One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.

AIMS: AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. METHODS AND RESULTS: We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. CONCLUSIONS: Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy.

A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial).

AIMS: AUGMENT-HF was an international, multi-centre, prospective, randomized, controlled trial to evaluate the benefits and safety of a novel method of left ventricular (LV) modification with alginate-hydrogel. METHODS: Alginate-hydrogel is an inert permanent implant that is directly injected into LV heart muscle and serves as a prosthetic scaffold to modify the shape and size of the dilated LV. Patients with advanced chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel (n = 40) in combination with standard medical therapy or standard medical therapy alone (Control, n = 38). The primary endpoint of AUGMENT-HF was the change in peak VO2 from baseline to 6 months. Secondary endpoints included changes in 6-min walk test (6MWT) distance and New York Heart Association (NYHA) functional class, as well as assessments of procedural safety. RESULTS: Enrolled patients were 63 ± 10 years old, 74% in NYHA functional class III, had a LV ejection fraction of 26 ± 5% and a mean peak VO2 of 12.2 ± 1.8 mL/kg/min. Thirty-five patients were successfully treated with alginate-hydrogel injections through a limited left thoracotomy approach without device-related complications; the 30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel treatment was associated with improved peak VO2 at 6 months-treatment effect vs. CONTROL: +1.24 mL/kg/min (95% confidence interval 0.26-2.23, P = 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both P < 0.001). CONCLUSION: Alginate-hydrogel in addition to standard medical therapy for patients with advanced chronic HF was more effective than standard medical therapy alone for improving exercise capacity and symptoms. The results of AUGMENT-HF provide proof of concept for a pivotal trial. TRIAL REGISTRATION NUMBER: NCT01311791.

Right ventricular myocardial infarction and pulmonary embolism differential diagnosis--a challenge for the clinician.

It is frequently recognized in medical literature as well as in daily clinical practice that right ventricular myocardial infarction and pulmonary embolism are two of the most challenging clinical pictures to differentiate in cardiology and the treatment, often chosen upon a mixture of clinical suspicion criteria subsequently confirmed by other diagnostic methods, can lead to therapeutic success. Differential diagnosis is often difficult due to similar clinical picture, unspecific electrocardiographic changes and unspecific biological markers. It is very important to know the risk factors and the associated comorbidities for these two clinical entities in order to be able to interpret them contextually. In most cases the diagnosis key is the clinical suspicion. Usually in evaluating these cases we are in the position of choosing more complex diagnostic procedures, most likely not available in Emergency Department. In conclusion it is expected from the clinician to use the available methods with a thorough approach to details but in the same time considering the whole clinical picture.

Myocardial infarction and patent coronary arteries--an uneventful association?

BACKGROUND: Although many studies addressed the issue of the occurrence of acute myocardial infarction (MI) in patients with angiographically patent coronary arteries, controversies exist concerning the pathophysiology and clinical outcome in this syndrome. AIM: To evaluate the clinical course of patients with MI and patent coronary arteries as well as to assess the post-infarction short-term prognosis. METHODS: A retrospective analysis of patients with acute MI admitted to our institution over a period of 8 years (1995-2002) was performed. The study group consisted of 62 patients with MI and angiographically patent coronary arteries, examined within the first 30 days after the infarction, and the age and gender-matched control group of 62 patients with acute MI and significant coronary artery stenoses. RESULTS: Cardiovascular risk factors found in the study group versus the control group were: smoking 47 (66.1%) vs 54 (87.1%) patients (NS); dyslipidemia 18 (29.0%) vs 44 (74.2%) patients (p<0.005), and family history of coronary artery disease 16 (25.8%) vs 37 (61.3%) patients (p<0.05). The post-infarction complications were: ischaemic recurrences in 25 (40.3%) vs 46 (74.2%) patients (p<0.05); heart failure in 11 (17.7%) vs 26 (41.9%) patients (p<0.05); mechanical events in 12 (19.4%) vs 16 (25.8%) patients (NS); arrhythmias in 18 (29.0%) vs 12 (19.4%) patients (NS); peripheral thromboembolic complications in 5 (8.1%) vs 2 (3.2%) patients (NS), respectively. CONCLUSIONS: In the population with MI and patent coronary arteries, smoking was the only well represented risk factor. Although there was a significantly lower incidence of ischaemic events and heart failure after MI in patients with patent rather than stenotic coronary arteries, the mechanical, arrhythmic and thromboembolic complications occurred with the same frequency.