Aims
To determine the effect of the glucagon‐like peptide‐1 analogue liraglutide on left ventricular function in chronic heart failure patients with and without type 2 diabetes.
Methods and results
LIVE was an investigator‐initiated, randomised, double‐blinded, placebo‐controlled multicentre trial. Patients (n = 241) with reduced left ventricular ejection fraction (LVEF ≤45%) were recruited (February 2012 to August 2015). Patients were clinically stable and on optimal heart failure treatment. Intervention was liraglutide 1.8 mg once daily or matching placebo for 24 weeks. The LVEF was similar at baseline in the liraglutide and the placebo group (33.7 ± 7.6% vs. 35.4 ± 9.4%). Change in LVEF did not differ between the liraglutide and the placebo group; mean difference (95% confidence interval) was −0.8% (−2.1, 0.5; P = 0.24). Heart rate increased with liraglutide [mean difference: 7 b.p.m. (5, 9), P < 0.0001]. Serious cardiac events were seen in 12 (10%) patients treated with liraglutide compared with 3 (3%) patients in the placebo group (P = 0.04).
Conclusion
Liraglutide did not affect left ventricular systolic function compared with placebo in stable chronic heart failure patients with and without diabetes. Treatment with liraglutide was associated with an increase in heart rate and more serious cardiac adverse events, and this raises some concern with respect to the use of liraglutide in patients with chronic heart failure and reduced left ventricular function. More data on the safety of liraglutide in different subgroups of heart failure patients are needed.
Segmental PV isolation using a high power output and short application time is safe and effective in PV isolation in patients with AF. This technique can significantly reduce the procedure and fluoroscopy time compared with a low-power output technique.
In patients with a history of paroxysmal or persistent AF treated with RF catheter ablation, elevated levels of IL-6 and hs-CRP before ablation are independent predictors of recurrence of AF.
BackgroundOpen heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis.MethodsOne hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions.ResultsDuring a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1–0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1–1.0, p = 0.05).ConclusionsIn a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline.Trial registrationLAACS study, clinicaltrials.gov NCT02378116, March 4th 2015, retrospectively registered.Electronic supplementary materialThe online version of this article (10.1186/s13019-018-0740-7) contains supplementary material, which is available to authorized users.
Background: Recent studies have demonstrated that delivering radiofrequency energy to isolate the pulmonary veins (PVs) can cure patients with paroxysmal atrial fibrillation (PAF). Objective: To quantify the effects of radiofrequency catheter isolation of PVs on quality of life (QoL), symptom burden and non-scheduled visiting to physicians in patients with PAF. Methods: Thirty consecutive patients referred for radiofrequency ablation of PAF were included. Questionnaires were administered retrospectively, 6.3 months after the ablation procedure. QoL was measured by the SF-36 (a measure of general health status) and symptoms and health care utilization by a locally constructed questionnaire. Results: Before ablation, patients with PAF had significantly lower scores on all SF-36 subscales with the exception of the pain subscale, compared with a healthy control group. Apart from bodily pain all subscales significantly improved after PV isolation. Twenty patients had an improvement in their total health perception. PV isolation significantly reduced the frequency of episodes of atrial fibrillation (AF) and the proportion of nonscheduled contacts to physicians for AF. Conclusion: QoL in patients with PAF is significantly impaired. PV isolation improves the QoL and reduces the frequency and severity of symptoms and non-scheduled contacts to physicians.
Aims
Patients suffering from chronic ischaemic heart failure with reduced left ventricular ejection fraction (HFrEF) have reduced quality‐of‐life, repetitive hospital admissions, and reduced life expectancy. Allogeneic cell therapy is currently investigated as a potential treatment option after initially encouraging results from clinical autologous and allogeneic trials in patients with HFrEF. We aimed to investigate the allogeneic Cardiology Stem Cell Centre Adipose tissue derived mesenchymal Stromal Cell product (CSCC_ASC) as an add‐on therapy in patients with chronic HFrEF.
Methods and results
This is a Danish multi‐centre double‐blinded placebo‐controlled phase II study with direct intra‐myocardial injections of allogeneic CSCC_ASC. A total of 81 HFrEF patients were included and randomized 2:1 to CSCC_ASC or placebo injections. The inclusion criteria were reduced left ventricular ejection fraction (LVEF ≤ 45%), New York Heart Association (NYHA) class II‐III despite optimal anti‐congestive heart failure medication and no further revascularization options. Injections of 0.3 mL CSCC_ASC (total cell dose 100 × 10
6
ASCs) (
n
= 54) or isotonic saline (
n
= 27) were performed into the viable myocardium in the border zone of infarcted tissue using the NOGA Myostar® catheter (Biological Delivery System, Cordis, Johnson & Johnson, USA). The primary endpoint, left ventricular end systolic volume (LVESV), was evaluated at 6‐month follow‐up. The safety was measured during a 3‐years follow‐up period.
Results
Mean age was 67.0 ± 9.0 years and 66.6 ± 8.1 years in the ASC and placebo groups, respectively. LVESV was unchanged from baseline to 6‐month follow‐up in the ASC (125.7 ± 68.8 mL and 126.3 ± 72.5 mL,
P
= 0.827) and placebo (134.6 ± 45.8 mL and 135.3 ± 49.6 mL,
P
= 0.855) group without any differences between the groups (0.0 mL (95% CI −9.1 to 9.0 mL,
P
= 0.992). Neither were there significant changes in left ventricular end diastolic volume or LVEF within the two groups or between groups −5.7 mL (95% CI −16.7 to 5.3 mL,
P
= 0.306) and −1.7% (95% CI −4.4. to 1.0,
P
= 0.212), respectively). NYHA classification and 6‐min walk test did not alter significantly in the two groups (
P
> 0.05). The quality‐of‐life, total symptom, and overall summary score improved significantly only in the ASC group but not between groups.
There were 24 serious adverse events (SAEs) in the ASC group and 11 SAEs in the placebo group without any significant differences between the two groups at 1‐year follow‐up. Kaplan–Meier plot using log‐rank test of combined cardiac events showed an overall mean time to event of 30 ± 2 months in the ASC group and 29 ± 2 months in the placebo group without any dif...
PV isolation in patients with AF may result in increased HR, which positively correlated with the ablation success. This change does not seem to resolve spontaneously after a follow-up of 12 months. Approximately 5% of patients may develop symptoms due to an increased HR, necessitating treatment with rate-controlling drugs.
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