Atherectomy System Helps Treat Severely Calcified Lesions at Lower Cost

 

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A novel atherectomy system that “sands away” hard plaque components facilitates stenting and may improve clinical outcomes in patients with severely calcified lesions.In addition, the technology lowers costs.

One-year results of the ORBIT II trial, along with an economic analysis, were presented May 30, 2014, at the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting in Las Vegas, NV. Early data were previously reported at the American College of Cardiology/i2 Scientific Session in March 2013, both times by Jeffrey Chambers, MD, of the Metropolitan Heart and Vascular Institute (Minneapolis, MN).

 

Durable Safety

One-year follow-up showed incremental increases in low, 30-day rates of cardiac death, TVR, and MACE (cardiac death, TVR, CK-MB > 3 times the upper limit of normal), but no additional MI (table 1).

Table 1. Outcomes at 30 Days and 1 Year

 

At 1 year, freedom from TVR/TLR (94.1%) was higher than previously reported,, ranging from 81.7% to 91.3%, despite inclusion of more severly calcified lesions, Dr. Chambers said, as were freedom from cardiac death (97.0%) and MACE (83.6%). 

In univariable analysis, the only predictor of 1-year MACE was a history of CABG (OR 1.89; 95% CI 1.10-3.26; P = .0214)

Considerable Cost Savings

For the economic analysis, Dr. Chambers and colleagues compared the impact of the Orbital system on medical care resource use and cost in elderly ORBIT II patients (n = 297)  vs a matched cohort of Medicare patients with calcified lesions (n = 308). In the adjusted base case comparison, the ORBIT II patients experienced a shorter mean length of stay by 1 to 3 days, depending on assumptions about outpatient stays. Considering both inpatient and outpatient procedures, mean costs were lower by $3,198 (P = .003).

After adjustment for differences in age, gender, and comorbidities, mean costs were 17% lower (P < .001) in ORBIT II patients compared with Medicare patients, or approximately $2,600 to $2,700.

“Using the Diamondback 360º coronary [orbital atherectomy system] as a lesion preparation tool prior to stent implantation offers patients with severely calcified coronary lesions a new treatment option with potential cost benefits,” Dr. Chambers concluded.

During a press conference, Dr. Chambers told TCTMD that the reduced length of stay in ORBIT II vs the Medicare cohort might be related to 2 factors: reduced periprocedural MACE and lack of ‘slow flow’ with Diamondback.

A newer iteration of the Diamondback system will soon be tested in a clinical trial, he reported, adding that another question is how the treatment might benefit more moderately calcified lesions.

As to whether the learning curve for this system might be less steep than for rotational atherectomy, Dr Chambers commented, “It’s much easier to use. The controls are right on the table. You just move it forward and back. There’s not a lot of set-up.”

 

 

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Source:Chambers J. Diamondback 360º coronary orbital atherectomy system for treating de novo, severely calcified lesions: ORBIT II 1-year results and cost comparison to a sample of Medicare hospital claims. Presented at: SCAI; May 30, 2014;Las Vegas, NV.

 

 

Disclosures:

• Dr. Chambers reports serving as a consultant to Cardiovascular Systems.

 

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• ORBIT II: Atherectomy System Shows Positive Results in Calcified Lesions
• Novel Atherectomy System Helps Treat Severely Calcified Lesions