Author + information
- Georgios Bouras1,
- Alexandra Lansky2,
- John McClure3,
- Mehdi Shishehbor4,
- Michael Jaff5,
- Prakash Makam6,
- Sarah Johnson7,
- Thomas Davis8 and
- Jihad Mustapha9
- 1Yale School of Medicine, New Haven, Connecticut, United States
- 2Yale School of Medicine, New Haven, Connecticut, United States
- 3Izumi Regional Medical Center
- 4Cleveland Clinic, Cleveland, Ohio, United States
- 5Massachusetts General Hospital, Boston, Massachusetts, United States
- 6Cardiology Associates, Munster, Indiana, United States
- 7Alexian Bros Hospital, Chicago, Illinois, United States
- 8st john hosoital, bloomfield hills, Michigan, United States
- 9Metro Heart & Vascular Institute, Wyoming, Michigan, United States
Percutaneous Transluminal Angioplasty (PTA) for peripheral vascular disease is often associated with suboptimal outcomes due to complications following usage of a standard balloon. New strategies improving acute and long-term outcomes by making angioplasty less traumatic, are under investigation.
The Chocolate Balloon Angioplasty Registry (Chocolate BAR) is an all-comers registry studying the outcomes of the Chocolate Balloon use, in a high-risk population including Rutherford 5-6, total occlusions, long lesions and calcified lesions. Patients were divided in two cohorts, an above the knee (ATK) group and a below the knee (BTK) group. Follow-up included clinical and duplex assessments at 1, 6, 12 months for ATK patients and clinical assessment at 1 and 3 months for BTK patients with a subset having 6 month visits. All Imaging outcomes were core-lab adjudicated.
A total of 262 ATK patients and 226 BTK patients were enrolled at 32 sites in the US. Optimal PTA (defined as <30% stenosis/no flow-limiting dissection) was demonstrated in 85.1% of ATK and 84.6% of BTK cases. Freedom from stenting occurred in 93.1% of ATK and 96.5% of BTK cases. Flow limiting dissections were reported in 2% of cases (ATK) and 1% of cases (BTK); all of these dissections were adjudicated to be non-flow limiting. The ATK cohort showed an average improvement of 2.0 Rutherford classes and 12 month results as follows: freedom from Target Lesion Revascularization (TLR) 78.5%; freedom from major amputation 97.2%; and freedom from all-cause mortality 93.3%. Core lab adjudicated duplex ultrasound results are under review. The BTK Cohort demonstrated an average improvement of 1.5 Rutherford classes (3 months); maintained through 6 months (subset of 112 patients). Clinical results thru 3 and 6 months are as follows: Freedom from TLR 94.7% and 88.9%; Freedom from major amputation 97.6% and 96.7%; freedom from all-cause mortality 98.1 and 97.1%.
The low rate of complications, including dissections and minimal stent use along with the low rates of amputations and TLR at follow-up, indicate the Chocolate Balloon as a safe and effective alternative for both ATK and BTK lesions.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention