Permanent pacemaker implantation after combined mitral- and tricuspid valve surgery-a nationwide multicentre study.

OBJECTIVES: The threshold to perform concomitant TV repair (TVr) during primary mitral valve (MV) surgery has decreased, based on recent randomized evidence. Based on these developments, the indication for TVr during MV surgery is expected to increase further. However, concerns have been raised regarding the risk of permanent pacemaker implantation (PPI) during a concomitant procedure. Therefore, we aim to assess the incidence of PPI in combined MV and TV surgery in a nationwide registry. METHODS: The current study uniquely cross-linked the Cardiothoracic and Pacemaker/ICD registry of the Netherlands Heart Registration. Patients undergoing primary MV and TV surgery (± ASD closure, rhythm surgery, CABG) between January 1st-December 31st 2021 were included. The primary outcome was PPI within 30 days after surgery. Subgroup analyses were performed for isolated MV and TV surgery and MV repair. The association between concomitant TV surgery and PPI was assessed using multivariable binary logistic regression analyses. RESULTS: A total of 1060 patients (n = 833 MV, n = 227 MV+TV) were included. The overall incidence of PPI was 4.3%. No significant difference in PPI between MV and MV+TV surgery were found (3.7% vs 6.6%, P = 0.06). Concomitant TV surgery was not an independent risk factor for PPI after surgery after adjustment for covariates. These results were robust across subgroup and sensitivity analyses. CONCLUSIONS: The current study was not able to find a statistical difference between the PPI rate in MV surgery patients and MV + TV surgery patients. Extension of the waiting period prior to PPI, may result in decreased PPI rates.

Long-term outcomes of left bundle branch area pacing compared to right ventricular pacing in TAVI patients.

BACKGROUND: New-onset permanent pacemaker implantation (PPMI) is still a common complication after transcatheter aortic valve implantation (TAVI) with adverse clinical outcomes. OBJECTIVE: To investigate whether left bundle branch area pacing (LBBAP) improves long-term clinical results compared to traditional right ventricular pacing (RVP) in patients requiring PPMI following TAVI. METHODS: A total of 237 consecutive patients undergoing RVP (N=117) or LBBAP (N=120) following TAVI were retrospectively included. Long-term outcomes including all-cause death, heart failure rehospitalization (HFH) and left ventricular ejection fraction (LVEF) change compared to baseline were obtained until 5 years post-TAVI. RESULTS: The mean age of the overall population was 74 years with a mean surgical risk score as 4.4%. The paced QRS duration was significantly longer in RVP group compared to LBBAP group (151 ± 18 vs. 122 ± 12 ms, P<0.001). There was no difference between two groups in all-cause death (13.7% vs. 13.3%, adjusted HR: 0.76; 95% CI: 0.37 to 1.58; P=0.466) or the composite endpoint of death and HFH (29.9% vs. 19.2%, adjusted HR: 1.22; 95% CI: 0.70 to 2.13; P=0.476), however, the risk of HFH was significantly higher in RVP group at 5 years after TAVI (21.4% vs. 7.5%, adjusted HR: 2.26; 95% CI: 1.01 to 5.08; P=0.048). There was a greater improvement of LVEF over time in LBBAP group (P=0.046 for LVEF changes over time between groups). CONCLUSIONS: LBBAP improved long-term clinical outcomes compared to RVP in patients undergoing PPMI after TAVI in terms of less HFH and better LVEF improvement.

Left Ventricular Outflow Tract Morphology as a Predictor of Conductance Disturbances Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Conduction disturbances represent one of the most common complications following transcatheter aortic valve replacement (TAVR). We sought to investigate the role of left ventricular outflow tract (LVOT) morphology in the development of conduction disturbances following TAVR. METHODS AND RESULTS: Consecutive patients who underwent TAVR in our center were included. The ratio between the LVOT area and the aortic annulus area was calculated. Patients were then divided into 2 groups on the basis of this ratio: group 1, which included patients with an LVOT area/aortic annulus area ratio <0.9; and group 2, which included patients with an LVOT area/aortic annulus area ratio ≥0.9. The primary end point was to assess the relationship between LVOT shape and the rate of permanent pacemaker implantation following TAVR. A multivariable analysis was performed to identify predictors of permanent pacemaker implantation following TAVR. From January 2018 to December 2020, 276 patients were included. Ninety-one patients with tapered LVOT morphology were assigned to group 1 and the rest (n=185 patients), tubular LVOT or flared LVOT shape, to group 2. The mean age was 81.5±5.7 years and 57% were women. After adjusting by confounding factors, tapered morphology of the LVOT and prior right bundle-branch block were found to be independent predictors of permanent pacemaker implantation (hazard ratio [HR], 2.6 [95% CI, 1.2-5.7]; P=0.014; and HR: 4.3 [95% CI 2.4-7.6], P<0.001); at a median follow-up time of 15.5 (interquartile range, 15) months. CONCLUSIONS: A tapered-LVOT morphology was associated with increased risk for permanent pacemaker implantation. LVOT morphology may be an additional factor to consider when choosing prosthesis size.

Investigation of the Prevalence and Clinical Characteristics of Early Complication of Electrode Dislodgement in Patients has Indications for Permanent Pacemaker Implantation.

Objective: To investigate the prevalence and reopen the drive procedure of early complications of electrode dislodgement in patients with an indication for permanent pacemaker implantation at the Vietnam National Heart Institute. Methods: This is a study on patients who received permanent pacemaker implantation at the Vietnam National Heart Institute during the period from August 1, 2019 to March 30, 2020. Results: In all cases with complications of electrode dislodgement after implantation indicated to reopen the machine to handle complications, the results of handling complications are safe and stable. Conclusion: There is a positive relationship between the events of electrode dislodgement on the pacemaker and the degree of tricuspid valve regurgitation with a statistically significant difference (P < 0.01, OR = 8.2; 95% CI: 1.6-42.9).

Study Factors Associated with Early Complications of the Permanent Pacemaker Implantation: A Research Report in Vietnam.

Introduction: The permanent pacemaker implantation has a history of more than 60 years with improved mortality and quality of life but also recorded many complications. Objectives: The objective is to evaluate the rate of early complications at the National Heart Institute of Vietnam and the factors associated with the early complication of the permanent pacemaker implantation procedure. Methods: A cross-sectional descriptive is about 294 patients who received permanent pacemaker implantation at the National Heart Institute of Vietnam from 01/08/2020 to 30/30/2020. Results: The rate of complications is statistically higher in the diabetic group (OR = 2.5; 95% CI: 1.1-5.6), chronic kidney failure (OR = 2.7; 95% CI: 1.1-6.6), preheart surgery (OR = 3.8; 95% CI: 1.3-11.8), taking oral anticoagulants (OR = 4.3; 95% CI: 1.9-9.9), dual antiplatelets (OR = 2.95; 95% CI: 1.1-8.1), continuation to maintain anticoagulants, or dual antiplatelets (OR = 2.7; 95% CI: 1.2-6.4). Conclusion: Early onset of complications (onset of early complications) has been associated with some factors such as diabetes disease, chronic kidney failure, preheart surgery, oral anticoagulants, dual antiplatelets, continuation to maintain anticoagulation, and antiplatelets with statistical significance.

Long-term outcome of permanent epicardial pacemaker implantation in neonates: Experience from an Indian center.

Introduction: Permanent pacemaker implantation (PPI) in neonates is challenging with respect to indications, device selection, implantation technique, and long-term outcomes. Complex anatomy, the need for long-term pacing with high rates, and a problematic postoperative period are the major problems. Methods: We prospectively followed up 22 newborns who underwent PPI below 28 days of life at our institute. Results: The median age at implantation was 2 days (interquartile range 1-9 days), and 9% were born preterm. The average heart rate before implantation was 46.4 ± 7.2 bpm. Maternal lupus antibodies were positive in 8 (36.4%) neonates, whereas 11 (50.0%) had associated congenital heart disease. Nineteen neonates underwent single chamber (VVI) and three underwent dual chamber (DDD) pacemaker implantation. Over a median follow-up of 46 months (range 2-123 months), the average ventricular pacing percentage was 87.5 ± 24.9%, with a stable pacing threshold. Seven children underwent pulse generator replacement due to battery depletion at a median age of 47 months. Pacing-induced ventricular dysfunction was seen in five children at a median age of 23.6 months, and two underwent upgradation to cardiac resynchronization therapy. Overall mortality was 13.6%, all due to tissue hypoperfusion and lactic acidosis in the postimplantation period. Conclusions: PPI in neonates has a favorable outcome with excellent lead survival. Overall mortality is 13.6%, which is predominantly in the postimplantation period and related to myocardial dysfunction.

Management of Postprocedural Conduction Disturbances Using a Prespecified Algorithm in the Optimize PRO Study.

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO+ valves. Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB). Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death. Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge.

Long-Term Outcomes Associated With Permanent Pacemaker Implantation in Low-Risk Surgical Aortic Valve Replacement.

Background: Permanent pacemaker implantation is associated with an increased risk of mortality and heart failure after surgical aortic valve replacement (SAVR). Objectives: The purpose of this study was to analyze long-term prognosis of permanent pacemaker implantation following SAVR on low-risk patients. Methods: This nationwide, population-based, observational cohort study included all patients who underwent SAVR in Sweden between 2001 and 2018 with low surgical risk, defined as logistic EuroSCORE I <10% or EuroSCORE II <4%. Patients received a permanent pacemaker implantation within 30 days after SAVR. Main outcomes were all-cause mortality, heart failure hospitalization, and endocarditis. Regression standardization addressed confounding. Results: We included 19,576 patients with low surgical risk. Of these, 732 (3.7%) patients received a permanent pacemaker within 30 days after SAVR. The mean age was 68 years and 33% were women. We found no difference in all-cause mortality between patients who received a pacemaker compared to those who did not (absolute survival difference at 17 years: 0.1% (95% CI: -3.6% to 3.8%). After 17 years, the estimated cumulative incidence of heart failure in patients who received a pacemaker was 28% (95% CI: 24%-33%) vs 20% (95% CI: 19%-22%) in patients who did not (absolute difference 8.2% [95% CI: 3.8%-13%]). We found no difference in endocarditis between the groups. Conclusions: We found an increased incidence of heart failure in patients with low surgical risk who received a permanent pacemaker after SAVR. Permanent pacemaker implantation was not associated with all-cause mortality or endocarditis. Efforts should be made to avoid the need for permanent pacemaker following SAVR.

Navigating challenges: Cleidocranial dysplasia and complexities in transvenous pacemaker implantation.

Cleidocranial dysplasia (CCD) is a rare genetic disorder characterized by skeletal abnormalities, including hypoplastic or absent clavicles, delayed closure of cranial sutures, and dental anomalies. We present a case of a 72-year-old female with a history of breast cancer treated with mastectomy and radio chemotherapy with the port-a catheter still in place in the left subclavian region. She presented to the emergency room with syncope related to a complete atrioventricular (AV) block. The patient underwent temporary pacing via femoral access while awaiting definitive pacemaker implantation. The absence of the right clavicle, first observed during prepuncture fluoroscopy and later confirmed on postprocedure imaging, significantly influenced the approach to pacemaker implantation. Venography played a crucial role in visualizing the venous trajectory and guiding the puncture, ensuring successful lead placement. The procedural challenges encountered due to the patient's skeletal anomalies highlight the importance of individualized approach and careful consideration of anatomical variations in interventional cardiology procedures.

Lumenless and Stylet-Driven Leads for Left Bundle Branch Area Pacing: Materials, Techniques, Benefits, and Trade-Offs of the Two Approaches.

Left bundle branch area pacing (LBBPa) is an innovative technique for physiological pacing. Compared with His bundle pacing, LBBPa provides better pacing thresholds, lower rates of macrodislodgment, and a reliable strategy for cardiac resynchronization. LBBPa traditionally employs lumenless leads (LLL), which are characterized by small lead bodies and a fixed helix design. These features guarantee stability, avoid helix retraction, and facilitate easier septal penetration, all contributing to an advantageous learning curve. On the other hand, stylet-driven pacing leads (SDL) have shown comparable success rates related to lumenless pacing leads, although they carry risks of helix retraction and lead fracture. SDL have been increasingly employed with favorable results, as they provide good maneuverability and support during implantation with continuous monitoring of ECG-paced morphology. Different manufacturers are offering a variety of SDL, and new dedicated tools are being developed to simplify lead implantation. In this review, we examine the procedural techniques, advantages, and limitations of the most commonly used pacing leads and tools for LBBPa, and we summarize the complications associated with both lumenless leads (LLL) and stylet-driven leads (SDL).

Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60). CONCLUSIONS: Women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

A detached helix of pacemaker pacing lead.

Permanent pacemaker implantation is the main treatment of symptomatic bradyarrhythmia, which has been widely used. Lead implantation is a critical step. When the lead malfunctions and needs to be replaced, extraction or abandonment of the primary lead (in whole or in part) should be determined according to the situation.

A novel balloon-expandable transcatheter aortic valve bioprosthesis: Myval and Myval Octacor.

INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.

Cardiac tamponade due to right coronary artery perforation following pacemaker implantation: a case report.

Background: Cardiac tamponade due to perforation of a cardiac chamber is a rare complication occurring in only 0.3% of patients undergoing permanent pacemaker (PM) implantation. Notably, perforation of the right coronary artery (RCA) following permanent PM implantation has only been reported twice in the literature. We report a rare case of RCA perforation leading to life-threatening cardiac tamponade with symptom onset 4 days after PM implantation. Case summary: A 75-year-old woman underwent permanent PM implantation without any difficulties in placing pacemaker leads and with good thresholds. Four days later, the patient was readmitted in a state of shock due to cardiac tamponade. A blood gas analysis on the bloody pericardial effusion raised suspicion of ongoing arterial bleeding. A CT scan ruled out aortic dissection; instead, the source of bleeding was identified as a perforation in the RCA, which was managed surgically. Discussion: This case highlights the necessity of coronary artery perforation being among the differential diagnoses of cardiac tamponade after PM implantation, and it stresses the usefulness of performing a blood gas analysis on the bloody pericardial effusion.

Incidence of Coronary Artery Disease After Permanent Pacemaker Implantation: A Hospital-based Study from East India.

Bradyarrhythmias, characterized by heart rates of <60 bpm due to conduction issues, carry risks of sudden cardiac death and falls. Pacemaker implantation is a standard treatment, but the interplay between bradyarrhythmias, coronary artery disease (CAD), and patient attributes requires further exploration. This study was a retrospective hospital record-based study that analyzed data from 699 patients who underwent pacemaker implantation for symptomatic bradyarrhythmias between February 2019 and February 2022. Clinical parameters, coronary angiography (CAG) findings, ejection fraction, and indications for pacemaker implantation were documented. The relationship between CAD severity, specific bradyarrhythmias, and ejection fraction was explored. Statistical analysis included chi-squared tests and t tests. The mean age of the study population (n = 699) was 66.75 years (male:female ratio, 70:30), with 77.2% having type 2 diabetes and 61.6% being hypertensive. The majority of patients had minor or non-obstructive CAD (61.8%), followed by normal CAG findings (25.75%) and obstructive CAD (12.45%). Complete heart block (CHB) was the primary indication for pacemaker implantation (55.2%), followed by sick sinus syndrome (22.3%). The results did not show any association between ejection fraction and CAG findings. Patients who presented with CHB had a higher incidence of obstructive CAD, indicating greater severity. This study sheds light on the intricate interplay between severe bradyarrhythmias, CAD, and patient characteristics. Our analysis revealed no statistical significance between obstructive CAD and the need for a permanent pacemaker. This makes us question our practice of maintaining a low threshold for coronary angiography during pacemaker implantation. The observed low yield and anticoagulation protocol reassure us of the choice to delay this diagnostic intervention. These insights can guide tailored management strategies, enhancing clinical care approaches for patients with severe bradyarrhythmias necessitating pacemaker implantation.

Prognosis and Predictor Factors of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Replacement: A Retrospective Analysis of the Post-Transcatheter Aortic Replacement Clairval Hospital Registry.

Background/Objectives: Despite procedural improvements, post-transcatheter aortic valve replacement (TAVR) conduction disorders remain high. Analyzing the data from a monocentric TAVR registry, this study aims to determine predictive factors for PPI (primary outcome), the indication for PPI, and long-term outcomes among these patients (secondary outcomes). Methods: Conducted at Clairval Hospital in Marseille, France, this retrospective study included all consecutive patients from June 2012 to June 2019. Clinical, electrocardiographic, echocardiographic, and procedural data were collected, with outcomes assessed annually. Logistic regression identified PPI predictors and survival analyses were performed. Results: Of the 1458 patients initially considered, 1157 patients were included. PPI was needed in 21.5% of patients, primarily for third-degree atrioventricular block (46.4%). Predictor factors for PPI included baseline right bundle branch block (ORadj 2.49, 95% CI 1.44 to 4.30; p = 0.001), longer baseline QRS duration (ORadj 1.01, 95% CI 1.00 to1.02, p = 0.002), and self-expandable valves (ORadj 1.82, 95% CI, 1.09 to 3.03; p = 0.021). Seven-year estimated mortality was higher in PPI (43.3%) vs. non-PPI patients (30.9%) (log rank p = 0.048). PPI was an independent predictive factor of death (ORadj 2.49, 95% CI 1.4 to 4.3; p = 0.002). Conclusions: This study reveals elevated rates of PPI post-TAVR associated with increased mortality. These results underscore the pressing necessity to refine our practices, delineate precise indications, and enhance the long-term prognosis for implanted patients.

Anatomical Annulus Predictors of New Permanent Pacemaker Implantation Risk After Balloon-Expandable Transcatheter Aortic Valve Implantation.

New-generation transcatheter heart valves have significantly improved technical success and procedural safety of transcatheter aortic valve implantation (TAVI) procedures; however, the incidence of permanent pacemaker implantation (PPI) remains a concern. This study aimed to assess the role of anatomic annulus features in determining periprocedural conduction disturbances leading to new PPI after TAVI using the last-generation Edwards SAPIEN balloon-expandable valves. In the context of a prospective single-center registry, we integrated the clinical and procedural predictors of PPI with anatomic data derived from multislice computed tomography. A total of 210 consecutive patients treated with balloon-expandable Edwards transcatheter heart valve were included in the study from 2015 to 2023. Technical success was achieved in 197 procedures (93.8%), and 26 patients (12.4%) required new PPI at the 30-day follow-up (median time to implantation 3 days). At the univariable logistic regression analysis, preprocedural right bundle branch block (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.01 to 4.97, p = 0.047), annulus eccentricity ≥0.25 (OR 5.43, 95% CI 2.21 to 13.36, p <0.001), calcium volume at annulus of the right coronary cusp >48 mm3 (OR 2.60, 95% CI 1.13 to 5.96, p = 0.024), and prosthesis implantation depth greater than membranous septum length (OR 2.17, 95% CI 1.10 to 4.28, p = 0.026) were associated with new PPI risk. In the multivariable analysis, preprocedural right bundle branch block (OR 2.81, 95% CI 1.01 to 7.85, p = 0.049), annulus eccentricity ≥0.25 (OR 4.14, 95% CI 1.85 to 9.27, p <0.001), and annulusright coronary cusp calcium >48 mm3 (OR 2.89, 95% CI 1.07 to 7.82, p = 0.037) were confirmed as independent predictors of new PPI. In conclusion, specific anatomic features of the aortic valve annulus might have an additive role in determining the occurrence of conduction disturbances in patients who underwent TAVI with balloon-expandable valves. This suggests the possibility to use multislice computed tomography to improve the prediction of post-TAVI new PPI risk.