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Biomedical subjects

T J Fogarty

Publications and source records attributed to T J Fogarty.

At least 37 records · Page 2Linked to original sources
PubMed2000

Endoleak as a predictor of outcome after endovascular aneurysm repair: AneuRx multicenter clinical trial.

OBJECTIVE: The purpose of this study was to determine whether evidence of blood flow in the aneurysm sac (endoleak) is a meaningful predictor of clinical outcome after successful endovascular aneurysm repair. METHODS: We reviewed all patients in Phase II of the AneuRx Multicenter Clinical Trial with successful stent graft implantation and predischarge contrast computed tomographic (CT) imaging. The clinical outcome of patients with evidence of endoleak was compared with the outcome of patients without evidence of endoleak. The CT endoleak status before hospital discharge at 6, 12, and 24 months was determined by each clinical center as well as by an independent core laboratory. Endoleak status at 1 month was assessed with duplex scanning examination or CT at each center without confirmation by the core laboratory. RESULTS: Centers reported endoleaks in 152 (38%) of 398 patients on predischarge CT, whereas the core laboratory reported endoleaks in 50% of these patients (P <.001). The center-reported endoleak rate decreased to 13% at 1 month. Follow-up extended to 2 years (mean, 10 +/- 4 months). One patient had aneurysm rupture and underwent successful open repair at 14 months. This patient had a Type I endoleak at discharge but no endoleak at 1 month or at subsequent follow-up times. There were no differences between patients with and patients without endoleak at discharge in the following outcome measures: patient survival, aneurysm rupture, surgical conversion, the need for an additional procedure for endoleak or graft patency, aneurysm enlargement more than 5 mm, the appearance of a new endoleak, or stent graft migration. Despite a higher endoleak rate identified by the core laboratory, neither the endoleak rate reported by the core laboratory nor the endoleak rate reported by the center at discharge was significantly related to subsequent outcome measures. Patients with endoleak at 1 month were more likely to undergo an additional procedure for endoleak than patients without endoleaks. Patients with Type I endoleaks at discharge and patients with endoleak at 1 month were more likely to experience aneurysm enlargement at 1 year. However, there was no difference in patient survival, aneurysm rupture rate, or primary or secondary success rate between patients with or without endoleak. Actuarial survival of all patients undergoing endovascular aneurysm repair was 96% at 1 year and was independent of endoleak status. Primary outcome success was 92% at 12 months and 88% at 18 months. Secondary outcome success was 96% at 12 months and 94% at 18 months. CONCLUSIONS: The presence or absence of endoleak on CT scan before hospital discharge does not appear to predict patient survival or aneurysm rupture rate after endovascular aneurysm repair using the AneuRx stent graft. Although the identification of blood flow in the aneurysm sac after endovascular repair is a meaningful finding and may at times indicate inadequate stent graft fixation, the usefulness of endoleak as a primary indicator of procedural success or failure is unclear. Therefore, all patients who have undergone endovascular aneurysm repair should be carefully followed up regardless of endoleak status.

Aortic Aneurysm, Abdominal↗
PubMed2000

Duplex ultrasound scanning versus computed tomographic angiography for postoperative evaluation of endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The purpose of this study was to compare duplex ultrasound scanning and computed tomographic (CT) angiography for postoperative imaging and surveillance after endovascular repair of abdominal aortic aneurysm (AAA). METHODS: One hundred consecutive patients with AAA underwent endovascular (Medtronic AneuRx, stent graft) aneurysm repair and were imaged with both CT angiography and duplex ultrasound scanning at regular intervals after the procedure. Each imaging modality was evaluated for technical adequacy and for documentation of aneurysm size, endoleak, and graft patency. In concurrent scan pairs, accuracy of duplex scanning was compared with CT. RESULTS: A total of 268 CT scans and 214 duplex scans were obtained at intervals of 1 to 30 months after endovascular aneurysm repair (mean follow-up interval, 9+/-7 months). All CT scans were technically adequate, and 198 (93%) of 214 duplex scans were technically adequate for the determination of aneurysm size, presence of endoleak, and graft patency. Concurrent (within 7 days of each other) scan pairs were obtained in 166 instances in 76 patients (1-6 per patient). The maximal transverse aneurysm sac diameter measured with both methods correlated closely (r = 0.93; P <.001) without a significant difference on paired analysis. In 92% of scans, measurements were within 5 mm of each other. Diagnosis of endoleak on both examinations correlated closely (P <.001), and compared with CT, duplex scanning had a sensitivity of 81%, a specificity of 95%, a positive predictive value of 94%, and a negative predictive value of 90%. Discordant results occurred in 8% of examinations, and in none of these was the endoleak close to the attachment sites or associated with aneurysm expansion. An endoleak was demonstrated on both tests in all eight patients who had an endoleak judged severe enough to warrant arteriography. Graft patency was documented in each instance, without discrepancy, with both modalities. CONCLUSIONS: High-quality duplex ultrasound scanning is comparable to CT angiography for the assessment of aneurysm size, endoleak, and graft patency after endovascular exclusion of AAA.

Aortic Aneurysm, Abdominal↗
PubMed2000

Will endovascular repair replace open surgery for abdominal aortic aneurysm repair?

OBJECTIVE: To evaluate of the impact of endovascular aneurysm repair on the rate of open surgical repair and on the overall treatment of abdominal aortic aneurysms (AAAs). METHODS: All patients with AAA who were treated during two consecutive 40-month periods were reviewed. During the first period, only open surgical repair was performed; during the subsequent 40 months, endovascular repair and open surgical repair were treatment options. RESULTS: A total of 727 patients with AAA were treated during the entire period. During the initial 40 months, 268 patients were treated with open surgical repair, including 216 infrarenal (81%), 43 complex (16%), and 9 ruptured (3%) aortic aneurysms. During the subsequent 40 months, 459 patients with AAA were treated (71% increase). There was no significant change in the number of patients undergoing open surgical repair and no significant difference in the rate of infrarenal (238 [77%]) and complex (51 [16%]) repairs. A total of 353 patients were referred for endovascular repair. Of these, 190 (54%) were considered candidates for endovascular repair based on computed tomography or arteriographic morphologic criteria. Analyzing a subgroup of 123 patients, the most common primary reasons for ineligibility for endovascular repair were related to morphology of the neck in 80 patients (65%) and of the iliac arteries in 35 patients (28%). A total of 149 patients underwent endovascular repair. Of these, the procedure was successful in 147 (99%), and 2 (1%) patients underwent surgical conversion. The hospital death rate was 0%, and the 30-day death rate was 1%. During a follow-up period of 1 to 39 months (mean 12 +/- 9), 21 secondary procedures to treat endoleak (20) or to maintain graft limb patency (1) were performed in 17 patients (11%). There were no aneurysm ruptures or aneurysm-related deaths. CONCLUSIONS: Endovascular repair appears to have augmented treatment options rather than replaced open surgical repair for patients with AAA. Patients who previously were not candidates for repair because of medical comorbidity may now be safely treated with endovascular repair.

Aged↗
PubMed2000

Does complete aneurysm exclusion ensure long-term success after endovascular repair?

PURPOSE: To examine whether complete aneurysm exclusion is a reliable marker for successful long-term endovascular abdominal aortic aneurysm (AAA) repair. METHODS: The medical records, computed tomographic (CT) scans, and duplex examinations of all the patients who underwent endovascular AAA repair at a single institution and had at least 12 months of follow-up were reviewed. Sixty-seven patients (58 men; mean age 74 years, range 57-87) were identified. Complete aneurysm exclusion was defined by the absence of an endoleak at any time before an adverse event. The primary endpoint included all major adverse events that occurred during the postoperative period, including aneurysm expansion, acute symptoms referable to the AAA, late secondary procedures, ruptures, and deaths from ruptures and all other causes. RESULTS: There were 44 adverse events (8 expanding aneurysms, 4 acute symptoms, 17 secondary procedures, and 15 deaths from other causes) in 28 (42%) patients. Among 36 (54%) patients who had initial complete aneurysm exclusion (no endoleak), 12 (33%) experienced adverse events, compared with 16 (52%) events in 31 patients who had endoleak (chi2 = 1.59, p = 0.21). CONCLUSIONS: There was no statistically significant difference in adverse events based on the presence or absence of endoleak. Complete aneurysm exclusion as defined by absence of an endoleak does not indicate an event-free postoperative course. A better marker of clinical success of endovascular AAA repair is needed.

Aged↗
PubMed1999

AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial.

The results of a prospective, nonrandomized, multicenter clinical trial that compared endovascular stent graft exclusion of abdominal aortic aneurysms with open surgical repair are presented. During an 18-month period, 250 patients with infrarenal aneurysms underwent treatment at 12 study sites-190 patients underwent endovascular repair using the Medtronic AneuRx stent graft (Sunnyvale, Calif), and 60 underwent open surgical repair. There was no significant difference in operative mortality rates between the groups. The patients who underwent stent grafting had significant reductions in blood loss, time to extubation, and days in the intensive care unit and in the hospital, with an earlier return to function. The major morbidity rate was reduced from 23% in the surgery group to 12% (P <. 05) in the stent graft group. There was no difference in the combined morbidity/mortality rates between the two groups. Primary technical success at the time of discharge for the patients with stent grafts was 77%, largely as a result of a 21% endoleak rate. At 1 month, the endoleak rate had decreased to 9%. There was no difference in the primary or secondary procedure success rates at 30 days between the surgery and stent graft groups. The primary graft patency rate at 6 months was 98% in the surgery group and 97% in the stent graft group. The aneurysm exclusion rate at 1 month and 6 months was 100% in patients who underwent surgery and 91% in patients who underwent stent grafting. Stent graft migration occurred in three patients and resulted in late endoleaks; each endoleak was corrected by means of endovascular placement of a stent graft extender cuff. There have been no aneurysm ruptures and no surgical conversions to open repair in the stent graft group. Stent graft repair compares favorably with open surgical repair, with a reduced morbidity rate, shortened hospital stays, and satisfactory short term outcomes.

Aged↗
PubMed1999

The use of the Fogarty catheter in 1998.

Catheter-mediated thromboembolectomy has evolved over the last three decades along with changes in vascular disease patterns. As in situ arterial thrombosis has become more common both in natural arteries and prosthetic grafts, changes in mechanical thromboembolectomy have been necessary to optimize treatment strategies. A variety of devices and techniques are now available for transluminal clot removal including the original thromboembolectomy catheter, newer adherent clot catheters, graft thrombectomy catheters, thru-lumen balloon catheters and methods that involve fragmentation and removal of fresh thrombus by hydrodynamic means.

Catheterization↗
PubMed1999

Prevention of spinal cord ischemia in an ovine model of abdominal aortic aneurysm treated with a self-expanding stent-graft.

PURPOSE: To present novel techniques to prevent spinal ischemia during aneurysm creation and chronic bifurcated stent-graft implantation in an ovine model of abdominal aortic aneurysm (AAA). METHOD: Experimental AAAs were created in 38 sheep. To prevent spinal ischemia, an internal aortic shunt was used during aneurysm creation. In the animals designated to receive bifurcated stent-grafts, a left external iliac-to-internal iliac bypass was performed to revascularize the caudal artery and prevent postdeployment spinal cord ischemia. Specimens were harvested at 1 week, 1, 3, and 6 months, and 1 year. RESULTS: Aneurysms were successfully created without paralysis in 35 animals. Two died due to aspiration pneumonia. Of the 33 animals implanted with endografts, 16 (94%) of 17 with straight devices and 15 (94%) of 16 with bifurcated stent-grafts survived with well-functioning, patent stent-grafts. Paralysis developed in 2 animals after endografting due to technical failures. CONCLUSIONS: The use of an internal shunt during aneurysm creation and internal iliac-to-external iliac transposition prior to bifurcated stent-graft deployment prevented spinal ischemia in an ovine AAA model. Chronically deployed stent-grafts were well tolerated.

Anastomosis, Surgical↗
PubMed1998

Balloon angioplasty, stenting, and role of atherectomy.

Endovascular interventions for the treatment of lower-extremity atherosclerotic disease have undergone a rapid course of development during the past 30 years. Balloon angioplasty is the most widely applied of these techniques and has been shown to yield excellent results, at least in the short and intermediate terms, in appropriately selected patients. The ideal candidate is one with a focal stenotic lesion of the iliac artery; this is also the type of patient in whom placement of an endoluminal stent, whether primarily or as an adjunct to balloon angioplasty, has been shown to be most effective. The initial enthusiasm for transluminal atherectomy of lower-extremity atherosclerotic lesions has met with some disappointing long-term results. It is now used mainly in conjunction with either or both of the above modalities in a select group of patients. Clearly, more controlled studies of all these techniques are needed to better define their exact indications and limitations in treatment of lower-extremity arterial disease.

Angioplasty, Balloon↗
PubMed1997

Modular bifurcation endoprosthesis for treatment of abdominal aortic aneurysms.

OBJECTIVE: The authors analyzed a single group's experience treating abdominal aortic aneurysms (AAAs) with a new self-expanding, modular, bifurcated device. SUMMARY BACKGROUND DATA: Successful exclusion of AAAs by prototype devices has led to several controlled clinical trials evaluating prostheses designed and manufactured specifically for this application. METHODS: Sixteen patients (15 males, 1 female) of American Society of Anesthesiologists grade 2 through 4 and average age of 72 years had AAAs (average 57-mm diameter) treated as part of a phase I Food and Drug Administration-approved trial. RESULTS: All patients were treated successfully with no surgical conversions. No endoleaks or aneurysm enlargement was noted either predischarge by contrast computed tomography or on follow-up at 1 month by duplex ultrasound examination. At 6 months, 12 of 13 patients who were observed for this interval had no endoleaks, whereas one patient (patient 3) showed a small area of extravasation that appeared to arise from the device in an area that was traumatized at the time of deployment. One procedure-related mortality (6%) occurred in a patient who died of septic complications secondary to a gangrenous gallbladder diagnosed 1 day after the procedure. There were no device-related mortalities. Complications included two iliac artery dissections, two groin wound infections, and two transient elevations of serum creatinine. Other significant variables including median procedure length (5 hours), intensive care unit stay (1 day), hospitalization postprocedure (4.5 days), and blood loss (1100 mL) all decreased as the study progressed. Blood replacement in all but three patients was accomplished by autotransfusion or banked-autologous blood replacement. At 6-month follow-up in 13 patients, the maximum diameter of the aneurysm decreased by an average of 5.6 mm (range, 0-15 mm), and the maximal cross-sectional area decreased an average of 20.3% (range, 0-72%). CONCLUSIONS: This study suggests that endovascular prosthesis exclusion of AAAs using a self-expanding modular device may be effective in many patients who are otherwise surgical candidates for repair if further clinical studies confirm these observations.

Aged↗
PubMed1997

What are the characteristics of the ideal endovascular graft for abdominal aortic aneurysm exclusion?

PURPOSE: To review the anatomic factors crucial to successful endoluminal abdominal aortic aneurysm (AAA) repair and propose an ideal endograft design for AAA exclusion. METHODS AND RESULTS: The anatomic features of critical importance to endovascular AAA exclusion comprise remote arterial access, proximal and distal fixation sites, AAA morphology, and arterial wall pathology. When designing an aortic endograft, the major components to consider are stent selection, graft material, and the delivery system. The ideal endograft design must be sufficiently versatile to treat a broad range of patients. To meet this requirement, the endograft should display a high degree of dimensional adaptability. A modular bifurcated endograft design permits intraoperative customization to tailor the device to each patient's anatomy and pathology. CONCLUSIONS: The modular stent-graft concept addresses many of the important factors in the evolution toward an ideal aortic endograft. Extensive testing will be needed to determine if the bifurcated stent-graft described here is the optimal design for effective AAA exclusion.

Aortic Aneurysm, Abdominal↗
PubMed1996

Endovascular stent-graft repair of thoracic aortic aneurysms.

Conventional repair of aneurysms of the descending thoracic aorta entails thoracotomy and graft interposition. For elderly patients and those with previous operations, obesity, respiratory insufficiency, or other comorbidities, such a procedure entails significant mortality and morbidity. Transluminal stent-graft placement offers an alternative approach with potentially less morbidity and quicker recovery; however, the effectiveness and durability of stent-grafts remain uncertain. METHODS: Since July 1992, thoracic aortic stent-grafts have been placed in 44 patients with a variety of pathologic conditions. Each graft was individually constructed from self- expanding, stainless-steel Z stents covered with a woven Dacron polyester fabric graft. Craft dimensions were determined from spiral computed tomographic scans. All implants were performed in the operating theater under fluoroscopic and transesophageal echocardiographic guidance. Follow-up was by computed tomography and contrast angiography in all cases. PATIENT DATA: There were 36 men and 8 women. Mean age was 66 years (range 35 to 88 years). Mean aneurysmal diameter was 6.3 cm (range 4.0 to 9.4 cm). Etiologies included 23 degenerative aneurysms, four posttraumatic aneurysms, four pseudoaneurysms, and one chronic aortic dissection. RESULTS: There were three early deaths (<30 days) and two late deaths. One early death resulted from graft failure. There were two instances of paraparesis or paraplegia, with one associated early death. A single stent was deployed in 27 patients, two stents were required in 14 patients, and three stents were required in three patients. In 23 patients, vascular access was attained through the femoral artery; abdominal aortic access, either native or graft, was necessary in the remaining 21 patients. Twelve grafts were placed in conjunction with open abdominal aortic surgical procedures. Mean follow-up (98% complete) was 12.6 months (range 1 to 34 months). One late death occurred from aneurysmal expansion and rupture in a patient with a persistent midgraft leak. The second late death may have resulted from aneurysmal rupture. Immediate thrombosis was achieved in 36 patients, and late thrombosis was achieved in three others. Failure to achieve complete aneurysmal thrombosis occurred in five patients, however, and one individual (previously noted) died of aneurysmal expansion and rupture; the remaining four are being carefully monitored. Only one patient has required conversion of the stent to an open procedure; a contained rupture of the false lumen of a chronic dissection eventually necessitated total descending thoracic aortic exclusion. CONCLUSIONS: These early results support the hypothesis that endovascular stent-graft placement may be a safe and durable treatment for selected patients with aneurysmal disease of the descending thoracic aorta. Large introducer size (26F outer diameter) and relatively limited angulation capability, as well as imprecise deployment techniques, currently limit its applicability. Distal embolization and stent migration have not been observed. Failure to achieve complete aneurysmal thrombosis may allow continued aneurysmal expansion and rupture. Further follow-up is clearly necessary to evaluate the true long-term effectiveness of this procedure.

Adult↗
PubMed1996

Evaluation of a modular endovascular bifurcation prosthesis in a canine aortic aneurysm model.

PURPOSE: The study evaluated the deployment and healing of a novel self-expanding modular bifurcation endovascular prosthesis in a canine abdominal aortic aneurysm model. The endoluminal prosthesis consists of self-expanding nitinol stents lined by a synthetic prosthesis. One component of the device is a bifurcated body with a 12- to 14-mm diameter aortic segment and an integral 7- to 8-mm diameter iliac limb. The bifurcated body also has a stent-reinforced opening (pant-leg) for subsequent insertion of a contralateral 7- to 8-mm diameter iliac limb component. METHODS: Seventeen bifurcated prosthesis were placed; 7 were inserted through the left common carotid artery and 10 from the femoral arteries. With either route of access the 16F or 17F aortoiliac limb and the 13F iliac limb delivery catheters enabled easy passage and secure positioning of the bifurcated prostheses. Predeployment and postdeployment inspection of the dimensions and continuity of the aortoiliac prosthetic components were evaluated by cinefluoroscopy and intravascular ultrasonography (IVUS). RESULTS: After deployment was done, interval patency was assessed with angiography, IVUS, and contrast-enhanced computed tomography with the prostheses removed for analysis at 1 week (n = 4), 1 month (n = 3), 3 months (n = 4), and 6 months (n = 6). Five of the first seven implanted prostheses had occlusion of segments of the device. In two dogs the bifurcated body and both legs were occluded. In the other three the nonoccluded leg and bifurcation body were fully patent. In the first seven animals IVUS at implantation showed compression of an iliac leg by the orifice of the contralateral iliac component. After concentric fixation of the flow divider was performed, only one additional iliac limb occlusion occurred in the next 10 animals. Cinefluoroscopy, computed tomography, IVUS imaging, and histologic analysis of retrieved specimens demonstrated healing of the aortoiliac prostheses without evidence of perigraft leaks. CONCLUSIONS: This feasibility study demonstrates the ability to deploy and maintain acceptable patency of a self-expanding endoluminal, modular bifurcation prosthesis in a canine aortic model. Clinical evaluation of the device is planned for the near future.

Alloys↗