Acute Procedural Outcomes of Orbital Atherectomy for the Treatment of Profunda Femoris Artery Disease: Subanalysis of the CONFIRM Registries

Abstract: Objectives. We compared the angiographic outcomes of patients treated with orbital atherectomy for profunda femoris artery (PFA) and superficial femoral artery (SFA) disease from the CONFIRM I-III registries. Background. Endovascular revascularization of the PFA is considered a high-risk procedure given that it is an important collateral vessel when the SFA becomes occluded. Data on outcomes of endovascular revascularization of calcified PFA disease are limited. Methods. The treatment of PFA disease with orbital atherectomy has not been previously reported. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one PFA lesion location (n = 33 patients; n = 33 lesions) were compared to patients with at least one SFA lesion location (n = 1574 patients; n = 1811 lesions). The primary endpoint was angiographic complication, defined as the composite of flow-limiting dissection, perforation, slow flow, vessel closure, spasm, embolism, or thrombosis. Results. The PFA group had a shorter lesion length, larger residual stenosis, shorter total run time, and shorter inflation time. Adjunctive stenting was only performed in the SFA group (10%); no patient in the PFA group underwent stenting. The primary endpoint was low in the PFA group and compared favorably with the SFA group (3% vs 11%; P=.15). One patient in the PFA group had vessel spasm, while no patients had flow-limiting dissection, perforation, slow flow, vessel closure, embolism, or thrombus. Conclusions. Orbital atherectomy of the PFA was feasible and safe. A randomized trial is needed to determine the ideal treatment strategy for calcified PFA disease. 

J INVASIVE CARDIOL 2018;30(5):177-181. Epub 2017 December 15.

Key words: atherectomy, peripheral arterial disease, endovascular intervention, profunda femoris artery

Endovascular revascularization for peripheral arterial disease is an attractive option given it is less invasive than surgery and does not require general anesthesia.^1,2 The profunda femoris artery (PFA) functions as a major collateral vessel to the lower extremity in those with severe superficial femoral artery (SFA) disease. The ideal revascularization strategy for severe PFA disease, especially when the vessel is severely calcified, is unknown. Profundoplasty without endarterectomy using a patch or a vein-graft has been performed for over 30 years.^2-5 Endovascular revascularization of the PFA is potentially a high-risk procedure because the potential risk of dissection, elastic recoil, and abrupt vessel closure can lead to severe limb ischemia and possible amputation.^6,7  

Atherectomy modifies severely calcified plaque, which facilitates balloon expansion. Orbital atherectomy (Cardiovascular Systems, Inc) is a minimally invasive catheter-based atherectomy system developed for the treatment of calcific peripheral arterial disease.^8,9 Randomized and single-arm trial data have shown that it is safe and effective for the treatment of infrainguinal disease, particularly in severe calcific disease.^10-13

Data are limited on the clinical outcomes for patients undergoing endovascular intervention of the PFA and there are no data on atherectomy of the PFA. We report the outcomes of patients with PFA disease who underwent orbital atherectomy in a large, prospective registry of patients treated with orbital atherectomy for peripheral arterial disease.

Methods

Study design. The CONFIRM I, II, and III registries were large, multicenter, non-randomized, all-comer registries of 3135 patients with 4766 calcified lower-extremity lesions who were treated with orbital atherectomy without exclusion from October 2009 through June 2011 from over 200 United States institutions.¹³ Medically necessary treatment in accordance with the device’s instructions for use (IFU) was the only inclusion criteria. The operator subjectively reported the severity of the calcium. Informed, written consent was obtained for all participants. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one PFA lesion location (n = 33 patients; n = 33 lesions) were compared to patients with at least one SFA lesion location (n = 1574 patients; n = 1811 lesions). Patients with lesions located in both the PFA and SFA were not included. 

Study endpoint. The primary endpoint was angiographic complication, defined as the composite of flow-limiting dissection, perforation, slow flow, vessel closure, spasm, embolism, or thrombus formation. 

Device description. Three different iterations of the orbital atherectomy system were evaluated over the registry series: CONFIRM I evaluated the Diamondback360° system; CONFIRM II evaluated the Predator360° system; and CONFIRM III evaluated the Diamondback360°, Predator360°, and Stealth360° devices. The orbital atherectomy system has been previously described.⁸

Statistical methods. Patient data were reported as frequency counts and percentages. Quantitative measurements were presented as means and standard deviations. Statistical analysis was performed using available data only, as missing values were excluded from the analysis. Relationships between various patient or lesion characteristics and patient outcomes were analyzed by cross-tab analysis. Rarely observed data categories were combined (eg, pretreatment stenosis percentages of <70% were collapsed into a single category of stenosis ≤70%) as necessary to allow sufficient counts in cells for valid Chi-square analysis. Chi-square P-values are reported; P<.05 was considered statistically significant. Statistical analyses were done using SAS version 9.3. 

Results

Patient and lesion characteristics. The PFA and SFA groups were well matched with respect to baseline characteristics (Table 1). The PFA group had a shorter lesion length compared with the SFA group (28.9 ± 21.8 mm vs 85.7 ± 80.9 mm; P<.001) (Table 2). 

Procedural characteristics and adjunctive therapy. The PFA group had a higher final residual stenosis, shorter total run time, and shorter total inflation time (Table 3). No patients in the PFA group were treated with adjunctive stenting, whereas stenting was performed in 179/1811 (10%) in the SFA group (Table 4). 

Procedural complications. The primary endpoint was low in the PFA group and compared well with the SFA group (3% vs 11%; P=.14) (Table 5). One patient in the PFA group had spasm (3%). No patient in the PFA group had flow-limiting dissection, perforation, slow flow, vessel closure, embolism, or thrombus.

Discussion

The main finding of our analysis was that orbital atherectomy appears to be feasible and safe for the treatment of calcific PFA disease. Only 1 patient had spasm of the PFA, while no patient experienced any other complications including flow-limiting dissection, perforation, slow flow, vessel closure, embolism, or thrombus. 

As compared with surgical treatment, endovascular revascularization of the PFA is an attractive option given that the lesions are typically focal and proximal in nature.¹⁴ Furthermore, it is an especially attractive option in patients with multiple comorbidities who are at high surgical risk. However, endovascular revascularization of the PFA can be a high-risk procedure given the potential for severe limb ischemia if the PFA is compromised during the intervention. 

Endovascular techniques for PFA revascularization (balloon angioplasty, scoring balloon, atherectomy and/or stenting) have not been standardized, especially for severely calcified vessels. Attempts to perform high-pressure balloon inflation to fully dilate the PFA may lead to dissection or perforation. Atherectomy of a severely calcified PFA can also lead to dissection or perforation. This subanalysis of the CONFIRM registries represents the only data available for the treatment of the PFA with atherectomy. Only 1 patient had an adverse angiographic result (vasospasm). The final residual stenosis was higher in the PFA group (17 ± 13% vs 10 ± 10%; P<.01), although well below the value of <30% residual stenosis generally defined as angiographic success in endovascular studies.¹⁵ This may be explained by the fact that stenting of the PFA was not performed in any patient. Stenting of the PFA may not be a good option given that the lesion commonly occurs at the ostium and therefore is in close proximity to the bifurcation. The repetitive flexion at the inguinal ligament may lead to stent fracture, which is a predictor for reintervention and amputation. Stent placement should also be avoided if possible to preserve the option for surgical intervention in the future. Orbital atherectomy followed by balloon angioplasty with a drug-coated balloon is a reasonable treatment strategy given the low rates of dissection and restenosis, respectively.¹⁶ Distal embolism was not observed in patients in the PFA group. Distal embolic protection with the Emboshield NAV6 embolic protection system (Abbott Vascular), which is compatible with the ViperWire, is a reasonable option during orbital atherectomy given the importance of this vessel in maintaining perfusion to the infrapopliteal vessels when the SFA is occluded. The use of distal embolic protection was not recorded in this analysis. Therefore, its impact on orbital atherectomy of the PFA is unknown. No patient in the PFA group who underwent orbital atherectomy experienced flow-limiting dissection or perforation.

Data with endovascular revascularization of the PFA are limited to small series of patients. One of the early descriptions of this approach was by Motarjeme et al,¹⁷ who demonstrated successful percutaneous profundoplasty of 12 patients in 1980. Symptom improvement indices and complications were not reported. A more recent evaluation reported experience with percutaneous profundoplasty in 31 patients, in which the clinical success rate was 91%, and the ankle-brachial index improved from 0.5 ± 0.2 to 0.7 ± 0.2 (P<.01).¹⁸ Symptomatic improvement was seen in 88% of patients. Limb salvage and mortality rates were similar to those seen using surgical intervention. Diehm et al¹⁹ published a series from 21 endovascular PFA revascularizations and concluded that isolated PFA revascularization was insufficient to support wound healing, but it might be a treatment option in critical limb ischemia patients with rest pain. Donas et al²⁰ reported a case series of 12 patients who underwent either balloon angioplasty alone or with additional stent placement and achieved postinterventional healing of all but 1 ischemic ulceration. A possible explanation for this was attributed to the quality of the distal runoff. 

Surgical revascularization of the PFA is associated with excellent long-term patency results and has been considered the gold standard for decades.^21-23 Different surgical techniques have evolved over the years, with bypass surgery (with or without adjunctive profundoplasty) being the preferred treatment modality for most patients. Primary profundoplasty remains controversial, with its use typically limited to patients with claudication, disease in the proximal one-third of the PFA, intact aorto-iliac inflow, and PFA stenosis >50%.⁴ In a series of 68 reconstructions of the PFA, profundoplasty was associated with primary patency rates of 81%, 64%, and 54% at 1 year, 2 years, and 4 years, respectively. The limb salvage rate at 4 years was 96%.²⁴ It has been postulated that patients who are good candidates for open surgery might benefit from the long-term durability of a surgical approach. However, not all patients are suitable surgical candidates, and the presence of multiple comorbid conditions and prior reconstructive vascular surgery to the ipsilateral groin make the morbidity and technical difficulty associated with surgical approach a limiting factor. An endovascular or hybrid approach is an attractive alternative in such patients. Isolated primary profundoplasty with an endarterectomized SFA patch has also been suggested as an alternative to bypass surgery in such patients, given its low mortality and high technical success rate in one series.²⁵ Infection of prosthetic vascular grafts remains a potential concern, along with potential lymphorrhea, which can be minimized using an endovascular approach.²⁶ 

Study limitations. Although this was a prospective registry, the analysis was a retrospective analysis, which is subject to selection bias. The number of patients who underwent orbital atherectomy of the PFA represented a small fraction of the total cohort of patients who underwent orbital atherectomy. The angiographic data were not adjudicated by a core lab, and thus selection bias was introduced. This study only analyzed angiographic outcomes rather than clinical outcomes, including mortality, repeat revascularization, and amputation-free survival. Long-term patency after orbital atherectomy of the PFA is unknown. The PFA is a distinct vascular bed and had a shorter lesion length compared with the SFA. This resulted in significant differences including a higher final residual stenosis, shorter total run time, and shorter total inflation time in the PFA group. Neither a propensity-matched analysis nor a comparison with surgical profundoplasty was performed. 

Conclusion

In the first and only analysis of its kind, this subanalysis of the CONFIRM registries suggests that orbital atherectomy of the PFA is feasible and safe. However, the small number of patients precludes any definitive conclusions regarding the use of this device. A prospective, randomized trial comparing percutaneous revascularization with surgical revascularization is needed to determine the ideal revascularization strategy for severely calcified PFA disease.

References

1.     Bradbury AW, Adam DJ, Bell J, et al; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg. 2010;51:5S-17S.

2.     Siracuse JJ, Giles KA, Pomposelli FB, et al. Results for primary bypass versus primary angioplasty/stent for intermittent claudication due to superficial femoral artery occlusive disease. J Vasc Surg. 2012;55:1001-1007.

3.     Lawson DW, Gallico GG 3rd, Patton AS. Limb salvage by extended profundaplasty of occluded deep femoral arteries. Am J Surg. 1983;145:458-463.

4.     Towne JB, Rollins DL. Profundaplasty: its role in limb salvage. Surg Clin North Am. 1986;66:403-414.

5.     Slovut DP, Sullivan TM. Critical limb ischemia: medical and surgical management. Vasc Med. 2008;13:281-291.

6.     Leads FH, Gilfillan RS. Importance of profundal femoris artery in the revascularization of the ischemic limb. Arch Surg. 1961;82:25-31.

7.     Waibel PP, Wolff G. The collateral circulation in occlusions of the femoral artery: an experimental study. Surgery. 1966;60:912-918.

8.     Adams GL, Khanna PK, Staniloae CS, et al. Optimal techniques with the Diamondback 360° system achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res. 2011;4:220-229.

9.     Heuser RR. Treatment of lower extremity vascular disease: the Diamondback 360 degrees orbital atherectomy system. Expert Rev Med Devices. 2008;5:279-286.

10.     Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19:480-488.

11.     Safian RD, Niazi K, Runyon JP, et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv. 2009;73:406-412.

12.     Korabathina R, Mody KP, Yu J, et al. Orbital atherectomy for symptomatic lower extremity disease. Catheter Cardiovasc Interv. 2010;76:326-332.

13.     Das T, Mustapha J, Indes J, et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv. 2014;83:115-122. 

14.     Beales JS, Adcock FA, Frawley JS, et al. The radiological assessment of disease of the profunda femoris artery. Br J Radiol. 1971;44:854-859.

15.     Siracuse JJ, Van Orden K, Kalish JA, et al; Vascular Quality Initiative. Endovascular treatment of the common femoral artery in the Vascular Quality Initiative. J Vasc Surg. 2017;65:1039-1046. Epub 2016 Dec 29.

16.    Sethi SS, Lee MS. Drug-coated balloons for infrainguinal peripheral artery disease. J Invasive Cardiol. 2016;28:281-286.

17.    Motarjeme A, Keifer JW, Zuska AJ. Percutaneous transluminal angioplasty of the deep femoral artery. Radiology. 1980;135:613-617.

18.    Silva JA, White CJ, Ramee SR, et al. Percutaneous profundaplasty in the treatment of lower extremity ischemia: results of long-term surveillance. J Endovasc Ther. 2001;8:75-82.

19.    Diehm N, Savolainen H, Mahler F, Schmidli J, Do DD, Baumgartner I. Does deep femoral artery revascularization as an isolated procedure play a role in chronic critical limb ischemia? J Endovasc Ther. 2004;11:119-124.

20.    Donas KP, Pitoulias GA, Schwindt A, et al. Endovascular treatment of profunda femoris artery obstructive disease: nonsense or useful tool in selected cases? Eur J Vas Endovasc Surg. 2010;39:308-313.

21.     Fugger R, Kretschmer G, Schemper M, Piza F, Polterauer P, Wagner O. The place of profundaplasty in the surgical treatment of superficial femoral artery occlusion. Eur J Vasc Surg. 1987;1:187-191.

22.     Ouriel K, DeWeese JA, Ricotta JJ, Green RM. Revascularization of the distal profunda femoris artery in the reconstructive treatment of aortoiliac occlusive disease. J Vasc Surg. 1987;6:217-220. 

23.     Prendiville EJ, Burke PE, Colgan MP, Wee BL, Moore DJ, Shanik DG. The profunda femoris: a durable outflow vessel in aortofemoral surgery. J Vasc Surg. 1992;16:23-29. 

24.     Jacobs DL, Seabrook GR, Freischlag JA, Towne JB. The current role of profundaplasty in complex arterial reconstruction. Vasc Surg. 1995;29:457-463.

25.     Witz M, Shnacker A, Lehmann JM. Isolated femoral profundoplasty using endarterectomised superficial femoral artery for limb salvage in the elderly. Minerva Cardioangiol. 2000;48:451-454.

26.     Rutherford RB. Lymphatic complication of vascular surgery. In: Vascular Surgery. Saunders Elsevier. 2005:922-930. 

From the ¹UCLA Medical Center, Los Angeles, California; and ²UC San Diego Medical Center, La Jolla, California.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Lee reports consulting fees from Cardiovascular Systems, Inc. The remaining authors report no conflicts of interest regarding the contents herein. 

Manuscript submitted July 15, 2017 and accepted August 1, 2017.

Address for correspondence: Michael S. Lee, MD, UCLA Medical Center, 100 Medical Plaza Suite 630, Los Angeles, CA 90095. Email: mslee@mednet.ucla.edu