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Laryngoscope Investigative... Apr 2023Safety and efficacy of the NEUROMARK® system for treating 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 < .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 < .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 < .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.
PubMed: 37090860
DOI: 10.1002/lio2.1040 -
Internal Medicine (Tokyo, Japan) 2017
Topics: Cerebrospinal Fluid Rhinorrhea; Cranial Fossa, Posterior; Endoscopy; Humans
PubMed: 28717069
DOI: 10.2169/internalmedicine.56.8744 -
Neurologia Medico-chirurgica 2010Here we describe the procedures of endoscopic pituitary and skull base surgery in our institute. We also review the literature to reveal recent advances in this field.... (Review)
Review
Here we describe the procedures of endoscopic pituitary and skull base surgery in our institute. We also review the literature to reveal recent advances in this field. Endonasal approach via the sphenoid ostium was carried out for pituitary lesions without the nasal speculum. Postoperative nasal packing was basically not needed in such cases. For meningiomas, craniopharyngiomas, and giant pituitary adenomas, which required intra-dural procedures, nasal procedures such as middle nasal conchotomy and posterior ethmoidectomy, and skull base techniques such as optic canal decompression and removal of the planum sphenoidale were carried out to gain a wider operative field. Navigation and ultrasonic Doppler ultrasonography were essential. Angled endoscopes allowed more successful removal of tumors under direct visualization extending into the cavernous sinus and lower clivus. If cerebrospinal fluid (CSF) leakage occurred during operation, the dural opening was covered with a vascularized mucoseptal flap obtained from the nasal septum. Lumbar drainage system to prevent postoperative CSF rhinorrhea was frequently not required. Angled suction tips, single-shaft coagulation tools, and slim and longer holding forceps, all of which were newly designed for endoscopic surgery, were essential for smoother procedures. Endonasal endoscopic pituitary surgery allows less invasive transsphenoidal surgery since no postoperative nasal packing and less dependence on lumbar drainage are needed. Endoscopic pituitary surgery will be more common and become a standard procedure. Endoscopic skull base surgery has enabled more aggressive removal of extrasellar tumors with the aid of nasal and skull base techniques. Postoperative CSF leakage is now under control due to novel methods which have been proposed to close the dural defect in a water-tight manner. Endoscopic skull base surgery is more highly specialized, so needs special techniques and surgical training. Patient selection is also important, which needs collaboration with ear, nose, and throat specialists. As a safe and successful procedure in skull base surgery, this complex procedure should be carried out only in specialized hospitals, which deal with many patients with skull base lesions.
Topics: Endoscopy; Humans; Nasal Cavity; Pituitary Neoplasms; Postoperative Complications; Skull Base Neoplasms
PubMed: 20885110
DOI: 10.2176/nmc.50.756 -
Chirurgia (Bucharest, Romania : 1990) Feb 2024Odontogenic sinusitis is a frequent disease of the maxillary sinus, resulting from a dental inflammatory condition or a foreign body migrated in the sinus cavity. We...
Odontogenic sinusitis is a frequent disease of the maxillary sinus, resulting from a dental inflammatory condition or a foreign body migrated in the sinus cavity. We performed a clinical retrospective study aimed to review the two surgical endoscopic approaches for odontogenic maxillary sinusitis middle and inferior meatotomy, in terms of realistic indications, efficacy, outcomes, and possible complications. In our study, we included a number of 400 patients with odontogenic maxillary sinusitis divided into two groups, treated in our hospital over five years, from January 2019 to December 2023. The patients included in this research were over 18 years old, diagnosed with odontogenic maxillary sinusitis, and underwent either middle meatal antrostomy or inferior meatotomy. We examined the medical records of 400 patients. The vast majority of patients had a history of dental interventions, and the most affected tooth was the first maxillary molar. The symptoms at admission were typical for sinusitis: nasal obstruction, anterior or posterior rhinorrhea, hyposmia to anosmia, cacosmia, and pain or facial pressure. 80% of the patients in the study underwent middle meatal antrostomy, while 20% underwent inferior meatotomy. There were no significant differences between these two approaches in terms of efficacy, complication rates, recovery, or relapses. The complications that occurred after the surgical treatment were minor and with a very low frequency. The most reported were middle meatus synechiae and the persistence of the meatotomy ostium, with mucus recirculation (in patients with inferior meatotomy). Endoscopic surgical treatment of odontogenic maxillary sinusitis can be done as middle or inferior meatotomy, each having specific indications. The maxillary antrostomy is preferred in the majority of cases, as it is a procedure in which the natural ostium of the maxillary sinus is enlarged, thereby maintaining the natural drainage pathway of the sinus. However, the inferior meatotomy is preferred in the case of foreign bodies or maxillary sinus retention cysts localized at the level of the sinus floor or in the alveolar or lateral recesses, or as part of a combined approach (inferior and middle meatotomy), when the ablation of a "fungus ball" is required.
Topics: Humans; Maxillary Sinusitis; Neoplasm Recurrence, Local; Retrospective Studies; Sinus Floor Augmentation; Sinusitis; Treatment Outcome; Adult
PubMed: 38465718
DOI: 10.21614/chirurgia.2024.v.119.i.1.p.76 -
Journal of Neurosciences in Rural... 2022The objectives of the study were to study the analysis of outcomes after endoscopic endonasal transsphenoidal surgery (EETSS) in acromegaly in terms of surgical...
OBJECTIVES
The objectives of the study were to study the analysis of outcomes after endoscopic endonasal transsphenoidal surgery (EETSS) in acromegaly in terms of surgical complications, clinical improvement, endocrinological remission, achievement of prognostically critical growth hormone (GH) level, and requirement of additional treatment.
MATERIALS AND METHODS
The study included 28 acromegaly patients, who underwent EETSS. A 2010 consensus criterion was used for defining remission. Assessment of prognostically critical GH level (random value <2.5 ng/ml), the extent of resection and additional treatment, was done at post-operative week (POW) 12.
RESULTS
All adenomas were macroadenomas; with a mean volume of 16.34 cm (range, 0.4-99 cm). Most adenomas had high-grade extensions. Most common suprasellar, infrasellar, anterior, and posterior extension grades were 3 ( = 13), 1 ( = 16), 1 ( = 14), and 0 ( = 20), respectively. Knosp Grade 3 was common on both sides (right, = 9 and left, = 8). One patient had already been operated on with EETSS, 1.5 years back from current surgery. Sixteen patients were on hormonal support, preoperatively. Four patients died during follow-up. Post-operative common complications were diabetes insipidus (DI, = 18), cerebrospinal fluid rhinorrhea ( = 10), surgical site hematoma ( = 3), meningitis ( = 3), hydrocephalus ( = 2), and syndrome of inappropriate antidiuretic hormone ( = 1). The mean hospital stay was 11.62 days and 12.17 months were the mean follow-up period. At 12 POW, no improvement was seen in body enlargement and visual complaints, but all other complaints improved significantly except perspiration. Adenomas were decreased in all extensions except posterior and mean adenoma volume was reduced from 16.34 cm to 2.92 cm after surgery. Sub-total resection (STR, = 10), near-total resection (NTR, = 7), gross-total resection (GTR, = 5), and partial resection (PR, = 2) were achieved. Endocrinological remission and prognostically critical GH levels were attained in 29.17% ( = 7) and 66.67% ( = 16), respectively. NTR, GTR, STR, and PR were associated with 57.14%, 40%, 10%, and 0% endocrinological remission, respectively. Additional treatment was required in a total of 17 patients, three in GTR, nine in STR, three in NTR, and two in PR. Ten were treated with Gamma Knife radiosurgery along with medical treatment and seven with medical treatment alone.
CONCLUSION
A successful EETSS can reduce adenoma volume to achieve clinical improvement, endocrinologic remission, and prognostically critical GH level with some complications related to surgery. Pre-operative larger volume and higher extension grades affect these outcomes adversely.
PubMed: 36743751
DOI: 10.25259/JNRP-2022-3-28-R1-(2453) -
International Forum of Allergy &... Oct 2017Endoscopic posterior nasal nerve (PNN) resection has been described as an efficacious surgical treatment of allergic and nonallergic rhinitis, but the requirement for... (Clinical Trial)
Clinical Trial
BACKGROUND
Endoscopic posterior nasal nerve (PNN) resection has been described as an efficacious surgical treatment of allergic and nonallergic rhinitis, but the requirement for surgery under general anesthesia has limited its acceptance. We report the first series of patients treated for chronic rhinitis using a novel device designed for office-based cryosurgical ablation of the PNN.
METHODS
Twenty-seven patients with chronic rhinorrhea and/or nasal congestion for >3 months were recruited (allergic or nonallergic rhinitis), with minimum rhinorrhea and/or congestion subscores of 2 as part of the Total Nasal Symptom Score [TNSS]). Under local anesthesia, the cryotherapy device was applied endoscopically to the posterior middle meatus and was used to freeze the PNN region bilaterally. Patients were followed up after 7, 30, 90, 180, and 365 days to assess TNSS.
RESULTS
The procedure was successfully completed in 100% of patients, with no complications; 74% reported no or mild discomfort by the first postprocedure day. TNSS was reduced significantly at 30 days (mean ± standard deviation: 6.2 ± 0.5 at baseline, 2.6 ± 0.3 at 30 days, n = 27, p < 0.001), with continued reduction at 90 (2.7 ± 0.4, n = 24, p < 0.001), 180 (2.3 ± 0.5, n = 21, p < 0.001), and 365 days (1.9 ± 0.3, n = 15, p < 0.001). Both rhinorrhea and congestion subscores decreased significantly at 30, 90, 180, and 365 days compared to baseline (p < 0.001). Allergic and nonallergic subcohorts both appeared to benefit from treatment.
CONCLUSION
Office-based cryotherapy of the PNN region is safe and well tolerated. Symptom scores were significantly decreased by 7 days postprocedure and remained lower at 30, 90, 180, and 365 days.
Topics: Ambulatory Surgical Procedures; Cryosurgery; Endoscopy; Female; Humans; Male; Middle Aged; Nasal Obstruction; Nose; Pilot Projects; Rhinitis
PubMed: 28799727
DOI: 10.1002/alr.21991 -
Journal of Asthma and Allergy 2022Chronic rhinosinusitis (CRS) is defined as the inflammation of nose and paranasal sinuses, affecting the patients' quality of life and productivity. Chronic... (Review)
Review
Chronic rhinosinusitis (CRS) is defined as the inflammation of nose and paranasal sinuses, affecting the patients' quality of life and productivity. Chronic rhinosinusitis with nasal polyps (CRSwNP) is a principal clinical entity confirmed by the existence of chronic sinonasal inflammation and is characterized by anterior or posterior rhinorrhea, nasal congestion, hyposmia and/or facial pressure or facial pain. Several epidemiologic studies have revealed wide variations in the incidence of CRS among regions globally ranging from 4.6% to 12%. The Gulf countries are also witnessing an unprecedented burden of CRSwNP. According to the current clinical guidelines, glucocorticosteroids and antibiotics are the principal pharmacotherapeutic approaches. Endoscopic sinus surgery is recommended for those who have failed maximal pharmacotherapy. Recently, biologics are considered as an alternative best approach due to the complications associated with medical therapy and surgery. However, precise data on the clinical position of biologic agents in the management of CRSwNP in the Gulf region is not available. The present review article addresses the current diagnostic and management approaches for CRSwNP and also emphasizes the role of emerging biologics in the current treatment strategies for CRSwNP in the Gulf region. Further, a consensus protocol was convened to rationalize the guideline recommendations, strategize the best practices with biologics, and develop clinical practice guidelines for all primary-care specialists in the Gulf region. The consensus-based report will be a useful reference tool for primary-care physicians in primary-healthcare settings, regarding the appropriate time for the initiation of biological treatment in the Gulf region.
PubMed: 35018101
DOI: 10.2147/JAA.S321017 -
Neurology International Sep 2023Ecchordosis physaliphora (EP) is a benign notochordal remnant, which is often an incidental finding; however, it can rarely present with neurological symptoms. We... (Review)
Review
Ecchordosis physaliphora (EP) is a benign notochordal remnant, which is often an incidental finding; however, it can rarely present with neurological symptoms. We performed a systematic review of the literature for cases of symptomatic EP published in PubMed, Web of Science and Embase from January 1982 to May 2023. This is the largest review to date and revealed 60 cases including ours. Headache (55%) and CSF rhinorrhea (32%) were the most frequent clinical manifestations. The majority of symptomatic EP lesions were located in the prepontine region (77%) and required surgical resection (75%). EP should be considered in patients with neurologic symptoms in the setting of prepontine or posterior sphenoid sinus lesions. While symptomatic patients often require surgical intervention, rare cases may respond to oral corticosteroids.
PubMed: 37873832
DOI: 10.3390/neurolint15040075 -
The Laryngoscope Aug 2020To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis. (Clinical Trial)
Clinical Trial
OBJECTIVE
To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis.
METHODS
This was a prospective single-arm trial of 98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis. PNN cryoablation was performed in-office under local anesthesia using a handheld device. Patients discontinued use of intranasal ipratropium 3 days prior to treatment and throughout the study period. Reflective Total Nasal Symptom Score (rTNSS) was measured at pretreatment baseline and posttreatment at 1 month, 3 months, 6 months, and 9 months. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at pretreatment and 3 months posttreatment. Adverse effects and postprocedure medication usage were recorded.
RESULTS
Ninety-eight procedures (100%) were successfully completed. rTNSS significantly improved over pretreatment baseline (6.1 ± 1.9) at 1 month (2.9 ± 1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups. RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis.
CONCLUSION
Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life.
LEVEL OF EVIDENCE
4 Laryngoscope, 130: 1877-1884, 2020.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anesthesia, Local; Chronic Disease; Cryosurgery; Female; Humans; Male; Middle Aged; Prospective Studies; Quality of Life; Rhinitis; Surveys and Questionnaires; United States
PubMed: 31566744
DOI: 10.1002/lary.28301 -
Journal of Neurological Surgery. Part... Aug 2018Primary closure of posterior fossa dura can be challenging, and postoperative cerebrospinal fluid (CSF) leaks continue to represent a common complication of the...
Primary closure of posterior fossa dura can be challenging, and postoperative cerebrospinal fluid (CSF) leaks continue to represent a common complication of the retrosigmoid approach. We describe a simple technique to allow for primary closure of the dura following retrosigmoid approaches. The incidence of CSF leaks using this method is reported. A retrospective chart review was conducted on all cases of retrosigmoid craniotomies performed by the senior surgeon from February 2009 to February 2015. The primary outcome was development of postoperative CSF leak or pseudomeningocele. Length of stay, lesion type, and other surgical complications were also reported. Eighty-six patients underwent a retrosigmoid craniotomy during the study period. The most common indications for retrosigmoid craniotomy were microvascular decompression (58%) and tumor resection (36%). No allo- or autografts to repair the dural defect were needed, and no lumbar drains were used. No patients developed CSF otorrhea, rhinorrhea, or incisional leak postoperatively. Primary dural closure is possible in retrosigmoid approaches without the use of allo- or autografts and may prevent postoperative CSF leaks when combined with other posterior fossa closure techniques. Careful attention to the handling of the dural flap is necessary to achieve this.
PubMed: 30009112
DOI: 10.1055/s-0037-1607455