PMID- 38364975
OWN - NLM
STAT- MEDLINE
DCOM- 20240318
LR  - 20240318
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 224
DP  - 2024 Apr
TI  - Efficacy and safety of the Spiration Valve System for the treatment of severe 
      emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE).
PG  - 107565
LID - S0954-6111(24)00039-8 [pii]
LID - 10.1016/j.rmed.2024.107565 [doi]
AB  - 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 (FEV(1)) 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 
      (FEV(1)) 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.
CI  - Copyright (c) 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Hogarth, Douglas K
AU  - Hogarth DK
AD  - University of Chicago Medical Center, Chicago, IL, USA. Electronic address: 
      dhogarth@uchicago.edu.
FAU - Delage, Antoine
AU  - Delage A
AD  - Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Hopital Laval, 
      Quebec, Canada; Universite de Sherbrooke, Sherbrooke, Canada.
FAU - Zgoda, Michael A
AU  - Zgoda MA
AD  - Dignity Health Medical Group, Phoenix, AZ, USA.
FAU - Nsiah-Dosu, Stephanie
AU  - Nsiah-Dosu S
AD  - Olympus Europa SE & Co. KG, Hamburg, Germany.
FAU - Himes, David
AU  - Himes D
AD  - Olympus Corporation of America, Westborough, MA, USA.
FAU - Reed, Michael F
AU  - Reed MF
AD  - Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20240214
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (alpha 1-Antitrypsin)
SB  - IM
MH  - Humans
MH  - Quality of Life
MH  - Prospective Studies
MH  - *Pulmonary Emphysema
MH  - *alpha 1-Antitrypsin Deficiency/complications
MH  - *Pulmonary Disease, Chronic Obstructive/complications
MH  - Forced Expiratory Volume
MH  - Dyspnea/complications
MH  - Treatment Outcome
MH  - alpha 1-Antitrypsin
OTO - NOTNLM
OT  - Alpha-1 antitrypsin deficiency
OT  - Bronchoscopic lung volume reduction
OT  - Emphysema
OT  - Lung volume reduction surgery
OT  - Spiration valve system
COIS- Declaration of competing interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: Dr. Hogarth is a consultant for Olympus/Spiration. Dr. Hogarth is a 
      consultant for PulmonX and teaches courses for PulmonX. Dr. Hogarth is a 
      consultant for Takeda (maker of AAT replacement product) and is on the MASEK 
      committee for the Alpha One Foundation. He is a consultant for Wave Lifesciences.
EDAT- 2024/02/17 10:43
MHDA- 2024/03/18 06:43
CRDT- 2024/02/16 19:15
PHST- 2023/11/21 00:00 [received]
PHST- 2024/02/09 00:00 [revised]
PHST- 2024/02/11 00:00 [accepted]
PHST- 2024/03/18 06:43 [medline]
PHST- 2024/02/17 10:43 [pubmed]
PHST- 2024/02/16 19:15 [entrez]
AID - S0954-6111(24)00039-8 [pii]
AID - 10.1016/j.rmed.2024.107565 [doi]
PST - ppublish
SO  - Respir Med. 2024 Apr;224:107565. doi: 10.1016/j.rmed.2024.107565. Epub 2024 Feb 
      14.