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Transcatheter aortic valve implantation (TAVI) has become a widely accepted strategy for the treatment of aortic stenosis in patients at intermediate, high, or prohibitive surgical risk. After >1 decade of innovation and clinical trial experience, the available technology for TAVI has grown enormously, and now includes a myriad of vascular access approaches and innovative valve designs. As a result, the range of patients who can benefit from these advances continues to grow rapidly. Furthermore, given the improved safety profile and clinical success of current-generation devices in randomized trials, the use of TAVI among even low-risk populations is justified in current trials. With the rapid dissemination and expansion of this technology, operators need to have a comprehensive understanding of how to select the appropriate procedural approach for each individual patient. In this Review, we detail the current evidence for TAVI among different patient populations, discuss the different vascular access approaches currently in use, and explore differences in design features among currently available and investigational valve systems. Furthermore, we provide an overview of important considerations for special patient populations, such as those with existing mitral prostheses, bicuspid aortic stenosis, isolated aortic regurgitation, or severe left ventricular outflow tract calcification.

In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown.To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR.Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017.Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status.Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years.Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population.clinicaltrials.gov Identifier: NCT01314313.

Objective Endovascular stent-grafting provides an alternative treatment option for high-risk patients with ascending aortic disease. The feasibility of this approach has been demonstrated before. We assess the updated experience with ascending thoracic endovascular aortic repair and propose a modification of the landing zone classification based on the outcomes. Methods From 2006 to 2016, 39 patients deemed very high risk for open replacement underwent endovascular repair of ascending aorta for acute type A dissection (12, 31%), intramural hematoma (2, 5%), pseudoaneurysm (22, 56%), and chronic dissection suture line entry tear (3, 8%). Ascending thoracic endovascular aortic repair was performed in 36 patients. In 3 patients with pseudoaneurysm, occluder devices were used. Computed tomography imaging analysis was performed, and the extent of aortic pathology was designated by segmental proximity to the left ventricle. Segmental anatomy of the proximal aorta was designed as zone 0A from the annulus to the distal margin of highest coronary, 0B extends from above the coronary to the distal margin of right pulmonary artery, and 0C extends from the right pulmonary artery border to the innominate artery. Multivariable time to event Cox regression analysis was performed to predict mortality, and long-term survival was estimated using the Kaplan–Meier method. Results Operative mortality was 13%; all 5 deaths occurred after emergency ascending thoracic endovascular aortic repair for type A dissection. Other complications included stroke in 4 patients (10%), myocardial infarction in 2 patients (5%), tracheostomy in 2 patients (5%), and dialysis in 2 patients (5%). In patients with acute type A dissection, the ascending pathology extended into zone 0A in 10 (71%) and 0B in 4 (29%). Among those with pseudoaneurysm, the location of the defect was in 0B in 11 (50%), 0C in 10 (45%), and 0A in 1. Among the patients with chronic dissection, the defect was located in 0C in all 3 (100%). After multivariable adjustment, Cox regression predicted significantly higher hazard of mortality with disease involving zone 0A versus 0C ( P = .020) and older age ( P = .026). Kaplan–Meier estimate of survival was also significantly worse in patients with disease extension into 0A versus 0C ( P = .0018). At 30 days, 1 year, and 5 years, the overall survival was 81%, 74%, and 64% and freedom from reintervention was 85%, 77%, and 68%, respectively. Conclusions The modified zone zero classification is useful for characterizing extent of ascending aortic pathology and assessing prognosis. Location of the defect varies by pathology, and the presence of 0A disease predicts worse outcomes. Design of endovascular devices should be tailored to the aortic pathology and zone characteristics.

To determine the value of aortic valve repair rather than replacement for valve dysfunction, we assessed late outcomes of various repair techniques in the contemporary era.From January 2001 to January 2011, aortic valve repair was planned in 1,124 patients. Techniques involved commissural figure-of-8 suspension sutures (n = 63 [6.2%]), cusp repair with commissuroplasty (n = 481 [48%]), debridement (n = 174 [17%]), free-margin plication (n = 271 [27%]) or resection (n = 75) or both, or annulus repair with resuspension (n = 230 [23%]), root reimplantation (n = 252 [25%]), or remodeling (n = 35 [3.5%]).Planned repair was aborted for replacement in 115 patients (10%); risk factors included greater severity of aortic regurgitation (AR; p = 0.0002) and valve calcification (p0.0001). In-hospital outcomes for the remaining 1,009 patients included death (12 [1.2%]), stroke (13 [1.3%]), and reoperation for valve dysfunction (14 [1.4%]). Freedom from aortic valve reoperation at 1, 5, and 10 years was 97%, 93%, and 90%, respectively. Figure-of-8 suspension sutures, valve resuspension, and root repair and replacement were least likely to require reoperation; cusp repair with commissural sutures, plication, and commissuroplasty was most likely (p0.05). Survival at 1, 5, and 10 years was 96%, 92%, and 83%. Immediate postoperative AR grade was none-mild (94%), moderate (5%), and severe (1%). At 10 years after repair, AR grade was none (20%), mild (33%), moderate (26%), and severe (21%). Patients undergoing root procedures were less likely to have higher-grade postoperative AR (p0.0001).Valve repair is effective and durable for treating aortic valve dysfunction. Greater severity of AR preoperatively is associated with higher likelihood of repair failure. Commissural figure-of-8 suspension sutures and repair with annular support have the best long-term durability.

Background— In patients with bicuspid aortic valve and dilated proximal ascending aorta, we sought to assess (1) factors associated with increased longer-term cardiovascular mortality and (2) incremental prognostic use of indexing aortic root to patient height. Methods and Results— We studied 969 consecutive bicuspid aortic valve patients (50±13 years; 87% men) with proximal aorta ≥4 cm, who also had a gated contrast-enhanced thoracic computed tomography or magnetic resonance angiography. A ratio of ascending aortic area/height was calculated on tomography, and ≥10 cm 2 /m was considered abnormal, as previously reported. Society of Thoracic Surgeons score and cardiovascular death were recorded. Greater than or equal to III+ aortic regurgitation and severe aortic stenosis were seen in 37% and 10%, respectively. Society of Thoracic Surgeons score and right ventricular systolic pressure were 2±3 and 15±16 mm Hg, respectively. Abnormal ascending aortic area/height ratio was noted in 33%; 44% underwent ascending aortic surgery at 34 days. At 10.8 years (interquartile range, 9.6–12.3), 82 (9%) died (0.4% in-hospital postoperative mortality). On multivariable Cox survival analysis, ascending aortic area/height ratio (hazard ratio, 2; 95% confidence interval, 1.20–3.35) was associated with cardiovascular death, whereas aortic surgery (hazard ratio, 0.46; confidence interval, 0.26–0.80) was associated with improved survival (both P Conclusions— In bicuspid aortic valve patients with dilated proximal ascending aorta, ascending aortic area/height ratio was independently associated with cardiovascular death.

Objectives Risk of reoperation and loss of a second native valve are major drawbacks of the Ross operation. Rather than discarding the failed autograft, it can be placed back into the native pulmonary position by "Ross reversal." We review our early and mid-term results with this operation. Methods From 2006 to 2017, 39 patients underwent reoperation for autograft dysfunction. The autograft was successfully rescued in 35 patients: by Ross reversal in 30, David procedure in 4, and autograft repair in 1. Medical records were reviewed for patient characteristics (mean age was 46 ± 13 years, range 18-67 years, and 23 were male), previous operations, indications for reoperation, hospital outcomes, and echocardiographic findings for the 30 patients undergoing successful Ross reversal. Follow-up was 4.1 ± 3.5 years (range 7 months-11 years). Results Median interval between the original Ross procedure and Ross reversal was 12 years (range 5-19 years). Eight patients also had absolute indications for replacement of the pulmonary allograft. There was no operative mortality. One patient required reoperation for bleeding. Another had an abdominal aorta injury from use of an endoballoon clamp. There was no other major postoperative morbidity, and median postoperative hospital stay was 7.2 days (range 4-41 days). No patient required reoperation during follow-up. Twenty-four patients had acceptable pulmonary valve function, and 6 had clinically well-tolerated moderate or severe pulmonary regurgitation. Conclusions Ross reversal can be performed with low morbidity and acceptable pulmonary valve function, reducing patient risk of losing 2 native valves when the autograft fails in the aortic position.

Background— Renal dysfunction is intricately linked to aortic stenosis, with over 25% patients presenting for transcatheter aortic valve replacement having chronic kidney disease (CKD). Prevalence and outcomes of patients with CKD, especially those with end-stage renal disease (ESRD), are controversial. We aimed to compare in-hospital outcomes of patients with CKD or ESRD with those patients with no CKD/ESRD. Methods and Results— Data were obtained using the national inpatient sample between the years 2011 and 2014. We used the International Classification of Diseases, Ninth Edition, Clinical Modification procedure codes 350.5 and 350.6 to identify patients undergoing transcatheter aortic valve replacement. Primary outcome of interest was in-hospital mortality. A 2-tailed P value P Conclusions— Patients with CKD and ESRD have increased in-hospital mortality and periprocedural adverse events with longer hospital length of stay, when compared with those without CKD

This review provides a general overview of the consensus statement from the 2010 more recent updates AHA/ACC Guidelines for the Diagnosis and Management of Patients with Thoracic Aortic Disease, and highlights current practice patterns. The suggestions herein are intended to facilitate clinical decision making in the management of thoracic aortic disease. The main intent of this report is to highlight screening, surveillance, initial and definitive management of thoracic aortic disease, and special populations that should be considered.

Background Cardiac disease after mediastinal radiotherapy for thoracic malignancy ( chest radiotherapy [XRT] ) often manifests as progressive aortic stenosis. In patients with XRT ‐induced severe aortic stenosis undergoing surgical aortic valve replacement ( SAVR ), we sought to: (1) study long‐term survival and compare these patients with a matched cohort undergoing SAVR during the same time frame; and (2) identify potential predictors of long‐term mortality. Methods and Results We studied patients with symptomatic severe aortic stenosis undergoing SAVR at our institution, of which there were 172 mediastinal XRT patients (63±13 years, 62% women) matched in a 1:1 fashion (based on age, sex, time of surgery, and aortic valve area) with 172 non‐ XRT patients (comparison group). Baseline clinical and postoperative data were obtained. Society of Thoracic Surgeons score was calculated and mortality was recorded. In the XRT group, the median Society of Thoracic Surgeons score was 4% (interquartile range 2–13), while mean left ventricular ejection fraction, left ventricular stroke volume index, and mean aortic valve gradient were 54±11%, 38±14 mL/m 2 , and 39±11 mm Hg, respectively. In the entire cohort, 27% and 34% of patients underwent concomitant coronary artery bypass grafting and aortic surgery at the time of SAVR , respectively. Thirty‐day/in‐hospital deaths occurred in 4 (2%) patients in the XRT group and 0 patients in the comparison group. At 6±3 years of follow‐up, on matched group analysis, there were 95 (28%) deaths (83 [48%] in the XRT group versus 12 [7%] in the comparison group (log‐rank 89, P Society of Thoracic Surgeons score (hazard ratio, 1.14; 95% CI, 1.03–1.26) and mediastinal XRT ( hazard ratio, 8.12; 95% CI, 4.26–15.64) were associated with increased longer‐term mortality (both P Conclusions In patients with severe aortic stenosis undergoing SAVR , patients with prior mediastinal XRT have significantly worse longer‐term survival versus a matched cohort.

At a center where surgeons favor mitral valve (MV) repair for all subsets of leaflet prolapse, we compared results of patients undergoing repair for simple versus complex degenerative MV disease.From January 1985 to January 2016, 6153 patients underwent primary isolated MV repair for degenerative disease, 3101 patients underwent primary isolated MV repair for simple disease (posterior prolapse), and 3052 patients underwent primary isolated MV repair for complex disease (anterior or bileaflet prolapse), based on preoperative echocardiographic images. Logistic regression analysis was used to generate propensity scores for risk-adjusted comparisons (n = 2065 matched pairs). Durability was assessed by longitudinal recurrence of mitral regurgitation and reoperation.Compared with patients with simple disease, those undergoing repair of complex pathology were more likely to be younger and female (both P values .0001) but with similar symptoms (P = .3). The most common repair technique was ring/band annuloplasty (3055/99% simple vs 3000/98% complex; P = .5), followed by leaflet resection (2802/90% simple vs 2249/74% complex; P .0001). Among propensity-matched patients, recurrence of severe mitral regurgitation 10 years after repair was 6.2% for simple pathology versus 11% for complex pathology (P = .007), reoperation at 18 years was 6.3% for simple pathology versus 11% for complex pathology, and 20-year survival was 62% for simple pathology versus 61% for complex pathology (P = .6).Early surgical intervention has become more common in patients with degenerative MV disease, regardless of valve prolapse complexity or symptom status. Valve repair was associated with similarly low operative risk and time-related survival but less durability in complex disease. Lifelong annual echocardiographic surveillance after MV repair is recommended, particularly in patients with complex disease.

This chapter stresses the impact and meaning of education in realizing the important ethnopolitical goals leading to the restoration of Sami autonomy. It examines various aspects of the system of education and socialization toward career opportunities available to the Sami. The Sami reactions and initiatives outlined above gradually have improved the level of education, making it possible for the Sami to develop adequate bi-cultural competence. Integration of the Sami school system into its community appears to be a key concept in this transformation. Sami schools should promote both general and special cultural competence and knowledge, for such an integrated orientation permits the Sami culture and language to develop and change dynamically, while at the same time maintaining its cultural peculiarity. The attempt to integrate the school into the local community is the latest standard plan for the Norwegian schools. This innovative proposition opens a new avenue to the Sami, strengthening the specific curriculum in their schools.

Aims In patients with aortic stenosis (AS), risk stratification for aortic valve replacement (AVR) relies mainly on valve-related factors, symptoms and co-morbidities. We sought to evaluate the prognostic impact of a newly-defined staging classification characterizing the extent of extravalvular (extra-aortic valve) cardiac damage among patients with severe AS undergoing AVR. Methods and results Patients with severe AS from the PARTNER 2 trials were pooled and classified according to the presence or absence of cardiac damage as detected by echocardiography prior to AVR: no extravalvular cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular damage (Stage 4). One-year outcomes were compared using Kaplan–Meier techniques and multivariable Cox proportional hazards models were used to identify 1-year predictors of mortality. In 1661 patients with sufficient echocardiographic data to allow staging, 47 (2.8%) patients were classified as Stage 0, 212 (12.8%) as Stage 1, 844 (50.8%) as Stage 2, 413 (24.9%) as Stage 3, and 145 (8.7%) as Stage 4. One-year mortality was 4.4% in Stage 0, 9.2% in Stage 1, 14.4% in Stage 2, 21.3% in Stage 3, and 24.5% in Stage 4 (Ptrend

Sensory information from periodontal mechanoreceptors (PMRs) surrounding the roots of natural teeth is important for optimizing the positioning of food and adjustment of force vectors during precision biting. The present experiment was designed to test the hypothesis; that reduction of afferent inputs from the PMRs, by anesthesia, perturbs the oral fine motor control and related jaw movements during intraoral manipulation of morsels of food. Thirty healthy volunteers with a natural dentition were equally divided into experimental and control groups. The participants in both groups were asked to manipulate and split a spherical candy into two equal halves with the front teeth. An intervention was made by anesthetizing the upper and lower incisors of the experimental group while the control group performed the task without intervention. Performance of the split was evaluated and the jaw movement recorded. The experimental group demonstrated a significant decrease in measures of performance following local anesthesia. However, there was no significant changes in the duration or position of the jaw during movements in the experimental and control group. In conclusion, transient deprivation of sensory information from PMRs perturbs oral fine motor control during intraoral manipulation of food, however, no significant alterations in duration or positions of the jaw during movements can be observed.

Background A modified technique for frozen elephant trunk (FET) repair of acute DeBakey type I dissection has evolved. Procedural modifications are described and midterm outcomes evaluated. Methods From 2009 to 2016, 72 patients with DeBakey type I dissection underwent emergency simplified FET. Mean age was 59 ± 15 years. Presentation included malperfusion (n = 22, 31%), rupture (n = 12, 16%), and aortic insufficiency (n = 42, 58%). Concomitant procedures included valve replacement (n = 9), root replacement (n = 11; valve sparing n = 6), cusp repair (n = 11), and valve resuspension (n = 21). The first 39 were treated by modifying an early generation stent graft. The next 16 received newer modified stent grafts, and the latest 17 underwent branched single anastomosis technique with left subclavian stent grafting. Results Operative mortality was 4.2% (n = 3 of 72). Two presented comatose without recovering, the other died from coagulopathy complications. Morbidity included stroke (n = 3, 4.2%), spinal injury (n = 3, 4.2%; 1 permanent), tracheostomy (n = 7, 9.7%), and renal failure (n = 2, 2.8%). Median follow-up was 28 ± 25 months. Survival was 92% at 6 months, 92% at 1 year, 89% at 3 years, and 80% at 5 years. Among 69 survivors, follow-up imaging was available in 63 (91%). Of these, 58 (92%) patients thrombosed the treated false lumen, with shrinkage in 37(54%) patients from 42 ± 8 mm to 37 ± 7 mm. Ten patients underwent 14 late reinterventions for growth and incomplete thrombosis (7 endo extension, 4 left subclavian embolization, 1 bypass, 2 false lumen embolization). Freedom from reintervention was 93% at 6 months, 87% at 1 year, 77% at 3 years, and 72% at 5 years. Conclusions Simplified FET for treating acute DeBakey type I dissection has evolved and remained safe. It promotes aortic remodeling, and simplifies management of chronic aortic complications.

Background The Placement of AoRtic TraNscathetER Valves trials (PARTNER) showed favorable safety and efficacy versus medical or surgical therapy in inoperable, high, and intermediate surgical risk patients with severe aortic stenosis. However, the biological responses to transcatheter aortic valves have not been well characterized. Objectives The aim of this study was to perform pathologic assessment of Edwards SAPIEN transcatheter aortic valves removed either at autopsy or surgically during the PARTNER I and II clinical trials. Methods Explanted valves and frame were evaluated for pathologic responses including extent of thrombus, inflammation, neointima, and leaflet degeneration/calcification according to semiquantitative grading by implant duration (≤30 days; 31–90 days; >90 days). Results A total of 22 cases (median age 82.0 years, 45% men) were included, with a duration of implantation that ranged from 0 to 1739 days (median duration 16.5 days [interquartile range, 2.8–68.3]). Valve thrombosis resulting in severe aortic stenosis was observed in one case. Moderate leaflet thrombus was seen in 14% of cases (n = 3) and all were asymptomatic. Calcification was seen in two valves: one with severe leaflet calcification had severe aortic stenosis requiring surgical replacement, while the other showed early calcification. Mild structural leaflet changes were exclusively seen in valve implants >90 days. Valve inflammation and thrombus formation was mild in majority of the cases. Conclusions Overall, our study demonstrates moderate thrombus formation in 14% and calcification in only 2 valves, ≥4 years duration. In this short-duration study, acceptable durability and biocompatibility of the Edwards SAPIEN transcatheter valve system was demonstrated; however, further studies are required to confirm the significance and application of our findings.

We describe an alternate technique to perform a replacement of the aortic hemiarch without the need for hypothermic circulatory arrest by axillary cannulation and arch vessel isolation. In 2015, 3 patients underwent hemiarch reconstructions for ascending aortic aneurysms that extended into the arch. Each was performed using right axillary cannulation, isolation and clamping of the innominate artery with isolation, and tangential clamping of the aorta distal to the innominate. There were no neurologic events and no perioperative morbidity or mortality.

This study sought to examine the prognostic utility of left ventricular (LV) global longitudinal strain (GLS) in asymptomatic patients with ≥III+ aortic regurgitation (AR), an indexed LV end-systolic dimension of 2.5 cm/mManagement of asymptomatic patients with severe chronic AR and preserved LVEF is challenging and is typically based on LV dimensions.We studied 1,063 such patients (age 53 ± 16 years; 77% men) seen between 2003 and 2010 (excluding those with symptoms, obstructive coronary artery disease, acute AR/dissection, aortic/mitral stenosis, more than moderate mitral regurgitation, and previous cardiac surgery). Society of Thoracic Surgeons (STS) score was calculated. The primary endpoint was mortality. Average resting LV-GLS was measured offline on 2-, 3-, and 4-chamber views using Velocity Vector Imaging (Siemens, Malvern, Pennsylvania).Mean STS score, LVEF, LV-GLS, and right ventricular systolic pressure were 4.4 ± 5.0%, 57.0 ± 4.0%, -19.5 ± 0.2%, and 31.0 ± 9.0 mm Hg, respectively. In total, 671 patients (63%) underwent aortic valve surgery at a median of 42 days after the initial evaluation. At 6.8 ± 3.0 years, 146 patients (14%) had died. On multivariable Cox survival analysis, LV-GLS (hazard ratio [HR]: 1.11), STS score (HR: 1.51), indexed LV end-systolic dimension (HR: 0.50), right ventricular systolic pressure (HR: 1.33), and aortic valve surgery (HR: 0.35) were associated with longer term mortality (all p 0.001). Sequential addition of LV-GLS and aortic valve surgery improved the C-statistic for longer term mortality for the clinical model (STS score + right ventricular systolic pressure + indexed LV end-systolic dimension) from 0.61 (95% confidence interval [CI]: 0.51 to 0.72) to 0.67 (95% CI: 0.54 to 0.87) and to 0.77 (95% CI: 0.63 to 0.90), respectively (p 0.001 for both). A significantly higher proportion (log-rank p = 0.01) of patients with LV-GLS worse than median (-19.5%) died versus those with an LV-GLS better than median (86 of 513 [17%] vs. 60 of 550 [11%]). The risk of death at 5 years significantly increased with an LV-GLS of worse than -19%.In asymptomatic patients with ≥III+ chronic AR and preserved LVEF, worsening LV-GLS was associated with longer term mortality, providing incremental prognostic value and improved reclassification.

Objectives The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). Methods Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. Results Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. Conclusions These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). Clinical trial registration clinicaltrials.gov: NCT01757665.

Background— In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. Methods and Results— Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. Conclusions— In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant–related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

In-depth interviews were conducted with the life skills coordinators of 9 of 21 institutions identified as being “dedicated” to service (Andrassy & Bruening, 2011). As a result of service being one portion of CHAMPS/Life Skills programming, we expanded our investigation to include all aspects of this student development program. In particular, we focused our inquiry on organizational capacity and its role in student involvement. Findings indicate these ‘dedicated’ athletic departments were characterized by strong organizational capacity for engaging student-athletes in meaningful service efforts. The critical role of coaches and mutual values among internal stakeholders emerged as the primary strengths of department’s human resources capacity. Despite the limited financial capacity, departments were able to creatively secure some funding for development programs. The ability to leverage external relationships, an organizational culture promoting participative decision-making and student-athlete developmen...

OBJECTIVE: To investigate if repeated holding and splitting of food morsel change the variability of force and jaw muscle activity in participants with natural dentition.METHODS: Twenty healthy volunteers (mean age=26.2±3.9 years) participated in a single session divided into six series. Each series consisted of ten trials of a standardized behavioural task (total 60 trials) involving holding and splitting a flat-faced tablet (8mm, 180mg) placed on a bite force transducer with the anterior teeth. The hold and split forces along with the electromyographic (EMG) activity of the left and right masseter (MAL and MAR), left anterior temporalis (TAL) and digastric (DIG) muscles were recorded. A series (ten trials) of natural biting tasks was also performed before and after the six series of the behavioural task.RESULTS: The mean hold force (PCONCLUSION: There was no evident optimization of jaw motor function in terms of reduction in the variability of bite force values and muscle activity, when this simple task was repeated up to sixty times in participants with normal intact periodontium.

Transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI) has emerged as an attractive treatment strategy for the treatment of patients with severe symptomatic aortic stenosis (AS), particularly those who are inoperable or at high risk for surgical aortic valve replacement. Several multicentre registries and randomised trials have demonstrated the safety and efficacy of this technology in improving the survival as well as functional capacity of patients with AS. Most of the elderly patients with severe AS have multiple non-cardiac comorbidities, which might limit survival and impede the improvement in functional capacity afforded by TAVR. Therefore, optimal patient selection based on precise risk assessment is currently the cornerstone of evaluation of patients for TAVR. Due to the need for a multifaceted approach in patient evaluation, procedural conduct as well as postprocedure management, multidisciplinary heart valve teams have assumed a paramount role in the TAVR process. This review presents the current perspectives in patient selection, risk assessment, procedural considerations and outcomes following TAVR, along with implications for the future.

Background The SAPIEN-XT is a newer generation balloon-expandable valve created of cobalt chromium frame, as opposed to the stainless steel frame used in the older generation SAPIEN valve. We sought to determine if there was difference in acute recoil between the two valves. Methods All patients who underwent transfemoral–transcatheter aortic valve replacement using the SAPIEN-XT valve at the Cleveland Clinic were included. Recoil was measured using biplane cine-angiographic image analysis of valve deployment. Acute recoil was defined as [(valve diameter at maximal balloon inflation) − (valve diameter after deflation)]/valve diameter at maximal balloon inflation (reported as percentage). Patients undergoing SAPIEN valve implantation were used as the comparison group. Results Among the 23 mm valves, the mean (standard deviation—SD) acute recoil was 2.77% (1.14) for the SAPIEN valve as compared to 3.75% (1.52) for the SAPIEN XT valve (P = 0.04). Among the 26 mm valves, the mean (SD) acute recoil was 2.85% (1.4) for the SAPIEN valve as compared to 4.32% (1.63) for the SAPIEN XT valve (P = 0.01). Multivariable linear regression analysis demonstrated significantly greater adjusted recoil in the SAPIEN XT valves as compared to the SAPIEN valves by 1.43% [(95% CI: 0.69–2.17), P

Background— The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown. Methods and Results— In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively ( P P P =0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P hazard ratio, 0.60; 95% confidence interval, 0.46–0.77; P Conclusions— TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Previous research suggests sport-for-development organizations strategically aim to engage people through social media in hopes of generating increased offline support (Thorpe & Rinehart, 2013). Using the framework set forth by Lovejoy and Saxton (2012), the purpose of this study was to explore how nonprofit organizations use Twitter to disseminate information, build engagement, and facilitate action. A content analysis of 3,233 tweets revealed a larger proportion of interactive communication, yet one-way communication was the most common function. Overall, the use of social media to facilitate action among stakeholders was scarce, but the way organizations used Twitter to provide information, interact with followers, and create a call for action varied considerably among them. Interestingly, these differences were not associated with annual revenue, organizational age, targeted social issues, or number of countries of operation. This study has important theoretical and practical implications, and provides a first look at how sport-for-development organizations use Twitter.

In this work, diffusion and dissociation mechanisms related to the formation and evolution of vacancy–oxygen complexes have been studied. Czochralski-grown silicon samples have been irradiated at room temperature using fast electrons resulting in the formation of several defects including vacancy–oxygen complexes (VO). The samples were isothermally annealed at different temperatures in the range of 370–470 C. Fourier-transform infrared spectroscopy has been employed to measure the local vibrational modes associated with the individual defects. The evolution and generation kinetics of vacancy–oxygen complexes have been simulated within the framework of the theory for diffusion-limited reactions and compared with the experimental data.

Objectives Transapical transcatheter aortic valve replacement (TA-TAVR) is a viable treatment option for selected high-risk elderly patients. We analyzed the 30-day mortality and perioperative complications, focusing on the "learning curve" since our first TA procedure in 2007. We also introduce unique cases, demonstrating new possibilities for alternate access sites and concurrent cardiac interventions using the apical approach. Methods From February 2007 to May 2013, 150 patients underwent TA-TAVR (mean age, 81.4 ± 7 years; mean Society of Thoracic Surgeons score, 9.8 ± 3.5). We compared 2 groups (group A, n = 65, procedures from February 2007 to December 2010; group B, n = 85, procedures from January 2011 to May 2013). Results Five deaths (3.3%) occurred within 30 days, with a decrease in 30-day mortality between the 2 groups (group A, n = 4, 6.2%; group B, n = 1, 1.2%) that became significant at 1 year (log-rank, P = .002). Severe bleeding from the apex (group A, 4.6%; group B 4.4%) and deployment of >1 valve (group A, 7.6%; group B, 10.5%) was similar in both groups. Valve embolization was less frequent in group B (group A, 4.6%; group B, 2.4%). Postoperative complications in groups A and B included stroke (3.1% vs 0%), renal failure (9.3% vs 4.7%), and permanent pacemaker implantation (6.1% vs 5.9%). No myocardial infarctions occurred in either group. Two patients received simultaneous aortic and mitral valve implantation; 1 patient undergoing TA-TAVR also underwent distal arch and descending aorta repair; all had favorable outcomes. With a further 25 TA-TAVR since May 2013, the overall mortality is 2.9% (5/175). Conclusions Although working with the fragile apical tissues in high-risk elderly patients remains a challenge, we have demonstrated a reduction in mortality and complications with increasing experience in TA-TAVR. We have successfully demonstrated novel combined procedures and uses for the transapical approach and alternate access sites, which should continue to be explored.

Background: Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).Objectives: The objective...

Concomitant aortic and mitral valve (MV) operations have more than doubled over the past decade. We utilized the Society of Thoracic Surgeons Adult Cardiac Surgery Database (ACSD) to evaluate outcomes for patients undergoing combined aortic valve replacement (AVR) and MV repair or replacement.From 1993 to 2007, 23,404 patients undergoing concomitant AVR+MV surgery were identified. Patients with mitral stenosis, emergent or salvage status, and endocarditis were excluded. Outcomes were expressed as unadjusted operative mortality, adjusted odds ratio (OR) for mortality, and a composite of mortality and major complications.The MV repair was performed in 46.0% and replacement in 54.0% of AVR patients. The rate of MV repair increased from 22.5% in 1993 to 59.1% in 2007 (p0.0001). Compared with the AVR+MV replacement group, the AVR+MV repair group was older (69.7±11.5 vs 67.2±12.7 years, p0.0001), had worse ejection fraction (0.449±0.153 vs 0.495±0.139, p0.0001), and more concomitant coronary artery bypass grafting (CABG) (50.5% vs 40.9%, p0.0001). Unadjusted operative mortality was lower in the AVR+MV repair group (8.2% vs 11.6%, p0.0001). Predictors of operative mortality by multivariable analysis included the following: age (OR 1.21, p0.0001); concomitant CABG (OR 1.49, p0.0001); diabetes mellitus (OR 1.56, p0.0001); reoperation (OR 1.53, p0.0001); and renal failure with dialysis (OR 3.57, p0.0001). Patients undergoing MV repair had a lower independent risk of operative mortality (OR 0.61, p0.0001), and mortality also independently improved over time (2003 to 2007 vs 1993 to 1997, OR 0.79, p0.002).When feasible, MV repair remains the most optimal method of correcting mitral regurgitation during concomitant AVR. Continued efforts to improve MV repair rates in this setting seem warranted.

Objectives Hybrid operations combining open and endovascular techniques have evolved for patients with complex aortic and coexisting cardiovascular disease. Our objectives were to describe the repair techniques and assess the outcomes in patients undergoing hybrid repair for aneurysm associated with previous aortic coarctation. Methods From 2004 to 2012, 14 patients underwent hybrid repair by elephant trunk with endovascular completion (n = 5), frozen elephant trunk (n = 8), or antegrade stent grafting (n = 1). The mean age at surgery was 45 ± 13.5 years. Of the 14 patients, 8 underwent supra-aortic arterial revascularization (ascending to subclavian bypass in 5, carotid–subclavian bypass in 2, or ascending to carotid and subclavian bypass in 1). Ten patients had a bicuspid aortic valve, 5 underwent concomitant aortic valve replacement, and 1 underwent valve repair. Six had a hypoplastic arch. Other procedures included ascending aortic repair (n = 4), coronary artery bypass grafting (n = 1), ascending to descending bypass (n = 1), and subclavian aneurysm repair (n = 1). One operation was an emergency, the others were elective. The mean maximum aneurysm diameter was 5.9 ± 1.5 cm. Data were obtained from a prospective database and chart review. Results No perioperative mortality, stroke, renal failure, or paraplegia occurred. One patient required prolonged intubation, another required reoperation for postoperative bleeding. Two endoleaks required repeat intervention. The mean length of stay was 9 ± 5.5 days. One late death occurred from hypertensive crisis and associated disseminated intravascular coagulation. At a mean follow-up of 26 months, no aortic growth was found. Conclusions Hybrid repair of postcoarctation repair aneurysm is a safe and effective, less-invasive treatment option for patients with complex anatomy and/or concomitant cardiac disease.

The Placement of Aortic Transcatheter Valves (PARTNER) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting (CABG) operation who received surgical aortic valve replacement (SAVR) in comparison with transcatheter aortic valve replacement (TAVR). We sought to further evaluate these groups.We reviewed the database of the 699 patients enrolled in the PARTNER trial. The cohort for this study consisted of 288 patients (41.2%) who had a history of CABG operation before enrollment in the PARTNER trial. All patients were followed up for 2 years.The mean age was 81.5±6.6 years, and 231 patients (80.2%) were men. The preoperative characteristics were similar in 140 patients (48.6%) who received SAVR and 148 (51.4%) who received TAVR. There were no differences between the two groups with respect to the operative outcomes of death, stroke, and myocardial infarction, but the TAVR patients experienced more paravalvular regurgitation (p0.0001). At 2 years, there was a trend toward greater all-cause mortality in the TAVR patients (hazard ratio [HR] 1.53; 95% confidence interval [CI]: 0.99, 2.35; p=0.052). Furthermore, the TAVR patients had more repeated hospitalization (HR 1.75; 95% CI: 0.99, 3.07; p=0.05), death of any cause or repeated hospitalization (HR 1.52; 95% CI: 1.06, 2.19; p=0.02), and death of any cause or stroke (HR 1.51; 95% CI: 1.00, 2.27; p=0.05).The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR. Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes.

Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

BackgroundPatients undergoing transcatheter aortic valve replacement (TAVR), as compared with those undergoing surgical aortic valve replacement (AVR), have higher postprocedural aortic regurgitation (AR), associated with higher mortality. We hypothesized that reduced annular deformation is associated with higher postprocedural AR and sought to assess incremental value of assessment of aortic annular deformation in prediction of post-TAVR AR.MethodsWe included 87 patients with high-risk severe aortic stenosis (AS) (81 ± 10 years, 54% men) who underwent preprocedural echocardiography and contrast-enhanced (4-dimensional) multidetector computed tomography (MDCT) of the aortic root, followed by TAVR (n = 55) or surgical AVR (n = 32). On MDCT, minimal/maximal annular circumference, circumferential deformation (maximum-minimum over cardiac cycle), and eccentricity (largest/smallest diameter during systole) were calculated. Degree of commissural/annular calcification was graded semiquantitatively (scale 1-3). Oversizing/undersizing of the prosthesis during TAVR was assessed.ResultsPre-AVR aortic valve area (0.6 ± 0.1 vs 0.6 ± 0.1 cm2), mean aortic valve gradient (46 ± 14 vs 45 ± 11 mm Hg), AR (1 ± 0.8 vs 0.9 ± 0.7), maximal annular circumference (8 ± 1 vs 7.9 ± 0.8 cm), annular deformation (0.3 ± 0.1 vs 0.3 ± 0.1 cm), eccentricity (1.2 ± 0.1 vs 1.2 ± 0.1), commissural (2.1 ± 0.6 vs 2 ± 0.7), and annular calcification scores (1.7 ± 0.8 vs 1.7 ± 0.8) were similar in TAVR and surgical AVR groups (P = not significant). A higher proportion of patients had ≥ mild AR in the TAVR than in the surgical AVR group (58% vs 34%; P

Background Bicuspid aortic valve (BAV) is the most common congenital cardiac malformation, occurring in 1% to 2% of the population. Eventually, 20% develop clinically important valvar regurgitation requiring surgical intervention. Aortic valve repair avoids anticoagulation and prosthetic valve-related complications. This study evaluated long-term durability of BAV repair. Methods From 1985 to 2011, 728 patients, mean age 42 ± 12 years, underwent BAV repair at Cleveland Clinic. Mean follow-up was 9.0 ± 6.2 years (median, 8.3). Factors associated with repair durability (expressed as aortic valve reoperations and echocardiographically estimated gradients and regurgitation) and survival were identified. Results Hospital mortality was 0.41% (n = 3), and stroke occurred in 0.27% (n = 2). Freedom from aortic valve reoperation at 10 years was 78%. Risk of reoperation was highest immediately after operation and fell rapidly to approximately 2.6%/year up to 15 years. Primary reasons for reoperation were cusp prolapse (38%), aortic stenosis or regurgitation (17%), and aortic regurgitation from root aneurysm (15%). Aortic valve gradients showed an early initial peak, rapidly declined, then rose steadily, accompanied by an increase in left ventricular mass. Survival was 94% at 10 years. A risk factor for early death was greater preoperative mitral valve regurgitation, and for late death, older age at operation, more severe symptoms, and poorer left ventricular function. Conclusions BAV repair is safe and durable with low mortality, low prevalence of reoperation, and good long-term survival. Cusp prolapse from technical errors and natural progression of disease are the most common causes for reoperation, but progressive natural increase in valve gradient accounts for a substantial proportion as well.

Background Although the operative risk of multivalve operations has historically been high, current outcomes are poorly understood. We sought to evaluate factors influencing contemporary results of triple-valve operations using The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Methods Among patients undergoing combined mitral, aortic, and tricuspid valve (triple- valve) operations between 1993 and 2011, aortic valve repair patients were excluded and those having aortic valve replacement were analyzed according to whether they underwent repair vs replacement of the mitral valve (MV) and tricuspid valve (TV). Temporal trends in operative death and clinical outcomes were examined using unadjusted and adjusted analyses. Results A total of 8,021 triple-valve patients were studied. The median (25 th percentile, 75 th percentile) age was 67 years (59, 77 years), 4,809 (60%) were women, 4,488 (56%) had New York Heart Association class III to IV symptoms, and the mean (25 th percentile, 75 th percentile) ejection fraction was 50% (40%, 60%). MV repair was performed in 2,728 (34%) patients overall and increased over time from 13% (1993 to 1997) to 41% (2008 to 2011). TV repair was performed in 7,512 (94%) patients overall and increased over time from 86% (1993 to 1997) to 96% (2008 to 2011). Unadjusted operative mortality decreased from 17% in 1993 to 9% in 2011. Adjusted odds ratios (95% confidence intervals) of operative mortality were lower in those having MV repair (0.72 [0.61 to 0.85]), TV repair (0.64 [0.50 to 0.83]), and MV + TV repair (0.46 [0.34 to 0.63]) compared with those having replacements. Unadjusted and adjusted odds of stroke were similar between groups and not significant for all. Conclusions This large series demonstrates that surgical results of triple-valve operations have continued to improve during the past 18 years. MV and TV repair were associated with improvements in early survival. Although further study is required to understand late outcomes, these data suggest that broader efforts to perform MV repair instead of replacement in this high-risk patient population appear warranted.

Objectives The study undertook a systematic review to establish and compare the risk of stroke between the 2 widely used approaches (transfemoral [TF] vs. transapical [TA]) and valve designs (CoreValve, Medtronic, Minneapolis, Minnesota vs. Edwards Valve, Edwards Lifesciences, Irvine, California) for transcatheter aortic valve replacement (TAVR). Background There has been a rapid adoption and expansion in the use of TAVR. The technique is however far from perfect and requires further refinement to alleviate safety concerns that include stroke. Methods All studies reporting on the risk of stroke after TAVR were identified using an electronic search and pooled using established meta-analytical guidelines. Results 25 multicenter registries and 33 single-center studies were included in the analysis. There was no difference in pooled 30-day stroke post-TAVR between the TF and TA approach in multicenter (2.8% [95% confidence interval (CI): 2.4 to 3.4] vs. 2.8% [95% CI: 2.0 to 3.9]) and single-center studies (3.8% [95% CI: 3.1 to 4.6] vs. 3.4% [95% CI: 2.5 to 4.5]). Similarly, there was no difference in pooled 30-day stroke post TAVR between the CoreValve and Edwards Valve in multicenter (2.4% [95% CI: 1.9 to 3.2] vs. 3.0% [95% CI: 2.4 to 3.7]) and single-center studies (3.8% [95% CI: 2.8 to 4.9] vs. 3.2% [95% CI: 2.4 to 4.3]). There was a decline in stroke risk with experience and technological advancement. There was no difference in the outcome of 30-day stroke between TAVR and surgical aortic valve replacement. Conclusions Our findings suggest that the risk of 30-day stroke after TAVR is similar between the approaches and valve types. There has been a decline in stroke risk after TAVR with improvements in valve technology, patient selection, and operator experience.

Background Computed tomography (CT) imaging has not been systematically studied for predicting vascular complications during transcatheter aortic valve replacement (TAVR). Methods Clinical data were obtained from the electronic medical record and analysis was performed for each individual patient's iliofemoral CT angiogram. Sheath : femoral artery diameter ratio (SFAR) and sheath : femoral artery area ratio (SFAAR) were defined as the ratio of the sheath outer diameter to the femoral minimal lumen diameter (MLD) and sheath area to the femoral minimal lumen area (MLA), respectively. Results A total of 255 patients underwent TF-TAVR with a 30-day mortality of 0.4% and 30-day stroke rate of 1.6%. Twenty-eight (11%) patients suffered a vascular complication, the majority of whom (82%) were managed percutaneously. Receiver operating characteristic (ROC) curve analysis demonstrated an SFAAR of 1.35 to predict the occurrence of vascular complications with a sensitivity of 78.6%. By comparison, similar analysis using SFAR provided a value of 1.45 with sensitivity of 64.2%. Multivariable modeling confirmed SFAR [OR (95% CI): 8.3(1.8–39.1)] and log-transformed SFAAR [OR (95% CI): 40.1 (2.4–650.0)] as significant predictors of vascular complication. Conclusions Using CT analysis, an SFAR of 1.45 and an SFAAR of 1.35 are each significant predictors of vascular complications among patients undergoing TF-TAVR. Utilization of CT-based area may provide a more accurate screen for patients undergoing evaluation for TF-TAVR as it takes into consideration the elliptical nature of the vessel. © 2014 Wiley Periodicals, Inc.

Objectives This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Objective Kommerell diverticulum carries the risk of rupture or dissection if left untreated. Various methods of repair have been described, and options have recently expanded to include the hybrid approach. This study describes hybrid repair techniques for Kommerell diverticulum and assesses outcomes. Methods Between 2005 and 2010, a total of 10 patients underwent hybrid repair of Kommerell diverticulum (3 right-sided arches) by elephant trunk with endovascular completion (n = 4), frozen elephant trunk (n = 3), or stent grafting with cervical debranching (n = 3). Mean age at procedure was 57 ± 25.5 years. Subclavian artery revascularization was performed preoperatively (n = 4), intraoperatively (n = 3), or postoperatively (n = 3), either as carotid-to-subclavian bypass (n = 7; n = 3 bilateral) or originating from the ascending aorta (n = 3). Data were obtained from the prospectively collected database and chart review. Results There was no in-hospital mortality, nor were there any cases of respiratory or renal failure. There were no cases of paraplegia, but there was 1 stroke. Two patients had type 2 endoleaks develop; 1 required subclavian coil embolization. Mean hospital stay was 8.73 ± 4 days. After repair, there were no ruptures, no significant growth, and all patients remain free of symptoms. Conclusions Hybrid repair is a safe and effective surgical treatment option for Kommerell diverticulum. Selection of the specific type of intervention is based on patient anatomy and comorbid conditions.

Objectives The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis >30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Background Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes. Methods Chart review and query of a prospectively collected database identified 50 patients who underwent thoracic aortic operation after prior TEVAR. Active follow-up was supplemented by Social Security information for vital status. Results From July 2001 to January 2012 open arch (n = 25), descending (n = 6), thoracoabdominal (n = 17), or extra-anatomic bypass (n = 2) operations were performed after previous TEVAR (median interval from TEVAR to open surgical procedure: 13.9 months; interquartile range, 0.5 to 24 months). Indications for open operation included type 1 endoleaks (n = 19), retrograde aortic dissection (n = 9), chronic aortic dissection with persistent growth of the false lumen (n = 16), and graft infection (n = 6). Sixty percent had prior cardiovascular surgical procedures and 18% were done as emergencies. Circulatory support was required in 78% and hypothermic arrest in 48%. Hospital mortality occurred in 3 (6%) patients with no strokes and 1 patient with myocardial infarction; 5 (10%) patients required tracheostomy and 1 required dialysis. Survival was 67% at a median follow-up of 2.9 years. Conclusions Conversion to open repair after thoracic stent-grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent-graft in most cases. Late outcomes are consistent with the chronic disease state of these patients.

Objective Aortic stenosis is the most common valvular pathology in the elderly. Transcatheter aortic valve replacement has emerged as a safe and feasible alternative for high-risk patients. However, a significant number of patients are still not transcatheter aortic valve replacement candidates because of poor peripheral access and chest pathology. We report the use of alternative access options for such patients. Methods Seven patients who had poor peripheral access and chest pathology had transcatheter aortic valve replacement using alternative access techniques. Five patients had the valve delivered by direct cannulation of the aorta via a mini-sternotomy, and 1 patient had the valve delivered via a mini–right thoracotomy. In 1 patient, the right subclavian artery was cannulated. Intraprocedural and 30-day outcome data were analyzed. Results The mean age of patients was 85.00 ± 9.59 years, with a Society of Thoracic Surgeons score of 16.81% ± 6.87% and logistic European System for Cardiac Operative Risk Evaluation of 21.59% ± 8.46%. Procedural success was 100%. Procedural and 30-day mortality were zero. There were no access-related complications or neurologic events. Two patients had worsening renal function that did not require dialysis. All patients were discharged with a median hospital stay of 7 days. In our experience of 138 transapical or alternative access patients, 7 died (5%) and for 257 transfemoral patients, 1 died (0.4%). Conclusions Despite the high surgical risk of the study population, these techniques had excellent outcome with no mortality and acceptable morbidity. With the use of currently available technologies, these approaches are promising and offer alternative options in patients with no access and prohibitive chest pathology or pulmonary function.

Objective Retrograde dissection is now recognized as an important complication after thoracic endovascular aortic repair (TEVAR), but its treatment is poorly understood. Our objectives were to investigate the risks, describe the repair methods, and assess the outcomes of this complication. Methods From 2000 to 2012, 766 patients underwent TEVAR. Of these patients, 14 (1.8%), plus 1 who had undergone TEVAR elsewhere (n = 15), developed retrograde dissection after stent grafting. They had undergone TEVAR for distal aortic dissection in 7, intramural hematoma in 5, aneurysm in 2, and transection in 1. Their mean age was 65 ± 9 years. At the initial TEVAR, the left subclavian artery was covered in 9, the mean stent graft diameter was 34 ± 2 mm, and >1 device was used in 8 patients. The site of entry tear was at the greater curvature in 11 and lesser curvature in 4. One patient ruptured and died 12 days after TEVAR and never made it to the operating room. The other 14 underwent proximal aortic repair. The median interval between TEVAR and repair of retrograde dissection was 6 months; 3 patients presented within 1 month. The repair techniques included reverse frozen elephant trunk in 5, total arch repair in 4, ascending or hemiarch repair in 4, and ascending TEVAR in 1. Concomitant procedures included aortic valve repair in 4, replacement in 2, root remodeling in 1, and coronary bypass in 1. Results No operative mortality occurred. One patient underwent reoperation for bleeding. Two required a tracheostomy for respiratory failure. However, no renal failure, stroke, or spinal injury occurred. At a median follow-up of 26 months, 4 aortic reoperations had occurred: 1 distal stent graft extension for type 1b endoleak, 2 hybrid thoracoabdominal completion repairs for growth of residual distal disease, and 1 emergency TEVAR for aortobronchial fistula. The latter patient died of septic complications, and 3 other late noncardiac deaths occurred. Conclusions Retrograde ascending dissection can present as an early or a late complication after descending stent grafting because of aortic instability or disease progression and has usually been associated with descending dissection or intramural hematoma. It is a life-threatening complication that can be managed safely with early recognition and rapid delivery of open or hybrid repair.

Objectives The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Background Outcomes of patients with CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. Methods All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Results Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test Conclusions Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Transcatheter aortic valve replacement (TAVR) has become a safe alternative to surgery regardless of the surgical risk. The need for permanent pacemaker (PPM) remains a common complication after the procedure. We conducted a retrospective single-center study to determine the predictors of PPM and