Long-Term Results of Carotid Artery Stenting in Veterans With Prior Head and Neck Cancer

Journal of Vascular Surgery

Abstracts

e91

Volume 66, Number 4 Table. Mean dose by stent graft device and level of fenestration CMD

ZFEN

OTS

Four vessels

2950

a

Three vessels

Two vessels

2200

3020

2670b

1600b

KAP, Gy-cm2

370

210a

280

400

320b

240b

Operator, mSv

370

120a

220a

440

170b

420

Assistant, mSv

210

60a

110a

210

150

140

Anesthesia, mSv

60

90

60

70

50

80

Circulator, mSv

30

10a

4a

30

10

7

Scrub, mSv

40

10a

20

40

30

20

RAK, mGy

1800

CMD, Custom-made device; KAP, kerma area product; OTS, off-the shelf device; RAK, reference air kerma; ZFEN, Zenith fenestrated endovascular graft. a Significantly different from CMD. b Significantly different from four vessels.

extending coverage, if anatomically required. Overall, patient and personnel radiation doses during FEVAR with all devices were within acceptable limits and lower in our series than previously reported. M. Kirkwood: None; K. Chamseddin: None; G. Arbique: None; J. Guild: None; D. Timaran: None; J. Anderson: None; C. Timaran: Honoraria; Speaker Cook Medical.

EndoAnchors Use With Infrarenal Versus Suprarenal Stent GraftsdResults From ANCHOR Global Registry Manish Mehta, MD, MPH,1 William Jordan, MD,2 Philip Paty, MD,1 Kenneth Ouriel, MD3. 1Vascular Health Partners, Queensbury, NY; 2 Emory Healthcare, Atlanta, Ga; 3Syntactx, New York City, NY Objective: EndoAnchors (Medtronic, Santa Rosa, Calif) have shown safety and efficacy in maintaining proximal seal and in treatment of type I endoleaks. The Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) data captured use of a variety of endografts with infrarenal (IR) and suprarenal (SR) fixation; approximately 75% of patients were considered to have one or more markers for hostile aortic neck anatomy. The outcomes of the EndoAnchor endovascular aneurysm repair (EVAR) with IR and SR stent grafts were analyzed. Methods: A propensity analysis was performed to compare the results of 254 subjects treated with EndoAnchors plus IR-EVAR (n ¼ 127) vs those subjects who were treated with EndoAnchors plus SR-EVAR (n ¼ 127). An independent core laboratory performed a propensity-matched analysis of 24 anatomic, physiologic, andgeographic factors in all patients. EndoAnchors were used at the time of primary IR-EVAR (83.5% [106/ 127]), primary SR-EVAR (89.0% [113/127]; P ¼ .27), delayed revision IREVAR (16.5% [21/127]), and delayed revision SR-EVAR (11.0% [14/127]). Results: In comparing the EndoAnchor plus IR-EVAR vs EndoAnchor plus SR-EVAR groups, there were no statistically significant differences in mean age (76.4 vs 76.1 years; P ¼ .76), gender (male, 75.6% vs 78.0%; P ¼ .77), mean abdominal aortic aneurysm (AAA) diameter (57.1 6 15.1 vs 57.3 6 12.0 mm; P ¼ .94), proximal neck length (19.6 6 13.5 vs 18.5 6 13.2 mm; P ¼ .64), or IR neck angulation (37 6 19 vs 36 6 19 degrees; P ¼ .86). Furthermore, in comparing the EndoAnchor plus IR-EVAR vs EndoAnchor plus SR-EVAR groups, there was no difference in the incidence of type Ia endoleak (6.3% [6/96] vs 5.2% [5/91]; P ¼ .99), AAA sac regression >5 mm (34.7% [35/101] vs 32.9% [27/82]; P ¼ .88), or AAA sac enlargement >5 mm (3.0% [3/101] vs 1.2% [1/82]; P ¼ .63). In primary cases (mean follow-up, 21.2 6 9.3 months), aneurysm-related reinterventions were similar in the IR-EVAR group (8.5% [9/106]) and the SR-EVAR group (11.5% [13/113]; P ¼ .51). Whereas aneurysm-related reinterventions were more common in revision cases (mean follow-up, 20.0 6 10.2 months), there were no differences in the rate in the IR-EVAR group (23.8% [5/21]) vs the SR-EVAR group (21.4% [3/14]; P ¼ .99). Conclusions: Propensity-matched analysis of the ANCHOR data indicates that at midterm follow-up, primary use and delayed secondary use of EndoAnchors with IR and SR stent grafts are equally effective in maintaining a low incidence of type Ia endoleaks, aneurysm sac regression, and need for secondary interventions.

M. Mehta: Consulting Fee; MicroVention, Medtronic Inc, SilkRoad Medical, Boston Scientific, Abbott Vascular, Endologix, W. L. Gore & Associates. Consulting Fee; My Role; speaker. Other financial benefit; Sponsored Clinical Research: Medtronic, Endologix, SilkRoad Medical, Bolton Medical, Boston Scientific, NIH, Abbott Vascular. Other financial benefit; My Role; Principal Investigator. W. Jordan: Consulting Fee; Gore, Medtronic, Aptus, Cook, Endologix, TriVascular, and Lombard. Consulting Fee; My Role; speaker. Other financial benefit; Sponsored Clinical Trials: Gore, Medtronic, Aptus, Cook, Endologix, TriVascular, Lombard. Other financial benefit; My Role; Principal Investigator. P. Paty: None; K. Ouriel: Other financial benefit; Dr Ouriel is employed by and holds equity ownership in Syntactx, a contract research organization that receives research funding from Medtronic, the sponsor for the ANCHOR study.

Long-Term Comparative Effectiveness of Carotid Stenting Versus Carotid Endarterectomy in a Large Tertiary Care Vascular Surgery Practice Robert Garvin, Evan Ryer, Andrea Berger, James Elmore. Geisinger Medical Center, Danville, Pa Objective: Carotid interventional trials have strict inclusion and exclusion criteria that make translation of their results to the real-world population challenging. In routine clinical practice, the role of clinical decision-making is difficult to evaluate. We designed this trial to compare the effectiveness of carotid artery stenting (CAS) vs carotid endarterectomy (CEA) in a real-world setting. Methods: A retrospective study was performed of all consecutive patients undergoing CAS and CEA performed only by vascular surgeons in a large rural tertiary health care system from 2004 to 2014. Postoperative outcomes of stroke, acute myocardial infarction (AMI), and death were analyzed at 30 days and in the long term (median follow-up of 4.8 years for CAS and 5.5 years for CEA). Standard statistical analysis was performed. Differences in long-term outcomes were expressed as cumulative incidence functions for stroke and AMI, which account for the high death rate in this population of vascular patients, and as Kaplan-Meier curves for death itself. Results: From January 1, 2004, through December 31, 2014, there were 2331 carotid interventions performed (CAS, 478; CEA, 1853), all by fellowship-trained vascular surgeons. The average age of patients was 71 years, and 63% were male. Preoperatively, 30% of patients were symptomatic, and 77% of patients had high-grade stenosis in the range of 70% to 99%. CEA patients were more likely to have preoperative hypertension (89.7% vs 86.2%; P ¼ .029) and were less likely to have a history of cardiovascular disease (53.4% vs 59.4%; P ¼ .018); otherwise, the two groups were comparable. There were no significant differences in 30-day outcomes (stroke, CAS 3.1% vs CEA 3.3% [P ¼ .817]; AMI, CAS 1.7% vs CEA 2.2% [P ¼ .474]; death, CAS 0.6% vs CEA 0.7% [P ¼ .859]) or long-term outcomes (stroke, CAS 35.6% vs CEA 33.6% [P ¼ .202]; AMI, CAS 21.0% vs CEA 22.7% [P ¼ .886]; death, CAS 28.2% vs CEA 28.4% [P ¼ .122]). Conclusions: The short- and long-term outcomes after CAS and CEA are similar when they are performed in a real-world setting by fellowship-trained vascular surgeons, whose clinical acumen is required in deciding which procedure to offer patients. R. Garvin: None; E. Ryer: None; A. Berger: None; J. Elmore: None.

Long-Term Results of Carotid Artery Stenting in Veterans With Prior Head and Neck Cancer Roy W. Jones, MD, Adam Tanious, MD, Paul Armstrong, DO, Neil Moudgill, MD, Karl A. Illig, MD, James D. Brooks, MD. University of South Florida, Tampa, Fla Objective: Patients meeting criteria for intervention of carotid stenosis with a history of prior cervical irradiation or neck dissection are considered “high risk” for carotid endarterectomy. This is a well-established indication for carotid artery stenting (CAS). The long-term outcomes of CAS in this population, however, are not so well established. The purpose of this study was to review the long-term results of CAS in veteran patients with a prior history of treatment for head and neck cancer. Methods: This is a retrospective review of a population of veteran patients from 2000 to 2016. All patients at our institution with a prior history of treatment of head and neck cancer who underwent CAS were included in the analysis. During this period, 38 patients met inclusion criteria and were treated with 50 carotid stenting interventions.

e92

Journal of Vascular Surgery

Abstracts

October 2017 Kaplan-Meier analysis was used to determine freedom from mortality and primary patency. The secondary aim was to identify predictive risk factors for mortality and reintervention. Results: At 5 years, freedom from mortality was 60%. Mean length of time from procedure to death was 1281.6 (61599) days. Primary patency at 5 years was 89% (Fig). No neurologic events occurred at 30 days. Two patients suffered a stroke in long-term follow-up. The reintervention rate was 8% (n ¼ 4), with an assisted primary patency rate of 100%. No stent occlusions occurred in this series. Eleven of 14 patients died of recurrent, active index, or other distinct primary cancer. Mortality and need for reintervention were not predicted by type of cancer, TNM stage at initial diagnosis, indication for surgery (irradiation, neck dissection, or both), preoperative symptom status, or preoperative demographic variables. Conclusions: Based on the results in this series, CAS in these patients can be performed with low long-term rates of neurologic events and need for reintervention. However, the survival of patients with head and neck cancer undergoing CAS in this cohort is reduced compared with published outcomes of other large series undergoing CAS for all indications. In this specific population of patients, a more critical analysis of the patient’s overall prognosis, especially as it relates to cancer, should be undertaken before offering CAS.

cases), whereas stent placement is the most common PVI in the HO setting (representing 37% of cases). Vascular surgeons and cardiologists continue to perform most of these interventions. There is a disproportionately high reimbursement for atherectomy procedures done in the office (Table). Conclusions: Interventions for lower extremity occlusive diseases between 2011 and 2015 have migrated to the outpatient setting, predominantly to OBLs. Atherectomy use in OBLs continues to grow at a rapid rate, and there is a high rate of repeated atherectomy within 12 months of the incident procedure. Table. Medicare reimbursement for atherectomy by clinical setting in 2016 CPT code

Description

Physician’s office

HO

Physician’s office as percentage of HO

37225

Femoral-popliteal atherectomy

$10,723

$9,542

112%

37227

Femoral-popliteal stent + atherectomy

$14,555

$14,612

100%

37229

Tibial/peroneal atherectomy

$10,483

$14,612

72%

37231

Tibial/peroneal stent + atherectomy

$12,976

$14,612

89%

CPT, Current Procedural Terminology; HO, hospital outpatient.

D. Mukherjee: None; B. Contos: None; E. Emery: None; H. Hashemi: None.

Fig. Kaplan-Meier curves for stent patency and patient survival. R. W. Jones: None; A. Tanious: None; P. Armstrong: None; N. Moudgill: None; K. A. Illig: None; J. D. Brooks: None.

Reimbursement, Particularly Atherectomy, Appears to Be a Principal Driver for Intervention for Lower Extremity Occlusive Disease, Particularly in Office-Based Laboratories Dipankar Mukherjee, MD,1 Brian Contos, BS,2 Erica Emery, MS,1 Homayoun Hashemi, MD1. 1Inova Fairfax Medical Campus, Falls Church, Va; 2Advisory Board, Washington, D.C. Objective: The purpose of this study was to examine the ongoing trend of migration of endovascular procedures being done for lower extremity occlusive disease from the hospital to office-based laboratories (OBLs) since our previous analysis reported a year ago. We also analyzed the 12-month downstream use of repeated atherectomy after the incident procedure. Methods: We analyzed fee-for-service Medicare claims data from 2011 to 2015. We examined the type of intervention (angioplasty, atherectomy, or stent), clinical setting (OBL, hospital outpatient [HO], and hospital inpatient [HI]), and operator specialty (vascular surgeon, cardiologist, interventional radiologist, and other). We also looked at repeated atherectomy procedures 12 months after the incident procedure. Results: Consistent with our previous analyses, there was a continued growth in use of atherectomy in all infrainguinal vascular beds. There was a 76% overall increase in atherectomy volume for Medicare beneficiaries between 2011 and 2015. In the same period, atherectomy increased by 380% in OBLs and by 30% in the HO setting and decreased by 16% in the HI setting. Across all settings of care, nonatherectomy peripheral vascular intervention (PVI) increased only by 2% between 2011 and 2015. During this time, case volume increased by 120% in OBLs and decreased by 12% in the HI setting, with no change in the HO setting. Atherectomy is the most common PVI in OBLs (representing 68% of

Metformin Is Associated With Improved Survival and Decreased Cardiac Events With No Impact on Patency and Limb Salvage After Revascularization for Chronic Limb Ischemia Sikandar Z. Khan, MBBS,1 Mariel Rivero, MD,2 Linda Harris, MD,1 Maciej Dryjski, MD,1 Gregory Cherr, MD,1 Nader D. Nader, MD,2 Hasan H. Dosluoglu, MD2. 1SUNY Buffalo, Buffalo, NY; 2VA Western NY Healthcare System, Buffalo, NY Objective: The incidence of cardiovascular and limb-specific adverse outcomes is higher in peripheral arterial disease (PAD) patients with diabetes. Metformin is the first-line drug therapy for type 2 diabetes and is associated with fewer adverse cardiovascular events. However, the effect of metformin on limb-specific outcomes is unclear. The objective of this study was to assess the effect of metformin on outcomes after intervention for PAD. Methods: Patients who underwent revascularization for chronic limb ischemia (Rutherford 3-6) between June 2001 and December 2014 were retrospectively identified. Primary patency, secondary patency, limb salvage, major adverse cardiac events (MACEs), and survival rates of patients taking metformin were compared with those not taking metformin using Kaplan-Meier and Cox regression. Results: There were 1564 limbs in 1204 patients identified (147 metformin, 196 other oral hypoglycemics [OHs], 216 insulin only, 645 nondiabetics). Nondiabetics had significantly lower incidence of coronary artery disease and hypertension compared with other subgroups (P < .05). Statin and aspirin use was significantly higher in the metformin group (P < .05). The insulin group had a significantly greater number of patients with end-stage renal disease and critical limb ischemia (P < .05). The 60-month primary patency was significantly greater in nondiabetics 62% (P ¼ .005), with no significant difference between metformin (56%), OH (60%), and insulin (51%) groups (P ¼ .06). The 60-month secondary patency was similar in metformin (76%), OH (85%), insulin (76%), and nondiabetic (80%) groups (P ¼ .272). Limb salvage was significantly worse in the insulin group (62%; P < .001), with no significant difference between metformin (84%), OH (83%), and nondiabetic (87%) groups (P ¼ .451). The 60-month survival was significantly improved in metformin (60%) and nondiabetic (60%) groups compared with the OH (41%) and insulin (30%) groups (P < .001). Freedom from MACEs was significantly greater in the metformin (44%) and nondiabetic (52%) groups compared with the OH (37%) and insulin (25%) groups (P <