One-hundred aortic valve replacements in octogenarians: Outcomes and risk factors for early mortality

Background and aim of the study: Today, ageing of the western population is causing aortic valve surgery to be performed in elderly patients with increasing frequency. The study aim was to evaluate surgical outcome in octogenarian patients undergoing aortic valve replacement (AVR). Methods: A total of 100 patients (mean age 82.1 +/- 2.7 years; range: 80-95 years) who underwent AVR over a three-year period was reviewed. Concomitant coronary artery bypass grafting was performed in 34% of cases, and a bioprosthesis was implanted in 80%. The mean logistic EuroSCORE was 13.3%. Results: Operative mortality was 8.0%. In multivariate analysis, a logistic EuroSCORE >= 13.5% (p = 0.02), cross-clamp time >= 75 min (p = 0.02) and postoperative acute renal failure were predictors for in-hospital mortality. Follow up was 100% complete; the mean follow up period was 10.6 months. At one year after surgery, the actuarial survival rate of those patients who survived surgery was 86.1%. Postoperative dyspnea at one month (p = 0.004) was the only predictor of short-term mortality. Conclusion: Age in itself should not contraindicate surgery, and healthcare systems should be prepared to accommodate elderly patients who may require special resources

Video-assisted mitral surgery through a micro-access: A safe and reliable reality in the current era

Background and aim of the study: Minimally invasive mitral valve surgery was introduced into clinical practice during the mid 1990s. The clinical benefits of the technique, namely a reduction of surgical trauma, increased patient comfort and shorter hospital stay, are achieved by using a video-assisted, mini-thoracotomy approach rather than a standard median sternotomy. Herein is described the authors' experience with video-assisted mitral surgery through a micro-access. Methods: Between September 2003 and September 2006, 100 patients (mean age 65.7 years; range: 16-84 years; 29 aged >75 years) underwent video-assisted port-access mitral valve surgery through a 4- to 6-cm anterior mini-thoracotomy. Mitral valve repair was carried out in 36 patients (36%) and mitral valve replacement (MVR) in 64 (64%) for degenerative (n = 54), rheumatic (n = 44), functional (n = 1) or infective disease (n = 1). Redo procedures were performed in 14 patients. Results: Peripheral extra-thoracic cardiopulmonary bypass (CPB) was used in all cases, and Endoclamp occlusion of the ascending aorta in 94%. The median intensive care unit and hospital stays were 20.0 +/- 30.8 h and 7.0 +/- 5.9 days, respectively. Hospital mortality was 4% (n = 4). No patient required conversion to sternotomy. Five patients (5%) underwent minimally invasive surgical revision for bleeding, and one patient (1%) had an early reoperation for MVR during the immediate postoperative course due to failure of a mitral valve repair. There were no perioperative myocardial infarctions, permanent strokes, major vascular complications, or peripheral ischemic events. Among the patients, 63% had no complications at all during the postoperative course, and no wound infections were observed. Conclusion: Video-assisted mitral surgery through a micro-access may be performed safely, at low risk of morbidity and mortality, and with results and quality standards similar to those reported for a sternotomy approach. Of note, older patients may be successfully treated using this technique

Understanding the toughness mechanism prompted by submicron rigid particles in polylactide/barium sulfate composites

Polylactides are extensively employed as bone-fixation devices, due to their degradability and high tensile modulus. As demonstrated in a previous study, the incorporation of barium sulfate submicron particles impressively enhanced toughness with almost no adverse effect on yield strength. It is therefore a promising strategy in the design of radiopaque materials intended for use in safety-critical systems. In the present study, the mechanism that causes high-level plastic deformation in this system is identified through tensile and fracture tests, together with a thorough analysis of the microstructure via transmission and SEM (Scanning Electron Microscopy). The presence of submicron particles was observed to reduce crystallinity and to increase energy dissipation during the plastic deformation of the polymer matrix, inducing crack widening and fibrillated crazing that propagated around the crack opening. The result is a five-fold increase in the energy that is required to fracture the composite with respect to its neat polymer counterpart.The authors are grateful for funds from POLYMAT Fundazioa, Basque Government (GV/EJ) (IT-927-16, S-PC13UN025) and MINECO (MAT-2016-78527-P).N.S.and I.M. are respectively thankful for the predoctoral and postdoctoral fellowships to POLYMAT and A.L. wishes to acknowledge support from the Basque Government for his postdoctoral fellowship

Critical appraisal of bilastine for the treatment of allergic rhinoconjunctivitis and urticaria

Bilastine is a second generation antihistamine indicated for the treatment of seasonal or perennial allergic rhinoconjunctivitis and chronic urticaria with a daily dose of 20 mg, in adults and children over 12 years of age. The efficacy of bilastine has been shown to be similar to that of the comparator drugs for the control of the nasal and nonnasal symptoms of allergic rhinoconjunctivitis, while also showing a subjective improvement in the quality of life and in overall clinical impression. For chronic urticaria the symptoms (itching and the development of papules) lessens from the second day of treatment onwards, in a similar way to other antihistamines used as comparators. Bilastine should not be administered at meal times to avoid interference with the absorption process. It is not distributed to the central nervous system, is scarcely metabolized, and elimination is through the kidneys and feces, with a 14-hour elimination half-life. It has no effect on cytochrome P450. During clinical development, bilastine was shown to be a drug that is adequately tolerated, with a similar effect to placebo with regard to drowsiness and changes in heart rate. In relation to its use, headaches were the most frequent adverse effect to be reported. No cardiotoxic effects have been observed, and the therapeutic dose does not alter the state of alertness

Termoterapia transpupilar en neovascularización subretiniana oculta secundaria a degeneración macular asociada a la edad. Primeros resultados

To determine the efficacy of transpupillary thermotherapy (TTT) to treat choroidal neovascularization (CNV) in patients with age-related macular degeneration (ARMD). Patients and Methods: Eight patients (ten eyes) with occult CNV were treated by TTT. A 810 nm diode laser was used to perform TTT. The diode laser was delivered through a panfunduscopic contact lens. Results: Three eyes showed a visual acuity improvement and a decrease in exudation on fluorescein angiography. Four eyes remained stable. Nevertheless, lesions worsened after treatment in three cases. One of these cases suffered an overtreatment. Conclusions: TTT may be a useful therapy in some cases of CNV in patients with age-related macular degeneration. Randomized and multicentric studies are necessary to stablish precise indications of this therap

The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial

Objectives: The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment

The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial.

Background Ivermectin inhibits the replication of SARS-CoV-2 in vitro at concentrations not readily achievable with currently approved doses. There is limited evidence to support its clinical use in COVID-19 patients. We conducted a Pilot, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a single dose of ivermectin reduce the transmission of SARS-CoV-2 when administered early after disease onset. Methods Consecutive patients with non-severe COVID-19 and no risk factors for complicated disease attending the emergency room of the Clínica Universidad de Navarra between July 31, 2020 and September 11, 2020 were enrolled. All enrollments occurred within 72 h of onset of fever or cough. Patients were randomized 1:1 to receive ivermectin, 400 mcg/kg, single dose (n = 12) or placebo (n = 12). The primary outcome measure was the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment. The primary outcome was supported by determination of the viral load and infectivity of each sample. The differences between ivermectin and placebo were calculated using Fisher's exact test and presented as a relative risk ratio. This study is registered at ClinicalTrials.gov: NCT04390022. Findings All patients recruited completed the trial (median age, 26 [IQR 19-36 in the ivermectin and 21-44 in the controls] years; 12 [50%] women; 100% had symptoms at recruitment, 70% reported headache, 62% reported fever, 50% reported general malaise and 25% reported cough). At day 7, there was no difference in the proportion of PCR positive patients (RR 0·92, 95% CI: 0·77-1·09, p = 1·0). The ivermectin group had non-statistically significant lower viral loads at day 4 (p = 0·24 for gene E; p = 0·18 for gene N) and day 7 (p = 0·16 for gene E; p = 0·18 for gene N) post treatment as well as lower IgG titers at day 21 post treatment (p = 0·24). Patients in the ivermectin group recovered earlier from hyposmia/anosmia (76 vs 158 patient-days; p < 0.001). Interpretation Among patients with non-severe COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 72 h of fever or cough onset there was no difference in the proportion of PCR positives. There was however a marked reduction of self-reported anosmia/hyposmia, a reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials. Funding ISGlobal, Barcelona Institute for Global Health and Clínica Universidad de Navarra

High Protein Binding and Cidal Activity against Penicillin-Resistant S. pneumoniae: A Cefditoren In Vitro Pharmacodynamic Simulation

BACKGROUND: Although protein binding is a reversible phenomenon, it is assumed that antibacterial activity is exclusively exerted by the free (unbound) fraction of antibiotics. METHODOLOGY/PRINCIPAL FINDINGS: Activity of cefditoren, a highly protein bound 3(rd) generation cephalosporin, over 24h after an oral 400 mg cefditoren-pivoxil bid regimen was studied against six S. pneumoniae strains (penicillin/cefditoren MICs; microg/ml): S1 (0.12/0.25), S2 (0.25/0.25), S3 and S4 (0.5/0.5), S5 (1/0.5) and S6 (4/0.5). A computerized pharmacodynamic simulation with media consisting in 75% human serum and 25% broth (mean albumin concentrations = 4.85+/-0.12 g/dL) was performed. Protein binding was measured. The cumulative percentage of a 24h-period that drug concentrations exceeded the MIC for total (T > MIC) and unbound concentrations (fT > MIC), expressed as percentage of the dosing interval, were determined. Protein binding was 87.1%. Bactericidal activity (> or = 99.9% initial inocula reduction) was obtained against strains S1 and S2 at 24h (T > MIC = 77.6%, fT > MIC = 23.7%). With T > MIC of 61.6% (fT > MIC = 1.7%), reductions against S3 and S4 ranged from 90% to 97% at 12h and 24h; against S5, reduction was 45.1% at 12h and up to 85.0% at 24h; and against S6, reduction was 91.8% at 12h, but due to regrowth of 52.9% at 24h. Cefditoren physiological concentrations exerted antibacterial activity against strains exhibiting MICs of 0.25 and 0.5 microg/ml under protein binding conditions similar to those in humans. CONCLUSIONS/SIGNIFICANCE: The results of this study suggest that, from the pharmacodynamic perspective, the presence of physiological albumin concentrations may not preclude antipneumococcal activity of highly bound cephalosporins as cefditoren