The VALID-CRT risk score reliably predicts response and outcome of cardiac resynchronization therapy in a real-world population.

OBJECTIVES: The aim of the study was to confirm the value of the VALID-cardiac resynchronization therapy (CRT) risk score in predicting outcome and to assess its association with clinical response (CR) in an unselected real-world CRT population. METHODS AND RESULTS: The present analysis comprised all consecutive CRT patients (pts) enrolled in the CRT-MORE registry from 2011 to 2013. Pts were stratified into five groups (quintiles 1-5) according to the VALID-CRT risk predictor index applied to the CRT-MORE population. In the analysis of clinical outcome, adverse events comprised death from any cause and non-fatal heart failure (HF) events requiring hospitalization. CR at 12-month follow-up was also assessed. We enrolled 905 pts. During a median follow-up of 1005 [627-1361] days, 134 patients died, and 79 had at least one HF hospitalization. At 12 months, 69% of pts displayed an improvement in their CR. The mean VALID-CRT risk score derived from the CRT-MOdular Registry (MORE) population was 0.317, ranging from -0.419 in Q1 to 2.59 in Q5. The risk-stratification algorithm was able to predict total mortality after CRT (survival ranging from 93%-Q1 to 77%-Q5; hazards ratio [HR] = 1.42, 95% confidence interval [CI]: 1.25-1.61, P < .0001), and HF hospitalization (ranging from 95% to 90%; HR = 1.24, 95% CI: 1.06-1.45, P = .009). CR was significantly lower in pts with a high-to-very high risk profile (Q4-5) than in pts with a low-to-intermediate risk profile (Q1-2-3) (55% vs 79%, P < .0001). CONCLUSION: The VALID-CRT risk-stratification algorithm reliably predicts outcome and CRT response after CRT in an unselected, real-world population.

The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria.

BACKGROUND: The European Society of Cardiology (ESC) Guidelines published in 2016 modified indications for cardiac resynchronization therapy (CRT) in comparison with the 2013 ESC Guidelines. The aim of this analysis was to evaluate the impact of the stricter criteria suggested by the 2016 ESC Guidelines on patient outcome in a real-world population. METHODS: We collected data on 930 consecutive patients with complete outcome information who had undergone CRT implantation from 2011 to 2013 from the CRT-MORE registry. Patients were classified according to 2013 (Reference) and 2016 (Current) ESC Guidelines. The primary end-point of the study was death from any cause and heart failure hospitalization. RESULTS: According to the Reference Guidelines, 650 (69.9%) patients met Class I indications, 190 (20.4%) Class IIa, 39 (4.2%) Class IIb and 51 (5.5%) Class III. According to the Current Guidelines, 563 (60.5%) patients met Class I indications, 145 (15.6%) Class IIa, 108 (11.6%) Class IIb and 114 (12.3%) Class III. On comparing the Reference and Current Guidelines, the 538 patients who confirmed their Class I indication had a better outcome in terms of freedom from the combined end-point of heart failure (HF) hospitalization or death from any cause (hazard ratio (HR) of 0.64; 95% CI 0.42 to 0.99; p = 0.0436) when compared to the 112 patients who lost their class I indication (84 moved to class IIb and 28 moved to class III). CONCLUSIONS: The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines excluded about 20% of patients with a worse prognosis. CLINICAL TRIAL REGISTRATION: CRT MORE: Cardiac Resynchronization Therapy Modular Registry URL: http://clinicaltrials.gov/Identifier:NCT01573091.

Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry.

BACKGROUND: There is controversy about the outcome of patients with acute myocarditis (AM), and data are lacking on how patients admitted with suspected AM are managed. We report characteristics, in-hospital management, and long-term outcome of patients with AM based on a retrospective multicenter registry from 19 Italian hospitals. METHODS: A total of 684 patients with suspected AM and recent onset of symptoms (<30 days) were screened between May 2001 and February 2017. Patients >70 years of age and those >50 years of age without coronary angiography were excluded. The final study population comprised 443 patients (median age, 34 years; 19.4% female) with AM diagnosed by either endomyocardial biopsy or increased troponin plus edema and late gadolinium enhancement at cardiac magnetic resonance. RESULTS: At presentation, 118 patients (26.6%) had left ventricular ejection fraction <50%, sustained ventricular arrhythmias, or a low cardiac output syndrome, whereas 325 (73.4%) had no such complications. Endomyocardial biopsy was performed in 56 of 443 (12.6%), and a baseline cardiac magnetic resonance was performed in 415 of 443 (93.7%). Cardiac mortality plus heart transplantation rates at 1 and 5 years were 3.0% and 4.1%. Cardiac mortality plus heart transplantation rates were 11.3% and 14.7% in patients with complicated presentation and 0% in uncomplicated cases (log-rank P<0.0001). Major AM-related cardiac events after the acute phase (postdischarge death and heart transplantation, sustained ventricular arrhythmias treated with electric shock or ablation, symptomatic heart failure needing device implantation) occurred in 2.8% at the 5-year follow-up, with a higher incidence in patients with complicated forms (10.8% versus 0% in uncomplicated AM; log-rank P<0.0001). ß-Adrenoceptor blockers were the most frequently used medications both in complicated (61.9%) and in uncomplicated forms (53.8%; P=0.18). After a median time of 196 days, 200 patients had follow-up cardiac magnetic resonance, and 8 of 55 (14.5%) with complications at presentation had left ventricular ejection fraction <50% compared with 1 of 145 (0.7%) of those with uncomplicated presentation. CONCLUSIONS: In this contemporary study, overall serious adverse events after AM were lower than previously reported. However, patients with left ventricular ejection fraction <50%, ventricular arrhythmias, or low cardiac output syndrome at presentation were at higher risk compared with uncomplicated cases that had a benign prognosis and low risk of subsequent left ventricular systolic dysfunction.

Cardiac Resynchronization Therapy MOdular REgistry: ECG and Rx predictors of response to cardiac resynchronization therapy (NCT01573091).

AIMS: A variable proportion, up to 30%, of patients who undergo cardiac resynchronization therapy (CRT) do not benefit from treatment. The aim of the Cardiac Resynchronization Therapy MOdular REgistry (CRT MORE) is to determine whether specific electrocardiographic and radiographic parameters can be used to predict clinical and echocardiographic response to CRT. METHODS: The CRT MORE is a prospective, single-arm, multicenter cohort study designed to evaluate the electrocardiographic and radiographic predictors of response to CRT. All study patients receive a pacemaker or implantable defibrillator for CRT delivery in accordance with current guidelines. Enrollment started in December 2011 and is scheduled to end in November 2013. Approximately 1100 consecutive patients will be enrolled in 30 Italian centers and will be followed up for 60 months after implantation. The primary endpoint is the improvement in clinical (Clinical Composite Score) and echocardiographic (a decrease of ≥ 15% in left ventricular end-systolic volume) parameters at the 6-month follow-up visit. CONCLUSION: This study might provide important information about which electrocardiographic and radiographic parameters better predict CRT response.