First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.

BACKGROUND: To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery. METHODS: Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed. CONCLUSIONS: MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA.

Totally endoscopic micro-invasive aortic valve replacement.

Micro-invasive totally endoscopic aortic valve replacement surgery is a minimally invasive cardiac procedure that can be performed with the help of several techniques and technologies that employ the latest innovations in instrumentation and technological advances in the field, thereby greatly limiting the overall invasiveness of the procedure. With the help of a 3-dimensional camera, long instruments, a very small thoracotomy and a soft-tissue retractor without any rib retractor, the aortic valve can be easily and safely accessed for replacement. The other main features of these techniques are extracorporeal circulation that is achieved through peripheral percutaneous cannulation of the femoral vessels, antegrade cardioplegia, the use of automated devices for suturing the valvular ring and the prosthetic suture cuff, namely the RAM device, the Sew-Easy device and the Cor-Knot Mini device. Additionally, an automated vascular closure device such as the MANTA device is later used to close the femoral artery following decannulation.

Totally Endoscopic Replacement of the Ascending Aorta and the Aortic Root including the Aortic Valve via Right Mini-Thoracotomy: A Multicenter Study.

Background: Recently, minimally invasive access via right anterolateral mini-thoracotomy (RAMT) has been gaining popularity in cardiac surgery. This approach is also an option for surgeons performing aortic surgery. The aim of this study is to present our surgical method, highlighting the total endoscopic minimally invasive approach via RAMT for replacement of the ascending aorta (AAR) with or without involvement of the aortic root and the aortic valve. Methods: Clinical data of 44 patients from three participating institutions with AAR with or without involvement of the aortic valve or aortic root via RAMT between April 2017 and February 2024 were retrospectively analyzed. According to surgical procedure, patients were divided into two groups, in the AAR and in the Wheat/Bentall group with concomitant valve or root replacement. Operative time, length of ventilation, perioperative outcome, length of intensive care unit (ICU) as well as postoperative hospital stay, and mid- and long-term results were retrospectively analyzed. Results: Mean age was 61.4 ± 10.7 years old with a frequency of male gender of 63.6%. Mean cardiopulmonary bypass (CBP) time and aortic cross-clamping time was 94.9 ± 32.5 min and 63.8 ± 25.9 min, respectively. CPB and aortic clamp time were significantly lower in AAR group. In the first 24 h, the mean drainage volume was 790.3 ± 423.6 mL. Re-thoracotomy due to bleeding was zero. Sternotomy was able to be avoided in all patients. Patients stayed 35.9 ± 23.5 h at ICU and were discharged 7.8 ± 3.0 days following surgery from hospital. Mean ventilation time was 5.8 ± 7.6 h. All patients survived and 30-day mortality was 0.0%. At a median follow-up time of 18.2 months, all patients were alive. The results were similar in both groups. Conclusions: The full endoscopic RAMT approach with 3D visualization is a safe, feasible and promising technique that can be transferred in the field of aortic surgery without compromising surgical quality, postoperative outcomes, or patient safety when performed by an experienced team in a high-volume center.

Hydrogeochemical characteristics and air quality risks associated with gold mining operations in Egypt using geochemical modeling and risk indices.

The success of industrial operations depends on the effective identification, appraisal, and mitigation of possible hazards and associated environmental concerns. This report provides a complete review of environmental management techniques at the Sukari Gold Mine (SGM), located in the southeastern desert of Egypt. Extensive environmental measurements were taken to assess air and water quality, identify hazards, and analyze risks on the SGM premises. Air quality and noise intensity levels were measured at 39 places around the mine's working region. The findings found noncompliance with the Egyptian Environmental Law's (EEL4/94) noise exposure limitations, with the Power Generator House having the maximum noise levels at 107 dB. Remedial measures such as personal protective equipment (PPE) and exposure limit reduction strategies are being considered to address elevated noise levels. Measurements of particulate matter (PM10) and noxious gases (e.g., CO, SO2, NO2, HCN, and NH3) were conducted in workplace and ambient environments. Elevated PM10 concentrations were particularly concerning in underground regions, forcing the deployment of water depression techniques and improved PPE measures. While gas emissions from most activities remained under regulatory limits, select zones showed hydrogen cyanide (HCN) levels that exceeded permitted thresholds, necessitating specific control actions. Using hazard index (HI) and risk rating assessments, this study found different risk profiles across SGM's workplaces, focusing on high-risk regions for focused intervention. Additionally, a water assessment near a Tailing Storage Facility (TSF) was conducted to monitor the impact of mining activities on groundwater quality. The study revealed that groundwater in the region belongs to the Na-K-Cl-SO4 and Ca-Mg-Cl-SO4 water classes, with potential degradation attributed to high mineralization processes induced by aquifer materials and seawater intrusion. The findings underscore the importance of ongoing monitoring, control measures, and implementation of programs to ensure environmental sustainability and minimize risks associated with mining activities in the Sukari Gold Mines. This research highlights the imperative of continuous monitoring, proactive control measures, and the implementation of environmental initiatives to ensure the sustainability of mining operations within the Sukari Gold Mines.

Extracorporeal membrane oxygenation for influenza-associated acute respiratory distress syndrome.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) therapy for patients with influenza A (H1N1)-related acute respiratory distress syndrome (ARDS) has been described once all other therapeutic options have been exhausted. The current report reviews our institutional experience and lessons learned in 18 consecutive patients. METHODS: Between December 2009 and March 2011, 18 patients underwent ECMO therapy for severe H1N1-related ARDS. Mean age was 40 ± 18 years (range 4-67 years). Ten patients (56%) received venoarterial cannulation (v-a ECMO) while venovenous cannulation (v-v ECMO) was initiated in the remaining patients (n = 8, 44%). To identify risk factors of adverse outcome, univariate analysis was performed for clinical parameters. RESULTS: Successful ECMO weaning was possible in 44% (n = 8) of patients and overall mortality was 61% (n = 11). Seven of the eight patients who could be successfully weaned from ECMO support fully recovered. Survival within the v-a ECMO group (60%) was superior to the v-v ECMO group (13%; p = 0.06). Two patients (11%) required re-exploration of the axillary artery cannulation site. No further adverse events associated with ECMO implantation occurred. Outcome was better when the time of severe deoxygenation (Pao2 < 70 mm Hg) despite maximally invasive respiratory support to ECMO implantation was less than 6 hours (odds ratio: 2.4; p = 0.05). CONCLUSIONS: ARDS associated with H1N1 remains a devastating clinical picture. In our hands, ECMO support offered survival to 40% of patients with otherwise fatal prognosis. While v-v ECMO remains the method of choice for patients suffering an isolated ARDS in the setting of stable hemodynamic conditions, v-a ECMO may be considered if the clinical picture of ARDS is aggravated by systemic inflammatory response syndrome with the requirement of high dose vasopressor support.

Simple and controlled method to avoid hyperperfusion of the right arm following axillary artery cannulation for extracorporeal membrane oxygenator support.

The right axillary artery has become the cannulation site of choice for establishment of extracorporeal membrane oxygenator support in many centers. Dissection and cannulation of this vessel are simple and safe in the majority of patients. Typically, a side graft is used to avoid malperfusion of the right arm. Although this protocol offers many advantages, a common complication is the critical hyperperfusion of the right arm. Subsequent compartment syndrome and decline of antegrade inflow of oxygenated blood, especially into the brain and coronary arteries, can be life threatening in such critical patients. We describe herein a simple yet effective and controlled technique to avoid this particular problem.

Activated Platelet Rich Plasma versus Non-Activated Platelet Rich Plasma in the Treatment of Alopecia Areata.

Introduction: Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair loss with not fully understood pathogenesis. It affects nearly 2% of the general population during lifetime. The course of the disease is unpredictable, and currently no treatment is available for complete cure or prevention. Platelet rich plasma (PRP) is an autologous blood-derived product, which has widely spread in the last decades for treatment of different dermatological conditions including hair disorders. Methods: The aim of this work was to evaluate the efficacy and safety of activated PRP in comparison to non-activated PRP in the treatment of alopecia areata. This study was conducted on two groups of 20 subjects each who received 4 treatments of intradermal injection of activated and non-activated PRP. Results and Conclusion: Data obtained in our research confirm that PRP is safe, effective, and well tolerated by patients as a treatment modality for alopecia areata. Besides, such a method is cost-effective as there is no need for any expensive tools for preparation and it can be done in outpatient clinics. Also, activation of PRP prior to injection is not mandatory as there was no statistically significant difference between both groups.

Femoral or Axillary Cannulation for Extracorporeal Circulation during Minimally Invasive Heart Valve Surgery (FAMI): Protocol for a Multi-Center Prospective Randomized Trial.

BACKGROUND: Minimally invasive heart valve surgery via anterolateral mini-thoracotomy with full endoscopic 3D visualization (MIS) has become the standard treatment of patients with valvular heart disease and low operative risk over the past two decades. It requires extracorporeal circulation and cardioplegic arrest. The most established form of arterial cannulation for MIS is through the femoral artery and is used by most surgeons, but it is suspected to increase the risk of stroke through retrograde blood flow. An alternative route of cannulation is the axillary artery, producing antegrade blood flow during extracorporeal circulation. METHODS: Femoral or axillary cannulation for extracorporeal circulation during minimally invasive heart valve surgery (FAMI) is a multicenter randomized controlled trial designed to determine whether axillary cannulation is superior to femoral cannulation for the outcome of a manifest stroke within 7 days postoperatively. The target sample size was 848 participants. Patients ≥ 18 years of age, with valvular regurgitation or stenosis scheduled for minimally invasive surgery via anterolateral mini-thoracotomy, were randomized to axillary cannulation (treatment group) or to femoral cannulation (standard care). Patients were followed up for seven days postoperatively. A CT scan was performed pre-operatively to screen patients for vascular calcifications and to assess the safety of femoral cannulation. The standard of care is femoral artery cannulation, but is performed only in patients without significant vascular calcifications or severe kinking of the iliac arteries and in patients with sufficient vessel diameter. The cannulation is performed via Seldinger's technique, and the vessel closed percutaneously using a plug-based vascular closure device. Only patients without significant vascular calcifications are considered for femoral cannulation, as an increased risk of stroke is assumed. In patients with vascular calcifications, axillary cannulation is the standard of care to avoid these risks. Retrospective studies have hinted that, even in patients without vascular calcifications, there may be a lower stroke risk with axillary cannulation compared to femoral cannulation. We present a protocol for a multi-center randomized trial to investigate this hypothesis. DISCUSSION: To date, evidence on the best access for peripheral artery cannulation during minimally invasive heart valve surgery has been scarce. Patients may benefit from axillary cannulation for extracorporeal circulation in terms of stroke risk and other neurological and vascular complications, though femoral cannulation is the gold standard. The aim of this study is to determine the risks of peri-operative stroke in a prospective randomized comparison of femoral vs. axillary cannulation.

The Long-Term Outcome and Quality of Life after Replacement of the Ascending Aorta.

(1) Background: Despite optimal surgical therapy, replacement of the ascending aorta leads to a significant reduction in the quality of life (QoL). However, an optimal result includes maintaining and improving the QoL. The aim of our study was to evaluate the long-term outcome and the QoL in patients with aneurysms in the ascending aorta; (2) Methods: Between 2014 and 2020, 121 consecutive patients who underwent replacement of the ascending aorta were included in this study. Acute aortic pathologies were excluded. A standard short form (SF)-36 questionnaire was sent to the 112 survivors. According to the surgical procedure, patients were divided into two groups (A: supracoronary replacement of the aorta, n = 35 and B: Wheat-, David- or Bentall-procedures, n = 86). The QoL was compared within these groups and to the normal population, including myocardial infarction (MI), coronary artery disease (CAD) and cancer (CAN) patients; (3) Results: 83 patients were males (68.6%) with a mean age of 62.0 ± 12.5 years. Early postoperative outcomes showed comparable results between groups A and B, with a higher re-thoracotomy rate in B (A: 0.0% vs. B: 22.1%, p = 0.002). The 30-day mortality was zero. Overall, mortality during the follow-up was 7.4%. The SF-36 showed a significant decay in both the Physical (PCS) and Mental Component Summary (MCS) in comparison to the normal population (PCS: 41.1 vs. 48.4, p < 0.001; MCS: 42.1 vs. 50.9, p < 0.001) but without significant difference between both groups. Compared to the MI and CAD patients, significantly higher PCS but lower MCS scores were detected (p < 0.05); (4) Conclusions: Replacement of the ascending aorta shows low risk regarding the operative and postoperative outcomes with satisfying long-term results in the QoL. The extent of the surgical procedure does not influence the postoperative QoL.

The prognostic value of triple negative in stage II/III breast cancer.

INTRODUCTION: Breast cancer is no longer seen as a single disease but rather a multifaceted disease composed of distinct biological subtypes with diverse natural history, clinical, pathological, and molecular features. Recent attention has been directed at the molecular classification of breast cancer. OBJECTIVE: To evaluate the prognostic value of triple-negative subtype in stage II/III breast cancer and to define the role of clinical stage in prognosis of breast cancer. METHODS: We used the immunohistochemical technique to divide 255 cases of breast cancer, stages II and III, into four subtypes according to estrogen receptor/progesterone receptor and Her-2 expression. RESULTS: Triple-negative subtype comprised 76.5% of the cases with 12.3% recurrence rate. Luminal A subtype also carried a poor outcome with 16.7% recurrence rate. CONCLUSION: Triple-negative subtype has the worst overall and disease-free survival in stage II/III breast cancer. Clinical stage is still an independent prognostic factor in the breast cancers of all types.

Hereditary Hyperekplexia in Saudi Arabia.

BACKGROUND: Hyperekplexia is a rare disorder characterized by exaggerated startle responses to unexpected sensory stimuli, recurrent apneas, and stiffness. Only few studies have been published on this disorder in populations with high rates of consanguinity. METHODS: We retrospectively reviewed Saudi patients with genetically confirmed hereditary hyperekplexia using a standard questionnaire that was sent to nine major referral hospitals in Saudi Arabia. RESULTS: A total of 22 Saudi patients (11 males, 11 females) from 20 unrelated families who had hereditary hyperekplexia were included. Based on molecular studies, they were classified into different subtypes: SLC6A5 variant (12 patients, 54.5%), GLRB variant (seven patients, 31.8%), and GLRA1 variant (three patients, 13.7%). All patients were homozygous for the respective causal variant. The combined carrier frequency of hereditary hyperekplexia for the encountered founder mutations in the Saudi population is 10.9 per 10,000, which translates to a minimum disease burden of 13 patients per 1,000,000. CONCLUSION: Our study provides comprehensive epidemiologic information, prevalence figures, and clinical characteristics of a large cohort of patients with hereditary hyperekplexia.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

Recessive AFG3L2 Mutation Causes Progressive Microcephaly, Early Onset Seizures, Spasticity, and Basal Ganglia Involvement.

BACKGROUND: Mutations in AFG3L2, a gene encoding a subunit of the mitochondrion m-AAA protease, cause spinocerebellar ataxia type 28 and recessive spastic ataxia type 5. Neuroimaging shows cerebellar atrophy. METHODS: Retrospective review of the patient charts including their clinical evaluation and molecular genetic, neurodiagnostic, and neuroradiological investigations. RESULTS: We describe five members of a large consanguineous family with a severe mitochondrial disease phenotype in the form of regression of the developmental milestones in the first year of life, refractory epilepsy, progressive microcephaly, increased blood lactate, basal ganglia involvement, and premature death. Exome sequencing showed homozygous mutation of the AFG3L2 gene in all individuals: c.1714G>A (p.Ala572Thr). CONCLUSIONS: Our findings add to the phenotypic, neuroradiological, genetic, and biochemical spectrum of AFG3L2 mutations.

The role of extracellular and intracellular proteolytic systems in aneurysms of the ascending aorta.

Aneurysms of the ascending aorta are an outstanding challenge to clinicians as they may persist asymptomatic until they present with dissection or rupture. Intensive research is performed to reveal the molecular mechanisms causing aneurysm formation. Calpains are ubiquitous non-lysosomal cysteine proteases which are classically activated by calcium signaling. The two major forms of the calpain-family are calpain-I and calpain-II. Calpastatin specifically inhibits the proteolytic activity of calpain-I and -II. Recently it has been demonstrated in aneurysm tissues from ascending aortas obtained from Marfan syndrome patients that calpain-II expression is increased and calpastatin expression is decreased. Thus, we were interested in the probable role of calpains in aneurysms of ascending aorta in non-Marfan patients. Therefore, ascending aortic samples of dilated and non-dilated aortas were analyzed according to their calpain-I, -II and calpastatin content as well as the expression levels of MMPs and elastin as well as the infiltration of inflammatory cells. We have found significant differences in calpain-I and calpastatin protein expression and serum levels in patients with aneurysm of the ascending aorta. Furthermore, MMP-1 and MMP-3 expression levels correlate with calpain-I protein levels. Due to our findings we conclude that calpain-1 seems to be related to fibrotic alteration in aortic aneurysm tissue in our experimental group. The change in calpain-1 modulates the structure of aortic tissue causing alteration in elastin structure, thus enabling macrophage infiltration and elevation of MMP levels. Circulating levels of calpain-1 may be used as a prognostic marker in the future if further correlation analyses are done.

Septo-optic Dysplasia Complex with Omphalocele, Pre-maxillary Agenesis and Encephalocele.

Septo-optic dysplasia complex (SODC) is a rare congenital anomaly, characterized with absence of septum pellucidum, optic nerve hypoplasia with or without pituitary dysfunction. Various midline defects are also associated with SODC in addition to its classical findings. We report, for the first time a rare presentation of SODC which is associated with pre-maxillary agenesis along with sphenoidal encephalocele and omphalocele. The case showed resulting median cleft lip and palate along with other multiple congenital defects including hydrocele, inguinal hernia, micropenis and a wide mediastinum.

Ketoconazole-tacrolimus coadministration in kidney transplant recipients: two-year results of a prospective randomized study.

BACKGROUND/AIMS: In developing countries, kidney transplantation is greatly hindered by financial problems, especially due to costly newer immunosuppressive medications. Ketoconazole increases blood levels of tacrolimus and cyclosporine through inhibition of cytochrome P450 microsomal enzymes. We previously reported on the 6-month safety and the outstanding impact on treatment costs of the ketoconazole-tacrolimus combination in kidney transplant recipients. Data of this combination are still lacking in the literature. We hereby report on the 2-year results of our trial. METHODS: This prospective, randomized study included 70 live-donor kidney transplant recipients receiving tacrolimus (age 16-45 years, 54 males and 16 females). Patients were randomized into two equal groups: group 1, where ketoconazole 100 mg/day was added, and group 2 (control group). RESULTS: After 2 years, group 1 (ketoconazole) patients still showed a highly significant reduction of the tacrolimus dose (by 53.8%) and cost (by 52.9%) compared with the control group (p < 0.001) and a significant improvement in graft function in comparison to their own initial graft function (p = 0.002). Throughout the 2 years, no side effects of ketoconazole were noted. CONCLUSION: We conclude that the long-term ketoconazole-tacrolimus combination therapy in kidney transplant recipients during the 2 years is safe, has an outstanding impact on treatment costs and improves graft outcome.

Co-administration of ketoconazole to tacrolimus-treated kidney transplant recipients: a prospective randomized study.

BACKGROUND: Since the introduction of calcineurin inhibitors, there has been a significant improvement in the results of solid organ transplantation, including graft and patient survival. However, high cost, chronic nephrotoxicity and other side effects stand as major challenges for long-term use of these drugs. The long-term safety and financial benefits of the combination ketoconazole-cyclosporine previously studied. However, data about the effect of the addition of ketoconazole addition to tacrolimus-treated patients are scarce. Therefore, this study was conducted to evaluate the safety and financial impact of that combination. METHODS: The subjects of this work included 70 live-donor stable kidney transplant recipients receiving tacrolimus. Their age ranged from 16 to 45 years. Among them, 54 were males and 16 were females. All of them were 6 months or more post-transplantation. Patients were randomly divided into two equal groups. Group I patients initially received ketoconazole 100 mg/day in addition to their usual treatment, while group II patients were considered a control. Patients were followed-up for 6 months. RESULTS: Concomitant ketoconazole-tacrolimus resulted in marked reduction of tacrolimus dose (by 58.7%) and cost (by 56.9%). It also resulted in significant improvement in graft function and fungal skin infection, in addition to a decrease of gastrointestinal episodes and hospitalization. CONCLUSION: We conclude that ketoconazole-tacrolimus combination in kidney transplant recipients is safe, has outstanding impact on treatment costs and improves patient and graft outcome.