Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation.

BACKGROUND: The interpretation of recent trials on pulmonary vein ablation (PVI) for the treatment of atrial fibrillation (AF) is hampered by the lack of blinding and sham controls. The feasibility of a sham-controlled trial has been questioned. We aimed to assess the attitude of potential participants regarding a sham-controlled trial in a common AF-patient population planned for PVI. METHODS: Patients in two tertiary care centres planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire 1 day before catheter ablation. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced, and patients were asked for their agreement in participation. Telephone follow-up of the AFEQT questionnaire was conducted 3 months after PVI. RESULTS: One hundred and ninety-six patients (mean age 64 ± 11 years, 63% male) were included. Seventy-nine (40%) patients expressed their agreement to participate in the hypothetical sham-controlled trial. An additional 7% agreed to participate if a cross-over option after three months was offered. Agreement rate was similar in patients with first and Redo-PVI and minimal, moderate or severe symptoms. Mean overall AFEQT at baseline was 55 ± 19 and improved by 25 ± 20 points after 3 months (p < 0.001 versus baseline). CONCLUSION: With a participation rate of 40% in potential study participants, a sham-controlled trial for pulmonary vein isolation seems feasible. Patient-reported symptom relief after pulmonary vein isolation is in accordance with previous randomized open studies. The benefit of PVI should be rigorously evaluated in a sham-controlled trial.

Signs of left atrial disease and 10-year risk of atrial fibrillation.

BACKGROUND: The contribution of left atrial disease and excessive supraventricular ectopic activity (ESVEA) to the risk for incident atrial fibrillation (AF) is incompletely understood. OBJECTIVE: To analyse the ten-year risk to develop AF in patients with cardiovascular risk factors and to define the impact of parameters of left atrial disease and ESVEA on AF risk. METHODS: 148 patients from the Diast-CHF trial with at least one cardiovascular risk factor and free of AF at baseline were followed for 10 years. Left atrial disease was defined as left atrial volume index (LAVI) >35 ml/m2, P-terminal force in lead V1 (PTFV1) >4000 ms*µV or elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) >250 pg/ml. We analyzed the association of these parameters and ESVEA (either >720 premature atrial contractions (PAC) or one atrial run >20 beats per day) on AF-free survival. RESULTS: After ten years, AF was newly detected in twelve patients (13.4%) with signs of left atrial disease and two patients (3.4%) without signs of left atrial disease (p = 0.04). LAVI (p = 0.005), ESVEA (p = 0.016) and NT-proBNP (p = 0.010) were significantly associated with AF-free survival in univariate analysis. A combined Cox model of left atrial disease parameters showed associations for NT-proBNP (HR 3.56; 95%CI 1.33-5.31; p = 0.04) and PAC (HR 2.66; 95%CI 1.25-10.15; p = 0.01) but not for LAVI or PTFV1 with AF-free survival. CONCLUSION: The risk for AF is higher in patients with cardiovascular risk factors and signs of left atrial disease. NT-proBNP and premature atrial contractions independently predict AF-free survival. The role of excessive supraventricular ectopic activity for the assessment of AF risk may be underestimated and requires further study.

Evaluation of the HFA-PEFF Score: results from the prospective DIAST-CHF cohort.

AIMS: Although the number of patients suffering from heart failure with preserved ejection fraction (HFpEF) increases, the routine diagnosis remains a challenge. In the absence of a pathognomonic sign for HFpEF or specific treatment strategies, a prognosis-based characterization of suspected patients remains promising for both the risk stratification of the patients and a disease definition. The Heart Failure Association (HFA) of the European Society of Cardiology has introduced an algorithm with different levels of likelihood regarding the diagnosis of HFpEF, the HFA-PEFF score. We aimed to evaluate the predictive value of this algorithm in a large cohort regarding mortality, symptom burden, and the functional status. METHODS AND RESULTS: DIAST-CHF is a multicentre, population-based, prospective, observational study in subjects with at least one risk factor for HFpEF between the age of 50 and 85. We calculated the HFA-PEFF score (n = 1668) and analysed the risk groups for overall mortality, cardiovascular hospitalization, and submaximal functional capacity (6-min walk distance) at baseline and after a follow-up period of 10 years. Patients with high HFA-PEFF score values 5&6 showed a higher mortality than those with an intermediate score (score values 2-4) and low score values (high 21.3% vs. intermediate 10.1% vs. low 4.3%, P < 0.001). Also, the burden of MACE (death, cardiovascular hospitalization, new myocardial infarction, first diagnosis of HF) was increased in the high score values group (high 40.7% vs. intermediate 25.9% vs. low 13.9%, P < 0.001). Similarly, patients with higher scores had higher cumulative incidences of cardiovascular hospitalizations (P = 0.011). Subjects with higher scores also had lower 6-min walk distance both at baseline and during follow-up. CONCLUSIONS: The HFA-PEFF score provides a reliable instrument to stratify suspected HFpEF patients by their risk for mortality, symptom burden, and functional status in cohort at risk with a follow-up period of 10 years. As high HFA-PEFF scores are associated with worse outcome, the HFA-PEFF algorithm describes a defining approach towards HFpEF.

Revisited Upper Reference Limits for Highly Sensitive Cardiac Troponin T in Relation to Age, Sex, and Renal Function.

(1) Background: Highly sensitive cardiac troponin T (hs-cTnT) plays an essential role in the diagnosis of myocardial injury. The upper reference limit of the respective assay is generally applied, irrespective of age, renal function, or sex. We aimed to identify age-adjusted and sex-adjusted upper reference limits in relation to renal function in a large population-based cohort without cardiac diseases. (2) Methods: We included 5428 subjects of the population-based LIFE-Adult cohort, free of diagnosed cardiac diseases. Sex-adjusted and age-adjusted 99th percentiles for hs-cTnT in subjects with preserved renal function were obtained. (3) Results: The hs-cTnT values were higher in men of all age groups. In both sexes, an increasing age positively correlated with higher hs-cTnT values. Hs-cTnT weakly correlated with serum creatinine. The three-dimensional analysis of age, creatinine, and hs-cTnT showed no relevant additional effect of creatinine on hs-cTnT. In men aged above 60 and women above 70, the calculated 99th percentiles clearly exceeded the commonly applied thresholds. (4) Conclusion: Age and sex have a major impact on the serum concentration of hs-cTnT, while renal function does not. We propose to consider age-adjusted and sex-adjusted reference values.