Tangutur Akshay, Brown Katherine K, Dedhia Raj C
Department of Otorhinolaryngology-Head & Neck Surgery, University of Pennsylvania, Philadelphia.
Department of Dermatology, University of Pennsylvania, Philadelphia.
JAMA Otolaryngol Head Neck Surg. 2025 Feb 27;151(4):401-4. doi: 10.1001/jamaoto.2024.5446.
Allergic contact reactions to medical implants are underrecognized and incompletely understood, particularly in hypoglossal nerve stimulation (HGNS), an increasingly popular and effective alternative to positive airway pressure therapy for patients with obstructive sleep apnea (OSA).
To document a rare case of allergic contact reaction in a patient following implantation of an HGNS device for OSA.
DESIGN, SETTING, AND PARTICIPANT: In this case report, the patient presented to a quaternary care academic medical center with localized erythema, swelling, and pustular drainage at the right neck incision site approximately 2 months following HGNS device implantation.
This patient underwent serial, bilateral HGNS device implantation and subsequent explantation.
The main outcomes were the findings from symptom monitoring and allergy patch testing.
A 64-year-old male patient with severe OSA (Apnea-Hypopnea Index, 54 events/h) underwent implantation of an HGNS device. His recovery was uneventful for 2 months until he reported localized erythema, swelling, and pustular drainage at the right neck incision site. HGNS device extrusion at the neck was noted approximately 3 months postoperatively, prompting device explantation. The patient underwent subsequent HGNS reimplantation in the left neck and chest 3 months after right-sided explantation. At postoperative day 10, swelling, erythema, and purulence were noted from neck and chest incisions. The device was re-explanted with odorless purulence noted in the chest and neck. The wound cultures were negative for infection, and at this time, the patient underwent allergy patch testing, which demonstrated a strong positive reaction to isophorone diisocyanate. Patch testing confirmed an allergy to isocyanates, evidenced by a strong positive reaction to isophorone diisocyanate, 1.0%, in petrolatum. This finding was further validated by the manufacturer, which confirmed isocyanates were used in the polyurethane components of the HGNS device.
Isocyanates are low-molecular weight compounds used in the production of polyurethanes, which are commonly found in medical devices. HGNS is a widely available implantable medical device for treatment of patients with OSA. The literature regarding isocyanate allergies with medical implants is limited, and this may be the first confirmed case with an HGNS device. This case report highlights the importance of noninfectious causes of device reactions, especially when occurring outside of the postoperative wound infection window. Patch testing for isocyanate and other components can inform both patient and clinician regarding the cause of device implantation failure and have implications for future implantable devices.
对医用植入物的过敏性接触反应未得到充分认识且了解不全面,尤其是在舌下神经刺激(HGNS)方面,HGNS作为阻塞性睡眠呼吸暂停(OSA)患者正压通气治疗的一种越来越流行且有效的替代方法。
记录1例OSA患者植入HGNS设备后发生罕见过敏性接触反应的病例。
设计、背景和参与者:在本病例报告中,患者在HGNS设备植入后约2个月因右颈部切口部位出现局部红斑、肿胀和脓疱引流而就诊于一家四级医疗学术医学中心。
该患者接受了连续的双侧HGNS设备植入及随后的取出。
主要结局为症状监测和过敏斑贴试验的结果。
一名64岁重度OSA男性患者(呼吸暂停低通气指数为54次/小时)接受了HGNS设备植入。其恢复情况在2个月内平稳,直到他报告右颈部切口部位出现局部红斑、肿胀和脓疱引流。术后约3个月发现HGNS设备在颈部突出,促使取出设备。患者在右侧取出后3个月于左颈部和胸部再次植入HGNS。术后第10天,颈部和胸部切口出现肿胀、红斑和脓性分泌物。设备再次取出,胸部和颈部有无味脓性分泌物。伤口培养未发现感染,此时患者接受了过敏斑贴试验,结果显示对异佛尔酮二异氰酸酯有强阳性反应。斑贴试验证实对异氰酸酯过敏,在凡士林基质中1.0%的异佛尔酮二异氰酸酯引发了强阳性反应,这一发现得到了制造商的进一步验证,制造商确认HGNS设备的聚氨酯部件中使用了异氰酸酯。
异氰酸酯是用于生产聚氨酯的低分子量化合物,在医疗设备中很常见。HGNS是一种广泛应用的可植入医疗设备,用于治疗OSA患者。关于医用植入物异氰酸酯过敏的文献有限,这可能是首例经证实的HGNS设备相关病例。本病例报告强调了设备反应非感染性原因的重要性,尤其是在术后伤口感染窗口期之外发生时。对异氰酸酯和其他成分进行斑贴试验可为患者和临床医生提供关于设备植入失败原因的信息,并对未来的可植入设备有启示意义。