Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history of the disease, according to data presented at the 2017 Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA).
Dipankar Mukherjee (Falls Church, USA), who presented the data, also told VAM delegates, “Our study supports the previously made observation that repeat interventions result in worse outcomes.”
The study was inspired by the combination of “massive increase” in outpatient atherectomy, especially in office settings with poorly understood outcomes. The study included real-world results of claudication for infrainguinal occlusive disease as determined from Medicare claims-based utilisation data—the first study to do so. Patients included in the analysis underwent either a femoropopliteal (n=924) or tibial-peroneal (n=423) atherectomy between January 2012 and June 2013. All were analysed for repeat intervention within 12 months of the first procedure.
Of the 924 femoropopliteal atherectomy patients, 28.4% (n=262) were treated in an office setting, of which 40.1% underwent a repeat interventions. The remaining 71.6% (n=662) were hospital outpatients, of which 31.6% underwent repeat intervention. The proportion of the office-based femoropopliteal atherectomy patients needing any lower extremity amputation was 2.7%, compared with 4.8% in the hospital outpatient group. The rate of any major lower amputation was 1.9% for office-based patients and 2.9% for hospital outpatients. Mukherjee also noted that repeat interventions were associated with worse outcomes—amputation rate for all patients after one repeat intervention was 7%, rising to 8.9% after two or more.
The tibial-peroneal atherectomy group was comprised of 423 patients. Of these, 47.8% (n=202) underwent office-based treatments, of which 44.6% required repeat intervention. The other 52.2% (n=221) were treated as hospital outpatients, and 34.8% underwent repeat intervention. Of the office-based patients, the rate of need for any lower extremity amputation was 4.4%, compared with 10.4 in the hospital outpatient group. The rate of required major lower extremity amputation was 3% for office-based patients and 7.2% for hospital outpatients.
Mukherjee compared these outcomes to the natural history of claudication, explaining that pre-1980 studies documented a cumulative amputation rate of 11% over 10 years at approximately 1% per year. More recent studies have shown similar rates, with approximately 30% of patients experiencing symptomatic deterioration over time. “Low ankle brachial index and diabetes have been associated with the development of ischaemic rest pain and ischaemic ulceration,” Mukherjee said, “and all prior studies confirm low amputation rates but high mortality rates.”
Mukherjee pointed to a 2013 study (Jones et al) on the growing impact of restenosis on the surgical treatment of peripheral artery disease, in which secondary revascularisation after failed previous intervention for claudication increased from 13% to 22% over eight years. This represents a “treatment gap”, Mukherjee said, by which each subsequent intervention—for an initially benign disease—produces worse outcomes. Furthermore, the BASIL-1 trial showed that bypass following the failure of endovascular treatment was significantly less successful than primary bypass, showing that “endovascular is not a free shot,” Mukherjee said.
“The results suggest that atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments when done for claudication in the office and hospital outpatient settings results in outcomes worse than the natural history of the disease,” Mukherjee told the audience.
“We recommend a prospective study to confirm the above mentioned findings and caution operators that our first responsibility to the patients is to ‘do no harm’.”