Efficacy of thoracic endovascular stent repair for chronic type B aortic dissection with aneurysmal degeneration.

The Food and Drug Administration has approved devices for endovascular management of thoracic endovascular aortic aneurysm repair (TEVAR); however, limited data exist describing the outcomes of TEVAR for aneurysms attributable to chronic type B aortic dissection (cTBAD). This study was undertaken to determine the results of endovascular treatment of cTBAD with aneurysmal degeneration. A retrospective analysis of all patients treated for cTBAD with aneurysmal degeneration at the University of Florida from 2004 to 2011 was performed. Computed tomograms with centerline reconstruction were analyzed to determine change in aortic diameter, relative proportions of aortic treatment lengths, and false lumen perfusion status. Reintervention and mortality were estimated using life-tables. Cox regression analysis was completed to predict mortality. Eighty patients underwent TEVAR for aneurysm due to cTBAD (mean age [± standard deviation], 60 ± 13 years [male, 87.5%; n = 70]; median follow-up, 26 [range, 1-74] months). Median time from diagnosis of TBAD to TEVAR was 16 (range, 1-72) months. Prior aortic root/arch replacement had been performed in 29% (n = 23) at a median interval of 28.5 (range, 0.5-312) months. Mean preoperative aneurysm diameter was 62.0 ± 9.9 mm. In 75% (n = 60) of cases, coverage was proximal to zone 3, and 24% (n = 19) underwent carotid-subclavian bypass or other arch debranching procedure. Spinal drains were used in 78% (pre-op 71%, n = 57; post-op 6%, n = 5). Length of stay was 6.5 ± 4.7 days with a composite morbidity of 26% and in-hospital mortality of 2.5% (n = 2). Overall neurologic event rate was 17% (spinal cord ischemia 10% [n = 8], with a permanent deficit observed in 6.2% [n = 5]; stroke 7.5%). Aneurysm diameter reduced or stabilized in 65%. The false lumen thrombosed completely within the thoracic aorta in 52%, and reintervention within the treated aortic segment was required in 16% (n = 13).One- and 3-year freedom from reintervention (with 95% confidence interval [CI]) was 80% (range, 68%-88%) and 70% (range, 57%-80%), respectively. Survival at 1 and 5 years was 89% (range, 80%-94%) and 70% (range, 55%-81%) and was not significantly different among patients requiring reintervention or experiencing favorable aortic remodeling. Multivariable analysis identified coronary artery disease (hazard ratio [HR], 6.4; 95% CI, 2.3-17.7; P < .005), prior infrarenal aortic surgery (HR, 8.6; 95% CI, 2.3-31.7; P = .001), and congestive heart failure (HR, 11.9; 95% CI, 1.9-73.8; P = .008) as independent risk factors for mortality. Hyperlipidemia was found to be protective (HR, 0.2; 95% CI, 0.05-0.6; P = .004). No significant difference in predictors of mortality were found between patients who underwent reintervention vs those who did not (P = .2). TEVAR for cTBAD with aneurysmal degeneration can be performed safely but spinal cord ischemia rates may be higher than previously reported. Liberal use of procedural adjuncts to reduce this complication, such as spinal drainage, is recommended. Reintervention is common, but long-term survival does not appear to be impacted by remediation.

Scali ST ，Feezor RJ ，Chang CK ，Stone DH ，Hess PJ ，Martin TD ，Huber TS ，Beck AW ... -  《-》

Outcomes of thoracic endovascular aortic repair using aortic arch chimney stents in high-risk patients.

Aortic arch disease is a challenging clinical problem, especially in high-risk patients, in whom open repair can have morbidity and mortality rates of 30% to 40% and 2% to 20%, respectively. Aortic arch chimney (AAC) stents used during thoracic endovascular aortic repair (TEVAR) are a less invasive treatment strategy than open repair, but the current literature is inconclusive about the role of this technology. The focus of this analysis is on our experience with TEVAR and AAC stents. All TEVAR procedures performed from 2002 to 2015 were reviewed to identify those with AAC stents. Primary end points were technical success and 30-day and 1-year mortality. Secondary end points included complications, reintervention, and endoleak. Technical success was defined as a patient's surviving the index operation with deployment of the AAC stent at the intended treatment zone with no evidence of type I or type III endoleak on initial postoperative imaging. The Kaplan-Meier method was used to estimate survival. Twenty-seven patients (age, 69 ± 12 years; male, 70%) were identified, and all were described as being at prohibitive risk for open repair by the treating team. Relevant comorbidity rates were as follows: coronary artery disease/myocardial infarction, 59%; oxygen-dependent emphysema, 30%; preoperative creatinine concentration >1.8 mg/dL, 19%; and congestive heart failure, 15%. Presentations included elective (67%; n = 18), symptomatic (26%; n = 7), and ruptured (7%; n = 2). Eleven patients (41%) had prior endovascular or open arch/descending thoracic repair. Indications were degenerative aneurysm (49%), chronic residual type A dissection with aneurysm (15%), type Ia endoleak after TEVAR (11%), postsurgical pseudoaneurysm (11%), penetrating ulcer (7%), and acute type B dissection (7%). Thirty-two brachiocephalic vessels were treated: innominate (n = 7), left common carotid artery (LCCA; n = 24), and left subclavian artery (n = 1). Five patients (19%) had simultaneous innominate-LCCA chimneys. Brachiocephalic chimney stents were planned in 75% (n = 24), with the remainder placed for either LCCA or innominate artery encroachment (n = 8). Overall technical success was 89% (one intraoperative death, two persistent type Ia endoleaks in follow-up). The 30-day mortality was 4% (n = 1; intraoperative death of a patient with a ruptured arch aneurysm), and median length of stay was 6 (interquartile range, 4-9) days. Seven (26%) patients experienced a major complication (stroke, three [all with unplanned brachiocephalic chimney]; respiratory failure, three; and death, one). Nine (33%) patients underwent aorta-related reintervention, and no chimney occlusion events occurred during follow-up (median follow-up, 9 [interquartile range, 1-23] months). The 1-year and 3-year survival is estimated to be 88% ± 6% and 69% ± 9%, respectively. TEVAR with AAC can be performed with high technical success and acceptable morbidity and mortality in high-risk patients. Unplanned AAC placement during TEVAR results in an elevated stroke risk, which may be related to the branch vessel coverage necessitating AAC placement. Acceptable midterm survival can be anticipated, but aorta-related reintervention is not uncommon, and diligent follow-up is needed.

Voskresensky I ，Scali ST ，Feezor RJ ，Fatima J ，Giles KA ，Tricarico R ，Berceli SA ，Beck AW ... -  《-》

Outcomes of thoracic endovascular aortic repair in adult coarctation patients.

Aortic coarctation (AC) is most commonly identified in pediatric patients; however, adults can present with late sequelae of untreated coarctation or complications of prior open repair. To date, there are limited data about the role of thoracic endovascular aortic repair (TEVAR) in this group of patients. The purpose of this analysis was to describe our experience with management of adult coarctation patients using TEVAR. All TEVAR patients treated for primary coarctation or late sequelae of previous open repair (eg, pseudoaneurysm, recurrent coarctation or anastomotic stenosis related to index open coarctation repair) were reviewed. Demographics, comorbidities, procedure-related variables, postoperative outcomes, and reintervention were recorded. Computed tomography centerline assessments of endograft morphology were completed to delineate stent anatomy at the coarctation site. Survival and reintervention were estimated using life-table analysis. A total of 21 patients were identified (median age, 46 years [range, 33-71 years]; 67% male [n = 14]). Nine patients (43%) were treated for symptomatic primary (n = 6) or recurrent (n = 3) coarctation. Other indications included degenerative thoracic aneurysm (n = 6), pseudoaneurysm (n = 4), and dissection (n = 2). Technical success was 100% (95% confidence interval [CI], 84%-100%). No 30-day mortality or paraplegia events occurred; however, two patients (10%) experienced postoperative nondisabling stroke. In primary or recurrent coarctation patients with available computed tomography imaging (n = 8 of 9), nominal stent graft diameters were achieved proximal and distal to the coarctation (range, -0.4 to -1.2 mm of desired final stent diameter). Specific to the coarctation site, there was a significant increase in aortic diameter after TEVAR (before stenting, 11.5 [95% CI, 6.8-12.3] mm; after stenting, 15 [95% CI, 13.7-15.7] mm; P = .004). Concurrently, systolic arterial blood pressure at time of discharge was significantly lower (before stenting: 147 mm Hg; 95% CI, 137-157 mm Hg; after stenting: 124 mm Hg; 95% CI, 118-134 mm Hg; P = .02). For all patients, median clinical follow-up time was 8 months (interquartile range, 3-13 months; range, 1-106 months). Three endoleaks were detected, all of which were type II related to left (n = 2) or aberrant (n = 1) subclavian arteries. Four patients (19%) underwent reintervention (median time, 7 months; range, 2-12 months), with three of four being subclavian artery embolization; one was an aortic root replacement for ascending aneurysm with bicuspid aortic valve. One-year freedom from reintervention was 78% ± 9% (95% CI, 42%-92%). The 1- and 3-year survival was 95% ± 5% (95% CI, 71%-99%). One late death was related to complications from pre-existing congenital heart disease. Adult AC patients can be treated safely with TEVAR, and the annular constriction of an AC can be successfully dilated by the stent graft. Given these findings, a greater number of patients with longer term follow-up is warranted to further define the role of TEVAR in the management of adult AC patients.

Lala S ，Scali ST ，Feezor RJ ，Chandrekashar S ，Giles KA ，Fatima J ，Berceli SA ，Back MR ，Huber TS ，Beaver TM ，Beck AW ... -  《-》

Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design.

This study evaluates the safety and effectiveness of a unique composite thoracic endovascular aneurysm repair (TEVAR) construct (proximal stent graft and distal bare metal stent) for the treatment of patients with complicated type B aortic dissection (cTBAD). In this prospective, single-arm, multicenter study, patients with cTBAD were treated with an endovascular system consisting of proximal TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical, Bloomington, Ind). Indications for enrollment were branch vessel malperfusion, impending rupture, aortic diameter ≥40 mm, rapid aortic expansion, and persistent pain or hypertension despite maximum medical therapy. One-year follow-up results, including clinical and radiographic (computerized tomography [CT] and X-ray) evaluation, were available for this report. Ten centers enrolled 40 patients (70% men; mean age 58 years old) between December 2007 and August 2009. The onset of symptoms was acute (≤14 days) in 24 patients (60%), subacute (15-30 days) in six patients (15%), and chronic (31-90 days) in 10 patients (25%); the overall mean time from symptom onset to treatment was 20 days (range, 0-78 days). A majority of patients (77.5%; 31 of 40 patients) presented with impending aortic rupture (indicated by periaortic effusion/hematoma) or branch vessel malperfusion. Seven combinations of stent grafts and dissection stents were used, and all devices were successfully deployed and patent. The 30-day mortality rate was 5% (2 of 40); two deaths occurred after 30 days, leading to a 1-year survival rate of 90%. Two deaths, occurring at 11 and 81 days postprocedure, respectively, were secondary to aortic rupture. Morbidity occurring within 30 days included stroke (7.5%), transient ischemic attack (2.5%), paraplegia (2.5%), retrograde progression of dissection (5%), and renal failure (12.5%). Additional morbidity after 30 days included one case of retrograde progression of dissection and one case of renal failure. None of the patients with renal failure became dialysis-dependent. Four patients (10%) underwent secondary interventions within 1 year. Favorable aortic remodeling was observed during the course of follow-up, indicated by an increase in the true lumen size and a concomitant decrease in the false lumen size along the dissected aorta, with completely thrombosed thoracic false lumen observed in 31% of patients at 12 months as compared to 0% at baseline. Initial data with a composite TEVAR construct have demonstrated favorable clinical and anatomic results. Continued enrollment and long-term data are needed to assess the overall effectiveness of this treatment strategy.

Lombardi JV ，Cambria RP ，Nienaber CA ，Chiesa R ，Teebken O ，Lee A ，Mossop P ，Bharadwaj P ，STABLE investigators ... -  《-》

Long-term results of total endovascular repair of arch-involving aortic pathologies using parallel grafts for supra-aortic debranching.

We evaluated the long-term morphologic and clinical outcomes after thoracic endovascular aortic repair combined with parallel grafts (PG-TEVAR) for arch-involving aortic pathologies. We performed a retrospective analysis of perioperative and follow-up data of patients who had undergone PG-TEVAR at a single vascular surgery center from November 2010 to April 2018. Patients with prior or simultaneous open chest or cervical debranching procedures or arch repair were excluded. The primary endpoint was freedom from overall PG-TEVAR-related reintervention. The secondary endpoints were parallel graft sealing zone failure (presence of gutter-related type I or Ic endoleak), PG failure (occlusion or reintervention), stroke, and 30-day and overall PG-TEVAR-related and all-cause mortality. Kaplan-Meier curves were used to estimate the freedom from reintervention and survival. Receiver operating characteristics curves were used to find the optimal cutoff to prevent type Ia endoleak-related reintervention. A total of 33 patients, including 8 women, with a median age of 74 years (interquartile range, 67-79 years) had undergone PG-TEVAR (chimney, periscope, and sandwich in 20, 15, and 13 patients, respectively) with proximal landing in Ishimaru zone 0, 1, or 2 in 4, 5, and 24 patients, respectively. The aortic pathologies included type B aortic dissection (acute and chronic, eight and six, respectively), degenerative aneurysm (n = 10), type Ia endoleak (n = 3), para-anastomotic/patch aneurysm (n = 4), left subclavian artery aneurysm (n = 1), and traumatic rupture (n = 1). The perioperative stroke rate and 30-day mortality was 6% and 9%, respectively. Direct postoperative computed tomography revealed 28 endoleaks (gutter-related type Ia, 12; gutter-related type Ib, 9; type Ia, 2; type Ic, 2; type III, 1; undetermined, 2) in 27 patients. The technical and clinical success rate was 37% and 30%, respectively. The mean follow-up for survival was 48 ± 31 months. The latest radiologic follow-up demonstrated 12 remaining and 1 new endoleak. The early and overall PG sealing zone failure and PG failure was 73% and 36% and 9% and 18%, respectively. The overall PG-TEVAR-related reintervention rate was 33% (n = 11). The estimated freedom from overall PG-TEVAR-related reintervention was 68% at 60 months. The main graft oversizing and length oversizing rates were not significantly associated statistically with the type Ia endoleak-related reintervention rate. The PG-TEVAR-related and all-cause mortality were 18% and 34%, respectively. PG-TEVAR for total endovascular repair of arch-involving aortic pathologies resulted in a high rate of type I endoleaks and the need for long-term reintervention. Gutter-related endoleaks might be more frequent than reported and should not be underestimated because they can lead to sac enlargement and reintervention. Frequent radiologic surveillance is mandatory. Further studies comparing PG-TEVAR to other total endovascular alternatives are required to confirm these findings.

Dueppers P ，Reutersberg B ，Rancic Z ，Messmer F ，Menges AL ，Meuli L ，Rychla M ，Zimmermann A ... -  《-》