The The Sandwich Technique For Minimally Invasive Repair Of Pectus Carinatum.

INTRODUCTION: Minimally invasive repair of pectus carinatum (MIRPC) has been performed using the Abramson technique in which the bar that compresses the sternum is fixed with steel wires on the ribs. A 14-year-old patient underwent to a MIRPC using a sandwich technique in which two metallic bars fixed with bridges were implanted below the sternum under thoracoscopic vision, and another bar in a subcutaneous tunnel was implanted above. This technique has the potential to avoid specific problems related to the original technique like loosening of support for correction (broken wire), avoidance of induction of pectus excavatum or subcutaneous tissue adhesion.

An update of the long-term outcome of patients with nonspecific pleurisy at medical thoracoscopy.

BACKGROUND: Medical thoracoscopy (MT) is recommended in patients with undiagnosed exudative pleural effusion and offers a degree of diagnostic sensitivity for pleural malignancy. However, not all patients who undergo MT receive an exact diagnosis. Our previous investigation from 2014 summarized the long-term outcomes of these patients with nonspecific pleurisy (NSP); now, we offer updated data with the goal of refining our conclusions. METHODS: Between July 2005 and August 2018, MT with pleural biopsies were performed in a total of 1,254 patients with undiagnosed pleural effusions. One hundred fifty-four patients diagnosed with NSP with available follow-up data were included in the present study, and their medical records were reviewed. RESULTS: A total of 154 patients were included in this study with a mean follow-up duration of 61.5 ± 43.7 months (range: 1-180 months). No specific diagnosis was established in 67 (43.5%) of the patients. Nineteen patients (12.3%) were subsequently diagnosed with pleural malignancies. Sixty-eight patients (44.2%) were diagnosed with benign diseases. Findings of pleural nodules or plaques during MT and the recurrence of pleural effusion were associated with malignant disease. CONCLUSIONS: Although most NSP patients received a diagnosis of a benign disease, malignant disease was still a possibility, especially in those patients with nodules or plaques as noted on the MT and a recurrence of pleural effusion. One year of clinical follow-up for NSP patients is likely sufficient. These updated results further confirm our previous study's conclusions.

Thoracoscopic Management of Pediatric Patients with Congenital Lung Malformations: Results of a European Multicenter Survey.

Background: This study aimed to report a European multi-institutional experience about thoracoscopic management of children with congenital lung malformations. Methods: The records of 102 patients (49 girls and 53 boys) with median age at surgery of 1 year (range 6 months-1.5 years), who underwent thoracoscopic lobectomy in five European Pediatric Surgery units, were retrospectively collected. Indications for surgery included congenital pulmonary airway malformation (CPAM) (n = 47), intra- and extralobar pulmonary sequestration (n = 34), hybrid lesion (CPAM/intralobar sequestration) (n = 2), severe bronchiectasis (n = 9), congenital lobar emphysema (n = 8), and others (n = 2). The condition was asymptomatic in 77/102 (75.5%), whereas symptoms such as recurrent pneumonia and/or respiratory distress were present in 25/102 (24.5%). Results: Surgical procedures included 18 upper, 20 middle, and 64 lower lobe resections. No conversions to open were reported. A 3 mm sealing device and 5 mm stapler were adopted in the last 48/102 patients (47%). The median operative time was 92.2 minutes (range 74-141). The median operative time significantly decreased in patients in whom the vessel division and bronchial sealing were performed using sealing devices (75.5 minutes) compared with suture ligations (118.9 minutes) (P = .001). The median hospital stay was 3.7 days (range 2-6.2). Three/102 patients (2.9%) developed postoperative complications, including air leakage requiring pleural drainage (n = 1) (Clavien IIIb) and respiratory infection (n = 2) (Clavien II). A reoperation was required in one patient with residual pleuropulmonary blastoma (0.9%). All symptomatic patients reported resolution of symptoms postoperatively. Conclusions: Thoracoscopic lobectomy is a safe and effective procedure with excellent cosmetic outcome, in expert hands. Based upon our experience, we strongly recommend surgery in patients with congenital lung malformations by the first year of life, to reduce the risk of infection and make the procedure technically easier, despite the small patients' size. Surgeon's experience and use of miniaturized instruments and sealing devices remain key factors for successful outcome.

Microcoil localization as an effective adjunct to thoracoscopic resection of pulmonary nodules in children.

BACKGROUND/PURPOSE: Thoracoscopic excision of pulmonary nodules is often required for diagnostic or therapeutic purposes, however subpleural and sub-centimeter nodules can be difficult to visualize. Various CT-guided localization techniques have been described, though there is minimal published pediatric data regarding the use of microcoils. We hypothesize that microcoil localization facilitates thoracoscopic resection of pulmonary nodules in children. METHODS: A multi-institutional retrospective review of children who underwent preoperative CT-guided localization of lung nodules was conducted from 2012 to 2019. A combination of methylene blue dye (MBD), wires, and microcoils were utilized for CT-guided localization. When microcoils were utilized, fluoroscopy assisted in lesion identification and resection. RESULTS: Eighteen patients (mean age 13 years, range 2-21 years) underwent thoracoscopic resection of 24 preoperatively localized pulmonary nodules. Mean size and depth of the lesions were 5.5 mm and 10 mm, respectively. Microcoil placement was successful 95% of the time and assisted in lesion localization in 88% of cases. Wire localization was not a durable technique, as 3 of 5 wires became dislodged upon lung  isolation. CONCLUSIONS: Preoperative CT-guided localization with microcoils can assist in fluoroscopic-guided resection of pulmonary nodules in children. This technique avoids the pitfall of wire dislodgement, and provides surgeons an additional technique to localize sub-centimeter, subpleural nodules. TYPE OF STUDY: Retrospective Review. LEVEL OF EVIDENCE: Level III.

Utility of the powered stapler for radical pulmonary resection: a propensity score-matched analysis.

PURPOSE: Anatomical pulmonary resection, such as lobectomy, is a common procedure. Staplers play an important role in dividing an incomplete interlobular fissure, especially in thoracoscopic surgery. This study evaluates the effectiveness of a powered stapler for reducing the need for intraoperative fibrin glue and the incidence of air leakage after radical pulmonary resection. METHODS: The subjects of this retrospective study were 478 patients who underwent radical pulmonary resection. Propensity score analysis generated two matched pairs of 177 patients treated using powered and manual staplers, respectively. RESULTS: The need for fibrin glue intraoperatively during radical pulmonary resection was significantly less in the powered-stapler group (47.5%) than in the manual-stapler group (58.8%, p = 0.033). The incidence of postoperative air leakage following radical pulmonary resection was also significantly lower in the powered-stapler group (2.8%) than in the manual-stapler group (10.7%, p = 0.003). Logistic regression analysis identified use of the powered stapler as a factor independently associated with both non-use of fibrin glue intraoperatively (odds ratio, 0.63; p = 0.040) and no postoperative air leakage (odds ratio, 0.26; p = 0.010). CONCLUSION: Using a powered stapler to divide the incomplete interlobular fissure decreased the need for additional intraoperative management using fibrin glue and reduced postoperative air leakage in radical pulmonary resection.

A randomized, prospective, comparative trial of a variable-angle versus fixed-angle endoscope for exploratory thoracoscopy in canine cadavers.

OBJECTIVE: To compare the efficacy of a variable-angle endoscope (VAE) for canine thoracoscopic exploration to a traditional fixed-angle endoscope (FAE). STUDY DESIGN: Randomized, prospective, comparative study. SAMPLE POPULATION: Five fresh canine cadavers. METHODS: Twelve predetermined anatomical locations were labeled after median sternotomy in each cadaveric thorax. Two board-certified veterinary surgeons performed thoracoscopic evaluation of each thorax using a fixed-angle (30°) and a variable-angle (0°-120°) endoscope with and without lungs mechanically ventilated. The order of surgeon, lung ventilation, and endoscope were determined using a randomized block design. Time to visualize each anatomical location was compared for surgeon, endoscope, and lung ventilation status. Primary outcome measures were time to individual anatomical location, total simulated thoracoscopic exploration time, and ability to identify anatomical location within the designated time period. RESULTS: Lung ventilation (difference = 184 seconds, P = .015, 95% CI = 45-342 seconds) and endoscope type (difference = 112 seconds, P = .029; 95% CI = 10-213 seconds) had an effect on the cumulative time for complete thoracoscopic exploration. The VAE shortened the time to identify three of the 12 anatomical locations when controlling for the effects of lung ventilation. Use of the VAE did not improve time to identification for any locations compared to the FAE when lungs were not ventilated. The VAE facilitated significantly shorter cumulative thoracoscopic exploration time compared with the FAE. Failure to identify predetermined locations was more common with the FAE than with the VAE. CONCLUSION: Use of a rigid VAE decreased cumulative thoracoscopic exploration time and provided an alternative to one-lung ventilation for circumventing the visual impediments of lung ventilation. CLINICAL SIGNIFICANCE: This cadaveric study provides evidence that one-lung ventilation and use of a VAE may improve surgeon efficiency during exploratory thoracoscopy.

VATS Uniportal, masterclass Guatemala / VATS Uniportal, masterclass Guatemala

En las dos últimas décadas la evolución de la cirugía mínimamente invasiva del tórax ha transmutado de un abordaje de tres puertos, siguiendo dos puertos hasta llegar a puerto único, conocido también como VATS Uniportal, procurando un confort mucho mejor para el paciente y resultados quirúrgicos similares. Objetivos. Presentar la técnica quirúrgica de VATS Uniportal en un hospital nacional, efectuadas por un experto internacional en este campo. Pacientes y Métodos. Se presentan dos casos clínicos quirúrgicos: El de una paciente con Miastenia Gravis a quien se le realizó timectomía por abordaje sub-xifoideo y otra paciente, a quien se le completó una lobectomía inferior derecha por hallazgos de patología posterior a la resección de un nódulo pulmonar solitario, reportado como cáncer primario de pulmón. Conclusiones. La técnica de cirugía mínimamente invasiva, VATS Uniportal, ofrece grandes beneficios para el paciente, tanto estéticos como funcionales y su aprendizaje es posible con la transmisión de conocimientos y experiencias directa con la presencia del experto o indirectas a través de la información publicada. (AU)

In the last two decades, the evolution of minimally invasive chest surgery has transmuted from a three-port approach, following two ports until reaching a single port, also known as VATS Uniportal, seeking much better comfort for the patient and similar surgical results. Objective. Present the VATS Uniportal surgical technique in a national hospital, performed by an international expert in this field. Patients and Methods. Two surgical clinical cases are presented: that of a patient with Myasthenia Gravis who underwent thymectomy through the sub-xiphoid approach and another patient, who underwent a right lower lobectomy due to findings of pathology after the resection of a pulmonary nodule. solitary, reported as primary lung cancer. Conclusions. The minimally invasive surgery technique, VATS Uniportal, offers great benefits for the patient, both aesthetic and functional and its learning is possible with the transmission of knowledge and experiences directly with the presence of the expert or indirectly through published information. (AU)

Single-Instrument Thoracic and Abdominal Surgery in Children: Minimizing Minimally Invasive Surgery.

Introduction: The use of single-port surgery is widely accepted in pediatric surgery, but the majority of reports are on its use for appendectomy or inguinal hernia repair using multiple instruments. The aim of this report is to demonstrate that both thoracic and abdominal single-instrument procedures are feasible and safe in children. Materials and Methods: The following cases were managed in our department for the past 12 months. Two types of telescopes (10- and 5-mm) with inbuilt working channels were used in all cases. Results: The 10-mm endoscope with a 6-mm inbuilt channel was used to partially reduce and then exteriorize an intussusception secondary to Meckel's diverticulum in a 9-year-old boy, to reduce a left ovarian torsion in a 8 year-old girl, and to perform a thoracoscopic exploration and lung decortication in a 16 year-old girl with empyema. A 5-mm endoscope with a 3-mm working channel was used to perform bilateral 2-level thoracic sympathotomy in a 13-year-old girl with palmar primary hyperhidrosis. There were no perioperative complications and follow-up was uneventful in all patients. Conclusion: Minimally invasive surgery is well established at present. Thoracic and abdominal single-port single-instrument procedures are safe and effective in children. This is a unique report on single-port single-instrument use in four completely different procedures and the first to describe its usage for thoracoscopic sympathotomy in children. Increasing technology development, allied to surgeons' skills, is crucial to worldwide adoption of this surgical modality.

Uni-Port Total Thoracoscopic Surgery Versus Median Sternotomy for Redo Tricuspid Valve Replacement: A Retrospective Study.

BACKGROUND: This study compared the perioperative and follow-up period data of patients who underwent redo tricuspid valve replacements performed via thoracoscopic surgery or median sternotomy. The purpose was to evaluate the feasibility, safety, and surgical outcomes of redo tricuspid valve replacement via uni-port thoracoscopic surgery. METHODS: Forty-nine patients with severe tricuspid valve regurgitation after left-side valve replacement underwent redo tricuspid valve replacements in our hospital from April 2012 to September 2019. Twenty-six patients underwent uni-port total thoracoscopy surgery, whereas 23 patients had the surgery performed via median sternotomy. We collected perioperative and 3- to 36-month postoperative data. RESULTS: No deaths occurred in the intraoperative period. Time of cardiopulmonary bypass in the study group significantly was longer than that in the control group (P < .05), but the operative times in the study and control groups were not significantly different. Thoracic drainage, length of ICU stay, postoperative hospital stay, and complication rates in the study group were significantly different from those in the control group (P < .05). Throughout the follow-up period, uni-port total thoracoscopic TVR was not inferior to traditional surgery with respect to cardiac function and recurrence of tricuspid valve regurgitation. CONCLUSIONS: Uni-port total thoracoscopic tricuspid valve replacement is safe,  feasible and effective, and that can be considered as a primary treatment strategy for patients with severe TR after previous left-sided valve procedure.

Three-Dimensional Imaging Improves Accuracy in Clip Sizing During Thoracoscopic Left Atrial Appendage Exclusion.

The AtriClip is an epicardially applied occlusion device for the left atrial appendage. Accurate sizing and placement of the device is essential to its success. We describe the use of 3-dimensional computed tomography imaging to aid in accurate sizing of the AtriClip device during thoracoscopic surgical ablation. This technique reduces the risk of improper sizing of the device and thus mitigates the risk of malpositioning and potential damage or compression to surrounding structures such as the circumflex coronary artery.

An improved method for gastric tube and anastomotic anvil placement during thoracoscopic and laparoscopic Ivor Lewis esophagectomy.

BACKGROUND: During esophagectomy for esophageal cancer, a gastric tube is necessary for the perioperative period. However, the gastric tube and anastomotic anvil placement is often extremely difficult and time consuming during surgery. METHODS: We used the traditional method or improved method to place the gastric tube and anastomotic anvil during thoracoscopic and laparoscopic Ivor Lewis esophagectomy. Thirty-seven patients were in the improved group: the gastric tube and anastomotic anvil were placed using the improved method; 35 patients were in the traditional group: the gastric tube and anastomotic anvil were placed using the traditional method. Retrospectively, we analyze the basic clinical characteristics, perioperative clinical features, and postoperative complications of the two groups of patients. RESULTS: The two groups were matched well for baseline characteristics. There was no significant difference between the two groups in blood loss, postoperative hospital stay, postoperative fasting time, drainage volume, and overall complications. But significant between-group differences were observed in time consuming and chest tube indwelling time (P < 0.05), both of which were significantly shorter in the improved group than in the traditional group. CONCLUSIONS: This improved method can reduce the difficulty of placing anastomotic anvil and gastric tube and prevent damage to the anastomosis during surgery.

Surgical Options to Tackle Coronary Artery Kinking in Thoracoscopic Left Atrial Appendage Clipping.

To close the left atrial appendage during thoracoscopic ablation of atrial fibrillation, the use of a clipping device has proven to be an elegant and efficacious technique. Although very rare, adequate ostial appendage clipping can provoke coronary artery kinking and thus lead to cardiac ischemia. We describe a minimally invasive surgical technique to deal with this potentially serious complication.

Development of an instrumented thoracoscopic surgical trainer for objective evaluation of esophageal atresia/tracheoesophageal fistula repair.

Operative repair of complex conditions such as esophageal atresia and tracheoesophageal fistula (EA/TEF) is technically demanding, but few training opportunities exist outside the operating theater for surgeons to attain these skills. Learning them during surgery on actual neonates where the stakes are high, margins for error narrow, and where outcomes are influenced by technical expertise, is problematic. There is an increasing demand for high-fidelity simulation that can objectively measure performance. We developed such a simulator to measure force and motion reliably, allowing quantitative feedback of technical skill. A 3D-printed simulator for thoracoscopic repair of EA/TEF was instrumented with motion and force tracking components. A 3D mouse, inertial measurement unit (IMU), and optical sensor that captured force and motion data in four degrees of freedom (DOF) were calibrated and verified for accuracy. The 3D mouse had low average relative errors of 2.81%, 3.15%, and 6.15% for 0 mm, 10 mm offset in Y, and 10 mm offset in X, respectively. This increased to - 23.5% at an offset of 42 mm. The optical sensors and IMU displayed high precision and accuracy with low SDs and average relative errors, respectively. These parameters can be a useful measurement of performance for thoracoscopic EA/TEF simulation prior to surgery. Graphical abstract Inclusion of sensors into a high-fidelity simulator design can produce quantitative feedback which can be used to objectively asses performance of a technically difficult procedure. As a result, more surgical training can be done prior to operating on actual patients in the operating theater.

Thoracoscopic Surgery for Congenital Lung Malformation Using Miniaturized 3-mm Vessel Sealing and 5-mm Stapling Devices: Single-Center Experience.

Aim: To evaluate the outcomes of thoracoscopic resection of congenital lung malformations (CLM) by using JustRight® (Bolder Surgical) 3-mm vessel sealing system and 5-mm stapler. Methods: Patients who underwent thoracoscopic resection of CLM in our Center from January 2016 to July 2019 were selected and divided into two groups: G1 (2018-2019), treated with the new JustRight instruments, and G2 (2016-2017), treated with Ligasure® and Hem-o-lok. Surgical outcomes in term of length of surgery and complications were compared between groups, stratifying the groups for type of resection (lobectomy, extralobar sequestration [ES] resection, and bronchogenic cyst [BC] resection). Results: Thirteen patients were included in G1, and 16 patients were included in G2. Seven lobectomies, 5 ES resections, and 1 BC resection were performed in G1; whereas 12 lobectomies, 3 ES resections, and 1 BC resection were performed in G2. Mean age at the time of surgery was 7.8 ± 6 months (G1) and 6.8 ± 3.3 months (G2) (P = .57). The average length of surgery was shorter for G1 (lobectomies: 120.7 ± 28.2 versus 171.7 ± 37.5, P = .006; ES resection: 63 ± 21.4 versus 91.7 ± 29.3, P = .15; BC 40 minutes versus 100 minutes). No significant difference was found for length of stay (4 ± 1 days versus 5 ± 2 days, P = .18). Neither the need for conversion nor major complications were observed in either group. Conclusion: In our experience, thoracoscopic resections of CLM with the new JustRight instruments were revealed to be safe and effective. On account of having adequate dimensions for small cavities, these instruments can facilitate the procedure and help to reduce the length of surgery.

Rigid Mini-Thoracoscopy Versus Semirigid Thoracoscopy in Undiagnosed Exudative Pleural Effusion: The MINT Randomized Controlled Trial.

BACKGROUND: There is debate regarding the ideal instrument for medical thoracoscopy. The authors compared rigid mini-thoracoscopy with semirigid thoracoscopy for thoracoscopic pleural biopsy. METHODS: Consecutive subjects with undiagnosed exudative pleural effusion were randomized (1:1 ratio) to mini-thoracoscopy or semirigid thoracoscopy groups. The primary objective was a comparison of the diagnostic yield of pleural biopsy. Key secondary outcomes were the comparison of sedative/analgesic dose, operator-rated and patient-rated pain on visual analog scale (VAS), operator-rated overall procedural satisfaction (VAS), pleural biopsy size, and complications between the groups. RESULTS: Of the 88 screened subjects, 73 were randomized: 36 to mini-thoracoscopy and 37 to semirigid thoracoscopy. Diagnostic yield of pleural biopsy in the mini-thoracoscopy (69.4%) and semirigid thoracoscopy groups (81.1%) was similar on intention-to-treat analysis (P=0.25). Although the operator-rated overall procedure satisfaction scores were similar between groups (P=0.87), operator-rated pain [VAS (mean±SD), 43.5±16.7 vs. 31.7±15.8; P<0.001] and patient-rated pain (VAS, 41.9±17.3 vs. 32.1±16.5; P=0.02) scores were greater in the mini-thoracoscopy group. Mean dose of fentanyl and midazolam received was similar between the 2 groups (P=0.28 and 0.68, respectively). Biopsy size was larger in the mini-thoracoscopy group (16.1±4.5 vs. 8.3±2.9 mm; P<0.001). Three minor complications occurred in the mini-thoracoscopy group and 6 in the semirigid thoracoscopy group (P=0.11). There were no serious adverse events or procedure-related mortality. CONCLUSION: Diagnostic yield of rigid mini-thoracoscopy is not superior to semirigid thoracoscopy. Use of semirigid thoracoscope may provide greater patient comfort.

Innovative fully robotic 4-arm Ivor Lewis esophagectomy for esophageal cancer (RAMIE4).

Nowadays robotic surgery is established for abdominal and thoracic surgery. It has been shown that complex procedures are feasible using robotic systems, e.g., da Vinci Xi, with a huge benefit in precision. Different techniques for esophageal cancer surgery are reported; however, only a few robotic and partial robotic procedures are described. Therefore, a fully robotic (abdominal and thoracic) Ivor Lewis esophageal resection using four robotic arms-RAMIE4-the standard technique used for lower esophageal cancer, is presented in this paper. The technique shown in the video was performed successfully in 100 cases in 24 months. The reconstruction is performed with a gastric conduit pull-up and intrathoracic manually inserted 28-mm circular end-to-side stapled anastomosis. This video demonstrates the feasibility of RAMIE4 in the abdomen and thorax and reveals advantages of the robotic assistance.

[Uni-port totally thoracoscopic surgery in tricuspid insufficiency patients after previous left-sided valve surgery].

Objective: To examine minimally invasive tricuspid valve operations applied in tricuspid valve insufficiency patients with previous left-sided valve surgery. Methods: Between September 2017 and June 2019, thirty-six consecutive patients received minimally invasive totally thoracoscopic tricuspid surgery through right thoracotomy at Department of Cardiovascular Surgery, Fisrt Medical Center, People's Liberation Army General Hospital. There were 13 males and 23 females, aging (56±11) years (range: 43 to 79 years). All the patients had isolated significant tricuspid regurgitation after previous left-sided cardiac surgeries. A right anterolateral thoracotomy incision about 4 cm was made from the fourth intercostal space as main operating port. The arterial cannula was placed in femoral artery. The venous cannula was placed in femoral vein using Seldingger technique. Tricuspid valve operation was performed on beating heart by assist of vena vacuum. Results: Tricuspid valve repair was performed in 7 patients. Tricuspid valve replacement with bioprosthesis was performed in 29 patients. The operation time was (2.9±0.3) hours (range:2.5 to 3.6 hours). There was no conversion to sternotomy during operation. There was no severe complications during operation period. There were no complications related to this cannulation technique. The time of cardiopulmonary bypass establishment was (22±5) minutes (range: 12 to 24 minutes) and pump time was (82±16) minutes (range: 62 to 93 minutes). The length of hospital stay was (9±3) days after operation (range: 5 to 13 days). There was no early death in hospital. All patients were followed up for 3 to 22 months. No patient died. Conclusions: One single port-based minimally invasive approach seems to be safe, feasible, and reproducible in case of redo tricuspid valve operations. Only cannulation of inferior vena cava significantly simplified the complexity of isolated redo tricuspid surgery.

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Prospective US FDA IDE Pilot Study of Titanium Clip-Screw Implant at Two to Five Years.

STUDY DESIGN: Prospective longitudinal study of growth modulation system for early adolescent idiopathic scoliosis (AIS), consecutive case series from first human use to skeletal maturity, fusion, or five years postoperation. OBJECTIVES: Determine adverse events and curvature changes to end of study; examine factors most likely to explain variability in curve changes. SUMMARY OF BACKGROUND: Pilot clinical safety study was performed under US Food and Drug Administration (FDA) Investigational Device Exemption (IDE). Safety and radiographic results were previously reported to 24 months postoperation. METHODS: Subjects with early AIS underwent thoracoscopic placement of titanium clip-screw devices designed to modify growth asymmetrically. Eligibility was based on high risk of progression to 50°: single major thoracic curve 25°-40°, Risser 0, open triradiate cartilages, and premenarchal if female. Six subjects, the maximum allowed, enrolled. Adverse events (AEs), clinical outcomes, and curvatures were systematically collected. Disc heights, vertebral heights, and implant-bone contact areas were assessed. RESULTS: Consecutive subjects enrolled, aged 12.1 years (±1.7), three were female. AEs from two to five years postoperation included deformity changes leading to a second surgery in three patients: two for posterior spinal fusion, and one for thoracoscopic removal of half the implants for overcorrection. In the latter case, overcorrection appeared halted for duration of study. One patient, whose curve exceeded 50° at age 18 years, did not choose fusion. Major thoracic curves were 34° (±3°) preoperatively and 42° (±20°) at end of study. CONCLUSIONS: In a study of spine growth modulation in patients with early AIS with high risk of progression, at skeletal maturity or five years postoperation, major thoracic curves of half progressed to >50°, whereas curves of the other half remained <40°, below fusion indications. Removal of selected implants may halt overcorrection. The next, pivotal, study phase was approved by FDA. LEVEL OF EVIDENCE: Level IV, prospective case series under stringent regulatory controls.