George Adams1, Nicolas Shammas2, Sarang Mangalmurti3, Nelson L Bernardo4, William E Miller5, Peter A Soukas6, Sahil A Parikh7, Ehrin J Armstrong8, Gunnar Tepe9, Alexandra Lansky10, William A Gray11. 1. UNC Rex Healthcare, Raleigh, NC, USA. 2. Midwest Cardiovascular Research Foundation, Davenport, IA, USA. 3. Bryn Mawr Hospital-Main Line Health, Bryn Mawr, PA, USA. 4. Medstar Washington Hospital Center, Washington, DC, USA. 5. University of Colorado Health Medical Group, Fort Collins, CO, USA. 6. The Miriam Hospital/Brown Medical School, Providence, RI, USA. 7. Columbia University Irving Medical Center and Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. 8. University of Colorado School of Medicine, Aurora, CO, USA. 9. RoMed Klinikum Rosenheim, Germany. 10. Yale School of Medicine, New Haven, CT, USA. 11. Main Line Health/Lankenau Heart Institute, Wynnewood, PA, USA.
Abstract
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.
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.
Authors: Wojciech Wańha; Mariusz Tomaniak; Piotr Wańczura; Jacek Bil; Rafał Januszek; Rafał Wolny; Maksymilian P Opolski; Łukasz Kuźma; Adam Janas; Tomasz Figatowski; Paweł Gąsior; Marek Milewski; Magda Roleder-Dylewska; Łukasz Lewicki; Jan Kulczycki; Adrian Włodarczak; Brunon Tomasiewicz; Sylwia Iwańczyk; Jerzy Sacha; Łukasz Koltowski; Miłosz Dziarmaga; Miłosz Jaguszewski; Paweł Kralisz; Bartosz Olajossy; Grzegorz Sobieszek; Krzysztof Dyrbuś; Mariusz Łebek; Grzegorz Smolka; Krzysztof Reczuch; Robert J Gil; Sławomir Dobrzycki; Piotr Kwiatkowski; Marcin Rogala; Mariusz Gąsior; Andrzej Ochała; Janusz Kochman; Adam Witkowski; Maciej Lesiak; Fabrizio D'Ascenzo; Stanisław Bartuś; Wojciech Wojakowski Journal: J Clin Med Date: 2022-03-23 Impact factor: 4.241
Authors: Piotr Rola; Jan Jakub Kulczycki; Adrian Włodarczak; Mateusz Barycki; Szymon Włodarczak; Marek Szudrowicz; Łukasz Furtan; Artur Jastrzębski; Maciej Pęcherzewski; Maciej Lesiak; Adrian Doroszko Journal: Int J Environ Res Public Health Date: 2022-07-25 Impact factor: 4.614