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The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions document was issued as a guidance for industry and for the Food and Drug Administration. The Expedited Access Pathway was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The Food and Drug Administration would consider assessments of a device’s effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit. The purpose of this review is to provide evidence to support the use of 3 such intermediate endpoints: natriuretic peptides, such as N-terminal pro–B-type natriuretic peptide/B-type natriuretic peptide, the 6-min walk test distance, and health-related quality of life in heart failure.

Enhanced External Counterpulsation is an outpatient treatment to improve myocardial perfusion in chronic stable angina patients. We studied, the clinical response of symptomatic heart failure patients with reduced left ventricular ejection fraction improvement in the exercise tolerance and

Frailty in elderly patients is a key determinant of outcomes of patients undergoing major cardiac procedures. Five-meter walk time (5MWT) has been shown to predict mortality risk following surgical aortic valve replacement, but its association with outcomes in patients undergoing transcutaneous

POTS manifests as chronic symptoms of orthostatic intolerance accompanied by an exaggerated HR response. Symptoms can be cardiac, non-cardiac, physically and mentally debilitating which can persistently interfere with an individual's functional capacity to cope with minimal exertions and demands of

Cardiac resynchronization therapy (CRT) has been shown to improve outcomes, but its impact on 6-minute walk test (6MWT) is less known. Furthermore, the utility of the change in 6MWT to predict long-term CRT outcomes compared to other well-known predictors such as echocardiography response is not

We read with interest the review by Ferreira et al. [(1)][1] about the use of clinically meaningful endpoints in heart failure (HF) trials, such as natriuretic peptides, the 6-min walking distance (6MWD) test, and quality of life. However, we would like to point out an important aspect in

The simple, functional 6-min walk test (6MWT) can predict exercise capacity and is widely used to assess treatment outcomes [(1)][1]. Transcatheter mitral valve repair (TMVR) (MitraClip, Abbott Vascular, Menlo Park, California) has become widely adopted for clinical use in high-risk or prohibitive

6-minute walk test (6MWT) is usually used as end-point in clinical trials to assess the benefit of therapies in patients with pulmonary arterial hypertension (PAH). The purpose of this study was to verify whether improvement in 6MWT is associated with reduced incidence of clinical outcomes in PAH.

The study by Forman et al. ([1][1]) increases the perspectives on how the distance of the 6-min walk test (6MWT) and the measured oxygen uptake (VO2) and ventilatory efficiency (VE/VCO2 slope) may add to the prognostic workup of heart failure (HF) patients. By examining these variables in a mild-to

“Golf is a good walk spoiled.” —Mark Twain ([1][1]) Walking is a basic form of locomotion that involves the coordination of numerous muscles to provide forward movement while maintaining body balance and limiting energy expenditure ([2][2]). The distance and speed that a healthy individual

Objectives The goal of this study was to compare the prognostic efficacy of the 6-min walk (6MW) and cardiopulmonary exercise (CPX) tests in stable outpatients with chronic heart failure (HF). Background CPX and 6MW tests are commonly applied as prognostic gauges for systolic HF patients, but few direct comparisons have been conducted. Methods Stable New York Heart Association (NYHA) functional class II and III systolic HF patients (ejection fraction ≤35%) from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial were studied. 6MW distance (6MWD) and CPX indices (peak oxygen consumption [VO2] and ventilatory equivalents for exhaled carbon dioxide [VE/VCO2] slope) were compared as predictors of all-cause mortality/hospitalization and all-cause mortality over 2.5 years of mean follow-up. Results A total of 2,054 HF-ACTION participants underwent both CPX and 6MW tests at baseline (median age 59 years; 71% male; 64% NYHA functional class II and 36% NYHA functional class III/IV). In unadjusted models and in models that included key clinical and demographic covariates, C-indices of 6MWD were 0.58 and 0.65 (unadjusted) and 0.62 and 0.72 (adjusted) in predicting all-cause mortality/hospitalization and all-cause mortality, respectively. C-indices for peak VO2 were 0.61 and 0.68 (unadjusted) and 0.63 and 0.73 (adjusted). C-indices for VE/VCO2 slope were 0.56 and 0.65 (unadjusted) and 0.61 and 0.71 (adjusted); combining peak VO2 and VE/VCO2 slope did not improve the C-indices. Overlapping 95% confidence intervals and modest integrated discrimination improvement values confirmed similar prognostic discrimination by 6MWD and CPX indices within adjusted models. Conclusions In systolic HF outpatients, 6MWD and CPX indices demonstrated similar utility as univariate predictors for all-cause hospitalization/mortality and all-cause mortality. However, 6MWD or CPX indices added only modest prognostic discrimination to models that included important demographic and clinical covariates.

Distance walked in Six minute walk test (SMWT) has been shown to give prognostic information in moderate heart failure. We studied the value of SMWT in 359 patients with severe CHF (NYHA III-IV) in a multicenter trial of continuous epoprostenol infusions. SMWT was performed in a 30 m long corridor. Perceived symptoms were evaluated by the Borg scale. Follow up was performed at 2 weeks, 1, 3, 6 and 9 months. Results SMWT at baseline was significantly related to survival (p = 0.0001). When SMWT distance was below median, 210 m, 6 month mortality was 50% vs 20% above median (p l 0.001). Median Borg scale at end of exercise was 3.2. A test with a Borg scale above median value was 174 m vs 230 m below median (p l 0.001). When all tests performed at baseline and during follow up were included (n = 1291) and related to changes in NYHA class, there was a significant relationship to NYHA class (p = 0.0001). Conclusion In severe CHF Six minute walk test is related to symptoms and perceived exertion. The test also gives prognostic information and it is related to functional classification.

Although maximal oxygen consumption (MVO2) is useful in predicting prognosis and need for cardiac transplantation (TX) in patients with advanced heart failure (HF), its determination requires sophisticated equipment. The six-minute walk test (6-MW) is a simple indirect measure of functional capacity, and predicts survival in moderate HF To assess the predictive value of the 6-MW, MVO2, and percent predicted age-sex adjusted MVO2 (%MVO2) in advanced HF, 45 pts (age 49 ± 8 yrs mean ± SD, LVEF 0.20 ± 0.06, RVEF 0.31 ± 0.11) underwent cardiopulmonary exercise testing (cycle ergometry) and the 6-MW during TX evaluation. Mean 6-MW distance ambulated was 310 ± 100 meters, MV02 12.2 ± 4.5 ml/kg/min, and %MVO2 38 ± 11%. Multivariate analysis of patient characteristics, resting hemodynamics and 6-MW (age, sex, weight, peak HR and BP during the 6-MW, right and left ventricular ejection fraction, right atrial pressure, mean pulmonary artery pressure, and cardiac index) identified distance ambulated during the 6-MW as the strongest predictor of MVO2 (p l 0.000) and %MVO2 (p l 0.000). In univariate survival analysis, 6-MW g 300 meters predicted survival to the combined end-point death or hospital admission for inotropic/mechanical support (IN) as a bridge to TX (p l 0.05). but not overall survival (p = 0.075). In multivariate proportional hazards survival analysis designed to compare %MVO2, MVO2, and 6-MW, MVO2 was selected as the best predictor of overall survival, and %MVO2 as the best predictor of IN-free survival. 6-MW was not selected in any multivariate analysis. Conclusions In pts with advanced HF evaluated for TX, distance ambulated during the 6-MW predicts 1) MVO2 and %MVO2 and 2) IN-free survival but not overall survival. MVO2 and %MVO2 may be superior to the 6-MW as predictors of survival in these pts: however, further studies to es1ablish the prognostic utility of the 6-MW in pts with advanced HF are warranted.

Background Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA). Objectives This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA. Methods Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm−5 based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test. Results After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm−5 in the PADN group versus 149 ± 73 dyn‧s‧cm−5 in the MED group, mean between-group difference was 109 dyn‧s‧cm−5 (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03). Conclusions PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.

Background The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. Objectives This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. Methods The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Results Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. Conclusions The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.