Aureline Boitet

Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery

Objective Drug‐coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent‐related risks. The purpose of this study was to use meta‐analytic data of DCB studies to compare the cost‐effectiveness of potential SFA treatments: DCB, drug‐eluting stent (DES), plain old balloon angioplasty (POBA), or bare‐metal stent (BMS). Methods A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time‐to‐event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta‐analysis, cost‐effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates. Results Eight studies (1352 patients) met inclusion criteria for meta‐analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1‐year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of

Peroneal bypass versus endovascular peroneal intervention for critical limb ischemia

9259.39 per patent limb at 1 year in the POBA‐first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated:

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease

14,136.10/additional patent limb for DCB,

VESS13. Peroneal Bypass vs Endovascular Peroneal Intervention for Critical Limb Ischemia

38,549.80/limb for DES, and

Aortic Non Covered Stents to Treat Complicated Acute Type B Aortic Dissections: Lessons Learned from Seven Years from S.O.S Aorta

59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs

Experimental Evaluation of the Embolizing Potential of “Active” Balloons

87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost‐effective compared with DES. At 2 years, DCB emerges as the most cost‐effective index strategy with the lowest overall cost and highest patency rates over that time horizon. Conclusions Current data and reimbursements support the use of DCB as a cost‐effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost‐effectiveness.

Prior Endovascular Intervention Is Not Detrimental to Pedal Bypasses for Ischemic Wounds

Objective: The peroneal artery is a well‐established target for bypass in patients with critical limb ischemia (CLI). The objective of this study was to evaluate the outcomes of peroneal artery revascularization in terms of wound healing and limb salvage in patients with CLI. Methods: Patients presenting between 2006 and 2013 with CLI (Rutherford 4‐6) and isolated peroneal runoff were included in the study. They were divided into patients who underwent bypass to the peroneal artery and those who underwent endovascular peroneal artery intervention. Demographics, comorbidities, and follow‐up data were recorded. Wounds were classified by Wound, Ischemia, foot Infection (WIfI) score. The primary outcome was wound healing; secondary outcomes included mortality, major amputation, and patency. Results: There were 200 limbs with peroneal bypass and 138 limbs with endovascular peroneal intervention included, with mean follow‐up of 24.0 ± 26.3 and 14.5 ± 19.1 months, respectively (P = .0001). The two groups were comparable in comorbidities, with the exception of the endovascular groups having more patients with cardiac and renal disease and diabetes mellitus but fewer patients with smoking history. Based on WIfI criteria, ischemia scores were worse in bypass patients, but wound and foot infection scores were worse in endovascular patients. Perioperatively, bypass patients had higher rates of myocardial infarction (4.5% vs 0%; P = .012) and incisional complications (13.0% vs 4.4%; P = .008). At 12 months, the bypass group compared with the endovascular group had better primary patency (47.9% vs 23.4%; P = .002) and primary assisted patency (63.6% vs 42.2%; P = .003) and a trend toward better secondary patency (74.2% vs 63.5%; P = .11). There were no differences in the rate of wound healing (52.6% vs 37.7% at 1 year; P = .09) or freedom from major amputation (81.5% vs 74.7% at 1 year; P = .37). In a multivariate analysis, neuropathy was associated with improved wound healing, whereas WIfI wound score, cancer, chronic renal insufficiency, and smoking were associated with decreased wound healing. Treatment modality was not a significant predictor (P = .15). Conclusions: Endovascular peroneal artery intervention results in poorer primary and primary assisted patency rates than surgical bypass to the peroneal artery but provides similar wound healing and limb salvage rates with a lower rate of complications. In appropriately selected patients, endovascular intervention to treat the peroneal artery is a low‐risk intervention that may be sufficient to heal ischemic foot wounds.

Heel Wounds Predict Mortality but Not Amputation after Infrapopliteal Revascularization

Objective: Pedal (inframalleolar) bypass is a long‐standing therapy for tibial arterial disease in patients with ischemic tissue loss. Endovascular tibial intervention is an appealing alternative with lower risks of perioperative mortality or complications. Our objective was to compare the effectiveness of these two treatment modalities with respect to patency and limb‐related clinical outcomes. Methods: We performed a retrospective chart review of patients presenting between 2006 and 2013 with ischemic foot wounds and infrapopliteal arterial disease who underwent a revascularization procedure (either open surgical bypass to an inframalleolar target or endovascular tibial intervention). Data were collected on baseline demographics and comorbidities, procedural details, and postprocedure outcomes. The primary outcome was successful healing of the index wound, with mortality, major amputation, and patency assessed as secondary outcomes. Results: We identified 417 patients who met our eligibility criteria; 105 underwent surgical bypass and 312 underwent endovascular intervention, with mean follow‐up of 25.0 and 20.2 months, respectively (P = .08). The endovascular patients were older at baseline (P = .009), with higher rates of hyperlipidemia (P = .02), prior cerebrovascular accidents (P = .04), and smoking history (P = .04). Within 30 days postoperatively, there was no difference in mortality (P = .31), but bypass patients had longer hospital length of stay (P < .0001), higher rate of discharge to nursing facility (P < .001), and higher rates of myocardial infarctions (P = .03) and wound complications (P < .001). At 6 months, the rate of wound healing was 22.4% in the bypass group compared with 29.0% in the endovascular group (P = .02). At 1 year, survival was higher after bypass (86.2% vs 70.4%; P < .0001), but freedom from major amputation was similar (84.9% vs 82.8%; P = .42). Primary patency (53.1% vs 38.2%; P = .002) and primary assisted patency (76.6% vs 51.7%; P < .0001) were higher in the bypass group, but there was no difference in secondary patency (77.3% vs 73.8%; P = .13). Conclusions: Endovascular tibial intervention is associated with poorer primary patency but similar secondary patency and wound healing rates compared with the “gold standard” of surgical bypass to a pedal target. In patients with tibial arterial disease, endovascular intervention should be considered a lower risk alternative to pedal bypass that provides similar clinical outcomes.

Heel Wounds Predict Poor Outcomes After Infrapopliteal Revascularization

(87.2% vs 67.7%; P 1⁄4 .001), and patients on dialysis (3.0% vs 0.0%; P 1⁄4 .009, Table I). There were fewer patients with comorbid coronary artery disease (32.3% vs 47.3%; P 1⁄4 .005). The CC includedmore patients who had undergone prior aortoiliac endovascular intervention that had failed (17.3% vs 4.8%; P 1⁄4 .0001), and there was a nonsignificant trend toward an increased number of patients undergoing AFB for critical limb ischemia (50.4% vs 40.7%; P 1⁄4 .07) as opposed to claudication symptoms. Overall and major morbidity were similar in both cohorts (Table II). Thirty-day mortality was similar and <1% in both cohorts, but 10-year survival was higher in the CC (67.7% vs 52.6%; P 1⁄4 .02). Ten-year primary patency was higher in the HC (75.8% vs 90.8%; P 1⁄4 .02), but secondary patency and limb salvage were similar in both cohorts, with the latter >95% in both cases. Conclusions: In the contemporary era, patients undergoing AFB for AOD are more likely to have undergone aortoiliac endovascular intervention, and to be females, smokers, and have comorbid dialysisdependent end-stage renal disease. Although long-term primary patency is lower among patients in the CC, during which a substantial subset of AOD patients are being treated primarily via the endovascular approach, secondary patency and limb salvage have not worsened, and long-term survival has increased. These changing characteristics should be considered when benchmarking for reintervention rates and other outcomes.

Cost-Effectiveness Analysis of Drug Coated Balloon vs. Drug Eluting Stent in the Superficial Femoral Artery

preoperative. Four patients (33%) had a preliminary replacement of the aortic arch. The average maximum diameter of the aorta was 62 + 10 mm. The procedure of embolization was possible in 100% of the cases. The thrombosis of the false lumen at the level of the thoracic dilation was obtained in 75% of the cases after the first embolization. One patient required two sessions of embolization and two patients required three sessions. No patient presented postoperative spinal cord ischemia. One patient presented a retrograde type A dissection due to the erosion of the arterial wall by the non-covered stent of a stentgraft and was operated with uneventful course. Finally two patients had a scheduled replacement of the aorta downstream from the stentgraft for a preexistent thoraco-abdominal dilatation. The average follow-up was 3.4±2 months. Conclusion: The embolization of the false lumen of the chronic aortic dissections is feasible technically and seems not very risky. It makes it possible to treat simply some symptomatic dissections. The result on aortic remodeling requires a longer follow-up. This technique could perhaps make it possible to improve the results of the thoracic stentgrafts in chronic dissections.