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

MedStar author(s):
Citation: Journal of Endovascular Therapy. 27(3):473-480, 2020 Jun.PMID: 32242768Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Endovascular Procedures | *Intermittent Claudication/th [Therapy] | *Ischemia/th [Therapy] | *Lithotripsy | *Lower Extremity/bs [Blood Supply] | *Peripheral Arterial Disease/th [Therapy] | *Vascular Calcification/th [Therapy] | Aged | Aged, 80 and over | Chronic Disease | Constriction, Pathologic | Endovascular Procedures/ae [Adverse Effects] | Endovascular Procedures/is [Instrumentation] | Female | Humans | Intermittent Claudication/dg [Diagnostic Imaging] | Intermittent Claudication/pp [Physiopathology] | Ischemia/dg [Diagnostic Imaging] | Ischemia/pp [Physiopathology] | Lithotripsy/ae [Adverse Effects] | Male | Middle Aged | Peripheral Arterial Disease/dg [Diagnostic Imaging] | Peripheral Arterial Disease/pp [Physiopathology] | Prospective Studies | Time Factors | Treatment Outcome | United States | Vascular Calcification/dg [Diagnostic Imaging] | Vascular Calcification/pp [Physiopathology]Year: 2020ISSN:
  • 1526-6028
Name of journal: Journal of endovascular therapy : an official journal of the International Society of Endovascular SpecialistsAbstract: 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.All authors: Adams G, Armstrong EJ, Bernardo NL, Gray WA, Lansky A, Mangalmurti S, Miller WE, Parikh SA, Shammas N, Soukas PA, Tepe GOriginally published: Journal of Endovascular Therapy. :1526602820914598, 2020 Apr 03Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-07-09
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 32242768 Available 32242768

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.

English

Powered by Koha