Efficacy and Safety of Leadless Pacemaker Implantation in Octogenarians

INTRODUCTION Long-term complication rates in standard transvenous pacemakers are reported around 4-12% with a higher incidence in the elderly population. We report our experience in octogenarians undergoing leadless pacemaker implantation in two large-volume centers in Switzerland. METHODS Consecutive patients undergoing leadless pacemaker implantation at two Swiss large volume centers (University Hospital Zurich, Zurich and Cardiocentro Ticino Institute, Lugano) between October 2015 and March 2020 were included in this retrospective analysis. Demographic information, clinical data, and procedural characteristics were recorded at the day of implantation and during follow-up. RESULTS Two hundred and twenty patients (mean age 80.6 ± 7.7 years, male 66%) were included. The main indication for pacemaker implantation was slow ventricular rate atrial fibrillation (111 of 220 patients, 50.4%). Out of the 220 patients, 124 (56.3%) were ≥80 years. Overall successful implantation rate was 98.6%. In the octogenarian population, the median procedure time (45 ± 20.2 min vs. 40 ± 19.6 min, p = 0.03) and radiation duration (6.1 ± 8.2 min vs. 5.0 ± 7.2 min, p = 0.03) were longer compared to patients <80 years. Major complications (2.7%, n = 6) and device measurements during follow-up were similar between patients ≥80 and <80 years. CONCLUSION Implantation of a leadless pacemaker device in octogenarians is safe and effective with a similarly low complication rate compared to non-octogenarians

CRT-700.1 Multi-Center Compassionate use Early Feasibility Evaluation of J-Valve Transcatheter Treatment for Severe Aortic Valve Regurgitation: Preliminary Results

Background: Although transcatheter aortic valve replacement (TAVR) is accepted therapy for treatment of symptomatic severe aortic valve stenosis (AS), current devices are associated with increased procedural complications and sub-optimal outcomes when used to treat of aortic valve regurgitation (AR). Severe AR is the indication for 20-30% of surgical aortic valve replacements and is associated with increased morbidity and mortality. J-valve is a short frame, self-expanding TAVR device. (Figure) specifically designed for treatment of severe AR. Anchor rings facilitate commissural alignment and secure attachment to non-calcified native valves. Methods: From Sept 2019 through Oct 2022, patients with symptomatic severe AR who were not surgical candidates or excluded from the ALIGN-AR trial were enrolled into a compassionate use early feasibility study at 5 North American centers. All patients signed informed consent for protocol approved by respective institutional review boards. Results: Data from 13/28 patients (mean age 80 yrs; 38.5% male) with symptomatic (92.3% NYHA class III/IV; mean LVEF 48% [range 23-64%]) severe (92% grade III/IV) AR, atrial fibrillation (53.8%), and pacemaker/ICD (15.4%), had J-valve TAVR (15.4% alternative access). There were no deaths to 30 days and post-procedural AR grade was none/trivial in all patients. In follow-up (mean 333 days) there are 0 cardiac deaths (total mortality 30.7%; 3 malignancies, 1 sepsis). Serial echocardiograms demonstrate AR grade none/mild in 89%, and 100% at 30 days and 1 year respectively). Conclusion: Despite high risk profile, preliminary analysis of this multi-center compassionate use study suggests that J-valve is safe with durable effectiveness for the treatment of symptomatic severe AR. Full data set on all patients will be presented

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

AIMS Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left-sided femoral venous approach may be necessary. We hypothesized that a left-sided femoral venous approach is as safe and effective when compared with a right-sided approach. We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach when compared with the conventional right-sided approach. METHODS AND RESULTS In this retrospective single-centre analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases when compared with 8% in the remaining population (P = 0.003). CONCLUSIONS A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left vs. right femoral venous access was a previous transfemoral TAVI procedure

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

AIMS Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left-sided femoral venous approach may be necessary. We hypothesized that a left-sided femoral venous approach is as safe and effective when compared with a right-sided approach. We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach when compared with the conventional right-sided approach. METHODS AND RESULTS In this retrospective single-centre analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases when compared with 8% in the remaining population (P = 0.003). CONCLUSIONS A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left vs. right femoral venous access was a previous transfemoral TAVI procedure

Case Report: Stretching the limits—late valvuloplasty for THV dysfunction following redo mitral valve-in-valve implantation

Late balloon valvuloplasty can be used to treat under-expansion-related transcatheter heart valve (THV) dysfunction. Whether this can be performed following redo-THV implantation is unknown. Herein, we report a case of a 72-year-old male presenting with symptomatic gradient elevation following redo mitral valve-in-valve implantation. The patient was successfully treated with late balloon valvuloplasty with gradient improvement. In conclusion, late valvuloplasty is effective even with several layers of valves. However, larger studies are required to clarify the role of this approach further

Insuffisance tricuspide en 2023 : modalités de traitement pour la valve oubliée

The negative impact of tricuspid regurgitation on prognosis in now well established. It also appears clear that surgical and possibly percutaneous treatment should be performed before reaching a point of no return with advanced heart failure and deterioration of right ventricle function. Percutaneous treatment has been divided into coaptation restoration devices, annuloplasty devices, and ortho- or heterotopic valve replacement. The present article offers a brief review of diagnostic modalities beyond echocardiography, surgical treatment as well as of the multiple recent development in the percutaneous treatment of this frequent condition.L’impact pronostique défavorable de l’insuffisance tricuspide (IT) est maintenant bien établi, ainsi que la nécessité d’intervenir chirurgicalement ou de manière percutanée lorsque le traitement médicamenteux est insuffisant. Des données récentes suggèrent par ailleurs qu’il est probablement judicieux d’intervenir avant qu’un stade trop avancé d’insuffisance cardiaque et d’atteinte du ventricule droit ne soit atteint. Le traitement percutané est divisé en dispositifs de restauration de la coaptation valvulaire, d’annuloplastie et de remplacement de valve ortho ou hétérotopique. Cet article propose une brève revue des modalités diagnostiques au-delà de l’échocardiographie, du traitement chirurgical ainsi que des multiples développements récents dans le traitement percutané de cette pathologie fréquente

Leadless Pacemaker Implantation, Focusing on Patients With Conduction System Disorders Post–Transcatheter Aortic Valve Replacement: A Retrospective Analysis

Background: Impairment of the conduction system is a common complication of transcatheter aortic valve replacement (TAVR), which is typically performed in elderly patients. A leadless pacemaker (LP) may be a suitable option in this frail population, but the available scientific data concerning the efficacy and safety of leadless pacing after TAVR are sparse. The purpose of this analysis was to evaluate the efficacy and safety of LP implantation in patients with relevant bradycardias after TAVR, compared to other indications. Methods: Consecutive patients were retrospectively enrolled. Demographics, background heart diseases, interventional parameters, and follow-up data were collected. Results: A total of 257 consecutive patients who underwent LP implantation were included. In 26 patients, the device was implanted due to bradycardias after TAVR (TAVR group), whereas the remaining 231 patients were in the population without previous TAVR (non-TAVR group). The mean implantation duration (56 ± 22 minutes in the TAVR group vs 48 ± 20 minutes in the non-TAVR group; P = not significant [NS]) and the implantation success rate (100% in the TAVR group vs 98.7% in the non-TAVR group; P = NS) were similar in the 2 cohorts. No significant differences occurred in pacing parameters (sensing, impedance, and threshold, respectively) between the 2 groups, either at implantation or during follow-up. A total of 8 major periprocedural complications (3.1% of patients in total; 3.8% in the TAVR group vs 3.0% in the non-TAVR group; P = NS) occurred within 30 days, without significant difference between the 2 groups. Conclusions: LP implantation appears to be safe and effective in patients after TAVR, and therefore, this procedure is a suitable option for this often old and frail population. Résumé: Contexte: L’atteinte du système de conduction cardiaque est une complication courante du remplacement valvulaire aortique par cathéter (RVAC), une intervention habituellement pratiquée chez les patients âgés. Un stimulateur cardiaque sans sonde peut être une option convenable pour cette population fragile, mais les données scientifiques actuelles concernant l’efficacité et l’innocuité de la stimulation sans sonde après un RVAC sont fragmentaires. Cette analyse visait à évaluer l’efficacité et l’innocuité de l’implantation d’un stimulateur cardiaque sans sonde chez des patients atteints de bradycardies pertinentes après un RVAC, comparativement à d’autres indications. Méthodologie: Des patients consécutifs ont été recrutés de manière rétrospective. Les données démographiques, les maladies cardiaques sous-jacentes, les paramètres interventionnels et les données de suivi ont été colligés. Résultats: Un total de 257 patients consécutifs qui se sont fait implanter un stimulateur cardiaque sans sonde ont été inclus. Chez 26 patients, le dispositif a été implanté en raison d’une bradycardie après un RVAC (groupe RVAC), alors que les 231 autres patients formaient la population sans RVAC antérieur (groupe sans RVAC). La durée moyenne de l’intervention d’implantation (56 ± 22 minutes dans le groupe RVAC vs 48 ± 20 minutes dans le groupe sans RVAC; p = non significatif [NS]) et le taux de réussite de l’implantation (100 % dans le groupe RVAC vs 98,7 % dans le groupe sans RVAC; p = NS) étaient similaires dans les deux cohortes. Aucune différence significative n’a été observée dans les paramètres de stimulation (sensibilité, impédance et seuil, respectivement) entre les 2 groupes, que ce soit au moment de l’implantation ou pendant le suivi. Un total de 8 complications périopératoires majeures (3,1 % de l’ensemble des patients; 3,8 % dans le groupe RVAC vs 3,0 % dans le groupe sans RVAC; p = NS) sont survenues dans les 30 jours, sans différence notable entre les 2 groupes. Conclusions: L’implantation d’un stimulateur cardiaque sans sonde semble sûre et efficace après un RVAC; par conséquent, cette intervention représente une option convenable pour cette population souvent âgée et fragile

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves

Objectives: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). Background: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. Methods: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. Results: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). Conclusions: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI