Update from the TCT conference in SF Sept 2019
News > Medscape Medical News > TCT 2019
Lithotripsy Is a Blast for Tough Coronary Calcium in the Disrupt-CAD 2 Trial
September 26, 2019
SAN FRANCISCO — The interventional answer to heavily calcified coronary lesions could reside in a balloon catheter that blasts calcifications with bursts of acoustic energy, suggests an early-stage study of 120 patients.
A series of such energy pulses can send fractures throughout calcified coronary plaques, extensive or more focal, that ease lesion compliance to facilitate subsequent deployment of a drug-eluting stent (DES), researchers say about the intravascular lithotripsy (IVL) technique.
"I think that based on the available safety and utility data, IVL could be the first-line therapy for severe calcification. It's safe, it's highly effective, and its mechanism of action is clear," Ziad A. Ali, MD, DPhil, New York-Presbyterian Hospital, New York City, told theheart.org | Medscape Cardiology.
Ali presented the results of a substudy from the Disrupt CAD 2 trial, based on optical coherence tomography (OCT) intravascular imaging with IVL, here at Transcatheter Cardiovascular Therapeutics Conference 2019. The substudy confirmed that IVL works by "circumferential calcium fracture."
He is also lead author on the September 25 publication of the full study, a single-group European postmarket evaluation of the Coronary IVL System (Shockwave Medical) that will be reported later in the meeting, in Circulation: Cardiovascular Interventions. The device in the coronaries remains investigational in the United States.
Ali said that in the current study and its 60-patient predecessor, Disrupt CAD 1, IVL wasn't hobbled by some of the limitations affecting other intravascular technologies currently used to prepare heavily calcified coronary lesions for subsequent stenting.
Those devices include rotational atherectomy (such as with Boston Scientific's Rotablator) and orbital atherectomy catheters — which as they advance can slide past heavily calcified segments of vessel wall — and laser catheters, whose energy can be hard to control, he observed.
All three can lead to coronary perforation and the poststenting "no reflow" phenomenon, and energy delivery in IVL is "more predictable" than in laser revascularization, Ali said.
The lithotripsy procedure appears to have at least two big advantages over those alternative technologies, he proposed.
"It has an extremely low complication rate. In the 180 patients so far in the trials, there have been no perforations, which is very surprising given that this is a high-energy device." There have been no instances of "no-reflow" or "slow flow," he said, "and no dissection that couldn't be treated by a stent. So its safety profile is as good as, if not better than, conventional balloon angioplasty and stenting."
The other likely advantage, he said, is that IVL "requires absolutely no training. You don't have to be an expert operator to slide in the balloon and then press the button" that triggers the energy pulses. "That's a big deal, because there is an apprehension worldwide about using atherectomy, in terms of its risks."
It amazes me that this has traded back down close to its IPO price .
Such promising technology .
Have to believe the sell off is related to the patent challenge . If anyone has any updates on that , please post