Reported by Debra L. Beck, MSc; Presented by Eric Secemsky, MD, MSc.
Market analysis suggest that the peripheral atherectomy market in the US and globally is a healthy and growing one, said Eric Secemsky, MD, MSc, the director of vascular intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts, during AMP 2020 Virtual. In 2017, the market was worth 592.9 million globally, and it is expected to grow substantially in the coming years.
The market is dominated by directional atherectomy (Silverhawk and TurboHawk), followed by rotational atherectomy (Jetstream), with orbital atherectomy (Diamondback 360) and photoablative/laser atherectomy also showing healthy growth in the next five years.
“Each one of these devices have areas where they’re strong and maybe areas that they’re weaker in, but, while I would say this is important, it really feeds into part of the issue with trying to study these in large databases because there's so much variation and practice among users,” said Dr. Secemsky.
There is very limited trial data to support the use of atherectomy, with most of what we know derived from small, single-arm trials primarily performed for approval from the FDA, so the field is really forced to use real-world data to help guide device choice and usage, he added.
Based on Medicare data looking at the years from 2011 to 2014, utilization of atherectomy is up substantially for peripheral vascular intervention. “This really involves many vascular territories, in particular the below-the-knee tibialperoneal and femoropopliteal regions, where there are newer devices that have been developed to accommodate smaller vessels below the knee.”
Cardiologists and vascular surgeons are both large users of atherectomy devices, with radiologist and general surgeons registering only small amounts of use, said Dr. Secemsky.
Some of the best data on atherectomy comes from Jihad Mustapha’s 2019 article in Circulation: Cardiovascular Interventions. He noted. “What they did in this analysis was use Medicare data to examine over 36 million beneficiaries and they identified from these about 73,000 primary incident CLI cases. Once they applied their exclusion criteria, primarily focusing on CLI patients who had endovascular or surgical bypass treatment, they ended up with 36,000 cases. A matched analysis showed that those undergoing atherectomy had the lowest mortality through 4 years, as compared to PTA, surgical bypass, or stent placement.
“And just noting that in the CLI population, that mortality is up to 50 to 60% during the follow-up period, so these are patients who really have a poor survival prognosis based on just having a diagnosis of CLI requiring revascularization,” noted Dr. Secemsky.
A separate Medicare analysis by Niveditta Ramkumar and colleagues, this one published in 2019 in Journal of the American Heart Association, was less positive for atherectomy, showing a higher rate of major amputation or any amputation for patients who underwent atherectomy compared to PTA, but Dr. Secemsky noted the interpretation of the findings requires caution because the researchers looked only at atherectomy alone, without stenting.
“This is a specific population where only atherectomy was used as the definitive treatment,” he said. “These are unique patients.”
“My take home for this talk is that examining some of the market share and real-world data, we see that there is an increasing use of atherectomy during peripheral endovascular interventions, there's a lot of variation in use by operators, specialties and centers, and overall it appears that long-term safety outcomes appear similar among patients treated with different endovascular device strategies,” he concluded, adding that it’s important to gather more and better data on utilization and outcomes as this field continues to grow.