Dual-chamber vs. single-chamber pacemaker in patients in sinus rhythm with an atrioventricular block: a nationwide cohort study.

AIMS: In complete atrioventricular block (AVB) with underlying sinus rhythm, it is recommended to implant a dual-chamber pacemaker rather than a single-chamber pacemaker. However, no large-scale study has been able to demonstrate the superiority of this choice on hard clinical criteria such as morbimortality. METHODS AND RESULTS: This retrospective observational study included all patients who received a primary pacemaker implantation in the indication of complete AVB with underlying sinus rhythm in France, based on the national administrative database between January 2013 and December 2022. After propensity score matching, we obtained two groups containing 19 219 patients each. The incidence of all-cause mortality was 9.22%/year for the dual-chamber pacemaker group, compared with 11.48%/year for the single-chamber pacemaker group (hazard ratio (HR) 0.807, P < 0.0001]. Similarly, there was a lower incidence of cardiovascular mortality (HR 0.766, P < 0.0001), heart failure (HR 0.908, P < 0.0001), atrial fibrillation (HR 0.778, P < 0.0001), and ischaemic stroke (HR 0.873, P = 0.008) in the dual-chamber pacemaker group than in the single-chamber pacemaker group. Regarding re-interventions and complications, there were fewer upgrades (addition of atrial lead or left ventricular lead) in the dual-chamber group (HR 0.210, P < 0.0001), but more haematomas (HR 1.179, P = 0.006) and lead repositioning (HR 1.123, P = 0.04). CONCLUSION: In the indication of complete AVB with underlying sinus rhythm, our results are consistent with current recommendations to prefer implantation of a dual-chamber pacemaker rather than a single-chamber pacemaker for these patients. Implantation of a dual-chamber pacemaker is associated with a lower risk of mortality, heart failure, atrial fibrillation, and stroke during follow-up.

Predictors of complications and mortality among patients undergoing pacemaker implantation in resource-limited settings: a 10-year retrospective follow-up study.

INTRODUCTION: Pacemakers (PMs) are used to treat patients with severe bradycardia symptoms. They do, however, pose several complications. Even with these risks, there are only a few studies assessing PM implantation outcomes in resource-limited settings like Ethiopia and other sub-Saharan countries in general. Therefore, this study aims to assess the mid-term outcome of PM implantation in patients who have undergone PM implantation in the Cardiac Center of Ethiopia by identifying the rate and predictors of complications and death. METHODOLOGY: This retrospective study was conducted at the Cardiac Center of Ethiopia from October 2023 to January 2024 on patients who had PM implantation from September 2012 to August 2023 to assess the midterm outcome of the patients. Complication rate and all-cause mortality rate were the outcomes of our study. Multivariable logistic regression was used to identify factors associated with complications and death. To analyze survival times, a Kaplan-Meier analysis was performed. RESULTS: This retrospective follow-up study included 182 patients who underwent PM implantation between September 2012 and August 2023 and were at least 18 years old. The patients' median follow-up duration was 72 months (Interquartile range (IQR): 36-96 months). At the end of the study, 26.4% of patients experienced complications. The three most frequent complications were lead dislodgement, which affected 6.6% of patients, PM-induced tachycardia, which affected 5.5% of patients, and early battery depletion, which affected 5.5% of patients. Older age (Adjusted Odds Ratio (AOR) 1.1, 95% CI 1.04-1.1, p value < 0.001), being female (AOR 4.5, 95%CI 2-9.9, p value < 0.001), having dual chamber PM (AOR 2.95, 95%CI 1.14-7.6, p value = 0.006) were predictors of complications. Thirty-one (17%) patients died during the follow-up period. The survival rates of our patients at 3, 5, and 10 years were 94.4%, 92.1%, and 65.5% respectively with a median survival time of 11 years. Patients with a higher Charlson comorbidity index before PM implantation (AOR 1.2, 95% CI 1.1-1.8, p = 0.04), presence of complications (AOR 3.5, 95% CI 1.2-10.6, p < 0.03), and New York Heart Association (NYHA) class III or IV (AOR 3.3, 95% CI 1.05-10.1, p = 0.04) were associated with mortality. CONCLUSION: Many complications were experienced by patients who had PMs implanted, and several factors affected their prognosis. Thus, it is essential to identify predictors of both complications and mortality to prioritize and address the manageable factors associated with both mortality and complications.

Sex differences in long-term outcomes following transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center. METHODS: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. RESULTS: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68). CONCLUSION: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed.

Clinical significance and prognostic value of right bundle branch block in permanent pacemaker patients.

AIMS: In patients undergoing pacemaker implantation with no prior history of heart failure (HF), the presence of left bundle branch block (LBBB) has been identified as an independent predictor of HF-related death or hospitalization, while the prognostic significance of right bundle branch block (RBBB) remains uncertain. We aimed to assess the long-term risk of all-cause mortality in patients with a standard indication for permanent pacing and normal or moderately depressed left ventricular function when RBBB is detected at the time of implantation. METHODS: We retrospectively enrolled 1348 consecutive patients who had undergone single- or dual-chamber pacemaker implantation at the study center, from January 1990 to December 2022. Patients with a left ventricular ejection fraction ≤35% or a prior diagnosis of HF were excluded. RESULTS: The baseline 12-lead electrocardiogram revealed an RBBB in 241 (18%) and an LBBB in 98 (7%) patients. During a median follow-up of 65 [25th-75th percentile: 32-117] months, 704 (52%) patients died. The combined endpoint of cardiovascular death or HF hospitalization was reached by 173 (13%) patients. On multivariate analysis, RBBB was confirmed as an independent predictor of death [hazard ratio, 1.33; 95% confidence interval (CI), 1.09-1.63; P  = 0.005]. However, when considering the combined endpoint of cardiovascular death and HF hospitalization, this endpoint was independently associated with LBBB (hazard ratio, 2.13; 95% CI, 1.38-3.29; P  < 0.001), but not with RBBB. CONCLUSION: In patients with standard pacemaker indications and normal or moderately depressed left ventricular function, the presence of basal RBBB was an independent predictor of mortality. However, it was not associated with the combined endpoint of cardiovascular death and HF hospitalization.

Contemporary trends of leadless pacemaker implantation in the United States.

INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Electrical storm: Prognosis and management.

Electrical storm is present when a cluster of ventricular arrhythmias (VAs) occurs within a short time frame. The most widely accepted definition is 3 or more episodes of VA within a 24-h period, although prognostic risk begins to rise when 2 or more events occur within 3months. Electrical storm often presents as a medical emergency in the form of recurrent implantable cardiac defibrillator (ICD) shocks, recurrent syncope in patients with no ICD or low cardiac output symptoms. Management often requires a multimodality approach including ICD management, pharmacologic therapy, catheter ablation and modulations of the autonomic nervous system. In this article, we review the definition, prognosis and management of electrical storm.

Factors associated with temporary pacing insertion in patients with inferior ST-segment elevation myocardial infarction.

BACKGROUND: High-degree atrioventricular block (HAVB) is a prognostic factor for survival in patients with inferior ST-segment elevation myocardial infarction (STEMI). However, there is little information about factors associated with temporary pacing (TP). The aim of this study was to find factors associated with TP in patients with inferior STEMI. METHODS: We included 232 inferior STEMI patients, and divided those into the TP group (n = 46) and the non-TP group (n = 186). Factors associated with TP were retrospectively investigated using multivariate logistic regression model. RESULTS: The incidence of right ventricular (RV) infarction was significantly higher in the TP group (19.6%) than in the non-TP group (7.5%) (p = 0.024), but the incidence of in-hospital death was similar between the 2 groups (4.3% vs. 4.8%, p = 1.000). Long-term major adverse cardiovascular events (MACE), which were defined as a composite of all-cause death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and readmission for heart failure, were not different between the 2 groups (p = 0.100). In the multivariate logistic regression analysis, statin at admission [odds ratio (OR) 0.230, 95% confidence interval (CI) 0.062-0.860, p = 0.029], HAVB at admission (OR 9.950, 95% CI 4.099-24.152, p<0.001), and TIMI-thrombus grade ≥3 (OR 10.762, 95% CI 1.385-83.635, p = 0.023) were significantly associated with TP. CONCLUSION: Statin at admission, HAVB at admission, and TIMI-thrombus grade ≥3 were associated with TP in patients with inferior STEMI. Although the patients with TP had the higher incidence of RV infarction, the incidence of in-hospital death and long-term MACE was not different between patients with TP and those without.

Mid-term results after isolated tricuspid valve surgery in the presence of right ventricular leads.

BACKGROUND: Patients with tricuspid valve (TV) disease and indication for TV surgery frequently have permanent pacemaker (PM) or defibrillator (AICD) leads, placed in the right ventricle (RV). The aim of this study was to analyze postoperative results and mid-term outcomes after isolated TV surgery (with no further concomitant cardiac procedures) in the presence of permanent RV leads. METHODS: From January 2005 to January 2019 a total of 80 patients (mean age: 67.7±10.3 yrs; 56.3% male) with isolated TV disease and presence of at least one permanent RV lead in place were referred to our institution for isolated TV repair/replacement; patients with concomitant procedures were excluded for this analysis. All data were retrospectively analyzed. The follow-up was 98% complete. RESULTS: Mean follow-up time was 4.3±3.9 years. Mean preoperative clinical NYHA status was 3.0±0.8, left ventricular ejection fraction 50.7±12.9%, mean pulmonary artery pressure 23.8±9.3mmHg, creatinine 125.7±57.5µmol/L, mean MELD-XI Score (Model of End-stage-Liver Disease excluding INR) was 14.6±5.0 µmol/L. Thirty-day mortality was 6.3% with a 5-years survival of 58.2±6.0%. Cox regression analysis revealed the MELD-XI-Score as the only highly significant predictor for postoperative mortality (P=0.002). CONCLUSIONS: Hepatorenal dysfunction - possibly indicating long lasting TV failure - could be a factor for limited postoperative survival in our patient cohort. This finding could underline our hypothesis, that early TV surgery may achieve better postoperative survival, even in patients with TV disease caused by RV leads. Therefore, further investigations are needed.

Prevention of Retrograde Ascending Aortic Dissection by Cardiac Pacing During Hybrid Surgery for Zone 0 Aortic Arch Repair.

BACKGROUND: Retrograde type A dissection (RTAD) after zone 0 hybrid aortic arch repair is highly lethal and not infrequent complication. The aim of this study was to assess the safety and effectiveness of rapid cardiac pacing as an adjunctive tool to prevent RTAD during or after hybrid procedures for zone 0 disease. METHODS: We performed a retrospective review of 42 consecutive patients with zone 0 hybrid aortic arch repair between November 2004 and January 2018. Right ventricular pacing was carried out through unipolar electrodes attached to the epicardium of the right ventricle through the sternotomy (the indifferent electrode was in the subcutaneous tissue). Pacing was utilised during the clamping of the ascending aorta, release of the aortic clamp, and stent-graft deployment. RESULTS: Operative indications were aortic arch aneurysm 45% (n = 19), aortic arch dissection 45% (n = 19), traumatic rupture of isthmus 7% (n = 3), and type IA endoleak 2% (n = 1). Urgent procedures 48% (n = 20). The mean proximal aortic diameter was 34.14 ± 2.9 mm. Mean stent-graft oversizing was 12.97 ± 3.4%. The 30-day mortality rate was 14% (n = 6). RTAD was observed in 7% (n = 3). The actuarial survival rate was 74% over a mean follow-up of 50 ± 30.2 months. Since January 2013, rapid right ventricular pacing (overdrive pacing at a rate of 200 beats/min) was systematically used (n = 24). No RTAD was observed in this group of patients. Rapid right ventricular pacing reduced significatively the risk of RTAD (P = 0.038). CONCLUSIONS: Rapid right ventricular pacing is an effective method of inducing hypotension and appears to decrease the risk of retrograde type A dissection after zone 0 hybrid aortic arch repair.

Long-term prognosis of patients with permanent cardiac pacemaker indication in three referral cardiac centers in Cameroon: Insights from the National pacemaker registry.

BACKGROUND: There is evidence that cardiac pacemakers improve symptoms and quality of life in patients with severe bradycardia. Globally, the number of pacemaker implantations is on the rise. However, the associated high-cost limits pacemaker's accessibility in low resource settings. This study aimed to investigate access to pacemakers and the long-term outcome of patients requiring a pacemaker. METHOD: We conducted a cohort study in 03 health care structures in Cameroon. Participants aged at least 18 years with indication for a permanent pacemaker between January 2010 and May 2016 were included. Clinical profile, electrocardiography, pacemaker implantation parameters were recorded. Long-term survival was studied by event-free analysis using the Kaplan-Meier method. RESULTS: In total, 147 participants (mean age 67.7±13.7 years, female 58.5%) were included. Fatigue (78.7%), dyspnoea (77.2%), dizziness (47.1%) and palpitations (40.4%) were the main symptoms while syncope was present in 35.7% of patients. The main indication for cardiac pacemaker was atrioventricular block (85.3%). Forty (27.2%) could not be implanted with 34 (85%) of participants highlighting cost of intervention as main reason. VVIR was the main mode of stimulation (70.5%). Of 125 patients in which follow-up was ascertained, 17(13.5%) died after a median survival time of 2.8 years post diagnosis [IQR: 1.8-4.2]. The survival curve was better in participants with a pacemaker with a Hazard ratio of 2.7 [CI: 1.0-7.3, P=0.045]. CONCLUSION: Our patients with severe heart blocks presented late and more than a quarter did not have access to pacemaker but its implantation multiplied the survival rate by 2.7 times at approximately 3 years post diagnosis. Improving early detection of heart blocks and access to cardiac pacing to reduce mortality shall be a key future priority.

Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement.

OBJECTIVES: The aim of this study was to determine the prevalence of pacemaker lead-related complications following transcatheter tricuspid valve replacement (TTVR). BACKGROUND: The rate of permanent pacemaker implantation following tricuspid valve (TV) surgery is high, and many patients have transvenous leads. The feasibility, safety, and outcomes of subsequently performing TTVR in the setting of transvenous pacemaker leads have not been established. METHODS: The VIVID (Valve-in-Valve International Database) registry was used to review 329 patients who underwent TTVR following TV repair or replacement. Patients were subdivided into 3 cohorts for intergroup comparisons: no lead, epicardial lead, and transvenous lead (entrapped or not entrapped during the TTVR procedure). RESULTS: Of 329 patients who underwent TTVR, 128 (39%) had prior pacing systems in place, 70 with epicardial and 58 with transvenous leads. A total of 31 patients had leads passing through the TV. Three patients had the right ventricular (RV) lead extracted prior to TTVR. The remaining 28 patients had the RV lead entrapped between the transcatheter TV implant and the surgical valve (n = 22) or the repaired TV (n = 6). One patient had displacement of the RV lead during the procedure, and 2 experienced lead failure during follow-up. Overall, there was no significant difference in the cumulative incidences of competing outcomes (death, TV reintervention, TV dysfunction) between patients with and those without pacing leads or entrapped RV leads. CONCLUSIONS: TTVR in the setting of trans-TV pacemaker leads without lead extraction or re-replacement can be performed safely with a low risk for complications, offering an alternative to surgical TV replacement.

Network meta-analysis of His bundle, biventricular, or right ventricular pacing as a primary strategy for advanced atrioventricular conduction disease with normal or mildly reduced ejection fraction.

INTRODUCTION: Although right ventricular pacing (RVP) may impair ventricular function, it is commonly used for advanced atrioventricular block (AVB) and normal or mildly reduced ejection fraction (EF). We aimed to compare His bundle pacing (HBP), biventricular pacing (BiVP), and RVP for advanced AVB in patients with normal or mildly reduced EF. METHODS AND RESULTS: MEDLINE, Embase, Cochrane CENTRAL, ClinicalTrials.gov, Scopus, and Web of Science were searched. Outcomes were all-cause death, heart failure hospitalizations (HFH), EF, left ventricular volumes, 6-minute walk test, and QRS duration. HBP or BiVP was compared with RVP. Subsequently, network meta-analysis compared the three pacing options. Our protocol was registered in PROSPERO (CRD42018094132). Six studies compared BiVP and RVP (704 vs 614 patients) and four compared HBP and RVP (463 vs 568 patients). Follow-up was 6 months to 5 years. There was significantly lower mortality and HFH with HBP or BiVP as compared with RVP (odds ratio [OR], 0.66, [0.51-0.85], P = .002; OR, 0.61 [0.45-0.82], P < .001, respectively]. HBP or BiVP also showed significant increase in EF and decrease in QRS duration (mean difference [MD], 5.27 [3.86-6.69], P < .001; MD -42.2 [-51.2 to -33.3], P < .001, respectively). In network meta-analysis, HBP and BiVP were associated with significantly improved survival compared to RVP, with surface under the cumulative ranking curve (SUCRA) probability of 79.4%, 69.4%, and 1.2% for HBP, BiVP, and RVP, respectively. For HFH, SUCRA probability was 91.5%, 57.2%, and 1.3%, respectively. CONCLUSION: HBP or BiVP were the superior strategies to reduce all-cause death and HFH for advanced AVB with normal or mildly reduced EF, with no significant difference between BiVP and HBP.

Implantable cardiac electronic device therapy for patients with a systemic right ventricle.

The systemic right ventricle (SRV), defined as the morphological right ventricle supporting the systemic circulation, is relatively common in congenital heart disease (CHD). Our review aimed at examining the current evidence, knowledge gaps and technical considerations regarding implantable cardiac electronic device therapy in patients with SRV. The risk of sinus node dysfunction (SND) after atrial switch repair and/or complete heart block in congenitally corrected transposition of great arteries requiring permanent pacing increases with age. Similar to acquired heart disease, indication for pacing includes symptomatic bradycardia, SND and high degree atrioventricular nodal block. Right ventricular dysfunction and heart failure also represent important complications in SRV patients. Cardiac resynchronisation therapy (CRT) has been proposed to improve systolic function in SRV patients, although indications for CRT are not well defined and its potential benefit remains uncertain. Amongst adult CHD, patients with SRV are at the highest risk for sudden cardiac death (SCD). Nevertheless, risk stratification for SCD is scarce in this cohort and implantable cardioverter-defibrillator indication is currently limited to secondary prevention. Vascular access and the incidence of device-related complications, such as infections, inappropriate shocks and device system failure, represent additional challenges to implantable cardiac electronic device therapy in patients with SRV. A multidisciplinary approach with tertiary expertise and future collaborative research are all paramount to further the care for this challenging nonetheless ever increasing cohort of patients.

Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial.

BACKGROUND: Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years. METHODS: In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin. RESULTS: Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively (P=0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50-0.63) in RFU and 2.01 (1.93-2.05) in conventional follow-up per patient-year (P<0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500-20 700 Yen) in RFU and 21 400 Yen (16 700-25 900 Yen) in conventional follow-up (P<0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable. CONCLUSIONS: Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01523704.

The long-term therapeutic effects of His-Purkinje system pacing on bradycardia and cardiac conduction dysfunction compared with right ventricular pacing: A systematic review and meta-analysis.

AIMS: His-Purkinje system pacing has been demonstrated as a synchronized ventricular pacing strategy via pacing His-Purkinje system directly, which can decrease the incidence of adverse cardiac structure alteration compared with right ventricular pacing (RVP). The purpose of this meta-analysis was to compare the effects of His-Purkinje system pacing and RVP in patients with bradycardia and cardiac conduction dysfunction. METHODS: PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases up to 15 December 2019. Studies on long-term clinical outcomes of His-Purkinje system pacing and RVP were included. Chronic paced QRS duration, chronic pacing threshold, left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), all-cause mortality, and heart failure hospitalization were collected for meta-analysis. RESULTS: A total of 13 studies comprising 2348 patients were included in this meta-analysis. Compared with RVP group, patients receiving His-Purkinje system pacing showed improvement of LVEF (mean difference [MD], 5.65; 95% confidence interval [CI], 4.38-6.92), shorter chronic paced QRS duration (MD, - 39.29; 95% CI, - 41.90 to - 36.68), higher pacing threshold (MD, 0.8; 95% CI, 0.71-0.89) and lower risk of heart failure hospitalization (odds ratio [OR], 0.65; 95% CI, 0.44-0.96) during the follow-up. However, no statistical difference existed in LVEDV, LVESV and all-cause mortality between the two groups. CONCLUSION: Our meta-analysis suggests that His-bundle pacing is more suitable for the treatment of patients with bradycardia and cardiac conduction dysfunction.

Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI.

BACKGROUND: The timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI. METHODS AND RESULTS: We performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours. CONCLUSIONS: Safe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present.

Very high pacing thresholds during long-term follow-up predicted by a combination of implant pacing threshold and impedance in leadless transcatheter pacemakers.

BACKGROUND: Micra transcatheter pacemaker system (TPS) usually achieves low implant pacing threshold (IPT). However, IPT may increase in some patients during follow-up. AIM: To apply implant parameters in predicting long-term occurrence of very high pacing threshold (VHPT) in patients with Micra-TPS. METHODS: A cohort of 110 consecutive patients implanted with a Micra-TPS from 2014 to 2018 was evaluated at discharge and at 1, 12, 24, 36, and 48 months follow-up. VHPT was defined as greater than 2 V/0.24 ms. VHPT predictors were identified. RESULTS: Micra-TPS was implanted successfully in 108 patients (98.2%). During a mean follow-up of 24 ± 16 months, 18 patients (16.7%) died of causes nonpacemaker-related, and 4 (3.8%) developed VHPT. Patients with VHPT had higher IPT and lower implant impedance than patients with non-VHPT: 1 ± 0.31 vs 0.55 ± 0.29 V/0.24 ms (P = .003) and 580 ± 59 vs 837 ± 232 Ω (P = .03), respectively. IPT and impedance had excellent discriminative power to predict VHPT (area under the curve: 0.85 ± 0.07 and 0.91 ± 0.05, respectively). Negative predictive value (NPV) of IPT ≤ 0.5 V/0.24 ms was 100%; positive predictive value (PPV) was 8% throughout follow-up. Implant impedance ≤ 600 Ω had NPV of 99% throughout follow-up, whereas PPV varied: 16%, 21%, 16%, and 28% at 1, 12, 24, and 36 months, respectively. Sequential combination of IPT greater than 0.5 V/0.24 ms and impedance ≤ 600 Ω improved PPV to 25%, 35%, 27%, and 44%, respectively, whereas NPV remained 99% throughout follow-up. CONCLUSION: Despite favorable long-term electrical performance of Micra-TPS, a small percent of patients developed VHPT during follow-up. A sequential combination of IPT and impedance could allow the implanter to identify patients who will develop VHPT during long-term follow-up.

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry.

OBJECTIVES: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. BACKGROUND: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. METHODS: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). CONCLUSIONS: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

Permanent His bundle pacing: shaping the future of physiological ventricular pacing.

Conventional right ventricular (RV) pacing, particularly RV apical pacing, can have deleterious effects on cardiac function. Long-term RV apical pacing has been associated with increased risk of atrial fibrillation, hospitalization for heart failure, pacing-induced cardiomyopathy and associated death. His bundle pacing (HBP) results in physiological ventricular activation and has generated tremendous research interest and enthusiasm. By stimulating the His-Purkinje network directly, HBP results in synchronized ventricular activation, which might translate into improved clinical outcomes compared with dyssynchronous ventricular activation with RV apical pacing. HBP can also overcome bundle branch block patterns, and data are accumulating on the benefit of HBP for cardiac resynchronization therapy. In this Review, we summarize the anatomy of the His bundle and early clinical observations, implantation techniques and available outcome data associated with permanent HBP. We also highlight the challenges with HBP and the need for additional tools and more randomized data before widespread application of permanent HBP.

Ultrasound guided vascular access site management and left ventricular pacing are associated with improved outcomes in contemporary transcatheter aortic valve replacement: Insights from the OxTAVI registry.

OBJECTIVES: To identify clinical and procedural practice predictors of avoidable complications during transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is evolving as a viable strategy for treatment of aortic stenosis (AS). Vascular complications, major bleeding, or pericardial tamponade may be influenced by procedural practice. METHODS: The Oxford TAVR (OxTAVI) prospective registry was retrospectively analyzed to identify predictors of avoidable procedural complications in a contemporary cohort of transfemoral TAVR between January 2015 and September 2018. The primary endpoint was defined as a hierarchic composite of in-hospital mortality, pericardial effusion/cardiac tamponade, major bleeding, and vascular access complications. Individual components of the primary endpoint have been analyzed separately. RESULTS: Five-hundred-twenty-nine patients underwent transfemoral TAVR using contemporary techniques during the study period and were enrolled in the OxTAVI registry. Female sex and high frailty were associated with a higher risk of death, major bleeding, vascular complication or pericardial tamponade. The use of ultrasound (US) guidance for vascular access management was independently associated with a reduced composite primary endpoint (OR = 0.35, CI:0.14-0.86, p = .02) after adjustment for clinical confounders, largely driven by a threefold reduction in vascular access complication (OR = 0.29, CI:0.15-0.55, p < .001). Performing rapid pacing via the left ventricle guidewire (LV-GW) was associated with a significant decrease in the risk of cardiac tamponade/pericardial effusion (OR = 0.19, CI:0.05-0.66, p = .009). CONCLUSION: US-guided vascular access management and rapid pacing via the LV-GW are important determinants of reduced procedural complications during TAVR.