Using Large Language Models to Enhance the Reusability of Sensor Data.

The Internet of Things generates vast data volumes via diverse sensors, yet its potential remains unexploited for innovative data-driven products and services. Limitations arise from sensor-dependent data handling by manufacturers and user companies, hindering third-party access and comprehension. Initiatives like the European Data Act aim to enable high-quality access to sensor-generated data by regulating accuracy, completeness, and relevance while respecting intellectual property rights. Despite data availability, interoperability challenges impede sensor data reusability. For instance, sensor data shared in HTML formats requires an intricate, time-consuming processing to attain reusable formats like JSON or XML. This study introduces a methodology aimed at converting raw sensor data extracted from web portals into structured formats, thereby enhancing data reusability. The approach utilises large language models to derive structured formats from sensor data initially presented in non-interoperable formats. The effectiveness of these language models was assessed through quantitative and qualitative evaluations in a use case involving meteorological data. In the proposed experiments, GPT-4, the best performing LLM tested, demonstrated the feasibility of this methodology, achieving a precision of 93.51% and a recall of 85.33% in converting HTML to JSON/XML, thus confirming its potential in obtaining reusable sensor data.

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry.

OBJECTIVES: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. BACKGROUND: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. METHODS: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). RESULTS: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. CONCLUSIONS: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

Long-term outcomes and predictors of morbi-mortality according to age in stemi patients with multivessel disease: Impact of an incomplete revascularization.

BACKGROUND: Optimal management strategy for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) still remains unclear, especially in the elderly population. The aim of this study was to assess long-term outcomes and predictors of morbi-mortality according to age in patients with a STEMI and MVD. METHODS: We prospectively included 381 consecutive patients with a STEMI who underwent primary angioplasty and showed MVD in the angiogram. 111 (29.1%) patients were older than 75 (≥75) years and 270 (70.9%) were younger than 75 (<75) years. The co-primary outcomes were the incidence of all-cause mortality and major adverse cardiac events (MACE) during follow-up. RESULTS: During a median follow-up of 22 months, patients ≥75 years showed a higher incidence of all-cause mortality and MACE, as compared to younger patients. On multivariate analysis, incomplete revascularization (IR) was only an independent predictor of MACE (HR = 3.1, CI 95%:1.9-4.7; P = .02) in younger patients; whereas in the elderly group severely depressed ejection fraction was the unique independent predictor of MACE (HR = 2.7, CI 95%:1.5-4.8; P = .001). IR was not associated with the risk of all-cause mortality in any group. CONCLUSION: This study confirms the relevant prevalence of MVD in STEMI patients, as well as the difference in outcomes of an IR strategy between both age-groups, being only independently associated with MACE in younger patients. This finding supports that a routine complete revascularization (CR) strategy seems to be the best therapeutic option in younguer patients, whereas in the elderly population may not confer a clear clinical benefit during a long-term follow-up.

In-hospital versus after-discharge complete revascularization in patients with ST segment elevation myocardial infarction and multivessel disease. REVIVA-ST trial.

INTRODUCTION: Complete revascularization (CR) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD), is associated with a reduction in major adverse cardiovascular events (MACE). However, there is uncertainty about whether nonculprit-lesion revascularization should be performed, during index hospitalization or delayed, especially regarding health care resources utilization. In this study, we aimed to evaluate the impact of in-hospital nonculprit-lesion revascularization vs. delayed (after discharge) revascularization on the length of index hospitalization. METHODS: In this single-center study, we randomly assigned patients with STEMI and MVD who underwent successful culprit-lesion PCI to a strategy of either CR during in-hospital admission or a delayed CR after discharge. The first primary endpoint was the length of hospital stay. The second endpoint was the composite of cardiovascular death, myocardial infarction or ischemia-driven revascularization at 12 months (MACE). RESULTS: From January 2018 to December 2022, we enrolled 258 patients (131 allocated to CR during in-hospital admission and 127 to an after-discharge CR). We found a significant reduction in the length of hospital stay in those assigned to after-discharge CR strategy [4 days (3-5) versus 7 days (5-9); p = 0.001]. At 12-month of follow-up, no differences were found in the occurrence of MACE, 7 (5.34%) patients in in-hospital CR and 4 (3.15%) in after-discharge CR strategy; (hazard ratio, 0.59; 95% confidence interval, 0.17 to 2.02; p = 0.397). CONCLUSIONS: In STEMI patients with MVD, an after-discharge CR strategy reduces the length of index hospitalization without an increased risk of MACE after 12 months of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04743154.

Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry.

INTRODUCTION AND OBJECTIVES: Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes. METHODS: This Investigator-initiated multicenter registry aimed to include consecutive patients with intermediate-high risk (IHR) or high-risk (HR), acute PE eligible for CDT. The primary outcome of the study was in-hospital all-cause death. RESULTS: A total of 253 patients were included, of whom 93 (36.8%) had HR-PE, and 160 (63.2%) had IHR-PE with a mean age of 62.3±15.1 years. Local thrombolysis was performed in 70.8% and aspiration thrombectomy in 51.8%, with 23.3% of patients receiving both. However, aspiration thrombectomy was favored in the HR-PE cohort (80.6% vs 35%; P<.001). Only 51 patients (20.2%) underwent CDT with specific PE devices. The success rate for CDT was 90.9% (98.1% of IHR-PE patients vs 78.5% of HR-PE patients, P<.001). In-hospital mortality was 15.5%, and was highly concentrated in the HR-PE patients (37.6%) and significantly lower in IHR-PE patients (2.5%), P<.001. Long-term (24-month) mortality was 40.2% in HR-PE patients vs 8.2% in IHR-PE patients (P<.001). CONCLUSIONS: Despite the high success rate for CDT, in-hospital mortality in HR-PE is still high (37.6%) compared with very low IHR-PE mortality (2.5%).

Spanish cardiac catheterization and coronary intervention registry. 33rd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2023).

INTRODUCTION AND OBJECTIVES: This article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC). METHODS: All interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board. RESULTS: A total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism. CONCLUSIONS: The 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases.

Long-term recurrent events in ST-elevation myocardial infarction and multivessel disease. The impact of different revascularization strategies.

INTRODUCTION: The benefit of complete revascularization (CR) on long-term total event reduction in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD), still remains unclear. We assessed the efficacy of three different revascularization strategies on long-term total recurrent events. METHODS: We retrospectively analyzed 414 consecutive patients admitted with STEMI and MVD who were categorized according to the revascularization strategy used: culprit-vessel-only percutaneous coronary intervention (PCI) (n=163); in-hospital CR (n=136); and delayed CR (n=115). The combined endpoint assessed was all-cause mortality, the total number of myocardial infarctions, ischemia-driven revascularizations or strokes. Negative binomial regression was used to assess the association between the revascularization strategy and total events; risk estimates were expressed as an incidence rates ratio (IRR). RESULTS: At a median follow-up of four years (1.2-6), rates of the combined endpoint per 10 patient-years were 18, 0.8, and 0.6 in culprit-vessel-only PCI, in-hospital CR, and delayed CR strategies, respectively (p<0.001). After multivariable adjustment and when compared with culprit-vessel-only PCI, both in-hospital and delayed CR strategies were significantly associated with a reduction in the combined endpoint (IRR=0.40: 95% confidence interval (CI), 0.25-0.64; p<0.001; and IRR 0.40: 95% CI, 0.24-0.62; p<0.001, respectively). No differences were observed across in-hospital and delayed CR strategies. CONCLUSIONS: Complete revascularization of non-culprit lesions in patients with STEMI and MVD reduces the risk of total recurrent events during long-term follow-up. No differences between in-hospital and delayed CR strategies were found.

Transcatheter aortic valve implantation in patients with extra-small aortic annuli.

BACKGROUND: A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce. AIMS: The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA. METHODS: A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV). RESULTS: A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up. CONCLUSIONS: TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.

Inaccuracy of a non-invasive estimation of pulmonary vascular resistance assessed by cardiovascular magnetic resonance in heart failure patients.

Pulmonary vascular resistance (PVR) is a marker of pulmonary vascular remodeling. A non-invasive model assessed by cardiovascular magnetic resonance (CMR) has been proposed to estimate PVR. However, its accuracy has not yet been evaluated in patients with heart failure. We prospectively included 108 patients admitted with acute heart failure (AHF), in whom a right heart catheterization (RHC) and CMR were performed at the same day. PVR was estimated by CMR applying the model: PVR = 19.38 - [4.62 × Ln pulmonary artery average velocity (in cm/s)] - [0.08 × right ventricle ejection fraction (in %)], and by RHC using standard formulae. The median age of the cohort was 67 years (interquartile range 58-73), and 34% were females. The median of PVR assessed by RHC and CMR were 2.2 WU (1.5-4) and 5 WU (3.4-7), respectively. We found a weak correlation between invasive PVR and PVR assessed by CMR (Spearman r = 0.21, p = 0.02). The area under the ROC curve for PVR assessed by CMR to detect PVR ≥ 3 WU was 0.57, 95% confidence interval (CI): 0.47-0.68. In patients with AHF, the non-invasive estimation of PVR using CMR shows poor accuracy, as well as a limited capacity to discriminate increased PVR values.

First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study.

OBJECTIVES: We sought to investigate stent healing and neointimal hyperplasia with ihtDEStiny drug-eluting stent (DES) by optical coherence tomography (OCT) examination conducted 9 months after implantation. BACKGROUND: The currently used DES present certain features that have been linked separately to their better performance in terms of efficacy and safety. METHODS: First-in-man, prospective and multicenter study including patients treated with ihtDEStiny stent undergoing OCT examination at 9 months follow up. The ihtDEStiny stent is a sirolimus eluting stent with an oval shape ultrathin struts (68 µm) and an abluminal coating of a fluoropolymer containing the antiplatelet agent triflusal. Primary endpoint was the percentage of obstruction of the in-stent volume by the neointima. RESULTS: In 58 patients (63 lesions) in-stent late lumen loss was 0.11 ± 0.23 mm (95% CI 0.05-0.16) with only in 6% of stents being > 0.5 mm and in-segment binary stenosis was 1.6%. In OCT mean neointima volume obstruction was 10.5 ± 6.9% with a mean neointima thickness of 110.9 ± 89.8 µm. The proportion of uncovered struts was 2.5%, malapposed struts 1.1% and malapposed/uncovered struts 0.7% and no subclinical thrombi detected. Mean incomplete stent apposition area was 0.1 ± 0.1 mm2. At 12 months target lesion revascularization rate was 3% and no stent thrombosis was reported. CONCLUSIONS: In this study the ihtDEStiny stent has shown a very low degree of neointimal proliferation associated with a low rate of uncovered/malapposed struts and total absence of subclinical thrombi at 9 months follow up.

Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device.

BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Acute Kidney Injury After Percutaneous Edge-to-Edge Mitral Repair.

BACKGROUND: In catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. OBJECTIVES: This study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. METHODS: A total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. RESULTS: The mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). CONCLUSIONS: Despite being a "zero-contrast" procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.

Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement.

BACKGROUND: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes. OBJECTIVES: This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade. METHODS: The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex. RESULTS: We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time. CONCLUSIONS: In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.

[Morbidity in Prematurity Associated with Fetal Growth Restriction: Experience of a Tertiary Care Center]. / Morbilidade na Prematuridade Associada a Restrição do Crescimento Fetal e nos Prematuros Leves para a Idade Gestacional: Experiência de um Centro de Referência.

INTRODUCTION: Prematurity and low birth weight have been associated with increased neonatal morbidity and mortality. This study aimed to evaluate possible risk factors for prematurity associated with fetal growth restriction and being small for gestational age and to determine the incidence of morbidity in these two groups of infants. MATERIAL AND METHODS: Retrospective case-control study of newborns with gestational age of less than 32 weeks, with obstetric diagnosis of fetal growth restriction and with the clinical diagnosis of small for gestational age, admitted to the Neonatal Intensive Care Unit of a tertiary hospital for a period of six years. RESULTS: A total of 356 newborns were studied, with an incidence of 11% of fetal growth restriction and 18% of small for gestational age. Pre-eclampsia was the risk factor for gestation with higher statistical significance (47% vs 16%, p < 0.001) in small for gestational age newborns. There was also a higher incidence of mild bronchopulmonary dysplasia (66% vs 38%, p = 0.005), late sepsis (59% vs 37%, p = 0.003), retinopathy of prematurity (58% vs 26%, p = 0.003) and necrotizing enterocolitis (20% vs 9%, p = 0.005). Mortality was similar in all three groups. DISCUSSION: There were fewer newborn males diagnosed with fetal growth restriction during pregnancy compared to women. Significant differences were observed in the group of these infants regarding the occurrence of chorioamnionitis and pre-eclampsia in comparison to the control group. Newborns with fetal growth restriction and small for age had higher scores on clinical risk indices compared to the control group. In general, small for gestational age newborns had a higher incidence of morbidity than infants with fetal growth restriction and the control group. CONCLUSION: Advances in neonatal intensive care decreased mortality in preterm infants. However, there are still significant differences in the incidence of morbidity in newborns with growth compromise. The collaboration between obstetricians and neonatologists provides the basis for a correct clinical evaluation, early signaling and global intervention on these newborns, with a significant impact on short and long-term prognosis.

Introdução: A prematuridade e o baixo peso ao nascer têm sido associados a maior morbilidade e mortalidade neonatais. Este estudo teve como objetivo avaliar possíveis fatores de risco para a prematuridade associada a restrição do crescimento fetal e a recém-nascidos leves para a idade gestacional e determinar a incidência da morbilidade nestes dois grupos de recém-nascidos.Material e Métodos: Estudo caso-controlo retrospetivo dos recém-nascidos com idade gestacional inferior a 32 semanas, com o diagnóstico obstétrico de restrição do crescimento fetal e com o diagnóstico clínico de leves para a idade gestacional, internados na Unidade de Cuidados Intensivos Neonatais de um hospital terciário, durante um período de seis anos.Resultados: Foram estudados 356 recém-nascidos, observando-se uma incidência de 11% de restrição do crescimento fetal e 18% de leves para a idade gestacional. A pré-eclâmpsia foi o fator de risco da gestação com maior significado estatístico (47% vs 16%, p < 0,001) nos recém-nascidos leves para a idade gestacional. Observou-se também, nestes recém-nascidos, maior incidência de displasia broncopulmonar ligeira (66% vs 38%, p = 0,005), de sépsis tardia (59% vs 37%, p = 0,003), de retinopatia da prematuridade (58% vs 26%, p = 0,003) e de enterocolite necrotizante (20% vs 9%, p = 0,005). A mortalidade foi idêntica nos três grupos.Discussão: Encontraram-se menos recém-nascidos do sexo masculino diagnosticados com restrição do crescimento fetal durante a gravidez comparativamente ao sexo feminino. Observaram-se diferenças significativas no grupo destes recém-nascidos, quanto à ocorrência de corioamnionite e de pré-eclâmpsia, face ao grupo controlo. Tanto os recém-nascidos com restrição do crescimento fetal como os leves para a idade gestacional apresentaram uma pontuação mais elevada nos índices de risco clínico comparativamente ao grupo controlo. De forma global, os recém-nascidos leves para a idade gestacional tiveram maior incidência de morbilidade que os recém-nascidos com restrição do crescimento fetal e que o grupo controlo.Conclusão: Os avanços nos cuidados intensivos neonatais diminuíram a mortalidade nos recém-nascidos prematuros. Contudo, observam-se ainda diferenças significativas na incidência da morbilidade nos recém-nascidos com compromisso do crescimento. A colaboração entre obstetras e neonatalogistas constitui a base para uma correta avaliação clínica, sinalização precoce e intervenção global sobre estes recém-nascidos, com impacto significativo no prognóstico a curto e longo prazo.

Diffuse infantile hepatic haemangioma-how to manage an incidental but potentially lethal finding.

Infantile hepatic haemangioma (IHH) is a rare vascular tumour that is potentially lethal due to its associated complications, including heart failure, hepatic failure, hypothyroidism and abdominal compartment syndrome. The authors report a case of an asymptomatic diffuse IHH in a newborn male, which was presented as an incidental finding at the time that the patient was diagnosed with pyloric stenosis. The patient was treated with increasing doses of propranolol that were well tolerated. With the regression of the IHH by the time that the patient reached one year of age, there was a significant imagiologic improvement. Because there is no consensus on the optimal approach for the treatment of liver tumours in newborns, it is important to adopt a systematic approach. After the diagnosis of diffuse IHH has been established, the decision to initiate treatment and the therapeutic of choice is often controversial. Regular follow-up is recommended to monitor possible complications.

Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry.

AIMS: The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications. METHODS AND RESULTS: A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027). The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009). CONCLUSIONS: Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.

[Efficacy of sirolimus-eluting stents in diabetics with complex coronary lesions]. / Utilidad de los stents recubiertos de rapamicina en pacientes diabéticos con lesiones coronarias complejas.

INTRODUCTION AND OBJECTIVES: Diabetics are at an increased risk of restenosis and adverse events after coronary stenting. Drug-eluting stents may, therefore, be useful in these patients. Our objective was to evaluate the use of sirolimus-eluting stents in diabetics with complex coronary lesions. PATIENTS AND METHOD: Between May 2002 and August 2003, we treated 231 patients with 260 complex coronary lesions using sirolimus-eluting stents. Of these patients, 56% did not have diabetes (ND), 22% had non-insulin-dependent diabetes (NIRD), and 20% had insulin-dependent diabetes (IRD). The primary clinical endpoint was target vessel failure at 1 year. The primary angiographic endpoints in the stent were late loss and binary restenosis at 6 months. RESULTS: At 6 months, late loss was greater in the IRD group (0.35 [0.71] mm) than in the ND group (0,096 [0.54] mm; P =.016) or the NIRD group (0.058 [0.52] mm; P=.017), and restenosis was more frequent (IRD, 16.3%; ND, 6.3%; and NIRD 7.8%; P=.05 for linear trend). At one year, target vessel failure occurred more frequently in the IRD group (IRD, 17.4%; NIRD, 7.7%; ND, 7.7%; P=.07 for linear trend) and the rate of survival free of target vessel failure was lower in the IRD group (82.1%) compared with the ND group (92.3%, P=.06) or the NIRD group (92.3%, P=NS). The only independent predictor of restenosis and target vessel failure was female sex. CONCLUSIONS: Despite IRD patients having greater late lumen loss and more frequent restenosis at six months and a trend towards a poorer clinical outcome at 1 year, no independent relationship was found between type of diabetes and clinical outcome.

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.

Incidence and predictors of restenosis after sirolimus-eluting stent implantation in high-risk patients.

BACKGROUND: Sirolimus-eluting stents (SESs) have not been evaluated systematically in clinical scenarios or with the vascular morphologies associated with the highest rates of restenosis. METHODS: Between May 2002 and August 2003, 1379 percutaneous interventions were carried out at our center, 231 with SES implantation in patients with complex coronary lesions: (1) left main trunk, (2) bifurcations, (3) long lesions, (4) calcified lesions, (5) proximal segment of the left anterior descending coronary, (6) restenotic lesions, (7) total occlusions, (8) ostial lesions, and (9) vessels < 2.75 mm. Angiographic follow-up was carried out in the 6th month in 201 patients. Clinical, angiographic, and procedural variables were analyzed to assess predictors of restenosis. RESULTS: Of the patients, 42.6% were diabetic and 20.2% were insulin dependent. A total of 263 lesions was treated. Mean lesion length was 16.5 +/- 11 mm and mean vessel diameter was 2.54 +/- 0.7 mm. A total of 327 stents was implanted to fully cover the entire lesion, in most cases after predilatation (89.1%). The mean segment length covered by the stent was 26 +/- 12 mm and the stent length/lesion length ratio was 1.7 +/- 0.9. Binary restenosis was found in 8.7%, but there was no edge restenosis. The only predictors of restenosis were female sex (OR 3.44, 95% CI 1.31-8.99, P = .011) and lesion length > 30 mm (OR 3.39, 95% CI 1.07-10.77, P = .038). CONCLUSIONS: In scenarios that usually entail high restenotic risk in patients with conventional stent implantation, SESs had a low incidence of restenosis without edge complications.