Impact of text reminders on pneumatic compression device (PCD) compliance in patients with breast cancer-related lymphedema.

PURPOSE: Do cell phone text reminders impact the rate of compliance with pneumatic compression device (PCD) therapy among women with breast cancer-related lymphedema (BCRL)? METHODS: A prospective, randomized, 2-group feasibility study conducted at 2 centers. Participants were adult females (≥18 years old) with unilateral BCRL who had the capability of receiving reminder text messages. All participants underwent PCD therapy. Participants were randomized 1:1 to control (no text messages) or test group (received text message reminders if the PCD had not been used for 2 consecutive days). The rate of compliance between treatment groups was the main outcome measure. Secondary outcome measures were changes in arm girth, quality of life (QOL), and symptom severity. RESULTS: Twenty-nine participants were enrolled and randomized, 25 were available for follow-up at 60 days (14 test, 11 control). Overall, 52.2% (12/23) of all participants were completely compliant, an additional 43.5% (10/23) were partially compliant, and 1 patient (4.3%) was noncompliant. The test and control groups did not differ in device compliance. In the pooled population, weight, BMI, and arm girth were improved. Overall disease-specific QOL and symptom severity were improved. Regression analysis showed benefits were greater among participants with higher rates of compliance. CONCLUSIONS: Automated text reminders did not improve compliance in patients with BCRL as compliance rates were already high in this patient population. Improvements in weight, BMI, arm girth, disease-specific quality of life, and symptom severity measures were observed regardless of the treatment assignment. Full compliance resulted in greater functional and QOL benefits. TRIAL REGISTRATION: The study was registered at www. CLINICALTRIALS: gov (NCT04432727) on June 16, 2020.

Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.

Objective: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods: A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results: Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post-procedure. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse.

We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures.

The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study.

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.