Introduction: Immune-mediated inflammatory disease (IMID) is a subset of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, and psoriasis that is emerging as a risk factor for many cardiovascular diseases including valvular disease. Objectives: To determine whether IMID is associated with frequent and early development of bioprosthetic valve failure (BVF) after surgical aortic valve replacement (SAVR) and transcatheter valve replacement (TAVR). Methods: Serial echocardiograms for patients who underwent SAVR and TAVR at Cleveland Clinic between 2000 and 2022 were assessed for time to development of BVF after procedure. ICD10 codes were used to stratify to those with and without IMID. Kaplan-Meier curve and cox proportional hazard regression analysis were used to assess for differences in development of BVF after TAVR and SAVR. Results: 351 TAVR patients (52 IMID and 299 controls) and 1961 SAVR patients (300 IMID and 1661 controls) were included. BVF after TAVR occurred in 12 (23.1%) IMID and 21 (7.0%) control patients, respectively, yielding an adjusted hazard ratio of 4.02 (1.81 - 8.92). Time to 50% of patients developing BVF was earlier among IMID, occurring at 6.6 years IMID and not reached in controls (p < 0.001). There were no significant differences in prevalence and time to development of BVF in IMID vs controls after SAVR. Conclusion: After TAVR, BVF occurred earlier and more frequently in patients with IMID than controls. This risk should be included during shared decision making among IMID patients considered for TAVR, and may warrant more frequent monitoring post procedure. These differences in BVF were not seen after SAVR. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement No external funding for report ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Approved by Cleveland Clinic IRB Study Number 23-095 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Internal Cleveland Clinic Dataset

Objective: To characterize residual aortic regurgitation (AR), identify its risk factors, and evaluate outcomes following aortic root replacement with aortic valve reimplantation. Methods: From 2002 to 2020, 756 patients with a tricuspid aortic valve underwent elective reimplantation for aortic root aneurysm. AR on transthoracic echocardiograms before hospital discharge was graded as mild or greater. Machine learning was used to identify risk factors for residual AR and subsequent aortic valve reoperation.Results: Sixty-five patients (8.6%) had mild (58 [7.7%]) or moderate (7 [0.93%]) residual postoperative AR. They had more severe preoperative AR (38% vs 12%; P < .0001), thickened cusps (7.7% vs 2.2%; P = .008), aortic valve repair (38% vs 23%; P = .004), and multiple returns to cardiopulmonary bypass for additional repair (11% vs 3.3%; P = .003) than those without AR. Predictors of residual AR were severe preoperative AR, smaller aortic root graft, and concomitant cusp repair. At 10 years, patients with versus without residual AR had more moderate or severe AR (48% vs 7.0%; P <.0001) and freedom from reoperation was worse (89% vs 98%; P < .0001). Residual AR was a risk factor for early reoperation. Concomitant coronary bypass, lower body mass index, and lower ejection fraction were risk factors for late reoperation. Ten-year survival was similar among patients with and without residual AR (97% vs 93%; P = .43).Conclusions: Residual AR after elective reimplantation of a tricuspid aortic valve for aortic root aneurysm is uncommon. Patients with severe preoperative AR and those who undergo valve repair have higher risk for residual AR, which can progress and increase risk of aortic valve reoperation.

A woman with shortness of breath underwent imaging that showed an isolated dilatation in the mid ascending aorta and a bicuspid aortic valve but no pulmonary infiltrates, effusion, or embolism and no aortic stenosis or regurgitation; her family history is notable for aortic dissection. What would you do next?

OBJECTIVE:Open surgery is the gold standard for patients a connective tissue disorder (CTD). Thoracic endovascular aortic repair (TEVAR) is used in emergencies and patient-specific situations. Limited data on durability of TEVAR in patients with CTD exist. The purpose of this study was to investigate the durability, complications, and outcomes of TEVAR in patients with CTD. METHODS:This single-center retrospective study included 40 patients with CTD who underwent TEVAR for thoracoabdominal aortic aneurysm or aortic dissection from February 2014 to April 2021. CTDs included Marfan syndrome, Loey-Dietz syndrome, and nonspecific CTD-related diagnoses. Primary outcomes included aortic-related morbidities, time to and type of postoperative reinterventions, and time to open/hybrid conversion. Time to conversion and reintervention was calculated using Kaplan-Meier estimation. Predictors of reintervention and open/hybrid conversion were evaluated using Cox proportional hazards models. RESULTS:The median age was 53 years with 52.5% of the patients being female. Marfan syndrome was diagnosed in 57.5%, Loey-Dietz syndrome in 2.5%, and 40% had a diagnosed nonspecific or other CTD. Thirty-two (80%) had prior aortic interventions. Thoracic aneurysm existed in 52.5% and dissection in 82.5%. The average maximum thoracic aortic diameter was 55.2 mm. There were two mortalities within the first month. Of the remaining 38 patients, 71.1% had aneurysm-related morbidities, including 81.5% with aneurysmal degeneration and 33.3% with endoleak. Overall, 62.5% required reintervention. Of those, median time to reintervention was 9.1 months, including redo-TEVAR/extension in 32%, ascending/arch repair in 24%, open thoracoabdominal aortic repair in 56%, and false lumen embolization in 16%. Open conversions and reintervention were most likely to occur within the first year, with freedom of open conversion of 67.2% at 1 year, and 59.7% at 2 and 3 years, and freedom of reintervention of 49.8%, 36.0%, and 30.0% at 1, 2, and 3 years, respectively. CONCLUSIONS:This study suggests that TEVAR for patients with CTD can be performed safely; however, patients are at high risk for aortic-related morbidities and reintervention. Reinterventions and open conversion are common and more likely to occur within 1 year. TEVAR should remain limited in this population until more durable outcomes are possible.

This research letter discusses the association between reoperative interval and perioperative mortality risk in cardiac surgery.

BACKGROUND:Aortic stenosis and prosthesis-patient mismatch complicate surgery for patients with small left ventricular outflow tracts. We present outcomes of a modified-Bentall single-patch Konno enlargement (BeSPoKE) technique for complex left ventricular outflow tract obstruction in adults. METHODS:The BeSPoKE technique facilitates a true outflow tract enlargement through an anterior septoventriculoplasty, using a single pericardial patch, followed by composite aortic valve-graft root replacement. Postoperative outflow tract geometry and valvular physiology were compared against preoperative measurements using echocardiography and computed tomographic angiography. Clinical outcomes at 2 years were assessed. RESULTS:From October 2017 to March 2022, 25 adults (median age, 60 years; 84% women) underwent a BeSPoKE repair. Mean preoperative aortic valve gradient was 44 ± 19 mm Hg. Twenty-one patients (84%) had previous aortic valve replacements with prosthesis-patient mismatch; median implant size preoperatively was 19 mm. Postoperatively, all patients received a prosthesis of at least 21 mm, with a median upsizing of 2 (15th-85th percentile, 2-3 sizes). Mean postoperative aortic valve gradient was 8.5 ± 4.1 mm Hg (P < .001). The mean 2-year gradient was 8.3 ± 1.3 mm Hg. All patients with bioprosthetic replacements qualified for future transcatheter valve replacements. Postoperative complications included atrial fibrillation in 9 (36%) and complete heart block requiring pacemaker placement in 8 (32%). There were no operative deaths, and no reoperations were reported. There were 2 late noncardiac-related deaths; 2-year survival was 92%. CONCLUSIONS:The BeSPoKE technique facilitates larger prosthesis placement, improves hemodynamics, and enables future transcatheter reinterventions. This approach is a safe treatment for complex left ventricular outflow tract obstruction and prosthesis-patient mismatch in adults.

Objective: Anterior mitral anular calcification, particularly in radiation heart disease, and previous valve replacement with destroyed intervalvular fibrosa are challenging for prosthesis sizing and placement. The Commando procedure with intervalvular fibrosa reconstruction permits double-valve replacement in these challenging conditions. We referenced outcomes after Commando procedures to standard double-valve replacements. Methods: From January 2011 to January 2022, 129 Commando procedures and 1191 aortic and mitral double-valve replacements were performed at the Cleveland Clinic, excluding endocarditis. Reasons for the Commando were severe calcification after radiation (n = 67), without radiation (n = 43), and others (n = 19). Commando procedures were referenced to a subset of double-valve replacements using balancing-score methods (109 pairs). Results: Between balanced groups, Commando versus double-valve replacement had higher total calcium scores (median 6140 vs 2680 HU, P = .03). Hospital outcomes were similar, including operative mortality (12/11% vs 8/7.3%, P = .35) and reoperation for bleeding (9/8.3% vs 5/4.6%, P = .28). Survival and freedom from reoperation at 5 years were 54% versus 67% (P = .33) and 87% versus 100% (P = .04), respectively. Higher calcium score was associated with lower survival after double-valve replacement but not after the Commando. The Commando procedure had lower aortic valve mean gradients at 4 years (9.4 vs 11 mm Hg, P = .04). After Commando procedures for calcification, 5-year survival was 60% and 59% with and without radiation, respectively (P = .47). Conclusions: The Commando procedure with reconstruction of the intervalvular fibrosa destroyed by mitral anular calcification, radiation, or previous surgery demonstrates acceptable outcomes similar to standard double-valve replacement. More experience and long-term outcomes are required to refine patient selection for and application of the Commando approach.

Objective: To maximize successful repair of bicuspid aortic valves by adding figure- of-8 hitch -up stitches at commissures. Methods: From 2000 to 2022, bicuspid aortic valve repair was performed on 1112 patients at Cleveland Clinic, with 367 patients receiving figure -of -8 hitch -up stitches along with classical techniques, including Cabrol suture, cusp plication, raphe resection, and valve -sparing root replacement. Operative outcomes, repair durability, and survival were assessed in the figure -of -8 hitch -up stitches cohort, and outcomes were compared among 195 balancing -score -matched patient pairs who underwent bicuspid aortic valve repair with and without figure -of -8 hitch -up stitches. Results: Patients who underwent bicuspid aortic valve repair with figure -of -8 stitches had an operative mortality of 0.3 % (1 of 367) and in -hospital reoperation for aortic valve dysfunction of 1.1 % (4 of 367). At 10 years, prevalence of severe aortic regurgitation was 8.6 % , mean gradient 24 mm Hg, freedom from aortic valve reoperation 75 % , and survival 98 % . In matched cohorts, operative mortality was similar (0.51 % vs 0 % ; P > .9) as were morbidities, including in -hospital reoperation due to aortic valve dysfunction (1.0 % vs 1.5 % ; P > .9). Comparable long-term outcomes were observed at 10 years (prevalence of severe aortic regurgitation of 8.7 % vs 5.0 % [ P = .11], mean gradient 18 vs 17 mm Hg [ P = .40]; freedom from aortic valve reoperation 80 % vs 81 % [ P = .73]; and survival 99.5 % vs 94.6 % [ P = .18]). Conclusions: Figure -of -8 hitch -up stitch is a safe bicuspid aortic valve repair technique. It increases the likelihood of a successful repair without increasing risk of cusp tear and achieves satisfactory long-term survival and durability when added to classical repair techniques. (JTCVS Techniques 2024;24:27-40)

OBJECTIVE:Patient characteristics, risks, and outcomes associated with reoperative multivalve cardiac surgery are poorly characterized. Effect of patient variables and surgical components of each reoperation were evaluated with regard to operative mortality. METHODS:From January 2008 to January 2022, 2324 patients with previous cardiac surgery underwent 2352 reoperations involving repair or replacement of multiple cardiac valves at Cleveland Clinic. Mean age was 66 ± 14 years. Number of surgical components representing surgical complexity (valve procedures, aortic surgery, coronary artery bypass grafting, and atrial fibrillation procedures) ranged from 2 to 6. Random forest for imbalanced data was used to identify risk factors for operative mortality. RESULTS:Surgery was elective in 1327 (56%), urgent in 1006 (43%), and emergency in 19 (0.8%). First-time reoperations were performed in 1796 (76%) and 556 (24%) had 2 or more previous operations. Isolated multivalve operations comprised 54% (1265) of cases; 1087 incorporated additional surgical components. Two valves were operated on in 80% (1889) of cases, 3 in 20% (461), and 4 in 0.09% (2). Operative mortality was 4.2% (98 out of 2352), with 1.7% (12 out of 704) for elective, isolated multivalve reoperations. For each added surgical component, operative mortality incrementally increased, from 2.4% for 2 components (24 out of 1009) to 17% for ≥5 (5 out of 30). Predictors of operative mortality included coronary artery bypass grafting, surgical urgency, cardiac, renal dysfunction, peripheral artery disease, New York Heart Association functional class, and anemia. CONCLUSIONS:Elective, isolated reoperative multivalve surgery can be performed with low mortality. Surgical complexity coupled with key physiologic factors can be used to inform surgical risk and decision making.

BACKGROUND:Multisegment thoracic aortic disease typically requires total aortic arch replacement, affects a heterogenous population, and carries a high risk even at centers of excellence. Risk has been associated with the duration of operation and complexity of repair. A novel branched stented anastomosis frozen elephant trunk repair (B-SAFER) technique has been developed at our center and is currently being studied as a physician-sponsored investigation device exemption (PS-IDE). OBJECTIVE:This study aimed to assess the early safety of using this investigational technique to treat the proximal aorta in subjects with aortic disease involving multiple segments. METHODS:This prospective, single center, nonrandomized study enrolled patients undergoing B-SAFER for acute aortic syndrome (n = 73), aortic aneurysm with chronic aortic dissection (n = 68), degenerative aortic aneurysm (n = 33), or congenital aortic arch disease (n = 4). Devices are delivered antegrade under hypothermic circulatory arrest, and the arch reconstruction is performed as a single anastomosis single stent (SASS; n = 70), single anastomosis multiple stent (SAMA; n = 68), multiple anastomosis single stent (MASS; n = 21), or multiple anastomosis multiple stent (MAMS; n = 16) reconstruction. The primary safety endpoints were operative mortality, disabling stroke, and paraparesis/paralysis. RESULTS:Between May 27, 2021, and December 31, 2022, 178 patients underwent B-SAFER in the configurations and for the indications as described above. The median patient age was 65 years (range, 21 to 85 years), and 52 (29%) were female. The median cardiopulmonary bypass time was 188 minutes (interquartile range [IQR], 155 to 226 minutes), and 97% of the patients underwent repair with antegrade brain perfusion for a median of 46 minutes (IQR, 38 to 61 minutes). Operative mortality occurred in 10 patients (5.6%, including 6 [8.2%] with acute dissection, 2 [2.9%] with chronic dissection, 2 [6.1%] with degenerative aneurysm, and 0 with a congenital disorder), disabling stroke in 5 patients (2.9%), and paraparesis in 1 patient. Other serious complications included respiratory failure (n = 20; 11.4%) and acute kidney injury (n = 18; 10%). Thirty-two patients (18%) had undergone second-stage repairs (28 endovascular and 4 open), with 1 operative mortality after that procedure due to distal rupture. Estimated survival was 95% at 30 days, 88% at 90 days, 84% at 6 months, and 79% at 1 year. One-year survival differed by indication (72% for acute dissection, 91% for chronic dissection, 71% for degenerative aneurysm, and 100% for congenital disorders). CONCLUSIONS:The B-SAFER technique for total arch replacement in a complex cohort of patients with various indications for surgery is a safe and reproducible operation, as demonstrated by the early results from a very inclusive PS-IDE study. Further follow-up and analysis will help refine the technique. Novel devices to perform this procedure should be developed.

Objective:The study objective was to determine repair durability and survival in patients with and without connective tissue disorders undergoing concomitant aortic valve reimplantation and mitral valve repair. Methods:From 2002 to 2019, 68 patients underwent concomitant aortic valve reimplantation and mitral valve repair, including 27 patients with Marfan syndrome (39.7%). Follow-up echocardiograms were analyzed using nonlinear multiphase mixed-effects cumulative logistic regression. The regurgitation grade over time was estimated by averaging patient-specific profiles. Survival and freedom from reoperation were estimated by the Kaplan-Meier method. Results:At 7 years, 11% of patients had aortic insufficiency greater than mild (severe in 2 patients). There was no difference in greater than mild aortic insufficiency between patients with or without Marfan syndrome (P = .37). Twenty percent of patients had progressed to mitral regurgitation greater than mild (severe in only 1 patient). The prevalence of recurrent mitral regurgitation was higher in those without Marfan syndrome, with greater than mild regurgitation increasing to 24% by 2 years and remaining constant thereafter (P = .04). Freedom from reoperation on the aortic valve or mitral valve was 83% at 10 years and did not differ between Marfan syndrome groups. There were no cases of perioperative mortality. Survival at 5 and 10 years was 94% and 87%, respectively, without a difference between those with and without Marfan syndrome. Conclusions:Patients can undergo a total repair strategy using combined aortic valve reimplantation and mitral valve repair procedures with a low risk of mortality and complications, with favorable freedom from both residual valve regurgitation and reoperation.

Objective: During aortic valve reimplantation, cusp repair may be needed to produce a competent valve. We investigated whether the need for aortic valve cusp repair affects aortic valve reimplantation durability. Methods: Patients with tricuspid aortic valves who underwent aortic valve reimplantation from January 2002 to January 2020 at a single center were retrospectively analyzed. Propensity matching was used to compare outcomes between patients who did and did not require aortic valve cusp repair. Results: Cusp repair was performed in 181 of 756 patients (24%). Patients who required cusp repair were more often male, were older, had more aortic valve regurgitation, and less often had connective tissue disease. Patients who underwent cusp repair had longer aortic clamp time (124 +/- 43 minutes vs 107 +/- 36 minutes, P = .001). In-hospital outcomes were similar between groups and with no operative deaths. A total of 98.3% of patients with cusp repair and 99.3% of patients without cusp repair had mild or less aortic regurgitation at discharge. The median follow-up was 3.9 and 3.2 years for the cusp repair and no cusp repair groups, respectively. At 10 years, estimated prevalence of moderate or more aortic regurgitation was 12% for patients with cusp repair and 7.0% for patients without cusp repair (P = .30). Mean aortic valve gradients were 6.2 mm Hg and 8.0 mm Hg, respectively (P = .01). Ten-year freedom from reoperation was 99% versus 99% (P = .64) in the matched cohort and 97% versus 97%, respectively (P = .30), in the unmatched cohort. Survival at 10 years was 98% after cusp repair and 93% without cusp repair (P = .05). Conclusions: Aortic valve reimplantation for patients with tricuspid aortic valves has excellent long-term results. Need for aortic valve cusp repair does not affect long-term outcomes and should not deter surgeons from performing valve-sparing surgery.

Journal Article Bare stenting of acute dissection: a gentle push forward Get access Eric E Roselli, Eric E Roselli Department of Thoracic and Cardiovascular Surgery, Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USADepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA Corresponding author. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Avenue/Desk J4-1, Cleveland, OH 44195, USA. Tel: +1-216-444-0995; e-mail: roselle@ccf.org (E.E. Roselli). https://orcid.org/0000-0003-1533-7987 Search for other works by this author on: Oxford Academic PubMed Google Scholar Patrick R Vargo Patrick R Vargo Department of Thoracic and Cardiovascular Surgery, Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA https://orcid.org/0000-0002-4313-0935 Search for other works by this author on: Oxford Academic PubMed Google Scholar European Journal of Cardio-Thoracic Surgery, Volume 63, Issue 3, March 2023, ezad039, https://doi.org/10.1093/ejcts/ezad039 Published: 15 February 2023 Article history Received: 29 January 2023 Published: 15 February 2023 Corrected and typeset: 07 March 2023

Objective: The durability of reimplanted myxomatous aortic valves in root replacements for patients with connective tissue disorders (CTD) is unclear; therefore, we sought to evaluate the long-term resilience of these repairs.Methods: From January 1980 to January 2020, 214 patients with CTD and 645 without CTD underwent primary, elective aortic valve reimplantation operations at Cleveland Clinic. The CTD cohort included 164 (77%) with Marfan, 23 (11%) with Loeys-Dietz, and 7 (3.3%) with Ehlers-Danlos CTD. We accounted for differing patient characteristics between the groups by propensity score matching to compare outcomes, yielding 96 matched pairs. Longitudinal echocardiographic measures were compared using nonlinear mixed effects models.Results: In the CTD cohort, there were no operative mortalities (30-day or inhospital), 1 (0.47%) stroke, and 1 (0.47%) early in-hospital reoperation for valve dysfunction. Ten-year prevalence of no aortic regurgitation was 86%, mild 11%, and moderate 3%. Ten-year freedom from reoperation was 97%. In propensity matched cohorts, there were no significant differences in in-hospital outcomes, longitudinal aortic regurgitation and mean gradient, risk of reoperation on the aortic valve, or risk of late death.Conclusions: Aortic valve reimplantation is a durable operation in patients with CTD and root aneurysms. These patients do not experience early degeneration of their reimplanted aortic valves. (J Thorac Cardiovasc Surg 2023;166:1617-26)

Objective: The study objective was to determine the effect of sinutubular junction stabilization on long-term outcomes of bicuspid aortic valve repair.Methods: From January 1998 to January 2020, 419 patients underwent bicuspid aortic valve repair with ascending aorta replacement and 421 without (bicuspid aortic valve repair alone). Propensity score matching (97 pairs) was used to compare outcomes. Results: Before matching, prevalence of severe aortic regurgitation at 10 years was 5.4% after bicuspid aortic valve repair + ascending aorta replacement and 10% after bicuspid aortic valve repair alone; aortic valve gradient was 20 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 19 mm Hg after bicuspid aortic valve repair alone. Ten-year freedom from reoperation overall was 79% after bicuspid aortic valve repair + ascending aorta replacement and 75% after bicuspid aortic valve repair alone; freedom from late aortic regurgitation was 93% after bicuspid aortic valve repair + ascending aorta replacement and 92% after bicuspid aortic valve repair alone; and freedom from aortic stenosis was 87% after bicuspid aortic valve repair + ascending aorta replacement and 93% after bicuspid aortic valve repair alone. Ten-year survival was 95% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone. After matching, prevalence of severe aortic regurgitation at 10 years was 11% after bicuspid aortic valve repair + ascending aorta replacement and 9.1% after bicuspid aortic valve repair alone (P = .33); aortic valve gradient was 16 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 25 mm Hg after bicuspid aortic valve repair alone (P<.0001). Ten-year freedom from reoperation was 85% after bicuspid aortic valve repair + ascending aorta replacement and 72% after bicuspid aortic valve repair alone (P = .08) overall. Ten-year freedom from reoperation for late aortic regurgitation was 88% after bicuspid aortic valve repair + ascending aorta replacement and 86% after bicuspid aortic valve repair alone (P = .65). Freedom from aortic stenosis was 97% after bicuspid aortic valve repair + ascending aorta replacement and 91% after bicuspid aortic valve repair alone (P = .03). Ten-year survival was 96% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone (P = .16).Conclusions: Bicuspid aortic valve repair with or without ascending aorta replacement is associated with good short-and long-term outcomes. Bicuspid aortic valve repair + ascending aorta replacement has a minimal effect on long-term repair durability. Sinutubular junction stabilization should not be performed for the sole purpose of long-term repair durability.

Background: Operative mortality for type A aortic dissection is still 10–20% at centers of excellence. Additionally, 10–20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). Objective: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. Methods: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. Results: Nineteen patients were enrolled with a mean age of 75.7 years (range 47–91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52–392) and median contrast used was 111 mL (range 75–200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). Conclusion: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.