Serration Angioplasty Is Associated With Less Recoil in Infrapopliteal Arteries Compared With Plain Balloon Angioplasty.

PURPOSE: Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss and widely considered to be a contributing factor in early failure or later restenosis. The Serranator balloon has been designed to provide a controlled lumen gain while minimizing vessel injury. The objective of this study was to assess the ability to define and measure postangioplasty recoil in infrapopliteal arteries and to compare recoil after serration angioplasty and plain balloon angioplasty (POBA). METHODS: This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis. RESULTS: This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Arterial recoil (>10%) occurred in 25% of Serranator-treated lesions versus 64% in POBA-treated lesions (p=0.02. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). There was no significant difference in technical success (100% for both), dissection rate between Serranator (5%) and POBA (5.2%). CONCLUSIONS: Arterial recoil occurs after infrapopliteal angioplasty. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes. CLINICAL IMPACT: Prior studies have demonstrated over 90% recoil in patients after balloon angioplasty (POBA) of the infrapopliteal vessels, which significantly impacts the durability and impact of endovascular interventions in this clinical space. This study compared recoil after infrapopliteal angioplasty with serration angioplasty and POBA. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes.

One-year outcomes following primary stenting of infrapopliteal steno-occlusive arterial disease using a non-polymer sirolimus-eluting stent: Results from a prospective single-centre cohort study.

Background: Clinical outcomes using new generation drug-eluting stents designed specifically for infrapopliteal disease are not widely available, especially in comparison to paclitaxel-based therapies. This series reports 1-year outcomes in patients with diabetes and chronic limb threatening ischaemia (CLTI) undergoing angioplasty, with a sirolimus-eluting tibial stent (Cre8, Alvimedica, Turkey), evaluating the feasibility, safety, and efficacy of this new device. Outcomes were compared to matched patients undergoing infrapopliteal angioplasty using a paclitaxel-coated balloon (DCB). Patients and Methods: Patients with diabetes and CLTI requiring infrapopliteal intervention were recruited prospectively to undergo angioplasty and primary stenting using the Cre8 sirolimus-eluting stent between January 2018 and October 2020 at a single high-volume vascular centre; outcomes were compared to a group of patients with diabetes and CLTI who had undergone infrapopliteal angioplasty using a DCB. All patients were followed up for at least 12 months using a uniform protocol with duplex ultrasound and examination. The primary outcome measure was target lesion patency (<50% restenosis). Clinically driven target lesion revascularisation (CD-TLR), amputations, Rutherford stage, and mortality were also recorded. Results: A total of 54 patients (61 target lesions; median age: 69 years, 74% male) were included [27 with the Cre8 device (main group) vs. 27 with a DCB (historical controls)]. Primary patency at 12 months was 81% in the Cre8 group vs. 71% in the control group (p = 0.498). Overall, four (15%) patients in the Cre8 group vs. three (11%) patients in the control group underwent a major amputation within 12 months (p = 1.0). CD-TLR (all endovascular) did not differ between groups at 12 months (4% Cre8 vs. 10% control group, p = 0.599). Rutherford stage improvement at 12 months was superior for the Cre8 group (52% vs. 15% improved by at least one stage, p = 0.039). One-year mortality was 15% in the Cre8 group vs. 22% in the control group, p = 0.726. Conclusions: Primary stenting with the Cre8 stent is feasible and safe in diabetic patients and CLTI. When compared to patients undergoing angioplasty with a DCB, there were no significant differences regarding primary patency, CD-TLR, major amputations, and mortality at 12 months. Those treated with a Cre8 stent were more likely to have an improvement in their Rutherford stage.

Endovascular reconstruction of popliteal and infrapopliteal arteries for limb salvage and wound healing in patients with critical limb ischemia - A retrospective analysis.

BACKGROUND: Advancement in endovascular techniques has led to rapid growth in endovascular revascularization, and it has emerged as a treatment for critical limb ischemia (CLI). Clinical effectiveness of revascularization has been frequently judged by vessel patency and limb salvage, but there is paucity of reports on outcomes of the wound. We present a retrospective analysis of immediate angiographic and 3-month clinical outcome of patients who underwent endovascular reconstruction of popliteal and infrapopliteal arteries for CLI. METHODS: All patients who underwent endovascular reconstruction of popliteal and/or infrapopliteal arteries for CLI and >70% stenosis on digital subtraction angiography between March 2010 and November 2014 and had a clinical follow-up of at least 3 months were selected for analysis. RESULTS: 34 patients underwent endovascular reconstruction. 9 patients (26%) underwent only POBA and remaining 25 (74%) underwent additional stenting. 13 patients (38%) had multiple segmental revascularization. 24 patients (71%) had successful vessel recanalization. Linear flow to foot in at least one artery could be achieved in 20 patients (59%) post revascularization. Successful wound healing occurred in 11 (35%) patients with an additional 7 (21%) patients showing clinical improvement in their wounds. Limb salvage was achieved in 33 patients (97%) at 3-month follow-up. CONCLUSION: Endovascular revascularization of popliteal and infrapopliteal arteries is a feasible, safe, and effective procedure for the treatment of CLI. Normal inflow and outflow with at least one of the three infrapopliteal vessels being patent is essential for adequate healing of chronic ulcers and prevention of major amputation.

Three-year clinical outcome after infrapopliteal angioplasty for critical limb ischemia in hemodialysis patients with minor or major tissue loss.

OBJECTIVES AND BACKGROUND: Among hemodialysis (HD)-dependent patients with critical limb ischemia (CLI), Endovascular therapy (EVT) of isolated infrapopliteal lesions improves limb salvage. Accordingly, we sought to determine the outcomes of this group of patients based on the extent of tissue loss at baseline. METHODS: From 2004 to 2011, 449 consecutive HD patients with CLI had ischemic wounds and underwent EVT for isolated infrapopliteal lesions. The "minor tissue loss" (MI) group was confirmed by 340 HD patients with wounds located distal to the metatarsophalangeal joints, and the "major tissue loss" (MA) group included 109 HD patients with wounds that extended beyond this point. The two groups were compared for limb salvage and amputation free survival (AFS) rates by Kaplan-Meier analysis. RESULTS: There was no significant difference in the percentage of diabetic patients (MI: 76.5 vs. MA: 75.2%). The percentage with direct flow to the wound site was lower in the MA group than in the MI group (MI: 63.5 vs. MA: 45.9%, P < 0.01). After EVT the MI group had a significantly better limb salvage rate (MI: 83.7 vs. MA: 71.2% at 3 years, P < 0.01), and AFS rate (MI: 44.1 vs. MA: 29.1% at 3 years, P < 0.01) compared to the MA group. CONCLUSIONS: EVT is an efficient treatment for HD patients with minor tissue loss, achieving >80% limb salvage rates at 3 years. However, AFS rates in all HD patients with tissue loss are <50% at 3 years, making their prognosis poor.

Balloon angioplasty in tibioperoneal interventions for patients with critical limb ischemia.

Tibial arterial disease represents the final frontier in the battle against critical limb ischemia (CLI). Isolated infrapopliteal (IP) disease is mainly seen in the elderly (>80 years old), diabetic, and dialysis-dependent patients with CLI. With the development and evolution of catheter-based technology, endovascular therapy (mainly balloon angioplasty) has become the method of choice for revascularization in these patients. The most common challenges are the severely calcified lesion recalcitrant to dilation (as calcium is heterogeneously distributed in the arterial wall) and the long tibial chronic total occlusions. Percutaneous transluminal angioplasty achieves a technically successful result (<30% residual stenosis) in most cases, but it is limited by high restenosis rates. Although several devices have been used in the IP arena (including orbital and directional atherectomy, laser atherectomy, "contact" atherectomy [CROSSER, Bard], and re-entry devices), percutaneous transluminal angioplasty with plain old balloons has been the subject of most studies with several modified iterations, that is, cryoplasty, cutting balloons, focal force balloons, nitinol-"cage"-constrained balloons, tapered balloons, and most recently drug-coated balloons. In this article, we share our current approach to endovascular IP endovascular interventions. We cover the spectrum from pathophysiology, clinical indications, equipment choices, and procedural steps used in our laboratory when treating patients with CLI (which is synonymous with complex anatomy). Regarding what represents the "gold standard" for the treatment of IP disease, a definite answer is currently not available, as multiple studies looking at new generation drug-coated balloons used alone or in combination with different forms of atherectomy are currently under way. We anxiously wait for these results and in the meantime continue to design newer approaches.

Does patency matter in patients with critical limb ischemia undergoing endovascular revascularization?

Restenosis is the major drawback in patients undergoing tibial angioplasty. In contrast to earlier observations, tibial patency was shown to impact on clinical outcomes in current randomized trials and is thus attributed more importance. Accordingly, intentions to reduce tibial restenosis have been intensified. Both drug-eluting balloons (DEB) and drug-eluting stents (DES) were shown to reduce tibial restenosis when compared with its plain counterparts. However, both endovascular technologies have its limitations for tibial arterial application. While DEB technology may not address elastic recoil, a pathophysiological mechanism frequently observed in tibial arteries and a significant contributor to restenosis, currently available DES do not fully address tibial arterial lesion morphology. Purpose of the present manuscript is to outline the problem and the incidence of tibial arterial restenosis, its importance on clinical outcomes and to provide an overview on technical developments aimed at its prevention.

Endovascular revascularization for patients with critical limb ischemia: impact on wound healing and long term clinical results in 189 limbs.

OBJECTIVE: To evaluate the impact on wound healing and long-term clinical outcomes of endovascular revascularization in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: This is a retrospective study on 189 limbs with CLI treated with endovascular revascularization between 2008 and 2010 and followed for a mean 21 months. Angiographic outcome was graded to technical success (TS), partial failure (PF) and complete technical failure. The impact on wound healing of revascularization was assessed with univariate analysis and multivariate logistic regression models. Analysis of long-term event-free limb survival, and limb salvage rate (LSR) was performed by Kaplan-Meier method. RESULTS: TS was achieved in 89% of treated limbs, whereas PF and CF were achieved in 9% and 2% of the limbs, respectively. Major complications occurred in 6% of treated limbs. The 30-day mortality was 2%. Wound healing was successful in 85% and failed in 15%. Impact of angiographic outcome on wound healing was statistically significant. The event-free limb survival was 79.3% and 69.5% at 1- and 3-years, respectively. The LSR was 94.8% and 92.0% at 1- and 3-years, respectively. CONCLUSION: Endovascular revascularization improve wound healing rate and provide good long-term LSRs in CLI.

Endovascular Revascularization for Patients with Critical Limb Ischemia: Impact on Wound Healing and Long Term Clinical Results in 189 Limbs

OBJECTIVE: To evaluate the impact on wound healing and long-term clinical outcomes of endovascular revascularization in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: This is a retrospective study on 189 limbs with CLI treated with endovascular revascularization between 2008 and 2010 and followed for a mean 21 months. Angiographic outcome was graded to technical success (TS), partial failure (PF) and complete technical failure. The impact on wound healing of revascularization was assessed with univariate analysis and multivariate logistic regression models. Analysis of long-term event-free limb survival, and limb salvage rate (LSR) was performed by Kaplan-Meier method. RESULTS: TS was achieved in 89% of treated limbs, whereas PF and CF were achieved in 9% and 2% of the limbs, respectively. Major complications occurred in 6% of treated limbs. The 30-day mortality was 2%. Wound healing was successful in 85% and failed in 15%. Impact of angiographic outcome on wound healing was statistically significant. The event-free limb survival was 79.3% and 69.5% at 1- and 3-years, respectively. The LSR was 94.8% and 92.0% at 1- and 3-years, respectively. CONCLUSION: Endovascular revascularization improve wound healing rate and provide good long-term LSRs in CLI.