In a press release today, NuVasive, a leader in the development of minimally invasive spine fusion, announced that Aetna has reversed its coverage decision for the eXtreme Lateral Interbody Fusion (XLIF) procedure. The updated policy states that lateral interbody fusion is considered an acceptable method of performing a medically necessary anterior interbody fusion, in accordance with the North American Spine Society (NASS) recommendation letter from January 5, 2010. I blogged a few months ago on the potential impact of Aetna's decision in November of 2009 to treat the XLIF as an investigational procedure.
Aetna is the first major commerical insurer to change its policy regarding XLIF. Other national insurers including Cigna Corp., Humana Inc. and UnitedHealth Group Inc. still consider the XLIF procedure experimental. However, the decision could signal the beginning of a shift by payer groups towards broader acceptance of minimally invasive techniques in spine surgery. Regardless, Aetna's coverage reversal is likely to help NuVasive continue to establish its market position as a world-wide leader in the development of minimally invasive spine technologies. We're keeping a close watch on technology developments in minimally invasive spine that are directly impacting hospitals and will continue to keep you up-to-date on the latest payer coverage decisions.
Final results of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) were presented at the 2010 American Stroke Association International Stroke Conference, showing similar outcomes for surgical endarterectomy and stenting for the treatment of carotid stenosis.
The long awaited trial results showed a composite primary endpoint of any stroke, MI, or death during the periprocedural or ipsilateral stroke at follow-up of 7.2% for stenting and 6.8% for endarterectomy, a nonsignificant difference. The event rates in the CREST trial, while varied for individuals, was overall lower than the rates seen in other trials comparing carotid artery stenting and endarterectomy.
The trial, which is the largest to-date to compare stenting and edarterectomy in both symptomatic and asymptomatic patients, enrolled 1,321 symptomatic patients and 1,181 asymptomatic patients at 117 centers in the US and Canada. Patients were randomized to stenting stents with distal protection devices or surgery. Somewhat surprisingly, researchers found slightly improved outcomes with surgery in the patient cohort 69 years of age or older. Carotid stenting has long been thought to be better suited for older patients, due to the less invasive nature of the procedure.
The CREST trial results have been awaited by both supporters and detractors of carotid artery stenting, due in large part to CMS's coverage of stenting, which falls short of the FDA indications. Trial results, such as the new CREST results, are expected to influence future coverage decisions. More information on the trial results can be found here.
As usual this year's Cardiovascular Research Therapies (CRT), a "boutique" conference sponsored annually by Washington Hospital Center and Medstar Health, provided a great opportunity to interact with leading physicians, vendors and DC policymakers to address the adoption of cardiovascular technologies. Following the trend of the other cardiovascular conferences across the past year, Cardiovascular Research Technologies (CRT) 2010 had ample coverage of percutaneous valve therapies. Coverage included the day one Innovative Valvular Therapies for the Surgeon workshop that featured percutaneous valve therapy simulator training, and an all-day workshop with the FDA on day 2.
The day two workshop with the FDA definitely had a different flavor than many of the percutaneous valve sessions I have attended this year. The sessions were designed to facilitate discussion and debate among the leading clinicians in this arena, the major device vendors of percutaneous valves (Edwards and Medtronic), and the FDA. While the majority of the day focused on percutaneous valve therapy for aortic valve replacement, considerable time was spent discussing percutaneous mitral valve repair, as results for the recently completed EVEREST II trial of Abbott's (Evalve) MitraClip will be presented in three weeks during the late-breaking clinical trials sessions at ACC 10 in Atlanta, GA.
The sessions devoted to percutaneous/transcatheter aortic valve replacement, or TAVI, were designed as formal debates covering many of the theoretical issues that current trial participants and interested hospitals are grappling with as they prepare for the commercial approval of these devices. The main issues discussed included long-term valve durability, an expansion into"low-risk" populations, and whether future approval will dictate the need for additional randomized controlled trials (RCTs) and long-term registries.
CRT 2010: Physicians, Industry and Policy Makers Discuss Percutaneous Valves