Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis: Data From a Nationwide Analysis.

BACKGROUND: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. METHODS: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. RESULTS: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P=0.005), cardiovascular death (relative risk, 0.82; corrected P=0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P<0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P<0.0001). CONCLUSIONS: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

Insights for increased risk of failed fibrinolytic therapy and stent thrombosis associated with COVID-19 in ST-segment elevation myocardial infarction patients.

Important health resources are dedicated worldwide to the management of COVID-19. This new disease, due to its large diffusion, may significantly hamper the prognosis of other pathologies, such as ST-segment elevation myocardial infarction (STEMI) because of (a) a possible direct negative impact and (b) shortage of first response medical resources and increased delays to reperfusion. We report the case of a 68-year-old man admitted for anterior STEMI and asymptomatic COVID-19. Due to extended transportation delays to a cathlab, he received intravenous fibrinolytic therapy, which failed. Reperfusion was achieved with rescue coronary angioplasty, but the patient experienced two episodes of acute stent thrombosis at 2- and 36-hr following admission and despite optimal medical therapy. He finally died because of cardiogenic shock. This raises concerns about a possible increase in platelet aggregability associated with COVID-19 leading to an increased risk of stent thrombosis, particularly in the context of STEMI. This pleads for the promotion of primary coronary angioplasty as the first-choice revascularization technique in this population and the use of new generation P2Y12 inhibitors. In addition, the use of GPIIb/IIIa inhibitors may be considered in every STEMI patient with COVID-19 to prevent the risk of acute stent thrombosis.

How to upgrade a leadless pacemaker to cardiac resynchronization therapy.

INTRODUCTION: We sought to develop an efficient method to upgrade pacing-induced cardiomyopathy (PICM) patients from a leadless pacemaker (LPM) to cardiac resynchronization therapy. METHODS AND RESULTS: Three consecutive patients with chronic atrial fibrillation, implanted with an LPM, with permanent right ventricular pacing, and who developed left ventricular systolic dysfunction due to PICM, were included. A conventional biventricular pacemaker with two different coronary sinus leads, one used for left lateral ventricular pacing, one for early right ventricular sensing, was implanted. It was then synchronized with the LPM working as the right ventricular pacing lead to provide biventricular pacing. The upgrading technique was feasible in all cases, without any perioperative complication. All patients had an improved clinical status during follow-up. CONCLUSION: This new upgrading technique allows efficient cardiac resynchronization therapy in LPM patients while preventing tricuspid valve crossing and providing an increased battery longevity.

Outcomes associated with pacemaker implantation following transcatheter aortic valve replacement: A nationwide cohort study.

BACKGROUND: Conduction abnormalities following transcatheter aortic valve replacement (TAVR) often may require permanent pacemaker implantation (PPM). OBJECTIVE: The purpose of this study was to evaluate outcomes associated with PPM after a TAVR procedure in a large, nationwide-level population. METHODS: Based on the administrative hospital discharge database, the incidence of all-cause death, cardiovascular death, and hospitalization for heart failure (HF) were retrospectively collected, based on the presence or absence of PPM, in the first 30 days following all TAVRs in France from 2010 to 2019. RESULTS: Among 520,662 patients hospitalized for aortic stenosis, 49,201 were treated with TAVR. A total of 29,422 patients had follow-up ≥6 months (median 1.7 years), 22% already had PPM at baseline, and 22% underwent PPM within the first 30 days post-TAVR. Adjusted hazard ratios for the combined risk of all-cause death and hospitalization for HF, during the whole follow-up, were higher in both patients with a previous PPM and in those implanted within 30 days (hazard ratio [95% confidence interval] 1.12 [1.07-1.17] and 1.11 [1.06-1.16], respectively). CONCLUSION: PPM at baseline and within 30 days post-TAVR are independently associated with higher mortality and HF hospitalization during follow-up.

Outcomes Following Aortic Stenosis Treatment (Transcatheter vs Surgical Replacement) in Women vs Men (From a Nationwide Analysis).

Gender-differences in survival following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) have been suggested. The objective of this study was to analyze outcomes following TAVR according to gender and to compare outcomes between TAVR and SAVR in women, at a nationwide level. Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with TAVR and SAVR between 2010 and 2019. Outcomes were analyzed according to gender and propensity score matching was used for the analysis of outcomes. In total 71,794 patients were identified in the database. After matching on baseline characteristics, we analyzed 12,336 women and 12,336 men treated with TAVR. In a second matched analysis, we compared 9,297 women treated with TAVR and 9,297 women treated with SAVR. Long term follow-up showed lower risk of all-cause death (12.7% vs 14.8%, hazard ratio (HR) 0.85, 95% CI 0.81 to 0.90) in women than men. Although the difference in cardiovascular death remained non-significant (5.8% vs 6.0%, HR 0.96, 95% CI 0.88 to 1.05), non-cardiovascular death was less frequent in women than in men following TAVR (6.9% vs 8.8% HR 0.78, 95%CI 0.72 to 0.84).When TAVR was compared with SAVR in women, long-term follow-up with TAVR showed higher rates of all-cause death (11.2% vs 6.5%, HR 1.91, 95%CI 1.78 to 2.05), cardiovascular death (5.0% vs 3.2%, HR 1.44, 95%CI 1.30 to 1.59), and non-cardiovascular death (6.2% vs 3.3%, HR 2.48, 95% CI 2.25 to 2.72). In conclusion, we observed that women undergoing TAVR have lower long-term all-cause mortality as compared with TAVR in men, driven by non-cardiovascular mortality. SAVR was associated with lower rates of long-term cardiovascular adverse events in women as compared with TAVR.

Valve-in-valve transcatheter aortic valve implantation after failed surgically implanted aortic bioprosthesis versus native transcatheter aortic valve implantation for aortic stenosis: Data from a nationwide analysis.

BACKGROUND: Valve-in-valve transcatheter aortic valve implantation (TAVI) has emerged as a treatment for aortic bioprosthesis failure in case of prohibitive risk for redo surgery. However, clinical evaluation of valve-in-valve TAVI remains limited by the number of patients analysed. AIM: To evaluate outcomes of valve-in-valve TAVI compared with native aortic valve TAVI at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated with TAVI for aortic stenosis or with isolated valve-in-valve TAVI for aortic bioprosthesis failure between 2010 and 2019. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 44,218 patients were found in the database. After matching on baseline characteristics, 2749 patients were analysed in each arm. At 30 days, no significant differences were observed regarding the occurrence of major clinical events (composite of cardiovascular mortality, all-cause stroke, myocardial infarction, major or life-threatening bleeding and conversion to open heart surgery) (odds ratio [OR] 0.83, 95% confidence interval [CI] 0.68-1.01; P=0.32). During follow-up (mean 516 days), the combined endpoint of cardiovascular death, all-cause stroke or rehospitalization for heart failure was not different between the valve-in-valve TAVI and native TAVI groups (RR 1.03, 95% CI 0.94-1.13; P=1.00). CONCLUSION: We observed that valve-in-valve TAVI was associated with good short- and long-term outcomes. No significant differences were observed compared with native valve TAVI regarding clinical follow-up.

Outcomes in nonagenarians undergoing transcatheter aortic valve implantation: a nationwide analysis.

AIMS: The aim of this study was to describe the midterm outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients with aortic stenosis (AS), and specifically those treated with TAVI between 2010 and 2018. Cox regression was used for the analysis of predictors of events. We compared patients according to their age. Within the studied period, 71,095 patients older than 90 years with AS were identified. After matching on baseline characteristics, TAVI was associated with lower rates of a combined outcome of all-cause death, rehospitalisation for heart failure and stroke (relative risk [RR] 0.58, p<0.001) in comparison with matched nonagenarians with AS treated medically. During follow-up (median 161 days, interquartile range 13-625), the combined outcome occurred more frequently in nonagenarians (RR 1.22, p<0.01) who had a TAVI than in younger patients undergoing this procedure. All-cause death was reported in 17.6% versus 14.5% of nonagenarians, rehospitalisation for heart failure in 21.3% versus 18.2%, and stroke in 3.7% versus 2.9% (p<0.01 for all parameters). We identified the Charlson comorbidity index, heart failure, atrial fibrillation, stroke, vascular disease, cognitive impairment and denutrition as independent predictors of adverse outcomes in nonagenarians undergoing TAVI. CONCLUSIONS: Among nonagenarians with AS, patients treated with TAVI had a lower risk of cardiovascular events than matched patients treated medically. The patients undergoing a TAVI at this age were often highly selected; the procedure was associated with acceptable long-term outcomes.

Transcatheter Valve-in-Valve Aortic Valve Replacement as an Alternative to Surgical Re-Replacement.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) and redo surgical aortic valve replacement (SAVR) represent the 2 treatments for aortic bioprosthesis failure. Clinical comparison of both therapies remains limited by the number of patients analyzed. OBJECTIVES: The purpose of this study was to analyze the outcomes of VIV TAVR versus redo SAVR at a nationwide level in France. METHODS: Based on the French administrative hospital-discharge database, the study collected information for patients treated for aortic bioprosthesis failure with isolated VIV TAVR or redo SAVR between 2010 and 2019. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 4,327 patients were found in the database. After matching on baseline characteristics, 717 patients were analyzed in each arm. At 30 days, VIV TAVR was associated with lower rates of the composite of all-cause mortality, all-cause stroke, myocardial infarction, and major or life-threatening bleeding (odds ratio: 0.62; 95% confidence interval: 0.44 to 0.88; p = 0.03). During follow-up (median 516 days), the combined endpoint of cardiovascular death, all-cause stroke, myocardial infarction, or rehospitalization for heart failure was not different between the 2 groups (odds ratio: 1.18; 95% confidence interval: 0.99 to 1.41; p = 0.26). Rehospitalization for heart failure and pacemaker implantation were more frequently reported in the VIV TAVR group. A time-dependent interaction between all-cause and cardiovascular mortality following VIV TAVR was reported (p-interaction <0.05). CONCLUSIONS: VIV TAVR was observed to be associated with better short-term outcomes than redo SAVR. Major cardiovascular outcomes were not different between the 2 treatments during long-term follow-up.

Futility Risk Model for Predicting Outcome After Transcatheter Aortic Valve Implantation.

Risk-benefit assessment for transcatheter aortic valve implantation (TAVI) is still a matter of debate. We aimed to identify patients with a bad outcome within 1 year after TAVI, and to develop a Futile TAVI Simple score (FTS). Based on the administrative hospital-discharge database, all consecutive patients treated with percutaneous TAVI in France between 2010 and 2018 were included. A prediction model was derived and validated for 1-year all-cause death after TAVI (considered as futility) by using split-sample validation: 20,443 patients were included in the analysis (mean age 83 ± 7 years). 7,039 deaths were recorded (yearly incidence rate 15.5%), among which 3,702 (53%) occurred in first year after TAVI procedure. In the derivation cohort (n = 10,221), the final logistic regression model included male sex, history of hospital stay with heart failure, history of pulmonary oedema, atrial fibrillation, previous stroke, vascular disease, renal disease, liver disease, pulmonary disease, anaemia, history of cancer, metastasis, depression and denutrition. The area under the curve (AUC) for the FTS was 0.674 (95%CI 0.660 to 0.687) in the derivation cohort and 0.651 (95%CI 0.637 to 0.665) in the validation cohort (n = 10,222). The Hosmer-Lemeshow test had a p-value of 0.87 suggesting an accurate calibration. The FTS score outperformed EuroSCORE II, Charlson comorbidity index and frailty index for identifying futility. Based on FTS score, 7% of these patients were categorized at high risk with a 1-year mortality at 43%. In conclusion, the FTS score, established from a large nationwide cohort of patients treated with TAVI, may provide a relevant tool for optimizing healthcare decision.