Sharif H. Ellozy

Challenges of endovascular tube graft repair of thoracic aortic aneurysm: midterm follow-up and lessons learned.

OBJECTIVES Endovascular stent-graft repair has great potential in treatment of thoracic aortic aneurysms. This study analyzed a single centers experience with first-generation commercially produced thoracic stent grafts used to treat descending thoracic aortic aneurysms. METHODS Over 58 months 84 patients underwent endovascular stent-graft repair of descending thoracic aortic aneurysms; 22 patients received the Gore TAG stent graft, and 62 patients received the Talent thoracic endovascular stent-graft system. Each patient was enrolled in one of three distinct US Food and Drug Administration trials at Mount Sinai Medical Center in accordance with strict inclusion and exclusion criteria, including suitability for open surgery, aneurysm anatomy, and presence of comorbid medical illness. Mean age of this cohort was 71 +/- 12 years. There were 54 men and 30 women, and 74 (88%) had three or more comorbid illnesses. Primary technical success was achieved in 76 patients (90%). Mean follow-up was 15 months (range, 0-52 months). RESULTS Successful aneurysm exclusion was achieved in 69 patients (82%). Major procedure-related or device-related complications occurred in 32 patients (38%). There were six proximal attachment failures (8%), four distal attachment failures (6%), one intergraft failure (1%), two mechanical device failures (3%), five periprocedural deaths (6%), and five late aneurysm ruptures (6%). At 40 months, overall survival was 67% (+/-10%), and freedom from rupture or from type I or type III endoleak was 74% (+/-10%). CONCLUSION While promising, this midterm experience with commercially available devices highlights the shortcomings of current stent-graft technology. Three significant advancements are required to fulfill the potential of this important treatment method: a stent graft with a durable proximal and distal fixation device, enhanced engineering to accommodate high thoracic aortic fatigue forces, and a mechanism to adapt to aortic arch and visceral segment branches to enable treatment of lesions that extend to or include these vessels.

Open Versus Endovascular Stent Graft Repair of Abdominal Aortic Aneurysms: A Meta-Analysis of Randomized Trials

OBJECTIVES This study sought to evaluate the short-, intermediate-, and longer-term outcomes after endovascular versus open repair of abdominal aortic aneurysms (AAA), including both AAA-related and all-cause mortality. BACKGROUND Endovascular stent graft placement for AAA has gained broad acceptance as an alternative to open surgical repair due to a lower perioperative morbidity and mortality. The intermediate- and long-term all-cause and aneurysm-related mortality vary among studies. Thus, we sought to perform a meta-analysis of open versus endovascular repair for treating AAA. METHODS Electronic databases were queried for identification of prospective, randomized trials of open surgery versus endovascular stent graft repair of AAA. A total of 10 published papers reporting on 6 studies at different follow-up intervals were identified; they involved 2,899 patients with AAA repair procedures, of whom, 1,470 underwent endovascular stent graft AAA exclusion and 1,429 were treated by open AAA repair. RESULTS At 30 days, the pooled relative risk of all-cause mortality was lower in the endovascular group (relative risk [RR]: 0.35, 95% confidence interval [CI]: 0.19 to 0.64) than in the open surgery group. At intermediate follow-up, the all-cause mortality had a nonsignificant difference (RR: 0.78, 95% CI: 0.57 to 1.08), the AAA-related mortality was significantly lower (RR: 0.46, 95% CI: 0.28 to 0.74) and reintervention rates were higher (RR: 1.48, 95% CI: 1.06 to 2.08) in the endovascular group than in the open surgery group. At long-term follow-up, there was no significant difference in all-cause mortality (RR: 0.99, 95% CI: 0.85 to 1.15) or AAA-related mortality (RR: 1.58, 95% CI: 0.20 to 12.74), whereas the significant difference in the rate of reinterventions persisted (RR: 2.54, 95% CI: 1.58 to 4.08). CONCLUSIONS In patients randomized to open or endovascular AAA repair, all-cause perioperative mortality, as well as AAA-related mortality at short- and intermediate-term follow-up are lower in patients undergoing endovascular stent graft placement. This was associated with greater reintervention in the endovascular group noted at intermediate follow-up. Long-term survival appears to converge between the 2 groups.

Early postoperative small-bowel obstruction: a prospective evaluation in 242 consecutive abdominal operations.

AbstractPURPOSE: Early postoperative small-bowel obstruction is a common but poorly defined complication of abdominal surgery. This prospective cohort study was undertaken to examine a reproducible definition of early postoperative small-bowel obstruction, determine its incidence, evaluate potential risk factors for its development, and delineate management strategies. METHODS: Two hundred twenty-five patients undergoing 242 consecutive abdominal operations during a 9-month period were prospectively evaluated from the time of admission until Postoperative Day 30. Early postoperative small-bowel obstruction was present if, within 30 days of surgery, all of the following criteria were met after the return of intestinal function: development of crampy abdominal pain, vomiting, and radiographic findings consistent with intestinal obstruction. Patients with early postoperative small-bowel obstruction were followed up until discharge or reexploration. All patients with early postoperative small-bowel obstruction were initially treated with nasogastric decompression. RESULTS: Two hundred forty-two abdominal procedures were performed on 119 males and 123 females aged 13 to 98 (mean, 51) years. Ulcerative colitis (n = 70), malignancy (n = 59), and Crohn’s disease (n = 41) were the most common diagnoses. One hundred nineteen patients (49.2 percent) had undergone previous laparotomy, and 45 patients (18.6 percent) had previously been diagnosed with intestinal obstruction. Early postoperative small-bowel obstruction occurred in 23 cases (9.5 percent). Patients with and without early postoperative small-bowel obstruction were similar with respect to diagnosis, preoperative immunosuppression, previous laparotomy or obstruction, surgery performed, and time to return of intestinal function. Twenty episodes (87 percent) resolved with nasogastric decompression alone; all but one resolved within six days or less. Three patients (13 percent) required relaparotomy; one required small-bowel resection. Two of three patients whose symptoms did not resolve with six days of nasogastric decompression required reexploration. There were no deaths and no major morbidity. CONCLUSIONS: Early postoperative small-bowel obstruction, defined by an objective data set, was observed in 9.5 percent of cases. No independent risk factors predisposing to early postoperative small-bowel obstruction were identified. Early postoperative small-bowel obstruction was safely and effectively managed by nasogastric decompression in the majority of cases, with low morbidity and no mortality. In general, reexploration should be reserved for those patients whose symptoms do not resolve within six days of nasogastric decompression.

Pathophysiology of Paraplegia Following Endovascular Thoracic Aortic Aneurysm Repair

Paraplegia following endovascular treatment of thoracic aortic aneurysms appears, from review of recent literature, to occur at a rate of 0% to 12%.1-6 If one excludes from these data, patients who required open conversion at the time of endovascular repair or endovascular thoracic repair with open abdominal aortic aneurysm repair, then paraplegia occurs less often. Early experience at our institution revealed an overall paraplegia/paraparesis rate of 5.7%, which included combined open abdominal and endovascular thoracic cases and patients who had previous abdominal aortic aneurysm repair. Patients undergoing endovascular repair with no previous or concurrent aortic surgery had 0% paraplegia.2 Dake et al. describe an overall paraplegia rate of 3%. A rate of 11% was seen in those patients who underwent surgical repair of abdominal aortic aneurysm and stent grafting of descending thoracic aortic aneurysm compared with 1% for those who had endovascular repair alone.4 While Greenberg et al. reported an overall paraplegia/paralysis of 12%, this included a case requiring emergent conversion for open repair, as well as a neurologic event four months postoperatively when an extension was placed to treat an endoleak.6 Prior or concomitant infrarenal aortic aneurysm repair as well as the overall length of aneurysm being excluded appear to increase the risk of

Inferior Mesenteric Artery Embolization before Endovascular Aneurysm Repair: Technique and Initial Results

PURPOSE To report a single centers technique and initial results in the preoperative embolization of the inferior mesenteric artery (IMA) before endovascular aneurysm repair (EVAR). MATERIALS AND METHODS Over a 3-year period, 102 patients at a single clinical site, including 86 men and 16 women aged 54-93 years (mean, 75 years), were found to have a patent IMA on computed tomographic (CT) angiography before EVAR. Coil embolization was performed after subselective catheterization with use of microcoils placed in the IMA proximal to the origin of the left colic artery. All patients in whom the IMA was visualized on flush aortography and successfully accessed underwent embolization. One month and 6 months after surgery, results in this cohort were retrospectively compared with those from a similar group of patients who underwent EVAR during the same period. These patients had patent IMAs on preoperative CT angiography but did not undergo embolization as a result of nonvisualization during flush aortography. All patients underwent EVAR with bifurcated modular devices with proximal transrenal fixation. All patients underwent postoperative follow-up with multiphase CT angiography to detect the presence of endoleak. Six-month follow-up data were available for 18 patients who underwent embolization and 54 patients who did not. Change in sac diameter was compared in these patients. RESULTS Embolization was technically successful in 30 of 32 patients (94%) in whom it was attempted. There were no complications. At 1-month follow-up, five of 30 patients in the embolization group were noted to have a type II endoleak (17%). None of the endoleaks in this group were related to the IMA. The group with patent IMAs who did not undergo preoperative embolization had a 42% incidence of type II endoleak (P < .05). At 6 months after surgery, three of 18 patients who had undergone embolization (17%) had a type II endoleak, compared with 26 of 54 in the other group (48%; P < .05). Among the patients in whom 6-month data were available, mean changes in sac diameter were -5.2 mm (range, -24 to 2 mm) in the embolized group and -2.1 mm (range, -19 to 8 mm) in the nonembolized group. CONCLUSION These initial results demonstrate that embolization of the IMA with subselective microcoils before EVAR is a safe and effective procedure to reduce the incidence of type II endoleaks. The data also suggest that preoperative embolization of the IMA is associated with greater shrinkage of aneurysm sac diameter at 6 months.

Endovascular stent graft repair of abdominal and thoracic aortic aneurysms: a ten-year experience with 817 patients.

Objective: On November 23, 1992, the first endovascular stent graft (ESG) repair of an aortic aneurysm was performed in North America. Following the treatment of this patient, we have continued to evaluate ESG over the past 10 years in the treatment of 817 patients. Summary and Background Data: Abdominal (AAA) or thoracic (TAA) aortic aneurysms are a significant health concern traditionally treated by open surgical repair. ESG therapy may offer protection from aneurysm rupture with a reduction in procedure morbidity and mortality. Methods: Over a 10-year period, 817 patients were treated with ESGs for AAA (723) or TAA (94). Patients received 1 of 12 different stent graft devices. Technical and clinical success of ESGs was reviewed, and the incidence of procedure-related complications was analyzed. Results: The mean age was 74.3 years (range, 25–95 years); 678 patients (83%) were men; 86% had 2 or more comorbid medical illnesses, 67% of which included coronary artery disease. Technical success, on an intent-to-treat basis was achieved in 93.8% of patients. Primary clinical success, which included freedom from aneurysm-related death, type I or III endoleak, graft infection or thrombosis, rupture, or conversion to open repair was 65 ± 6% at 8 years. Of great importance, freedom from aneurysm rupture after ESG insertion was 98 ± 1% at 9 years. There was a 2.3% incidence of perioperative mortality. One hundred seventy five patients died of causes not related to their aneurysm during a mean follow-up of 15.4 months. Conclusions: Stent graft therapy for aortic aneurysms is a valuable alternative to open aortic repair, especially in older sicker patients with large aneurysms. Continued device improvements coupled with an enhanced understanding of the important role of aortic pathology in determining therapeutic success will eventually permit ESGs to be a more durable treatment of aortic aneurysms.

Left subclavian artery coverage during thoracic endovascular aortic aneurysm repair does not mandate revascularization

OBJECTIVE This study assessed the risk of left subclavian artery (LSA) coverage and the role of revascularization in a large population of patients undergoing thoracic endovascular aortic aneurysm repair. METHODS A retrospective multicenter review of 1189 patient records from 2000 to 2010 was performed. Major adverse events evaluated included cerebrovascular accident (CVA) and spinal cord ischemia (SCI). Subgroup analysis was performed for noncovered LSA (group A), covered LSA (group B), and covered/revascularized LSA (group C). RESULTS Of 1189 patients, 394 had LSA coverage (33.1%), and 180 of these patients (46%) underwent LSA revascularization. In all patients, emergency operations (9.5% vs 4.3%; P=.001), renal failure (12.7% vs 5.3%; P=.001), hypertension (7% vs 2.3%; P=.01), and number of stents placed (1=3.7%, 2=7.4%, ≥3=10%; P=.005) were predictors of SCI. History of cerebrovascular disease (9.6% vs 3.5%; P=.002), chronic obstructive pulmonary disease (9.5% vs 5.4%; P=.01), coronary artery disease (8.5% vs 5.3%; P=.03), smoking (8.9% vs 4.2%) and female gender (5.3% men vs 8.2% women; P=.05) were predictors of CVA. Subgroup analysis showed no significant difference between groups B and C (SCI, 6.3% vs 6.1%; CVA, 6.7% vs 6.1%). LSA revascularization was not protective for SCI (7.5% vs 4.1%; P=.3) or CVA (6.1% vs 6.4%; P=.9). Women who underwent revascularization had an increased incidence of CVA event compared with all other subgroups (group A: 5.6% men, 8.4% women, P=.16; group B: 6.6% men, 5.3% women, P=.9; group C: 2.8% men, 11.9% women, P=.03). CONCLUSIONS LSA coverage does not appear to result in an increased incidence of SCI or CVA event when a strategy of selective revascularization is adopted. Selective LSA revascularization results in similar outcomes among the three cohorts studied. Revascularization in women carries an increased risk of a CVA event and should be reserved for select cases.

Improved outcomes are associated with multilevel endovascular intervention involving the tibial vessels compared with isolated tibial intervention

OBJECTIVE Endovascular intervention is increasingly accepted as an alternative to surgery for the treatment of tibial vessel disease. Tibial vessel disease can occur in isolation or in conjunction with disease that involves the proximal lower extremity vasculature (multilevel disease). This study evaluated the overall efficacy of endovascular intervention for tibial vessel disease and whether the requirement for single-level compared with multilevel intervention affected outcomes. METHODS This study evaluated a consecutive unselected group of patients who underwent an infrapopliteal intervention from November 2002 to February 2008. The primary end points evaluated were technical success, limb salvage, primary patency, and secondary patency. The secondary end points evaluated were 30-day access site (ie, hematoma, pseudoaneurysm, and wound infection), intervention site (ie, thrombosis), and systemic (ie, acute renal failure, myocardial infarction, and mortality) complications. Patency and limb salvage were evaluated using Kaplan-Meier life-table analyses and compared using Cox regression analysis. P < .05 was considered statistically significant. RESULTS The study comprised 85 patients, 89 limbs, and 114 procedures. Age was 72.4 +/- 13.1 years, 67% were men, and follow-up was 245.8 +/- 290.8 days. The technical success rate for all procedures was 91%. Limb salvage rates for patients with critical limb ischemia at 6, 12 and 18 months were 85% +/- 0%, 81% +/- 0%, and 69% +/- 0%, respectively. For the complete patient cohort, primary patency rates at 6, 12 and 18 months were 68% +/- 6%, 50% +/- 8%, and 37% +/- 9%, respectively, and secondary patency rates were 81% +/- 5%, 71% +/- 7%, and 63% +/- 8%. Multilevel intervention was associated with significantly improved secondary patency compared with single-level intervention (P = .045). CONCLUSIONS Patency and limb salvage rates for endovascular treatment of tibial vessel disease in this study are comparable with prior reports and with historical surgical controls. Patients who undergo multilevel intervention involving the tibial vessels exhibit improved secondary patency compared with those who undergo intervention for lesions isolated to the tibial vessels. This may reflect increased distal disease burden for patients who undergo isolated tibial intervention. The study data suggest that the presence of multilevel disease should not preclude an attempt at percutaneous revascularization. Further study is required before formulating definitive recommendations for the endovascular treatment of tibial vessel disease.

Staged Approach Prevents Spinal Cord Injury in Hybrid Surgical-Endovascular Thoracoabdominal Aortic Aneurysm Repair: An Experimental Model

BACKGROUND In a porcine model, we investigated the impact of sudden stent graft occlusion of thoracic intercostal arteries after open lumbar segmental artery (SA) ligation. METHODS After randomization into two groups, 20 juvenile Yorkshire pigs (27.1±0.6 kg) underwent open lumbar SA sacrifice (T13-L5) followed by endovascular coverage of all thoracic SAs (T4-T12) at 32°C, either in a single operation (group 1) or in two stages separated by seven days (group 2). Collateral network pressure (CNP) was monitored by catheterization of the SA L1, and postoperative hind limb function was assessed using a modified Tarlov score. RESULTS The CNP in group 1 decreased to 34% of baseline, whereas CNP after lumbar SA ligation in group 2 fell to 55% of baseline (74±2.4 to 25±3.6 mm Hg vs 74±4.5 to 41±5.5 mm Hg; p<0.0001). Subsequent thoracic stenting (group 2) led to another significant but milder drop (p=0.002 versus stage 1) from the restored CNP (71±4.2 to 54±4.9 mm Hg). Five of ten pigs in group 1 suffered paraplegia, in contrast to none in group 2 (median Tarlov score 6, vs 9; p=0.0031). Histopathologic analysis showed more severe ischemic damage to the lower thoracic (p=0.05) and lumbar spinal cord (p=0.002) in group 1. CONCLUSIONS These results underline the potential of the staged approach in hybrid procedures. Furthermore they highlight the need for established adjuncts for preventing paraplegia in hybrid and pure stent-graft protocols in which sudden occlusion of multiple SAs occurs.

Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy

OBJECTIVES The pivotal trial of the Talent enhanced Low Profile System (eLPS; Medtronic Vascular, Santa Rosa, Calif) stent graft evaluated short and long-term safety and efficacy of endovascular aneurysm repair (EVAR). These data and a confirmatory group assessing the performance of the CoilTrac delivery system supported the United States premarket approval application for the device. METHODS The pivotal trial was a prospective, nonrandomized study conducted at 13 sites from February 2002 to April 2003. The study group (n = 166) underwent EVAR using the Talent eLPS stent graft. The control group (n = 243) underwent open surgical AAA repair. Data for this group were obtained from the Society for Vascular Surgery Endovascular AAA Surgical Controls project. Outcomes were compared at 30 days and 12 months. Additional 5-year follow-up was obtained for the eLPS group. A single-center cohort of 137 patients was the confirmatory group for the assessment of the clinical performance of the CoilTrac delivery system, with analysis of outcomes <or=30 days from the procedure. RESULTS AAA anatomy with neck length as short as 3 mm and maximum neck diameter of 32 mm were included in the eLPS group. EVAR was superior to open repair for periprocedural outcomes, including mean procedure duration (167.3 vs 196.4 minutes, P < .001), blood transfusion (18.2% vs 56.8%, P < .001), median intensive care unit stay (19.3 vs 74.3 hours, P < .001), and mean hospital stay (3.6 vs 8.2 days, P < .001). Freedom from major adverse events was 89.2% for EVAR at 30 days vs 44.0% (P < .001) and 81.3% vs 42.4% at 1 year (P < .001). Freedom from all-cause mortality and aneurysm-related mortality (ARM) was 93.7% and 98.2% for EVAR vs 92.4% and 96.7% for the controls. Through 5 years for the EVAR group, rates of freedom from all-cause mortality, ARM, aneurysm rupture, and conversion to surgery were 69.8%, 96.5%, 98.2%, and 99.1%, respectively, with one conversion to surgery, 25 secondary reinterventions, and five site-reported instances of stent graft migration. The technical success rate for the CoilTrac confirmatory group was 100%, with no aneurysm rupture or conversion to open repair at 30 days. The 30-day all-cause mortality rate was 1.5% (2 of 137). CONCLUSIONS In a population with challenging anatomic characteristics, EVAR with the Talent eLPS and use of the CoilTrac delivery system compared favorably with open repair through 1 year. Sustained protection from ARM, with minimal reinterventions, was attained through 5 years.