Effect of SAcubitril/Valsartan on left vEntricular ejection fraction and on the potential indication for Implantable Cardioverter Defibrillator in primary prevention: the SAVE-ICD study.

PURPOSE: Sacubitril/valsartan has been associated with a positive reverse left ventricular remodelling in patients with heart failure with reduced ejection fraction (HFrEF). These patients may also benefit from an ICD implant. We aimed to assess EF improvement after 6 months of treatment with sacubitril/valsartan, evaluating when ICD as primary prevention was no longer indicated. METHODS: Multicentre, observational, prospective study enrolling all consecutive patients with HFrEF and EF ≤ 35% with an ICD as primary prevention and starting treatment with sacubitril/valsartan (NCT03935087). Resynchronization therapy and patients experiencing appropriate ICD therapies before sacubitril/valsartan were excluded. RESULTS: Two-hundred-and-thirty patients were enrolled (73.9% males, mean age 64.3 ± 12.1 years) After 6 months of treatment, a reduction in left ventricular end-diastolic and end-systolic volumes was noted and LVEF increased from 28.3 ± 5.6% to 32.2 ± 6.5% (p < 0.001). At 6 months, a non-ischemic aetiology of cardiomyopathy and a final dose of sacubitril/valsartan > 24/26 mg twice daily were associated with a higher probability of an absolute increase of > 5% in LVEF. A total of 5.3% of primary prevention patients still had an arrhythmic event in the first 6 months after treatment with sacubitril/valsartan started. CONCLUSIONS: Sacubitril/valsartan improves systolic function in HFrEF, mainly due to reverse left ventricular remodelling. Improvement in EF after 6 months of treatment could help prevent ICD implantation in nearly one out of four patients, with important clinical and economic implications. However, the risk of sudden cardiac death in this recovered HFrEF population has not been thoroughly studied, and the present data should be interpreted only as hypothesis-generating.

Cardiac contractility modulation in left ventricular systolic dysfunction: one-year experience in a pilot study and design of a prospective registry.

BACKGROUND: Cardiac contractility modulation (CCM) is a treatment option for patients suffering symptomatic chronic heart failure (CHF) with reduced left ventricular ejection fraction (LVEF) who are not eligible for cardiac resynchronization. Data on mid-term follow-up are limited to small observational studies. The aim of this study was to assess the impact of CCM on quality of life, symptoms, exercise tolerance and left ventricular function in patients with CHF and moderate-to-severe left ventricular systolic dysfunction. METHODS: Patients suffering CHF with LVEF <45% and NYHA class >II despite optimal medical therapy, underwent CCM implantation. Enrolled patients underwent baseline and 3, 6 and 12-months evaluation with ECG, echocardiogram, clinical assessment, 6-minute walking test and Minnesota Living with Heart Failure Questionnaire (MLWHFQ). RESULTS: Ten patients underwent CCM implantation. All patients were actively treated with the optimal pharmacological therapy as tolerated and had at least one hospitalization for worsening heart failure during the previous year. After a mean follow-up of 15 months, 9 patients were alive, while one patient died for worsening heart failure precipitated by pneumonia. Among the remaining 9 patients, LVEF improved non-significantly from 29.4±8% to 32.2±10% (P=0.092), 6-minute walking test distance improved from 179±73 m to 304±99 m (P<0.001), NYHA class reduced from 3.0±0.4 to 1.6±0.5 (P=0.003) and MLWHFQ score improved from 59.6±49 to 34.2±32 (P=0.037). Only 2 patients have been hospitalized during the 12 months. Overall, a net clinical benefit was detected in 6 out of 9 patients. CONCLUSIONS: CCM could be effective in improving quality of life, symptoms and exercise tolerance, and reduces hospitalizations in patients with symptomatic CHF on top of optimal medical and electrical therapy. A prospective registry has been designed to identify the subsets of patients gaining more benefit, and to assess the long-term effect of CCM on those clinical endpoints.

Incremental value of right atrial strain for early diagnosis of hemodynamic deterioration in pulmonary hypertension: a new noninvasive tool for a more comprehensive diagnostic paradigma.

AIMS: Increased right atrial size is related to adverse prognosis in pulmonary hypertension. The potential incremental value of right atrial function assessment is still unclear. We tested the relationship between right atrial two-dimensional speckle-tracking echocardiography impairment and hemodynamic, functional and clinical deterioration in patients with pulmonary hypertension. METHODS: We prospectively evaluated 36 patients (27 female, 9 male; mean age 68 ±â€Š13 years) with suspected pulmonary hypertension undergoing right heart catheterization and 16 matched controls. All patients underwent baseline evaluation by New York Heart Association functional class, 6-min walking test, brain natriuretic peptide (BNP), and standard two-dimensional echocardiography in less than 48 h of right heart catheterization. Right atrial two-dimensional speckle-tracking echocardiography was assessed by averaging all segments in standard four-chamber apical view. RESULTS: Right atrial global integral strain was significantly lower in patients compared with controls (11.40 ±â€Š5.22% vs. 25.72 ±â€Š5.95 P < 0.001). Moreover, right atrial global strain, but not right atrial area or volume, was correlated with invasively measured cardiac index (CI) (r = 0.72; P < 0.0001) and pulmonary vascular resistances in all patients, even though stronger in subjects with precapillary pulmonary hypertension (r = -0.42, P = 0.018; r = -0.54, P = 0.007 respectively; P = 0.007). It was also correlated with New York Heart Association (P = 0.027), BNP (P = 0.002), and 6-min walking test (P = 0.006). After multivariate analysis including right atrial volume, tricuspid annular plane systolic excursion, left atrial strain, and BNP, right atrial global strain showed the strongest correlation with CI. Area under the curve optimal cutoff for predicting CI at least 2.4 l/min/m was 17% (area under the curve: 0.83, sensitivity: 90%, specificity: 54%). CONCLUSION: Right atrial global strain can identify right atrial functional impairment before structural changes and may be implemented in a comprehensive, noninvasive right heart assessment for diagnosis and follow-up of pulmonary hypertension patients.