A Validated Practical Risk Score to Predict the Need for RVAD after Continuous-flow LVAD

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Maude Newman
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1 A Validated Practical Risk Score to Predict the Need for RVAD after Continuous-flow LVAD SK Singh MD MSc, DK Pujara MBBS, J Anand MD, WE Cohn MD, OH Frazier MD, HR Mallidi MD Division of Transplant & Assist Devices, Baylor College of Medicine Houston, Texas, USA 95 th Annual AATS Meeting, Seattle, WA April 28 th, 2015

2 Disclosures The authors have NO disclosures relevant to this research project.

3 Background RV failure after LVAD implant occurs in 20-50% of patients. Severe RV failure post-lvad, requiring RVAD support has an incidence of 10-25%. The causes are multifactorial. RV failure & RVAD after LVAD are well described as significant, independent risk factors for morbidity & mortality. Kormos et al. JTCVS 2010;139:

4 Background Identifying patients high risk for RVAD after LVAD, may improve outcomes via: Peri-operative RV optimization Lower threshold for RVAD support Alternate strategies (Transplant, TAH, planned BiVAD) Existing risk scores are limited: RV failure outcome, vs RVAD Inconsistent variables Few reproduced Small sample sizes Based on univariate analyses Include obsolete pulsatile LVADs None have been robustly validated

5 Objective To review the largest single-center experience with CF LVADS to create a simple, portable & robustly validated risk score, that accurately predicts patients at risk for a RVAD after CF LVAD.

6 Methods A retrospective review of consecutive patients implanted with a CF LVAD at our single institution ( ) N = 469 patients. Stratified by RVAD required during admission for CF LVAD. n = 42 RVADs (9.0%) Univariate summary statistics & Kaplan-Meier survival. Multivariable logistic regression identified predictors of requiring RVAD.

7 Methods Risk Score: Predictors dichotomized at clinically relevant thresholds; weighted odds ratios Created simple acronym & simple to remember risk coefficients ROC AUC c-statistics were calculated for accuracy Validated internally Bootstrapping (case resampling) Validated prospectively patient cohort (N=78)

8 Results

9 RVAD Incidence Era

10 RVAD Survival

11 Baseline Characteristics CF LVAD (n=427) +RVAD (n=42) Age (years) Ischemic Etiology 175 (41%) 20 (48%) Bridge-to-transplant 254 (59%) 26 (62%) INTERMACS 1 or (53%)* 31 (77%)* Inotropic Support 361 (84%)* 41 (98%)* Vasopressor Support 59 (14%)* 12 (29%)* Pre-operative temporary circulatory support Extra-corporal membrane oxygenation (ECMO)** Abiomed Impella or TandemHeart** Intra-aortic balloon pump (IABP)** 214 (50%)* 1 (0.2%) 63 (14.8%)* 184 (43.1%)* 30 (71%)* 2 (4.8%) 12 (28.6%)* 24 (57.1%)*

12 Baseline Characteristics CF LVAD (n=427) +RVAD (n=42) Diabetes 178 (42%) 15 (36%) Chronic Obstructive Pulmonary Disease 55 (13%) 3 (7%) Renal Replacement Therapy 20 (5%)* 9 (21%)* Hemoglobin (g/dl) White blood count (10 6 /ml) * * Sodium (meq/l) Creatinine (mg/dl) Albumin (g/dl) * *

13 Hemodynamics CF LVAD (n=427) +RVAD (n=42) CI (L/min/m 2 ) PCWP (mmhg) CVP (mmhg) PVR (Wood s Units) LVEDD (cm) * * TR (mod sev) 170 (43%)* 24 (60%)* MR (mod sev) 230 (57%) 25 (63%) RV depression (mod-sev) 287 (73%) 32 (86%)

14 Operative CF LVAD (n=427) +RVAD (n=42) Previous Sternotomy 144 (34%)* 21 (50%)* Operative Approach Sternotomy Thoracotomy Subcostal/Other 366 (86%) 37 (9%) 19 (5%) 35 (83%) 6 (14%) 1 (2%) CPB (minutes) * * Concomitant Procedure Atrial septal defect repair** Tricuspid valve repair/replacement** Mitral valve repair/replacement** Aortic valve repair/replacement** Left ventricle geometry restoration** Coronary artery bypass grafting** 159 (37%) 45 (10.5%) 7 (1.6%)* 49 (11.5%) 16 (3.7%) 29 (6.8%) 14 (3.3%) 22 (52%) 7 (16.7%) 3 (7.1%)* 4 (9.5%) 2 (4.8%) 4 (9.5%) 3 (7.1%)

15 Predictors of RVAD OR (95% CI) P-value Tricuspid regurgitation (1-4) 1.6 ( ) 0.03 Renal Replacement Therapy (yes/no) 2.9 ( ) 0.04 Albumin (g/dl) 0.3 ( ) <0.001 LVEDD (cm) 0.6 ( ) 0.01 Previous sternotomy 1.7 ( ) 0.2 Vasopressor use preoperatively 1.4 ( ) 0.5

16 TRAPPS Predictor Odds Ratio TRAPPS Score (Total = 27) Tricuspid regurgitation (any) Renal Replacement Therapy (yes/no) Albumin (low; <3.5 g/dl) Previous sternotomy (yes/no) VasoPressor required (yes/no) Small LV cavity size (LVEDD <6 cm) TRAPPS SCORE Low risk (0-5) Intermediate risk (6-16) High risk (17-27) Probability of RVAD 2.5% 10% 25%

17 Accuracy (N=469) TRAPPS (continuous) TRAPPS (risk groups)

18 Validation - Bootstrapping

19 Validation Prospective (n=78) TRAPPS (continuous) TRAPPS (risk groups)

20 Conclusions Severe RV failure requiring RVAD after CF LVAD is a significant risk factor for considerable early mortality. This review of the largest, single-center CF LVAD experience found a 9% incidence of RVAD after CF LVAD. The TRAPPS risk score, is a simple, portable, accurate & validated, pre-operative score to identify patients at risk for RVAD after CF LVAD. TR (any) Renal replacement therapy Albumin (<normal) Previous sternotomy Pressor requirement Small LV cavity (<6cm)

21 Conclusions The TRAPPS variables are intuitive & reproduced in literature. The score is novel in its robust validation retrospectively, prospectively & derived from a large cohort of solely CF LVADs. Limitations include external validation (pending), and exclusion of important intra-operative variables (i.e. transfusions). While TRAPPS accurately identifies those at risk for RVAD, there remains a large margin where further aspects of a heart failure program s practice may impact RVAD incidence.

22 A Validated Practical Risk Score to Predict the Need for RVAD after Continuous-flow LVAD SK Singh MD MSc, DK Pujara MBBS, J Anand MD, WE Cohn MD, OH Frazier MD, HR Mallidi MD Division of Transplant & Assist Devices, Baylor College of Medicine Houston, Texas, USA 95 th Annual AATS Meeting, Seattle, WA April 28 th, 2015

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