Background—
Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. It is not known whether complete pulmonary vein isolation (PVI) is superior to incomplete PVI with regard to the patients’ clinical outcome.
Methods and Results—
Patients with drug-refractory, symptomatic paroxysmal AF were randomly assigned to either incomplete (group A) or complete PVI (group B). In group A, a persistent gap was intentionally left within the circumferential ablation line, whereas in group B, complete PVI without any gaps was intended. At 3 months, all patients underwent invasive reevaluation to assess the rate of persistent PVI. Clinical follow-up was based on daily 30-s transtelephonic ECG transmissions. Primary study end point was the time to first recurrence of (symptomatic or asymptomatic) AF. A total of 233 patients were enrolled (116 in group A and 117 in group B). AF recurrence within 3 months was observed in a total of 161 patients (136 [84.5%] with symptomatic and 25 [15.5%] with asymptomatic AF); AF recurred in 62.2% of group B patients and 79.2% of group A patients (
P
<0.001), for a difference in favor of complete PVI of 17.1% (95% confidence interval, 5.3%–28.9%). Invasive restudy in 103 group A patients and 93 group B patients revealed conduction gaps in 92 (89.3%) and 65 (69.9%) patients, respectively.
Conclusions—
This study proves the superiority of complete PVI over incomplete PVI with respect to AF recurrence within 3 months. However, the rate of electric reconduction 3 months after PVI is high in patients with initially isolated PVs.
Clinical Trial Registration—
URL:
http://clinicaltrials.gov
; Unique identifier: NCT00293943.
IMPORTANCE Cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia. Metacognitive training (MCT) is targeted at cognitive biases involved in the pathogenesis of delusions.OBJECTIVE To examine the long-term efficacy of group MCT for schizophrenia in order to explore whether previously established effects were sustained.
DESIGN, SETTING, AND PARTICIPANTSA 2-center, randomized, controlled, assessor-blind, parallel group trial was conducted. A total of 150 inpatients or outpatients with DSM-IV diagnoses of schizophrenia spectrum disorders were enrolled. All patients were prescribed antipsychotic medication. The second follow-up assessment took place 3 years later after the intervention phase was terminated.
INTERVENTIONS Group MCT targeting cognitive biases vs neuropsychological training (COGPACK).Patients received a maximum of 16 sessions.
MAIN OUTCOMES AND MEASURESThe primary outcome measure was a delusion score derived from the Positive and Negative Syndrome Scale (PANSS). The PANSS positive syndrome and total scores, the Psychotic Symptom Rating Scales, the jumping to conclusions bias, self-esteem, and quality of life served as secondary outcome measures.
RESULTSThe intention-to-treat analyses demonstrated that patients in the MCT group had significantly greater reductions in the core PANSS delusion score, after 3 years compared with the control group (η 2 partial = .037; P = .05). Among the secondary outcomes, the intention-to-treat analyses also demonstrated that patients in the MCT group had significantly greater reductions in the PANSS positive syndrome score (η 2 partial = .055; P = .02) and the Psychotic Symptom Rating Scales delusion score (η 2 partial = .109; P = .001). Significant group differences at the 3-year follow-up were also found on measures of self-esteem and quality of life, which did not distinguish groups at earlier assessment points. Attention was improved in the neuropsychological training group relative to the MCT group. The completion rate was 61.3% after 3 years.
CONCLUSIONS AND RELEVANCEMetacognitive training demonstrated sustained effects in the reduction of delusions, which were over and above the effects of antipsychotic medication. Moreover, there were some unanticipated ("sleeper") effects as both self-esteem and quality of life were improved after 3 years. Effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias.
Sensitivity of a first-time CCDS or an MRI for detection of GCA rapidly decreases under corticosteroid treatment. Therefore imaging of patients with suspected GCA should be performed as soon as possible, preferably within the first days of treatment.
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