Jeffrey M. Rhodes

Mid-term results of endoscopic perforator vein interruption for chronic venous insufficiency: Lessons learned from the North American Subfascial Endoscopic Perforator Surgery registry

Abstract Purpose: The safety, feasibility, and early efficacy of subfascial endoscopic perforator surgery (SEPS) for the treatment of chronic venous insufficiency were established in a preliminary report. The long-term clinical outcome and the late complications after SEPS are as yet undetermined. Methods: The North American Subfascial Endoscopic Perforator Surgery registry collected information on 148 SEPS procedures that were performed in 17 centers in the United States and Canada between August 1, 1993, and February 15, 1996. The data analysis in this study focused on mid-term outcome in 146 patients. Results: One hundred forty-six patients (79 men and 67 women; mean age, 56 years; range, 27 to 87 years) underwent SEPS. One hundred and one patients (69%) had active ulcers (class 6), and 21 (14%) had healed ulcers (class 5). One hundred and three patients (71%) underwent concomitant venous procedures (stripping, 70; high ligation, 17; varicosity avulsion alone, 16). There were no deaths or pulmonary embolisms. One deep venous thrombosis occurred at 2 months. The follow-up periods averaged 24 months (range, 1 to 53 months). Cumulative ulcer healing at 1 year was 88% (median time to healing, 54 days). Concomitant ablation of superficial reflux and lack of deep venous obstruction predicted ulcer healing ( P P P Conclusions: The interruption of perforators with ablation of superficial reflux is effective in decreasing the symptoms of chronic venous insufficiency and rapidly healing ulcers. Recurrence or new ulcer development, however, is still significant, particularly in post-thrombotic limbs. The reevaluation of the indications for SEPS is warranted because operations in patients without previous deep vein thrombosis are successful but operations in those patients with deep vein thrombosis are less successful. Operations on patients with deep vein occlusion have poor outcomes. (J Vasc Surg 1999;29:489-502.)

Endoscopic perforator vein division with ablation of superficial reflux improves venous hemodynamics

PURPOSEnHemodynamic consequences of incompetent perforator vein interruption have not been well documented. The effects of perforator interruption, with or without ablation of superficial venous reflux, on venous function in patients with advanced chronic venous insufficiency was studied.nnnMETHODSnCalf muscle pump function, venous incompetence, and outflow obstruction were assessed by means of strain-gauge plethysmography (SGP) before and within 6 months after subfascial endoscopic perforator surgery (SEPS). SEPS was performed with laparoscopic instrumentation and CO2 insufflation. Concomitant high ligation or saphenous vein stripping was performed in 24 limbs (77%).nnnRESULTSnTwenty-six patients, 18 women and 8 men, with a mean age of 50 years (range, 20 to 77 years) underwent SEPS. Preoperative evaluation confirmed superficial reflux in 65% of limbs, deep venous reflux in 77% of limbs, and perforator incompetence in 97% of limbs. All limbs had advanced venous dysfunction (C3, C4, C5, C6). All active ulcers (C6, n = 12) healed after surgery (mean, 32 +/- 3 days), and only 1 recurred during a mean follow-up period of 11 months (range, 1 to 43 months). Clinical score improved from 6.58 +/- 0.50 to 2.19 +/- 0.25 (P <.0001). Improved calf muscle pump function was demonstrated by means of postoperative SGP and was indicated by increased refill volume (RV: 0.27 +/- 0.06 vs 0.64 +/- 0.10 mL/100 mL tissue, P <.01). Venous incompetence also improved, as evidenced by prolonged duration to refill after exercise (T90: 7. 71 +/- 1.20 vs 16.71 +/- 1.98 seconds, P <.001) and a decrease in RV after passive drainage (3.23 +/- 0.19 vs 2.63 +/- 0.15 mL/100 mL tissue, P <.01). Improved refill rate (RR) correlated with improvements in clinical scores (P <.01, r = 0.77).nnnCONCLUSIONnSEPS with ablation of superficial reflux improved calf muscle pump function, reduced venous incompetence, and produced excellent midterm clinical results. However, functional improvement directly related to SEPS requires further investigation. This study supports adding SEPS to ablation of superficial reflux in patients with advanced chronic venous insufficiency.

Simulation Case Rehearsals for Carotid Artery Stenting

A case series of 5 patients is presented assessing the utility of simulation case rehearsals of individual patients for carotid artery stenting on an endovascular simulator. Simulated and operative device dimensions were similar. Results of subjective surveys indicated that face and content validity were excellent. The simulations predicted difficulty with vessel cannulation, however had difficulty predicting post-stent changes in bifurcation angulation. Our experience suggests that it may be feasible to use patient-specific CTA-derived data in the creation of a realistic case rehearsal simulation. The overall utility of this concept, including cost-benefit analysis, has yet to be determined.

The benefits of secondary interventions in patients with failing or failed pedal bypass grafts

BACKGROUNDnAutogenous bypass grafts to pedal arteries have successfully salvaged limbs and restored function in patients with critical ischemia. The benefits of secondary interventions to save failing or already failed grafts remains uncertain.nnnMETHODSnA retrospective analysis was made of consecutive pedal bypasses performed between 1987 and 1998. Patency and limb salvage by life-table analysis and variables affecting outcome were compared with the log-rank test.nnnRESULTSnTwo hundred thirteen patients, 144 males, 69 females (mean age 68 years, range 30 to 91) underwent pedal bypass grafting in 228 limbs using autogenous vein grafts (nonreversed saphenous vein, n = 190; reversed, n = 15; composite, n = 23). One-hundred fifty-seven patients were diabetic, 34 had renal insufficiency (serum creatinine >2.0), and 14 were on dialysis. Gangrene or ulceration were present in 224 patients, rest pain in 24. Cumulative primary and secondary patency rates were 57% and 67% at 5 years. Limb salvage was 78% at 5 years. Secondary interventions in 46 patients included patch angioplasty/surgical revision (n = 28), thrombectomy (n = 15), thrombolysis (n = 11), and balloon angioplasty (n = 6). Patency in 19 of 26 (73%) failed grafts and in 19 of 20 (95%) failing grafts could be restored initially. Cumulative 2-year patency and limb salvage rates following reinterventions were 36% and 58%, respectively. Patency rates and limb salvage for failed grafts (7%, 44%) were significantly worse than those for failing grafts (81%, 77%; P <0.0001, P <0.05, respectively). All patients with renal insufficiency who underwent reinterventions for failed or failing grafts required major amputation within 1 year (P <0.0001 versus those without renal insufficiency).nnnCONCLUSIONnAutogenous pedal bypass grafts are durable operations with excellent long-term patency and limb salvage rates. Revision of failing grafts has been effective using both endovascular and surgical techniques. Failed grafts have poor long-term patency and moderate limb salvage rates, and our data do not justify secondary procedures to attempt to save failed grafts in patients with renal insufficiency.

Aortic-origin reconstruction of the great vessels: risk factors of early and late complications.

OBJECTIVEnGreat vessel reconstruction for arterial occlusive disease has been shown to be a durable procedure. The purpose of this report is the examination of the influence of cause and risk factors on outcomes for the identification of patients who may be better treated with endovascular techniques or other surgical approaches.nnnMETHODSnData for patients who underwent aortic-origin great vessel reconstruction between 1988 and 1998 were reviewed. The data were analyzed with Fisher exact test, life-table analysis, and log-rank test.nnnRESULTSnNinety-two vessels underwent revascularization in 58 patients (15 men, 43 women; mean age, 54 years; age range, 20 to 82 years). Etiology was atherosclerosis obliterans (n = 40; 69%), Takayasus arteritis (n = 13; 22%), radiation arteritis (RA; n = 4; 7%), and mediastinal fibrosis (n = 1; 2%). The symptoms were cerebrovascular (n = 25), upper extremity (n = 8), or both (n = 23), and two patients were asymptomatic. The bypass grafting was performed with single-limb synthetic grafts (n = 23) or grafts plus side arms (n = 28). Seven patients underwent innominate endarterectomy. The mean follow-up period was 45 months (range, 0 to 126 months). The perioperative stroke (n = 4; 7%) and death (n = 2; 3%) rates were not related to the cause of disease. The patients with creatinine levels of 2 or more (n = 4) had a combined perioperative stroke/death rate of 50% (vs 7% for patients with healthy creatinine levels; P <.05). The patients with hypercoagulable states (ie, thrombophilia; n = 6) had an increased perioperative stroke rate (33% vs 4% for patients without hypercoagulable states; P <.05) and an increased late thrombosis rate. The primary and secondary graft patency rates at 5 years were 80% +/- 7% and 91% +/- 5%, respectively. Patients with RA had a greater risk of stroke or death at 3 years (33% free of stroke or death vs 79% for patients with atherosclerosis obliterans and 92% for patients with Takayasus arteritis; P =.02) and an increased major late infection rate (50% vs 2% for all others; P =.01).nnnCONCLUSIONnPatients with thrombophilia and renal insufficiency have increased perioperative stroke and stroke/death rates, respectively. Patients with RA have an increased incidence rate of late major infection, which directly contributes to an increased rate of stroke or death. Patients with thrombophilia have an increased rate of late graft thrombosis. These patient conditions should be approached cautiously, and some patients may benefit from endovascular therapy.

Impact of Chronic Kidney Disease on Outcomes of Superficial Femoral Artery Endoluminal Interventions

While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of chronic kidney disease (CKD) on long-term outcomes in this population are unclear. We examined the consequences of endovascular treatment of the SFA in patients with and without varying stages of CKD. A database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried, and two groups were defined: estimated glomerular filtration rate (eGFR) <or=60 and >60 mL/min/1.73 cm(2). Intention-to-treat analysis was performed. Results were standardized to TransAtlantic Inter-Society Consensus (TASC-II) and Society for Vascular Surgery criteria. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Data are presented as mean +/- standard deviation where appropriate. There were 525 limbs in 535 patients (68% male, average age 66 +/- 14 years) that underwent endovascular treatment for claudication or chronic critical limb ischemia (51%). Patients with eGFR <or=60 were older and had significantly more coronary artery disease, congestive heart failure, diabetes mellitus, and hyperlipidemia. TASC-II lesion distribution was equivalent (37% for TASC-II C and D), but tibial runoff was significantly worse in the eGFR <or=60 group. In addition, there were more inflow and outflow interventions in the eGFR <or=60 group. In patients with claudication, there was no difference in patency or limb salvage between those with eGFR <or=60 and >60. In patients with critical limb ischemia, there was no difference in patency between those with eGFR <or=60 and >60. Limb salvage was worse in patients with eGFR <or=60 compared to eGFR >60. With respect to limb salvage, six factors were significantly associated with a reduction in rates: presence of tissue loss at presentation (relative risk [RR] = 6.45, p = 0.003), 0 or 1 vessel tibial runoff (RR = 2.56, p < 0.01), progression of distal disease noted in follow-up (RR = 4.62, p < 0.01), embolization at the initial intervention (RR = 2.70, p < 0.05), diabetes mellitus (RR = 3.71, p < 0.01), and a history of congestive heart disease (RR = 2.42, p < 0.01). Notable factors that were not significantly associated included lesion calcification (p = 0.64), TASC C or D lesion categorization (p = 0.99), acute occlusion at initial intervention (p = 0.40), and adjuvant stenting (p = 0.67). CKD does not impact the patency of SFA interventions. Limb salvage in patients with critical ischemia is significantly worse when the eGFR is <or=60 mL/min/1.73 cm(2).

Popliteal-to-Distal Bypass: Identifying Risk Factors Associated with Limb Loss and Graft Failure

Modern therapy, including endoluminal procedures and improved medical management, still yield less than desired results for tibial vessel occlusive disease. Despite the recent focus on these newer interventions, few modern series have evaluated the efficacy of popliteal-to-distal bypass procedures. The authors aimed to determine the efficacy of popliteal-distal bypass and to identify adverse prognostic factors for ultimate limb salvage. Eighty-seven patients (54 men; average age: 63 years) underwent 92 popliteal-distal bypasses. Duplex ultrasound was utilized to assess patency of all grafts. Data were analyzed by life-table analysis to determine patency rates at postoperative intervals. Median patient follow-up was 2.4 years. Major indications for bypass included chronic limb ischemia (86%) and disabling claudication (8%); 62% of the limbs were considered threatened, and 74% of the proximal anastomoses were above-knee. All procedures were technically successful. There were no perioperative (<30 days) deaths, and 86% of patients were alive at 5 years. Cumulative patency rates were 74% at 6 months, 70% at 2 years, and 63% at 5 years. Limb salvage rates closely paralleled patency rates. At 5 years, 62% of the affected limbs were intact; 72% of the limbs lost were associated with early (<180 days) bypass failures. Predictors of limb loss included early graft failure (84 days vs 1,288 days, p <0.0001), younger age (57 years vs 64 years, p = 0.039), history of previous ipsilateral vascular procedures (50% vs 21%, p = 0.03), heavy (>1 ppd) tobacco use (p = 0.001), and a thrombosed femoral-popliteal bypass at presentation (p = 0.002). When successful, popliteal-distal bypass is associated with excellent long-term patency and limb salvage rates. Early failures are often associated with limb loss. Heavy tobacco use, younger age, early graft failures, repeat revascularization, and presentation with a thrombosed femoral-popliteal graft are associated with limb loss.

Endoscopic perforating vein surgery.

Perforator incompetence, caused by primary valvular incompetence or by previous deep venous thrombosis, contributes to ambulatory venous hypertension and the development of chronic venous disease. Although the exact role and contribution of perforators to the development of ulcers are still debated, poor results of nonoperative management to prevent ulcer recurrence justify surgical attempts at perforator ligation, in addition to ablation of superficial reflux. The endoscopic technique of perforator interruption has significantly fewer wound complications than the open technique and is the preferred method for ablation of medial perforating veins. Interruption of incompetent perforators with ablation of the superficial reflux, if present, effectively and durably decreases symptoms of CVI and rapidly heals ulcers. Ulcer recurrence following correction of perforator and superficial reflux in patients with post-thrombotic syndrome is much higher than in patients with primary valvular incompetence. A prospective randomized trial is needed to define the long-term benefits of interrupting incompetent perforators in all patients with advanced chronic venous disease and which patients with post-thrombotic syndrome should undergo perforator interruption.

Outcomes of Endoluminal Therapy for Ostial Disease of the Major Branches of the Aortic Arch

While aggressive endoluminal therapy for occlusive disease of the major branches of the arch of the aorta (brachiocephalic [BCA], left common carotid [LCCA], and left subclavian [LSCA] arteries) is commonplace, long-term outcomes in this population are unclear. We examined the long-term outcomes of endoluminal therapy for ostial aortic arch disease at a single tertiary referral academic medical center. A prospective database of patients undergoing endovascular treatment of aortic arch vessel atherosclerotic occlusive disease between 1990 and 2004 was maintained and retrospectively analyzed. Patients with stenotic ostial lesions of the major thoracic aorta branches were selected. Angiograms were reviewed in all cases to assess lesion characteristics. Patency was assessed by routine clinical and, in the LCCA and LSCA, duplex ultrasound follow-up at 1, 6, and 12 months postintervention and every 12 months thereafter. Results were standardized to current Trans-Atlantic Inter-Society Consensus and Society for Vascular Surgery criteria. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Data are presented as mean +/- SEM. Forty-four patients (average age 64 +/- 2 years, 59% male) underwent 26 LSCA, 11 LCCA, and eight BCA interventions for primary indications of arm ischemia (29%), prevention or treatment of coronary steal syndrome (29%), or cerebrovascular signs/symptoms (42%). The technical success rate was 98%, with a 90-day mortality rate of 0% and a major adverse event rate of 2%. There were no strokes and no upper extremity embolic events. Cumulative patency was 88 +/- 8% at 3 years, with a reintervention rate of 7%. The overall symptom recurrence rate was 4%. No local or systemic factors were associated with poor outcomes. Endoluminal stenting for ostial disease of the branches of the aortic arch provides excellent and long-term patency rates with low morbidity, mortality, and secondary intervention rates. With an overall technical success of 98%, our results parallel those for lesions located more distally in the arch branches and support the continued use of percutaneous therapy for atherosclerotic disease throughout the arch branches.

Stacked proximal aortic cuffs: an "off-the-shelf" solution for treating focal thoracic aortic pathology.

Purpose: To report our early experience with the endovascular placement of stacked Zenith main body extensions (cuffs) in the treatment of focal thoracic aortic pathology in high-risk patients. Methods: Between January 2003 and May 2004, 6 patients (3 men; mean age 59 years, range 37–82) with focal aortic pathology underwent endovascular repair using stacked 30 and 32-mm-diameter Zenith main body extensions. The setting was a university tertiary referral center for vascular disease. Indication for treatment included 2 descending thoracic aneurysms and individual cases of traumatic thoracic tear, diverticulum of Kommerell, thoracic pseudoaneurysm, and aortoesophageal fistula. Results: All procedures were performed successfully, with a mean of 3 cuffs used. The patient with an aortoesophageal fistula expired after successful cuff placement due to sequela of massive pretreatment hemorrhage; fistula coverage was confirmed at autopsy. There were no type l endoleaks. Morbidity included an occluded right subclavian artery from traumatic passage of the device through the artery. No left subclavian arteries were covered. No neurological deficits or paraplegia was observed. The cuffs were patent in all surviving patients at an average follow-up of 7 months (range 3–12). Computed tomography in all survivors confirmed adequate cuff placement, absence of endoleak, and lack of cuff migration. Based on this experience, the following technical recommendations are offered: (1) right subclavian cutdown when needed to reach a lesion beyond the range of the sheath, (2) Dacron chimney placement, (3) stiff guidewire usage, (4) wire placement from the right subclavian artery through the common femoral artery if necessary to ease a sharp bend in the arch, and (5) cuff overlap of 25% to 50%. Conclusions: In high-risk patients, focal aortic pathology can be successfully treated with off-the-shelf commercially available cuffs using a stacking technique with acceptable mortality, morbidity, and short-term durability.