Bone Marrow Function After (131)I Therapy in Patients With Differentiated Thyroid Carcinoma.

OBJECTIVE: The primary objective was to evaluate the short- and long-term toxic effects of radioiodine ((131)I) therapy on bone marrow function in differentiated thyroid carcinoma (DTC) patients. The secondary objective was to define characteristics of patients at risk for impaired bone marrow function after (131)I treatment. PATIENTS AND METHODS: DTC patients treated with (131)I between 1989 and 2013 were included. We excluded patients with morbidities or treatments that could have influenced blood count parameters. Baseline platelets, leukocytes, and hemoglobin levels were compared with blood counts at 3 and 6 months and at 1 and 5 years after treatment. Logistic multivariate regression analyses were performed to determine patient characteristics associated with thrombocytopenia. RESULTS: We included 331 patients. Mean ± SD age was 47.5 ± 17.2 years, and 74.0% were female. Posttreatment platelets were significantly decreased at 6 months and 1 year, as compared with baseline. Leukocyte counts were also decreased at 3 and 6 months and at 1 year after treatment. No decreases in hemoglobin were found. Five years after treatment, platelet and leukocyte counts were comparable with baseline. Fourteen patients (4.2%) developed transient posttreatment thrombocytopenia. Risk factors for thrombocytopenia were older age, T4 tumor stage, male gender, and cumulative dose (131)I. After a multivariate regression analysis, the cumulative dose (131)I remained independently associated with thrombocytopenia. CONCLUSION: Posttreatment platelets and leukocytes were transiently decreased compared with pretreatment values in a general DTC population. Cumulative (131)I dose was independently associated with thrombocytopenia. Platelets and leukocytes normalized to baseline levels 5 years after treatment, implying that in most patients the clinical effects of bone marrow toxicity are limited.

The medial column Synthes Midfoot Fusion Bolt is associated with unacceptable rates of failure in corrective fusion for Charcot deformity: Results from a consecutive case series.

Charcot neuro-osteoarthropathy (CN) of the midfoot presents a major reconstructive challenge for the foot and ankle surgeon. The Synthes 6 mm Midfoot Fusion Bolt is both designed and recommended for patients who have a deformity of the medial column of the foot due to CN. We present the results from the first nine patients (ten feet) on which we attempted to perform fusion of the medial column using this bolt. Six feet had concurrent hindfoot fusion using a retrograde nail. Satisfactory correction of deformity of the medial column was achieved in all patients. The mean correction of calcaneal pitch was from 6° (-15° to +18°) pre-operatively to 16° (7° to 23°) post-operatively; the mean Meary angle from 26° (3° to 46°) to 1° (1° to 2°); and the mean talometatarsal angle on dorsoplantar radiographs from 27° (1° to 48°) to 1° (1° to 3°). However, in all but two feet, at least one joint failed to fuse. The bolt migrated in six feet, all of which showed progressive radiographic osteolysis, which was considered to indicate loosening. Four of these feet have undergone a revision procedure, with good radiological evidence of fusion. The medial column bolt provided satisfactory correction of the deformity but failed to provide adequate fixation for fusion in CN deformities in the foot. In its present form, we cannot recommend the routine use of this bolt.

Outcome of one-stage correction of deformities of the ankle and hindfoot and fusion in Charcot neuroarthropathy using a retrograde intramedullary hindfoot arthrodesis nail.

We report the outcomes of 20 patients (12 men, 8 women, 21 feet) with Charcot neuro-arthropathy who underwent correction of deformities of the ankle and hindfoot using retrograde intramedullary nail arthrodesis. The mean age of the patients was 62.6 years (46 to 83); their mean BMI was 32.7 (15 to 47) and their median American Society of Anaesthetists score was 3 (2 to 4). All presented with severe deformities and 15 had chronic ulceration. All were treated with reconstructive surgery and seven underwent simultaneous midfoot fusion using a bolt, locking plate or a combination of both. At a mean follow-up of 26 months (8 to 54), limb salvage was achieved in all patients and 12 patients (80%) with ulceration achieved healing and all but one patient regained independent mobilisation. There was failure of fixation with a broken nail requiring revision surgery in one patient. Migration of distal locking screws occurred only when standard screws had been used but not with hydroxyapatite-coated screws. The mean American Academy of Orthopaedic Surgeons Foot and Ankle (AAOS-FAO) score improved from 50.7 (17 to 88) to 65.2 (22 to 88), (p = 0.015). The mean Short Form (SF)-36 Health Survey Physical Component Score improved from 25.2 (16.4 to 42.8) to 29.8 (17.7 to 44.2), (p = 0.003) and the mean Euroqol EQ­5D­5L score improved from 0.63 (0.51 to 0.78) to 0.67 (0.57 to 0.84), (p = 0.012). Single-stage correction of deformity using an intramedullary hindfoot arthrodesis nail is a good form of treatment for patients with severe Charcot hindfoot deformity, ulceration and instability provided a multidisciplinary care plan is delivered.

Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy.

BACKGROUND: Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps. OBJECTIVES: The authors evaluate the safety and efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (Artiss; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy. METHODS: Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other. RESULTS: Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0 (11.3) mL from the SoC-only sides (P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration). CONCLUSIONS: Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence. LEVEL OF EVIDENCE: 2.

Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy.

BACKGROUND: Suction drains are commonly placed after rhytidectomy surgery to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by cross-linking with extracellular matrix proteins, which may reduce the dead space under skin flaps. OBJECTIVES: The authors evaluate the safety and preliminary efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (ARTISS; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, on tissue plane adherence and local hemostasis in rhytidectomy patients. METHODS: In this phase 2, prospective, controlled, randomized, evaluator- and patient-blinded, multicenter study, 45 patients (of 56 possible enrollees) received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr treatment on the other side. Outcomes measures included visual assessments of ecchymosis (by blinded reviewers), grading of ecchymosis and edema, drainage volumes, occurrence of hematoma/seroma, safety evaluations, and patient-reported assessments of pain, numbness, and treatment preferences postoperatively. RESULTS: Mean patient age was 55.1 years. Rates and grades of ecchymosis and edema were similar for the 2 treatments. The mean (SD) drainage volume 24 hours after surgery was 11.5 (13.7) mL from the FS VH S/D 4 s-apr-treated sides of the face and 26.8 (24.0) mL from the SoC-only sides (P < .0001). Patient assessments of pain, numbness, and preference favored treatment with FS VH S/D 4 s-apr. Adverse events were mild to moderate in severity. CONCLUSIONS: Adjuvant use of FS VH S/D 4 s-apr appears to be safe and results in lower drainage volumes than SoC treatment alone.

Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.

BACKGROUND: In March of 2012, the U.S. Food and Drug Administration approved Sientra's application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra's study through 5 years. METHODS: Sientra's study is an ongoing, 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's implants in patients undergoing augmentation and reconstruction. A total of 1788 subjects were implanted with 3506 implants, including 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction subjects. Physical evaluations and complications were recorded at each visit. Effectiveness was measured by postimplantation bra cup size and assessment of subject satisfaction and quality of life. Of the 1788 subjects, 571 underwent magnetic resonance imaging to assess silent rupture. Safety endpoints were analyzed using the Kaplan-Meier method. RESULTS: Across all cohorts, the risk of rupture was 1.8 percent (95 percent CI, 1.2 to 2.6 percent), the risk of capsular contracture (Baker grade III/IV) was 9.0 percent (95 percent CI, 7.6 to 10.6 percent), and the risk of reoperation was 23.8 percent (95 percent CI, 21.8 to 26.0 percent). Over 99 percent of surgeons reported satisfaction with the postoperative results, and subject satisfaction remained high 5 years after implantation. CONCLUSION: The 5-year results of Sientra's study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Use of dermal matrix to prevent capsular contracture in aesthetic breast surgery.

Capsular contracture remains a challenging complication of implant-based aesthetic breast surgery despite improvements in implant design. The lowering of capsular contracture rates noted with the past use of polyurethane foam-covered implants has increased awareness of the importance of the biologic response at the interface between the implant surface and breast tissue. Emerging evidence indicates that much like the polyurethane foam, acellular dermal matrices alter the biologic response at the surface interface, resulting in a more vascular and less constrictive pattern of collagen deposition. This study reports on the authors' clinical experience using Strattice Reconstructive Tissue Matrix (LifeCell Corporation, Branchburg, N.J.) for the treatment of capsular contracture in patients with established capsules and for prevention in patients undergoing primary augmentation or augmentation/mastopexy. Of 80 patients (154 breasts) in whom Strattice was used, clinically significant contracture (Baker grade III/IV) occurred in three breasts (3.75 percent), all of which were in the treatment of previous contracture group. In addition, the authors noted two seromas requiring implant removal (both patients developed capsules, as mentioned above) and two hematomas requiring revision, for an overall failure rate of 6.25 percent for Strattice-assisted surgery. The data confirm that the use of Strattice significantly lowers the incidence of capsular contracture in the first 3.5 years after implant placement.

A 15-year experience with primary breast augmentation.

BACKGROUND: This study evaluated patients who underwent primary breast surgery within a single group practice from 1994 to 2009. Reoperations were divided by reoperation reason into total reoperations and implant-specific reoperations. The authors hypothesized that the implant-specific reoperation rate will provide the most accurate measurement of complications caused by the breast implant device. METHODS: A total of 812 patients received the same brand of breast implant for primary breast augmentation or augmentation/mastopexy. Safety and efficacy data were recorded and complication rates were calculated. Statistics were applied using Kaplan-Meier estimated cumulative incidence calculations. RESULTS: This study included 482 patients with saline and 330 patients with silicone implants. The most common complications included capsular contracture, rippling, rupture, infection, and hematoma. A total of 8.2 percent of patients developed Baker grade III/IV capsular contracture by 6 years. The raw incidence of rippling was 7.1 percent, and the rate was significantly increased in underweight patients with subglandular saline implants (p = 0.045). The rate of total reoperation at 1 year was 14.2 percent. While a significantly increased rate of total reoperation was seen for silicone compared with saline implants (p < 0.01), no difference was seen in the rate of implant-specific reoperation for saline compared to silicone implants (p = 0.582). CONCLUSIONS: The use of total reoperation rates as an indication of complications of breast implants can lead to both an overestimation of implant-related complications and the inaccurate conclusion that silicone implants result in higher complication rates than saline implants. The implant-specific reoperation rate may provide a more accurate incidence of implant complications than the total reoperation rate, which includes reoperations for factors unrelated to the implant.

A hypothesis and model of reduced fetal movement as a common pathogenetic mechanism in clubfoot.

BACKGROUND: Clubfoot or Talipes equinovarus is characterised by an adducted forefoot, hindfoot varus, and ankle equinus deformity, varying in severity and ease of correction. It is one of the most common congenital defects, with a prevalence of around 1 per 1000. Ambiguity still surrounds the classification and pathogenesis of clubfoot. METHODS: A literature search was performed using Pubmed, Ovid, and the Cochrane Databases, using search terms in isolation or combination: clubfoot, Talipes equinovarus, congenital foot deformities and joint development, identified articles were further hand searched and relevant references identified. CONCLUSION: We propose that the underlying unifying factor in all cases of clubfoot is a lack of fetal movement. Fetal movement is a key developmental signal in the development of joints, and we suggest that this applies to the morphogenesis of the forefoot. Theories exist to explain specific individual features of clubfoot in certain cases and to explain experimental studies, however no common final pathway has been described. We believe that our hypothesis brings together key elements of these and will simplify understanding and classification of clubfoot.

Decreasing complications in lower lid and midface rejuvenation: the importance of orbital morphology, horizontal lower lid laxity, history of previous surgery, and minimizing trauma to the orbital septum: a critical review of 269 consecutive cases.

BACKGROUND: Minimizing complications following surgical rejuvenation of the lower lid and midface continues to challenge plastic surgeons. The evolution of refinements of the authors' technique designed to identify high-risk patients and minimize morbidity is described. METHODS: The records of 269 patients having consecutive transorbital, endoscope-assisted lower lid and midface rejuvenation were reviewed and complications identified. High-risk patients were defined based on orbital morphology, degree of horizontal lower lid laxity, and history of previous lower lid or midface surgery. RESULTS: The authors found that patients with enophthalmic orbits and significant horizontal lower lid laxity were at increased risk of postoperative lower lid malposition. They found that identifying these patients preoperatively, combined with intraoperative correction of laxity when indicated, minimized the risk. They also confirmed that patients with a previous history of lower lid manipulation were at increased risk. CONCLUSIONS: Minimizing trauma to the orbital septum of the lower lid and correction of horizontal lower lid laxity when present are effective techniques in lowering the risk of postoperative lower lid complications. Trauma is minimized by eliminating dissection in the plane between the orbicularis muscle and orbital septum. The passive septal tightening that occurs with this technique combined with fat micrographs to the tear trough and over the inferior orbital rim has rendered more traumatic open surgical manipulation of the septum or postseptal fat almost universally unnecessary.

Use of porcine acellular dermal matrix (Enduragen) grafts in eyelids: a review of 69 patients and 129 eyelids.

BACKGROUND: Spacer grafts in the eyelid are used in both reconstructive and aesthetic procedures. The authors report their experience using a new acellular porcine dermal graft (Enduragen) in 129 eyelids. METHODS: A retrospective chart review was performed that included every case in which Enduragen was used by the two primary authors in the upper or lower eyelid. Patient demographics, type of procedure performed, and complications were reviewed. RESULTS: Sixty-nine patients and a total of 129 eyelids were included in the study. Eight procedures were spacers in the upper lid, 104 were for spacers in the lower lid, and 17 were for lateral canthal reinforcement. Twenty-two procedures were in primary cases and 47 were in eyelids for secondary reconstructions, for a total of 69 patients. There were 13 eyelid complications, for a complication rate of 10 percent. Nine cases required surgical revision, and there were four cases of infection, all of which were successfully treated with oral and topical antibiotics. CONCLUSIONS: Enduragen has proved to be a very satisfactory substitute for ear cartilage and fascia in eyelid surgery in both reconstructive and primary eyelid cases. It seems to be far superior to other commercially available tissue substitutes because of its predictability of structure and robust behavior. All problems that were encountered in this series seemed to be related more to technical errors than to any deficiency in or reaction to the Enduragen. The increased strength, rigidity, and durability give support to the lids comparable to that obtained with autogenous ear cartilage and fascia.

Single-stage muscle flap reconstruction of the postpneumonectomy empyema space: the Emory experience.

BACKGROUND: Postsurgical chronic empyema continues to present a complicated treatment scenario for thoracic and reconstructive surgeons. Muscle flaps are an important option in the management of complex thoracic wounds. This study was designed to report the Emory experience with muscle flaps for the management of complex postsurgical empyema. The authors also present their treatment algorithm for managing empyema thoracis. METHODS: The authors retrospectively reviewed the charts of 55 patients requiring different treatment modalities, including muscle flap transposition. Patients were divided into four groups according to the initial thoracic procedure: group A, no surgical resection; group B, postpneumonectomy; group C, postlobectomy; and group D, prophylactic postpneumonectomy or postlobectomy. The study included 42 men (76.4 percent) and 13 women with a mean age of 62 years (range, 39 to 77 years). RESULTS: Fifty-one muscle flap procedures were performed in 42 patients (serratus anterior flaps, 16 patients and 23 flaps; latissimus dorsi flaps, 16 patients and 18 flaps; pectoralis major muscle flaps, intercostal muscle flaps, and rectus abdominis flaps, three patients each: omental flap, one patient). The mean number of ribs resected before flap intervention, usually during the open window thoracostomy, was three. The average time from initial thoracic operation to flap intervention was 4 months. Average time from flap intervention to discharge was 12.5 days. Average hospital stay was 26.6 days. The 51 muscle flaps represented an average of 1.2 procedures per patient. CONCLUSION: Because of the excellent blood supply of extrathoracic muscle flaps and their ability to reach any place in the pleural cavity, they represent an ideal tissue with which to fill the contaminated pleural space.

Cardiac luxation to facilitate off-pump bilateral lung transplantation.

To facilitate access to the left hilum during off-pump bilateral lung transplantation we used the Xpose 4 apical suction device (Guidant Corp., Indianapolis, IN), an off-pump coronary bypass device to luxate the heart out of the pericardium. The effects on circulation and possible myocardial injury were studied in retrospect. We found the device to provide us with an elegant and nondamaging method to visualize the left hilum.

The role of muscle flaps in wound salvage after vascular graft infections: the Emory experience.

BACKGROUND: The incidence of prosthetic graft infection is 1 to 6 percent, and the mortality rate of infected aortoiliac or aortofemoral bypass is 25 to 75 percent. The goal of this study was to report the use of muscle flaps in the management of patients presenting with infected vascular grafts. METHODS: A total of 22 patients required 26 muscle flaps to cover 24 infected vascular grafts. Muscle flaps were used for local wound control in all patients regardless of the fate of the graft. The vascular surgeons elected for graft salvage in eight of the 24 grafts. All of the muscle flaps survived. RESULTS: The average time interval between the bypass and infection was 371 days. One-month follow-up revealed an 88 percent salvage rate, but this decreased to 50 percent during the mean follow-up of 23 months. None of the patients originally managed with a salvaged graft lost a limb, and overall, 14 of 22 limbs in this series remained viable (64.0 percent). The mortality rate during the index hospitalization was 9 percent. In this series, suprainguinal grafts had a higher mortality rate. In addition, infection occurring more than 1 month postoperatively, culture-positive Pseudomonas and methicillin-resistant species, and exposure of the arterial-graft anastomosis were poor prognostic indicators of graft preservation. CONCLUSIONS: Management of infected vascular grafts remains a challenging problem. Muscle flap coverage should have a high priority, as the chance of a good outcome is highly favorable in early infections.

The association between metal ions from hip resurfacing and reduced T-cell counts.

We have studied the relationship between metal ion levels and lymphocyte counts in patients with metal-on-metal hip resurfacings. Peripheral blood samples were analysed for lymphocyte subtypes and whole blood cobalt and chromium ion levels in 68 patients (34 with metal-on-metal hip resurfacings and 34 with standard metal-on-polyethylene total hip replacements). All hip components were radiologically well-fixed and the patients were asymptomatic. Cobalt and chromium levels were significantly elevated in the patients with metal-on-metal hip resurfacings, compared with the patients with standard metal-on-polyethylene designs (p < 0.0001). There was a statistically significant decrease in the level of CD8(+) cells (T-cytotoxic/suppressor) (p = 0.005) in the metal-on-metal hip resurfacing group. A threshold level of blood cobalt and chromium ions was associated with reduced CD8(+) T-cell counts. We have no evidence that our patients suffered as a result of this reduced level of CD8(+) T-cells.

Managing postseptal fat in periorbital rejuvenation: anatomic intraorbital replacement using passive septal tightening.

The authors provide their perspective on managing postseptal fat in lower lid and midface rejuvenation. Using the concept of "passive septal tightening," the technique corrects "apparent" lower lid fat excess by restoring the fat to a more youthful intraorbital position. The potential surgical trauma in the critical plane between the orbicularis oculi and septum is avoided, minimizing the risk of middle lamella scarring and postoperative lower lid malposition.