5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results.

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC). OBJECTIVES: The aim of this study was to evaluate 5-year outcomes among these patients. METHODS: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. RESULTS: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. CONCLUSIONS: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

Determinants of change in code status among patients with cardiopulmonary arrest admitted to the intensive care unit.

BACKGROUND: Patients with cardiopulmonary arrest often have a poor prognosis, prompting discussion with families about code status. The impact of socioeconomic factors, demographics, medical comorbidities and medical interventions on code status changes is not well understood. METHODS: This retrospective study included adult patients presenting with cardiac arrest to the intensive care unit of a hospital group between 5/1/2010-5/1/2020. We extracted chart data on socioeconomic factors, demographics, and medical comorbidities. RESULTS: We identified 1,254 patients, of which 57.5% were males. Age was different across the groups with (61.2 ± 15.5 years) and without (61.2 ± 15.5 years) code status change (p= <0.0001). Code status was changed in 583 patients (46.5%). Among patients with code status change, the highest prevalence was White patients (34.8%), followed by African Americans (30.9%), and Hispanics (25.4%). Compared to patients who did not have a code status change, those with a change in code status were older (66.7 ± 14.8 years vs 61.2 ± 15.5 years). They were also more likely to receive vasopressor/inotropic support (74.6% vs 58.5%), and broad-spectrum antibiotics (70.3% vs 57.7%). Insurance status, ethnicity, religion, education, and salary did not lead to statistically significant changes in code status. CONCLUSIONS: In patients with cardiopulmonary arrest, code status change was more likely to be influenced by the presence of medical comorbidities and medical interventions during hospitalization rather than by socioeconomic factors.

Racial and Socioeconomic Disparities in Out-Of-Hospital Cardiac Arrest Outcomes: Artificial Intelligence-Augmented Propensity Score and Geospatial Cohort Analysis of 3,952 Patients.

INTRODUCTION: Social disparities in out-of-hospital cardiac arrest (OHCA) outcomes are preventable, costly, and unjust. We sought to perform the first large artificial intelligence- (AI-) guided statistical and geographic information system (GIS) analysis of a multiyear and multisite cohort for OHCA outcomes (incidence and poor neurological disposition). METHOD: We conducted a retrospective cohort analysis of a prospectively collected multicenter dataset of adult patients who sequentially presented to Houston metro area hospitals from 01/01/07-01/01/16. Then AI-based machine learning (backward propagation neural network) augmented multivariable regression and GIS heat mapping were performed. RESULTS: Of 3,952 OHCA patients across 38 hospitals, African Americans were the most likely to suffer OHCA despite representing a significantly lower percentage of the population (42.6 versus 22.8%; p < 0.001). Compared to Caucasians, they were significantly more likely to have poor neurological disposition (OR 2.21, 95%CI 1.25-3.92; p=0.006) and be discharged to a facility instead of home (OR 1.39, 95%CI 1.05-1.85; p=0.023). Compared to the safety net hospital system primarily serving poorer African Americans, the university hospital serving primarily higher income commercially and Medicare insured patients had the lowest odds of death (OR 0.45, p < 0.001). Each additional $10,000 above median household income was associated with a decrease in the total number of cardiac arrests per zip code by 2.86 (95%CI -4.26- -1.46; p < 0.001); zip codes with a median income above $54,600 versus the federal poverty level had 14.62 fewer arrests (p < 0.001). GIS maps showed convergence of the greater density of poor neurologic outcome cases and greater density of poorer African American residences. CONCLUSION: This large, longitudinal AI-guided analysis statistically and geographically identifies racial and socioeconomic disparities in OHCA outcomes in a way that may allow targeted medical and public health coordinated efforts to improve clinical, cost, and social equity outcomes.

TAVR and cancer: machine learning-augmented propensity score mortality and cost analysis in over 30 million patients.

INTRODUCTION: Cardiovascular disease (CVD) and cancer are the top mortality causes globally, yet little is known about how the diagnosis of cancer affects treatment options in patients with hemodynamically compromising aortic stenosis (AS). Patients with cancer often are excluded from aortic valve replacement (AVR) trials including trials with transcatheter AVR (TAVR) and surgical AVR (SAVR). This study looks at how cancer may influence treatment options and assesses the outcome of patients with cancer who undergo SAVR or TAVR intervention. Additionally, we sought to quantitate and compare both clinical and cost outcomes for patients with and without cancer. METHODS: This population-based case-control study uses the most recent year available National Inpatient Sample (NIS (2016) from the United States Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ). Machine learning augmented propensity score adjusted multivariable regression was conducted based on the likelihood of undergoing TAVR versus medical management (MM) and TAVR versus SAVR with model optimization supported by backward propagation neural network machine learning. RESULTS: Of the 30,195,722 total hospital admissions, 39,254 (0.13%) TAVRs were performed, with significantly fewer performed in patients with versus without cancer even in those of comparable age and mortality risk (23.82% versus 76.18%, p < 0.001) despite having similar hospital and procedural mortality. Multivariable regression in patients with cancer demonstrated that mortality was similar for TAVR, MM, and SAVR, though LOS and cost was significantly lower for TAVR versus MM and comparable for TAVR versus SAVR. Patients with prostate cancer constituted the largest primary cancer among TAVR patients including those with metastatic disease. There were no significant race or geographic disparities for TAVR mortality. DISCUSSION: Comparison of aortic valve intervention in patients with and without cancer suggests that interventions are underutilized in the cancer population. This study suggests that patients with cancer including those with metastasis have similar inpatient outcomes to patients without cancer. Further, patients who have symptomatic AS and those with higher risk aortic valve disease should be offered the benefit of intervention. Modern techniques have reduced intervention-related adverse events, provided improved quality of life, and appear to be cost effective; these advantages should not necessarily be denied to patients with co-existing cancer.

Catastrophic Cardiac Events During Transcatheter Aortic Valve Replacement.

BACKGROUND: Perioperative complications of transcatheter aortic valve replacement (TAVR) are decreasing but can be catastrophic when they occur. Systematic reports of the nature of these events are lacking in the contemporary era. Our study aimed to report the incidence, outcomes, and perioperative management of catastrophic cardiac events in patients undergoing TAVR and to propose a working strategy to address these complications. METHODS: This is a retrospective cohort study of patients who developed catastrophic cardiac events during or immediately after TAVR between 2015 and 2019 at a single academic centre. RESULTS: Of 2102 patients who underwent TAVR, 51 (2.5%) developed catastrophic cardiac events. The causes included cardiac perforation and tamponade (n = 19, 37.3%), acute left- ventricular failure (n = 10, 19.6%), coronary artery obstruction (n = 10, 19.6%), aortic-root disruption (n = 7, 13.7%), and device embolization (n = 5, 9.8%). Twenty-four patients (47.0%) with catastrophic cardiac events required stabilization by either intra-aortic balloon counter-pulsation or extracorporeal membrane oxygenation. The in-hospital mortality rate increased by 11.7-fold for patients with catastrophic cardiac events compared with those without (25.5% vs 2.0%, P < 0.001). Patients who developed aortic root disruption had the highest mortality rate (42.8%) compared with the others. The incidence of catastrophic cardiac events remained stable over a 5-year period, but the associated mortality decreased from 38.5% in 2015 to 9.1% in 2019. CONCLUSIONS: Catastrophic cardiac events during TAVR are rare, but they account for a dramatic increase in perioperative mortality. Early recognition and development of a standardized perioperative team approach can help manage patients experiencing these complications.

Decreasing Rates of Acute Kidney Injury After Percutaneous Coronary Interventions Through Education and Standardized Order Sets in a Large Tertiary Teaching Center.

Acute kidney injury (AKI) is a common complication of percutaneous coronary interventions (PCI), and it is associated with increased morbidity, mortality, and healthcare costs. Post-PCI AKI is a major quality outcome measured by the National Cardiovascular Data Registry for hospitals that perform PCI. We report the experience of a large, tertiary center with high standardized, post-PCI AKI rates in which we implemented multilevel interventions that included: (1) a multidisciplinary education module for all personnel involved in care of patients undergoing cardiac angiography, (2) a standardized electronic medical record based preprocedure hydration protocol order set for patients undergoing cardiac angiography, and (3) a hydration task list to be completed by the care team the evening before the procedure or prior to admission. All this resulted in a constant decrease of the post-PCI AKI rates in remarkable magnitude, significantly stronger than the national tendency, demonstrating a center-specific behavior.

Delirium Among Hospitalized Older Adults With Acute Heart Failure Exacerbation.

BACKGROUND: Delirium among older adults hospitalized with acute heart failure is associated with increased mortality. However, studies concomitantly assessing the association of delirium with both clinical and economic outcomes in this population, such as mortality, hospital cost, or length of stay, are lacking. METHODS AND RESULTS: We conducted a retrospective observational study using National Inpatient Sample data from 2011 to 2014. Using multivariable logistic regression, we assessed the association of delirium with in-hospital mortality, then estimated the incremental hospital cost and excessive length of stay adjusting for demographic and clinical factors using multivariable generalized linear regression. The association of other medical complications on clinical and economic outcomes was also assessed. A total of 568,565 (weighted N = 2,826,131) hospitalizations of patients 65 years or older with acute heart failure from 2011 to 2014 were included in the final analysis. The reported prevalence of delirium was 4.53%. After multivariable adjustment, delirium was associated with a 2.35-fold increase in the odds of in-hospital mortality (95% confidence interval [CI] 2.23-2.47), which was lower than the odds ratio for sepsis/septicemia (5.36; 95% CI, 5.02-5.72) or respiratory failure (4.53; 95% CI, 4.38-4.69), but similar to that for acute kidney injury (2.39; 95% CI, 2.31-2.48) and higher than for non-ST elevation myocardial infarct (1.57; 95% CI, 1.46-1.68). Delirium increased the total hospital cost by $4,262 (95% CI, $4,002-4,521) and the length of stay by 1.73 days (95% CI, 1.68-1.78), which was slightly lower than, but similar to, acute kidney injury ($4,771; 95% CI, $4,644-4,897) and 1.82 days (95% CI, 1.79-1.84), and higher than non-ST elevation myocardial infarct ($1,907; 95% CI, $1,629-2,185) and 0.31 days (95% CI, 0.25-0.37). CONCLUSIONS: Delirium was associated with increased in-hospital mortality, total hospital cost, and length of stay, and the magnitude of the effect was similar to that for acute kidney injury. Enhanced efforts to prevent delirium are needed to decrease its adverse impact on clinical and economic outcomes for hospitalized older adults with acute heart failure.

Outcomes of Patients Undergoing Transcatheter Aortic Valve Implantation With Incidentally Discovered Masses on Computed Tomography.

Routine preprocedural chest and abdomen computed tomography is done prior to transcatheter aortic valve implantation (TAVI), which, in turn, have led to the discovery of radiographic potentially malignant incidental masses (pMIM). It is largely unknown whether pMIM impact the outcomes of patients undergoing TAVI. In this retrospective cohort study from a single center, 1,081 patients underwent TAVI from 2012 to 2016, who had available computed tomographies, survived the index hospitalization, and also had 1 year follow-up data for review. Machine learning (backward propagation neural network)-augmented multivariable regression for mortality by pMIM was conducted. In this cohort of 1,081 patients, the mean age was 79.1 (± 9.0), 48.8% were females, 16.8% had a history of prior malignancy, and 21.1% had pMIM. One-year mortality for the entire cohort was 12.6%. The most common prior malignancies were prostate, breast, and lymphoma and the most common pMIM were present in the lung, kidneys, and thyroid. In a fully adjusted regression analysis, neither prior malignancy nor pMIM increased mortality odds. However, having both was associated with a higher 1-year mortality (odds ratio 4.02, 95% confidence interval 1.50 to 10.73, p = 0.006). In conclusion, presence of pMIM alone was not associated with an increased 1-year mortality among patients undergoing TAVI. However, the presence of pMIM and a history of prior malignancy was associated with a significant increase in 1-year mortality.

Controversies on the Cusp: Anomalous Origin of the Left Coronary Artery From the Non-Coronary Cusp.

Anomalous origin of the left coronary artery from the non-coronary cusp (LCANCC) is extremely rare and its prognosis and management are still controversial. We present two cases of symptomatic women with LCANCC and a comprehensive review of 19 studies reporting the prevalence, presentation, and management of LCANCC among 174,262 patients. Despite case reports of LCANCC in the pediatric population suggest a much worse prognosis, the optimal risk-stratification scheme for this type of anomaly in adults is yet to be defined, and it should not necessarily be considered a benign condition solely based on its anatomic origin or lack of an interarterial course.

Demographics, Procedural Characteristics, and Clinical Outcomes When Cardiogenic Shock Precedes TAVR in the United States.

OBJECTIVES: This paper details trends and outcomes in U.S. patients undergoing transcatheter aortic valve replacement (TAVR) who present pre-procedurally with cardiogenic shock. BACKGROUND: Demographic, procedural characteristics, and clinical outcomes in U.S. patients undergoing TAVR after presenting with cardiogenic shock are unknown. METHODS: The STS/ACC TVT (Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy) registry linked with Centers for Medicare & Medicaid Services claims data was used to identify patients between 2014 and 2017 who presented with cardiogenic shock before TAVR in comparison to a high-risk cohort that did not present with cardiogenic shock. The primary outcome of interest was 30-day mortality. Secondary outcomes included 30-day procedural complications. RESULTS: Presentations with cardiogenic shock currently represent 4.1% of the U.S. TAVR population. A total of 2,220 patients with acute cardiogenic shock undergoing TAVR (median STS 9.8) were compared with 12,851 high-risk patients (median STS 10.2). Cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%) and higher rates of complications. The absence of 30-day major complications was not associated with a marked reduction in 30-day mortality, and overall procedural success rates were high. The risk of death from acute cardiogenic shock before TAVR was strongly related to the degree of shock pre-procedure. CONCLUSIONS: TAVR appears to be a viable treatment option for patients presenting with aortic stenosis and acute cardiogenic shock. Although procedural success is high, this population remains at an elevated risk of death, which appears to be mostly driven by the degree of pre-procedural shock.

Validation of scoring system predicting permanent pacemaker implantation after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with severe aortic stenosis. Despite newer generation valves, atrioventricular (AV) conduction disturbance is a common complication, necessitating permanent pacemaker (PPM) implantation in about 10% of patients. Hence, it is imperative to improve periprocedural risk stratification to predict PPM implantation after TAVR. The objective of this study was to externally validate a novel risk-stratification model derived from the National Inpatient Sample (NIS) database that predicts risk of PPM from TAVR. METHODS: Components of the score included pre-TAVR left and right bundle branch block, sinus bradycardia, second-degree AV block, and transfemoral approach. The scoring system was applied to 917 patients undergoing TAVR at our institution from November 2011 to February 2017. We assessed its predictive accuracy by looking at two components: discrimination using the C-statistic and calibration using the Hosmer-Lemeshow goodness of fit test. RESULTS: Ninety patients (9.8%) required PPM. The scoring system showed good discrimination with C-statistic score of 0.6743 (95% CI: 0.618-0.729). Higher scores suggested increased PPM risk, that is, 7.3% with score ⩽3, 19.23% with score 4-6, and 37.50% with score ≥7. Patients requiring PPM were older (81.4 versus 78.7 years, P = .002). Length of stay and in-hospital mortality was significantly higher in PPM group. CONCLUSIONS: The NIS database derived PPM risk prediction model was successfully validated in our database with acceptable discriminative and gradation capacity. It is a simple but valuable tool for patient counseling pre-TAVR and in identifying high-risk patients.

Massive TAVR: Complex Transcatheter Aortic Valve Replacement in the Setting of an Enormous Adnexal Mass.

A 65-year-old woman with a large adnexal mass was found to have severe bicuspid aortic valve stenosis. Transcatheter aortic valve replacement was chosen rather than surgical aortic valve replacement because of concerns over risks. We demonstrate the value of pre-operative transcatheter aortic valve replacement before prompt noncardiac surgery. Furthermore, it illustrates some useful bailout techniques in this challenging scenario. (Level of Difficulty: Intermediate.).

Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement.

BACKGROUND: Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS: In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS: A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS: In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).

The cardiac arrest survival score: A predictive algorithm for in-hospital mortality after out-of-hospital cardiac arrest.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is associated with high mortality. Current methods for predicting mortality post-arrest require data unavailable at the time of initial medical contact. We created and validated a risk prediction model for patients experiencing OHCA who achieved return of spontaneous circulation (ROSC) which relies only on objective information routinely obtained at first medical contact. METHODS: We performed a retrospective evaluation of 14,892 OHCA patients in a large metropolitan cardiac arrest registry, of which 3952 patients had usable data. This population was divided into a derivation cohort (n = 2,635) and a verification cohort (n = 1,317) in a 2:1 ratio. Backward stepwise logistic regression was used to identify baseline factors independently associated with death after sustained ROSC in the derivation cohort. The cardiac arrest survival score (CASS) was created from the model and its association with in-hospital mortality was examined in both the derivation and verification cohorts. RESULTS: Baseline characteristics of the derivation and verification cohorts were not different. The final CASS model included age >75 years (odds ratio [OR] = 1.61, confidence interval [CI][1.30-1.99], p < 0.001), unwitnessed arrest (OR = 1.95, CI[1.58-2.40], p < 0.001), home arrest (OR = 1.28, CI[1.07-1.53], p = 0.008), absence of bystander CPR (OR = 1.35, CI[1.12-1.64], p = 0.003), and non-shockable initial rhythm (OR = 3.81, CI[3.19-4.56], p < 0.001). The area under the curve for the model derivation and model verification cohorts were 0.7172 and 0.7081, respectively. CONCLUSION: CASS accurately predicts mortality in OHCA patients. The model uses only binary, objective clinical data routinely obtained at first medical contact. Early risk stratification may allow identification of more patients in whom timely and aggressive invasive management may improve outcomes.

Outcomes of Acute Myocardial Infarction in Patients with Influenza and Other Viral Respiratory Infections.

BACKGROUND: Acute influenza infection can trigger acute myocardial infarction, however, outcome of patients with acute myocardial infarction during influenza infection is largely unknown. METHODS: Patients ≥18 years old with ST-elevation and non-ST-elevation myocardial infarction during January 2013-December 2014 were identified using the National Inpatient Sample. The clinical outcomes were compared among patients who had no respiratory infection to the ones with influenza and other viral respiratory infections using propensity score-matched analysis. RESULTS: Of 1,884,985 admissions for acute myocardial infarction, acute influenza and other viral infections were diagnosed in 9,885 and 11,485 patients, respectively, accounting for 1.1% of patients. Acute myocardial infarction patients with concomitant influenza infection had a worse outcome than those with acute myocardial infarction alone, in terms of in-hospital case fatality rate, development of shock, acute respiratory failure, acute kidney injury, and higher rate of blood transfusion after propensity scores. The length of stay is also significantly longer in influenza patients with acute myocardial infarction, compared with patients with acute myocardial infarction alone. However, patients who developed acute myocardial infarction during other viral respiratory infection have a higher rate of acute respiratory failure but overall lower mortality rate, and are less likely to develop shock or require blood transfusion after propensity match. Despite presenting with acute myocardial infarction, less than one-fourth of patients with concomitant influenza infection underwent coronary angiography, but more than half (51.4%) required revascularization. CONCLUSION: Influenza infection is associated with worse outcomes in acute myocardial infarction patients, and patients were less likely to receive further evaluation with invasive coronary angiography.