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International Angiology 2020 October;39(5):390-7

DOI: 10.23736/S0392-9590.20.04375-8


language: English

High-pressure, non compliant balloon angioplasty for long and calcified infrapopliteal and inframalleolar lesions is feasible

Eline HUIZING 1 , Steven KUM 2, George ADAMS 3, Roberto FERRARESI 4, Jean-Paul P. M. DE VRIES 5, Çağdaş ÜNLÜ 1

1 Department of Surgery, Northwest Clinics, Alkmaar, the Netherlands; 2 Vascular Service, Department of Surgery, Changi General Hospital, Singapore, Singapore; 3 Rex Healthcare, Raleigh, NC, USA; 4 Peripheral Interventional Unit, Humanitas Gavazzeni, Bergamo, Italy; 5 Division of Vascular Surgery, Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands

BACKGROUND: To evaluate the safety, feasibility and effectiveness of high-pressure, noncompliant balloon angioplasty in the management of long infrapopliteal calcified lesions.
METHODS: Consecutive patients, presenting with chronic limb-threatening ischemia (CLTI) and long (>100 mm) calcified infrapopliteal lesions who were treated with a high pressure, noncompliant balloon (JADE, OrbusNeich, Hong Kong) between January 2016 and July 2016 were retrospectively analyzed. Angioplasty was performed by inflating the balloon to a pressure of 22 to 24 atm for 90 seconds. Primary outcome was technical success. Secondary outcomes were procedure-related complications, limb salvage, amputation-free survival (AFS), wound healing, overall survival, freedom from clinically driven target lesion reintervention (CD-TLR), and resolution of CLTI at 2 and 3 years.
RESULTS: Overall, 23 lesions in 21 limbs of 20 patients were treated. All patients had tissue loss (Rutherford 5 or 6). The mean lesion length was 374.8 mm. Of all lesions, 56.5% were occlusions, 91.3% were classified as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, and 78.3% had severe calcification classification. Of all lesions, 52.2% extended into the below-the-ankle arteries. Technical success was achieved in 22 lesions (95.7%). There were no procedure-related complications. No bailout stenting was required. At 2 and 3 years, limb salvage was 84.7% and 78.7%, AFS was 71.4% and 56.1%, wound healing was 81.0% and 85.7%, overall survival was 75.0% and 64.3% and freedom from CD-TLR was 77.6% and 63.5%, respectively. Resolution of CLTI without TLR was 81.0% at 2 and 3 years.
CONCLUSIONS: This study is the first to analyze safety and feasibility of a high-pressure, noncompliant balloon for long, calcified infrapopliteal and inframalleolar lesions.

KEY WORDS: Critical limb ischemia; Peripheral arterial disease; Vascular calcification; Balloon angioplasty; Endovascular procedures

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