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Although cardiac computed tomography angiography (CCTA) assessment of right ventricular dysfunction (RVD) is feasible, the incremental prognostic value remains uncertain in patients undergoing transcatheter aortic valve replacement (TAVR) evaluation. This study sought to determine the incremental clinical utility of RVD identification by CCTA while accounting for clinical and echocardiographic parameters.Patients who underwent multiphasic ECG-gated functional CCTA using dual-source system for routine TAVR planning were evaluated. Biphasic contrast protocol injection allowed for biventricular contrast enhancement. CCTA-based RVD was defined as right ventricular ejection fraction (RVEF) ​ ​50%. The association of CCTA-RVD with all-cause mortality and the composite outcome of death or heart failure hospitalization after TAVR was evaluated and examined for its incremental utility beyond clinical risk assessment and echocardiographic parameters.A total of 502 patients were included (median [IQR] age, 82 [77 to 87] years; 56% men) with a median follow-up of 22 [16 to 32] months. Importantly, 126 (25%) patients were identified as having RVD by CCTA that was not identified by echocardiography. CCTA-defined RVD predicted death and the composite outcome in both univariate analyses (HR for mortality, 2.15; 95% CI, 1.44-3.22; p ​ ​0.001; HR for composite outcome, 2.11; 95% CI, 1.48-3.01; p ​ ​0.001) and in multivariate models that included clinical risk factors and echocardiographic findings (HR for mortality, 1.74; 95% CI, 1.11-2.74; p ​= ​0.02; HR for composite outcome, 1.63; 95% CI, 1.09-2.44; p ​= ​0.02).Functional CCTA assessment pre-TAVR correctly identified 25% of patients with RVD that was not evident on 2D echocardiography. The presence of RVD on CCTA independently associates with clinical outcomes post-TAVR.

Transcatheter tricuspid valve interventions (TTVIs) are rapidly growing as a less invasive treatment of high surgical risk patients with advanced TR. A comprehensive anatomic and functional assessment of the tricuspid valve and right-sided chambers is essential for candidate selection and procedural planning. Advanced imaging with cardiac computed tomography (CCT) and cardiac magnetic resonance (CMR) can provide accurate anatomic and functional assessment of the tricuspid valve, its apparatus, and the right-sided chambers. In this review, we provide an updated overview of the emerging role of CCT and CMR for TR patient evaluation, TTVI planning, and follow-up.

Background Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported. Objectives This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR. Methods The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years. Results The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P 1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P Conclusions In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514 )

Despite continued efforts, a majority of patients with valvular heart disease (VHD) remain undiagnosed and untreated. This study aimed to assess the adoptability and accuracy of point-of-care handheld echocardiographic assessments (POCE) in the primary care setting.Eleven previously untrained primary care providers were trained to use the Vscan Extend (GE, WI) POCE to assess VHD, left ventricular function (LVEF), and major extra-cardiac findings. Their assessments were compared to those of three blinded expert readers. A total of 175 patients underwent POCE assessments which were evaluated using Kappa statistics (κ) together with their estimated standard error, p value, and 95% CI bounds.Each patient had a mean of 3.3 ± 1.1 (±SD) assessments performed. Identical or nearly identical agreement between previously untrained primary providers and expert readers was evident for the diagnosis of tricuspid regurgitation, mitral regurgitation, pericardial effusion, and volume status. These agreements were strongest in apical long axis (κ = 1, p 0.001) and parasternal long and short axis views (κ =0.82 p 0.001), though agreement remained robust in apical 4-chamber views (κ ≥ 0.76). The agreements in LVEF assessment were identical in the apical long axis view (κ = 1, p 0.001) and robust in the remaining 3 views (κ =0.66, p 0.001). The assessments of aortic stenosis (parasternal/long, κ = 0.42, and parasternal/short, κ = 0.47, both p 0.001) were weak in their agreement.Compared to expert echocardiography readers, the untrained providers' use of POCE for VHD shows high user adoptability and diagnostic accuracies in the primary care setting.

The outcomes of patients with previous coronary bypass graft surgery (CABG) presenting with ST-segment elevation acute myocardial infarction (STEMI) have received limited study. We compared the clinical and procedural characteristics and outcomes of STEMI patients with and without previous CABG in a contemporary multicenter STEMI registry between 2003 and 2020. The primary outcomes of the study were mortality and major cardiac adverse events (MACE: death, MI or stroke). Survival curves were derived using the Kaplan-Meier method and compared with the log-rank test. Of the 13,893 patients included in the analyses, 7.2% had previous CABG. Mean age was 62.4 ± 13.6 years, most patients (71%) were men and 22% had diabetes. Previous CABG patients were older (69.0 ± 11.7 vs 61.9 ± 13.6 years, p0.001) and more likely to have diabetes (40% vs 21%, p0.001) compared with patients without previous CABG. Previous CABG patients had higher mortality and MACE at 5 years (p0.001). Outcomes were similar with saphenous vein graft vs native coronary culprits. Previous CABG remained associated with mortality from discharge to 18 months (p = 0.044) and from 18 months to 5 years (p0.001) after adjusting for baseline characteristics. Long term outcomes after STEMI were worse among patients with previous CABG compared with patients without previous CABG, even after adjustment for baseline characteristics.

Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.

Evaluation of prosthesis-patient mismatch (P-PM) after transcatheter aortic valve replacement (TAVR) by transthoracic echocardiography (TTE) has provided conflicting results regarding its impact on outcomes. Whether post-TAVR computed tomography angiography (CTA) evaluation of P-PM can improve our understanding is unknown. We aimed to evaluate the inter-modality (TTE vs. CTA) agreement, inter-valve platform (balloon-expanding valve [BEV] vs. self-expandable valve [SEV]) differences in P-PM severity, and outcomes related to P-PM after TAVR.We analyzed patients with both CTA and TTE before and after TAVR. Indexed effective orifice area was calculated using two methods: TTE-derived left ventricular outflow tract (LVOT) area from measured diameter and post-TAVR CTA-measured area. Body size specific cut-offs for P-PM severity were used: for body mass index (BMI) ​ ​30 ​kg/mA total of 447 patients were included (median age, 83 years; 54% male). The prevalence of P-PM (moderate or severe) was lower with CTA vs. TTE (3.5% vs. 19.5%, p ​ ​0.001). The prevalence of P-PM measured by TTE was more common in BEV compared to SEV (p ​= ​0.002), while CTA assessment showed no difference in P-PM incidence and severity between TAVR platforms (p ​= ​0.40). In multivariable analysis, CTA-defined but not TTE-defined P-PM was associated with mortality after TAVR (HR:3.97; 95%CI,1.55-10.2; p ​= ​0.004). Both CTA-defined and TTE-defined P-PM were associated with the composite of death and heart failure rehospitalization.Although post-TAVR CTA substantially downgraded the prevalence of P-PM compared to TTE, it identified a subset of patients with clinically relevant P-PM which associated with outcomes.

The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate 60 mL/min/mThe study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P 0.05) but not for SAPIEN 3 TAVR.In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

The double kissing crush (DK crush) is the most studied two-stent coronary bifurcation stenting strategy. While published data support its use, DK crush can be challenging to perform. In this review we provide a detailed step-by-step description and troubleshooting for each stage of the DK crush technique.

Transcatheter options for treating significant symptomatic mitral valve regurgitation (MR) have gained a significant role over the past decade in clinical practice. Increasing clinical trial eviden...

Functional mitral regurgitation (FMR) is a common and complex valve disease, in which severity and risk stratification is still a conundrum. Although risk increases with FMR severity, it is modulated by subjacent left ventricular (LV) disease. The extent of LV remodeling and dysfunction is traditionally evaluated by echocardiography, but a growing body of evidence shows that myocardial fibrosis (MF) assessment by cardiac magnetic resonance (CMR) may complement risk stratification and inform treatment decisions. This review summarizes the current knowledge on the comprehensive evaluation that CMR can provide for patients with FMR, in particular for the assessment of MF and its potential impact in clinical decision-making.

Aim This executive summary of the hypertrophic cardiomyopathy clinical practice guideline provides recommendations and algorithms for clinicians to diagnose and manage hypertrophic cardiomyopathy in adult and pediatric patients as well as supporting documentation to encourage their use. Methods A comprehensive literature search was conducted from January 1, 2010, to April 30, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Structure Many recommendations from the earlier hypertrophic cardiomyopathy guidelines have been updated with new evidence or a better understanding of earlier evidence. This summary operationalizes the recommendations from the full guideline and presents a combination of diagnostic work-up, genetic and family screening, risk stratification approaches, lifestyle modifications, surgical and catheter interventions, and medications that constitute components of guideline directed medical therapy. For both guideline-directed medical therapy and other recommended drug treatment regimens, the reader is advised to follow dosing, contraindications and drug-drug interactions based on product insert materials.

Background A linear increase in the number of valvular heart disease is expected due to the aging population, yet most patients with severe valvular heart disease remain undiagnosed. Hypothesis POCUS can serve as a screening tool for valvular heart disease. Methods We reviewed the literature to assess the strengths and limitations of POCUS in screening and diagnosing valvular heart disease. Results POCUS is an accurate, affordable, accessible, and comprehensive tool. It has a fast learning curve and can prevent unnecessary and more expensive imaging. Challenges include training availability, lack of simplified screening protocols, and reimbursement. Large scale valvular screening data utilizing POCUS is not available. Conclusion POCUS can serve as a screening tool and guide the management of patients with valvular heart disease. More data is needed about its efficacy and cost‐effectiveness in the screening of patients with valvular heart disease.

The impact of new-onset persistent left bundle branch block (LBBB) after transcatheter aortic valve replacement (TAVR) on all-cause mortality has been controversial.We conducted a systematic review and meta-analysis of eleven studies (7398 patients) comparing the short- and long- outcomes in patients who had new-onset LBBB after TAVR vs. those who did not.During a mean follow-up of 20.5±14months, patients who had new-onset persistent LBBB after TAVR had a higher incidence of all-cause mortality (29.7% vs. 23.6%; OR 1.28 (1.04-1.58), p=0.02), rehospitalization for heart failure (HF) (19.5% vs. 17.3%; OR 1.4 (1.13-1.73), p=0.002), and permanent pacemaker implantation (PPMi) (19.7% vs. 7.1%; OR 2.4 (1.64-3.52), p0.001) compared with those who did not. Five studies (4180 patients) reported adjusted hazard ratios (HR) for all-cause mortality; new LBBB remained associated with a higher risk of mortality (adjusted HR 1.43 (1.08-1.9), p0.01, IPost-TAVR persistent LBBB is associated with higher PPMi, HF hospitalizations, and all-cause mortality. While efforts to identify patients who need post-procedural PPMi are warranted, more studies are required to evaluate the best follow-up and treatment strategies, including the type of pacing device if required, to improve long-term outcomes in these patients.

Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group.Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P.001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P.001).Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit.In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P.001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P.001).

Objectives The objective of this study was to evaluate in-hospital outcomes with use of the Sentinel cerebral protection system (CPS) in transcatheter aortic valve replacement (TAVR). Background The role of the Sentinel CPS in preventing clinical ischemic stroke has been controversial. Methods The Nationwide Inpatient Sample database from the last three quarters of 2017, after the approval of the Sentinel CPS device, was queried to identify hospitalizations for TAVR. A 1:2 propensity score–matched analysis to compare in-hospital outcomes with versus without use of the CPS. The primary outcome was the occurrence of ischemic strokes. Results A total of 36,220 weighted discharges of patients who underwent TAVR (525 with the CPS and 35,695 without) were identified. The overall percentages of ischemic and hemorrhagic strokes were 2.4% and 0.2%, respectively. After propensity score matching (525 CPS, 1,050 no CPS), the risk for ischemic stroke was lower with use of the CPS (1 % vs. 3.8%, odd ratio [OR]: 0.243 (95% confidence interval: 0.095 to 0.619); p = 0.003). The cost of the index hospitalization was higher with use of the CPS ($47,783 vs. $44,578; p = 0.002). In multivariate regression analysis, use of the CPS was independently associated with a lower risk for ischemic stroke (OR: 0.380; 95% confidence interval: 0.157 to 0.992; p = 0.032). Conclusions Use of the Sentinel CPS in patients undergoing TAVR is associated with a lower incidence of ischemic stroke and in-hospital mortality, without an increased risk for procedural complications but with an increased cost of the index hospitalization.

Objectives The aim of this study was to describe the anatomic and functional changes in left-sided chambers using computed tomographic angiography (CTA) from baseline to 1 month after transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis. Background Data on changes in left atrial and left ventricular (LV) volumes after TMVR implantation are very limited. Methods Patients who underwent TMVR with the Tendyne prosthesis between 2015 and 2018 were analyzed. Changes in LV end-diastolic volume, ejection fraction, LV mass, left atrial volume, and global longitudinal strain were assessed at baseline and 1 month after TMVR using CTA. Specific Tendyne implant characteristics were identified and correlated with remodeling changes. Results A total of 36 patients (median age 74 years; interquartile range [IQR]: 69 to 78 years; 78% men; 86% with secondary mitral regurgitation) were included in this study. There were significant decreases in LV end-diastolic volume (281 ml [IQR: 210 to 317 ml] vs. 239 ml [IQR: 195 to 291 ml]; p Conclusions TMVR with Tendyne results in favorable left-sided chamber remodeling in the majority of patients treated, as detected on CTA at 1 month after implantation. CTA identifies favorable post-TMVR changes, which could be related to specific characteristics of the device implantation.

Objectives Our study reports the first-in-human experience of a novel approach for left atrial access via the coronary sinus—the percutaneous atriotomy—which is used for left atrial decomp...

This study sought to compare the clinical characteristics and long-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with and without cardiogenic shock (CS) or cardiac arrest (CA) before percutaneous coronary intervention (PCI).Patients with STEMI complicated by CS or CA are underrepresented in STEMI registries.Consecutive patients with STEMI or new left bundle branch block within 24 h of symptom onset were included in a regional STEMI program comprising a PCI center (Minneapolis Heart Institute at Abbott Northwestern Hospital), 11 hospitals 60 miles from PCI center (zone 1), and 19 hospitals 60 to 210 miles from PCI center (zone 2). No patients were excluded. Patients were stratified based on the presence (+) or absence (-) of CS or CA before PCI. Patients with CA were further classified based on initial rhythm. Primary outcomes were in-hospital and 5-year mortality.Between March 2003 and December 2014, 4,511 STEMI patients were included in the regional program, including 398 (9%) with CS and 499 (11%) with CA. Hospital mortality was: CS+ and CA+, 44%; CS+ and CA-, 23%; CS- and CA+, 19%; and CS- and CA-, 2% (p 0.001). The 5-year survival probability for CS+ and CA+ patients was 0.69 (95% confidence interval: 0.61 to 0.76) and 0.89 (95% confidence interval: 0.84 to 0.93), respectively (p 0.01). Compared with patients with shockable rhythms, CA patients with nonshockable rhythms had significantly lower odds of survival at hospital discharge and at 5 years (both p 0.001).The combination of CS and CA significantly increases short-term mortality in patients with STEMI. After 5 years of follow-up, CS patients remained at high risk of fatal events, whereas the prognosis of CA patients was determined by initial rhythm at presentation.

Background We sought to quantify and compare changes in quality of life measures after transcatheter aortic valve replacement (TAVR) in patients with low-flow (LF) and normal-flow (NF) aortic stenosis (AS). Methods We included 297 patients treated with TAVR at Abbott Northwestern Hospital from January 2015 to October 2017. Health status was assessed at baseline and 30 days post-procedure using the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12). Overall (KCCQ-OS) and domain-specific (physical limitation, symptom frequency, quality of life, and social limitation) scores were compared in three subsets of patients as defined by stroke volume index (≤ or >35 ml/m2 ), ejection fraction (EF) (≤ or >40%), and mean gradient (≤ or >40 mmHg). Results Of the 297 patients included, 129 (43%) had NF high-gradient (NF AS group) and 168 (56%) had LF severe AS, including 25 (8%) with low EF (8%) ("Classical" low-flow low-gradient LEF [LF-LG-LEF] group) and 143 (48%) with preserved EF ("Paradoxical" LF-LG group). At baseline, patients with LF-LG-LEF AS had more severe impairment in symptoms frequency (p = .06) but similar KCCQ-OS. At 1-month after TAVR, all groups had moderate improvements in quality of life (Delta KCCQ-OS: "Classical" LF-LG-LEF 18 ± 21, paradoxical AS 14 ± 18, and NF AS 15 ± 16, p = .57). During a median follow-up time of 2.4 years, there was no difference in mortality (p = .34) but patients with paradoxical LF-LG AS had a higher risk of rehospitalization for heart failure (p = .01). Conclusions Patients with LF severe AS derive significant improvements in quality of life measures after TAVR, indistinguishable from patients with NF AS.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Background Chronic aortic regurgitation (AR) causes left ventricular (LV) volume overload resulting in progressive LV remodeling, which negatively affect clinical outcome. Clinical Guidelines recommend assessment of LV remodeling by echocardiography, but little is known about comparative remodeling quantification by cardiac magnetic resonance (CMR) and association with outcomes. Purpose To assess LV remodeling in AR by CMR, compared with echocardiographic measures and determine its impact on clinical outcome. Methods Patients with native, ≥moderate, chronic AR by echocardiography who underwent CMR exam within 90 days of diagnosis from January 2012 to February 2020 were enrolled. The endpoint was a composite of death, heart failure hospitalization, and heart failure symptom exacerbation during follow-up. Results The 178 patients included had median age (IQR) of 58 years (44–69), and most (88%, n=158) presented with no or minimal symptoms (NYHA class I/II). At diagnosis symptomatic vs. no/minimal symptoms patients presented with much more advanced LV remodeling by CMR (EDVI 133 [83–151] vs. 96 [80–123] p=0.024, ESVI 66 [46–85] vs. 42 [30–58], P=0.001) while echocardiography showed limited differences (EDVI 76 [57–93] vs. 65 [54–87] p=0.507, ESVI 38 [30–58] vs. 27 [20–42], p=0.072). During follow-up (3.3 years [1.6–5.8]), aortic valve replacement (AVR) was performed in 49 patients. In patients with no/minimal symptoms, the composite endpoint occurred in 54 (34%) patients including eight deaths and 30 heart failure hospitalizations. Patients with LV end-systolic volume index (LVESVi) >45 ml/m2 by CMR had higher likelihood for composite endpoint (Panel A) confirmed in multivariate models, adjusting for age, sex, AVR (time-dependent), EuroSCORE2, and LV End-systolic-dimension-index (LVESDi) >25 mm/2, with adjusted hazard ratio 1.84 [1.02–3.33], p Conclusion Assessment of LV remodeling by CMR in patients with clinically significant AR is feasible in routine clinical practice, detects with high sensitivity LV remodeling associated with development of HF symptoms and is independently predictive of clinical outcome. Hence, CMR provides a powerful tool for evaluation and risk stratification of patients with AR. Funding Acknowledgement Type of funding sources: None. Panel APanel B

Dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized in our aging population. In hindsight, this may not come as a surprise as AS is the most common valvul...

A 69-year-old woman presented with recurrent heart failure, mild hypertrophy (13.5-mm septal thickness), and severe functional mitral regurgitation. The heart team recommended nonsurgical therapy. Leaflet calcifications precluded edge-to-edge repair; therefore, transcatheter mitral valve replacement

Left atrial appendage occlusion (LAAO) is frequently performed during mitral valve surgery. Dedicated transcatheter mitral valve bioprostheses have anchoring atrial cuffs that interfere with transcatheter LAAO. We highlight the challenges of Watchman LAAO after Tendyne transcatheter mitral valve

New-onset left bundle branch block (N-LBBB) after transcatheter aortic valve replacement (TAVR) is a challenging clinical dilemma. In our single-center study, 60 out of 172 patients who underwent permanent pacemaker implantation (PPM) after TAVR had N-LBBB (34.9%). At a median follow-up duration of 357 days (IQR, 178; 560 days), two patients (3.5%) were completely pacemaker-dependent, and four others (7%) were partially dependent. Twelve patients (24%) recovered conduction in their left bundle at a median follow-up duration of 5 weeks (IQR, 4; 14 weeks). Due to the lack of clinical predictors of pacemaker dependency, active surveillance is warranted and may be an alternative to permanent pacemaker implantation.

Transcatheter therapy with the MitraClip system (Abbott Structural, Menlo Park, CA) is the most commonly used transcatheter therapy for patients with tricuspid regurgitation, with over 1000 cases performed worldwide. The procedure is an off-label approach that requires meticulous attention to anatomical features obtained via comprehensive echocardiography and, in some cases, using cardiac computed tomography. Herein, we describe patient selection, procedural performance, and clinical outcomes of this therapy.

Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p0.001), albumin3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.

Background Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. Objectives The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. Methods Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. Results Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. Conclusions Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.

AIMS We aimed to examine the effectiveness and the optimal technique for transcatheter therapy for residual mitral regurgitation (MR) after MitraClip therapy with the AMPLATZER Vascular Plug II (AVP-II). METHODS AND RESULTS Nine patients (mean age, 78±4 years) underwent transcatheter therapy with the AVP-II for residual MR after MitraClip therapy. We examined procedural, in-hospital, and 30-day outcomes. Our technique was successful in all cases, with treatment of different types of residual MR, including paraclip, interclip, and leaflet perforation. MR grade decreased significantly from 4+ to 1+ (p

Objectives The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair. Background Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance. Methods MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable. Results MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p Conclusions For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.

Transfemoral aortic valve implantation (TAVI) has become a viable alternative to surgical valve implantation, particularly for higher risk patients; however, vascular complications (VCs) remain a concern in transfemoral TAVI. We aimed to determine clinical and computed tomographic angiography-derived risk factors associated with Valve Academic Research Consortium (VARC)-2 criteria VCs in patients who underwent TAVI. From 2011 to 2017, 481 patients underwent percutaneous transfemoral TAVI at the Minneapolis Heart Institute and were screened for procedural and postprocedural access-related VC according to VARC-2 criteria. Clinical and clinical and computed tomographic angiography-derived data were collected to establish risk factors for VC. A total of 99 (21%) patients had VARC-2 VCs. Closure device failure (CDF) occurred in 56 of 99 (57%), minor VCs in 37 of 99 (37%), and major VCs occurred in 6 of 99 (6%). Access site-related VCs were preceded by CDF in 18 of 43 (42%) patients and the risk of major/minor VCs was 14 times greater in patients who experienced closure complications. The incidence of CDF was higher in common femoral artery (CFA) access sites with circumferential vessel wall calcification of more than 90° (p = 0.02) and when skin-surface to CFA access-site distance at an optimal access angle of 45° exceeded 80 mm (p = 0.03). In conclusion, both the degree of circumferential CFA access site calcification and distance to skin surface at an optimal access angle may improve risk stratification of access planning in patients who underwent percutaneous transfemoral TAVI.

Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease.

Background Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is know...

Structural heart disease (SHD) is an innovative field driven forward by the success of novel transcatheter device technologies. Much of the rapid progress and expansion of this field can be attribu...

Objectives The aim of this study was to compare 1-year outcomes following transcatheter mitral valve (MV) repair in patients with and without atrial fibrillation (AF). Background The development of AF in degenerative mitral regurgitation (MR) is considered a sign of MR progression and is associated with adverse clinical events. However, the impact of AF in patients undergoing transcatheter MV repair remains uncertain. Methods The TVT (Transcatheter Valve Therapy) Registry was used to identify patients undergoing transcatheter MV repair with the MitraClip between November 2013 and June 2016. Using Centers for Medicare and Medicaid Services–linked data, the 1-year rate of death, heart failure hospitalization, stroke, and bleeding following transcatheter MV repair was compared in patients with and without AF. Outcomes were analyzed using multivariate Cox regression modeling. Results A total of 5,613 patients underwent commercial transcatheter MV repair in the United States during the study period, including 3,555 (63%) with pre-existing AF. Compared with patients without AF, patients with AF were older, were more likely to be male and Caucasian, had more comorbidities, and had higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (median 7% vs. 5%; p Conclusions In patients undergoing transcatheter MV repair, AF is common and is associated with worse clinical outcomes at 1 year despite similar acute procedural success. Further study is needed to investigate if early treatment of MR reduces the future risk for developing AF and to identify therapies that improve outcomes in these patients.

Background Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. Objectives The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. Methods The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. Results In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p Conclusions In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.

Background: To examine contemporary clinical and economic outcomes with the implementation of a minimalist program (MP) for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis. TAVR continues to evolve with the adoption of methods intended to maximize cost-savings while maintaining clinical effectiveness, patient safety, and satisfaction.Methods: A multidisciplinary collaboration was undertaken to develop a MP for transfemoral TAVR using conscious sedation anesthesia (CS) and resource optimization. Outcomes for 107 patients treated with MP were compared to 107 univariate-matched control patients who underwent TAVR with general anesthesia (GA).Results: There were no differences between the two groups with respect to demographics, aortic stenosis severity, morbidities, symptoms, or frailty. Procedural success, major adverse complications and quality of life were also comparable. During the use of MP, there were no conversions to GA. In comparison to control patients...

Transfemoral transcatheter aortic valve replacement (TF-TAVR) is mostly performed under general anesthesia (GA) in most US centers. We examined in-hospital and 30-day outcomes in patients who underwent TF-TAVR with a self-expanding bioprosthesis using local anesthesia (LA) or GA. Patients from the Transcatheter Valve Therapeutics Registry who underwent TF-TAVR from January 2014 to June 2016 with LA or GA were evaluated. Propensity matching was performed and procedural and clinical outcomes compared up to 30 days. A total of 11,006 patients were included (GA: 8,239 [74.9%] and LA: 2,767 [25.1%]). After propensity matching (n = 1,988 matched sets), device success was similar (94.5% vs 94.6%, p = 0.905). No differences in in-hospital stroke (2.7% vs 2.3%, p = 0.413) or paravalvular regurgitation grade (p = 0.113) were noted. Fewer LA patients were converted to open heart surgery (0.2% vs 0.6%, p = 0.076) or experienced an in-hospital major vascular complication (0.7% vs 1.4%, p = 0.026). Intensive care unit time (40.1 ± 58.4 vs 50.9 ± 72.1 hours, p0.001) and postprocedure length of stay (4.1 ± 3.6 vs 5.0 ± 4.5 days, p0.001) were significantly shorter with LA. In-hospital and 30-day all-cause mortality were lower in the LA cohort compared to the GA cohort ([1.1% vs 2.7%, p0.001] and [2.1% vs 3.9%, p = 0.001]). In conclusion, in the largest series of self-expanding bioprostheses for TF-TAVR, these propensity-matched cohorts demonstrate that LA is an acceptable alternative to GA with comparable success, lower safety outcomes, complications rates, and in-hospital and 30-day all-cause mortality.

BACKGROUND: An independent panel of experts reviewed all investigator-reported cases of mitral valve leaflet adverse events (LAE) after MitraClip NTR/XTR in the EXPAND study. AIMS: We aimed to report the findings of the expert panel and standardise definitions for LAE. METHODS: Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel. RESULTS: Enrolling centres reported LAE in 35 cases, 11 leaflet injuries (9 tears, 2 perforations) and 24 single leaflet device attachment (SLDA). The panel confirmed LAE in 20 cases (2.0% incidence), 18 patients had SLDA and 4 had leaflet injury (2 cases had both SLDA and injury). Leaflet injury occurred during device implant and resulted in surgical valve replacement or death. SLDA-alone events were identified during implant (n=2), pre-discharge (n=7) or at 30 days of follow-up (n=7) and were resolved (≤2+ residual MR) with additional clips in 75% of cases. CONCLUSIONS: Mitral valve repair with MitraClip NTR/XTR is safe. The rate of LAE is lower than previously reported using older-generation devices. The proposed definitions and findings will help to differentiate leaflet injury from inadequate leaflet insertion and SLDA and provide guidance for consistent diagnosis of LAE post MitraClip implantation.

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high‐volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre‐SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9–9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In‐hospital all‐cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

Objectives The aims of this study were to describe trends and hospital variation in same-day discharge following elective percutaneous coronary intervention (PCI) and to evaluate the association between trends in same-day discharge and patient outcomes. Background Insights on contemporary use of same-day discharge following elective PCI are limited. Methods In a sequential cross-sectional analysis of 819,091 patients undergoing elective PCI at 1,716 hospitals in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009, to December 31, 2017, overall and hospital-level trends in same-day discharge were assessed. Among the 212,369 patients who linked to Centers for Medicare and Medicaid Services data, the association between same-day discharge and 30-day mortality and rehospitalization was assessed. Results A total of 114,461 patients (14.0%) were discharged the same day as PCI. The proportion of patients with same-day discharge increased from 4.5% in the third quarter of 2009 to 28.6% in the fourth quarter of 2017. From 2009 to 2017, the rate of same-day discharge increased from 4.3% to 19.5% for femoral-access PCI and from 9.9% to 39.7% for radial-access PCI. Hospital-level variation in the use of same-day discharge persisted throughout (median odds ratio adjusted for year and radial access: 4.15). Risk-adjusted 30-day mortality did not change over time, while risk-adjusted rehospitalization decreased over time and more quickly for same-day discharge (P for interaction Conclusions In the past decade, a large increase in the use of same-day discharge following elective PCI was not associated with worse 30-day mortality or rehospitalization. Hospital-level variation in same-day discharge may represent an opportunity to reduce costs without compromising patient outcomes.