Responsiveness of quality of life measures in children with peripheral vascular malformations: The OVAMA project.

BACKGROUND: The OVAMA (Outcome Measures for VAscular MAlformations) project determined quality of life (QoL) as a core outcome domain for evaluating treatment effect in vascular malformations. To correctly evaluate treatment effect on QoL, patient-reported outcome measures (PROMs) are needed that are responsive to changes. In children with vascular malformations, we explored if two widely used PROMs were responsive to changes: the Pediatric Quality of Life Inventory (PedsQL) and the Children's Dermatology Life Quality Index (CDLQI). METHODS: In an international multicenter prospective study, conservatively and invasively treated children completed the PedsQL and CDLQI at baseline and after follow-up of 6-8 weeks. At follow-up, change in health was assessed by a global rating of change (GRC) scale. Responsiveness was assessed by testing hypotheses on expected correlation strength between change scores of the PROMs and the GRC scale, and by calculating the area under the receiver operating characteristics curve (AUC). The PROMs were considered responsive if ≥75% of the hypotheses were confirmed or if the AUC was ≥0.7. RESULTS: Twenty-nine children were recruited in three centers in the Netherlands and United States, of which 25 completed all baseline and follow-up measurements. For both the PedsQL and CDLQI, less than 75% of the hypotheses were confirmed and the AUC was <0.7. DISCUSSION: The results suggest that these PROMs are not sufficiently responsive for evaluating treatment effect in peripheral vascular malformations. Our study emphasizes the need for assessing responsiveness before using a PROM in evaluating treatment effect.

Responsiveness of quality-of-life measures in patients with peripheral vascular malformations: the OVAMA project.

BACKGROUND: The OVAMA (Outcome Measures for Vascular Malformations) project determined quality of life (QoL) as a core outcome domain for patients with vascular malformations. In order to measure how current therapeutic strategies alter QoL in these patients, a patient-reported outcome measurement (PROM) responsive to changes in QoL is required. OBJECTIVES: To assess the responsiveness of two widely used generic QoL PROMs, the Medical Outcomes Study Short Form 36 (SF-36) and Skindex-29, in adult patients with vascular malformations. METHODS: In an international multicentre prospective study, treated and untreated patients completed the SF-36 and Skindex-29 at baseline and after a follow-up period of 6-8 weeks. Global rating of change (GRC) scales assessing various QoL-related outcome domains were additionally completed. Per subscale, responsiveness was assessed using two methods: by testing hypotheses on expected correlation strength between change scores of the questionnaires and the GRC scales, and by calculating the area under the receiver operating characteristics curve (AUC). The questionnaires were considered responsive if ≥ 75% of the hypotheses were confirmed or if the AUC was ≥ 0·7. RESULTS: Eighty-nine participants were recruited in three centres in the Netherlands and the U.S.A., of whom 67 completed all baseline and follow-up questionnaires. For all subscales of the SF-36 and Skindex-29, < 75% of the hypotheses were confirmed and the AUC was < 0·7. CONCLUSIONS: Our findings suggest that the SF-36 and Skindex-29 seemed unresponsive to change in QoL. This suggests that alternative PROMs are needed to measure - and ultimately improve - QoL in patients with vascular malformations. What's already known about this topic? Quality of life is often impaired in patients with vascular malformations. Quality of life is considered a core outcome domain for evaluating treatment of vascular malformations. To measure the effect of treatment on quality of life, a patient-reported outcome measure is required that is responsive to changes in quality of life. What does this study add? This is the first study assessing the responsiveness of quality-of-life measures in patients with vascular malformations. The results seem to indicate that the Medical Outcomes Study Short Form 36 (SF-36) and Skindex-29 are not responsive to changes in quality of life in patients with vascular malformations. What are the clinical implications of this work? Medical Outcomes Study Short Form 36 (SF-36) and Skindex-29 are not ideal to assess the effect on quality of life over time, of treatment strategies for peripheral vascular malformations.

PHACES association: a neuroradiologic review of 17 patients.

BACKGROUND AND PURPOSE: We present neuroradiologic findings in 17 patients with posterior fossa malformations, hemangiomas, arterial anomalies, cardiac defects, eye abnormalities, and sternal or ventral defects (PHACES) association and identify those at highest risk of central nervous system (CNS) structural, cerebrovascular, and neurodevelopmental abnormalities. MATERIALS AND METHODS: Patients with PHACES association were identified in the Vascular Anomalies Program at New York University Medical Center from 1998 to 2007. Many patients were followed in conjunction with other specialists at the Birthmark Institute at Roosevelt Hospital. Clinical records and imaging studies were reviewed retrospectively. Criteria for diagnosis of PHACES were based on previously published indicators. Imaging studies were independently re-reviewed by a neuroradiologist. Segmental mapping of cutaneous hemangioma distribution by photograph review and presence or absence of other PHACES-associated findings were correlated with radiologic findings. RESULTS: Patients with large facial cutaneous (S1-S4) hemangiomas were especially at risk of CNS structural and cerebrovascular anomalies; S1 with ocular anomalies; and S3 with airway, ventral, and cardiac anomalies. All patients with CNS structural malformations had a cerebrovascular abnormality, and this cohort was at risk for developmental and/or other neurologic sequelae. Four patients had supratentorial CNS anomalies, including cortical dysgenesis and migration abnormalities. Some patients with CNS arteriopathy progressed to aneurysms. CONCLUSION: Our data support and expand the work of others, identifying risk factors for segmental hemangiomas. In addition to posterior fossa CNS anomalies, supratentorial anomalies may be present in patients with PHACES, and this may correlate with significant clinical sequelae. The long-term prognosis of these patients remains unknown.

[Surgical treatment of haemangiomas]. / Tratamiento quirúrgico de los hemangiomas.

The therapeutic approach to haemangiomas has changed slightly in recent years, moving from a generally conservative attitude to a more aggressive one in some cases. Chronic unaesthetic alterations that might be caused by haemangiomas, psychosocial traumas that can be caused during childhood, together with a better understanding of the behaviour of this type of lesions and advances in safer and more efficient surgical techniques are the basic factors behind this change of attitude. The present paper concentrates on the surgical treatment of haemangiomas, explaining their indications according to the stage of evolution at which they are found, and the surgical techniques employed to resect the lesion with the least morbidity. Similarly, a detailed treatment is given to those lesions that, because of their specific facial anatomical localization, require a special surgical treatment.

[Laser and intense pulsed light in the treatment of infantile haemangiomas and vascular malformations]. / Láser y luz intensa en el tratamiento de hemangiomas infantiles y malformaciones vasculares.

The use of the indications of the laser in treating vascular malformations and infantile haemangiomas is based on the theory of selective photothermolysis, in which the oxyhaemoglobin is the target chromophore on which the light of the laser acts, thus avoiding damage to neighbouring tissues. The pulsed dye laser is the most employed and at present is the treatment of choice in capillary malformations (port-wine stains). A variable response is obtained, with a substantial clearing of the colour of the lesion after several sessions. Application at early ages seems to improve the results. Venous malformations, especially those localised in the mucosa, respond better to the Nd:YAG laser; lymphatic malformations to the CO2 laser. Arteriovenous malformations rarely respond. Use of the pulsed dye laser in the phase of proliferation of the haemangiomas is subject to controversy, except where there is ulceration. A rapid re-epithelialization is obtained in these cases following its use. In the involution phase, patients with residual vascular lesions can benefit from other lasers such as KTP or Nd:YAG. If they show an atrophic surface and scars these complications improve with the CO2 laser or Er:YAG. New treatment modalities are emerging, such as photodynamic therapy, whose efficacy and safety, both in the treatment of haemangiomas and vascular malformations, have yet to be confirmed.

Láser y luz pulsada intensa en el tratamiento de hemangiomas infantiles y malformaciones vasculares / Laser and intense pulsed light in the treatment of infantile haemangiomas and vascular malformations

El uso de las indicaciones del láser en el manejo de las malformaciones vasculares y los hemangiomas infantiles se fundamenta en la teoría de la fototermolisis selectiva, siendo la oxihemoglobina el cromóforo diana sobre el cual actúa la luz del láser, evitándose así el daño a tejidos vecinos. El láser de colorante pulsado es el más utilizado y es, actualmente, el tratamiento de elección en las malformaciones capilares (mancha en vino de Oporto). La respuesta obtenida es variable, alcanzándose un aclaramiento sustancial del color de la lesión, tras varias sesiones. La aplicación en edades tempranas parece mejorar los resultados. Las malformaciones venosas, especialmente las localizadas en la mucosa, responden mejor al láser de Nd:YAG; las malformaciones linfáticas al láser de CO2. Las malformaciones arteriovenosas raramente responden. El uso del láser de colorante pulsado en la fase proliferativa de los hemangiomas es controvertido, excepto si existe ulceración. En estos casos se obtiene una reepitelización rápida tras su empleo. En la fase involutiva, los pacientes con lesiones residuales vasculares pueden beneficiarse de otros láseres como KTP o Nd:YAG. Si presentan superficie atrófica y cicatrices mejoran con láser de CO2 o Er:YAG. Están emergiendo nuevas modalidades como la terapia fotodinámica cuya eficacia y seguridad, tanto en el tratamiento de los hemangiomas como de las malformaciones vasculares, está aún por confirmar (AU)

Tratamiento quirúrgico de los hemangiomas / Surgical treatment of haemangiomas

El planteamiento terapéutico ante los hemangiomas ha cambiado ligeramente estos últimos años, pasando de mantener una actitud general conservadora a ser más agresivos en algunos casos. Las alteraciones inestéticas crónicas que pueden originar los hemangiomas, el trauma psicosocial que pueden desencadenar en la niñez, junto con un mejor conocimiento del comportamiento de este tipo de lesiones y el avance en técnicas quirúrgicas más seguras y eficaces, han sido los factores fundamentales de este cambio de actitud. El presente trabajo se centra en el tratamiento quirúrgico de los hemangiomas, explicando las indicaciones que tienen según la etapa de evolución en que se encuentren y las técnicas quirúrgicas empleadas para resecar la lesión con la mínima morbilidad. Así mismo, se tratan de forma detallada aquellas lesiones que, por presentar una localización anatómica facial concreta, requieren un tratamiento quirúrgico especial (AU)

Retinal neovascular markers in retinopathy of prematurity: aetiological implications.

AIM: (1) To determine if expression of the blood-tissue barrier associated glucose transporter GLUT1 is preserved by the neovasculature of retinopathy of prematurity (ROP), in contrast with the reported loss of GLUT1 expression in preretinal vessels of proliferative diabetic retinopathy. (2) To compare the vascular immunophenotype of ROP to juvenile haemangioma, another perinatal neovascular disorder that has recently been shown to express placental type vascular antigens, including GLUT1 and Lewis Y antigen. METHODS: A retrospective case report was carried out. Immunoreactivities for GLUT1 and Lewis Y antigen were assessed in a human eye with stage 3 ROP and compared with those in a control (paediatric) eye. The presence or absence of endothelial GLUT1 and Lewis Y immunoreactivity was determined in preretinal and intraretinal vessels. RESULTS: Immunoreactivity was positive for GLUT1 and negative for Lewis Y in the intraretinal and preretinal neovasculature of the ROP affected eye and in the normal retinal vessels of the control eye. CONCLUSIONS: Retention of immunoreactivity for GLUT1 distinguishes ROP from proliferative diabetic retinopathy. Furthermore, absence of Lewis Y antigen co-expression distinguishes ROP from juvenile haemangioma, a perinatal form of GLUT1 positive neovascularisation that has recently been linked to placental vasculature.

[The current approach to hemangiomas and vascular malformations of the head and neck].

Though most hemangiomas do not need treatment, a significant minority are associated with complications and external deformities that demand intervention. Steroids play an important role in therapy, but not infrequently afford only partial and temporary benefit. Thanks to improvements in the surgical approach and equipment, hemostasis control devices and laser techniques, we can now treat patients who would otherwise go untreated. Moreover, in certain cases, we can now recommend earlier intervention, saving patients from years of living with deformities and the concomitant psychosocial problems. Vascular anomalies of the head and neck include venular, venous and arteriovenous malformations. These lesions are slow growing vascular ectasia that never involute spontaneously and almost always require intervention. Treatment includes laser therapy, injection of sclerosing agents, embolization through angiography and surgery, which in many cases is the only definitive treatment. We present the current treatment approach and describe our experience in the treatment of 16 patients.

Congenital nonprogressive hemangioma: a distinct clinicopathologic entity unlike infantile hemangioma.

BACKGROUND: Infantile hemangiomas are common tumors, distinctive for their perinatal presentation, rapid growth during the first year of life, and subsequent involution-and for their expression of a unique immunophenotype shared by placental microvessels. Occasional "hemangiomas" differ from the classic form in presenting fully formed at birth, then following a static or rapidly involuting course. These congenitally fully developed lesions have generally been assumed to be clinical variants of more typical, postnatally developing hemangiomas. This assumption has not been tested by rigorous histologic and immunophenotypic comparisons. OBJECTIVE: To compare the histologic and immunohistochemical features of congenital nonprogressive hemangiomas with those of typical, postnatally proliferating, hemangiomas. DESIGN: All cellular vascular tumors resected from infants younger than 4 months at Arkansas Children's Hospital, Little Rock, over the past 20 years (43 lesions from 36 patients) were first characterized histologically and immunohistochemically, then clinically by chart review. SETTING: A university-affiliated pediatric hospital. MAIN OUTCOME MEASURES: Histologic appearance, immunoreactivity for the infantile hemangioma-associated antigens GLUT1 and LeY, and clinical behavior. RESULTS: Congenital nonprogressive hemangiomas differed from postnatally proliferating infantile hemangiomas in histologic appearance and immunohistochemical profile. Distinguishing pathologic features of these tumors were lobules of capillaries set within densely fibrotic stroma containing hemosiderin deposits; focal lobular thrombosis and sclerosis; frequent association with multiple thin-walled vessels; absence of "intermingling" of the neovasculature with normal tissue elements; and lack of immunoreactivity for GLUT1 and LeY. CONCLUSION: Congenital nonprogressive hemangiomas are histologically and immunophenotypically distinct from classically presenting hemangiomas of infancy, unlikely to be related to the latter in pathogenesis.

A unique microvascular phenotype shared by juvenile hemangiomas and human placenta.

BACKGROUND: Juvenile hemangiomas are common, benign tumors, distinctive for their perinatal presentation, rapid growth during the first year of life, and subsequent involution. We recently reported that endothelia of hemangiomas highly express GLUT1, a glucose transporter normally restricted to endothelia with blood-tissue barrier function, as in brain and placenta. OBJECTIVE: To investigate possible further similarities between hemangioma and placental vessels. DESIGN: In a retrospective study of a variety of vascular tumors and anomalies, we assessed lesional immunoreactivities for the placenta-associated vascular antigens FcgammaRII, Lewis Y antigen (LeY), merosin, and GLUT1. SETTING: A university-affiliated pediatric hospital. MAIN OUTCOME MEASURE: Immunoreactivities scored for each antigen were summarized according to lesional type, compared with those of normal skin, brain, and placenta, and correlated with patient age, sex, and lesional location. RESULTS: All of 66 hemangiomas (patients aged 22 days to 7 years) showed intense immunoreactivity for FcgammaRII, merosin, LeY, and GLUT1. No immunoreactivities for these markers were seen in any of 26 vascular malformations, 4 granulation tissue specimens, 13 pyogenic granulomas, or in the tumor vasculature of 6 malignant tumors of nonvascular origin. Microvascular immunoreactivity for all 4 markers was observed in placental chorionic villi, but was absent in microvessels of normal skin and subcutis. Brain microvessels expressed only GLUT1 and merosin. CONCLUSIONS: A distinct constellation of tissue-specific markers is uniquely coexpressed by hemangiomas and placental microvessels. These findings imply a unique relationship between hemangioma and the placenta and suggest new hypotheses concerning the origin of these tumors.

Evidence for loss of heterozygosity of 5q in sporadic haemangiomas: are somatic mutations involved in haemangioma formation?

BACKGROUND/AIMS: Haemangiomas are common benign tumours of infancy that consist of rapidly proliferating endothelial cells. A locus for an autosomal dominant predisposition to haemangioma has been identified recently on chromosome 5q. This study aimed to investigate loss of heterozygosity on chromosomes 5 and 9 in haemangiomas. METHODS: Sporadic proliferative phase haemangiomas were microdissected. Polymerase chain reaction amplification and analysis of microsatellite markers on chromosomes 5 and 9 was carried out. RESULTS: There was a significant loss of heterozygosity for markers on chromosome 5q in haemangioma tissue, when compared with either markers from chromosome 5p (p < 0.05) or markers from chromosome 9 (p < 0.05). CONCLUSIONS: These results suggest that haemangioma formation might be associated with somatic mutational events, and provides evidence that a locus on 5q is involved in the formation of sporadic haemangiomas.

Optimizing effectiveness of laser tympanic membrane fenestration in chronic otitis media with effusion. Clinical and technical considerations.

OBJECTIVE: To describe the patient, disease and clinical characteristics that optimize the effectiveness of laser tympanic membrane fenestration (LTMF) to treat chronic otitis media with effusion (OME). SETTING: Four pediatric otolaryngology tertiary referral centers. IRB approved; participation by informed consent. METHODS: An observational clinical effectiveness trial was conducted in 164 ears (94 children), who had chronic OME. All patients were candidates for insertion of pressure equalization tubes (PETs) but agreed to undergo LTMF instead. Clinical and audiologic follow-up are reported at 90 days after LTMF. OUTCOME MEASURES: Clinical effectiveness was defined as an effusion free middle ear at otoscopy with A or C1 tympanogram and normal hearing. RESULTS: At 90 days, 66% of the 95 evaluable ears were effusion free, all with normal hearing. Children younger than 4 years (P<0.04), who had shorter durations of effusion (P<0.009), and who experienced longer duration of fenestration patency (FP) (P<0.009) correlated to improved outcomes. CONCLUSIONS: The use of LTMF to create 2--3 weeks of middle ear ventilation in patients with chronic OME (middle ear effusion (MEE) for 3 months or greater) is effective in 66% of 95 (58%) of ears evaluable at 90 days follow-up. This study provides basic information needed to optimize the use of LTMF today and enhance research efforts in the future.

Effectiveness of adenoidectomy and laser tympanic membrane fenestration.

OBJECTIVE: Adenoidectomy alone or with tonsillectomy (A+/-T) is an effective surgical intervention in the management of otitis media in children, especially when it is performed in conjunction with insertion of pressure equalization tubes (PETs). Otorrhea and persistent tympanic membrane (TM) perforation are frequent complications. This study evaluates the effectiveness of intermediate duration middle ear ventilation using laser tympanic membrane fenestration (LTMF) without tube insertion and as an adjunct to adenoidectomy in resolving middle ear disease within the first 90 days after surgery. STUDY DESIGN: This pilot study was a multicenter, prospective clinical cohort trial. Institutional review board approval and informed consent were obtained. The study involved four tertiary care pediatric otolaryngology departments. Fifty children (96 ears) were treated with LTMF in conjunction with A+/-T from June 1, 1998, through March 30, 1999. Ages ranged from 9 months to 12 years. Patients undergoing A+/-T who would have been recommended for PET insertion instead underwent middle ear ventilation with LTMF using the Oto-LAM device (ESC/Sharplan, Yokneam, Israel). Patients were seen at 30, 60, and 90 days postoperatively. Resolution of otitis media with effusion was determined by clinical examination, which included pneumatic otoscopy, audiometry, and tympanometry. RESULTS: Of the treated ears, 88%, 86%, and 83% had clinical resolution of middle ear disease at 30, 60, and 90 days, respectively. Preoperatively, 45% (n = 85) of ears had normal hearing; 92% (n = 49) had normal hearing at 90 days. Eighty-nine percent (n = 92) had type C2 or B tympanograms preoperatively, and 12% (n = 60) had type C2 or B at 90 days. CONCLUSION: Laser tympanic membrane fenestration in conjunction with adenoidectomy was effective in restoring normal middle ear function at 90 days post-treatment in greater than 80% of children who otherwise may have had placement of PETs.

Office-based laser assisted tympanic membrane fenestration in adults and children: pilot data to support an alternative to traditional approaches to otitis media.

OBJECTIVES: To determine the role of intermediate duration ( approximately 3 weeks) middle ear ventilation using office-based laser assisted tympanic membrane fenestration in resolving an episode of otitis media with effusion in adults and children who otherwise would have been treated with insertion of pressure equalization tubes. METHODS: A retrospective chart review of 92 patients (162 ears) was conducted to identify the utility and technical challenges associated with laser assisted tympanic membrane fenestration in an office setting. Clinical characteristics reviewed included: age, gender, duration of effusion, season performed, and hearing and health status of middle ear upon healing of the fenestration. RESULTS: 69% of all patients were effusion free upon closure of the fenestration; 68% of those <3 years; 70% of those 3-7 years; and 70% of those 25-80 years. Some episodes recurred and at final follow-up 64% had normal middle ear structure and function (range of follow-up =1-18 months, mean 2.5 months, median 2.0). Shorter duration of effusion pre-fenestration was more often associated with return to normal middle ear structure and function (P<0.01). Season performed, number of previous episodes of otitis media and pre-treatment tympanometry were not predictive of result. No significant complications were observed. CONCLUSIONS: The use of office-based laser assisted tympanic membrane fenestration is a reasonably safe and effective procedure for the treatment of otitis media in most adults and children. As a minimally invasive otologic procedure, laser assisted tympanic membrane fenestration has great potential to decrease the rates of both antibiotic usage and insertion of ear tubes.

GLUT1: a newly discovered immunohistochemical marker for juvenile hemangiomas.

Juvenile hemangiomas are common, benign vascular tumors of infancy. These lesions enlarge rapidly through cellular hyperplasia during the first year of life and then involute over several years. Distinctive histopathologic features of hemangiomas diminish during this evolution, and differentiation from vascular malformations becomes increasingly difficult. This distinction has important therapeutic implications, as juvenile hemangiomas differ from malformations in natural history and in potential for recurrence. We report here that high endothelial immunoreactivity for the erythrocyte-type glucose transporter protein GLUT1 is a specific feature of juvenile hemangiomas during all phases of these lesions. In a retrospective study, we found intense endothelial GLUT1 immunoreactivity, involving more than 50% of lesional microvessels, in 97% (139 of 143) of juvenile hemangiomas from patients aged 1 month to 11 years. No endothelial GLUT1 immunoreactivity was found in any of 66 vascular malformations (17 arteriovenous, 33 venous, 11 lymphatic, and 5 port-wine) from patients aged 5 days to 75 years, or in any of 20 pyogenic granulomas or 7 granulation tissue specimens. Abundant Ki-67 positivity in these latter lesions established that GLUT1 expression does not simply reflect mitotically active endothelium. Focal GLUT1 immunoreactivity was found in 3 of 12 angiosarcomas, but not in any of 5 hemangioendotheliomas (epithelioid or infantile kaposiform). These findings establish GLUT1 immunoreactivity as a highly selective and diagnostically useful marker for juvenile hemangiomas. Because high levels of endothelial GLUT1 expression in normal tissue are restricted to microvessels with blood-tissue barrier function, these findings also have implications for the molecular and developmental pathogenic mechanisms of juvenile hemangiomas.

Office-based insertion of pressure equalization tubes: the role of laser-assisted tympanic membrane fenestration.

OBJECTIVE: To describe the role of the hand-held otoscope combined with a flashscanner CO2 laser, OtoLAM (ESC/Sharplan, Yokneam, Israel), for pressure equalization tube (PET) insertion in an office setting. STUDY DESIGN: Prospective, multisite, clinical cohort trial (Institutional Review Board approved; informed consent) in the setting of pediatric otolaryngology outpatient departments at four tertiary care children's hospitals. METHODS: Selected for the study were 54 patients (96 ears), ages 6 months to 23 years, who met standard indications for PET insertion using cold-knife myringotomy and tube insertion under general anesthesia. PETs were indicated for recurrent otitis media, chronic otitis media with effusion, and eustachian tube dysfunction-all unresponsive to medical therapy. Topical anesthesia was achieved with iontophoresis (n = 1) or topical anesthesia: 8% tetracaine on an Otowick (Xomed Surgical Products, Jacksonville, FL, catalogue No. 400141) against the tympanic membrane for 45 to 180 minutes (n = 53). Laser-assisted tympanic membrane fenestration was performed with the OtoLAM set at single pulse, 2.0- to 2.6-mm spot size, and between 3 and 18 W. Insertion of grommets was accomplished using the otomicroscope and an "alligator" microforceps. Restraints with papoose were used in 79% of children with a mean age of 34.4 months (SD = 60.9 mo). Clinical, parent/patient, and physician satisfaction and comparative cost impact outcomes are described. RESULTS: All ears but three (3%) underwent successful placement of a PET. Pain was described as "absent" in 39%, "present but tolerable" in 30%, and "severe" in 30% of children at the time of procedure; 5 minutes after the procedure pain was described as "absent" in 75%, "present but tolerable" in 22%, and "severe" in 3%. Tube plugging (3 of 74 available ears; 4%) or persistent otorrhea (1 of 74 ears; 1.4%) occurred infrequently at the 1-month follow-up. Before PET insertion, hearing loss was noted in 66% of cases (mild, 38%; moderate, 22%; and severe, 6%). Mild hearing loss was noted in only 8% and moderate hearing loss in 2% of 47 (50%) of the ears at the 3-month follow-up. Ninety-two percent of parents were highly satisfied with the procedure in preference to PETs in the operating room under general anesthesia, and 97% preferred OtoLAM with PET insertion, rather than further courses of antibiotics; only one parent would rather have had the PET insertion under general anesthesia. Cost savings to health care organizations, particularly payers, and to parents are substantial (32%-48%) and warrant attention. Cost to the physician is manageable only if an appropriate approach to the third party payers results in a substantial increase in reimbursements. CONCLUSIONS: The data indicate excellent clinical effectiveness, reduced risk, and high parent and physician satisfaction. Strong incentives for physicians to use this technique are in all stakeholders' best interests. These incentives need to evolve as soon as possible for the more widespread acceptance of OtoLAM with PET insertion in an office setting for appropriately selected patients.