Cryoballoon pulmonary vein isolation in treating atrial fibrillation using different freeze protocols: The "ICE-T 4 minutes vs 3 minutes" propensity-matched study (Frankfurt ICE-T 4 vs. 3).

BACKGROUND: Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI). OBJECTIVE: The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol. METHODS: This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included. RESULTS: A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups. CONCLUSION: As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.

Catheter ablation of atrial fibrillation using ablation index-guided high power (50 W) for pulmonary vein isolation with or without esophageal temperature probe (the AI-HP ESO II).

BACKGROUND: High-power, short-duration ablation for pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF) facilitates the procedure and improve effectiveness; however, esophageal injury remains a safety concern. OBJECTIVE: The purpose of this study was to investigate the role of luminal esophageal temperature (LET) monitoring during high-power ablation for PVI in terms of endoscopic esophageal lesion. METHODS: Patients with symptomatic AF underwent ablation index-guided high-power (AI-HP) PVI (50 W; AI anterior wall/posterior wall: 550/400). In the first consecutive set of patients, an insulated esophageal temperature probe was used for LET monitoring (cutoff LET >39°C) (group A). In the second consecutive set of patients, the probe was not used (group B). All patients were scheduled to undergo esophageal endoscopy 1-3 days after ablation. RESULTS: A total of 120 patients (60 group A; 60 group B) were included in the study (mean age 67.8 years; 64% male). Baseline characteristics and procedural outcomes were similar between the 2 groups. Procedural PVI was achieved in all patients. First-pass PVI rate was 96.6%. Mean procedural radiofrequency (RF) time was 11.5 minutes, mean procedural time was 55.5 minutes, and fluoroscopic time was 5.6 minutes. Mean contact force at the LA posterior wall was 23 g, and mean RF ablation time at the LA posterior wall was 3.2 minutes. Two patients in group A and 1 patient in group B had endoscopic small esophageal lesions (P = .99). No serious procedural adverse events were observed. CONCLUSION: Among patients undergoing AI-HP (50 W) PVI, the incidences of ablation-related endoscopic esophageal lesion in patients with and those without use of a temperature probe for LET monitoring (cutoff 39°C) were comparably low.

Higher Fit-fOR-The-Aged (FORTA) Scores Comprising Medication Errors are Associated with Impaired Cognitive and Physical Function Tests in the VALFORTA Trial.

BACKGROUND: The Fit fOR The Aged (FORTA) list, a drug classification combining positive and negative labelling of drugs, has been clinically (VALFORTA-trial) validated to improve medication quality and clinical endpoints. OBJECTIVE: The objective of this study was to determine the association of medication quality with functional abilities tested in cognitive and physical function tests. PATIENTS AND METHODS: Data from the prospective, randomized controlled VALFORTA trial on 409 geriatric (mean age 81.53 years) in-hospital patients were tested for associations between the FORTA score (sum of over- and under-treatment errors) on admission and cognitive and physical function tests. Univariate and multivariate linear correlations corrected for age, sex, number of medications, number of chronic conditions, and body mass index as well as comparisons between high and low FORTA-score (cut-off 3) patients were performed. RESULTS: The FORTA score was significantly correlated with Instrumental Activities of Daily Living (p < 0.0001), the Tinetti test (p < 0.002), Essen Questionnaire on Age and Sleepiness (p < 0.0001), Mini-Mental State Examination (p < 0.0001), and handgrip strength (p < 0.04) in the univariate analysis, and with Instrumental Activities of Daily Living (p < 0.003), the Tinetti test (p < 0.003), and the Essen Questionnaire on Age and Sleepiness (p < 0.0001) in the multivariate analysis. Effect size was weak for Instrumental Activities of Daily Living (R-squared = 0.12) and the Tinetti test (R-squared = 0.03) and medium for the Essen Questionnaire on Age and Sleepiness (R-squared = 0.22). Significant differences between patients with high and low FORTA scores were found for Instrumental Activities of Daily Living, the Tinetti test, mini-nutritional assessments, Mini-Mental State Examination, Essen Questionnaire on Age and Sleepiness, and the Geriatric Depression Scale. All significant tests revealed that higher FORTA scores (lower medication quality) were associated with less favorable test outcomes. CONCLUSIONS: The FORTA score is associated with relevant aspects of comprehensive geriatric assessment, underlining the importance of medication quality for the functional and cognitive well-being of older patients. TRIAL REGISTRATION NUMBER: DRKS00000531.

Changes in prescription patterns in older hospitalized patients: the impact of FORTA on disease-related over- and under-treatments.

PURPOSE: Physicians often face difficulties in choosing appropriate medications for multimorbid older people. The FORTA (Fit for the Aged) classification (A: absolutely, B: beneficial, C: careful, D: don't) was proposed as a clinical tool for improving the quality of drug treatment in the aged. As an implicit tool, FORTA has been shown to aid medication optimization and improve clinical end points in the VALFORTA trial. In this prospective randomized controlled study, 207 older hospitalized patients received standard geriatric treatment and 202 patients received FORTA-guided treatment. METHODS: Here, changes of drug prescriptions at the anatomical-therapeutic-chemical system (ATC) level were evaluated separately for important diagnoses in descriptive analyses; over- and under-treatment rates were compared between groups. RESULTS: At the individual drug/drug class level related to all important diagnoses, the application of FORTA significantly improved under-treatments for 12 drugs/drug classes (e.g., ACE inhibitors to treat arterial hypertension) and over-treatments for 7 drugs/drug classes (e.g., proton pump inhibitors to treat gastroesophageal reflux disease). CONCLUSIONS: FORTA representing the first combined positive/negative labeling approach at the individual drug level aids the optimization of drug treatment in older people as detected for drugs/drug classes at the ATC level in important indications. FORTA is effective in addressing over- and under-treatments even if analyzed for smaller subgroups of VALFORTA.

VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification.

TRIAL DESIGN: to further validate the FORTA (Fit fOR The Aged) concept, a bicentric randomised, controlled trial was run in two geriatric clinics. METHODS: patients (≥65 years, ≥3 drugs or ≥60 years, ≥6 drugs) with three relevant diseases and hospitalisation for ≥5 days were randomised. In the intervention, but not the control group, a FORTA team instructed ward physicians on FORTA. FORTA is the first positive/negative listing approach labelling medications used to treat chronic illnesses in older patients from A (indispensable), B (beneficial), C (questionable) to D (avoid). The primary end point was the FORTA score: sum of medication errors classified as over-, under- and mistreatment. Consecutive patients were randomised to the intervention and control ward; outcome assessment was blinded. RESULTS: four hundred and nine patients (age 81.5 years, 64% female, hospitalisation 17.4 days) were included. The primary end point was significantly (P < 0.0001) more reduced in the intervention versus control groups (2.7 ± 2.25 versus 1 ± 1.8, mean ± SD, intergroup comparison of admission/discharge differences). Over- and under-treatment scores and use of A (increase) and D (decrease) drugs were significantly improved (P < 0.01). The total number of adverse drug reactions (ADRs) was significantly reduced by FORTA (P < 0.05, number needed to treat is 5). Activities of daily living and renal failure improved significantly (P < 0.05). Blood pressure remained constant in the intervention, but decreased significantly in the control group. CONCLUSION: applying FORTA to hospitalised geriatric patients leads to improvement of medication quality and may improve secondary clinical end points (e.g. ADRs). The concept is amenable to successful communication and implementation. Registration (DRKS-ID): DRKS00000531. FUNDING: DFG-German Research Foundation (WE 1184/15-1).

[Polypharmacy in the elderly - choosing wisely by using the FORTA list]. / Polypharmazie im Alter - klug entscheiden mit dem FORTA-Prinzip.

Multimorbidity and polypharmacy are threats to elderly patients; improvement of medication is important and a novel listing approach - the FORTA [Fit fOR The Aged] list - should support this in clinical practice. Here, we aim to describe procedural details of successful application of FORTA. FORTA labels range from A (indispensable), B (beneficial), C (questionable) to D (avoid), depending on evidence for safety, efficacy and overall age-appropriateness. As an implicit tool, it is only applicable if medical details of the patient are known. The process starts with history taking and diagnostic assessment including disease grading. This is the base for FORTA-assisted selection of drugs to avoid overtreatment (drug not necessary), undertreatment (condition not or not sufficiently treated by positively labeled drugs) or mistreatment (drugs indicated, but negatively rather than positively labeled drug chosen). Selection is followed by secondary analyses, e. g. regarding dosing or contraindications. The medication scheme is updated in reflection of wanted clinical effects (e. g. blood pressure lowering) and side effects (e. g. dizziness).