Dataset Information

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

ABSTRACT:

Objective

To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs).

Methods

Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database.

Results

TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed.

Conclusions

TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

SUBMITTER: Kroon HG

PROVIDER: S-EPMC8881514 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

Kroon H G HG van Gils L L Ziviello F F van Wiechen M P H MPH Ooms J F W JFW Rahhab Z Z El Faquir N N Maugenest A-M AM Goudzwaard J A JA Cummins P P Lenzen M M Kardys I I Daemen J J Mattace-Raso F F de Jaegere P P T PPT Van Mieghem N M NM

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 20210429 3

<h4>Objective</h4>To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs).<h4>Methods</h4>Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database.<h4>Results</h4>TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent ...[more]

PMID: 33914259

Similar Datasets

Project description:BackgroundSevere calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear.MethodsData from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population.ResultsTechnical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2.ConclusionA porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

Project description:AimsTo evaluate the patient- and procedure-related predictors of transcatheter aortic-valve implantation (TAVI)-associated ischemic brain lesions and to assess the effect of silent cerebral ischemic lesions (SCIL) on neurocognitive function.Methods and resultsWe investigated 113 consecutive patients with severe aortic stenosis who underwent brain magnetic resonance imaging (MRI) within a week following TAVI. To assess periprocedural cerebral ischemic lesions, diffusion-weighted MRI was utilized. We used multivariate linear regression to identify the independent predictors of TAVI-related ischemic lesion volume (ILV) and periprocedural stroke. Neurocognitive evaluation was performed before and following TAVI at 6-month and one-year follow-up. Following TAVI, a total of 944 new cerebral ischemic lesions were detected in 104 patients (92%). The median ILV was 257 μl (interquartile range [IQR]:97.1-718.8μl) with a median lesion number of 6/patient [IQR:2-10]. The majority of ischemic lesions were clinically silent (95%), while 5% of the lesions induced a stroke, which was confirmed by MRI. Predilatation (β = 1.13[95%CI:0.32-1.93], p = 0.01) and the number of valve positioning attempts during implantation (β = 0.28[95%CI:0.06-0.50], p = 0.02) increased the log-transformed total ILV. Predilatation (OR = 12.04[95%CI:1.46-99.07], p = 0.02) and alternative access routes (OR = 7.84[95%CI:1.01-61.07], p = 0.02) were associated with stroke after adjustments for comorbidities and periprocedural factors. The presence of SCILs were not associated with a change in neurocognitive function that remained stable during the one-year follow-up.ConclusionWhile periprocedural ischemic lesions are frequent, most of them are clinically silent and might not impact the patients' neurocognitive function. The number of valve positioning attempts, predilatation, and alternative access routes should be taken into consideration during TAVI to reduce the ILV and risk for stroke.

Dataset Information

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

Objective

Methods

Results

Conclusions

Publications

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets