Mediterranean diet and psychological well-being intervention to reverse metabolic syndrome in Chile (CHILEMED trial).

Psychosocial status and lifestyle are key risk factors of non-communicable diseases (NCDs), which, in turn, are main drivers of healthcare costs and morbimortality worldwide, including Chile. Mediterranean diet (MedDiet) is one of the healthiest dietary patterns under study. However, its impact on high-risk conditions, such as metabolic syndrome (MetS), and NCDs outside the Mediterranean Basin remains mostly unexplored. Even though Central Chile has an environment, food production, and culinary traditions comparable to those present in Mediterranean countries, few studies -some with significant methodological limitations- have evaluated the effect of MedDiet on health and/or disease in Chilean subjects. Importantly, a Mediterranean lifestyle is a modus vivendi that integrates physical health with mental and social well-being. Psychological well-being (PWB) is associated with healthy behaviors, positive health outcomes, and longevity, thereby emerging as a novel healthcare goal. We report here an ongoing randomized controlled clinical trial in Chilean patients with MetS seeking to test whether (1) a PWB theory-based intervention facilitates induction to and increases long-term adherence to a locally adapted MedDiet, and (2) a MedDiet intervention -implemented alone or combined with well-being promotion- is more effective at reversing MetS compared to individuals following a low-fat diet without psychological support. The CHILEan MEDiterranean (CHILEMED) diet intervention study is a 1-year trial including patients with MetS living in Chile. Participants will be assigned randomly by a computer-generated random number sequence to one of the three intervention arms: a) low-fat diet as control group, b) MedDiet alone, and c) MedDiet plus well-being support. Patients will be followed-up by individual and/or group online nutritional sessions or phone cal as well as 6- and 12-month in-person re-assessment of medical history, medication use, food intake, PWB, anthropometrics/physical exam, and blood collection for laboratory analysis. The primary outcome of the trial will be the effect of the MedDiet -with or without PWB intervention- on overall reversal of MetS compared to low-fat diet alone. Based on a statistical superiority trial, expected impact, and patient loss, the estimated study sample is 339 subjects (113 individuals per arm in 3 equal-sized groups). Currently, we have enrolled 179 patients, predominantly women, evenly distributed by age (group means ranging from 45.7 to 48,9 years-old), 3/4 are obese with almost all of them showing abdominal obesity, 70% are hypertensive, whereas <10% exhibit diabetes. If findings turn out as expected (e.g., MedDiet -with or without PWB intervention- is better than the low-fat diet for reversion of MetS at 1-year follow-up), CHILEMED will provide further beneficial evidence of the MedDiet on NCD risk conditions beyond the Mediterranean region.

Mesenchymal Stem Cells for the Compassionate Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID 19.

Mesenchymal stem cells (MSC) have received particular attention due to their ability to inhibit inflammation caused by cytokine storm induced by COVID-19. In this way some patients have been treated successfully. The aim of this study was to evaluate the safety and describe the clinical changes after IV administration of allogeneic human umbilical cord MSC (ahUCMSC), in patients with bilateral pneumonia caused by COVID-19, complicated with severe ARDS, as compassionate treatment. This was a pilot, open-label, prospective, longitudinal study. Five patients that did not improve in their clinical conditions after 48 hours of receiving the standard medical management used by the Medical Center and with persistent PaO2/FiO2 less than 100 mmHg were enrolled. ahUCMSC were infused IV, at dose of 1x106 per Kg of body weight over 15 minutes. Patients were monitored after the infusion to detect adverse event. Pa02/FiO2, vital signs, D-dimer, C reactive protein and total lymphocytes were monitored for 21 days after the infusion or until the patient was discharged from the hospital. Descriptive statistics were used with means or medians and standard deviation or interquartile range according to the type of variable. The Wilcoxon's rank-sum was used for stationary samples. Adverse events occurred in three patients and were easily and quickly controlled. Immediately after the infusion of ahUCMSC, constant rise of PaO2/FiO2 was observed in all patients during the first 7 days, with statistical significance. Three patients survived and were extubated on the ninth day post-infusion. Two patients died at 13 and 15 days after infusion. The infusion of ahUCMSC in patients with severe ARDS caused by COVID-19, was safe, and demonstrated its anti-inflammatory capacity in the lungs, by improving the respiratory function expressed by PaO2 / FiO2, which allowed the survival of 3 patients, with extubation at 9 days.

Bilateral Proximal Forearm Transplantation: Case Report at 7 Years.

BACKGROUND: Although return of function has been reported in patients undergoing proximal forearm transplantations (PFTs), reports of long-term function are limited. In this study, we evaluated the clinical progress and function 7 years postoperatively in a patient who underwent bilateral PFT. CASE PRESENTATION: A 58-year-old man underwent bilateral PFT in May 2012. Transplantation involved all of the flexor and extensor muscles of the forearm. Neurorrhaphies of the median, ulnar, and radial nerves were epineural and 7 cm proximal to the elbow. Immunosuppressive maintenance medications during the first 3 years postoperatively were tacrolimus, mycophenolate, and steroids, and later, tacrolimus, sirolimus, and steroids. Forearm function was evaluated annually using the Disabilities of the Arm, Shoulder, and Hand; Carroll; Hand Transplantation Score System; Short Form-36; and Kapandji scales. We also evaluated his grip and pinch force. RESULTS: Postoperatively, the patient developed hypertriglyceridemia and systemic hypertension. He experienced 6 acute rejections, and none were resistant to steroids. Motor function findings in his right/left hand were: grip strength: 10/13 kg; key pinch: 3/3 kg; Kapandji score: 6/9 of 10; Carroll score: 66/80; Hand Transplantation Score System score: 90/94. His preoperative Disabilities of the Arm, Shoulder, and Hand score was 50 versus 18, postoperatively; his Short Form-36 score was 90. This function improved in relation with the function reported in the second year. CONCLUSIONS: Seven years following PFT, the patient gained limb strength with a functional elbow and wrist, although with diminished digital dexterity and sensation. Based on data presented by other programs and our own experience, PFT is indicated for select patients.

Absence of an Additional Metabolic Effect of Body Contour Surgery in Patients With Massive Weight Loss After Laparoscopic Roux-En-Y Gastric Bypass.

INTRODUCTION: Body contour surgery (BCS) is a combination of soft tissue resections that have proven to be an effective treatment for the aesthetic and functional problems related to massive weight loss (MWL). There are no studies analyzing the metabolic effect of large volume adipose tissue flap resection in patients with MWL after bariatric surgery. METHODS: This study was a retrospective review of adults who underwent BCS after gastric bypass. Preoperative clinical and laboratory data were compared with 1- and 2-year postoperative follow-up. RESULTS: A total of 62 patients with a mean age of 41 years were analyzed. Seventy-nine percent of them were women. Most procedures included abdominal flap resection alone or in combination with other areas. Mean resected tissue weight was 6.2 kg. We found that weight and body mass index (BMI) were lower 1 year after BCS (P < 0.05), but this was not maintained after 2 years. There were no differences for systolic or diastolic blood pressure, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, or fasting glucose after 1 and 2 years of the BCS. A subgroup analysis showed that the transient weight and BMI improvement was only apparent 1 year after BCS in those patients with flap resections more than 8 kg. CONCLUSIONS: There are no differences in blood pressure, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, or fasting glucose 1 and 2 years after BCS in patients who experienced MWL after gastric bypass. Although weight and BMI were transiently lower in those patients with tissue flap resections more than 8 kg, this effect disappeared after 2 years.

Digital Joint Reconstruction with Osteotendinous Joint Allograft: Experimental Study in Rats.

BACKGROUND: Fresh or frozen nonvascularized osteotendinous joint allografts (OTJA) have not been used previously, clinically or experimentally, for metacarpophalangeal joint reconstruction. Therefore, we evaluated the viability of OTJA for metatarsophalangeal joint (MTJ) reconstruction in rats. METHODS: In the experimental group of 12 Lewis rats, we reconstructed the MTJ of the third digit of the hindlimb with a fresh, nonvascularized OTJA obtained from the same digit from 12 donor rats. In the control group of 6 Lewis rats, an autologous composite osteotendinous graft of the MTJ of the same digit was obtained and repositioned in situ as an auto-transplant. Weight, pain, edema, dehiscence, and wound infection were evaluated every 24 hours for 30 days postoperatively. At the end of 30 days, we evaluated digit position, flexion and extension, passive mobility, radiological bone healing, and histological grades of rejection. RESULTS: We found no statistically different changes in weight, edema, pain, digit position, or radiological bone healing in either group. No wound dehiscence or infection was seen in any of the rats. Ten degrees of flexion and extension mobility were lost in the control group; the experimental group lost up to 30 degrees (P = 0.009). Histologically, 9 of the experimental group rats (9/12, 75%) showed rejection reactions compared with none of the controls (0%) (P = 0.009). CONCLUSIONS: Fresh nonvascularized OTJA caused an immune reaction without exposure of the graft, but with bone resorption. However, the rats maintained digital form and alignment with decreased passive flexion and extension of 10-30 degrees.

Bilateral Forearm Transplantation in Mexico: 2-Year Outcomes.

BACKGROUND: Patients with proximal forearm and arm transplantation have obtained and/or maintained function of the elbow joint and full active range of motion of the extrinsic muscles of the hand, but with diminished protective sensibility and a lack of good function of the intrinsic muscles. These patients have improved function, as measured by the Disabilities of the Arm, Shoulder and Hand questionnaire. METHODS: We report the case of a 52-year-old man who suffered a high-voltage electrical burn requiring amputation of his upper limbs. He underwent bilateral proximal forearm transplantation in Mexico City in May 2012. RESULTS: At 2-year follow-up, immunosuppressive treatment has not led to metabolic, oncologic, or infectious complications. Keloid scars developed at the graft-recipient interface. There have been 4 acute rejections: the fourth was treated with methylprednisolone, rituximab, and immunoglobulin. Chronic rejection has not been detected. The extrinsic muscles of the wrist and digits have good function. Although the intrinsic muscles demonstrated electrical activity 15 months postoperatively, clinically, they are nonuseful. After 2 years, hand function is sufficient to allow the patient to grasp lightweight and medium-sized objects. The patient's Disabilities of the Arm, Shoulder and Hand questionnaire score improved from 50.00 points to 30.83 points, and his Hand Transplantation Score System rating is good, at 69/73 (right/left) of 100. The patient and his family are very satisfied with the functional and aesthetic outcomes. CONCLUSIONS: Upper arm or proximal forearm transplantation is a reconstructive option for patients who have experienced amputation because of trauma.

Digital Reconstruction with a Nonfrozen Osteotendinous Allograft, Nerve Allografts, and Autogenous Radial Free Flap.

A 21-year-old man underwent amputation of his second to fifth fingers at the proximal phalanx level on the right hand. The third and fourth fingers were reconstructed with 2 toe-to-hand free transfers. The fifth digit was reconstructed with a nonfrozen osteotendinous allograft, nerve allografts, and autogenous radial free flap without immunosuppression. The patient was lost to follow-up for 19 years. He received no rehabilitation. He reported that he had experienced no adverse reactions to the materials or the graft, or infection, or fractures. No additional surgical procedures were performed. Today, the digit is functional and has acceptable aesthetic appearance. This outcome is similar to those obtained in digits reconstructed with frozen osteotendinous allografts and autologous cutaneous covers and opens the possibility for future research.

Soft tissue reconstruction with omental free flap in complex upper extremity injuries: report of 13 cases.

Although there is a wide list of free flaps options for soft tissue reconstruction of complex upper extremity injuries, the omental flap has some useful anatomical and biochemical advantages. We report 13 patients who underwent hand or upper extremity reconstruction with omental free flaps. Nine patients had extensive tissue damage, resulting with digital cyanosis and hypothermia, and some of them with areas of cutaneous necrosis, or avulsed tissues with tendons and bones exposed or infected. The remaining four patients had minor extensive tissue damage without circulatory problems. Patient's average age was 34.6 years. Twelve flaps were harvested through laparotomy and one laparoscopically. All flaps were covered with a skin graft. None of the flaps were lost. The average follow-up time was 20 months. There was one major and two minor donor site complications. One patient had minor loss of the skin graft in the recipient site, and two required minor additional surgeries to improve the appearance or function of the hand or upper extremity. There were no late abdominal complications in any patient. The morphological appearance and functional results were favorable in 11 of them, and permitted their reincorporation into society without the need for additional complex surgeries. Only two patients had a poor outcome. Our experience confirms that the omental flap may be a good option for reconstruction of some complex hand and upper extremity injuries.

Revascularization of Arterialized Venous Flaps through a Total Retrograde Reverse Blood Flow: Randomized Experimental Trial of Viability.

BACKGROUND: Arterialized venous flaps (AVFs) have been used for reconstruction of soft tissue defects throughout the body. Several different revascularization models have been performed, but venous drainage through the arterial system has not been studied. In our total retrograde reverse blood flow (TRRBF) perfusion model, the arterial blood flow enters through the venous system and venous drainage exits through the arterial system. METHODS: We developed a novel experimental model in rabbit ears to evaluate the capacity of TRRBF perfusion pattern to allow AVF viability. The ears were assigned to 3 groups: group 1, total devascularization without revascularization (n = 3); group 2, TRRBF (n = 12); and group 3, conventional AVF (n = 12). The ears were observed during a 30-day follow-up period, and clinical serial assessment of edema, cyanosis, and necrosis was performed. Tissue oxygenation was determined at the beginning and end of the follow-up. Histological analysis was performed. RESULTS: Necrosis was found in 3/3 (100%) ears in group 1, 3/12 (25%) in group 2, and 0/12 (0%) in group 3 (95% CI, 0.505-0.994; P = 0.0001). In group 2, edema was higher (5/12, 41.66%) than in group 3 (0/12, 0%) (95% CI, 0.0135-0.65; P = 0.041). Cyanosis and venous congestion was of greater intensity and duration in group 2 than in group 3 (10.33 ± 4.51 vs 4.5 ± 2.06 d). CONCLUSIONS: Although evolution is torpid and prolonged in ears with TRRBF, 9/12 (75%) survived, suggesting that TRRBF can be used as a rescue method.

Demographic factors, outcomes, and complications in abdominal contouring surgery after massive weight loss in a developing country.

Few reports about body contouring surgery after massive weight loss (MWL) have been produced in the developing countries. As Mexico is considered a developing country, we performed a retrospective analysis of medical records of patients who underwent this type of surgery to evaluate their demographic characteristics as well as their outcomes and complications. Results from 684 patients with MWL, 69 (10%) had abdominoplasty; the type of abdominoplasty influenced the operative time, bleeding, and complications (P < 0.05); the body mass index influenced the weight of resected tissue (P < 0.000) and hospital stay (P < 0.020), but did not affect the type of abdominoplasty performed, surgical time, complications, reoperation, or transfusion rates. In contrast with the developed countries, in these procedures, operating time was higher and the patients had more surgical bleeding with higher rates of transfusion and a longer hospital stay, but with the same clinical results and percentage of complications.

An anthropometric classification of body contour deformities after massive weight loss.

Deformities caused by massive weight loss were originally subsidized at the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán." This caused great economical losses, which led to the development of a classification to select patients with functional problems secondary to massive weight loss. The parameter used is the size of the pannus in relation to fixed anatomic structures within the following anatomic regions: abdomen, arms, thighs, mammary glands, lateral thoracic area, back, lumbar region, gluteal region, sacrum, and mons pubis. Grade 3 deformities are candidates for body contouring surgery because they constitute a functional problem. Grade 2 deformities reevaluated whether the patient has comorbidities. Lesser grades are considered aesthetic procedures and are not candidates for surgical rehabilitation at the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán." This classification allowed an improvement in communication between the different surgical-medical specialties; therefore, we suggest its application not only for surgical-administrative reasons but also for academic purposes.

Arterialized venous free flap for reconstruction of burned face.

In this study, a forearm arterialized venous free flap (23 cm x 14 cm) was used in a 25-year-old male with facial burns sequels to reconstruct both cheeks, chin, lips, nose, columnella, nasal tip, and nostrils. It was arterialized by the facial artery to an afferent vein anastomosis. The venous flow was drained by four efferent vein to vein anastomoses. Although it developed small inferior marginal necrosis in the lower lip, the rest of the flap survived with good quality of the skin in both texture and color, with self-delimitation of the different esthetics units of the center of the face such as the nasogenian folds, nostrils, and upper lip filtrum, without the need of additional thinning surgical procedures. From all of the above, the arterialized venous free flap is an alternative reconstructive option for the treatment of burn sequels especially those that include the centrofacial region.