Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers

C-A Behrendt, F Heidemann, K Haustein, R T Grundmann, E S Debus, PSI Collaborators, K M Balzer, R Banafsche, L Barbera, M Baumhäkel, E Blajan, H Böhner, P Breuer, U Brune, J Brunkwall, T Bürger, S Classen, A Cöster, P Dahl, E S Dus, J P Delgado, H Dill, S Eder, T Fährenkemper, B Feidicker, J Forkel, J Gahlen, B Geier, R Ghoi, H Görtz, J Gräbedünkel, W Gunkel, O Hader, T Hammermüller, J Hatzl, J Hoffmann, M Hofmann, U Huberts, M Jacobs, V Kiechle, M Kindermann, M Kleemann, P Kolka, M Krahl, T Krönert, G Krupski-Berdien, H Kuffner, M Kuhnert, T Lange, V K Lauff, T Lesser, F Liewald, D Lommel, M Naundorf, K Nitschmann, S Nöldeke, T Noppeney, A Oberhuber, D M Ockert, K-H Orend, U Ossig, C Petridis, A Pflugradt, U Quellmalz, P Reimer, J Remig, P Richter, G Riepe, G Rümenapf, T Schaefer, H Schelzig, G Schmidt, M Schneider, J Schofer, S Seifert, M Siggelkow, S Sixt, E Stautner, A Stehr, M Storck, J Teßarek, O E Teebken, K-D Thom, W P Tigges, G Voshage, K-D Wagenbreth, K P Walluscheck, D Walter, R Weidenhagen, B Weis-Müller, H Wenk, M Wenk, M Wiedner, J Wilde, F T Wittstock, C-A Behrendt, F Heidemann, K Haustein, R T Grundmann, E S Debus, PSI Collaborators, K M Balzer, R Banafsche, L Barbera, M Baumhäkel, E Blajan, H Böhner, P Breuer, U Brune, J Brunkwall, T Bürger, S Classen, A Cöster, P Dahl, E S Dus, J P Delgado, H Dill, S Eder, T Fährenkemper, B Feidicker, J Forkel, J Gahlen, B Geier, R Ghoi, H Görtz, J Gräbedünkel, W Gunkel, O Hader, T Hammermüller, J Hatzl, J Hoffmann, M Hofmann, U Huberts, M Jacobs, V Kiechle, M Kindermann, M Kleemann, P Kolka, M Krahl, T Krönert, G Krupski-Berdien, H Kuffner, M Kuhnert, T Lange, V K Lauff, T Lesser, F Liewald, D Lommel, M Naundorf, K Nitschmann, S Nöldeke, T Noppeney, A Oberhuber, D M Ockert, K-H Orend, U Ossig, C Petridis, A Pflugradt, U Quellmalz, P Reimer, J Remig, P Richter, G Riepe, G Rümenapf, T Schaefer, H Schelzig, G Schmidt, M Schneider, J Schofer, S Seifert, M Siggelkow, S Sixt, E Stautner, A Stehr, M Storck, J Teßarek, O E Teebken, K-D Thom, W P Tigges, G Voshage, K-D Wagenbreth, K P Walluscheck, D Walter, R Weidenhagen, B Weis-Müller, H Wenk, M Wenk, M Wiedner, J Wilde, F T Wittstock

Abstract

Background: The percutaneous infrainguinal stent (PSI) register study aimed to collate all percutaneous endovascular procedures for infrainguinal peripheral arterial occlusive disease (PAOD) conducted in 74 German vascular centers between September and November 2015 (3 months). In order to obtain representative results all consecutive treatment procedures had to be submitted by the participating trial centers.

Material and methods: This was a prospective, nonrandomized multicenter study design. All patients suffering from intermittent claudication (IC, Fontaine stage II) or critical limb ischemia (CLI, Fontaine stages III and IV) were included. Trial centers with less than 5 cases reported within the 3‑month trial period or centers that could not ensure the submission of all treated patients were excluded.

Results: In the final assessment 2798 treated cases from 74 trial centers were reported of which 65 (87.8 %) centers were under the leadership of a vascular surgeon. Approximately 33 % of the interventions in centers under the leadership of vascular surgeons were conducted by radiologists. Risk factors, especially chronic renal disease, diabetes and cardiac risk factors were significantly different between patients with IC and CLI. Of the patients with Fontaine stage II PAOD 41.3 % had 3 patent crural vessels compared to only 10.8 % of patients with Fontaine stage IV. With respect to peri-interventional complications, percutaneous endovascular treatment of IC was a safe procedure with severe complications in less than 1 % and no fatalities. Only 4.5 % of the procedures were conducted under ambulatory conditions. In the supragenual region self-expanding bare metal stents, standard percutaneous transluminal angioplasty (PTA) and drug-coated balloons were the most frequently used procedures. For interventions below the knee, standard PTA was the most commonly employed treatment.

Conclusion: The main aim of the PSI study was to obtain a realistic picture of percutaneous endovascular techniques used to treat suprapopliteal and infrapopliteal PAOD lesions and to describe the treatment procedures used by vascular specialists in Germany. To investigate the change in trends for treatment over time, this study has to be repeated in the future in order to test how quickly the results of randomized studies can be implemented in practice.

Keywords: Endovascular; GermanVasc; Percutaneous; Percutaneous infrainguinal stent; Peripheral arterial occlusive disease.

Conflict of interest statement

C.-A. Behrendt, F. Heidemann, K. Haustein, R.T. Grundmann, E.S. Debus and the PSI collaborators state that they have no competing interests.

The supplement containing this article is not sponsored by industry.

This article does not contain any studies with human participants or animals performed by any of the authors.

Figures

Fig. 1
Fig. 1
Reported data from the participating trial centers as name of the chief investigator(s) (average 38 cases per center)
Fig. 2
Fig. 2
Distribution of treatment indications and outflow prior to intervention, grouped according to indications (PAOD peripheral arterial occlusive disease, Fontaine stage)
Fig. 3
Fig. 3
Distribution of the procedures and devices according to region (PTA percutaneous transluminal angioplasty, DCB drug-coated balloons, Atherect. atherectomy, BMS bare metal stents, DES drug-eluting stent, mech. thrombect. mechanical thrombectomy)
Fig. 4
Fig. 4
Length of hospital stay prior to and following interventions according to treatment indications

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