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Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking. The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality. Using Centers for Medicare and Medicaid Services–linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement. Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001). Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions. [Display omitted] [ABSTRACT FROM AUTHOR]

The management of aortic stenosis has evolved to stratification by age as reflected in recent societal guidelines. We evaluated age-stratified surgical aortic valve replacement (SAVR) trends and outcomes in patients with bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) from The Society of Thoracic Surgeons Adult Cardiac Surgery Database. This cohort included adults (≥18 years) undergoing SAVR for severe aortic stenosis between July 2011 and December 2022. Comparisons were stratified by age (<65 years, 65-79 years, ≥80 years) and BAV or TAV status. Primary end points included operative mortality, composite morbidity and mortality, and permanent stroke. Observed to expected ratios by The Society of Thoracic Surgeons predicted risk of mortality were calculated. In total, 200,849 SAVR patients (55,326 BAV [27.5%], 145,526 TAV [72.5%]) from 1238 participating hospitals met study criteria. Annual SAVR volumes decreased by 45% (19,560 to 10,851) during the study period. The decrease was greatest (96%) for patients ≥80 years of age (4914 to 207). The relative prevalence of BAV was greater in younger patients (<65 years, 69,068 [49.5% BAV]; 65-79 years, 104,382 [19.1% BAV]; ≥80 years, 27,399 [4.5% BAV]). The observed mortality in <80-year-old BAV patients (<65 years, 1.08; 65-79 years, 1.21; ≥80 years, 3.68) was better than the expected mortality rate (<65 years, 1.22; 65-79 years, 1.54; ≥80 years, 3.14). SAVR volume in the transcatheter era has decreased substantially, particularly for patients ≥80 years old and for those with TAV. Younger patients with BAV have better than expected outcomes, which should be carefully considered during shared decision-making in the treatment of aortic stenosis. SAVR should remain the preferred therapy in this population. [ABSTRACT FROM AUTHOR]

Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR). The aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER. All patients (n = 168) who underwent T-TEER between January 2017 and November 2022 at 2 centers were included in the derivation cohort. Additionally, 126 patients from 2 separate institutions served as a validation cohort. T-TEER was performed using 2 commercially available technologies. Core laboratory assessment of procedural transesophageal echocardiograms was used to determine septolateral and anteroposterior coaptation gap, leaflet morphology, septal leaflet length and retraction, chordal structure density, tethering height, en face TR jet morphology and TR jet location, image quality, and the presence of intracardiac leads. A scoring system was derived using univariable and multivariable logistic regression. Endpoints assessed were immediate postprocedural TR reduction ≥2 grades and TR grade moderate or less. The median age was 82 years (Q1-Q3: 78-84 years); 48% of patients were women; and patients presented with severe (55%), massive (36%), and torrential (8%) TR. Five variables (septolateral coaptation gap, chordal structure density, en face TR jet morphology, TR jet location, and image quality) were identified as best predicting procedural outcome and were incorporated in the GLIDE (Gap, Location, Image quality, density, en-face TR morphology) score (range 0-5). TR reduction ≥2 grades and TR grade moderate or less were observed in >90% of patients with GLIDE scores of 0 and 1 and in only 5.6% and 16.7% of those with GLIDE scores ≥4. The GLIDE score was then externally validated in a separate cohort (area under the curve: 0.77; 95% CI: 0.69-0.86). TR reduction significantly correlated with functional improvement assessed by NYHA functional class and 6-minute walk distance at 3 months. The GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER. [Display omitted] [ABSTRACT FROM AUTHOR]

Severe tricuspid regurgitation (TR) is a progressive condition associated with substantial morbidity, poor quality of life, and increased mortality. Patients with TR commonly have coexisting conditions including congestive heart failure, pulmonary hypertension, chronic lung disease, atrial fibrillation, and cardiovascular implantable electronic devices, which can increase the complexity of medical and surgical TR management. As such, the optimal timing of referral for isolated tricuspid valve (TV) intervention is undefined, and TV surgery has been associated with elevated risk of morbidity and mortality. More recently, an unprecedented growth in TR treatment options, namely the development of a wide range of transcatheter TV interventions (TTVI) is stimulating increased interest and referral for TV intervention across the entire medical community. However, there are no stepwise algorithms for the optimal management of symptomatic severe TR before TTVI. This article reviews the contemporary assessment and management of TR with addition of a medical framework to optimize TR before referral for TTVI. [Display omitted] • Severe TR is common and is associated with increased mortality. • Medical optimization and multidisciplinary expertise are often required before TTVI. • Comprehensive evidence is needed to discern the ideal timing of TTVI. [ABSTRACT FROM AUTHOR]

The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). This study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). The 1-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAEs]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. A total of 300 patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (for PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of −0.8% and 95% upper confidence bound of 4.6%. The 6-month MR ≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of −2.5%, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR ≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of −4.1%. The MR ≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of −5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P < 0.05 for all vs baseline). The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR. [Display omitted] [ABSTRACT FROM AUTHOR]

Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options. [Display omitted] [ABSTRACT FROM AUTHOR]

Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions. [Display omitted] [ABSTRACT FROM AUTHOR]

Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [ P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [ P = 0.003 vs discharge]). The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR. [Display omitted] [ABSTRACT FROM AUTHOR]

Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). Patients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2008.05.023 Byline: Michael R. Rudnick (a), Charles Davidson (b), Warren Laskey (c), J. Lawrence Stafford (d), Paul F. Sherwin (e) Abstract: Iso-osmolar contrast medium iodixanol has been reported to be less nephrotoxic than selected low-osmolar contrast media (LOCM) in chronic kidney disease (CKD) patients with diabetes mellitus. This study compared the nephrotoxicity of iodixanol and the LOCM ioversol in CKD patients undergoing coronary angiography. Author Affiliation: (a) Division of Nephrology, University of Pennsylvania School of Medicine, Philadelphia, PA (b) Division of Cardiology, Northwestern University School of Medicine, Chicago, IL (c) Division of Cardiology, University of New Mexico School of Medicine, Albuquerque, NM (d) Division of Cardiology, University of Maryland School of Medicine, Baltimore, MD (e) General Electric Healthcare, Princeton, NJ (f) for a list of investigators in the trial study see Appendix A Article History: Received 15 February 2008; Accepted 14 May 2008 Article Note: (footnote) M.R.R., C.D., and W.L. have received lecture honorarium, consulting fees, and research support from Amersham Health. P.S. is an employee of General Electric Healthcare (formerly Amersham Health)., This work was supported by a grant from Amersham Health.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/S0002-8703(00)90316-8 Byline: Lucian L. Leape, Rolla Edward Park, Thomas M. Bashore, J.Kevin Harrison, Charles J. Davidson, Robert H. Brook Abstract: Background Evidence from numerous studies of coronary angiography show differences between observers' assessments of 15% to 45%. The implication of this variation is serious: If readings are erroneous, some patients will undergo revascularization procedures unnecessarily and others will be denied an essential treatment. We evaluated the variation in interpretation of angiograms and its potential effect on appropriateness of use of revascularization procedures. Methods and Results Angiograms of 308 randomly selected patients previously studied for appropriateness of angiography, coronary artery bypass grafting (CABG), and percutaneous transluminal coronary angioplasty (PTCA) were interpreted by a blinded panel of 3 experienced angiographers and compared with the original interpretations. The potential effect on differences on the appropriateness of revascularization was assessed by use of the RAND criteria. Technical deficiencies were found in 52% of cases. Panel readings tended to show less significant disease (none in 16% of vessels previously read as showing significant disease), less severity of stenosis (43% lower, 6% higher), and lower extent of disease (23% less, 6% more). The classification of CABG changed from necessary/appropriate to uncertain/inappropriate for 17% to 33% of cases when individual ratings were replaced by panel readings. Conclusions The general level of technical quality of coronary angiography is unsatisfactory. Variation in the interpretation of angiograms was substantial in all measures and tended to be higher in individual than in panel readings. The effect was to lead to a potential overestimation of appropriateness of use of CABG by 17% and of PTCA by 10%. These findings indicate the need for increased attention to the technical quality of studies and an independent second reading for angiograms before recommending revascularization. (Am Heart J 2000;139:106-13.) Author Affiliation: Santa Monica, Calif; Boston, Mass; Durham, NC; Chicago, Ill; and Los Angeles, Calif From.sup.aRAND;.sup.bHarvard School of Public Health;.sup.cDuke University Medical Center;.sup.dNorthwestern University Medical Center; and the.sup.eSchools of Medicine and Public Health, UCLA Article History: Received 13 May 1998; Accepted 26 October 1998 Article Note: (footnote) [star] Guest Editor for this manuscript was Blase A. Carabello, MD, Medical University of South Carolina, Charleston. , [star][star] Reprint requests: Lucian L. Leape, MD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115., a 0002-8703/2000/$12.00 + 0 4/1/96001

The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk. Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life. In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days. Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001). Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway. [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the incidence and prognostic significance of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) according to racial groups. PPM after TAVR may be of more concern in Asian populations considering their relatively small annular and valve sizes compared with Western populations. TP-TAVR (Transpacific TAVR Registry) was an international multicenter cohort study of patients with severe aortic stenosis who underwent TAVR in the United States and South Korea from January 2015 to November 2019. PPM was defined as moderate (0.65-0.85 cm2/m2) or severe (<0.65 cm2/m2) at the indexed effective orifice area. The primary outcome was a composite of death, stroke, or rehospitalization at 1 year. Among 1,101 eligible patients (533 Asian and 569 non-Asian), the incidence of PPM was significantly lower in the Asian population (33.6%; moderate, 26.5%; severe, 7.1%) than in the non-Asian population (54.5%; moderate, 29.8%; severe, 24.7%). The 1-year rate of the primary outcome was similar between the PPM and non-PPM groups (27.5% vs 28.1%; P = 0.69); this pattern was consistent between Asian (25.4% vs 25.2%; P = 0.31) and non-Asian (28.7% vs 32.1%; P = 0.97) patients. After multivariable adjustment, the risk for the primary outcome did not significantly differ between the PPM and non-PPM groups in the overall population (HR: 0.95; 95% CI: 0.74-1.21), in Asian patients (HR: 1.07; 95% CI: 0.74-1.55), and in non-Asian patients (HR: 0.86; 95% CI: 0.63-1.19). In this study of patients with severe aortic stenosis who underwent TAVR, the incidence of PPM was significantly lower in Asian patients than in non-Asian patients. The 1-year risk for the primary composite outcome was similar between the PPM and non-PPM groups regardless of racial group. (Transpacific TAVR Registry [TP-TAVR]; NCT03826264) [Display omitted] [ABSTRACT FROM AUTHOR]

The aortic valve is a heart valve that directs the flow of blood from the left ventricle to the aorta, a major blood vessel carrying oxygenated blood to vessels throughout the body. Under abnormal conditions, the aortic valve may become stenosed, or narrowed. Aortic valve stenosis is treatable by percutaneous aortic balloon valvuloplasty, a procedure in which a balloon is inserted into the stenosed aortic valve and inflated, dilating the narrowed valve. The effect of this procedure on the function of the ventricles was examined in 15 patients whose average age was 75 years. The patients were examined at various times before and after balloon valvuloplasty by radionuclide angiocardiography, an X-ray image of the heart and blood vessels after injection of a radioactive substance. There were significant changes in the pressure within the aortic valve and in the size of the aortic valve immediately after valvuloplasty. In addition, there were decreases in the pressure and volumes of blood within the left ventricle during both contraction and relaxation, whereas the left ventricular ejection fraction (LVEF), or the amount of blood emptied from the left ventricle during contraction, increased after valvuloplasty. LVEF, which is a measure of heart contractility, increased, whereas the volume in the ventricle at the end of contraction decreased within six hours after valvuloplasty. This enhanced contractile function was due to improved blood flow through the aortic valve after valvuloplasty. (Consumer Summary produced by Reliance Medical Information, Inc.)

Transcatheter mitral valve replacement with the Intrepid device is intended for patients who need mitral valve replacement and who are at an increased risk for conventional surgery. The early published results of the early feasibility trial are reviewed as well as device design and the implant procedure. The Apollo trial is reviewed: a randomized trial of the Intrepid device versus conventional surgery including a single arm study for inoperable patients. The mitral valve structure, pathophysiology, and postimplant physiology pose unique hurdles for any transcatheter implant. [ABSTRACT FROM AUTHOR]

Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313) [Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: We aimed to test the impact of race/ethnicity on coronary artery disease (CAD) after adjusting for baseline risk factors. Background: Whether race/ethnicity remains an important determinant of the burden of CAD even among patients with long-standing type 2 diabetes (diabetes mellitus) and established CAD is unknown. Methods: Analysis of baseline data from the BARI 2D trial (January 1, 2001, to March 31, 2005) was performed. Myocardial jeopardy index (MJI) was evaluated by a blinded core angiographic laboratory. Multivariate regression analysis was performed to determine the independent association of race/ethnicity on the burden of CAD after adjusting for baseline risk factors. Data were collected from US and Canadian academic and community hospitals. The baseline analysis was performed on patients with long-standing diabetes and documented CAD with no prior revascularization at study entry (n = 1,331). The main outcome measure was MJI, which represents the percentage of myocardium jeopardized by significant lesions (≥50%). The secondary outcome measure was ≥2 lesions with ≥50% stenosis. Results: Risk factors varied significantly among racial/ethnic groups. Blacks were significantly more likely to be women, have no health insurance, be current smokers, have higher body mass index, have hypertension, have a longer duration of diabetes, a higher hemoglobin A1c level, and were more likely to be taking insulin. Their mean total, low-density lipid, and high-density lipid cholesterol levels were higher, whereas their triglycerides were lower than others. After controlling for baseline risk factors, blacks had a significantly lower burden of CAD; the adjusted MJI was 5.43 U lower (95% CI −9.13 to −1.72), and the adjusted number of lesions was 0.53 fewer (95% CI −0.88 to −0.18) in blacks compared to whites. Conclusions: In the BARI 2D trial, self-reported race/ethnicity is associated with important differences in baseline risk factors and is a powerful predictor of the burden of CAD adjusting for such baseline differences. These findings may help direct medical intervention and resources and further investigation into the basis of racial/ethnic differences in CAD burden. [Copyright &y& Elsevier]

Objectives: We undertook a meta-analysis to assess outcomes for drug-eluting stents (DES) and bare-metal stents (BMS) in percutaneous coronary intervention for unprotected left main coronary artery (ULMCA) stenosis. Background: Uncertainty exists regarding the relative performance of DES versus BMS in percutaneous coronary intervention for unprotected left main coronary stenosis. Methods: Of a total of 838 studies, 44 met inclusion criteria (n = 10,342). The co-primary end points were mortality, myocardial infarction (MI), target vessel/lesion revascularization (TVR/TLR), and major adverse cardiac events (MACE: mortality, MI, TVR/TLR). Results: Event rates for DES and BMS were calculated at 6 to 12 months, at 2 years, and at 3 years. Crude event rates at 3 years were mortality (8.8% and 12.7%), MI (4.0% and 3.4%), TVR/TLR (8.0% and 16.4%), and MACE (21.4% and 31.6%). Nine studies were included in a comparative analysis (n = 5,081). At 6 to 12 months the adjusted odds ratio (OR) for DES versus BMS were: mortality 0.94 (95% confidence interval [CI]: 0.06 to 15.48; p = 0.97), MI 0.64 (95% CI: 0.19 to 2.17; p = 0.47), TVR/TLR 0.10 (95% CI: 0.01 to 0.84; p = 0.01), and MACE 0.34 (95% CI: 0.15 to 0.78; p = 0.01). At 2 years, the OR for DES versus BMS were: mortality 0.42 (95% CI: 0.28 to 0.62; p < 0.01), MI 0.16 (95% CI: 0.01 to 3.53; p = 0.13), and MACE 0.31 (95% CI: 0.15 to 0.66; p < 0.01). At 3 years, the OR for DES versus BMS were: mortality 0.70 (95% CI: 0.53 to 0.92; p = 0.01), MI 0.49 (95% CI: 0.26 to 0.92; p = 0.03), TVR/TLR 0.46 (95% CI: 0.30 to 0.69; p < 0.01), and MACE 0.78 (95% CI: 0.57 to 1.07; p = 0.12). Conclusions: Our meta-analysis suggests that DES is associated with favorable outcomes for mortality, MI, TVR/TLR, and MACE as compared to BMS in percutaneous coronary intervention for unprotected left main coronary artery stenosis. [Copyright &y& Elsevier]

Objectives: This study examined the contribution of symptom-to-reperfusion time, collateral flow, and antegrade flow in the infarct-related artery on myocardial salvage using a combined angiographic–cardiac magnetic resonance (CMR) method. Background: The myocardium supplied by an acutely occluded artery defines the anatomical area at risk for infarction. This area can be determined independently of residual coronary flow to the risk region. Moreover, the difference between this area and infarct size constitutes viable myocardium that has been salvaged. Methods: In 121 subjects presenting with ST-segment elevation myocardial infarction revascularized by primary percutaneous intervention, the angiographic anatomical area at risk was retrospectively measured using the Bypass Angioplasty Revascularization Investigation Myocardial Jeopardy Index (BARI score). Within 1 week, CMR was performed in the entire cohort and repeated in 89 subjects at 5 ± 3 months to determine infarct size and wall motion recovery. The myocardial salvage index (MSI) was computed as (BARI score − infarct size)/left ventricular mass. Results: The MSI was negligible in patients with Thrombolysis In Myocardial Infarction (TIMI) flow grade ≤1, absent collateral vessels, and >4 h of symptom-to-reperfusion time, as compared with patients with TIMI flow grade >1 or existent collateral vessels (0.2 ± 1.0 vs. 6.1 ± 2.0, p < 0.001). The initial TIMI flow grade, time to reperfusion, presence of microvascular obstruction, and collateral flow were found to be independent predictors of MSI and infarct transmurality (p < 0.05 for both). The BARI score was only predictive of MSI (p < 0.001). The MSI correlated inversely with wall motion score at baseline (R = −0.27, p < 0.01) and at follow-up (R = −0.38, p < 0.001). Infarct transmurality also correlated with wall motion score at baseline (R = 0.52, p < 0.001) and at follow-up (R = 0.58, p < 0.001). Increasing MSI (p < 0.01) and decreasing infarct transmurality (p < 0.001) were associated with an improvement in wall motion and prognosis. Conclusions: Early mechanical reperfusion and maintenance of antegrade or collateral flow independently preserves myocardial salvage primarily through a reduction in infarct transmurality. This novel integration of coronary angiography and CMR techniques to quantify myocardial salvage predicts functional recovery and improved prognosis. [Copyright &y& Elsevier]

Background: Transcatheter aortic valve implantation may become a potential treatment for high-risk patients with aortic stenosis (AS). We analyzed our contemporary series of isolated aortic valve replacement (AVR) for AS to determine implications for patients referred for AVR. Methods: From April 2004 through December 2008, 190 patients (mean age, 68 years; 68% men) underwent isolated AVR for AS. Mean ejection fraction was 0.58. Sixty-one percent underwent minimally invasive AVR and 18% were reoperations. Twenty-one percent were aged 80 years or older, and 34% were in New York Heart Association functional class III-IV. Estimated operative mortality was 3.6%. Results: Thirty-day mortality was 0%. One in-hospital death (0.5%) occurred from complications of an esophageal perforation. Reoperation for bleeding occurred in 4.7%. Acute renal failure developed in 2.1%. Actuarial survival was 97% at 1 year and 94% at 3 years. Hospital length of stay was 7.0 days for patients aged 80 and older vs 5.0 days (p < 0.001), and they were less likely to be discharged to home (50% vs 83%, p < 0.001). Conclusions: Contemporary results show that AVR for AS can be performed with low operative mortality and morbidity, although patients aged 80 years and older are at increased risk of prolonged recovery. Transcatheter aortic valve implantation may be an alternative for high-risk patients, but AVR is still appropriate for low-risk patients. The low risk of AVR supports the argument that asymptomatic patients who have a high likelihood of progression of AS may be considered for earlier surgical referral. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to investigate the correspondence between the coronary arterial anatomy and supplied myocardium based on the proposed American Heart Association 17-segment model. Background: Standardized assignment of coronary arteries to specific myocardial segments is currently based on empirical assumptions. Methods: A cardiac magnetic resonance study was performed in 93 subjects following acute myocardial infarction treated with primary percutaneous coronary intervention. Two observers blindly reviewed all angiograms to examine the location of the culprit lesion and coronary dominancy. Two additional observers scored for the presence of cardiac magnetic resonance hyperenhancement (HE) on a 17-segment model. Segments were divided based on anatomical landmarks such as the interventricular grooves and papillary muscles. Results: In a per-segment analysis, 23% of HE segments were discordant with the empirically assigned coronary distribution. Presence of HE in the basal anteroseptal, mid-anterior, mid-anteroseptal, or apical anterior wall was 100% specific for left anterior descending artery occlusion. The left anterior descending artery infarcts frequently involved the mid-anterolateral, apical lateral, and apical inferior walls. No segment was 100% specific for right coronary artery or left circumflex artery (LCX) occlusion, although HE in the basal anterolateral wall was highly specific (98%) for LCX occlusion. Combination of HE in the anterolateral and inferolateral walls was 100% specific for a LCX occlusion, and when extended to the inferior wall, was also 100% specific for a dominant or codominant LCX occlusion. Conclusions: Four segments were completely specific for left anterior descending artery occlusion. No segment can be exclusively attributed to the right coronary artery or LCX occlusion. However, analysis of adjacent segments increased the specificity for a given coronary occlusion. These findings bring objective evidence in the appropriate segmentation of coronary arterial perfusion territories and assist accurate assignment of the culprit vessel in various imaging modalities. [Copyright &y& Elsevier]

Various properties of iodinated contrast media (osmolality, ionic versus nonionic, and viscosity) may contribute to contrast-induced nephropathy (CIN). Therefore, the choice of contrast medium affects the risk for CIN. There is good evidence that low-osmolar contrast media are less nephrotoxic than high-osmolar contrast media in patients at increased risk for CIN who receive intra-arterial iodinated contrast. Current evidence suggests that nonionic isosmolar contrast presents the lowest risk for CIN in patients with chronic kidney disease (CKD), particularly in those patients with diabetes mellitus. Intra-arterial administration of contrast media may be associated with a greater risk for CIN above that observed with intravenous administration. The use of gadolinium or CO2 as alternative contrast media to avoid the risk of nephrotoxicity cannot be substantiated by clinical trials and therefore cannot be recommended. Most studies show that, within a class, higher volumes (>100 mL) of iodinated contrast medium are associated with a higher risk for CIN. However, in patients at high risk, such as those with CKD and diabetes, even small volumes of contrast medium can have adverse effects on renal function. [Copyright &y& Elsevier]

With the wider use of imaging and interventional techniques that require the use of iodinated contrast media in seriously ill patients, many clinical situations occur where patients may be at increased risk for contrast-induced nephropathy (CIN). There is little guidance for clinicians in these areas. The aim of this review is to assess the available literature. Acute renal failure is a common complication following coronary artery bypass surgery, and exposure to contrast medium may increase the risk for this condition, although there is insufficient evidence to make a definitive statement. Evidence is also limited for patients with liver disease: in those undergoing transarterial chemoembolization, cirrhosis may be a risk factor for renal failure. There is some evidence that periprocedural hypotension may be a risk factor for CIN after percutaneous coronary intervention, but no published information was identified on the significance of shock or hypotension in other groups of patients. The published evidence on the risk of CIN in renal transplant recipients is inconsistent. In emergency situations, the course of action is usually dictated by clinical circumstances; the renal status of a patient is likely to be unknown and it is important to ensure adequate volume expansion, especially after the procedure. In all clinical situations that are potentially associated with a high risk for CIN, the decision to administer contrast medium is a matter for clinical judgment, based on the clinical status of the patient and the expected benefits of the investigation or procedure. [Copyright &y& Elsevier]

To determine predictors of a long-term major adverse cardiac event (MACE) in unselected patients undergoing direct percutaneous coronary intervention (PCI), 274 consecutive patients presenting within 12 hours of ST-segment elevation acute myocardial infarction (AMI) were evaluated. No patient with ST-segment elevation AMI received intravenous thrombolytic drugs. Chest pain to balloon time was 3.8 hours (range 2.5 to 6.9). percutaneous transluminal coronary angioplasty was successful in 95% of patients. Abciximab was administered to 69% of patients, stents were deployed in 53%, and 17% underwent only catheterization. In-hospital events were death (7%), abrupt closure (2%), emergent coronary artery bypass grafting (CABG) (5%), repeat PCI (3%), and recurrent myocardial infarction (1%). In patients undergoing direct PCI (n = 227), the in-hospital event rate was death 5.3%, abrupt closure 2.2%, emergency CABG 0.9%, repeat PCI 3.1%, and repeat myocardial infarction 1.3%. Median time to last follow-up or death was 20 months (range 11 to 34), and to any event, 0.3 months (range 0.03 to 24.0). Postdischarge MACE included death (5%), AMI (4%), repeat PCI (8%), CABG (9%), and stroke (0.7%). Among those undergoing direct PCI (n = 227), 10% died, 3.5% had a repeat AMI, 9% had a repeat PCI, 5% had CABG, and 1% had a stroke at long-term follow-up. At long-term follow-up, 75% were event free. Multivariate predictors were (hazard ratio [95% confidence interval (CI)]): abciximab use 0.6 (95% CI 0.43 to 0.95), Killip class 2.2 (95% CI 1.1 to 4.4), and number of narrowed coronary arteries 1.7 (95% CI 1.4 to 2.2). In this unselected consecutive series of patients presenting with ST-segment elevation AMI, direct PCI was associated with sustained long-term efficacy. Outcomes were predicted by cardiac impairment at presentation and number of narrowed coronary arteries. MACE is not related to device selection but is significantly improved with abciximab. [ABSTRACT FROM AUTHOR]