Victoria Teodorescu

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.

Limitation of the resting ankle-brachial index in symptomatic patients with peripheral arterial disease

Peripheral arterial disease (PAD) has been demonstrated to be prevalent in the primary care setting. However, it has also been shown to be unrecognized and under-treated. Owing to the association with cardiovascular disease it has been recommended to screen high-risk patients for PAD in the primary care setting using the ankle-brachial index (ABI). ABI has been demonstrated to be highly sensitive and specific in diagnosing PAD in patients with significant stenosis. However, the utility in patients with less severe stenosis and calcified vessels is in question. The aims of this study were to determine the diagnostic utility of measuring the ABI at rest in patients referred to the vascular laboratory for evaluation of suspected PAD, and to assess the added value of pulse volume recordings and post-exercise studies in patients with a normal ABI. A computerized vascular diagnostic laboratory database was queried for symptomatic outpatients referred for measurement of segmental blood pressure, the ABI or pulse volume recordings by physicians not specialized in the evaluation and management of patients with peripheral vascular disease. Of 707 patients undergoing outpatient physiologic arterial evaluations between February 1, 2003 and July 31, 2004, 396 met these inclusion criteria. Data recorded included resting ABI, ABI following treadmill exercise test and the presence of abnormal pulse volume recordings. The study population (n = 396) consisted of equal numbers of men and women (mean age 69 years, range 19-100 years). Among 396 studies, resting ABI values were normal in 183 (46.2%) and abnormal in 159 (40.2%). Of the 138 patients who underwent exercise testing, 84 had normal ABI readings at rest. In the 84 patients who had a normal ABI at rest and underwent exercise testing, the ABI fell below 0.9 after exercise in 26 (31%). Arterial non-compressibility was detected in 54 (13.6%) patients, whose average age was 67 years. Thirteen (24%) of those with non-compressible vessels had abnormal pulse volume recording (PVR) results, compared to five with normal resting ABI who had abnormal PVR findings (2.7%). In conclusion, this study demonstrated that nearly half of patients referred to the outpatient vascular laboratory because of suspected arterial disease had a normal resting ABI. While it is recommended that the ABI be measured at rest in patients at risk of PAD in primary care practice, these findings suggest that patients with symptoms of PAD should be more completely evaluated in a vascular laboratory. Furthermore, when the ABI is normal at rest in patients with symptoms of intermittent claudication, exercise testing is recommended to enhance the sensitivity for detection of PAD.

A Randomized, Controlled Pilot Study of Autologous CD34+ Cell Therapy for Critical Limb Ischemia

Background—Critical limb ischemia portends a risk of major amputation of 25% to 35% within 1 year of diagnosis. Preclinical studies provide evidence that intramuscular injection of autologous CD34+ cells improves limb perfusion and reduces amputation risk. In this randomized, double-blind, placebo-controlled pilot study, we evaluated the safety and efficacy of intramuscular injections of autologous CD34+ cells in subjects with moderate or high-risk critical limb ischemia, who were poor or noncandidates for surgical or percutaneous revascularization (ACT34-CLI). Methods and Results—Twenty-eight critical limb ischemia subjects were randomized and treated: 7 to 1×105 (low-dose) and 9 to 1×106 (high-dose) autologous CD34+ cells/kg; and 12 to placebo (control). Intramuscular injections were distributed into 8 sites within the ischemic lower extremity. At 6 months postinjection, 67% of control subjects experienced a major or minor amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.137). This trend continued at 12 months, with 75% of control subjects experiencing any amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.058). Amputation incidence was lower in the combined cell-treated groups compared with control group (6 months: P=0.125; 12 months: P=0.054), with the low-dose and high-dose groups individually showing trends toward improved amputation-free survival at 6 months and 12 months. No adverse safety signal was associated with cell administration. Conclusions—This study provides evidence that intramuscular administration of autologous CD34+ cells was safe in this patient population. Favorable trends toward reduced amputation rates in cell-treated versus control subjects were observed. These findings warrant further exploration in later-phase clinical trials. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00616980

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.

The role of surgical revascularization in the management of diabetic foot wounds

Diabetic foot wounds affect an estimated 15% of all patients with diabetes. These wounds are typically multifactorial in origin. Neuropathy of the foot and impaired wound healing are frequently associated with peripheral arterial occlusive disease. These factors combine to contribute to the development of foot ulcers. Successful wound healing and limb salvage require prompt recognition and treatment. Assessment of arterial perfusion is imperative and may be accomplished by a combination of physical examination and noninvasive vascular laboratory studies. When associated with significant ischemia, diabetic foot ulcers require arterial revascularization to achieve wound healing.

Aortic Arch and Descending Thoracic Aortic Aneurysms: Experience with Stent Grafting for Second-Stage “Elephant Trunk” Repair

Reconstruction of aortic arch and descending thoracic aortic aneurysms (TAAs) is technically challenging and associated with significant morbidity and mortality. We report our experience with extensive TAAs using a two-stage “elephant trunk” repair, with the second stage completed using an endovascular stent graft (ESG). Over 6 years, 111 patients underwent ESG treatment of TAAs at Mount Sinai Medical Center. Twelve of these patients were referred for ESG placement for the second stage of elephant trunk reconstruction because comorbidities placed them at high risk of open surgical repair. Our database was analyzed for technical and clinical success and perioperative complications. The mean follow-up was 11.8 months (range 1–64 months). Twelve patients (five women and seven men) with a mean age of 69 ± 10 years underwent repair of their distal aortic arch and descending TAAs. These aneurysms included nine atherosclerotic aneurysms, one pseudoaneurysm, and two penetrating atherosclerotic ulcers. Three patients were symptomatic. Stent graft repair was technically successful in 91.7% or 11 of 12 patients. Excessive aortic arch tortuosity resulted in failure to deploy a stent graft in one patient. An antegrade approach through the open elephant trunk was used in two patients with severe iliac occlusive disease. Endoleaks (type 2) were identified in two patients with no aneurysm expansion; however, a 14 mm expansion over 1 year occurred in a patient with no identifiable endoleak. One early mortality occurred in a patient with a ruptured 6 cm infrarenal AAA after successful exclusion of the 8 cm TAA. Second-stage elephant trunk reconstruction of an extensive TAA using an ESG is effective in the short term. Its long-term durability remains to be determined.

Experience with endovascular abdominal aortic aneurysm repair in nonagenarians.

Purpose: To report a single-institution experience with endovascular abdominal aortic aneurysm (AAA) repair (EVAR) in nonagenarians. Methods: A retrospective review was performed of all patients >90 years old undergoing EVAR over an 8-year period at a major academic medical center. The patient population was investigated for the presence of various comorbidities, initial aneurysm size, successful aneurysm exclusion, perioperative complications, disposition, endoleaks, secondary interventions, and overall survival. Results: EVAR was performed in 18 male nonagenarians (mean age 92.4 years, range 90–95). Mean aneurysm diameter was 7.3 cm (range 5.5–9.8). The cohort had an average of 3.2 comorbid conditions. Sixteen patients were treated electively, while 2 patients underwent emergent repair for contained rupture and bleeding aortoenteric fistula, respectively. Immediate technical success was 100%. Perioperative local/vascular complications occurred in 4 (22%) patients. Perioperative systemic complications occurred in 3 (17%) patients. There were 2 (11%) perioperative (<30 days) deaths. Three (17%) patients required secondary interventions. Mean survival in patients who expired during the follow-up period beyond the first 30 days was 34 months (range 8–78). Mean survival in 8 patients who are still alive is 17.4 months (range 9–39). Conclusion: Endovascular AAA repair in nonagenarians is associated with a high rate of technical success and relatively low morbidity rate. Survival times following successful hospital discharge are significant. Suitable patients over 90 years of age may benefit from an endovascular AAA repair.

Endovascular treatment of visceral artery aneurysms.

Visceral artery aneurysms, although uncommon, can present with life-threatening hemorrhage. The increasing use of imaging studies has allowed for earlier identification and intervention of these aneurysms, thus avoiding the high morbidity and mortality associated with rupture. The treatment options for visceral artery aneurysms range from conventional open surgical repair to minimally invasive techniques using covered stents or embolization materials. Anatomic features and patient selection determine which treatment option would result in the most durable treatment and outcome. This article reviews our experience with the endovascular treatment of visceral artery aneurysms.

Peripheral arterial disease in women

Peripheral arterial disease (PAD) affects a significant portion of the United States population, and much research has been conducted on identifying populations at risk for PAD, evaluating appropriate diagnostic modalities for PAD, studying the effect of risk factor reduction on PAD progression, and determining the best method of treatment for symptomatic PAD. However, most PAD research and clinical trials have focused on whole populations, or populations consisting mostly of men. Little data exist with respect to PAD in women. The goal of this review is to highlight what is known about gender-related differences for PAD.