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’.”
Since there is no clarification what kind of atherectomy the patient population received (orbital atherectomy, directional atherectomy, rotablation, laser debulking, etc.) the headline of this article is a dangerous simplification.
Hi Arne. Thank you for your comment. According to the author, this paper reported billing data of all atherectomy procedures. All atherectomy devices were included and no specific device or type was selected.
Dr Schwindt is correct here.
The problem with this analysis is they are lumping all kinds of atherectomy devices into one category. There is tremendous variability in the efficacy of these devices depending on a number of factors including lesion type, length etc.
In addition there is variability in efficacy for each device depending on the user. It is common knowledge that some operators simply don’t use atherectomy properly (e.g. Ensuring adequate debulking, using the right size device, minimizing adjunctive therapy etc). This is especially true for the directional devices like the silver hawk for example
Atherectomy when used properly significantly improves outcomes in patients with less need for additional work compared to classic balloon and stent techniques.
Just because multiple atherectomy devices were used in the analysis doesn’t mean they were used exactly as intended.
Congrats for the observation
I guess that the revascularisation for claudication should be carefully selected.
In the real life revasc for claidicants is much more offered than needed
Medicare should strengthen its payment policies and only reimburse atherectomy for the indications of rest pain and tissue loss, given the generally benign natural history of claudicants.
Tibial atherectomy for claudication? Are people doing that? Really?
I think it would be dangerous to ask Medicare to limit atherectomy to only rest pain or ulcer/gangrene. In the few appropriate times to treat claudicants for true disability I do not want to be told what I can and cannot use. Each case is individual. I also cannot agree more that it is an oversimplification to lump all atherectomy in one category. I agree that there should be more regulation i.e. Stricter clinical criteria for interventions and outcomes registries. But please let’s be more thoughtful to the many facets of this type of treatment before making blanket statements. I even think it would be useful to look at the office based interventions based on specialty….I think you will see some interesting differences!
I am reporting the results of Atherectomy looking at billing date for Medicare recipients. This paper was not on the merits or demerits of Atherectomy, rather as how it is being used on a everyday basis in the real world. Anyone questioning the relationship between explosive growth of Atherectomy in the office and reimbursement for the same?
I agree with the above comment regarding type of device used. There are several variables that could skew the results of this study if controlled for or mitigated.
Reimbursement for outpatient Atherectomy is approximately $15,000 per intervention with no 30 day global or criteria necessary for use. The explosion in the volume of Atherectomy for PAD particularly in the OBL is motivated by the generous reimbursement. Anyone wish to challenge that?
The second paper is a reflection of poor results with repeated interventions once again motivated by the generous reimbursement. Anyone wish to challenge that?
This is Medicare billing data reflecting what is really going on in the real world and not best in class as is reported in the Atherectomy trials.