Dataset Information

Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis.

ABSTRACT:

Objective

To evaluate whether transcatheter or surgical aortic valve replacement (TAVR or SAVR) affects clinical and haemodynamic outcomes in symptomatic patients with moderately-severe aortic stenosis (AS).

Methods

Echocardiographic evidence of severe AS for enrolment in the Evolut Low Risk trial was based on site-reported measurements. For this post hoc analysis, core laboratory measurements identified patients with symptomatic moderately-severe AS (1.02, 3.0ResultsModerately-severe AS was identified in 113 out of 1414 patients (8%). Baseline AVA was 1.1±0.1 cm², peak velocity 3.7±0.2 m/s, MG 32.7±4.8 mm Hg and aortic valve calcium volume 588 (364, 815) mm³. Valve haemodynamics improved following TAVR (AVA 2.5±0.7 cm², peak velocity 1.9±0.5 m/s and MG 8.4±4.8 mm Hg; p<0.001 for all) and SAVR (AVA 2.0±0.6 cm², peak velocity 2.1±0.4 m/s and MG 10.0±3.4 mm Hg; p<0.001 for all). At 24 months, the rates of death or disabling stroke were similar (TAVR 7.7% vs SAVR 6.5%; p=0.82). Kansas City Cardiomyopathy Questionnaire overall summary score assessing quality of life improved from baseline to 30 days after TAVR (67.0±20.6 to 89.3±13.4; p<0.001) and SAVR (67.5±19.6 to 78.3±22.3; p=0.001).

Conclusions

In symptomatic patients with moderately-severe AS, AVR appears to be beneficial. Determination of the clinical and haemodynamic profile of patients who can benefit from earlier isolated AVR needs further investigation in randomised clinical trials.

SUBMITTER: Ito S

PROVIDER: S-EPMC10186477 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis.

Ito Saki S Laham Roger R Nkomo Vuyisile T VT Forrest John K JK Reardon Michael J MJ Little Stephen H SH Mumtaz Mubashir M Gada Hemal H Bajwa Tanvir T Langholz David D Heiser John J Chawla Atul A Jenson Bart B Attizanni Guilherme G Markowitz Alan H AH Huang Jian J Oh Jae K JK

Open heart 20230501 1

<h4>Objective</h4>To evaluate whether transcatheter or surgical aortic valve replacement (TAVR or SAVR) affects clinical and haemodynamic outcomes in symptomatic patients with moderately-severe aortic stenosis (AS).<h4>Methods</h4>Echocardiographic evidence of severe AS for enrolment in the Evolut Low Risk trial was based on site-reported measurements. For this post hoc analysis, core laboratory measurements identified patients with symptomatic moderately-severe AS (1.0<aortic valve area (AVA)<1 ...[more]

PMID: 37173100

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Project description:Impaired left ventricular (LV) ejection fraction is a common finding in patients with aortic stenosis and serves as a predictor of morbidity and mortality after transcatheter aortic valve replacement. However, conflicting data on the most accurate measure for LV function exist. We wanted to examine the impact of LV ejection fraction, mean pressure gradient, and stroke volume index on the outcome of patients treated by transcatheter aortic valve replacement. Patients treated by transcatheter aortic valve replacement were primarily separated into normal flow (NF; stroke volume index >35 mL/m2) and low flow (LF; stroke volume index ≤35 mL/m2). Afterwards, patients were divided into 5 groups: "NF-high gradient," "NF-low gradient" (NF-LG), "LF-high gradient," "paradoxical LF-LG," and "classic LF-LG." The 3-year mortality was the primary end point. Of 1600 patients, 789 (49.3%) were diagnosed as having LF, which was characterized by a higher 30-day (P=0.041) and 3-year (P<0.001) mortality. LF was an independent predictor of all-cause (hazard ratio, 1.29; 95% confidence interval, 1.03-1.62; P=0.03) and cardiovascular (hazard ratio, 1.37; 95% confidence interval, 1.06-1.77; P=0.016) mortality. Neither mean pressure gradient nor LV ejection fraction was an independent predictor of mortality. Patients with paradoxical LF-LG (35.0%), classic LF-LG (35.1%) and LF-high gradient (38.1%) had higher all-cause mortality at 3 years compared with NF-high gradient (24.8%) and NF-LG (27.9%) (P=0.001). However, surviving patients showed a similar improvement in symptoms regardless of aortic stenosis entity. LF is a common finding within the aortic stenosis population and, in contrast to LV ejection fraction or mean pressure gradient, an independent predictor of all-cause and cardiovascular mortality. Despite increased long-term mortality, high procedural success and excellent functional improvement support transcatheter aortic valve replacement in patients with LF severe aortic stenosis.

Project description:ImportanceThe outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.ObjectiveTo evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.Design, setting, and participantsThe Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.InterventionsPatients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.Main outcomes and measuresThe prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.ResultsA total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.Conclusions and relevanceTranscatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.Trial registrationClinicalTrials.gov Identifier: NCT03635424.

Project description:Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33-0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42-1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17-0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14-0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14-0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31-11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33-9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41-1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53-1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43-1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

Project description:AimsConcurrent mitral regurgitation (MR) influences treatment considerations in patients with severe aortic stenosis (sAS). Limited information exists regarding haemodynamic effects of sAS on MR severity and outcome of these patients. We assessed the impact of aortic valve replacement (AVR) on MR according to mechanism in patients with sAS and MR.Methods and resultsIn patients with sAS who received surgical or transcatheter AVR from 2008 to 2017, those with effective mitral regurgitant orifice area (ERO) ≥ 10 mm2 prior to AVR were evaluated. The change in MR after AVR was considered significant when there was at least one grade difference. We compared the all-cause mortality of patients with and without improvement in MR. Of 234 patients with sAS and MR (age 80 ± 9 years, 52% male, ERO 19 ± 7 mm2 ), organic and functional MR were present in 166 (71%) and 68 (29%), respectively. MR improved in 136 (58%); improvement occurred with similar frequency in organic versus functional MR (59% and 57%, P = 0.88). Associated determinants were absence of atrial fibrillation in organic MR [odds ratio (OR) 2.09, 95% confidence interval (CI) 1.00-4.37; P = 0.049] and indexed aortic valve area (iAVA) ≤ 0.40 cm2 in functional MR (OR 3.28, 95% CI 1.13-9.47; P = 0.028). In the overall cohort, mitral annulus diameter < 3 cm (OR 1.74, 95% CI 1.02-2.97; P = 0.041) and QRS duration < 115 ms (OR 1.73, 95% CI 1.00-2.98; P = 0.049) were independently associated with improvement in MR. During median follow-up of 3.5 years, lack of improvement in MR was not associated with higher mortality in the overall cohort of patients with ERO ≥ 20 mm2 [adjusted hazard ratio (HR) 1.71, 95% CI 0.90-3.27; P = 0.10, adjusted for age, New York Heart Association III or IV, diabetes, and creatinine ≥ 2.0 mg/dL]. Lack of improvement in organic MR was associated with higher mortality (adjusted HR 3.36, 95% CI 1.40-8.05; P < 0.01). In patients with functional MR, change in MR was not associated with mortality (HR 1.24, 95% CI 0.44-3.47; P = 0.68).ConclusionsIn nearly 60% of patients with sAS and MR, MR improved after AVR, even in the majority of patients with organic MR. Absence of atrial fibrillation in organic MR, iAVA ≤ 0.40 cm2 in functional MR, and mitral annulus diameter < 3 cm and QRS duration < 115 ms in the overall population were associated with MR improvement. Post-operative improvement in organic MR was associated with better survival.

Dataset Information

Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis.

Objective

Methods

Conclusions

Publications

Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis.

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