RS07 - Multi-Center Experience with Intravascular Lithotripsy for Treatment of Severe Calcification During TCAR for High-Risk Patients

Wednesday, June 14, 2023

10:29 AM – 10:36 AM ET

Submitting & Presenting Author(s)

Kathryn L. DiLosa, MD

Resident Physician
University of California Davis
Sacramento, California

Co-Author(s)

SS

Sally Schonefeld

Fellow
Cedars Sinai Health System
Rym El Khoury, MD

Fellow Physician
University of California San Francisco
San Francisco, California
CE

Charles Eichler

University of California San Francisco
San Francisco, California
AD

Alexander D. DiBartolomeo, MD (he/him/his)

Resident Physician
University of Southern California
Los Angeles, California
Gregory A. Magee, MD, MS

Assistant Professor of Surgery
University of Southern California
Los Angeles, California
Jeniann A. Yi, MD, MS

Faculty
University of Colorado
Aurora, Colorado
Andrea Simioni, MD

Resident Physician
University of Colorado
Aurora, Colorado
Nicolas J. Mouawad, MD, MBA

Chief, Vascular & Endovascular Surgery
McLaren Bay Region
Bay Region, Michigan
SM

Steven Maximus, MD

Assistant Professor of Surgery
University of California Davis
Sacramento, California
DB

Donald Baril

Cedars-Sinai Medical Center
Los Angeles, California
NA

Nathan Aranson

Maine Medical Center
Ali Azizzadeh, MD

Professor & Director, Division of Vascular Surgery
Cedars-Sinai Medical Center, Smidt Heart Center
Los Angeles, California
Misty D. Humphries, MD, MS

Associate Professor of Surgery
University of California Davis
Sacramento, California

Objectives: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease.

Methods: Patients who underwent TCAR+IVL between 2017-2022 at seven institutions were identified. IVL was combined with pre-dilatation angioplasty for treatment of severely calcified vessels prior to stent deployment. The primary outcome was safety (freedom from stroke/TIA) and the secondary outcome effectiveness (technical success and < 30% residual stenosis).

Results: Forty-nine patients (61% Male, 79±6.9 years) underwent TCAR+IVL, 20 (41%) for symptomatic disease (Table I). All patients had high-risk anatomical factors or comorbid conditions favorable for TCAR over CEA. 38 patients had calcific lesions, 10 (20%) with eccentric, 18 (37%) with circumferential, and 10 with eccentric+circumferential calcification (20%). Mean calcific lesion thickness was 3.5 mm (range 2.0-7.1), with mean pre-procedure stenosis 86±9%.

Mean procedure and flow reversal times were 90±26 and 26±14 minutes. Average number of lithotripsy pulses per case was 115 (range 30-330) and mean contrast usage 30 mL. Post-stent angioplasty was completed in 21 patients (43%). No patients had EEG changes or new neurological deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 48 patients (98%) having < 30% residual stenosis (40% residual stenosis in 1 case) on completion angiography.

Four patients had a stroke/TIA within 30-days for an overall rate of 8% (2 symptomatic in stroke/TIA patients versus 20 symptomatic in non-stroke-TIA patients, p=.70). 1 TIA and 1 stroke occurred during the index hospitalization post-procedure and 2 TIAs occurred after discharge. Preoperative mean stenosis in stroke/TIA patients was 93% (versus 86% in non-stroke/TIA patients, p=.35), chronic renal insufficiency was higher (75% vs 24%, p=.01), and anesthesia type (general versus local) significantly differed between groups (50% general anesthesia in stroke/TIA versus 84% in non-stroke/TIA cases, p=.05). Otherwise, there were no observed differences in calcium, procedural, or patient characteristics compared to the non-stroke/TIA cases (Table II). The mean follow-up was 131 days (range 19-520). Three stents developed recurrent stenosis (6%) on follow-up duplex; the remainder were patent without issue.

Conclusions: In this multicenter series, IVL sufficiently remodels calcified carotid arteries to effectively facilitate TCAR in patients with traditionally prohibitive calcific disease. However, there appears to be a safety concern as the stroke/TIA rate is higher than in conventional TCAR or CEA, which warrants further investigation.