A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.

BACKGROUND: Great saphenous vein (GSV) incompetence is the most common cause of superficial venous insufficiency. Radiofrequency catheter ablation (RFA) is superior to conventional ligation and stripping, and endovenous laser treatment (EVL) has emerged as an effective alternative to RFA. This randomized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results. METHODS: Between June 2006 and May 2008, patients with symptomatic primary venous insufficiency due to GSV incompetence were randomized to RFA or EVL. Patients with bilateral disease were randomized for treatment of the first leg and received the alternative method on the other. Pretreatment examination included a leg assessment using the Venous Clinical Severity Score (VCSS) and CEAP classification. Patients completed the Chronic Venous Insufficiency Questionnaire 2 (CIVIQ2). RFA was performed with the ClosurePlus system (VNUS Medical Technologies, Sunnyvale, Calif). EVL was performed with the EVLT system (AngioDynamics Inc, Queensbury, NY). Early (1-week and 1-month) postoperative results of pain, bruising, erythema, and hematoma were recorded. Duplex ultrasound (DU) imaging was used at 1 week and 1 year to evaluate vein status. VCSS scores and CEAP clinical class were recorded at each postoperative visit, and quality of life (QOL) using CIVIQ2 was assessed at 1 month and 1 year. RESULTS: The study enrolled 118 patients (141 limbs): 46 (39%) were randomized to RFA and 48 (40%) to EVL, and 24 (20%) had bilateral GSV incompetence. At 1 week, one patient in the RFA group had an open GSV and was deemed a failure. More bruising occurred in the EVL group (P = .01) at 1 week, but at 1 month, there was no difference in bruising between groups. At 1 year, DU imaging showed evidence of recanalization with reflux in 11 RFA and 2 EVL patients (P = .002). The mean VCSS score change from baseline to 1 week postprocedure was higher for RFA than EVL (P = .002), but there was no difference between groups at 1 month (P = .07) and 1 year (P = .9). Overall QOL mean score improved over time for all patients (P < .001). CEAP clinical class scores of >or=3 were recorded in 21 RFA (44%) and 24 EVL patients (44%) pretreatment, but at 1-year, 9 RFA (19%) and 12 EVL patients (24%) had scores of >or=3 (P < .001). This represented a significant improvement in all patients compared with baseline. CONCLUSION: Both methods of endovenous ablation effectively reduce symptoms of superficial venous insufficiency. EVL is associated with greater bruising and discomfort in the perioperative period but may provide a more secure closure over the long-term than RFA.

Elective endovascular and open repair of abdominal aortic aneurysms in octogenarians.

OBJECTIVES: Endovascular aortic aneurysm repair (EVAR) is an increasingly popular treatment option for patients with abdominal aortic aneurysms (AAA), although open repair is considered the standard by virtue of its durability. Octogenarians, as a subgroup, may stand to benefit the most by EVAR. The purpose of this study is to review operative results and durability of open AAA repair and EVAR in octogenarians. METHODS: From May 1996 to August 2006, 150 patients aged >or=80 years underwent elective repair of their infrarenal AAA. Eighty-one underwent EVAR and 69 had open repair. Demographic data, aneurysm specifics, comorbidities, operative morbidity and mortality, intensive care unit and hospital length of stay, and late outcomes were analyzed. RESULTS: In the EVAR group, 27 of 81 (33%) patients died during a mean follow-up of 25 months. In the open repair group, 34 of 69 (49%) patients died during a mean follow-up of 43 months. The median survival time for EVAR was 350 weeks (range, 145-404 weeks) compared with 317 weeks (range, 233-342 weeks) for the open repair group. A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between EVAR and open repair (P = .13). EVAR was associated with decreased blood loss, decreased length of intensive care unit and hospital stays, and a greater number of patients discharged to home. CONCLUSIONS: EVAR and open repair are comparable in safety and efficacy in octogenarians. Operative repair outcomes remain acceptable. Mid- and long-term survival are similar, indicating no survival advantage of one procedure compared with the other.

Elective treatment of abdominal aortic aneurysm with endovascular or open repair: the first decade.

OBJECTIVES: The development of endovascular aneurysm repair (EVAR) as an alternative to open repair of abdominal aortic aneurysms (AAA) has led to an increasing number of patients being treated by this less-invasive technique. It was anticipated that EVAR would reduce the operative mortality and morbidity compared with open repair. This study examined the initial 10-year experience in one center when both techniques were available to determine if there were advantages to one technique or the other, putting the results into the perspective of routine clinical care of patients with infrarenal AAA. METHODS: From June 1996 to May 2005, 677 patients underwent elective repair of their infrarenal AAA, of which 417 were treated with open repair and 260 by EVAR. Demographic and aneurysm-specific data, comorbidities, operative morbidity, mortality, and late outcome were analyzed. RESULTS: Open repair patients were 2 years younger (71 vs 74 years, P < .001), had larger aneurysms (6.01 +/- 1.38 cm vs 5.45 +/- 0.99 cm, P < .001), greater familial predisposition, a higher incidence of current smokers, and a higher incidence of chronic obstructive pulmonary disease than the EVAR group. There were no differences in renal function, hypertension, coronary artery disease, or heart failure between the two groups. Overall operative mortality was 3.1%; operative mortality per group was 3.5% for open and 2.7% for EVAR (P = .627). Procedure-related outcomes showed significant differences in operative blood loss and length of hospital stay in favor of EVAR, and 95% of the EVAR patients were discharged home vs 83% in the open repair group (P < .001). A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between open repair and EVAR (P = .20), but did show a difference in mid-term (3-year) survival favoring open repair (P < .002). Survival analysis by age (<70 and > or =70 years) showed no difference between treatment groups. CONCLUSIONS: Open repair and EVAR are both performed safely in patients treated for elective infrarenal AAA. EVAR has the perioperative advantages of reduced blood loss, reduced length of intensive care unit and hospital stay, and increased number of patients discharged to home. The mid-term survival advantage of open repair has been observed in other reports and deserves further study.