Author + information
- Todd Brinton1,
- Marianne Brodmann2,
- Martin Werner3,
- Gunnar Tepe4,
- Andrew Holden5,
- Dierk Scheinert6,
- Florian Wolf7,
- Giovanni Torsello8,
- Alexandra Lansky9,
- Michael Jaff10 and
- Thomas Zeller11
- 1Stanford University Medical Center, Stanford, California, United States
- 2Medical University Graz, Graz, Austria
- 3Parkkrankenhaus, Leipzig, Germany
- 4Hospital of Rosenheim, Rosenheim, Germany
- 5Auckland City Hospital, Auckland, New Zealand
- 6University Hospital Leipzig, Leipzig, Germany
- 7Medical University of Vienna
- 8Universitätsklinikum Münster
- 9Yale School of Medicine, New Haven, Connecticut, United States
- 10Massachusetts General Hospital, Boston, Massachusetts, United States
- 11Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
The treatment of calcified peripheral lesions remains a challenge as evidenced from multiple studies targeting this patient population. Calcified peripheral artery disease (PAD) is associated with vascular complications, high stent use and poor outcomes.
This study sought to investigate the acute and chronic outcomes of the Shockwave Medical Peripheral Lithoplasty Catheter System (Shockwave Medical, Fremont CA), a lithotripsy-enhanced, low pressure balloon catheter for treatment of calcified peripheral arteries. The DISRUPT PAD Study is a single arm, two-phase multicenter study that enrolled 95 patients with symptomatic (Rutherford 2 to 4) calcified femoropopliteal lesions up to 15 cm in length. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days. Acute procedural success, the primary performance endpoint, was defined as <50% residual diameter stenosis, with or without adjunctive PTA therapy. Patency defined as <50% restenosis will be assessed at 6 months in the entire cohort and at 12 months in the 60 patient second phase of the study. The 30-day, 6 month, and 12 month secondary endpoints include freedom from clinically-driven target lesion revascularization (TLR), MAE, and functional outcomes as assessed by the walking impairment questionnaire, ABI and Rutherford class change.
Mean lesion length, percent stenosis and total occlusions were 7.3 ± 3.8 cm, 77.8 ±13.6% and 18.9%, respectively. Lesions had moderate (44.2%) or severe (54.7%) calcification. Lithoplasty treatment resulted in 100% procedural success, with an acute gain of 3.0 ± 0.8 mm and mean residual stenosis of 23.8 ± 5.7%. The 30 day MAE rate was 1.1% due to a single stent placement for a flow-limiting dissection. There were no thrombus, perforations or distal embolization events. Six-month MAE, patency and TLR will be available at the time of presentation.
Lithoplasty is a novel therapy for treatment of calcified vascular lesions of the lower extremities. The DISRUPT PAD study acute effectiveness outcomes show consistent procedural success with excellent acute gain and limited adjunctive tools. The safety profile is also compelling. Importantly, the use of stents was minimal providing a wide range of therapeutic options. Minimized vascular injury should translate to improved patency and TLR with sustained functional improvement in this difficult to treat patient population.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention