Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia
| Autor: | Shereen Xue Yun Soon, Charyl Jia Qi Yap, Edward Choke, Shaun Q.W. Lee, Tze Tec Chong, Bryan P Y Yan, Sze Ling Chan, Tjun Y. Tang |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Limb salvage Ischemia Occlusive disease Balloon Percutaneous angioplasty Peripheral Arterial Disease Humans Medicine Popliteal Artery Prospective Studies Vascular Patency Aged business.industry Middle Aged Atherosclerosis Limb Salvage medicine.disease Surgery Treatment Outcome High pressure Female Cardiology and Cardiovascular Medicine business Angioplasty Balloon |
| Zdroj: | Vasa. 49:475-482 |
| ISSN: | 1664-2872 0301-1526 |
| DOI: | 10.1024/0301-1526/a000888 |
| Popis: | Summary: Background: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. Patients and methods: Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. Results: 86 patients (63% males, mean age 68.9 ± 9.9 years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6 = 91% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate/severe vessel wall calcification. 90% had > = 1 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower baseline toe pressure (OR 1.03, 95%CI 1.00–1.05) and elastic recoil post angioplasty (OR 0.20, 95%CI 0.05–0.79) were associated with a worse 6 month tibial patency. One-year AFS was 67%. 47/66 (71%) patients had a clinical improvement of at least one Rutherford class at 6 months and 52/59 (88%) experienced complete wound healing at 12 months. Conclusions: Use of a high pressure non-compliant balloon is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging population of CLTI patients with a high incidence of DM and ESRF. It is associated with highly satisfactory acute technical success, 6-month target lesion patency and one-year limb salvage. |
| Databáze: | OpenAIRE |
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