Intravascular lithotripsy promising in real-world cohort at 2 years
Real-world data suggest intravascular lithotripsy appears to be safe with low complications rates during nearly 2 years of follow-up when used for complex calcified coronary lesions, researchers reported.
“Intravascular lithotripsy (IVL) is a new technology that delivers pulsatile sonic pressure waves converted to mechanical energy to modify vascular calcium,” Sandeep Basavarajaiah, MD, MRCP, FESC, a consultant cardiologist with Heartlands Hospital, University Hospitals, Birmingham, U.K., and colleagues wrote in the study background. “It leverages similar principles to urologic lithotripsy, which has been used as a safe and effective treatment for kidney stones for several decades. IVL safely and effectively modifies both intimal and medial calcium. Although there are single‐arm studies of IVL in coronary arteries from the DISRUPT CAD trials, long‐term data from real‐world populations are scarce.”
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In a retrospective, observational study, Basavarajaiah and colleagues analyzed data from 273 patients treated with IVL from November 2018 to February 2021 at high-volume PCI centers in Italy and the United Kingdom. The mean age of participants was 73 years and 79% were men; 40% had diabetes and 16% had chronic kidney disease. Follow‐up included clinic visits, telephone calls and correspondence from general practitioners and records from hospital admissions. Researchers assessed procedural success, complications and clinical outcomes, including cardiac death, target vessel MI, target lesion revascularization and MACE.
The findings were published in Catheterization and Cardiovascular Interventions.
Within the cohort, 48% of patients had ACS and 52% had stable angina. De novo lesions and in‐stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used for 33% of patients.
An upfront IVL strategy was adopted in 34% of patients, whereas the rest were bailout procedures. For 11% of cases, adjuvant rotational atherectomy was required.
The procedural success was 99%. During a median follow‐up of 687 days, cardiac death occurred in 5% of patients, target vessel MI occurred in 3% of patients and TLR occurred in 6% of patients. The MACE rate was 11%.
“Our results are very promising with high procedural success and excellent clinical outcomes,” the researchers wrote. “This study will instill confidence among operators and centers who are in the initial phase of IVL use or those who are in the process of adopting this novel technology.”