P5383Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial) - 3-years follow-up results

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A A Qayyum ◽  
A B Mathiasen ◽  
S Helqvist ◽  
E Joergensen ◽  
M H Haack-Soerensen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Exercise Performance ◽  
Left Ventricular Ejection ◽  
Refractory Angina ◽  
Bicycle Exercise ◽  
Exercise Time ◽  
Cardiac Symptoms

Abstract Background Improvements in medical and interventional therapies have transformed ischemic heart disease into a chronic illness for lot of patients. The disease is in progress and by time patients suffer from cardiac symptoms, reduced work capacity and decline in quality of life. Stem cell therapy is investigated as a treatment option for these patients. Purpose In this study, long-term safety and efficacy of autologous intra-myocardial injections of adipose-derived stromal cells (ASCs) were studied in patients with refractory angina. Methods Sixty patients were double-blinded 2:1 randomised to ASC or saline injections and followed for three years. The patients had significant angina due to ≥1 coronary artery stenosis but preserved left ventricular ejection fraction. ASCs were obtained from abdomen, ex vivo culture expanded and VEGF-A165 stimulated before delivery into the ischemic myocardium. Results The cardiac symptoms, CCS and NYHA classification, were significantly reduced in the ASC group during the three years follow-up period (2.5±0.9 to 1.8±1.2, P=0.002 and 2.4±0.6 to 2.2±0.8, P=0.007, respectively). However, no significant change was observed in CCS or NYHA in the placebo group during the follow-up period (2.5±0.8 to 2.1±1.3, P=0.186 and 2.7±0.6 to 2.4±0.8, P=0.314, respectively). Moreover, the number of weekly angina attacks reported was significantly reduced in the ASC group (P=0.017), but not in the placebo group (P=0.425). For patients in the ASC group, the bicycle exercise time (383±30s to 370±44s, P=0.052) and the exercise performance in watt were un-changed (81±6 to 78±10, P=0.123), but the performance in METs was reduced significantly (4.2±0.3 to 4.0±0.4, P=0.027) during the follow-up period. At the same time in the placebo group, there was a significant decline in bicycle exercise time (437±53s to 383±58s, P=0.001), the exercise performance measured in watt (87±12 watt to 80±12 watt, P=0.019) and in METs (4.5±0.4 to 4.1±0.4, P=0.002). In both groups, significant improved quality-of-life, angina stability, angina frequency and physical limitation score was observed but not for overall satisfaction score. Conclusion Patients receiving ASCs had improved cardiac symptoms during the three years follow-up period, which was not the case for patients in the placebo group. Moreover, patients receiving ASCs had unchanged exercise capacity, in opposition to deterioration in the placebo group. Acknowledgement/Funding Arvid Nilssons Foundation; Rigshospitalets Research Foundation; Aase and Ejnar Danielsens Foundation

scholarly journals Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Abbas Ali Qayyum ◽  
Anders Bruun Mathiasen ◽  
Steffen Helqvist ◽  
Erik Jørgensen ◽  
Mandana Haack-Sørensen ◽  
...  
Keyword(s):  
Placebo Group ◽  
Exercise Performance ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Refractory Angina ◽  
Bicycle Exercise ◽  
Ventricular Ejection Fraction ◽  
Exercise Time ◽  
Cardiac Symptoms

Abstract Background Stem cell therapy is investigated as a treatment option for patients with ischemic heart disease. In this study, long-term safety and efficacy of autologous intra-myocardial injections of adipose-derived stromal cells (ASCs) was studied in patients with refractory angina. Methods Sixty patients with coronary artery stenosis and preserved left ventricular ejection fraction were 2:1 randomised to intramyocardial injections of ASCs or saline and followed for 3 years. Results For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period. However, in the same period, there was in the placebo group a significant decline in bicycle exercise time (437 ± 53 s to 383 ± 58 s, P = 0.001), the exercise performance measured in watt (87 ± 12 W to 80 ± 12 W, P = 0.019) and in METs (4.5 ± 0.4 to 4.1 ± 0.4, P = 0.002). Moreover, angina measured as CCS class was significantly reduced in the ASC group but not in the placebo group (2.5 ± 0.9 to 1.8 ± 1.2, P = 0.002 and 2.5 ± 0.8 to 2.1 ± 1.3, P = 0.186, respectively). However, no significant change was observed between the two groups. Conclusions Patients receiving ASCs had improved cardiac symptoms and unchanged exercise capacity, in opposition to deterioration in the placebo group. Trial registration ClinicalTrials.gov Identifier: NCT01449032. Registered 7 October 2011—Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT01449032?term=jens+kastrup&rank=7

scholarly journals Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction: The Cardiac Rehabilitation Outcome Study in Heart Failure (CROS-HF): A systematic review and meta-analysis

2019 ◽  
Vol 27 (9) ◽  
pp. 929-952 ◽  
Author(s):  
Birna Bjarnason-Wehrens ◽  
R Nebel ◽  
K Jensen ◽  
M Hackbusch ◽  
M Grilli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Relative Risk ◽  
Left Ventricular Ejection Fraction ◽  
Confidence Interval ◽  
Cardiac Rehabilitation ◽  
Left Ventricular ◽  
Left Ventricular Ejection

Background In heart failure with reduced left ventricular ejection fraction (HFrEF) patients the effects of exercise-based cardiac rehabilitation on top of state-of-the-art pharmacological and device therapy on mortality, hospitalization, exercise capacity and quality-of-life are not well established. Design The design of this study involved a structured review and meta-analysis. Methods Evaluation of randomised controlled trials of exercise-based cardiac rehabilitation in HFrEF-patients with left ventricular ejection fraction ≤40% of any aetiology with a follow-up of ≥6 months published in 1999 or later. Results Out of 12,229 abstracts, 25 randomised controlled trials including 4481 HFrEF-patients were included in the final evaluation. Heterogeneity in study population, study design and exercise-based cardiac rehabilitation-intervention was evident. No significant difference in the effect of exercise-based cardiac rehabilitation on mortality compared to control-group was found (hazard ratio 0.75, 95% confidence interval 0.39–1.41, four studies; 12-months follow-up: relative risk 1.29, 95% confidence interval 0.66–2.49, eight studies; six-months follow-up: relative risk 0.91, 95% confidence interval 0.26–3.16, seven studies). In addition there was no significant difference between the groups with respect to ‘hospitalization-for-any-reason’ (12-months follow-up: relative risk 0.79, 95% confidence interval 0.41–1.53, four studies), or ‘hospitalization-due-to-heart-failure’ (12-months follow-up: relative risk 0.59, 95% confidence interval 0.12–2.91, four studies; six-months follow-up: relative risk 0.84, 95% confidence interval 0.07–9.71, three studies). All studies show improvement of exercise capacity. Participation in exercise-based cardiac rehabilitation significantly improved quality-of-life as evaluated with the Kansas City Cardiomyopathy Questionnaire: (six-months follow-up: mean difference 1.94, 95% confidence interval 0.35–3.56, two studies), but no significant results emerged for quality-of-life measured by the Minnesota Living with Heart Failure Questionnaire (nine-months or more follow-up: mean difference –4.19, 95% confidence interval –10.51–2.12, seven studies; six-months follow-up: mean difference –5.97, 95% confidence interval –16.17–4.23, four studies). Conclusion No association between exercise-based cardiac rehabilitation and mortality or hospitalisation could be observed in HFrEF patients but exercise-based cardiac rehabilitation is likely to improve exercise capacity and quality of life.

scholarly journals Influence of Craniosacral Therapy on Anxiety, Depression and Quality of Life in Patients with Fibromyalgia

2011 ◽  
Vol 2011 ◽  
pp. 1-9 ◽  
Author(s):  
Guillermo A. Matarán-Peñarrocha ◽  
Adelaida María Castro-Sánchez ◽  
Gloria Carballo García ◽  
Carmen Moreno-Lorenzo ◽  
Tesifón Parrón Carreño ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Sleep Quality ◽  
Treatment Period ◽  
Quality Index ◽  
Pittsburgh Sleep Quality Index ◽  
Intervention Group ◽  
Craniosacral Therapy

Fibromyalgia is considered as a combination of physical, psychological and social disabilities. The causes of pathologic mechanism underlying fibromyalgia are unknown, but fibromyalgia may lead to reduced quality of life. The objective of this study was to analyze the repercussions of craniosacral therapy on depression, anxiety and quality of life in fibromyalgia patients with painful symptoms. An experimental, double-blind longitudinal clinical trial design was undertaken. Eighty-four patients diagnosed with fibromyalgia were randomly assigned to an intervention group (craniosacral therapy) or placebo group (simulated treatment with disconnected ultrasound). The treatment period was 25 weeks. Anxiety, pain, sleep quality, depression and quality of life were determined at baseline and at 10 minutes, 6 months and 1-year post-treatment. State anxiety and trait anxiety, pain, quality of life and Pittsburgh sleep quality index were significantly higher in the intervention versus placebo group after the treatment period and at the 6-month follow-up. However, at the 1-year follow-up, the groups only differed in the Pittsburgh sleep quality index. Approaching fibromyalgia by means of craniosacral therapy contributes to improving anxiety and quality of life levels in these patients.

Abstract 15680: Sinus Node Dysfunction in Associated With Higher Symptom Burden and Increased Risk of Progression to Permanent Atrial Fibrillation: Results From ORBIT-AF Registry

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Larry R Jackson ◽  
Sung Hee Kim ◽  
Jonathan P Piccini ◽  
Bernard J Gersh ◽  
Gerald V Naccarelli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Sinus Bradycardia ◽  
Sinus Node ◽  
Sinus Node Dysfunction ◽  
Left Ventricular Ejection ◽  
Increased Risk ◽  
Risk Of Progression

Background: Patients with sinus node dysfunction (SND) are at increased risk of atrial tachyarrhythmias, including atrial fibrillation (AF). Whether the presence of SND is also associated with worse outcomes among those with AF has not been well described. Methods: The ORBIT-AF registry enrolled patients with AF from a range of clinical practices across the US. SND was defined clinically, based on the presence of sinus bradycardia, severe sinus bradycardia, sinus arrest, sinoatrial exit block, or features of tachycardia-bradycardia syndrome. Descriptive statistics and multivariable logistic regression analysis were used to describe treatment patterns and outcomes for patients with and without SND and AF. Results: Overall, 1,710 (17.7%) patients had SND at enrollment. Patients with SND had lower left-ventricular ejection fractions, higher CHA 2 DS 2 -VASc risk scores, and more prior cerebrovascular events. Patients with SND had more severe symptoms (EHRA class IV: 17.5% vs. 13.9%; p=0.007) and poorer quality of life (median AFEQT 77.5 vs. 81.1; p=0.008) as compared to those without. SND patients were more frequently treated with oral anticoagulants (79.2% vs. 75.9%, p=0.004) and had more often received interventional therapy for AF (16.1% vs. 10.5%, p<0.0001). There were no differences in the current AF management strategy between patients with SND and those without [rate control (69.7% vs. 67.7%), rhythm control (30.0% vs. 32.0%); P=0.11]. After adjustment, significantly more patients with SND had progressed from paroxysmal AF at baseline to persistent or permanent AF at any follow-up or persistent AF at baseline to permanent AF at any follow-up than those without (OR 1.23, 95% CI 1.01-1.49, p=0.035). Conclusion: Sinus node dysfunction is associated worse symptoms, lower quality of life, and higher risk of progression to permanent AF. However, SND is not associated with increased risk of all-cause hospitalization, incident stroke, or all-cause death.

scholarly journals Mid-term outcomes with the use of extracorporeal membrane oxygenation for cardiopulmonary failure secondary to massive pulmonary embolism

2020 ◽  
Vol 58 (5) ◽  
pp. 923-931
Author(s):  
Federico Sertic ◽  
Dieynaba Diagne ◽  
Lexy Chavez ◽  
Thomas Richards ◽  
Ashley Berg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Hospital Mortality ◽  
Functional Status ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Acute Pe

Abstract OBJECTIVES There has been increasing interest in using extracorporeal membrane oxygenation (ECMO) to rescue patients with pulmonary embolism (PE) in the advanced stages of respiratory or haemodynamic decompensation. We examined mid-term outcomes and risk factors for in-hospital mortality. METHODS We conducted a retrospective study of 36 patients who required ECMO placement (32 veno-arterial ECMO, 4 veno-venous) following acute PE. Survival curves were estimated using the Kaplan–Meier method. Risk factors for in-hospital mortality were assessed by logistic regression analysis. Functional status and quality of life were assessed by phone questionnaire. RESULTS Overall survival to hospital discharge was 44.4% (16/36). Two-year survival conditional to discharge was 94% (15/16). Two-year survival after veno-arterial ECMO was 39% (13/32). In patients supported with veno-venous ECMO, survival to discharge was 50%, and both patients were alive at follow-up. In univariable analysis, a history of recent surgery (P = 0.064), low left ventricular ejection fraction (P = 0.029), right ventricular dysfunction ≥ moderate at weaning (P = 0.083), on-going cardiopulmonary resuscitation at ECMO placement (P = 0.053) and elevated lactate at weaning (P = 0.002) were risk factors for in-hospital mortality. In multivariable analysis, recent surgery (P = 0.018) and low left ventricular ejection fraction at weaning (P = 0.013) were independent factors associated with in-hospital mortality. At a median follow-up of 23 months, 10 patients responded to our phone survey; all had acceptable functional status and quality of life. CONCLUSIONS Massive acute PE requiring ECMO support is associated with high early mortality, but patients surviving to hospital discharge have excellent mid-term outcomes with acceptable functional status and quality of life. ECMO can provide a stable platform to administer other intervention with the potential to improve outcomes. Risk factors for in-hospital mortality after PE and veno-arterial ECMO support were identified.

scholarly journals Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation

2020 ◽  
Vol 28 (9) ◽  
pp. 478-484
Author(s):  
F. E. Vervaat ◽  
A. van der Gaag ◽  
H. van Suijlekom ◽  
C. J. Botman ◽  
K. Teeuwen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Angina Pectoris ◽  
Spinal Cord Stimulation ◽  
Refractory Angina ◽  
Refractory Angina Pectoris

scholarly journals Thiamin supplementation does not improve left ventricular ejection fraction in ambulatory heart failure patients: a randomized controlled trial

2019 ◽  
Vol 110 (6) ◽  
pp. 1287-1295 ◽  
Author(s):  
Mary Keith ◽  
Shirley Quach ◽  
Mavra Ahmed ◽  
Parastoo Azizi-Namini ◽  
Abdul Al-Hesayen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Placebo Group ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Ambulatory Patients

ABSTRACT Background Thiamin, a water-soluble B-complex vitamin, functions as a coenzyme in macronutrient oxidation and in the production of cellular ATP. Data suggest that thiamin depletion occurs in heart failure (HF). Therefore, thiamin supplementation in HF patients may improve cardiac function. Objective We sought to determine whether oral thiamin supplementation improves left ventricular ejection fraction (LVEF), exercise tolerance, and quality of life among patients with HF and reduced LVEF. Methods In this prospective, multicenter, double-blind, placebo-controlled randomized trial, eligible ambulatory patients with HF and reduced LVEF were recruited from 4 academic and community hospitals between 2010 and 2015. Participants were randomly assigned to receive either 200 mg oral thiamin mononitrate per day or placebo for 6 mo. Results Sixty-nine patients (mean ± SD age: 64 ± 12 y; 83% men; LVEF: 37% ± 11%) were randomly assigned: 34 received placebo and 35 received thiamin supplementation. Erythrocyte thiamin pyrophosphate and urine thiamin concentrations were significantly higher in the supplemented group than in the placebo group at 6 mo (P = 0.02 and <0.001, respectively). At 6 mo, LVEF was significantly higher in the placebo group than in the thiamin group (38%; 95% CI: 36%, 39% compared with 35%; 95% CI: 33%, 37%, P = 0.047) after adjusting for baseline measurements. There were no significant differences in Minnesota Living with Heart Failure score, distance walked in 6 min, and N-terminal prohormone of brain natriuretic peptide concentrations between the 2 groups. One patient (2.9%) in the thiamin-supplemented group and none in the control group died at 6 mo. Conclusions In ambulatory patients with HF and reduced LVEF, thiamin supplementation for 6 mo did not improve LVEF, quality of life, or exercise capacity, despite increases in thiamin concentrations. These findings do not support routine thiamin supplementation in the treatment of HF and reduced LVEF. This trial was registered at clinicaltrials.gov as NCT00959075.

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