SeptAlign™ biosorbable implant for correction of mobile cartilaginous nasal septum deviation: A case report

Abstract

Introduction

The standard of care for symptomatic nasal septal deviation in adults, refractory to medical management, is septoplasty. SeptAlign™ is a minimally-invasive, bioabsorbable implant cleared by the United States Food and Drug Administration for mechanical correction of minor nasal septal deviation and a novel alternative to traditional septoplasty.

Presentation of case

We present a case report of a 42 year old male with a history of symptomatic nasal septal deviation and nasal airway obstruction who strongly wished to avoid open surgical correction.

Discussion

We successfully implanted the SeptAlign device to correct the cartilaginous deviation with severe anterior caudal deflection. We present pre- and post-procedure computed tomography and endoscopy imaging and patient reported outcomes to demonstrate correction of nasal airway obstruction and symptoms.

Conclusion

SeptAlign is a less invasive alternative to traditional septoplasty or septorhinoplasty in patients with cartilaginous nasal septal deviation, with the added benefits of avoiding general anesthesia and the convenience of an in-office procedure.

Highlights

• •Minimally invasive alternative to septoplasty in patients with nasal septal deviation.
• •Bioabsorbable implant for mechanical correction of cartilaginous nasal septal deviations.
• •Benefits to patients may include the convenience of in-office procedure and reduced recovery time.

1. Introduction

Nasal septal deviation (NSD) is a leading cause of nasal airway obstruction (NAO) symptoms [1]. NAO is associated with reduced quality of life [[2], [3], [4]] and symptoms include difficulty breathing, poor quality of sleep [5], headaches, facial pain, and decreased olfaction [6,7]. The current standard of care for treatment of NSD refractory to medical management is septoplasty, with or without turbinate reduction [8,9].

While a common intervention, septoplasty is technically challenging, particularly for correction of caudal septal deviation [10]. Septoplasty may involve the resection of cartilage and/or bone, and is generally performed in an operating room under general anesthesia. Post-operative symptoms include pain, swelling, and bleeding [11]. Patients are advised to take up to a week off of work and refrain from usual activities for up to 3 weeks [12].

For these reasons, in this case, our patient was extremely reluctant to proceed to septoplasty. A minimally invasive alternative exists in the form of a bioabsorbable implant which leverages techniques and materials already used in septal surgery. Importantly, general anesthesia is not required. Davis et al. recently published a pilot study demonstrating the safety and feasibility of the device with significant improvement in patient reported outcomes [13]. Thus, we present a case report of a 42 year old male demonstrating that the device can correct severe caudal septal deviation with minimal downtime.

1.1. Device description

The device (SeptAlign™, Spirair Inc., San Francisco, CA, USA) is a novel, minimally-invasive, bioabsorbable implant made from poly(dioxanone) (Fig. 1). It is cleared by the US Food and Drug Administration (FDA) for mechanical correction of minor NSD, and is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques. Its use as a bridge or scaffold for multiple pieces of cartilage is contraindicated, as is its use in patients with an allergy to the device materials or an active infection at the implantation site.

Fig. 1.

SeptAlign bioabsorbable septal implant (Model SPLN001).

Prior to placement of the implant, appropriate local and/or topical anesthesia is administered. The SeptAlign implant is provided preloaded into a single-use delivery device (Fig. 2). To place the implant, the septal mucosa is elevated using standard septoplasty techniques and the delivery device cannula is placed submucosally along the convex side of the deviation. When the surgeon activates the device, a sharp trocar punctures the distal cartilage and the implant's distal anchor is deployed through the cartilage onto the contralateral side of the septum. The delivery device is then removed, unsheathing the implant in the process. The implant has a pre-attached proximal needle which the surgeon drives through the cartilage proximal to the septal deviation and enables the implant to be pulled through the cartilage to the contralateral side (Fig. 3). A Freer or blunt surgical tool is used to deflect the cartilage medially to the desired degree of correction and the implant is pulled through the cartilage until it lays flat along the cartilage, holding the straightened cartilage in place via small anchors. The excess portion of implant, which includes the proximal needle, is trimmed off after the implant is in place.

Fig. 2.

Delivery device.

Fig. 3.

SeptAlign implant placement.

2. Presentation of case

We obtained written informed consent from the patient for the publication of this case report. This case report has been reported in line with the SCARE checklist [14].

A 42 year old Caucasian male presented for nasal obstruction, “sinusitis” with congestion, facial pressure, post nasal drip, ear fullness. He has tried Flonase, nasal saline, Astelin, multiple courses of antibiotics and steroids with no real improvement. He has a history of a Jet Ski accident nearly 20 years ago with severe nasal trauma and nasal obstruction since that time. He has seen multiple providers previously who have recommended surgical correction. He is also bothered by recurrent sinusitis with worsening of symptoms over the past 3–4 years in addition to ear pressure and fullness.

Examination of the nose revealed severe septal deviation of caudal septum to the right, as well as mild external deviation. Preoperative CT scan and nasal endoscopy showed severe anterior caudal septal deflection to the right but superior deviation to the left. The patient's score on the Nasal Obstruction and Septoplasty Effectiveness (NOSE) [15] questionnaire was 95, indicating severe NAO symptoms.

The case was performed in an outpatient surgical center under local anesthetic and propofol sedation with minimal procedural time. The patient was discharged to home. He reported minimal discomfort and no associated complications. He returned to work the following day and was actually able to play golf on the afternoon of the procedure with no difficulty.

After placement of the SeptAlign device, the three month postoperative CT demonstrated a modest improvement in nasal airway patency as the distance from the lateral wall to the nasal septum increased from 3.62 mm to 4.42 mm (22 % increase) at the piriform aperture and from 2.83 mm to 5.20 mm (84 % increase) at the anterior facial plane (Fig. 4). Endoscopy similarly demonstrated improvement in nasal airway diameter (Fig. 5). The patient's external deviation subjectively improved post-procedure. The three-month NOSE score normalized to 0, indicating that NAO symptoms largely resolved.

Fig. 4.

Pre (left) and 3-month post (right) axial CT demonstrating airway patency at the piriform aperture (A) and anterior facial plane (B).

Fig. 5.

Pre (left) and 3-month post (right) endoscopic images of the patient's anterior caudal deviation demonstrating increased airway patency between lateral wall and nasal septum.

3. Discussion

This case describes the use of SeptAlign, a minimally invasive device, for the correction of cartilaginous deviation in a patient with severe anterior caudal deflection who strongly wished to avoid open surgical correction vis-a-vis a traditional septorhinoplasty. The patient was able to resume normal activities the same day. Importantly, he also described a dramatic improvement in subjective NAO symptoms and his NOSE score normalized from 95 to 0 at three months post-treatment. There were no complications or adverse outcomes reported by the subject or observed by the clinician.

This case emphasizes the impact that modest increases in nasal airway patency can have on nasal airflow and, therefore, patient improvement in NAO symptoms. Of course, Pouiselle's law is well known to describe airflow scaling to the 4th power as a function of airway radius. Therefore, a 10 % increase in nasal airway radius results in a 46 % increase in airflow. Similarly, a 20 % increase in radius results in greater than 107 % increase in airflow.

These fundamental dynamics are known to be particularly impactful in the region of the anterior caudal septum which is the site of greatest nasal airway resistance. For example, by inserting a 1 to 5 mm artificial obstruction into the nose, Cole et al. were able to demonstrate that nasal airway resistance changes dramatically with small changes in thickness of an obstruction in the region of the caudal septum and upper lateral cartilage [16]. By changing the artificial obstruction from 4 to 3 mm at the level of the upper lateral cartilage, the authors were able to demonstrate that airway resistance decreased from approximately 20 cmH₂O/L/s to 3 cmH₂O/L/s. Stated differently, a 1 mm change in deviation resulted in an approximately 85 % reduction in measured airway resistance.

While the current study is lacking in rhinomanometry measurements, Pouiselle's law would stipulate this amount of improvement in airway patency should yield a 121 % improvement in airflow at the piriform aperture and 1040 % improvement at the anterior facial plane. This appears to be reflected in the patient's experience as the patient reported substantial improvement in the relevant PRO measures including a reduction of his baseline NOSE score from 95 to 0. Where reduction in NOSE scores were previously reported after SeptAlign placement in Davis et al., this case study provides objective measurement of NSD correction with measurable improvement vis-a-vis CT scan [13].

Another important point emphasized by this case is simplicity of case and recovery from a patient perspective, by resuming moderate physical activity (golfing) on the same day as the procedure, and returning to work the next day.

4. Conclusion

In conclusion, the current case achieved radiographically meaningful and symptomatically significant correction of the patient's anterior caudal deviation. Of course, traditional surgical correction would likely have achieved a greater degree of anatomic correction, and in cases where a cosmetically straight septum is desired, the procedure described herein may be insufficient. This device appears to provide a nice option for cartilaginous deviations when the goal is improving patient breathing symptoms. The SeptAlign device offers an approach that is easy to use for the surgeon and associated with minimal recovery for the patient.

As this case demonstrates, this may represent a less invasive alternative to traditional septoplasty or septorhinoplasty in patients with cartilaginous NSD, with the added benefits of avoiding general anesthesia and the convenience of an in-office procedure. Additionally, patients can avoid extended recovery periods, and may be able to resume work sooner than patients undergoing more invasive operative intervention. Finally, solutions such as SeptAlign afford the additional benefit of cartilage preservation which is useful for preserving structural integrity, and may be particularly advantageous in the case of a revision septoplasty.

Consent

The authors obtained written Informed Consent from the patient for the publication of this case report.

Ethical approval

Case report is exempt from ethical approval.

Funding

None.

Author contribution

All authors have contributed in design, interpretation and writing the case report.

Guarantor

Henry P. Barham, MD, FARS.

Research registration number

NA.

Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.