Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

Q: What does this research mean for the field?

Intravascular lithotripsy guided by the TREATABLE classification enables safe and effective transfemoral transcatheter aortic valve replacement in patients with severe peripheral artery disease, eliminating post-interventional vascular stenosis or occlusion. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Constantin von zur Mühlen; Christian Valina; Laura Vagner; Alexander Asmussen; Alexandra Lindau; Philipp Ruile; Manuel Hein; Martin Moser; Peter Stachon; Klaus Kaier; Tau Hartikainen; Alexander Maier; Markus Jäckel; Martin Czerny; Dirk Westermann; Vera Oettinger; Jonathan Rilinger

doi:10.1007/s00392-025-02779-1

November 6, 2025Clinical Research in CardiologyOpen Access

Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

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Why the study?

Transfemoral TAVR is often not feasible in patients with severe peripheral artery disease, and iliofemoral calcium modification by intravascular lithotripsy may enable transfemoral access.

Does intravascular lithotripsy improve procedural success and safety in patients with severe peripheral artery disease undergoing transfemoral TAVR?

Structured PICO

Does intravascular lithotripsy improve procedural success and safety in patients with severe peripheral artery disease undergoing transfemoral TAVR?

P

Population

1,229 patients with severe symptomatic aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR), including a prospective cohort (n=229) and a retrospective cohort (n=1,000). Median age ~83 years, ~51-56% male, single-center in Germany. Includes patients with severe peripheral artery disease (PAD) and iliofemoral calcification evaluated by the TREATABLE classification.

I

Intervention

Intravascular lithotripsy (IVL) using 7 and 8-mm catheters (300 shocks applied to the most severe calcifications and other calcified lesions of the iliofemoral access vessel) prior to insertion of the TAVR sheath to facilitate transfemoral access.

C

Comparator

Transfemoral TAVR without IVL support (including concurrent low-risk patients in the prospective cohort and a retrospective cohort of high-risk patients where IVL was unavailable).

O

Outcome

Composite of successful TAVR procedure and safety (aneurysm, dissection, perforation, stenosis, vascular occlusion as well as surgical or interventional bailout).composite

Intravascular lithotripsy is a safe and effective strategy to facilitate transfemoral TAVR in patients with severe iliofemoral peripheral artery disease who would otherwise be ineligible for this access route.

Limitations

Non-randomized observational design with potential unmeasured confounders (e.g., frailty, comorbidities)
Single-center study limiting generalizability
Small number of patients treated with IVL limiting statistical power for rare safety endpoints
Short follow-up period of 3 months missing late vascular complications
Follow-up conducted via telephone without new diagnostic data

Implication

IVL may enable transfemoral TAVR in severe PAD; leaves open safety, efficacy, and need for randomized confirmation.

Abstract

BACKGROUND: In patients with severe peripheral artery disease (PAD), transfemoral transcatheter aortic valve replacement (TAVR) is often not feasible. OBJECTIVES: Iliofemoral calcium modification by intravascular lithotripsy (IVL) may enable transfemoral access in PAD patients. METHODS: Between June 2022 and February 2024, all consecutive TAVR patients at our institution were prospectively screened for use of IVL according to the predefined TREATABLE classification, involving parameters such as calcification, vessel kinking and stenosis. Endpoints comprised successful TAVR, safety, and three-month outcomes (DRKS00034681). In an independent retrospective approach, all TAVR patients treated between February 2020 and June 2022 were evaluated with the TREATABLE classification towards complication rates without use of IVL (DRKS00029242). RESULTS: Two hundred twenty-nine prospective patients were included and after application of the TREATABLE classification, 26 patients (11.4%) received IVL-supported transfemoral TAVR. According to the TREATABLE classification, there was a similar extent of kinking (p = 0.468), but a significantly higher severity of calcification in the IVL-treated group (p < 0.001). In the retrospective analysis of the additional 1000 patients, 966 (96.6%) received transfemoral and 34 alternative access TAVR. 154 transfemoral and all alternative access TAVR were identified as high-risk according to the TREATABLE classification. Comparing the retrospective and prospective TREATABEL cohorts, transfemoral high-risk patients in the retrospective cohort without IVL showed a higher rate of post-interventional stenosis or occlusion (12.3% vs. 0%, p = 0.049). CONCLUSION: This observational study shows a favourable success and safety level of IVL-supported transfemoral TAVR despite severe PAD, based on the TREATABLE classification. Therefore, the newly developed classification provides a suitable tool for identifying patients who would benefit from facilitating transfemoral TAVR by IVL.

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Cite This Study

Mühlen et al. (2025) studied this question.

synapsesocial.com/papers/6a8727393f44447e627cc525 https://doi.org/10.1007/s00392-025-02779-1

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Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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