Abstract Objectives The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with ...symptomatic, severe aortic stenosis (AS) who were not candidates for surgery. Background Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve compared with standard therapy, but the SAPIEN valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile SAPIEN XT system was developed to reduce these adverse events. Methods A total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography). Results Both overall and major vascular complications were higher at 30 days in patients undergoing TAVR with SAPIEN compared with SAPIEN XT (overall: 22.1% vs. 15.5%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value <0.002); no differences in the other major pre-specified endpoints were found. Conclusions In inoperable patients with severe, symptomatic AS, the lower-profile SAPIEN XT is noninferior to SAPIEN with fewer vascular complications and a lesser need for blood transfusion. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves; NCT01314313 )
Summary Background Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with ...severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients. Methods We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1:1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with ClinicalTrials.gov , number NCT00530894. Findings We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 71·8% in the TAVR group versus 93·6% in the standard treatment group (hazard ratio 0·50, 95% CI 0·39–0·65; p<0·0001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1·52 cm2 at 5 years, mean gradient 10·6 mm Hg at 5 years), with no evidence of structural valve deterioration. Interpretation TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities. Funding Edwards Lifesciences.
Objectives This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). Background The introduction of transcatheter aortic valve ...implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. Methods A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected. Results The cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm2 to 0.96 ± 0.3 cm2 (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm2 , and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm2 versus 0.28 ± 0.24 cm2 in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm2 was significantly lower than in the group with final AVA of <1 cm2 (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001). Conclusions Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone.
Objectives The logistic European System for Cardiac Operative Risk Evaluation (LES) score and the Society of Thoracic Surgeons (STS) score are validated to predict 30-day outcomes following surgical ...aortic valve replacement (SAVR) with or without coronary artery bypass grafting. Their performance when applied to patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. Methods We compared predicted and observed 30-day/in-hospital and 1-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry (N = 2466). The performance of the LES and STS scores (prospectively calculated) was evaluated using standard assessments of discrimination and calibration. Performance of STS and LES scores among 307 patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined. Results In patients undergoing TAVR, the observed 30-day/in-hospital mortality was 6.5%, whereas the predicted 30-day mortality was higher by both STS score (11.4% ± 3.9%) and LES score (26.6% ± 16.2%). The discrimination for both scores was poor for 30-day/in-hospital and 1-year mortality. Calibration was better for STS score than for LES at 1 year but poor for both at 30 days among TAVR cohort. These results were consistent among the subgroups of patients undergoing transfemoral and transapical access; however, the STS score had better performance among the high-risk patients who underwent SAVR at 30 days but not 1 year. Conclusions The STS and LES surgical risk scores overestimated 30-day/in-hospital mortality and were poor discriminators of post-TAVR mortality, but the calibration of the STS score was better in these high-risk patients. These data highlight the need for TAVR-specific risk models to optimize patient selection.
Objectives The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Background Outcomes of patients with ...CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. Methods All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Results Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test <50 m; hazard ratio: 1.67, p = 0.0009) and oxygen-dependency (hazard ratio: 1.44, p = 0.02). Although CLD patients undergoing TAVR have worse outcomes than patients without CLD, TAVR is better in these patients than standard therapy and is similar to SAVR. Conclusions Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
Abstract We sought to determine whether balloon-expandable (BEV) and self-expanding (SEV) valves affect valve hemodynamics differently according to native aortic annulus size. TAVR can achieve ...superior prosthetic valve hemodynamics compared with SAVR, particularly in patients with small aortic annulus. 193 consecutive TAVR patients were grouped into tertiles defined by CT angiography-derived aortic annulus systolic perimeter. The pre-discharge echocardiogram was analyzed for prosthetic valve hemodynamics. Tertile perimeter cutoffs were 73mm and 80mm. STS score decreased as annulus size increased (7.8% vs. 7.6% vs. 6.0%, p=<0.05 for small, medium and large annulus, respectively). In patients with small aortic annulus, SEV was associated with significantly higher dimensionless index (0.64 vs. 0.53, p=0.02) and lower peak velocity (1.8 vs. 2.4m/sec, p<0.001), and a trend toward lower mean gradient (7.5 vs. 10.0mmHg, p=0.07) compared with BEV. These differences were attenuated and absent in patients with medium and large annulus, respectively. Few patients had moderate/severe paravalvular leak, with no association with valve type or annulus size. There was no difference in mortality between tertiles or valve type at 30 days or 1 year. There was no association between aortic annulus perimeter and 1-year mortality by univariate analysis (HR 1.00, 95% CI 0.95-1.05, p=0.86) or multivariate analysis (HR 1.02, 95% CI 0.95-1.09, p=0.60). In conclusion, SEV hemodynamics were superior to BEV in patients with small aortic annulus. This difference was diminished in patients with larger aortic annulus. This study highlights the importance of valve selection in patients with small aortic annulus.
The incidence, correlates, and prognostic implications of pulmonary hypertension (PH) are unclear in patients with severe aortic stenosis (AS). We studied 509 patients with severe AS evaluated for ...transcatheter aortic valve implantation (TAVI). Patients were divided into groups based on pulmonary artery systolic pressure (PASP): group I, 161 (31.6%) with PASP <40 mm Hg; group II, 175 (34.3%) with PASP 40 to 59 mm Hg; and group III, 173 (33.9%) with PASP ≥60 mm Hg. Group III patients were more symptomatic and had higher creatinine levels and higher left ventricular end-diastolic pressure. Transpulmonary gradient was >12 mm Hg in 17 patients (10.5%), 31 patients (17.7%), and 80 patients (46.2%) in groups I through III, respectively. In a median follow-up of 202 days (73 to 446) mortality rates were 35 (21.7%), 69 (39.3%), and 85 (49.1%) in groups I through III, respectively (p <0.001). Immediately after TAVI, in patients with PASP >40 mm Hg there was significant decrease in PASP (63.1 ± 16.2 to 48.8 ± 12.4 mm Hg, p <0.0001), which remained at 1 year (50.1 ± 13.1 mm Hg, p = 0.04). After surgical aortic valve replacement there was a significant immediate decrease in PASP (66.1 ± 16.3 to 44.7 ± 14.2 mm Hg, p <0.0001), which persisted at 3 to 12 months (44.8 ± 20.1 mm Hg, p <0.001). In patients who underwent balloon aortic valvuloplasty, PASP decreased immediately after the procedure (63.2 ± 14.8 to 51.8 ± 17.1 mm Hg, p <0.0001), yet at 3 to 12 months pressure returned to baseline levels (57.4 ± 17.0 mm Hg, p = 0.29). In conclusion, patients with severe AS have a high prevalence of PH, and in patients with severe AS increased PASP is associated with increased mortality. Surgical aortic valve replacement and TAVI are effective treatments for these patients and result in a significant PASP decrease.
Risk assessment for transcatheter aortic valve replacement (TAVR) patients is challenging, and surgical scores do not optimally correlate with outcome. The aim of this study was to assess the ...correlation between serum albumin and survival of patients with symptomatic severe aortic stenosis undergoing TAVR. Patients with severe aortic stenosis who underwent TAVR were categorized into 2 groups according to low and normal preprocedural serum albumin (<3.5 and ≥3.5 g/dl, respectively). The all-cause mortality rates at hospital discharge, at 30-day and 1-year follow-up were compared across the groups. Additionally, a Cox proportional-hazards model was generated to assess the independent effect of serum albumin at 1-year follow-up. Among 567 consecutive patients who underwent TAVR, 476 (84%) had documented preprocedural serum albumin measurements. Of these, 50% had low serum albumin levels, and 50% had normal serum albumin levels. Baseline and procedural characteristics, including age, gender, and transapical access, were similar among the groups. Prevalence of left ventricular ejection fraction <40% was higher in patients with low albumin (29% vs 20%, p = 0.02), and risk assessment according to Society of Thoracic Surgeons score tended to be higher in the low-albumin group (10 ± 4.7 vs 9.4 ± 4.4, p = 0.09). Patients presenting with low albumin had higher in-hospital mortality (11% vs 5%), as well as at 30-day (12% vs 6%, p = 0.01) and 1-year (29% vs 19%, p = 0.02) follow-up. Serum albumin was independently associated with 1-year mortality (adjusted hazard ratio per 0.1 g/dl decrease 1.64, 95% confidence interval 2.50 to 1.75, p = 0.02), along with body mass index <20 kg/m2 (hazard ratio 1.89, 95% confidence interval 3.33 to 1.75, p = 0.03). In conclusion, preprocedural serum albumin level and low body mass index are independently associated with mortality in patients who undergo TAVR. Patients with severe aortic stenosis and low albumin levels should undergo careful evaluation before and after TAVR.
Abstract Background Right ventricular (RV) dysfunction was shown to be associated with adverse outcomes in a variety of cardiac patients and is considered a risk factor for adverse outcome according ...to the updated Valve Academic Research Consortium criteria. Objective Our goal was to assess the impact of RV function at baseline on 1-year mortality among severe aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). Methods All severe AS patients treated with TAVR from May 2007 to March 2015 at our center were included in the present study, and baseline and procedural characteristics were recorded for each patient. The patients were categorized according to RV function at baseline as assessed by current guidelines, and a comparison of mortality rates up to 1-year was performed. Results Among 650 patients, 606 had adequate echocardiogram quality and 146 (24%) had RV dysfunction. There were significant differences between the 2 groups, as patients with RV dysfunction were younger (81 ± 9 vs. 84 ± 7, P = .01) and were more likely to be male (65% vs. 42%, P < .001). In addition, patients with RV dysfunction had higher rates of prior myocardial infarction (26% vs. 16%, P = .02) and atrial fibrillation (51% vs. 39%, P = .02). Echocardiographic parameters demonstrated higher rates of left ventricular ejection fraction <40% (40% vs. 18%, P < .001), tricuspid regurgitation above moderate (16% vs. 9%, P = .04), and higher pulmonary artery systolic pressure (50 ± 17 vs. 44 ± 16, P < .001) among severe AS patients with RV dysfunction compared to patients with normal RV function. Despite the unfavorable cardiac function, severe AS patients undergoing TAVR have similar functional class ( P = .22) and mortality rates at 1 year (27% vs. 23%, log-rank P = .45). Conclusions Severe AS patients with RV dysfunction have similar 1-year mortality and functional class following TAVR as patients with normal RV function. The presence of RV dysfunction does not correlate with outcome in patients with severe AS.
Background Patients undergoing transcatheter aortic valve replacement (TAVR) are at increased risk for acute kidney injury (AKI). The Valve Academic Research Consortium (VARC) recently published ...criteria for AKI after TAVR. We aimed to identify predictors, assess the prognostic impact of AKI after TAVR, and compare various criteria for AKI. Methods Patients with aortic stenosis undergoing TAVR were retrospectively analyzed for periprocedural AKI (<72 hours) according to the VARC definition (increase in serum creatinine ≥0.3 mg/dL or ≥1.5× baseline) or according to the modified Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria (decrease of >25% in estimated glomerular filtration rate at 48 hours). Results Acute kidney injury, according to the VARC definition, occurred in 24 (14.6%) of 165 patients after TAVR. Acute kidney injury, according to RIFLE criteria, occurred in 19 patients (11.5%). Men (63% vs 38%, P = .03) and patients receiving blood transfusion (63% vs 39%, P = .04) were more likely to develop AKI. In multivariable analysis, only blood transfusion emerged as a predictor for AKI (odds ratio 3.74, 95% CI 1.36-10.3). Patients who developed AKI had higher in-hospital (21% vs 4%, P = .007) and 30-day mortality (29% vs 7%, P = .004) as compared with patients without AKI. Conclusion Acute kidney injury is a frequent complication of TAVR. Even a small increase (0.3 mg/dL) in baseline creatinine post-TAVR is associated with worse outcome. The poor prognosis of these patients should encourage improvement in patient selection and careful management for prevention of this complication.
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