1

Introduction

There is no current consensus on the best strategy to treat in-stent restenotic femoropopliteal (FP) lesions. Treatment of these lesions has a high rate of procedural success but an overall poor long-term patency and high target lesion revascularization (TLR) . Restenosis in the FP segment is an independent predictor of recurrent restenosis, lower patency rates, and higher repeat target vessel revascularization . Debulking of in-stent restenotic FP lesions has been attempted in small observational studies. SilverHawk atherectomy (SA) has been shown to be effective in acutely treating these lesions with high procedural success, but skills and techniques of the operator are important to avoid complications . Currently, in the “Instructions for Use,” SA is contraindicated for in-stent restenosis at a peripheral site.

Randomized studies have shown that there is a small but significant reduction in restenosis and TLR with stenting of de novo lesions of the femoral artery with nitinol self-expanding stents compared to plain old balloon angioplasty (POBA), but these trials did not include restenotic lesions . There are no randomized data on angioplasty vs. debulking or restenting of in-stent restenotic FP lesions.

A recent randomized trial has shown that the long-term outcome of SA was similar to POBA in treating de novo FP lesions , but atherectomy seems to reduce the need for stenting significantly . There are no randomized studies to compare atherectomy (laser or SA) vs. POBA for in-stent FP restenotic lesions.

In this retrospective study, we examine our procedural and long-term outcome of in-stent restenotic FP lesions treated with the SA device. Secondary end points in this study are the safety in the off-label use of this device within stented segments, the rate of restenting by the operator, and distal embolization.

2

Methods

A total of 457 patients with FP disease were treated by two operators at our medical center from February 2005 to April 2010. Patients were included if their index lesions were restenotic, in-stent, and were only in the FP arteries. Patients were excluded if they had de novo lesions or non-FP segments treated during the index procedure or if they were treated with a non-SilverHawk atherectomy device. There were no prespecified guidelines to the choice of the device which was based on operator’s judgment.

Demographics, clinical, procedural, and angiographic variables were retrospectively reviewed from a prospective peripheral vascular database developed at our institution. One-year follow-up was achieved on all patients by reviewing medical records and phone calls by a dedicated research coordinator. The study was approved by the institutional review board.

Major in-hospital and 1-year adverse events included device-induced vascular injury as reported by the operator, amputation (major and minor, planned and unplanned), death, distal embolization (as captured by an embolic filter or distally embolized and requiring further treatment with pharmacologic or mechanical means), vessel perforation, major bleeding, myocardial infarction, stroke, access complications, acute renal failure, and acute or subacute vessel closure. Major bleeding was defined as a drop of ≥ 3 g/dl Hb with a clear source of bleed, retroperitoneal bleed, or intracranial bleed. Acute renal failure was defined as an increase in creatinine within 48–72 h of the procedure by ≥ 0.5 mg/dl. The TransAtlantic InterSociety Consensus (TASC I) was used to classify lesion complexity.

The primary effectiveness end point was acute procedural angiographic success defined as obtaining less than 30% residual narrowing with no serious adverse events at the end of the procedure. Secondary end points included acute device success defined as a residual narrowing of < 50% by the SA device alone and before adjunctive treatment, distal embolization, clinically driven TLR and TVR at 1 year based on symptom recurrence, ankle brachial indices (ABI), and Rutherford–Becker class at 1 month and 1 year, death, and amputation. Patients were followed up at approximately 1 month and 1-year intervals in the office. Follow-up ABI testing was not part of a mandatory protocol but was generally done on the majority of patients.

Descriptive analysis was done on all variables. Continuous variables were presented as mean ± S.D. and dichotomous variables as percentages. Kaplan–Meier survival curve for TVR was plotted.

2

Methods

A total of 457 patients with FP disease were treated by two operators at our medical center from February 2005 to April 2010. Patients were included if their index lesions were restenotic, in-stent, and were only in the FP arteries. Patients were excluded if they had de novo lesions or non-FP segments treated during the index procedure or if they were treated with a non-SilverHawk atherectomy device. There were no prespecified guidelines to the choice of the device which was based on operator’s judgment.

Demographics, clinical, procedural, and angiographic variables were retrospectively reviewed from a prospective peripheral vascular database developed at our institution. One-year follow-up was achieved on all patients by reviewing medical records and phone calls by a dedicated research coordinator. The study was approved by the institutional review board.

Major in-hospital and 1-year adverse events included device-induced vascular injury as reported by the operator, amputation (major and minor, planned and unplanned), death, distal embolization (as captured by an embolic filter or distally embolized and requiring further treatment with pharmacologic or mechanical means), vessel perforation, major bleeding, myocardial infarction, stroke, access complications, acute renal failure, and acute or subacute vessel closure. Major bleeding was defined as a drop of ≥ 3 g/dl Hb with a clear source of bleed, retroperitoneal bleed, or intracranial bleed. Acute renal failure was defined as an increase in creatinine within 48–72 h of the procedure by ≥ 0.5 mg/dl. The TransAtlantic InterSociety Consensus (TASC I) was used to classify lesion complexity.

The primary effectiveness end point was acute procedural angiographic success defined as obtaining less than 30% residual narrowing with no serious adverse events at the end of the procedure. Secondary end points included acute device success defined as a residual narrowing of < 50% by the SA device alone and before adjunctive treatment, distal embolization, clinically driven TLR and TVR at 1 year based on symptom recurrence, ankle brachial indices (ABI), and Rutherford–Becker class at 1 month and 1 year, death, and amputation. Patients were followed up at approximately 1 month and 1-year intervals in the office. Follow-up ABI testing was not part of a mandatory protocol but was generally done on the majority of patients.

Descriptive analysis was done on all variables. Continuous variables were presented as mean ± S.D. and dichotomous variables as percentages. Kaplan–Meier survival curve for TVR was plotted.

3

Results

Of 457 FP-treated patients, 41 patients met the inclusion criteria of the study. Patients were excluded if they were treated with laser atherectomy ( n = 119), orbital atherectomy ( n = 7), or they had mixed FP de novo and restenotic lesions or had additional non-FP lesions treated ( n = 290).

Demographic and clinical variables are presented in Table 1 . Patients had multiple comorbidities with a high frequency of hypertension (90.2%), hyperlipidemia (95.1%), smoking history (85.4%), and diabetes (61%). The majority of the patients were claudicants (87.5%) and with chronic symptoms (> 6 months) (85.4%). Angiographic and procedural variables are presented in Table 2 . The mean lesion length was 126.2 mm and 73.2% of the lesions were TASC C and D. Procedural and device success were achieved in 100% and 92.7% of patients, respectively. Bailout stenting was performed in 24.4% of patients. Macroembolization occurred in 36.4% of filters ( Fig. 1 ). Three patients with distal embolization (DE) required additional treatment successfully.

Table 1

Demographics and clinical characteristics.

	n	Mean ± S.D.
Age	41	70.9 ± 9.2
Body mass index	41	29.4 ± 5.5
Baseline ABI of treated Leg at rest	36	0.66 ± 0.2
Baseline ABI of treated leg with exercise	26	0.42 ± 0.2
		Percentage
Gender—male	23/41	56.1
Prior percutaneous coronary intervention	24/41	58.5
Prior coronary bypass surgery	16/41	39
Previous myocardial infarction	11/41	26.8
Family history premature CAD	15/39	38.5
Renal failure (creatinine > 2.0)	6/41	14.6
Chronic obstructive lung disease	6/41	14.6
Peripheral vascular disease	41/41	100
Hypertension	37/41	90.2
Cerebrovascular disease	11/41	26.8
Hyperlipidemia	39/41	95.1
History of smoking	35/41	85.4
Diabetes mellitus	25/41	61
Onset of symptoms—subacute	6/41	14.6
Onset of symptoms—chronic	35/41	85.4
Claudicants (Rutherford–Becker 1–3)	35/40	87.5
Limb ischemia (Rutherford–Becker 4–5)	5/40	12.5

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