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.

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.

Impact of atrioventricular junction ablation and CRT-D on long-term mortality in patients with left ventricular dysfunction, permanent, refractory atrial fibrillation, and narrow QRS: Results of a propensity-matched analysis.

INTRODUCTION: In patients with symptomatic permanent atrial fibrillation (PEAF) and narrow QRS, atrio-ventricular junction ablation (AVJA) plus cardiac resynchronization therapy (CRT) is superior to medical therapy in reducing heart failure (HF) hospitalization and all-cause mortality. To compare the mortality of a population of patients with HF, reduced EF (rEF), and PEAF treated with AVJA plus CRT with that of a contemporary cohort of patients in sinus rhythm (SR) with similar baseline characteristics. METHODS AND RESULTS: In this prospective, multicentre, observational study, all-cause mortality in a group of consecutive patients undergoing AVJA and implantable cardioverter-defibrillator (ICD) combined with CRT implantation for HFrEF, narrow QRS, and PEAF with uncontrolled ventricular rate was compared with that of a contemporary cohort of patients in SR undergoing ICD implantation (not combined with CRT) for HFrEF and narrow QRS. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 824 patients were enrolled. Propensity matching yielded 107 matched pairs. After a median follow-up of 52 months, all-cause mortality was similar in patients treated with AVJA plus CRT and in the control group (p = .434). In AVJA plus CRT patients, mortality was significantly lower than in control group patients with a history of paroxysmal/persistent AF (n = 45, p = .020), and similar to that of patients without a history of AF (n = 62, p = .459). CONCLUSIONS: After adjustment for patient characteristics, the long-term prognosis of patients with HFrEF, narrow QRS, and PEAF who underwent AVJA plus CRT was similar to that of a population of patients in SR with similar characteristics.

Management of older patients with unexplained, recurrent, traumatic syncope and bifascicular block: Implantable loop recorder versus empiric pacemaker implantation-Results of a propensity-matched analysis.

BACKGROUND: In patients with unexplained syncope and bifascicular block (BFB), syncope may be caused by intermittent atrioventricular (AV) block. When a correlation between syncope and bradyarrhythmia is not documented in these patients, 2 alternative management strategies can be adopted: (1) empiric pacemaker (PM) implantation or (2) long-term continuous electrocardiographic monitoring by implantable loop recorder (ILR). OBJECTIVE: The purpose of this study was to compare the risk of syncope recurrence associated with empiric PM implantation or ILR monitoring. METHODS: A prospective, multicenter, observational study enrolled consecutive patients with unexplained, recurrent, traumatic syncope and BFB who underwent ILR monitoring or empiric PM implantation. The risk and causes of syncope recurrence were assessed and compared between the 2 groups. Individual 1:1 propensity matching of baseline characteristics was performed. RESULTS: A total of 309 consecutive patients (age 77.2 ± 12.2 years; 60.8% male) were enrolled. Propensity matching yielded 89 matched pairs. After median follow-up of 33 months, empiric PM implantation was associated with a significantly lower risk of syncope recurrence than ILR monitoring (19.1 vs 46.1%; P <.001). A total of 35 patients (39.3%) who underwent ILR monitoring developed bradyarrhythmias (68.6% paroxysmal AV block) requiring PM implantation during follow-up. Excluding bradyarrhythmic syncope, the most frequent causes of syncope recurrence in both study groups were reflex syncope and orthostatic hypotension. CONCLUSION: In patients with unexplained, recurrent, traumatic syncope and BFB, empiric PM implantation significantly reduced the risk of syncope recurrence in comparison with ILR monitoring. A high rate of patients who underwent ILR monitoring developed bradyarrhythmias requiring PM implantation.

Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy.

INTRODUCTION: Comparison data on management of device-related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous ICD (TV-ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long-term device-related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S-ICD or TV-ICD implantation. METHODS AND RESULTS: A total of 1099 consecutive patients who underwent S-ICD or TV-ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device-related complications were analyzed and compared between two groups. During a mean follow-up of 30 months, device-related complications requiring surgical revision were observed in 20 patients: 3 in S-ICD group (1.8%) and 17 in TV-ICD group (10.1%; p = .002). Compared with TV-ICD patients, S-ICD patients showed a significantly lower risk of lead-related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket-related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S-ICD patients resulted in a significantly lower number of complications-related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV-ICD patients. CONCLUSIONS: Compared with TV-ICD, S-ICD is associated with a lower risk of complications, mainly due to a lower risk of lead-related complications. The management of S-ICD complications requires fewer and shorter rehospitalizations.

Axillary vein access for antiarrhythmic cardiac device implantation: a literature review.

The current narrative review provides an update of available knowledge on venous access techniques for cardiac implantable electronic device implantation, with a focus on axillary vein puncture. Lower procedure-related and lead-related complications have been reported with extrathoracic vein puncture techniques compared with intrathoracic accesses. In particular, extrathoracic lead access through the axillary vein seems to be associated with lower complication incidence than subclavian vein puncture and higher success rate than cephalic vein cutdown. In literature, many techniques have been described for axillary vein access. The use of contrast venography-guided puncture has facilitated the diffusion of the axillary vein approach for device implantation. Venography may be particularly useful in specific demographic and clinical device implantation contexts. Ultrasound-guided or microwire-guided vascular access for lead positioning can be considered a valid alternative to venography, although current applications for axillary vein puncture need further evaluations.

Causes of syncopal recurrences in patients treated with permanent pacing for bradyarrhythmic syncope: Findings from the SYNCOPACED registry.

BACKGROUND: Few studies have examined the causes of syncope/collapse recurrences in patients with a previously implanted pacemaker for bradyarrhythmic syncope. OBJECTIVE: The purpose of this study was to assess the causes of syncope/collapse recurrences after pacemaker implantation for bradyarrhythmic syncope in a large patient population. METHODS: The SYNCOpal recurrences in patients treated with permanent PACing for bradyarrhythmic syncope (SYNCOPACED) registry was a prospective multicenter observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope. During follow-up, the time to the first syncope/collapse recurrence was recorded. Patients with syncope/collapse recurrences underwent a predefined diagnostic workup aimed at establishing the mechanism of syncope/collapse. RESULTS: During a median follow-up of 50 months, 213 patients (15.6%) reported at least 1 syncope/collapse recurrence. The risk of syncope/collapse recurrence was highest in patients who underwent implantation for cardioinhibitory vasovagal syncope (26.4%), followed by unexplained syncope and chronic bifascicular block (21.5%), cardioinhibitory carotid sinus syndrome (17.2%), atrial fibrillation needing pacing (15.5%), atrioventricular block (13.6%), and sinus node disease (12.5%) (P = .017). The most frequent cause of syncope/collapse recurrence was reflex syncope (27.7%), followed by orthostatic hypotension (26.3%), pacemaker or lead malfunction (5.6%), structural cardiac disease (5.2%), and atrial and ventricular tachyarrhythmias (4.7% and 3.8%, respectively). In 26.8% of cases, the mechanism of syncope/collapse remained unexplained. CONCLUSION: In patients receiving a pacemaker for bradyarrhythmic syncope, reflex syncope and orthostatic hypotension are the most frequent mechanisms of syncope/collapse recurrence after implantation. Pacing system malfunction, structural cardiac diseases, and tachyarrhythmias are rare mechanisms. The mechanism remains unexplained in >25% of patients.

Risk of syncopal recurrences in patients treated with permanent pacing for bradyarrhythmic syncope: role of correlation between symptoms and electrocardiogram findings.

AIMS: To evaluate the risk of syncopal recurrences after pacemaker implantation in a population of patients with syncope of suspected bradyarrhythmic aetiology. METHODS AND RESULTS: Prospective, multicentre, observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed). Before pacemaker implantation, all patients underwent a cardiac work-up in order to establish the bradyarrhythmic aetiology of syncope. According to the results of the diagnostic work-up, patients were divided into three groups: Group A, patients in whom a syncope-electrocardiogram (ECG) correlation was established (n = 329, 24.1%); Group B, those in whom clinically significant bradyarrhythmias were detected without a documented syncope-ECG correlation (n = 877, 64.3%); and Group C, those in whom bradyarrhythmias were not detected and the bradyarrhythmic origin of syncope remained presumptive (n = 158, 11.6%). During a median follow-up of 50 months, 213 patients (15.6%) reported at least one syncopal recurrence. Patients in Groups B and C showed a significantly higher risk of syncopal recurrences than those in Group A [hazard ratios (HRs): 1.60 and 2.66, respectively, P < 0.05]. Failure to establish a syncope-ECG correlation during diagnostic work-up before pacemaker implantation was an independent predictor of syncopal recurrence on multivariate analysis (HR: 1.90; P = 0.002). CONCLUSION: In selecting patients with syncope of suspected bradyarrhythmic aetiology for pacemaker implantation, establishing a correlation between syncope and bradyarrhythmias maximizes the efficacy of pacing and reduces the risk of syncopal recurrences.

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.

OBJECTIVES: This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. BACKGROUND: Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. METHODS: The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. RESULTS: During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. CONCLUSIONS: All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.

Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy.

AIMS: Anatomical placement of the coronary sinus (CS) lead in basal or mid-ventricular positions of the posterior and lateral walls is associated with a better clinical outcome of cardiac resynchronization therapy (CRT). We hypothesized that optimization of CS lead placement targeted the right-to-left electrical delay (RLD) predicts an additional clinical benefit. METHODS AND RESULTS: The CS lead was placed according to current standards in 90 patients (Conventional group) and at the site of the longest RLD in 121 patients (RLD group). Non-responders were defined as those who died or underwent hospitalization for heart failure or did not improve in their Clinical Composite Score within 6 months. There were 67 (32%) non-responders. Compared with Conventional group, the final CS pacing site was more frequently in the basal segments in the RLD group (40% vs. 23%, P = 0.007); moreover, the RLD ratio (%RLD) of the total QRS width was longer (77 ± 13 vs. 73 ± 15, P = 0.05) and biventricular QRS shortened more from the baseline (-31 ± 21 ms vs. -21 ± 26 ms, P = 0.004). Nevertheless, the rate of non-responders was similar in the RLD and Conventional groups (35% vs. 28%, P = 0.30), as was %RLD (76 ± 16 vs. 75 ± 13, P = 0.66). QRS width during right ventricular (RV) pacing was an independent predictors of adverse outcome, with a 2% increase in the risk of failure for each 1 ms increase in QRS (P = 0.006). CONCLUSION: Optimization of CS lead placement targeted to latest electrical activation does not provide additional clinical benefit to anatomical placement in basal or mid-ventricular positions of the posterior and lateral walls. QRS width during RV pacing was a strong predictor of CRT failure. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT03204864.

Optimization of coronary sinus lead placement targeted to the longest right-to-left delay in patients undergoing cardiac resynchronization therapy: The Optimal Pacing SITE 2 (OPSITE 2) acute study and protocol.

AIMS: Left ventricular (LV) lead positioning at the site of delayed electrical activation is associated with better response to cardiac resynchronization therapy (CRT). We hypothesized that a long electrical conduction delay between right ventricular (RV) and coronary sinus (CS) leads during RV pacing (RLD index) is correlated with a better clinical outcome METHODS AND RESULTS: RLD is measured intraprocedurally, during RV pacing, as the time interval between the intracardiac electrograms of RV and CS leads. Initially, we did a prove-of-concept, feasibility, acute study in 97 patients who underwent CRT implantation. The CS lead position was assessed in the 40° right anterior oblique and 40° left anterior oblique views and assigned to one of 11 prespecified segments of a schematic eyeball depiction of the LV walls. Acute outcomes were QRS width during biventricular (BIV) pacing. The longest RLD were found in the basal and mid lateral segments; these accounted for 82% and 78%, respectively, of the total QRS width (%RLD). %RLD was inversely correlated with BIV-paced QRS (P  =  0.0001). A similar slope was present either in the 78 patients with preserved atrioventricular (AV) conduction and in the 19 without AV conduction (- 0.34 vs - 0.27, P  =  0.7). CONCLUSION: We showed that RLD can be used to guide lead placement at the time of CRT implantation and that it is correlated with BIV-QRS width, an indirect predictor of clinical outcome. Based on these findings we started the prospective, multicenter Optimal Pacing SITE 2 (OPSITE 2) trial with the objective to demonstrate a relationship between RLD and clinical outcomes assessed as death, hospitalization for heart failure, New York Heart Association class, and clinical composite score. The protocol is provided.

Risk of syncope during work.

AIMS: Little is known regarding the overall prevalence of syncope in a population of workers and the risk of occurrence during working time. METHODS AND RESULTS: A total of 452 consecutive workers (mean age: 46 ± 9 years) were invited to answer an anonymous questionnaire. They had been employed for 22 ± 10 years for a total of 9765 years worked. In the cohort, 160 subjects (35%) reported a total of 465 episodes of syncope during their lives; 64 (14%) suffered a syncopal episode after the start of employment, but only 26 (5.7%) reported syncope at work, 7 (1.5%) having had 2 episodes, and 1 (0.2%) 3 episodes (total: 36 episodes). The risk of syncope during work was 4.6 times higher for those who had a prior history of syncope [18 of 138 (13%)] than for those who did not [8 of 314 (3%), P = 0.001]. The occurrence of syncope during work for the patients with a history of syncope was one syncopal episode in every 99 years worked and for those who had already had an episode during work, one episode in every 16 years worked. Only one patient experienced minor trauma as a consequence of syncope during work and three were referred to the emergency department. All patients continued their employment without any problems. CONCLUSION: The prevalence of syncope during work is low and its impact is benign. The probability of syncope during work is higher for subjects with a history of syncope.