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Otolaryngology–Head and Neck Surgery (2006) 134, 558-564 ORIGINAL RESEARCH
Palatal implants for the treatment of
snoring: Long-term results
Ståle Nordgård, MD, PhD, Brit Kari Stene, MD,
Ketil Wichman Skjøstad, MD, Vegard Bugten, MD, Kjell Wormdal, MD,
Nina Vanvik Hansen, Ann Helen Nilsen, and Tove Helen Midtlyng,
Trondheim, Norway
diminished in uvulopalatopharyngoplasty (UPPPand la- OBJECTIVE:
To evaluate the safety and long-term effective- ser-assisted uvuloplasty by reducing the pharyn- ness of a new treatment for snoring using permanent palatal geal tissue volume and increasing palatal stiffness through postoperative scarring. However, these procedures are pain- STUDY DESIGN:
Prospective study with 35 patients referred ful and may cause considerable morbidity and functional to the clinic for the treatment of snoring. The patients were fol- lowed for 1 year, and a sleep analysis was performed and repeatedat 360 days. During the procedure, 3 braided polyethylene tereph- These concerns have resulted in the development of thalate implants were placed in the palate of each patient.
targeted procedures that produce less surgical trauma for the RESULTS:
The average duration for nonnarcotic analgesics patients. The cautery-assisted palatal stiffening operation was 1.3 days. No adverse events were observed. The mean snoring has lower morbidity than UPPP and LAUP but intensity was reduced from 7.1 at baseline to 4.8 at 1 year (P Ͻ similar postsurgical pain. Radiofrequency (RF) tissue abla- 0.001). Bed partner satisfaction rate was very high at 70.6% after tion of the soft creates submucosal scarring to re- 1 year. Six patients (17.8%) experienced a total of 9 partial duce tissue volume and stiffen overly compliant soft tissue.
However, RF often requires multiple treatment sessions CONCLUSIONS:
The palatal implant system is safe, and the with single-use instruments, which increases the cost of effectiveness in treating snoring is comparable to other surgical care. Injection sclerotherapy of the palate has been intro- methods. Advantages are virtually no tissue damage and minimal duced with favorable results, but the drug is not available in patient discomfort as a result of one standardized, low-costprocedure.
the United States. As with RF, most patients required more EBM rating: C-4
than 1 treatment for optimal palatal stiffening, and tissue 2006 American Academy of Otolaryngology–Head and Neck damage can cause mucosal breakdown and The Surgery Foundation, Inc. All rights reserved.
newly introduced palatal implant has been designedto achieve palatal stiffening without tissue damage and Because habitual snoring is so common, finding an ef- volume reduction. The intention of the system is to reduce
fective, minimally invasive, and cost-effective treat- snoring through placement of permanent implants, causing ment for those failing conservative therapy has received fibrosis and submucosal scarring in a single procedure. The considerable attention over the last several years. Snoring is implant itself is a segment of braided polyethylene tereph- From the Department of Otolaryngology–Head and Neck Surgery, St Presented at the Annual Meeting of the Academy of Otolaryngology– Olav University Hospital, Trondheim, Norway (Drs Nordgård, Stene, Head and Neck Surgery, New York, NY, September, 19, 2004.
Skjøstad, Bugten, Wormdal, Nilsen, Midtlyng); Sintef Health Research, Reprint requests: Ståle Nordgård, MD, PhD, Department of Otolaryn- Trondheim, Norway (Dr Hansen); and the National University of Science gology, Head and Neck Surgery, St Olav University Hospital, 7006 Trond- and Technology, Trondheim, Norway (Drs Nordgård, Stene, Skjøstad).
Costs of performing the study were supported by a grant from Restore E-mail address: [email protected].
0194-5998/$32.00 2006 American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. All rights reserved.
doi:10.1016/j.otohns.2005.09.033 Palatal implants for the treatment of . . .
ing. The intensity of snoring and the degree of pain, speech, and swallowing problems were recorded on a visual analog Selection criteria
scale (VAS) from 0 to 10. For snoring intensity, 0 was no snoring and 10 related to an intensity that causes the partner to leave the bedroom. The Epworth Sleepiness Score (ESS) was used to describe the patient’s daytime sleepiness. To evaluate the satisfaction rate, the patients and their partners were asked if they would recommend the procedure to a friend or a family member based on how they felt at the timeof follow-up.
The ambulatory, nocturnal polysomnography was per- formed with a thin transnasal esophageal catheter with pres- thalate (PET). PET has a long history of human implanta- sure transducers combined with pulse oximetry and an ac- tion, causing a well-characterized fibrotic response with a timeter (Reggie system; Camtech AS, Sandvika, Oslo, fibrous capsule formation typically complete by 4 weeks.
Norway). The airflow in the nose, oro- and hypopharynx Advantages are expected to be low morbidity, simplicity, was calculated from the differential pressures in these loca- and low cost. The objective of this study was to evaluate the tions. Apneas were defined as an airflow of less than 10% of safety and efficacy through long-term follow-up.
baseline and hypopnea as a greater than 50% reduction inairflow, both needed a duration of 10 seconds and a 3% dropin SaO . The combined apnea-hypopnea index (AHI) was PATIENTS AND METHODS
registered and the events registered as obstructive, central,or mixed. This system also allows for an analysis of the Patient Evaluation
distribution level of obstructions in the airway (transpalatal Thirty-five consecutive patients referred to St Olav Univer- sity Hospital, Trondheim, Norway, for habitual snoring and Follow-up office visits were performed at 2 to 3 days, 14 those who met the selection criteria listed inwere days, 30 days, 90 days, 180 days, and 360 days after treat- included in this prospective, nonrandomized study. The ment. These follow-ups consisted of a physical examination study protocol was reviewed and approved by the Regional and the completion of questionnaires to evaluate the safety Research and Ethical Committee, and informed consent was and efficacy for the procedure. A polysomnography was A complete medical history and physical ear, nose, and throat examination was conducted. To evaluate the physical The Palatal Implant Procedure
dimensions of the upper airway, the following parameters The Palatal Implant System (Pillar System, Restore Medi- were recorded: the modified Mallampati index (MMP) cal, St Paul, MN) consists of a delivery system and an grade I to IV and tonsil size grade 0 to IV according to implant The delivery system is comprised of a and the tongue base volume related to the val- handle and a needle assembly for positioning and placement lecula grade I-IV (grade I open vallecula, grade II vallecula of the implant within the soft palate. A thumb slider on the filled, grade III and IV epiglottis pushed posteriorly or handle is pulled down to retract the needle tip once the against the posterior pharyngeal wall) on transnasal fibre- appropriate depth is reached, while an obturator housed optic laryngoscopy or related to the visibility of larynx on within the needle maintains the position of the implant, indirect laryngoscopy (I: anterior comissure visible, II: pos- leaving it in place when the delivery device is withdrawn terior comissure visible, or III: not visible). The patient and from the tissue. The implant is 18 mm long and 1.5 mm in the bed partner completed questionnaires to evaluate the diameter. The implant is designed to be permanent while the severity, intensity, duration, and social effects of the snor- The palatal implant system with the delivery handpiece and the implant.
Otolaryngology–Head and Neck Surgery, Vol 134, No 4, April 2006 The implantation procedure. Three implants are placed parallel to the midline in the muscular layer of the palate.
The operative procedure has been described earlier in the muscular layer toward the base of the uvula until the In brief, the patients were given paracetamol 400 insertion depth marker reached the insertion point. The implant mg/codeine 40 mg and diclofenac 50 mg orally. Local anes- was deployed while retracting the cannula, and the proce- thesia was obtained by topical lidocaine spray and infiltration dure was repeated twice more in order to place 2 more of the palate with lidocaine/adrenaline solution. No sedation implants 5 mm lateral to either side of the midline was given. Surgery was performed by 3 of the authors (SN, The patients were given penicillin V orally 660 mg 3 times KW, and VB). The mucosa of the soft palate was perforated a day for 7 days as a prophylaxis against infection and in the midline about 5 mm distal to the trailing edge of the diclofenac 50 mg 3 times a day as analgesic, if necessary.
hard palate with the insertion of the cannula moving through The VAS scores for pain, speech, and swallowing VAS score of snoring intensity before and after difficulties at baseline (0) and 2, 14 and 30 days postoperatively.
Palatal implants for the treatment of . . .
Table 2
Treatment success according to different criteria
Recurrence is defined as patients no longer fulfilling the criteria for success.
Statistical Analysis
The implant procedure was easy to perform under The statistical analyses of the results were performed with local anesthesia with minimal discomfort for the patients.
the SPSS statistical program version 12 (SPSS Inc, Chicago, Four implants were immediately replaced because of IL). A Wilcoxon signed rank test was used for analysis of paired data from VAS scores and ESS and a paired t test placement. Average operation time was 8 minutes (range when data had a normal distribution (AHI and body mass 3-16 minutes, decreasing with experience). There were index [BMI]). When analyzing independent samples, a no perforations of the soft palate. No bleeding, hema- Mann-Whitney U test was used to compare data from 2 toma, or infection was experienced during the procedure groups (satisfaction or extrusion related to physical param- or in the follow-up period. The patients described the eters and snoring-related symptoms). When these data had a postoperative discomfort as a mild sore throat similar to normal distribution, a t test was used. A chi-square test was a beginning of an upper-airway infection. On average, the used for analysis of categorical data in 2 groups. P values patients took their prescribed analgesics 1.3 days after the procedure (range 0-6 days), and mean total dose was2.1 pills of diclofenac 50 mg (range 0-15 pills). Eight ofthe patients (24%) did not take any analgesics at all. One patient had a minor edema at the base of the uvula, whichresolved in 5 days. Two patients reported a mild transient One patient was excluded from the study because of a metal taste. No adverse swallowing or speech dysfunc- tonsillectomy in the observation period. After this, the study tion was noted. The VAS scores for pain, speech, and group comprised 26 men and 8 women with a mean age of 43.7 years (range 23-67 years). The mean BMI was 26.1 The snoring intensity reported by the patient’s bed part- (SD 2.3) and did not change significantly after 1 year (BMI ners throughout the observation period is described in 26.3, SD 2.3). Four patients did not repeat the polysomnog- The mean VAS value was reduced from 7.1 (SD 2.1) raphy, leaving 30 pairs of data for comparison of the sleep at baseline to 4.8 (SD 3.1) at 360 days (P Ͻ 0.001, Wil- study results. There was no significant change in mean AHI coxon signed ranks test). This corresponds to a reduction of (baseline mean 2.2, SD 2.3 and 360 days mean 3.3, SD 3.8).
33.8% with 50% of the patients (17 of 34) having their None of the patients withdrew from the study, and all snoring reduced to less than or equal to 5. Eight of these completed their follow-up visits at 2, 14, 30, 90, 180, and (24% of the total group) had a final score of less than 3 on the VAS scale for snoring intensity The ESS Table 3
The relationship of partner satisfaction to snoring reduction and physical parameters
Otolaryngology–Head and Neck Surgery, Vol 134, No 4, April 2006 changed from 9.3 (SD 4.1) to 5.6 (SD 3.8) at 360 days (P Ͻ mild foreign-body sensation, leaving a tip of the implant 0.001, Wilcoxon signed ranks test). At the last follow-up, visible. Because patients reported improvement of snoring 70.6% (24 of 34) of the partners and 79.7% (27 of 34) of the after temporary worsening related to partial extrusion, we patients were satisfied with the results. The satisfaction rate is did not replace any of the removed implants. The correlation significantly associated with the snoring reduction in the VAS of treatment results for the partial extrusion and nonextru- Insufficient reduction of snoring was the reason for sions groups may indicate an increased fibrosis caused by not recommending the procedure among the unsatisfied the partial extrusion process itself. Therefore, it is advisable partners. Satisfactory snoring reduction was also inversely to wait with the removal of a partially extruding implant a correlated with the MMP (P Ͻ 0.05, Mann-Whitney U test) few days until it penetrates the mucosa. This also facilitates the removal itself. These observations are valid only for During the observation period, 6 of the patients (17.6%) partial extrusions taking place after 1 month because this experienced a partial extrusion of, in total, 9 implants (8.8% was the earliest-occurring partial extrusion in this study.
of 102 implants). Three of the patients experienced 2 partial The partial extrusions took place with no regular consis- extrusions. Partial extrusions were only seen with the lateral tency or pattern from 1 to 12 months postoperatively. Only implants, 6 on the right and 3 on the left side. The most one of the patients with a partial extrusion had a partner common site for partial extrusion was the cranial end of the dissatisfied with the result and that partial extrusion oc- palate, corresponding to the insertion site, where 6 extru- curred at 7½ months. There were no parameters that could sions took place. The remaining 3 implants were partially predict a partial extrusion, except for the first-observed exposed at the caudal end of the palate. One implant was partial extrusion (1 month) in which the implant was placed removed under local anesthesia, and the others were easily too superficial during the procedure and was visible under retracted with a forceps without any anesthesia. None of the the mucosa. However, the fact that all partial extrusions partially extruded implants were replaced.
were lateral indicates that a partial extrusion is more likely There was no significant difference in snoring intensity when the tissue thickness is low. Therefore and despite the reduction or partner/patient recommendation between the patients’ wishes, we have not advised any placement of extrusion and the nonextrusion group No re- additional implants further laterally in patients that may corded physical parameters could be correlated to the oc- benefit from an additional “tune-up” palatal surgery. In- stead, partial uvula resection or RF treatment of the otherparts of the palate may be an option. From our data, there isno evidence that there is an increase in obstructive eventswith the use of palatal implants. Only one of the patients DISCUSSION
changed from an AHI of less than 10 to an AHI of greaterthan 10 (4.8-18.4). This patient had only hypopnea and went The use of these implants introduces a new philosophy of from a preoperatively 50% high to a mainly low (84%) stiffening the palate to reduce snoring. Unlike UPPP,LAUP, RF, CAPSO, and injection snoreplasty where scar- location of the obstructive events. The Camtech Reggie ring takes place after tissue resection or ablation, this pro- system is a powerful tool for discriminating between high cedure causes virtually no tissue damage and the implants and low obstructions. However, when the AHI is less than serve as a template for fibrous ingrowths. This is reflected in 5, the site of obstruction varies considerably from night to the very low patient morbidity observed in this study. No The sleep study findings were not emphasized here mucosal breakdown, palatal swelling, discomfort, or fistu- because of the fact that 15 of 34 patients (42%) showed no obstructive events at all and the rest of this population also noted with the palatal implant system. In this study, pain had low figures (median AHI 1.0). When evaluating patients was not registered on a day-to-day basis, but the objective with more obstructive events and sleep apnea, however, data related to analgesic use places it at least similar to the these figures will be helpful and can override the physical most favorable results from However, the single pro- parameters. Traditionally, evaluation of site of obstruction cedure results in less total trauma for the patient. RF also is is based on clinical evaluation and radiography and even- a heterogeneous and nonstandardized procedure. Because tually endoscopic evaluation under anesthesia. However, the implants procedure is standardized, the learning curve these methods are highly subjective and are not based on the will be short and mastering a technique will also reduce the number of complications. Interestingly, swallowing discom- No consensus has been reached regarding the evalua- fort was significantly less at the 14-day control period than tion of treatment results, and VAS scales frequently dif- preoperatively. This may be attributed to less dryness of the fer. Therefore, the comparison of the results between different studies is difficult. Yet-suggested criteria for Hypothetically, the most serious complication related to success include endpoints such as VAS Ͻ3,VAS Ͻ5, the implant method would probably be an extrusion fol- VAS reduction ϾVAS reduction Ͼor differ- lowed by aspiration and pneumonia. In all 9 partial extru- ent statements of patient/partner satisfactionIn this sions, however, the process was gradual and proceeded by a study, 4 of the partners reported an initial VAS score Ͻ4, Palatal implants for the treatment of . . .
Table 4
Implant extrusions related to physical parameters and treatment results
the lowest 1.8 with the use of earplugs. In these patients, After a median of 1.8 (range 1-3) treatments, 75% of 27 the 3 that reported satisfaction with the results, a defini- patients receiving injection sclerotherapy in the palate re- tion of VAS Ͻ5 or VAS Ͻ3 as success, would be mean- ported a greater-than 50% reduction of pretreatment snoring ingless and a reduction of 4 units would be impossible For LAUP, success figures for treating snoring is because the baseline scores were low. We have therefore reported in the range of 57% to but in the latter focused on partner satisfaction when evaluating the re- study 10% and 8% had concomitant surgery on tonsils or sults and searching for factors that can predict a favorable turbinates. Relapse rates in the same populations were re- outcome. Interestingly, partner satisfaction was signifi- cantly associated with endpoint VAS score and VAS The gradual reduction of snoring for up to 3 months score reduction (P ϭ 0.002 and P ϭ 0.007, Mann-Whit- postoperatively corresponds well with the time observed ney test). It is not surprising that favorable results are for PET-induced fibrosis to take place. Together with the related to low MMP, which is an indicator of tongue size observation that results are the same after a partial ex- and hence a possible contributor to subpalatal snoring.
trusion, this indicates that the induced fibrosis is more When selecting only patients with an MMP class of I or important than the presence of the implants themselves.
II, the partner satisfaction with the result increases from All operations aimed at treating snoring by stiffening thepalate seem to tell a quite similar history of a significant 70% to 84% (16/19 cases) in this study population. This initial reduction in snoring and a partial relapse over shows the importance of proper patient selection for this time, either by palatal stretching or by increased contri- targeted procedure, and the lack of selection for MMI in bution from other parts of the upper airway, possibly also this study should be kept in mind when comparing the combined with some wearing off of an initial placebo results with other studies. Reports on long-term results effect. The variations reported in the different studies are for the different treatment modalities are relatively few, probably caused by different patient selection and by the but all include a proportion of relapse to snoring symp- degree of palatal fibrosis achieved by adjusting the de- toms over time. Regarding RF treatment, Ferguson et a gree of trauma in the palatal tissues. When the treatment showed that 61% had VAS reduction of 50% after 16 results are quite similar, the choice of method therefore months but with 1.9 treatments per patient. The VAS will be more focused on discomfort, morbidity, safety, reduction per treatment session in the multilesion group and cost. It also seems logical to try to conserve the was 2.1, which is comparable to our results. The study delicate tissues of the palate like muscle, nerve ends, and was, however, limited to patients with MMP Ͻ3. Bäck et salivary glands without tissue destruction. In all these showed VAS scores of 9, 4 and 6 at baseline, 3 and respects, palatal implants compete favorably.
12 months after 2 treatment sessions. The total VAS Limitations of this study are a relatively small series, the reduction of 33% was very close to the results in our lack of a control group, and the limited objective data for study. Said and reported a 52% improvement snoring assessment. Further studies should include a ran- (11% reported deterioration after 2 months) on the VAS domized, controlled study with placebo (no implant) and the and a patient satisfaction rate of 67%. The data collection use of different rigidity of the implants.
was done retrospectively, and only patients with MMPI/IA were included. Li et had better results, with anend score of 3.8, but the patients had several treatments(n ϭ 3.6, SD 1.2). Forty-one percent reported relapse CONCLUSION
during mean follow-up of 14 months. On the other hand,Trotter et used only a single session, with 22% The palatal implant system is safe, and the procedure is improving greater than 50% after 17 months and 44% associated with a very low patient morbidity and virtually recommending the procedure. In a 1-year follow-up after no tissue damage. The effectiveness in treating snoring is CAPSO, 77% of patients reported that snoring was no comparable to other surgical methods, but the patient selec- longer a problem compared with 92% at 4 to 6 weeks tion is important and can affect the outcome. Up to 30% of Otolaryngology–Head and Neck Surgery, Vol 134, No 4, April 2006 patients are unsatisfied at 1 year, but this figure can be 9. Friedman M, Tanyeri H, La Rosa M, et al. Clinical predictors of reduced significantly by selecting only patients with MMI obstructive sleep apnea. Laryngoscope 1999;109:1901–7.
10. Emery BE, Flexon PB. Radiofrequency volumetric tissue reduction of 3. Partial extrusion of 1 or 2 implants, the most frequently the soft palate: a new treatment for snoring. Laryngoscope 2000;110: observed adverse reaction, does not affect the overall treat- ment results. The advantages when compared with other 11. Troell RJ, Powell NB, Riley RW, et al. Comparison of postoperative methods are simplicity, low cost, and minimal patient dis- pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngo- comfort from only a single procedure in which the majority plasty, and radiofrequency volumetric tissue reduction of the palate.
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of bed partners remained satisfied long term.
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