Incidence, characteristics, and outcomes of reintervention after mitral transcatheter edge-to-edge repair.

OBJECTIVE: The use of transcatheter edge-to-edge repair (TEER) is growing substantially, and reintervention after TEER by way of repeat TEER or mitral valve surgery (MVS) is increasing as a result. In this nationally representative study we examined the incidence, characteristics, and outcomes of reintervention after index TEER. METHODS: Between July 2013 and November 2017, we reviewed 11,396 patients who underwent index TEER using Medicare beneficiary data. These patients were prospectively tracked and identified as having repeat TEER or MVS. Primary outcomes included 30-day mortality, 30-day readmission, 30-day composite morbidity, and cumulative survival. RESULTS: Among 11,396 patients who underwent TEER, 548 patients (4.8%) required reintervention after a median time interval of 4.5 months. Overall 30-day mortality was 8.6%, 30-day readmission was 20.9%, and 30-day composite morbidity was 48.2%. According to reintervention type, 294 (53.7%) patients underwent repeat TEER, and 254 (46.3%) underwent MVS. Patients who underwent MVS were more likely to be younger and female, but had a similar comorbidity burden compared with the repeat TEER cohort. After adjustment, there were no differences in 30-day mortality (adjusted odds ratio [AOR], 1.26 [95% CI, 0.65-2.45]) or 30-day readmission (AOR, 1.14 [95% CI, 0.72-1.81]). MVS was associated with higher 30-day morbidity (AOR, 4.76 [95% CI, 3.17-7.14]) compared with repeat TEER. Requirement for reintervention was an independent risk factor for long-term mortality in a Cox proportional hazard model (hazard ratio, 3.26 [95% CI, 2.53-4.20]). CONCLUSIONS: Reintervention after index TEER is a high-risk procedure that carries a significant mortality burden. This highlights the importance of ensuring procedural success for index TEER to avoid the morbidity of reintervention altogether.

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves.

BACKGROUND: The relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients. METHODS: All patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed. RESULTS: A total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05). CONCLUSIONS: In this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: In some patients, the alternative access route for transcatheter aortic valve replacement (TAVR) is utilized because the conventional transfemoral approach is not felt to be either feasible or optimal. However, accurate prognostication of patient risks is not well established. This study examines the associations between peripheral (transsubclavian/transaxillary, and transcarotid) versus central access (transapical and transaortic) in alternative access TAVR and 30-day and 1-year end points of mortality and stroke for all valve platforms. METHODS: Using data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry with linkage to Medicare claims, patients who underwent alternative access TAVR from June 1, 2015 to June 30, 2018 were identified. Adjusted and unadjusted Cox proportional hazards modeling were performed to determine the association between alternate access TAVR site and 30-day and 1-year end points of mortality and stroke. RESULTS: Of 7187 alternative access TAVR patients, 3725 (52%) had peripheral access and 3462 (48%) had central access. All-cause mortality was significantly lower in peripheral access versus central access group at in-hospital and 1 year (2.9% versus 6.3% and 20.3% versus 26.6%, respectively), but stroke rates were higher (5.0% versus 2.8% and 7.3% versus 5.5%, respectively; all P<0.001). These results persisted after 1-year adjustment (death adjusted hazard ratio, 0.72 [95% CI, 0.62-0.85] and stroke adjusted hazard ratio, 2.92 [95% CI, 2.21-3.85]). When broken down by individual subtypes, compared with transaxillary/subclavian access patients, transapical, and transaortic access patients had higher all-cause mortality but less stroke (P<0.05). CONCLUSIONS: In this real-world, contemporary, nationally representative benchmarking study of alternate access TAVR sites, peripheral access was associated with favorable mortality and morbidity outcomes compared with central access, at the expense of higher stroke. These findings may allow for accurate prognostication of risk for patient counseling and decision-making for the heart team with regard to alternative access TAVR.

Ninety-Day Risk-Standardized Home Time as a Performance Metric for Cardiac Surgery Hospitals in the United States.

BACKGROUND: Assessing hospital performance for cardiac surgery necessitates consistent and valid care quality metrics. The association of hospital-level risk-standardized home time for cardiac surgeries with other performance metrics such as mortality rate, readmission rate, and annual surgical volume has not been evaluated previously. METHODS: The study included Medicare beneficiaries who underwent isolated or concomitant coronary artery bypass graft, aortic valve, or mitral valve surgery from January 1, 2013, to October 1, 2019. Hospital-level performance metrics of annual surgical volume, 90-day risk-standardized mortality rate, 90-day risk-standardized readmission rate, and 90-day risk-standardized home time were estimated starting from the day of surgery using generalized linear mixed models with a random intercept for the hospital. Correlations between the performance metrics were assessed using the Pearson correlation coefficient. Patient-level clinical outcomes were also compared across hospital quartiles by 90-day risk-standardized home time. Last, the temporal stability of performance metrics for each hospital during the study years was also assessed. RESULTS: Overall, 919 698 patients (age 74.2±5.8 years, 32% women) were included from 1179 hospitals. Median 90-day risk-standardized home time was 71.2 days (25th-75th percentile, 66.5-75.6), 90-day risk-standardized readmission rate was 26.0% (19.5%-35.7%), and 90-day risk-standardized mortality rate was 6.0% (4.0%-8.8%). Across 90-day home time quartiles, a graded decline was observed in the rates of in-hospital, 90-day, and 1-year mortality, and 90-day and 1-year readmission. Ninety-day home time had a significant positive correlation with annual surgical volume (r=0.31; P<0.001) and inverse correlation with 90-day risk-standardized readmission rate (r=-0.40; P <0.001) and 90-day risk-standardized mortality rate (r=-0.60; P <0.001). Use of 90-day home time as a performance metric resulted in a meaningful reclassification in performance ranking of 22.8% hospitals compared with annual surgical volume, 11.6% compared with 90-day risk-standardized mortality rate, and 19.9% compared with 90-day risk-standardized readmission rate. Across the 7 years of the study period, 90-day home time demonstrated the most temporal stability of the hospital performance metrics. CONCLUSIONS: Ninety-day risk-standardized home time is a feasible, comprehensive, patient-centered metric to assess hospital-level performance in cardiac surgery with greater temporal stability than mortality and readmission measures.

The impact of hospital size on national trends and outcomes in isolated open proximal aortic surgery.

OBJECTIVE: To determine the impact of hospital size on national trend estimates of isolated open proximal aortic surgery for benchmarking hospital performance. METHODS: Patients age >18 years who underwent isolated open proximal aortic surgery for aneurysm and dissection from 2002 to 2014 were identified using the National Inpatient Sample. Concomitant valvular, vessel revascularization, re-do procedures, endovascular, and surgery for descending and thoracoabdominal aorta were excluded. Discharges were stratified by hospital size and analyzed using trend, multivariable regression, propensity-score matching analysis. RESULTS: Over a 13-year period, 53,657 isolated open proximal aortic operations were performed nationally. Although the total number of operations/year increased (∼2.9%/year increase) and overall in-hospital mortality decreased (∼4%/year; both P < .001 for trend), these did not differ by hospital size (P > .05). Large hospitals treated more sicker and older patients but had shorter length of stay and lower hospital costs (both P < .001). Even after propensity-score matching, large hospital continued to demonstrate superior in-hospital outcomes, although only statistically for major in-hospital cardiac complications compared with non-large hospitals. In our subgroup analysis of dissection versus non-dissection cohort, in-hospital mortality trends decreased only in the non-dissection cohort (P < .01) versus dissection cohort (P = .39), driven primarily by the impact of large hospitals (P < .01). CONCLUSIONS: This study demonstrates increasing volume and improving outcomes of isolated open proximal aortic surgeries nationally over the last decade regardless of hospital bed size. Moreover, the resource allocation of sicker patients to larger hospital resulted shorter length of stay and hospital costs, while maintaining similar operative mortality to small- and medium-sized hospitals.

The Sky Is Not Falling: Surgical Perspectives on a New Transcatheter Paradigm.

The role of cardiac surgeons in the treatment of aortic valve disease is changing with the expansion of transcatheter aortic valve replacement. Recent trials in patients at low surgical risk will further this paradigm shift, and the future cardiac surgeons in this space remain uncertain. In this Viewpoint article, we discuss the role that surgeons can play in the future of structural heart medicine. We examine the potential effects of the low-risk transcatheter aortic valve replacement trials on overall operative volumes and how these effects may be limited through structured training programs and strong collaboration within the heart team. Finally, future considerations and cautions for the cardiac surgical community are discussed. The coming era presents an opportunity for growth, leadership, and strong interdisciplinary collaboration for the cardiac surgery community.

Incidence, Characteristics, Predictors, and Outcomes of Surgical Explantation After Transcatheter Aortic Valve Replacement.

BACKGROUND: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database. METHODS: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis. RESULTS: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05). CONCLUSIONS: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.

Quantifying the Impact of Care Fragmentation on Outcomes After Transcatheter Aortic Valve Implantation.

The Center for Medicare & Medicaid Services has identified readmission as an important quality metric in assessing hospital performance and value of care. The aim of this study was to quantify the impact of "care fragmentation" on transcatheter aortic valve implantation (TAVI) outcomes. Readmission to nonindex hospitals was defined as any hospital other than the hospital where the TAVI was performed. In this multicenter, population-based, nationally representative study, a nationally weighted cohort of US adult patients who underwent TAVI in the National Readmission Database between 01/01/2010 and 9/31/2015 were analyzed. Patient characteristics, trends, and outcomes after 90-day nonindex readmission were evaluated. Thirty-day metric was used as a reference group for comparison. A weighted total of 51,092 patients met inclusion criteria. Overall, the 90-day readmission rate after TAVI was 27.6% (30-day reference group: 17.4%), and 42% of these readmissions were to nonindex hospitals. Noncardiac causes accounted for most nonindex readmissions, but major cardiac procedures were more likely performed at index hospitals during readmission within 90 days. Despite the high co-morbidity burden of patients readmitted to nonindex hospitals, unadjusted and risk-adjusted all-cause mortality, readmission length of stay and total hospital costs following nonindex readmission were lower compared with index readmission at 90 days. In conclusion, in this real world, nationally representative cohort of TAVI patients in the United States, care fragmentation remains prevalent and represent an enduring, residual target for future health policies. Although the impactful readmissions may be directed toward index hospitals, concerted efforts are needed to address mechanisms that increase care fragmentation.

Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes.

AIMS: We sought to perform a head-to-head comparison of contemporary 30-day outcomes and readmissions between valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) patients and a matched cohort of high-risk reoperative surgical aortic valve replacement (re-SAVR) patients using a large, multicentre, national database. METHODS AND RESULTS: We utilized the nationally weighted 2012-16 National Readmission Database claims to identify all US adult patients with degenerated bioprosthetic aortic valves who underwent either VIV-TAVR (n = 3443) or isolated re-SAVR (n = 3372). Thirty-day outcomes were compared using multivariate analysis and propensity score matching (1:1). Unadjusted, VIV-TAVR patients had significantly lower 30-day mortality (2.7% vs. 5.0%), 30-day morbidity (66.4% vs. 79%), and rates of major bleeding (35.8% vs. 50%). On multivariable analysis, re-SAVR was a significant risk factor for both 30-day mortality [adjusted odds ratio (aOR) of VIV-SAVR (vs. re-SAVR) 0.48, 95% confidence interval (CI) 0.28-0.81] and 30-day morbidity [aOR for VIV-TAVR (vs. re-SAVR) 0.54, 95% CI 0.43-0.68]. After matching (n = 2181 matched pairs), VIV-TAVR was associated with lower odds of 30-day mortality (OR 0.41, 95% CI 0.23-0.74), 30-day morbidity (OR 0.53, 95% CI 0.43-0.72), and major bleeding (OR 0.66, 95% CI 0.51-0.85). Valve-in-valve TAVR was also associated with shorter length of stay (median savings of 2 days, 95% CI 1.3-2.7) and higher odds of routine home discharges (OR 2.11, 95% CI 1.61-2.78) compared to re-SAVR. CONCLUSION: In this large, nationwide study of matched high-risk patients with degenerated bioprosthetic aortic valves, VIV-TAVR appears to confer an advantage over re-SAVR in terms of 30-day mortality, morbidity, and bleeding complications. Further studies are warranted to benchmark in low- and intermediate-risk patients and to adequately assess longer-term efficacy.

Benchmarking the value of care: Variability in hospital costs for common operations and its association with procedure volume.

BACKGROUND: Efforts to improve health care value (quality/cost) have become a priority in the United States. Although many seek to increase quality by reducing variability in adverse outcomes, less is known about variability in costs. In conjunction with the American Association for the Surgery of Trauma Healthcare Economics Committee, the objective of this study was to examine the extent of variability in total hospital costs for two common procedures: laparoscopic appendectomy (LA) and laparoscopic cholecystectomy (LC). METHODS: Nationally weighted data for adults 18 years and older was obtained for patients undergoing each operation in the 2014 and 2016 National Inpatient Sample. Data were aggregated at the hospital-level to attain hospital-specific median index hospital costs in 2019 US dollars and corresponding annual procedure volumes. Cost variation was assessed using caterpillar plots and risk-standardized observed/expected cost ratios. Correlation analysis, variance decomposition, and regression analysis explored costs' association with volume. RESULTS: In 2016, 1,563 hospitals representing 86,170 LA and 2,276 hospitals representing 230,120 LC met the inclusion criteria. In 2014, the numbers were similar (1,602 and 2,259 hospitals). Compared with a mean of US $10,202, LA median costs ranged from US $2,850 to US $33,381. Laparoscopic cholecystectomy median costs ranged from US $4,406 to US $40,585 with a mean of US $12,567. Differences in cost strongly associated with procedure volume. Volume accounted for 9.9% (LA) and 12.4% (LC) of variation between hospitals, after controlling for the influence of other hospital (8.2% and 5.0%) and patient (6.3% and 3.7%) characteristics and in-hospital complications (0.8% and 0.4%). Counterfactual modeling suggests that were all hospitals to have performed at or below their expected median cost, one would see a national cost savings of greater than US $301.9 million per year (95% confidence interval, US $280.6-325.5 million). CONCLUSION: Marked variability of median hospital costs for common operations exists. Differences remained consistent across changing coding structures and database years and were strongly associated with volume. Taken together, the findings suggest room for improvement in emergency general surgery and a need to address large discrepancies in an often-overlooked aspect of value. LEVEL OF EVIDENCE: Epidemiological, level III.

Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes.

OBJECTIVES: The aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes. BACKGROUND: Recent studies have demonstrated a volume-outcome relationship for TAVR. METHODS: In total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression. RESULTS: A total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure. CONCLUSIONS: Total hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.

Determining eligibility for lung transplantation: A nationwide assessment of the cutoff glomerular filtration rate.

BACKGROUND: Historical concerns about lung transplantation in patients with a glomerular filtration rate (GFR) ≤ 50 ml/min/1.73 m(2) have not been validated. We hypothesize that a pre-transplant GFR ≤ 50 ml/min/1.73 m(2) represents a high mortality risk, especially in the setting of acute GFR decline. In addition, we explore the potential for improved risk stratification using a statistically derivable alternative cutoff. METHODS: Adult, primary, lung recipients in the United Network for Organ Sharing database were analyzed (October 1987 to December 2011). Recursive partitioning identified the GFR value that provides maximal separation in 1-year mortality. Survival over/under the cutoffs was compared using stratified log-rank, Cox, and Kaplan-Meier methods, before and after 1:2 propensity score matching. RESULTS: Median GFR at time of transplant for 19,425 study patients was 94.2 ml/min/1.73 m(2) (quartile 1-quartile, 2 76.9-105.9 ml/min/1.73 m(2)). Recursive partitioning identified a GFR of 40.2 ml/min/1.73 m(2) as the ideal inflection point for predicting 1-year survival. Cutoffs demonstrated statistically significant effects on survival after 840 patients with a GFR ≤ 50 ml/min/1.73 m(2) (hazard ratio, 1.28; 95% confidence interval, 1.15-1.43) and 401 patients with a GFR ≤ 40.2 ml/min/1.73 m(2) (hazard ratio, 1.57; 95% confidence interval, 1.36-1.83) were matched with high GFR controls (p < 0.001). In 13,509 patients with available GFR at the time of listing and transplant, a pre-transplant GFR decline of ≥ 50% from baseline was associated with worse survival (p < 0.001). CONCLUSIONS: A pre-transplant GFR ≤ 50 ml/min/1.73 m(2) is associated with decreased survival. However, patients with GFR between 40 and 50 ml/min/1.73 m(2) do not suffer excessive post-transplant mortality and should not be automatically excluded from listing. Notably, outcomes are worse in patients with poor renal function and concomitant pre-transplant GFR decline. Strategies should be devised to detect and manage interval renal deterioration before lung transplantation.

Assessment of different threshold preoperative glomerular filtration rates as markers of outcomes in lung transplantation.

BACKGROUND: The evidence behind the widely used pre-lung transplant glomerular filtration rate (GFR) cutoff of 50 mL/min per 1.73 m2 is limited. This study reviews data from a large cohort to assess outcomes associated with this historical cutoff and to estimate other possible cutoffs that might be appropriate in lung transplantation. METHODS: We conducted a retrospective cohort analysis of lung recipients at a single center. Recursive partitioning and receiver operating characteristics analysis were used to estimate other potential GFR cutoffs with 1-year mortality as the outcome. Postoperative outcomes around the various cutoffs, including survival, acute kidney injury, and dialysis, were assessed using χ2, Kaplan-Meier, and Cox regression methods. RESULTS: A total of 794 lung recipients met study inclusion criteria. Compared with 778 patients with GFR 50 mL/min per 1.73 m2 or greater at time of transplant, 16 patients with GFR below this cutoff were older and more likely to have restrictive disease. One-year mortality below the cutoff was 31.3% compared with 15.1% above the cutoff (p=0.021). Recursive partitioning estimated potential GFR cutoff values between 46 and 61 mL/min per 1.73 m2. Patients with GFR below these cutoffs were at significantly higher risk for adverse outcomes (p<0.05). Receiver operating characteristics analysis was less successful at identifying meaningful cutoff values with areas under the curve approximately 0.5. CONCLUSIONS: Study results support the practice of requiring candidate GFR 50 mL/min per 1.73 m2 or greater for lung transplantation. Future work should focus on reproducing the analysis in a larger cohort of patients including more individuals with low GFR.