Search

Background Prosthesis-patient mismatch (PPM) is associated with poor outcomes after surgical aortic valve replacement, but evidence in the era of transcatheter aortic valve replacement (TAVR) is small. Although PPM is conventionally defined by transthoracic echocardiogram (TTE) derived indexed effective orifice area (EOAi), TTE may underestimate left ventricular outflow tract (LVOT) area when compared with cardiac computed tomography angiography (CTA). Purpose To evaluate the inter-modality (TTE vs CTA) agreement and inter-valve (balloon-expanding valve (BEV) vs. self-expandable valve (SEV)) differences in EOAi and the severity of PPM after TAVR. Methods We analyzed all patients who underwent TAVR between 2015 to 2017and who had both of CTA and TTE at 30-days after TAVR. EOAi was calculated using the continuity equation and then indexed to body surface area as per guidelines using TTE derived LVOT diameter (EOAi-TTE) or post-procedure CTA derived LVOT area (EOAi-CTA). The external LVOT diameter was measured at inflow of TAVR bioprosthetic stent frame as per recommendations. The EOAi was used to define the grading severity of PPM: None (> 0.85 cm²/m²); Moderate (0.65 to 0.85 cm²/m²); and Severe (< 0.65 cm²/m²). Paired or Student t-test and Chi-square test were used to assess the inter-modality and inter-valve difference. Results A total of 280 patients were included (the mean age, 81.2 ± 8.1 years; 48%, female). BEV was used in 150 patients (54%). The mean EOAi-TTE vs. EOAi-CTA was 1.00 ± 0.32 and 1.41 ± 0.50 cm²/m², respectively, p Conclusion EOAi-CTA was larger and downgraded the severity of PPM than the EOAi-TTE. There was no significant difference in the severity of PPM defined by post-procedure CT between patients treated with BEV and those with SEV. Abstract P212 Figure.

Background: Secondary mitral regurgitation (MR) arises from left ventricular (LV) dilatation and remodeling, and commonly is treated with transcatheter mitral valve repair. We examined the impact of MitraClip on reverse cardiac remodeling in patients with severe, symptomatic secondary MR.Methods:: An electronic search was performed through January 2018 for studies that reported cardiac chamber dimensions prior to and after treatment with MitraClip in patients with secondary MR. The mean difference (MD) with 95% CI was calculated using fixed or random inverse variance models. Outcomes of interest were changes in LV end-systolic and end-diastolic volumes (LVESV, LVEDV) and dimensions (LVESD, LVEDD). Secondary outcomes included left atrial (LA) volume, systolic pulmonary artery pressure (sPAP) and LV ejection fraction (LVEF).Results: A total of 16 studies with 1,266 patients were included in the present analysis. The weighted mean follow-up period (±SD) was 11.5 ± 7.2 months. MitraClip was associated...

Edge-to-edge repair with the percutaneous MitraClip technology has changed the landscape for patients with symptomatic, severe degenerative mitral valve regurgitation who are at prohibitive surgical risk. While the results of randomized controlled trials of MitraClip therapy in patients with functional mitral valve regurgitation are still pending, single center experiences as well as registry data generally support the real-world application of the MitraClip therapy. In the majority of individuals treated with MitraClip, complete or near-complete relief of mitral regurgitation occurs, with results approaching the effectiveness of open surgery. This perspective summarizes the data, with a focus on current selection criteria of percutaneous MitraClip edge-to-edge repair that can optimize clinical outcomes.

Introduction: Coronary artery perforations are more likely to occur during percutaneous coronary intervention of complex coronary lesions, such as heavily calcified lesions and chronic total occlusions.Areas covered: Authors provide an update on the management of coronary perforations by performing a critical review of the related, recently published literature.Expert commentary: Meticulous attention to guidewire position and to device selection is critical for minimizing the risk for coronary perforation. If a perforation occurs, following a structured, algorithmic approach can maximize the likelihood of a successful outcome.

Background: The pathologic processes of aortic regurgitation (AR) and aortic stenosis (AS) can affect the rate of progression to symptoms differently, and insight into the management of mixed aorti...

Ischemic mitral regurgitation occurs relatively frequently in patients with coronary artery disease and is associated with an increased long-term risk. The pathophysiology of ischemic mitral regurgitation is vexing and poses both diagnostic and therapeutic challenges, leading to the need for a comprehensive, multidisciplinary approach. The management is largely focused on medical therapy, and for those eligible, coronary revascularization or cardiac resynchronization therapy may be considered. In select patients, mitral valve surgery or catheter-based therapy may be undertaken with careful consideration of the underlying pathophysiology, surgical risk, and expected long-term outcomes. The appropriate evaluation of patients with ischemic mitral regurgitation involves a careful multidisciplinary approach that carefully considers symptomatology, the etiology and severity of the mitral regurgitation, and the assessment of comorbidities and operative risk to individualize the care of these patients.

Background The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. Objectives The goal of this study was to evaluate 1-year outcomes in this registry. Methods This study was a multicenter retrospective review of clinical outcomes. Results A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. Conclusions TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Surgical mitral valve repair or replacement (SMVR) remains the standard therapy for symptomatic patients with severe degenerative mitral regurgitation (MR). However, a sizable proportion of patients with symptomatic severe MR have prohibitively high surgical risk ([1][1]). Randomized trials have

Background: The role of women and foreign medical graduates (FMGs) in cardiology research published in the United States has received limited study. Methods: We examined the characteristics of the first and last authors of all original contributions and review articles published in the Journal of the American College of Cardiology from October 1, 2015, to October 1, 2016. Results: A total of 345 articles were identified, with 687 first and last authors originating from ≥50 different countries. Overall, 17% of authors were women (20% of the first and 14% of the last authors). Overall, 86% of authors held a medical degree (MD) or equivalent, and 25% of those also held another advanced degree (PhD, MPH, and/or MBA). The proportion of authors with an advanced degree in addition to an MD/equivalent was higher among foreign graduates and international contributors as compared with American graduates (31% vs. 30% vs. 17%, respectively, p

Surgical mitral valve repair (SMVr) is the gold-standard therapy for patients with degenerative mitral regurgitation (MR), and early intervention is associated with low operative mortality and excellent long-term outcomes. Nonetheless, for some patients, recurrent MR after SMVr can occur, lead to

Mitral valve regurgitation poses a significant public health burden, with more than 3 million people in the US alone suffering from moderate or severe mitral valve regurgitation. Surgical correction with mitral valve repair or replacement is the mainstay of therapy. However, a significant proportion of elderly patients are not eligible for mitral valve repair or replacement due to prohibitive surgical risk from increased age, poor ventricular function, or associated comorbidities. Percutaneous mitral valve repair/replacement techniques have been developed to fill this void. The most advanced percutaneous technique with the highest safety and efficacy to date is the edge-to-edge MitraClip repair system. The majority of other catheter-based mitral valve repair/replacement devices are at early developmental stages, but have shown encouraging initial results in feasibility trials. Transcatheter mitral valve replacement holds promise to emerge as the leading transcatheter treatment of choice in the fu...

Obtaining femoral and radial arterial access in the cardiac catheterization laboratory using state-of-the-art techniques is essential to optimize outcomes, patient satisfaction, and procedural efficiency. Although transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, femoral access remains necessary for numerous procedures, many requiring large-bore access, including complex high-risk coronary interventions, structural procedures, and procedures involving mechanical circulatory support. For femoral access, contemporary access techniques should combine the use of fluoroscopy, ultrasound, micropuncture needle, femoral angiography, and vascular closure devices, when feasible. For radial access, ultrasound may reveal important anatomic features and expedite access. Despite randomized controlled trials supporting use of routine ultrasound guidance for femoral and/or radial arterial access, ultrasound remains underused in cardiac catheterization laboratories. This article reviews contemporary techniques to achieve optimal arterial access in the cardiac catheterization laboratory.

Background Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration–approved devices. Objectives The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. Methods Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses. Results The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation. Conclusions Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.

Objectives The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. Background TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed. Methods Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined. Results Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p Conclusions Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.

Severe mitral regurgitation is a common and complex disease that is associated with an adverse prognosis. For decades, surgical treatment has been the standard of care. Recently, multiple technologies for transcatheter mitral therapy have emerged, with the potential for both repair and replacement in patients with native mitral regurgitation. Transcatheter mitral technologies have potential as solutions for unmet clinical needs. Further rigorous clinical studies are needed to determine their efficacy and safety, as well as the appropriate patient candidates. These evaluations will help to define the role of transcatheter mitral therapy as a potentially exciting new strategy to improve the lives of patients with mitral regurgitation.

The burden and impact of sleep deprivation on both patient care and on the health of interventional cardiologists is not well understood. Due to the nature of emergent procedures occurring in the cardiac catheterization laboratory, interventionalists are prone to suffer from acute and/or chronic sleep deprivation. Sleep deprivation has been associated with numerous adverse effects, such as impaired performance, cognitive deficits, reduced psychomotor vigilance, and workplace errors and injuries, among many others. Although sleep deprivation has been linked to more errors in trainees, there is paucity of data addressing outcomes in interventional cardiology. The purpose of this overview is to explore the possible impact of sleep deprivation on interventional cardiology in relation to patient care and physician health, and examine potential approaches to this issue.

The management of drug-refractory symptoms of obstructive hypertrophic cardiomyopathy has long been debated and is primarily centered on the choice between surgical myectomy and alcohol septal ablation. Decision making in these patients requires consideration of procedural risk, expertise and efficacy, and the long-term impact on patients' survival. Although there have been numerous reports on these procedures that may help guide decision making, these data continue to be self-reported and voluntary. Greater insight into the real-world experience for these therapies and how they should be applied in practice would be gained from mandatory reporting, akin to other multidisciplinary, transcatheter-based therapies.

Pericardial diseases can be classified broadly as 3 entities: acute pericarditis, cardiac tamponade, and constrictive pericarditis. These disorders can be diagnosed and managed with noninvasive studies following a comprehensive history and physical examination, without the need for cardiac catheterization in most patients. Despite the advances in noninvasive cardiac imaging, there are limitations to their diagnostic accuracy. The invasive hemodynamic study offers the advantage of simultaneous, direct pressure measurement across multiple chambers, with direct examination of blood flow. Herein, the authors review the techniques for obtaining and interpreting invasive hemodynamic data in patients with suspected pericardial disease.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Background Right heart structural abnormalities occur in both tricuspid regurgitation (TR) and pulmonary hypertension (PH). They may occur independently or together, but their joint effects on cardiac structure are incompletely described. This study examined the interactions of TR severity and PH on right heart structural changes. Methods The study evaluated 455 patients undergoing both echocardiography and CT angiography (CTA). Cases were divided into 3 groups by TR severity: trace (n=217), mild (n=174), and significant (moderate or severe, n=64). Each TR level was subdivided into two groups by PH absent or present. Cardiac structural measurements included tricuspid annulus area (TAA), right atrial (RA) and right ventricular volume (RV) indexed to body surface area. Results Analysis by TR and PH showed that indexed RA Volume and TAA were very sensitive to TR severity. RA volume was most affected by pulmonary hypertension when TR was trace or mild, while PH had less effect on TAA. In significant TR, neither RA volume nor TAA were changed by PH. Indexed RV volume was insensitive to trace and mild TR, and PH similarly had little effect. Conclusions RA volume and tricuspid annulus area enlarge in proportion to TR severity, trace through significant. PH impacts RA volume but only in trace and mild TR. RA volume best reflects TR impact on right heart structure, both with and without PH. Right atrial volume and tricuspid annulus area are the cardinal indices of TR-induced right heart structural disease et al.l severities. Ultramini abstract Right heart structural effects of TR and PH were examined in this study. Patients were evaluated by echo and CTA, and grouped by TR severity as trace, mild, and significant, and were subdivided by PH absence/presence. Analysis by TR severity and PH showed that Indexed RA volume is the parameter most sensitive to TR severity, and PH causes incremental RA volume increases in trace/mild TR. Indexed tricuspid annulus area (TAA) similarly increases with TR severity, but was unaffected by PH at any TR severity. RV volume is insensitive to TR severity and PH. Indexed right atrial volume and tricuspid annulus area are cardinal indices for TR-induced right heart structural disease and increase proportionally to TR severity. RA volume is more sensitive to PH than is tricuspid annular area. TR severity may be more accurately assessed by increased RA volume and annulus area. Perspective statement The right atrium (RA) and tricuspid annulus (TA) are the cardinal cardiac structures affected by tricuspid regurgitation (TR). They each enlarge with TR severity. The right ventricle exhibits minimal change across TR severity. Pulmonary hypertension (PH) enhances TR-mediated RA and TA dilation, but only in trace and mild TR. PH has no effect on RA, TA, or RV size in significant TR. Central message Right atrial volume and tricuspid annulus area are the most sensitive to TR severity, and are also sensitive to pulmonary hypertension.

Mitral valve regurgitation (MR) is common, with a prevalence that exceeds 9% for those patients >75 years of age. For symptomatic patients with prohibitive surgical risk, transcatheter mitral valve repair with the MitraClip® system (Abbott Vascular, Menlo Park, CA) is available for clinical use and is effective in reducing MR in select patients. For optimal clinical success, the procedure requires mastery of complex catheterization skills with application of an in-depth understanding of the mitral valve anatomy. We herein describe elementary and advanced maneuvers for successful transcatheter mitral valve repair with MitraClip® . © 2017 Wiley Periodicals, Inc.

Background Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. Objectives This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. Methods Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. Results Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. Conclusions TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514)

With the expansion of transcatheter aortic valve replacement in low-risk patients, we sought to explore current implanters' predictions on the future of this therapy by sending a survey to a sample of 8,261 healthcare professionals using Internet-based software. The survey contained six questions regarding physician specialty and experience, transcatheter aortic valve replacement age cutoff, optimal treatment for low-risk patients, transcatheter aortic valve replacement valve sequence, and transcatheter aortic valve replacement concerns. The majority, 29% percent, of all respondents felt that transcatheter aortic valve replacement will become the first-choice therapy for all patients, regardless of age and 70% felt that the optimal treatment would be transcatheter aortic valve replacement, with transcatheter aortic valve replacement valve-in-valve if the first valve degenerates. Regarding the sequence of transcatheter aortic valve replacement valves, 78% preferred the Edwards Sapien 3 valve (ES-3) as the first transcatheter aortic valve replacement valve followed by either a second ES-3 or Medtronic Evolut valve. Despite the high acceptance of transcatheter aortic valve replacement, many respondents (56%) felt that surgical aortic valve replacement might still remain the preferred treatment in low-risk patients due to an unknown durability of transcatheter aortic valve replacement valves. A majority of implanters see transcatheter aortic valve replacement followed by valve-in-valve transcatheter aortic valve replacement as the first-line therapy for low-risk patients with severe aortic stenosis, but long-term durability of transcatheter aortic valve replacement is an unanswered concern.

The rapid development of transcatheter tricuspid valve intervention (TTVI) therapies has quickly provided the opportunity to improve patient selection and procedural planning for patients with significant tricuspid regurgitation (TR) considered at high surgical risk. This review focuses on the contributions which both computed tomography angiography and cardiac magnetic resonance can provide in the better understanding of the natural history of TR, in the comprehensive anatomical and functional assessment of right heart involvement and in the timing and planning for TTVI. We also discuss areas of potential importance such as the quantification of response to TTVI, which will be informative for future trials.

Objectives To examine the outcomes of vascular brachytherapy (VBT) for recurrent drug-eluting stents (DES) in-stent restenosis (ISR). Background Recurrent DES-ISR can be challenging to treat. VBT has been used with encouraging results. Methods We report the long-term outcomes of patients with recurrent DES-ISR treated with VBT between January 2014 and September 2018 at a tertiary care institution. The main outcome was target lesion failure (TLF), defined as the composite of clinically driven target lesion revascularization (TLR), target lesion myocardial infarction (MI), and target lesion-related cardiac death. Cox proportional hazards analysis was performed to identify variables associated with recurrent TLF. Results During the study period, 116 patients (143 lesions) underwent VBT. Median follow-up was 24.7 (14.5-35.4) months. The incidence of TLR, target-lesion MI, and TLF was 18.9%, 5.6%,and 20.1% at 1 year, and 29.4%, 10.5%, and 32.9% at 2 years.Initial presentation with acute coronary syndrome (ACS) was independently associated with TLF (hazard ratio = 1.975, 95% CI [1.120, 3.485], p = .019). Lesions treated with intravascular ultrasound (IVUS) guidance had a lower incidence of TLR (14.3% vs. 39.6%, log-rank p = .038), and a trend toward lower incidence of TLF (19% vs. 42.6%, log-rank p = .086). Conclusions VBT can improve the treatment of recurrent DES-ISR, but TLF occurs in approximately one in three patients at 2 years. Initial presentation with ACS was associated with higher TLF and the use of IVUS with a trend for lower incidence of TLF.

Background Transcatheter mitral valve repair (TMVr) using edge-to-edge mitral valve clip is effective for patients with mitral regurgitation (MR) and high or prohibitive surgical risk. Global longitudinal strain (GLS) allows evaluation of subclinical myocardial dysfunction, but its incremental clinical utility into risk stratification, beyond traditional clinical parameters, is unknown in patients treated with TMVr. We sought to evaluate the association of baseline GLS with 1-year all-cause mortality in patients treated with TMVr using edge-to-edge mitral valve clip. Methods We analyzed 155 patients who underwent transcatheter edge-to-edge mitral valve clip implantation (mean age, 83 ± 7 years; 48% were women; mean left ventricular ejection fraction, 56% ± 10%, Society of Thoracic Surgeons Predicted Risk of Mortality score for repair, 6.62% ± 5.22%). Baseline left ventricular GLS was obtained by two-dimensional speckle-tracking echocardiography, averaging 18 segments from three apical views. Receiver operating characteristic analyses were used to assess the GLS cut point associated with all-cause mortality. Multivariable models with Cox regression tested its relationship after adjustment for baseline comorbidities. Results During a median follow-up of 316 days, all-cause deaths occurred in 30 patients at a median of 156 days after TMVr. The area under the curve of preoperative GLS associated with the outcome was 0.60, with a cutoff point of −14.5%. Baseline GLS > −14.5% was associated with 1-year mortality (hazard ratio = 2.50; 95% CI, 1.20-5.21; P = .02) before and after adjustment for baseline characteristics. After accounting for baseline characteristics, patients with GLS > −14.5% had worse 1-year mortality than those with GLS ≤ −14.5% (χ2 P Conclusions Baseline GLS is independently associated with 1-year all-cause mortality in patients who undergo TMVr, and its assessment improves risk stratification in these patients.

Transcatheter mitral valve repair (TMVR) with MitraClip (Abbott Structural, Menlo Park, California) is currently approved for use in patients with degenerative valve disease and prohibitive risk for surgery, as well as those with secondary moderate-to-severe or severe mitral regurgitation who

Background/Introduction Severe mitral regurgitation (MR) produces volume overload resulting in progressive cardiac dysfunction that can extend beyond the left-sided chambers. It is unknown whether a specific MR staging system, that would quantify the extent of structural and functional cardiac changes, would be associated with outcomes in severe MR patients receiving mitral valve (MV) intervention. Purpose To examine the clinical utility of a novel MR staging system, based on the extent of cardiac damage, for prediction of clinical outcomes for patients with severe MR who underwent surgical or transcatheter therapy. Methods Patients were categorized into five stages using pre-procedural echocardiography; Stage 0: no other cardiac damage detected; Stage 1: Left atrium (LA) abnormality, as defined by the presence of atrial fibrillation or LA chamber enlargement; Stage 2: LV dysfunction, as defined by LV ejection fraction mild RV dysfunction. The primary outcomes were all-cause mortality, and the combined endpoint of death or heart failure rehospitalization at one-year follow-up. Results A total of 696 patients with MR (age 70±14 years; 60% men) who underwent MV surgery (69%) or transcatheter MV repair with MitraClip device (31%) were examined. Prevalences of stage 0, 1, 2, 3, and 4 were 6.6%, 34.6%, 20.0%, 26.6%, and 12.2%, respectively. The median follow-up time was 15 months (IQR, 6.4, 24.4 months). At one-year, there was graded increase in all-cause death and in the combined endpoint of death or heart failure rehospitalization with each MR stage (Figure). In multivariate models, these associations remained independently associated with both one-year endpoints for patients receiving either surgical or transcatheter interventions. Figure 1 Conclusion This novel MR staging system is practical and may improve clinical risk stratification of patients with severe MR being considered for MV interventions.

Background Contemporary outcomes of transcatheter aortic valve replacement ( TAVR ) in nonagenarians are unknown. Methods and Results We identified 13 544 nonagenarians (aged 90–100 years) who underwent TAVR between 2012 and 2016 using Medicare claims. Generalized estimating equations were used to study the change in short‐term outcomes among nonagenarians over time. We compared outcomes between nonagenarians and non‐nonagenarians undergoing TAVR in 2016. A mixed‐effect multivariable logistic regression was performed to determine predictors of 30‐day mortality in nonagenarians in 2016. A center was defined as a high‐volume center if it performed ≥100 TAVR procedures per year. After adjusting for changes in patients’ characteristics, risk‐adjusted 30‐day mortality declined in nonagenarians from 9.8% in 2012 to 4.4% in 2016 ( P TAVR procedures were performed, of which 12.7% were in nonagenarians. Overall, in‐hospital mortality in 2016 was higher in nonagenarians compared with younger patients (2.4% versus 1.7%, P CI , 0.97–1.81; P =0.07). Important predictors of 30‐day mortality in nonagenarians included in‐hospital stroke (adjusted odds ratio [aOR]: 8.67; 95% CI , 5.03–15.00), acute kidney injury ( aOR : 4.11; 95% CI , 2.90–5.83), blood transfusion ( aOR : 2.66; 95% CI , 1.81–3.90), respiratory complications ( aOR : 2.96; 95% CI , 1.52–5.76), heart failure ( aOR : 1.86; 95% CI , 1.04–3.34), coagulopathy ( aOR : 1.59; 95% CI , 1.12–2.26; P Conclusions Short‐term outcomes after TAVR have improved in nonagenarians. Several procedural complications were associated with increased 30‐day mortality among nonagenarians.

Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset.The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr.TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables.All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases.For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) often requires administration of large contrast volume. The DyeVert system (Osprey Medical) is a disposable, Food and Drug Administration (FDA)-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in cardiac catheterization.We compared the procedural outcomes of patients in whom the DyeVert system was used vs those in whom it was not used during CTO-PCI at a single center between 2017 and 2018.The DyeVert system was used in 39 of 134 CTO-PCIs performed in 130 patients (30%). Most patients (79%) were men and the mean age was 66.6 ± 10.9 years. The most common target vessel was the right coronary artery (54.5%), followed by the left anterior descending artery (26.1%), and circumflex artery (15.7%). The median contrast volume used in DyeVert patients was significantly lower (200 mL [interquartile range, 153-256 mL] vs 250 mL [interquartile range, 170-303 mL]; P=.04). There were no in-hospital major complications with the DyeVert system, nor device-related procedural complications. One patient in the DyeVert group had contrast-induced nephropathy following CTO-PCI that did not require dialysis.Use of the DyeVert system is feasible during CTO-PCI and may reduce the contrast volume administered to the patient. Additional larger studies with a primary clinical endpoint are needed to confirm these findings.

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.

Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation.The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757.Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years [SD 7·9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, three (4%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, myocardial infarctions, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients.The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure.Abbott.

Atrial fibrillation (AF) and atrial flutter (AFL) are associated with increased risk of stroke and mortality after transcatheter aortic valve replacement (TAVR). Many episodes of new-onset AF/AFL (NOAF) occur after hospital discharge and may not be clinically apparent. Pacemakers can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF.From 2012 to 2017, patients who underwent pacemaker implantation after TAVR were reviewed, and pacemaker data from device checks were analyzed for detection of NOAF. Patients with prior AF/AFL were excluded. Secondary outcomes were mortality and ischemic stroke.A total of 172 patients underwent TAVR and pacemaker implantation, and 95 were without pre-existent AF/AFL. Over a median follow-up of 15 months, a total of 24 patients had NOAF (25%), of which 10 patients (10.5%) had manifest NOAF detected on electrocardiography, and 14 patients (14.7%) had subclinical NOAF first identified on device interrogation. The cumulative incidence of mortality was 16.7% for NOAF and 15.5% for normal sinus rhythm (P=.83). The cumulative incidence of stroke was 12.5% for NOAF and 1.4% for normal sinus rhythm (P=.04). Subclinical NOAF patients were less likely to be started on anticoagulation compared with manifest NOAF patients (70% vs 15.3%, respectively; P=.02).Subclinical NOAF is common after TAVR, usually occurs months after hospital discharge, and is associated with lack of anticoagulation therapy and increased risk of stroke. Prolonged surveillance of subclinical NOAF may be warranted after TAVR.

Aims Longitudinal outcomes of transcatheter therapies for secondary mitral regurgitation (MR) have been variable. This study examined predictors of one-year outcome following transcatheter mitral valve implantation (TMVI) with the Tendyne device. Methods and results The first 100 consecutive patients with moderate-severe or severe MR enrolled in the Tendyne CE Mark trial were examined. Multivariable analyses assessed the impact of preoperative clinical and echocardiographic characteristics on one-year freedom from death or heart failure hospitalisation (HFH). All 100 patients underwent Tendyne TMVI without operative mortality. Univariate analysis was performed on implanted subjects, followed by multivariate analysis in those with complete predictive variable data. Patient characteristics: 76.5% male, 60.8% NYHA Class III/IV, age 75.6±7.5 years and Society of Thoracic Surgeons predicted risk of mortality of 8.5±6.1%. Increased left ventricular end-diastolic dimension was associated with one-year Tendyne benefit following univariate analysis (OR 0.35, p=0.010). Following multivariable adjustment, only severe MR, defined as a composite of effective regurgitant orifice area ≥0.3 cm2 or regurgitant volume ≥45 ml, was associated with freedom from death or HFH at one year (OR 0.16, p=0.032). Conclusions Preoperative severe MR was predictive of improved one-year outcome following Tendyne TMVI. These results may inform therapy selection for the management of secondary MR and left ventricular dilatation.