Dataset Information

Transcatheter Aortic Valve Replacement with Minimal Contrast Dye in Patients with Renal Insufficiency.

ABSTRACT:

Purpose

Concerns have been consistently raised in regards to the considerable amount of contrast dye used during transcatheter aortic valve replacement (TAVR) in patients with renal insufficiency. In the present study, we introduced minimal contrast TAVR and compared its 30-day clinical outcomes with conventional TAVR.

Materials and methods

We retrospectively investigated 369 patients who underwent TAVR between July 2011 and April 2020 in our institute. Among them, 93 patients with severe aortic stenosis and renal insufficiency (estimated glomerular filtration rate ≤50 mL/min/1.73 m²) were included and divided into a conventional TAVR group (n=56) and a minimal contrast TAVR group (n=37). In the minimal contrast TAVR group, the total amount of contrast was <10 mL during the entire TAVR procedure. Thirty-day major adverse clinical events (MACE), including death, stroke, implantation of permanent pacemaker, and initiation of hemodialysis, were investigated.

Results

The incidence of MACE was significantly lower in the minimal contrast TAVR group than the conventional TAVR group (16.2% vs. 42.9%, p=0.010). Death occurred in 9 patients (16.1%) in the conventional TAVR group and in 0 patients in the minimal contrast group (p=0.011). Hemodialysis was initiated in 2 patients (5.4%) in the minimal contrast TAVR group and in 7 patients (12.5%) in the conventional TAVR group (p=0.256). Multivariate regression analysis showed that the minimal contrast TAVR procedure was an independent predictor for reducing MACE (hazard ratio 0.208, 95% confidence interval: 0.080-0.541, p=0.001).

Conclusion

Minimal contrast TAVR is feasible and shows more favorable short-term clinical outcomes than conventional TAVR in patients with renal insufficiency.

SUBMITTER: Choi JY

PROVIDER: S-EPMC8542473 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.