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Published on: December 23, 2014
Cerebrovascular events with self-expanding versus balloon-expandable valves in patients with or without peripheral
Tullio Palmerini1, Francesco Saia1, Antonio Giulio Bruno1
1Cardiology Unit, Cardiac Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Cardiac Thoracic and Vascular Department, Università di Bologna, Bologna, Italy.
Insights
Self-expanding valves (SEV) showed a higher risk of cerebrovascular events (CVE) in patients with peripheral artery disease (PAD) compared to balloon-expandable valves (BEV). This risk was not observed in patients without PAD undergoing transcatheter aortic valve replacement.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Peripheral artery disease (PAD) complicates transcatheter aortic valve replacement (TAVR) procedures.
- The choice of valve prosthesis, self-expanding valves (SEV) versus balloon-expandable valves (BEV), may influence periprocedural risks, particularly cerebrovascular events (CVE).
- Access route and PAD complexity (Hostile score) are critical factors in TAVR outcomes.
Purpose of the Study:
- To compare the risk of CVE between SEV and BEV in patients with and without PAD undergoing TAVR.
- To stratify the risk based on access route and PAD complexity (Hostile score).
Main Methods:
- An observational study (HOSTILE Registry) of 1707 patients with severe PAD undergoing TAVR analyzed CVE risk between SEV and BEV.
- A meta-analysis of randomized controlled trials (RCTs) compared SEV and BEV in patients without PAD undergoing transfemoral access (TFA)-TAVR.
- The primary endpoint was the 30-day risk of CVE.
Main Results:
- In patients with PAD (n=1021), SEV use was associated with a higher 30-day (aHR, 2.70) and 1-year (aHR, 2.98) risk of CVE compared to BEV.
- No significant interaction was found between valve type and access route or Hostile score in the PAD cohort.
- In patients without PAD (n=2131) from RCTs, no significant difference in 30-day CVE rates was observed between SEV and BEV.
Conclusions:
- SEVs are associated with an increased risk of CVE in TAVR patients with PAD.
- This elevated risk in patients with PAD is not seen in patients with suitable femoral arteries included in RCTs.
- Valve selection in TAVR should consider patient-specific factors like PAD severity and access route.
Objectives:
The authors compared the risk of cerebrovascular events (CVE) with self-expanding vales (SEV) vs balloon-expandable valves (BEV) in patients with or without peripheral artery disease (PAD), stratified by the access route and the complexity of PAD (Hostile score).
Methods:
The PAD-related risk of CVE between SEV vs BEV was investigated using data from the HOSTILE Registry, an observational study including 1707 patients with severe PAD undergoing transcatheter aortic valve replacement (TAVR) via different access routes. The relative risk of CVE with SEV vs BEV in patients without PAD was investigated in a meta-analysis of randomized controlled transfemoral access (TFA)-TAVR trials of patients with normal femoral arteries. The primary endpoint was the risk of 30-day CVE.
Results:
Among the 1021 patients undergoing TAVR through TFA or transaxillary access (TAxA), 674 (66.0%) received SEVs and 329 (32.2%) received BEVs. The 30-day propensity-adjusted risk of CVE was higher for SEV compared with BEV (adjusted hazard ratio [HR], 2.70; 95% CI, 1.16-6.23), with no significant interaction between the transcatheter heart valve and either the access route or the Hostile score. Similar results were apparent at 1 year (adjusted HR, 2.98; 95% CI, 1.30-6.83). In contrast, in a meta-analysis of 4 RCTs and 2131 patients with femoral arteries suitable for TAVR, there were no significant differences in the 30-day rates of CVE between SEV and BEV (odds ratio, 0.58; 95% CI, 0.24-1.40).
Conclusions:
Compared with BEVs, SEVs were associated with higher 30-day and 1-year rates of CVE in patients with PAD, a finding not apparent in patients with suitable femoral arteries enrolled in RCTs.
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