Improvement In 6-minute Walk Distance Research Articles

Atrial Fibrillation Status and Physical Rehabilitation in Older Patients With Acute Decompensated Heart Failure: An Analysis From the REHAB-HF Trial.

The REHAB-HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) trial demonstrated that a transitional, tailored, progressive rehabilitation intervention improved physical function, 6-minute walk distance, frailty, quality-of-life, and depression in older patients hospitalized for acute decompensated heart failure. This analysis assessed the impact of atrial fibrillation (AF) on intervention benefits. Of 349 enrolled patients hospitalized for acute decompensated heart failure (mean age 72.7±8.1 years), 176 (50.4%) had AF. Participants were randomly assigned to 12-week rehabilitation intervention or attention control. The primary outcome was Short Physical Performance Battery score at 3 months. Participants with AF were older (74.4±8.3 versus 70.8±7.5, P<0.0001) and had higher prevalence of heart failure with preserved ejection fraction (58.5% versus 47.4%, P=0.037). Patients with and without AF had similar improvement in Short Physical Performance Battery score (mean difference between rehabilitation intervention and attention control, 1.5 [95% CI, 0.6-2.3] versus 1.5 [95% CI, 0.7-2.3]; P<0.001). Those with AF had significant improvement in 6-minute walk distance (all P<0.05) and each of the Short Physical Performance Battery domains: balance, 4-meter walk, and chair rise. Kansas City Cardiomyopathy Questionnaire score significantly improved in patients with AF (P<0.05) but not those without AF (P>0.05). Interaction P values for 3-month outcomes by AF status were not significant (P>0.1). No significant differences were observed in deaths, all-cause rehospitalizations, or heart failure hospitalizations at 6 months. In older, hospitalized patients with acute decompensated heart failure, the presence of AF did not significantly affect the benefit of the rehabilitation intervention on physical function and quality of life. The intervention appears safe and effective regardless of AF status. URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02196038.

Tadalafil for Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension in Patients With Heart Failure and Preserved Ejection Fraction: A Randomized Controlled Phase 3 Study.

We assessed the efficacy and safety of tadalafil, a phosphodiesterase type 5 inhibitor, in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension. In the double-blind PASSION study (Phosphodiesterase-5 Inhibition in Patients With Heart Failure With Preserved Ejection Fraction and Combined Post- and Pre-Capillary Pulmonary Hypertension), patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension were randomized 1:1 to receive tadalafil at a target dose of 40 mg or placebo. The primary end point was the time to the first composite event of adjudicated heart failure hospitalization or all-cause death. Secondary end points included all-cause mortality and improvements in New York Heart Association functional class or ≥10% improvement in 6-minute walking distance from baseline. Initially targeting 372 patients, the study was terminated early because of disruption in study medication supply. At that point, 125 patients had been randomized (placebo: 63; tadalafil: 62,). Combined primary end-point events occurred in 20 patients (32%) assigned to placebo and 17 patients (27%) assigned to tadalafil (hazard ratio, 1.02 [95% CI, 0.52-2.01]; P=0.95). There was a possible signal of higher all-cause mortality in the tadalafil group (hazard ratio, 5.10 [95% CI, 1.10-23.69]; P=0.04). No significant between-group differences were observed in other secondary end points. Serious adverse events occurred in 29 participants (48%) in the tadalafil group and 35 (56%) in the placebo group. The PASSION trial, terminated prematurely due to study medication supply disruption, does not support tadalafil use in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension, with potential safety concerns and no observed benefits in primary and secondary end points. URL: https://www.clinicaltrialsregister.eu/; Unique identifier: 2017-003688-37. URL: https://drks.de; Unique identifier: DRKS -DRKS00014595.

Pulmonary Arterial Hypertension (PAH) Group 1: Overview, Workup, Risk Stratification, and Current (and Future) Treatment Approaches

Abstract: Risk assessment (or risk stratification) and both current and future therapies for pulmonary arterial hypertension (PAH) will be discussed in part B. Risk assessment is key in the initial evaluation and follow-up of persons with PAH. Risk assessment provides information on disease severity and mortality, which, over time, have been incorporated into the application of PAH therapies. After the initial risk assessment, a 4-strata approach is recommended at subsequent follow- up evaluations by the 2022 ERS/ESC pulmonary hypertension (PH) guidelines as described initially in COMPERA 2.0. This method appears to have increased sensitivity to changes in risk from baseline to follow-up and to changes in long-term mortality risk. Current PAH therapies target the prostacyclin, endothelin, and nitric oxide pathways. A sequential approach to therapy has been recommended since publication of the 2009 guidelines and, in the most recent iteration incorporates the 4-strata approach at follow-up. Additional therapy is recommended when intermediate- high or high-risk status is present. New therapies are under active investigation that include targeting novel pathways. Sotatercept, a fusion protein that binds to and sequesters select transforming growth factor β superfamily ligands, is the most promising novel therapy at this time. A recent phase 3, randomized, double-blind, placebo-controlled study in group 1 PAH patients showed a statistically significant improvement in 6-minute walk distance and additional studies of this drug in PH populations are ongoing. Progress in phenotyping this heterogeneous disease is being made, and as PAH therapies continue to evolve, the use of personalized treatment regimens may be possible in the care of this complex, and highly morbid and mortal disease.

A Personalized Cell-Based Therapy for Ischemic Heart Failure With Reduced Ejection Fraction: Safety and Feasibility Outcomes of the Roll-In Cohort of the CardiAMP Cell Therapy Trial and Review of Similar Trials.

CardiAMP Cell Therapy for Heart Failure trial is a prospective, multicenter, randomized, controlled, double-blinded trial that has been granted breakthrough designation by the United States Food and Drug Administration. This trial evaluates clinical outcomes of intramyocardial delivery of a high dose of autologous bone marrow mononuclear cells in chronic postmyocardial infarction heart failure patients. This trial represents the first attempt to personalize marrow-derived cell-based therapy for the treatment of ischemic heart failure with reduced ejection fraction. The roll-in cohort of 10 patients demonstrated improvements in 6-minute walk distance at 6 months (+47.8 m, P = 0.01), 12 months (+46.4 m, P = 0.06), and 24 months (+31 m), and improvements in New York Heart Association class at 3 months (P = 0.015) and 6 months (P = 0.037). Four patients were reduced to New York Heart Association class I at 24 months and Minnesota Living with Heart Failure Questionnaire score was improved in 6 of 10 patients at 24 months. The improved clinical outcomes demonstrated in CardiAMP are consistent with previous clinical trials including the Transendocardial Autologous Cells in Ischemic Heart Failure (TAC-HFT) trial, Prospective Randomized Trial of Direct Endomyocardial Implantation of Bone Marrow Cells for Treatment of Severe Coronary Artery Diseases (PROTECT-CAD), and REGENERATE-Ischemic Heart Disease trial.

Macitentan tadalafil Fixed Dose Combination (FDC) in treatment-naive and prior monotherapy patients with Pulmonary Arterial Hypertension (PAH): insights from A DUE

Abstract Background Combination therapy is recommended for the management of pulmonary arterial hypertension (PAH). The A DUE study showed that M/T FDC, a fixed dose combination (FDC) of the endothelin receptor antagonist (ERA) macitentan 10mg (M) and the phosphodiesterase type 5 inhibitor (PDE5i) tadalafil 40mg (T), led to a clinically relevant improvement in pulmonary vascular resistance (PVR) vs macitentan and tadalafil monotherapies in PAH patients. A clinically meaningful trend for improvement in 6-minute walk distance (6MWD) in favor of M/T FDC vs macitentan and tadalafil was observed. Purpose Here we analysed the effect of M/T FDC in the subgroups of treatment-naïve and prior monotherapy patients. Methods In A DUE 187 adult PAH patients in WHO functional class II / III were randomised 2:1:1 to M/T FDC, macitentan or tadalafil if treatment-naïve, 2:1 to M/T FDC or macitentan if on prior ERA, and 2:1 to M/T FDC or tadalafil if on prior PDE5i. The treatment effect of M/T FDC vs macitentan and M/T FDC vs tadalafil was calculated using ANCOVA models for PVR (geometric mean ratios [95% CL]) and for 6MWD (mean change [95% CL]) in treatment-naïve patients and in patients on prior monotherapy (ERA or PDE5i) at randomisation. Results Treatment effects for M/T FDC versus macitentan and versus tadalafil on the change in PVR and 6MWD are reported in the table for each subgroup, along with those for the overall population. The safety profile of M/T FDC was in line with the safety profiles of macitentan and tadalafil. Conclusions In A DUE, the effect of M/T FDC vs both monotherapies on PVR and 6MWD in treatment-naïve and prior ERA/PDE5i patients was consistent with that observed in the overall population.

Abstract 13431: Safety and Efficacy of Pulmonary Artery Denervation Therapy for the Treatment of Pulmonary Artery Hypertension

Background: Despite recent advances in the treatment of pulmonary arterial hypertension (PAH), the survival rate remains poor in severe PAH. Pulmonary artery denervation (PADN) therapy for PAH is gaining popularity, although the safety and efficacy of PADN were not fully evaluated. Therefore, we conducted an updated systematic review and meta-analysis of the safety and efficacy of PADN in the treatment of patients with PAH. Methods: Using PRISMA guidelines, we searched PubMed, Embase, Cochrane, and the Clinical Trials.gov databases from inception till May 2023 for placebo-controlled outcome studies that compared PADN therapy to placebo in patients with moderate-severe PAH. The literature was screened for appropriate randomized clinical trials (RCT) and prospective studies, and data were extracted and analyzed. Comprehensive meta-analysis software (CMA v3, Biostat Inc. Englewood, NJ, USA) was utilized to perform statistical analyses. Results: The metanalysis included 8 studies (7 RCTs and 1 prospective) with 577 patients (PADN group = 270, placebo = 307). PADN treatment was associated with a significant reduction in mean pulmonary artery pressure [weighted mean difference (WMD) = -6.9 mmHg; 95% CI = -9.7, -4.1; P &lt; 0.01; I 2 = 61] and pulmonary vascular resistance [WMD = -3.2 dyne.s.cm -5 ; 95% CI = -5.4, -0.9; P = 0.005; I 2 = 95]. There was a statistically significant improvement in the cardiac output [WMD = 0.3 l/min; 95% CI = 0.07, 0.6; P=0.012; I 2 = 76] and numerical improvement in 6-minute walking distance [WMD = 67.7m; 95% CI = -3.73, 139.2; P = 0.06; I 2 = 95] in the PADN group. There were fewer side effects in the PADN group as compared to the placebo group. Conclusion: This updated metanalysis supports PADN as a safe and efficacious therapy for moderate-severe PAH. Findings are limited by small sample size, medium-quality literature, and large data heterogeneity, necessitating larger RCT with clinical endpoints comparing PADN therapy with optimal medical treatment.

Cardiac contractility modulation therapy in patients with implanted cardiac resynchronization therapy: results of the 2 year follow-up

Aim. Cardiac contractility modulation (CCM) is a device therapy for patients with heart failure with reduced ejection fraction (HFrEF), most of the data on its programming are concerned patients with narrow QRS and of limited follow up. Our aim was to propose programming approach for Optimizer device in setting of wide QRS complex and fragmented ventricular local activation.Methods. We enrolled 11 patients with HFrEF (median age, 8 males, median NYHA class 3) and LBBB-related wide QRS complex, who underwent Optimizer™ device implantation. Three patients got Optimizer™ IV system and eight patients were implanted Optimizer™ Smart. Ten patients were previously implanted with CRT-D due to HFrEF and LBBB; one patient received CRT-D after Optimizer™ implantation.Results. During the implantation procedure ventricular local sense (LS) channel signal fragmentation was detected in all patients. In five patients signal detection was optimized by lead relocation. In six patients LS signal sensitivity limitations were resolved by programming. At two-year follow-up survival 4 patients died of noncardiac causes (1 intracranial hemorrhage, 1 gastrointestinal bleeding and 2 - terminal kidney failure). At 12-month follow-up we observed a non-significant improvement in 6-minute walking distance (300 vs 305, p=0.093), NYHA class (2.75 vs 2, p=0.085), MLHF score (53 vs 42, p=0.109) and left ventricular ejection fraction (LVEF) (30 vs 33.5, p=0.212).Conclusion. CCM system implantation is feasible and safe in patients with HFrEF and LBBB-related wide QRS complex. Device programming maneuvers can resolve the challenges of ventricular local signal detection in these patients.

Short-Term Pulmonary Rehabilitation Among Post-Pulmonary Tuberculosis Patients During Coronavirus Disease 2019 Pandemic.

Coronavirus disease 2019 is expected to have a widespread and significant impact on pulmonary tuberculosis services. This study aims to investigate the effect of comprehensive short-term, outpatient pulmonary rehabilitation program among treated pulmonary tuberculosis patients during the coronavirus disease 2019 pandemic. Forty-five pulmonary tuberculosis patients who completed their tuberculosis treatment were randomly allocated to the outpatient pulmonary rehabilitation group and the other 45 were allocated to the control group for 4 weeks. The pulmonary rehabilitation program comprised supervised endurance and resistance training, breathing techniques, self-management strategies, and patient education. The outcome measures evaluated in both groups were functional capacity assessed by a 6-minute walk test, healthrelated quality of life (short-form 36 questionnaire), pulmonary function (forced expiratory volume in 1 second/forced vital capacity, forced vital capacity, and forced expiratory volume in 1 second), and dyspnea by modified Medical Research Council dyspnea scale. All measurements were performed at enrolment and after completion of 4 weeks protocol in both the groups. There was a significant improvement in 6-minute walk distance in meters (P = .001) and percentage predicted (P = .014) in the pulmonary rehabilitation group compared to the control group. All domains of the short-form 36 questionnaire showed significant improvement post-pulmonary rehabilitation (P < 0.05), and modified Medical Research Council dyspnea scale also significantly improved in the pulmonary rehabilitation group (P < .001). However, no significant differences were observed in any of the pulmonary function measures (P > .05) between the groups after 4 weeks. Short-term pulmonary rehabilitation program in pulmonary tuberculosis demonstrated improvement in functional capacity, quality of life, and dyspnea. However, it failed to register changes in pulmonary function. The study results provide motivation to consider the implementation of a short-term pulmonary rehabilitation program after pulmonary tuberculosis treatment to reduce the impairment the patient may suffer even after microbiological cure.

Efficacy of Multiple Exercise Therapy after Coronary Artery Bypass Graft: A Systematic Review of Randomized Control Trials.

Coronary artery bypass graft (CABG) is intended to restore myocardial perfusion and alleviate morbidity among patients suffering from coronary artery disease. Due to procedural complexity, and anesthetic medications, post-operative complications are more prevalent, requiring the integration of rehabilitation strategies. This review aimed to determine the effect of single and multiple exercise therapy on rehabilitation after CABG surgery. We conducted a systematic search of databases (EBSCOhost, Scopus, PubMed, and Web of Science) from 01 January 2000 to 15 September 2022. The protocol of this systematic review is registered to PROSPERO. We found nine randomized control trials composed of 599 CABG patients. In-patient cardiac rehabilitation (CR), a combination of inspiratory muscle training, mobilization, active upper and lower limb exercise, and aerobic exercise as multiple exercise therapy, found significant improvement in 6-minute walking distance (6MWD) than single exercise therapy (breathing exercise) at discharge and follow-up (moderate quality evidence). Contrary, multiple exercises group compared to single exercise groups did not improve the peak volume of oxygen ( ) at discharge. Still, significant improvement was found at follow-up (moderate quality of evidence). On the other hand, the out-patient CR made up of high-intensity inspiratory muscle training, upper and lower limbs resistance training, and aerobic exercise as multiple exercise therapy significantly improved 6MWD and peak at discharge (High-quality evidence). Our review revealed that multiple exercise therapy significantly improves functional and exercise capacity in in-patient and out-patient cardiac rehabilitation settings than single exercise therapy, but more than double exercise therapy protocol may be inefficient for improvement of quality of life. Inspiratory muscle training and resistance training in exercise therapy protocols significantly supplant the outcome, which requires further investigation.

Pulmonary vasodilator therapy in sarcoidosis-associated pulmonary hypertension may decrease lung function decline and mortality.

The efficacy of treating sarcoidosis-associated pulmonary hypertension (SAPH) with pulmonary vasodilator therapy is unclear. The INCREASE trial showed improvement in 6-minute walk distance (6MWD) and in decline in functional vital capacity (FVC) in patients with interstitial lung disease and pulmonary hypertension. We hypothesize that patients with SAPH treated with pulmonary vasodilators have reduced decline in FVC. We retrospectively analyzed patients with SAPH who underwent lung transplantation evaluation. The primary objective was to compare change in FVC between patients with SAPH who received pulmonary vasodilators (treated) and those who did not (untreated). Secondary objectives were to compare the change in 6MWD, change in oxygen requirement, transplant rates, and mortality between treated and untreated SAPH patients. We identified 58 patients with SAPH; 38 patients received pulmonary vasodilator therapy, and 20 patients did not. Treated SAPH patients had significantly less decline in FVC than untreated SAPH patients (+54 mL vs. -357 mL, p < 0.01). Treated SAPH patients had significantly higher survival than untreated SAPH patients. Receiving PH therapy was significantly associated with a change in FVC (estimate 0.36 ± 0.07, p < 0.01) and decreased mortality (hazard ratio 0.29, confidence interval 0.12-0.67, p < 0.01). Among patients with SAPH, those who received pulmonary vasodilator therapy had significantly less decline in FVC and increased survival. Receiving pulmonary vasodilator therapy was significantly associated with FVC change and decreased mortality. These study findings point towards potential benefit of pulmonary vasodilator therapy in SAPH patients. Further prospective studies are required to fully elucidate the benefits of pulmonary vasodilator therapy in SAPH.

Safe and Effective Balloon Pulmonary Angioplasty in the Outpatient Setting: The Michigan Medicine Experience.

Balloon pulmonary angioplasty (BPA) is currently performed at select centers worldwide, with the current standard of practice being postprocedural inpatient monitoring for 24 to 72 hours. We sought to evaluate the safety and efficacy of BPA in a cohort of patients with chronic thrombo-embolic pulmonary disease (CTEPD) and chronic thromboembolic pulmonary hypertension (CTEPH) and outline a protocol for implementation in the outpatient setting. All patients with distal, inoperable CTEPH, residual symptoms after pulmonary endarterectomy, or symptomatic CTEPD from July 1, 2020, to June 30, 2022, were evaluated by a multidisciplinary chronic thromboembolic pulmonary hypertension team for consideration of BPA. Patients undergoing each BPA session adhered to a regimented protocol developed and implemented at our institution. Safety and efficacy were retrospectively evaluated with a mean follow-up time of 8.5 months. Eighteen patients underwent a total of 78 BPA sessions. Overall, there was a significant improvement in World Health Organization functional class and mean improvement in 6-minute walking distance of +67 m. Hemodynamic parameters significantly improved with a mean decrease in mean pulmonary artery pressure and pulmonary vascular resistance of 7.3 ± 5.8 mm Hg and 1.7 ± 1.5 Wood units, respectively (P <.05). Complication rates were low with 3 (3.9%) of 78 patients developing scant hemoptysis and 1 (1.3%) of 78 experiencing vascular injury requiring inpatient hospitalization. BPA is both safe and effective when implemented in the outpatient setting using a regimented protocol provided there are necessary contingencies in place.

Attendance at Supervised Exercise Sessions and Walking Outcomes in Peripheral Artery Disease: Results From 2 Randomized Clinical Trials.

Background Supervised exercise therapy (SET) is the first-line therapy for walking impairment in peripheral artery disease (PAD). This study evaluated the association between attendance at SET and improved walking performance, compared with a control group, in PAD. Methods and Results Data from 2 randomized clinical trials of SET for PAD were combined. In each trial, participants were randomized to 3 times weekly supervised treadmill exercise or an attention control group for 6 months (maximum, 77 exercise sessions). Participants randomized to SET were categorized into tertiles, according to the proportion of exercise sessions they attended. Results adjusted for age, sex, race, baseline walking performance, comorbidities, and other potential confounders. A total of 272 participants with PAD (mean age, 67.9±9.3 years; 44% women; 61% Black race) were included. For participants randomized to SET, tertiles of attendance rates at exercise sessions were as follows: 11% to 68% (N=45), 69% to <85% (N=46), and ≥85% (N=46). Compared with control, mean improvement in 6-minute walk was significantly greater in each SET tertile: mean (95% CI) for tertile 1, 27.9 m (1.3-54.4 m; P=0.04), tertile 2, 38.2 m (12.2-64.2 m; P=0.001), and tertile 3, 56.9 m (29.9-83.8 m; P<0.0001). Among participants randomized to SET, greater SET attendance was associated with greater improvement in 6-minute walk distance (overall P for trend=0.025). Compared with control, improvement in maximal treadmill walking time was greater in each SET attendance tertile: tertile 1 (3.3 minutes [95% CI, 1.7-4.8 minutes]; P<0.0001), tertile 2 (3.8 minutes [95% CI, 2.3-5.3 minutes]; P<0.0001), and tertile 3 (5.4 minutes [95% CI, 3.9-7.0 minutes]; P:<0.0001). Among participants randomized to SET, greater attendance at SET was not significantly associated with greater improvement in maximal treadmill walking time (overall P for trend=0.064). Conclusions Among people with PAD randomized to SET, better attendance at exercise sessions was associated with significantly greater 6-minute walk improvement. Among all participants with PAD, even relatively low SET attendance was associated with significantly greater improvement in walking performance, compared with a control group who did not exercise. Registration URL: https://clinicaltrials.gov/ct2/show/NCT01408901. URL: https://clinicaltrials.gov/ct2/show/NCT00106327.

Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial

BackgroundWorld Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary artery pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial. ObjectivesThe aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH. MethodsPatients with WHO group 1 PAH not taking PAH-specific drugs for at least 30 days were enrolled in a multicenter, sham-controlled, single-blind, randomized trial. Patients were assigned to receive PADN plus a phosphodiesterase-5 inhibitor or a sham procedure plus a phosphodiesterase-5 inhibitor. The primary endpoint was the between-group difference in the change in 6-minute walk distance from baseline to 6 months. ResultsAmong 128 randomized patients, those treated with PADN compared with sham had a greater improvement in 6-minute walk distance from baseline to 6 months (mean adjusted between-group difference 33.8 m; 95% CI: 16.7-50.9 m; P < 0.001). From baseline to 6 months, pulmonary vascular resistance was reduced by −3.0 ± 0.3 WU after PADN and −1.9 ± 0.3 WU after sham (adjusted difference −1.4; 95% CI: −2.6 to −0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation, and decreased N-terminal pro–brain natriuretic peptide. Clinical worsening was less (1.6% vs 13.8%; OR: 0.11; 95% CI: 0.01-0.87), and a satisfactory clinical response was greater (57.1% vs 32.3%; OR: 2.79; 95% CI: 1.37-5.82) with PADN treatment during 6-month follow-up. ConclusionsIn patients with WHO group 1 PAH, PADN improved exercise capacity, hemodynamic status, and clinical outcomes during 6-month follow-up. (Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension [PADN-CFDA]; NCT03282266)

Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside.

Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy. The aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR. The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography. Nineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30days that were maintained after a median of 265days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage. Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements inmitral regurgitation and in heart failure quality-of-life assessments.

Total body recumbent stepping vs treadmill walking in supervised exercise therapy: A pilot study.

Background: Treadmill walking is the most commonly recommended exercise modality in supervised exercise therapy (SET) for peripheral artery disease (PAD); however, other modalities may be equally effective and more tolerable for patients. The primary aim of this single-blind, randomized pilot study was to compare the feasibility, safety, and preliminary efficacy of a treadmill walking (TM) versus a total body recumbent stepping (TBRS) exercise program for treatment of PAD (i.e., "Stepper Study").. Methods: Participants (n = 19) enrolled in a 12-week SET program and were randomized to either a TM (n = 9) or TBRS (n = 10) exercise group that followed current SET exercise guidelines. Feasibility, safety, and efficacy outcomes were assessed. Results: SET attendance was 86% and 71%, respectively, for TBRS and TM groups (p = 0.07). Session exercise dose (metabolic equivalents of task [MET] minutes) (mean [SD]) for TM was 117.6 [27.4] compared to 144.7 [28.7] in the TBRS group (p = 0.08). Study-related adverse events were nine in 236 training hours and three in 180 training hours for the TBRS and TM groups, respectively. There were no significant differences between groups for improvement in 6-minute walk distance (mean [SD]) (TM: 133.2 ft [53.5] vs TBRS: 154.8 ft [49.8]; p = 0.77) after adjusting for baseline 6-minute walk distance. Conclusion: This is the first randomized study comparing TBRS to TM exercise in SET using current SET guidelines. This pilot study showed that TBRS is a feasible and safe exercise modality in SET. This study provides preliminary efficacy of the use of TBRS exercise in SET programs following current guidelines. Larger studies should be conducted to confirm these findings.

A primary care medical home approach to pulmonary rehabilitation.

BackgroundPulmonary rehabilitation (PR) is an evidence-based, nonpharmacological intervention aimed to improve quality of life for patients living with Chronic Obstructive Pulmonary Disease (COPD). Unfortunately, in Canada, most PR programs are hospital based and these are few in number; therefore, accessibility to PR programs is limited.MethodsThe Edmonton Southside Primary Care Network implemented an evidence-based PR program within the setting of the patient’s medical home.ResultsPost-program evaluation demonstrated improvement in 6-minute walk distance, lower body strength, COPD health status, and quality of life, as well as a reduction in emergency department visits 1 year after program completion.ConclusionThe results conclude that delivery of a PR program in a primary care setting is effective and can help address the issue of accessibility.

Increased Pulmonary Arterial Compliance after Balloon Pulmonary Angioplasty Predicts Exercise Tolerance Improvement in Inoperable CTEPH Patients with Lower Pulmonary Arterial Pressure

BackgroundBalloon pulmonary angioplasty (BPA) improved pulmonary arterial compliance (CPA) and exercise tolerance in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). ObjectivesTo investigate whether CPA is a useful index to indicate exercise tolerance improvement by BPA in CTEPH patients. MethodsThe correlation between changes in CPA and improvements in 6-minute walk distance (6MWD) by BPA was retrospectively analyzed in 70 patients (Analysis 1), and it was sequentially analyzed in 46 symptomatic patients who achieved mean pulmonary arterial pressure (mPAP)<30mmHg (Analysis 2). ResultsWe enrolled 70 patients (female/male:57/13, mean age:59 years) who underwent a total of 352 BPA sessions which significantly increased CPA (1.5±0.8 vs. 3.0±1.0 mL/mmHg) and decreased pulmonary vascular resistance (PVR) (8.0 ± 3.9 vs. 3.6 ± 1.7 wood units). The correlation coefficient between improvement in 6MWD and changes in PVR and CPA were r=0.21 (p=0.09) and r=0.14 (p=0.26) (Analysis 1). In Analysis 2, those were r=0.32 (p=0.06) and r=0.38 (p=0.02), respectively. ConclusionsCPA can be a useful index to indicate the improvement in exercise tolerance by BPA in symptomatic patients with lower mPAP.

PH Roundtable: Conundrums and Controversies in PH-ILD: To Treat or Not to Treat—Identifying Optimal Treatment Candidates

PH Roundtable: Conundrums and Controversies in PH-ILD: To Treat or Not to Treat—Identifying Optimal Treatment Candidates

Survival after inpatient or outpatient pulmonary rehabilitation in patients with fibrotic interstitial lung disease: a multicentre retrospective cohort study

BackgroundThe impact of pulmonary rehabilitation (PR) on survival in patients with fibrotic interstitial lung disease (ILD) is unknown. Given the challenges conducting a large randomised controlled trial, we aimed to...

Improvement in 6-Minute Walking Distance after Supervised Exercise Training Is Related to Changes in Quality of Life in Patients with Lower Extremity Peripheral Artery Disease.

This study aimed to investigate the relationship between supervised exercise training (SET)-induced changes in treadmill performance and 6 min walking distance, and changes in general (physical and mental) self-perceived health-related quality of life (HRQoL) in symptomatic patients with lower extremity peripheral artery disease (PAD). This is an observational study investigating Fontaine stage II PAD patients participating in 3-month SET. Before and following SET, treadmill performance (pain-free (PFWD) and maximal (MWD)), and 6 min walking distance (6MWD) were assessed. Self-perceived HRQoL was assessed with the Medical Outcomes Study Short-Form 36 (SF-36). Ankle- and toe-brachial indexes were also measured. One-hundred forty-seven patients with PAD were included (64.9 ± 9.6 y, 70% men). After SET, PFWD (+102%, p ≤ 0.001), MWD (+87%, p ≤ 0.001), and 6MWD (+14%, p ≤ 0.001) significantly increased. All eight SF-36 subscale scores significantly improved following SET (p ≤ 0.04). SET significantly improved physical and mental component summaries of the SF-36 (p ≤ 0.001). Larger increases in 6MWD were associated with greater improvements in physical (β = 0.19; p = 0.02) and mental (β = 0.24; p = 0.005) component summaries of the SF-36. No significant relationship was observed between changes in treadmill performance and changes in physical and mental component summaries of the SF-36. These results show that improvements in 6MWD following SET are related to improvements in general self-perceived HRQoL in patients with symptomatic lower extremity PAD. On the contrary, changes in treadmill performance were not related to improvements in HRQoL. These results suggest that the 6 min walking test is an essential outcome measure to assess overall patient functional status following interventions in patients with PAD.