In the past decade, unfortunately, despite a continuous improvement of techniques and materials, for up to 20% of CLTI patients, revascularization is not possible or is not effective.1
For these patients, arterialization of the foot venous system could be considered an alternative treatment for limb salvage2-5.
The aim of this study is to evaluate the safety and effectiveness of our own standardized technique (Pioneer Peschiera Revascularization technique, PiPeR-technique) using an IVUS guided catheter, published on the EJVES 2018, in order to reduce major amputation in “no-option” CLTI patients6.
Material(s) and Method(s):
This study represents a prospective monocentric analysis on a continuous series of 18 “no-option” CLTI patients treated, from April 2019 to August 2021, in our department using the PiPeR technique6.
This study is conducted after the approval of the Verona-Rovigo Ethical Committee (n°6106, 30.01.2020) and all patients subscribed a specific consent.
The primary end-point is the limb salvage rate. The secondary end-points are: survival, amputation free-survival (AFS), wound healing. Furthermore, we analysed the quality of life of every patient during the healing process (Vascu Qol-6 Quest, Eq-5D-3L Quest and Eq-VAS Quest).
Eleven indWe performed 18 p-DVA in patients with “no-option” CLTI, 12 male and 6 female. Median age is 74,4 years (60-87). Eleven patients in Rutherford 5 class (61,1%) and 7 in Rutherford 6 class (38,9%). Based on the WIfI classification: 16 (88,9%) in stage 4; 1 in stage 3 and 1 in stage 2. All these patients with a previous failed angioplasty of the tibial and foot arteries.Severe MAC-SAD is present in 15 patients (83,3%) and the median TcpO2 was 13,5 (8,53) mmHg. Procedural success rate is 100%. The median duration of the operation was 169,7 minutes (100-280). The median flow rate in the common plantar vein was 312,4 cm/sec (166-440).During the follow-up (median 502,7 day) we had 3 deaths (16,7%), not directly related to the arterialization. The limb salvage rate is 83,3%, because we had 3 major amputations; the AFS is 66,7%.
Despite a quite poor patency (38,9%), we obtained a good improvement of the TcpO2 from 13,7 (1-26) mmHg to 54,9 (31-84) and, also, the complete wound healing was obtained in 13 patients (72,2%), with a median time of 213,7 days (89-385).
Analysing our data, it’s possible to state that the patency of the p-DVA is mandatory during the first 6 months; after this period, probably due to the remodelling process of the arterialized veins and angiogenesis, if there is an occlusion of the p-DVA the TcpO2 remains high and the wound healing continues anyway.
Quality-of-life questionaries showed a tendence to the worsening during the first month and after a progressive improvement.
Based on these interim analysis results of our registry, p-DVA, using the PiPeR-technique, seems to be safe and effective for “no-option” CLTI patients facing major amputation, with no mortality related to the intervention and an acceptable limb salvage rate and amputation free survival.