Intravascular lithotripsy (IVL) has emerged as a significant therapy that can enable improvements in the treatment of calcified coronary artery disease. The technology is advancing with a new catheter that can break calcium in half the time, the ongoing Empower CAD study focused on IVL in women, and reimbursement changes that encourage a more widespread use of the technology.
"It's a balloon-based therapy and all interventional cardiologists are facile with delivering balloons. There are some technical nuances in terms of delivery sizing and utilizing the pulses effectively, but it can all be taught very easily. And I would say that one of the big advances of IVL is that it is going to open up calcium treatment to more patients," Yousif Ahmad, MD, an assistant professor of medicine and associate program director of the interventional cardiology fellowship at Yale, told Cardiovascular Business. Ahmad has been involved in multiple IVL trials, gaining substantial experience using the technology.
IVL is not associated with complications such as dissections or vessel barotrauma, contrasting with other procedures like atherectomy or high-pressure balloon angioplasty. Instead, Ahmad highlights IVL's unique mechanism, delivering focused energy waves at low pressure to specifically target calcified lesions, and improved patient safety.
The introduction of Shockwave's latest catheter, the C2+ model, offers 120 pulses compared to the previous 80. This enhanced capability offers greater versatility in addressing diverse lesions, particularly longer or more resistant calcium patterns.
In addition, multiple studies presented at TCT 2023 showed IVL's versatility in addressing various calcium morphologies, including concentric, eccentric and nodular patterns.
New, higher reimbursement for IVL
IVL is now reimbursed at a higher rate under new Medicare in-hospital codes. These are the first new Medicare severity diagnosis related group (MS-DRG) codes in 20 years for the percutaneous coronary intervention (PCI) space. The bump in reimbursement is meant to cover more than the cost of the device and a physician current procedural terminology (CPT) Level I add-on code.
The new reimbursement codes will provide a $8,000 increase on average nationwide for coronary IVL procedures compared to standard PCI DRGs. Shockwave, the maker of IVL catheters, said this is about a 55% increase in payment and more than covers the cost of the technology. Shockwave said MS-DRG 323 for coronary IVL with an intraluminal device with major complications and comorbidities (MCC) the payment will be $28,987. MS-DRG 324 for coronary IVL with intraluminal device without MCC will be $20,785. MS-DRG 325 for coronary IVL without intraluminal device without MCC, the payment is $18,514.
This higher reimbursement will likely help expand IVL use in 2024.
"We're now going to be liberated to just treat patients appropriately, use the right tool for the right patient and it's no longer going to be financially prohibitive to treat very complex patients who need multiple devices," Ahmad said.
Empower CAD study focuses on IVL use in women
The ongoing Empower CAD study is focusing exclusively on female patients, Ahmad explained. This comprehensive study not only aims to include a broader spectrum of lesions but also emphasizes the safety and efficacy of IVL in treating complex cases, including acute coronary syndromes and multivessel disease.
"We know if you look historically even in contemporary studies, both in interventional cardiology and cardiovascular medicine, broadly female patients are very, very underrepresented. So we have limited data for any of the technologies we use. This study is going to directly address that," Ahmed said.
Almost any lesion can be included and any clinical presentation can be included. This is different from previous IVL studies, which had a more narrow focus. This is going to be a much broader patient population with acute coronary syndromes, multivessel disease and IVL used in conjunction with other calcium modification techniques, which was not the case in early studies. The study will enroll 400 patients across 50 sites.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com