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ImportanceThoracic endovascular aortic repair (TEVAR) has increasingly been used for uncomplicated type B aortic dissection (uTBAD) despite limited supporting data.ObjectiveTo assess whether initial TEVAR following uTBAD is associated with reduced mortality or morbidity compared with medical therapy alone.Design, Setting, and ParticipantsThis cohort study included Centers for Medicare & Medicaid Services inpatient claims data for adults aged 65 years or older with index admissions for acute uTBAD from January 1, 2011, to December 31, 2018, with follow-up available through December 31, 2019.ExposuresInitial TEVAR was defined as TEVAR within 30 days of admission for acute uTBAD.Main Outcomes and MeasuresOutcomes included all-cause mortality, cardiovascular hospitalizations, aorta-related and repeated aorta-related hospitalizations, and aortic interventions associated with initial TEVAR vs medical therapy. Propensity score inverse probability weighting was used.ResultsOf 7105 patients with eligible index admissions for acute uTBAD, 1140 (16.0%) underwent initial TEVAR (623 [54.6%] female; median age, 74 years [IQR, 68-80 years]) and 5965 (84.0%) did not undergo TEVAR (3344 [56.1%] female; median age, 76 years [IQR, 69-83 years]). Receipt of TEVAR was associated with region (vs South; Midwest: adjusted odds ratio [aOR], 0.66 [95% CI, 0.53-0.81]; P P P = .003), hypertension (aOR, 1.26; 95% CI, 1.03-1.54; P = .03), peripheral vascular disease (aOR, 1.24; 95% CI, 1.02-1.49; P = .03), and year of admission (2012, 2013, 2014, and 2015 were associated with greater odds of TEVAR compared with 2011). After inverse probability weighting, mortality was similar for the 2 strategies up to 5 years (hazard ratio [HR], 0.95; 95% CI, 0.85-1.06), as were aorta-related hospitalizations (HR, 1.12; 95% CI, 0.99-1.27), aortic interventions (HR, 1.01; 95% CI, 0.84-1.20), and cardiovascular hospitalizations (HR, 1.05; 95% CI, 0.93-1.20). In a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality over a period of 1 year (adjusted HR [aHR], 0.86; 95% CI, 0.75-0.99; P = .03), 2 years (aHR, 0.85; 95% CI, 0.75-0.96; P = .008), and 5 years (aHR, 0.87; 95% CI, 0.80-0.96; P = .004).Conclusions and RelevanceIn this study, 16.0% of patients underwent initial TEVAR within 30 days of uTBAD, and receipt of initial TEVAR was associated with hypertension, peripheral vascular disease, region, Medicaid dual eligibility, and year of admission. Initial TEVAR was not associated with improved mortality or reduced hospitalizations or aortic interventions over a period of 5 years, but in a sensitivity analysis that included deaths within the first 30 days, initial TEVAR was associated with lower mortality. These findings, along with cost-effectiveness and quality of life, should be assessed in a prospective trial in the US population.

New-onset postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery and is associated with increased long-term stroke and mortality. Anticoagulation has been suggested as a potential therapy, but data on safety and efficacy are scant.To determine the association between anticoagulation for POAF and long-term outcomes.Adult patients with POAF after isolated coronary artery bypass surgery (CABG) were identified through the Society of Thoracic Surgeons Adult Cardiac Surgery Database and linked to the Medicare Database. Propensity-matched analyses were performed for all-cause mortality, stroke, myocardial infarction, and major bleeding for patients discharged with or without anticoagulation. Interaction between anticoagulation and CHAOf 38,936 patients, 9861 (25%) were discharged on oral anticoagulation. After propensity score matching, discharge anticoagulation was associated with increased mortality (hazard ratio [HR] 1.16, 95% confidence interval [CI] 1.06-1.26). There was no difference in ischemic stroke between groups (HR 0.97, 95% CI 0.82-1.15), but there was significantly higher bleeding (HR 1.60, 95% CI 1.38-1.85) among those discharged on anticoagulation. Myocardial infarction was lower in the first 30 days for those discharged on anticoagulation, but this effect decreased over time. The incidence of all complications was higher for patients with CHAAnticoagulation is associated with increased mortality after new-onset POAF following CABG. There was no reduction in ischemic stroke among those discharged on anticoagulation regardless of CHA

OBJECTIVES Porcelain aorta complicates aortic valve replacement and is an indication for transcatheter approaches. No study has compared surgical and transcatheter valve replacement in the setting of porcelain aorta. We characterize porcelain aorta patients undergoing aortic valve replacement and the association of aortic calcification and outcomes. METHODS Patients undergoing aortic valve replacement with porcelain aorta were identified. Aortic calcium volume was determined using 3D computed tomography thresholding techniques. Propensity scoring was performed to assess the effect of surgical versus transcatheter approaches. Risk factors for composite major hospital complications (death, stroke and dialysis) were identified using random forest machine learning. RESULTS From January 2006 to January 2015, 164 patients with porcelain aorta underwent aortic valve replacement [105 (64%) surgical replacement, 59 (36%) transcatheter replacement]. Propensity scoring matched 29 pairs (49% of transcatheter patients). Before matching, 5-year survival was 41% [(43% surgical, 35% transcatheter, P(log-rank) = 0.9]. After matching, mortality for surgical versus transcatheter replacement was 3.4% (n = 1) vs 10% (n = 3), stroke 14% (n = 4) vs 3.4% (n = 1) and dialysis 6.9% (n = 2) versus 11% (n = 3). Matched 5-year survival was 40% after surgical replacement and 29% after transcatheter replacement [P(log-rank) = 0.4]. Total aortic calcium volume was greater in transcatheter than surgical patients [18 (8.0) vs 17 (7.7) ml] and was associated with more major hospital complications after either approach. CONCLUSIONS Surgical and transcatheter approaches are complementary options for aortic stenosis with porcelain aorta. Surgical valve replacement remains an effective treatment for patients requiring concomitant procedures. Quantifying aortic calcium volume is a helpful risk predictor in all patients with porcelain aorta.

Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from a novel approach to a well-established treatment modality for aortic arch pathology in appropriately selected patients. HAR procedures have been proposed as a means to circumvent the perioperative morbidity and mortality associated with open total arch replacement. These procedures, all of which remain off-label applications of approved endograft technology, combine more conventional open surgical techniques, to create endograft landing zones, with thoracic endovascular aortic repair to exclude the aortic pathology from the circulation. The current classification system for HAR was proposed in 2013 and consists of three types, designated by the Roman numerals I, II and III. The current system has become outdated, however, with the advent of newer technologies, and herein we propose a new, updated classification system that is more encompassing with regards to the broad array of options available to treat aortic arch disease. Likewise, an institutional algorithm to guide patient and operative selection for HAR is presented. Patients are considered for HAR if they have either high-risk comorbidities or high-risk anatomy, with an important feature of the algorithm being that any decisions about repair strategy should be made by a surgical team with expertise in both open and endovascular techniques. Despite being performed for nearly two decades, the evidence around HAR consists mainly of single center series (level B–C evidence) with no randomized controlled trials. The data suggest HAR to be a safe alternative to open repair with acceptable short and mid-term results. As we as aortic surgeons continue to move towards less invasive approaches, both conventional open and hybrid techniques will remain important tools in the toolbox for arch repair, although the advent of multi-branched arch endografts will almost certainly reduce the extent of open or hybrid repair in many patients and eliminate it altogether in others.

There are limited therapeutic options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) with inflammation-mediated lung injury. Mesenchymal stromal cells offer promise as immunomodulatory agents.Evaluation of efficacy and safety of allogeneic mesenchymal cells in mechanically-ventilated patients with moderate or severe COVID-induced respiratory failure.Patients were randomized to two infusions of 2 million cells/kg or sham infusions, in addition to standard of care. We hypothesized that cell therapy would be superior to sham-control for the primary endpoint of 30-day mortality. The key secondary endpoint was ventilator-free survival within 60 days, accounting for deaths and withdrawals in a ranked analysis.At the third interim analysis, the Data and Safety Monitoring Board recommended that the trial halt enrollment as the pre-specified mortality reduction from 40% to 23% was unlikely to be achieved (n=222 out of planned 300). Thirty-day mortality was 37.5% (42/112) in cell recipients versus 42.7% (47/110) in control patients (RR 0.88;95% CI 0.64,1.21;p=0.43). There were no significant differences in days alive off ventilation within 60 days (median rank 117.3 [IQR:60.0,169.5] in cell patients and 102.0 [IQR:54.0,162.5] in controls; higher is better). Resolution or improvement of ARDS at 30-days was observed in 51/104 (49.0%) cell recipients and 46/106 (43.4%) of control patients (OR 1.36;95% CI 0.57, 3.21). There were no infusion-related toxicities and overall serious adverse events over 30 days were similar.Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate/severe COVID-related acute respiratory distress syndrome. Clinical trial registration available at www.gov, ID:NCT04371393. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multinational, multicenter trial. PARTICIPANTS: Adults hospitalized with COVID-19. INTERVENTION: Intravenous ensovibep, 600 mg, or placebo. MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. RESULTS: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR

Aortic arch reconstruction after prior cardiac surgery is technically complex, especially after proximal aortic surgery. While multiple surgical adaptations in the redo setting have been described, traditional open reconstruction remains the most common approach with significant variability in outcomes in prior reports. This study describes institutional adaptations to surgical technique and perioperative care and assesses operative and long-term outcomes after redo-aortic arch repair in the modern era.Patients undergoing hemi- or total arch reconstruction after prior cardiac surgery (2005-2022) were identified from a prospectively maintained institutional database. Strategic adaptations in approach over the study interval included a shift towards Type II hybrid arch repair for patients with "mega-aorta," redo-cannulation of the axillary artery when necessary, and adoption of transfusion and early extubation protocols. Outcomes of interest included 30-day/in-hospital adverse events and actuarial long-term overall and aorta-specific survival.The study cohort included 214 patients undergoing hemi-arch (N.=154, 72%) or total arch (N.=60, 28%) after prior cardiac surgery (50% prior proximal aortic surgery). Surgical indications included degenerative aneurysm (47%, N.=101), residual arch dissection after prior type A repair (29%, N.=61), acute or chronic type A dissection (18%, N.=39) or other (6%, N.=13). 30-day/in-hospital mortality was 6% (5% hemi-arch; 10% total arch) and stroke was 3% (3% hemi-arch; 2% total arch). At median follow-up of 56 months, overall 5- and 10-year survival was 76% and 58% (hemi-arch: 81%, 62%; total arch: 63%, 43%); aorta-specific survival was 91% and 90% (hemi-arch: 96%, 94%; total arch: 79%, 79%).In this modern single-institution series, a systematic approach to redo-arch repair yields excellent operative outcomes and late aorta-specific survival. Reduced late overall survival reflects the comorbidity burden of this population. Open reconstruction continues to play an important role in reoperative arch repair in the modern era.

Recent esophagectomy trends were evaluated to describe the shift in surgical approach and outcomes using the Society of Thoracic Surgeons General Thoracic Surgery Database (STS-GTSD).All patients who underwent an esophagectomy with gastric conduit were identified from 2015-2019 and analyzed according to original intended approach. After performing volume trend analysis of patients, operative outcomes were evaluated.Among 10,607 patients, esophagectomy was open in 5763 (54.3%), minimally-invasive (MIE) in 3524 (33.2%) and robotic (RAMIE) in 1320 (12.4%). Within five years, MIE and RAMIE combined rose to majority approach (open from 58 to 42% of annual volume). While MIE and RAMIE were associated with higher rates of anastomotic leak, loss of conduit, pulmonary embolus, and reoperation, R0 resection and harvested number of lymph nodes exceeded those in open approaches. Operative mortality did not differ by approach (3.21% open vs. 2.72% MIE vs. 2.50% RAMIE; p=0.2329). On multivariable analysis, RAMIE was independently associated with higher rate of anastomotic leak compared to open (aOR 1.53, 95% CI 1.14-2.04), while both MIE and RAMIE had lower mean length of stay. Propensity matching of 1,320 pairs found a higher risk of anastomotic leak requiring surgery for RAMIE compared to MIE (aOR 1.39, 95% CI 1.01-1.92).In less than a decade, the dominant surgical approach in the STS-GTSD has become minimally invasive (RAMIE and MIE). While anastomotic leak and reoperation, more common in RAMIE, require a technical solution, these complications have not raised operative mortality. Further studies are needed to address long-term results and oncologic outcome.

The majority of congenital and adult cardiac surgery is performed through a median sternotomy. For surgeons, this incision provides excellent exposure; however, for patients, a median sternotomy confers a poorer cosmetic outcome and the possibility of postoperative respiratory dysfunction, chronic pain, and deep sternal wound infections. Despite the advances in adult cardiac surgery, the use of minimally invasive techniques in pediatric patients is largely limited to small case series and less complex repairs. In this article, we review the risks, benefits, and limitations of the minimally invasive congenital cardiac approaches being performed today. The interest in these approaches continues to grow as more data supporting reduced morbidity, decreased length of stay, and faster recovery are published. In the future, as the technology and surgical familiarity improve, these alternative approaches will become more common, and may someday become the standard of care.

Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices.Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR2 and chi squared value4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE.There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material.The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.

BackgroundThe optimal delivery route to enhance effectiveness of regenerative therapeutics to the human heart is poorly understood. Direct intra-myocardial (IM) injection is the gold standard, however, it is relatively invasive. We thus compared targeted IM against less invasive, catheter-based intra-coronary (IC) delivery to porcine myocardium for the acute retention of nanoparticles using cardiac magnetic resonance (CMR) imaging and viral vector transduction using qPCR.MethodsFerumoxytol iron oxide (IO) nanoparticles (5 ml) were administered to Yorkshire swine (n = 13) by: (1) IM via thoracotomy, (2) catheter-based IC balloon-occlusion (BO) with infusion into the distal left anterior descending (LAD) coronary artery, (3) IC perforated side-wall (SW) infusion into the LAD, or (4) non-selective IC via left main (LM) coronary artery infusion. Hearts were harvested and imaged using at 3T whole-body MRI scanner. In separate Yorkshire swine (n = 13), an adeno-associated virus (AAV) vector was similarly delivered, tissue harvested 4–6 weeks later, and viral DNA quantified from predefined areas at risk (apical LV/RV) vs. not at risk in a potential mid-LAD infarct model. Results were analyzed using pairwise Student's t-test.ResultsIM delivery yielded the highest IO retention (16.0 ± 4.6% of left ventricular volume). Of the IC approaches, BO showed the highest IO retention (8.7 ± 2.2% vs. SW = 5.5 ± 4.9% and LM = 0%) and yielded consistent uptake in the porcine distal LAD territory, including the apical septum, LV, and RV. IM delivery was limited to the apex and anterior wall, without septal retention. For the AAV delivery, the BO was most efficient in the at risk territory (Risk: BO = 6.0 × 10−9, IM = 1.4 × 10−9, LM = 3.2 × 10−10 viral copies per μg genomic DNA) while all delivery routes were comparable in the non-risk territory (BO = 1.7 × 10−9, IM = 8.9 × 10−10, LM = 1.2 × 10−9).ConclusionsDirect IM injection has the highest local retention, while IC delivery with balloon occlusion and distal infusion is the most effective IC delivery technique to target therapeutics to a heart territory most in risk from an infarct.

After limited root/ascending with or without hemiarch repair for acute type A aortic dissection (ATAAD), 20% to 30% of patients require distal reintervention, frequently for arch pathology. In this report, we describe an institutional algorithm for arch management after previous limited ATAAD repair and detail operative and long-term outcomes.From August 2005 to April 2021, 71 patients status post previous limited ATAAD repair underwent reoperative arch repair involving zones 1 to 3 for aneurysmal degeneration of residual arch dissection including complete cervical debranching with zone 0/1 thoracic endovascular aortic repair in 6 (8%), open total arch in 13 (18%), type I hybrid arch repair in 23 (32%), and type II/III hybrid arch repair in 29 (41%).Mean age was 59 ± 12 years; time from index ATAAD repair to reoperation was 4 (interquartile range, 2-9) years. There were 2 (2.8%) in-hospital deaths and 2 (2.8%) postdischarge deaths within 30 days of surgery. Three patients suffered stroke (4.2%) and 2 (2.8%) had acute renal failure requiring dialysis. Overall Kaplan-Meier survival was 78%, 70%, and 58% at 1, 3, and 5 years, respectively. Institutional experience appeared to play a significant role in early and late outcomes, because there have been no operative mortalities in the past 9 years and improved survival of 87% versus 66%, 79% versus 58%, and 79% versus 40% at 1, 3, and 5 years in comparisons of the past 9 years with the previous era (P = .01).Aneurysmal degeneration of residual arch dissection after limited ATAAD repair presents a complex reoperative challenge. An algorithmic operative approach tailored to patient anatomy and comorbidities yields excellent early and late outcomes, which continue to improve with increasing institutional experience.

Chronic thromboembolic pulmonary hypertension is a progressive disease, which may lead to severe right ventricular dysfunction and debilitating symptoms. Pulmonary thromboendarterectomy (PTE) provides the best opportunity for complete resolution of obstructing thromboembolic disease and functional improvement in appropriately selected patients. In this article, the authors review preoperative workup, patient selection, operative technique, postoperative care, and outcomes after PTE.

Public interest in stratifying hospital performance has led to the proliferation of commercial, consumer-oriented hospital rankings. In cardiac surgery, little is known about how these rankings correlate with clinical registry quality ratings.The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried for isolated coronary artery bypass grafting or coronary artery bypass grafting/valve patients at hospitals among the top 100 U.S. NewsWorld Report (USNWR) CardiologyHeart Surgery rankings from 2016 to 2020. Hospitals were grouped into deciles by risk-adjusted observed/expected (O/E) ratios for morbidity and mortality using the STS 2018 risk models. Agreement between STS Adult Cardiac Surgery Database and USNWR ranked deciles was calculated by Bowker symmetry test. The association between each center's annual change in STS O/E ratio and change in USNWR ranking was modeled in repeated measures regression analysis.Inclusion criteria were met by 524 393 patients from 149 hospitals that ranked in USNWR top 100 at least once during the study period. There was no agreement between USNWR ranking and STS major morbidity and mortality O/E ratio (P.50 for all years). Analysis of patients undergoing surgery at the 65 hospitals that were consistently ranked in the top 100 during the study period demonstrated no association between annual change in hospital ranking and change in O/E ratio (P all.3).There was no agreement between annual USNWR hospital ranking and corresponding risk-adjusted STS morbidity or mortality. Furthermore, annual changes in USNWR rankings could not be accounted for using clinical outcomes. These findings suggest that factors unrelated to key surgical outcomes may be driving consumer-directed rankings.

Introduction: The optimal cardiac delivery route for stem cell and gene therapeutics is poorly understood. Direct intramyocardial (IM) injection has been proposed as the gold standard, however, it is invasive and not studied in detail against targeted intra-coronary (IC) delivery techniques. We sought to compare effectiveness of IM and targeted IC methods using cardiac magnetic resonance imaging (CMR) of nanoparticles in a porcine model. Hypothesis: IM provides the highest retention of delivered therapeutic, while targeted IC delivery yields high-volume retention in the perfused coronary territory. Methods: In Yorkshire swine (n=10), 5ml of ferumoxytol iron oxide (IO) nanoparticles, similar in size to therapeutic viral vectors, were injected: 1) IM via thoracotomy (n=3), 2) catheter based IC balloon-occlusion (BO) with distal infusion of the LAD (n=4), 3) IC with perforated balloon side wall (SW) infusion in the LAD (n=2), or 4) IC non-selective left main (LM) (n=1). Hearts were harvested and imaged with CMR using T1 and 3D inversion-recovery sequences. Retention of nanoparticles was quantified by percent of myocardium occupied. Results: IM delivery yielded the highest retention (16.3±5.5% of myocardial volume, p=0.04). Of the IC approaches, BO had the highest retention (8.7±2.2%, p=0.13 vs IM) compared to SW (5.5±4.9%) and LM (0%). On 3D CMR, BO yielded consistent uptake in the distal LAD territory, including the anterior wall and septum. IM delivery was limited to the anterior wall with no nanoparticles in the septum. Troponin increased 15,600±4,910 with IM vs.184±262 with IC (p=0.14). Conclusions: Direct IM injection offers the highest retention of delivered therapeutics to the heart. IC balloon occlusion-distal infusion has highest retention among IC techniques and provides an effective approach to direct therapeutics to the vascular bed most impacted by an infarct.

Selective sinus replacement (SSR) allows a tailored repair approach in patients with sinus of Valsalva or asymmetric aortic root aneurysm. SSR avoids the need for coronary reimplantation for nondiseased sinuses and shortens operative time, although potential for late growth of retained sinuses exists. This study describes selection of patients and assesses operative outcomes and late root dimensions after SSR.From 2006 to 2020, 60 patients underwent SSR at a single referral institution. Mixed effect models were used to assess trajectory of postoperative growth of remaining sinuses, adjusting for age of the patient, valve morphology, and baseline root diameter.Median age of the patients was 57 (interquartile range [IQR], 48-65) years. Twenty-four (40%) had a bicuspid aortic valve. Most patients (n = 55 [92%]) underwent single sinus replacement (n = 46 noncoronary, n = 9 right), whereas 5 (8%) underwent repair of both the right and noncoronary sinuses. Concomitant aortic valve replacement was performed in 15 patients (25%); aortic valve repair with internal ring annuloplasty or cusp plication was performed in 37 (62%). There was no operative death, stroke, renal failure, or respiratory failure. Median preoperative root diameter was 53 mm (IQR, 51-56 mm) vs 42 mm (IQR, 39-45 mm) at median imaging follow-up of 34 (IQR, 13-49) months. Rate of midterm root growth was 0.2 mm/y, and there were no late root reinterventions.For patients with sinus of Valsalva or asymmetric root aneurysm, SSR is associated with excellent operative outcomes, and midterm follow-up suggests that the technique is durable. Longer term follow-up is needed to confirm continued stability of the aortic root.

With transcatheter aortic valve replacement being increasingly utilized in a younger and lower risk population, we can expect to see larger numbers of patients presenting with structural deterioration of aortic valves replaced by the transcatheter route that now require explantation and surgical replacement. Surgical aortic valve replacement after transcatheter aortic valve replacement is associated with operative morbidity and mortality rates significantly higher than those seen in the setting of surgical replacement of the native valve, which had a 30-day mortality of 12–20% in recent series. Centers performing transcatheter aortic valve replacement in lower risk patients with longer expected lifespans and a higher probability of late structural deterioration of the transcatheter aortic valve replacement should carefully consider their choice of valve type (balloon-expandable versus self-expanding) and patient anatomy, including annulus and root diameter, at the time of the initial valve intervention. Further, one should not forget the mechanical surgical aortic valve replacement option in younger patients with risk factors for early structural valve deterioration such as obesity, metabolic syndrome, and chronic kidney disease. The objectives of this tutorial are to describe the preoperative workup for a patient with late structural valve deterioration after transcatheter aortic valve replacement, detail the explantation approach specific to self-expanding valves, and illustrate the key decisions and techniques needed for subsequent surgical aortic valve replacement.

AimsIn contrast to patient-reported health status measures (such as the Kansas City Cardiomyopathy Questionnaire), the New York Heart Association class is based on a physician's assessment of heart failure symptoms and functional limitations on behalf of the patient. We sought to determine the concordance and predictors of physician under- and overestimation of symptoms prior to and after transcatheter aortic valve replacement (TAVR).Methods and resultsThe analytic cohort included 172 667 patients within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent transfemoral TAVR. At baseline, physicians underestimated patients’ symptoms in 47.4%, correctly assessed symptoms in 26.6%, and overestimated symptoms in 26.0%. At 30 days after TAVR, these proportions were 22.8%, 50.3%, and 26.9%, respectively. Using nominal logistic regression with random intercepts to account for within-hospital clustering, we found that physicians were more likely to incorrectly estimate patients’ symptoms when patients were older, women, had a prior stroke, had severe lung disease, had atrial fibrillation, or were more obese. There was marked variability in the rates of underestimation, correct estimation, and overestimation across the 641 sites.ConclusionAmong patients undergoing treatment for severe aortic stenosis, physicians estimate patients’ symptoms and functional status poorly both prior to and after TAVR, with different patterns. These findings emphasize the need to collect patient-reported health status to more reliably assess the benefits of TAVR in routine clinical practice.

Stanford Type B aortic dissection (TBAD) is a deadly cardiovascular disease with mortality rates as high as 50% in complicated cases. Patients with TBAD are often medically managed, but in ~20--40% of cases, patients experience aneurysmal degeneration in the dissected aorta, and surgical intervention is required. In this work, we simulated blood flow using computational fluid dynamics (CFD) to determine relationships between hemodynamics and aneurysmal degeneration, providing an important step towards predicting the need for intervention prior to significant aneurysm occurrence. Currently, surgeons intervene in TBAD cases based on the aneurysms growth rate and overall size, as well as a variety of other factors such as malperfusion, thrombosis, and pain, but predicting future risk of aneurysmal degeneration would allow earlier intervention leading to improved patient outcomes. Here, we hypothesized that hemodynamic metrics play an important role in the formation of aneurysms and that these metrics could be used to predict future aneurysmal degeneration in this patient population. Our retrospective dataset consisted of 16 patients with TBAD where eight required intervention due to aneurysmal degeneration and eight were medically managed. The patients with surgical intervention were examined in our study prior to the formation of an aneurysm. For each patient, we segmented and reconstructed the aortic geometry and simulated blood flow using the lattice Boltzmann method. We then compared hemodynamic metrics between to the two groups of patients, including time-averaged wall shear stress, oscillatory shear index, relative residence time, and flow fractions to the true and false lumen. We found significant differences in each metric between the true and false lumen. We also showed that flow fractions to the false lumen was higher in patients with aneurysmal degeneration (p = 0.02). These results are an important step towards developing more precise methods to predict future aneurysmal degeneration and the need for intervention in TBAD patients.

Kommerell diverticulum (KD) is an uncommon congenital vascular anomaly. This study assessed outcomes of open and endovascular repair of this disorder.Between 1997 and 2016, 152 adult patients presented with KD at Cleveland Clinic (Cleveland, OH), 87 had no intervention, and 65 underwent open repair (n = 55; 19 elephant trunk [ET] procedures [9 with aortic dissection], including 7 frozen ET, and completions with 5 thoracic endovascular aortic repairs, 2 open, and 5 lost to follow-up) or endovascular procedures (n = 10). Non-ET open KD repairs consisted of resection (n = 15), interposition graft (n = 16), patch (n = 4), or aortopexy (n = 1). Maximum KD diameter was 2.1 cm for nonsurgical patients and 3.2 cm for surgical patients. Among surgical patients, 51 of 65 had dysphagia or dyspnea. A total of 608 patient-years of follow-up were available.For patients who underwent open and endovascular procedures, after multivariable adjustment, symptoms of dysphagia and hypertension predicted the likelihood of surgery (P.05, all). There was no operative mortality. Complications included nondisabling stroke (n = 5; 8%), tracheostomy (n = 3; 4.6%), vocal cord paralysis (n = 2; 3%), and reoperation for bleeding (n = 3; 4.6%). During follow-up, 3 of 10 patients treated with hybrid or endovascular procedures required reinterventions for endoleaks. One patient had residual symptoms after aortopexy. Among nonsurgical patients, 2 patients refused surgery, and 1 died of aortic rupture, with a 4.7-cm descending aorta and a 3.4-cm KD. Seven additional patients died of nonaortic comorbidities. The remaining patients were asymptomatic, with an aortic diameter smaller than 4.5 cm.Open and endovascular approaches have a high success rate and low mortality risk. Selection of the specific type of intervention should be based on patient anatomy, additional needed procedures, and comorbid conditions.

After surgical repair for acute aortic syndromes, whether with open, endovascular or hybrid approaches, immediate post-operative and long-term monitoring require a patient specific approach. In the acute phase, dissection, in particular, can create a cascade of malperfusion of branch vessels accompanied by profound metabolic derangements. In the long term, consistent institutional guidelines for imaging modality and frequency are critical to monitor for complications of repair or degeneration of native aorta, which may require late intervention. In this chapter, we discuss immediate post-operative monitoring and long term surveillance approaches for both Type A and Type B acute aortic syndromes.

Objective The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services–linked data. Methods A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model. Results A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies. Conclusions In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.

OBJECTIVES The impact of hypothermic circulatory arrest (HCA) temperature on postoperative acute kidney injury (AKI) has not been evaluated. This study examined the association between circulatory arrest temperatures and AKI in patients undergoing proximal aortic surgery with HCA. METHODS A total of 759 consecutive patients who underwent proximal aortic surgery (ascending ± valve ± root) including arch replacement requiring HCA between July 2005 and December 2016 were identified from a prospectively maintained institutional aortic surgery database. The primary outcome was AKI as defined by Risk, Injury, Failure, Loss, End Stage Renal Disease (ESRD) criteria. The association between minimum nasopharyngeal (NP) and bladder temperatures during HCA and postoperative AKI was assessed, adjusting for patient-level factors using multivariable logistic regression. RESULTS A total of 85% (n = 645) of patients underwent deep hypothermia (14.1–20.0°C), 11% (n = 83) low-moderate hypothermia (20.1–24.0°C) and 4% (n = 31) high-moderate hypothermia (24.1–28.0°C) as classified by NP temperature. When analysed by bladder temperature, 59% (n = 447) underwent deep hypothermia, 22% (n = 170) low-moderate, 16% (n = 118) high-moderate and 3% mild (n = 24) (28.1–34.0°C) hypothermia. The median systemic circulatory arrest time was 17 min. The incidence of AKI did not differ between hypothermia groups, whether analysed using minimum NP or bladder temperature. In the multivariable analysis, the association between degree of hypothermia and AKI remained non-significant whether analysed as a categorical variable (hypothermia group) or as a continuous variable (minimum NP or bladder temperature) (all P > 0.05). CONCLUSIONS In patients undergoing proximal aortic surgery including arch replacement requiring HCA, degree of systemic hypothermia was not associated with the risk of AKI. These data suggest that moderate hypothermia does not confer increased risk of AKI for patients requiring circulatory arrest, although additional prospective data are needed.

Pulmonary insufficiency is a known complication following Tetralogy of Fallot repair. With over 90% of patients now surviving to adulthood, surgeons are once again faced with the question of when, and more importantly, how to reintervene. We developed a novel approach to pulmonary valve replacement in this population through a 5-cm left anterior mini-incision. The incision is optimized for exposing and operating on the right ventricular outflow tract and the main pulmonary artery in patients with a history of median sternotomy. Early outcomes are reassuring, and we believe our approach is a safe and reliable alternative to median sternotomy within this patient population, with the ability to quickly convert intraoperatively when needed.

OBJECTIVESAortic insufficiency (AI) is common in patients with proximal aortic disease, but limited options exist to facilitate aortic valve repair (AVr) in this population. This study reports ‘real-world’ early results of AVr using newly FDA-approved trileaflet and bicuspid geometric annuloplasty rings for patients with AI undergoing proximal aortic repair (PAR) in a single referral centre.METHODSAll patients undergoing AVr with a rigid internal geometric annuloplasty ring (n = 47) in conjunction with PAR (ascending +/− root +/− arch) were included. Thirty-six patients underwent AVr with a trileaflet ring, and 11 patients underwent AVr with a bicuspid ring. The rings were implanted in the subannular position, and concomitant leaflet repair was performed if required for cusp prolapse identified after ring placement.RESULTSThe median age was 58 years [interquartile range (IQR) 46–70]. PAR included supracoronary ascending replacement in 26 (55%) patients and remodelling valve-sparing root replacement with selective sinus replacement in 20 (42%) patients. Arch replacement was performed in 38 (81%) patients, including hemi-arch in 34 patients and total arch in 4 patients. There was no 30-day/in-hospital mortality. Preoperative AI was 3–4+ in 37 (79%) patients. Forty-one (87%) patients had zero–trace AI on post-repair transoesophageal echocardiography, and 6 patients had 1+ AI. The median early post-repair mean gradient was 13 mmHg (IQR 5–20). Follow-up imaging was available in 32 (68%) patients at a median of 11 months (IQR 10–13) postsurgery. AI was ≤1+ in 97% of patients with 2+ AI in 1 patient. All patients were alive and free from aortic valve reintervention at last follow-up.CONCLUSIONSEarly results with geometric rigid internal ring annuloplasty for AVr in patients undergoing PAR appear promising and allow a standardized approach to repair with annular diameter reduction and cusp plication when needed. Longer-term follow-up will be required to ensure the durability of the procedure.

Stent graft-induced new entry has been described in thoracic endovascular aortic repair for aortic dissection. The incidence of stent graft-induced aortic wall injury (SAWI) related to iatrogenic injury in nondissections is incompletely described. We describe incidence, risk factors, and outcomes of SAWI.All post-thoracic endovascular aortic repair computed tomography angiograms (January 2005 to December 2018) were reviewed for radiographic evidence of SAWI. Endograft-induced aortic dissections were likewise considered SAWI. Patient characteristics, time to SAWI, and need for reintervention were noted. Cox proportional hazards modeling was used to identify risk factors for SAWI.Within the study cohort (n = 430), 38 patients (9%) had SAWI during a median follow-up of 2.3 years (interquartile range, 4.8); 42% (n = 16) were proximal, 53% (n = 20) distal, and 5% (n = 2) both proximal and distal. Nine (23%) were distal intimal flap injuries in dissection cases, thus subclassifying them as stent graft-induced new entry. Twenty-nine percent of SAWI (n = 11) required reintervention. Of these, 45% (n = 5) were open, and 55% (n = 6) were endovascular. Thoracic endovascular aortic repair for acute dissection had a higher incidence of SAWI development (hazard ratio 4.6; 95% confidence interval, 2.4 to 9; P.001) as compared with other indications. Use of devices with proximal bare springs or barbs was also associated with increased SAWI incidence (hazard ratio 5.3; 95% confidence interval, 2.6 to 11.0; P.001).The rate of SAWI after thoracic endovascular aortic repair is low (9%), but nearly one third will require reintervention. Thoracic endovascular aortic repair in the setting of acute dissection and use of devices with proximal bare springs or barbs were associated with an increased incidence of SAWI.

Purpose Patients with chronic thromboembolic pulmonary hypertension (CTEPH) frequently present with extensive distal clot burden, which adds complexity to pulmonary thromboendarterectomy (PTE). Complete endarterectomy often necessitates prolonged periods of hypothermic circulatory arrest (HCA), the ramifications of which are poorly understood. Objectives were to describe the association of HCA time with post-operative neurologic complications, operative mortality and other major morbidity after PTE. Methods From 2013 to 2019, 163 patients underwent PTE at a single academic institution. Median age was 51 [IQR 23] and 55% (N=89) were female. Operative approach involved profound hypothermia with multiple brief periods of HCA without aortic crossclamping. As event rates were low, the primary outcome was a composite of operative mortality, stroke, respiratory failure requiring tracheostomy and renal failure requiring dialysis. Both univariate and multivariable logistic regression analyses were performed to examine association between HCA and this composite outcome. Results Overall operative mortality was 6.8% (N=11), while 1% of patients (n=2) suffered stroke, 5% (n=8) required dialysis and 10% (n=17) required tracheostomy. In terms of hemodynamic outcomes, median improvement in mean PA pressures was 15mmHg [IQR 16] comparing pre-operative to last post-operative invasive monitoring. Median HCA time was 46 minutes [IQR 32] over a median of 3 [IQR 2] arrest periods at median core temperature of 17°C [IQR 2.2]. When grouped by HCA time less than or greater than 60 minutes, there was no significant difference in the composite outcome (15% versus 12%, p=0.720). Among nine patients with very prolonged HCA time greater than 90 minutes, the composite outcome occurred in one (11%). In a univariate logistic regression analysis, neither HCA time (OR 1.00, CI 0.99-1.01) nor number of arrests (OR 0.98, CI 0.94-1.02) were significant predictors of the composite. In a multivariable model, increasing age was the only significant predictor of the composite (OR 1.05, CI 1.01-1.10). Conclusion Prolonged HCA during PTE does not appear to confer increased risk of neurologic or other major complications. Therefore, more extensive endarterectomy should be pursued, when appropriate, to achieve the best hemodynamic outcome for patients with distal and bilateral disease.

Objective Patients with complex aortic disease often require multistaged repairs with numerous anastomoses. Manual suturing can be time consuming. To reduce ischemic time, a circular stapling device has been used to facilitate prosthetic graft-to-graft anastomoses. Objectives are to describe this technique and assess outcomes. Methods From February 2009 to May 2014, 44 patients underwent complex aortic repair with a circular end-to-end anastomosis (EEA) stapler at Cleveland Clinic. All patients had extensive aneurysms: 17 after ascending dissection repair, 10 chronic type B dissections, and 17 degenerative aneurysms. Stapler was used during total arch repair as an end-to-side anastomosis (n = 36; including first stage elephant trunk [ET] in 32, frozen ET in 3) and an end-to-end anastomosis during redo thoracoabdominal repair (n = 11). Three patients had the stapler used during both stages of repair. Patients underwent early and annual follow-ups with computed tomography analysis. Results There were no bleeds, ruptures, or leaks at the stapled site, but 2 patients died. Complications included 7 reoperations not related to the site of stapled anastomosis and 6 tracheostomies, but there was no paralysis or renal failure. Mean circulatory arrest time was 16 ± 5 minutes. Mean follow-up was 26 ± 17 months and consisted of imaging before discharge, at 3 to 6 months, and at 1 year. Planned reinterventions included 21 second-stage ET completion: Endovascular (n = 18) and open (n = 3). There were 4 late deaths. Conclusions Use of an end-to-end anastomotic automated circular stapler is safe, effective, and durable in performing graft-to-graft anastomoses during complex thoracic aortic surgery. Further evaluation and refinement of this technique are warranted.