This commentary provides a concise overview of the epidemiology of cancer survivorship and work, common functional limitations experienced by cancer survivors, and evidence‐based recommendations for interventions available to improve function. It also describes the US Social Security Administration's disability claims process, its eligibility requirements, and barriers for long‐term survivors in securing approval for disability claims, and offers insights for practicing clinicians in holistically addressing functional limitations in practice.

Objective

This work presents a highly-accelerated, self-gated, free-breathing 3D cardiac cine MRI method for cardiac function assessment.

Materials and methods

A golden-ratio profile based variable-density, pseudo-random, Cartesian undersampling scheme was implemented for continuous 3D data acquisition. Respiratory self-gating was achieved by deriving motion signal from the acquired MRI data. A multi-coil compressed sensing technique was employed to reconstruct 4D images (3D+time). 3D cardiac cine imaging with self-gating was compared to bellows gating and the clinical standard breath-held 2D cine imaging for evaluation of self-gating accuracy, image quality, and cardiac function in eight volunteers. Reproducibility of 3D imaging was assessed.

Results

Self-gated 3D imaging provided an image quality score of 3.4 ± 0.7 vs 4.0 ± 0 with the 2D method (p = 0.06). It determined left ventricular end-systolic volume as 42.4 ± 11.5 mL, end-diastolic volume as 111.1 ± 24.7 mL, and ejection fraction as 62.0 ± 3.1%, which were comparable to the 2D method, with bias ± 1.96 × SD of -0.8 ± 7.5 mL (p = 0.90), 2.6 ± 3.3 mL (p = 0.84) and 1.4 ± 6.4% (p = 0.45), respectively.

Conclusion

The proposed 3D cardiac cine imaging method enables reliable respiratory self-gating performance with good reproducibility, and provides comparable image quality and functional measurements to 2D imaging, suggesting that self-gated, free-breathing 3D cardiac cine MRI framework is promising for improved patient comfort and cardiac MRI scan efficiency.

Background

The 6-minute walk test (6MWT) independently predicts congestive heart failure severity, death, and heart failure hospitalizations, but must be administered in clinic by qualified staff on a premeasured course. As part of the Health eHeart Study, we sought to develop and validate a self-administered 6MWT mobile application (SA-6MWTapp) for independent use at home by patients.

Methods and results

We performed a validation study of an SA-6MWTapp in 103 participants. In phase 1 (n=52), we developed a distance-estimation algorithm for the SA-6MWTapp by comparing step counts from an Actigraph and measured distance on a premeasured 6MWT course with step counts and estimated distance obtained simultaneously from our SA-6MWTapp (best estimation algorithm, r=0.89 [95% confidence interval 0.78-0.99]). In phase 2, 32 participants (including those with congestive heart failure and pulmonary hypertension) used the SA-6MWTapp independently in clinic, and the distance estimated by the SA-6MWTapp was compared with the measured distance (r=0.83 [95% confidence interval 0.79-0.92]). In phase 3, 19 patients with congestive heart failure and pulmonary hypertension consecutively enrolled from clinic performed 3.2±1 SA-6MWTapp tests per week at home over 2 weeks. Distances estimated from the SA-6MWTapp during home 6MWTs were highly repeatable (coefficient of variation =4.6%) and correlated with in-clinic-measured distance (r=0.88 [95% confidence interval 0.87-0.89]). Usability surveys performed during the second (in-clinic) and third (at-home) phases demonstrated that the SA-6MWTapp was simple and easy to use independently.

Conclusions

An SA-6MWTapp is easy to use and yields accurate repeatable measurements in the clinic and at home.

Rationale and objectives

We investigated the feasibility of detecting left ventricular (LV) cardiac magnetic resonance (CMR) strain abnormalities using feature-tracking in patients with pulmonary hypertension (PH).

Materials and methods

CMR was performed in 16 patients with all groups of PH and in 13 controls. Global and regional peak circumferential strains (%) (which have been shown to be robust by CMR), peak diastolic strain rate (%/s), and dyssynchrony index (ms) were quantified with feature-tracking software. Ventricular function and volumes were calculated from CMR, and right heart pressures were measured with catheterization.

Results

Left ventricular ejection fraction (LVEF) was similar in patients (60.2% ± 11.0%) and controls (61.9% ± 4.5%), P = .150. Global LV peak circumferential strain was significantly different in patients compared to controls, -16.7 ± 2.8% vs -19.9 ± 1.8%, respectively (P = .001). The greatest difference in strain was seen in the LV septum, -11.6 ± 4.3% in patients vs -16.7 ± 4.0% in controls (P < .001). There was a significant association between septal strain and right ventricular end-diastolic volume index (P = .047) in patients with PH; however, there were no associations with pulmonary artery pressures or right ventricular ejection fraction.

Conclusions

Feature-tracking CMR can detect LV strain abnormalities in patients with PH and preserved or mildly depressed LVEF, with greatest abnormality in the septum. The association between septal strain and right ventricular end-diastolic volume index suggests that ventricular interdependence may be a mechanism of LV dysfunction in PH. Feature-tracking CMR may be useful for identification of LV dysfunction before LVEF significantly declines in patients with PH. The feasibility of detecting LV strain abnormalities in patients with PH shown by this study paves the way for a variety of future investigations into the applications of LV strain in this patient population.

Background

Persistent severe left ventricular (LV) systolic dysfunction after myocardial infarction (MI) is associated with increased mortality and is a class I indication for implantation of a cardioverter-defibrillator.

Objectives

This study developed models and assessed independent predictors of LV recovery to >35% and ≥50% after 90-day follow-up in patients presenting with acute MI and severe LV dysfunction.

Methods

Our multicenter prospective observational study enrolled participants with ejection fraction (EF) of ≤35% at the time of MI (n = 231). Predictors for EF recovery to >35% and ≥50% were identified after multivariate modeling and validated in a separate cohort (n = 236).

Results

In the PREDICTS (PREDiction of ICd Treatment Study) study, 43% of patients had persistent EF ≤35%, 31% had an EF of 36% to 49%, and 26% had an EF ≥50%. The model that best predicted recovery of EF to >35% included EF at presentation, length of stay, prior MI, lateral wall motion abnormality at presentation, and peak troponin. The model that best predicted recovery of EF to ≥50% included EF at presentation, peak troponin, prior MI, and presentation with ventricular fibrillation or cardiac arrest. After predictors were transformed into point scores, the lowest point scores predicted a 9% and 4% probability of EF recovery to >35% and ≥50%, respectively, whereas profiles with the highest point scores predicted an 87% and 49% probability of EF recovery to >35% and ≥50%, respectively.

Conclusions

In patients with severe systolic dysfunction following acute MI with an EF ≤35%, 57% had EF recovery to >35%. A model using clinical variables present at the time of MI can help predict EF recovery.

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions.