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Updated: Jun 22, 2026
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Percutaneous transcatheter aortic valve implantation: assessing results, judging outcomes, and planning trials: the
Paul T L Chiam1, Carlos E Ruiz
1Department of Cardiac and Vascular Interventional Services, Lenox Hill Heart and Vascular Institute, New York, New York 10021, USA. cruiz@lenoxhill.net
Insights
Percutaneous aortic valve replacement (PAVR) offers a vital alternative for high-risk patients with severe aortic valve stenosis. This review explores optimal methods for assessing PAVR outcomes and trial designs for its evolving clinical application.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Aortic valve stenosis (AVS) prevalence is rising due to an aging population.
- Surgical aortic valve replacement (SAVR) is the standard treatment for severe symptomatic AVS.
- High-risk patients with comorbidities often cannot undergo SAVR.
Purpose of the Study:
- To discuss optimal methods for assessing percutaneous aortic valve replacement (PAVR) results and outcomes.
- To explore novel trial designs for evaluating PAVR's clinical applicability.
- To consider a paradigm shift in assessing outcomes for this rapidly advancing technology.
Main Methods:
- Review of current percutaneous heart valve (PHV) technologies and their modifications.
- Discussion of outcome assessment strategies beyond traditional randomized controlled trials.
- Exploration of innovative clinical trial designs for PAVR.
Main Results:
- PAVR has emerged as a significant alternative to SAVR for high-risk patients.
- Multiple percutaneous heart valve devices, including balloon-expandable and self-expandable, are in clinical use.
- Rapid technological advancements suggest PAVR will remain a key treatment option.
Conclusions:
- Further refinement of outcome assessment goals and trial methodologies is crucial for PAVR.
- Novel trial designs may be better suited to evaluate the evolving landscape of PAVR.
- A shift in mindset is needed to effectively assess the long-term impact and applicability of PAVR.
Abstract:
Aortic valve stenosis is increasing in frequency as the population ages. Surgical aortic valve replacement is the gold standard for symptomatic patients with severe aortic valve stenosis. However, in a subset of high-risk patients, the surgical option is excluded due to severe comorbidities. Recently, an alternative to surgical aortic valve replacement--percutaneous aortic valve replacement (PAVR)--has emerged. Since the first PAVR in a human in 2002, the percutaneous heart valves (PHVs) have already undergone several modifications from first generation devices. Currently, there are 2 PHVs in clinical application, a balloon-expandable and a self-expandable PHV, with several others achieving first-in-man application. With the extremely rapid technological advancements, PAVR is probably here to stay. The next steps required would be to formulate goals to assess results and outcomes of PAVR, and plan trials to test their clinical applicability. This article discusses how best to assess results and outcomes, which may require a paradigm shift in mindset. Apart from the randomized controlled trial, some of the more novel concepts in trial design, which may be more suitable in this area, are also explored.
