Impact of burden and distribution of aortic valve calcification on the hemodynamic performance and procedural outcomes of a self-expanding, intra-annular transcatheter aortic valve system.

Aortic valve calcification (AVC) has been explored as a powerful predictor of procedural complications in patients undergoing transcatheter aortic valve implantation (TAVI). However, little evidence exists on its impact on intra-annular devices' performance. We aimed to investigate the impact of AVC burden and distribution pattern on the occurrence of paravalvular leak (PVL), conduction disturbances requiring permanent pacemaker implantation (PPI) and 30-day clinical outcomes in patients undergoing TAVI with a self-expanding, intra-annular device. According to AVC, 103 patients enrolled in a single medical centre from November 2019 to December 2022 were divided into tertiles. Valve Academic Research Consortium (VARC)-3 definitions were used to classify procedural complications and outcomes. Patients in the highest AVC tertile showed an increased occurrence of mild or more PVL and conduction disorders (p < 0.001 and p = 0.006). AVC tertiles (highest tertile) emerged as an independent predictor of PVL (OR 7.32, 95%CI 3.10-17.28, p < 0.001) and post-TAVI conduction disturbances (OR 3.73, 95%CI 1.31-10.60, p = 0.013) but not of PPI (OR 1.44, 95%CI 0.39-5.35, p = 0.579). Considering calcium distribution, ROC analyses revealed that annular AVC but not left ventricle outflow tract (LVOT) calcium burden significantly indicated the development of PVL (AUC 0.863, 0.77-0.93, p < 0.001) and conduction disorders/PPI (AUC 0.797, 0.70-0.89, p < 0.001 and 0.723, 0.58-0.86, p = 0.018, respectively). After adjustment for age and sex, the highest tertile remained an independent predictor of the 30-day composite outcome (death, myocardial infarction, stroke, major vascular complications, type 3/4 bleedings, acute kidney injury, PPI and ≥ moderate PVL) (OR 3.26; 95%CI 1.26-8.40, p = 0.014). A higher AVC is associated with an increased risk of PVL and conduction disturbances after TAVI with a self-expanding, intra-annular device. However, our findings suggest a minor role for LVOT calcification compared with annular AVC in the performance of this specific prosthesis.

Initial Findings Concerning the Latest Self-expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data.

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement (TAVR) with Evolut FX up until October 2023. Patients who underwent TAVR with Evolut EPO between 2018 and 2020 (n = 1128), and those with Evolut EPO+ between 2020 and 2023 (n = 1696) served as control groups. Exclusion criteria comprised patients on dialysis, with a history of infective endocarditis, or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score (PS)-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs. 5.2% vs. 4.5%, respectively; p < 0.01) and new pacemaker implantation (PMI) rates (11.2% vs. 6.1% vs. 7.7%, respectively; p < 0.01) differed significantly. In the PS-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), while all vascular complications (4.6% vs. 4.6%, respectively; p = 1.00) and new PMI (5.9% vs. 7.6%, respectively; p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs. 1.9%, p = 0.095) without statistical significance. In conclusion, compared with Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce an in-hospital stroke incidence.

Persistent Left Superior Vena Cava: Unanticipated Stumbling Block in Cardiac Resynchronization Therapy.

Persistent left superior vena cava (PLSVC) is a relatively rare anatomical anomaly, with a higher prevalence in those with congenital heart defects. While typically asymptomatic, its presence can complicate certain medical procedures, particularly cardiac interventions, such as the implantation of cardiac resynchronization therapy (CRT) devices, due to acute angulation. In this report, we discuss the challenges posed by the unanticipated presence of PLSVC during CRT device implantation and describe the technique used for lead placement using Judkins Right catheter for support, placing coronary wire, and later placing the left ventricle (LV) lead with the help of buddy wire technique, resulting in successful insertion of all three CRT leads despite the anatomical challenges.

Development of Pericarditis Following Implantation of Micra Leadless Pacemaker.

Pacemakers are frequently essential in managing conduction disorders. Recently, the advancement of leadless pacemakers (LPs) has emerged, offering an alternative without the need for an upper shoulder incision or pacing leads. Despite the advantages, including reduced infection risk and improved durability, the novel nature of LPs means that some complications are still being identified. This report presents a unique case of pericarditis occurring after the implantation of a Micra leadless pacemaker (MLP) (Medtronic, Minneapolis, MN). It demonstrates the critical need for careful post-procedural monitoring to promptly detect and address potential complications associated with this emerging technology.

Recurrence rate and predictors in non-ischemic reversible bradyarrhythmias.

Objective: Non-ischemic symptomatic reversible bradyarrhythmia is a poorly characterized yet common clinical challenge. This study aimed to assess the incidence and predictors of recurrence and the need for permanent cardiac pacing in patients with non-ischemic symptomatic reversible bradyarrhythmia. Methods: This prospective single-center study enrolled 124 consecutive adult patients with non-ischemic symptomatic reversible bradyarrhythmia who were followed up for up to 24 months after conservative management during index hospitalization. The primary endpoint was a recurrence of bradyarrhythmia requiring permanent cardiac pacing. The secondary endpoint was a composite of recurrence requiring permanent pacing, readmission, or death. Univariate and multivariate analyses were conducted to determine the predictors of the endpoints. Results: Sinus node and atrioventricular node diseases were seen in 66.1% and 33.9% of patients, respectively. The most common causes of bradyarrhythmia were negative chronotropic drugs (58.1%) and hyperkalemia (55.6%). Permanent pacing was required in 21.8% of patients after a recurrence. Advanced atrioventricular block at presentation (HR: 6.10, 95% CI: 2.45-15.20, p < 0.001) and bifascicular block at discharge (HR: 3.63, 95% CI: 1.58-8.33, p = 0.002) during index hospitalization were significant independent predictors of recurrence requiring cardiac pacing. Conclusion: Non-ischemic symptomatic reversible bradyarrhythmia is associated with a high risk of recurrence. Permanent cardiac pacing should be considered during index hospitalization in patients with advanced atrioventricular block and/or bifascicular block.

Immune checkpoint inhibitor-associated sick sinus syndrome and cardiogenic shock.

Immune checkpoint inhibitors (ICI) represent a major advance in the treatment of cancer. Most studies of ICI have underestimated their cardiotoxicity; however, an increasing number of cases of cardiotoxicity are being reported. Herein we discussed a 67-year-old, male, Japanese patient who presented with cardiogenic shock accompanied by sick sinus syndrome 4 days into his second course of ipilimumab plus nivolumab combination therapy. A temporary transvenous pacemaker was subsequently placed, and a permanent pacemaker was implanted for persistent, symptomatic, intermittent bradycardia. The permanent implantation of the pacemaker improved his symptoms and allowed him to continue his ICI therapy.

Long-term outcomes of left bundle branch area pacing compared with 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: The purpose of this study was to investigate whether left bundle branch area pacing (LBBAP) improves long-term clinical results compared with traditional right ventricular pacing (RVP) in patients requiring PPMI after TAVI. METHODS: A total of 237 consecutive patients undergoing RVP (N = 117) or LBBAP (N = 120) after 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 of 4.4%. The paced QRS duration was significantly longer in the RVP group compared with the LBBAP group (151 ± 18 vs 122 ± 12 ms; P < .001). No difference was found between the 2 groups in all-cause death (13.7% vs 13.3%; adjusted hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.37-1.58; P = .466) or the composite endpoint of death and HFH (29.9% vs 19.2%; adjusted HR, 1.22; 95% CI, 0.70-2.13; P = .476); however, the risk of HFH was significantly higher in the RVP group at 5 years after TAVI (21.4% vs 7.5%; adjusted HR, 2.26; 95% CI, 1.01-5.08; P = .048). There was greater improvement of LVEF over time in the LBBAP group (P = .046 for LVEF changes over time between groups). CONCLUSIONS: LBBAP improved long-term clinical outcomes compared with RVP in patients undergoing PPMI after TAVI in terms of less HFH and better LVEF improvement.

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

OBJECTIVES: The threshold to perform concomitant tricuspid valve (TV) repair during primary mitral valve (MV) surgery has decreased, based on recent randomized evidence. Based on these developments, the indication for TV repair 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 (± atrial septal defect closure, rhythm surgery, coronary artery bypass grafting) between 1 January and 31 December2021 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 after 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.

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.

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.

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.

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.