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1.
Arch Surg ; 139(3): 308-14, 2004 Mar.
Article in English | MEDLINE | ID: mdl-15006890

ABSTRACT

HYPOTHESIS: During the past decade, endovascular stent graft repair (EVSG) of abdominal aortic aneurysms has emerged as a less invasive and less morbid alternative to open surgical repair. We hypothesize that EVSG may become the treatment method of choice among patients older than 80 years. DESIGN: Retrospective case series. SETTING: Major academic medical center with extensive experience in endovascular and open aortic aneurysm surgery. PATIENTS AND METHODS: During a 5-year period, EVSG was performed in 595 patients at our institution. One hundred fifty (25.2%) of these patients were older than 80 years. Our prospectively acquired database was reviewed with respect to the demographic, intraoperative, and outcome data of this elderly population. MAIN OUTCOME MEASURES: Technical and clinical success, aneurysm-related events (aneurysm-related death, type I or type III endoleaks, aneurysm expansion, or aneurysm rupture), and secondary interventions. RESULTS: There were 119 men (79.3%) and 31 women (20.7%) (mean age, 84.6 years). Mean aneurysm diameter was 6.7 cm. Comorbidities including chronic obstructive pulmonary disease, coronary artery disease, chronic renal insufficiency, peripheral vascular disease, hypertension, and hypercholesterolemia were common in these patients, with an average of 2.9 comorbid conditions per patient. Mean follow-up was 16.9 months (range, 1.0-61.4 months). One hundred forty-six patients (97.3%) received only regional anesthesia, and the average intraoperative blood loss was 369 mL. Average hospital and intensive care unit stays were 2.5 days and 0.1 day, respectively. The procedure was performed emergently in 3 patients, and each recovered uneventfully. There were 5 aborted procedures (3.3%) for technical reasons and 4 conversions to open aortic repair (2.6%). In addition to these aborted procedures, there were 2 additional technical failures resulting in a technical success rate of 95.3%. Endoleaks were common and included 9 type I (6.90%), 35 type II (24.10%), and 1 type III (0.69%). The majority either resolved spontaneously (type IIs) or with minimally invasive secondary intervention, which was performed in 13 patients. Perioperative local/vascular and systemic complications occurred in 16 (10.7%) and 8 (5.3%) patients, respectively. There were 5 perioperative deaths (3.3%)(<30 days postoperatively). Forty late deaths (26.7%)(>30 days postoperatively) occurred, which were unrelated to the EVSG procedure. CONCLUSIONS: Endovascular repair of abdominal aortic aneurysms can be performed safely and successfully in the majority of octogenarians with relatively low complication rates. Improved EVSG devices and operator experience may make this procedure the treatment method of choice for patients in this age group who meet specific anatomical criteria.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Stents , Age Factors , Aged , Aged, 80 and over , Female , Humans , Male , Patient Selection , Prosthesis Failure , Statistics, Nonparametric , Survival Analysis , Treatment Outcome
2.
J Vasc Surg ; 38(4): 676-83, 2003 Oct.
Article in English | MEDLINE | ID: mdl-14560212

ABSTRACT

OBJECTIVES: Endovascular stent-graft repair has great potential in treatment of thoracic aortic aneurysms. This study analyzed a single center's 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.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation , Stents , Aged , Aortic Aneurysm, Thoracic/diagnostic imaging , Female , Follow-Up Studies , Humans , Male , Postoperative Complications , Prosthesis Failure , Radiography
3.
Ann Surg ; 238(4): 586-93; discussion 593-5, 2003 Oct.
Article in English | MEDLINE | ID: mdl-14530730

ABSTRACT

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.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation , Stents , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prosthesis Design , Treatment Outcome
4.
Ann Vasc Surg ; 17(1): 43-8, 2003 Jan.
Article in English | MEDLINE | ID: mdl-12545253

ABSTRACT

Failure of endovascular or conventional abdominal aortic aneurysm (AAA) repair may occur as a result of attachment site endoleak (type I) or paraanastomotic aneurysm and pseudoaneurysm formation. This study examined the results of the use of secondary endovascular grafts for the treatment of failed prior infrarenal AAA repair procedures. Forty-seven patients were treated with endovascular grafts. These included 14 patients with type I endoleaks (5 proximal, 8 distal, 1 proximal and distal) and 33 patients with paraanastomotic aneurysms after standard open surgical AAA repair (3 proximal aorta, 5 distal aorta, 21 iliac, 4 proximal and distal). The interval between the primary aortic procedure and the endovascular repair was significantly shorter for failed endovascular procedures (mean, 18.2 months; range, 1-42 months) than for failed conventional procedures (mean, 108.9 months; range, 12-216 months) (p <0.01). The endovascular devices used for correction of the failed AAA repairs were Talent (23), physician-made (19), AneuRx (2), Vanguard (2), and Excluder (1). Transrenal fixation was used for repair of all proximal anastomotic failures. Mean follow-up after reintervention was 12.2 months in patients with failed endovascular grafts and 10.6 months in patients with failed conventional grafts. Patient demographics were as follows: average age, 78 years; 36 male and 11 female; and 4.1 comorbid medical conditions per patient. The endovascular graft was successfully deployed in all 47 cases; 1 patient experienced a persistent proximal attachment site endoleak after endograft deployment. Endovascular grafts may be used to treat previously failed endovascular and conventional AAA repair procedures with good short- and intermediate-term results. Endovascular treatments in these cases may avoid the difficulties of aortic reoperation or AAA repair in the setting of prior endovascular aortic grafting.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Aged , Aortic Aneurysm, Abdominal/epidemiology , Blood Vessel Prosthesis , Comorbidity , Female , Humans , Male , Prosthesis Design , Reoperation , Treatment Failure
5.
J Vasc Surg ; 35(6): 1123-8, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12042722

ABSTRACT

OBJECTIVE: The Talent endovascular graft has been used in the treatment of abdominal aortic aneurysms (AAAs) in more than 13,000 patients worldwide. However, information regarding the results of its use has been limited. This report describes the experience with 368 patients with AAAs who underwent treatment at four medical centers as part of an investigator-sponsored investigational device exemption trial. METHODS: Patients with AAAs were enrolled at four sites during a 32-month period from January 1999 to July 2001. All patients underwent treatment for infrarenal AAA with the Talent endovascular graft. Repair was performed with transrenal stent fixation under epidural (362/368 patients; 98.3%), local (4/368 patients; 1.1%), or general (2/368 patients; 0.5%) anesthesia. The average diameters were: maximum aortic aneurysm, 6.2 +/- 1.2 cm; proximal aortic fixation site, 2.6 +/- 0.4 cm; and distal iliac fixation site, 1.4 +/- 0.6 cm. Bifurcated grafts were used in 276 of 366 patients (75%), aortouniiliac in 57 of 366 patients (16%), and tube aortoaortic in 33 of 366 patients (9%). Multiple comorbid medical conditions were present in all patients (average, 4.7 conditions/patient). The mean age was 75.8 years, and 85% of the patients were male. Follow-up period ranged from 2 to 33 months (mean, 7.3 months). RESULTS: Endovascular graft deployment was accomplished in 366 of 368 patients. In the 263 patients followed for at least 6 months after endovascular repair, AAA diameter decreased by 5 mm or more in 83 patients (32%); diameter remained unchanged (change < 5 mm) in 157 patients (60%) and increased by 5 mm or more in 23 patients (8.7%). Major morbidity occurred in 46 of 368 patients (12.5%), and minor morbidity occurred in 31 of 368 (8.4%). The 30-day mortality rate was 1.9%. Secondary procedures were performed in 32 patients (8.7%). Late rupture occurred in two patients, and late deaths unrelated to AAA occurred in 32 patients (8.7%) during the follow-up period. The primary technical success rate for all patients was 93.4%. The 30-day primary procedural success rate was 73.3%. The 30-day secondary procedural success rate was significantly higher at 85.8%. Computed tomographic scan was performed within 1 month after surgery in 349 patients. An endoleak was present in 43 of 349 patients (12.3%). These endoleaks were comprised of 10 attachment site (type I; 2.9%), 31 retrograde side-branch (type II; 8.9%), and two transgraft (type III; 0.6%). CONCLUSION: These midterm findings show a high degree of technical and procedural success achieved in a patient population with extensive comorbid medical illnesses with low perioperative morbidity and mortality rates. Further follow-up study will be necessary to determine the effectiveness of the Talent endograft for the long-term treatment of AAA.


Subject(s)
Aortic Aneurysm, Abdominal/therapy , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Aged , Aortic Aneurysm, Abdominal/mortality , Comorbidity , Equipment Design , Female , Follow-Up Studies , Humans , Male , Stents , Time Factors
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