PMID- 33616224
OWN - NLM
STAT- MEDLINE
DCOM- 20210920
LR  - 20210929
IS  - 1531-4995 (Electronic)
IS  - 0023-852X (Print)
IS  - 0023-852X (Linking)
VI  - 131
IP  - 9
DP  - 2021 Sep
TI  - Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a 
      Prospective Multicenter Study.
PG  - 1952-1957
LID - 10.1002/lary.29453 [doi]
AB  - OBJECTIVES/HYPOTHESIS: To assess the long-term (12-24 months) safety and 
      effectiveness of cryoablation of the posterior nasal nerve as treatment for 
      chronic rhinitis. STUDY DESIGN: A multicenter, prospective, single-arm clinical 
      study. METHODS: The study was conducted from February 2017 to April 2020. Study 
      endpoints included change from baseline in the reflective Total Nasal Symptom 
      Score (rTNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), 
      physician assessment of improvement using the Clinical Global 
      Impression-Improvement (CGI-I), and the incidence of treatment-related adverse 
      events. RESULTS: Ninety-one participants completed the study through the initial 
      12-month study period. Sixty-two participants consented to the long-term 
      follow-up with 57 completing the 24-month follow-up. Significant improvements in 
      the total rTNSS were reflected in a median change from baseline of -3.0 or -4.0 
      at all timepoints (P < .001). Greater than 80.0% of participants achieved the 
      minimum clinically important difference (MCID) of improvement by >/=1 point on the 
      rTNSS at all follow-ups. Total RQLQ scores indicated significant improvement 
      (P < .0001) in quality of life. Over 77% of participants achieved the MCID (>/=0.5 
      points) for the total RQLQ score. According to the CGI-I, >/=83.0% experienced 
      improvement at all but the 12-month visit (61.9%). One participant experienced 
      two treatment-related serious adverse events (epistaxis and retained pledget). A 
      total of 29 nonserious treatment-related AEs were reported in 23 participants; 
      most events were transient and resolved with little to no intervention. 
      CONCLUSIONS: Cryotherapy significantly and clinically improves rhinitis symptoms 
      and quality of life with outcomes that are durable through 24 months after 
      treatment. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1952-1957, 2021.
CI  - (c) 2021 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf 
      of The American Laryngological, Rhinological and Otological Society, Inc.
FAU - Ow, Randall A
AU  - Ow RA
AD  - Sacramento Ear, Nose, and Throat, Roseville, CA, U.S.A.
FAU - O'Malley, Ellen M
AU  - O'Malley EM
AUID- ORCID: 0000-0002-3751-764X
AD  - Clinical Affairs, Stryker ENT, Plymouth, MN, U.S.A.
FAU - Han, Joseph K
AU  - Han JK
AD  - Otolaryngology, Eastern Virginia Medical School, Norfolk, VA, U.S.A.
FAU - Lam, Kent K
AU  - Lam KK
AD  - Otolaryngology, Eastern Virginia Medical School, Norfolk, VA, U.S.A.
FAU - Yen, David M
AU  - Yen DM
AD  - Specialty Physician Associates, Bethlehem, PA, U.S.A.
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210222
PL  - United States
TA  - Laryngoscope
JT  - The Laryngoscope
JID - 8607378
SB  - IM
MH  - Adult
MH  - Aged
MH  - Chronic Disease
MH  - Cryosurgery/*adverse effects/methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nasal Mucosa/*innervation/pathology
MH  - Prospective Studies
MH  - Quality of Life
MH  - Rhinitis/diagnosis/*psychology/*surgery
MH  - Safety
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Treatment Outcome
PMC - PMC8451775
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - chronic rhinitis
OT  - cryotherapy
OT  - nonallergic rhinitis
OT  - posterior nasal nerve cryoablation
EDAT- 2021/02/23 06:00
MHDA- 2021/09/21 06:00
PMCR- 2021/09/20
CRDT- 2021/02/22 09:19
PHST- 2021/01/12 00:00 [revised]
PHST- 2020/11/24 00:00 [received]
PHST- 2021/01/30 00:00 [accepted]
PHST- 2021/02/23 06:00 [pubmed]
PHST- 2021/09/21 06:00 [medline]
PHST- 2021/02/22 09:19 [entrez]
PHST- 2021/09/20 00:00 [pmc-release]
AID - LARY29453 [pii]
AID - 10.1002/lary.29453 [doi]
PST - ppublish
SO  - Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 
      22.