Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

Worsening heart failure includes worsening heart failure requiring unplanned hospitalization and worsening heart failure requiring urgent visits.

In addition to signs and symptoms of HF, the patient should also receive treatment specifically directed at HF, including at least 1 of the following: 1) significant augmentation in oral diuretic therapy; 2) initiation of intravenous diuretic (even a single dose) or vasoactive agent (eg, vasodilator, vasopressor, or inotropic therapy); or 3) mechanical circulatory support or fluid removal.

Unplanned hospitalization is defined as any unscheduled hospital admission with a length of stay that either exceeds 24 h or crosses a calendar day, and not planned by the investigators. In case the hospitalization is classified as planned by the Investigator and the time interval between the decision to admit and the admission is less than 24 hours, the End Point and Adverse Event Committee will give final classification concerning planned or unplanned.

Worsening of Heart Failure Requiring Unplanned Urgent Visits Patients have an urgent, unscheduled office or emergency visit for HF with signs, symptoms, and diagnostic testing results identical to those already described for an HF hospitalization. The patient must also (with the exception of significant augmentation in oral diuretic therapy) require therapy similar to that previously described for an HF hospitalization.

All deaths due to cardiovascular reasons and all heart transplants because of terminal HF. Deaths due to worsening of HF, acute coronary syndrome, cerebrovascular accident.

All deaths were reviewed and adjudicated by the Clinical Events Committee

Unplanned Hospitalization due to Cardiovascular Reasons Any in-hospital stay over one date change due to cardiovascular reason, which includes worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events, and not planned by the investigator. In case the hospitalization is classified as planned by the investigator, and the time interval between the decision to hospitalize and the hospitalization is less than 24 hours, the End Point and Adverse Event Committee will give final classification concerning planned or unplanned.

KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score).

The 6-minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.

The H2FPEF score is a clinical scoring system used to assess the likelihood of heart failure with preserved ejection fraction (HFpEF) in patients with suspected heart failure. It helps in differentiating HFpEF from other causes of dyspnea. The total score ranges from 0 to 5, with higher scores indicating a greater likelihood of HFpEF.

Elevated levels of NT-pro BNP are indicative of increased cardiac stress and can help in the diagnosis, assessment, and monitoring of heart failure.

NYHA class is a widely used system for assessing the functional status and severity of heart failure symptoms in patients, with NYHA class IV being the worst.

Based on status of baseline diuretics, the intention to treat population will be divided into patients with baseline diuretics and patients without.

For patients without the usage of baseline diuretics, the outcome of changes in diuretics is the initiation of diuretics during the follow-up period.

For patients without the usage of baseline diuretics, the outcomes including:

• permanent discontinuation;
• escalation defined as increased dosage, iv fused diuretic or combination with another diuretic;
• de-escalation (including permanent discontinuation or decrease in dosage); Changes in diuretic therapy are analyzed in a time-to-first event fashion using a multivariable Cox regression model to obtain hazard ratios (HRs) and 95% confidence intervals (CIs).

Atrial fibrillation burden refers to the amount of time that a person with atrial fibrillation spends in an irregular heart rhythm over a specific period, using a Holter monitor.

A 30-second episode of AF in ablation group following the 90 day blanking period, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF.