Clinical utility of the Covidien Closure Fast™ Endovenous Radiofrequency Ablation Catheter.

The Closure Fast™ Endovenous Radiofrequency Ablation Catheter is the latest version of a minimally invasive system for the treatment of patients with superficial venous disease. The Closure Fast™ catheter heats the vein wall to 120°C, causing denaturation of the collagen of the vein wall and contraction of the vessel such that no blood can flow through it. Nearly one million systems have been sold since the product was launched. Many, if not all, patients can be treated under local anesthesia with the Closure Fast™ catheter. Duplex ultrasound reports occlusion rates for the treated vein of 94%-98% at 1 year and 85%-93% at 3 years. The system produces average postoperative pain scores of less than 2 out of 10 on a visual analog score. In the first postoperative week, 76% of patients do not require analgesia. Some 45% of patients return to normal activity on the first postoperative day. Serious complications appear to be rare following the Closure Fast™ procedure. Transient paresthesia occurs in 0.2% of cases, thrombophlebitis in 1%-10%, and thromboembolic events in up to 1.4%, mainly heat-induced thrombosis. Closure Fast™ adds significant costs to treating superficial venous disease but studies have shown it to be cost-effective when used in an office setting.

Early results with the use of heparin-bonded stent graft to rescue failed angioplasty of chronic femoropopliteal occlusive lesions: TASC D lesions have a poor outcome.

PURPOSE: To evaluate early patency rate of the heparin-bonded stent grafts in atherosclerotic long femoropopliteal occlusive disease, and to identify factors that affect outcome. METHODS: Heparin-bonded Viabahn stent grafts were placed in 33 limbs in 33 patients during 2009-2010. The stents were deployed to rescue failed conventional balloon angioplasty. Mean age was 69 (range 44-88) years, and 67 % (22 of 33) were men. Most procedures (21 of 33, 64 %) were performed for critical limb ischemia (33 % for rest pain, 30 % tissue loss). Kaplan-Meier plots and Cox regression analysis were used to identify significant risk factors. RESULTS: The average length of lesions treated was 25 ± 10 cm, and they were predominantly TASC (Transatlantic Intersociety Consensus) D (n = 13) and C (n = 17) lesions. The median primary patency was 5.0 months (95 % confidence interval 1.22-8.77). The mean secondary patency was 8.6 months (95 % confidence interval 6.82-10.42). Subsequently, 4 patients underwent bypass surgery and 5 patients underwent major amputation. One patient died. There were 5 in-stent or edge-stent stenoses. Cox multivariate regression analysis identified TASC D lesions to be a significant risk factor for early occlusion (p = 0.035). CONCLUSION: TASC D lesions of femoropopliteal occlusions have poor patency rates with the use of heparin-bonded stent grafts after failed conventional angioplasty. Alternative options should be considered for these patients.

Use of the Hardman index in predicting mortality in endovascular repair of ruptured abdominal aortic aneurysms.

PURPOSE: The Hardman index is a predictor of 30-day mortality after open ruptured abdominal aneurysm repair through the use of preoperative patient factors. The aim of this study was to assess the Hardman index in patients undergoing endovascular repair of ruptured aortic aneurysms. MATERIALS AND METHODS: A retrospective analysis of 95 patients undergoing emergency endovascular repairs of computed tomography-confirmed ruptured aneurysms from 1994 to 2008 in a university hospital was performed. All relevant patient variables, calculations of the Hardman index, and the incidence of 30-day mortality were collected in these patients. Correlation of the relationship between each variable and the overall score with the incidence of 30-day mortality was undertaken. RESULTS: The 24-hour mortality was 16% and 30-day mortality 36%. Increasing scores on the Hardman index showed an increasing mortality rate. Thirty-day mortality in patients with a score of 0 to 2 was 30.5%, and in those with a score of ≥3 was 69.2% (P = .01, risk ratio = 2.26, 95% confidence interval = 0.98 to 5.17). This is lower than predicted in both patient groups based on Hardman index score. Loss of consciousness was the only statistically significant independent predictor of 30-day mortality with a risk ratio of 3.16 (95% confidence interval = 2.00-4.97, P < .001). CONCLUSION: These data suggest that the Hardman index can predict an increased risk of 30-day mortality from endovascular repairs of ruptured aortic aneurysms. However, mortality from endovascular repair is much lower than would be predicted in open repair and it therefore cannot be used clinically as a tool for exclusion from intervention.

Ruptured abdominal aortic aneurysm: endovascular repair does not confer any long-term survival advantage over open repair.

Recent studies have suggested that endovascular aneurysm repair (EVAR) may reduce the perioperative mortality of ruptured abdominal aortic aneurysm (AAA). Whether EVAR confers any long-term survival advantage over published results for open repair of ruptured AAA has not been established. We conducted a single-center retrospective study over a 10-year period (1994-2004) examining the long-term outcome of patients who have undergone endovascular repair of ruptured AAA. Fifty-four patients underwent endovascular repair of a ruptured AAA. The median age was 75 years (interquartile range 69.5-79.5 years); 42 (78%) patients were male. The perioperative mortality rate was 37%. During a median follow-up of 32 months (range 14-48 months), there were 5 aneurysm-related and 13 non-aneurysm-related deaths. Overall, the 3- and 5-year survival rates were 36% and 26%, respectively. EVAR does not appear to confer any overall survival advantage in the mid- to long term compared with the published results for open repair. The reasons for this remain unclear. Further, larger studies are required to confirm these results.

Long-term renal function following endovascular aneurysm repair with infrarenal and suprarenal aortic stent-grafts.

PURPOSE: To determine in a retrospective analysis the incidence of renal impairment (RI) following endovascular repair (EVR) of abdominal aortic aneurysm (AAA), to assess the morbidity and mortality in endograft patients with preoperative RI, and to examine the impact of suprarenal stent-grafts on renal function. METHODS: From March 1994 to October 2001, 315 AAA patients (289 men; mean age 72.4+/-7.0 years) undergoing EVR were entered prospectively into a vascular registry. The patients received either an in-house custom-made stent-graft or one of several commercially made devices implanted with infrarenal or suprarenal fixation. Renal function was monitored by serum creatinine measurements prior to discharge and at 3, 6, and 12 months and annually thereafter. Preoperative RI was defined as a serum creatinine >130 micro mol/L and/or long-term dialysis. Postoperative RI referred to a >20% increase in the serum creatinine over baseline. Additional deterioration of renal function in patients with preoperative RI was referred to as postoperatively worsened RI. RESULTS: Of the 315 patients treated, 220 (69.8%) were considered high risk (ruptured AAA or ASA grade III or IV). Sixty-nine (21.9%) patients had preoperative RI (6 [1.9%] on preoperative dialysis). A suprarenal stent-graft was used in 169 (53.7%) patients and infrarenal stent-graft in the remaining 146 (46.3%). The mean follow-up was 30.1+/-22.7 months. Postoperative RI occurred in 53 (16.8%) patients (24 [7.6%] transient, 29 [9.2%] persistent). Patients with preoperative RI had a significantly higher incidence of postoperatively worsened RI (37.7% versus 11.0%, p<0.0001) and a higher mortality related to RI (7.2% versus 1.6%, p=0.02). Suprarenal fixation had no influence on the incidence of RI, on perioperative mortality, or on mortality related to RI. The only significant predictive factor of postoperative RI was preoperative RI (risk ratio 5.09, 95% CI 2.38 to 10.87, p=0.0001). CONCLUSIONS: Endovascular AAA repair may lead to persistent postoperative RI in nearly 10% of cases, especially in patients with preoperative RI. Suprarenal stent-graft fixation does not seem to have any deleterious effect on renal function. Further long-term studies are required to confirm the innocuous nature of transrenal stent placement.