Right ventricular outflow tract velocity time integral-to-pulmonary artery systolic pressure ratio: a non-invasive metric of pulmonary arterial compliance differs across the spectrum of pulmonary hypertension.

Pulmonary arterial compliance (PAC), invasively assessed by the ratio of stroke volume to pulmonary arterial (PA) pulse pressure, is a sensitive marker of right ventricular (RV)-PA coupling that differs across the spectrum of pulmonary hypertension (PH) and is predictive of outcomes. We assessed whether the echocardiographically derived ratio of RV outflow tract velocity time integral to PA systolic pressure (RVOT-VTI/PASP) (a) correlates with invasive PAC, (b) discriminates heart failure with preserved ejection-associated PH (HFpEF-PH) from pulmonary arterial hypertension (PAH), and (c) is associated with functional capacity. We performed a retrospective cohort study of patients with PAH (n = 70) and HFpEF-PH (n = 86), which was further dichotomized by diastolic pressure gradient (DPG) into isolated post-capillary PH (DPG \u3c 7 mmHg; Ipc-PH, n = 54), and combined post- and pre-capillary PH (DPG ≥ 7 mm Hg; Cpc-PH, n = 32). Of the 156 patients, 146 had measurable RVOT-VTI or PASP and were included in further analysis. RVOT-VTI/PASP correlated with invasive PAC overall (ρ = 0.61, P \u3c 0.001) and for the PAH (ρ = 0.38, P = 0.002) and HFpEF-PH (ρ = 0.63, P \u3c 0.001) groups individually. RVOT-VTI/PASP differed significantly across the PH spectrum (PAH: 0.13 [0.010-0.25] vs. Cpc-PH: 0.20 [0.12-0.25] vs. Ipc-PH: 0.35 [0.22-0.44]; P \u3c 0.001), distinguished HFpEF-PH from PAH (AUC = 0.72, 95% CI = 0.63-0.81) and Cpc-PH from Ipc-PH (AUC = 0.78, 95% CI = 0.68-0.88), and remained independently predictive of 6-min walk distance after multivariate analysis (standardized β-coefficient = 27.7, 95% CI = 9.2-46.3; P = 0.004). Echocardiographic RVOT-VTI/PASP is a novel non-invasive metric of PAC that differs across the spectrum of PH. It distinguishes the degree of pre-capillary disease within HFpEF-PH and is predictive of functional capacity

Predicting Long Term Outcome in Patients Treated With Continuous Flow Left Ventricular Assist Device: The Penn—Columbia Risk Score

Background: Predicting which patients are unlikely to benefit from continuous flow left ventricular assist device (LVAD) treatment is crucial for the identification of appropriate patients. Previously developed scoring systems are limited to past eras of device or restricted to specific devices. Our objective was to create a risk model for patients treated with continuous flow LVAD based on the preimplant variables. Methods and Results: We performed a retrospective analysis of all patients implanted with a continuous flow LVAD between 2006 and 2014 at the University of Pennsylvania and included a total of 210 patients (male 78%; mean age, 56±15; mean follow‐up, 465±486 days). From all plausible preoperative covariates, we performed univariate Cox regression analysis for covariates affecting the odds of 1‐year survival following implantation (P<0.2). These variables were included in a multivariable model and dropped if significance rose above P=0.2. From this base model, we performed step‐wise forward and backward selection for other covariates that improved power by minimizing Akaike Information Criteria while maximizing the Harrell Concordance Index. We then used Kaplan–Meier curves, the log‐rank test, and Cox proportional hazard models to assess internal validity of the scoring system and its ability to stratify survival. A final optimized model was identified based on clinical and echocardiographic parameters preceding LVAD implantation. One‐year mortality was significantly higher in patients with higher risk scores (hazard ratio, 1.38; P=0.004). This hazard ratio represents the multiplied risk of death for every increase of 1 point in the risk score. The risk score was validated in a separate patient cohort of 260 patients at Columbia University, which confirmed the prognostic utility of this risk score (P=0.0237). Conclusion: We present a novel risk score and its validation for prediction of long‐term survival in patients with current types of continuous flow LVAD support

QOLVAD Detects Changes in Emotional, Social, Cognitive and Physical Wellbeing after Continuous-Flow LVAD Implant

Purpose: Most studies report little change in quality-of-life (QOL) during continuous flow left ventricular assist device (CFLVAD) support. The aim herein is to compare a new disease-specific questionnaire (QOLVAD) vs. existing metrics of QOL at various times during CFLVAD. Methods: We conducted a multicenter descriptive survey of QOL in operative survivors of CFLVAD support using the following measures: KCCQ (subjective health status); PHQ9 (depressive symptoms); 4-item PROMIS (anxiety); and QOLVAD (quality-of-life). The QOLVAD is a questionnaire with Likert-type responses for physical, emotional, social, cognitive, and spiritual domains. Standardized QOLVAD scores range from 0-100 (higher=better QOL). Patients were grouped by quintiles according to time postop. that scores were obtained. Scores were compared using linear regression, adjusting for age. Results: The sample of 146 was obtained from the overall cohort which was 82% male, 77% white, 50% BTT, with mean age of 58.5±13.8 years. Surveys were completed at mean 82±97 weeks postop with testing time frame quintiles as below (Table). While there were no significant differences in overall QOLVAD scores based on time postop testing occurred, there were time-dependent differences in components of the scores (Table). Physical wellbeing was lower in those tested after shorter durations of support, possibly reflecting operative debilitation. Patients tested after longer periods of support had lower emotional, social and cognitive wellbeing compared with earlier implants. Depression, anxiety, and KCCQ metrics did not change over time. Conclusion: These results suggest that the QOLVAD is sensitive to time-dependent changes in patient measures of physical, emotional, social, and cognitive wellbeing after CFLVAD. In contrast, the KCCQ, PHQ9 and Promis failed to show similar changes over time. These results support need for prospective, longitudinal analyses to detect within-patient differences of QOLVAD measures

Health-related quality of life in patients with a left ventricular assist device (QOLVAD) questionnaire : Initial psychometrics of a new instrument

Background Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. Objective We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. Methods In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. Results Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79–.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). Conclusion Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed

Performance of Prognostic Heart Failure Models in Patients With Nonischemic Cardiomyopathy Undergoing Ventricular Tachycardia Ablation

Objectives: This study sought to assess the performance of established risk models in predicting outcomes after catheter ablation (CA) in patients with nonischemic dilated cardiomyopathy (NIDCM) and ventricular tachycardia (VT). Background: A correct pre-procedural risk stratification of patients with NIDCM and VT undergoing CA is crucial. The performance of different pre-procedural risk stratification approaches to predict outcomes of CA of VT in patients with NIDCM is unknown. Methods: The study compared the performance of 8 prognostic scores (SHFM [Seattle Heart Failure Model], MAGGIC [Meta-analysis Global Group in Chronic Heart Failure], ADHERE [Acute Decompensated Heart Failure National Registry], EFFECT [Enhanced Feedback for Effective Cardiac Treatment-Heart Failure], OPTIMIZE-HF [Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure], CHARM [Candesartan in Heart Failure-Assessment of Reduction in Mortality], EuroSCORE [European System for Cardiac Operative Risk Evaluation], and PAINESD [Chronic Obstructive Pulmonary Disease, Age > 60 Years, Ischemic Cardiomyopathy, New York Heart Association Functional Class III or IV, Ejection Fraction <25%, Presentation With VT Storm, Diabetes Mellitus]) for the endpoints of death/cardiac transplantation and VT recurrence in 282 consecutive patients (age 59 ± 15 years, left ventricular ejection fraction: 36 ± 13%) with NIDCM undergoing CA of VT. Discrimination and calibration of each model were evaluated through area under the curve (AUC) of receiver-operating characteristic curve and goodness-of-fit test. Results: After a median follow-up of 48 (interquartile range: 19–67) months, 43 patients (15%) died, 24 (9%) underwent heart transplantation, and 58 (21%) experienced VT recurrence. The prognostic accuracy of SHFM (AUC = 0.89; goodness-of-fit p = 0.68 for death/transplant and AUC = 0.77; goodness-of-fit p = 0.16 for VT recurrence) and PAINESD (AUC = 0.83; goodness-of-fit p = 0.24 for death/transplant and AUC = 0.68; goodness-of-fit p = 0.58 for VT recurrence) were significantly superior to that of other scores. Conclusions: In patients with NIDCM and VT undergoing CA, the SHFM and PAINESD risk scores are powerful predictors of recurrent VT and death/transplant during follow-up, with similar performance and significantly superior to other scores. A pre-procedural calculation of the SHFM and PAINESD can be useful to predict outcomes

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire

Background Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. Objective We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. Methods In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. Results Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79–.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). Conclusion Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed

LVAD Strategy Reflects Emotional Functioning after Implant.

Purpose: With an increased prevalence of anxiety and depression in advanced heart failure, left ventricular assist device (LVAD) implantation has recently been shown to mitigate some of these mental health issues by improved functional capacity and quality of life (QOL). There is mixed data available regarding LVAD strategy, so our aim was to compare emotional wellbeing between destination therapy (DT) and bridge to transplant (BTT) post LVAD based on existing QOL tools and preliminary data from a new tool, Quality of Life with a Left Ventricular Assist Device (QOLVAD). Methods: LVAD strategy was identified on initial questionnaire as BTT, DT, Bridge to Decision, and other. A new validation tool currently being tested at our consortium (QOLVAD) consisting of 10 items in the emotional subset (score 0-100, higher better), was compared with other well-established measures of QOL; Patient Health Questionnaire (PHQ-9, score 0-27, higher worse), Patient Reported Outcomes Measurement Information System (PROMIS, score 40.3-81.6, higher worse), and Euroqol 5 dimensions (EQ-5D, score 0-100, higher better). Surveys were completed at a median time of 44 weeks after implantation. Results: Preliminary findings from the 186 LVAD patients enrolled across seven centers participating in evaluation of the QOLVAD tool included 50% BTT (n=87) and 30.1% DT (n=53). There was no statistical difference in emotional domain (p=0.11). Interestingly, social functioning was higher in DT vs. BTT (p=0.04) which might suggest patients that are more socially content function better emotionally. There was no statistical significance in PHQ-9 scores between DT and BTT (p=0.43). There was less anxiety and better emotional scoring in DT patients vs BTT in PROMIS scores which was statistically significant (p=0.03). Conclusion: Recent observations suggest that social functioning, such as return to work and intimacy (physical and emotional) can affect emotional status. Furthermore, literature suggest that VAD implantation partially alleviates depression and anxiety but LVAD patients continue to experience this more than heart transplant recipients. Studies also demonstrate BTT patients have increased anxiety in anticipation of a life-altering event compared to either post-transplant or other LVAD patients which is supported by our findings. This illustrates the need for more aggressive psychotherapeutic interventions in these patients

Relationship of Spiritual Wellbeing and Depressive Symptoms for Patients with a Left-Ventricular Assist Device (LVAD).

Purpose: Although quality of life (QOL) has been widely reported in patients receiving LVADs, spiritual wellbeing among LVAD recipients is rarely included in these reports. Methods: Prospective, multi-site, cross-sectional, descriptive study of patient-reported outcomes. Depressive symptoms were measured by PHQ9 (lower = fewer symptoms). Spiritual wellbeing was measured through two different questionnaires. The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp) (12-items) is an established independent measure (possible score 0-48, higher better) with a faith subscale (score 0-16) and a meaning/peace subscale (score 0-32). The QOLVAD Meaning/Spirituality subscale (5-items) is one of five domains for QOL included in the new, valid and reliable Quality of Life with an LVAD (QOLVAD) questionnaire (domain possible score 0-100, higher better). Results: There were 186 LVAD patients in the overall sample: 83% male, 77% white, 22% African American, 90% HeartMate II and 3, 50% bridge to transplant, 30% destination therapy, with average age of 58.5±13.8 years. We report preliminary findings from surveys completed at median time (25th, 75th percentile) of 44 weeks (17.5±115.5) post-VAD. Faith affiliation was 69% Protestant, 19% Catholic, 6% Agnostic/Atheist, and 6% other. The mean PHQ9 score was 3.97±4.16 and FACIT-Sp 38.7±8.8. Meaning/Peace and Faith subscale scores were 26.1±5.5 and 13.0±4.0, respectively. The PHQ9 and the faith subscale of the FACIT-Sp had a significant inverse relationship (r = -0.2166, p=0.004), suggesting that patients with higher faith had fewer depressive symptoms. Similarly, scores for the PHQ and the Meaning/Spirituality subscale of the QOLVAD had a significant inverse relationship (r = -0.3121; p\u3c0.001), suggesting that patients with higher wellbeing in meaning and spirituality had fewer depressive symptoms. Conclusion: Spiritual wellbeing is an important facet of assessing patient-reported outcomes in LVAD patients. Given the strong inverse correlation between spiritual wellbeing and depressive symptoms, some patients may benefit from interventions targeted at improving spiritual wellbeing during LVAD support. Findings may suggest a role for institutional support of resources to promote patient spiritual wellbeing

Validity and Reliability of the Quality of Life with a Left Ventricular Assist Device (QOLVAD) Questionnaire.

Purpose: A valid and reliable quality of life (QOL) measure designed for left ventricular assist device (LVAD) patients has not been established. We report second stage preliminary psychometrics for the QOLVAD Questionnaire. Methods: Prospective, cross-sectional study at 7 sites. QOLVAD construct validity (overall, physical, emotional, social, cognitive and meaning/spiritual QOL) was tested using confirmatory factor analysis. Convergent validity was tested using correlations between QOLVAD scores and well-established measures of subjective health status (KCCQ12), depressive symptoms (PHQ9) anxiety (PROMIS), meaning/peace and faith (FACIT). Reliability was quantified using Cronbach\u27s alpha (for domain scores) and factor determinacy score (multidimensional reliability). Test re-test reliability was quantified using correlations and Bland-Altman tests (enrollment vs. 1 week later). Results: There were 186 LVAD patients in the overall sample: 58.5±13.8 years; 82.7% male, 77.3% white, 50% bridge to transplant. Surveys were completed at median time (25th, 75th percentile) of 44 weeks (17.5±115.5) post-VAD. The five domains of the QOLVAD had good construct validity (RMSEA = 0.07, Comparative and Tucker Lewis fit indices = 0.90, weighted and standardized root mean square residual = 1.348 and 0.09, respectively). QOLVAD scores were standardized to range from 0-100 with higher values indicating better QOL. The overall and domain specific scores were significant correlated with the various other tools to which they were compared (Table). Additionally, with the exception of the cognitive domain (α=0.60), reliability was high among all areas (range 0.79 to 0.93) as was test re-test reliability (range 0.71 to 0.94; p\u3c0.001 for all). Conclusion: While a subsequent version will focus on strengthening reliability of the cognitive domain, the existing QOLVAD is a valid, reliable measure of overall QOL with an LVAD and of physical, emotional, social and meaning/spiritual domains