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Aims: We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).Methods and Results: Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or implantable cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year.Conclusion: Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307). [ABSTRACT FROM AUTHOR]

Background In a three-month report from the CGA-TAVI registry, we found the Multidimensional Prognostic Index (MPI) and Short Physical Performance Battery (SPPB) to be of value for predicting short-term outcomes in elderly patients undergoing transcatheter aortic valve implantation (TAVI). In the present analysis, we examined the association of these tools with outcomes up to one year post-TAVI. Methods CGA-TAVI is an international, observational registry of geriatric patients undergoing TAVI. Patients were assessed using the MPI and SPPB. Efficacy of baseline values and any postoperative change for predicting outcome were established using logistic regression. Kaplan- Meier analysis was carried out for each comprehensive geriatric assessment tool, with survival stratified by risk category. Results One year after TAVI, 14.1% of patients deceased, while 17.4% met the combined endpoint of death and/or non-fatal stroke, and 37.7% the combined endpoint of death and/or hospitalisation and/or non-fatal stroke. A high-risk MPI score was associated with an increased risk of all-cause mortality (aOR = 36.13, 95% CI: 2.77-470.78, P = 0.006) and death and/or non-fatal stroke (aOR = 10.10, 95% CI: 1.48-68.75, P = 0.018). No significant associations were found between a high-risk SPPB score and mortality or two main combined endpoints. In contrast to a worsening SPPB, an aggravating MPI score at three months post-TAVI was associated with an increased risk of death and/or non-fatal stoke at one year (aOR = 95.16, 95% CI: 3.41-2657.01). Conclusions The MPI showed value for predicting the likelihood of death and a combination of death and/or non-fatal stroke by one year after TAVI in elderly patients. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve implantation (TAVI) is becoming a reality in the management of patients with severe aortic stenosis and high or prohibitive risk for standard surgical management. Current understanding of the potential adverse events associated with this procedure is limited. Risks associated with TAVI differ from those related to surgical valve replacement and include vascular injury; stroke; cardiac injury such as heart block, coronary obstruction, and cardiac perforation; paravalvular leak; and valve misplacement. The clinical experience of multiple centers experience with different valve implantation systems and techniques was reviewed. Awareness of how complications occur might help in their avoidance, recognition, and management. Ultimately, improved understanding of the potential complications associated with TAVI might help improve outcomes and allow wider application of this therapy. [Copyright &y& Elsevier]

Background: We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation. Methods: Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results. Results: The mean age was 80 ± 9 years, and the predicted operative mortality was 37% ± 20% by using logistic EuroSCORE and 11% ± 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 ± 0.3 cm2 and 9.6 ± 4.8 mm Hg, respectively). Conclusion: Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients. [Copyright &y& Elsevier]

Off-pump transcatheter, transapical valve-in-valve aortic valve implantation into a failed surgically implanted aortic valve was successfully performed in an 85-year-old man. He was discharged on postoperative day 5, and remained well at his 16-month follow-up. Echocardiography at 12 months showed normal prosthetic valve function without displacement, recoil, or regurgitation. Transcatheter transapical valve-in-valve aortic valve implantation is feasible and could be a viable approach for selected patients. [Copyright &y& Elsevier]

Background: We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. Methods: Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 ± 11.5 months with a total of 917.3 months of follow-up. Results: Mean age was 80.0 ± 8.1 years and predicted operative mortality was 34.5% ± 20.4% by logistic EuroSCORE and 12.1% ± 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% ± 6.4% and 58.0% ± 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% ± 6.4% and 69.8% ± 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 ± 0.8 to 1.8 ± 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 ± 0.3 cm2 and 10.3 ± 5.9 mm Hg, respectively). Conclusion: Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis. [Copyright &y& Elsevier]

Background: Data is controversial regarding the existence of an "obesity paradox" in patients undergoing Transcatheter Aortic Valve Replacement (TAVR). We sought to investigate the prognostic value of the body mass index (BMI) on outcomes following TAVR.Methods: This is an observational, single-center study involving all patients who underwent TAVR from 2009 to 2019. BMI was calculated in all patients before TAVR. The cohort was subdivided into four groups: underweight (<20 kg/m2), normal weight (≥20 to <25 kg/m2), overweight (≥25 to <30 kg/m2) and obese (≥30 kg/m2). The main endpoint was all-cause 30-day and one-year mortality.Results: A total of 412 patients (mean age 79.6 ± 7.8 years, mean STS score 5.3 ± 3.6) were included. Patients were grouped as follows: underweight (n = 35, 8.5%), normal weight (n = 121, 29.4%), overweight (n = 140, 34%) and obese (n = 116, 28.1%). Obese patients were younger, included more females and had lower STS score than the rest of the cohort whereas underweight patients were older, had higher STS score, more chronic kidney disease, more left ventricular dysfunction and more often underwent non-transfemoral TAVR. BMI predicted 30-day survival (AUC:0.692 [95%CI 0.522-0.862]; p = 0.030) with an optimal cut-off of 24.4 (sensitivity = 66.6%, specificity = 63.6%). On multivariate analysis, higher BMI trended toward lower 30-day mortality (HR = 0.87 [95%CI 0.75-1.01]; p = 0.071). Thirty-day mortality was higher in the underweight group (8.3%) in comparison with other BMI subgroups (normal weight 2.5%, overweight 1.4%, obese 0.9%; p = 0.045). However, no significant difference was found after adjustment of confounders (all p = NS). BMI did not predict one-year mortality. No significant difference in one-year survival was observed between the four BMI subgroups (log rank p = 0.925).Conclusion: BMI could represent an interesting prognostic tool for short-term mortality in patients undergoing TAVR. BMI < 20 kg/m2 was associated with higher 30-day mortality. Symptoms improved similarly in obese patients compared to lower BMI patients. For 30-day survivors, no evidence of the existence of an obesity paradox was observed in this cohort. [ABSTRACT FROM AUTHOR]

Objectives: We describe procedural and clinical outcomes in a high-risk cohort undergoing transcatheter aortic valve replacement with early next-generation transcatheter valve and delivery systems. Background: Percutaneous aortic valve replacement is gaining acceptance as a viable option in patients at high surgical risk. Broader application will require further advances in valve and delivery system technology. Methods: Transarterial aortic valve replacement was attempted in 25 patients (mean age 85 years) determined to be at high surgical risk due to comorbidities. A new delivery catheter system (RetroFlex 2, Edwards Lifesciences, Irving, California) was utilized in combination with either a balloon-expandable SAPIEN (Edwards Lifesciences) valve or a next-generation low-profile cobalt-chromium bovine pericardial SAPIEN XT (Edwards Lifesciences) valve. Results: Percutaneous valve replacement was successful in all 25 high-risk patients. Aortic valve area increased from 0.59 ± 0.15 cm2 to 1.60 ± 0.27 cm2. In this high-risk cohort (Society of Thoracic Surgeons and logistic EuroSCORE estimates of surgical mortality were 8.9% and 21.0%, respectively), 30-day mortality was 0%. Conclusions: Technical and procedural advances in catheter systems and prosthetic valves designed for percutaneous aortic valve delivery may contribute to increased procedural success and improved clinical outcomes. [Copyright &y& Elsevier]

Background–We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). Methods and Results–This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. Conclusions–The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period. [ABSTRACT FROM AUTHOR]