The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Why Are We Weighting? Understanding the Estimates From Propensity Score Weighting and Matching Methods.

BACKGROUND: Propensity score methods are used in observational studies to compensate for the lack of random allocation by balancing measured baseline characteristics between treated and untreated patients. We sought to explain the treatment effect estimates derived from different propensity score methods. METHODS: We performed a retrospective analysis of long-term mortality after single internal mammary artery versus bilateral internal mammary artery (BIMA) conduit in 47 984 index isolated coronary artery bypass grafting procedures from 1992 to 2014 in the Northern New England Cardiovascular Disease Study Group registry using multivariable Cox regression, 1:1 propensity score matching, inverse probability weighting (IPW) among the treated, and IPW among the overall population treatment estimates. RESULTS: The mean duration of follow-up was 13.2 (interquartile range, 7.4-17.7) years. In multivariable Cox regression, the adjusted hazard ratio for mortality was 0.83 (95% CI, 0.75-0.92) in patients receiving BIMA compared with a single internal mammary artery. The 1:1 propensity matched (hazard ratio, 0.79 [95% CI, 0.69-0.91]) and IPW among the treated (hazard ratio, 0.83 [95% CI, 0.75-0.92]) estimates showed a protective treatment effect of BIMA use on mortality. However, the IPW estimate of treatment effect for the overall population showed an increased risk of mortality after BIMA that was not statistically significant (hazard ratio, 1.08 [95% CI, 0.94-1.24]). CONCLUSIONS: While the multivariable Cox regression, 1:1 propensity matching, and IPW treatment effect in the treated estimates demonstrate that BIMA was associated with a statistically significantly decreased risk of mortality, the IPW treatment effect in the average study population showed an increased risk of mortality associated with BIMA that was not statistically significant. This is attributed to the different populations (weighted to look like the overall study population versus treated group) represented by the 2 IPW approaches. Determining how the study population is balanced is a large driver of the treatment effect. Ultimately, the treatment effect estimate desired should drive the choice of the propensity score method.

Multicenter experience with valve-in-valve transcatheter aortic valve replacement compared with primary, native valve transcatheter aortic valve replacement.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) offers an alternative to reoperative surgical aortic valve replacement. The short- and intermediate-term outcomes after ViV TAVR in the real world are not entirely clear. PATIENTS AND METHODS: A multicenter, retrospective analysis of a consecutive series of 121 ViV TAVR patients and 2200 patients undergoing primary native valve TAVR from 2012 to 2017 at six medical centers. The main outcome measures were in-hospital mortality, 30-day mortality, stroke, myocardial infarction, acute kidney injury, and pacemaker implantation. RESULTS: ViV patients were more likely male, younger, prior coronary artery bypass graft, "hostile chest," and urgent. 30% of the patients had Society of Thoracic Surgeons risk score <4%, 36.3% were 4%-8% and 33.8% were >8%. In both groups many patients had concomitant coronary artery disease. Median time to prosthetic failure was 9.6 years (interquartile range: 5.5-13.5 years). 82% of failed surgical valves were size 21, 23, or 25 mm. Access was 91% femoral. After ViV, 87% had none or trivial aortic regurgitation. Mean gradients were <20 mmHg in 54.6%, 20-29 mmHg in 30.6%, 30-39 mmHg in 8.3% and ≥40 mmHg in 5.87%. Median length of stay was 4 days. In-hospital mortality was 0%. 30-day mortality was 0% in ViV and 3.7% in native TAVR. There was no difference in in-hospital mortality, postprocedure myocardial infarction, stroke, or acute kidney injury. CONCLUSION: Compared to native TAVR, ViV TAVR has similar peri-procedural morbidity with relatively high postprocedure mean gradients. A multidisciplinary approach will help ensure patients receive the ideal therapy in the setting of structural bioprosthetic valve degeneration.

Unravelling the Difference Between Men and Women in Post-CABG Survival.

Objectives: Women have a worse prognosis after coronary artery bypass grafting (CABG) surgery compared to men. We sought to quantify to what extent this difference in post-CABG survival could be attributed to sex itself, or whether this was mediated by difference between men and women at the time of intervention. Additionally, we explored to what extent these effects were homogenous across patient subgroups. Methods: Time to all-cause mortality was available for 102,263 CABG patients, including 20,988 (21%) women, sourced through an individual participant data meta-analysis of five cohort studies. Difference between men and women in survival duration was assessed using Kaplan-Meier estimates, and Cox's proportional hazards model. Results: During a median follow-up of 5 years, 13,598 (13%) patients died, with women more likely to die than men: female HR 1.20 (95%CI 1.16; 1.25). We found that differences in patient characteristics at the time of CABG procedure mediated this sex effect, and accounting for these resulted in a neutral female HR 0.98 (95%CI 0.94; 1.02). Next we performed a priori defined subgroup analyses of the five most prominent mediators: age, creatinine, peripheral vascular disease, type 2 diabetes, and heart failure. We found that women without peripheral vascular disease (PVD) or women aged 70+, survived longer than men (interaction p-values 0.04 and 6 × 10-5, respectively), with an effect reversal in younger women. Conclusion: Sex differences in post-CABG survival were readily explained by difference in patient characteristics and comorbidities. Pre-planned analyses revealed patient subgroups (aged 70+, or without PVD) of women that survived longer than men, and a subgroup of younger women with comparatively poorer survival.

The National Cardiovascular Data Registry Data Quality Program 2020: JACC State-of-the-Art Review.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use.

Concordance of Guideline-Based Risk Stratification and Selection of Patients for Transcatheter Aortic Valve Implantation or Surgical Replacement.

The 2020 American Health Association/American College of Cardiology valve guidelines recommend surgical aortic valve replacement (SAVR) for symptomatic patients with aortic stenosis (AS) age <65 years and transcatheter aortic valve implantation (TAVI) for patients with AS age >80 years. We analyzed TAVI versus SAVR practice patterns using age-based recommendations. We compared 2016-to-2019 TAVI and isolated SAVR in northern New England at 5 centers according to guideline-recommended age groups. Multivariable logistic regression was performed to identify independent predictors of TAVI for the intermediate age group. The study was approved by each site's institutional review board in accordance with ongoing participation and quality improvement efforts in the Northern New England Cardiovascular Study Group. Among 4,161 patients with isolated severe AS, TAVI increased from 2016 to 2019: 55.8% versus 76.1%, p <0.01 for trend. SAVR for patients with AS age >80 years was uncommon and decreased over time: 13.1% versus 1.6%, p <0.01. TAVI utilization nearly doubled over time in young patients with AS age <65 years (14.3% vs 26.2%, p <0.01). Preference for SAVR decreased by 50% over time (p <0.01) in the intermediate age group (65 to 80 years). Independent predictors of TAVI among patients aged 65 to 80 years included older age, chronic obstructive pulmonary disease, previous stroke, and coronary artery bypass grafting, whereas vascular disease and clinical urgency favored SAVR. In conclusion, consistent with current American Health Association/American College of Cardiology guidelines, TAVI was the treatment of choice in >97% of severe patients with AS age >80 years by 2019. TAVI utilization in patients <65 years has doubled over time and thus may not reflect current guideline recommendations. TAVI is the preferred choice in those aged 65 to 80 years, especially among patients with previous stroke or coronary artery bypass grafting.

Comparative effectiveness of revascularization strategies for early coronary artery disease: A multicenter analysis.

OBJECTIVES: The goal of this analysis was to examine the comparative effectiveness of coronary artery bypass grafting versus percutaneous coronary intervention among patients aged less than 60 years. METHODS: We performed a multicenter, retrospective analysis of all cardiac revascularization procedures from 2005 to 2015 among 7 medical centers. Inclusion criteria were age less than 60 years and 70% stenosis or greater in 1 or more major coronary artery distribution. Exclusion criteria were left main 50% or greater, ST-elevation myocardial infarction, emergency status, and prior revascularization procedure. After applying inclusion and exclusion criteria, the final study cohort included 1945 patients who underwent cardiac surgery and 2938 patients who underwent percutaneous coronary intervention. The primary end point was all-cause mortality stratified by revascularization strategy. Secondary end points included stroke, repeat revascularization, and 30-day mortality. We used inverse probability weighting to balance differences among the groups. RESULTS: After adjustment, there was no significant difference in 30-day mortality (surgery: 0.8%; percutaneous coronary intervention: 0.7%, P = .86) for patients with multivessel disease. Patients undergoing surgery had a higher risk of stroke (1.3% [n = 25] vs 0.07% [n = 2], P < .001). Overall, surgery was associated with superior 10-year survival compared with percutaneous coronary intervention (hazard ratio, 0.71; 95% confidence interval, 0.57-0.88; P = .002). Repeat procedures occurred in 13.4% (n = 270) of the surgery group and 36.4% (n = 1068) of the percutaneous coronary intervention group, with both groups mostly undergoing percutaneous coronary intervention as their second operation. Accounting for death as a competing risk, at 10 years, surgery resulted in a lower cumulative incidence of repeat revascularization compared with percutaneous coronary intervention (subdistribution hazard ratio, 0.34; 95% confidence interval, 0.28-0.40; P < .001). CONCLUSIONS: Among patients aged less than 60 years with 2-vessel disease that includes the left anterior descending or 3-vessel coronary artery disease, surgery was associated with greater long-term survival and decreased risk of repeat revascularization.

Decade Long Temporal Trends in Revascularization for Patients With Diabetes Mellitus (From the Northern New England Cardiovascular Disease Study Group).

The FREEDOM trial demonstrated superiority of coronary artery bypass grafting (CABG) for patients with diabetes mellitus (DM) and multivessel coronary artery disease (MV CAD) as compared to percutaneous coronary intervention (PCI) with drug eluting stent (PCI-DES). We sought to study the impact of the FREEDOM trial on clinical practice. We studied trends in the use of CABG vs. PCI and factors associated with revascularization strategy among 6,985 patients with concomitant CAD and MV CAD at 7 centers pre- and post-trial (2008-2012 vs. 2013-2017) as well as hospital outcomes. Multivariable mixed effects logistic regression was performed to identify risk factors associated with choice of revascularization strategy among the patients with 3-vessel CAD (3V CAD). 41% of patients had 3V CAD and 18% were ≥75 years of age. While PCI-DES was the preferred strategy in 2-vessel CAD (2V CAD), 72% of patients with 3V CAD underwent CABG. For patients with 3V CAD, the ratio of CABG to PCI-DES procedures was 2.47 over the decade and did not differ pre- and post-trial (adjusted odds ratio (OR) for CABG (vs. PCI) 1.01, 95% confidence interval (CI) 0.84-1.20). Independent risk factors of CABG among patients with DM and 3V CAD included peripheral arterial disease and absence of prior myocardial infarction and prior PCI. The risk factors for PCI were female sex (OR 0.60, 95% CI 0.50-0.73, p<0.001) and age ≥75 (OR 0.50, 95% CI 0.35-0.72, p<0.001). Center based variability was observed for CABG vs. PCI (center effect, rho=14%, p<0.001). In conclusion, PCI-DES is the preferred strategy for DM patients with MV CAD. Yet, among those with 3V CAD, CABG was chosen in ¾ of patients with no change in clinical practice related to the publication of the FREEDOM trial.

Cardiology providers' recommendations for treatments and use of patient decision aids for multivessel coronary artery disease.

BACKGROUND: Rates of recommending percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) vary across clinicians. Whether clinicians agree on preferred treatment options for multivessel coronary artery disease patients has not been well studied. METHODS AND RESULTS: We distributed a survey to 104 clinicians from the Northern New England Cardiovascular Study Group through email and at a regional meeting with 88 (84.6%) responses. The survey described three clinical vignettes of multivessel coronary artery disease patients. For each patient vignette participants selected appropriate treatment options and whether they would use a patient decision aid. The likelihood of choosing PCI only or PCI/CABG over CABG only was modeled using a multinomial regression. Across all vignettes, participants selected CABG only as an appropriate treatment option 24.2% of the time, PCI only 25.4% of the time, and both CABG or PCI as appropriate treatment options 50.4% of the time. Surgeons were less likely to choose PCI over CABG (RR 0.14, 95% CI 0.03, 0.59) or both treatments over CABG only (RR 0.10, 95% CI 0.03, 0.34) relative to cardiologists. Overall, 65% of participants responded they would use a patient decision aid with each vignette. CONCLUSIONS: There is a lack of consensus on the appropriate treatment options across cardiologists and surgeons for patients with multivessel coronary artery disease. Treatment choice is influenced by both patient characteristics and clinician specialty.

Association of plasma-soluble ST2 and galectin-3 with cardiovascular events and mortality following cardiac surgery.

BACKGROUND: Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant post-operative morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) and galectin-3 (gal-3) are biomarkers of myocardial remodeling and fibrosis; however, their potential association with post-operative changes is unknown. METHODS: We measured peri-operative plasma sST2 and gal-3 levels in two prospective cohorts (TRIBE-AKI and NNE) of over 1800 patients who underwent cardiac surgery. sST2 and gal-3 levels were evaluated for association with a composite primary outcome of cardiovascular event or mortality over median follow-up periods of 3.4 and 6.0 years, respectively, for the two cohorts. Meta-analysis of hazard ratio estimates from the cohorts was performed using random effects models. RESULTS: Cohorts demonstrated event rates of 70.2 and 66.8 per 1000 person-years for the primary composite outcome. After adjustment for clinical covariates, higher post-operative sST2 and gal-3 levels were significantly associated with cardiovascular event or mortality [pooled estimate HRs: sST2 1.29 (95% CI 1.16, 1.44); gal-3 1.26 (95% CI 1.09, 1.46)]. These associations were not significantly modified by pre-operative congestive heart failure or AKI. CONCLUSIONS: Higher post-operative sST2 and gal-3 values were associated with increased incidence of cardiovascular event or mortality. These two biomarkers should be further studied for potential clinical utility for patients undergoing cardiac surgery.

Acute Kidney Recovery in Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement (from the Northern New England Cardiovascular Disease Study Group).

Acute kidney recovery (AKR) is a recently described phenomenon observed after transcatheter aortic valve replacement (TAVR) and is more frequent than acute kidney injury (AKI). To determine the incidence and predictors of AKR between surgical aortic valve replacement (SAVR) and TAVR, we examined patients with chronic kidney disease and severe aortic stenosis who underwent SAVR or TAVR procedure between 2007 and 2017; excluding age <65 or >90, dialysis, endocarditis, non-aortic valve stenosis, or patients died within 48-hours postprocedure. AKR was defined as an increase of estimated glomerular filtration rate (eGFR) >25% and AKI as decrease in eGFR >25% at discharge. Stroke, mortality, major bleeding, transfusion, and length of stay were examined. Multivariate logistic regression analysis was used to examine predictors of AKR. There were 750 transcatheter and 1,062 surgical patients and 319 pairs after propensity matching. AKR was observed in 26% TAVR versus 23.2% SAVR, p = 0.062. Highest recovery was in patients with eGFR <30 for both TAVR (33.7%) and SAVR (34.5%) patients. Independent predictors of AKR were ejection fraction <50% (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.02 to 2.71, p = 0.042), female gender (OR 1.66, 95% CI 1.1 to 2.5, p = 0.015), and obesity (OR 1.5, 95% CI 1.04-2.3, p = 0.032). Diabetes was a negative predictor of AKR (OR 0.55, 95% CI 0.36 to 0.84, p = 0.005). AKR was associated with improved secondary clinical outcomes compared with AKI. In conclusion, AKR is a generalizable phenomenon occurring frequently and similarly among transcatheter or surgical aortic valve patients. Diabetes is a negative predictor of AKR, possibly indicative of less reversible kidney disease.

Galectin-3 as a Predictor of Long-term Survival After Isolated Coronary Artery Bypass Grafting Surgery.

BACKGROUND: Galectin-3 (Gal-3) is a well-established biomarker of adverse clinical outcomes, but its prognostic value for long-term survival after cardiac surgery is not well understood. Elevated levels of Gal-3 have been found to be remarkably associated with higher risk of death in both acute decompensated and chronic heart failure populations. Its prognostic value for long-term survival after cardiac surgery is not known. METHODS: A sample of patients contributing to the Northern New England Cardiovascular Disease Study Group Cardiac Surgery Registry from 2004 to 2007 were enrolled in a prospective biomarker cohort (N = 1690). Preoperative Gal-3 levels were measured and categorized by quartile. We used Kaplan-Meier survival analysis and Cox regression models, adjusting for variables in The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategy probability calculator to evaluate the association between elevated Gal-3 levels and survival to 6 years. RESULTS: Preoperative Gal-3 levels ranged from 1.72 to 28.89 ng/mL (mean, 8.96 ng/mL; median, 8.06 ng/mL; interquartile range, 5.42-11.08 ng/mL). Crude survival decreased by increasing quartile. After adjustment, serum levels of Gal-3 in the highest quartile of the cohort were associated with significantly decreased survival compared with the lowest quartile (hazard ratio [HR] 2.22; 95% confidence interval [CI], 1.40-3.54; P = .001). No decrease in survival was found for the middle quartiles (HR 1.36; 95% CI, 0.87-2.12; P = .177). CONCLUSIONS: A substantial association was found between elevated preoperative Gal-3 levels and risk of mortality after isolated coronary artery bypass grafting surgery. An assessment of the relationship between preoperative serum biomarkers and long-term survival can be used for risk stratification or estimating postsurgical prognosis.

The 30-Year Influence of a Regional Consortium on Quality Improvement in Cardiac Surgery.

BACKGROUND: The Northern New England Cardiovascular Disease Study Group (NNECDSG) was founded in 1987 as a regional consortium to improve cardiovascular quality in Maine, New Hampshire, and Vermont. We sought to assess the longitudinal impact of the NNECDSG on quality and cost of coronary artery bypass grafting (CABG) during the past 30 years. METHODS: Patients undergoing isolated CABG at 5 medical centers from 1987-2017 were retrospectively reviewed (n = 67,942). They were divided into 4 time periods: 1987-1999 (n = 36,885), 2000-2005 (n = 14,606), 2006-2011(n = 8470), and 2012-2017 (n = 7981). The first period was the time the NNECDSG initiated a series of quality improvement initiatives including data feedback, quality improvement training, process mapping, and site visits. RESULTS: Throughout the 4 time intervals, there was a consistent decline in in-hospital mortality, from 3.4% to 1.8% despite an increase in predicted risk of mortality (P < .001), and a significant decline in in-hospital morbidity, including return to the operating room for bleeding, acute kidney injury, mediastinitis, and low output failure (P < .001). Median length of stay decreased from 7 to 5 days (P < .001), which translated into potential savings of $82,722,023. There was a decrease in use of red blood cells from 3.1 units to 2.6 units per patient in the most current time, which translated into potential savings of $1,985,456. CONCLUSIONS: By using collaborative quality improvement initiatives, the NNECDSG has succeeded in significant, sustained improvements in quality and cost for CABG during the past 30 years. These data support the utility of a regional consortium in improving quality.

Cardiac Biomarkers Predict Long-term Survival After Cardiac Surgery.

BACKGROUND: Cardiac biomarkers soluble ST-2 (sST-2) and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) may be associated with long-term survival after cardiac surgery. This study explored the relationship between long-term survival after cardiac surgery and serum biomarker levels. METHODS: Patients undergoing cardiac surgery from 2004 to 2007 were enrolled in a prospective biomarker cohort in the Northern New England Cardiovascular Disease Study Group Registry. Preoperative serum biomarker levels, postoperative serum biomarker levels, and the change in serum biomarker levels were categorized by quartile. The study used Kaplan-Meier survival analysis and Cox regression models adjusted for variables in the American College of Cardiology Foundation-Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategy (ASCERT) long-term survival calculator to study the association of biomarker levels with long-term survival. After Kaplan-Meier analysis, quartiles 2 and 3 were found to have similar survival and were therefore combined into 1 category. RESULTS: In the study cohort (n = 1648), median follow-up time was 8.5 years (interquartile range, 7.6-9.7 years), during which there were 227 deaths. The 10-year survival rate was 86%. Kaplan-Meier survival analysis demonstrated a significant (P < .001) difference across quartiles of each biomarker level measurement. After adjustment, preoperative levels, postoperative levels, and the change in biomarker levels in quartile 4 (highest serum levels or change) were significantly predictive of worse survival (hazard ratio range, 1.77-2.89; all P < .05) compared with quartile 1; however, levels of sST-2 and NT-proBNP in quartiles 2 and 3 demonstrated a nonstatistically significant trend with long-term survival. CONCLUSIONS: Elevated preoperative and postoperative levels of sST-2 or NT-proBNP and large changes in these biomarkers' levels are associated with an increased risk of worse survival after cardiac surgery. These biomarkers can be used for risk stratification or assessing postsurgical prognosis.

A multi-center analysis of readmission after cardiac surgery: Experience of The Northern New England Cardiovascular Disease Study Group.

BACKGROUND: Readmissions after cardiac surgery are common and associated with increased morbidity, mortality and cost of care. Policymakers have targeted coronary artery bypass grafting to achieve value-oriented health care milestones. We explored the causes of readmission following cardiac surgery among a regional consortium of hospitals. METHODS: Using administrative data, we identified patients readmitted to the same institution within 30 days of cardiac surgery. We performed standardized review of readmitted patients' medical records to identify primary and secondary causes of readmission. We evaluated causes of readmission by procedure and tested for univariate associations between characteristics of readmitted patients and nonreadmitted patients in our clinical registry. RESULTS: Of 2218 cardiac surgery patients, 272 were readmitted to the index hospital within 30 days for a readmission rate of 12.3%. Median time to readmission was 9 days (interquartile range 4-16 days) and only 13% of patients were evaluated in-office before readmission. Readmitted patients were more likely to have had valve surgery (31.3% vs 22.7%) than patients not readmitted. Readmitted patients were also more likely to have preoperative creatinine more than or equal to 2 mg/dL (P = .015) or congestive heart failure (CHF) (P = .034), require multiple blood transfusions or sustained inotropic support (P < .001), and experience postoperative atrial fibrillation (P = .022) or renal insufficiency (P < .001). Infection (26%), pleural or pericardial effusion (19%), arrhythmia (16%), and CHF (11%) were the most common primary etiologies leading to readmission. CONCLUSIONS: Ensuring early follow-up for high-risk patient groups while improving early detection and management of the principal drivers of readmission represent promising targets for decreasing readmission rates.

Tissue versus mechanical aortic valve replacement in younger patients: A multicenter analysis.

OBJECTIVE: The goal of this study was to examine the long-term survival of patients between the ages of 50 and 65 years who underwent tissue versus mechanical aortic valve replacement (AVR) in a multicenter cohort. METHODS: A multicenter, retrospective analysis of all AVR patients (n = 9388) from 1991 to 2015 among 7 medical centers reporting to a prospectively maintained clinical registry was conducted. Inclusion criteria were: patients aged 50 to 65 years who underwent isolated AVR. Baseline comorbidities were balanced using inverse probability weighting for a study cohort of 1449 AVRs: 840 tissue and 609 mechanical. The primary end point of the analysis was all-cause mortality. Secondary end points included in-hospital morbidity, 30-day mortality, length of stay, and risk of reoperation. RESULTS: During the study period, there was a significant shift from mechanical to tissue valves (P < .001). There was no significant difference in major in-hospital morbidity, mortality, or length of hospitalization. Also, there was no significant difference in adjusted 15-year survival between mechanical versus tissue valves (hazard ratio, 0.87; 95% confidence interval [CI], 0.67-1.13; P = .29), although tissue valves were associated with a higher risk of reoperation with a cumulative incidence of 19.1% (95% CI, 14.4%-24.3%) versus 3.0% (95% CI, 1.7%-4.9%) for mechanical valves. The reoperative 30-day mortality rate was 2.4% (n = 2) for the series. CONCLUSIONS: Among patients 50 to 65 years old who underwent AVR, there was no difference in adjusted long-term survival according to prosthesis type, but tissue valves were associated with a higher risk of reoperation.

The Association between Cytokines and 365-Day Readmission or Mortality in Adult Cardiac Surgery.

Cardiac surgery results in a multifactorial systemic inflammatory response with inflammatory cytokines, such as interleukin-10 and 6 (IL-10 and IL-6), shown to have potential in the prediction of adverse outcomes including readmission or mortality. This study sought to measure the association between IL-6 and IL-10 levels and 1-year hospital readmission or mortality following cardiac surgery. Plasma biomarkers IL-6 and IL-10 were measured in 1,047 patients discharged alive after isolated coronary artery bypass graft surgery from eight medical centers participating in the Northern New England Cardiovascular Disease Study Group between 2004 and 2007. Readmission status and mortality were ascertained using Medicare, state all-payer claims, and the National Death Index. We evaluated the association between preoperative and postoperative cytokines and 1-year readmission or mortality using Kaplan-Meier estimates and Cox's proportional hazards modeling, adjusting for covariates used in the Society of Thoracic Surgeons 30-day readmission model. The median follow-up time was 1 year. After adjustment, patients in the highest tertile of postoperative IL-6 values had a significantly increased risk of readmission or death within 1 year (HR: 1.38; 95% CI: 1.03-1.85), and an increased risk of death within 1 year of discharge (HR: 4.88; 95% CI: 1.26-18.85) compared with patients in the lowest tertile. However, postoperative IL-10 levels, although increasing through tertiles, were not found to be significantly associated independently with 1-year readmission or mortality (HR: 1.25; 95% CI: .93-1.69). Pro-inflammatory cytokine IL-6 and anti-inflammatory cytokine IL-10 may be postoperative markers of cardiac injury, and IL-6, specifically, shows promise in predicting readmission and mortality following cardiac surgery.

Surgical Atrial Fibrillation Ablation Improves Long-Term Survival: A Multicenter Analysis.

BACKGROUND: The Society of Thoracic Surgeons guidelines recommend surgical ablation (SA) at the time of concomitant mitral operations, aortic valve replacement, coronary artery bypass grafting (CABG), and aortic valve replacement plus CABG for patients in atrial fibrillation (AF). The goal of this analysis was to assess the influence of SA on long-term survival. METHODS: A retrospective analysis of 20,407 consecutive CABG or valve procedures from 2008 to 2015 among seven centers reporting to a prospectively maintained clinical registry was conducted. Patients undergoing operation with documented preoperative AF were included (n = 2,740). Patients receiving SA were compared with patients receiving no SA. The primary end point was all-cause mortality. Secondary end points included in-hospital morbidity and mortality. RESULTS: The frequency of SA was 23.1% (n = 634), and an increase was seen in the rate of SA over the study period (p < 0.001). Concomitant SA was performed in 16.2% of CABG, 30.6% of valve, and 24.3% of valve plus CABG procedures. A substantial improvement was found in unadjusted survival among patients undergoing SA (hazard ratio 0.54, 95% confidence interval: 0.42 to 0.70). Moreover, no differences were found in postoperative complications. SA did have longer bypass times (p < 0.001) but a shorter overall length of stay (p < 0.001). After risk adjustment, SA patients had an improved 5-year survival (hazard ratio 0.69, 95% confidence interval: 0.51 to 0.92), and the effect was observed across all operations. CONCLUSIONS: In a multicenter cohort of patients with AF, concomitant SA resulted in substantially improved long-term survival across patients who underwent CABG, valve, and valve plus CABG. These findings support current guidelines from The Society of Thoracic Surgeons that recommend broader application of concomitant SA.

Intensity of Glycemic Control Affects Long-Term Survival After Coronary Artery Bypass Graft Surgery.

BACKGROUND: A patient's hemoglobin (Hb) A1c level, regardless of diabetic status, is a measure of glycemic control. Studies have found it is an independent predictor of short-term death in patients undergoing coronary artery bypass grafting (CABG). In this study, we used preoperative HbA1c to assess whether levels are associated with short-term and long-term survival after CABG. METHODS: From a regional registry of consecutive cases, we identified 6,415 patients undergoing on-pump isolated CABG from 2008 to 2015 with documented preoperative HbA1c level. We defined four HbA1c groups: less than 5.7% (n = 1,713), 5.7% to 6.4% (n = 2,505), 6.5% to 8.0% (n = 1,377), and more than 8% (n = 820). Relationship to in-hospital outcomes and long-term survival was assessed. Outcome rates and hazard ratios were adjusted for patient and disease risk factors using multivariable logistic regression and Cox models. RESULTS: The study included 3,740 patients (58%) not diagnosed as having diabetes and 2,674 with diabetes. Prediabetes (HbA1c 5.7% to 6.4%) was documented in 52% (n = 1,933) of nondiabetic patients. Higher HbA1c values were associated with younger age, female sex, greater body mass index, more comorbid diseases, lower ejection fraction, more 3-vessel coronary disease, and recent myocardial infarction (p < 0.05 trend for all). After adjustment for patient risk, greater HbA1c values were not associated with higher rates of in-hospital death or morbidity. Long-term survival was significantly worse as HbA1c increased. Risk of death increased by 13% for every unit increase in HbA1c (adjusted hazard ratio, 1.13; 95% confidence interval, 1.07 to 1.19; p < 0.001). CONCLUSIONS: Preadmission glycemic control, as assessed by HbA1c, is predictive of long-term survival, with higher levels associated with poorer prognosis. Whether this risk can be modified by better glycemic control postoperatively remains to be determined.

The efficacy and safety of pulmonary vasodilators in patients with Fontan circulation: a meta-analysis of randomized controlled trials.

No previous meta-analysis has evaluated the efficacy and safety of pulmonary vasodilators in Fontan physiology. Recent relative trials have obtained conflicting results regarding improvements in peak oxygen consumption; the relatively small number of patients in each study may be a limiting factor. We aimed to evaluate the efficacy and safety of pulmonary vasodilators in Fontan patients. Relevant studies were identified by searching the PubMed, Embase, and Cochrane Library databases. Pooled outcomes were determined to assess the efficacy and safety of pulmonary vasodilators in Fontan patients. Nine randomized controlled studies involving 381 patients with Fontan circulation were included. Pulmonary vasodilator therapy led to significant improvement (mean difference = -0.39, 95% CI: [-0.72, -0.05]) in the New York Heart Association (NYHA) functional class. The 6-minute walking distance (6MWD) was significantly increased by 134 m (95% CI: [86.07, 181.94]), and the peak VO2 was also significantly improved (mean difference = 1.42 ml·(kg·min)-1, 95% CI: [0.21, 2.63]). Additionally, the mean pulmonary artery pressure (mPAP) was significantly reduced (mean difference = -2.25 mmHg, 95% CI: [-3.00, -1.50]). No significant change was found in mortality or in brain natriuretic peptide (BNP) or N-terminal pronatriuretic peptide (NT-proBNP). Four studies reported no side effects and good drug tolerance, and two studies reported mild adverse effects. The present meta-analysis indicated that pulmonary vasodilators (primarily the PDE-5 inhibitor and endothelin-1 receptor antagonist) significantly improved the hemodynamics of Fontan patients, reduced the NYHA functional class and increased the 6MWD. The peak oxygen consumption was also improved. No significant change was observed in mortality or in the BNP or NT-proBNP level. Overall, the pulmonary vasodilators were well tolerated. This finding needs to be confirmed in future studies.