ABSTRACT
BACKGROUND: Intravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. METHODS: In a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. RESULTS: Among 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). CONCLUSION: IVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.
Subject(s)
Angioplasty, Balloon , Lithotripsy , Peripheral Arterial Disease , Aged , Angioplasty, Balloon/adverse effects , Coated Materials, Biocompatible , Constriction, Pathologic , Female , Femoral Artery/diagnostic imaging , Follow-Up Studies , Humans , Lithotripsy/adverse effects , Male , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/etiology , Peripheral Arterial Disease/therapy , Popliteal Artery , Retrospective Studies , Treatment Outcome , Vascular PatencyABSTRACT
Background: Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease. Methods: In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test. Results: Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group (P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167). Conclusions: The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings.