Julio A. Rodriguez‐Lopez

Endovenous Ablation of Incompetent Saphenous Veins: A Large Single-Center Experience

Purpose: To evaluate the effectiveness of endovenous treatment of symptomatic varicose veins using the endovenous laser (EVL) or radiofrequency (RF) energy over a >3-year follow-up. Methods: From February 2002 to August 2005, 981 consecutive patients (770 women; mean age 51 years, range 15–90) with symptomatic varicose veins in 1250 lower limbs underwent endovenous ablation of 1149 great saphenous veins (GSV) and 101 small saphenous veins (SSV) under tumescent anesthesia without intravenous sedation or regional anesthesia. There were 990 GSV and 101 SSV procedures using EVL; 159 GSVs were treated with RF energy. An ultrasound evaluation was performed within 2 weeks of the procedure to evaluate occlusion of the vein, wall thickness, and clot extension into the deep venous system. Follow-up from the first 200 procedures in the series included clinical evaluation and duplex ultrasound scanning at 6 and 12 months and annually thereafter. Results: Of the 1149 GSVs treated, 39 (3.4%) recanalizations were seen in 33 of the EVL and 6 of the RF procedures for inadequate treatment as judged by ultrasound. There were 9 (9.0%) failures among the 101 SSVs treated with EVL. Overall, both EVL and RF procedures were well tolerated, with only minor complications. One obese patient with ulcer developed pulmonary embolus on the fourth postoperative day. There were no differences between EVL and RF in efficacy or complications. Follow-up at a mean 3 years (range 30–42 months) in 143 treated limbs showed no neovascularization in the groin. Conclusion: Outcomes with EVL and RF were good, with low complication rates that may be related to the use of local tumescent anesthesia without intravenous sedation.

Renal artery stenosis treated with stent deployment: Indications, technique, and outcome for 108 patients

From January 1993 to May 1996, 108 patients (64 men, 44 women; mean age, 72 years; age range, 37 to 87 years) underwent 125 percutaneous transluminal angioplasties and stent implantations primarily for atherosclerotic lesions of the renal artery. Sixty-four patients underwent treatment for renovascular hypertension (two antihypertensive medications or more), 32 patients underwent treatment for a combination of hypertension and renal failure (serum creatinine level >/=1.6 mg/dL), and a small group of six patients (5%) without hypertension or diminished renal function underwent treatment to prevent the progression to renal artery occlusion and kidney loss. Thirty-three patients (31%) had renovascular hypertension that was classified as severe on three or more medications, 31 patients (29%) had renovascular hypertension that was classified as moderate on two medications, and 38 patients (35%) had renovascular hypertension that was classified in the mild group on a single antihypertensive agent. Stenotic lesions were located at the ostium of the renal artery in 82 cases (65%) and were ostial-adjacent (<5 mm from renal ostium) in the other 43 cases (34%). A total of 125 stents were deployed in 125 arteries (procedural success 97.6%). Renovascular hypertension either was cured or was improved in 73 patients (68%), with 14 patients (13%) considered cured (normotensive on no medications). The conditions of 29 patients (27%) were unchanged, and 6 patients (5%) had worsening hypertension after surgery. We were unable to demonstrate a statistically significant improvement in serum creatinine levels after renal artery balloon angioplasty/stenting. Complications occurred in a total of nine cases (7.2%), six of which were related to technical problems. One patient had worsening renal insufficiency caused by contrast agent, and another patient had a perinephric hematoma develop that necessitated evacuation. There were four postoperative deaths (30-day mortality). Two of these deaths were caused by postoperative myocardial infarction. The other two patients had progressive renal failure develop that necessitated dialysis. These patients later died of the disease process despite supportive care. Follow-up renal artery duplex scan studies and angiograms were available on 96 patients (76%). The mean peak systolic renal/aortic ratio on duplex scanning was 2.2. Life-table analysis yielded a 74% primary patency rate and an 85% secondary patency rate at 36 months. This retrospective analysis showed the effectiveness of combining percutaneous transluminal angioplasty with stent deployment for significant renal artery stenosis to treat renovascular hypertension.

Endovenous Laser Ablation of the Saphenous Vein for Treatment of Venous Insufficiency and Varicose Veins: Early Results from a Large Single-Center Experience

Purpose: To report early results of a single-center experience with endovenous laser ablation of the saphenous vein (ELAS). Methods: From February 2002 to January 2003, 165 eligible patients (116 women; mean age 59.1 years, range 27–90) were treated with ELAS for venous insufficiency in 203 lower limbs. All patients were symptomatic, and the majority (62%) had class 4 or higher clinical disease (CEAP classification). Eighteen (8.9%) patients had ulcers. A 940-nm diode laser was used in an office setting under local tumescent anesthesia to deliver 100 to 140 laser applications along the course of the vein. Two weeks of compression bandages and a 1-week course of ibuprofen were prescribed postoperatively. All patients underwent a duplex scan of the target vein at 2 weeks. Results: The great (154, 76%), short 37 (18%), and accessory 12 (6%) saphenous veins were ablated, achieving a 97% clinical success rate. Postoperative complications were few (mild induration and ecchymosis) and well tolerated (no DVT or nerve injury). Of the 6 (3.0%) recanalized target veins, 4 were only partially open and successfully treated with sclerosis. Of the 18 patients with active ulceration, 15 (83%) demonstrated healing after ELAS. In a satisfaction survey of patients more than 1 year after ELAS treatment, 84% of the 31 responders claimed their symptoms had diminished to none or minimal; 97% were mostly or very satisfied with their treatment results. Conclusions: ELAS for symptomatic saphenous vein incompetence and varicose veins has excellent short-term subjective and objective outcomes. This technique appears to be very successful in reducing symptoms, resolving varicose veins, and healing ulcers.

Hybrid repair of thoracic aortic lesions for zone 0 and 1 in high-risk patients

PURPOSE Some patients with aortic arch or descending thoracic aorta pathologies are not suited for open repair because of comorbidities that may increase their risk of procedural complications or death. Endovascular approaches may also be difficult when there are inadequate proximal landing zones in the aortic arch. We report our experience using rerouting techniques with bypass, stenting of the branches, or a combination of both to create a landing area in zones 0 and 1 of the aortic arch. METHODS Since November 2002, thoracic aortic endoluminal grafts were placed in 38 patients in whom the endograft was deployed in zone 0 (n = 27) or zone 1 (n = 11). A retrospective review is included. RESULTS There were 11 women and 27 men with a mean age of 65.4 years (range 38-88). Aortic pathology included 12 Stanford type A dissections, 10 aortic arch aneurysms, 8 Stanford type B dissections, 3 descending thoracic aortic aneurysms, 2 aortobronchial fistulas, 1 innominate artery aneurysm and 2 aortic arch pseudoaneurysms. In zone 0, 21 had thoracic debranching with an ascending bypass, three patients had a remote-inflow and three patients had a chimney-stent with carotid-carotid bypass. In zone 1, five patients had a carotid-carotid bypass, one patient had an aortic to left common carotid artery (LCCA) bypass and five patients had chimney-stent on the LCCA. Fifty-eight percent of the patients were symptomatic and 26% emergent. Three patients required hemodialysis postoperatively (7.9%), 18 patients (47.4%) required prolonged mechanical ventilation for respiratory insufficiency. Paraplegia occurred in one patient (2.7%), and five patients suffered a cerebrovascular accident (13.1%). There were four early type I and two type II endoleaks. Overall 30-day mortality was 23.7%. CONCLUSIONS The hybrid approach for repair of the aortic arch pathologies is feasible in patients unfit for open repair. We present the results of performing different techniques to treat the aortic arch with hybrid repair with antegrade or retrograde inflow, stenting of the branches or a combination of both. Long-term results are unknown, and larger series results and comparative studies are needed to determine safety and efficacy.

Endoluminal stent-graft stabilization for thoracic aortic dissection.

Purpose: To review our experience with thoracic endografting for type B aortic dissection using the TAG Endoprosthesis. Methods: A retrospective analysis was performed of data collected prospectively from March 2000 to July 2004 under an investigational device exemption protocol for the TAG thoracic endograft. In this time period, 40 patients (29 women; mean age 67 years, range 39–91) were treated with this endograft for type B aortic dissection. Results: Technical success was 95%. There was 1 (2.5%) perioperative death, and 1 (3%) endoleak was treated with an additional graft on postoperative day 2. Fifteen (38%) patients experienced postoperative complications, mainly renal or pulmonary, and 1 (3%) patient developed postoperative paraplegia that did not resolve. The 1-year survival was 85%. Follow-up computed tomography was available for 31 patients with an average 15-month follow-up. There was no significant change in size of the thoracic aorta in 22 patients; 8 aneurysmal segments were significantly reduced in size and 1 thoracic aortic aneurysm expanded. No thoracic aortic ruptures were seen in this series. Conclusions: These early results indicate type B thoracic aortic dissections can be treated with acceptable morbidity and mortality using endografts. Stent-graft repair of the thoracic aorta may decrease the incidence of thoracic aortic expansion and rupture.

Transrenal Fixation of Aortic Endografts: Intermediate Follow-up of a Single-Center Experience

Purpose: To examine the fate of the renal ostia following transrenal fixation of endovascular aortic stent-grafts. Methods: Thirty-five patients (29 men; mean age 75 years) undergoing endovascular repair for abdominal aortic aneurysms (AAAs) had transrenal fixation of the uncovered proximal stent due to a short (<1.5 cm long) or conical neck or a periprocedural endoleak. Eighteen (51%) patients were hypertensive; 7 (20%) had renal artery stenoses (RAS). Outcome measures included blood pressure, serum creatinine, computed tomography, and renal artery duplex scans. Results: Two patients with ≥60% RAS had renal stents placed during the endograft procedure; the other 5 RAS patients were normotensive and their renal lesions were not treated. Overall technical success was 82.9% (29/35). One (2.9%) case was converted due to graft twisting. There were 5 (14.2%) early endoleaks. Transient postoperative creatinine elevations were observed in 5 (14.2%) cases. Over a median 11-month period (range 2–24), no secondary endoleaks or silent renal artery occlusions were seen. One normotensive patient with an untreated ≥60% renal lesion developed hypertension and severe stenosis (99%) at 4 months; stenting through the interstices of the transrenal stent was performed. No disease progression was seen in the other 6 RAS patients. Conclusions: In the intermediate period, transrenal fixation appears to have no adverse effects on renal blood flow. Moreover, in patients with no evidence of renal disease or preoperative RAS <60%, it does not precipitate or cause progression of renal stenosis. However, patients with preoperatively documented RAS ≥60% are a concern and mandate further study.

Endografting of the Thoracic Aorta

Abstract  Background: Thoracic aortic dissections, ruptures, fistulae, and aneurysms pose a unique surgical challenge. Traditional repair of thoracic aortic aneurysms involves thoracotomy with graft interposition. Despite advances in perioperative care and both total and partial cardiopulmonary bypass, conventional surgery carries a significant morbidity and mortality. Principal complications include bleeding, paraplegia, stroke, cardiac events, pulmonary insufficiency, and renal failure. Recent enthusiasm for innovative endovascular therapies to treat aortic disease has spurred many centers to investigate endoluminal grafting of the thoracic aorta. Early reports on endovascular repair using custom made “first generation devices” demonstrated the technique to be feasible with a mortality and morbidity comparable to open repair. Methods and results: From February 2000 to February 2001, endovascular stent graft repair of the thoracic aorta was performed in 46 patients (mean age 70; 29 male and 17 female) using the Gore Excluder. Twenty‐three patients (50%) had atherosclerotic aneurysms, fourteen patients (30%) had dissections, three patients (7%) had aortobronochial fistulas, three patients (7%) had pseudoaneurysms, two patients (4%) had traumatic ruptures, and one patient (2%) had a ruptured aortic ulcer. Patient characteristics, procedural variables, outcomes, and complications were recorded. All patients were followed with chest CT scans at 1, 3, 6, and 12 months. Mean follow up was 9 months ranging from 1 to 15 months. All procedures were technically successful. There were no conversions. Average duration of the procedure was 120 minutes. Average length of stay was 6 days, but most patients left the hospital within 4 days (64%) after endoluminal grafting. Overall morbidity was 23%. Two patients (4%) had endoleaks that required a second procedure for successful repair. Two patients (4%) died in the immediate postoperative period. There were no cases of paraplegia. At follow‐up, one patient had an endoleak found the day after the procedure and another patient had an endoleak 6 moths post procedure. Both were treated successfully with additional stent grafts. There were no cases of migration. One patient died of a myocardial infarction 6 months after graft placement. The Gore Excluder device was voluntarily recalled on February 26, 2001. Therefore, from June 2000 to January 2001, 37 patients underwent endovascular stent graft repair of the thoracic aorta for various disease entities using our customized thoracic graft (Endomed). Twenty‐seven patients (73%) had aneurysms, six (16%) had dissections, two (5%) had pseudoaneurysms, one (2%) had a traumatic transection, and one patient (2%) had an embolizing ulcer. Patients were followed with CT scans at 1, 3, 6, and 12 months. All procedures were technically successful. There were no conversions. The average age was 68 years.(17–87). And the male and female ratio was 24/13. One patient died in the operating room from iliac rupture and one died from embolization/stroke in the immediate postoperative period. Two patients died within 30 days from comorbid factors. The total 30‐day mortality was 10%. Two patients had endoleaks. One returned to the operating room and needed an additional cuff. The other had a small leak in a proximal dissection that is being followed. There were no cases of paraplegia. Conclusion: Thoracic endoluminal grafting is a safe and feasible alternative to open graft repair and can be performed successfully with good results. Early data suggest that an endoluminal approach to these disease entities maybe favorable to open resection and graft replacement. Technical details of Endoluminal stent grafting of the thoracic aorta for different disease entities have been discussed at length.

Learning curve for endovascular abdominal aortic aneurysm repair: evaluation of a 277-patient single-center experience.

Purpose: To determine the minimum number of stent-graft deployments that an interventional team with endovascular skills must do to be considered well trained in endovascular abdominal aortic aneurysm (AAA) exclusion. Methods: The records of 277 consecutive patients (236 men; median age 73 years, range 49–91) undergoing endovascular AAA repair at a single institution between 1994 and 1998 were reviewed. Information was collected on procedural success, conversion, time interval between procedures, operative complications, operative mortality, contrast volume, blood loss, intensive care unit (ICU) length of stay (LOS), and hospital LOS. A first-order differential equation was used to calculate a learning curve based on the success rate. Patients were subsequently divided into 5 sequential groups of 55 patients (the last group had 57 patients). Results: Analyzing the pattern of procedural success to failures, a sharp change in the slope was observed between 50 and 65 trials. The number 55 was arbitrarily chosen to represent the point after which the incremental change in the success rate never exceeded 0.01 (<1 failure per 100 attempts). In the intergroup comparisons, success rate (p<0.04), conversion rate (p<0.0001), and procedural frequency (p<0.0001) were statistically significant when the first 55-patient group was compared to the others. Operative complications (p=0.08) and operative mortality (p=0.16) were numerically but not significantly different. Contrast volume was significantly reduced for the last group (p<0.0001). A Cox regression model identified only procedural frequency (p=0.03) and procedural volume (p=0.04) as predictive of technical success. Performing endovascular AAA repairs at a ≤10-day interval was associated with a >80% success rate. Conclusions: This study shows that not only is the number of procedures important to outcome, but also the frequency with which they are performed. Based on our teams performance data, 55 cases would appear to be the minimum volume and 1 case every 10 days the minimum frequency to obtain good operative results with aortic endografting.

Immediate endovascular repair for descending thoracic aortic transection secondary to blunt trauma.

PURPOSE To report the immediate endovascular treatment of a thoracic aortic tear secondary to blunt trauma. METHODS AND RESULTS A 39-year-old man was injured in a motor vehicle collision. In addition to significant trauma to the head, chest, and abdomen, there were signs of a deceleration injury to the thoracic aorta. After urgent celiotomy to repair a lacerated spleen, the thoracic aortic transection was treated intraluminally using an endograft made of Gianturco Z-stents covered with polytetrafluoroethylene. The patient recovered from his injuries, and the thoracic endograft shows no evidence of endoleak 7 months after treatment. CONCLUSIONS Endoluminal techniques can be used successfully in the immediate repair of thoracic aortic injuries.

Management of endoleaks associated with endovascular treatment of descending thoracic aortic diseases

OBJECTIVE Endoluminal grafting is emerging as a less invasive alternative to the treatment of descending thoracic aorta diseases. Endoleaks (continued pressurization of the treated aorta external to the endoluminal graft) are a potential complication. We reviewed our cumulative endovascular experience for descending thoracic aorta pathologies with respect to the management of endoleaks and associated patient outcomes. METHODS As part of a single-site investigational device-exemption protocol, 249 patients (146 men, 103 women) with thoracic aortic diseases underwent attempted delivery of a TAG endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) between February 2000 and August 2005. Indications for study enrollment included 111 atherosclerotic aneurysms (44.6%), 67 aortic dissections (26.9%), 27 penetrating aortic ulcers (10.8%), 14 contained ruptures (5.6%), 11 pseudoaneurysms (4.4%), 9 acute aortic transections (3.6%), 7 aortobronchial fistulas (2.8%), 2 endoleaks (0.8%) after prior thoracic endoluminal grafting, and 1 (0.4%) adult coarctation. Endoleak surveillance was performed using serial computed tomography scans. RESULTS Mean patient age was 68 years (range, 23-91 years). Endoleak developed in 38 patients (15.3%): 15 distal type I (39.5%), 13 proximal type I (34.2%), 8 type II (21.1%) and 2 type III (5.3%). No surgical intervention was performed in 26 patients (68.4%), in which the endoleak spontaneously resolved in 14 (53.8%), 8 (30.8%) are being monitored and are asymptomatic, 3 (11.5%) died of unrelated causes, 2 (7.7%) withdrew from the study, and 1 (3.8%) was lost to follow-up. Twelve patients (31.6%) required reintervention using an additional endoluminal graft: 8 (66.7%) with a proximal type I endoleak, 2 (16.7%) with a distal type I endoleak, 1 (8.3%) with both distal type I and type III endoleaks, and 1 (8.3%) with a type III endoleak. Open conversions were necessary secondary to device deployment difficulties in two patients (0.8%), and due to expansion of a thoracoabdominal aneurysm and rupture of an aneurysm secondary to a type II endoleak in one patient (0.5%) each. CONCLUSION Endoleaks are an infrequent, yet important, complication after thoracic endografting. Many endoleaks will resolve spontaneously, but some patients may require another endovascular intervention. Close surveillance is recommended for these patients; however, open conversion is rarely indicated. Because more diseases of the thoracic aorta are being treated using an endovascular approach, a standardized treatment algorithm is essential to safely and effectively manage associated endoleaks.