Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies.

Bronchial thermoplasty is an endoscopic therapy for severe asthma. The previously reported, randomised sham-controlled AIR2 (Asthma Intervention Research 2) trial showed a significant reduction in severe asthma exacerbations, emergency department visits and hospitalisations after bronchial thermoplasty. More "real-world" clinical outcome data is needed.This article compares outcomes in bronchial thermoplasty subjects with 3 years of follow-up from the ongoing, post-market PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study with those from the AIR2 trial.279 subjects were treated with bronchial thermoplasty in the PAS2 study. We compared the first 190 PAS2 subjects with the 190 bronchial thermoplasty-treated subjects in the AIR2 trial at 3 years of follow-up. The PAS2 subjects were older (mean age 45.9 versus 40.7 years) and more obese (mean body mass index 32.5 versus 29.3 kg·m-2) and took higher doses of inhaled corticosteroids (mean dose 2301 versus 1961 µg·day-1). More PAS2 subjects had experienced severe exacerbations (74% versus 52%) and hospitalisations (15.3% versus 4.2%) in the 12 months prior to bronchial thermoplasty. At year 3 after bronchial thermoplasty, the percentage of PAS2 subjects with severe exacerbations, emergency department visits and hospitalisations significantly decreased by 45%, 55% and 40%, respectively, echoing the AIR2 results.The PAS2 study demonstrates similar improvements in asthma control after bronchial thermoplasty compared with the AIR2 trial despite enrolling subjects who may have had poorer asthma control.

Clinical pacing post-conditioning during revascularization after AMI.

Intermittent dyssynchrony, induced by ventricular pacing, during early reperfusion reduces infarct size in pre-clinical studies. We evaluated cardioprotection by pacing post-conditioning (PPC) in ST-segment elevation myocardial infarction in a randomized, controlled, single-center, single-blinded, first-in-man study. Patients with first ST-segment elevation myocardial infarction received either PPC plus percutaneous coronary intervention (PCI) (n = 30) or PCI (n = 30). PPC consisted of 10 episodes of 30-s right ventricular pacing. Infarct size was measured as the area under the curve of creatine kinase (CK) (primary endpoint) and by contrast-enhanced cardiac magnetic resonance. The CK area under the curve was not significantly different between study groups. Adjusted contrast-enhanced cardiac magnetic resonance data showed ∼25% smaller infarct size in PPC + PCI than in PCI patients after 4 days (p = 0.01), 4 months (p = 0.02), and 1 year of PCI (p = 0.08). In PPC + PCI, (uncomplicated) ventricular fibrillation (n = 3) and paroxysmal atrial fibrillation (n = 4) were observed as opposed to 1 and 0 cases in PCI, respectively. We conclude PPC is feasible and may induce cardioprotection during PCI treatment of ST-segment elevation myocardial infarction, but technical improvements are needed to improve safety. (PROTECT: Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel[s]; NCT00409604).