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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2009.08.003 Byline: Mehdi H. Shishehbor (a), Riem Hawi (b), Inder M. Singh (c), E. Murat Tuzcu (a), Deepak L. Bhatt (d), Stephen G. Ellis (a), Samir R. Kapadia (a) Abstract: Current data show conflicting results regarding safety and efficacy of drug-eluting stents (DES) versus bare-metal stents (BMS) for treating saphenous vein grafts (SVG). Our objective was to compare DES with BMS for SVG intervention. Author Affiliation: (a) Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH (b) Department of Internal Medicine, Cleveland Clinic, Cleveland, OH (c) Division of Cardiovascular Medicine, Indiana University School of Medicine, Indianapolis, IN (d) Veterans Affairs Boston Healthcare System and Brigham and Women's Hospital, Boston, MA Article History: Received 9 May 2009; Accepted 6 August 2009 Article Note: (footnote) Dr Shishehbor is supported in part by the National Institutes of Health, National Institute of Child Health and Human Development, Multidisciplinary Clinical Research Career Development Programs grant K12 HD049091, and the National Institutes of Health Loan Repayment Program.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2005.12.029 Byline: Ilke Sipahi (a), E. Murat Tuzcu (a), Paul Schoenhagen (a)(b), Stephen J. Nicholls (a), Timothy Crowe (a), Samir Kapadia (a), Steven E. Nissen (a) Abstract: Arterial remodeling is a major determinant of the clinical manifestations of coronary artery disease. Assessment of arterial remodeling with intravascular ultrasound (IVUS) used to rely on comparing the external elastic membrane (EEM) areas of lesion and reference sites at a single time point (static assessment). Recently, performance of serial IVUS provided the opportunity for direct assessment of remodeling. Our aim was to study the concordance of the static and serial methods. Author Affiliation: (a) Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, OH (b) Department of Diagnostic Radiology, The Cleveland Clinic Foundation, Cleveland, OH Article History: Received 21 September 2005; Accepted 24 December 2005 Article Note: (footnote) The REVERSAL trial was funded by Pfizer. This substudy is part of a National Institutes of Health, National Center for Research Resources, General Clinical Research Center grant MO1 RR-018390., Paul Schoenhagen was supported by a postdoctoral fellowship grant of the Ohio Affiliate of the American Heart Association. A Ralph Reader Overseas Research Fellowship from the National Heart Foundation of Australia supports Dr Nicholls., Disclosure: Dr Sipahi received an educational grant from Pfizer. Dr. Tuzcu has received research support and lecture honoraria from Pfizer. Dr Nicholls received lecture honoraria from Pfizer. Dr Nissen has received research support from and is an unpaid consultant to Pfizer.

Percutaneous transluminal coronary angioplasty (PTCA) is a procedure in which a balloon at the end of a catheter is inflated inside a coronary artery to widen areas constricted by build-up of plaques. Although originally used primarily in patients with severe symptoms of coronary artery disease, its use has extended to patients with less severe disease. The short- and long-term outcomes of patients who had nonsymptomatic (''silent'') but documented myocardial ischemia (diminished circulation to the heart) are described here. Ischemia was determined by abnormal electrocardiograph (ECG) readings or exercises stress tests. Angioplasty was successful in 31 of 34 patients. Constriction decreased from 80 to 16 percent, on average. At one to two months following PTCA, 21 patients had no abnormal ECG readings during exercise testing, and 2 had improved over pre-PTCA findings. Five patients showed similar improvement, while two had abnormal stress tests and eventually needed coronary bypass surgery. Tests on patients at approximately one year showed restenosis (recurrence of artery constriction) in seven patients, and six had further angioplasty or surgery. There were no cardiac deaths in the three-year follow-up period. Eighty-seven percent of patients did not experience heart attack, surgery, angioplasty, or death. The study suggests that PTCA is an effective treatment for patients with silent ischemia. (Consumer Summary produced by Reliance Medical Information, Inc.)

This study sought to evaluate and assess the extent of serial coronary artery calcification in response to oral calcium supplementation. Oral calcium supplements are frequently used despite their cardiovascular safety remaining controversial. Their effects on serial coronary calcification are not well established. In a post hoc patient-level analysis of 9 prospective randomized trials using serial coronary intravascular ultrasound, changes in serial percentage of atheroma volume (PAV) and calcium indices (CaI) were compared in matched segments of patients coronary artery disease who were receiving concomitant calcium supplements (n = 447) and in those who did not receive supplements (n = 4,700) during an 18- to 24-month trial period. Patients (mean age 58 ± 9 years; 73% were men; 43% received concomitant high-intensity statins) demonstrated overall annualized changes in PAV and CaI with a mean of −0.02 ± 1.9% (p = 0.44) and a median of 0.02 (interquartile range: 0.00 to 0.06) (p < 0.001) from baseline, respectively. Following propensity-weighted mixed modeling adjusting for treatment and a range of demographic, clinical, ultrasonic, and laboratory parameters (including but not limited to sex, race, baseline, and annualized change in PAV, baseline CaI, concomitant high-intensity statins, diabetes mellitus, renal function), there were no significant between-group differences in annualized changes in PAV (least-squares mean: 0.09; 95% confidence interval [CI]: −0.20 to 0.37 vs. 0.01; 95% CI: −0.27 to 0.29; p = 0.092) according to calcium supplement intake. Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004). Oral calcium supplementation may increase calcium deposition in the coronary vasculature independent of changes in atheroma volume. The impact of these changes on plaque stability and cardiovascular outcomes requires further investigation. [ABSTRACT FROM AUTHOR]

This study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries. Evidence about incidence and outcomes of ACS after TAVR is scarce. We identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non–ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis. Out of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non–ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001). After TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) in patients with pure aortic stenosis (AS) (i.e., no or trivial associated aortic regurgitation [AR]) with those in patients with AS and mild or more severe AR (i.e., mixed aortic valve disease [MAVD]). TAVR is indicated in treating patients with severe AS. Limited data exist regarding the outcomes of TAVR in patients with MAVD. A total of 1,133 patients who underwent TAVR between January 2014 and December 2017 were included. The primary outcome was all-cause mortality. The comparison was adjusted to account for post-TAVR AR development in both groups. The secondary outcomes included composite endpoints of early safety and clinical efficacy as specified in the Valve Academic Research Consortium-2 criteria. Variables were compared using Mann-Whitney, chi-square, and Fisher exact tests, while Kaplan-Meier analyses were used to compare survival. A total of 688 patients (61%) had MAVD (median age 83 years , 43% women). Among these, 17% developed mild, 2% moderate, and <1% severe post-TAVR AR. Overall, patients with MAVD had better survival compared with patients with pure AS (p = 0.03). Among patients who developed post-TAVR AR, those in the MAVD group had better survival (p = 0.04). In contrast, in patients who did not develop post-TAVR AR, pre-TAVR AR did not improve survival (p = 0.11). Patients with MAVD who underwent TAVR had better survival compared with patients with pure AS. This is explained by the better survival of patients with MAVD who developed post-TAVR AR, likely due to left ventricular adaptation to AR. [ABSTRACT FROM AUTHOR]

Objectives This study compared serial changes in coronary percent atheroma volume (PAV) and calcium index (CaI) in patients with coronary artery disease who were treated with and without warfarin. Background Warfarin blocks the synthesis and activity of matrix Gla protein, a vitamin K–dependent inhibitor of arterial calcification. The longitudinal impact of warfarin on serial coronary artery calcification in vivo in humans is unknown. Methods In a post hoc patient-level analysis of 8 prospective randomized trials using serial coronary intravascular ultrasound examinations, this study compared changes in PAV and CaI in matched arterial segments in patients with coronary artery disease who were treated with (n = 171) and without (n = 4,129) warfarin during an 18- to 24-month period. Results Patients (mean age 57.9 ± 9.2 years; male 73%; prior and concomitant 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statin) use, 73% and 97%, respectively) demonstrated overall increases in PAV of 0.41 ± 0.07% (p = 0.001 compared with baseline) and in CaI (median) of 0.04 (interquartile range [IQR]: 0.00 to 0.11; p < 0.001 compared with baseline). Following propensity-weighted adjustment for clinical trial and a range of clinical, ultrasonic, and laboratory parameters, there was no significant difference in the annualized change in PAV in the presence and absence of warfarin treatment (0.33 ± 0.05% vs. 0.25 ± 0.05%; p = 0.17). A significantly greater annualized increase in CaI was observed in warfarin-treated compared with non–warfarin-treated patients (median 0.03; IQR: 0.0 to 0.08 vs. median 0.02; IQR: 0.0 to 0.06; p < 0.001). In a sensitivity analysis evaluating a 1:1 matched cohort (n = 164 per group), significantly greater annualized changes in CaI were also observed in warfarin-treated compared with non–warfarin-treated patients. In a multivariate model, warfarin was independently associated with an increasing CaI (odds ratio: 1.16; 95% confidence interval: 1.05 to 1.28; p = 0.003). Conclusions Warfarin therapy is associated with progressive coronary atheroma calcification independent of changes in atheroma volume. The impact of these changes on plaque stability and cardiovascular outcomes requires further investigation. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to study differences in progression of aortic stenosis (AS) in patients with mediastinal radiotherapy (XRT)-associated moderate AS versus a matched cohort during the same time frame, and to ascertain need for aortic valve replacement (AVR) and longer-term survival. Background Rate of progression of XRT-associated moderate AS and its impact on outcomes is not well-described. Methods We included 81 patients (age 61 ± 13 years; 57% female) with at least XRT-associated moderate AS (aortic valve area [AVA] 1.05 ± 0.3 cm 2 ; mean gradient 24 ± 10 mm Hg) who had ≥2 transthoracic echocardiograms (TTEs) 1 year apart and matched them in a 1:2 fashion on the basis of age, sex, and AVA with those without prior XRT. Serial aortic valve gradients and AVA were recorded. AVR and longer-term all-cause mortality during follow-up were recorded. Results A total of 100% of patients had 1, a total of 71% had 2, and 39% had 3 follow-up TTEs. Before AVR, mean AVG and AVA were not significantly different between XRT and comparison groups. At 3.6 ± 2.0 years from baseline TTE, 146 (60%) underwent AVR (16% transcatheter), with significantly more patients in the XRT group undergoing AVR (80% vs. 50%; p < 0.01), at a much shorter time (2.9 ± 1.6 years vs. 4.1 ± 2.4 years; p < 0.01). At 6.6 ± 4.0 years from the initial TTE, 49 (20%) patients died, with a significantly higher mortality in the XRT group (40% vs. 11%; p < 0.01), with prior XRT associated with increased longer-term mortality, whereas AVR was associated with improved longer-term survival. Conclusions In patients with moderate AS, those with prior XRT have a similar rate of progression of AS versus a comparison group. A higher proportion of patients in the XRT group were referred for AVR at a shorter time from baseline TTE. Despite that, the XRT patients had significantly higher longer-term mortality, and prior exposure to XRT was associated with significantly increased longer-term mortality. [ABSTRACT FROM AUTHOR]

Background: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been shown to be feasible, yet the safety and efficacy in relation to native valve (NV) TAVR are not known.Objectives: This study sought to evaluate the safety and effectiveness of ViV TAVR for failed surgical aortic valve replacement (SAVR) by comparing it with the benchmark of NV TAVR.Methods: Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (on sex, high or extreme risk, hostile chest or porcelain aorta, 5-m-walk time, and Society of Thoracic Surgeons Predicted Risk of Mortality for reoperation) to patients undergoing NV-TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the Transcatheter Valve Therapy Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data.Results: Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with NV-TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio: 0.503; 95% confidence interval: 0.302 to 0.839; p = 0.008), lower 1-year mortality (hazard ratio: 0.653; 95% confidence interval: 0.505 to 0.844; p = 0.001), and hospitalization for heart failure (hazard ratio: 0.685; 95% confidence interval: 0.500 to 0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest in small SAVRs and stenotic SAVRs.Conclusions: Comparison with the benchmark NV-TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR). Background In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation. Methods Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups. Results Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes. Conclusions Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR. [ABSTRACT FROM AUTHOR]

Background The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration–approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. Objectives This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. Methods We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. Results The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients ( p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. Conclusions The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies. [ABSTRACT FROM AUTHOR]

Corresponding Author [ABSTRACT FROM AUTHOR]

The mechanism of wet grinding is still an object of interest and the better estimation of grinding kinetics provides greater benefits in terms of energy saving. The primary objective of this paper is to investigate reasons and causative factors contributing to nonlinearities in breakage rates for wet grinding systems. In ball milling the breakage rates vary mainly with the size distribution of the powder generated in the mill. 1st order and 2nd order breakage kinetics have been considered in this work to provide detailed insight into the mechanism of milling during wet grinding operations. Two methods have been used for breakage rate parameter estimation: cumulative input procedure and incremental input procedure. These methods are compared against each other to get a better understanding of how breakage rates evolve. Three different ore types are used as natural and monosized feeds. Results derived from both methods have been lucidly explained. The 2nd order specific selection functions, based on incremental inputs of specific energy, displayed inherent nonlinearities in the wet grinding process. It was observed that the breakage rates varied with the size consist in the mill for all three ore types. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is a viable option for patients with severe chronic obstructive pulmonary disease (COPD) who are deemed inoperable or high risk for surgery. We sought to determine outcomes of patients with severe aortic stenosis (AS) and severe COPD referred for aortic valve replacement (AVR). One hundred thirty-one patients with severe AS and severe COPD (GOLD criteria) were evaluated at our center between 2008 and 2013 and were divided retrospectively into 4 groups: 1-medical management, 2-balloon aortic valvuloplasty, 3-surgical aortic valve replacement (SAVR), and 4-TAVR. Baseline, clinical, and echo data were recorded. Primary outcome was cardiovascular death. From the study cohort, 54 (41.2%), 29 (22.1%), 21 (16.0%), and 27 (20.6%) were included in groups 1-4, respectively; the age was 74.9 ± 8.8, 76.2 ± 8.8, 78.8 ± 7.4, and 82.8 ± 6.8 years, respectively (P < 0.01). There was no significant difference between the groups for hypertension, diabetes, aortic valve area or gradients, forced expiratory volume in first second, right ventricular systolic pressure, ejection fraction, and Society of Thoracic Surgeons predicted risk of mortality score. At 3 ± 1.5 years, death occurred in 87%, 97%, 47.7%, and 51.8% of patients in groups 1-4, respectively. Heart failure readmissions occurred in 43%, 42%, 9.6%, and 14.8% of patients in groups 1-4, respectively. When SAVR and TAVR groups were compared, there was no significant difference in survival (P = 0.719) or heart failure readmissions (P = 0.19). In patients with severe or very severe COPD and severe AS, replacing the severely stenotic aortic valve by either SAVR or TAVR improves survival and reduces rehospitalization compared with medical therapy or balloon aortic valvuloplasty. [ABSTRACT FROM AUTHOR]

Background Although preoperative renal dysfunction (RD) is associated with increased mortality and morbidity after surgical aortic valve replacement, its impact on clinical outcomes after transcatheter aortic valve replacement (TAVR) is less defined. Methods TAVR patients in the PARTNER (Placement of Aortic Transcatheter Valves) trial with a calculable glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation were included. Patients were divided into three groups: GFR >60 mL/min (none/mild RD), GFR 31 to 60 mL/min (moderate RD), and GFR ≤30 mL/min (severe RD). Operative characteristics and clinical outcomes were analyzed. Cox regression models were used to determine multivariable predictors of 1-year all-cause mortality. Results A total of 2,531 inoperable or high surgical risk patients from the PARTNER trial and continued access registries had a calculable GFR level: 767 (30%) had normal renal function or mild RD, 1,473 (58%) had moderate RD, and 291 (12%) presented with severe RD. The mean Society of Thoracic Surgeons Predicted Risk of Mortality for the cohort was 11.5%, and it was highest in those with severe RD (13.8%). Patients with severe RD were more often women with a higher prevalence of diabetes. Patients with severe RD had the highest incidence of 30-day and 1-year all-cause mortality and rehospitalization. The 30-day rate of death from any cause was 10.7% in the severe RD group versus 6.0% in the moderate and mild RD groups ( p = 0.01). The 1-year rate of death from any cause was 34.4% in the severe RD group versus 21.5% in the moderate RD and 20.8% in the none/mild RD groups (adjusted hazard ratio [HR] 2.24, p < 0.0001 for severe versus none/mild; adjusted HR 1.14, p = 0.24 for severe versus moderate). Other significant predictors of 1-year all-cause mortality included lower body mass index, frailty, the transapical approach, a lower ejection fraction, oxygen-dependent chronic obstructive pulmonary disease, liver disease, and male sex. Conclusions Preoperative severe RD is a significant predictor for 1-year mortality in TAVR patients. Careful risk stratification by the heart team is required in patients with severe preprocedural RD. [ABSTRACT FROM AUTHOR]

Objective Moderate to severe aortic regurgitation after transcatheter aortic valve replacement is associated with worse outcomes. The impact of mild aortic regurgitation has been less clear, possibly because of the broad categories that have been used in clinical trials, but holds increasing importance in the study of next-generation devices in low- and intermediate-risk cohorts. A more granular scheme, which is common in clinical practice and proposed for future trials, may add prognostic value. Methods We evaluated all patients undergoing transfemoral transcatheter aortic valve replacement at the Cleveland Clinic from 2006 to 2012. The degree of aortic regurgitation after transcatheter aortic valve replacement was reported from the echocardiography database based on a clinical, transthoracic echocardiogram performed within 30 days of the procedure. Aortic regurgitation was finely discriminated on the basis of a multiwindow, multiparametric, integrative approach using our usual clinical scale: none, trivial to 1+, 1+, 1 to 2+, 2+, 2 to 3+, 3+, 3 to 4+, or 4+. Results There were 237 patients included in the analysis. By controlling for age, gender, Society of Thoracic Surgeons score, baseline ejection fraction, and aortic regurgitation before transcatheter aortic valve replacement, there was a significant increase in mortality for each half grade of aortic regurgitation compared with the complete absence of aortic regurgitation after transcatheter aortic valve replacement. The unit hazard ratio for each 1+ increase in aortic regurgitation after transcatheter aortic valve replacement was 2.26 (95% confidence interval, 1.48-3.43; P < .001) considering aortic regurgitation as a continuous variable. Other clinical variables did not significantly affect mortality. Conclusions Even mild aortic regurgitation after transcatheter aortic valve replacement is associated with worse long-term mortality. There may be prognostic value in reporting milder categories of aortic regurgitation with more granular gradations. [ABSTRACT FROM AUTHOR]

Transcatheter valve-in-valve mitral valve replacement provides treatment options to high-risk patients but is subject to its own complications. We present the migration of a transcatheter balloon-expandable Edwards-SAPIEN XT valve (Edwards Lifesciences, Irvine, CA) within a previously implanted surgical Carpentier-Edwards valve (Edwards Lifesciences) and our novel approach to its treatment. [ABSTRACT FROM AUTHOR]

Background The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. Objectives This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. Methods The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Results Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. Conclusions The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement. [ABSTRACT FROM AUTHOR]

Background When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States. Methods Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored. Results Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable ( p = 0.012). Conclusions Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) using a balloon-expandable valve is an accepted alternative to surgical replacement for severe, symptomatic aortic stenosis in high risk or inoperable patients. Intraprocedural transesophageal echocardiography (TEE) offers real-time imaging guidance throughout the procedure and allows for rapid and accurate assessment of complications and procedural results. The value of intraprocedural TEE for TAVR will likely increase in the future as this procedure is performed in lower surgical risk patients, who also have lower risk for general anesthesia, but a greater expectation of optimal results with lower morbidity and mortality. This imaging compendium from the PARTNER (Placement of Aortic Transcatheter Valves) trials is intended to be a comprehensive compilation of intraprocedural complications imaged by intraprocedural TEE and diagnostic tools to anticipate and/or prevent their occurrence. [ABSTRACT FROM AUTHOR]

Objectives The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial. Background The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosis patients, allowing outcome analysis of unoperated-on patients. Methods The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV. Results In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up. Conclusions BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosis patients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 ) [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). Background Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve. Methods The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM. Results Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year. Conclusions PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894 ) [ABSTRACT FROM AUTHOR]

Background Preprocedural 3-dimensional CT imaging of the aortic annular plane plays a critical role for transcatheter aortic valve replacement (TAVR) planning; however, manual reconstructions are complex. Automated analysis software may improve reproducibility and agreement between readers but is incompletely validated. Methods In 110 TAVR patients (mean age, 81 years; 37% female) undergoing preprocedural multidetector CT, automated reconstruction of the aortic annular plane and planimetry of the annulus was performed with a prototype of now commercially available software (syngo.CT Cardiac Function—Valve Pilot; Siemens Healthcare, Erlangen, Germany). Fully automated, semiautomated, and manual annulus measurements were compared. Intrareader and inter-reader agreement, intermodality agreement, and interchangeability were analyzed. Finally, the impact of these measurements on recommended valve size was evaluated. Results Semiautomated analysis required major correction in 5 patients (4.5%). In the remaining 95.5%, only minor correction was performed. Mean manual annulus area was significantly smaller than fully automated results ( P < .001 for both readers) but similar to semiautomated measurements (5.0 vs 5.4 vs 4.9 cm 2 , respectively). The frequency of concordant recommendations for valve size increased if manual analysis was replaced with the semiautomated method (60% agreement was improved to 82.4%; 95% confidence interval for the difference [69.1%–83.4%]). Conclusions Semiautomated aortic annulus analysis, with minor correction by the user, provides reliable results in the context of TAVR annulus evaluation. [ABSTRACT FROM AUTHOR]

Objectives: The logistic European System for Cardiac Operative Risk Evaluation (LES) score and the Society of Thoracic Surgeons (STS) score are validated to predict 30-day outcomes following surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting. Their performance when applied to patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. Methods: We compared predicted and observed 30-day/in-hospital and 1-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry (N = 2466). The performance of the LES and STS scores (prospectively calculated) was evaluated using standard assessments of discrimination and calibration. Performance of STS and LES scores among 307 patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined. Results: In patients undergoing TAVR, the observed 30-day/in-hospital mortality was 6.5%, whereas the predicted 30-day mortality was higher by both STS score (11.4% ± 3.9%) and LES score (26.6% ± 16.2%). The discrimination for both scores was poor for 30-day/in-hospital and 1-year mortality. Calibration was better for STS score than for LES at 1 year but poor for both at 30 days among TAVR cohort. These results were consistent among the subgroups of patients undergoing transfemoral and transapical access; however, the STS score had better performance among the high-risk patients who underwent SAVR at 30 days but not 1 year. Conclusions: The STS and LES surgical risk scores overestimated 30-day/in-hospital mortality and were poor discriminators of post-TAVR mortality, but the calibration of the STS score was better in these high-risk patients. These data highlight the need for TAVR-specific risk models to optimize patient selection. [ABSTRACT FROM AUTHOR]

Background Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals’ surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown. Methods We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers. Results From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08). Conclusions Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve. [ABSTRACT FROM AUTHOR]

Objectives This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. Background The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. Methods The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. Results In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were significantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. Conclusions The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 ). [ABSTRACT FROM AUTHOR]

Objectives This study investigated whether patients with patent foramen ovale (PFO) have an increased risk of stroke due to permanent pacemaker (PPM)/implantable cardioverter-defibrillator (ICD) implantation. Background Data are lacking on the risk of stroke in patients with PFO and implantable intracardiac devices, either a PPM or an ICD. We investigated whether patients with PFO have increased risk of stroke due to PPM/ICD implantation. Methods Between 2001 and 2008, 2,921 consecutive patients with PFO (67.5 ± 16.4 years of age, 52.2% male) were identified from our echocardiography database. These patients were divided into a device group (patients had PPM/ICD implantation for any reason after receiving a diagnosis of PFO) and a no device group (patients did not have PPM or ICD implantation). Patients who had PFO closure during follow-up were excluded. Both groups were matched for baseline characteristics and medications. The incidence of ischemic stroke was assessed in each group after propensity score matching (case:control ratio of 1:1 yielding 231 pairs). All patients completed at least 4 years of follow-up until May 2012. Results There were 2,690 patients in the n device group (67.3 ± 16.4 years of age, 51.6% male) and 231 patients in the device group (75.4 ± 14.6 years of age, 59.3% male). Six patients (2.6%) in the no device group and 6 (2.6%) in the device group had a stroke during the follow-up period. No difference in the rate of stroke, transient ischemic stroke, or stroke/transient ischemic stroke was observed between the 2 groups. Conclusions The risk of stroke in patients with PFO and an implantable intracardiac device is similar to those without an intracardiac device. In patients with PFO, without a history of stroke, device implantation might not be considered a risk factor for future stroke occurrence. [ABSTRACT FROM AUTHOR]

Background: Patients 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. Methods: We 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. Results: Pre-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 < .03). In TAVR patients, reduced annular deformation (P = .01) predicted postprocedural AR, in addition to prosthesis undersizing (P = .03) and higher annular calcification (P = .03). Conclusions: Residual post-TAVR AR is predicted by reduced aortic annular deformity, higher annular calcification, and prosthesis undersizing. Pre-TAVR 4-dimensional annular assessment aids in prediction of post-TAVR AR. [Copyright &y& Elsevier]

Objectives: The aim of this study was to analyze the relationship between beam angulation and air kerma in a modern cardiac catheterization laboratory. Background: Recent reports have identified the merits of reducing radiation scatter, an important determinant of radiation dose in the catheterization laboratory. Radiation scatter is poorly characterized in the context of catheterization laboratories using modern digital equipment. Understanding the principles of dosimetry may reduce the radiation exposure to patients, providers, and medical staff. Methods: Prospectively captured radiation data were extracted from a database of 1,975 diagnostic catheterizations (DCs) and 755 percutaneous coronary interventions (PCIs), which included 138,342 fluoroscopic and 35,440 acquisition (cine) sequences. Fluoroscopy and acquisition modes were categorized into tertiles based on the total air kerma measured at a standard reference point. Radiation maps were modeled according to the relative proportion of exposure in each projection. Results: Median air kerma during DCs and PCIs was 677 and 2,188 mGy, respectively. Fluoroscopy contributed to 66.3% of total dose during PCIs compared with 39.7% during DCs (p < 0.001). Fluoroscopy was more sensitive to changes in angulation with a rapid increase in total air kerma on small increases in beam angulation. Complex spatial maps were created to study the impact of angulation and other covariates on total air kerma. Besides beam angulation, body surface area was the strongest predictor of the total air kerma. Conclusions: This study uniquely describes radiation dosimetry using contemporary equipment in a real-world setting. Extreme angulations were associated with high air kerma values. Fluoroscopy compared with acquisition was more sensitive to changes in angulation, with relatively larger increases in total air kerma with small increases in steepness of the angulation. [Copyright &y& Elsevier]

Objectives: The goal of this study was to provide a systematic review and analysis of observational studies on percutaneous left atrial appendage (LAA) occlusion for stroke prophylaxis in nonvalvular atrial fibrillation (NVAF). Background: A recent randomized controlled trial in patients with NVAF suggested noninferiority of percutaneous LAA occlusion versus medical management for stroke prevention. However, the use of percutaneous devices remains controversial because of limited literature on their efficacy and safety. We performed a systematic analytical review of existing observational studies to assess the rate of neurological events for patients treated with occlusion devices. Methods: A comprehensive search of the Medline, Scopus, and Web of Science databases from inception through August 1, 2013, was conducted using pre-defined criteria. We included studies reporting implantation in at least 10 patients and a follow-up of 6 months or more. Results: In 17 eligible studies, a total of 1,052 devices were implanted in 1,107 patients with 1,586.4 person-years (PY) of follow-up. The adjusted incidence rate of stroke was 0.7/100 PY (95% confidence interval [CI]: 0.3 to 1.1/100 PY), of transient ischemic attacks was 0.5/100 PY (95% CI: 0.1 to 1.8/100 PY), and of combined neurological events (strokes or transient ischemic attacks) was 1.1/100 PY (95% CI: 0.6 to 1.6/100 PY). Access site vascular complications and pericardial effusion were the most commonly observed procedural complications at a rate of 8.6% (95% CI: 6.3% to 11.7%) and 4.3% (95% CI: 3.1% to 5.9%), respectively. Conclusions: Our systematic review suggested comparable efficacy of LAA occlusion devices compared with historical controls treated with adjusted-dose warfarin and other anticoagulation strategies for prevention of stroke in patients with NVAF. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

Background: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. Methods: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. Results: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. Conclusions: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique. [Copyright &y& Elsevier]

Abstract: Coronary angiography has been widely used for five decades to evaluate a range of vascular pathologies and triage patients to therapeutic interventions. The inability to directly visualize the artery wall with conventional angiographic techniques has stimulated development of a number of intravascular imaging modalities. These approaches have the potential to provide a more comprehensive characterization of the burden, composition and functionality of atherosclerotic plaque, neointimal hyperplasia and allograft vasculopathy that develop within coronary arteries. The ability to use these modalities in vivo and in a serial fashion has provided a greater insight into the factors that underlie the disease process and guide therapeutic interventions. [Copyright &y& Elsevier]