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Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.This Review discusses the evolving indications of transcatheter aortic valve implantation (TAVI), including the latest clinical trials in young and low-risk patients with symptomatic severe aortic stenosis and ongoing studies exploring TAVI for other indications, including severe bicuspid aortic valve stenosis and pure native aortic regurgitation, highlighting procedural implications and caveats of new and future indications.

Little is known about the impact of bleeding and red blood cells transfusion (RBC) on the outcome post transcatheter aortic valve implantation (TAVI). Between November 2005 and August 2011, 943 consecutive patients underwent TAVI. Bleeding was assessed according to the Valve Academic Research Consortium definitions. Patients receiving RBC were compared to those not requiring transfusion. Life-threatening and major bleedings occurred respectively in 13.9% and 20.9% of the patients, significantly more frequently in the RBC cohort. Vascular complications occurred in 23.2% of the patients. Major and minor vascular complications were more frequent in the RBC group: 19.3 vs 5.2%, P < .001; 15.3 vs 9%, P = .003, respectively. Thirty-day all-cause mortality was 7.2%. Of the overall cohort, 38.9% required RBC transfusion; those receiving at least 4 U of RBC had higher 30-day all-cause mortality than those receiving 1 to 4 U of RBC and those not requiring transfusion: 14.4%, vs 6.3% vs 6.3%, respectively, P = .008. By multivariate analysis, transfusion of RBC was associated with an increased 30-day and 1-year mortality. Major stroke and all stages of acute kidney injury were significantly more frequent in the RBC cohort. Bleeding is frequent after TAVI, mainly driven by vascular complications. RBC transfusion was associated with increased mortality at 1 year and increased risk of major stroke and acute kidney injury. Specific scores are needed to identify the patients at higher risk for TAVI-related bleeding and RBC transfusion.

Contemporary guidelines on valvular heart disease have embraced transcatheter aortic valve replacement (TAVR) as the standard treatment for older patients with symptomatic severe degenerative aortic valve stenosis. 1,2 It is remarkable that randomised controlled trials comparing TAVR and surgical aortic valve replacement with only 1 or 2 years of clinical follow-up formed the foundation for these recommendations. Extended follow-up to 5 years and longer in these randomised and other trials justified this policy because there has been no signal of accelerated transcatheter valve degeneration or impaired durability. 3,4 Regardless, surgical and transcatheter bioprosthetic valves will eventually degenerate. Because of TAVR adoption in younger and patients with lower risk, the individual's lifespan might outlast the bioprosthesis and transcatheter valve failure will become a genuine clinical scenario. [...]5-year and 8-year echocardiography follow-up data demonstrated more structural valve degeneration with surgical valves than with self-expanding transcatheter valves. 7,8 As far as management of transcatheter valve failure goes, explant surgery is a relatively complex procedure that might require advanced surgical skills including aortic root replacement and enlargement techniques. 9 A recent international registry reported a four-times higher 30-day mortality rate after explant surgery as compared with redo-TAVR (13·6% vs 3·4%, p<0·001).

Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available. We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival. A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively). Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.

Better outcomes have been reported after percutaneous cardiac intervention in obese patients (“obesity paradox”). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the “obesity paradox” in patients undergoing TAVI.

Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction.

High bleeding risk (HBR) is a challenge in patients with complex coronary lesions undergoing percutaneous coronary intervention (PCI). This study investigates HBR in a wide and comprehensive cohort of patients undergoing left main (LM) PCI and reports in-hospital and follow-up outcomes. The analysis was performed on data from the DELTA (Drug Eluting Stent for Left Main Coronary Artery) 2 Registry, which included patients who underwent LM PCI at 19 centres worldwide. The patients were defined to be at HBR if ≥1 major criterion or ≥2 minor criteria from the Academic Research Consortium (ARC) were met. The primary endpoint was a composite of all-cause death, myocardial infarction (MI) or cerebrovascular accident (CVA) at median follow-up. A total of 1531 patients were included, and the rate of HBR was 65.8%. Besides the different clinical characteristics embedded in the ARC definition, HBR patients had higher prevalence of acute coronary syndrome (ACS) at presentation (49.2% vs. 26.8%, p < 0.001) and experienced higher in-hospital mortality (1.8% vs. 0.2%; p = 0.029) and MI (5.0% vs. 2.1%, p = 0.009). The median follow-up was 473 days. The rate of the primary endpoint was more than three times higher in HBR patients (20.8% vs. 6.1%; HR 3.3; 95%CI: 2.2–4.8) and driven by all-cause death at multivariate regression analysis. Conversely, no significant difference in target lesion revascularization and probable or defined stent thrombosis was reported. HBR patients undergoing LM PCI experienced higher rates of all-cause death at follow-up; similar outcomes were also reported in-hospital.

•Predictors of mortality after aortic valve implantation were identified.•A novel mortality risk assessment tool was developed.•Improved discriminatory ability compared with other risk score models.•Clinical characteristics were associated with greater all-cause mortality. Prevalent and incident atrial fibrillation are common in patients who undergo transcatheter aortic valve implantation and are associated with impaired postprocedural outcomes, including mortality. We determined predictors of long-term mortality in patients with atrial fibrillation after successful transcatheter aortic valve implantation. The EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation–Atrial Fibrillation (ENVISAGE-TAVI AF) trial (NCT02943785) was a multicenter, prospective, randomized controlled trial in patients with prevalent or incident atrial fibrillation after successful transcatheter aortic valve implantation who received edoxaban or vitamin K antagonists. A Cox proportional hazard model was performed to identify predictors of all-cause mortality using a stepwise approach for multiple regression analysis. In addition, we assessed the performance of different risk scores and prediction models using ENVISAGE-TAVI AF data. Of 1,426 patients in ENVISAGE-TAVI AF, 178 (12.5%) died during the follow-up period (median 548 days). Our stepwise approach identified greater risk of mortality with older age, impaired renal function, nonparoxysmal atrial fibrillation, excessive alcohol use, New York Heart Association heart failure class III/IV, peripheral artery disease, and history of major bleeding or predisposition to bleeding. The present model (concordance statistic [c-statistic] 0.67) was a better discriminator than were other frequently used risk scores, such as the Society of Thoracic Surgeons score (c-statistic 0.56); Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke, Vascular disease, Age 65 to 74 years, and Sex category (CHA2DS2-VASc) score (c-statistic 0.54); or Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly, and Drugs/alcohol concomitantly (HAS-BLED) score (c-statistic 0.58). In ENVISAGE-TAVI AF, several modifiable and nonmodifiable clinical characteristics were significantly associated with greater long-term all-cause mortality. Improved risk stratification to estimate the probability of mortality after successful transcatheter aortic valve implantation in patients with atrial fibrillation may improve long-term patient prognosis.

Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.

Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).