washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.
Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.
On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).
Ted Bosworth/MDedge News
Dr. Julian Yeoh
In what was characterized as a “real-world series,” 14 procedures were performed at Dr. Yeoh’s institution as part of a clinical study, but 40 procedures were completed on an all-comer basis. Many were performed for indications, such as multivessel disease, that would have been excluded from the DISRUPT CAD study.
“We included elderly patients, patients in cardiogenic shock, and patients with chronic total occlusions,” Dr. Yeoh reported. Presenting specific cases, he described using IVL to permit venous access for a transcatheter aortic valve replacement (TAVR), a failed rotational atherectomy, and to salvage a percutaneous angioplasty thwarted by residual calcium calcification.
“Total procedural success in this series was 91% with 100% facilitation of stent delivery,” Dr. Yeoh said. “There have been no cases of coronary perforation and no reflow or 30-day target lesion failure.”
In this series, the mean age of the patients was 75.9 years. On optical coherence tomography (OCT), which was employed in about half of the cases, the mean residual stenosis was approximately 20%.
IVL involves passing a balloon into the target lesion with the same guidewire used for other percutaneous interventions. Once in position, sonic pressure waves fracture the calcium deposit “with no injury to the intimal soft tissue,” according to Dr. Yeoh, who said that there were no serious adverse events associated with IVL in the series he presented.
In DISRUPT CAD, which enrolled 60 patients, procedural success was 95% with a reduction in mean stenosis from 68.1% to 13.1%. The rate of major adverse cardiovascular event (MACE) events was 5% at 30 days.
While DISRUPT CAD-II is an on-going post-market registry collecting data in Europe and other areas of the world where IVL is approved for treatment of coronary artery disease, a pivotal trial called DISRUPT CAD III has been launched to gain an indication for treatment of coronary calcifications in the U.S. The prospective global trial has a planned enrollment of nearly 400 patients with expected completion in August 2020.
SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.