6-minute Walk Distance Research Articles

Abstract 15572: Assessing the Impact of Renal Denervation on Heart Failure: Results From the Pooled Analysis of Randomized Controlled Trials

Introduction: Renal denervation (RDN), first developed for hypertension management, is currently being investigated as a potential treatment for heart failure (HF). However, its efficacy and safety for these patients necessitate further investigation. Hypothesis: This study aimed to assess the impact of renal denervation on various clinical and hemodynamic parameters in heart failure patients. Methods: A comprehensive search of PubMed, Cochrane Library, and Embase databases was performed for randomized controlled trials (RCTs) comparing RDN with standard care or placebo in HF patients, published until January 2023. Data were pooled using a random-effects model, and results were reported as Mean Differences (MD) with a 95% confidence interval (CI). All statistical analyses were performed using R software (version 4.0.3) with the metafor and meta packages. Results: The search identified five RCTs involving 208 patients (103 in the RDN group and 105 in the control group). RDN was associated with significant improvements in left ventricular ejection fraction (MD: 4.48%, 95% CI: 0.57-8.4%, P=0.02, I2=77%), 6-minute walk distance (MD: 78.71 meters, 95% CI: 47.01-110.41 meters, P<0.01, I2=0%), left ventricular end-systolic diameter (MD: -3.18 mm, 95% CI: -5.64 to -0.72 mm, P=0.01, I2=24%), and left ventricular end-diastolic diameter (MD: -4.16 mm, 95% CI: -6.04 to -2.29 mm, P<0.01, I2=0%). However, no significant changes were noted in left atrial diameter (MD: -4.49 mm, 95% CI: -9.19 to 0.20 mm, P=0.06, I2=79%), New York Heart Association class (MD: -0.71, 95% CI: -1.65 to 0.24, P=0.14, I2=96%), heart rate (MD: -3.71 beats per minute, 95% CI: -8.45 to 1.03 beats per minute, P=0.12, I2=62%), systolic blood pressure (MD: -0.35 mmHg, 95% CI: -11.51 to 10.79 mmHg, P=0.95, I2=88%), and diastolic blood pressure (MD: -1.46 mmHg, 95% CI: -7.12 to 4.19 mmHg, P=0.61, I2=79%). Conclusions: RDN has shown the potential to improve left ventricular function and exercise capacity in managing heart failure. The results, marked by high heterogeneity in some outcomes and constrained by the limited number of trials and patients, necessitate larger multicenter trials for validation and further exploration of renal denervation's role in heart failure management.

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study

Context/Objective To explore changes in gait functions for patients with chronic spinal cord injury (SCI) before and after standard rehabilitation and rehabilitation with a wearable hip device, explore the utility of robot-assisted gait training (RAGT), and evaluate the safety and dose of RAGT. Design Single-arm, open-label, observational study. Setting A rehabilitation hospital. Participants Twelve patients with SCI. Interventions Standard rehabilitation after admission in the first phase. RAGT for two weeks in the second phase. Outcome measures Self-selected walking speed (SWS), step length, cadence, and the 6-minute walking distance were the primary outcomes. Walking Index for SCI score, lower extremity motor score, and spasticity were measured. Walking abilities were compared between the two periods using a generalized linear mixed model (GLMM). Correlations between assessments and changes in walking abilities during each period were analyzed. Results After standard rehabilitation for 66.1 ± 36.9 days, a period of 17.6 ± 3.3 days of RAGT was safely performed. SWS increased during both periods. GLMM showed that the increase in cadence was influenced by standard rehabilitation, whereas the limited step length increase was influenced by RAGT. During RAGT, the increase in step length was related to an increase in hip flexor function. Conclusions Gait speed in patients with SCI increased after rehabilitation, including RAGT, in the short-term. This increase was associated with improved muscle function in hip flexion at the start of RAGT. Trial Registration: This study was registered with the UMIN Clinical Trials Registry (UMIN-CTR; UMIN000042025)

Abstract 16040: Atrial Fibrillation Status and Physical Rehabilitation in Older Patients With Acute Decompensated Heart Failure: An Analysis From the Rehab-HF Trial

Background: The REHAB-HF randomized, controlled 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 (ADHF). Atrial fibrillation (AF) is common in patients with HF and associated with poor exercise tolerance. However, exercise has proven safe and effective in improving quality of life in AF patients. It is unknown if AF impacts the benefit gained by rehabilitation intervention. Question: We hypothesized that patients with AF and ADHF would significantly improve physical function outcomes, and these improvements would not differ significantly from those gained by patients without AF. Methods: REHAB-HF enrolled 349 patients hospitalized for ADHF. Mean age was 72.7 ± 8.1 years. Participants were randomly assigned to the 12-week progressive rehabilitation intervention or attention control. The trial’s primary outcome was change in short physical performance battery (SPPB) score between baseline and 3 months. Secondary outcomes were clinical endpoints (rehospitalization or death). Results: AF was prevalent in 176 patients (50.4%). Participants with AF were significantly older than those without (74.4 ± 8.3 vs. 70.8 ± 7.5, p<0.001) and had higher prevalence of HFpEF (58.5% vs 47.4%, p=0.037). Patients with and without AF had similar improvement in SPPB score (mean between-group difference, 1.5; 95% CI 0.4-2.5; p=0.001). There was no significant difference in mean SPPB between the two groups (p=0.98). KCCQ score and 6-minute walk distance significantly improved in patients with AF (p<.05). The interaction P-values for 3-month outcomes by AF status were not significant (P >0.1). There were no significant differences in deaths, all-cause rehospitalizations, or HF hospitalizations at 6 months. Conclusions: In older, hospitalized patients with ADHF, the presence of AF did not significantly affect the benefit of the transitional, tailored, progressive rehabilitation intervention. These findings suggest the intervention is safe to use to improve physical function and quality of life in patients hospitalized for ADHF regardless of AF status.

Abstract 14319: Riociguat in Pulmonary Arterial Hypertension: Application of the 4-strata COMPERA 2.0 Risk Assessment Tool in the PATENT Studies

Background: The 2022 ESC/ERS treatment guidelines for pulmonary arterial hypertension (PAH) recommend using a four-strata risk assessment strategy at follow-up. COMPERA 2.0 is a refined four-strata risk assessment tool that subdivides patients at intermediate risk of mortality at 1 year into intermediate-low and intermediate-high risk groups for a more granular approach to risk prediction. Aim: This post-hoc analysis applied COMPERA 2.0 to the PATENT studies of riociguat in patients with PAH. Methods: COMPERA 2.0 was applied to patients who were pretreated with PAH therapy at PATENT-1 entry. Patients with missing data for COMPERA 2.0 variables were excluded. In PATENT-1, risk strata were assessed at baseline and Week 12; and 6-minute walking distance (6MWD) at Week 12 was analyzed by risk strata at baseline. All pretreated patients entering the PATENT-2 open-label extension were included in Kaplan-Meier analyses to assess association of risk strata at PATENT-1 baseline and Week 12 with clinical worsening and survival. Results: At PATENT-1 baseline (riociguat 2.5 mg n=102, placebo n=49), more patients were at intermediate-low risk than intermediate-high risk (Figure 1). At PATENT-1 Week 12, a higher proportion of patients were at low risk with riociguat vs placebo (Figure 1). At PATENT-1 Week 12, the following mean [SD] changes in 6MWD were seen in patients at intermediate-low risk (riociguat 24 m [57 m], placebo 10 m [60 m]) and intermediate-high risk (riociguat 34 m [56 m], placebo –2 m [70 m]) by COMPERA 2.0 at baseline. COMPERA 2.0 assessed at PATENT-1 baseline and Week 12 was able to discriminate between risk strata for clinical worsening and survival in PATENT-2 (n=167, log-rank tests: p≤0.001 for all analyses). Conclusion: This analysis confirmed the risk-reduction benefits of riociguat in patients with PAH and validated the utility of COMPERA 2.0 in the long-term risk assessment of patients from a clinical trial 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 < 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.

Abstract 13995: Remote, Smart Device Based Cardiac Rehabilitation After Myocardial Infarction - Smart Rehab Study

Introduction: After myocardial infarction (MI), increasing functional capacity is an important goal of cardiac rehabilitation, that improves prognosis. However, standard cardiac rehabilitation is not accessible to many patients. Telemedicine programs are emerging as promising alternatives to in-person programs, but evidence confirming its benefits is lacking. Hypothesis: Smart device based remote cardiac rehabilitation can improve functional capacity assessed by VO2peak after MI. Methods: Patients were offered participation at the time of hospitalization for MI. One month after MI, patients underwent a cardiopulmonary exercise test, 6-minute walking test (6MWT) and were randomized 1:1. In the intervention group, patients received a smart watch to track the recommended number of steps, that was derived from the 6MWT. Adherence to the recommendations was telemonitored by a study nurse, with an over the phone motivation talk if compliance was unsatisfactory. In the control group, patients were recommended 150 minutes/week of moderate intensity exercise. Exercise stress tests were repeated after 3 months. Results: In total, 59 patients (mean age 51.5±10.4 years, 10.2% women, 67.8% STEMI, 96.6% PCI, mean discharge EF 48±10%) were included in the study. At baseline, there was no difference in clinical characteristics and functional capacity between the intervention (n=29) and control (n=30) groups. After 3 months of the intervention, VO2peak improved in the intervention arm with between group difference of 1.56 ml/kg/min (95%CI 0.06-3.05, p=0.041), with no difference in 6-minute walking distance (p=0.11). The effect of intervention differed by baseline functional capacity (p for interaction <0.01). Among patients with VO2peak at baseline ≤95% predicted, the between-group VO2peak difference after 3 months was 2.46 ml/kg/min (95% CI 0.78-4.13, p=0.005), and also oxygen uptake efficiency slope (between group difference 235, 95% CI 43-428, p=0.02) and 6-minute walking distance improved (between group difference 60m, 95% CI 1.5-119, p=0.045). Conclusions: Smart device based remote cardiac rehabilitation improves functional capacity after myocardial infarction, particularly in those with decreased functional capacity. NCT03926312

Abstract 14936: Integrated Text Messaging for Patients Attending Cardiac and Pulmonary Rehabilitation: A Multicentre Randomised Controlled Trial

Introduction: People living with cardiac and respiratory disease require improved post-hospital support that is readily available and efficient. Hypothesis/Aims: Support via text message alongside cardiac and pulmonary rehabilitation (rehab) improves clinical, lifestyle and attendance. Aim was to test effectiveness of an automated, semi-personalised text message support program on clinical and lifestyle outcomes among patients attending cardiac and pulmonary rehab and evaluate program acceptability and utility for patients. Methods: Multicentre randomised controlled trial (3:1, intervention:control) among patients attending cardiac and pulmonary rehab. Control received usual care. Intervention received a 6-month text message lifestyle and support program. Primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included clinical measures, lifestyle, medication adherence and rehab program attendance. Results: Of the 316 participants (mean age±standard deviation, 66.7±10.1years) randomised, 60% were male (190/327), 156 were recruited from cardiac rehab. At 6 months, 6MWD improved in both groups and was significantly greater among intervention than control participants (unadjusted mean difference [95% CI]: 43.4m [4.3 to 82.4];p=0.0296). After adjustment for baseline values, there was no significant difference between intervention and control groups for 6MWD (adjusted mean difference 2.2m [-21.2 to 25.6];p=0·85), medication adherence or cardiovascular risk factors. At 6 months, intervention participants reported significantly lower depression scores (adjusted mean diff [95%CI] -1.3 [-2.2 to -0.3], p=0.012) and anxiety (adjusted mean diff [95%CI] -1.1 [-2.1 to 0.0], p=0.046). Sub-group analysis of cardiac rehab participants found a clinically meaningful increase in 6MWD at 6 months in the intervention compared to control group (mean diff 18.9m, 95% CI -29.2 to 67.1). The majority of participants found the messages easy to understand (99%) and useful (86%). Conclusion: An education and support-based text message program for cardiac and pulmonary rehab attendees improved anxiety and depression plus program attendance, was useful for patients and suitable for implementation.

Abstract 17136: Prospective Cohort Study for Evaluating the Safety and Efficacy of Mobile, Motorized Enhanced Extracorporeal Counterpulsation in Refractory Angina Patients

Introduction: Enhanced external counterpulsation (EECP) therapy is a potential treatment for refractory angina, which refers to persistent symptoms despite optimal treatment. However, the immobility, cost, and lack of individualized pressure control limit the accessibility and clinical implications of EECP. To address these limitations, a new Mobile, Motorized Enhanced Counterpulsation (MECP) device has been developed. Hypothesis: To investigate efficacy of MECP in improving in angina functional class and exercise tolerance in patients with refractory angina and to validate the consistency in outcomes observed with conventional EECP treatment. Methods: This prospective study enrolled patients with symptomatic refractory angina between September 2020 and December 2022 at two tertiary centers in Korea. Baseline and post-treatment assessments included measurements of angina scale, 6-minute walking test, cardiopulmonary exercise test, and central arterial pressure. Results: The study included 71 patients (70.4% male, median age 66 years). After the 10-hour MECP treatment session, 57.7% of patients showed improvement in angina scale based on Canadian Cardiovascular Society classification, with a significant distribution change from 76.8% to 49.3% in class II and from 21.7% to 5.7% in class III (p<0.001). Furthermore, patients demonstrated an increase of 20 meters in the 6-minute walk distance after MECP treatment (464 meters vs. 484 meters, p<0.001). However, there were no statistically significant differences in the baseline characteristics of patients based on their response to MECP. Conclusion : Our study highlights the substantial benefits of MECP in relieving symptoms for patients with refractory angina and suggests its potential for broader clinical applications which merits further investigation.

Abstract 12748: Continuous Measurement of Percutaneous Oxygen Saturation During 6-Minute Walk Test is Useful for Predicting the Prognostic Risk in Patients With Heart Failure

Background: The 6-minute walk test (6MWT) is an established test to assess functional exercise performance and the 6-minute walk distance (6MWD) is strongly correlated with the functional capacity and the prognosis in patients with heart failure (HF). However, the clinical implication of sequential changes in percutaneous oxygen saturation (SpO2) during 6MWT has not been investigated in HF patients. Purpose: To prospectively clarify the association between sequential changes in SpO2 during 6MWT and prognosis in patients with HF. Methods: Fifty patients admitted with acute heart failure were enrolled. The 6MWT was performed at the time before discharge, after hemodynamic stability was confirmed. The average of SpO2 was calculated from data obtained at rest and during 6MWT by employing the wearable pulse-oximeter which is designed to record the SpO2 value every second. Alternations in SpO2 (ΔSpO2) were obtained by subtracting the average during 6MWT from that at rest. Patients were followed up to 9 months for the composite outcome of heart failure-hospitalization and death. Results: The mean age of participants was 78.8 years, and 23 (46%) were female. The mean EF was 46.1% and the number of patients with EF ≦40 was 22. The 6MWD was 250 ± 112m and the ΔSpO2 was 2.88 ± 4.3%. All cases were classified by walk distance and ΔSpO2; long- (>220m) vs. short-distance group (≦220m) and low- (<3.5%) vs. high-ΔSpO2 group (≧3.5%). There were no significant differences in cardiac parameters and respiratory function between long- and short-distance group as well as between low- and high-ΔSpO2 group. Kaplan-Meier analysis revealed that higher ΔSpO2 showed a more strong and statistically significant impact on cardiovascular outcome compared to longer 6MWD (HR=3.25, CI=1.40-7.51, p=0.006, HR=2.24, CI=0.94-5.32, p=0.067, respectively). Conclusions: This study showed that, compared to walk distance, ΔSpO2 during 6MWT was more predictive of the prognosis of heart failure patients.

Abstract 11656: Relation Between Method of Indexation for Normal Chamber Dimensions and Association With Functional Measures: The Multi-Ethnic Study of Atherosclerosis

Background: Normalization of echocardiographic chamber measurements for body surface area (BSA) may result in biased estimation of dimensions in obese or sarcopenic individuals. While alternative scaling systems that circumvent this issue have been proposed, there remains a dearth of information on normal values indexed to scaling parameters other than BSA and whether they vary by sex or race/ethnicity. Methods: Of 3032 individuals who underwent echocardiography at Exam 6 in the Multi-Ethnic Study of Atherosclerosis (MESA), we identified 608 without apparent cardiopulmonary or cardiometabolic disease (69.5 ± 7.0 years, 46.2% male, 47.5% White). Normal values for left and right heart variables across a variety of ratiometric (BSA, body mass index [BMI], height) and allometric (height 1.6 , and height 2.7 ) scaling systems were defined as the mean value ± 1.96 standard deviations and compared across sex and race/ethnicity categories. In the broader cohort (N = 3032), we evaluated the correlation of indexed parameters and functional measures (NT-proBNP, 6-minute walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire [KCCQ]). Results: Height 2.7 had the best overall mean correlation with functional measures (mean correlation -0.12 ± 0.04 with KCCQ; mean correlation -0.15 ± 0.08 with 6MWD) and was superior to BSA for KCCQ and 6MWD (both p < 0.001) but not NT-proBNP (both p > 0.05). Mean correlations for allometric scaling were greater than ratiometric scaling for KCCQ and 6MWD (both p < 0.001) but not NT-proBNP (both p > 0.05). For 6MWD, mean correlations for allometric scaling (p = 0.001) but not ratiometric scaling (p = 0.8) were more negative (suggestive of impaired function) than unindexed measures. Conclusions: In this a multi-ethnic cohort of community-dwelling older adults free from apparent cardiopulmonary or cardiometabolic diseases, we provide normative indexed values for commonly measured echocardiographic parameters across a variety of indexation methods and show that they differ across sex and race/ethnicity categories. Allometric height 2.7 correlated best with functional measures and was superior to BSA. Current chamber quantification guidelines should be updated to reflect normative data on scaled parameters.

Abstract 18210: Renal Denervation in Management of Heart Failure: A Systematic Review and Meta-Analysis

Introduction: Renal denervation (RDN) is a novel intervention targeting sympathetic nerves along the renal artery. Ablation of this neurohormonal pathway alters the pathophysiology of heart failure (HF) and can lead to improvements in clinical outcomes. We conducted a systematic review and meta-analysis to review the outcome of heart failure patients undergoing RDN. Methods: We performed a comprehensive search on PubMed, Cochrane, and Embase from inceptions through June 2023 using the string “(“renal denervation” OR “renal sympathetic denervation “) AND (“heart failure” OR “congestive heart failure”)”. Exclusion criteria include non-human trials, studies without a baseline and control, and studies without outcomes of interest. We collected the number of patients with HF and the resulting outcomes. Outcomes of interest include left ventricular ejection fraction (LVEF), six minute walk distance (SMWD), NT- proBNP, and systolic and diastolic pressures. The random-effects model was used to calculate the odds ratios (OR), mean differences (MD), and confidence intervals (CI). A p value <0.05 was considered statistically significant. Heterogeneity was assessed using the Higgins I2 index. Results: Nine randomized control trials involving a total of 513 patients were included in our analysis. We found a significant difference when comparing the RDN group to the control groups for LVEF (MD 1.39, 95% CI [0.03,2.75]), SMWD (MD 200.13 m, 95% CI [187.32,212.95]), NT-proBNP (MD -397.16 pg/ml, 95% CI [-438.90, -355.42]), SBP (MD -3.69 mmHg, 95% CI [-7.24, -0.14]) within 12 months. Interestingly, difference in DBP was insignificant (MD -1.13 mmHg, 95% CI [-3.33,1.07]). Our RDN group had a significant decrease in hospital admissions (OR 0.83, 95% CI [0.25,2.77]) for HF exacerbation within 12 month following denervation. When comparing RND to baseline, we found a significant difference in LVEF (MD 1.90, 95% CI [0.64,3.16]) and SMWD (MD 106.56 m, 95% CI [88.72,124.40]). Conclusions: Our analysis demonstrates RDN results in a significant difference in LVEF, SMWD, NT-proBNP, and SBP in patients with HF when compared to control and baseline. However, further research is needed with larger samples to establish the safety and effectiveness of RDN as a viable therapy in HF.

Abstract 14435: Psoas Muscle Index as a Tool to Predict Outcomes in a Pulmonary Hypertension Population Undergoing Pulmonary Thromboendarterectomy

Introduction: Sarcopenia is defined as an overall decline in skeletal muscle mass and has been associated with a range of cardiac pathologies. Psoas Muscle Index (PMI) has emerged as a metric of sarcopenia. We investigated the prognostic value of PMI on six-minute walk distance (6MWD), and length of stay (LOS) in pulmonary hypertension patients following Pulmonary Thromboendarterectomy (PTE). Hypothesis: Sarcopenic patients will have lower 6MWD meters and increased LOS compared to non-sarcopenic patients. Methods: Retrospective chart review of 65 patients with CTEPH who had undergone PTE with CT scans of the abdomen between 2017-2022. Psoas muscle area was measured at the L3 level on CT scan. PMI was calculated using the formula (left psoas area + right psoas area)/height 2 . Patients in the 1 st quartile PMI for their gender were classified as sarcopenic. 1 st quartile PMI values were calculated as 5.34 cm 2 /m 2 for males, and 3.30 cm 2 /m 2 for females. Results: 17 (26%) patients were classified as sarcopenic. There were no significant differences between sarcopenic and non-sarcopenic groups comparing hemodynamics (mean PA 45 vs 42 mmHg, PVR 9 vs 8 WU, CI 2 vs 2.1-l/min/m 3 ), age (61.2 vs 59.7-years), female sex (52.9 vs 55.3%), ethnicity or comorbidities. Regarding 6 minute walk distance (6MWD), the sarcopenic group had significantly lower meters walked than the non-sarcopenic group pre-PTE (220 vs. 322-meters, p=0.049). Following PTE, there was less distinction between groups in 6MWD (347.1 meters vs 345.1, p=0.970). The sarcopenic group increased their 6MWD more than the non-sarcopenic group (137.3 meters vs 43.7, p=0.055). The sarcopenic group had significantly longer overall length of stay (LOS) (27 vs 14-days, p=0.001), and intensive care unit stay (19 days vs. 6-days, p=0.002) than the non-sarcopenic group. Conclusions: Sarcopenia is prevalent in patient with CTEPH. Sarcopenic patients with CTEPH had lower pre-PTE 6MWD, longer ICU stays and overall hospital LOS.

Abstract 13407: Long-Term Outcomes of Chronic Thromboembolic Pulmonary Hypertension Treated With Pulmonary Endarterectomy and Balloon Pulmonary Angioplasty: Results From the Japanese Prospective CTEPH Registry (CTEPH AC Registry)

Introduction: In Japan, balloon pulmonary angioplasty (BPA) is more commonly adopted in patients with chronic thromboembolic pulmonary hypertension (CTEPH) compared to European countries or US due to their expertise. However, there are no reports from regions where BPA is extensively practiced. Aims: This study aims to explore the treatment outcomes in Japan. Methods: The study involved a nationwide, prospective, observational registry that included all patients diagnosed with CTEPH from August 2018 to February 2023 in Japan. Patients were categorized as naïve or prevalent cases based on their previous reperfusion therapy (pulmonary endarterectomy and/or BPA) at the time of enrollment. Each case was further classified as operable or BPA group. The primary outcome measure was morbidity and mortality (MM) events since enrollment, which comprised all-cause death, CTEPH-related hospitalization, rescue reperfusion therapy, initiation of parenteral pulmonary vasodilators, and worsening of CTEPH characterized by a decrease in 6-minute walk distance greater than 15% and deterioration of the WHO functional class. Results: A total of 1194 patients, including naïve cases (operable: n = 54, BPA: n = 293) and prevalent cases (operable: n=125, BPA: n = 532), were identified. Among the naïve cases, there were no significant differences in age or disease severity between the operable and BPA groups. Among the prevalent cases, the BPA group was older (63 ± 13 vs. 58 ± 14 years old, p < 0.0001) and had higher pulmonary vascular resistance (364 ± 279 vs. 293 ± 206 dyne*sec/cm5, p = 0.001) compared to the operable group. The results of primary outcome measures were comparable between both the groups (Figure). Conclusions: BPA as well as pulmonary endarterectomy is considered as safety and effective therapeutic option in CTEPH patients.

Abstract 17599: Sotatercept for the Treatment of Pulmonary Arterial Hypertension: A Systematic Review and Single-Arm Meta-Analysis

Introduction: Pulmonary arterial hypertension (PAH) is associated with progressive clinical worsening and a 50% 5-year survival rate with current PAH therapies. Sotatercept is a first-in-class fusion protein with promising results in preclinical trials, but clinical evidence on its role in treating PAH remains limited. Hypothesis: Sotatercept may provide clinical benefits for patients with symptomatic PAH. Aims: To assess the efficacy of sotatercept in addition to background PAH therapy in this population. Methods: We searched PubMed, Embase, Cochrane and Clinicaltrials.gov in April 2023 for clinical trials assessing efficacy outcomes of sotatercept in patients with PAH. Using a random-effects model, we performed a single-arm meta-analysis of proportions for binary outcomes and applied generic inverse variance weighting formulas to pool arithmetic means and least squares means for continuous outcomes. Statistical analyses were performed using Review Manager 5.4.1 and R software 4.2.2. Results: We included three clinical trials comprising 254 patients with WHO functional class II or III PAH. At 24 weeks, only 2% of patients on sotatercept experienced symptoms of clinical worsening (95% CI 1 to 5; Fig. 1A). Sotatercept was also associated with a reduction in pulmonary vascular resistance (mean change from baseline -199.92 dyn·sec·cm -5 ; 95% CI -256.83 to -143.0; Fig. 1B), while improving 6-minute walk distance (mean change from baseline 45.86 m; 95% CI 28.54 to 63.18; Fig. 1C). Conclusions: These findings suggest that sotatercept may improve exercise capacity while decelerating clinical worsening and attenuating pulmonary vascular resistance in patients with mild to moderate PAH.

Abstract 13038: Predictive Value of Cardiac Function Parameters and NT-proBNP in Patients With Pulmonary Arterial Hypertension (PAH) Treated With Sotatercept in the STELLAR Trial

Background: Sotatercept is an activin signaling inhibitor under investigation for PAH. Goal: Evaluate the prognostic utility of hemodynamic and cardiac function parameters in PAH patients receiving sotatercept vs placebo. Methods: Participants in STELLAR, a phase 3 trial (NCT04576988), were randomized 1:1 to sotatercept (0.3 up to 0.7 mg/kg once every 3 weeks) or placebo added to background therapies. Eligible participants had WHO functional class II-III, pulmonary vascular resistance ≥400 dyn·s·cm -5 , and 6-minute walk distance 150-550 m. This post-hoc analysis assessed clinical worsening events at last measurement by baseline echocardiography (ECHO), right heart catheterization (RHC), and NT-proBNP parameters. Clinical worsening events were assessed up to week 60. Uni-/multivariate-adjusted Cox models identified baseline parameters significantly (p<0.05) associated with events. Parameters with p-values <0.10 were carried forward to multivariate model. Receiver operating characteristic curves assessed discriminatory utility of cutoff values. Results: Of the significant univariate predictors, only study treatment and log2 NT-proBNP were significant independent predictors of clinical worsening in multivariate model (Table). Each unit increase in log2 NT-proBNP at baseline was associated with a 61% increase in risk (HR 1.61, 95% CI 1.39, 1.88; p<0.001). The AUC for log2 NT-proBNP (0.76 [95% CI 0.67, 0.85]) showed good performance. The optimal NT-proBNP cutoff value was 322 pg/mL. Sotatercept treatment was associated with an 81% reduction in risk vs placebo (HR 0.19, 95% CI 0.10 to 0.38; p<0.001), even after adjusting for NT-proBNP. Conclusions: This post-hoc analysis demonstrated that NT-proBNP is a strong predictor of clinical worsening events in PAH patients. Sotatercept treatment offered protection beyond that achieved with standard therapies alone, even after adjusting for the impact of NT-proBNP.

Abstract 13991: Sleep Patterns and Quality of Life in Pulmonary Arterial Hypertension

Introduction: Data on sleep duration and quality of life (QOL) in PAH are limited to self-reported surveys. Commercial wearables represent a cost-effective, low-burden approach to objectively assess real-world sleep patterns. We aimed to describe sleep patterns and associations with quality of life (QOL) in a cohort of PAH patients. Methods: We enrolled patients with expert adjudicated PAH from the NHLBI-funded Pulmonary Vascular Disease Phenomics (PVDOMICS) and compared them with individuals from the All of Us Research Program matched on age, sex, body mass index, and monitoring dates. Sleep variables were measured using Fitbit devices, which patients wore continuously for 12 weeks at baseline and again after 1 year. In PAH patients, QOL (Minnesota Living with Heart Failure (MLHF) survey) was assessed at baseline and 1 year; higher MLHF scores indicate greater impairment. Results: We enrolled 36 patients with PAH (48.9 ± 13.2 years, 81% female). Total minutes in bed and total minutes per sleep stage at baseline and 1 year follow-up are shown in Table 1. Compared with matched controls, patients with PAH have similar minutes in bed and asleep but markedly reduced minutes of deep (p<0.001) and REM sleep (p <0.001). In the PAH cohort, changes in sleep parameters from baseline to year 1 correlated inversely with changes in MLHF emotional score from baseline to year 1 including: time in bed (r = - 0.61, p = 0.017), total minutes asleep (r = -0.59, p = 0.020), total minutes light sleep (r = -0.53, p = 0.041), and total minutes deep sleep (r = - 0.52, p = 0.047). Minutes of deep and REM sleep over 1 year were inversely correlated with medication escalation over that year (rs = -0.49 and -0.47, p<0.02 for both). No sleep measures correlated with baseline 6-minute walk distance. Conclusions: Patients with PAH have poor sleep quality compared to healthy controls. Poor sleep quality may contribute to or result from some of the common symptoms of PAH such as fatigue, mood disorders, and decreased QOL.

Abstract 13679: Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair

Introduction: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by TEE. Hypothesis: Safety and efficacy of T-TEER can be increased by multimodality imaging (MMI) guidance. Methods: From December 2020 to January 2022, we performed T-TEER in 40 inoperable patients. All patients received TTE, TEE and cardiac CT screening, and were assigned to a MMI (n=17) guidance group, provided good TTE acoustic window, or otherwise classical TEE (n=23). Multimodality imaging employed the 4 right-sided chamber views. Accordingly, the 1-chamber view was obtained in the transgastric short-axis view on TEE, but also from a modified subcostal TTE short axis. The 2-chamber view was visualized from a low-esophageal position, or from a parasternal long axis view of the right ventricle. The 3-chamber view was seen on mid-esophageal TEE 50-100°, but also in the parasternal short axis view. Finally, the 4-chamber view was obtained on mid-esophageal 0-30°, or the classical four-chamber TTE view. CT derived fluoroscopic angulations of these views allowed interventionalists and imaging specialists to speak a common language. Results: Device success was achieved in all patients, with 1.5±0.6 implanted clips / patient in the MMI vs 1.5±0.5 in the TEE group (p=0.851). Device times were 66.1±35.1 vs 58.7±27.5 minutes (p=0.459). TR reduction was successful in 94% vs 95% of patients, p=1.000. Two- or more grade TR improvement occurred in 65% vs 52% of cases. There were no device associated complications but 3 TEE-related gastro-esophageal bleedings occurred in the 2 nd group. By 12 months, 4 vs 8 patients (p=0.504) were readmitted for acute heart failure, and 2 vs 4 (p=0.686) died. NYHA class decreased by one grade in all survivals. However, Kansas City Cardiomyopathy Questionnaire score and 6-minute walk distance significantly increased in each respective group, more with MMI ( Δ 29±21.4 vs 22±13.6 points, p=0.227; Δ 101±100.4 vs 85±64 meters, p=0.121). Conclusions: A patient-tailored MMI approach to T-TEER guidance, by using TTE in patients with good acoustic window and cardiac CT for fluoroscopic determination of the 4 right-sided chamber views, is feasible and improves safety, procedural success and, in turn, clinical outcomes.

Preoperative 6-minute walk distance is associated with postoperative complications in patients undergoing laparoscopic gastrointestinal cancer surgery

ObjectiveThe 6-min walk test (6MWT) is a simple and valid method to evaluate cardiopulmonary function. We performed this prospective study in patients undergoing laparoscopic gastrointestinal cancer surgery to explore the association between preoperative 6MWT performance and overall postoperative complications. MethodsThis study was registered at clinicaltrials.gov (NCT03711526). The study consecutively enrolled patients receiving laparoscopic gastrointestinal cancer surgery in our institution. All patients performed the 6MWT upon recruitment and received 30 days of postoperative follow-up. The primary outcome was overall complications, defined by ≥ grade I Clavien–Dindo (CD) classification (2004) complications. Multivariable logistic regression was used to test the association of 6-min walk distance (6MWD) with the outcome. ResultsA total of 184 patients were included in the final analyses. In the 37 (20.1 %) patients with overall complications, the mean (standard deviation) preoperative 6MWD was 469.1 (86.8) m. In patients with no complications, the 6MWD was 502.6 (90.2) m. The mean difference was 33.5 m (95 % confidence interval, 1.3, 65.7; P = 0.042). A longer preoperative 6MWD was associated with a lower odds of developing postoperative complications (odds ratio, 0.994 per meter increase; 95 % confidence interval, 0.989, 0.999; p = 0.023). ConclusionThis study indicated an association between the preoperative 6MWD and postoperative complications in patients undergoing laparoscopic gastrointestinal cancer surgery.

Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction.

Many therapies for heart failure (HF) have shown differential impact across the spectrum of left ventricular ejection fraction (LVEF). In this prespecified analysis, the authors assessed the effects of semaglutide across the baseline LVEF strata in patients with the obesity phenotype of HF with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) trial. STEP-HFpEF randomized 529 patients (263 semaglutide; 266 placebo). For this prespecified analysis, patients were categorized into 3 groups based on LVEF: 45% to 49% (n=85), 50% to 59% (n=215), and≥60% (n=229). At 52weeks, semaglutide improved the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (estimated treatment difference: EF [ejection fraction] 45%-49%: 5.0 points [95%CI:-2.7 to 12.8 points], EF 50%-59%: 9.8 points [95%CI: 5.0 to 14.6 points], and EF≥60%: 7.4 points [95%CI: 2.8 to 12.0 points]; P interaction=0.56) and body weight (EF: 45%-49%:-7.6 [95%CI:-10.7 to-4.4], EF 50%-59%:-10.6 [95%CI:-12.6 to-8.6] and EF≥60%:-11.9 [95%CI:-13.8 to-9.9]; P interaction=0.08), to a similar extent across LVEF categories. Likewise, LVEF did not influence the benefit of semaglutide on confirmatory secondary endpoints: 6-minute walk distance (P interaction=0.19), hierarchal composite endpoint (P interaction=0.43), and high-sensitivity C-reactive protein (P interaction=0.26); or exploratory endpoint of N-terminal pro-brain natriuretic peptide (Pinteraction=0.96). Semaglutide was well-tolerated across LVEF categories. In patients with HFpEF and obesity, semaglutide 2.4mg improved symptoms, physical limitations, and exercise function, and reduced inflammation and body weight to a similar extent across LVEF categories. These data support treatment with semaglutide in patients with the obesity phenotype of HFpEF regardless of LVEF. (Research Study to Investigate How Well Semaglutide Works in People Living With HeartFailure and Obesity [STEP-HFpEF]; NCT04788511).

Enhancing early functional independence following cardiac surgery: a quality improvement programme

Early mobility and activity programmes following cardiac surgery are vital for improved patient outcomes, as they accelerate the recovery of functional capacity and walking distance. We observed that only 5.3%...