First Month Of Follow-up Research Articles

Seroprevalence of Anti-SARS-CoV-2 Antibodies in Iquitos, Loreto, Peru

Background: Detection of SARS-CoV-2 antibodies among people at risk is critical for understanding both the prior transmission of COVID-19 and vulnerability of the population to the continuing transmission and, when done serially, the intensity of ongoing transmission over an interval in a community. In this study, we estimated the seroprevalence of COVID-19 in a representative population-based cohort of Iquitos, one of the regions with the highest mortality rates from COVID-19 in Peru, where a devastating number of cases occurred in March 2020.Methods: We conducted a population-based study of transmission tested each participant using the COVID-19 IgG/IgM Rapid Test from Orient Gene Biotech and used survey analysis methods to estimate seroprevalence accounting for the sampling design effect and test performance characteristics. Here we report results from the baseline (13 to 18 July 2020) and the first month of follow-up (13 to 18 August 2020) study.Findings: We enrolled a total of 716 participants and estimated seroprevalence of 70.0% (95% CI: 67.0%–73.4%), a test-re-test positivity of 65% (95% CI: 61.0%–68.3%), and an incidence of new exposures of 1.8% (95% CI: 0.9%–3.2%) data that suggest that transmission is ongoing but is occurring at low levels. We observed significant differences in the seroprevalence between age groups, with participants 18 to 29 years of age having lower seroprevalence than children Interpretation: Iquitos demonstrates one of the highest rates of seroprevalence of COVID-19 worldwide. Current data shows a limited case burden in Iquitos for the past seven months and suggests that these levels are sufficient to provide significant but incomplete herd immunity.Funding Statement: Dirección Regional de Salud de Loreto, DIRESA, Loreto, PeruDeclaration of Interests: We declare no conflict of interest.Ethics Approval Statement: The study was approved by the hospital health network Institutional Scientific Committee and Institutional Review Board of the Regional Hospital, Iquitos.

Assessment of the role of intranasal silicone-tube fixation in congenital nasolacrimal duct obstruction: a comparative study

Purpose The aim of this study was to compare the efficacy of intranasal lacrimal tube fixation compared with no fixation on postoperative lacrimal tube stability.Patients and methods This is a prospective, comparative, interventional study that included 160 eyes of 133 children with congenital nasolacrimal duct obstruction. Cases were randomly categorized into two groups: group A that included 80 eyes for whom intranasal fixation of lacrimal tube was performed and group B that included 80 eyes for whom lacrimal intubation without tube fixation was performed.Results Tube extrusion occurred in three (3.8%) eyes of group A compared with 14 (17.5%) eyes of group B after the first month of follow-up, a statistically significant difference (P=0.005). At the end of the sixth postoperative month, the tube was still present in 71 (88.75%) eyes in group A compared with 58 (72.5%) eyes in group B with a statistically significant difference (P=0.009). Loose tube occurred in five (6.25%) eyes of group A compared with 16 (20%) eyes of group B with a statistically significant difference between the two groups (P=0.018). Tubes were well tolerated in 68 (85%) eyes of group A and in 54 (67.5%) eyes of group B, a statistically significant difference (P=0.009). A positive correlation was detected between the looseness of the tube and tube tolerance (P<0.001).Conclusion Intranasal lacrimal tube fixation resulted in lowering of the rate of tube extrusion, especially in the first postoperative month.

Umbilical cord Metals concentration and Neurodevelopment in a birth cohort - Pipa Project - Rio de Janeiro - Brazil

The world population, in general, is simultaneously exposed to various metals that can affect children’s neurodevelopment. Aims: Analyze the association between metal concentrations in umbilical cord blood and the child's neurodevelopment up to the sixth month old. Methods: A pilot study was conducted from October 2017 to August 2018, at the Maternity School of the Federal University of Rio de Janeiro, Brazil. Infant’s neurodevelopment was evaluated using Denver Developmental Screening Test II (Denver-II) at six months old. The neurodevelopment assessment considered the conclusions according to the test criteria and the proportion of failure according to the test analysis fields. Exposure was assessed for lead (Pb), Arsenium (AS), Mercury (Hg) and Cadmium (Cd) based on tertiles. Results: 135 babies participated in the cohort, 58 attended the 6 month follow-up and among these 5.17% were considered suspected according to the classification criteria for neurodevelopment of DENVER II. The analysis of the occurrence of failures showed a total of 31.7%, 4.8% in personal social development, 4.8% fine motor, 4.8% language and 19.5% gross motor. The concentration of metals in the umbilical cord blood, classified by tertile, did not show a clear association for lead (RR = 0.735 95% CI - 0.199 - 2.714) and mercury (RR = 0.59 95% CI 0.191 - 1.828). Arsenic and cadmium showed an association with the proportion of failures only in the first month of follow-up, with RR = 6.26 (0.856 - 45.85) when comparing the second tertile of AS with the first (reference). And the Cd RR = 0.18 CI 95% 0.024 - 1.298). New studies with a greater number of follow-ups are needed to reinforce the rejection of such notes. The PIPA Project cohort will start in the year 2020 and allow greater power of analysis.

Superior rectal artery embolization for bleeding internal hemorrhoids.

The aim of the present study was to evaluate clinical efficacy and safety of superselective embolization of the superior rectal artery (SRA) for the treatment of internal hemorrhoidal bleeding. Patients with stage II and stage III internal hemorrhoids, treated by interventional embolization of the SRA in our department between January 2017 and June 2019 were retrospectively evaluated. All patients suffering from disabling chronic hematochezia and some with relative contraindications for operation (n = 17) orrejectionofconventional hemorrhoidectomy (n = 15). Superselective SRA branch embolization was performed using gelatin sponge particles (350-560μm) and metallic coils (2-3mm). This treatment process was planned by a multidisciplinary team consisting of proctologist,gastroenterologist and radiologist. The surgical efficacy, postoperative complications and follow-up outcomes were observed. There were 32 patients (18 males, mean age 52 ± 12years, range: 22-78years), 12 (37%) with stage II hemorrhoids and 20 (63%) with stage III hemorrhoids. Embolization was successful in all patients, and bleeding symptoms resolved in 27 (84.4%) patients. The remaining 5 (15.6%) patients underwent either stapled hemorrhoidopexy (n = 4) or sclerotherapy (n = 1). Some patients experienced different degrees of pain (n = 4;12.5%), low fever (n = 11;34.4%), and tenesmus (n = 17;53.1%), which all spontaneously regressed without further treatment. All patients were followed up for at least 1year. There were no serious complications, such as infection, intestinal ischemia or massive hemorrhage. Four patients (14.8%) had rebleeding during the first months of follow-up. All patients with re-bleeding were successfully treated with internal iliac arteriography and branch embolization and did not experience further bleeds after a minimum follow up 3months follow-up. The short-term efficacy of superselective SRA embolization for grade II-III internal hemorrhoids is good, and this method is safe and feasible.

Circulating mitochondrial DNA (mtDNA) variants to predict metastatic progression of rectal cancer.

e16132 Background: High rates of systemic failure after curative-intent therapy in locally advanced rectal cancer (LARC) call for new diagnostic tools to improve risk-based treatment stratification. We hypothesized that blood mtDNA polymorphisms, generated by the high mtDNA mutation rate when the mitochondrial biogenesis is mobilized during clonal immune cell activation, correlate with systemic immune control of LARC dissemination and thus can be used as diagnostic marker. Methods: 41 LARC patients given neoadjuvant (chemo)radiotherapy had DNA extracted from whole blood (WB) sampled at the time of diagnosis, for high-throughput full-length mtDNA sequencing followed by annotation of mtDNA variants using the curated reference genome (mitomap.org). The composition of peripheral blood mononuclear cell (PBMC) subpopulations was analyzed by high-dimensional single-cell mass cytometry. Metastatic events were recorded over 24-60 months of follow-up after completion of the multimodal treatment. Results: The total number of WB-mtDNA variants was strikingly different across the study cases but without correlation to patient’s age, body mass index, or metformin use, which may affect mitochondrial function, or to the disease extension at presentation or the local tumor response to the neoadjuvant therapy. All patients had microsatellite-stable tumor. The higher the number of variants in MT-RNR2, encoding one of the two ribosomal subunits of mitochondria, the better distant metastasis-free survival (DMFS). For each patient, two MT-RNR2 sites were homoplasmic for either the normal or a deletion (3105AC &gt; A, 3106CN &gt; C) variant, categorizing the patients into two groups that comprised the same cases for both mtDNA sites. Nine of a total of 10 DMFS events occurred during the 18 first months of follow-up in one of the patient groups ( n = 23). The single event in the other group ( n = 18) appeared in a patient who had declined primary tumor surgery. In the former group, a low number of variants in the ribosomal subunit MT-RNR1 identified all patients who had metastatic progression. These patients had reduced PBMC frequency of CD8+ (cytolytic) T cells that were positive for CXCR4 ( p = 0.001), a chemokine receptor that promotes their homing to tumor sites. Conclusions: The WB-ribosomal mtDNA polymorphisms reflected systemic immune cells endowed with cytolytic and tumor-homing properties. The actual mtDNA variants were single-base alterations and might thus be analyzed by PCR and developed as a feasible assay for metastatic risk assessment in rectal cancer. Clinical trial information: 01816607 .

SAT-LB3 Developing an Integrative Medicine Patient Care Protocol for Natural Fertility in Primary Infertile Couples: A Case Series

Background:Although advances in the field of Assisted Reproduction have improved significantly the reproductive outcome for infertile couples, success rates nonetheless remain low. Furthermore, several infertile couples are skeptical of using experimental or even established ART treatments, resulting in the need for reproductive health professionals to discuss other models which might best benefit patients who need fertility care.Clinical case series:All patients that were referred to our clinic for primary infertility (no positive pregnancy test after at least 2 years of unprotected intercourse) and had been either offered to proceed with IVF or had already a history of at least 1 failed IVF cycle, in the course of 1 year (March 2018-February 2019) were included in this study. All patients were younger than 42 years of age, AMH less than 1 ng/mL, FSH less than 12 IU/L (follicular phase FSH normal range 2.8-9.3 IU/L) and normal ovulation was present. Couples were counseled regarding a novel integrative model of achieving spontaneous pregnancy through expectant management while modifying key parameters affecting female fertility, developed after evidence-based appraisal of all relative literature. All 14 patients were examined for insulin resistance, subclinical thyroid disease, thrombophilia, and chronic endometritis and were offered the appropriate treatment, aiming for optimal (as opposed to within normal range) figures. For chronic endometritis both spouses received a one-month long triple antibiotic treatment. All patients were given careful personalized nutritional and vitamin supplementation guidelines. Regarding the psychological component of fertility all patients underwent monthly homeopathy and/or weekly acupuncture courses. All patients were designed to be followed-up for 6 months after completion of treatment (9 months after antibiotic treatment). 3 patients dropped out before receiving full treatment (rate 21%). 2 patients did not have a positive pregnancy test. All 9 remaining patients came back with a positive pregnancy test (rate 81% of those who completed treatment) on the first month of follow-up that resulted in an uncomplicated pregnancy and delivery of healthy singleton babies. Conclusion:This is the first case series indicating that expectant management could be the answer to some cases of infertility. Poor responders are sometimes reluctant to be involved in the global trend of IVF and ART, therefore a more holistic integrative approach might balance the imbalances and increase their fecundity. However, no causal inferences should be made from this consecutive case series regarding the efficacy of the investigated treatment.

Evaluation of olfactory function in patients undergoing endoscopic skull base surgery with nasoseptal flap

IntroductionEndoscopic transnasal access to the skull base, both for treatment and reconstruction, can cause olfactory morbidity. Knowing the main consequences of this intervention is essential to have objective criteria for decision-making regarding the appropriate surgical technique. ObjectivesThe aim of this study is to determine the impact on olfactory function of the endonasal endoscopic access to the skull base with the creation of the nasoseptal flap. MethodsA prospective research was carried out in which 22 patients who underwent endoscopic transnasal surgery at the skull base, with the creation of a nasoseptal flap. The Connecticut Chemosensory Clinical Research Center test was applied before and at the 1st, 3rd and 6th postoperative months. ResultsThe results showed that only in the first month of follow-up the mean patient classification was statistically worse than at the other evaluation moments (p<0.05), but there was no mean difference in the Connecticut score classification between the other moments (p>0.05); that is, patients showed worsening in the 1st month and returned to the preoperative mean after the 3rd month of follow-up. ConclusionThe present study showed that the postoperative decrease in olfaction is transient, since the patient's sense of smell returns to pre-surgical values in the 3rd postoperative month.

SUN-357 RABBIT ANTI-THYMOCYTE GLOBULIN INDUCTION THERAPY IN RENAL TRANSPLANTATION

Rabbit anti-thymocyte globulin (rATG) is a preparation of polyclonal antilymphocyte antibodies. It is used not only as an induction therapy to decrease delayed function or rejection of the graft, but also to reverse rejection, with slightly higher rates of complications such as infections and malignancy. The purpose of this study is to review the experience on the use of thymoglobulin as induction treatment in patients with renal transplantation in Cuenca, Ecuador. A retrospective study was conducted in a series of cases (June-September 2019) in the Departament of Nephrology. Universe consisted of 10 patients who underwent renal transplantation from cadaveric donors. All patients received Thymoglobulin induction (daily dose 1,5mg/Kg; 4 patients for 3 days and 6 patients for 5 days), tacrolimus (initial dose 0,075mg/kg per day; if renal function allowed it, dose was adjusted at day five after surgery, increasing it to 1mg/kg per day), mycophenolate (2g/day), and methylprednisolone (inicial daily dose 250mg intravenous for 3 days, then progressive decrease until reaching 20mg daily at first month of follow-up). Leukocyte, lymphocyte, platelet, hemoglobin, urea and creatinine levels were evaluated at five, ten and thirty days after transplantation. Patients age ranked between 20-60 years old (average of 38) and where predominantly female (70%). Hemodialysis (60%). Hypertension was the first cause of renal disease (30%) and cold ischemia time was between 5 to 10 hours. There was an average 50% histocompatibility between donor and recipient. Peak panel-reactive antibody presented in 4% cases. Marked lymphopenia and anemia were evidenced at 5 days with recovery at 10 and 30 days after transplantation. None showed platelet disease. Recovery of renal function became evident from day 5 (1.6mg/dl) presenting at 30 days an improved function of 1.27mg/dl. Infection rate was 50%. In this study, the use of thymoglobulin dose for 3 to 5 days does not represent a risk for infections, so it is considered effective and safe.

Predictors of Increased Left Ventricular Filling Pressure After Transcatheter Atrial Septal Defect Closure

Background: The aim of this study was to identify factors of left ventricular filling pressure (LVFP) elevation following transcatheter atrial septal defect (ASD) closure.Methods and Results: The study involved 97 adult patients with sinus rhythm who underwent both transcatheter ASD closure and transthoracic echocardiography. Elevated LVFP was diagnosed during the first month of follow-up according to the American Society of Echocardiography guidelines: that is, ratio of transmitral early filling to the lateral annular diastolic velocity (lateral E/e’) >13 was used to exclude the effect of the device on the atrial septum. Fifteen patients (15.5%) were diagnosed with increased LVFP during the 1-month follow-up period (median lateral E/e’: from 9.2, IQR, 6.6–10.8; to 15.5, IQR, 13.8–17.8; P<0.001). Independent predictors of LVFP elevation were left ventricular (LV) relative wall thickness, lateral E/e›, and peak tricuspid regurgitation pressure gradient (TRPG) at baseline (OR, 1.67; 95% CI: 1.04–2.69; OR, 1.52; 95% CI: 1.07–2.15; and OR, 1.14; 95% CI: 1.04–1.25; cut-offs: 0.42, 7.5, and 27.0 mmHg, respectively). Median lateral E/e› returned to baseline in most patients with LVFP elevation during 6 months of subsequent follow-up (1-month–6-month follow-up: 15.5, IQR, 13.8–17.8; 11.1, IQR, 8.8–14.8, respectively; P=0.001).Conclusions: The increase in Doppler-estimated LVFP following transcatheter ASD closure may be related to LV hypertrophy, diastolic dysfunction, and peak TRPG in elderly patients.

Clinical outcomes of hepatocellular carcinoma patients with Child-Pugh class B treated with stereotactic body radiation therapy.

560 Background: Caution is usually employed in the treatment of patients with hepatocellular carcinoma (HCC) due to the inherent liver radiosensitivity, especially in patients with Child Pugh (CP) B and C classes. This study aims to review the outcomes of patients treated with SBRT for CP class B with HCC. Methods: Medical records of all patients with HCC and compromised liver function (CP class B) treated with SBRT between 2003 and 2018 were retrieved after institutional review board approval. Clinical, laboratory, and treatment-related data were collected and analyzed for their correlation to toxicity and survival. Liver function was assessed prior to SBRT and at 1, 3 and 6 months after treatment using the CP score classification. Patients were censored for toxicity after extensive tumor progression in the liver, new liver-directed therapies, or liver transplant. Time-to-events were calculated from date of SBRT. Results: A total of 22 patients were identified, but 3 were excluded for incomplete follow-up. Median follow-up time was 33 months (range: 11-95 months). At baseline, 13 (68%) patients had a CP score of 7, and 6 (32%) had a CP score of 8. The median PTV volume was 94 cc (range: 14-710 cc). The median prescribed dose was in 5 fractions (range: 35-45 Gy in 3-5 fractions). After SBRT, 8 (42%) patients presented with worsening in CP score, with a mean increase of 1.5 points (95% CI, 0.6-2.5; p = 0.005) at the first month of follow-up, but followed by recovery in liver function with change in CP score not statistically different from baseline at 3- or 6-month follow-up times (p = 0.35 and p = 0.13, respectively). Eight patients (42%) presented with acute hepatobiliary toxicity, with six of those presenting with ≥grade 2 toxicity. Patients with CP score change ≥2 points (n = 6) showed a significantly higher incidence of acute grade 2 or higher hepatobiliary toxicity (p = 0.001) with a trend toward worse overall survival (33 vs. 51 months, p = 0.45). Conclusions: In our cohort, SBRT demonstrated to be safe for patients with Child Pugh Class B liver function.

Analysis of the effect of early multi-dimensional cardiac rehabilitation nursing mode on patients after PCI

Objective To investigate the effect of early multi-dimensional cardiac rehabilitation (CR) nursing mode on patients after percutaneous coronary intervention (PCI). Methods From August 2017 to July 2018, 100 patients with coronary heart disease (CHD) underwent PCI in the Department of Cardiology, the Third Affiliated Hospital of Sun Yat-sen University were selected as subjects. According to the random number table, the patients were divided into control group and observation group, 50 in each group. The control group received routine CR nursing intervention, and the observation group was given early multi-dimensional CR nursing mode for intervention. All patients were followed up for 6 months. The incidence of major cardiovascular adverse events (MACE) was observed 1 month and 6 months of follow-up. Patients with somatization were evaluated on the 2nd day after PCI and in the first month of follow-up using the Somatic Self-rating Scale (SSS). In the first month and the 6th month of follow-up, patient compliance was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). Results During the study period, 3 patients were detached from each group, and there were 47 patients in both groups who completed the study. The incidence of MACE in the control group in 1 month and 6 months was 8.51% (4/47) and 4.26% (2/47), respectively. The incidence of MACE in the observation group was 10.64% (5/47) and 4.26%, (2/47) respectively. There was no significant difference in the incidence of MACE between the two groups (χ2 value was 0.123, 0.000, P>0.05). In the first month of follow-up, the SSS scores of the control group (34.32±6.59) and the observation group (31.04±7.04) were lower than those of the second day after surgery (37.21±6.19, 37.43±7.29), and the difference was statistically significant (t value was 4.633, 2.660, P 0.05). In the 6th month of follow-up, the MMAS-8 score (5.72±0.62) in the control group was lower than the first month of follow-up (6.93±0.54), and the difference was statistically significant (t value was 10.028, P 0.05). Conclusion Early multi-dimensional CR nursing mode has a limited effect on improving the incidence of MACE in patients after PCI, but it can effectively reduce the somatization symptoms of patients and maintain good medication compliance. Key words: Cardiac rehabilitation; Major cardiovascular adverse events; Somatic symptoms; Medication compliance

Is there an interest in performing a systematic CT scan within the first two months after chronic subdural hematoma evacuation? A ten-year single-center retrospective study

ObjectivesThe aims of the present study were to evaluate the frequency of late recurrence after chronic subdural hematoma (CSDH) evacuation and to examine the interest in the use of a systematic CT scan within the first two months after surgery. Patients and MethodsWe performed a retrospective study that included all patients who underwent CSDH evacuation between 2007 and 2017. We evaluated the rate of late recurrence, defined as the need to perform a new surgery after the first month of follow-up. All the patients underwent a clinical examination and a systematic CT scan between one and 2 months after the first surgery (delayed systematic CT scan). We evaluated the rate of clinical recurrence, defined as the association between clinical symptoms and radiological abnormalities, and of radiological recurrence, defined only on CT scan data. ResultsDuring the inclusion period, 696 patients underwent CSDH evacuation in our unit. Overall, 54 patients (7.7%) had recurrence, of whom 21 (39%) had recurrence after 4 weeks (late recurrence). Of the 21 patients with late recurrence, 7 (1%) had radiological recurrence, and 14 (2%) had clinical recurrence. There was no difference in the CT scan characteristics between patients with clinical and radiological recurrence. ConclusionThe use of a delayed systematic CT scan after CSDH surgery has a marginal impact on patient management, and the indication for reoperation without symptoms seems highly subjective. In patients without neurological symptoms, the use of a delayed cerebral CT scan may not be indicated.

Treatment of Vitreomacular Traction with Intravitreal Injection of Perfluoropropane.

To evaluate the effect of one intravitreal injection of expansile gas in the treatment of vitreomacular traction (VMT). Aretrospective review of eyes with VMT treated with singl injection of 0,3 ml of 100% C3F8 gas was performed. The procedure was performed on an outpatient basis under topical anesthesia. Twelve consecutive patient (14 eyes) with symptomatic VMT underwent pneumatic vitreolysis. Mean extend of vitreomacular adhesion was 490,5 µm (408-751). Aposterior vitreous detachment developed in 13 eyes (92,9 %) after asingle gas injection, in 11 eyes (84,6 %) during the first month of follow-up, in 2 eyes within two month of injection. Mean baseline and last BCVA were 0,5 (0,16-0,18) and 0,67 (0,2-1,0) respectively (p.

P1256 Salvage mitraclip implantation for postmyocardial infarction mitral regurgitation: 2 case reports

Abstract Introduction Acute mitral regurgitation (MR) secondary to AMI is associated with a poor clinical outcome. The role of MitraClip implantation (MCI) in this population is still not well established. We report two successful cases of salvage MCI in acute ischaemic MR. Case Report 1: A 66-year-old diabetic woman was admitted to our institution due to extensive anterior STEMI with cardiogenic shock. Urgent cardiac catheterization (CC) revealed 100% occlusion of the left anterior descending and critical stenosis of the obtuse marginal artery, with successful PCI of both vessels and implantation of an intra-aortic balloon pump. Early transthoracic echocardiogram (TTE) revealed a dilated left ventricle with severe systolic dysfunction (LVEF – 35%), apical and anterior wall akinesia and functional grade IV MR (EROA - 40mm2 and regurgitant volume - 45mL), that was later confirmed by transesophageal echocardiography (TEE). 48h after AMI, the patient developed an arrhythmic storm requiring multiple shocks and a prolonged period of mechanical ventilation. Due to an extremely slow clinical improvement, with the need for prolonged inotropic support and refractory pulmonary congestion (NYHA IV), she was submitted to MCI, resulting in post-procedural grade I MR (EROA 7mm2 and regurgitant volume 11mL) and a marked clinical and hemodynamic improvement. An ICD for secondary prevention was implanted. At the 3 month follow-up the patient presented in NYHA II functional class without congestive symptoms. Case Report 2: An 82-year old female patient was admitted with an inferior STEMI, with CC documenting severe 3 vessel disease with a calcified occlusion of the right coronary artery, not amenable to PCI, so the patient was submitted to emergent CABG. There was a prolonged period of post-operatory mechanical ventilation with an extremely difficult weaning process, including the need for re-intubation due to acute pulmonary edema. TTE revealed LVEF of 39% with a large inferobasal aneurysm and severe eccentric MR due to tendinous cord rupture. The patient was submitted to MCI with immediate significant improvement of the MR, allowing successful extubation 36 hours after the procedure. In the end of first month of follow-up, the TTE revealed a well-positioned clip with mild-to-moderate MR (EROA – 21.5mm2 and regurgitant volume – 38mL) with the patient being completely asymptomatic. Conclusion Treatment of acute MR following AMI with MCI may be a safe and effective approach in critically ill patients. In our experience, it can lead to a rapid clinical recovery and resolution of cardiogenic shock.

Cellular and humoral cytomegalovirus immunity changes in one-year combined prophylaxis after lung transplantation: suggestions from and for clinical practice.

Background:Immune responses, both cellular and humoral, against cytomegalovirus (CMV) are used to predict CMV manifestations in solid organ recipients. The aim of this study is to evaluate CMV enzyme-linked immunospot (ELISPOT) assay and serology during CMV infections, their concordance and variations after lung transplantation (LTx).Methods:We retrospectively analysed in one year the follow-up data of 43 patients receiving combined CMV prophylaxis with antiviral agents and CMV-specific immunoglobulin G (IgG). CMV infections were investigated by using molecular analyses on both 167 bronchoalveolar lavage and biopsy specimens and 1134 blood samples. Cellular CMV immunity was assessed with specific ELISPOT whereas the humoral one was assessed by quantifying specific immunoglobulins.Results:At the first month after LTx the majority of patients were ELISPOT responders (52.3%) and 30.9% were non-responders. ELISPOT responders had a lower incidence of CMV viremia (p = 0.047), whereas neither effects on CMV pulmonary asymptomatic infection nor on acute rejection were observed. Responders had a higher CMV IgG titre (p < 0.0001) in particular at the first month after LTx (p = 0.0001). Concordance among CMV ELISPOT assay and IgG levels was moderate (Cohen’s K 0.524), with an agreement of 89.8%. All ELISPOT responders maintained their status and almost all non-responders became responders during follow-up (92.3%); the percentage of IgG seropositive subjects increased from 74.4% at the first month of follow-up to 97.4% after 1 year.Conclusions:Despite a moderate concordance with serology, ELISPOT response predicted a lower incidence of CMV viremia in LTx patients; no effects were reported on pulmonary clinical manifestations nor on acute rejection. The ELISPOT response as well as serology changed during the follow-up, not only after first CMV contact. The reviews of this paper are available via the supplemental material section.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. Prospective longitudinal cohort study using a surgical registry. Thirteen public hospitals in France. A cohort of 1873 women undergoing surgery between February 2017 and August 2018. Preliminary analysis of serious complications after a mean follow-up of 7months (0-18months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. Fifty-two women (2.8%, 95%CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

Intermediate-High Risk Pulmonary Embolism.

Limited information exists about the prevalence, management, and outcomes of intermediate-high risk patients with acute pulmonary embolism (PE). In a prospective cohort study, we evaluated consecutive patients with intermediate-high risk PE at a large, tertiary, academic medical center between January 1, 2015 and March 31, 2019. Adjudicated outcomes included PE-related mortality and a complicated course through 30 days after initiation of PE treatment. Repeat systolic blood pressure (SBP), heart rate (HR), brain natriuretic peptide (BNP), and cardiac troponin I (cTnI) measurements, and echocardiography were performed within 48 hours after diagnosis. Among 1,015 normotensive patients with acute PE, 97 (9.6%) had intermediate-high risk PE. A 30-day complicated course and 30-day PE-related mortality occurred in 23 (24%) and 7 patients (7.2%) with intermediate-high risk PE. Seventeen (18%) intermediate-high risk patients received reperfusion therapy. Within 48 hours after initiation of anticoagulation, normalization of SBP, HR, cTnI, BNP, and echocardiography occurred in 82, 86, 78, 72, and 33% of survivors with intermediate-high risk PE who did not receive immediate thrombolysis. A complicated course between day 2 and day 30 after PE diagnosis for the patients who normalized SBP, HR, cTnI, BNP, and echocardiography measured at 48 hours occurred in 2.9, 1.4, 4.5, 3.3, and 14.3%, respectively. Intermediate-high risk PE occurs in approximately one-tenth of patients with acute symptomatic PE, and is associated with high morbidity and mortality. Normalization of HR 48 hours after diagnosis might identify a group of patients with a very low risk of deterioration during the first month of follow-up.

P577Early experience with the first pacemakers to directly connect with smart devices for remote monitoring

Abstract Background Remote monitoring is associated with improved patient outcomes; however, adoption and adherence to remote monitoring via home-based consoles remains suboptimal. BlueSync technology in new generation pacemaker and CRT-P models enables the implanted device to communicate directly with patient-owned, Bluetooth-equipped smartphones/tablets and an app (MyCareLink Heart). The app can automatically retrieve information from the cardiac device and transmit the data to the remote network, eliminating the need for traditional remote monitoring consoles. Objectives To characterize the communication process between implanted pacemakers and smart device remote monitoring apps by assessing the success of prescheduled remote transmissions in the first month of follow-up. Additionally, to assess the feedback of both patients and clinicians about the process of device pairing. Methods Enrollment in the BlueSync Field Evaluation began in April 2018 and was completed November 2018. Follow-up is ongoing. Prior to enrollment in the evaluation, patients completed the device pairing process with the app using their own compatible smartphone or tablet. Patient and clinician questionnaires were completed at the time of the device pairing process. After enrollment, successful completion of scheduled transmissions occurring in the first month were analyzed. Results Preliminary data includes 241 enrolled patients with mean age of 64.7±15.5 yrs (min 20, max 90 yrs), who completed device pairing between their implanted device and their smart device app. Of enrolled patients, 79% felt that the device paring was easy to do, 85% were satisfied with the amount of time it took to complete it, and 93% felt that they would be comfortable using the app. Clinicians reported that 67% of the device pairings took less than 20 minutes and 78% felt patients would be able to use the app independently. At the time of analysis 174 patients had at least one scheduled transmission within the first month, and collectively had a total of 322 scheduled transmissions. Out of these, 309 (96%, 95% CI: 93%-98%) were successfully completed. MyCareLink Heart App Conclusions Initial experience with the world's first app based remote monitoring system for Bluetooth enabled pacemakers demonstrated success to scheduled transmissions in the first month across a wide range of patient ages. Patients and clinicians reported high satisfaction with this novel technology. Acknowledgement/Funding Medtronic PLC

The experience of sibutramine administration in patients with obesity and controlled arterial hypertension

BACKGROUND: Obesity is a metabolic disorder that becomes epidemic. Visceral adiposity increases the risk of arterial hypertension, diabetes mellitus and other comorbidities. According to this, the main aim of obesity treatment is not only a weight loss but also a decrease of the risk of comorbidities.&#x0D; AIMS: to assess the efficiency and safety of sibutramine in patients with obesity and arterial hypertension, to evaluate the drug influence on epicardial fat thickness.&#x0D; MATERIALS AND METHODS: 57 patients aged 35-60 with obesity and arterial hypertension were included in the study. All patients at the beginning and after 7 months of follow-up underwent complex examination including anthropometric measurement, ECG, office and ambulatory blood pressure measurement, echocardiography. Patients with controlled arterial hypertension were included. During the first month of follow-up patients were given general weight loss recommendations. Then sibutramine was added. Control visits to assess efficiency and safety of drug treatment were held after 1 and 6 months of follow-up.&#x0D; RESULTS: Women predominated among the study participants. Visceral adiposity was approved by anthropometric measurements among all patients. Most patients had impaired left ventricle geometry: concentric remodeling or hypertrophy. During the first month of follow-up the weight loss was mild: 2 kg (less than 2%) in average. Sibutramine for 1 month the weight loss increased: 3.7 kg (more than 2%) in average. After 6 months of drug administration the weight loss of patients consisted 8.6 kg (6.2%) in average. According to echocardiography results indexed mass of LV myocardium decreased in all patients more significantly in women. Also in this group of patients significant decrease of epicardial fat thickness was revealed. Adverse events of sibutramine were revealed in 26.3% of patients. The most frequent were constipation (12.3%) and dry mouth (10.6%). The severity of symptoms persisted for 1 month and then decreased, additional therapy was not required.&#x0D; CONCLUSIONS: Sibutramine treatment of obesity promotes effective weight loss, influences the adipose tissue distribution, decreases the progress of associated comorbidities. Sibutramine is an effective and safe drug that can be used in patients with visceral adiposity and controlled arterial hypertension.

Could Hyperbaric Oxygen Be a Solution in the Treatment of Spinal Infections?

Background and Objective: Pyogenic spinal infections are rare and potentially devastating, requiring prompt recognition and management. Parallel to the ever-increasing number of invasive spinal procedures, its incidence is on a steady rise, particularly in an expanding elderly population. The aim of this study was to evaluate the efficacy of hyperbaric oxygen (HBO2) therapy in the treatment of this heterogeneous group of disorders. Materials and Methods: Nineteen patients who were referred to our center for HBO2 with a clinical diagnosis of spinal infections (vertebral osteomyelitis, pyogenic spondylitis, spondylodiscitis, surgical site infection following spine surgery, epidural abscess) were retrospectively reviewed. Results: Infection resolution was adequately achieved in 12 of 13 patients (92.3%) on magnetic resonance imaging at the end of HBO2 treatment or during the first month of follow-up. The mean follow-up period was 11 months (range 1 month to 3 years). Conclusions: This study suggests that HBO2 therapy is efficacious in patients with pyogenic spinal infections complicated by primary therapy failure or by medical comorbidities that may impede the eradication of microbial infection and delay wound healing. HBO2 therapy may be useful for reducing long hospital stays, repeated surgeries, and morbidities.