Remote endarterectomy versus supragenicular bypass surgery for long occlusions of the superficial femoral artery: medium-term results of a randomized controlled trial (the REVAS trial).

BACKGROUND: To investigate the optimal surgical treatment, remote superficial femoral artery endarterectomy (RSFAE) or supragenicular bypass, for Transatlantic Inter-Society Consensus (TASC) C and D lesions of the superficial femoral artery. Medium-term results will be presented. METHODS: The study randomized 116 patients, 61 to RSFAE and 55 to supragenicular bypass surgery. Indications for surgery were claudication in 77, rest pain in 21, or tissue loss in 18. RESULTS: Primary patency after 3 years of follow-up was 47% for RSFAE and 60% for bypass (p = 0.107), assisted primary patency was 63 and 69% (p = 0.406), and secondary patency was 69 and 73% (p = 0.541), respectively. For venous (n = 25) and prosthetic grafts (n = 30) at 3-year follow-up, primary patency was 65% and 56 versus 47% for RSFAE (p = 0.143), assisted primary patency was 84% and 56 versus 63% for RSFAE (p = 0.052), and secondary patency was 89% and 59 versus 69% for RSFAE (p = 0.046), respectively. Limb salvage was 97% after RSFAE and 95% after bypass surgery (p = 0.564). CONCLUSION: RSFAE is a minimally invasive option for surgical repair of TASC C and D superficial femoral artery obstructions, with assisted primary and secondary patency rates comparable with bypass surgery. Venous bypass grafting is superior to both RSFAE and polytetrafluoroethylene grafting, but only 45% of patients had a sufficient saphenous vein available. If the saphenous vein is not applicable, RSFAE should be considered because it is less invasive and prosthetic graft material can be avoided.

Initial results of concomitant cryoplasty after remote endarterectomy of the superficial femoral artery: a feasibility study (cryoplasty following remote endarterectomy).

OBJECTIVE: Remote endarterectomy is a less invasive technique compared with supragenicular bypass surgery for superficial femoral artery (SFA) occlusive disease. Early restenosis remains one of the drawbacks of this procedure. To prevent restenosis following remote endarterectomy, concomitant cryoplasty of the desobstruct SFA was introduced. METHODS: A prospective cohort study was initiated with 17 patients treated with cryoplasty of the SFA after remote endarterectomy. Indications for surgery were claudication (n = 12), rest pain (n = 3), or tissue loss (n = 2). RESULTS: There were no technical failures. The Kaplan-Meier estimate of the primary and assisted primary patency rate after 1 year of follow-up was 74%. Secondary patency was 89%. Limb salvage was 100%. No aneurysmal degeneration and no other adverse events occurred during the follow-up. CONCLUSIONS: This pilot study showed that cryoplasty after remote SFA endarterectomy is a safe procedure, with promising patency rates.

Thoracic stent grafting for acute aortic pathology.

BACKGROUND: Elective endovascular repair of the thoracic aorta has shown reduced morbidity and mortality when compared with open surgery. The number of studies describing the use of thoracic endovascular stent grafts for acute pathology is limited, however. The purpose of this study was to describe our increasing experience with stent grafting for acute thoracic aortic pathology. METHODS: Since January 2002, 28 patients underwent endovascular stent graft treatment for various types of acute thoracic aorta diseases, including complicated Stanford type B dissection (n = 12), ruptured descending aorta aneurysms (n = 7), intramural hematoma (n = 4), traumatic rupture of the thoracic aorta (n = 2), aortopulmonary fistula (n = 2), and penetrating aortic ulcer (n = 1). These acute thoracic aortic syndromes were predominantly localized in the proximal descending thoracic aorta (75%). Talent stent grafts were used in 26 patients and Excluder stent grafts in 2 patients. RESULTS: Stent graft deployment at the intended position was successful in all patients. There was 1 intraoperative death (3.6%), due to acute myocardial infarction, after successful exclusion of the lesion with a stent graft. Hospital mortality was 21.4% (n = 6). Four of 6 hospital deaths, however, were directly related to the severely compromised clinical status preoperatively, including extensive bowel ischemia and irreversible cerebral damage after resuscitation. New neurologic symptoms were seen in 4 patients. The majority of the neurologic symptoms improved and faded away during hospital stay. Mean follow-up was 11 months (range, 1 to 31), and all the hospital survivors (n = 22) were alive. There was 1 nonrelated stroke 4 months postoperatively. During follow-up, 2 patients required transposition of the left subclavian artery for malperfusion, and 2 patients required a second stent graft procedure for endoleak. Additionally, 2 patients with early type II endoleaks were treated conservatively, and 1 of them sealed spontaneously at 6 months. CONCLUSIONS: Thoracic stent grafting for acute aortic pathology is feasible in critically ill patients. Postoperative morbidity and mortality is predominantly related to the compromised preoperative clinical status, illustrating its use as salvage strategy.

Endovascular recanalization of chronic long-segment occlusions of the inferior vena cava: midterm results.

PURPOSE: To report the midterm results of endovascular recanalization of chronic long-segment (> 5 cm) occlusions of the inferior vena cava (IVC) with stent placement. METHODS: Nine patients (5 men; median age 30 years, range 14-58) with disabling complaints for more than 6 months caused by IVC occlusions were treated by endovascular recanalization. Mean occlusion length was 11 cm (range 6-22); some occlusions extended to the iliac (n = 3) or common femoral (n = 2) veins. All procedures were performed under local anesthesia via a bilateral femoral (n = 7) or popliteal (n = 2) approach. In 3 patients, combined access to the brachial or internal jugular vein was necessary. Patients with acute-on-chronic thrombosis were pretreated with urokinase. After guidewire recanalization, the chronic occlusions were predilated and self-expanding Wallstents were implanted. RESULTS: The initial technical and clinical success was 100%. The venous clinical severity score (pain, venous edema, inflammation, and active ulceration) decreased from a mean 8 +/- 2 to 5 +/- 1 after the procedure. Over a median follow-up of 9 months (mean 21, range 4- 110), 3 patients died. One rethrombosis occurred, and an asymptomatic restenosis was discovered on routine imaging. The primary patency rate was 78%, and the 9-month occlusion-free survival rate was 56%. CONCLUSION: Endovascular recanalization of chronic long-segment occlusions of the IVC is a safe and worthwhile technique to offer patients with debilitating symptoms.

Clinical outcome and technical considerations of late removal of abdominal aortic endografts: 8-year single-center experience.

During an 8-year period, 355 patients underwent endovascular repair of mainly true (97%) infrarenal aneurysms. After a mean follow-up of 48 months, 11 (3.1%) patients required conversion to open repair and 10 were eligible for open surgical intervention. Via a midline incision, explantation of the endograft was performed by using an infrarenal aortotomy. Explantation was done for rupture in four patients (40%), with a marked difference in mortality rates between acute (50%) and elective (0%) explantations. The main reason for explantation was proximal type I endoleak caused by (1) malposition of the device, (2) proximal migration of the endograft, and (3) dislodgment of a tube endograft that followed former central reconstruction. Proximal migration is most worrisome and demands preventive endovascular reintervention. The mortality and morbidity rates of elective explantation are acceptable. When delayed conversion is indicated, priority has to be given to operate on these patients.

Prediction of early cerebral outcome by transcranial Doppler monitoring in carotid bifurcation angioplasty and stenting.

OBJECTIVE: The outcomes of carotid angioplasty and stenting (CAS) are, in addition to patient baseline characteristics, highly dependent on the safety of the endovascular procedure. During the successive stages of CAS, transcranial Doppler (TCD) monitoring of the middle cerebral artery was used to assess the association of cerebral embolism and hemodynamic changes with transient (amaurosis fugax and transient ischemic attack) and persistent (minor and major stroke) cerebral deficits, and death. METHODS: By use of a prospectively completed database of 550 patients, the association of various TCD emboli and velocity variables with periprocedural cerebral outcome 5) at postdilation after stent deployment (odds ratio [OR] 2.6, 95% confidence interval [CI], 1.3 to 5.1), particulate macroembolus (OR, 27.0; 95% CI, 4.5 to 157), and massive air embolism (OR, 51.4; 95% CI, 5.4 to 492), as well as angioplasty-induced asystole and prolonged hypotension with a >70% reduction of middle cerebral artery blood flow velocities (OR, 6.4; 95% CI, 2.3 to 17.8) were independently associated with cerebral deficits. The ROC area of this model was 0.72. Of the patient characteristics, only preprocedural cerebral ischemia (OR, 5.0; 95% CI, 2.4 to 10.4) was associated with outcome. Adding this patient characteristic to the model, the area under the ROC curve increased to 0.80. CONCLUSIONS: In CAS, in addition to such obviously adverse events as particulate macroembolism and massive air embolism, multiple microemboli (>5 showers) at postdilation after stent deployment and angioplasty-induced asystole and hypotension with a significant reduction of middle cerebral artery blood flow velocities are associated with periprocedural cerebral deficits. In combination with the presence of preprocedural cerebral symptoms, these four TCD monitoring variables reasonably differentiate between patients with and without adverse cerebral outcome. TCD monitoring provides insight into the pathogenesis of CAS related adverse cerebral events.

Durability of percutaneous transluminal angioplasty for obstructive lesions of proximal subclavian artery: long-term results.

PURPOSE: Percutaneous transluminal angioplasty (PTA) is one of the treatment options for localized obstruction of the subclavian artery. To document long-term durability of this kind of PTA we report a 10-year single-center experience in 110 patients. METHODS: From January 1993 to July 2003, 110 patients (72 women; mean age, 62 +/- 10 years) underwent PTA of symptomatic (>75%) stenosis (n = 90) or occlusion of the proximal subclavian artery (84 left-sided). Forty one patients (37%) had symptoms of vertebrobasilar insufficiency, 29 patients (26%) had disabling chronic arm ischemia, and 20 patients had both symptoms. Twenty patients with coronary artery disease underwent PTA in preparation for myocardial revascularization with the internal mammary artery. Duplex scans and arteriograms confirmed significant stenosis or occlusion. All PTA procedures were performed with the patient under local anesthesia, through the femoral artery (n = 89), brachial artery (n = 6), or combined route (n = 15). In 59 patients (58%) an additional stent was placed. RESULTS: Angioplasty was initially technically and clinically successful in 102 patients (93%). Seven occlusions could not be recanalized, and 1 procedure had to be stopped because of ischemic stroke. Of the 102 patients in whom treatment was successful, 1 patient (1%) had a minor stroke in the contralateral hemisphere 2 hours post-PTA. Seven patients (7%) had minor problems, all without permanent sequelae. Follow-up with duplex scanning ranged from 3 months to 10 years (mean, 34 months). Primary clinical patency at 5 years was 89%, with a median recurrent obstruction-free period of 23 months. The local complication rate was 4.5%, and the combined stroke and death rate was 3.6%. Significant recurrent obstruction (>70%) developed in 8 patients with clinical symptoms. Four stenoses were successfully treated with repeat PTA (2 with additional stent placement); 4occlusions required surgery. CONCLUSIONS: PTA of obstructive lesions of the proximal subclavian artery is not only an effective initial treatment, but is also successful over the long-term. Inasmuch as all clinical failures occured within 26 months after initial therapy, we recommend regular follow-up for at least 2 years post-PTA. All clinically significant recurrent stenoses can be treated with repeat endovascular procedures. We could not prove positive or negative influence of additional placement of stents; however, the number of recurrent stenoses might be too small in this retrospective study to draw firm conclusions. Adverse events of any kind are certainly no greater than with invasive surgical procedures. Therefore PTA must be seriously considered in patients with localized obstruction of the proximal subclavian artery.

Endovascular stent-grafting for descending thoracic aortic aneurysms.

OBJECTIVE: Endoluminal placement of covered stent-grafts emerges as a less-invasive alternative to open surgical repair of thoracic aortic aneurysms (TAA). The present report describes our experience with endovascular stent-grafting in the treatment of descending TAA. METHODS: From 1997 to 2001, 28 descending TAA's were treated in 27 patients (17 male, mean age 70 years) by endovascular stent-grafting. The aneurysms (mean diameter, 6.6 cm) had diverse causes, but the majority were due to atherosclerosis (71%). They were predominantly localized in the proximal (32%), central (39%), and distal part (22%) of the descending thoracic aorta. In two patients (7%), the entire thoracic aorta was treated. Preliminary subclavian-carotid artery transposition was performed in five patients. AneurX (n=6), Talent (n=9), and Excluder (n=13) stent-grafts were used. In 13 cases (46%), multiple stents were necessary for complete aneurysm exclusion. RESULTS: In 27 of 28 cases (96%), the endovascular stent-grafts were successfully deployed. In one patient, stent dislocation into the aneurysm required open surgical repair in a subsequent procedure. There was no operative mortality. None of the patients developed paraplegia or paraparesis. No distal embolization occurred. After a median follow-up of 21 months (range, 1-49 months), there was one non-related late death. There was no aneurysm rupture. Maximal aneurysm diameter either remained stable or decreased slightly over time in all but one patient with evidence of an endoleak. Endoleaks occurred in eight patients (29%) during follow-up. In five of them the endoleaks sealed spontaneously, whereas in two patients a distal extension was inserted. CONCLUSIONS: Endovascular repair of descending TAA's is a promising less-invasive alternative to open repair. Extended follow-up is necessary to determine its definite efficacy in the longer term.