scholarly journals Absorbable Implant to Treat Nasal Valve Collapse

2017 ◽  
Vol 33 (02) ◽  
pp. 233-240 ◽  
Author(s):  
Marion Nicoló ◽  
Klaus Stelter ◽  
Haneen Sadick ◽  
Murat Bas ◽  
Alexander Berghaus

Objective To evaluate the safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with nasal valve collapse (NVC) with 12 months follow-up. Methods Thirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 12 months postprocedure. Results Fifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 12 months, the mean score was 35.2 ± 29.2, reflecting an average within-patient reduction of –40.9 ± 31.2 points. The majority (76%) of the subjects were responders defined as having at least one NOSE class improvement or a NOSE score reduction of at least 20%. There were no adverse changes in cosmetic appearance at 12 months postprocedure. Three implants in three subjects required retrieval within 30 days postprocedure and resulted in no clinical sequelae. Conclusion This study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.

2018 ◽  
Vol 34 (05) ◽  
pp. 545-550 ◽  
Author(s):  
Marion San Nicoló ◽  
Klaus Stelter ◽  
Haneen Sadick ◽  
Murat Bas ◽  
Alexander Berghaus

AbstractThe safety and effectiveness of an absorbable implant for lateral cartilage support have been recently demonstrated in subjects with nasal valve collapse (NVC) at 12 months postprocedure. This follow-up study aimed to assess whether the safety and effectiveness of the implant persist in these patients for 24 months after the procedure. Thirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 24 months postprocedure. Fifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 24 months, the mean score was 32.0 ± 29.3, reflecting an average within-patient reduction of −44.0 ± 31.1 points. There were no device-related adverse events in the 12 to 24 months period. There were five subjects who exited the study prior to the 24-month follow-up. Four of the five subjects who exited were elected for further intervention and one subject was lost to follow-up. This study demonstrates safety of an absorbable implant for lateral nasal wall support and symptom improvement in some subjects with NVC at 24 months postprocedure.


2018 ◽  
Vol 127 (9) ◽  
pp. 598-603
Author(s):  
Ahmed Ibrahim Elsayed ◽  
Yasser Ahmed Fouad ◽  
Ashraf El Malt ◽  
Ahmed Hassan Sweed

Background: The nasal valve area is the narrowest point in the nasal airway. External nasal valve (ENV) collapse during inspiration occurs if external valve area is too narrow or its lateral component is too floppy. Patients and Method: Twelve patients (7 males, 5 females) aged 8 to 12 years complaining of nasal obstruction due to ENV dysfunction underwent surgical intervention using alar batten graft assisted by temporary external suspensory suture. Results: All patients showed subjective and objective improvement of the nasal airway. The mean Nasal Obstructive Symptom Evaluation (NOSE) was 14 ± 1.71 before surgery and 7.83 ± 1.47 1 year after surgery (significant improvement, p ≤ .0001). The mean Peak Inspiratory Flow Rate was 29.92 ± 4.46 before surgery and 42.58 ± 4.93 1 year after surgery (significant improvement, P ≤ .0001). Conclusion: External nasal valve collapse in children can be managed surgically by using alar batten graft. Temporary suspension suture can be helpful for supporting of the graft until complete healing occurs.


Author(s):  
Douglas M. Sidle ◽  
Pablo Stolovitzky ◽  
Ellen M. O'Malley ◽  
Randall A. Ow ◽  
Nathan E. Nachlas ◽  
...  

AbstractThe 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).


2020 ◽  
Vol 36 (1) ◽  
Author(s):  
Maged Baher Naguib ◽  
Mohamed Rifaat Ahmed ◽  
Yasser Taha Madian ◽  
Tarek Mohamady Elnahriry ◽  
Wael Elshahat Eldeeb

Abstract Background Following the reduction of the nasal hump to a desired level, spreader grafts are usually positioned to prevent the complication of nasal valve collapse. Auto-spreader flap is a new technique that gained more popularity recently and can be used as an alternative to spreader graft. This RCCT compared between both techniques aesthetically and functionally as well as the operative time. Results Forty patients, 17 males (42.5%) and 23 females (57.5%), were included. The mean duration of operation in auto-spreader flap was 11.8 ± 3.4 min, while it was 19.2 ± 3.2 min in spreader graft. The difference between the two procedures was statistically significant (P < 0.05). Functional assessment of nasal obstruction was done for all patients in both groups preoperative that was (75.6 ± 19.9) which showed marked improvement when re-evaluated 3 moths postoperatively (18.9 ± 14.7), and after 6 months NOSE scale was (29.1 ± 20.2). The overall aesthetic satisfaction was 62.5% (25 of 40) irrespective of the surgery done. Sixteen out of 20 patients in spreader group and 9 out of 20 in auto-spreader flap group. Conclusion Auto-spreader flap and spreader graft are very effective surgical procedure for treatment of nasal obstruction due to internal nasal valve dysfunction, but the auto-spreader flap had shorter operative time. However, spreader graft has a superior aesthetic outcome.


2000 ◽  
Vol 122 (2) ◽  
pp. 204-211 ◽  
Author(s):  
Robert J. Troell ◽  
Nelson B. Powell ◽  
Robert W. Riley ◽  
Kasey K. Li

OBJECTIVE A new operative technique to improve nasal valve collapse by placement of cartilage struts along the alar rim was compared with the standard nasal valve cartilage graft (NVG) technique. METHODS AND PATIENTS A retrospective study of consecutive patients with nasal valve collapse was performed at Stanford University Medical Center. Seventy-nine patients with nasal valve collapse underwent reconstruction with either the classic NVG technique or a newly developed nasal alar rim reconstructive (NARR) procedure. The mean age of the NARR group was 50.13 years (SD ± 9.40), with 36 men (92.3%) and 3 women (7.7%). The mean age of the NVG group was 52.14 years (SD ± 10.83), with 36 men (90%) and 4 women (10%). MAIN OUTCOME MEASURES These included functional and subjective evaluation of nasal valve collapse. RESULTS Forty patients (50.6%) underwent the NVG technique, and 39 (49.4%) received the NARR procedure. The NVG technique revealed 0% worsened, 15.0% (6/40) unchanged, 25.0% (10/40) improved, and 60% (24/40) free of obstruction. The NARR procedure revealed 2.6% worsened, 2.6% unchanged, 7.7% improved, and 87.1% free of obstruction. CONCLUSIONS Nasal alar cartilage struts placed along the caudal alar rim offers sufficient support to the alar rim and valve area. This procedure appears to be as effective as currently available reconstructive alternatives, while being technically uncomplicated.


2016 ◽  
Vol 9 (3) ◽  
pp. 125-129
Author(s):  
Avinash Das

ABSTRACT Introduction Posttraumatic nasal valve collapse (NVC) is an underdiagnosed cause of nasal obstruction causing significant symptoms and has been treated by various techniques, the results of which have been variable. In our study, alar batten graft (ABG) has been used to strengthen the nasal wall. Techniques A prospective interventional study was done on 13 patients of posttraumatic NVC using an ABG to reinforce the ala, and results were measured on the basis of standardized nasal obstruction symptom evaluation (NOSE) and nasal obstruction visual analog scale (NO-VAS) scores at 6 months. Results There was a statistically significant improvement in 12 out of 13 patients, with mean improvement of 25.62 on NOSE and 2.4 on NO-VAS scores. There was a visible improvement in the extent of collapse also. Conclusion Posttraumatic NVC can be treated effectively using ABG, with significant improvement in standard scores as well as the symptomatology. How to cite this article Maggon NV, Sethi A, Das A. Posttraumatic Nasal Valve Collapse: Is Alar Batten Graft the Answer? Clin Rhinol An Int J 2016;9(3):125-129.


1996 ◽  
Vol 110 (3) ◽  
pp. 221-224 ◽  
Author(s):  
Samy Elwany ◽  
Hossam Thabet

AbstractObstruction of the nasal valve is an important cause of chronic nasal obstruction in adults. In a series of 500 patients, obstruction at the level of the nasal valve was diagnosed in 65 of them (13 per cent). The obstruction was unilateral in 57 patients (88 per cent). Forty-seven patients (72 per cent) had history of previous nasal surgery of accidental trauma. Causes of obstruction of the nasal valve included high septal deviations, a weak or deformed upper lateral cartilage, adhesions, and alar collapse. All patients underwent corrective nasal surgery and the surgical procedures were tailored according to the existing pathology. Post-operatively, the mean nasal patency score increased from 2.9 to 8.6, the mean nasal airflow increased from 579.5 to 727 cm/sec (at 150 Pa), and the mean nasal resistance decreased from 0.31 to 0.23 Pa/cm3sec-1.


ISRN Urology ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Raashid Hamid ◽  
Aejaz A. Baba ◽  
Altaf H. Shera

Objective. Present study was undertaken to compare the results of two single stage hypospadias repairs, namely, Tubularized Incised Plate (TIP) repair and Mathieu’s repair. Methods. The study included 100 patients of distal penile hypospadias, from January, 2008 to January, 2013. After a detailed history, local examination was performed with reference to the site of meatus, shape of glans, and presence of chordee. TIP repair was performed in 52 patients and Mathieu’s repair in 48 patients. On follow-up, the patients were examined for the position of meatus, shape of meatus, urinary stream, urethrocutaneous fistula, and stricture formation. Results. The mean age of presentation was 6.2 ± 3.2 years (range 1.5–15years). The mean operative time was 63.7 ± 14.3 (45–90) minutes and 95.0 ± 19.1 (70–125) minutes in TIP and Mathieu’s repair, respectively.Complications after surgery were urethero cutaneous fistula in 3(5.76%) and 7 (14.5%), meatal stenosis in 3(5.33%) and 4(8.33%), wound infection in 19.2% and 8.3% cases in TIP repair and Mathieu repair, respectively. The shape of meatus was slit-like and vertically oriented in 48(92.3%) patients who had undergone TIP repair. Conclusion. The Snodgrass repair is significantly faster, with more natural cosmetic appearance of the meatus than the Mathieu’s repair.


Author(s):  
Nadim Bikhazi ◽  
Randall A. Ow ◽  
Ellen M. O'Malley ◽  
Nora Perkins ◽  
Douglas M. Sidle ◽  
...  

AbstractWe 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.


2017 ◽  
Vol 33 (03) ◽  
pp. 353-354
Author(s):  
Klaus Stelter ◽  
Haneen Sadick ◽  
Murat Bas ◽  
Alexander Berghaus ◽  
Marion San Nicoló

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