A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial.

Background: Third generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES. Methods: A total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected. Results: Most of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints. Conclusions: The study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT03745053).

Morphological and ecological revision of Himantariella scutellaris Brolemann, 1926(Chilopoda: Geophilomorpha: Himantariidae).

Himantariella scutellaris Brolemann, 1926 has previously been considered a French endemic species from the eastern Pyrenees. New collecting data from the Spanish Pre-Pyrenees, the Prelitoral Mountain Range and the Cantabric Region, make it possible to expand its known distribution to the northern Iberian Peninsula. Intraspecific variability, habitat preferences and ethology are assessed for the first time. New figures on the morphology of H. scutellaris and identification keys for the European Himantariidae with terminal pore-fields are provided. Results showed a wider range of morphological variability than previously reported and allowed to update the diagnostic characters needed for identification. Additionally, results showed monticolous, synanthropic and nocturnal habits for the Iberian populations and suggest that H. scutellaris is a common species at a local scale. Finally, morphology and ecology of H. scutellaris from the Iberian Peninsula and the Pyrenees are discussed in depth.

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality. Clinical trial registration: [https://clinicaltrials.gov], identifier [NCT04500964].

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. METHODS: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. RESULTS: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. CONCLUSIONS: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bio prostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. METHODS: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. RESULTS: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. CONCLUSIONS: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.

Evolution, Clinical and Microbiological Characteristics of Invasive Pneumococcal Disease since the Introduction of the Pneumococcal Conjugate Vaccine 13-Valent in Adults over 18 Years Old.

Invasive pneumococcal disease (IPD) presents high mortality in the population at risk. The aim of this work is to know the evolution, clinical and microbiological characteristics of IPD in the adult population of Majorca, since the introduction of a public funded program for pneumococcal conjugate vaccine (PCV-13) in the pediatric population in the Balearic Islands in 2016. For this purpose, a retrospective multicenter study was carried out in which all episodes of IPD in adult patients from the four hospitals of the public health system of Majorca were included, comparing the periods between 2012 and 2015 and between 2016 and 2019. Clinical variables, serotypes and antibiotic sensitivity were collected. There were 498 cases of IPD; 56.8% were male with a mean age of 67 (standard deviation: 16). Most infections were bacterial pneumonias (73.7%). Of the total cases, 264 (53%) presented complications. Of the 498 cases, 351 strains were obtained, of which 145 (41.3%) belong to vaccinal serotypes (included in the PCV-13 vaccine) and 206 (58.7%) to non-vaccinal serotypes (not included in the PCV-13 vaccine). The percentage of IPD caused by vaccinal serotypes was lower in the second period (47.8% vs. 34.5%; p = 0.012).

A Genomic Snapshot of the SARS-CoV-2 Pandemic in the Balearic Islands.

Objective: To analyze the SARS-CoV-2 genomic epidemiology in the Balearic Islands, a unique setting in which the course of the pandemic has been influenced by a complex interplay between insularity, severe social restrictions and tourism travels. Methods: Since the onset of the pandemic, more than 2,700 SARS-CoV-2 positive respiratory samples have been randomly selected and sequenced in the Balearic Islands. Genetic diversity of circulating variants was assessed by lineage assignment of consensus whole genome sequences with PANGOLIN and investigation of additional spike mutations. Results: Consensus sequences were assigned to 46 different PANGO lineages and 75% of genomes were classified within a VOC, VUI, or VUM variant according to the WHO definitions. Highest genetic diversity was documented in the island of Majorca (42 different lineages detected). Globally, lineages B.1.1.7 and B.1.617.2/AY.X were identified as the 2 major lineages circulating in the Balearic Islands during the pandemic, distantly followed by lineages B.1.177/B.1.177.X. However, in Ibiza/Formentera lineage distribution was slightly different and lineage B.1.221 was the third most prevalent. Temporal distribution analysis showed that B.1 and B.1.5 lineages dominated the first epidemic wave, lineage B.1.177 dominated the second and third, and lineage B.1.617.2 the fourth. Of note, lineage B.1.1.7 became the most prevalent circulating lineage during first half of 2021; however, it was not associated with an increased in COVID-19 cases likely due to severe social restrictions and limited travels. Additional spike mutations were rarely documented with the exception of mutation S:Q613H which has been detected in several genomes (n = 25) since July 2021. Conclusion: Virus evolution, mainly driven by the acquisition and selection of spike substitutions conferring biological advantages, social restrictions, and size population are apparently key factors for explaining the epidemic patterns registered in the Balearic Islands.

Automated urinalysis combining physicochemical analysis, on-board centrifugation, and digital imaging in one system: A multicenter performance evaluation of the cobas 6500 urine work area.

BACKGROUND: We evaluated the analytical performance of the fully automated cobas® 6500 urine work area and its automated components-cobas u 601 and cobas u 701. DESIGN AND METHODS: The study was conducted at three European centers using un-centrifuged surplus routine urine samples; all measurements were performed within 2 h of sample collection. Precision, sample carry-over, and method comparisons were evaluated per Clinical and Laboratory Standards Institute guidelines. Method comparisons: cobas u 601 versus Urisys 2400 and cobas u 411 urine test strips; and cobas u 701 versus KOVA® visual microscopy and iQ200 analyzer. Operability and functionality were assessed using questionnaires. RESULTS: Precision of the entire cobas 6500 system was within predefined acceptance limits and no significant carry-over was observed. Erythrocytes, leukocytes, nitrites, and protein were in good agreement (≥93%) with cobas u 411 reflectometry. High correlation was shown between the cobas u 701 analyzer and KOVA visual microscopy for red blood cells (RBC; slope, 0.89; Pearson's r, 0.95) and white blood cells (WBC; slope, 0.96; Pearson's r, 0.96), demonstrating equivalence of test results. The 97.5% percentile reference values on the cobas u 701 analyzer were 5.3 cells/µL (RBC) and 6.2 cells/µL (WBC). The cobas 6500 system showed good sensitivity for small bacteria (>1 µm) and pathological casts, and the user interface, maintenance wizards, and system design were highly rated by operators. CONCLUSIONS: The fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.

Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?

BACKGROUND: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

BACKGROUND: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AIM: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). METHODS: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. CONCLUSIONS: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.

Radial Artery Embolism: A Rare Complication of Angioplasty.

We present a 55-year-old man with multivessel coronary artery disease previously treated with stenting of the left main, left anterior descending, right coronary, circumflex, and first diagonal branch. He was diagnosed with in-stent restenosis of a diagonal branch, but treatment was complicated by radial artery coronary embolism, which is a rare complication of radial intervention.

Assessment of Inducible Myocardial Ischemia, Quality of Life, and Functional Status After Successful Percutaneous Revascularization in Patients With Chronic Total Coronary Occlusion.

The benefits of chronic total coronary occlusion (CTO) revascularization are not well established. In this prospective cohort study, 47 consecutive patients with successful percutaneous recanalization of CTO underwent adenosine stress cardiac magnetic resonance (CMR), 6-minute walk test (6MWT), and the Short Form-36 Health Survey before and 6 months after the procedure. Successful recanalization of a CTO was followed by significant improvement of (1) global physical and mental health status; (2) the distance walked in the 6MWT; (3) the incidence of chest pain at the end of the 6MWT; and (4) the score of a novel CMR ischemic burden index on the basis of the characteristics of adenosine stress perfusion defects (extension, persistence, transmurality, and induced contractile regional dysfunction). Patients with greater CMR ischemic index before percutaneous revascularization showed better improvement in the 6MWT. In conclusion, successful recanalization of a CTO leads to a concurrent improvement in ischemic burden, exercise tolerance, angina frequency, and quality of life scores. Patients with a high ischemic CMR score before CTO recanalization showed the better improvement in exercise tolerance.

[Health in all policies and intersectoriality in health promotion: the Public Health Interdepartmental Plan of Catalonia]. / Salud en Todas las Políticas e intersectorialidad en la promoción de la salud: el Plan Interdepartamental de Salud Pública (PINSAP) de Cataluña.

In February 2014, the autonomous government in Catalonia, the Generalitat de Catalunya, approved the Catalan Public Health System Interdepartmental Plan (PINSAP, as per the Catalan acronym), responsible for the strategy in Catalonia for Health in All Policies, as recommended by the WHO and other international institutions. The PINSAP, as outlined under the Catalan Public Health Law, is binding for the government. The Plan was drawn up by the Interdepartmental Health Commission (CIS, as per the Catalan acronym) and is a collaboration between all Departments of the Generalitat. The Plan also receives contributions from 42 local, social and scientific bodies. Apart from the specific initiatives performed by each department which have a greater impact on health, the Plan proposes 30 initiatives, which are defined by their collaboration between public sectors, targeting determining health factors and paying special attention to combating inequalities and measuring the impact on health. The PINSAP encourages interdepartmental initiatives and collaboration between public sectors regarding determinants of health. Although it is only in its first year of implementation, many of their initiatives are already up and running and involving many healthcare professionals in Catalonia.

Salud en Todas las Políticas e intersectorialidad en la promoción de la salud: el Plan Interdepartamental de Salud Pública (PINSAP) de Cataluña / Health in all policies and intersectoriality in health promotion: the Public Health Interdepartmental Plan of Catalonia

En febrero de 2014, el Gobierno de Cataluña aprobó el Plan Interdepartamental de Salud Pública (PINSAP), que concreta para esta comunidad la estrategia de Salud en Todas las Políticas recomendada por la Organización Mundial de la Salud y otras instituciones internacionales. El PINSAP, recogido en la Ley de Salud Pública de Cataluña, es vinculante para el gobierno. Fue elaborado por la Comisión Interdepartamental de Salud, en la que participan todos los departamentos de la Generalitat de Catalunya, y recibió aportaciones de 42 entidades locales, sociales y científicas. Aparte de las actuaciones propias de cada departamento que tienen más impacto sobre la salud, propone 30 actuaciones de marcado carácter intersectorial centradas en los determinantes de la salud, y con especial énfasis en la lucha frente a las desigualdades y la evaluación del impacto en salud. El PINSAP potencia la actuación interdepartamental e intersectorial sobre los determinantes de la salud. Aunque solo está en su primer año de implementación, muchas de sus actuaciones ya están en marcha e implica a numerosos profesionales de Cataluña (AU)

In February 2014, the autonomous government in Catalonia, the Generalitat de Catalunya, approved the Catalan Public Health System Interdepartmental Plan (PINSAP, as per the Catalan acronym), responsible for the strategy in Catalonia for Health in All Policies, as recommended by the WHO and other international institutions. The PINSAP, as outlined under the Catalan Public Health Law, is binding for the government. The Plan was drawn up by the Interdepartmental Health Commission (CIS, as per the Catalan acronym) and is a collaboration between all Departments of the Generalitat. The Plan also receives contributions from 42 local, social and scientific bodies. Apart from the specific initiatives performed by each department which have a greater impact on health, the Plan proposes 30 initiatives, which are defined by their collaboration between public sectors, targeting determining health factors and paying special attention to combating inequalities and measuring the impact on health. The PINSAP encourages interdepartmental initiatives and collaboration between public sectors regarding determinants of health. Although it is only in its first year of implementation, many of their initiatives are already up and running and involving many healthcare professionals in Catalonia (AU)

Cierre percutáneo de la orejuela izquierda con el nuevo dispositivo Amulet TM: factibilidad, seguridad y eficacia a corto plazo / Left atrial appendage occlusion with the new Amulet TM device: feasibility, safety and short-term efficacy

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Cierre de comunicación interventricular posinfarto guiado por tomografía computarizada cardiaca / Cardiac computed tomography-guided closure of ventricular septal defect secondary to myocardial infarction

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Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis.

BACKGROUND: Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. METHODS: We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. RESULTS: A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). CONCLUSIONS: A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.

Is response to fire influenced by dietary specialization and mobility? A comparative study with multiple animal assemblages.

Fire is a major agent involved in landscape transformation and an indirect cause of changes in species composition. Responses to fire may vary greatly depending on life histories and functional traits of species. We have examined the taxonomic and functional responses to fire of eight taxonomic animal groups displaying a gradient of dietary and mobility patterns: Gastropoda, Heteroptera, Formicidae, Coleoptera, Araneae, Orthoptera, Reptilia and Aves. The fieldwork was conducted in a Mediterranean protected area on 3 sites (one unburnt and two burnt with different postfire management practices) with five replicates per site. We collected information from 4606 specimens from 274 animal species. Similarity in species composition and abundance between areas was measured by the Bray-Curtis index and ANOSIM, and comparisons between animal and plant responses by Mantel tests. We analyze whether groups with the highest percentage of omnivorous species, these species being more generalist in their dietary habits, show weak responses to fire (i.e. more similarity between burnt and unburnt areas), and independent responses to changes in vegetation. We also explore how mobility, i.e. dispersal ability, influences responses to fire. Our results demonstrate that differences in species composition and abundance between burnt and unburnt areas differed among groups. We found a tendency towards presenting lower differences between areas for groups with higher percentages of omnivorous species. Moreover, taxa with a higher percentage of omnivorous species had significantly more independent responses of changes in vegetation. High- (e.g. Aves) and low-mobility (e.g. Gastropoda) groups had the strongest responses to fire (higher R scores of the ANOSIM); however, we failed to find a significant general pattern with all the groups according to their mobility. Our results partially support the idea that functional traits underlie the response of organisms to environmental changes caused by fire.