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Circulation Aug 2022Clinical worsening (CW) is a composite end point commonly used in pulmonary arterial hypertension (PAH) trials. We aimed to assess the trial-level surrogacy of CW for... (Meta-Analysis)
Meta-Analysis
Assessment of Clinical Worsening End Points as a Surrogate for Mortality in Pulmonary Arterial Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
BACKGROUND
Clinical worsening (CW) is a composite end point commonly used in pulmonary arterial hypertension (PAH) trials. We aimed to assess the trial-level surrogacy of CW for mortality in PAH trials, and whether the various CW components were similar in terms of frequency of occurrence, treatment-related relative risk (RR) reduction, and importance to patients.
METHODS
We searched MEDLINE, Embase, and the Cochrane Library (January 1990 to December 2020) for trials evaluating the effects of PAH therapies on CW. The coefficient of determination between the RR for CW and mortality was assessed by regression analysis. The frequency of occurrence, RR reduction, and importance to patients of the CW components were assessed.
RESULTS
We included 35 independent cohorts (9450 patients). PAH therapies significantly reduced CW events (RR, 0.64 [95% CI, 0.55-0.73]), including PAH-related hospitalizations (RR, 0.61 [95% CI, 0.47-0.79]), treatment escalation (RR, 0.57 [95% CI, 0.38-0.84]) and symptomatic progression (RR, 0.58 [95% CI, 0.48-0.69]), and modestly reduced all-cause mortality when incorporating deaths occurring after a primary CW-defining event (RR, 0.860 [95% CI, 0.742-0.997]). However, the effects of PAH-specific therapies on CW only modestly correlated with their effects on mortality (, 0.35 [95% CI, 0.10-0.59]; <0.0001), and the gradient in the treatment effect across component end points was large in the majority of trials. The weighted proportions of CW-defining events were hospitalization (33.5%) and symptomatic progression (32.3%), whereas death (6.7%), treatment escalation (5.6%), and transplantation/atrioseptostomy (0.2%) were infrequent. CW events were driven by the occurrence of events of major (49%) and mild-to-moderate (37%) importance to patients, with 14% of the events valued as critical.
CONCLUSIONS
PAH therapies significantly reduced CW events, but study-level CW is not a surrogate for mortality in PAH trials. Moreover, components of CW largely vary in frequency, response to therapy, and importance to patients and are thus not interchangeable.
REGISTRATION
URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42020178949.
Topics: Familial Primary Pulmonary Hypertension; Humans; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Randomized Controlled Trials as Topic; Regression Analysis
PubMed: 35862151
DOI: 10.1161/CIRCULATIONAHA.121.058635 -
Heart Failure Reviews Jan 2023The impact of exercise training and physiotherapy on heart function and pulmonary circulation parameters in heart failure with preserved ejection fraction (HFpEF)... (Review)
Review
The impact of exercise training and physiotherapy on heart function and pulmonary circulation parameters in heart failure with preserved ejection fraction (HFpEF) patients is uncertain. Hence, we performed a systematic review of published trials studying physical training in HFpEF population, with a focus on exercise and physiotherapy effect on left ventricular (LV), right ventricular (RV) morphological, functional, and pulmonary circulation parameters. We searched Cochrane Library and MEDLINE/PubMed for trials that evaluated the effect of exercise training and/or physiotherapy in adult HFpEF patients (defined as LVEF ≥ 45%), including publications until March 2021. Our systematic review identified eighteen articles (n = 418 trained subjects, 4 to 52 weeks of training) and covered heterogeneous trials with various populations, designs, methodologies, and interventions. Five of twelve trials revealed a significant reduction of mitral E/e' ratio after the training (- 1.2 to - 4.9). Seven studies examined left atrial volume index; three of them showed its decrease (- 3.7 to - 8 ml/m). Findings were inconsistent regarding improvement of cardiac output, E/A ratio, and E wave DecT and uncertain for RV function and pulmonary hypertension parameters. For now, no reliable evidence about rehabilitation effect on HFpEF cardiac mechanisms is available. There are some hypotheses generating findings on potential positive effects to parameters of LV filling pressure (E/e'), left atrium size, cardiac output, and RV function. This encourages a broader and more complex assessment of parameters reflecting cardiac function in future HFpEF exercise training studies.
Topics: Adult; Humans; Heart Failure; Stroke Volume; Ventricular Function, Left; Exercise; Physical Therapy Modalities
PubMed: 35831689
DOI: 10.1007/s10741-022-10259-1 -
Frontiers in Cardiovascular Medicine 2022Catheter-directed therapies (CDT) are an alternative to systemic thrombolysis (ST) in pulmonary embolism (PE) patients, but the mortality benefit of CDT is unclear.
BACKGROUND
Catheter-directed therapies (CDT) are an alternative to systemic thrombolysis (ST) in pulmonary embolism (PE) patients, but the mortality benefit of CDT is unclear.
OBJECTIVE
We conducted a systematic review with meta-analysis to compare the efficacy and safety of CDT and ST in intermediate-high and high-risk PE.
METHODS
We included (P) participants, adult PE patients; (I) intervention, CDT; (C) comparison, ST; (O) outcomes, mortality, complications, in-hospital treatment, and length of hospital stay; (S) study design, randomized controlled trials (RCTs), or cohort comparing CDT and ST. The primary endpoint was 30-day mortality. Secondary outcomes included treatment-related complications including bleeding, the use of hospital resources, and length of hospital stay.
RESULTS
Eleven studies including 65,589 patients met the inclusion criteria. Thirty-day mortality was lower in the CDT group, compared to ST group [7.3 vs. 13.6%; odds ratio (OR) = 0.51, 95% confidence interval (CI) 0.38-0.69, < 0.001]. The rates of myocardial injury, cardiac arrest, and stroke were lower in CDT group, compared to ST group ( < 0.001 for all). The rates of any major bleeding, intracranial hemorrhage, hemoptysis, and red blood cell transfusion were lower in patients treated with CDT, compared to ST ( ≤ 0.01 for all). Extracorporeal life support was used more often in patients treated with CDT, compared to ST (0.5 vs. 0.2%, OR = 2.52, 95% CI 1.88-3.39, < 0.001). The use of hospital resources and length of hospital stay were comparable in both groups.
CONCLUSION
CDT might decrease mortality in patients with intermediate-high and high-risk PE and were associated with fewer complications, including major bleeding.
PubMed: 35783825
DOI: 10.3389/fcvm.2022.861307 -
Journal of the American Heart... Jul 2022Background In patients with ductal-dependent pulmonary blood flow, initial palliation includes catheter-based patent ductus arteriosus (PDA) stent or surgical... (Meta-Analysis)
Meta-Analysis Review
Patent Ductus Arteriosus Stent Versus Surgical Aortopulmonary Shunt for Initial Palliation of Cyanotic Congenital Heart Disease with Ductal-Dependent Pulmonary Blood Flow: A Systematic Review and Meta-Analysis.
Background In patients with ductal-dependent pulmonary blood flow, initial palliation includes catheter-based patent ductus arteriosus (PDA) stent or surgical aortopulmonary shunt (APS). This meta-analysis aimed to compare outcomes between PDA stent and APS. Methods and Results A comprehensive literature search yielded six retrospective observational studies. Pooled adjusted hazard ratios (HR) were included to control for covariates and assess time to event analysis. Of 757 patients, 243 (32.1%) underwent PDA stent and 514 (67.9%) underwent APS. Pulmonary atresia with intact ventricular septum and expected biventricular repair were more common with PDA stent compared with APS (39.6% versus 21.2%, <0.001 and 57.9% versus 46.6%, =0.007, respectively). There was no statistically significant difference in mortality between PDA stent and APS (HR, 0.71; [95% CI, 0.26-1.93]; =0.50). PDA stent was associated with lower risk of postprocedural complications (odds ratio [OR], 0.45; [95% CI, 0.25-0.81]; =0.008), mechanical circulatory support (OR, 0.27; [95% CI, 0.09-0.79]; =0.02), and shorter intensive care unit length of stay (-4.03 days; [95% CI, -5.99 to -2.07]; <0.001), hospital length of stay (-5.54 days; [95% CI, -9.20 to -1.88]; =0.003), and duration of mechanical ventilation (-3.41 days; [95% CI, -5.29 to -1.52]; <0.001). There was no difference in pulmonary artery growth or hazard of unplanned reintereventions. Conclusions PDA stent has a similar hazard of mortality compared with APS. Benefits to PDA stent include shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer complications. Differences in patient characteristics exist with more patients with pulmonary atresia with intact ventricular septum and expected biventricular repair undergoing PDA stent.
Topics: Cardiac Catheterization; Cyanosis; Ductus Arteriosus, Patent; Heart Defects, Congenital; Humans; Hypoxia; Pulmonary Atresia; Pulmonary Circulation; Retrospective Studies; Stents; Treatment Outcome
PubMed: 35766251
DOI: 10.1161/JAHA.121.024721 -
Research and Practice in Thrombosis and... May 2022Many cardiac arrest cases are encountered annually worldwide, with poor survival. The use of systemic thrombolysis during cardiopulmonary resuscitation for the treatment...
BACKGROUND
Many cardiac arrest cases are encountered annually worldwide, with poor survival. The use of systemic thrombolysis during cardiopulmonary resuscitation for the treatment of cardiac arrest remains controversial.
OBJECTIVES
Evaluate the safety and efficacy of systemic thrombolysis in patients with cardiac arrest due to presumed or confirmed pulmonary embolism or cardiac etiology.
METHODS
We searched the PubMed and Cochrane databases from inception through April 2021 to identify relevant randomized controlled trials and observational studies. The primary efficacy and safety outcomes were survival to hospital discharge and reported bleeding, respectively. Sensitivity analysis was performed on the basis of study design and etiology of cardiac arrest.
RESULTS
Eleven studies were included, with 4696 patients (1178 patients received systemic thrombolysis, and 3518 patients received traditional therapy). There was a higher rate of survival to hospital discharge in patients who received systemic thrombolysis versus no systemic thrombolysis (risk ratio [RR], 1.35; 95% confidence interval [CI], 0.95-1.91). There were also higher rates of survival at 24 hours (RR, 1.24; 95% CI, 0.97-1.59) and hospital admission (RR, 1.53; 95% CI, 1.04-2.24), and return of spontaneous circulation (ROSC) (RR, 1.34; 95% CI, 1.05-1.71) with the use of systemic thrombolysis. Impacts on survival to discharge and survival at 24 hours were not statistically significant. Patients receiving systemic thrombolysis had a 65% increase in bleeding events compared with no systemic thrombolysis (RR, 1.65; 95% CI, 1.20-2.27).
CONCLUSION
Systemic thrombolysis in cardiac arrest did not improve survival to hospital discharge and led to more bleeding events. However, it increased the rates of hospital admission and ROSC achievement.
PubMed: 35755853
DOI: 10.1002/rth2.12745 -
Pulmonary Circulation Apr 2022Pulmonary hypertension (PH) is a heterogeneous condition, associated with a high symptom burden and high rates of disability. While nonprofessional caregivers are... (Review)
Review
Pulmonary hypertension (PH) is a heterogeneous condition, associated with a high symptom burden and high rates of disability. While nonprofessional caregivers are essential in helping patients live better, little is known about the impact on caregivers and support that is currently available. This review has synthesised evidence examining experiences of caregivers of adults with PH. Web of Science, PubMed, PsycINFO, and Cochrane Library were searched for all types of study design. Articles were evaluated and analysed using a Joanna Briggs Institute approach. Eight articles primarily focussed on pulmonary arterial hypertension and chronic thromboembolic PH were identified investigating 456 caregivers from at least 10 countries. Four categories were identified describing caregiver demographics, responsibilities, impact, and support. Four integrated themes emerged identifying possible unmet needs and therapeutic targets: (1) Change, reflecting the various demands caring had on people as they attempted to balance the needs of the patient and their own; (2) Preparedness, discussing how caregivers could feel uncertain and unskilled for their duties and unsupported; (3) Isolation, with caregivers often encountering challenges to gaining information on PH turning to PH organisations and others affected for support and connection; and (4) Physical and mental demands, reflecting the multifaceted impact of caring. Findings add to the evidence demonstrating that PH can have a considerable impact on patients' support network. Providing support for caregivers of people with PH is an unmet need and may have a positive impact on patients and is an area that requires further research.
PubMed: 35514773
DOI: 10.1002/pul2.12077 -
Pulmonary Circulation Jan 2022Pulmonary arterial hypertension (PAH) is characterized by increased resistance in the pulmonary arterioles as a result of remodeled blood vessels. We sought all...
Pulmonary arterial hypertension (PAH) is characterized by increased resistance in the pulmonary arterioles as a result of remodeled blood vessels. We sought all available epidemiologic data on population-based prevalence, incidence, and 1-year survival of PAH as part of the Global Burden of Disease Study. We performed a systematic review searching Global Index Medicus (GIM) for keywords related to PAH between 1980 and 2021 and identified population-representative sources of prevalence, incidence, and mortality for clinically diagnosed PAH. Of 6772 articles identified we found 65 with population-level data: 17 for prevalence, 17 for incidence, and 58 reporting case fatality. Reported prevalence ranged from 0.37 cases/100,000 persons in a referral center of French children to 15 cases/100,000 persons in an Australian study. Reported incidence ranged from 0.008 cases/100,000 person-years in Finland, to 1.4 cases/100,000 person-years in a retrospective chart review at a clinic in Utah, United States. Reported 1-year survival ranged from 67% to 99%. All studies with sex-specific estimates of prevalence or incidence reported higher levels in females than males. Studies varied in their size, study design, diagnostic criteria, and sampling procedures. Reported PAH prevalence, incidence, and mortality varied by location and study. Prevalence ranged from 0.4 to 1.4 per 100,000 persons. Harmonization of methods for PAH registries would improve efforts at disease surveillance. Results of this search contribute to ongoing efforts to quantify the global burden of PAH.
PubMed: 35506069
DOI: 10.1002/pul2.12020 -
Surgical Endoscopy Oct 2022It has been previously demonstrated that the rise of intra-abdominal pressures and prolonged exposure to such pressures can produce changes in the cardiovascular and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
It has been previously demonstrated that the rise of intra-abdominal pressures and prolonged exposure to such pressures can produce changes in the cardiovascular and pulmonary dynamic which, though potentially well tolerated in the majority of healthy patients with adequate cardiopulmonary reserve, may be less well tolerated when cardiopulmonary reserve is poor. Nevertheless, theoretically lowering intra-abdominal pressure could reduce the impact of pneumoperitoneum on the blood circulation of intra-abdominal organs as well as cardiopulmonary function. However, the evidence remains weak, and as such, the debate remains unresolved. The aim of this systematic review and meta-analysis was to demonstrate the current knowledge around the effect of pneumoperitoneum at different pressures levels during laparoscopic cholecystectomy.
MATERIALS AND METHODS
This systematic review and meta-analysis were reported according to the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines, and the Cochrane handbook for systematic reviews of interventions.
RESULTS
This systematic review and meta-analysis included 44 randomized controlled trials that compared different pressures of pneumoperitoneum in the setting of elective laparoscopic cholecystectomy. Length of hospital, conversion rate, and complications rate were not significantly different, whereas statistically significant differences were observed in post-operative pain and analgesic consumption. According to the GRADE criteria, overall quality of evidence was high for intra-operative bile spillage (critical outcome), overall complications (critical outcome), shoulder pain (critical outcome), and overall post-operative pain (critical outcome). Overall quality of evidence was moderate for conversion to open surgery (critical outcome), post-operative pain at 1 day (critical outcome), post-operative pain at 3 days (important outcome), and bleeding (critical outcome). Overall quality of evidence was low for operative time (important outcome), length of hospital stay (important outcome), post-operative pain at 12 h (critical outcome), and was very low for post-operative pain at 1 h (critical outcome), post-operative pain at 4 h (critical outcome), post-operative pain at 8 h (critical outcome), and post-operative pain at 2 days (critical outcome).
CONCLUSIONS
This review allowed us to draw conclusive results from the use of low-pressure pneumoperitoneum with an adequate quality of evidence.
Topics: Cholecystectomy, Laparoscopic; Humans; Pain, Postoperative; Pneumoperitoneum; Pneumoperitoneum, Artificial; Randomized Controlled Trials as Topic
PubMed: 35437642
DOI: 10.1007/s00464-022-09201-1 -
Frontiers in Cardiovascular Medicine 2022Patients with a Fontan circulation are at risk for sequelae of Fontan physiology during follow-up. Fontan physiology affects all organ systems and an overview of...
INTRODUCTION
Patients with a Fontan circulation are at risk for sequelae of Fontan physiology during follow-up. Fontan physiology affects all organ systems and an overview of end-organ damage is needed.
METHODS
We performed a systematic review of abnormalities in multiple organ systems for patients with a longstanding Fontan circulation. We searched online databases for articles describing abnormalities in multiple organ systems. Cardio-pulmonary abnormalities, protein losing enteropathy, and Fontan associated liver disease have already extensively been described and were excluded from this systematic review.
RESULTS
Our search returned 5,704 unique articles. After screening, we found 111 articles relating to multiple organ systems. We found abnormalities in, among others, the nervous system, pituitary, kidneys, and musculoskeletal system. Pituitary edema-relating to the unique pituitary vasculature- may affect the thyroid axis. Renal dysfunction is common. Creatinine based renal function estimates may be inappropriate due to myopenia. Both lean muscle mass and bone mineral density are decreased. These abnormalities in multiple organ systems may be related to Fontan physiology, cyanosis, iatrogenic factors, or lifestyle.
CONCLUSIONS
Health care providers should be vigilant for hypothyroidism, visual or hearing deficits, and sleep disordered breathing in Fontan patients. We recommend including cystatin C for assessment of renal function. This review may aid health care providers and guide future research. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021232461, PROSPERO, identifier: CRD42021232461.
PubMed: 35391839
DOI: 10.3389/fcvm.2022.826096 -
PloS One 2022Chinese herbs for supplementing qi and activating blood circulation (CH) combined with N-acetylcysteine (NAC) is widely used for idiopathic pulmonary fibrosis (IPF) in... (Meta-Analysis)
Meta-Analysis
Clinical efficacy of Chinese herbs for supplementing qi and activating blood circulation combined with N-acetylcysteine in the treatment of idiopathic pulmonary fibrosis: A systematic review and network meta-analysis.
BACKGROUND
Chinese herbs for supplementing qi and activating blood circulation (CH) combined with N-acetylcysteine (NAC) is widely used for idiopathic pulmonary fibrosis (IPF) in China, but there is a lack of literature to evaluate its efficacy and clinical value.
PURPOSE
This study compared CH + NAC with other treatments by network meta-analysis to clarify its clinical value.
METHODS
Cochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure, WanFang Data, VIP Database, and China Biology Medicine were searched. Outcomes included lung function (DLCO (%), VC (%), FVC (%), FVC (L)), 6-min walking distance (6MWD), score of St George's respiratory questionnaire (SGRQ), blood gas analysis (PaO2, PaCO2). The data were analyzed by Review Manager 5.4, Stata 12.0 and ADDIS 1.16.5.
RESULTS
23 studies including 1390 patients (702 in intervention group and 688 in control group) were collected to compare 8 outcome indicators among different treatments involving CH, CH+NAC, CH+PFD, NAC, PFD and PFD+NAC on IPF. Network meta-analysis showed that CH was better than NAC in terms of DLCO (%) (MD = 5.14, 95%CI: 1.01 to 8.68) and 6MWD (MD = 49.17, 95%CI: 25.97 to 71.36) as well as PFD + NAC was better than NAC in terms of FVC (L) (MD = -0.56, 95%CI: -0.83 to -0.31). In rankings results, CH + NAC is the best in terms of FVC (%), SGRQ, PaO2 and PaCO2; CH is the best in terms of DLCO (%), VC (%) and 6MWD; CH + PFD is the best in terms of FVC (L).
CONCLUSION
CH related treatments may have advantages in the treatment of IPF and CH + NAC may have clinical application value. However, limited by the quality and quantity of researches included, more rational and scientific randomized controlled trials containing large sample sizes need to be conducted to further verify our conclusions.
Topics: Acetylcysteine; Humans; Idiopathic Pulmonary Fibrosis; Network Meta-Analysis; Oxygen; Qi; Treatment Outcome
PubMed: 35245333
DOI: 10.1371/journal.pone.0265006