Permissive Hypertension and Collateral Revascularization May Allow Avoidance of Cerebrospinal Fluid Drainage in Thoracic Endovascular Aortic Repair.

BACKGROUND: The utility of cerebrospinal fluid drainage (CSFD) for prevention of spinal cord ischemia (SCI) after thoracic endovascular aortic repair (TEVAR) remains unclear. We previously published our institutional algorithm restricting preoperative CSFD to patients deemed high risk for SCI. Since that publication, our algorithm has evolved with preoperative CSFD avoided in all patients undergoing isolated descending TEVAR with or without arch involvement (+/- arch TEVAR). This study evaluated the updated algorithm in a contemporary cohort. METHODS: Patients who underwent TEVAR for descending aortic +/-arch pathology between February 2012 and September 2018 at a single center were identified from an institutional aortic surgery database. The algorithm includes left subclavian artery (LSA) revascularization in cases of coverage with no preservation of antegrade flow, permissive hypertension, and use of evoked potential monitoring. The primary end points were SCI or postoperative CSFD. RESULTS: During the study interval, 225 patients underwent descending +/- arch TEVAR. CSFD was used before TEVAR in 2 patients (0.9%) in violation of the algorithm, and they were excluded from the study cohort. Endograft coverage below T6 occurred in 81%. The LSA was fully covered in 100 patients (47%), all of whom underwent LSA revascularization. Following the updated algorithm, the incidence of temporary or permanent SCI was 0%. No patient required postoperative CSFD. CONCLUSIONS: A restrictive lumbar CSFD algorithm, including permissive hypertension and LSA revascularization in the setting of descending +/- arch TEVAR, appears safe, with a 0% incidence of SCI in 223 consecutive patients treated during a 6.5-year interval. We recommend consideration of further prospective study to evaluate this algorithm.

Back stabber: ladder fall causing traumatic aortic transection.

A 68-year-old man presented with back pain after falling from a ladder and was found to have anterolisthesis of thoracic vertebrae T11-12 with secondary focal aortic injury and disruption of the aortic wall. This was successfully repaired using thoracic endovascular aortic repair (TEVAR) followed by spinal fusion with excellent result.

Outcomes of carotid-subclavian bypass performed in the setting of thoracic endovascular aortic repair.

BACKGROUND: Subclavian artery revascularization is frequently performed in the setting of thoracic endovascular aortic repair (TEVAR). However, there is little information on the short- and long-term outcomes of patients undergoing carotid to subclavian artery bypass in this clinical setting. As such, this study sought to define the early and late outcomes associated with this procedure. METHODS: Patients undergoing carotid-subclavian bypass in conjunction with TEVAR between June 2005 and September 2016 were retrospectively identified from a prospectively maintained, single-center aortic surgery database. The 30-day outcomes specific to the carotid-subclavian bypass procedure were analyzed, including cervical plexus nerve injury, bleeding complications, and local vascular complications. All preoperative and postoperative chest radiographs were carefully analyzed to assess for hemidiaphragm elevation indicative of phrenic nerve palsy. Long-term outcomes included primary graft patency and anastomotic complications. RESULTS: Of 579 consecutive patients undergoing TEVAR during this time interval, 112 patients (19%) underwent concomitant carotid-subclavian bypass. The cohort was 38% female (n = 43), with a mean age of 65 ± 14 years. The majority of conduits were 8-mm polytetrafluoroethylene grafts (n = 107 [95.5%]), with a minority being reversed saphenous vein (n = 4 [3.6%]) or Dacron (n = 1 [0.9%]) grafts. The bypass procedure was done concurrently at the time of TEVAR in 91% (n = 102) of cases. The short-term complication rate attributed specifically to the carotid-subclavian bypass was 29% (n = 33). These complications included phrenic nerve palsy in 25% (n = 27), recurrent laryngeal nerve palsy in 5% (n = 6), axillary nerve palsy in 2% (n = 2), and neck hematoma requiring re-exploration in 1% (n = 1) of patients. The 30-day in-hospital all-cause mortality rate was 5% (n = 6), and the rate of permanent paraparesis or paraplegia was 0.9% (n = 1). Of the operative survivors (n = 106), follow-up imaging of the bypass graft was available in 87% (n = 92) of patients. Actuarial primary graft patency was 97% at 5 years. There were three patients (3%) with bypass graft occlusions, two of which were clinically silent and detected on follow-up imaging. The third was detected because of symptoms of subclavian steal and required repeated revascularization. Two patients (2%) developed a late anastomotic pseudoaneurysm requiring either endovascular (n = 1) or surgical (n = 1) intervention. CONCLUSIONS: Carotid-subclavian bypass for revascularization of the subclavian artery performed in the setting of TEVAR is durable, although the true complication rate is likely higher than is generally reported in the literature because of a not insignificant rate of phrenic nerve palsy. These data should serve well as "gold standard" comparison data for emerging branch graft devices.

Outcomes of Planned Two-Stage Hybrid Aortic Repair With Dacron-Replaced Proximal Landing Zone.

BACKGROUND: Results of hybrid arch repair (HAR) using the native zone 0 proximal landing zone (PLZ) have been unsatisfactory in many series, especially in the setting of ascending aortic dilation (>4.0 cm). This study reports early and late outcomes of planned two-stage HAR with open first-stage proximal aortic replacement, followed by second-stage thoracic endovascular aortic repair (TEVAR) with PLZ within the Dacron-replaced zone 0. METHODS: Between January 2006 and August 2017, 34 patients underwent planned two-stage HAR. The first-stage proximal aortic replacement included ascending aorta (with or without valve, with or without root) and total arch replacement, which was performed with creation of an elephant trunk in 22 patients (65%) and without an elephant trunk in 12 (35%). Primary outcomes included 30-day/in-hospital results and Kaplan-Meier estimates of overall/aorta-specific survival and freedom from reintervention. RESULTS: Mean age was 59 ± 12 years. Both stages of repair were completed in a single hospitalization in 53% of patients, including operations done since January 2012. The 30-day/in-hospital rates of mortality, stroke, permanent paraparesis/plegia, and new dialysis were 6%, 3%, 0%, and 0%, respectively. Kaplan-Meier overall and aorta-specific survivals at 5 years were 63% and 94%, respectively, with 5-year freedom from reintervention of 78%. CONCLUSIONS: Planned two-stage HAR with open first-stage proximal aortic replacement, followed by second-stage TEVAR with Dacron-replaced PLZ yields excellent short-term and long-term results, including low rates of reintervention likely due to the long-segment PLZ within the Dacron-replaced aorta. The technique should be considered in patients with even mild (>4.0 cm) ascending aortic dilation in whom HAR is otherwise the preferred treatment option.

Jejunal arterial access for retrograde mesenteric stenting.

Endovascular approaches have replaced open surgical revascularization in most patients with mesenteric ischemia; however, flush ostial occlusions may not be amenable to traditional antegrade access. Retrograde mesenteric stenting has been previously described, but this technique requires a formal laparotomy and dissection of the proximal superior mesenteric artery. We present here a modification of this technique that requires only a "mini-laparotomy" and no open vascular repair of the superior mesenteric artery as well as a review of our initial institutional experience with this procedure. Our approach differs from previously described work by minimizing mesenteric dissection, avoiding the need for repair of an arteriotomy, and limiting the size of the laparotomy incision in this population of profoundly comorbid patients.

Long-term results of endovascular repair for descending thoracic aortic aneurysms.

OBJECTIVE: Since thoracic endovascular aortic repair (TEVAR) received U.S. Food and Drug Administration approval for the treatment of descending thoracic aneurysms in March 2005, excellent 30-day and midterm outcomes have been described. However, data on long-term outcomes are lacking with Medicare data suggesting that TEVAR has worse late survival compared with open descending repair. As such, the purpose of this study was to examine the long-term outcomes for on-label use of TEVAR for repair of descending thoracic aneurysms. METHODS: Of 579 patients undergoing TEVAR between March 2005 and April 2016 at a single referral center for aortic surgery, 192 (33.2%) were performed for a descending thoracic aneurysm indication in accordance with the device instructions for use, including 106 fusiform (55.2%), 80 saccular (41.7%), and 6 with both saccular and fusiform (3.1%) aneurysms. All aneurysms were located distal to the left subclavian artery and proximal to the celiac axis, and hybrid procedures including arch or visceral debranching were excluded with the exception of left carotid-subclavian artery bypass. Aortic dissection and intramural hematoma as indications for TEVAR were also excluded. Primary 30-day and in-hospital outcomes included mortality, stroke, need for new permanent dialysis, and permanent paraparesis or paraplegia. Primary long-term outcomes included survival and rate of reintervention secondary to endoleak. The Kaplan-Meier method was used to estimate long-term overall and aorta-specific survivals. RESULTS: The mean age was 71.1 ± 10.4 years. All aneurysms in this series were degenerative in nature and no patients with a connective tissue disorder were included. The mean aortic diameter was 5.9 ± 1.5 cm at time of intervention. Rates of 30-day and in-hospital mortality, stroke, permanent dialysis, and permanent paraparesis and paraplegia were 4.7%, 2.1%, 0.5%, and 0.5%, respectively. At a mean follow-up of 69 ± 44 months (range, 3-141 months), there were 68 late deaths (35.4%), two of which were due to aortic rupture. Overall and aorta-specific survivals at 141 months (11.8 years) were 45.7% and 96.2%, respectively. Endovascular reintervention was required in 14 patients (7.3%) owing to type I (n = 10), type II (n = 2), and type III (n = 2) endoleak, all of which subsequently resolved. No patient required open reintervention for any cause. CONCLUSIONS: Long-term (12-year) aorta-specific survival after on-label endovascular repair of degenerative descending thoracic aneurysms in nonsyndromic patients is excellent (96%) with sustained protection from rupture, and a low rate of reintervention owing to endoleak (7%). Endovascular repair should be considered the treatment of choice for this pathology.

Outcomes of Reoperation After Acute Type A Aortic Dissection: Implications for Index Repair Strategy.

BACKGROUND: The optimal surgical approach for management of acute type A aortic dissection remains controversial. This study aimed to assess outcomes of reoperation after acute type A dissection repair to help guide decision making around index operative strategy. METHODS AND RESULTS: All aortic reoperations (n=129) at a single referral institution from August 2005 to April 2016 after prior acute type A dissection repair were reviewed. The primary outcome was 30-day or in-hospital mortality. Secondary outcomes included organ-specific morbidity and 1- and 5-year outcomes as estimated using the Kaplan-Meier method. The majority of initial reoperations were proximal aortic (aortic valve, aortic root, or ascending) or aortic arch procedures (62.5%, n=55); most initial reoperations were performed in the elective setting (83.1%, n=74). Additional nonstaged second or more reoperations were required in 21 patients (23.6%) after the initial reoperation, during a median follow-up of 2.5 years after the initial reoperation. Thirty-day or in-hospital mortality for all reoperations was 7.0% (elective: 6.3%; nonelective: 11.1%) with acceptable rates of organ-specific morbidity, given the procedural complexity. One- and 5-year overall survival after initial reoperation was 85.9% and 64.9%, respectively, with aorta-specific survival of 88% at 5 years. CONCLUSIONS: Reoperation after acute type A aortic dissection repair is associated with low rates of mortality and morbidity. These data support more limited index repair for acute type A dissection, especially for patients undergoing index repair in lower volume centers without expertise in extensive repair, because reoperations, if needed, can be performed safely in referral aortic centers.

Management of a cutaneous squamous cell carcinoma overlying an AV fistula.

Cutaneous squamous cell carcinoma (cSCC) currently affects over 700 000 patients per year in the USA alone, and its incidence continues to rise in recent years. A known risk factor for cSCC is chronic inflammation; a cSCC that develops at a site of chronic inflammation is known as Marjolin's ulcer. We present the case of a 76-year-old man with end-stage renal disease requiring chronic haemodialysis who developed an invasive cSCC at the cannulation site of an underlying arteriovenous (AV) fistula. In this instance, treatment with standard surgical excision or Mohs surgery would pose unique risks associated with injury to an otherwise functional AV fistula. Thus, the lesion was treated with electron beam radiation therapy, which offers a similar efficacy to surgery while minimising risk to the fistula. This resulted in a successful oncological outcome with no complications.

Endovascular and Open Repair of Ruptured Infrarenal Aortic Aneurysms at a Tertiary Care Center.

BACKGROUND: The mortality of ruptured abdominal aortic aneurysms (rAAAs) has been reported as high as 90%. Loss of consciousness and a systolic blood pressure of <80 mm Hg on presentation are the most important predictors of mortality after emergent open repair (OR). Endovascular repair of abdominal aortic aneurysm (EVAR) has reduced short-term operative mortality and morbidity for elective abdominal aortic aneurysm repair, and may be advocated for wider application of EVAR for rAAA. The objective of this study is to compare our experience with OR and EVAR management of rAAA. METHODS: Retrospective review of all rAAAs presenting to a tertiary care center between January 1, 2000 and December 31, 2011 was performed. Patients were grouped based on the surgical approach (OR versus EVAR). Patient demographics, intraoperative details, and postoperative mortality and morbidity rates were compared. Statistical analyses were conducted with Stata, version 12. RESULTS: One hundred twenty-six patients presented with rAAA over the study period. Patients who declined repair (n = 14) or died before repair (n = 13) were excluded from this study. Of the 99 patients who underwent repair, 25 patients (25.3%) received EVAR and 74 (74.7%) underwent OR. One patient required conversion to OR from EVAR (1.0%). Overall, 30-day and 1-year mortality was 35.4% and 41.4%, respectively, with no difference seen between the 2 types of repair (30-day mortality: EVAR = 24.0%, OR = 39.2%, P = 0.17; 1-year mortality: EVAR = 32.0%, OR = 44.6%, P = 0.27). Major morbidity also did not differ between the 2 repair procedures (EVAR = 60.0%, OR = 60.8%, P = 0.94). However, patients undergoing EVAR had significantly less estimated blood loss (median: 0.3 vs. 3.0 L, P < 0.0001) and transfusion requirement (median: 5.0 vs. 9.0 U, P = 0.0041). Furthermore, although there was no significant difference in length of overall hospital stay between the 2 groups (8.5 vs. 15 days in the OR group, P = 0.18), significantly more patients in the EVAR group were discharged to home (66.7% vs. 57.1% in the OR group, P = 0.03). CONCLUSIONS: In contrast to recently published series, this series shows no differences in morbidity or mortality between EVAR or OR of rAAAs. EVAR is appropriate in stable patients with a rAAA and favorable anatomy.

Concomitant Thoracic Aortobifemoral Bypass With Left Ventricular Assist Device Implantation.

Improved quality of life for patients after left ventricular assist device (LVAD) implantation can be greatly limited by peripheral vascular disease even if heart failure symptoms are resolved by LVAD support. We present a case of concomitant thoracic aortobifemoral bypass and LVAD implantation in a patient with ischemic cardiomyopathy, severe peripheral vascular disease, and multiple previous failed revascularization attempts. In this patient, we used the LVAD outflow to provide the inflow to the femoral artery bypass graft. This graft has remained patent at a 2-year follow-up, without claudication symptoms. Performing concomitant major vascular operations safely and successfully is feasible in patients with LVADs. Quality of life after ventricular assist device placement can be limited by vascular disease, but it can be markedly improved after vascular surgical intervention.

Complementary roles of open and hybrid approaches to thoracoabdominal aortic aneurysm repair.

OBJECTIVE: Thoracoabdominal aortic aneurysm (TAAA) repair remains a significant challenge with considerable perioperative morbidity and mortality. A hybrid approach utilizing visceral debranching with endovascular aneurysm exclusion has been used to treat high-risk patients and therefore allow repair in more patients. Limited data exist regarding long-term outcomes with this procedure as well as comparison to conventional open repair. This study describes our institutional algorithmic approach to TAAA repair using both open and hybrid techniques. METHODS: Hybrid and open TAAA repairs performed between July 2005 and August 2015 were identified from a prospectively maintained institutional aortic surgery database. Perioperative morbidity and mortality, freedom from reintervention, and long-term and aorta-specific survival were calculated and compared between the two groups. RESULTS: During the study period, 165 consecutive TAAA repairs were performed, including 84 open repairs and 81 hybrid repairs. Patients in the hybrid repair group were significantly older, were more frequently female, and had a generally greater comorbid disease burden, including significantly more chronic kidney disease. Despite the older and sicker cohort, there was no difference in in-hospital mortality between the two groups (9.9% hybrid vs 7.1% open; P = .59). Major morbidity rates differed by procedure, with patients undergoing open repair having a significantly higher rate of postoperative stroke (9.5% open vs 0% hybrid; P = .017), whereas patients undergoing hybrid repair had a higher rate of new permanent dialysis (14.8% hybrid vs 3.6% open; P = .043). There was no difference between groups in the rate of postoperative permanent paraplegia/paresis (8.3% open vs 7.4% hybrid; P = .294). There was a significantly increased rate of reintervention in the hybrid repair group (12.3% hybrid vs 1.2% open, P = .004), with all hybrid reinterventions performed because of endoleak. One-year survival was similar between groups at 69% in hybrid repairs vs 77% in open repairs. Long-term survival was worse in the hybrid group (5-year survival, 32% hybrid vs 56% open), although late survival appeared to be influenced mainly by comorbid disease burden, given the similar long-term aorta-specific survival between groups. CONCLUSIONS: Use of an algorithmic approach whereby higher risk patients with TAAA are treated by a hybrid approach and lower risk patients with conventional open repair yields satisfactory short- and long-term outcomes. The availability of multiple options for TAAA repair within a single center likely allows repair in more patients with consequent decrease in the risk of aorta-related death, at the expense of increased reinterventions for endoleak.

Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair.

OBJECTIVE: The role of hybrid repair in the management of aortic arch pathology, and long-term outcomes with these techniques, remains uncertain. We report a decade of experience with hybrid arch repair (HAR) and assess institutional practice patterns with regard to the use of hybrid and open techniques. METHODS: Hybrid and open total and distal arch procedures performed between July 2005 and January 2015 were identified from a prospectively maintained, institutional aortic surgery database. Perioperative morbidity and mortality, freedom from reintervention, and long-term survival were calculated. Hybrid and open procedural volumes over the study period were assessed to evaluate for potential practice pattern changes. RESULTS: During the study period 148 consecutive procedures were performed for repair of transverse and distal aortic arch pathology, including 101 hybrid repairs and 47 open total or distal arch repairs. Patients in the hybrid repair group were significantly older with a greater incidence of chronic kidney disease, peripheral vascular disease, and chronic lung disease. Perioperative mortality and outcomes were not significantly different between the hybrid and open groups, aside from decreased median length of stay after hybrid repair. Need for subsequent reintervention was significantly greater after hybrid repair. Unadjusted long-term survival was superior after open repair (70% 5-year survival open vs 47% hybrid; P = .03), although aorta-specific survival was similar (98% 5-year aorta-specific survival open vs 93% hybrid; P = .59). Institutional use of HAR decreased over the final 3 years of the study, with an associated increased use of open total or distal arch repairs. This was primarily the result of decreased use of native zone 0 hybrid procedures. Concurrent with this apparent increased stringency around patient selection for HAR, perioperative morbidity and mortality was reduced, including avoidance of retrograde type A dissection. CONCLUSIONS: HAR remains a viable option for higher-risk patients with transverse arch pathology with perioperative outcomes and long-term aorta-specific survival similar to open repair, albeit at a cost of increased reintervention. This observational single-institution study would suggest decreased use in more recent years in favor of open repair due to avoidance of native zone 0 hybrid procedures. This decline in the institutional use of native zone 0 hybrid repairs was associated with improved perioperative outcomes.

Spliced arm vein grafts are a durable conduit for lower extremity bypass.

BACKGROUND: Many patients with peripheral vascular disease (PAD) requiring revascularization do not have adequate ipsilateral great saphenous vein (GSV) for constructing a bypass because of intrinsic vein disease or prior harvesting for limb or coronary bypass. Prosthetic conduits have poor long-term patency, especially for distal bypass. With advancing endovascular sophistication, tibial angioplasty may be a good revascularization option, but we hypothesize that using spliced arm vein for distal lower extremity bypass is still a well-tolerated and more durable solution. METHODS: A retrospective chart review was conducted of all PAD patients undergoing lower extremity bypass or tibial angioplasty for lifestyle-limiting claudication or critical limb ischemia at a single institution over a 7-year period. Statistical analysis was conducted by Kaplan-Meier survival analysis and Cox proportional hazards model. Statistical significance was set at P = 0.05. RESULTS: From 2005 to 2012, there were 120 patients who underwent infrageniculate revascularization with conduit other than GSV. Over half of the patients (66 patients, 71.2% male, mean age 62 years) underwent bypass operations using arm vein conduit, and 88% of those bypasses were to tibial vessels. Patency was 100% at 1 year and 85% at 2 years. There was no impact on patency or amputation rate based on the source of vein or the number of splices. Forty-three patients underwent tibial angioplasty and patency was 70% at 1 year and 50% at 2 years. CONCLUSIONS: When GSV is not available, spliced arm vein grafts provide durable lower extremity revascularization with favorable patency and limb preservation rates. Spliced arm vein grafts should be considered over prosthetic grafts and angioplasty alone in patients with distal occlusive disease.

Adult surgical experience with Loeys-Dietz syndrome.

BACKGROUND: Loeys-Dietz syndrome (LDS) results from mutations in receptors for the cytokine transforming growth factor-ß leading to aggressive aortic pathology sometimes accompanied by specific phenotypic features including bifid uvula, hypertelorism, cleft palate, and generalized arterial tortuosity. We reviewed our adult surgical experience with LDS in order to validate current recommendations regarding management of this newly described disease. METHODS: All adult (≥ 18 years old) patients with LDS undergoing surgical treatment at a single referral institution from September 1999 to May 2013 were retrospectively reviewed. RESULTS: Eleven adult LDS patients were identified by clinical criteria and genotyping. Seven (64%) experienced acute type A dissection at some point in their lives. All eventually required aortic root replacement, and 73% required multiple vascular surgical interventions. Over a mean follow-up of 65 ± 49 months, 2.8 cardiovascular procedures per patient were performed. In patients with type A dissection, a mean of 3.4 operations were performed versus 1.8 operations for patients without dissection. Total aortic replacement was required in 5 patients (45%) and 2 (18%) required neurosurgical intervention for cerebrovascular pathology. There was 1 late death from infectious complications, and no deaths from vascular catastrophe. CONCLUSIONS: These results confirm the aggressive nature of LDS aortic pathology. However, the improved survival compared with earlier LDS reports suggest that aggressive treatment strategies may alter outcomes and improve the natural history of this syndrome.

Thoracic endovascular aortic repair for chronic DeBakey IIIb aortic dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) for chronic DeBakey IIIb dissection with associated descending aneurysm remains controversial. This study examines long-term results of TEVAR for this disorder including examination of anatomic features associated with TEVAR outcomes. METHODS: Between July 2005 and January 2013, 32 patients underwent TEVAR for chronic (>30 days) DeBakey IIIb dissection involving the descending thoracic aorta at a single institution and constituted the study cohort. RESULTS: The mean interval from dissection to TEVAR was 32 ± 44 months (range, 1 to 146 months). There were no 30-day or in-hospital deaths, strokes, or paraplegia. During a 54-month median follow-up, there were no aortic-related deaths. Significant thoracic aneurysm sac regression (>1 cm) in the intervened segment was observed in 89%. Thoracic remodeling was not correlated with the number of visceral vessels arising from the true lumen or the number or size of residual distal fenestrations; failure of thoracic remodeling was associated with fenestrations distal to the endograft(s) in the descending thoracic aorta, most often stent graft-induced new entry tears. Complete resolution of the thoracic and abdominal false lumen after TEVAR was observed in 15.6% (n = 5). All patients in this group had all visceral vessels arising from the true lumen and fewer than three residual distal fenestrations. CONCLUSIONS: Thoracic endovascular aortic repair is effective for chronic DeBakey IIIb dissection with associated descending aneurysm, with excellent 30-day and long-term outcomes and significant aortic remodeling in the vast majority of patients. Thoracic remodeling does not appear dependent on distal anatomic characteristics of the true and false lumens, although care should be taken to cover all thoracic fenestrations and avoid creation of stent graft-induced new entry tears to ensure clinical success. Complete aortic remodeling was observed only in the setting of all visceral vessels off the true lumen with fewer than three residual distal fenestrations, and this would appear the ideal anatomy for TEVAR in this scenario.

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system.

OBJECTIVE: Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). METHODS: This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. CONCLUSIONS: Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.

Current management and outcome of chronic type B aortic dissection: results with open and endovascular repair since the advent of thoracic endografting.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become the preferred treatment for chronic type B aortic dissection (CTBAD) at our institution. However, it remains incapable of treating all patients with CTBAD. The present study aims to review our contemporary results with open and endovascular CTBAD repairs since the advent of thoracic endografting. METHODS: The records of all patients undergoing index repair of CTBAD (chronic DeBakey type IIIA, IIIB and repaired type I) at our institution between June 2005 and December 2013, were retrospectively reviewed. RESULTS: A total of 107 patients underwent CTBAD repair, of whom 70% (n=75) underwent endovascular-based procedures [44 TEVAR, 27 hybrid arch and four hybrid thoracoabdominal aortic aneurysm (TAAA) repair] and 30% (n=32) underwent open procedures (nine open descending and 23 open TAAA). Connective tissue disease (CTD), prior aortic surgery and DeBakey dissection type were strongly associated with the choice of operation. The rates of stroke, paraplegia and operative mortality following endovascular-based repairs were 0%, 0% and 4% (n=3), respectively. Adverse neurologic events were higher following open repair, and rates of stroke, paraplegia, and operative mortality were 16% (n=5), 9% (n=3), and 6% (n=2), respectively. However, 1- and 5-year survival rates were similar for endovascular-based repairs (86% and 65%, respectively), and open repairs (88% and 79%, respectively). Over a median follow-up interval of 34 months, the rate of descending aortic reintervention was 24% (n=18) following endovascular-based repairs and 0% following open repairs (P=0.001). Forty-four percent (n=8) of descending aortic reinterventions were required to treat stent graft complications (five endoleak, two stent graft collapse and one stent graft-induced new entry tear) and the remainder were required to treat metachronous pathology (n=2) or progressive aneurysmal disease related to persistent distal fenestrations (n=8). CONCLUSIONS: Endovascular repair of CTBAD was associated with excellent procedural and survival outcomes, but at the expense of further reinterventions. Open repair remains relevant for patients who are not candidates for endovascular repair and was associated with higher procedural morbidity but similar overall survival and fewer reinterventions.

Role of cardiac evaluation before thoracic endovascular aortic repair.

BACKGROUND: Patients with thoracic aortic disease undergoing thoracic endovascular aortic repair (TEVAR) often have concomitant coronary artery disease and are at risk for perioperative adverse cardiac events. Despite this risk, the need for and extent of preoperative cardiac workup before TEVAR remain undefined. This study seeks to assess the adequacy of a limited cardiac evaluation before TEVAR, including assessment of cardiac symptoms, resting electrocardiography (ECG), and transthoracic echocardiography (TTE), as well as to estimate the incidence of perioperative cardiac events in patients undergoing TEVAR. METHODS: Retrospective analysis of a prospectively maintained Institutional Review Board-approved database was performed for all patients undergoing TEVAR at a single referral institution between May 2002 and June 2013. The analysis identified 463 TEVAR procedures. All procedures involving median sternotomy were excluded, and 380 procedures (343 patients) were included in the final analysis. Degree of cardiac workup was classified on the basis of the highest level of preoperative testing: no workup, resting ECG only, resting TTE, exercise/pharmacologic stress testing, or coronary angiography. Standard workup consisted of cardiac symptom assessment along with resting ECG or TTE, with further workup indicated for unstable symptoms, significantly abnormal findings on ECG or TTE, or multiple cardiac risk factors. Categorical and continuous variables were compared by Fisher's exact test and analysis of variance, respectively. RESULTS: No preoperative cardiac workup was performed for 28 patients (7.4%); 127 patients (33.4%) had resting ECG only, 208 patients (54.7%) had resting echocardiography, 12 patients (3.2%) underwent stress testing, and five patients (1.3%) had coronary angiography. Patients undergoing stress testing or coronary angiography were older and had a higher incidence of known coronary artery disease (P < .01) and prior myocardial infarction (P = .01). Complex hybrid aortic repairs and TEVAR for aneurysmal disease were more likely to have an extensive workup, whereas nonelective procedures more commonly had no workup. A total of nine patients (2.4%) experienced a perioperative cardiac event (myocardial infarction or cardiac arrest), with no significant difference noted among all groups (P = .45), suggesting that the extent of cardiac workup was appropriate. The incidence of 30-day/in-hospital mortality (5.5%) and cardiac-specific mortality (0.8%) was similar among all groups. CONCLUSIONS: The risk of a postoperative cardiac event after TEVAR is low (2.4%), and initial screening with either resting TTE or ECG, in addition to assessment of cardiac symptom status, appears adequate for most TEVAR patients. As such, we recommend resting TTE or ECG as the initial cardiovascular screening mechanism in patients undergoing TEVAR, with subsequent more invasive studies if initial screening reveals cardiovascular abnormalities.

Atypical aortic thrombus: should nonoperative management be first line?

BACKGROUND: Aortic thrombus in the absence of atherosclerotic plaque or aneurysm is rare, and its optimal management remains unclear. Although atypical aortic thrombus (AAT) has been historically managed operatively, successful nonoperative strategies have been recently reported. Here, we report our experience in treating patients with AAT that has evolved from a primarily operative approach to a first-line, nonoperative strategy. METHODS: Records of patients treated for AAT between 2008 and 2011 at our institution were reviewed. RESULTS: Ten female and three male patients with ages ranging from 27 to 69 were identified. Seven were treated operatively and 6 nonoperatively. Initial presentation was variable and included limb thromboembolic events (n = 6), visceral ischemia (n = 5), and stroke (n = 1). Associated risk factors included hypercoagulability (76%; n = 10) and hyperlipidemia (38%, n = 5). In the nonoperative group, complete thrombus resolution was obtained via anticoagulation (n = 5) or systemic thrombolysis (n = 1). Complete thrombus extraction was achieved in all operative patients. There were 11 significant complications in 5 of the 7 patients (71%) in the operative group, including intraoperative lower extremity embolism, pericardial effusion, stroke, and 1 death. There was 1 complication in the patients treated nonoperatively. The median hospital length of stay was 9 days (range 3-49) for those treated nonoperatively and 30 days (range 4-115) for those undergoing operative thrombectomy. CONCLUSIONS: Although AAT has traditionally been treated operatively, nonoperative management of AAT with anticoagulation or thrombolysis is feasible in selected patients and may lessen morbidity and length of hospitalization in those patients for whom it is appropriate.

Insurance status predicts acuity of thoracic aortic operations.

OBJECTIVE: Nonelective case status is the strongest predictor of mortality for thoracic aortic operations. We hypothesized that underinsured patients were more likely to require nonelective thoracic aortic surgery because of reduced access to preventative cardiovascular care and elective surgical services. METHODS: Between June 2005 and August 2011, 826 patients were admitted to a single aortic referral center and underwent 1 or more thoracic aortic operations. Patients with private insurance or Medicare (insured group, n=736; 89%) were compared with those with Medicaid or no insurance (underinsured group, n=90; 11%). RESULTS: The proportion of patients requiring nonelective surgery was higher for underinsured than insured patients (56% vs 26%, P<.0001). Multivariable analysis revealed underinsurance to be the strongest independent predictor of nonelective case status (odds ratio [OR], 2.67; P<.0001). Preoperative use of lipid-lowering medications (OR, 0.63; P<.009) or a history of aortic surgery (OR, 0.48; P<.001) was associated with a decreased risk of nonelective operation. However, after adjustment for differences in preoperative characteristics and case status, underinsurance did not confer an increased risk of procedural morbidity or mortality (adjusted OR, 0.94; P=.83) or late death (adjusted hazard ratio, 0.83, P=.58) when compared with insured patients. CONCLUSIONS: Underinsured patients were at the greatest risk of requiring nonelective thoracic aortic operation, possibly because of decreased use of lipid-lowering therapies and aortic surveillance. These data imply that greater access to preventative cardiovascular care may reduce the need for nonelective thoracic aortic surgery and lead to improved survival from thoracic aortic disease.