San Nicoló Marion, Stelter Klaus, Sadick Haneen, Bas Murat, Berghaus Alexander
Department of Otorhinolaryngology, Head and Neck Surgery, Ludwig Maximilian University of Munich, Munich, Germany.
HNO Zentrum Mangfall-Inn, Rosenheim, Germany.
Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7.
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. 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. 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. This study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.
为评估可吸收植入物用于鼻瓣膜塌陷(NVC)患者外侧软骨支撑的安全性和有效性,并进行12个月的随访。对30名鼻塞症状评估(NOSE)评分≥55且单纯NVC的患者进行了治疗;14例在手术室全身麻醉下进行,16例在门诊局部麻醉下进行。该植入物为聚乳酸共聚物,通过输送工具放置在鼻壁内以提供外侧软骨支撑。对患者进行术后12个月的随访。30名患者共植入56枚植入物。术前平均NOSE评分为76.7±14.8,范围为55至100。在12个月时,平均评分为35.2±29.2,反映出患者体内平均降低了-40.9±31.2分。大多数(76%)患者为反应者,定义为至少有一项NOSE分级改善或NOSE评分降低至少20%。术后12个月时外观无不良变化。3名患者的3枚植入物在术后30天内需要取出,且未产生临床后遗症。本研究证明了可吸收植入物用于NVC患者外侧软骨支撑在术后12个月时的安全性和有效性。