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1.

Purpose

The aim of this study was to demonstrate the efficacy of the minimally invasive technique for recurrent pectus excavatum.

Methods

Fifty patients with recurrent pectus excavatum underwent a secondary repair using the minimally invasive technique. Data were reviewed for preoperative symptomatology, surgical data, and postoperative results.

Results

Prior repairs included 27 open Ravitch procedures, 23 minimally invasive (Nuss) procedures, and 2 Leonard procedures. The prior Leonard patients were also prior Ravitches and are therefore counted only once in the analyses. The median age was 16.0 years (range, 3-25 years). The median computed tomography index was 5.3 (range, 2.9-20). Presenting symptoms included shortness of breath (80%), chest pain (70%), asthma or asthma symptoms (26%), and frequent upper respiratory tract infections (14%). Both computed tomography scan and physical exam confirmed cardiac compression and cardiac displacement. Cardiology evaluations confirmed cardiac compression (62%), cardiac displacement (72%), mitral valve prolapse (22%), murmurs (24%), and other cardiac abnormalities (30%). Preoperative pulmonary function tests demonstrated values below 80% normal in more than 50% of patients. Pectus repair was done using a single pectus bar (66%), 2 bars (32%), or 3 bars (2%). Stabilizers were used in 88% of the patients. Median length of surgical time did not significantly differ from that of primary surgeries. Complications were slightly higher than those in primary repairs and included pneumothorax requiring chest tube (14%), hemothorax (8%), pleural effusion requiring drainage (8%), pericarditis (4%), pneumonia (4%), and wound infection (2%). There were no deaths or cardiac perforations. Initial postoperative results were excellent in 70%, good in 28%, and fair in 2%. Late complications of bar shift requiring revision occurred in 8%. Seventeen patients have had bar removals with 9 patients being more than 1 year postremoval. For the 17 patients who are postremoval, excellent results have been maintained in 8 (47%), good in 7 (41%), fair in 1 (6%), and failed in 1 (6%). There have been no recurrences postremoval.

Conclusions

Although failed or recurrent pectus excavatum repairs are technically more challenging, reoperative correction by the Nuss procedure has met with excellent success.  相似文献   

2.

Purpose

Controversy exists as to the best operative approach to use in patients with failed pectus excavatum (PE) repair. We examined our institutional experience with redo minimally invasive PE repair along with the unique issues related to each technique.

Methods

We conducted an institutional review board-approved review of a prospectively gathered database of all patients who underwent minimally invasive repair of PE.

Results

From June 1987 to January 2010, 100 patients underwent minimally invasive repair for recurrent PE. Previous repairs included 42 Ravitch (RAV) procedures, 51 Nuss (NUS) procedures, 3 Leonard procedures, and 4 with previous NUS and RAV repairs. The median Haller index at reoperation was 4.99 (range, 2.4-20). Fifty-five percent of RAV patients and 25% of NUS patients required 2 or more bars (P = .01). Two RAV patients had intraoperative nonfatal cardiac arrest owing to thoracic chondrodystrophy—1 at insertion and 1 upon removal. Bar displacements occurred in 12% RAV and 7.8% NUS patients (P = .05). Overall reoperation for bar displacement is 9%.

Conclusions

The minimally invasive NUS technique is safe and effective for the correction of recurrent PE. Patients with prior NUS repair can have extensive pleural adhesions necessitating decortication during secondary repair. Patients with a previous RAV repair may have acquired thoracic chondrodystrophy that may require a greater number of pectus bars to be placed at secondary repair and greater risk for complications. We have a greater than 95% success rate regardless of initial repair technique.  相似文献   

3.

Purpose

The Ravitch and minimally invasive Nuss procedures have brought widespread relief to children with pectus excavatum, chest wall deformities, over the last half century. Generally accepted long-term complications of pectus excavatum repair are typically limited to recurrence of the excavatum deformity or persistent pain. This study examines the authors' experience with patients who develop a subsequent carinatum deformity within 1 year of pectus excavatum repair.

Methods

The authors retrospectively assessed the charts of all patients diagnosed as having a carinatum deformity subsequent to treatment for pectus excavatum at a tertiary urban hospital. We noted age at original correction of pectus excavatum, time from original correction to diagnosis of carinatum deformity, age at correction of carinatum deformity, complaints before correction, methods of repair, postoperative complications, and we reviewed relevant radiography.

Results

Three patients who underwent pectus excavatum repair between January 2000 and August 2007 developed a subsequent carinatum deformity. Two patients initially underwent minimally invasive Nuss correction of pectus excavatum; 1 patient underwent the Ravitch procedure. Within 1 year of original correction and despite intraoperative achievement of neutral sternal position, a protruding anterior chest deformity resembling de novo pectus carinatum emerged in each patient; we term this condition reactive pectus carinatum. The mean age of patients undergoing initial pectus excavatum repair was 13 years (range, 11-16 years). The pathophysiology of this reactive lesion is not well understood but is thought to originate from reactive fibroblastic stimulation as a result of sternal manipulation and bar placement. Patients who underwent Nuss correction initially were managed with early bar removal. Two of the patients eventually required surgical resection of the carinatum deformity at a time interval of 3 to 6 years after initial excavatum repair. In one patient, the carinatum deformity resolved spontaneously. Neutral chest position and absence of dyspenic symptoms were achieved in all patients.

Conclusions

Reactive pectus carinatum is functionally encumbering and a poor cosmetic complication of either the Ravitch or minimally invasive Nuss procedures. Our experience with reactive pectus carinatum introduces the importance of postoperative vigilance even in patients without underlying fibroelastic disease. Examination of the chest with attention to the possibility of an emerging carinatum deformity, particularly in the first 6 postoperative months, is paramount. A telephone call to the patient at 3 months may be a useful adjunct to clinic visits. An optimal long-term result may be achieved through a combination of early Nuss bar removal or postpubertal pectus carinatum repair.  相似文献   

4.

Background

Recent publications have advocated a minimally invasive approach to repair of the pectus deformity. Efforts to evaluate this new approach have been hampered by lack of comparative information regarding outcomes of the standard Ravitch approach. We use a modified Ravitch procedure, and present our series as a basis for comparison.

Methods

Records of 69 consecutive patients undergoing repair of the pectus deformity were retrospectively reviewed. Modifications included a minimal incision and a new technique to address sternal angulation. A patient satisfaction survey evaluated the patients' perception of the outcome.

Results

We found one wound infection (1.4%). Five patients (7.2%) had a seroma, and were treated as outpatients. Because the minimally invasive approach is used for pectus excavatum, we divided our series into excavatum and carinatum subsets. The subset of 44 pectus excavatum patients had a mean postoperative length of stay (LOS) of 2.9 days. The median patient satisfaction score was 4 on a scale of 1 to 5, at an average of 4.75 years after repair. The subset of 25 pectus carinatum patients had a mean LOS of 2.4 days and a median patient satisfaction score of 5.

Conclusions

The modified Ravitch procedure yields excellent results with low morbidity, hospital LOS, and cost, combined with high patient satisfaction. These current data will be useful for comparison as newer techniques for pectus repair continue to evolve.  相似文献   

5.
6.

Purpose

Pectus excavatum is frequently repaired using the minimally invasive placement of a substernal bar (Nuss procedure). Infectious complications after the Nuss procedure are potentially devastating. To date, the management of postoperative infectious complications has not been well described.

Methods

A retrospective review of all patients (N = 168) who underwent the Nuss procedure from January 1, 1997, to October 1, 2003, at our institution was performed. Six patients (4%) had postoperative infections, and their medical records were reviewed.

Results

Of the 6 patients, 5 underwent operative drainage for wound abscesses that developed 2 to 76 weeks postoperatively. The other patient developed cellulitis 12 months postoperatively and was treated effectively with antibiotics alone. Recurrent infections were treated in 3 of 6 patients, one of whom eventually required removal of the bar resulting in a mild, residual pectus excavatum defect. One of 6 patients has had the substernal bar removed electively. The remaining 4 continue to be without clinically apparent infection at this time and are over 1 year removed from their infection.

Conclusions

Although uncommon, infectious complications after the Nuss procedure require complex management strategies. Despite recurrent infection in some cases, most infectious complications occurring after the minimally invasive repair can be effectively treated without having to remove the substernal bar.  相似文献   

7.

Background/Purpose

Although minimally invasive repair of pectus excavatum has gained worldwide acceptance, treatment of pectus carinatum is mostly performed with open procedures. Different minimally invasive alternatives have been proposed in the last few years, including subpectoral CO2 dissection and intrathoracic compression (Abramson technique), or conservative procedures, as dynamic compression system. Recently, another surgical technique has been proposed for the treatment of unilateral pectus carinatum, consisting of a thoracoscopic approach and multiple cartilage incisions. The aim of this work is to present our modification to this approach.

Methods

We have modified this technique by introducing complete cartilage resection of all anomalous costal cartilages, performed thoracoscopically. Three thoracoscopic ports were used. Cartilage is removed progressively using a rongeur and preserving the anterior perichondrium.

Results

We have performed this technique in 4 patients during the last year. Follow-up ranged from 6 to 14 months. No intraoperative or postoperative complications were observed. The results, assessed by the patients themselves, were good in 2 cases, quite good in one, and fair in the first patient of our series, who was reoperated using a classical open approach. Pain was well controlled without the need of an epidural catheter.

Conclusion

Thoracoscopic cartilage resection with perichondrium preservation can be considered as feasible alternative for the treatment of unilateral pectus carinatum.  相似文献   

8.

Background

The Nuss procedure is a minimally invasive procedure for correction of pectus excavatum. It involves insertion of a substernal metal bar. A feared complication of any implanted device is infection, which often necessitates removal. The purpose of this report is to describe the authors' experience with infectious complications after the Nuss procedure.

Methods

From February 2000 to July 2002, 102 patients underwent the Nuss procedure in 2 pediatric surgical centers. In a retrospective way, the files of those patients in whom a postoperative infection developed were studied.

Results

Seven patients suffered postoperative infectious complications. Only one bar needed to be removed.

Conclusion

The authors' experience indicates that there is no need for immediate removal of an infected Nuss bar. Most of these infections can be managed conservatively. However, early antibiotic treatment is warranted to ensure salvage of the bar.  相似文献   

9.

Background/Purpose

The minimally invasive Nuss procedure is emerging as the preferred technique for repair of pectus excavatum. Original methods of pectus bar placement have been modified to improve safety and efficacy and avoid cardiothoracic complications. The currently reported modifications to facilitate retrosternal pectus bar placement include routine use of right thoracoscopy or a subxiphoid incision. The purpose of this article is to describe additional modifications of the Nuss procedure to improve safety and efficacy.

Methods

A retrospective analysis was performed on 51 patients who have had a thoracoscopic-assisted Nuss procedure at The Children's Hospital, Denver, Colo, between 1999 and 2002. Technical modifications included patient positioning, routine use of left thoracoscopy, and an Endo-kittner.

Results

Fifty-one patients have successfully undergone the Nuss procedure using the new modifications. Surgical time ranged from 45 to 120 minutes. There have been no intraoperative or postoperative bleeding complications. There have been 2 large pneumothoraces requiring needle thoracenteses in the operating room before extubation. No chest tubes were required postoperatively. Subjectively, all patients have been satisfied with their surgical correction. Average length of hospital stay was 4 to 6 days.

Conclusions

By using left chest thoracoscopy and Endo-kittner dissectors, the risk of cardiothoracic injury can be eliminated. Moreover, other methods to ensure safe substernal dissection are unnecessary.  相似文献   

10.
Background/Purpose: A small percentage of patients who have undergone traditional, [ldquo ]Ravitch-type[rdquo ] pectus excavatum repair present with unsatisfactory results and require a second procedure for correction. Reoperative open surgery for pectus excavatum has been associated with extensive dissection and substantial blood loss. The minimally invasive (MIS) bar repair for the correction of pectus excavatum has been gaining acceptance. This study evaluates the authors results with patients who have undergone the MIS bar repair for redo correction of their pectus excavatum. Methods: A retrospective chart review of all patients undergoing MIS bar repair between December 1997 and August 2001 was performed. Information about demographics, deformity, operative course, complications, and early outcome was recorded. Results: Ninety-two patients underwent MIS repair during this period. Ten patients had redo MIS bar repair for unsatisfactory prior open correction. Operating time was 52 minutes for standard patients and 70 minutes for the redo patients (P [lt ] .001). Blood loss and postoperative hospitalization were similar between groups. Conclusion: The minimally invasive pectus repair can be performed safely with minimal blood loss and short operating time in patients who have undergone prior unsatisfactory open repair of pectus excavatum and can be an alternative approach to reoperative open repair in these patients. J Pediatr Surg 37:1090-1092.  相似文献   

11.

Purpose

A nemesis of surgical implants is infection. We evaluated the various infectious complications after Nuss repair of pectus excavatum in 863 patients over 18 years.

Methods

After institutional review board approval, a retrospective review of a prospectively gathered database of patients was performed who underwent minimally invasive repair of pectus excavatum and developed an infection. All patients received intravenous antibiotics before surgery continuing until discharge. Patients with a persistent fever after operation were discharged with oral antibiotics.

Results

From January 1987 to September 2005, 863 patients underwent a minimally invasive pectus excavatum repair and 13 (1.5%) developed postoperative infections. These included 6 bar infections, 4 cases of cellulitis, and 3 stitch abscesses. Cellulitis was defined as erythema and warmth which responded to a single course of antibiotics. Bar infections were defined as an abscess in contact with the bar. Surgical drainage and long-term antibiotics resolved 3 of these abscesses, whereas 3 patients required early bar removal (1 after 3 months and 2 after 18 months). Cultures identified a single organism in each case and Staphylococcus aureus was the most common organism (83%) identified, and all being methicillin sensitive. All infections occurred on the side of the stabilizer if a stabilizer had been placed.

Conclusions

Infectious complications after Nuss repair are uncommon and occurred in 1.5% of our patients. Published rates of postoperative infection range from 1.0% to 6.8%. Superficial infections responded to antibiotics alone. Bar infection occurred in only 0.7% and required surgical drainage and long-term antibiotics. Only 3 of these (50% of bar infections and 0.34% overall) required early bar removal at 3 and 18 months because of recurring infections. Early bar removal should be a rare morbidity with the Nuss repair.  相似文献   

12.

Background

Minimally invasive repair of pectus excavatum (MIRPE) has become widely popular since its introduction in the late 1990s by Nuss. We describe 1 unusual complication after MIRPE and 1 life-threatening bleeding during removal of the pectus bar.

Methods

We report the cases of 2 patients in a single institution, more than 100 MIRPE procedures performed so far, and review of literature.

Cases

A 14-year-old girl presented 6 months after MIRPE in another institution. During removal of the pectus bar, a massive hemorrhage from both chest wounds occurred, requiring emergency sternotomy. Arrosion of a pulmonary vessel close to the metal bar had led to the bleeding. The second case was a bilateral sternoclavicular dislocation after MIRPE, which has not caused symptoms so far, in a 13-year-old girl.

Conclusions

Numerous operative and postoperative complications after MIRPE are feasible. This is the first report of a life-threatening bleeding during removal of the pectus bar. Minimally invasive repair of pectus excavatum procedure and removal of the pectus bar should only occur in specialized institutions with wide experience in thoracic surgery.  相似文献   

13.

Background/Purpose

The purpose of this study was to determine the frequency of pectus excavatum and associated conditions in a large autopsy series. It also sought to determine whether there were different survival patterns for pectus excavatum patients than for patients without pectus excavatum.

Methods

A computer-assisted search of autopsy files maintained by Johns Hopkins University was conducted, dating from 1889 to 2001. Each patient's Autopsy Pathology Information System report was reviewed for diagnosis and comorbid conditions. To determine whether there were differences in survival patterns, we tested whether pectus excavatum patients survived longer than controls, using a standard epidemiological method. Each patient in the autopsy series was compared with the 2 patients entered in the autopsy database chronologically immediately before and the 2 patients immediately after the case. A Kaplan-Meier survival analysis was conducted.

Results

Pectus excavatum was identified at autopsy in 62 of 50,496 cases. Of these 62 patients, 17 were 65 years or older and appeared to have died of causes unrelated to pectus excavatum, the oldest being 91 years. Twenty-one were between the ages of 14 and 65 years and were found to have coexisting conditions or syndromes. Six were between the ages of 1 and 4 years. One of the 6 died in 1947 because of complications from pectus repair. No autopsied patient with pectus excavatum died between the ages of 5 and 14 years. Eighteen were infants younger than 1 year, and all 18 died because of conditions unrelated to pectus excavatum. There were no reported cases of pectus excavatum before 1947, and the severity of deformity could not be determined from the autopsy data. Survival analysis indicated that pectus excavatum patients had a different survival than the controls. Pectus excavatum patients tended to die earlier (P = .0001). However, pectus excavatum patients who survived past the age of 56 years tended to survive longer than their matched controls (P = .0001).

Conclusion

Although there were no histological abnormalities noted in the cartilage of the pectus excavatum patient's conditions, pectus excavatum was associated with several connective tissue abnormalities. Analysis is consistent with the theory that this condition can impact survival.  相似文献   

14.

Background

Adolescents with a pectus excavatum mostly present with cosmetic complaints and rarely have significant physical limitations. The preoperative evaluation includes pulmonary functions tests, echocardiography, and chest computed tomography (CT) scan to measure the Haller index. In most patients, the chest CT is performed only to measure the Haller index. The purpose of this study was to evaluate whether indices measured on chest radiograph (CXR) and CT scan are comparable.

Methods

Cases of pectus excavatum treated with the minimally invasive approach in the last year were prospectively collected. In patients for whom a preoperative CXR and CT scan were available, an index was measured using both imaging modalities and compared.

Results

Both preoperative imaging studies were available in 12 patients. The mean Haller indices on CT scan and CXR were 3.97 and 4.08, respectively. The Pearson correlation score between the 2 groups was 0.984.

Conclusions

We propose that the Haller index measured on CT scan be replaced by CXR measurement in asymptomatic patients in whom a chest CT scan is otherwise not necessary. This will limit radiation exposure to children. When in doubt, a CT scan of the chest can be used for the preoperative evaluation.  相似文献   

15.

Background/Purpose

Since the introduction of the closed technique for repair of pectus excavatum, increasing numbers of patients are presenting for surgery. However, controversy exists regarding the effects of repair on long-term cardiopulmonary outcome. This report details the effects over time of closed repair of pectus excavatum on pulmonary function, cardiac function, exercise tolerance, and the patient's perception of appearance and subjective ability to exercise.

Methods

All patients undergoing closed repair of pectus excavatum were evaluated prospectively. Preoperative computed tomography scan, static pulmonary function studies, exercise tolerance, and echocardiographic evaluation of cardiac function were done. Studies were repeated at 3 and 21 months post-bar placement, and then 3 months after bar removal.

Results

Pre- and postoperative data were available for an initial 48 patients, with 11 patients completing the full evaluation after bar removal. All measures of pulmonary function including forced expiratory volume in 1 second and forced vital capacity were reduced at 3 months postoperation, with a gradual increase during follow-up; however, pulmonary function remained below normative values for patients without pectus excavatum of similar age. Cardiac function as measured by cardiac output and index was increased at 3 months postoperation and maintained thereafter. Exercise tolerance declined initially and then increased by the 21-month evaluation point and after bar removal. Patients reported a subjective improvement in the ability to exercise immediately after bar insertion.

Conclusions

These results corroborate previous studies which suggested that after closed repair of pectus excavatum there is an immediate subjective improvement in the ability to exercise which is paralleled by an improvement in cardiac output. However, there is an early postoperative decline in pulmonary function which does improve over time; however, this does not reach normal values for similar weight. Further studies are needed to determine whether these results are maintained, or whether after bar removal there is a further improvement in pulmonary status. These results do support the use of the closed repair of pectus excavatum for maintaining and possibly improving cardiopulmonary function in this patient population.  相似文献   

16.

Objective

The repair of pectus excavatum with bar placement is associated with substantial postoperative pain. Optimal pain control strategy has not been addressed with level 1 or substantial level 2 evidence. Many institutions operate under the assumption that a thoracic epidural offers the best pain control for these patients. Therefore, we conducted a retrospective evaluation to examine the validity of this assumption.

Methods

A retrospective review of patients undergoing pectus excavatum repair with bar placement from January 2000 to February 2006 was conducted. The demographic variables collected included age, sex, weight, and Haller's index scores. Outcome variables included total operating room time, number of calls to the anesthesiologist, hours of urinary catheterization, hours until complete transition to oral pain medication, length of hospitalization, and maximum pain scores for each of the first 5 postoperative days.

Results

There were a total of 203 patients, of which 188 had an epidural, compared with 15 with intravenous narcotic therapy. Of the 188 patients committed to an epidural, 65 had a failed attempt in the operating room or a dysfunctional catheter removed within 24 hours. Patients without an epidural had a shorter operating room time, less time of urinary catheterization, decreased time to complete transition to oral medication, and decreased length of hospitalization with lower maximum scores.

Conclusions

Our data challenge the assumption that routine epidural catheter placement on all patients undergoing pectus excavatum repair with bar placement offers the best pain management strategy. There is clearly a role for a prospective randomized trial to clarify the best management for these patients.  相似文献   

17.

Purpose

The purpose of this study was to compare clinical and health-related quality-of-life (HRQL) outcomes within a group of patients treated for pectus excavatum (PE).

Methods

A retrospective 3-year review of patients undergoing Nuss or Ravitch correction of PE was performed. Health-related quality-of-life assessment was performed using the Child Health Questionnaire (CHQ-CF87) and the 17-item Pectus Excavatum Evaluation Questionnaire, and results were compared between groups and with age-matched CHQ-CF87 normative data.

Results

Forty-three patients (39 males; 91%) underwent surgery; 19 (44%) by Nuss procedure. Duration of postoperative opioid analgesia and length of hospital stay (LOS) were significantly longer in Nuss patients. The overall survey response rate was 53%. The groups differed significantly in the CHQ on one item (Change in Health). On the Pectus Excavatum Evaluation Questionnaire, Nuss patients reported being “less bothered” by the appearance of their chest. Compared to Australian age-matched norms, the aggregate PE sample showed better scores for family activity domain and worse scores in mental health, general health perceptions, change in health, bodily pain, and self-esteem.

Conclusions

Patients undergoing surgery for PE by either Nuss or Ravitch procedure have similar clinical and HRQL outcomes, but as a group have poorer HRQL scores than age-matched population norms.  相似文献   

18.

Background/Purpose

To describe the dysmorphology of pectus excavatum, the most common congenital chest wall anomaly.

Methods

A stratified sample of 64 patients, representative of a patient population with pectus excavatum of the Children's Hospital of King's Daughters in Norfolk, Va, was described and classified. The sample was stratified by sex to represent a 4:1 male-to-female ratio. The sample was further stratified to represent categories of age (3-10, 11-16, and 17 years and older). Preoperative photos and baseline chest computed tomography scans were examined and categorized according to the chief criteria, including asymmetry/symmetry of the depression, localized vs diffuse morphology, sternal torsion, cause of asymmetric appearance, and the length of the depression.

Results

Useful morphologic distinctions in pectus excavatum are localized depressions vs diffuse depressions, short and long length, symmetry, sternal torsion, slope/position of absolute depth, and unique patterns such as the horns of steer depression.

Conclusions

These classifications simplify the diagnosis of pectus excavatum, aid in corrective surgery, and should improve correlation of phenotype and genotype in future genetic analysis.  相似文献   

19.

Background/Purpose

Pectus excavatum is a common chest wall deformity, and several procedures have been developed for its correction. We allow patients to choose among Leonard, Nuss, and Ravitch procedures. This study aimed to determine which procedure most patients select and the resultant outcomes.

Methods

Charts were reviewed of all pectus excavatum repairs performed for 4 years by a practice covering a university-based children's hospital. Procedure choice, operative time, length of stay, analgesia, fees, and complications were recorded.

Results

The Ravitch procedure was chosen by 60.9% of our patients, Leonard procedure by 23.9%, and Nuss procedure by 15.2%. Operative times were not significantly different among the groups. The mean length of stay was 2.2 days (Ravitch), 1.5 days (Leonard), and 3.9 days (Nuss) (P < .005). Epidural analgesia/patient-controlled analgesia pump requirements were 50% (Ravitch), 5% (Leonard), and 100% (Nuss). The mean charges were $27,414 (Ravitch), $18,094 (Leonard), and $43,749 (Nuss) (P < .05). The overall complication rate was 16.3%. The complications among each group were as follows: Ravitch, 14.3%; Leonard, 9.1%; and Nuss, 35.7%.

Conclusions

We allow patients to choose among Leonard, Ravitch, and Nuss procedures for repair of pectus excavatum. Most select the Ravitch procedure. Length of stay, fees, analgesic needs, and complication rate were highest among patients in the Nuss group; all of these variables were lowest in the Leonard group.  相似文献   

20.

Purpose

The Magnetic Mini-Mover Procedure (3MP) uses a magnetic implant coupled with an external magnet to generate force sufficient to gradually remodel pectus excavatum deformities. This is an interim report of the evolution of the 3MP during a Food and Drug Administration-approved clinical trial.

Methods

After obtaining Institutional Review Board approval, we performed the 3MP on 10 otherwise healthy patients with moderate to severe pectus excavatum deformities (age, 8-14 years; Haller index >3.5). Operative techniques evolved to improve ease of implantation. Patients were evaluated monthly by a pediatric surgeon and orthotist. Electrocardiograms were performed pre- and postoperatively. Sternal position was documented by pre- and postprocedure computed tomographic scan, interval chest x-ray, depth gauge, and interval photographs.

Results

There was no detectable effect of the static magnetic field on wound healing or cardiopulmonary function. No detectable injuries and minimal skin changes resulted from brace wear. Operative techniques evolved to include a custom sternal punch and a flexible guide wire to guide the posterior plate into position behind the sternum, reducing outpatient operating time to one-half hour. In 9 patients, the procedure was performed as an outpatient basis; and 1 patient was observed overnight. Three patients required evacuation of retained pleural air postoperatively, and 2 required an outpatient revision. A custom-fitted orthotic brace (Magnatract) was extensively modified to increase user friendliness and functionality while incorporating several novel functions: a screw displacement mechanism so patients can easily self-adjust magnetic force, a miniature data logger to measure force and temperature data every 10 minutes, and an interactive online Web portal for remote patient evaluation. All attempts to quantitate sternal position (radiographic, fluid volume, and depth gauge) were inadequate. Visual assessment remains the best indicator.

Conclusions

In this interim report, the 3MP appears to be a safe, minimally invasive, outpatient, cost-effective alternative treatment of pectus excavatum. Outcomes will be reported upon the completion of this phase II clinical trial.  相似文献   

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