Characterization of Strokes following Gore Thoracic Branch Endografting requiring Zone 2 landing.

OBJECTIVES: The GORE® TAG® Thoracic Branch Endoprosthesis (TBE)is the only currently FDA-approved branched device for the treatment of thoracic aortic pathology requiring landing in Zone 2 in the US. While the aneurysm cohort disabling stroke rate in the pivotal trial has previously been reported, a more complete and granular description has not yet been published. This is a descriptive series detailing the neurologic sequelae from the pivotal trial, out to 12 months. METHODS: All patients underwent Modified Rankin Scale (MRS) assessment at screening, discharge, 1-, 6-, and 12-month intervals. A disabling stroke was defined as occurring within 30-days of the index procedure, combined with a MRS ≥2 with an increase from baseline of at least one grade. Descriptive statistics with important associations with aortic pathology, landing in native aorta versus Dacron graft, and intraoperative ballooning were noted. Further granularity with regard to the distribution and type of stroke are also reported, where available. RESULTS: A total of 238 patients were included in the pivotal trial. The treated aortic pathologies were: aneurysm (n=84), dissection (n=132), traumatic transection (n=9), other isolated lesions(n=13). Through 12 months, the overall stroke rate was 5.9%, with the highest rate of stroke in the aneurysm cohort (aneurysm-8.3%, dissection-4.6%, traumatic transection-0%, other-7.7%). The frequency of disabling strokes through 12 months were: aneurysm-4.3%, dissection-2.3%, other lesion-7.7%. Forty percent of strokes (n=6) occurred within 30 days and included both hemorrhagic (n=3) as well as ischemic (n=3) events. The distribution of strokes within 30 days included left carotid (n=1), posterior circulation (n=2), as well as unknown (n=3). The strokes occurring after 30 days were primarily ischemic (6/8), and included left carotid (n=2), right carotid (n=1), posterior circulation (n=1), posterior circulation and right carotid (n=1), posterior circulation and left and right carotid (n=1), and unknown location (n=1). The majority of patients suffering from stroke had aortic component landing in the native aortic arch, as well as ballooning of the aortic component (10/14). CONCLUSIONS: The TBE prosthesis is associated with comparable 30-day stroke rates to similar series of patients undergoing Zone 2 landing after debranching procedures. Stroke rates were highest in aneurysm pathology patients, with no strokes in the traumatic transection cohort. Perioperative strokes were hemorrhagic and ischemic, whereas those occurring after the perioperative period were primarily ischemic in nature. The distribution of stroke covered multiple territories, suggesting an embolic etiology. These data better define the neurologic risks associated with placement of this branched technology in the aortic arch.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

Editor's Choice - Trends in Management and Outcomes of Type B Aortic Dissection: A Report From the International Registry of Aortic Dissection.

OBJECTIVE: To describe the trends in management and outcomes of patients with acute type B aortic dissection in the International Registry of Acute Aortic Dissection. METHODS: From 1996 - 2022, 3 908 patients were divided into similar sized quartiles (T1, T2, T3, and T4). In hospital outcomes were analysed for each quartile. Survival rates following admission were compared using Kaplan-Meier analyses with Mantel-Cox Log rank tests. RESULTS: Endovascular treatment increased from 19.1% in T1 to 37.2% in T4 (ptrend < .001). Correspondingly, medical therapy decreased from 65.7% in T1 to 54.0% in T4 (ptrend < .001), and open surgery from 14.8% in T1 to 7.0% in T4 (ptrend < .001). In hospital mortality decreased in the overall cohort from 10.7% in T1 to 6.1% in T4 (ptrend < .001), as well as in medically, endovascularly and surgically treated patients (ptrend = .017, .033, and .011, respectively). Overall post-admission survival at three years increased (T1: 74.8% vs. T4: 77.3%; p = .006). CONCLUSION: Considerable changes in the management of acute type B aortic dissection were observed over time, with a significant increase in the use of endovascular treatment and a corresponding reduction in open surgery and medical management. These changes were associated with a decreased overall in hospital and three year post-admission mortality rate among quartiles.

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. METHODS: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. RESULTS: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. CONCLUSIONS: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

The impact of local vs general anesthesia in patients undergoing thoracic endovascular aortic surgery.

OBJECTIVE: General anesthesia (GA) is associated with inherent risks that can be avoided by the use of lesser invasive anesthetic strategies. We hypothesize that examine and compare the use of local or regional anesthesia (LRA) to that of GA in patients undergoing thoracic endovascular aortic repair (TEVAR). METHODS: Patients undergoing TEVAR between 2010 and 2020 in the Vascular Quality Initiative were analyzed. Exclusion criteria included receipt of branched or physician-modified endografts and devices extending distally beyond zone 5. Patients were categorized as receiving LRA or GA. Center volume was reported by quartile according to annualized TEVAR volume, and operative outcomes were compared using appropriate frequentists tests. Univariable and multivariable regression models for anesthesia type and operative outcomes were created to compare unadjusted and adjusted rates of each outcome. Long-term survival was estimated using a Kaplan-Meier survival estimator, whereas adjusted survival analysis was performed using a Cox proportional hazards model. RESULTS: Of the 17,099 patients who underwent TEVAR, 7299 met the inclusion and exclusion criteria. Of these, 3.8% received LRA. There were no significant differences in the annual proportion of patients who received LRA from 2011 to 2020 (P = .49, χ2 test for trend). Only 18.8% of patients who received LRA were treated at the highest quartile volume centers. Patients who received LRA were older and more comorbid compared with those who received GA. There were no differences in in-hospital mortality (odds ratio [OR], 0.79; 95% confidence interval [CI], 0.42-1.38; P = .44) or composite of any complication (OR, 0.79; 95% CI, 0.54-1.14; P = .22) between patients who received LRA compared with those who received GA. This also applied to patients presenting with rupture. Receipt of LRA was associated with lower odds of postoperative congestive heart failure (OR, 0.19; 95% CI, 0.01-0.89; P = .01) as well as decreased length of intensive care unit (OR, 0.54; 95% CI, 0.40-0.72; P < .01) and hospital length of stay (OR, 0.64; 95% CI, 0.46-0.84; P < .01). LRA was not associated with decreased long-term survival compared with GA (hazard ratio, 0.95; 95% CI, 0.72-1.25; P = .72). CONCLUSIONS: Despite a greater number of baseline comorbidities, patients undergoing TEVAR with LRA experienced shorter intensive care unit and postoperative lengths of stay, with similar operative outcomes and long-term survival compared with patients who received GA. Similar findings were found among the rupture cohort. LRA should be considered more frequently in select patients undergoing TEVAR.

Midterm Outcomes of Endovascular Repair of Aortic Arch Aneurysms with the Gore Thoracic Branch Endoprosthesis.

OBJECTIVE: Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported. METHODS: This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported. RESULTS: The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm. CONCLUSION: Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

Evaluation of the Gore TAG thoracic branch endoprosthesis in the treatment of proximal descending thoracic aortic aneurysms.

BACKGROUND: Thoracic endovascular aortic repair has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts have provided a new option to maintain branch patency. METHODS: Six investigative sites enrolled 31 patients in a nonrandomized, prospective investigational device exemption feasibility trial of a single branched aortic endograft for the management of aneurysms that include the distal aortic arch. The Gore TAG thoracic branch endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz), an investigational device, allows for graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion. RESULTS: All 31 patients (100%) had undergone successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Their average age was 74.1 ± 10.4 years. The aneurysm morphology was fusiform in 12 and saccular in 19 patients, with a mean maximum aortic diameter of 54.8 ± 10.9 mm. The mean follow-up period for the cohort was 25.2 ± 11.1 months. We have reported the patient outcomes at 1 month and 1 year. At 1 month, the side branch patency was 100% and the freedom from core laboratory-reported device-related endoleak (types I and III) was 96.7%, without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through 1 year, five patients had died; none of the deaths were related to the device or procedure (clinical endpoint committee adjudicated). One thoracic reintervention was required. No conversions were required, and no aneurysm growth (core laboratory) was reported. One case of the loss of side branch patency was diagnosed in the left subclavian artery in an asymptomatic individual from computed tomography at 6 months, with no reported subsequent adverse events due to loss of patency. Endoleaks were reported by the core laboratory in five patients at 12 months (two, type II; and three, indeterminate). CONCLUSIONS: The present investigational device exemption feasibility study has reported the preliminary results of the use of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.

The impact of surgeon and hospital procedural volume on outcomes after aortic root replacement in the United States.

OBJECTIVE: Surgeon procedural volume for complex cardiac procedures have become important quality metrics. The objective is to determine the association of surgeon and hospital case volume on patient outcomes after an aortic root replacement for aortic root aneurysms. METHODS: From 2009 to 2014, 4629 Medicare patients underwent an aortic root replacement for a root aneurysm. Procedures were performed by 1276 surgeons at 718 hospitals. Patients with endocarditis, aortic rupture, or Type-A dissection were excluded. Procedural volume was defined as mean number of cases performed each year during the study period. The impact of hospital and surgeon volume on adjusted 30-day mortality was analyzed as a continuous variable using adjusted logistic regression with cubic splines. RESULTS: After an aortic root replacement, we observed a nonlinear reduction in the adjusted odds ratio for 30-day mortality as surgeon and hospital volume increased. Surgeons that performed approximately five cases/year and hospitals that completed approximately five cases/year had the greatest reduction in the odds of perioperative death. Patients treated at high-volume hospitals (≥4.5 cases/year) had a lower risk for 30-day postoperative stroke (hazard ratio [HR] = 0.51, p = .008), myocardial infarction (HR = 0.49, p = .016), hemodialysis (HR = 0.44, p = .005), and reoperation (HR = 0.48, p = .003). Additionally, patients treated with high-volume surgeons (≥9 cases/year) had lower risk for stroke (HR = 0.65, p = .005), hemodialysis (HR = 0.65, p = .03), sepsis (HR = 0.62, p = .03), and reoperation (HR = 0.67, p = .004). CONCLUSION: Among Medicare patients undergoing an aortic root replacement, there is a strong inverse relationship between annualized surgeon and hospital case volume and postoperative outcomes. Procedural volume is an important quality metric for this high-risk procedure.

Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections.

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.

Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Conscious sedation is used during transcatheter aortic valve replacement (TAVR) with limited evidence as to the safety and efficacy of this practice. METHODS: The National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to characterize the anesthesia choice and clinical outcomes of all US patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014, and June 30, 2015. Raw and inverse probability of treatment-weighted analyses were performed to compare patients undergoing TAVR with general anesthesia with patients undergoing TAVR with conscious sedation on an intention-to-treat basis for the primary outcome of in-hospital mortality, and secondary outcomes including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, intensive care unit and hospital length-of-stay, and rates of discharge to home. Post hoc falsification end point analyses were performed to evaluate for residual confounding. RESULTS: Conscious sedation was used in 1737/10 997 (15.8%) cases with a significant trend of increasing usage over the time period studied (P for trend<0.001). In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% versus 98.5%, P=0.31). The conscious sedation group was less likely to experience in-hospital (1.6% versus 2.5%, P=0.03) and 30-day death (2.9% versus 4.1%, P=0.03). Conversion from conscious sedation to general anesthesia was noted in 102 of 1737 (5.9%) of conscious sedation cases. After inverse probability of treatment-weighted adjustment for 51 covariates, conscious sedation was associated with lower procedural success (97.9% versus 98.6%, P<0.001) and a reduced rate of mortality at the in-hospital (1.5% versus 2.4%, P<0.001) and 30-day (2.3% versus 4.0%, P<0.001) time points. Conscious sedation was associated with reductions in procedural inotrope requirement, intensive care unit and hospital length of stay (6.0 versus 6.5 days, P<0.001), and combined 30-day death/stroke rates (4.8% versus 6.4%, P<0.001). Falsification end point analyses of vascular complications, bleeding, and new pacemaker/defibrillator implantation demonstrated no significant differences between groups after adjustment. CONCLUSIONS: In US practice, conscious sedation is associated with briefer length of stay and lower in-hospital and 30-day mortality in comparison with TAVR with general anesthesia in both unadjusted and adjusted analyses. These results suggest the safety of conscious sedation in this population, although comparative effectiveness analyses using observational data cannot definitively establish the superiority of one technique over another.

Impact of acute postoperative limb ischemia after cardiac and thoracic aortic surgery.

OBJECTIVE: Acute limb ischemia (ALI) is the cause of significant morbidity and mortality. Although ALI after cardiac surgery is associated with high rates of morbidity and mortality, there are no robust, controlled analyses of the risk factors and outcomes of ALI in this setting. We aimed to identify risk factors for and to delineate outcomes after ALI in patients undergoing cardiac surgery. METHODS: We performed a retrospective review of prospectively collected data on patients undergoing cardiac surgery at our institution between 2002 and 2012. RESULTS: Between 2002 and 2012, there were 11,343 patients who underwent major open cardiac surgery, with 156 cases of ALI for an incidence of 1.4%. In a multivariable model, significant risk factors for ALI included body surface area (odds ratio [OR], 0.41; 95% confidence interval [CI], 0.18-0.92), current smoking status (OR, 2.2; 95% CI, 1.3-3.7), peripheral arterial disease (OR, 2.5; 95% CI, 1.6-3.7), nonelective operative status (OR, 1.9-5.0; 95% CI, 1.2-19.7), use of extracorporeal membrane oxygenation (OR, 5.6; 95% CI, 2.5-11.6) or intra-aortic balloon pump (OR, 4.7; 95% CI, 2.9-7.5), and valve operation (OR, 2.1; 95% CI, 1.1-4.0). There were 105 (67%) patients who developed ALI who required an operation, and 27 (17%) required an amputation on the index admission. ALI was associated with a significant reduction in long-term survival (hazard ratio, 3.72; 95% CI, 2.97-4.65; P < .0001). CONCLUSIONS: ALI is associated with significant morbidity and mortality, and it is also associated with reduced long-term survival. Those patients with the risk factors described require extra vigilance to limit the risk of ALI and should be managed in accordance with the patient's overall clinical condition and goals of care.

Long-term outcome of surgical cryoablation for refractory ventricular tachycardia in patients with non-ischemic cardiomyopathy.

Aims: Limited data exist on the long-term outcome of patients (pts) with non-ischemic cardiomyopathy (NICM) and ventricular tachycardia (VT) refractory to conventional therapies undergoing surgical ablation (SA). We aimed to investigate the long-term survival and VT recurrence in NICM pts with VT refractory to radiofrequency catheter ablation (RFCA) who underwent SA. Methods and results: Consecutive pts with NICM and VT refractory to RFCA who underwent SA were included. VT substrate was characterized in the electrophysiology lab and targeted by RFCA. During SA, previous RFCA lesions/scars were identified and targeted with cryoablation (CA; 3 min/lesion; target -150 °C). Follow-up comprised office visits, ICD interrogations and the social security death index. Twenty consecutive patients with NICM who underwent SA (age 53 ± 16 years, 18 males, LVEF 41 ± 20%; dilated CM = 9, arrhythmogenic right ventricular CM = 3, hypertrophic CM = 2, valvular CM = 4, and mixed CM = 2) were studied. Percutaneous mapping/ablation in the electrophysiology lab was performed in 18 and 2 pts had primary SA. During surgery, 4.9 ± 4.0 CA lesions/pt were delivered to the endocardium (2) and epicardium (11) or both (7). VT-free survival was 72.5% at 1 year and over 43 ± 31 months (mos) (range 1-83mos), there was only one arrhythmia-related death. There was a significant reduction in ICD shocks in the 3-mos preceding SA vs. the entire follow-up period (6.6 ± 4.9 vs. 2.3 ± 4.3 shocks/pt, P = 0.001). Conclusion: In select pts with NICM and VT refractory to RFCA, SA guided by pre-operative electrophysiological mapping and ablation may be a therapeutic option.

Aortic Regurgitation in Acute Type-A Aortic Dissection: A Clinical Classification for the Perioperative Echocardiographer in the Era of the Functional Aortic Annulus.

The functional aortic annulus offers a clinical approach for the perioperative echocardiographer to classify the mechanisms of aortic regurgitation in acute type-A dissection. Comprehensive examination of the functional aortic annulus in this setting using transesophageal echocardiography can guide surgical therapy for the aortic root by considering the following important aspects: severity and mechanism of aortic regurgitation, extent of root dissection, and the pattern of coronary artery involvement. The final choice of surgical therapy also should take into account factors, such as patient presentation and surgical experience, to limit mortality and morbidity from this challenging acute aortic syndrome. This review explores these concepts in detail within the framework of the functional aortic annulus, detailed anatomic considerations, and the latest literature.

Association of Renin-Angiotensin Inhibitor Treatment With Mortality and Heart Failure Readmission in Patients With Transcatheter Aortic Valve Replacement.

Importance: Data are lacking on the effect of a renin-angiotensin system (RAS) inhibitor prescribed after transcatheter aortic valve replacement (TAVR). Treatment with a RAS inhibitor may reverse left ventricular remodeling and improve function. Objective: To investigate the association of prescription of a RAS inhibitor and outcomes after TAVR. Design, Setting, and Participants: Retrospective cohort study of TAVR procedures performed in the United States (using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry) between July 2014 and January 2016 that were linked to Medicare claims data (final date of follow-up: March 31, 2017). To account for differences in demographics, echocardiographic findings, and in-hospital complications, 1:1 propensity matching was performed. Exposures: Initial hospital discharge prescription of a RAS inhibitor after TAVR. Main Outcomes and Measures: Primary outcomes were all-cause death and readmission due to heart failure at 1 year after discharge, which were considered separately. The secondary outcome was health status assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ; score range: 0-100, with a higher score indicating less symptom burden and better quality of life; a small effect size was defined as 5 points) at 1 year. Results: Among 21 312 patients who underwent TAVR at 417 US sites, 8468 patients (39.7%) were prescribed a RAS inhibitor at hospital discharge. After propensity matching, 15 896 patients were included (mean [SD] age, 82.4 [6.8] years; 48.1% were women; mean [SD] left ventricular ejection fraction [LVEF], 51.9% [11.5%]). Patients with a prescription for a RAS inhibitor vs those with no prescription had lower mortality rates at 1 year (12.5% vs 14.9%, respectively; absolute risk difference [ARD], -2.4% [95% CI, -3.5% to -1.4%]; hazard ratio [HR], 0.82 [95% CI, 0.76 to 0.90]) and lower heart failure readmission rates at 1 year (12.0% vs 13.8%; ARD, -1.8% [95% CI, -2.8% to -0.7%]; HR, 0.86 [95% CI, 0.79 to 0.95]). When stratified by LVEF, having a prescription for a RAS inhibitor vs no prescription was associated with lower 1-year mortality among patients with preserved LVEF (11.1% vs 13.9%, respectively; ARD, -2.81% [95% CI, -3.95% to -1.67%]; HR, 0.78 [95% CI, 0.71 to 0.86]), but not among those with reduced LVEF (18.8% vs 19.5%; ARD, -0.68% [95% CI, -3.52% to 2.20%]; HR, 0.95 [95% CI, 0.81 to 1.12]) (P = .04 for interaction). Of 15 896 matched patients, 4837 (30.4%) were included in the KCCQ score analysis and improvements at 1 year were greater in patients with a prescription for a RAS inhibitor vs those with no prescription (median, 33.3 [interquartile range, 14.2 to 51.0] vs 31.3 [interquartile range, 13.5 to 51.1], respectively; difference in improvement, 2.10 [95% CI, 0.10 to 4.06]; P < .001), but the effect size was not clinically meaningful. Conclusions and Relevance: Among patients who underwent TAVR, receiving a prescription for a RAS inhibitor at hospital discharge compared with no prescription was significantly associated with a lower risk of mortality and heart failure readmission. However, due to potential selection bias, this finding requires further investigation in randomized trials.

Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft.

BACKGROUND: The 1-year results of endovascular exclusion of degenerative descending thoracic aortic aneurysms (DTA) with the Valiant Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, Calif) have been previously reported. With long-term follow-up now complete, the 5-year results are reported. METHODS: The VALOR II trial (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized trial of the Valiant Thoracic Stent Graft system in patients with degenerative DTA. The trial involved 24 sites in the United States and enrolled patients between December 2006 and September 2009. Standard follow-up included physical examination, computed tomography, and chest radiography through 5 years. RESULTS: The study enrolled 160 patients. The average age was 72.2 years (range, 36-85 years), 95 (59%) were men, 150 (94%) had hypertension, and 26 (16%) had renal insufficiency. There were 50 patients (31%) who presented with symptoms; back pain was the most common (34 [68%]). The average aneurysm diameter was 57 mm (range, 32-96 mm). There were 103 patients (64%) with a fusiform aneurysm and 57 (36%) with a saccular aneurysm or penetrating ulcer. Two or more devices were implanted in 126 patients (79%), and the maximum number of grafts implanted was four. There were 54 deaths during the study. The 5-year actuarial survival was 64%. There were eight aneurysm-related deaths (5 deaths ≤30 days of implant), and the 5-year freedom from aneurysm-related death was 95%. There was one conversion to open repair at 36 months. Eleven patients underwent 13 secondary procedures (9 for endoleak, 3 for aneurysm expansion, and 1 rupture). Follow-up imaging was available at 5 years for 56 patients. The average aortic diameter decreased >5 mm in 27 patients (48%), increased >5 mm in 6 patients (11%), and remained unchanged in 23 (41%). CONCLUSIONS: The VALOR II 5-year results demonstrate that the reintervention and aneurysm-related death rates are low. The Valiant Thoracic Stent Graft is an effective treatment of degenerative DTA.

Central cannulation strategy for extent I thoracoabdominal aneurysm repair of chronic type B aortic dissection.

INTRODUCTION: We evaluated the safety profile of a central cardiopulmonary bypass (CPB) cannulation strategy for repair of extent I thoracoabdominal aortic aneurysms (TAAA) with chronic type B dissection in comparison to traditional peripheral CPB cannulation strategies. METHODS: Patients undergoing extent I TAAA repair for chronic type B dissection from 2002 to 2011 were retrospectively reviewed. Patients were grouped by their CPB cannulation strategy. Patients in Group I underwent central aortic cannulation (n = 28) through a left thoracotomy incision. The true lumen of the descending thoracic aorta was cannulated using an echocardiogram-guided Seldinger wire technique. The right atrium was directly accessed for venous drainage. In Group II (n = 31), arterial and venous cannulation of the femoral vessels was achieved using a left-sided groin incision. All patients underwent deep hypothermic circulatory arrest for proximal aortic reconstruction. RESULTS: Preoperative aortic dimensions (6.5 ± 0.79 cm in Group I vs 7.0 ± 1.15 cm in Group II p = 0.8) were similar between groups. CPB time (240 ± 37 min in Group I vs 174 ± 68 min in Group II p < 0.01) was significantly higher in the central cannulation group whereas circulatory arrest times (43 ± 5 min Group I vs 37 ± 7 min in Group II p = 0.1) were similar between the two groups. In-hospital 30-day mortality (N = 0, 0% in Group I; N = 2, 6.5% in Group II), stroke (N = 1, 3.5% in Group I; N = 0, 0% in Group II), paraplegia (N = 1, 3.5% in Group I; N = 1, 3.2% in Group II), reoperation for bleeding (N = 1, 3.5% in Group I; N = 1, 3.2% Group II), tracheostomy rate (N = 2, 7% in Group I; N = 3, 9.7% Group II), and mean length of stay (19 days in Group I vs 17 days in Group II) were similar (p > 0.05). Median follow-up was 3.6 ± 2.0 in Group I and 5.6 ± 2.6 years in Group II. Actuarial survival at 5 years was 84.6 % for Group I and 77.6% for Group II (p = 0.52). CONCLUSIONS: Central true lumen cannulation through a left thoracotomy incision for repair of extent I TAAA with chronic type B dissection is an acceptable approach with equivalent early and midterm outcomes compared to more standard femoral cannulation techniques. It may provide a safe alternative cannulation site for patients with diseased femoral vessels.

The role of extracorporeal membrane oxygenator therapy in the setting of Type A aortic dissection.

BACKGROUND AND AIM: Patients presenting with type A aortic dissection (TAAD) present with a wide clinical spectrum ranging from hemodynamic stability to multiorgan malperfusion with cardiovascular collapse. Extracorporeal membrane oxygenator (ECMO) therapy is increasingly being utilized as salvage therapy in patients with acute cardiopulmonary failure and for post-cardiotomy shock. We sought to determine the utility of ECMO implementation post-TAAD repair. METHODS: The Pennsylvania Health Care Cost Containment Council (PHC4) database, maintained by an independently functioning state agency, was retrospectively reviewed from 2004 to 2014. Patients with a primary diagnosis of aortic dissection requiring ECMO support during the same hospital visit were included in the analysis. RESULTS: Thirty-nine patients were identified with diagnosis/procedure codes for TAAD repair and ECMO, of which four patients did not undergo TAAD repair. Of the remaining 35, 31 patients underwent open repair, and four patients underwent TEVAR. ECMO was instituted on the same day of TAAD surgery in 27 (69.2%) patients, and on post-operative day >1 in eight (20.5%) patients. Overall mortality in patients who were on ECMO the same day was 88.9% and 87.5% when it was done after the first post-operative day. All four patients with TAAD who underwent ECMO only died. Median time from ECMO implantation to death was 1.0 day. CONCLUSIONS: Requirement for ECMO support in acute aortic dissection is associated with extremely high mortality irrespective of when the intervention is performed.

Concomitant antegrade stent grafting of the descending thoracic aorta during transverse hemiarch reconstruction for acute DeBakey I aortic dissection repair improves aortic remodeling.

BACKGROUND AND AIM: Concomitant endovascular stent grafting of the descending thoracic aorta during open repair for acute DeBakey I aortic dissection can be performed in patients with extensive dissection and malperfusion. We analyzed the effects of this strategy on distal aortic remodeling. METHODS: From 2006-2014, acute DeBakey I dissection patients without primary aortic arch tear undergoing open distal hemiarch reconstruction (Standard group) versus those undergoing hemiarch with descending thoracic aorta (DTA) thoracic endovascular aortic repair (TEVAR group) were retrospectively reviewed. We studied aortic remodeling only in patients with three-dimensional computed tomography scans available at 1 and 12 months following surgery (Standard group n = 26; Stent group n = 21). RESULTS: At 1 month, abdominal aortic diameters were similar, but true lumen (TL) and true lumen to total diameter ratios (TL index [TLI]) in the DTA were significantly improved in the TEVAR group (P < 0.05). Mean number of fenestrations were similar (1.8 ± 1.5 vs. 2.4 ± 1.9, P = 0.32). At 12 months, DTA true lumen and TLI remained significantly improved in the TEVAR group at all locations (P < 0.01). This translated to increased complete false lumen thrombosis rates in the thoracic aorta (83% vs. 32%, P = 0.01) in the TEVAR group. In the Standard group, DTA true lumen diameter and TL index were significantly decreased at 12 months compared to 1 month time period (P < 0.05). In the TEVAR group, DTA true lumen diameters and TLI were significantly improved at 12 months (P < 0.05). CONCLUSIONS: Antegrade TEVAR during open repair for DeBakey I dissection improves DTA remodeling by increasing true lumen diameter without enlargement of the total aortic diameter and by promoting false lumen thrombosis.

Pathogenesis and Risk Factors for Cerebral Infarct After Surgical Aortic Valve Replacement.

BACKGROUND AND PURPOSE: Stroke is a potentially devastating complication of cardiac surgery. Identifying predictors of radiographic infarct may lead to improved stroke prevention for surgical patients. METHODS: We reviewed 129 postoperative brain magnetic resonance imagings from a prospective study of patients undergoing surgical aortic valve replacement. Acute infarcts were classified as watershed or embolic using prespecified criteria. RESULTS: Acute infarct on magnetic resonance imaging was seen in 79 of 129 patients (61%), and interrater reliability for stroke pathogenesis was high (κ=0.93). Embolic infarcts only were identified in 60 patients (46%), watershed only in 2 (2%), and both in 17 (13%). In multivariable logistic regression, embolic infarct was associated with aortic arch atheroma (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.0-12.0; P=0.055), old subcortical infarcts (OR, 5.5; 95% CI, 1.1-26.6; P=0.04), no history of percutaneous transluminal coronary angioplasty or coronary artery bypass graft (OR, 4.0; 95% CI, 1.2-13.7; P=0.03), and higher aortic valve gradient (OR, 1.3 per 5 mm Hg; 95% CI, 1.09-1.6; P=0.004). Watershed infarct was associated with internal carotid artery stenosis ≥70% (OR, 11.7; 95% CI, 1.8-76.8; P=0.01) and increased left ventricular ejection fraction (OR, 1.6 per 5% increase; 95% CI, 1.08-2.4; P=0.02). CONCLUSIONS: The principal mechanism of acute cerebral infarction after aortic valve replacement is embolism. There are distinct factors associated with watershed and embolic infarct, some of which may be modifiable.