Objective This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, ...Ind) for treatment of juxtarenal abdominal aortic aneurysms (AAAs). Methods Sixty-seven patients with juxtarenal AAAs were prospectively enrolled in 14 centers in the United States from 2005 to 2012. Custom-made fenestrated stent grafts were designed with one to three fenestrations on the basis of analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography imaging at hospital discharge and at 1 month, 6 months, and 12 months and yearly thereafter up to 5 years. Results There were 54 male and 13 female patients with a mean age of 74 ± 8 years enrolled. Mean aneurysm diameter was 60 ± 10 mm. A total of 178 visceral arteries required incorporation with small fenestrations in 118, scallops in 51, and large fenestrations in nine. Of these, all 118 small fenestrations (100%), eight of the scallops (16%), and one of the large fenestrations (11%) were aligned by stents. Technical success was 100%. There was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3.3 ± 2.1 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 37 ± 17 months (range, 3-65 months). Two patients (3%) had migration ≥10 mm with no endoleak, both due to cranial progression of aortic disease. Of a total of 129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) stenoses. Fifteen patients (22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, type II endoleak in three patients, and type I endoleak in one patient. At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ± 5% and 97% ± 2%, freedom from renal function deterioration was 91% ± 5%, and freedom from secondary interventions was 63% ± 9%. Conclusions This prospective study demonstrates that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft is safe and effective. Mortality and morbidity are low in properly selected patients treated in centers with experience in these procedures.
Global experience with an inner branched arch endograft Haulon, Stéphan, MD, PhD; Greenberg, Roy K., MD; Spear, Rafaëlle, MD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
10/2014, Letnik:
148, Številka:
4
Journal Article
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Background Branched endografts are a new option to treat arch aneurysm in high-risk patients. Methods and results We performed a retrospective multicenter analysis of all patients with arch aneurysms ...treated with a new branched endograft designed with 2 inner branches to perfuse the supra aortic trunks. Thirty-eight patients were included. The median age was 71 years (range, 64-74 years). An American Society of Anesthesiologists score of 3 or 4 was reported in 89.5% (95% confidence interval CI, 79.7-99.3) of patients. The 30-day mortality rate was 13.2% (95% CI, 2.2-24.2). Technical success was obtained in 32 patients (84.2% 95% CI, 72.4-95.9). Early secondary procedures were performed in 4 patients (10.5% 95% CI, 0.7-20.3). Early cerebrovascular complications were diagnosed in 6 patients (15.8% 95% CI, 4.0-27.6), including 4 transient ischemic attacks, 1 stroke, and 1 subarachnoid hemorrhage. The median follow-up was 12 months (range, 6-12 months). During follow-up, no aneurysm-related death was detected. Secondary procedures during follow-up were performed in 3 patients (9.1% 95% CI, 0.0-19.1), including 1 conversion to open surgery. We compared the first 10 patients (early experience group) with the subsequent 28 patients. Intraoperative complications and secondary procedures were significantly higher in the early experience group. Although not statistically significant, the early mortality was higher in the early experience group (30% 95% CI, 0.0-60.0) versus the remainder (7.1% 95% CI, 0.0-16.9; P = .066). Being part of the early experience group and ascending aortic diameter ≥38 mm were found to be associated to higher rates of combined early mortality and neurologic complications. Conclusions Our preliminary study confirms the feasibility and safety of the endovascular repair of arch aneurysms in selected patients who may not have other conventional options. Clinical trial registration information: Thoracic IDE NCT00583817 , FDA IDE# 000101.
The Society for Vascular Surgery® pursued development of clinical practice guidelines for the management of traumatic thoracic aortic injuries with thoracic endovascular aortic repair. In formulating ...clinical practice guidelines, the Society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the Grading of Recommendations Assessment, Development and Evaluation methods (GRADE) to develop and present their recommendations. The systematic review included 7768 patients from 139 studies. The mortality rate was significantly lower in patients who underwent endovascular repair, followed by open repair, and nonoperative management (9%, 19%, and 46%, respectively, P < .01). Based on the overall very low quality of evidence, the committee suggests that endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, graft, and systemic infections compared with open repair or nonoperative management (Grade 2, Level C). The committee was also surveyed on a variety of issues that were not specifically addressed by the meta-analysis. On these select matters, the majority opinions of the committee suggest urgent repair following stabilization of other injuries, observation of minimal aortic defects, selective (vs routine) revascularization in cases of left subclavian artery coverage, and that spinal drainage is not routinely required in these cases.
Objective Branched and fenestrated repair has been shown to be effective for treatment of complex aortic aneurysms. However, the long-term durability of branches is not well reported. Methods ...Prospective data collected for all patients enrolled in a physician-sponsored investigational device exemption trial for branched and fenestrated endografts were analyzed. Retrospective review of imaging studies and electronic records was used to supplement the dataset. Incidences of branch stent secondary intervention, stent fracture, migration, branch-related rupture, and death were calculated. A time-to-event analysis was performed for secondary intervention for any branch. Univariable and multivariable analyses were performed to identify related variables. Branch instability, a composite outcome of any branch event, was reported as a function of exponential decay to capture the loss of freedom from complications over time. Results Between the years 2001 and 2010, 650 patients underwent endovascular aortic repair with branched or fenestrated devices. Over 9 years of follow-up (mean standard deviation, 3 2.3 years), secondary procedures were performed for 0.6% of celiac, 4% of superior mesenteric artery (SMA), 6% of right renal artery, and 5% of left renal artery stents. Mean time to reintervention was 237 (354) days. The 30-day, 1-year, and 5-year freedom from branch intervention was 98% (95% confidence interval CI, 96%-99%), 94% (95% CI, 92%-96%), and 84% (95% CI, 78%-90%), respectively. Death from branch stent complications occurred in three patients, two related to SMA thrombosis and one due to an unstented SMA scallop. Multivariable analysis revealed no factors as independent predictors of need for branch reintervention. Conclusions Branches, after branched or fenestrated aortic repair, appear to be durable and are rarely the cause of patient death. The absence of long-term data on branch patency in open repair precludes comparison, yet the lower morbidity and mortality risk coupled with longer-term durability data will further alter the balance of repair options.
Endovascular stent grafting for ascending aorta repair in high-risk patients Roselli, Eric E., MD; Idrees, Jahanzaib, MD; Greenberg, Roy K., MD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
2015, January 2015, 2015-Jan, 2015-01-00, 20150101, Letnik:
149, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Objectives Standard treatment of ascending aortic pathology is open repair, but some patients are too high risk. Thoracic endovascular aortic repair (TEVAR) of the ascending aorta has been used as an ...alternative. Our objectives were to characterize patients, describe repair methods, and assess outcomes. Methods From 2006 to 2014, 22 patients underwent supracoronary ascending TEVAR for acute Type A dissection (n = 9), intramural hematoma (n = 2), pseudoaneurysm (n = 9), chronic dissection (n = 2), or aorta-cardiac fistula (n = 2). Mean age was 71 ± 13 years and the maximum proximal aortic diameter was 6 ± 1 cm. Devices were delivered via a transfemoral (n = 10), transapical (n = 7), or axillary (n = 5) artery approach. The proximal landing zone was at the sinotubular junction in 14 patients, mid to distal ascending aorta in 3 patients, and surgical graft from previous ascending repair in 5 patients. More than 1 device was used in 15 patients. Imaging and engineering analysis was performed for all patients. Results There were 3 hospital deaths (13.6%) (tamponade in 1 patient, bleed from left atrial fistula in another patient). One patient had partial occlusion of the left coronary artery requiring open conversion and died later from multiorgan failure. One patient required early open conversion for retained delivery system. There were 3 strokes, 2 myocardial infarctions, and 2 tracheostomies, but there was no new-onset renal failure. Median follow-up was 12 months. Six patients developed type 1 endoleak: 2 were treated endovascularly, 1 with open repair, 1 resolved, 1 refused treatment, and 1 is being watched. In 2 patients, initial TEVAR was performed as a bridge for ruptured high-risk dissection and were later converted to open repair. Reoperations also included removal of stent graft due to distal migration and repair of left ventricular pseudoaneurysm. There were 3 late deaths. Actual survival at 30 days, 1 year, and 5 years was 86%, 80%, and 75%, respectively. Conclusions Ascending TEVAR is a feasible alternative to medical therapy for repair of acute and chronic ascending disease in high-risk patients. Development of devices dedicated to treat ascending aortic pathology is needed to improve outcomes.
Objective This article reports the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, ...Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysms with short proximal necks. The study goals were to evaluate the safety and preliminary effectiveness of the device and refine patient selection criteria. Methods Five centers in the United States enrolled 30 patients with juxtarenal aortic aneurysms with ≥50-mm diameter and short proximal necks. Devices were custom-designed for each patient based on measurements from reconstructed computed tomography (CT) data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound imaging, and abdominal flat plate radiographs at hospital discharge, at 1, 6, and 12 months, and yearly thereafter up to 5 years. Results During a 1-year period, 30 patients (80% men; mean age, 75 years) with a mean aneurysm size of 61.4 mm were enrolled. In these 30 patients, 77 visceral vessels were accommodated by fenestrations located within the sealing segment of the grafts. The most common design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully. No visceral arteries were lost. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed. Type II endoleaks were noted in six (26.1%) at 12 months and four (20.0%) at 24 months. No patients had aneurysm growth >5 mm. Aneurysm size decreased in 16 of 23 (69.6%) and was stable in the remaining patients at 24 months. Eight patients experienced a renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts). Five underwent secondary interventions. No renal failure developed requiring dialysis. Conclusions The intermediate-term (24-month) results of the 30 patients in this multicenter study are concordant with previous single-center studies and support the concept that placement of fenestrated endovascular grafts is safe and effective at centers with experience in endovascular repair and renal/mesenteric stent placement.
The Society for Vascular Surgery pursued development of clinical practice guidelines for the management of the left subclavian artery with thoracic endovascular aortic repair (TEVAR). In formulating ...clinical practice guidelines, the society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the grading of recommendations assessment, development, and evaluation (GRADE) method to develop and present their recommendations. The overall quality of evidence was very low. The committee issued three recommendations. Recommendation 1: In patients who need elective TEVAR where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest routine preoperative revascularization, despite the very low-quality evidence (GRADE 2, level C). Recommendation 2: In selected patients who have an anatomy that compromises perfusion to critical organs, routine preoperative LSA revascularization is strongly recommended, despite the very low-quality evidence (GRADE 1, level C). Recommendation 3: In patients who need urgent TEVAR for life-threatening acute aortic syndromes where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest that revascularization should be individualized and addressed expectantly on the basis of anatomy, urgency, and availability of surgical expertise (GRADE 2, level C).
Objective Spinal cord ischemia (SCI) is a devastating complication associated with aortic aneurysm repair. The aim of the current study was to evaluate factors affecting outcomes from SCI associated ...with endovascular aortic aneurysm repair. Methods A total of 1251 patients underwent endovascular repair of aortic aneurysm as part of a device trial between 1998 and 2010 utilizing endovascular abdominal aortic aneurysm repair (n = 351), thoracic endovascular aortic aneurysm repair (n = 201), fenestrated endovascular aortic aneurysm repair (n = 227), and visceral branched endografts (n = 472). Records and imaging studies were reviewed to supplement prospective outcome data. Demographics, type of repair, collateral bed (hypogastric/subclavian) patency, clinical presentation, and outcomes were evaluated on patients with SCI. Survival was calculated using life-table analysis. Results SCI occurred in 2.8% (n = 36) of patients: abdominal aortic aneurysm, 0.3%, juxtarenal, 0.4%, thoracic aortic aneurysm, 4.6%, and thoracoabdominal aortic aneurysm, 4.8%). Four (11%) required carotid-subclavian bypass prior to endografting, and two underwent coverage of the left subclavian artery. Unilateral hypogastric artery occlusion was present in 11 (31%) patients prior to endograft placement, and three had bilateral occlusions. An additional seven patients had occlusion of at least one hypogastric artery during surgery. SCI was apparent immediately in 15 (42%) patients. Immediate onset of symptoms was observed in 73% of patients with at least one occluded collateral bed but in only 24% of those with patent collateral beds ( P = .021). Of those presenting in a delayed fashion, nine (43%) had a clear precipitating event prior to onset of SCI (hypotension, n = 6, and segmental artery drain removal, n = 3). Recovery occurred in 24 (67%) patients, most within 7 days. Immediate presentation was a negative predictor of recovery ( P = .025), as was occlusion of at least one collateral bed ( P = .035). Mean follow-up was 22 ± 4 months with 30-day and 1-year survival of 92 ± 4.6% and 56 ± 8.3%. Survival was only 36% at 3 months in those with permanent SCI compared with 92% ( P < .001) in those with temporary symptoms. Conclusions SCI continues to complicate aortic surgery despite the advent of endovascular therapy. Occlusion of a single collateral bed is associated with an increased risk for immediate onset of SCI and lack of recovery. These factors are harbingers of poor outcomes and increased short-term mortality. This may be prevented by preserving collateral bed patency in patients undergoing extensive endovascular procedures.
Introduction Patients with chronic distal aortic dissection (CDAD) remain at high risk for late aorta-related events and reinterventions, and the ideal management strategy remains undefined. Open ...surgical procedures carry morbidity, but scant data for thoracic endovascular aortic repair (TEVAR) of CDAD exist. This study reports our intermediate-term results with TEVAR for complicated CDAD. Methods All cases of TEVAR for complicated (aortic growth, malperfusion, intractable pain) CDAD at our institution between 2000 and 2007 were retrospectively reviewed. Demographic information, indications for repair, complications, and aortic morphologic changes were collected from medical records and imaging studies. Aortic morphology (aneurysm size, false lumen thrombosis) was assessed at multiple levels with 3-dimensional image analysis techniques. Kaplan-Meier analysis was used to estimate survival, freedom from reintervention, and likelihood of false lumen thrombosis, with log-rank tests used to discriminate between Kaplan-Meier curves. Results In total, 144 stent–grafts were implanted in 76 consecutive patients (49 male) with complicated CDAD. Early (<30 postoperative days) mortality was 5%. There was no paraplegia, and 1 patient died of stroke. At mean follow-up of 34 months, 12 patients had died (1 aorta-related death). Seventeen patients (22%) underwent 19 secondary aortic reinterventions, mainly for enlargement of the untreated aorta remote to stent–graft repair. Three secondary procedures treated retrograde proximal dissections. Estimated survivals were 86%, 82%, and 80% at 12, 24, and 36 months, respectively, and freedoms from both death and reintervention were 72%, 64%, and 59% at similar time points. Of 67 patients (88%) with complete imaging follow-up, TEVAR resulted in significantly decreased aortic diameter through the stent–grafted segment but not untreated segments. Complete thrombosis of the entire false lumen was uncommon in patients with extensive dissections (13% vs 78% P < .001). Conclusions Management of complicated CDAD remains challenging for clinicians. TEVAR is a reasonable treatment modality for dissections limited to the thoracic aorta and for prevention of focal aortic growth in extensive dissections. Late complications and the need for secondary interventions emphasize the complexity of this patient population and the need for long-term follow-up.
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