.7 years, 53.9% male, 68.9% with NYHA class ≥III) were enrolled: 263 with BVP, 68 with HBP, and 42 with LBBAP. Baseline characteristics of the three groups were similar. Compared to BVP and HBP, LBBAP was associated with the shortest mean procedural and fluoroscopy times and with the lowest acute capture thresholds (all p < .05). At 12-month follow-up LBBAP maintained the lowest capture thresholds and showed the longest estimated residual battery longevity (all p < .05). At 12-months follow-up the three study groups showed a similar risk of device-related complications (5.7%, 4.4%, and 2.4% for BVP, HBP, and LBBAP, respectively; p = .650), and of HF hospitalization (2.7%, 1.5%, and 2.4% for BVP, HBP, and LBBAP, respectively; p = .850). CONCLUSIONS: In the setting of A&P, CSP is a feasible pacing modality, with a midterm safety profile comparable to BVP. LBBAP offers the advantage of reducing procedural times and obtaining lower and stable capture thresholds, with a positive impact on the device longevity.

Possible systolic fascicular potentials in patients with left bundle branch block undergoing left bundle branch area pacing: A case series.

INTRODUCTION: In left bundle branch area pacing (LBBAP), several methods allow determination of lead depth during active fixation inside the septum: among these, visualization of a Purkinje potential indicates that the subendocardial area has been reached. In LBB block (LBBB) patients, fascicular potentials are visible as presystolic only in rare conditions. METHODS AND RESULTS: Since October 2022 until August 2023, LBBAP was attempted in 21 patients with LBBB at our Center: among the 18 consecutive patients (86%) in which it was successful, focusing on the terminal part of the unipolar ventricular electrogram (VEGM) recorded in the LBBA (where fixation beats occurred and conduction system (CS) capture was confirmed), we always observed discrete high-frequency, low-amplitude signals during spontaneous rhythm with LBBB morphology, showing a consistent coupling with the QRS onset, falling in a portion of QRS interval ranging from 58% to 80% of its overall duration, and disappearing during pacing. As found in a recently published case report, these sharp signals could represent the activation of left ventricular CS fibers, occurring passively from the septal working myocardium, and thus appearing lately in the VEGM. CONCLUSION: The possibility of recognizing discrete high-frequency, low-amplitude signals within the terminal portion of the unipolar VEGM, possibly representing left CS potentials, even in patients with LBBB, may constitute a useful additional means to notice operators about having reached the LBBA, thus helping to avoid perforation in the left ventricle.

Success and complication rates of conduction system pacing: a meta-analytical observational comparison of left bundle branch area pacing and His bundle pacing.

BACKGROUND: Left bundle branch area pacing (LBBAP) and His bundle pacing (HBP) are the main strategies to achieve conduction system pacing (CSP), but only observational studies with few patients have compared the two pacing strategies, sometimes with unclear results given the different definitions of the feasibility and safety outcomes. Therefore, we conducted a meta-analysis aiming to compare the success and complications of LBBAP versus HBP. METHODS: We systematically searched the electronic databases for studies published from inception to March 22, 2023, and focusing on LBBAP versus HBP. The study endpoints were CSP success rate, device-related complications, CSP lead-related complications and non-CSP lead-related complications. RESULTS: Fifteen observational studies enrolling 2491 patients met the inclusion criteria. LBBAP led to a significant increase in procedural success [91.1% vs 80.9%; RR: 1.15 (95% CI: 1.08-1.22); p < 0.00001] with a significantly lower complication rate [1.8% vs 5.2%; RR: 0.48 (95% CI: 0.29-0.78); p = 0.003], lead-related complications [1.1% vs 4.3%; RR: 0.38 (95% CI: 0.21-0.72); p = 0.003] and lead failure/deactivation [0.2% vs 3.9%; RR: 0.16 (95% CI: 0.07-0.35); p < 0.00001] than HBP. No significant differences were found between CSP lead dislodgement and non-CSP lead-related complications. CONCLUSION: This meta-analysis of observational studies showed a higher success rate of LBBAP compared to HBP with a lower incidence of complications.

Endocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis.

INTRODUCTION: Pacemaker-dependent (PM) patients with cardiac implantable electronic device (CIED) infection require implantation of a temporary-pacemaker (TP) and delayed endocardial reimplantation or implantation of an epicardial-pacing-system (EPI) before device extraction. Our aim was to compare the TP and EPI-strategy after CIED extraction through a meta-analysis. METHODS: We searched electronic databases up to 25 March 2022, for observational studies that reported clinical outcomes of PM-dependent patients implanted with TP or EPI-strategy after device extraction. RESULTS: 3 studies were included enrolling 339 patients (TP: 156 patients; EPI: 183 patients). TP compared to EPI showed reduction in the composite outcome of relevant complications (all-cause death, infections, need for revision or upgrading of the reimplanted CIED) (12.1% vs 28.9%; RR: 0.45; 95%CI: 0.25-0.81; p = 0.008) and a trend in reduction of all-cause death (8.9% vs 14.2%; RR: 0.58; 95%CI: 0.33-1.05; p = 0.07). Furthermore, TP-strategy proved to reduce need of upgrading (0% vs 12%; RR: 0.07; 95%CI: 0.01-0.52; p = 0.009), reintervention on reimplanted CIED (1.9% vs 14.7%; RR: 0.15; 95%CI: 0.05-0.48; p = 0.001) and significant increase in pacing threshold (0% vs 5.4%; RR: 0.17; 95%CI: 0.03-0.92; p = 0.04), with a longer discharge time (MD: 9.60 days; 95%CI: 1.98-17.22; p = 0.01). CONCLUSION: TP-strategy led to a reduction of the composite outcome of all-cause death and complications, upgrading, reintervention on reimplanted CIED, and risk of increase in pacing threshold compared to EPI-strategy, with longer discharge time.

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.

Left bundle branch pacing versus biventricular pacing for cardiac resynchronization therapy: A systematic review and meta-analysis.

INTRODUCTION: Cardiac resynchronization therapy (CRT) reduces heart failure (HF) hospitalization and all-cause mortality in HF patients with left bundle branch block (LBBB). Biventricular pacing (BVP) is the gold standard for achieving CRT, but about 30%-40% of patients do not respond to BVP-CRT. Recent studies showed that left bundle branch pacing (LBBP) provided remarkable results in CRT. Therefore, we conducted a meta-analysis aiming to compare LBBP-CRT versus BVP-CRT in HF patients. METHODS: We systematically searched the electronic databases for studies published from inception to December 29, 2022 and focusing on LBBP-CRT versus BVP-CRT in HF patients. The primary endpoint was HF hospitalization. The effect size was estimated using a random-effect model as Risk Ratio (RR) and mean difference (MD). RESULTS: Ten studies enrolling 1063 patients met the inclusion criteria. Compared to BVP-CRT, LBBP-CRT led to significant reduction in HF hospitalization [7.9% vs.14.5%; RR: 0.60 (95%CI: 0.39-0.93); p = .02], QRSd [MD: 30.26 ms (95%CI: 26.68-33.84); p < .00001] and pacing threshold [MD: -0.60 (95%CI: -0.71 to -0.48); p < .00001] at follow up. Furthermore, LBBP-CRT improved LVEF [MD: 5.78% (95%CI: 4.78-6.77); p < .00001], the rate of responder [88.5% vs.72.5%; RR: 1.19 (95%CI: 1.07-1.32); p = .002] and super-responder [60.8% vs. 36.5%; RR: 1.56 (95%CI: 1.27-1.91); p < .0001] patients and the NYHA class [MD: -0.42 (95%CI: -0.71 to -0.14); p < .00001] compared to BVP-CRT. CONCLUSION: In HF patients, LBBP-CRT was superior to BVP-CRT in reducing HF hospitalization. Further significant benefits occurred within the LBBP-CRT group in terms of QRSd, LVEF, pacing thresholds, NYHA class and the rate of responder and super-responder patients.

The PhysioVP-AF study, a randomized controlled trial to assess the clinical benefit of physiological ventricular pacing vs. managed ventricular pacing for persistent atrial fibrillation prevention in patients with prolonged atrioventricular conduction: design and rationale.

AIMS: In patients with prolonged atrioventricular (AV) conduction and pacemaker (PM) indication due to sinus node disease (SND) or intermittent AV-block who do not need continuous ventricular pacing (VP), it may be difficult to determine which strategy to adopt. Currently, the standard of care is to minimize unnecessary VP by specific VP avoidance (VPA) algorithms. The superiority of this strategy over standard DDD or DDD rate-responsive (DDD/DDDR) in improving clinical outcomes is controversial, probably owing to the prolongation of the atrialventricular conduction (PR interval) caused by the algorithms. Conduction system pacing (CSP) may offer the most physiological-VP approach, providing appropriate AV conduction and preventing pacing-induced dyssynchrony. METHODS AND RESULTS: PhysioVP-AF is a prospective, controlled, randomized, single-blind trial designed to determine whether atrial-synchronized conduction system pacing (DDD-CSP) is superior to standard DDD-VPA pacing in terms of 3-year reduction of persistent-AF occurrence. Cardiovascular hospitalization, quality-of-life, and safety will be evaluated. Patients with indication for permanent DDD pacing for SND or intermittent AV-block and prolonged AV conduction (PR interval > 180 ms) will be randomized (1:1 ratio) to DDD-VPA (VPA-algorithms ON, septal/apex position) or to DDD-CSP (His bundle or left bundle branch area pacing, AV-delay setting to control PR interval, VPA-algorithms OFF). Approximately 400 patients will be randomized in 24 months in 13 Italian centres. CONCLUSION: The PhysioVP-AF study will provide an essential contribution to patient management with prolonged AV conduction and PM indication for sinus nodal disease or paroxysmal 2nd-degree AV-block by determining whether CSP combined with a controlled PR interval is superior to standard management that minimizes unnecessary VP in terms of reducing clinical outcomes.

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.

Effectiveness and safety of implantable loop recorder and clinical utility of remote monitoring in patients with unexplained, recurrent, traumatic syncope.

BACKGROUND: Implantable loop recorder (ILR) is still underutilized in clinical practice, especially in the setting of elderly patients with recurrent, traumatic, unexplained syncope. Data on the actual risk of traumatic syncopal recurrence during ILR monitoring in this specific patient setting are lacking. RESEARCH DESIGN AND METHODS: Prospective, multicentre registry enrolling consecutive patients undergoing ILR insertion for unexplained, recurrent, traumatic syncope. In a proportion of enrolled patients, remote monitoring (RM) was used for device follow-up. The risk of traumatic and non-traumatic syncopal recurrences during ILR observation were prospectively assessed. RESULTS: A total of 483 consecutive patients (68±14 years, 59% male) were enrolled. During a median follow-up of 18 months, a final diagnosis was reached in 270 patients (55.9%). The risk of syncopal and traumatic syncopal recurrence was of 26.5 and 9.3%, respectively. RM significantly reduced the time to diagnosis (19.7±10.3 vs. 22.1±10.8 months; p=0.015) and was associated with a significant reduction in the risk of syncope recurrence of 48% (p<0.001), and of traumatic syncope recurrence of 49% (p=0.018). CONCLUSIONS: ILR monitoring is effective and safe in patients with unexplained, recurrent, traumatic syncope. RM reduces the time to diagnosis and significantly reduces the risk of traumatic and non-traumatic syncopal relapses.