Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

The Relay Thoracic Stent-Graft with Plus Delivery System (RelayPlus; Terumo Aortic, Sunrise, Fla) was designed to handle the curvature and tortuosity of the thoracic aorta. It was approved by the Food and Drug Administration in 2012; the postapproval study was stopped early because of adequate safety and efficacy data, and no difference was identified in experienced vs first-time users of RelayPlus. The purpose of this study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus. This is a prospective, multicenter, nonrandomized postapproval study that required the use of novice implanters in the United States. Primary and secondary end points included device-related adverse events (deployment failure, conversion to open repair, endoleaks, migration, rupture, and mortality) and major adverse events (stroke, paraplegia/paraparesis, renal failure, respiratory failure, and myocardial infarction), respectively. Continuous and categorical covariates were reported in means or medians and percentages, respectively. Kaplan-Meier survival estimates were used to report long-term TEVAR-related mortality, all-cause mortality, and reinterventions at 3 years. A total of 45 patients with mean age (standard deviation [SD]) of 73.5 (±7.20) years were treated for descending thoracic fusiform aneurysm (56%) or saccular aneurysm/PAU (44%). The patients were predominantly white (80.0%) and male (68.9%). Mean (SD) proximal neck, distal neck, and lesion lengths were 38.2 (±37) mm, 42.1 (±28) mm, and 103.8 (±74) mm, respectively. Mean (SD) aneurysm, proximal neck, and distal neck diameters were 53.9 (±13) mm, 31.3 (±4) mm, and 31.7 (±6) mm, respectively. Technical success was 100%. TEVAR-related mortality at 30 days was 4.4%; two patients died postoperatively, one of shock and the second of bilateral hemispheric stroke. No patient in the study had any conversion to open repair or post-TEVAR rupture. Two patients experienced three major adverse events, which included stroke (2.2%), paraplegia (2.2%), and respiratory failure (2.2%) at 30 days. Three-year freedom from TEVAR-related mortality, all-cause mortality, and reinterventions was 95.6%, 84.0%, and 97.2%, respectively. There were two type I endoleaks at 3 years: one type IB associated with no migration or aneurysm sac increase and one type IA associated with caudal migration of proximal neck and expansion of the proximal aorta. The RelayPlus postapproval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and PAU endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.

Malas M ，Locham S ，Hughes C ，Bacharach M ，Brinster D ，McKinsey J ，Mannava K ，Wu J ，Rahimi S ，Sharafuddin M ... -  《-》

Initial and midterm results of the Bolton Relay Thoracic Aortic Endovascular Pivotal Trial.

To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]. The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012. TEVAR outcomes were compared with a prospectively and retrospectively enrolled surgical cohort consisting of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were prescribed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality. Stent grafts were successfully delivered and deployed in 129 of 133 patients (97.0%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10.0%; P = .230), and TEVAR was associated with a significantly lower rate of MAEs (20.3% vs 48.3%; P < .001), primarily driven by a lower frequency of respiratory failure in the cohort (5.5% vs 21.6%; P = .007) and procedural bleeding. Freedom from aneurysm-related mortality through 5 years was similar at 91.3% for the TEVAR cohort and 89.4% for the surgical cohort (P = .406); with 5-year freedom from all-cause mortality at 57.1% and 50.2% (P = .289), respectively. Freedom from MAEs through 5 years was significantly higher in the TEVAR cohort (65.7% vs 44.7%; P = .001). Six TEVAR patients (4.5%) experienced core laboratory-reported type I or III endoleaks, and secondary procedures were performed in 10 patients (7.5%), with seven procedures to correct endoleak and one surgical conversion. Endograft migration occurred in three patients (2.3%) and wireform fractures were assessed in two patients (1.5%). Aneurysm sac size decreased or remained stable in 113 patients (85.0%) over 5-year follow-up. There were no instances of rupture or endograft occlusion. A 38-subject subset treated with the newer Relay Plus Delivery System had a significantly reduced MAE rate (15.8% vs 35.8%; P = .035), and fewer perioperative strokes (2.6% vs 12.6%; P = .108). Data from the Relay TEVAR clinical trial demonstrate safety and effectiveness of the Relay device compared with surgical controls, indicating continued device durability with a low rate of device-related complications through 5 years.

Farber MA ，Lee WA ，Szeto WY ，Panneton JM ，Kwolek CJ ... -  《-》

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 ... -  《-》

Clinical impact of proximal fixation augmentation using the Najuta thoracic fenestrated stent graft during endovascular treatment for distal aortic arch aneurysm.

Prevention of late type Ia endoleaks is the main concern in thoracic endovascular aortic aneurysm repair (TEVAR) for thoracic aortic aneurysm. Since 2017, we have performed zone 0 TEVAR with proximal fixation augmentation using a Najuta thoracic fenestrated stent graft in addition to zone 2 TEVAR for distal arch aneurysms. We report the early and midterm outcomes of TEVAR performed using this strategy. This single-center retrospective study enrolled 386 cases of TEVAR for thoracic aortic disease between January 2013 and December 2020. Patients with thoracic aortic aneurysm treated by TEVAR landing at zone 2 was referred to as the standard group, whereas those treated by TEVAR landing at zone 0 using a Najuta fenestrated stent graft in addition to zone 2 TEVAR was referred to as the augmentation group. We retrospectively compared the clinical outcomes between the two groups. The primary end point was secondary intervention for postoperative type Ia endoleaks. Secondary end points were technical success, aneurysm-related death, and major adverse events (MAEs), including stroke, paraplegia, endoleaks, and secondary interventions. We performed TEVAR in 41 and 30 cases in the standard and augmentation groups, respectively. The mean aneurysm sizes in the standard and augmentation groups were 54.5 and 57.3 mm (P = .23), and the proximal neck lengths were 16.8 and 17.4 mm (P = .65), respectively. The anatomical characteristics seemed to be similar in both groups. The technical success rate in both groups was 100%. Three cases in the standard group had MAEs, including two stroke and one brachial artery pseudoaneurysm; whereas two cases had MAEs in the augmentation group, including one stroke and one paraplegia. There was no 30-day mortality or retrograde type A dissection in both groups. The mean observation periods in the standard and augmentation groups were 46 months (range, 1-123 months) and 35 months (range, 1-73 months), respectively. At 36 and 60 months after the procedure, the freedom from aneurysm-related death was 97.6% and 97.6% in the standard group, 100.0% and 100.0% in the augmentation group (P = .39); and the freedom from reintervention for type Ia endoleaks was 79.2% and 65.2% in the standard group, 100.0% and 100.0% in the augmentation group (P = .0087). A statistically significant decrease in reinterventions for type Ia endoleaks was observed in the augmentation group. Proximal fixation augmentation using the Najuta fenestrated stent graft during TEVAR for distal arch aneurysm is effective in preventing the postoperative late type Ia endoleaks.

Fukushima S ，Ohki T ，Tachihara H ，Shukuzawa K ，Ohmori M ，Ozawa H ，Shirouzu M ，Nakagawa H ，Yamada Y ，Kasa K ... -  《-》

One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies.

The study objective was to evaluate the safety and effectiveness of the second-generation, low-profile RelayPro (Terumo Aortic) thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer. A prospective, international, nonblinded, nonrandomized, pivotal trial analyzed a primary safety end point of major adverse events at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss) and a primary effectiveness end point of treatment success at 1 year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared with performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the United States and Japan and enrolled participants between 2017 and 2019. The study population of 110 patients had a median (interquartile range) age of 76 (70-81) years, 69 (62.7%) were male, and 43 (39.1%) were Asian. Patients were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 penetrating atherosclerotic ulcers (9%). Most patients (82.7%) were treated with a non-bare stent configuration. Technical success was 100%. The median (interquartile range) procedure time was 91 (64-131) minutes, and the deployment time was 16 (10-25) minutes. A total of 50 patients (73.5%) in the US cohort had percutaneous access, whereas centers in Japan used only surgical cutdown. The 30-day composite major adverse events rate was 6.4% (95% upper confidence interval, 11.6%; P = .0002): 2 strokes, 2 procedural blood losses greater than 1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% confidence interval, 81.8%; P = .0185). Nine subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, and 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration. The low-profile RelayPro thoracic endograft met the study primary end points and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or penetrating atherosclerotic ulcers. Follow-up is ongoing to evaluate longer-term outcomes and durability.

Szeto WY ，Vallabhajosyula P ，Matsuda H ，Moainie SL ，Sharafuddin MJ ，Corvera J ，Smolock CJ ，Miyamoto S ，Naslund T ，Ramaiah V ，RelayPro-A Investigators ... -  《-》