Abstract
Background
With recent approval of transcatheter tricuspid valve (TV) interventions for high/prohibitive surgical risk patients, understanding the long-term outcomes of isolated TV surgery has become increasingly relevant.
Objectives
The objective of the study was to evaluate longitudinal outcomes and health care costs of isolated surgical TV surgery to provide a potential benchmark for emerging transcatheter therapies.
Methods
Using the U.S. fee-for-service Medicare database, we evaluated longitudinal outcomes of all beneficiaries undergoing isolated TV repair or replacement (TVR) from 2018 to 2022. Patients with endocarditis were excluded. A claims-based, frailty-inclusive multivariable logistic regression model of predicted in-hospital mortality was developed (optimism-corrected area under the receiver-operating characteristic curve = 0.870). Patients were stratified by low (<4%), intermediate (4% to 8%), or high (>8%) predicated risk of surgical mortality. Kaplan-Meier and Fine Gray methods were used for time to event analysis.
Results
A total of 3,437 patients underwent isolated TVR (n = 1,285) or TV repair (n = 2,152). In-hospital mortality was higher for TVR (8.1% vs 5.3%; P = 0.001). Most patients (71.0%) were low risk, 9.0% intermediate, and 20.0% high risk. Three-year survival was significantly higher in the low (84.9%) and intermediate (66.5%) risk groups compared to high risk (49.6%), P < 0.001. Heart failure readmission–free survival correlated with predicted risk whereas valve reintervention was low in all groups (2.5% at 3 years). Index hospitalization costs increased with predicted risk.
Conclusions
In Medicare beneficiaries undergoing isolated TV surgery, predicted operative mortality was associated with 3-year survival, heart failure readmission, and health care costs. These contemporary real-world data may inform heart team discussions and future trial designs for emerging transcatheter therapies.
Key words: Health care Cost, longitudinal outcomes, tricuspid valve surgery, TVR, TVr
Central Illustration
Recent advances in transcatheter tricuspid valve (TV) intervention (TTVI) and the completion of randomized trials, have led to the Food and Drug Administration approval of tricuspid transcatheter valve edge-to-edge repair and transcatheter TV replacement devices.1,2 To date, clinical trials have largely focused on patients at high to prohibitive surgical risk demonstrating a quality-of-life benefit compared with medical therapy. To ensure rational dispersion of these technologies, dedicated studies are needed to define the patient populations and pathologies that will benefit most with surgical vs transcatheter repair vs replacement. The recent publication of TV Academic Research Consortium guidance highlights the need for a risk and pathoanatomy based approach to stratify patients for intervention.3
The Society of Thoracic Surgeons has developed a clinical risk model to predict risk of operative mortality for patients undergoing isolated TV surgery.4 This model provides objective short-term risk stratification for patients being considered for surgical intervention and is analogous to risk scores that were originally used for clinical trials comparing transcatheter aortic valve replacement with surgery for patients with severe aortic stenosis and were subsequently incorporated in indications for device approval and reimbursement. However, contemporary longitudinal outcomes of patients undergoing isolated TV surgery remain poorly defined. This is particularly relevant given the high prevalence of medical comorbidities in patients with TV disease, which may impact long-term outcomes.
The purpose of this study was to evaluate the longitudinal outcomes of surgical tricuspid valve repair (TVr) and replacement (TVR), stratified by surgical risk, to develop benchmarks to guide the multidisciplinary heart team in determination of timing and appropriateness of therapy. These benchmarks may inform patient selection for future clinical trial enrollment. We hypothesized that low-and intermediate-risk surgical patients would have favorable longitudinal outcomes, particularly after accounting for recovery from the surgical procedure.
Methods
Patient data
Using the U.S. Centers for Medicare and Medicaid Services (CMS) fee-for-service inpatient claims database, we evaluated all beneficiaries undergoing isolated TVr or TVR between January 1, 2018, and December 31, 2022. Isolated TVr included annuloplasty (ICD-10-PCS 02UJ) in addition to the tricuspid repair codes; patients undergoing concomitant other-valve procedures or coronary artery bypass grafting were excluded. Patients with a history of endocarditis or noncontinuous enrollment in Medicare were excluded. The West Virginia University Institutional Review Board approved this study with a waiver of consent (Protocol #2210660362, 3/23/23).
Variables and definitions
Procedures were identified through diagnosis-related groups and International Classification of Diseases-10th Revision (ICD-10) Procedure Coding System codes. Variable adjudication followed the standard methodology of ICD-10 coding (Supplemental Table 1).5 The Charlson Comorbidity Index (CCI), a widely used clinical tool that predicts the 10-year mortality risk for patients based on 19 medical conditions, such as congestive heart failure (HF), diabetes, cancer, and liver disease, was used to account for comorbidities.6 Frailty status was ascertained using claims via the Johns Hopkins Clinical Frailty Index.7 This index was developed and validated using claims chosen on the basis of their correlation with the Fried index as the reference standard, predicts outcomes similarly to the Fried index, and has been used previously in claims-based studies of frailty.8 Claims for hospitalizations in the 6 months preceding the baseline visit were used to construct the frailty index. Modifiers present on admission were used to distinguish preoperative risk factors from postoperative complications out to 30 days. Total direct hospital costs and payments were assessed within the CMS fee-for-service inpatient claims database. There were no missing data, and the absence of a claim was treated as an absence of the condition.
Predicted risk score
A claims-based predicted risk of in-hospital mortality for isolated TV surgery was developed using multivariable logistic regression in 4,754 patients undergoing isolated TV surgery (Supplemental Table 2). The outcome for the prediction model was in-hospital (index admission) death. The number of patients and events at each stage of cohort construction is reported in Supplemental Table 3: of 24,232 beneficiaries undergoing TV surgery, 20,937 remained after excluding endocarditis (1,308 deaths, 6.25%), 5,688 after excluding concomitant other-valve procedures (355 deaths, 6.24%), and 4,756 after excluding concomitant coronary artery bypass grafting (246 deaths, 5.17%), yielding a model development cohort of 4,754 with 246 in-hospital deaths (5.17%). The reported fee-for-service cohort, after excluding Medicare Advantage beneficiaries, comprised 3,437 patients with 217 in-hospital deaths (6.31%). The model was fit by maximum likelihood without case weighting, oversampling, or synthetic observations; the low event rate was addressed by restricting model complexity and by internal validation with bootstrap optimism correction. The predictor panel comprised: age category, elective (vs nonelective) admission, CCI category, Claims-Based Fried Frailty Index category, gastrointestinal bleeding present on admission, malnutrition, coronary artery disease, diabetes mellitus, chronic lung disease, HF present on admission, chronic kidney disease, liver disease present on admission, obesity, type of valve management (repair vs replacement), long-term anticoagulant use, coagulopathy, cardiomyopathy, acute kidney injury (AKI), cardiogenic shock, and cardiac pacemaker at the index visit. ORs with 95% CIs were used for interpretation. A mortality risk score was created by scaling the model coefficients. Discrimination and calibration were assessed primarily by bootstrap optimism correction (500 resamples), supplemented by 20 repeats of stratified 10-fold cross-validation and 200 repeated stratified 60/20/20 train/validation/test splits; a single split was not relied on. For all downstream analyses predictions were generated by cross-fitting, so that no patient contributed to the model predicting their own outcome. In the reported cohort the apparent area under the receiver-operating characteristic curve (AUC) was 0.884 with an optimism-corrected AUC of 0.870, a calibration slope of 0.921, and calibration intercept of −0.142. Repeated 10-fold cross-validation gave an AUC of 0.867 (95% interval 0.863-0.871). Across 200 repeated splits, the median AUC was 0.865 (2.5th-97.5th percentile 0.822-0.906) on the validation sets and 0.867 (0.812-0.901) on the test sets (Supplemental Table 3, Supplemental Figure 2). The mean predicted mortality (5.4%) closely approximated observed in-hospital mortality (6.3%), and the distribution of predicted risk is summarized in Supplemental Figure 2.
Outcomes
The primary outcome was all-cause mortality through 3 years of follow-up. Secondary outcomes were in-hospital (index admission) mortality; index hospitalization complications, including AKI, major bleeding, stroke, and new pacemaker placement; all-cause readmission; readmission for HF as a primary diagnosis; readmission for valve reintervention; and health care utilization, including length of stay, index hospitalization cost, and payments for subsequent readmissions. All outcomes were obtained from the CMS fee-for-service inpatient claims database. Vital status was ascertained from the Medicare enrollment and vital status files, and readmission, complication, and reintervention outcomes were identified using ICD-10 diagnosis and procedure codes (Supplemental Table 1). Costs and payments were derived from the corresponding CMS inpatient claims.
Statistical analysis
Patients were stratified into 3 risk groups based on their predicted in-hospital mortality (<4%, 4%-8%, and >8%) to simulate clinical decision-making. Categorical variables are presented as n (%). Continuous variables were assessed for normality and are presented as mean (SD) or median (Q1, Q3) as appropriate. Because length of stay, costs, and payments were markedly right-skewed (skewness 5.3-33.7), these variables are summarized using medians with IQRs and compared across risk strata using the Kruskal-Wallis test. Univariable comparisons were performed using chi-square for categorical comparisons, whereas nonparametric tests assessed continuous variables given non-normal distribution. Time to event data are presented using Kaplan-Meier estimates or Fine-Gray time to-event analysis accounting for competing risk of death. Sensitivity analysis was performed among patients who survived at least 30 days to understand longitudinal outcomes in patients who survival the initial surgical intervention. Subgroup analysis evaluated 30 day and 1-year outcomes stratified by risk in patients undergoing isolated TVr and those undergoing isolated TVR. All patients including Medicare Advantage were evaluated for this analysis given the small sample size especially for TVr group and limited follow-up to 1-year.
Results
Patients
A total of 3,437 patients underwent isolated TVR (n = 1,285) or TVr (n = 2,152). In-hospital mortality was lower for patients undergoing TVr compared with TVR (5.3% vs 8.1%, P = 0.001). Stratification by predicted risk of index mortality indicated that 2,441 patients (71.0%) were low risk (<4% predicted operative mortality), 310 (9.0%) were intermediate risk (4% to 8%), and 686 (20.0%) were high risk (>8%). The mean predicted risk of mortality for the overall cohort was 5.4% and increased across strata 1.2%, 5.8%, and 20.3% for low, intermediate, and high risk, respectively. Patient preoperative comorbidities similarly increased with increasing risk in the overall cohort (Table 1) as well as the isolated TVr (Supplemental Table 4) and isolated TVR cohorts (Supplemental Table 5). Finally, incidence of elective admission for index procedure was inversely correlated with predicted risk (low 84.8%, intermediate 61.6%, high 41.7%, P < 0.001).
Table 1.
Overall Baseline Demographics, Comorbidities, and Outcomes
| Total (N = 3,437) | <4% (n = 2,441) | 4%-8% (n = 310) | >8% (n = 686) | P Value | |
|---|---|---|---|---|---|
| Age, y | 73.8 ± 10.9 | 74.5 ± 10.9 | 73 ± 11.1 | 72 ± 10.6 | <0.001 |
| Male | 1,458 (42.4%) | 942 (38.6%) | 150 (48.4%) | 366 (53.4%) | <0.001 |
| Race (White) | 2,882 (83.9%) | 2,077 (85.1%) | 247 (79.7%) | 558 (81.3%) | 0.006 |
| Low-risk frailty | 1,476 (42.9%) | 1,032 (42.3%) | 147 (47.4%) | 297 (43.3%) | <0.001 |
| Elective admission | 2,548 (74.1%) | 2,071 (84.8%) | 191 (61.6%) | 286 (41.7%) | <0.001 |
| Charlson score | 2.36 ± 1.34 | 2.24 ± 1.33 | 2.63 ± 1.37 | 2.68 ± 1.29 | <0.001 |
| Diabetes mellitus | 839 (24.4%) | 587 (24%) | 76 (24.5%) | 176 (25.7%) | 0.686 |
| GI bleeding, ulcer, reflux | 775 (22.5%) | 631 (25.9%) | 57 (18.4%) | 87 (12.7%) | <0.001 |
| Liver disease | 445 (12.9%) | 215 (8.81%) | 38 (12.3%) | 192 (28%) | <0.001 |
| Anemia | 763 (22.2%) | 512 (21%) | 86 (27.7%) | 165 (24.1%) | 0.011 |
| Obesity | 523 (15.2%) | 371 (15.2%) | 56 (18.1%) | 96 (14%) | 0.254 |
| Malnutrition | 465 (13.5%) | 159 (6.51%) | 60 (19.4%) | 246 (35.9%) | <0.001 |
| Chronic kidney disease | 1,487 (43.3%) | 990 (40.6%) | 178 (57.4%) | 319 (46.5%) | <0.001 |
| End-stage renal disease | 168 (4.89%) | 125 (5.12%) | 10 (3.23%) | 33 (4.81%) | 0.344 |
| Peripheral artery disease | 337 (9.81%) | 240 (9.83%) | 32 (10.3%) | 65 (9.48%) | 0.914 |
| Coronary artery disease | 1,501 (43.7%) | 1,158 (47.4%) | 132 (42.6%) | 211 (30.8%) | <0.001 |
| Chronic lung disease | 714 (20.8%) | 528 (21.6%) | 63 (20.3%) | 123 (17.9%) | 0.106 |
| Atrial fibrillation | 2,680 (78%) | 1,970 (80.7%) | 237 (76.5%) | 473 (69%) | <0.001 |
| Cancer | 145 (4.22%) | 100 (4.1%) | 13 (4.19%) | 32 (4.66%) | 0.807 |
| Cerebrovascular accident | 218 (6.34%) | 123 (5.04%) | 18 (5.81%) | 77 (11.2%) | <0.001 |
| Permanent pacemaker | 544 (15.8%) | 488 (20%) | 33 (10.6%) | 23 (3.35%) | <0.001 |
| Heart failure | 2,836 (82.5%) | 1,962 (80.4%) | 265 (85.5%) | 609 (88.8%) | <0.001 |
| Anticoagulation | 1,485 (43.2%) | 1,350 (55.3%) | 79 (25.5%) | 56 (8.16%) | <0.001 |
| Predicted mortality (%) | 5.43 ± 9.35 | 1.19 ± 0.96 | 5.8 ± 1.22 | 20.3 ± 12.1 | <0.001 |
| TV repair | 2,152 (62.6%) | 1,624 (66.5%) | 162 (52.3%) | 366 (53.4%) | <0.001 |
Values are mean ±10.9 SD or n (%).
PROM = Surgical Predicted Risk of Mortality; AKI = acute kidney injury; TV = tricuspid valve; GI = gastrointestinal.
Perioperative outcomes
Mortality at the index admission ranged from 1.5% in the low-risk cohort to 8.4% for intermediate-risk and 22.6% in the high-risk cohort (Table 2). Perioperative complications increased with escalating risk cohort including incidence of AKI, major bleeding, stroke, and new pacemaker (Table 2). Health care utilization was high for all patients, with a median length of stay of 7 days (Q1-Q3: 3-14), which increased with increasing risk (low 5, intermediate 12, high 22 days; P < 0.001). Similarly, the median index hospital total CMS cost and payments were $58,280 ($39,678-$98,622) and $55,478 ($42,903-$76,735), respectively, which increased with increasing risk (Table 2). Despite a long initial hospital length of stay, the 30-day all-cause readmission rate was 18.6% which was predominately driven by HF rehospitalization (Table 2).
Table 2.
Outcomes and Health Care Costs
| Total (N = 3,437) | <4% (n = 2,441) | 4%-8% (n = 310) | >8% (n = 686) | P Value | |
|---|---|---|---|---|---|
| Index hospitalization | |||||
| Acute kidney injury | 1,124 (32.7%) | 234 (9.59%) | 227 (73.2%) | 663 (96.6%) | <0.001 |
| Bleeding | 237 (6.9%) | 93 (3.81%) | 25 (8.06%) | 119 (17.3%) | <0.001 |
| Stroke | 52 (1.51%) | 19 (0.778%) | 4 (1.29%) | 29 (4.23%) | <0.001 |
| New pacemaker | 251 (7.3%) | 143 (5.86%) | 35 (11.3%) | 73 (10.6%) | <0.001 |
| Death | 217 (6.31%) | 36 (1.47%) | 26 (8.39%) | 155 (22.6%) | <0.001 |
| Length of stay (days) | 7 [3, 14] | 5 [1, 9] | 12 [7, 20] | 22 [13, 37] | <0.001 |
| Total index cost ($) | 58,280 [39,678, 98,622] | 49,934 [35,068, 68,498] | 78,522 [52,284, 134,925] | 149,816 [82,154, 268,616] | <0.001 |
| Total index payments ($) | 55,478 [42,903, 76,735] | 50,646 [40,155, 64,419] | 65,638 [51,205, 98,654] | 111,843 [63,074, 237,518] | <0.001 |
| 30-days | |||||
| Death | 323 (9.4%) | 71 (2.91%) | 37 (11.9%) | 215 (31.3%) | <0.001 |
| All-cause readmission | 639 (18.6%) | 413 (16.9%) | 78 (25.2%) | 148 (21.6%) | <0.001 |
| HF readmission | 542 (15.8%) | 341 (14%) | 70 (22.6%) | 131 (19.1%) | <0.001 |
| Valve reintervention | 7 (0.204%) | 6 (0.246%) | 0 (0%) | 1 (0.146%) | 0.619 |
| Stroke | 6 (0.175%) | 4 (0.164%) | 0 (0%) | 2 (0.292%) | 0.578 |
| Myocardial infarction | 28 (0.815%) | 18 (0.737%) | 3 (0.968%) | 7 (1.02%) | 0.730 |
| 1-year | |||||
| Death | 645 (18.8%) | 259 (10.6%) | 82 (26.5%) | 304 (44.3%) | <0.001 |
| All-cause readmission | 1,525 (44.4%) | 1,050 (43%) | 165 (53.2%) | 310 (45.2%) | 0.003 |
| HF readmission | 1,294 (37.6%) | 873 (35.8%) | 149 (48.1%) | 272 (39.7%) | <0.001 |
| Valve reintervention | 53 (1.54%) | 49 (2.01%) | 1 (0.323%) | 3 (0.437%) | 0.002 |
| Endocarditis | 70 (2.04%) | 40 (1.64%) | 8 (2.58%) | 22 (3.21%) | 0.029 |
| Stroke | 33 (0.96%) | 23 (0.942%) | 4 (1.29%) | 6 (0.875%) | 0.812 |
| Myocardial infarction | 92 (2.68%) | 71 (2.91%) | 9 (2.9%) | 12 (1.75%) | 0.243 |
| 3-year | |||||
| Death | 818 (23.8%) | 368 (15.1%) | 104 (33.5%) | 346 (50.4%) | <0.001 |
| All-cause readmission | 1,884 (54.8%) | 1,327 (54.4%) | 195 (62.9%) | 362 (52.8%) | 0.008 |
| HF readmission | 1,602 (46.6%) | 1,108 (45.4%) | 176 (56.8%) | 318 (46.4%) | <0.001 |
| Valve reintervention | 85 (2.47%) | 77 (3.15%) | 3 (0.968%) | 5 (0.729%) | <0.001 |
| Endocarditis | 106 (3.08%) | 62 (2.54%) | 14 (4.52%) | 30 (4.37%) | 0.015 |
| Stroke | 55 (1.6%) | 42 (1.72%) | 6 (1.94%) | 7 (1.02%) | 0.385 |
| Myocardial infarction | 155 (4.51%) | 125 (5.12%) | 10 (3.23%) | 20 (2.92%) | 0.025 |
| Readmission days | 11 [4, 26] | 10 [4, 24] | 14 [6, 29] | 15 [6, 33] | <0.001 |
| Readmission cost ($) | 38,611 [15,994, 89,895] | 35,567 [14,267, 84,174] | 41,247 [21,450, 95,999] | 49,994 [20,748, 111,315] | <0.001 |
Values are n (%) or median [Q1, Q3].
HF = heart failure.
Longitudinal outcomes
In the overall population, 1-year mortality increased with increasing predicted surgical risk with 10.6% mortality in low-risk patients (<4%) but 44.3% in the high-risk (>8%) cohort (Table 2). All-cause and HF-specific readmission was high in all risk strata with over one-third of low-risk patients having a HF readmission in the first year (Table 2).
In the overall cohort 3-year mortality was significantly lower in the low (15.1%) and intermediate (33.5%) risk groups compared to the high (50.4%) risk (Figure 1) (P < 0.001). Similarly, HF readmission highly correlated with baseline risk (P < 0.001) (Figure 2). Valve reintervention was rare in all groups (2.5% at 3 years). The median number of rehospitalization days and total inpatient readmission costs were 11 days (Q1-Q3: 4-26) and $38,611 ($15,994-$89,895), with a monotonic increase across the risk strata (Table 2).
Figure 1.
Survival in Isolated Tricuspid Valve Surgery
Kaplan-Meier survival curves for all-cause mortality stratified by predicted risk group (<4%, 4%-8%, >8%) truncated at 4 years. Log-rank, P < 0.001.
Figure 2.
Heart Failure Readmission–Free Survival in Isolated Tricuspid Valve Surgery
Kaplan-Meier survival curves for heart failure readmission free survival stratified by predicted risk group (<4%, 4%-8%, >8%) truncated at 4 years. Log-rank, P < 0.001.
Subgroup analysis of isolated TVr demonstrated similar trends with 9.2% 1-year mortality in the low-risk cohort despite high incidence of all-cause and HF rehospitalization (Table 3). Similarly, 1-year survival after isolated TVR correlated with predicted risk with patients at low risk demonstrating 8.5% mortality which increased to 41.4% in the high-risk group. All-cause and HF–specific rehospitalization at 1 year were 45.1% and 37.2% respectively, with a low incidence of valve reintervention after isolated TVR (Table 3).
Table 3.
30-Day and One-Year Outcomes Stratified by Tricuspid Valve Repair and Replacement
| Total | <4% | 4%-8% | >8% | P Value | |
|---|---|---|---|---|---|
| 30 days | |||||
| Repair | N = 2,958 | n = 2,215 | n = 257 | n = 486 | |
| Death | 194 (6.56%) | 52 (2.35%) | 27 (10.5%) | 115 (23.7%) | <0.001 |
| All-cause readmission | 493 (16.7%) | 316 (14.3%) | 64 (24.9%) | 113 (23.3%) | <0.001 |
| HF readmission | 415 (14%) | 262 (11.8%) | 55 (21.4%) | 98 (20.2%) | <0.001 |
| Valve reintervention | 8 (0.27%) | 6 (0.271%) | 0 (0%) | 2 (0.412%) | 0.590 |
| Stroke | 6 (0.203%) | 4 (0.181%) | 0 (0%) | 2 (0.412%) | 0.444 |
| Myocardial infarction | 19 (0.642%) | 14 (0.632%) | 2 (0.778%) | 3 (0.617%) | 0.959 |
| Replacement | N = 1,796 | n = 1,186 | n = 195 | n = 415 | |
| Death | 170 (9.47%) | 30 (2.53%) | 16 (8.21%) | 124 (29.9%) | <0.001 |
| All-cause readmission | 371 (20.7%) | 230 (19.4%) | 51 (26.2%) | 90 (21.7%) | 0.081 |
| HF readmission | 308 (17.1%) | 188 (15.9%) | 45 (23.1%) | 75 (18.1%) | 0.039 |
| Valve reintervention | 2 (0.111%) | 2 (0.169%) | 0 (0%) | 0 (0%) | 0.598 |
| Stroke | 4 (0.223%) | 1 (0.084%) | 0 (0%) | 3 (0.723%) | 0.047 |
| Myocardial infarction | 18 (1%) | 9 (0.759%) | 2 (1.03%) | 7 (1.69%) | 0.263 |
| 1-year | |||||
| Repair | N = 2,958 | n = 2,215 | n = 257 | n = 486 | |
| Death | 431 (14.6%) | 204 (9.21%) | 55 (21.4%) | 172 (35.4%) | <0.001 |
| All-cause readmission | 1,269 (42.9%) | 898 (40.5%) | 135 (52.5%) | 236 (48.6%) | <0.001 |
| HF readmission | 1,087 (36.7%) | 764 (34.5%) | 118 (45.9%) | 205 (42.2%) | <0.001 |
| Valve reintervention | 58 (1.96%) | 52 (2.35%) | 1 (0.389%) | 5 (1.03%) | 0.027 |
| Replacement | N = 1,796 | n = 1,186 | n = 195 | n = 415 | |
| Death | 312 (17.4%) | 101 (8.52%) | 39 (20%) | 172 (41.4%) | <0.001 |
| All-cause readmission | 810 (45.1%) | 517 (43.6%) | 105 (53.8%) | 188 (45.3%) | 0.028 |
| HF readmission | 669 (37.2%) | 414 (34.9%) | 89 (45.6%) | 166 (40%) | 0.007 |
| Valve reintervention | 12 (0.668%) | 12 (1.01%) | 0 (0%) | 0 (0%) | 0.045 |
Values are n (%).
Abbreviation as in Table 2.
30-day survival landmarked outcomes
Low- and intermediate-risk patients who survived 30 days after the index procedure had low 1-year mortality (low 4.8%, intermediate 10.5%), whereas patients who survived 30 days in the high-risk strata had 12.3% 1-year mortality (P < 0.001). However, 3-year mortality still strongly correlated with predicted risk even if patient survived the first 30 days after surgery (Figure 3) (P < 0.001).
Figure 3.
Landmark Survival
Kaplan-Meier survival curves for all-cause mortality landmarked at 30-day survival stratified by predicted risk group (<4%, 4%-8%, >8%) truncated at 4 years. Log-rank, P < 0.001.
Discussion
The present analysis of 6 years of Medicare Beneficiaries undergoing isolated TVr or TVR highlights 5 important findings. First, a majority of patients undergoing isolated TVr or TVR for nonendocarditis tricuspid regurgitation are at low surgical risk (<4%). Second, low-risk patients undergoing isolated TV surgery have good longitudinal survival despite a high incidence of all-cause and HF rehospitalization. Third, valve reintervention was very infrequent across all risk strata for isolated TVr or TVR. Fourth, favorable longitudinal outcomes across both low- and intermediate-risk cohorts who recover from surgery suggest they may gain significant benefit from correction of TV pathology. Finally, health care costs and rehospitalization are highly correlated with predicted risk with high-risk patients representing a major financial burden with poor outcomes despite correction of the TV pathology. In summary, these data provide important insights about current practice in isolated TV surgery which may serve as a benchmark for emerging transcatheter tricuspid technologies (Central Illustration).
Central Illustration.
Early and Longitudinal Outcomes After Isolated Tricuspid Surgery
Conceptual snapshot of study including a description of the study cohort, the main findings, and the conclusions. AUC = area under the receiver-operating characteristic curve; CABG = coronary artery bypass grafting; HF = heart failure; TV = tricuspid valve.
These data highlight that patients at low or intermediate risk are currently undergoing surgical repair or replacement with favorable longitudinal outcomes.9,10 Importantly, the risk profile in TV is different than those seen in other valvular diseases where 5-year survival can approach 95% with low incidence of readmission.9,11,12 TV disease is commonly a late stage sequela of cardiovascular diseases including functional valve disease related to ventricular dysfunction and pulmonary disease with pulmonary hypertension both of which have multiorgan effects that impact longitudinal outcomes highlighted by the continued survival difference across risk strata in the landmarked analysis. Furthermore, the differences in repair and replacement likely highlight fundamental differences in pathology and stage of disease as we cannot account for the relative candidacy of patients for the other therapy. Therefore, patient selection for TV intervention is critical particularly given the rapid expansion of transcatheter technology.
To ensure rational dispersion of these technologies, the TV Academic Research Consortium has provided recommendations to guide evidence generation and development.3 To date, outcomes reported from TTVI in high/prohibitive-risk patients reveal these to be safe in experienced centers with low risk of procedural morbidity and mortality.1,2,13,14 High-risk patients in the current analysis demonstrate in-hospital mortality above 20% as well as poor 1-year survival with very high rehospitalization and resource utilization. Efficacy of TTVI compared to optimal medical therapy alone has been primarily focused on quality of life in recent trials with both TRILUMINATE and TRISCEND.15 As these technologies expand to low/intermediate-risk patients with isolated TV disease, the present analysis can serve as a benchmark of longitudinal clinical outcomes including death and HF readmission–free survival.
For appropriate pathoanatomic disease states, surgical repair is preferred over replacement given the durability and longitudinal sequelae of structural valve degeneration associated with bioprostheses.16 This is particularly relevant for the low-velocity flow state of the tricuspid position, often requiring prolonged oral anticoagulation prophylaxis to mitigate structural valve degeneration. These data further highlight the worse longitudinal outcomes in patients requiring valve replacement at the time of isolated TV surgery likely related to pathoanatomy and comorbid disease.9 Interestingly, the same concepts hold true for TTVI therapy based on the trial data highlighting higher rates of procedural morbidity and mortality with transcatheter TV replacement vs transcatheter valve edge-to-edge repair but further work is needed to clarify any differences in longitudinal outcome and the extent to which these reflect cardiovascular causes vs differences in rates of comorbid conditions.1,17,18
Study Limitations
The present analysis has important limitations, including confounding by indication and the use of administrative claims for assessment of patient-related factors. In particular, we were unable to assess echocardiographic characteristics including degree of tricuspid regurgitation as well as clinical variables in the data set which may confound comparisons. Furthermore, the current analysis is limited to 3-year follow-up; longer-term follow-up is likely to demonstrate more frequent valve reintervention. In addition, CMS only captures Medicare Beneficiaries precluding assessment of overall center case volumes. Similarly, we are only able to assess patients who receive surgery with inherent selection bias excluding patients who are prohibitive surgical risk. Although the nature of the database precludes the determination of the timing of events during hospitalization, the “present on admission” modifier assists in accurate categorization of predictor and outcome variables. Several variables demonstrated associations that may appear counterintuitive from a clinical perspective, including apparently protective associations for coronary artery disease, diabetes, chronic kidney disease, and long-term anticoagulation. These findings likely reflect the limitations of claims-based analyses, including coding practices, collinearity between variables, and selection of patients considered suitable for surgery; chronic, well-managed, and reliably coded comorbidities tend to identify stable patients selected for elective surgery, whereas in-hospital mortality is driven predominantly by acute intra-admission events such as AKI, cardiogenic shock, and coagulopathy. In addition, the risk model was developed and applied within the same source population, which may render performance estimates optimistic; we therefore used cross-fitted predictions and bootstrap optimism correction rather than a single data split, but external validation in an independent population remains necessary. Predicted probabilities were low for most patients, consistent with a predominantly low-risk surgical population, and the distribution of predicted risk with observed-versus-predicted mortality by decile and risk stratum is provided in Supplemental Figure 2. Finally, we were unable to calculate the Society of Thoracic Surgeons risk score based on claims data but stratify patients using the CMS-based isolated TV surgery risk score inclusive of CCI and Fried Frailty index with an optimism-corrected AUC of 0.87.
Conclusions
Among Medicare Beneficiaries undergoing isolated tricuspid surgery, predicted surgical mortality was associated with survival, readmission, and cost through 3-year follow-up. As many of these patients may be considered for emerging transcatheter TV therapy in the future, these data may serve as benchmarks to not only inform heart team discussion but also guide future trial design for emerging transcatheter therapies.
Perspectives.
COMPETENCY IN MEDICAL KNOWLEDGE: TTVI is safe and may enhance quality of life. TV surgery remains an option but data on outcomes remain limited. The risk of TV surgery in Medicare beneficiaries is lower, and the frequency of isolated surgery is higher than previously recognized. Baseline preoperative risk is predictive of longer-term outcome.
TRANSLATIONAL OUTLOOK: These data may inform heart team decision-making as well as future trial design when evaluating patients for transcatheter or surgical tricuspid intervention.
Funding support and author disclosures
The study was supported by NIH NHLBI #2UM1HL088925 12 (Dr Mehaffey, Dr Hayanga, and Dr Badhwar). Dr Cohen has received research grant support from Edwards Lifesciences, Boston Scientific, Abbott, and Philips; and consulting income from Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic. Dr Davidson has received research grant support from Edwards Lifesciences and Abbott Vascular; and served as an uncompensated advisor for Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifescience; institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifescience, Medtronic, and Novartis; equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Acknowledgments
The authors would like to thank Ricardo Pietrobon MD, PhD, Aline Machiavelli MS, and Livia Eslabao MS, for their statistical support. In addition, the authors would like to thank Kalee Vincent and Mandy Moore for data and coding support.
Footnotes
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.
Appendix
For supplemental tables and figures, please see the online version of this paper.
Supplementary material
References
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