Trends in transcatheter and surgical aortic valve replacement in the United States, 2008-2018.

We conducted a retrospective study using the NIS database from 2008 to 2018 to examine the most contemporary national hospitalization trends of transcatheter (TAVR) and surgical (SAVR) aortic valve replacement regarding volume, patient and hospital demographics and economics, resource utilization, total cost of stay, and in-hospital mortality. We demonstrate that TAVR procedures have been performed on a slow by steadily diversifying patient population while volume has grown significantly, while in-hospital mortality, length of stay, discharge home, and costs have improved, whereas these metrics have generally remained stable for SAVR. These trends will likely drive continued TAVR adoption, greatly expanding the overall aortic stenosis patient population eligible for AVR.

The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial.

BACKGROUND: It remains unclear why depression is associated with adverse outcomes in patients with heart failure (HF). We examine the relationship between depression and clinical outcomes among patients with HF with reduced ejection fraction managed with guideline-directed medical therapy (GDMT). METHODS AND RESULTS: Using the GUIDE-IT trial, 894 patients with HF with reduced ejection fraction were stratified according to a history of depression, and Cox proportional hazards regression modeling was used to examine the association with outcomes. There were 140 patients (16%) in the overall cohort who had depression. They tended to be female (29% vs 46%, P < .001) and White (67% vs 53%, P = .002). There were no differences in GDMT rates at baseline or at 90 days; nor were there differences in target doses of these therapies achieved at 90 days (NS, all). amino-terminal pro-B-type natriuretic peptide levels at all time points were similar between the cohorts (P > .05, all). After adjustment, depression was associated with all-cause hospitalizations (hazard ratio, 1.42, 95% confidence interval 1.11-1.81, P < .01), cardiovascular death (hazard ratio, 1.69, 95% confidence interval 1.07-2.68, P = .025), and all-cause mortality (hazard ratio, 1.54, 95% confidence interval 1.03-2.32, P = .039). CONCLUSIONS: Depression impacts clinical outcomes in HF regardless of GDMT intensity and amino-terminal pro-B-type natriuretic peptide levels. This finding underscores the need for a focus on mental health in parallel to achievement of optimal GDMT in these patients. TRIAL REGISTRATION: NCT01685840, https://clinicaltrials.gov/ct2/show/NCT01685840.

Impact of chronic lung disease on quality-of-life outcomes in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: As the symptoms for both chronic lung disease (CLD) and aortic stenosis (AS) frequently overlap, it may be challenging to determine the degree of symptomatic improvement expected for a patient with CLD after correction of AS. Our aim was to determine if patients with CLD have the same degree of quality-of-life improvement following transcatheter aortic valve replacement (TAVR) as patients without CLD. METHODS: A retrospective review of 238 TAVR patients from January 2017 to November 2018 who underwent preoperative pulmonary function tests and completed 30-day follow-up was performed. Patients were identified as having CLD with FEV1 more than 75% predicted. Postoperative outcomes and changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) were compared between groups. RESULTS: Of the 238 patients identified, 143 (60.0%) had CLD, 50 (35.0%) of whom had an obstructive disease pattern. Patients with CLD were more likely to be male, had higher rates of peripheral artery disease, and had lower baseline ejection fraction. There was no difference in STS Predicted Risk of Mortality, but patients with CLD were more likely to be designated as high-risk by surgeon evaluation. While initial and follow-up KCCQ-12 was lower for patients with CLD, there was no significant difference in degree of improvement (p = .900). When comparing patients with obstructive lung disease (FEV1/FVC < 0.70) to those without CLD, there was also no significant difference in the change of quality of life (p = .720). CONCLUSION: Although patients with concomitant severe AS and CLD have reduced baseline quality of life compared to patients without CLD, they experience a comparable degree of improvement following TAVR.

The impact of trainees' working hour regulations on outcome in CABG and valve surgery in the State of New York.

BACKGROUND AND AIM: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) restricted the first-year residents' duty-hour to less than 16-hour shifts, decreased the maximum shift duration for senior residents, and increased minimum time off after on-call duties. Whether these changes may have impacted the outcomes in cardiac surgery remains unclear. METHODS: We performed a difference-in-difference analysis of the New York State Cardiac Surgery Reporting System data in 2004-2006 (before the duty-hour policies change) and 2014-2016 (after the change). We evaluated differences in 30-day risk-adjusted mortality rates (RAMR) in coronary artery bypass grafting (CABG) and valve surgeries, stratifying data by hospital type: teaching hospitals (TH) versus nonteaching hospitals (NTH). NTH served as the control not affected by the duty-hour policies. RESULTS: (1) The overall surgical volume for CABG surgery has decreased over time (37,645-24,991), while the volume for valve surgery remained similar (20,969-21,532); (2) TH had better short-term outcomes for CABG procedures during 2014-2016 (median RAMR: 1.01% vs. 1.55% in TH vs. NTH, respectively; p = .025) as well as for valve procedures during both 2004-2006 (5.16% vs. 7.49%, p = .020) and 2014-2016 (2.59% vs. 4.09%, p = .033); (3) at difference-in-difference analysis, trainees' duty-hour regulations were not associated with worsening short-term outcomes in both CABG (p = .296) and valve (p = .651) procedures performed in TH. CONCLUSION: The introduction of the 2011 trainees' duty-hour regulations was not associated with worse short-term outcomes for CABG and valve surgery performed in the State of NY by TH.

Relationship of surgeon experience and outcomes of surgery for degenerative mitral valve disease.

OBJECTIVE: To assess the impact of surgeon experience on the outcomes of degenerative mitral valve disease. METHODS: We reviewed all patients who had surgery for degenerative mitral valve disease between 2011 and 2016. Experienced surgeon was defined as performing ≥ 25 mitral valve operations/year. Patient characteristics and outcomes were compared. Competing risk analysis was performed to identify factors associated with mitral regurgitation (MR) recurrence. Survival analysis for mortality was done using Kaplan Meier curve and Cox proportional hazard method. RESULTS: There were 575 patients treated by 9 surgeons for severe MR caused by degenerative mitral valve disease between 2011 and 2016. Three experienced surgeons performed 77.2% of the operations. Patients treated by less experienced surgeons had worse comorbidity profile and were more likely to have an urgent or emergent operation (p = .001). Experienced surgeons were more likely to attempt repair (p = .024), to succeed in repair (94.7% vs. 87%; p = .001), had shorter cross-clamp times (p = .001), and achieved higher repair rate (81.3% vs. 69.7%; p = .005). Experienced surgeons were more likely to use neochordae (p = .001) and less likely to use chordae transfer (p = .001). Surgeon experience was not associated with recurrence of moderate or higher degree of MR after repair but was an independent risk factor for mortality (HR = 2.64; p = .002). CONCLUSIONS: Techniques of degenerative mitral valve surgery differ with surgeon experience, with higher rates of repair and better outcomes associated with more experienced surgeons.

Variants of the aortic arch in adult general population and their association with thoracic aortic aneurysm disease.

BACKGROUND: Query a single institution computed tomography (CT) database to assess the prevalence of aortic arch anomalies in general adult population and their potential association with thoracic aortopathies. METHODS: CT chest scan reports of patients aged 50-85 years old performed for any indication at a single health system between 2013 and 2016 were included in the analysis. Characteristics of patients with and without aortic arch anomalies were compared by t test and Fisher exact tests. Logistic regression analysis was performed to assess for independent risk factors of thoracic aortic aneurysm (TAA). RESULTS: Of 21,336 CT scans, 603 (2.8%) described arch anomalies. Bovine arch (n = 354, 58.7%) was the most common diagnosis. Patients with arch anomalies were more likely to be female (p < .001), non-Caucasian(p < .001), and hypertensive (p < .001). Prevalence of TAA in arch anomalies group was 10.8% (n = 65) compared to 4.1% (n = 844) in the nonarch anomaly cohort (p < .001). The highest prevalence of thoracic aneurysm was associated with right-sided arch combined with aberrant left subclavian configuration (33%), followed by bovine arch (13%), and aberrant right subclavian artery (8.2%). On binary logistic regression, arch anomaly (OR = 2.85 [2.16-3.75]), aortic valve pathology (OR 2.93 [2.31-3.73]), male sex (OR 2.38 [2.01-2.80]), and hypertension (OR 1.47 [1.25-1.73]) were significantly associated with increased risk of thoracic aneurysm disease. CONCLUSIONS: Reported prevalence of aortic arch anomalies by CT imaging in the older adult population is approximately 3%, with high association of TAA (OR = 2.85) incidence in this subgroup. This may warrant a more tailored surveillance strategy for aneurysm disease in this subpopulation.

United States national trends in comorbidity and outcomes of adult cardiac surgery patients.

BACKGROUND: Comorbidity profiles of cardiac surgery patients are known to have changed over time, but modern national trends in these comorbidities and outcomes are not described. This study describes comorbidity trends over time for common adult cardiac surgery procedures. METHODS: A retrospective, cross-sectional analysis of the National Inpatient Sample was conducted for years 2005-2014. Hospitalizations with coronary artery bypass grafting (CABG), aortic valve replacement (AVR), and mitral valve repair/replacement (MVRR), as well as combined CABG/valve operations, were identified by ICD-9 procedure codes. Comorbidities were defined based on ICD-9 codes to discriminate between comorbidities and complications. Surgical volume, patient age, in-hospital mortality, and length of stay trends over time were evaluated by linear regression. RESULTS: Incidence increased for AVR, MVRR, and CABG + AVR and declined for CABG and CABG + MVRR (P < .001). The mean number of comorbidities across all surgeries increased from 1.4 to 1.9 (P < .001). Length of stay declined for AVR, CABG + AVR, and CABG + MVRR (P < .001) with an overall decline from 10.1 to 9.7 days (P = .003). In-hospital mortality decreased in all categories over time (P < .001). Overall, in-hospital mortality decreased from 2.9% to 2.3% (P < .001). CONCLUSIONS: Despite increasing comorbidity in cardiac surgery, operations are being conducted with fewer in-hospital mortalities across all types of surgery and decreasing length of stay for most types of surgery, which should inform the frequency of risk model updates and raise questions of the applicability of earlier studies in cardiac surgery to the modern population.

Drug use associated tricuspid valve infective endocarditis in pregnancy.

BACKGROUND AND AIM: We report a case of intravenous drug use associated tricuspid valve endocarditis in a 28-year-old pregnant female at 26-week gestation. METHODS: Patient management required a multidisciplinary collaboration between cardiac surgery, obstetrics and gynecology, and neonatal critical care. RESULTS: Despite appropriate intravenous antibiotics, the patient developed life-threatening complications and underwent planned cesarean delivery at 28 weeks 6 days gestation followed by interval tricuspid valve replacement 1 week later. CONCLUSIONS: Both the patient and her infant were successfully managed through the perioperative period.

Pediatric thymectomy: a study of national trends in demographics, short-term outcomes, and cost.

BACKGROUND: Thymectomy in pediatric patients is an effective treatment for myasthenia gravis (MG), thymic neoplasms, and other rarer pathologies. It is an uncommon procedure in children and studies have focused on small, single-institution cohorts. We sought to better characterize its use by utilizing a national database. METHODS: The Kids' Inpatient Database was used to identify hospital discharge records of patients ≤ 20 years old who underwent thymectomy. A retrospective cross-sectional analysis for 2003, 2006, 2009, and 2012 was performed. Trends in patient characteristics, diagnosis, surgical approach, and short-term outcomes were analyzed. Risk factors were identified using univariate and multivariate analyses. RESULTS: There were 600 thymectomies identified. MG was the most common indication. Thoracoscopy is being used increasingly for all diagnoses except malignancy. The overall morbidity rate was 14.0%, with respiratory complications representing the largest group. No in-hospital deaths were identified. Private insurance was associated with shorter hospital stays and lower costs. Hispanic race was associated with more complications, longer stays, and higher costs. Thoracoscopic thymectomies had shorter stays than open procedures. CONCLUSION: Thymectomy in the pediatric population is being performed safely, with low morbidity and no identified mortalities. Thoracoscopy results in reduced length of stay and is being used increasingly. Of note, socioeconomic and racial factors impact outcomes.

Broad blockade antibody responses in human volunteers after immunization with a multivalent norovirus VLP candidate vaccine: immunological analyses from a phase I clinical trial.

BACKGROUND: Human noroviruses (NoVs) are the primary cause of acute gastroenteritis and are characterized by antigenic variation between genogroups and genotypes and antigenic drift of strains within the predominant GII.4 genotype. In the context of this diversity, an effective NoV vaccine must elicit broadly protective immunity. We used an antibody (Ab) binding blockade assay to measure the potential cross-strain protection provided by a multivalent NoV virus-like particle (VLP) candidate vaccine in human volunteers. METHODS AND FINDINGS: Sera from ten human volunteers immunized with a multivalent NoV VLP vaccine (genotypes GI.1/GII.4) were analyzed for IgG and Ab blockade of VLP interaction with carbohydrate ligand, a potential correlate of protective immunity to NoV infection and illness. Immunization resulted in rapid rises in IgG and blockade Ab titers against both vaccine components and additional VLPs representing diverse strains and genotypes not represented in the vaccine. Importantly, vaccination induced blockade Ab to two novel GII.4 strains not in circulation at the time of vaccination or sample collection. GII.4 cross-reactive blockade Ab titers were more potent than responses against non-GII.4 VLPs, suggesting that previous exposure history to this dominant circulating genotype may impact the vaccine Ab response. Further, antigenic cartography indicated that vaccination preferentially activated preexisting Ab responses to epitopes associated with GII.4.1997. Study interpretations may be limited by the relevance of the surrogate neutralization assay and the number of immunized participants evaluated. CONCLUSIONS: Vaccination with a multivalent NoV VLP vaccine induces a broadly blocking Ab response to multiple epitopes within vaccine and non-vaccine NoV strains and to novel antigenic variants not yet circulating at the time of vaccination. These data reveal new information about complex NoV immune responses to both natural exposure and to vaccination, and support the potential feasibility of an efficacious multivalent NoV VLP vaccine for future use in human populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01168401.

Double Papillary Muscle Relocation: A Totally Endoscopic, Robotic-Assisted Approach.

We detail our technique for totally endoscopic, robotic-assisted mitral valve repair with the reimplantation of a ruptured papillary muscle head supported by double papillary muscle relocation and mitral annuloplasty for the treatment of nonacute ischemic mitral regurgitation.

Totally endoscopic, robotic-assisted tricuspid valve repair with neochords.

We describe our technique for totally endoscopic, robotic-assisted tricuspid valve repair with neochords and annuloplasty in a high-risk, obese patient.

Clinical implications of Type 2 diabetes on outcomes after cardiac transplantation.

BACKGROUND: T2D is an increasingly common disease that is associated with worse outcomes in patients with heart failure. Despite this, no contemporary study has assessed its impact on heart transplantation outcomes. This paper examines the demographics and outcomes of patients with type 2 diabetes (T2D) undergoing heart transplantation. METHODS: Using the United Network for Organ Sharing (UNOS) database, patients listed for transplant were separated into cohorts based on history of T2D. Demographics and comorbidities were compared, and cox regressions were used to examine outcomes. RESULTS: Between January 1st, 2011 and June 12th, 2020, we identified 9,086 patients with T2D and 23,676 without T2D listed for transplant. The proportion of patients with T2D increased from 25.2% to 27.9% between 2011 and 2020. Patients with T2D were older, more likely to be male, less likely to be White, and more likely to pay with public insurance (p<0.001, all). After adjustment, T2D patients had a lower likelihood of transplantation (Hazard Ratio [HR]: 0.93, CI: 0.90-0.96, p<0.001) and a higher likelihood of post-transplant mortality (HR: 1.30, CI: 1.20-1.40, p<0.001). Patients with T2D were more likely to be transplanted in the new allocation system compared to the old allocation system (all, p<0.001). CONCLUSIONS: Over the last ten years, the proportion of heart transplant recipients with T2D has increased. These patients are more likely to be from traditionally underserved populations. Patients with T2D have a lower likelihood of transplantation and a higher likelihood of post-transplant mortality. After the allocation system change, likelihood of transplantation has improved for patients with T2D.

Redo mitral valve surgery: A totally endoscopic, robotic-assisted approach for adhesiolysis and complex repair.

We describe our technique for totally endoscopic, robotic-assisted thoracic and pericardial adhesiolysis and redo complex mitral valve repair.

Association between coronary artery bypass graft center volume and year-to-year outcome variability: New York and California statewide analysis.

OBJECTIVE: We evaluated whether volume-based, rather than time-based, annual reporting of center outcomes for coronary artery bypass grafting may improve inference of quality, assuming that large center-level year-to-year outcome variability is related to statistical noise. METHODS: We analyzed 2012 to 2016 data on isolated coronary artery bypass grafting using statewide outcome reports from New York and California. Annual changes in center-level observed-to-expected mortality ratio represented stability of year-to-year outcomes. Cubic spline fit related the annual observed-to-expected ratio change and center volume. Volume above the inflection point of the spline curve indicated centers with low year-to-year change in outcome. We compared observed-to-expected ratio changes between centers below and above the volume threshold and observed-to-expected ratio changes between consecutive annual and biennial measurements. RESULTS: There were 155 centers with median annual volume of 89 (interquartile range, 55-160) for isolated coronary artery bypass grafting. The inflection point of observed-to-expected ratio variability was observed at 111 cases/year. Median year-to-year observed-to-expected ratio change for centers performing less than 111 cases (62 centers) was greater at 0.83 (0.26-1.59) compared with centers performing 111 cases or more (93 centers) at 0.49 (022-0.87) (P < .001). By aggregating the outcome over 2 years, centers above the 111-case threshold increased from 93 centers (60%) to 118 centers (76%), but the median observed-to-expected change for all centers was similar between annual aggregates at 0.70 (0.26-1.22) compared with observed-to-expected change between biennial aggregates at 0.54 (0.23-1.02) (P = .095). CONCLUSIONS: Center-level, risk-adjusted coronary artery bypass grafting mortality varies significantly from one year to the next. Reporting outcomes by specific case volume may complement annual reports.

Mechanical ventilation at the time of heart transplantation and associations with clinical outcomes.

AIMS: The impact of mechanical ventilation (MV) at the time of heart transplantation is not well understood. In addition, MV was recently removed as a criterion from the new US heart transplantation allocation system. We sought to assess for the association between MV at transplantation and 1-year mortality. METHODS AND RESULTS: We utilized the United Network for Organ Sharing database and included all adult, single organ heart transplantations from 1990 to 2019. We utilized multivariable logistic regression adjusting for demographics, comorbidities, and markers of clinical acuity. We identified 60 980 patients who underwent heart transplantation, 2.4% (n = 1431) of which required MV at transplantation. Ventilated patients were more likely to require temporary mechanical support, previous dialysis, and had a shorter median waitlist time (21 vs. 95 days, P < 0.001). At 1 year, the mortality was 33.7% (n = 484) for ventilated patients and 11.7% (n = 6967) for those not ventilated at the time of transplantation (log-rank P < 0.001). After multivariable adjustment, patients requiring MV continued to have a substantially higher 90-day [odds ratio (OR) 3.20, 95% confidence interval (CI): 2.79-3.66, P < 0.001] and 1-year mortality (OR 2.67, 95% CI: 2.36-3.03, P < 0.001). For those that survived to 90 days, the adjusted mortality at 1 year continued to be higher (OR 1.48, 95% CI: 1.16-1.89, P = 0.002). CONCLUSION: We found a strong association between the presence of MV at heart transplantation and 90-day and 1-year mortality. Future studies are needed to identify which patients requiring MV have reasonable outcomes, and which are associated with substantially poorer outcomes.

Brief report: Cannabis and opioid use disorder among heart failure admissions, 2008-2018.

BACKGROUND: In the United States, both cannabis use disorder (CUD) and opioid use disorder (OUD) have increased in prevalence. The prevalence, demographics, and costs of CUD and OUD are not well known in heart failure (HF) admissions. This study aimed to use a national database to examine the prevalence, demographics, and costs associated with CUD and OUD in HF. METHODS: This study used the National Inpatient Sample from 2008 to 2018 to identify all primary HF admissions with and without the co-diagnosis of OUD or CUD using International Classification for Diagnosis, diagnosis codes. Demographics, costs, and trends were examined. RESULTS: Between 2008 and 2018, we identified 11,692,995 admissions for HF of which 84,796 (0.8%) had a co-diagnosis of CUD only, and 67,137 (0.6%) had a co-diagnosis of OUD only. The proportion of HF admissions with CUD significantly increased from 0.3% in 2008 to 1.3% in 2018 (p<0.001). The proportion of HF admissions with OUD significantly increased from 0.2% in 2008 to 1.1% in 2018 (p<0.001). Patients admitted with HF and either CUD or OUD were younger, more likely to be Black, and from lower socioeconomic backgrounds (p<0.001, all). HF admissions with OUD or CUD had higher median costs compared to HF admissions without associated substance abuse diagnoses ($8,611 vs. $8,337 for CUD HF and $10,019 vs. $8,337 for OUD HF, p<0.001 for both). CONCLUSIONS: Among discharge records for HF, CUD and OUD are increasing in prevalence, significantly affect underserved populations and are associated with higher costs of stay. Future research is essential to better delineate the cause of these increased costs and create interventions, particularly in underserved populations.

Impact of the new heart allocation policy on patients with restrictive, hypertrophic, or congenital cardiomyopathies.

BACKGROUND: Patients with restrictive or hypertrophic cardiomyopathy (RCM/HCM) and congenital heart disease (CHD) do not derive clinical benefit from inotropes and mechanical circulatory support. Concerns were expressed that the new heart allocation system implemented in October 2018 would disadvantage these patients. This paper aimed to examine the impact of the new adult heart allocation system on transplantation and outcomes among patients with RCM/HCM/CHD. METHODS: We identified adult patients with RCM/HCM/CHD in the United Network for Organ Sharing (UNOS) database who were listed for or received a cardiac transplant from April 2017-June 2020. The cohort was separated into those listed before and after allocation system changes. Demographics and recipient characteristics, donor characteristics, waitlist survival, and post-transplantation outcomes were analyzed. RESULTS: The number of patients listed for RCM/HCM/CHD increased after the allocation system change from 429 to 517. Prior to the change, the majority RCM/HCM/CHD patients were Status 1A at time of transplantation; afterwards, most were Status 2. Wait times decreased significantly for all: RCM (41 days vs 27 days; P<0.05), HCM (55 days vs 38 days; P<0.05), CHD (81 days vs 49 days; P<0.05). Distance traveled increased for all: RCM (76 mi. vs 261 mi, P<0.001), HCM (88 mi. vs 231 mi. P<0.001), CHD (114 mi vs 199 mi, P<0.05). Rates of transplantation were higher for RCM and CHD (P<0.01), whereas post-transplant survival remained unchanged. CONCLUSIONS: The new allocation system has had a positive impact on time to transplantation of patients with RCM, HCM, and CHD without negatively influencing survival.