Efficacy and safety of the Spiration Valve System™ for the treatment of severe emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE).

OBJECTIVES: Alpha-1 antitrypsin deficiency (AATD) is a hereditary condition associated with emphysema. This study analyzed the efficacy and safety of Spiration Valve System TM (SVS) among AATD patients with severe emphysema. METHODS: This multicenter prospective study included 20 patients demonstrating AATD as assessed by quantitative levels of AAT and genotype containing two ZZ alleles. Most diseased lobe based on high resolution computed tomography was selected for treatment with endobronchial SVS. The change from baseline in forced expiratory volume in 1 s (FEV1) at 6 months (Primary outcome) and at 12 months, quality-of-life (QoL) measured by St. George's Respiratory Questionnaire (SGRQ) as health status, dyspnea scale measured by mMRC, Chronic obstructive pulmonary disease (COPD) Assessment Test (CAT), 36-item Short Form Health Survey (SF-36) physical component summary (PCS) and safety were assessed. RESULTS: Lung function (FEV1) significantly improved at 6 months (P = 0.02); but did not reach statistical significance at 12 months (P = 0.22). Significant improvement was observed in dyspnea (at all time points), QoL measures (3, 6, and 12 months), CAT score and PCS of SF-36 (1, 3 and 6 months). Response rates based on minimal clinically important difference reached 50-80% for all variables. Overall, 4.4 valves/patient were used to isolate the target lobe, with a mean procedure time of 20.3 min. Serious adverse events included COPD exacerbations (5%), pneumonia (10%), pneumothorax (15%) and death (5%), occurring within first three months. CONCLUSION: SVS endobronchial valve treatment showed improvement in lung function, dyspnea, and QoL in AATD patients with severe emphysema.

Balloon-facilitated percutaneous dilational tracheostomy tube placement: preliminary report of a novel technique.

OBJECTIVE: To describe a novel technique for percutaneous tracheotomy (PT) that could be an alternative to current dilational techniques. DESIGN: An observational animal study of PT was performed using the Seldinger guide wire technique with a tracheostomy tube preloaded onto a dilational balloon catheter. A small skin incision was done with an 11-blade scalpel, but no blunt subcutaneous tissue dissection was performed. SETTING: Animal laboratory in a university hospital. SUBJECTS: Seven adult pigs (approximate weight, 16 to 21 kg). MEASUREMENTS AND RESULTS: Successful tracheostomy was accomplished in all seven pigs without apparent complication. Vital signs and oximetry results remained unchanged throughout the procedure. The mean duration of the procedure was 5.5 min from tracheal puncture to ventilation. CONCLUSION: This novel procedure is a simple and effective means of PT tube placement without subcutaneous tissue dissection and could potentially have decreased complications when compared to the standard methods of PT currently employed in humans. Human studies are pending.