Improvement In 6MWD Research Articles

FP.17 Long-term follow-up of cipaglucosidase alfa/miglustat in ambulatory patients with Pompe disease: An open-label phase I/II study (ATB200-02)

Cipaglucosidase alfa/miglustat is an investigational, two-component therapy (cipaglucosidase alfa: novel recombinant human GAA; miglustat: enzyme stabiliser) being studied in patients Pompe disease. We report data for up to 36 months for 6-minute walk distance (6MWD) and % predicted sitting forced vital capacity (FVC) from ATB200-02 (NCT02675465). Our ongoing study enrolled 3 cohorts of ambulatory patients: 2–6 years (n=11; age 18–65 years) or ≥7 years (n=6; age 18–75 years) prior enzyme replacement therapy (ERT) with 20 mg/kg alglucosidase alfa biweekly, and ERT naïve (n=6; age 18–65 years). Doses were 20 mg/kg cipaglucosidase alfa by intravenous infusion/260 mg miglustat orally biweekly in the long-term extension. Change from baseline (CFBL) in multiple endpoints were assessed at intervals. We report data at 6, 12, 24 and 36 months. Baseline characteristics were representative of the Pompe population. At 6, 12, 24 and 36 months, durable improvements in 6MWD (metres) were seen: integrated analyses of ERT-experienced cohorts, mean(±standard deviation [SD]) CFBL: 23.1(±44.75), n=16; 33.5(±49.62), n=16; 21.3(±60.90), n=10; 47.8(±53.80), n=8; respectively; ERT-naïve cohort: 36.7(±29.08), n=6; 57.0(±29.96), n=6; 60.7(±36.52), n=5; 43.5(±45.19), n=5; respectively. FVC (%) was mostly stable in ERT-experienced cohorts, mean(±SD) CFBL: –0.8(±8.69), n=16; –1.3(±5.95), n=16; –0.9(±7.65), n=10; –0.4(±7.56), n=8; respectively, but improved in the ERT-naïve cohort: 5.5(±5.68), n=6; 4.5(±7.92), n=6; 6.8(±6.76), n=5; 6.2(±3.42), n=5; respectively. Over 36 months, cipaglucosidase alfa/miglustat was associated with reductions in creatine kinase and urine Hex4. The safety profile for cipaglucosidase alfa/miglustat was similar to that of approved ERT. In conclusion, most ERT-experienced patients either improved or stabilised in efficacy and biomarker outcomes. ERT-naïve patients showed clinical benefit with cipaglucosidase alfa/miglustat. Overall, improvements in clinical response up to 36 months follow-up were sustained and durable.

Selexipag-based triple combination therapy improves prognosis in Chinese pulmonary arterial hypertension patients.

AimSelexipag is an oral selective prostacyclin receptor agonist approved for treatment of patients with pulmonary arterial hypertension (PAH). In the present study, we aim to assess the safety and efficacy of selexipag in triple combination therapy with endothelial receptor antagonists (ERAs) and PDE5is for Chinese PAH patients.Methods and resultsA single center retrospective study was performed on group 1 PAH patients (n = 68) initiating triple combination therapy with selexipag from 1 February 2020 to 31 August 2021 in Qilu Hospital of Shandong University (Shandong, China). Adolescents, children, and PAH patients with unrepaired congenital heart disease were excluded. The French pulmonary hypertension network (FPHN) non-invasive risk assessment, echocardiogram parameters, and clinical data, including tolerability, safety, and death/hospitalization events associated with PAH, were collected. Of the 68 patients, 31 (45.6%) patients had tolerable side effects while only a single patient discontinued selexipag due to severe diarrhea. In the analysis of the efficacy set of 62 patients, the median selexipag treatment time from selexipag initiation to last risk assessment was 27 (21, 33) weeks. Compared to baseline parameters, the percentage of WHO FC III/IV decreased from 77.4% (48) to 24.2% (15) (p = 0.000), median 6-min walk distance (6MWD) increased 82 m [from 398 (318, 450) to 480 (420, 506) m; p = 0.000], and NT-proBNP levels decreased from 1,216 (329, 2,159) to 455 (134, 1,678) pg/mL (p = 0.007). Patients who improved to three low-risk criteria increased from 9.7 to 38.7%. Right ventricular diameter (RV) diameter also decreased and was accompanied by an improved tricuspid annular plane systolic excursion (TAPSE). Patients transitioning from subcutaneous treprostinil to selexipag continued to show improvements in WHO FC, 6MWD (404 ± 94 vs. 383 ± 127 m) and NT-proBNP levels (2,319 ± 2,448 vs. 2,987 ± 3,770 pg/mL). Finally, the 1-year event free survival rate was 96.7% for patients initiating the triple combination therapy within 3 years of PAH diagnosis.ConclusionTriple combination therapy with selexipag was safe and effective in Chinese PAH patients, which was confirmed by acceptable tolerability, and improved exercise capacity, right heart function, risk assessment, and prognosis.

Prognostic value of improvement endpoints in pulmonary arterial hypertension trials: A COMPERA analysis.

The prognostic value of improvement endpoints that have been used in clinical trials of treatments for pulmonary arterial hypertension (PAH) needs to be further investigated. Using the COMPERA database, we evaluated the prognostic value of improvements in functional class (FC) and absolute or relative improvements in 6-min walking distance (6MWD) and N-terminal fragment of pro-brain natriuretic peptide (NT-proBNP). In addition, we investigated multicomponent endpoints based on prespecified improvements in FC, 6MWD and NT-proBNP that have been used in recent PAH trials. Finally, we assessed the predictive value of improvements determined by risk stratification tools. The effects of changes from baseline to first follow-up (3-12 months after initiation of PAH therapy) on consecutive survival were determined by Kaplan-Meier analysis with Log-Rank testing and Cox proportional hazard analyses. All analyses were based on 596 patients with newly diagnosed PAH for whom complete data were available at baseline and first follow-up. Improvements in FC were associated with improved survival, whereas absolute or relative improvements in 6MWD had no predictive value. For NT-proBNP, absolute declines conferred no prognostic information while relative declines by ≥35% were associated with better survival. Improvements in multicomponent endpoints were associated with improved survival and the same was found for risk stratification tools. While sole improvements in 6MWD and NT-proBNP had minor prognostic relevance, improvements in multicomponent endpoints and risk stratification tools based on FC, 6MWD, and NT-proBNP were associated with improved survival. These tools should be further explored as outcome measures in PAH trials.

Meta-analysis Analyzing the Effect of Therapies on 6-Minute Walk Distance in Heart Failure With Reduced Ejection Fraction

The 6-minute walk distance (6MWD) carries prognostic value in patients with heart failure with reduced ejection fraction (HFrEF). We performed this systematic review and meta-analysis to evaluate the effect of heart failure therapies on improvement in 6MWD. A systematic search of MEDLINE and Embase was conducted for randomized controlled trials measuring 6MWD at baseline and at follow-up in at least 50 patients with HFrEF across both arms. The primary outcome was improvement in 6MWD at follow-up. Meta-analysis was stratified in groups on the basis of medical therapy, device-based therapy, autonomic modulation, and exercise. Mean differences (MDs) with 95% confidence interval (CI) were reported across multiple studies that were included in the meta-analysis. A total of 44 studies met the inclusion criteria for systematic review; 17 of which were included for meta-analysis. Statistical analysis showed a statistically significant improvement in 6MWD in meters (m) at follow-up for device-based therapy (MD 20.01 m, 95% CI 18.71 to 21.31), autonomic modulation (MD 76.64 m, 95% CI 54.10 to 99.19), and exercise group (MD 39.52 m, 95% CI 19.68 to 59.35). Pooled analysis of medical therapy did not show statistically significant improvement in 6MWD at follow-up (MD 31.69 m, 95% CI -6.52 to 69.91). Device-based therapy (cardiac resynchronization therapy and cardiac contractility modulation), autonomic modulation, and exercise training programs are associated with improvement in 6MWD in patients with HFrEF. 6MWD is a useful test to gauge improvement in functional capacity among patients with HFrEF, especially those with severe symptomatic heart failure.

Forced Oscillation Measurements in Patients with Idiopathic Interstitial Pneumonia Subjected to Pulmonary Rehabilitation.

(1) Background: Pulmonary rehabilitation (PR) plays a significant therapeutic role for patients with idiopathic interstitial pneumonia (IIP). The study assessed the impact of physical activity on lung function measured by forced oscillation technique (FOT). (2) Methods: The study involved 48 patients with IIP subjected to a 3-week inpatient PR. The control group included IIP patients (n = 44) on a 3-week interval without PR. All patients were assessed at baseline and after 3 weeks of PR by FOT, spirometry, plethysmography, grip strength measurement and the 6-minute walk test. (3) Results: There were no significant changes in FOT measurements in the PR group, except for reduced reactance at 11 Hz, observed in both groups (p < 0.05). Patients who completed PR significantly improved their 6-min walk distance (6MWD) and forced vital capacity (FVC). The change in 6MWD was better in patients with higher baseline reactance (p = 0.045). (4) Conclusions: Patients with IIP benefit from PR by an increased FVC and 6MWD; however, no improvement in FOT values was noticed. Slow disease progression was observed in the study and control groups, as measured by reduced reactance at 11 Hz. Patients with lower baseline reactance limitations achieve better 6MWD improvement.

The effectiveness of additional long-term use of bottle-positive expiratory pressure in chronic obstructive pulmonary disease: A single-blind, randomized study.

Objectives This study aimed to investigate the long-term use of bottle-positive expiratory pressure (PEP) in addition to breathing exercises as a home-based rehabilitation aid on exercise capacity, spirometric parameters, and quality of life in chronic obstructive pulmonary disease (COPD) patients. Patients and methods From a total of 30 patients with stable moderate-to-severe COPD, 24 (22 males, 2 females; mean age: 62.4+7.2 years; range, 40 to 75 years) were included in the final study and randomized into two groups: the group that performed breath retaining techniques and the group that was instructed to use the bottle-PEP in addition to these techniques. Patients were evaluated with modified Medical Research Council scale, COPD assessment test (CAT), spirometry, St. George`s Respiratory Questionnaire (SGRQ), and 6-min walk distance (6MWD) before, three months and six months after the initiation of the program. Results In the bottle-PEP group, patients` mean 6MWD increased from 380.6±67.6 to 444.1±22.0 m (p=0.002), the mean CAT score decreased from 17.8±36.8 to 12.9±6.2 (p=0.03), and the mean SGRQ total score significantly decreased from 57.1±23.1 to 47.6±21.9 (p<0.05) after three months. The improvement in 6MWD continued in six months but disappeared in SGRQ and CAT scores. In the exercise group, only the 6MWD improved, and there were no significant improvements in other parameters regardless of time. There were no significant differences between the groups in any of the parameters at any follow-up session. Conclusion While bottle-PEP does not significantly contribute when added to breathing exercises in patients with moderate-to-severe COPD in improving function and quality of life, it can be used as a safe choice in patients` home rehabilitation programs.

Feasibility and effectiveness of home-based phase III exercise program for frail patients after heart surgery: results of a pilot study

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Research Council of Lithuania Introduction The number of elderly frail patients after cardiac surgery is increasing. Frailty has become an important burden to be treated in cardiac rehabilitation (CR). Purpose To evaluate feasibility and effectiveness of home-based exercise program including endurance, flexibility, sensomotoric and resistance training specially tailored for elderly frail patients after open heart surgery. Methods A pilot study of a prospective, single-center, randomized controlled trial. Inclusion criteria: CR after open heart surgery, age ≥ 65 years, Edmonton frailty scale (EFS) score ≥ 4, patient’s agreement to participate in the study. A sample of 30 Patients (73.1±4.16 years, 73% male, EFS-score 5.68±0.28) were randomly assigned to intervention group (IG n=17) or control group (CG n=13). All patients completed comprehensive 20-days inpatient CR program, including aerobic cycle ergometer training (30 min, 6 sessions/week), sensomotoric and flexibility training (15 min. 3d/w for each), resistance training (25 min, 3 d/w) and respiratory exercises (15 min, 5 days/week). After completion of inpatient-CR, the intervention group (IG) participated in a 12-week home-based exercise program including 30 to 45 minutes exercise sessions on 5 days/week, with endurance, flexibility, balance, and resistance training of low to moderate intensity. IG-participants received baseline instructions and the participation was monitored by telephone calls every second week. The CG received usual care. The 6-minutes-walking-test (6MWT) was used to assess functional capacity, the EFS to assess frailty level. Examination times were baseline, after 20-days CR and 12 weeks after completion of CR. Repeated measures ANOVA was used for statistical analysis. Results Baseline evaluation revealed good comparability of the groups showing significant difference only in the gender distribution (age IG 73.2±0.97 years vs. CG 73.5±1.59 years), p=0.722), frailty level (EFS score CG 6.3±0.4 vs. 5.58±0.35, p=0.56), functional capacity (6MWD IG 285.94±19.92 m. vs. CG 309.62±21.55 m, p=0.430, gender distribution IG were 9 (53%) males vs. CG 13 (100%), p=0.04). Main results are summarized in Table 1. The results show significant improvements in EFS-score and 6MWD over the observation time with no differences between the groups. The home-based program was feasible and safe for the IG, and no adverse effects or events occurred that led to premature discontinuation of study participation. Conclusions The specially tailored home-based-program for elderly frail patients after open heart surgery was well accepted and tolerated by the patients. The results are promising, but probably because of the small sample size, no significant differences were found between the groups in the degree of frailty or functional capacity.

Clustering of COPD patients and their response to pulmonary rehabilitation

Background and objectivePulmonary rehabilitation (PR) is fundamental in the management of chronic obstructive pulmonary disease (COPD). COPD patients show a large clinical heterogeneity that may influence their response to PR. Identification of homogeneous clusters of patients who may or may not respond to PR is important to personalize patient care. This study aimed at identifying distinct clinical phenotypes of COPD patients and assessing their respective 6-min walking distance (6MWD) response to in-patient PR. MethodsThis is a cohort-based analysis of COPD patients admitted to a PR center between January 2012 and December 2017. Pre-PR patients' characteristics, lung function and 6-min walking test parameters were introduced in a hierarchical ascending clustering approach to identify distinct clusters. ResultsOut of 835 patients, 4 distinctive clusters were identified. The most likely to show clinically significant 6MWD improvement post-PR (responders) were cluster 1 (younger men, GOLD I-II, average walkers, obese; non-response rate: 16%), cluster 2 (older women, GOLD II-III, slow walkers; 18%), and cluster 3 (older men, GOLD II-III, dyspneic, slow walkers; 11%). The most likely to be non-responders were cluster 4 (older men, GOLD III-IV, dyspneic, very slow walkers, oxygen-dependent; 26%). ConclusionOur data identified homogeneous patient clusters representing clinically relevant subgroups of COPD patients regarding their 6MWD response to PR. Clusters having the largest probability of being non-responders were older, more severe, with severe oxygen desaturation and dyspnea, limited 6MWD and requiring long-term oxygen therapy. These results may improve patient phenotyping in clinical practice and allow individualization of therapy.

Effect of exercise-based pulmonary rehabilitation in patients with bronchiectasis: A meta-analysis

ObjectiveWe aimed to assess the effectiveness of exercise training in patients with bronchiectasis in terms of exercise capacity, pulmonary function, and quality of life. MethodsPubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs) examining pulmonary rehabilitation to treat bronchiectasis, and the search timeline was from inception through November 2020. Two researchers independently screened the literature, extracted data, evaluated the risk of bias in the included studies, and used Review Manager 5.3 software to perform the meta-analysis. The primary outcomes were incremental shuttle walk distance (ISWD) and 6-minute walk distance (6-MWD) at 8 weeks. The secondary outcomes were forced expiratory volume in 1 second (FEV1), St. George's Respiratory Questionnaire (SGRQ) score, and Leicester Cough Questionnaire (LCQ) score at 8 weeks. ResultsA total of five RCTs with a total of 198 patients were included. A pooled analysis showed that improvements in ISWD (mean difference [MD] = 92.47 m, 95% confidence interval [CI] 49.87, 135.08; P < 0.0001), 6-MWD (MD = 31.01 m, 95% CI 1.60, 60.42; P = 0.04), and FEV1 (MD = 0.08 L, 95% CI 0.04, 0.12; P = 0.0002) in the pulmonary rehabilitation group were more marked than in the control group. There was no significant difference between the two groups in terms of the improvement in SGRQ and LCQ scores. ConclusionsPulmonary rehabilitation improves exercise capacity and pulmonary function (specifically FEV1) in patients with bronchiectasis. However, due to limitations in the number and quality of current studies, the above conclusions need to be verified in future research.

Efficacy and safety of endothelin receptor antagonists combined with phosphodiesterase 5 inhibitor in the treatment of pulmonary arterial hypertension: a network meta-analysis

Objective: To examine the efficacy and safety of endothelin receptor antagonists (ERA) combined with phosphodiesterase 5 inhibitors (PDE5i) in the treatment of pulmonary artery hypertension (PAH). Methods: Computer-based retrieval was performed on PubMed, Cochrane Library, CNKI, Wanfang, and VIP database (up to February 12th, 2021). Randomized controlled trials about endothelin receptor antagonists (ERAs) or PDE5i in patients with PAH were collected. The change of 6-minute walking distance (6MWD) in 12-16 weeks was used as primary outcome index. Case fatality rate, worsening clinical events, WHO functional class (FC) improvement, adverse events (AEs), serious adverse events (SAE) were the key secondary outcomes indicators. STATA 16.0 software was used for network meta-analysis, and the pooled estimates of odds ratios (ORs) or weighted mean differences (WMDs) and 95% confidence intervals (CIs) of the results were shown. To help explain ORs and WMDs, we used the surface under the cumulative ranking curve (SUCRA) to calculate the probability of each intervention. Results: We included 29 trials with 5 949 participants. In network meta-analysis, Bosentan combined with Sildenafil (WMD=53.93, 95%CI=6.19-101.66) had shown the greatest improvement in 6MWD compared with placebo, followed by Bosentan combined with Tadalafil (WMD=50.84, 95%CI=7.05-94.62), Ambrisentan combined with Tadalafil (WMD=46.67, 95%CI=15.88-77.45), Bosentan (WMD=29.44, 95%CI=5.86-53.02), Ambrisentan (WMD=23.90, 95%CI=0.31-47.48) and Macitentan (WMD=21.57, 95%CI=2.45-40.69). According to SUCRA, the effects of different intervention measures on improving 6MWD in patients with arterial pulmonary hypertension were as follows: Bosentan+Sildenafil (82.9%)>Bosentan+Tadalafil (78.4%)>Ambrisentan+Tadalafil (77.1%)>Bosentan (49.2%)>Sildenafil (48.5%)>Ambrisentan (40.3%)>Macitentan (37.3%)>Tadalafil (33.0%)>Placebo (3.3%). For the WHO functional class, Sildenafil (OR=2.90, 95%CI=1.04-8.08) was optimal compared with placebo, followed by Bosentan (OR=2.15, 95%CI=1.15-4.04), and there was no significant difference in the rest. For clinical worsening, Bosentan combined with Tadalafil (OR=0.08, 95%CI=0.01-0.49) performed best compared with placebo, followed by Bosentan (OR=0.20, 95%CI=0.11-0.38), Bosentan combined with Sildenafil (OR=0.21, 95%CI=0.09-0.46), Ambrisentan combined with Tadalafil (OR=0.27, 95%CI=0.15-0.50), Sildenafil (OR=0.33, 95%CI=0.17-0.66) and Tadalafil (OR=0.44, 95%CI=0.21-0.90). There was no statistical difference between all interventions and placebo in terms of the incidence of adverse events and serious adverse events. For case fatality rate, Ambrisentan (OR=0.28, 95%CI=0.11-0.74) was statistically superior to placebo and there was no statistics difference in the rest. Conclusions: The combination therapy of ERAs and PDE5i performed well in the short-term improvement of motor function. Furthermore, there was no significant difference with monotherapy in terms of safety. However, it is worth emphasizing that the choice of treatment should be based on the patient's individualized situation and the patient's requirements.

Outcome of Surgery for Chronic Thromboembolic Pulmonary Disease without Pulmonary Hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a serious condition that results from incomplete resolution of thromboemboli in pulmonary arteries. Symptomatic patients with chronic thromboembolic disease may have normal hemodynamic at rest. The aim of this study is to evaluate the outcome of pulmonary endarterectomy (PEA) in symptomatic patients with chronic thromboembolic pulmonary disease (CTEPD) in the absence of pulmonary hypertension as currently defined (mean pulmonary artery pressure [mPAP] < 20 mm Hg). Here, we report four symptomatic patients with chronic thromboembolic and normal hemodynamic at rest (mPAP ≤20 mm Hg or 20 < mPAP < 25 mm Hg and pulmonary vascular resistance [PVR] < 240 dyn·s/cm5) who underwent PEA between September 2015 and September 2019. The main outcome measures were functional New York Heart Association class, 6-minute walk distance (6MWD), hemodynamic measures in right heart catheterization (RHC), morbidity, and mortality. There were significant improvement in function class (2.6 ± 0.54 vs. 1 ± 0.2, p = 0.00), mPAP (preoperative: 23.3 ± 0.5 mm Hg vs. postoperative: 18.6 ± 1.5 mm Hg, p = 0.02), 6MWD (preoperative: 378.2 ± 68.7 m vs. postoperative: 432.9 ± 44.5 m, p = 0.01), and PVR (215.33 ± 91 vs. 101 ± 32 dyn·s/cm5, p = 0.1) 6 months after surgery based on data from RHC which was done during exercise. Also, RHC showed a significant decrease in mPAP (preoperative: 37 ± 7.7 mm Hg vs. postoperative 28 ± 3.2 mm Hg, p = 0.06). PEA could improve function class and hemodynamic in patients with CTEPD. Considering hemodynamic improvement in this group of patients after PEA, definition of CTEPH may need to be revised.

Association of improvement in functional capacity after rehabilitation with long-term survival in heart failure

BackgroundThe prognostic value of change in six-minute walking distance (6MWD) after treatment to predict mortality in heart failure (HF) remains a controversial issue. We assessed the prognostic value of rehabilitation-induced improvement in 6MWD in predicting mortality in patients with HF. MethodsWe studied 2257 patients admitted to six inpatient rehabilitation facilities after a hospitalization for HF (N. 912) or because of worsening functional capacity and/or deteriorating clinical status (N. 1345). A six-minute walking test was performed at admission and discharge. The primary outcome was 3-year all-cause mortality after discharge from cardiac rehabilitation. We used multivariable Cox proportional hazard modeling to assess the association of increase in 6MWD with 3-year mortality, adjusting for established predictors of mortality. Results6MWD significantly increased by 61 m (p < .001) from admission to discharge and 969 patients (42.9%) achieved an increase in 6MWD >50 m. After full adjustment, an increase in 6MWD >50 m was associated with a 22% decreased risk for 3-year mortality (HR 0.78 [95% CI 0.68–0.91]; p = .002). When modeled as a continuous variable, improvement in 6MWD remained independently associated with decreased risk for 3-year mortality (HR per each 50 m increase: 0.92 [95% CI 0.88–0.96]). ConclusionsRehabilitation–induced improvement in 6MWD was associated with a significantly reduced risk for 3-year mortality. Our data also suggest that an improvement in 6MWD of more than 50 m could represent a clinically meaningful endpoint of cardiac rehabilitation for patients with heart failure.

Effect of Buteyko Breathing Technique on Haemodynamic Parameters and Functional Capacity in Subjects with Primary Hypertension

The Buteyko Breathing Technique (BBT) has been found to be effective in the treatment of Asthma, ObstructiveAirway Disease and other diseases. Its effect on Hypertension has not been studied.Aim and Objectives: To study the effect of Buteyko Breathing technique for 4 weeks on Hemodynamic parametersand functional capacity in subjects with primary hypertension.Methodology: Parallel group study design in which 66 subjects from Hypertension OPD of Tertiary Health CareCentre were enrolled after taking their consent and Institutional Ethical approval. The subjects were randomlyallocated to Control (N=33) (receiving standard treatment of care) and Experimental (N=33) (receiving Buteykoand standard treatment of care). Standard treatment of care included medication and educational videos onHypertension, its complications and management. Buteyko Breathing Technique included supervised session of30 minutes using a video once in a week for 4 weeks. Subjects were informed to perform these exercises at homedaily.Results: The experimental group showed a significant reduction in SBP (p=0.00), DBP (p=0.00), Resting HR (p=0.00)and a significant improvement in Control Pause (p=0.00) and 6MWD (p=0.00). There was a mean reduction in SBPof 8.6 + 6.31 mmHg (95% CI, 10.84- 6.36 mmHg) and in DBP of 4.606 + 4.34 mmHg (95% CI, 6.14-3.06mmHg).Conclusion: Buteyko Breathing Technique has a positive effect on Haemodynamic parameters and functionalcapacity in subjects with Essential Hypertension.

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.

Abstract 12557: Echo-Guided vs. Device-Based Strategies for Optimization of Cardiac Resynchronization Therapy and Long-Term Clinical Outcomes: A Meta-Analysis

Introduction: CRT optimizations has the potential to improve the 30% non-response rate. Randomized trials (RCTs) comparing device and echo-guided CRT optimization have been overall small and results have been conflicting. Methods: We searched the EMBASE and MEDLINE databases from January 2008 through September 2020 for RCTs and prospective observational studies that randomized patients to either echo-guided or device-based CRT optimization. Included studies had to report on at least one of the following outcomes of interest: all-cause mortality, heart failure hospitalization (HFH), NYHA class improvement, mean EF at follow up, LVEDD, 6MWD, and QoL. A meta-analyses on the outcomes of interest was performed using random effects models. Results: We included seven RCTs representing a total of 2,730 patients. Of those, 1,113 patients were randomized to echo-guided optimization, and 1,617 were randomized to device-based optimization. The mean age of patients was 64.5 years, and they were predominantly men (60%). In the device-based optimization group, there was 93 deaths (5.7%) and 142 HFH (5.1%). In the echo-guided optimization group, there was 57 deaths (10.2%) and 112 HFH (12.4%). On random effects meta-analysis, the device-based optimization group had a lower rate of HFH compared with the echo-guided optimization group (OR 0.81, 95% CL 0.70-0.95, Figure). However, differences in the following outcomes between the two groups were not statistically significant: all-cause mortality, mean follow up EF, LVEDD, NYHA class improvement, 6MWD improvement range or QoL. Conclusions: This meta-analysis suggests that echo-guided optimization of CRT is equivalent to device-based optimization in relation to the clinical outcomes of death, EF, LVEDD, NYHA and 6MWD but suggests that device-related optimization could reduce HFH. The latter merits further investigation in relation to different device-base optimization algorithms.

Trajectories of COPD patients’ response to repeated pulmonary rehabilitation programs

Background and objectivePulmonary rehabilitation (PR) is essential in the management of chronic obstructive pulmonary disease (COPD), but the long-term effects and the outcomes of repeated programs especially in non-responders remain to be clarified. The aim of this study is to evaluate the long-term effect of PR 12 months after and the effect of repeated PR depending on the patient's response to the first PR. MethodsThis is a single center retrospective analysis of COPD patients admitted to two or three PR programs between January 2012 and December 2017, using the 6-min walking distance (6MWD) to determine the functional response to PR. ResultsOne hundred ninety patients completed PR twice and 62 completed PR three times with 10–14 months delay between programs. The effect of the first PR program (PR1) on 6MWD was mostly lost after one year. The 6MWD change after the second PR program (PR2) was smaller than after PR1 (+65 ± 30 m post-PR1, +44 ± 20 m post-PR2; p = 0.001). Out of the 149 responders post-PR1, 44 (30%) became non-responders post-PR2. Out of the 41 non-responders post-PR1, 23 (56%) became responders post-PR2. Patients with long term oxygen therapy and severe exercise dyspnea were most likely to remain non-responders to repeated PR. ConclusionThis study showed that most of the 6MWD improvement following PR disappears over 12 months and emphasized the clinical relevance of repeating PR including for non-responders to initial PR. However, some patients did not respond systematically to PR and may require specific PR modalities to improve their functional status.

Exercise capacity, muscle strength and objectively measured physical activity in patients after heart transplantation.

Maximal exercise capacity of patients after heart transplantation (HTX) remains limited, affecting their quality of life. Evidence on the evolution of muscle strength and physical activity (PA) post-HTX is lacking, but a prerequisite to tailor cardiac rehabilitation programmes. Forty-five consecutive patients were evaluated every 3months during the first year post-HTX. Functional exercise capacity (Six minutes walking distance test (6MWD)), peripheral (Quadriceps strength (QF)) and respiratory (Maximal inspiratory strength (MIP)) muscle strength were evaluated. PA (number of steps (PAsteps), active time (PAactive) and sedentary time (PAsed)) was objectively measured. 6MWD, QF, MIP, PAsteps and PAactive significantly improved over time (P<0.001). No change in PAsed was noticed (P=0.129). Despite improvements in 6MWD and QF, results remained substantially below those of age-and gender-matched healthy subjects. One year post-HTX, 30% of patients presented with peripheral muscle weakness. Baseline levels of 6MWD and QF were significantly higher in patients with pretransplant LVAD-implantation and this difference was maintained during follow-up. cardiac rehabilitation, combining aerobic exercise training and peripheral muscle strength training, is mandatory in patients post-HTX. Inspiratory muscle training should be implemented when respiratory muscle weakness is present. Programmes improving physical activity and reducing sedentary time post-HTX are essential.

Changes in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD

Pulmonary Rehabilitation (PR) is a key intervention in the management of people with chronic obstructive pulmonary disease (COPD), though few studies have assessed where changes in outcomes occur during a PR program. The aim of this study was to determine the changes in exercise capacity and health-related quality of life at four and eight weeks during a twice-weekly supervised PR program in people with COPD. Fifty participants with COPD were recruited and attended PR twice-weekly for eight weeks. The outcome measures were the endurance shuttle walk test (ESWT), six-minute walk distance (6MWD), St George’s Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and the Hospital Anxiety and Depression Scale (HADS) which were measured at baseline, four and eight weeks. Compared to baseline, at week four there were significant improvements in ESWT (mean difference [95%CI] 197 [89 to 305] seconds), 6MWD (22 [8 to 36] metres), SGRQ symptom score (-6 [-12 to −1] points) and SGRQ total score (-4 [-7 to −1] points). Between week four and eight there were further significant improvements in ESWT (94 [8 to 181] seconds) only. By week eight, ESWT, 6MWD, SGRQ symptoms and total score, and CAT had all improved significantly compared to baseline measures. This study demonstrated that participants with moderate to very severe COPD who participated in a twice weekly, eight-week PR program (16 sessions) had significant improvement in ESWT, 6MWD, SGRQ, and CAT score with the greatest improvements occurring in the first four weeks of the program. Supplemental data for this article is available online at https://doi.org/10.1080/15412555.2021.2013793 .

Predictors of changes in 6-min walking distance following pulmonary rehabilitation in COPD patients: a retrospective cohort analysis.

Pulmonary rehabilitation (PR) is fundamental in chronic obstructive pulmonary disease (COPD) management but not all patients may show functional benefits from PR. The aim of this study was to identify predictors of non-response in functional capacity to PR. Observational study. Inpatient pulmonary rehabilitation center. COPD patients. This single center study is a retrospective analysis of data in COPD patients admitted to a PR center between January 2012 and December 2017. Post-PR change in 6-min walking distance (6MWD) was used to determine the functional response to PR. Patients characteristics and pre-PR 6-min walking test responses were analyzed to determine factors associated with post-PR changes in 6MWD. Data from 835 patients were analyzed as well as a subgroup of 190 patients with additional variables available. Eighty percent of the patients showed clinically significant 6MWD improvement post-PR. The predictors of 6MWD response to PR were age, pre-PR 6MWD, pre-PR end-of-test dyspnea and long-term oxygen therapy. Older patients, longer pre-PR 6MWD, higher pre-PR end-of-test dyspnea score and the use of oxygen supplementation were associated with lesser post-PR 6MWD improvement. This study identified four important clinical variables predicting a lack of 6MWD response to PR. Patients with such clinical characteristics may require specific PR modalities to improve their functional benefit.

Clinical outcomes following isolated transcatheter tricuspid valve repair: a meta-analysis and meta-regression study

Abstract Background Significant tricuspid regurgitation (TR) is a common valvular heart disease worldwide. Purpose We aimed to assess the pooled clinical and echocardiographic outcomes of different isolated transcatheter tricuspid valve repair (ITTVR) strategies for significant (≥ moderate) TR. Methods We systematically searched the literature for studies evaluating the efficacy and safety of ITTVR for significant TR in adult. The primary outcomes were the improvement of New York Heart Association (NYHA) functional class and 6-minutes walking distance (6MWD) and the presence of severe or greater TR at the last available follow-up of each individual study. Random-effect meta-analysis was performed comparing outcomes before and after ITTVR. Results 14 studies with 771 patients were included. Mean age was 77±8 years and mean EuroScore II was 6.8%±5.4%. At a weighted mean follow-up of 212 days, 209 (35%) patients had a NYHA III to IV functional class compared to 586 (84%) patients at baseline (risk ratio: 0.23, 95% CI 0.13 to 0.40, P-value&amp;lt;0.001). 6MWD significantly improved from 237±113 meters to 294±105 meters (mean difference: +50 meters, 95% CI +34 to +66 meters, P-value&amp;lt;0.001). 147 (24%) patients showed severe or greater TR after ITTVR compared to 616 (96%) at baseline (risk ratio: 0.29, 95% CI 0.20 to 0.42, P-value&amp;lt;0.001). Conclusion Patients undergoing ITTVR for significant TR experienced a significant improvement in NYHA functional status and 6MWD and a significant reduction in TR severity at mid-term follow-up. Funding Acknowledgement Type of funding sources: None.