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Palatal implants: A new method for the treatment of snoring
Abstract
To evaluate the safety, feasibility and effectiveness of a treatment for snoring using permanent palatal implants.
This was a prospective, non-randomized study involving 35 healthy patients (26 males, 9 females) referred for treatment of habitual snoring. A baseline medical examination, an evaluation of snoring-related subjective symptoms and an overnight sleep analysis were performed. Three PET implants were placed in the palate of each patient using a new delivery device under local anaesthesia. The patients were followed by means of office visits at 2-3, 14, 30 and 90 days postoperatively, at which discomfort, pain, adverse events and changes in snoring-related parameters were recorded.
The average time required for the procedure was 8 min; 23% of the patients required no postoperative analgesia; the average consumption of analgesic was 125 mg of diclofenac and the average duration of analgesia was 1.5 days after the procedure. No bleeding, haematoma or infection were observed. Two of the implants were extruded; both of these patients experienced a satisfactory reduction in snoring intensity and no replacements were necessary. The mean reduction in snoring intensity was 51%, with the visual analogue scale score evaluated by the bed partner falling from 7.3 to 3.6 (p<0.001). The Epworth Sleepiness Score dropped from 9.3 to 4.6 (p<0.001). In total, 86% of the bed partners and 89% of the patients recommended the procedure.
The new palatal implant system is safe and is associated with low morbidity. It is a fast, simple and effective treatment for snoring.
... Likewise, the most studied surgery targeting dilator muscle tone is hypoglossal nerve stimulation, which increases the pharyngeal dilator muscle tone during sleep (Certal et al. 2015). On the other hand, a surgical technique that targets soft tissue elasticity in the upper airway includes palatal implants that increase the stiffness of the soft palate (Nordgård et al. 2004). However, the short-term and long-term success rate of these surgeries varies highly between patients, occasionally even resulting in a negative outcome (Sher et al. 1996;Carvalho et al. 2012). ...
... Polyethylentherephthalate implants of Young's modulus 244 MPa as recommended in Nordgård et al. (2004) were inserted in the soft palate and the tongue (in two configurations). ...
... Palatal implants For palatal stiffening, we simulated the insertion of 3 palatal implants as reported in Nordgård et al. (2004). The implants had a length of 18 mm, a radius of 0.75 mm, and center to center separation of 5 mm. ...
The upper airway experiences mechanical loads during breathing. Obstructive sleep apnea is a very common sleep disorder, in which the normal function of the airway is compromised, enabling its collapse. Its treatment remains unsatisfactory with variable efficacy in the case of many surgeries. Finite element models of the upper airway to simulate the effects of various anatomic and physiologic manipulations on its mechanics could be helpful in predicting surgical success. Partial 3D finite element models based on patient-specific CT-scans were undertaken in a pilot study of 5 OSA patients. Upper airway soft tissues including the soft palate, hard palate, tongue, and pharyngeal wall were segmented around the midsagittal plane up to a width of 2.5 cm in the lateral direction. Simulations of surgical interventions such as Uvulopalatopharyngoplasty (UPPP), maxillo-mandibular advancement (MMA), palatal implants, and tongue implants have been performed. Our results showed that maxillo-mandibular advancement (MMA) surgery of 1 cm improved the critical closing pressure by at least 212.2%. Following MMA, the best improvement was seen via uvulopalatopharyngoplasty (UPPP), with an improvement of at least 19.12%. Palatal and tongue implants also offered a certain degree of improvement. Further, we observed possible interacting mechanisms that suggested simultaneous implementation of UPPP and tongue stiffening; and palatal and tongue stiffening could be beneficial. Our results suggest that computational modeling is a useful tool for analyzing the influence of anatomic and physiological manipulations on upper airway mechanics. The goal of personalized treatment in the case of OSA could be achieved with the use of computational modeling.
... Introduced as an in-office surgical procedure, the Pillar Palatal Implant System (PPIS) or "pillar procedure" is marketed as a minimally invasive treatment for obstructive sleep apnea (OSA) and snoring [1][2][3][4][5]. PPIS works by adding stiffness to the soft palate and reducing its dynamic flutter [6]. Although some studies have demonstrated improvements in apnea-hypoxia index and Epworth Sleepiness Scale of OSA when compared to placebo, the efficacy of the procedure remains largely uncertain [1,7,8]. ...
... However, only one of these patients continued to complain of this issue beyond a 3-month follow-up [22]. In other small clinical trials that assessed for difficulty swallowing or dysphagia in the post-operative period, there were no patients who reported these complications [3,6,23]. Additionally, in this present study, difficulty swallowing was significantly more common in cases that described extruding parts. ...
... Skjøstad et al. described similar results in their 10 patients, with pain being described as no more than a mild throat infection lasting for a few days [4]. Other studies also did not present any significant number of patients with prolonged post-operative pain or any patients requiring persistent use of pain medication [3,6,23,24]. Patient complaints of pain should always be investigated, but both providers and patients can expect the symptoms to resolve on their own after a short time period if there is no evidence of implant failure. ...
... In recent years, another surgical treatment called palatal implant surgery has been presented (Nordgård et al., 2004). It has the advantage of being a minimally invasive procedure causing little discomfort for patients and is easily performed under local anesthesia. ...
... The typical one is called the Palatal Implant System (Pillar TM System, Restore Medical, St Paul, MN), consisting of an implant device and a delivery part. Through palatal implant surgery, the stiffness of the soft palate is thought to be increased (Nordgård et al., 2004;Friedman et al., 2006a,b). The palatal implant surgery's efficacy as a snoring treatment has been clarified to be ideal (Friedman et al., 2008). ...
Obstructive sleep apnea (OSA) affects a large percentage of the population and is increasingly recognized as a major global health problem. One surgical procedure for OSA is to implant polyethylene (PET) material into the soft palate, but its efficacy remains to be discussed. In this study, we provide input to this topic based on numerical simulations. Three 3 dimensional (3D) soft palate finite element models including mouth-close and mouth-open cases were created based on three patient-specific computed tomography (CT) images. A simplified material modeling approach with the Neo-Hookean material model was applied, and nonlinear geometry was accounted for. Young's modulus for the implant material was obtained from uniaxial tests, and the PET implant pillars were inserted to the 3D soft palate model. With the finite element model, we designed different surgical schemes and investigated their efficacy with respect to avoiding the soft palate collapse. Several pillar schemes were tested, including different placement directions, different placement positions, different settings for the radius and the array parameters of the implant pillars, and different Young's moduli for the pillars. Based on our simulation results, the longitudinal-direction implant surgery improved the stiffness of the soft palate to a small degree, and implanting in the transverse direction was evaluated to be a good choice for improving the existing surgical scheme. In addition, the Young's modulus of the polyethylene material implants has an influence on the reinforcement efficacy of the soft palate.
... Recently, palatal implants were developed and have been applied to increase soft palate stiffness by reducing vibration and collapse [6]. However, side effects after surgery such as pain, inflammation, and foreign body sense persist and caused extrusion in up to 25 % of cases [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. Although surgical treatment limited to the soft palate has not been perfected, this approach has been proposed to treat snoring and obstructive sleep apnea, and there are a number of studies that indicate the importance of palatal surgery. ...
... To address these shortcomings, palatal implants (Medtronic, Minneapolis, MN), which are advantageous because of the relatively simple procedure, short recovery period, and less reported pain, have been developed and implemented [6]. However, this method can produce side effects such as extrusion, postoperative pain, inflammation, foreign body sense, and uneasiness when speaking or swallowing [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. ...
We investigated a novel, minimally invasive surgery that uses an absorbable suture technique to treat snoring and mild obstructive sleep apnea. This simple procedure was developed to increase the stiffness of the soft palate and to promote uvula elevation with sutures. Thirty-five snorer and mild obstructive sleep apnea syndrome patients were included in this study. The palate was sutured with the newly developed technique. The results of our surgery were evaluated using polysomnography (PSG), the Epworth sleepiness scale (ESS), and a visual analogue scale (VAS) before surgery and 90 days after surgery. One year after surgery, telephone interviews were performed to assess patient satisfaction. Postoperative physical examinations of all patients showed increased stiffness of the soft palate and superiorly displaced uvula. These findings were consistent after the postoperative day 90. The patients' snoring symptoms and their bed partners' complaints, assessed by ESS and VAS, significantly improved compared to the pre-treatment value (p < 0.05). Additionally, the apnea-hypopnea index (AHI), assessed by PSG, was significantly improved compared to the pre-treatment value (p < 0.05). Based on the results from the telephone interviews analyzed 1 year after surgery, about 88 % of patients were satisfied with the outcome. This minimally invasive snoreplasty that uses absorbable suture material is an effective and simple procedure for treating snoring and mild obstructive sleep apnea.
... Palatal implants were introduced in 2002 as a minimally invasive, singlestage treatment for snoring and sleep apnea with low morbidity and promising results. [9][10][11] In the Pillar procedure, three polyethylene terephthalate (PET) implants are inserted in the mucosal layer of the soft palate sagittally, parallel to each other, and spaced 2 mm apart in a simple office procedure. Research and clinical results demonstrate that PET material is safe to be used in humans. ...
... There were no changes observed in the patients' BMI and AHI in this trial. Nordgard et al. [10] reported a decrease in the snoring intensity VAS value from 7.3 to 3.6 and a decrease in ESS from 9.3 to 4.6, with 89% patient satisfaction. The one-year follow-up results for this group reported a decrease in the snoring intensity VAS from 7.1 to 4.1 with 70.6% patient partner satisfaction. ...
In this study the efficacy of palatal implants for treatment of snoring was evaluated.
Seventeen patients (10 males, 7 females; mean age 49.2+/-7.8 years; range 31 to 66 years) with primary snoring and an apnea-hypopnea index of less than 15 were treated with palatal implants after clinical and endoscopic examination. Snoring-related symptoms were evaluated at baseline and 90 days after surgery and polysomnography was performed. Patients and their spouses completed questionnaires and visual analog scales (VAS) evaluating snoring, apneas, and the intensity, duration, and social effects of daytime sleepiness at baseline and 90 days after surgery. Pre- and postoperative assessment results were compared.
Epworth sleepiness scale score was significantly decreased in the postoperative period (p<0.05). Postoperative mean VAS snoring, apnea, and daytime sleepiness scores were also significantly improved (p<0.01). No patients reported worsening of apnea, 5.9% of patients reported no change in apnea, and 94.1% of patients reported a marked decrease in apneas. In the postoperative period, 76.4% of patients reported reduced snoring, and 88.3% of patients reported reduced daytime sleepiness.
Palatal implants have been demonstrated to be a safe and effective treatment for snoring with minimal patient discomfort. Establishing realistic pretreatment expectations can maximize patient satisfaction.
... In an attempt to address these problems, palatal implants were introduced with promising results. [6][7][8][9] For RFTA, experience has shown that the number of lesions, 10 the amount of energy introduced into the soft palate, 11 and repeated treatment sessions 11 have an impact on the snoring intensity. This indicates that further stiffening of the palate can improve the final treatment results. ...
... The implant material (PET) has been shown to induce a well-defined fibrous capsule within 6 to 8 weeks. 12 In an earlier study, 7 we found that reduction of snoring continued up to 3 months after implantation, so any extrusion in this time interval probably reduces the fibrous formation. ...
Palatal implants have seen an increased role in the treatment of snoring. In this study, we evaluate the safety and possible treatment effect of adding further stiffness to the palate through the use of a more rigid implant.
Randomized double-blind study of 20 patients with primary snoring. Three polyethylene teralphate implants were placed in the soft palate with the patient under local anesthesia. Ten patients received regular implants (rigidity 1.0) and 10 patients received stiffer implants (rigidity 1.8). The patients and their bed partners were followed for 6 months with questionnaires and office visits. A sleep study was performed preoperatively and at the last follow-up.
Four of the 10 patients with stiffer implants had 5 partial extrusions in the observation period. There was a nonsignificant reduction in snoring intensity from 8.1 to 6.1 evaluated by the bed partner on a visual analogue scale in this group. No extrusions were seen in the group with regular implants. This group showed a significant reduction in snoring intensity from 7.7 to 4.7. No other major adverse events were observed.
Rigid implants cause short time extrusions with loss of treatment effect. Regular implants reduce palatal snoring intensity with high patient and bed partner satisfaction. EBM rating: A-1b.
... In the early 2000s, pillar implants were introduced to stiffen the broad and long soft palate in a single application [18,52]. The implant itself is a segment of braided, polyethylene terephthalate (PET) woven yarns around 18 mm long with an outer diameter of 1.5 mm. ...
Purpose of Review
To describe the current knowledge about palate surgery in obstructive sleep apnea (OSA). Basic and advanced surgical techniques developed during the last years will be illustrated.
Recent Findings
Palate surgery has evolved from ablative and aggressive surgeries to more selective and conservative surgery. Minimally invasive surgery has a role in palate surgery, including radiofrequency of the soft palate that can be performed in the office. Nevertheless, invasive techniques may be more effective in the long term. From tonsillectomy to modern lateral wall addressing pharyngoplasties have shown some good results in selected OSA patients. Several randomized controlled trials and meta-analysis are reviewed. A description of each technique is included.
Summary
Selecting a successful surgical approach depends on many factors such as the age of the patients, AHI severity, patient’s airway collapse pattern, body mass index, surgeon experience, and patient’s preference. It is important to discuss also surgical treatment expectations and outcomes. Lateral wall addressing pharyngoplasties have shown best results in OSA patients.
... 72,100 A binary (yes or no) assessment of pain was used by 2 studies. 57,55 Self-report of pain by the patient was collected primarily in 6 studies 22,27,37,47,62,85 and was a secondary measure in 1 study. 41 Patient appearance of pain-as ascertained by the clinician-was used in 1 study. ...
Objective:
To qualitatively assess practices of periprocedural pain assessment and control and to evaluate the effectiveness of interventions for pain during in-office procedures reported in the otolaryngology literature through a systematic review.
Data sources:
PubMed, CINAHL, and Web of Science searches from inception to 2018.
Review methods:
English-language studies reporting qualitative or quantitative data for periprocedural pain assessment in adult patients undergoing in-office otolaryngology procedures were included. Risk of bias was assessed via the Cochrane Risk of Bias or Cochrane Risk of Bias in Non-Randomized Studies of Interventions tools as appropriate. Two reviewers screened all articles. Bias was assessed by 3 reviewers.
Results:
Eighty-six studies describing 32 types of procedures met inclusion criteria. Study quality and risk of bias ranged from good to serious but did not affect assessed outcomes. Validated methods of pain assessment were used by only 45% of studies. The most commonly used pain assessment was patient tolerance, or ability to simply complete a procedure. Only 5.8% of studies elicited patients' baseline pain levels prior to procedures, and a qualitative assessment of pain was done in merely 3.5%. Eleven unique pain control regimens were described in the literature, with 8% of studies failing to report method of pain control.
Conclusion:
Many reports of measures and management of pain for in-office procedures exist but few employ validated measures, few are standardized, and current data do not support any specific pain control measures over others. Significant opportunity remains to investigate methods for improving patient pain and tolerance of in-office procedures.
... Because PI implementation is a treatment to the soft palate, like other surgical techniques, it is possible to have dysphagia, foreign body sensation, and mouth dryness, depending upon the fibrosis on the soft palate following this procedure. Nordgård et al., [3] reported a metallic taste complaint in two patients, but they had no patients with dysphagia or speech disorder. Akpinar et al. [15] performed acoustic voice analysis preoperatively on 23 patients who underwent PI and on the eighth day postoperative. ...
Objectives:
This study aims to investigate the long-term efficiency and reliability of the Pillar Implant (PI) procedure.
Patients and methods:
Between January 2008 and January 2010, a total of 27 patients (16 males, 11 females; mean age 45.8±7.2 years; range 31 to 58 years) who were diagnosed with low obstructive sleep apnea syndrome and simple snoring underwent the PI procedure in this retrospective, nonrandomized study. The patients were evaluated preoperatively with visual analog scale (VAS) scores in terms of snoring, dysphagia, mouth dryness, foreign body sensation, and pain at the first month, third month, and sixth year intervals.
Results:
Based on the snoring scale, VAS scores were statistically significantly lower in the first month, third month and sixth year compared to preoperative scores (p=0.001, p=0.008, p=0.017, respectively). There was no pain in any patients beyond the third day. The VAS score averages in all evaluations were higher by statistical significance relative to the preoperative averages (p=0.018, p=0.027, p=0.025, respectively). Mouth dryness was encountered in seven patients. It persisted in seven patients at the third month and in five patients at the sixth year interval. The VAS score averages were statistically significantly higher in all evaluations compared to the preoperative scores (p=0.017, p=0.018, p=0.042, respectively).
Conclusion:
Pillar implant is an efficient, reliable method in the long-term; however, it should be considered that it could cause complaints such as dysphagia, foreign body sensation, and mouth dryness.
... The use of PIs has demonstrated clinical benefits with minimal postoperative morbidity and complications. [3][4][5] These benefits, along with acceptable surgical results of the PIs for patients with OSA, make it a possible option that can be offered to properly selected patients with OSA and obvious palatal vibration. 6 Traditionally, hypopharyngeal procedures for OSA are generally more technically challenging and time consuming. ...
Importance:
This study adds to the literature on the efficacy and low complication rates associated with minimally invasive, single-stage, multilevel surgery for Asian adults with obstructive sleep apnea (OSA) for whom conservative treatment had failed. Overall, our experience has produced results that make this procedure an option for select patients with snoring and OSA.
Objective:
To investigate the effectiveness and safety of anatomy-based, minimally invasive, single-stage, multilevel surgery in the treatment of OSA in an Asian population.
Design, setting, and participants:
This retrospective study enrolled 59 consecutive patients with OSA from a tertiary academic medical center who had multilevel obstruction and unsuccessful conservative therapy and then underwent minimally invasive, single-stage, multilevel surgery. The subjective symptoms and objective polysomnographic findings were collected preoperatively and at a minimum of 3 months postoperatively. The Global Patient Assessment questionnaire was used to assess patient satisfaction after minimally invasive, single-stage, multilevel surgery.
Main outcomes and measures:
Scores on the Epworth Sleepiness Scale and bed partner evaluation of patient's snoring on a visual analog scale (scale of 0-10, with 0 indicating no snoring and 10 indicating the bed partner to leave the room or sleep separately, as assessed by the bed partner). The primary outcomes are a 50% decrease in bed partner's snoring visual analog scale level postoperatively and an improvement of 50% or more in apnea-hypopnea index by an at least 3-month follow-up. Adverse events and patient-reported quality measures were also assessed.
Results:
Forty-seven patients (36 men and 11 women; mean [SD], 47.3 [10.9] years) with a minimum 3-month follow-up and complete data were included in the analysis. None of the patients had serious perioperative or postoperative complications. Three months postoperatively, the mean (SD) scores on the Epworth Sleepiness Scale and bed partner evaluation of patient's snoring on the visual analog scale decreased from 11.6 (4.3) to 9.2 (3.1), with a mean (SD) difference of -2.4 (3.7) (95% CI, -3.5 to -1.3), and 9.4 (1.5) to 3.9 (1.9), with a mean (SD) difference of -5.6 (2.0) (95% CI, -6.2 to -5.0), respectively. The mean (SD) apnea-hypopnea index and lowest oxygen saturation changed from 30.5 (18.8) to 26.0 (16.5), with a mean (SD) difference of -4.5 (14.1) (95% CI, -8.6 to -0.3), and 78.2% (9.9%) to 80.8% (8.2%), with a mean (SD) difference of +2.6 (8.7) (95% CI, 0-5.1), respectively. The surgical response rate was 46.8% (22 of 47 patients) (95% CI, 32.5%-61.1%). The classical success rate was 14.9% (7 of 47 patients) (95% CI, 6.2%-28.3%).
Conclusions and relevance:
This study reveals the improvement of the 2 relevant clinical outcomes in snoring severity and daytime sleepiness after minimally invasive, single-stage, multilevel surgery for patients with OSA but the limited effects on the polysomnographic parameters. Although the current role of minimally invasive, single-stage, multilevel surgery for Asian adults with OSA remains to be established, it is hoped that ongoing and future studies will solidify their role in the treatment of OSA.
... The ideal surgical procedure should be minimally invasive, single-staged, and minimally morbid. Recent studies of isolated palate implants for snoring and OSA have demonstrated some benefit clinically, but there was no placebo control (4). Pillar procedure has been a treatment of snoring and mild-moderate sleep apnea since early 2000. ...
Objective:The aim of this prospective study is to determine which patients may benefit from pillar procedure as a treatment for snoring.Methods:A total of 37 patients (25 males and 12 females) with a history of snoring were implanted with 3 pillar palatal implants. Flexible fiberoptic examination was used to evaluate the upper airway, especially the retropalatal and retrolingual areas. Visual analog scale (VAS) and polysomnography were performed on before and 3rd months after the pillar procedure. The implantation was performed under local anesthesia.Results:The mean VAS score was reduced from 9.3±0.6 to 6.2±1.1 at the 3rd month. VAS scores of snoring intensity were reduced >50% in 24 of the patients (64.8%). The mean apnea-hypopnea index (AHI) was 11.7±2.3 before the implantation and was reduced to 8.4±1.6 at the 3rd month. VAS and AHI had a close relation with gender, body weight, and oropharynx class. There were no major complications, such as infection, extrusion, and major bleeding.Conclusion:Pillar procedure has a high success rate if it is done with appropriate patient selection, but overall effectiveness remains limited. Initial AHI and VAS values, oropharynx and tonsil position scores, and gender are important determinants of pillar procedure.
... Palatal implants have been recently introduced, with minimally invasive technology, in the management of primary snoring and mild to mod-erate sleep apnea. 2 The aim is to support and prevent vibration and fluttering in the soft palate through both the mass and fibrosis effect. 3 Although there are previous studies reporting the short-and long-term results of palatal implants, 4,5 studies investigating outcome-associated factors are few. ...
To evaluate the impact of the uvular length on the efficacy of palatal implants in primary snoring.
Prospective case series, tertiary hospital, snoring and respiratory sleep disorders center.
Forty subjects with inserted palatal implants and diagnoses of primary snoring were included. All met the inclusion criteria of age >18 years, body mass index <30, apnea-hypopnea index <5, tonsil grade <3, soft-palate length >25 mm, and Friedman tongue position <3 following clinical, endoscopic, and polysomnographic evaluation. Epworth sleepiness scale (ESS) and the snoring-intensity visual analogue scale (VAS) were recorded before and 9 months after the implant. Four subjects with extruded implants were excluded; the remaining 36 subjects were divided into two groups, Group I and Group II, with uvular lengths of ≤15 mm and >15 mm, respectively. The study assessed and compared subjective outcome measures including the partner's satisfaction (PS), partner's reported improvement (PRI), 50% VAS and ESS reduction, and subjective success (SS) defined as 50% VAS reduction. The Student t test, χ(2) test, and logistic regression models were used for statistical evaluation.
SS (50% VAS reduction), PS, PRI, and 50% ESS reduction were significantly higher in Group I (P < .001, P = .0257, P = .027, P < .001). The overall SS, PRI, PS, and 50% ESS reduction were 33%, 78%, 50%, and 50%, respectively. The uvular length was found to be the determinant factor of SS (P = .005; odds ratio = 0.75), PRI (P = .039; odds ratio = 0.83), and 50% ESS reduction (P = .038; odds ratio: 0.84) following implant insertion through stepwise logistic regression analysis.
Excess uvular length (>15 mm) is an important anatomic feature decreasing the efficacy of palatal implants in snoring, and additional measures, such as uvulectomy, should be considered simultaneously for better outcomes (level 4).
... The implants consist of three 18-millimeter polyethylene terephthalate fibers permanently inserted within the muscular layer of the soft palate at the hard palate junction. 3 The fibers induce a chronic inflammatory response that creates a fibrous capsule around the implants, which is designed to reduce the soft palate flutter and collapsibility that contribute Gillespie et al 231 to sleep-disordered breathing at the velopharyngeal level. In properly selected patients, the use of Pillar implants has been shown to have a modest effect in reducing the apnea-hypopnea index (AHI). ...
Determine if the Pillar palatal implant system reduces continuous positive airway pressure (CPAP) pressure and improves patient compliance with CPAP therapy.
Randomized, double-blind, placebo-controlled study.
Four geographically dispersed tertiary sleep disorder referral centers.
Subjects with mild to moderate sleep apnea dissatisfied with CPAP because of pressure-related complaints were randomized to receive Pillar implants or a sham procedure performed in double-blind fashion. Active and sham groups were compared for changes in therapeutic CPAP pressures (primary outcome) with a 90-day follow-up sleep study and CPAP compliance (secondary outcome) with a 90-day smart card report.
Twenty-six subjects were randomized to Pillar implants and 25 to a sham implant procedure. There were no differences between groups with regard to demographics and baseline parameters. Both sham and active groups had reduced mean CPAP pressure (-1.1 vs -0.5 cm H(2)O) with no difference between groups (P = .32) at 90-day follow-up. In addition, there was no difference in average daily CPAP use between groups (P = .80). Both groups experienced improvements in Epworth sleepiness scores and Functional Outcome of Sleep Questionnaire scores at 90 days with no differences between groups. The active group reported significantly higher CPAP satisfaction scores than the sham group (P = .04).
Pillar implants do not significantly reduce CPAP pressure or increase CPAP compliance compared to sham controls but may subjectively improve CPAP satisfaction. These findings do not presently support the use of Pillar implants as an adjunctive treatment to improve CPAP compliance.
... Fibrosis generates stiffening in the soft palate structure over the 8-12 weeks following implantation. 3 Palatal surgery in the management of snoring and OSA has a 30-year history, including uvulopharyngopalatoplasty (UPPP), laser-assisted uvulopalatoplasty (LAUPP), cautery-assisted palatal stiffening operation (CAPSO), and radiofrequency (RF) palatal volume reduction. 4,5 Soft palate implant insertion and RF palatal volume reduction are palatal stiffening techniques. ...
To evaluate the effects of soft palate implants on voice and articulation.
Prospective case series.
Male subjects (n=23) diagnosed with mild obstructive sleep apnea and/or habitual snoring underwent acoustic analysis with the Multidimensional Voice Program (Kay Multi-Speech Model 3700 Advanced Version; Kay Elemetrics [KayPentax], Lincoln Park, NJ) before and 8 weeks after insertion of palatal implants to determine the effects of soft palate implants on voice and articulation. Sustained vowels (/a/e/u/o/i/) and phonetically balanced carrier sentences were used for acoustic analyses. Parameters measured were fundamental frequency (F0), jitter, shimmer, noise-to-harmonics ratio, Voice Turbulence Index, Soft Phonation Index, degree of voiceless, degree of voice breaks and peak amplitude variation, first formant (F1) and second formant (F2) frequencies, and voice onset time (VOT). F1 and F2 for each vowel were determined using linear predictive analysis on a spectrogram. VOT was measured for the palatal consonant /k/ and the dental consonant /t/ on a wideband spectrogram from a carrier sentence segment that contained a syllable with a stop consonant.
No statistically significant difference was detected in F0, F1, F2, or other MDVP parameters before and after implantation. Average VOT values measured for /t/ were not significantly different. On the other hand, average VOT values of /k/ were found to be significantly shorter.
Implant insertion had no significant effect on MDVP parameters, F0, F1, or F2. On the other hand, articulation as a function of velar region seemed to be affected because VOT values of velar /k/ were changed.
... The effects of palatal implants in the treatment of simple snoring have been well documented in previous reports. [8][9][10][11] In expanding on these results, it was decided to apply this new technology to a population of patients suffering from mild to moderate OSA. This is the first United States based multicenter study utilizing palatal implants in the treatment of obstructive sleep apnea. ...
To evaluate the short-term safety and efficacy of palatal implants in patients with mild and moderate obstructive sleep apnea (OSA).
A prospective, non-randomized study conducted at 5 clinical sites. Three polyester implants were placed in the soft palate under local anesthesia during a single-stage office procedure. Polysomnography was conducted at baseline and 90 days post-procedure. Subjective quality of life data were collected.
Fifty-three patients were evaluated; the apnea hypopnea index (AHI) decreased from 25.0 +/- 13.9 to 22.0 +/- 14.8 events/hour (P = 0.05). The Epworth Sleepiness Scale (ESS) decreased from 11.0 +/- 5.1 to 6.9 +/- 4.5 (P < 0.001), and the snore score decreased from 7.9 +/- 2.1 to 4.0 +/- 3.0 (P < 0.001). No serious complications occurred during the study.
Palatal implants can be an effective initial low morbidity treatment option for patients diagnosed with mild to moderate OSA.
... Several authors 16,17 have reported improvements in snoring for palatal implants that range from 67% to 100%, as determined by bed partner satisfaction questionnaires. We did not collect bed partner satisfaction data but did utilize a VAS snoring intensity scale that has been utilized previously in clinical studies of palatal implants with reported improvements of 39% to 88%. ...
Randomized, double-blinded, placebo-controlled, clinical trial to determine the effectiveness of palatal implants for treatment of mild/moderate obstructive sleep apnea/hypopnea syndrome (OSAHS).
Sixty-two non-obese adults with history of snoring, daytime sleepiness, and mild/moderate OSAHS, were randomized to receive palatal implants (n = 31) or placebo procedure (n = 31). Complete follow-up including quality of life (QOL, SF-36), snoring visual analog scale (VAS), and Epworth Sleepiness Scale (ESS) data were obtained in 62 patients. Seven patients refused follow-up polysomnography for a total of 55 patients (29 implant and 26 placebo).
The treatment group (change in score of -7.9 +/- 7.7) was significantly improved compared with the placebo group (change in score of 0.9 +/- 4.3) for apnea/hypopnea index (AHI) (P < 0.0001), QOL, SF-36 (P < 0.0001), snoring VAS (P < 0.0001), and ESS (P = 0.0002).
Palatal implants improve AHI, QOL, snoring intensity, and daytime sleepiness for selected patients with mild/moderate OSAHS.
Surgical intervention is a durable solution for patients with sleep pathology. Operative techniques are vast, ranging from office injections to maxillary mandibular bony osteotomies. Recent innovations trend toward minimally invasive procedures. Novel concepts such as endoscopic surgery, robotic surgery, and nerve stimulation have improved recovery and outcomes. Thorough diagnostic algorithms can identify the source of obstruction. Resulting treatments are tailored toward the involved anatomy.
Sleep-disordered breating (SDB), including obstructive sleep apnea–hypopnea syndrome (OSAS) is a clinical syndrome mainly characterized by recurrent upper airway collapse during sleep, which leads to snoring, respiratory disturbance, sleep interruption, hypoxemia, and subsequent chronic diseases. The options for intervention of OSAS include continuous positive airway pressure (CPAP), sleep surgery, body weight reduction, and so on. In the past decades, technology has had a huge impact on the diagnosis and treatment of sleep disorders. We reviewed the literature of recent years and summarized the progress of technology in sleep surgery. Computer-assisted algorithm and airway fluid dynamics have been facilitating the airway evaluation of patients with SDB. Accurate measurement of the obstruction plane and extent of the upper airway are helpful for targeted surgery. Wearable devices and smart bedding make patient monitoring more convenient and comfortable. Technology is making surgical procedures less invasive and allowing patients who don't tolerate CPAP to improve symptoms and/or experience remission.
Highly compliant tissue supporting the pharynx and low muscle tone enhance the possibility of upper airway occlusion in children with obstructive sleep apnea (OSA). The present study describes subject-specific computational modeling of flow-induced velopharyngeal narrowing in a female child with polycystic ovarian syndrome (PCOS) with OSA and a non-OSA control. Anatomically accurate three-dimensional geometries of the upper airway and soft-palate were reconstructed for both subjects using magnetic resonance (MR) images. A fluid-structure interaction (FSI) shape registration analysis was performed using subject-specific values of flow rate to iteratively compute the biomechanical properties of the soft-palate. The optimized shear modulus for the control was 38 percent higher than the corresponding value for the OSA patient. The proposed computational FSI model was then employed for planning surgical treatment for the apneic subject. A virtual surgery comprising of a combined adenoidectomy, palatoplasty and genioglossus advancement was performed to estimate the resulting post-operative patterns of airflow and tissue displacement. Maximum flow velocity and velopharyngeal resistance decreased by 80 percent and 66 percent respectively following surgery. Post-operative flow-induced forces on the anterior and posterior faces of the soft-palate were equilibrated and the resulting magnitude of tissue displacement was 63 percent lower compared to the pre-operative case. Results from this pilot study indicate that FSI computational modeling can be employed to characterize the mechanical properties of pharyngeal tissue and evaluate the effectiveness of various upper airway surgeries prior to their application.
(Adeno)tonsillar hypertrophy occurs much more frequently in children than it does in adults. Therefore, this issue is discussed separately. Concerning simple snoring, only a few studies investigate the influence of adenotonsillectomy (ATE) on breathing sounds. Data originate in part from controlled studies; these studies document an efficiency of ATE for simple snoring. (Adeno)tonsillar hypertrophy is the most common etiology for pediatric obstructive sleep apnea (OSA). Accordingly, (adeno)tonsillectomy is often performed as first-line treatment of OSA in children. Cure rates are high. With tonsillotomy (TT) and interstitial radiofrequency treatment (RFT), less invasive surgical alternatives for ATE are available (see Sects. 6.1.2 and 6.1.3). Substantial tonsillar hypertrophy is a rare condition in adulthood. Data for simple snoring do not exist. In contrast, a strong correlation between tonsillar hypertrophy and severity of OSA has recently been described.
Snoring is part of a spectrum of diseases that includes upper airway resistance syndrome and obstructive sleep apnea (OSA). Snoring is due to the vibration of the structures in the oral cavity and oropharynx. It usually bothers the spouse more than the patient. Owing to poor sleep quality, fragmented sleep, intermittent nighttime hypoxemia, reduced percentage of slow-wave sleep and increased sympathetic overdrive, OSA results in daytime somnolence, morning headaches, poor concentration, loss of memory, frustration, depression and even marital discord. Many surgical procedures of the soft palate focus on soft tissue volume reduction. The basis of each method is to create scar tissue, to incite fi brosis and to stiff en the palate, therefore resulting in reduced vibration and collapsibility of the soft palate. A new method involves the use of synthetic implants inserted into the soft palate. Palatal implants (Pillar® system, Restore Medical, St. Paul, MN, USA) are made of poly(ethylene terephthalate) (PET), a linear, aromatic polyester that was fi rst manufactured in the late 1940s. Current medical applications for PET include sutures, surgical mesh, vascular graft s, and cuff s for heart valves [9, 11]. Extensive research on PET has demonstrated its biostability [2], promotion of tissue ingrowth [1] and a well-characterized fi brotic response [10, 12]. Each soft-palate implant is cylindrical in shape, measures 18 mm × 1.8 mm, and is made of a porous and braided PET.
For more than 40 years, surgical procedures were described for the treatment of sleep-related breathing disorders (SRBD) [43, 44, 49]. The physiological spectrum of these diseases range from partial upper-airway collapse with an increase in upper-airway resistance, manifested as snoring, fl ow limitation and hypopnea, to complete upper-airway collapse and apnea. The soft palate is assumed to be the primary noise generator during sleep, although other structures in the upper airway may generate obstruction to airfl ow and subsequently hypopnea-apnea. The collapsibility of the upper airway was demonstrated to be diff erent in healthy patients (low), snorers (intermediate) and patients with apnea (high). On the basis of this pathophysiology, surgical procedures fi rstly focused on intervention at the velopharyngeal level. Uvulopalatoplasty, uvulopalatopharyngoplasty (UPPP), laser-assisted uvulo(palato)plasty (LAUP), transpalatal advancement procedure, injection of a sclerotherapy agent into the soft palate, radiofrequency tissue-volume reduction (RFTVR) of the soft palate, cautery-assisted uvulopalatoplasty and, fi nally, soft-palate pillar implantation were explored and proposed for patients with SRBD. Perhaps the number of multiple diff erent procedures available refl ects the relatively unsatisfactory outcome for a signifi cant number of patients with SRBD and probably means that none represent a perfect solution. Additional procedures were developed to address areas of the upper airway other than the soft palate. Lower pharyngeal airway surgery saw the development of genioglossus advancement, hyoid suspension or advancement, tongue-base reduction, maxillomandibular advancement and RFTVR of the tongue. All these procedures were reserved for patients with moderate to severe apneic episodes whose compliance with continuous positive airway pressure (CPAP) was poor, and were based on diff erent methods of assessing the upper airway both in static and dynamic states. Surgery for patients with SRBD should be proposed aft er the failure of conservative management. It should always be remembered that SRBD is a continuum from primary snoring, to moderate and to severe obstructive sleep apnea-hypopnea syndrome (OSAHS). Site-specifi c and less aggressive surgical procedures should be proposed for primary snoring, upper-airway resistance syndrome (UARS) and patients with mild OSAHS. More aggressive surgical procedures should be restricted to patients with moderate to severe OSAHS (Fig. 48.1).Before a new surgical procedure can be introduced in the clinical area, diff erent steps need to be followed. Firstly, safety and feasibility need to be demonstrated on animal models. Secondly, objective methods of assessment of eff ectiveness are needed. This has been particularly diffi cult for primary snoring, especially for long-term follow-up, and always required polysomnographic data for patients with OSAHS [20]. Finally, the side eff ects and long-term complications of the procedure must be considered (Fig. 48.2). In this chapter, we will review the general philosophy leading to the diff erent surgical procedures dedicated to patients with SRBD both at the upper and at the lower pharyngeal airway level and focus on new developments in this area. Conservative treatment, medication and CPAP treatment for the management of patients with SRBD will not be discussed in this chapter.
Many patients with the obstructive sleep apnoea syndrome (OSAS) look for alternative conservative or surgical therapies to avoid treatment with continuous positive airway pressure. In view of the high prevalence and the relevant impairment of the patients, lots of methods are offered that promise a definitive cure or relevant improvement of OSAS. The "Apnoea" working group of the German Society of Sleep Medicine and Research established a task force to evaluate the scientific literature on non-CPAP therapies in the treatment of OSAS according to the standards of evidence-based medicine (EBM). This paper presents the results of the task force. The authors performed a literature search until 31 December 2005 (Medline and hand search of relevant papers). The studies were evaluated according the recommendations of the "Oxford Centre for Evidence-based Medicine Levels of Evidence". The data were unsatisfactory for most of the methods. Sufficient data were available for intraoral appliances (IOA) and maxillomandibular osteotomy (MMO). IOAs can reduce mild to moderate respiratory disturbances; MMOs are efficient in the short- and long-term but are performed only in special situations such as craniofacial dysmorphias. Weight reduction and body positioning cannot be recommended as a single treatment of OSAS. Most surgical procedures still lack sufficient data according to EBM criteria. Resections of muscular tissue within the soft palate have to be strictly avoided. But even success following gentle soft palate procedures is difficult to predict and often decreases over the years. Results in other anatomical regions seem to be more stable over time. Today combined surgeries in the sense of multilevel surgery concepts are of increasing interest in the secondary treatment after failure of nasal ventilation therapy, although more data from prospective controlled studies are needed. There is no evidence for any other treatment options studied in this paper.
Objectives/hypothesis:
Determine safety and efficacy of the TranQuill Sling Snoreplasty (TSS) (Surgical Specialties Corp., Vancouver, BC, Canada) for the treatment of snoring in adults with benign snoring or mild obstructive sleep apnea.
Study design:
Prospective, unblinded, single-center pilot study.
Methods:
From February 2014 to July 2014, 20 adult patients with chronic, disruptive snoring assessed by bed partner were recruited to undergo TSS. Subjects with apnea hypopnea index < 15, minimum oxygen saturation > 85%, and body mass index (BMI) < 32 were included. Outcomes were assessed comparing the results of quality-of-life questionnaires, bed partner-assessed snoring, pain visual analog scales, WatchPAT (Itamar Medical Ltd, Caesarea Ind. Park, Israel) home sleep studies, and flexible endoscopy at baseline and 90-day follow-up.
Results:
Thirteen males and seven females were enrolled. Average age was 49.1 (range 31-67) and BMI of 25.8 ± 2.66. TranQuill Sling Snoreplasty significantly reduced snoring symptom scores from 8.70 ± 4.27 to 6.42 ± 4.14, P = 0.012. Snoring visual analog scores demonstrated reduction of 17.8 mm (59.4 mm ± 22.1 to 41.6 mm ± 29.2), P = 0.0184. Thirty-five percent (7/20) of subjects reported complications related to the trial, with no serious adverse events.
Conclusion:
TranQuill Sling Snoreplasty is a safe therapy that improves snoring symptoms in most adult subjects with benign snoring or mild sleep apnea. Further study is required to better identify patients likely to respond to the therapy.
Level of evidence:
4. Laryngoscope, 2015.
Chae-Seo Rhee, M.D., Ph.D., Doo Hee Han, M.D.Department of Otorhinolaryngology, Seoul National University Co llege of Medicine, Seoul, KoreaAddress for correspondence: Chae-Seo Rhee, M.D., PhD.Department of Otorhinolaryngology, Seoul National Univer-sity College of Medicine, 101, Daehang-no, Jongno-gu, Seoul 110-744, KoreaPhone: 82-2-2072-3991, Fax: 82-2-745-2387E-mail: csrhee@snu.ac.kr
Pillar implants provide a reasonable outcome with minimal post-operative morbidity and complications in treating patients with sleep-disordered breathing (SDB) who had obvious palatal obstruction. The palatal structure is responsible for a normal functioning Eustachian tube; however, little is known if there is any potential otologic implication of minimally invasive palatal stiffening surgery for SDB. The aim of this study is to evaluate the effects of Pillar implantation on middle ear function. We performed a prospective study in a tertiary referral center. Thirty SDB patients (25 men, 5 women; mean age, 44.3 years) who underwent Pillar implants for treating palatal obstruction were enrolled. The subjects had normal otologic exam and no previous history of chronic ear disease. Pure-tone audiometry and tympanometry were performed pre-operatively, and post-operative days 1 and 7, and months 1 and 3. Baseline and post-operative middle ear pressures (MEPs) in decipascals were compared. Statistical analysis was performed by repeated measures of ANOVA. Eight patients (8/30, 26.7 %) reported otologic complaints such as ear pressure and/or otalgia within 1 week post-operatively. No permanent otologic discomfort occurred. A trend toward reduced MEP was noted in this study. The decrease in MEP became apparent on post-operative day 1 after surgery. However, mean pressure changes were no longer significantly different from pre-operative values by 1 week after surgery. Pillar implantation for SDB induces changes in middle ear function. However, the changes were temporary and not significant 1 week after surgery.
Objectives/hypothesis:
The Pillar implant is one of the surgical options for snoring and obstructive sleep apnea (OSA). It is designed to be inserted into the soft palate to reduce vibration and collapsibility. The efficacy of the Pillar implant has been evaluated in various studies. However, only one study conducted a meta-analysis of the findings, and was based on only three studies. We tried to get a more definite conclusion on the efficacy of the Pillar implant.
Study design:
Meta-analysis.
Methods:
Efficacies were analyzed separately, one for snoring and the other for mild-to-moderate OSA. We searched MEDLINE, LILACS, SCOPUS, and the Cochrane Library. The key words "snoring AND implants" were used for snoring, and "apnea AND implants" for OSA. Seven studies for snoring and seven studies for mild-to-moderate OSA were finally included for meta-analysis. For snoring patients, a visual analogue scale that is scored by the bed partner was used to evaluate the loudness of the snoring sound.
Results:
The Pillar implant reduced snoring sound significantly (standardized mean difference [SMD], -0.591; 95% confidence interval [CI], -0.753 to -0.429, P < .001). For mild-to-moderate OSA patients, the Pillar implant significantly reduced the Epworth Sleepiness Scale (SMD, -0.481; 95% CI, -0.606 to -0.358, P < .001), and apnea-hypopnea index (SMD, -0.378; 95% CI, -0.619 to -0.138, P = .002). Mean extrusion rate was 9.3% (95% CI, 7.0 to 12.2%).
Conclusions:
The present results indicate that the Pillar implant has a moderate effect on snoring and mild-to-moderate OSA. However, we need more studies with high level of evidence to arrive at a definite conclusion.
Ein Großteil der Patienten mit einem obstruktiven Schlafapnoe-Syndrom (OSAS) sucht nach konservativen oder operativen Behandlungsverfahren mit deren Hilfe sie die kontinuierliche Positivdruckatmung (CPAP) vermeiden können. Angesichts der hohen Prävalenz der Erkrankung und der Beeinträchtigung der Patienten wird eine Vielzahl von Methoden angeboten, mit denen eine definitive Heilung oder entscheidende Besserung der Erkrankung versprochen wird. Demgegenüber können nur selten fundierte Daten angegeben werden, die eine evidenzbasierte Bewertung der Verfahren ermöglicht. Ziel dieser Arbeit war es daher, den wissenschaftlichen Kenntnisstand zu den Nicht-CPAP-Verfahren zu erfassen und dem Schlafmediziner Empfehlungen zur Beratung und Behandlung der Patienten zu geben. Die Datenlage stellete sich für die meisten Nicht-nCPAP-Verfahren als sehr unbefriedigend dar. Ausreichende Untersuchungen liegen lediglich für die Unterkieferprotrusionsschienen, die beim leichten bis allenfalls mittelgradigen OSAS eine signifikante Besserung der Atmung bewirken können, und die maxillo-mandibuläre Osteotomie, die auch im Langzeitverlauf ausreichend effizient ist, jedoch nur Einzelfällen angewandt wird, vor. Gewichtsreduktion oder Lagetherapie können nicht als alleinige, allenfalls als ergänzende Therapie des OSAS empfohlen werden. Muskelresezierende Verfahren am Weichgaumen sind abzulehnen. Aber auch die Effekte muskelschonender Operationsverfahren am Weichgaumen sind individuell kaum vorhersehbar und lassen über die Jahre oft nach. Die Ergebnisse nach Operationen an and eren anatomischen Regionen scheinen dagegen stabil zu bleiben. Kombinierte Eingriffe im Sinne einer Multi-Level-Chirurgie gewinnen sekundär nach erfolgloser oder abgebrochener Beatmungsbehandlung an Bedeutung, auch wenn hier noch weitere Daten nötig sind. Alle übrigen Verfahren entbehren der ausreichenden Validierung oder sind beim Schlafapnoe-Syndrom als nicht indiziert anzusehen.
Soft palate implants are a new office-based procedure for snoring and sleep apnea. A single session is needed to insert 3 implants into the soft palate using only local anesthesia. The implants have been shown to reduce snoring. A less collapsible airway occurs as a result of the implants, and this change has been demonstrated to reduce obstructive airway events. The procedure will be described in detail. The current literature is briefly reviewed.
The objective of this study was to evaluate the long-term effectiveness of palatal implants as the treatment of primary snoring.
Prospective longitudinal cohort study.
This study compared snoring outcomes before and after soft palate implantation for patients diagnosed with primary snoring (no sleep apnea). Snoring severity was obtained by the subjects' sleep partners on a 10-point Likert scale. A paired Student t test compared the mean scale values preoperatively at week 52 and at the current 4-year follow-up. Body mass index for each patient was also compared to evaluate for any significant confounders.
Data were obtained from 23 patients out of 26 who were followed for the full study term. The follow-up time was on average 4 years following palatal implantation. A statistically (P < .016) and clinically significant improvement in the snoring scale was noted when comparing snoring severity between the preoperative and 4-year period and between the 52-week and 4-year scores. Although statistically significant improvement was found between the preoperative period and 52 weeks, there was a clinical deterioration in snoring scale scores between 52 weeks and 4 years. The mean (standard deviation) preoperative score was 9.5 (0.5), mean week-52 score was 5.0 (1.6), and mean 4-year score was 7.0 (1.8). Body mass index did not change through the observation interval.
Soft palate implantation is a possible surgical technique with which to attempt to achieve subjective improvement of primary snoring severity. Subjective improvement, however, deteriorates significantly over time, and is only minimally sustained at 4 years postoperatively. This study provides new information on long-term palatal implant effectiveness.
The safety of treatment with palatal implants remains high 3 years after the procedure. The implant extrusion rate decreases over time. Additional surgery to the palate is safe. The presence of the implants seems important in sustaining efficacy past 1 year.
To investigate long-term safety and treatment results of palatal implants for treatment of snoring.
A prospective clinical non-randomized trial of 55 patients with primary snoring followed over a period of 3 years.
No major adverse events were observed. Eleven of the 55 patients (20%) experienced implant extrusions, 8 during the first year, 3 in the second, and none in the third year. Twenty-six patients (47.3%) had additional procedures past 1 year. Only one post-implant surgery caused an extrusion. The success defined as no additional surgery followed by endpoint satisfaction rate was 34.6%. For patients with implants intact it was 41.5% (17/41) at 3 years, significantly better than for those who experienced loss of implants.
Les progrès remarquables réalisés dans le domaine des biomatériaux ont permis de proposer aux patients de remplacer certains organes déficients. Malheureusement, utilisés à l'état originel, certains matériaux ne répondent pas parfaitement aux exigences qui leurs sont imposées ; c'est le cas notamment des prothèses vasculaires en polyéthylène téréphthalate (PET) qui sont aujourd'hui couramment employées, mais qui peuvent encore être à l'origine de troubles importants pour le patient lorsqu'elles remplacent des vaisseaux de faible diamètre. Il est cependant désormais possible de faire progresser certaines propriétés de ces dispositifs grâce à diverses méthodes de fonctionnalisation de surface. C'est ce que nous avons voulu réaliser dans notre étude, en utilisant différentes sources de LASERS afin d'irradier des échantillons de PET sous forme de film dans le but d'étudier les modifications physico-chimiques et biologiques induites à la surface du matériau.
Dans un premier temps, nous avons testé différents types de PET afin de sélectionner le matériau le plus apte à simuler le comportement d'une prothèse vasculaire, ce qui n'avait jamais été réalisé. Les résultats sont explicites, et démontrent l'intérêt de choisir minutieusement tout matériau avant de réaliser toutes recherches approfondies. Notre travail a permis de retenir le Melinex® (DuPont Teijin FilmsTM).
La deuxième partie du travail nous a permis de tester différentes sources LASER afin de sélectionner la plus performante vis-à-vis de l'amélioration du comportement cellulaire. Sans hésitation, le LASER excimère à 248 nm de longueur d'onde s'est révélé le plus performant en permettant d'améliorer les prolifération, vitalité et adhésion cellulaires sans modifier la morphologie des cellules. Ces bons résultats sont à attribuer aux modifications de rugosité, de tension de surface et de chimie de surface du matériau irradié. Ces travaux nous donnent l'espoir de pouvoir transformer le PET de simple matériau implantable en un véritable biomatériau dans le sens le plus noble du terme.
Determine patient factors associated with the success and complications of using the Pillar palatal implants for snoring management.
Retrospective series of 79 consecutive adult patients receiving Pillar implants for snoring management between January 2005 and December 2007. Multiple regression analysis was used to determine factors associated with initial and final bed partner satisfaction with the snoring result, and factors associated with Pillar-related complications.
A total of 64 of 79 (81%) bed partners reported snoring improvement in patients after initial Pillar implantation; however, only 31 (39%) were satisfied with the level of reduction. Following secondary procedures, the number of satisfied bed partners improved to 52 (66%). Factors associated with final bed partner satisfaction included lower initial apnea-hypopnea index (AHI) (P = 0.029), Friedman tongue position I or II (P = 0.008), and shorter follow-up time (P = 0.001). Sixteen patients (20%) experienced procedure-related complications. Factors associated with Pillar complications included female gender (P = 0.001) and placement under general anesthesia (P = 0.009).
Initial AHI values and tongue position scores are important determinants of final snoring success. Pillar implants placed in women and under general anesthesia may have a higher risk of poor placement and extrusion.
To evaluate the efficacy of palatal implants in primary snoring patients and to determine the long-term results.
Retrospective clinical trial.
Twenty-one adult primary snorers treated with palatal implants were reviewed. Apnea-hypopnea indexes of all the patients were <5. Patients and their partners were evaluated together at 0, 30, and 90 days and at 6, 12, and 18 months. The partners' visual analog scale (VAS) for snoring intensity and the patients' overall satisfaction, along with the Epworth sleepiness scale, were used for assessments.
The mean VAS score was reduced from 9.1 +/- 1.1 to 5.4 +/- 2.7 at the 3rd month, and to 5.1 +/- 3.15 at the 1st year (P < .05). At the 6th month, VAS scores of snoring intensity were reduced >50% in 13 of the patients (61.9%) and 52.3% (n = 11) at the 12th month. Eleven successfully treated patients and their partners were revisited at the 18th month, and both recommended the implant to others. The patient satisfaction rate was over 80% in 14 of the patients after 1 year. The mean ESS scores decreased from 7.8 to 5.5 after 180 days (P < .05). There was a strong correlation between low oxygen desaturation index and treatment success (coefficient, 0.779; P < .001). There were no postprocedure complications, such as bleeding, infection, and extrusion.
In primary snoring patients, pillar implant is a safe and easy single procedure. At the 18th-month follow-up, partners' VAS score improvement was 53%, along with 80% patient satisfaction.
To review the evidence on the clinical effects and associated treatment costs of surgical procedures and non-surgical devices for the management of non-apnoeic snoring.
Major electronic databases were searched for relevant studies published between 1980 and 2007. All treatment costs were estimated based on data from NHS reference costs, device manufacturers and clinical opinion.
Studies were screened, data extracted and quality assessed according to standard methods. Results were broadly grouped according to the intervention and comparator when applicable, and further subgrouped according to the specific intervention type and study design. Results were combined using a narrative synthesis with relevant quantitative results tabulated. Differences between studies assessing the same intervention were explored narratively by examining differences in the intervention, study duration and study quality.
The systematic review included 27 studies (three randomised controlled trials, two controlled clinical trials and 22 pre-post studies) reported in 30 publications assessing uvulopalatopharyngoplasty (UP3) versus laser-assisted uvulopalatoplasty (LAUP), UP3 alone, LAUP alone, palatal stiffening techniques (Pillar implants and injection snoreplasty), radiofrequency ablation (RFA) of the soft palate or tongue base, continuous positive airway pressure (CPAP) devices and mandibular advancement splints (MAS). Studies were generally of a low methodological quality with small sample sizes. A total of 1191 patients was included. Both UP3 and LAUP reduced the number of snores per hour and produced a modest reduction in snoring loudness. UP3 was effective in reducing a number of subjectively reported snoring indices, but results on objective measures were equivocal. Limited evidence indicates that subjectively assessed snoring is improved after LAUP; no objective measures were assessed. RFA was associated with a reduction in partner-assessed snoring intensity, though evidence for an objective reduction in snoring sound levels was mixed. Pillar implants were moderately effective at reducing partner-rated snoring intensity, but had no effect on objective snoring indices. Use of CPAP reduced the number of snores per hour; no subjective measures were evaluated. Use of MAS improved objective snoring outcomes, including the maximal snoring sound volume, the mean snoring sound volume and the percentage of time spent in loud snoring; no subjective measures were evaluated. The cost for UP3 ranges from approximately 1230 pounds to approximately 1550 pounds. For LAUP the cost varies from 790 pounds to 2070 pounds depending on the number of stages of the procedure. The treatment costs associated with the use of Pillar implants range from 1110 pounds to 1160 pounds. The approximate annual treatment costs associated with the use of a CPAP machine and MAS are 220 pounds and 130 pounds respectively.
This study highlighted the paucity and poor quality of the evidence available on the effects of both surgical procedures and non-surgical devices for the management of primary snoring. Any conclusions to be drawn from the results are therefore somewhat tentative. There was no procedure that was clearly the least-cost option. Further research should focus on standardising methods of measuring outcomes and reporting, undertaking active controlled trials, and investigating the longer-term effects of treatments.
To determine the safety and efficacy of the Pillar Palatal Implant System over a 1-year follow-up period.
In this prospective study, 40 healthy adult patients with primary snoring due to palatal flutter were treated after clinical, polysomnographic, and endoscopic examination. Under local anesthesia 3 implants were placed into the soft palate. Postoperative morbidity and functional parameters were assessed. Snoring and daytime sleepiness were assessed before and 90, 180, and 360 days after surgery. Objective data were obtained by polysomnography and SNAP-recording before and 90 days after treatment.
All implants were placed without complications. A total of 13 implants partially extruded uneventfully in 10 patients. Functional parameters remained unchanged. After 1 year, snoring was reduced from 7.1 +/- 1.9 to 4.8 +/- 2.5 (Visual-Analogue-Scale, P < 0.05) and daytime sleepiness from 6.1 +/- 3.2 to 4.9 +/- 3.1 (Epworth-Sleepiness-Scale, P < 0.05). SNAP data and polysomnography parameters showed clinically irrelevant changes.
Our data demonstrate a significant decrease in snoring and daytime sleepiness over a period of one year.
To evaluate the initial short-term effectiveness of palatal implants in treating patients with mild to moderate obstructive sleep apnea (OSA). Previous published studies have focused on snoring without OSA.
A prospective, nonrandomized study of 25 previously untreated patients with an apnea-hypopnea index (AHI) of 10 to 30 and a body mass index (BMI) of <or=30. Three permanent implants (Pillar; Restore Medical, St Paul, MN) were placed in the soft palate of each patient with a specially designed delivery tool in an office setting under local anesthesia after a formal polysomnography. A repeat polysomnography was obtained after 90 days.
The AHI was reduced from a mean of 16.2 to a mean of 12.1 (P < 0.05) for the study group. Twenty of 25 patients (80%) experienced a decrease in the AHI. Twelve of 25 patients (48%) showed a post-90-day implant AHI of 10 or less, a benchmark for the possible cessation of continuous positive airway pressure therapy. The Epworth Sleepiness Score decreased from 9.7 to 5.5 (P < 0.001) and the visual analog Scale of snoring intensity reported by bed partners decreased from 8.4 to 4.3 (P < 0.001).
The palatal implant method can significantly improve AHI and other sleep-related parameters in patients with mild to moderate OSA and a BMI of <or=30. Short-term results are comparative to those reported for uvulopalatopharyngoplasty but achieved in a low-cost, single-stage, outpatient office setting with low morbidity. EBM rating: C-4.
To evaluate the safety and long-term effectiveness of a new treatment for snoring using permanent palatal implants.
Prospective study with 35 patients referred to the clinic for the treatment of snoring. The patients were followed for 1 year, and a sleep analysis was performed and repeated at 360 days. During the procedure, 3 braided polyethylene terephthalate implants were placed in the palate of each patient.
The average duration for nonnarcotic analgesics was 1.3 days. No adverse events were observed. The mean snoring intensity was reduced from 7.1 at baseline to 4.8 at 1 year (P < 0.001). Bed partner satisfaction rate was very high at 70.6% after 1 year. Six patients (17.8%) experienced a total of 9 partial extrusions.
The palatal implant system is safe, and the effectiveness in treating snoring is comparable to other surgical methods. Advantages are virtually no tissue damage and minimal patient discomfort as a result of one standardized, low-cost procedure. EBM rating: C-4.
To assess efficacy of polyethylene terephthalate (PET) implants in the soft palate for the treatment of socially significant snoring.
A prospective, interventional case series.
Hospital-based multi-specialty clinic.
Twenty-five consecutive patients with socially significant snoring without history of obstructive sleep apnea.
Three PET implants were inserted into the soft palate of each patient (Pillar procedure, Restore Medical, Inc., St. Paul, Minnesota).
Change in snoring severity measured by the bed partner using a 10-centimeter visual analog scale (VAS) where 0 = "no snoring noise" and 10 = "extreme snoring noise causing (the bed partner) to leave the bedroom."
Ninety-day follow-up data was collected for 21 patients. Four patients had incomplete follow-up. Snoring VAS rated by the bed partner had a baseline mean value of 8.5 +/- 1.4, which decreased to 5.0 +/- 2.1 at 30 days and to 4.4 +/- 2.5 at 90 days (P < 0.001). All patients tolerated the procedure well and no procedure-related complications were observed. Two implants partially extruded in 1 patient within the 90-day follow-up period, for an implant partial extrusion rate of 2.7% (2/75 implants) and patient partial extrusion rate of 4% (1/25 patients). At 90 days, 75% of patients and 90% of their bed partners recommended the procedure.
In this case series, PET implants into the soft palate significantly reduced snoring with few extrusions and no complications. Controlled studies are needed to confirm effectiveness and to refine patient selection criteria. EBM rating: C-4.
The objective of this study was to measure subjective and objective improvement after palatal stiffening in patients after uvulopalatopharyngoplasty (UPPP) who were experiencing persistence or recurrence of snoring with or without daytime sleepiness symptoms.
The authors conducted a prospective, nonrandomized study of 26 patients after UPPP who underwent the Pillar Implant Technique (PIT) as a revision procedure.
Patients were selected to undergo revision PIT if they presented with recurrence or persistence of snoring after UPPP. Patients had mild or moderate obstructive sleep apnea-hypopnea syndrome (OSAHS) (apnea-hypopnea index [AHI] >5 and < or =40), persistent retropalatal obstruction, and a residual palate > or =2 cm. Some patients experienced daytime somnolence as well. Patients with severe OSAHS (AHI > or =40), Friedman anatomic stage IV, and/or nasopharyngeal stenosis were excluded. Pre-/postoperative snoring levels, Epworth Sleepiness Scale (ESS), SF-36v2 Quality of Life (QOL) questionnaires, and polysomnograms were obtained.
We completed data on 23 patients. Postoperative snoring levels (3.4 +/- 1.8) and ESS (8.7 +/- 1.8) significantly improved (P < .0001) compared with preoperative values (8.7 +/- 1.8 and 13.2 +/- 2.9). A total of 73.9% of patients improved subjectively. Seven of eight SF-36v2 QOL domains showed significant improvement (P < .05). Postoperative AHI and minimum oxygen saturation also improved significantly (P < .05). Objective cure was only achieved in 21.7% of patients.
Revision PIT is effective in achieving subjective improvement of recurrent symptoms after UPPP. Objective cure was only obtained in 21.7% of patients. As a result of the safety and low morbidity of the procedure, it is an alternative to improve symptoms, especially snoring, in patients not willing to accept continuous positive airway pressure permanently or patients who refuse revision surgery.
The palatal implant method originally designed to reduce snoring can significantly reduce the apnea-hypopnea index (AHI) in some patients with mild to moderate obstructive sleep apnea (OSA) in a single office-based procedure.
An initial study designed to evaluate the short-term efficacy and safety of palatal implants as primary treatment for patients with mild to moderate OSA.
This was a prospective, non-randomized study of 16 previously untreated and undiagnosed patients with sleep apnea. The inclusion criteria were an AHI of 10-30/h and a body mass index (BMI) < or = 30.
The mean AHI was reduced following implantation, from 16.1 to 11.8 (p<0.01). A reduction in AHI was achieved in 13 patients (81%). Ten of 16 patients had their AHI reduced to <10.0. Snoring intensity decreased from 8.3+/-1.8 to 4.7+/-2.5 on a visual analog scale (p<0.001) and daytime sleepiness dropped from 7.2+/-2.5 to 4.6+/-3.2 on the Epworth Sleepiness Scale (p<0.05). No significant adverse events were reported.
To evaluate safety and efficacy of additional palatal implants for snoring treatment.
A prospective case series at two clinical sites in an office setting. Patients who did not have an acceptable reduction in snoring intensity after an initial 3 implant procedure received additional implants. Bed partners rated snoring intensity on a 10 cm visual analog scale (VAS) at baseline and 90 days postprocedure.
Snoring intensity VAS decreased significantly from 6.4 +/- 2.3 to 4.6 +/- 2.9 (P < 0.01) for patients who received an additional fourth implant, and to 4.1 +/- 2.8 after the 5th implant (P<0.01). Epworth sleepiness scale scores also decreased significantly for patients who received additional fourth or fifth implants. There were no adverse events.
Additional palatal implants for snoring treatment were safe and effective in this case series.
Additional implants may offer relief for snorers not responding to the initial 3 implant procedure.
Evaluate long-term safety and outcomes of palatal implants for patients with mild to moderate obstructive sleep apnea (OSA).
Continuation of a prospective case series of patients with palatal implants. Polysomnography, daytime sleepiness, and snoring intensity were measured at baseline, 90 days, and extended follow-up.
Twenty-two (42%) patients from the previous study were followed for a median of 435.5 days. Thirteen were classified as responders, based on their 90-day evaluation. 76.9% of initial responders maintained improvements in apnea-hypopnea index (AHI), daytime sleepiness, and snoring at extended follow-up. Nine patients were initial nonresponders for AHI and daytime sleepiness and remained unchanged at extended follow-up. However, snoring for these nine patients initially improved, and the improvement continued through extended follow-up.
Initial response or nonresponse to palatal implants remains stable over an extended period. The generalizability of these results is unknown because of significant loss to follow-up.
Study results report safety and beneficial long-term outcomes of palatal implants for mild to moderate OSA treatment in selected patients.
The main characteristic of all types of sleep disordered breathing (SDB) is partial or complete obstruction in the upper airway. Patency of the pharyngeal airway is maintained by two opposing forces: negative intraluminal pressure and the activity of the upper airway musculature. Different anatomical abnormalities can disrupt this delicate balance with resultant compromise of the upper airway. Thus, the main goal of the medical and surgical therapy is to alleviate this obstruction and increase airway patency. If multilevel obstruction is noted, multilevel-surgery is needed. It can be done as one-stage or multi-stage procedure which depends on the current patient state and surgical skill. Technical developments and their implementation in everyday surgical practice made some of the surgical methods for SDB treatment more convinient for the patient. Surgery can be performed in ambulatory facility and the procedures are repeatable with no adverse effects which significantly decreases the postoperative morbidity. Almost all surgical techniques for SDB treatment have good results in properly selected patients. That is why the key for the successful SDB treatment is a proper multidisciplinary diagnostic algorithm and a team work.
The purpose of this study was to examine whether snoring adversely affects sleep architecture and sleep efficiency, and thus may account for the frequent complaints of daytime tiredness and fatigue expressed by heavy snorers. We recruited eight self-confessed heavy snorers and six self-confessed nonsnorers. All subjects had full nocturnal polysomnography, including continuous monitoring of snoring, which was quantified by counting the number of snores per hour of sleep (snoring index), the number of snores per minute of snoring time (snoring frequency), maximal and mean nocturnal sound intensity (dBmax and dBmean, respectively). We found that even the self-confessed nonsnorers snored lightly, with significantly smaller frequency and index than the heavy snorers. Sleep architecture was similar in both groups. Distribution of snoring among the sleep stages differed for light and heavy snorers: light snorers snored uniformly throughout all sleep stages, whereas heavy snorers tended to snore more during slow-wave and REM sleep. Snoring frequency and snoring index were similar during all sleep stages in light snorers, but they were higher during slow-wave sleep in heavy snorers. Wakefulness time after sleep onset and sleep efficiency correlated significantly with the snoring index. We conclude that although snoring does not affect sleep architecture in general, it influences sleep efficiency and wakefulness time after sleep onset; this may have an adverse effect on daytime function of heavy snorers.
The material properties of ten 2-O suture materials were evaluated tensiometrically at time = 0 and again after 6 weeks incubation in rats. All suture material was incubated and tested without knots. Specialized machinery was used with a custom securing apparatus to pull suture material apart at constant speed. Stress-strain curves were derived, and from these strength, toughness, strain at rupture, and elastic modulus were determined. Sutures tested included Vicryl [poly(glycolide-lactide)], Dexon (polyglycolic acid), Ethibond (polyester), silk, plain gut, chromic gut, Maxon (polyglyconate), PDS (polydioxanone), nylon, and Prolene (polypropylene). Elastic modulus was greatest for braided, least for monofilament, and intermediate for gut sutures, regardless of chemical composition (ANOVA, P = 0.0001). Strength, strain, and toughness decreased in all of the sutures over time in vivo with the exception of braided polyester (Ethibond), which remained stable. Silk demonstrated the least strength and toughness while PDS and Maxon were the strongest and toughest at time = 0. Vicryl, Dexon, and gut sutures were absorbed to the point that they could not be tested after 6 weeks in vivo. Performance tables are provided for all sutures.
To evaluate pain, swallowing, speech, edematous response, tissue shrinkage, sleep, snoring, and safety (energy limits and adverse effects) following radiofrequency (RF) treatment to the palate in 22 subjects with sleep-disordered breathing.
This investigation is a prospective nonrandomized study. Polysomnography, radiographic imaging, and infrared thermography, along with questionnaires and visual analog scales, were used to evaluate the effects of RF treatment to the palate.
Treatments were delivered on an outpatient basis at Stanford University Medical Center.
Twenty-two healthy patients (18 men), with a mean age of 45.3+/-9.1 years, were enrolled. All were snorers seeking treatment and met predetermined criteria: a respiratory disturbance index < or = 15, oxygen saturation > or = 85%, and a complaint of daytime sleepiness.
RF was delivered to the submucosa of the palate with a custom-fabricated electrode for a mean duration of 141+/-30 s with a mean of 3.6+/-1.2 treatments per patient. Reduction of their snoring scores determined the end point of the study.
Neither speech nor swallowing was adversely affected. Pain was of short duration (0 to 48 h) and was controlled with acetaminophen. There were no infections. Although there was documented edema at 24 to 48 h, there were no clinical airway compromises. Polysomnographic data showed improvement in esophageal pressure measurements of the mean nadir and the 95th percentile nadir (p=0.031, p=0.001) respectively, as well as the mean sleep efficiency index (p=0.002). Radiographic imaging showed a mean shrinkage of 5.5+/-3.7 mm (p< or =0.0001). Subjective snoring scores fell by a mean of 77% (8.3+/-1.8 to 1.9+/-1.7, p=0.0001) accompanied by improved mean Epworth sleepiness scores (8.5+/-4.4 to 5.2+/-3.3, p=0.0001).
The results of this investigation allowed the formulation of safety parameters for RF in this defined population with mild sleep-disordered breathing. There was a documented tissue reduction and improvement in symptoms in all subjects. However, given the small sample size and short-term follow-up, these results should be confirmed by further investigation.
Cautery-assisted palatal stiffening operation (CAPSO) is a single office-based surgical procedure that treats both snoring and obstructive sleep apnea syndrome (OSAS) at the level of the soft palate. CAPSO uses standard electrocautery to remove an oral mucosal strip from the midline soft palate. The wound heals by secondary intention inducing a scar that stiffens the floppy palate. It is a safe, simple, and cost-effective procedure with comparable success rates to other palatal surgeries that treat primary palatal snoring or OSAS (1-3).
Soft palate sclerotherapy (“injection snoreplasty”) is a popular technique as a primary treatment of palatal snoring because of its comparative advantages over other snoring procedures. It is very simple to perform during a routine office visit, is minimally painful, is highly effective, and is very inexpensive. After topical anesthesia, the midline soft palate is injected submucosally with a small amount of sodium tetradecyl sulfate—a well-described, safe sclerotherapy agent. Controlled fibrosis eliminates or significantly diminishes palatal flutter snoring. The technique with “How I Do It” pearls is described in this article.
We excised the anterior cruciate ligament from the left stifle of 24 sheep and replaced it by a polyester fibre implant routed 'over the top' of the femoral condyle and fixed, using grommets and screws. All the joints were sound, and the animals moved normally until they were killed at six, 12 and 24 months after operation. We found that the implants were always covered by host tissue, which matured into bundles with a histological appearance similar to the natural ligament. The implants were joined to the bones by organised fibrous tissue and there was no anchorage loosening. There was no synovitis, but the operated joints showed progressive cartilage degeneration. The reconstructed joints became less stable immediately after operation, but regained normal stability as the neoligaments developed. The neoligaments lost strength with time, despite tissue ingrowth. The good functional, biomechanical, and histological results justify clinical trials of this type of implant.
CO2 Laser Vaporizations of the PalatoPharynx (LVPP), is a new technique, safe and effective, ambulant, by local anesthetic spray, performed for the treatment of snoring. The LVPP is based on the progressive enlargement of the airspace in the oropharynx, to eliminate or reduce obstructions that occurs during sleep, by successive "vaporizations" (or laser-strip carbonization) of the vibrating soft palate, wide posterior tonsil pillars and redundant posterior pharyngeal mucosa. From December 1988 to July 1990, 31 snorers have been treated by LVPP and have been cured or, at least, improved in their snoring. Advantages of this technique are that it is a simple, reliable, bloodless and painless procedure (under local anesthesia), without hospitalization, just like an ordinary consultation. Disadvantages are the multiples and successives sessions, the high technical effort and cost of the laser. In conclusion, it can be a simple alternative for many patients who are afraid of surgery.
Uvulopalatopharygoplasty has become widely performed for chronic snoring and for cases of obstructive sleep apnoea. Unfortunately this operation is not without morbidity and complications. We report our results of a prospective series of 50 patients undergoing uvulopalatopharyngoplasty with a minimum follow-up of one year. Snoring was abolished in 18 (36 per cent) and substantially reduced in the remainder. Obstructive sleep apnoea syndrome, identified in 11 patients pre-operatively, was reduced in severity in all but three. Troublesome complications were seen in 18 (36 per cent) patients, namely intermittent velopharyngeal incompetence in five (10 per cent), pharyngeal dryness in 11 (22 per cent) and loss of taste in five (10 per cent). One patient had nasopharyngeal stenosis requiring correction. A cautious approach to this operation is required with rigorous case selection. The importance of full assessment and careful follow-up should not be underestimated.
This study examined the hypothesis that healing within porous implants differs from that in normal connective tissue. Special attention was given to extracellular components including collagen, reticular fibers, and ground substance, and to enzymes associated with activated macrophages. Using Dacron velour and the rabbit as host, the healing of normal connective tissue and that of the tissue/implant interface were histologically compared 10 and 28 days postimplantation. The results exhibited significant differences between connective tissue healing, implant capsule formation, and granulation tissue generation. The healing of connective tissue and implant capsule formation were essentially complete at 28 days. However, tissue inside the implant was qualitatively different and did not significantly change between 10 and 28 days. It was characterized by macrophages and giant cells, a predominantly acid mucopolysaccharide ground substance, and qualitatively fewer and less well defined collagen and reticular fibers were observed than in normal wound healing. Thus we conclude that the connective tissue inside Dacron velour does not resemble normal connective tissue after 10 or 28 days of healing. Furthermore, the collagen never fully matures into orderly bundles, a phenomenon which may be related to an altered mucopolysaccharide composition and a diminished reticular network. The lysosomal enzymatic activity of the macrophages and perhaps the giant cells at the tissue/implant interface may be linked to these differences.
Synthetic polymers as tissue substitute are more and more widely used in medicine today. Therefore it is necessary to continue to complete our knowledge on the subject of the mutual interaction of the organism and tissue substitutes of synthetic polymers. The influence of the organism on the degradation processe of some synthetic textile fibres made of polyester was studied polypropylene and polyamide, which are either suggested or already used in the production of vascular protheses and other tissue substitutes. The morphological picture of tissue reaction to implanted synthetic fibres, the mechanical properties of the fibres and changes in their surface structure after 4-360 days after implantation were also studied.
Twenty-two cases of vascular graft failures (thrombosis, pseudoaneurysm, dilation, infection) were investigated by means of physicochemical, histological, and ultrastructural studies. A general decrease of mechanical resistance to stress of the prostheses was observed. Its magnitude ranged from 2 to 75% of the values of identical virgin prostheses and there was no relation with the duration of implantation. In addition to the breakage of yarn filaments (SEM), migration of fiber debris (histology) was observed in 7 cases. The structure of the polyester molecule had evolved after implantation. A decrease of crystallinity (x-ray diffraction and differential scanning calorimetry) was noted. These observations raise the question of the established stability of vascular prostheses and emphasize the need for further investigations in human graft retrieval programs.
Maximum extraction stress and integrated extraction work were measured for sutures implanted for 3, 7, and 14 day periods. Six common non-absorbable sutures, representative of braided and monofilamentary forms, were implanted subdermally and were used for cutaneous incision closure with purebred pointer dogs. The data show: (1) Braided sutures, polyester/Teflon, silk-type B, and silk–silicone interacted with peripheral tissue to a significantly greater degree than the monofilamentary types, nylon, polypropylene, and polyethylene; (2) polyester–Teflon braided suture interacted to a lesser degree than the other braided sutures; (3) the relatively intense interaction of plain silk and silicone-treated silk appears to reflect the combined effects of mechanical aspects of braiding and of biochemical response; and (4) all braided sutures swelled over the implantation periods with as much as a 70% increase in diameter after 14 days for silk.
Electron microscopic and light microscopic analyses were performed on Dacron velour covered percutaneous devices implanted in the dorsum of canines for periods between 1 week and 9 months. The results indicated that although the capsular region around the implant was mature collagen after the 1st week of implantation, the tissue ingrowth region remained mostly immature collagen through 9 months of implantation. It appears that increasing the diameter of the fibres, which would decrease the chronic inflammatory response, and increasing the average distance between fibres should increase the amount of mature collagen between the velour fibres. In view of species differences between canines and humans, further investigations are needed before the relevancy of these findings can be extended to possible clinical applications with humans.
Excessive daytime sleepiness and loud snoring are the major symptoms of obstructive sleep apnea, often leading to serious medical complications if unrecognized and untreated. Tracheostomy has been the only effective treatment in most adult cases. This paper reports on a new surgical approach to treat obstructive sleep apnea by uvulopalatopharyngoplasty designed to enlarge the potential airspace in the oropharynx. Twelve patients underwent this operation. In nine there was relief of symptoms and in eight there was objective improvement in nocturnal respiration and sleep pattern, demonstrated by polysomnography.
Uvulopalatopharyngoplasty (UPPP) has become a widely practiced procedure in the management of snoring. In a number of studies, all based on short-term follow-up, snoring was reduced or eliminated in 75% to 95% of patients. Because a declinein the initial success rate was casually observed, a formal analysis of the initial and long-term results of UPPP for snoring was made in the present study. From 1985 to 1989, 69 patients with severe habitual snoring were retrospectively analyzed. A scoring system was devised for snoring, and each patient was interviewed regarding the effects of UPPP on his or her snoring 16 to 75 (mean 44) months after surgery. In 60 (87%) of 69 patients, snoring was initially significantly reduced or totally eliminated. After 13 months the success rate dropped to 46% (32 of 69 patients). Most failures occurred between 6 and 12 months of surgery, after which time the success rate remained relatively stable.
The authors' conclusion that the long-term success rate of UPPP for snoring declines significantly with time has obvious implications regarding pre-surgical patient counseling.
Due to a steadily growing number of patients and considerable diagnostic and therapeutic advances, vascular diseases are becoming more and more important in general and clinical practice. According to their type, localisation, severity, overall prognosis and associated illnesses, various conservative and surgical measurements are used (for survey studies see Vollmar 1982; Giessler 1987). Since the beginning of the 1950s reconstructive vascular surgery has established its position through the use of artificial prosthetic tubing.
The biocompatibility of a silver-coated polyethylene terephthlate (PET, polyester) fabric for the inhibition of prosthetic valve endocarditis (PVE) associated with mechanical heart valves (MHVs) was assessed. The infrequency of PVE is outweighed by mortality rates commonly exceeding 50%. These high mortality rates have been attributed to the poor effect of antibiotic therapy on colonized valves and infected myocardial tissue. Silver has been used as an antimicrobial for centuries due to its general effectiveness and relative lack of toxicity. Our previous work has shown PET polyester fabric coated with metallic silver by an ion beam-assisted deposition (IBAD) process to: (i) be effective in vitro in the inhibition of microbial attachment and colonization; (ii) be tightly adherent and low leaching; and (iii) promote tissue ingrowth and the organization of tissue pannus in a short-duration (five weeks) sheep mitral mechanical heart valve model.
This paper addresses additional biocompatibility assessment consisting of a cell compatibility assay in which serum extracts of silver-coated fabric were exposed to fibroblasts for 48 hours, after which cell viability and function were measured. The amount of silver in the extract was measured using elemental analysis techniques.
No signs of toxicity were seen in the cells until the extract concentration reached 1200 p.p.m. Ten-week duration mechanical valve replacement studies in sheep with uncoated or coated polyester sewing cuffs showed comparable tissue ingrowth and mature pannus with a suggestion of a thinner pannus on the silver-coated fabric. Additional antimicrobial testing confirmed the effectiveness of this coating in inhibiting colonization of polyester fabric.
These current results, together with the earlier data, suggest that IBAD silver coating on polyester facilitates healing and may provide protection against PVE.
Our ongoing evaluation of the results of laser assisted uvulopalatoplasty (LAUP) for snoring is presented. Follow-up between 18 and 24 months post-treatment completion, of patients with a successful result at six months, reveals that 22 per cent of these patients suffer failure of snoring control between these two evaluation points. This equates to an overall success rate at this time of 55 percent.
LAUP, like other surgical remedies for snoring, has a continued relapse rate. This must be considered when counselling patients.
The goal was to evaluate the effect of radiofrequency (RF) of the palate on speech, swallowing, taste, sleep, and snoring 12 to 18 months after treatment.
Twenty-two patients were evaluated by clinical examination, questionnaires, and visual analog scales. The patients with relapse of snoring were offered further RF treatment.
After a mean follow-up of 14 months, no adverse effect was reported. Subjective snoring scores relapsed by 29% overall. Nine patients (41%) noted relapse of snoring from 2.1 +/- 1. 1 to 5.7 +/- 2.7 (P < 0.001). Eight of the patients underwent further RF treatment with a reduction of snoring from 5.8 +/- 2.9 to 3.3 +/- 3.1 (P = 0.01).
The success of RF volumetric reduction of the palate diminishes with time, as with other surgical procedures of the palate. However, the minimal invasiveness of the RF provided a high patient acceptance for retreatment, and relapse of snoring can be improved.
Outpatient surgical therapy of habitual snoring and mild obstructive sleep apnea has evolved significantly in recent years. We introduce the cautery-assisted palatal stiffening operation (CAPSO) and detail its important advantages over uvulopalatopharyngoplasty, laser-assisted uvulopalatoplasty, and palatal radiofrequency ablation. CAPSO is critically analyzed with regard to extent of surgery, need for repetition of procedure, results, complications, predictors of success, and cost analysis. CAPSO is a mucosal surgery that induces a midline palatal scar that stiffens the floppy palate. Two hundred six consecutive patients underwent CAPSO over an 18-month period, followed by office examination and telephone evaluation. The success rate was initially 92% and dipped to 77% after 1 year. CAPSO eliminates excessive snoring caused by palatal flutter and has success rates that were comparable with those of traditional palatal surgery. CAPSO is a simple and safe office procedure that avoids the need for multiple-stage operations and does not rely on expensive laser systems or radiofrequency generators and hand pieces.
We introduce Injection Snoreplasty: an innovative, safe, and effective palatal snoring procedure with minimal cost and discomfort to the patient. A well-described sclerotherapy agent, Sotradecol, is injected into the soft palate to reduce/eliminate palatal flutter snoring.
Twenty-seven patients with a diagnosis of palatal flutter snoring (respiratory disturbance index less than 10) by sleep study were enrolled in the protocol. Office treatment sessions were performed 6 to 8 weeks apart. Success was judged by subjective improvement in snoring and objective evidence of palatal stiffening/scarring.
Twenty-five (92%) of 27 patients reported significant decrease in snoring. There were no significant postinjection complications. Visual analog pain scale confirmed minimal discomfort. Most patients received more than 1 treatment (average, 1.8) in order to receive optimal palatal stiffening.
Injection Snoreplasty is a simple, safe, and effective office treatment for primary snoring. Advantages over current snoring procedures include simplicity, low cost, decreased posttreatment pain levels, and minimal/no convalescence.
To evaluate repeatability of overnight continuous airway pressure and flow recordings for assessment of obstructive sites and their distribution in patients with obstructive sleep apnea (OSA).
Open, prospective study of 30 men with sleep-induced obstructive events (apnea and hypopnea).
Repeated ambulatory sleep recordings of airway pressure and flow to assess the localization of sites of obstructive events were compared. Obstructive sites were divided into upper (transpalatal) or lower (subpalatal). The exact distribution of obstructive sites was expressed as percentage upper obstructive events. A cut-off at apnea index (AI) = 5 was used for comparison between frequent and infrequent obstructers.
Eighty-two percent (14/17) of patients with frequent, and 58% of those with infrequent apneic events maintained their predominant site of obstructive events classified as upper (transpalatal) or lower (subpalatal) [72% (21/29) in the entire group]. We found a significant correlation between recordings for the percentage upper apneic (R = 0.54, P = 0.024, n = 17) and hypopneic (R = 0.59, P = 0.012, n = 17) events in patients with frequent, but not in those with infrequent apneic events. Patients who had the vast majority of obstructive events located at a single site were more stable than those with more evenly distributed obstructive events.
Repeatability of sites of obstructive events is influenced by the severity of illness and the degree of upper or lower obstructive predominance. The distribution of sites of obstructive events (classified as mainly "upper"/"lower" or as percent upper obstructive events of all) can be identified with relative confidence in patients who have frequent apneic events (AI > or = 5) or a high degree of upper or lower obstructive predominance and especially in those who have a combination of these two criteria.
To validate the use of temperature-controlled radiofrequency energy applied to the soft palate in a multicenter setting for reduction of snoring in a minimally morbid manner.
Prospective, nonrandomized multicenter study of 113 patients who had a respiratory disturbance index less than 15 and minimum oxygen saturation not less than 85% and who were seeking treatment for habitual disruptive snoring. Patients were given either single or multiple lesions to the soft palate during each treatment session.
Patients received 1978 J on average with an overall average of 2.4 treatments. Snoring scores went from an average of 7.8 (visual analog scale (VAS), 0-10) pretreatment to 3.2 posttreatment. Pain was minimal, averaging 1.7 (VAS 0-10) on days 1 to 6. Complications were few and transient, and mild.
The multiple lesion protocol was the most successful; reducing snoring from 7.6 to 2.7, on a VAS with an average of 1232 J delivered over 1.6 treatments. Temperature-controlled radiofrequency was found to be a minimally invasive, well-tolerated procedure that was safe and efficacious in this study group.
To assess medium- to long-term subjective and objective results of laser-assisted uvulopalatoplasty (LAUP) for patients with obstructive sleep apnea.
A nonrandomized prospective before-after trial.
Twenty-six patients underwent LAUP by means of vertical trenches along either side of the uvula and reduction of the uvula.
Subjective analysis included a preoperative and 2 postoperative evaluations of the state of snoring: 4 weeks and a mean +/- SD of 12.3 +/- 9.1 months after completion of treatment. In addition, a score on 5 other sleep-related symptoms was recorded before treatment and after 12.3 +/- 9.1 months; at that time, patients also estimated their overall satisfaction with the procedure. Objective analysis included preoperative polysomnographic studies that were repeated postoperatively.
A significant decline in snoring improvement from 88% (23/26) to 65% (17/26) was recorded; furthermore, the state of snoring worsened from 4% (1/26) to 12% (3/26). Reevaluation of 5 other sleep-related symptoms after completion of LAUP uncovered a 50% improvement rate (13/26), and a 15% (4/26) worsening rate. Overall satisfaction from the procedure was 58% (15/26). Postoperative objective studies revealed that only 31% (8/26) of the procedures were successful, while 31% were associated with worsening of respiratory disturbance index. Fifty-four percent (14/26) of the patients had a sensation of pharyngeal dryness. In addition, 1 patient developed velopharyngeal stenosis.
The favorable subjective short-term results of LAUP deteriorated in time. Postoperative polysomnography revealed that LAUP might lead to deterioration of existing apnea. These findings are probably related to velopharyngeal narrowing and progressive palatal fibrosis inflicted by the laser beam.
Modified mesh for hernia repair that is adapted to the physiology of the abdominal wall
- U Klinge
- B Klosterhalfen
- J Conze
- W Limberg
- B Obolenski
- A Ottinger