Risk scoring model for prediction of non-home discharge after transcatheter aortic valve replacement.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) are likely to be discharged to a location other than home. We aimed to determine the association between preoperative risk factors and non-home discharge after TAVR. METHODS: Patients discharged alive after TAVR at three centers were identified from a prospectively maintained database randomly divided into 80% derivation and 20% validation cohorts. Logistic regression models were fit to identify preoperative factors associated with non-home discharge in the derivation cohort. Multivariable models were developed and a nomogram based risk-scoring system was developed for use in preoperative counseling. RESULTS: Between June 2012 and December 2018, a total of 1, 163 patients had TAVR at three centers. Thirty-seven patients who died before discharge were excluded. Of the remaining 1, 126 patients (97%) who were discharged alive, the incidence of non-home discharge was 25.6% (n = 289). The patient population was randomly divided into the 80% (n = 900) derivation cohort and 20% (n = 226) validation cohort. Mean ± SD age of the study population was 83 ± 8 years. In multivariable analysis, factors that were significantly associated with non-home discharge were extreme age, female sex, higher STS scores, use of general anesthesia, elective procedures, chronic liver disease, non-transfemoral approach and postoperative complications. The unbiased estimate of the C-index was 0.81 and the model had excellent calibration. CONCLUSIONS: One out of every four patients undergoing TAVR is discharged to a location other than home. Identification of preoperative factors associated with non-home discharge can assist patient counseling and postoperative disposition planning.

Periprocedural Complications After Transcatheter Aortic Valve Replacement and Their Impact on Resource Utilization.

BACKGROUND: To examine the incidence and trends of peri-procedural complications after TAVR and their impact on resource utilization. METHODS: The incidence of complications by type [acute kidney injury (AKI), permanent pacemaker (PPM), vascular, paravalvular leak, in-hospital mortality, others] was calculated for TAVR patients at a high-volume center between 2012 and 2018. Clinical data were matched with hospital-billing data of patients. Trends in high resource utilization (discharge to a rehabilitation facility or PLOS >7 days) (HRU) and complication rates were assessed. Multivariable logistic regression models were used to determine predictors of HRU. RESULTS: Out of 1163 patients, 966 (83%) had no complications, others in 95 (8%), PPM in 56 (5%), AKI alone in 32 (3%), vascular in 31 (3%), in-hospital mortality in 28 (2%) and PVL in 10 (1%). A significant decreasing trend in the incidence of complications (29% vs 10%; p trend <0.001) and HRU (75% vs 12%; p trend <0.001) was observed between 2012 and 2018 respectively. Mean ±â€¯SD direct procedure cost of having a complication was $58,234 ±â€¯$24,568, was associated with an incremental cost of $10, 649 and a prolonged stay of 3-days. On multivariable logistic regression analysis, PPM, vascular complications, high STS risk score, NYHA class III/IV, frailty and ≥ moderate tricuspid regurgitation were significantly associated with HRU. TAVR year was protective against HRU. CONCLUSIONS: We established that, post-TAVR resource utilization and morbidity is high among frail and patients with higher STS risk scores. However, these rates decrease over time with experience.

Outcomes After Transcatheter Mitral Valve-in-Valve Replacement in Patients With Degenerated Bioprosthesis: A Single-Center Experience.

BACKGROUND: This study sought to describe a single center's experience with transcatheter mitral valve-in-valve (TM-ViV) implantation. METHODS: Consecutive patients who had TM-ViV due to degenerative biological valve prosthesis at a single center during a 4-year period were identified from a prospectively maintained database. Operative outcomes were assessed both in-hospital and at 30 days. The primary outcome was in-hospital mortality. Secondary outcomes included valve function, functional status, and quality of life at follow-up. RESULTS: Mean (± standard deviation) patient age was 69 ± 12 years and all patients were high risk for redo surgery (STS risk score, 9.6 ± 6.2%). The primary mechanism of bioprosthetic valve failure was stenosis in 7 patients (47%) and regurgitation in 8 patients (53%). Mean duration between mitral valve replacement (MVR) and transcatheter MVR was 89 months (range, 66-72 months). Failed bioprosthetic valves were replaced with Sapien XT (n = 10; 67%), Sapien (n = 4; 26%), or Sapien S3 valves (n = 1; 7%) (all valves manufactured by Edwards Lifesciences). Procedural success was 100%. No intraoperative deaths were recorded. Postimplantation valve hemodynamics was satisfactory, with a significant improvement in mean valvular gradient (Δ = -12 mm Hg; P<.001) and mitral valve area (Δ = 0.9 cm²; P<.01). At 30-day follow-up, no reports of death, disabling stroke, or rehospitalization for cardiac reasons was recorded. Health status scores were available for 11 of the 15 study patients (73%). Except for 1 patient, significant improvements were seen for all components of the health assessment survey. CONCLUSIONS: TM-ViV for failing biological mitral prosthesis can be performed with minimal operative morbidity and acceptable mid-term clinical and hemodynamic outcomes.

Left Ventricular Function Recovery After Transapical TAVR in Patients With Previous Coronary Artery Bypass Graft Surgery.

OBJECTIVE: The transapical (TA) approach is an alternative access technique for transcatheter aortic valve replacement (TAVR) in patients with symptomatic aortic valve stenosis. The impact of prior coronary artery bypass graft (CABG) surgery and how it affects left ventricular function recovery is not well defined. METHODS: Patients who had TAVR at a single center between June 2012 and December 2016 were reviewed. High-risk patients who underwent the procedure via a TA approach were divided into 2 groups based on their history of CABG surgery. Postoperative outcomes were compared between groups. CABG/TA-TAVR patients were subdivided into 2 per baseline left ventricular ejection fraction (LVEF) <50%. The changes in LVEF and valve function at follow-up (1 to 12 months) were analyzed using paired t-tests. RESULTS: Of 923 cases in total, 183 (19.8%) were performed via a TA approach. The mean ± SD Society of Thoracic Surgeons risk score of TA patients was 10.2 ± 4.6. Forty-nine (27%) had a surgical history of CABG. Overall all-cause mortality rates at 30 days, 1 year, and 2 years were similar for both groups (P = 0.59, P = 0.64, P = 0.78). Subgrouping of CABG-TAVR patients (n = 49) identified 24 patients (49%) with LVEF ≥50% vs. 25 (51%) with LVEF <50%. At 1-year follow-up, significant improvements in LVEF (low LVEF group) and valve function for both groups were observed. LVEF ≥50% group (LVEF: ∆: -3%, P = 0.878; aortic valve area [AVA]: ∆: 1.3 cm2, P < 0.001; mean gradient: ∆: -38 mmHg, P < 0.001); LVEF <50% group (LVEF: ∆: 10%, P = 0.01; AVA: ∆: 1.3 cm2, P < 0.001; MG: ∆: -31 mmHg, P < 0.001). CONCLUSIONS: TA-TAVR can be safely performed with acceptable postoperative outcomes in patients with a history of CABG surgery. In those with reduced EF, significant improvements in LV and valve functions are seen at 1-year follow-up.

Effect of Transcatheter Aortic Valve Implantation on Renal Function in Patients With Previous Renal Dysfunction.

The study aims to investigate the incidence of immediate renal function improvement in renal dysfunction patients who had transcatheter aortic valve implantation (TAVI). TAVI patients with ≥ moderate reduced renal function [estimated GFR ≤ 60 ml/min/1.73 m2] at baseline were identified from a prospectively maintained database. Patients were divided into 3 groups based on percent change [(discharge eGFR - baseline eGFR/baseline GFR) × 100] in eGFR post-TAVR. Improvement ≥ 10%, no change, Decline ≥ 10%. Multivariable logistic regression was performed to identify factors that predicted improvement/decline in GFR postprocedure. Out of 677 patients, 359 (53%) had eGFR ≤ 60 ml/min/1.73 m2. Of these, 188 (52%) had an improvement in eGFR ≥ 10%, 125 (34%) had no change and 48 (14%) observed decline ≥ 10%. All groups had similar proportions of females and age was comparable in patient groups. Patients in whom a decline in eGFR was observed had significantly higher Society of thoracic Surgeons scores (10.7 vs 8.2 vs 8.2; p = 0.007) and incidence of liver disease (6% vs, 0% vs 2%; p = 0.014) than the no-change or improved groups respectively. On multivariable analysis, independent predictors of decline/improvement in eGFR were being female, low left ventricular ejection fraction and baseline liver dysfunction. In conclusion, over half of patients with compromised renal function who underwent TAVI experience an immediate improvement in kidney function post-TAVI. Being female, baseline liver dysfunction and a low left ventricular ejection fraction is associated with an immediate decline in eGFR.

Predictors of Extended Postoperative Length of Stay After Uncomplicated Transcatheter Aortic Valve Replacement.

BACKGROUND: The current study aims to identify predictors of extended postoperative length of stay (PLOS) after uncomplicated transcatheter aortic valve replacement (TAVR). METHODS: Patients who underwent TAVR at a single center between June 2012 and June 2016 were analyzed. Patients were stratified by time into an early cohort (EC; 2012-2014) and current cohort (CC; 2015-2016). Those who had complications post procedure were excluded. The CC group was dichotomized based on its median PLOS. Factors associated with a longer PLOS were investigated by using multivariable logistic regression analysis. RESULTS: Mean age of the 686 patients (299 in the EC group and 387 in the CC group) was 82 ± 8 years. PLOS in the CC group was significantly lower than in the EC group (4 days vs 6 days, respectively; P<.001). Median PLOS in the CC group was 2 days. Dichotomizing the CC group by median PLOS resulted in 148 patients (54%) ≤2 days vs 128 patients (46%) >2 days. Of these, PLOS was 1 day in 71 patients (26%) and 2 days in 61 patients (28%). Independent predictors of PLOS >2 days were non-transfemoral approach, non-elective admission, female sex, low mean transaortic gradient, presence of chronic renal failure, and pulmonary hypertension. CONCLUSION: Experience coupled with improvements in TAVR technology over the past few years have led to a significant decrease in PLOS after TAVR. In the current TAVR era, 1 out of every 2 patients stays for a day or two in the absence of perioperative adverse events.

Discharge disposition of older patients undergoing trans-catheter aortic valve replacement and its impact on survival.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) are likely to be discharged to a location other than home. We aimed to assess the association between discharge disposition after TAVR and patient survival at 1 year. METHODS: Patients admitted from home and survived till discharge after TAVR were divided into two groups based on discharge disposition (home discharge vs. non-home discharge). Pre-operative factors predicting the odds of not being discharged home were identified by using multivariable logistic regression analysis. Study patients were matched one-to-one via a propensity scoring method. Differences in procedural outcomes were compared. Survival of both unmatched and matched pairs was evaluated by using the Kaplan-Meier method with the Kleine-Moesch-Berger stratified log-rank test. RESULTS: Out of 1,160 TAVR patients, 851 were admitted from home and survived till discharge. The incidence non-home discharge was 19% (n = 159). Factors that were significantly associated with non-home discharge were older age, non-transfemoral approach, female sex, frailty status, history of chronic lung disease, pacemaker placement and insulin-dependent diabetes mellitus. One-to-one propensity score matching resulted in 141 patient pairs with similar age, operative risk, frailty and functional status. At 1-year follow-up, all-cause mortality rates were significantly higher in the non-home group than their home counterparts (18% vs. 3%, P = 0.006; stratified log rank test: P = 0.006). CONCLUSIONS: A considerable number of TAVR patients are discharged to a location other than home after the procedure. Not being discharged home after TAVR is associated with a high mortality risk at 1 year.

Percutaneous Transaxillary Transcatheter Aortic Valve Replacement.

The axillary artery is an alternative, large-caliber vessel that can be utilized in the presence of hostile aortoiliac segments. It can accommodate sheaths up to 18 Fr and is infrequently affected by atherosclerosis.

The impact of frailty status on clinical and functional outcomes after transcatheter aortic valve replacement in nonagenarians with severe aortic stenosis.

BACKGROUND: The impact of frailty status on TAVR outcomes in nonagenarians is unknown. The present study aims to investigate the impact of frailty status on procedural outcomes and overall survival in nonagenarians after TAVR. METHODS: A frailty score (FS) was derived by using preoperative grip strength, gait speed, serum albumin, and daily activities. Patients were divided into two groups: Frail (FS ≥ 3/4) and Non-Frail (FS <3/4). Health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline demographic and clinical characteristics were compared in both groups. The effect of frailty status on outcomes was investigated. Cox regression analyses were performed to determine predictors of overall all-cause mortality. Kaplan-Meier survival curves were used to estimate survival. RESULTS: Seventy-five patients >90 years underwent full assessment for frailty status. There was a significant improvement in overall health status of non-frail patients (mean difference: 11.03, P = 0.032). Unadjusted 30-day and 2-year mortality rates were higher in the frail group than the non-frail group. (14% vs. 2% P = 0.059; 31% vs. 9% P = 0.018). Kaplan-Meier estimated all-cause mortality to be significantly higher in the frail group (log-rank test; P = 0.042). Frailty status was independently associated with increased mortality (hazard ratio: 1.84, 95% C.I: 1.06-3.17; P = 0.028) after TAVR. CONCLUSION: Among nonagenarians selected to undergo TAVR for severe aortic stenosis, a considerable number are frail. Nonfrail patients report a significant improvement in overall health status in the short term. Worse frailty is strongly associated with diminished long-term survival. © 2017 Wiley Periodicals, Inc.

Association of Change in Patient-Reported Health Status after Transcatheter Aortic Valve Replacement, and Postoperative Outcomes.

BACKGROUND: The study aim was to investigate the relationship between postoperative morbidity after transcatheter aortic valve replacement (TAVR) and short-term patient-reported health status, using the Kansas City Cardiomyopathy Questionnaire (KCCQ). METHODS: The association between 30-day post-procedure changes in patient-reported heath status and post-TAVR outcomes was examined. Patients were stratified into three groups based on observed changes in KCCQ-Overall scores (OS): Group A, increase in KCCQ-OS ≥10 points; Group B, KCCQ-OS scores <10 points; and Group C, decline in KCCQ-OS ≥10 points. Variation components of KCCQ scores were determined using paired t-tests. Postoperative morbidity was investigated. Multivariable logistic regression was used to identify pre-procedural factors associated with an increase or decline in KCCQ-OS at 30 days. RESULTS: A total of 223 patients with complete baseline and postoperative 30-day KCCQ responses was studied. At the 30-day follow up there was a significant change in baseline mean KCCQ-OS for all patients (mean difference 14.1; p <0.0001). Improvement in KCCQ-OS ≥10 was observed in 130 patients (58%), 64 patients (29%) had no change, and 29 patients (13%) had a decline in KCCQ-OS ≥10. The incidence of acute kidney injury (AKI), permanent pacemaker (PPM) placement and new-onset arrhythmia (NOA) was higher in group C than in groups A and B: AKI, 11%, 0%, 0%; p <0.001; PPM, 21%, 4%, 6%; p = 0.004; and NOA, 21%, 5%, 8%, p = 0.026. Independent predictors of decline in KCCQ scores after TAVR were PPM requirement (estimate: 0.76 CI 0.22, 1.29; p = 0.005) and NYHA functional class (III/IV) (estimate: -0.41 CI -0.71, 0.10; p = 0.009). CONCLUSIONS: TAVR patients experienced an improvement in health status after the procedure, but for a smaller proportion their health status worsened. Patients who experience perioperative complications may have a decline in their health status after the procedure in the short term.

Impact of Tricuspid Valve Regurgitation on Early Outcomes after Transcatheter Aortic Valve Replacement.

BACKGROUND AND AIM OF THE STUDY: Tricuspid valve regurgitation (TR) is often not taken into consideration in the prognostication of patients undergoing transcatheter aortic valve replacement (TAVR). Accordingly, its impact on such patients remains relatively poorly defined. The study aim was to explore the effect of TR and parameters of right ventricular (RV) function on outcomes in patients undergoing TAVR. METHODS: Baseline demographic and echocardiographic data were collected for 460 consecutive patients undergoing TAVR at the authors' institution between 2012 and 2015. A retrospective analysis was performed to determine the association of TR with all-cause mortality in these patients. The primary endpoint was 30-day rate of all-cause mortality and/or hospital re-admission. RESULTS: Among 460 patients included in the study analysis there were 25 deaths and 40 re-admissions. Univariate analysis showed that a higher Society of Thoracic Surgeons (STS) score, severe preoperative mitral and tricuspid regurgitation were associated with statistically significant higher 30-day mortality and/or re-admission rates. On multivariate analysis, STS score (OR 1.07, 95% CI 1.012-1.126), moderate TR (OR 3.24, 95% CI 1.52-6.87) and severe TR (OR 2.5, 95% CI 1.04-6.04) were identified as significant independent predictors of all-cause mortality. CONCLUSIONS: The severity of TR is a strong independent parameter predictive of death at 30 days. Therefore, parameters of RV function such as TR should be incorporated into predictive models for patients undergoing TAVR.

Quantitative increase in frailty is associated with diminished survival after transcatheter aortic valve replacement.

BACKGROUND: The purpose of this study is to assess the impact of frailty index comprised of commonly used frailty metrics on outcomes following transcatheter aortic valve replacement (TAVR) outcomes, including mortality, length of stay, and discharge destination. METHODS AND RESULTS: Retrospective data collection was performed for 342 consecutive patients who underwent TAVR at a single center from May 15, 2012, to September 17, 2015. Frailty index score was calculated using 15-ft walk test, Katz activities of daily living, preoperative serum albumin, and dominant handgrip strength. Patients were given a frailty score from 0/4 to 4/4, with higher scores indicating greater levels of frailty. There were 27 patients (8%) in 0/4, 82 patients (24%) in 1/4, 129 patients (38%) in 2/4, 73 patients (21%) in 3/4, and 31 patients (9%) in 4/4 frailty group. Multivariate cox, logistic, and linear regression analyses showed that patients with frailty score of 3/4 or 4/4 had increased all-cause mortality (P = .015 and P < .001) and were more likely to be discharged to an acute care facility (P = .083 and P = .001). 4/4 frail patients had increased post-operative length of stay (P = .014) when compared to less frail patients. Individual components of the frailty score were also independent predictors of all-cause mortality. Median survival in 4/4 frail patients was 7 months. CONCLUSIONS: Frailty index comprised of commonly used frailty metrics and its components are independent predictors of poor post-TAVR outcomes. There is a stepwise increase in mortality and post-TAVR length of stay with increasing frailty with dismal prognosis in extremely frail patients.

Impact of Coronary Artery Disease on Postoperative Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR): Is Preoperative Coronary Revascularization Necessary?

BACKGROUND: There remains much controversy on impact of preoperative coronary artery disease (CAD) and necessity of preoperative coronary revascularization on postoperative outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Data were collected retrospectively for 364 consecutive patients undergoing TAVR at Newark Beth Israel Medical Center, New Jersey, from May 15, 2012 to September 17, 2015. Preoperative CAD burden was calculated by three different measures of CAD: SYNTAX score, Duke Myocardial Jeopardy score (DMJS), and number of diseased coronary arteries. A composite endpoint of allcause mortality, major adverse cardiac and cerebrovascular event, and postoperative revascularization procedures was used as the primary endpoint in the survival analysis. Association of measures of CAD to composite endpoint were evaluated by multivariate Cox regression model for the first measure and log-rank test for the last two measures, respectively. Kaplan-Meier survival curves were derived by all three CAD measures. Thirty-day and 1-year composite endpoint rates were compared among strata defined by tertiles of SYNTAX score, DMJS, and number of diseased coronary vessels. RESULTS: A subset of 238 patients who met all inclusion criteria were eligible for final analysis. There was no significant association between the composite endpoint and SYNTAX score (hazard ratio, 0.77; 95% confidence interval, 0.47-1.23; P=.27); CAD by DMJS (P=.24), or number of diseased coronary arteries (P=.60). Independent predictors of poor postoperative outcomes included male gender, STS score, and frailty. There was no statistically significant association between preoperative CAD measures and 30-day or 1-year composite endpoint rates. CONCLUSION: In patients with asymptomatic CAD undergoing TAVR for severe symptomatic aortic stenosis, preoperative coronary revascularization may not be necessary.