Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

Autor: William Miller, Sahil A. Parikh, George L. Adams, Ehrin J. Armstrong, Alexandra Lansky, Nicolas W. Shammas, William A. Gray, Gunnar Tepe, Sarang Mangalmurti, Peter A. Soukas, Nelson L. Bernardo
Rok vydání: 2020
Předmět:
Male
Time Factors
medicine.medical_treatment
Constriction
Pathologic
lithotripsy
030204 cardiovascular system & hematology
Lithotripsy
Balloon
calcification
Atherectomy
0302 clinical medicine
Ischemia
Prospective Studies
chronic total occlusion
Aged
80 and over
Endovascular Procedures
stenosis
Middle Aged
infrapopliteal arteries
popliteal artery
Treatment Outcome
Lower Extremity
Female
Radiology
medicine.symptom
Cardiology and Cardiovascular Medicine
medicine.medical_specialty
Perforation (oil well)
complication
occlusion
superficial femoral artery
Lower Limb Interventions
peripheral artery disease
Peripheral Arterial Disease
03 medical and health sciences
medicine.artery
medicine
Humans
Radiology
Nuclear Medicine and imaging
Vascular Calcification
iliac artery
Aged
Arterial stenosis
business.industry
Intermittent Claudication
acute gain
medicine.disease
United States
Popliteal artery
Stenosis
common femoral artery
Chronic Disease
lithoplasty
Surgery
Claudication
business
030217 neurology & neurosurgery
Zdroj: Journal of Endovascular Therapy
ISSN: 1545-1550
1526-6028
DOI: 10.1177/1526602820914598
Popis: Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study ( ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.
Databáze: OpenAIRE
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