Prognostic Power of Quantitative Assessment of Functional Mitral Regurgitation and Myocardial Scar Quantification by Cardiac Magnetic Resonance.

BACKGROUND: The severity classification of functional mitral regurgitation (FMR) remains controversial despite adverse prognosis and rapidly evolving interventions. Furthermore, it is unclear if quantitative assessment with cardiac magnetic resonance can provide incremental risk stratification for patients with ischemic cardiomyopathy (ICM) or non-ICM (NICM) in terms of FMR and late gadolinium enhancement (LGE). We evaluated the impact of quantitative cardiac magnetic resonance parameters on event-free survival separately for ICM and NICM, to assess prognostic FMR thresholds and interactions with LGE quantification. METHODS: Patients (n=1414) undergoing cardiac magnetic resonance for cardiomyopathy (ejection fraction<50%) assessment from April 1, 2001 to December 31, 2017 were evaluated. The primary end point was all-cause death, heart transplant, or left ventricular assist device implantation during follow-up. Multivariable Cox analyses were conducted to determine the impact of FMR, LGE, and their interactions with event-free survival. RESULTS: There were 510 primary end points, 395/782 (50.5%) in ICM and 114/632 (18.0%) in NICM. Mitral regurgitation-fraction per 5% increase was independently associated with the primary end point, hazards ratios (95% CIs) of 1.04 (1.01-1.07; P=0.034) in ICM and 1.09 (1.02-1.16; P=0.011) in NICM. Optimal mitral regurgitation-fraction threshold for moderate and severe FMR were ≥20% and ≥35%, respectively, in both ICM and NICM, based on the prediction of the primary outcome. Similarly, optimal LGE thresholds were ≥5% in ICM and ≥2% in NICM. Mitral regurgitation-fraction×LGE emerged as a significant interaction for the primary end point in ICM (P=0.006), but not in NICM (P=0.971). CONCLUSIONS: Mitral regurgitation-fraction and LGE are key quantitative cardiac magnetic resonance biomarkers with differential associations with adverse outcomes in ICM and NICM. Optimal prognostic thresholds may provide important clinical risk prognostication and may further facilitate the ability to derive selection criteria to guide therapeutic decision-making.

Survival After Septal Reduction in Patients >65 Years Old With Obstructive Hypertrophic Cardiomyopathy.

BACKGROUND: Obstructive hypertrophic cardiomyopathy (oHCM) is increasingly being diagnosed in elderly patients. OBJECTIVES: The authors sought to study long-term outcomes of septal reduction therapies (SRT) in Medicare patients with oHCM, and hospital volume-outcome relation. METHODS: Medicare beneficiaries aged >65 years who underwent SRT, septal myectomy (SM) or alcohol septal ablation (ASA), from 2013 through 2019 were identified. Primary outcome was all-cause mortality, and secondary outcomes included heart failure (HF) readmission and need for redo SRT in follow-up. Overlap propensity score weighting was used to adjust for differences between both groups. Relation between hospital SRT volume and short-term and long-term mortality was studied. RESULTS: The study included 5,679 oHCM patients (SM = 3,680 and ASA = 1,999, mean age 72.9 vs 74.8 years, women 67.2% vs 71.1%; P < 0.01). SM patients had fewer comorbidities, but after adjustment, both groups were well balanced. At 4 years (IQR: 2-6 years), although there was no difference in long-term mortality between SM and ASA (HR: 0.87; 95% CI: 0.74-1.03; P = 0.1), on landmark analysis, SM was associated with lower mortality after 2 years of follow-up (HR: 0.72; 95% CI: 0.60-0.87; P < 0.001) and had lower need for redo SRT. Both reduced HF readmissions in follow-up vs 1 year pre-SRT. Higher-volume centers had better outcomes vs lower-volume centers, but 70% of SRT were performed in low-volume centers. CONCLUSIONS: SRT reduced HF readmission in Medicare patients with oHCM. SM is associated with lower redo and better long-term survival compared with ASA. Despite better outcomes in high-volume centers, 70% of SRT are performed in low-volume U.S. centers.

Interaction Between Race and Income on Cardiac Outcomes After Percutaneous Coronary Intervention.

Background Compared with White Americans, Black Americans have a greater prevalence of cardiac events following percutaneous coronary intervention. We evaluated the association between race and neighborhood income on post-percutaneous coronary intervention cardiac events and assessed whether income modifies the effect of race on this relationship. Methods and Results Consecutive patients (n=23 822) treated with percutaneous coronary intervention from January 1, 2000, to December 31, 2016, were included. All-cause mortality and major adverse cardiac event were assessed at 3 years. Extended 10-year follow-up was performed for those residing locally (n=1285). Neighborhood income was derived using median adjusted annual gross household income reported within the patient's zip code. We compared differences in treatment and outcomes, adjusting for race, income, and their interaction. In total, 3173 (13.3%) patients self-identified as Black Americans, and 20 649 (86.7%) self-identified as White Americans. Black Americans had a worse baseline cardiac risk profile and lower neighborhood income compared with White Americans. Although risk profile improved with increasing income in White Americans, no difference was observed across incomes among Black Americans. Despite similar long-term outpatient cardiology follow-up and medication prescription, risk profiles among Black Americans remained worse. At 3 years, unadjusted all-cause mortality (18.0% versus 15.2%; P<0.001) and major adverse cardiac event (37.3% versus 34.6%; P<0.001) were greater among Black Americans and with lower income (both P<0.001); race, income, and their interaction were not significant predictors in multivariable models. At 10-year follow-up, increasing income was associated with improved outcomes only in White Americans but not Black Americans. In multivariable models for major adverse cardiac event, income (hazard ratio [HR], 0.97 [95% CI, 0.96-0.98]; P=0.005), Black race (HR, 1.77 [95% CI, 1.58-1.96]; P=0.006), and their interaction (HR, 0.98 [95% CI, 0.97-0.99]; P=0.003) were significant predictors. Similar findings were observed for cardiac death. Conclusions Early 3-year post-percutaneous coronary intervention outcomes were driven by worse risk factor profiles in both Black Americans and those with lower neighborhood income. However, late 10-year outcomes showed an independent effect of race and income, with improving outcomes with greater income limited to White Americans. These findings illustrate the importance of developing novel care strategies that address both risk factor modification and social determinants of health to mitigate disparities in cardiac outcomes.

Machine learning models predict total charges and drivers of cost for transcatheter aortic valve replacement.

Background: Given the increasing healthcare costs, there is an interest in developing machine learning (ML) prediction models for estimating hospitalization charges. We use ML algorithms to predict hospitalization charges for patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing the National Inpatient Sample (NIS) database. Methods: Patients who underwent TF-TAVR from 2012 to 2016 were included in the study. The primary outcome was total hospitalization charges. Study dataset was divided into 80% training and 20% testing sets. We used following ML regression algorithms: random forest, gradient boosting, k-nearest neighbors (KNN), multi-layer perceptron and linear regression. ML algorithms were built for for 3 stages: Stage 1, including variables that were known pre-procedurally (prior to TF-TAVR); Stage 2, including variables that were known post-procedurally; Stage 3, including length of stay (LOS) in addition to the stage 2 variables. Results: A total of 18,793 hospitalization for TF-TAVR were analyzed. The mean and median adjusted hospitalization charges were $220,725.2 ($137,675.1) and $187,212.0 ($137,971.0-264,824.8) respectively. Random forest regression algorithm outperformed other ML algorithms at all stages with higher R2 score and lower mean absolute error (MAE), root mean squared area (RMSE) and root mean squared logarithmic error (RMSLE) (Stage 1: MAE 79,979.11, R2 0.157; Stage 2: MAE 76,200.09, R2 0.256; Stage 3: MAE 69,350.09, R2 0.453). LOS was the most important predictor of hospitalization charges. Conclusions: We built ML algorithms that predict hospitalization charges with good accuracy in patients undergoing TF-TAVR at different stages of hospitalization and that can be used by healthcare providers to better understand the drivers of charges.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis.

BACKGROUND: Patients with rheumatic aortic stenosis (AS) were excluded from transcatheter aortic valve replacement (TAVR) trials. OBJECTIVES: The authors sought to examine outcomes with TAVR versus surgical aortic valve replacement (SAVR) in patients with rheumatic AS, and versus TAVR in nonrheumatic AS. METHODS: The authors identified Medicare beneficiaries who underwent TAVR or SAVR from October 2015 to December 2017, and then identified patients with rheumatic AS using prior validated International Classification of Diseases, Version 10 codes. Overlap propensity score weighting analysis was used to adjust for measured confounders. The primary study outcome was all-cause mortality. Multiple secondary outcomes were also examined. RESULTS: The final study cohort included 1,159 patients with rheumatic AS who underwent aortic valve replacement (SAVR, n = 554; TAVR, n = 605), and 88,554 patients with nonrheumatic AS who underwent TAVR. Patients in the SAVR group were younger and with lower prevalence of most comorbidities and frailty scores. After median follow-up of 19 months (interquartile range: 13 to 26 months), there was no difference in all-cause mortality with TAVR versus SAVR (11.2 vs. 7.0 per 100 person-year; adjusted hazard ratio: 1.53; 95% confidence interval: 0.84 to 2.79; p = 0.2). Compared with TAVR in nonrheumatic AS, TAVR for rheumatic AS was associated with similar mortality (15.2 vs. 17.7 deaths per 100 person-years (adjusted hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.09; p = 0.2) after median follow-up of 17 months (interquartile range: 11 to 24 months). None of the rheumatic TAVR patients, <11 SAVR patients, and 242 nonrheumatic TAVR patients underwent repeat aortic valve replacement (124 redo-TAVR and 118 SAVR) at follow-up. CONCLUSIONS: Compared with SAVR, TAVR could represent a viable and possibly durable option for patients with rheumatic AS.

Five years of a comprehensive ST-elevation myocardial infarction protocol and its association with sex disparities.

Aims: To determine whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol is associated with reduced sex disparities over 5 years. Methods and results: This was an observational cohort study of 1833 consecutive STEMI patients treated with percutaneous coronary intervention (PCI) before (1 January 2011-14 July 2014, control group) and after (15 July 2014-15 July 2019, protocol group) implementation of a protocol for early guideline-directed medical therapy (GDMT), rapid door to balloon time (D2BT), and use of trans-radial PCI. In the control group, females had less GDMT (77.1% vs. 68.1%, P = 0.03), similarly low trans-radial PCI (19.0% vs. 17.6%, P = 0.73), and longer D2BT [104 min (79, 133) vs. 112 min (85, 147), P = 0.02] corresponding to higher in-hospital mortality [4.5% vs. 10.3%, odds ratio (OR) 2.44 (1.34-4.46), P = 0.004], major adverse cardiac and cerebrovascular events [MACCE, 9.8% vs. 16.3%, OR 1.79 (1.14-2.84), P = 0.01], and net adverse clinical events [NACE, 16.1% vs. 28.3%, OR 2.06 (1.42-2.99), P < 0.001]. In the protocol group, no significant sex differences were observed in GDMT (87.2% vs. 86.4%, P = 0.81) or D2BT [85 min (64-106) vs. 89 min (65-111), P = 0.06], but trans-radial PCI was used less in females (77.6% vs. 71.2%, P = 0.03). In-hospital mortality [2.5% vs. 4.4%, OR 1.78 (0.91-3.51), P = 0.09] and MACCE [9.0% vs. 11.1%, OR 1.27 (0.83-1.92), P = 0.26] were similar between sexes, but higher NACE in females approached significance [14.8% vs. 19.4%, OR 1.38 (0.99-1.92), P = 0.05] due to higher bleeding risk [7.2% vs. 11.1%, OR 1.60 (1.04-2.46), P = 0.03]. Conclusions: A comprehensive STEMI protocol was associated with sustained reductions for in-hospital ischaemic outcomes over 5 years, but higher bleeding rates in females persisted.

Trends in Outcomes of Transcatheter and Surgical Aortic Valve Replacement in the United States (2012-2017).

As the use of transcatheter aortic valve implantation (TAVI) expands to varying patient populations, impacting the landscape of surgical aortic valve replacement (SAVR), this study sought to assess volume and performance trends of aortic valve replacement (AVR) in the United States during 2012-2017. The Nationwide Readmissions Database was queried for patients who underwent endovascular/transapical TAVI, isolated SAVR, or complex aortic valve surgery between 2012 and 2017. Temporal trends in annual case volume, admission costs, in-hospital outcomes, and 30-day readmission were evaluated. Of 624,303 patients (median age 72 years) who received AVR, 387,011 (62%) were men. Among these patients, 170,521 (27%) underwent TAVI and 453,782 (73%) underwent SAVR with 299,398 isolated and 154,384 complex aortic valve surgery. TAVI patients were significantly older and higher risk compared with SAVR patients. From 2012 to 2017, the annual number of TAVI increased from 8,295 to 55,168 whereas SAVR volume remained remarkably stable. Patients who underwent AVR demonstrated significant improvements in mortality, stroke, duration of hospitalization, and 30-day readmission. In conclusion, this large contemporary analysis reports the considerable growth of AVR in the United States. It remains unequivocal that the treatment of aortic stenosis is improving overall with reduced mortality following AVR, highlighting the effectiveness of various process improvements such as newer valves, enhanced patient selection, and the interdisciplinary Heart Team approach.

Impact of Economic Status on Utilization and Outcomes of Transcatheter Aortic Valve Implantation and Mitraclip.

Data on the impact of economic status on Transcatheter aortic valve implantation (TAVI) and MitraClip (MC) is lacking. Patients who underwent TAVI and/or MC during 2012 to 2017 were identified in the Nationwide Readmission Database and divided by zip code estimated income quartile into 4 groups (Q1 to Q4). The utilization of TAVI and/or MC was defined as the number of TAVIs and/or MCs over all admissions with an aortic and/or mitral valve disease (AVD and/or MVD) and represented per 1,000 admissions. A total of 168,853 patients underwent TAVI; 20.6% in Q1, 26.3% in Q2, 27.3% in Q3, and 25.8% in Q4, while 15,387 patients underwent MC; 22% in Q1, 26.2% in Q2, 26.3% in Q3, and 25.5% in Q4. The annual utilization of TAVIs and/or MCs increased over the study period and was generally lower with lower income. In 2012, TAVI was performed for 8.2, 8.8, 10.8, and 11.3 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, TAVI was performed for 54.1, 65.1, 68.6, and 71 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2014, MC was performed for 1.6, 2.1, 1.8, and 1.9 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, MC was performed for 5.6, 6.5, 8, and 8 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In-hospital mortality, stroke, and 30-day readmissions were generally comparable across groups. Lower-income patients may be underrepresented among patients undergoing TAVI and MC despite comparable outcomes. Further studies are needed to examine the etiologies behind these disparities and identify targeted strategies for its mitigation.

Be Prepared for the Unexpected: Importance of Careful Intraprocedural Transesophageal Echocardiography Assessment During MitraClip.

Transesophageal echocardiography plays a central role in the evaluation and guidance of mitral valve interventions. Our case highlights the importance of thorough intraprocedural valve evaluation using 3-dimensional and multiplanar reconstruction transesophageal echocardiography, discovering an unexpected mechanism for mitral regurgitation, to guide an alternative intervention strategy by an experienced interventional team. (Level of Difficulty: Intermediate.).

Clevidipine as a therapeutic and cost-effective alternative to sodium nitroprusside in patients with acute aortic syndromes.

BACKGROUND: Sodium nitroprusside is the preferred agent for the treatment of high blood pressure during acute aortic syndrome if blood pressure remains elevated after heart rate control with beta-blockers. The increasing cost of sodium nitroprusside in the USA led us to assess the efficacy and safety of intravenous clevidipine, a calcium channel blocker with quick onset of action, short half-life and significantly lower costs than sodium nitroprusside, in patients presenting with acute aortic syndrome. METHODS: We performed a retrospective chart review of consecutive patients admitted to the Cleveland Clinic Cardiac Intensive Care Unit from 2013-2016 with a diagnosis of acute aortic syndrome. Patients who received intravenous sodium nitroprusside were compared with those receiving intravenous clevidipine. The primary outcome was a significant difference in blood pressure at one, three and six hours. Secondary outcomes included time to achieving blood pressure target and in hospital mortality with rates of hypotension and bradycardia as safety endpoints. RESULTS: A total of 85 patients with suspected acute aortic pathology received clevidipine and 50 received sodium nitroprusside. Clinical and demographic characteristics were similar in both groups, except for a higher incidence of abdominal aortic aneurysm in the clevidipine group and for a trend towards higher use of labetalol in the clevidipine group. There were no significant differences in blood pressure or heart rate at one, three and six hours after starting either infusion. The rates of hypotension, bradycardia and in-hospital mortality did not differ. Time to achieve blood pressure control were also similar between groups. CONCLUSION: Intravenous clevidipine appears to be a safe and effective alternative to sodium nitroprusside for the management of high blood pressure during acute aortic dissection. In the USA, clevidipine could represent a cost effective therapy providing similar outcomes than sodium nitroprusside.

Degenerative Mitral Stenosis: Unmet Need for Percutaneous Interventions.

Degenerative mitral stenosis (DMS) is an important cause of mitral stenosis, developing secondary to severe mitral annular calcification. With the increase in life expectancy and improved access to health care, more patients with DMS are likely to be encountered in developed nations. These patients are generally elderly with multiple comorbidities and often are high-risk candidates for surgery. The mainstay of therapy in DMS patients is medical management with heart rate control and diuretic therapy. Surgical intervention might be delayed until symptoms are severely limiting and cannot be managed by medical therapy. Mitral valve surgery is also challenging in these patients because of the presence of extensive calcification. Hence, there is a need to develop an alternative percutaneous treatment approach for patients with DMS who are otherwise inoperable or at high risk for surgery. In this review, we summarize the available data on the epidemiology of DMS and diagnostic considerations and current treatment strategies for these patients.

Renin-Angiotensin System Antagonists in Patients Without Left Ventricular Dysfunction After Percutaneous Intervention for ST-Segment Elevation Myocardial Infarction.

There is a paucity of evidence on the impact of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on long-term outcomes in patients with ejection fraction (EF) >40% after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). We compared long-term all-cause mortality between patients with left ventricular ejection fraction (LVEF) >40% discharged on ACEi/ARB with patients who were discharged on neither of these agents. Patients discharged after percutaneous intervention for STEMI from our catheterization laboratories from January 2002 to December 2011 were considered for inclusion. Patients were excluded if they had LVEF <40% or chronic kidney disease or hypotension (systolic blood pressure <90 mm Hg any time after the procedure). Long-term mortality and discharge medications were determined using the Social Security Death Index and electronic medical record review, respectively. A total of 988 patients were included. The median follow-up duration was 4.6 years. Kaplan-Meier analysis showed no significant difference in long-term all-cause mortality in patients discharged on ACEi/ARB compared with those who were not discharged on these medications. The number needed to treat to prevent 1 death at 1 year was 714. In addition, multivariable Cox proportional hazard modeling failed to demonstrate any beneficial effect of ACEi/ARB similar to Kaplan-Meir analysis (hazard ratio 0.88, 95% confidence interval 0.57 to 1.36). In conclusion, we found no significant benefit in long-term mortality using ACEi/ARB in patients with LVEF >40% after primary percutaneous coronary intervention for STEMI.

Novel hemodynamic index for assessment of aortic regurgitation after transcatheter aortic valve replacement.

BACKGROUND: Paravalvular aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) has been associated with increased mortality. Precise assessment of the degree of AR within the catheterization laboratory is crucial to take counter measures, but it remains challenging. The aim of this study was to determine whether any modification to AR index can improve its performance. METHODS: The study included 64 patients treated with the Sapien valve (Edwards Life Sciences, Inc., Irvine, CA). The severity of AR was evaluated using echocardiography, angiography, and invasive hemodynamic parameters. We evaluated the time-integrated aortic regurgitation (TIAR) index as follows: (LV - Ao diastolic pressure time integral)/(LV systolic pressure time integral) × 100. We analyzed the AR index and TIAR index with the receiver operating characteristic (ROC) curve. RESULTS: AR was observed in 58 patients (90.7%) and graded as mild in 33 (51.6%), moderate in 20 (31.3%), or moderate to severe in 5 (7.8%) patients. No severe AR was detected. The AR index and TIAR index decreased proportionately to the increased severity of AR (P = 0.002 and P < 0.001, respectively). TIAR index < 80 was associated with a sensitivity of 86% and a specificity of 83% for ≥mild AR. The area under the curve was greater for the TIAR index compared to the AR index (0.93 vs. 0.74). CONCLUSION: The TIAR index provides a better hemodynamic measure for assessing severity of AR compared to the AR index.