https://doi.org/10.1007/s00392-025-02625-4
1Universitäts-Herzzentrum Freiburg - Bad Krozingen Klinik für Kardiologie und Angiologie Freiburg im Breisgau, Deutschland; 2Universitäts-Herzzentrum Freiburg / Bad Krozingen Klinik für Kardiologie und Angiologie Bad Krozingen, Deutschland; 3Universitäts-Herzzentrum Freiburg - Bad Krozingen Innere Medizin III, Kardiologie und Angiologie Freiburg im Breisgau, Deutschland; 4Albert- Ludwigs-Universität Freiburg Innere Medizin III, Kardiologie und Angiologie Freiburg im Breisgau, Deutschland
In many transcatheter aortic valve replacement (TAVR) patients, the transfemoral access route is complicated by severe peripheral artery disease (PAD), leading to an increased rate of iliofemoral complications or forcing the choice of alternative access routes. Calcification modification by intravascular lithotripsy (IVL) might be a valuable tool to overcome these challenges. We hypothesize that the availability of IVL can reduce the need for alternative access routes and vascular complications.
Methods
To define the severity of PAD, we applied the TREATABLE classification, which comprises the most kinked area of the femoral and iliac arteries (inner angle from 120° to 45° and the level of calcification (from no calcification to stenotic calcification with lumen diameter < 5 mm).
First we performed a retrospective analysis of 1000 consecutive TAVR patients without the availability of IVL, which were divided into a group with vs. without IVL indication using the TREATABLE classification. In addition to the hospital outcome, the rate of alternative access routes and the prevalence of vascular complications were analysed.
Second, TREATBLE high-risk patients of this cohort were compared to patients from a prospective TAVR cohort with the availability of IVL (229 consecutive patients).
Results
In 1000 retrospective analysed TAVR patients (age 83 (79.5-86.1), 490 (49%) male, BMI 25.9 (23.5-28.8) kg/m², STS score 3.2 (2.0-5.0)), 188 (18.8%) patients showed a high-risk iliofemoral access profile. Of these patients, 34 (18.5%) were treated via an alternative access route (31 transapical, 3 subclavian), whereas 154 (81.9%) patients underwent transfemoral TAVR without IVL support.
The high-risk group showed a lower rate of hospital survival (96.3% vs. 98.9%, p=0.010). Moreover, patients in the high-risk group (IVL indication) who received transfemoral access had significantly more vascular complications (stenosis or vascular occlusion, dissection, perforation, aneurysm) as well as more interventional or surgical bail outs compared to patients of the low-risk group (no IVL indication, figure 1).
In the prospective cohort with IVL availability (n=229, age 83 (78-86) years, 56% male, BMI 25.7 (22.8-29.3) kg/m², STS score 3.9 (2.5-6.4)), there was no need for alternative access routes (0%).
Transfemoral high-risk TAVR patients with the availability of IVL (n=26) showed less complications like stenosis or occlusion compared to the group of transfemoral TAVR patients without IVL availability (n=154, 0 (0%) vs. 19 (12.3%), p=0.043, figure 2).
Conclusion
The TREATABLE classification successfully predicted patients with a complex iliofemoral access, causing alternative access routes, an increased level of iliofemoral complications and worse overall outcome.
The availability of IVL showed a reduced rate of iliofemoral complications in transfemoral TAVR patients with severe PAD.
Figure 1: Vascular complications of transfemoral TAVR patients with (red, n=188) or without (blue, n=812) IVL indication following the TREATABLE classification.
* p<0.05, **** p<0.001
Figure 2: Vascular complications of transfemoral TAVR patients with severe peripheral artery disease with (IVL, n=26) vs. without (no IVL, n=154) IVL support.