BACKGROUND:Transcatheter devices designed for calcific aortic stenosis are not optimised for use in native aortic regurgitation, and data on aortic regurgitation-dedicated platforms are limited. The extended ALIGN-AR pivotal experience with a prospectively enrolled continued-access cohort and longer follow-up aimed to characterise the safety, valve function, and clinical outcomes of transcatheter aortic valve intervention (TAVI) with a dedicated device in aortic regurgitation. METHODS:ALIGN-AR is a prospective, multicentre, single-arm study enrolling patients at high surgical risk to undergo TAVI with a dedicated valve (Trilogy valve) for symptomatic moderate-to-severe or severe aortic regurgitation at 30 centres in the USA. Coprimary endpoints were a safety composite of major adverse events within 30 days post procedure (all-cause death, stroke, life-threatening or major bleeding, acute kidney injury, major vascular complications, need for additional surgical or percutaneous interventions, new pacemaker implantation, and moderate or greater aortic regurgitation), tested for non-inferiority against a margin of 1·35 applied to literature-based incidence of safety endpoint of 30% translating to performance goal of 40·5%, and 1-year all-cause mortality, tested for superiority against a performance goal of 25·0%. Analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04415047), and is ongoing. FINDINGS:Between June 8, 2018, and July 29, 2025, we screened 1352 patients and enrolled 700 patients (pivotal cohort n=180; continued access cohort n=520). Median age was 79·0 years (IQR 72·0-84·0), 321 (46%) were female, 379 (54%) were male, and 532 (76%) were White, 68 (10%) were Black or African American, and 36 (5%) were Asian. Technical success was achieved in 664 (95%) patients. The median duration of follow-up was 472 days (IQR 352-891). The 30-day primary safety composite endpoint occurred in 168 patients (24·0% [upper 97·5% CI 27·3%]; pnon-inferiority<0·0001), meeting the performance goal. Among components of the composite safety endpoint, death occurred in 11 (1·6%), stroke in 12 (1·7%), new pacemaker implantation in 127 (21·6%) of 589, moderate aortic regurgitation in three (0·5%) of 569 and severe aortic regurgitation in none. All-cause mortality occurred in 38 at 1 year (7·7% [upper 97·5% CI 10·4%]; psuperiority<0·0001), meeting the performance goal, and in 53 (13·3%) at 2 years. INTERPRETATION:In patients with symptomatic moderate-to-severe or severe aortic regurgitation considered to be of high surgical risk, TAVI with a dedicated platform met prespecified safety and effectiveness performance goals. We observed substantial reductions in aortic regurgitation, favourable valve haemodynamics and myocardial remodelling, with associated improvements in functional status and quality-of-life gains up to 2 years. These data support TAVI with a purpose-built device as a feasible and effective treatment option for selected patients with native aortic regurgitation who are at high risk for death or complications after surgery. FUNDING:JenaValve Technology.

Allergic granulomatous angiitis depicts the pathological basis of the so-called ChurgStrauss syndrome, an autoimmune process characterised by asthma or allergic rhinitis, symptomatic vasculitis and prominent eosinophilia. The myocardium is affected in two-thirds of cases, associated with a mortality rate >50 when the lung or gastro-intestinum is afflicted. We report the case of a 25-year-old male patient who was referred to our institution owing to dyspnoea and angina pectoris. Chest radiography showed bilateral alveolar …

Background JenaValve’s Trilogy transcatheter heart valve (THV) (JenaValve Inc, Irvine, CA) is the only conformité européenne-marked THV system for the treatment of aortic regurgitation (AR) or aortic stenosis (AS). However, its efficacy has not been quantitatively investigated pre- and post-implantation using video-densitometric analysis. Methods Using the CAAS-A-Valve 2.1.2 software (Pie Medical Imaging, Maastricht, the Netherlands), an independent core lab retrospectively analyzed the aortograms of 88 consecutive patients (68 severe AR; 20 severe AS) receiving the JenaValve THV in three European centers. Video-densitometric AR was categorized by the regurgitant fraction (RF) as none/trace AR (RF ≤ 6%), mild (6% < RF ≤ 17%), and moderate/severe AR (RF > 17%). Results Pre- and post-THV aortograms were analyzable in 17 (22.4%) and 47 (54.0%) patients, respectively. The main reasons preventing analysis were the descending aorta overlap of the outflow tract (30%) and insufficient frame count (6%). The median RF pre- and post-THV implant was 31.0% (interquartile range 21.5-38.6%) and 5.0% (interquartile range 1.0-7.0%, p < 0.001), respectively. The post-THV incidence of none/trace AR was 72.3%, and of mild AR, 27.7%, with no cases of moderate/severe AR. Video-densitometry analysis of the 12 AR cases with paired pre- and post-THV showed a reduction in the RF of 21.8% ± 8.1%. Conclusions Quantitative aortography confirms the low rates of AR and the large reduction in RF following the implantation of Jenavalve’s Trilogy THV, irrespective of implant indication. However, these limited data need corroborating in prospective studies using standardized acquisition protocols.

• We report the step by step approach for JenaValve TAVR and early use of non-dedicated THV devices for severe pure native AR • This is the first report on videodensitometry quantification of AR before and after JenaValve TAVR for severe pure native AR. • Videodensitometry shows decrease of AR regurgitation fraction from 55% to 0% after JenaValve TAVR.

Vitamin D has a well-known critical role in calcium and bone homeostasis. In recent years, there has been an increased interest in the potential regulatory role of vitamin D on metabolic pathways implicated in muscle functions. Evidence coming from epidemiologic studies has demonstrated that poor vitamin D status is associated with worse muscle functions. However, whether vitamin D deficiency and supplementation has a role on sarcopenia is not fully known. This review will focus on current knowledge and emerging data regarding the role of vitamin D in muscle functions and sarcopenia.

Recently, transcatheter therapy has expanded the treatment options for patients with heart valve disease. With the growing understanding of tricuspid regurgitation and its natural history, it becomes increasingly obvious that this patient population is a heterogeneous cohort presenting for treatment in different stages of a continuous disease process. It is still unclear which interventional approach will result in functional and clinical success and in which subtype of patient population. This article reviews the pathophysiologic background and current evidence for caval valve implantation and examines the potential role of this approach for the treatment of severe tricuspid regurgitation.

Sylvian arteriovenous malformations (sAVMs) are rare and account for approximately 8%–11% of all intracranial arteriovenous malformations (AVMs).1 Because of their proximity to eloquent structures such as the motor speech center, insular cortex, and internal capsule, microsurgical resection of sAVMs remains a challenge.Several classifications have already been suggested for sAVMs, such as Sugita and Yasargil.1,2 It is well established that for low-grade AVMs, results of the microsurgical resection are excellent and tend to favor surgery,1, 2, 3 but in high-grade AVM, a multimodal assessment is necessary for formulating treatment strategies.1In Video 1, we demonstrate the surgical resection of a ruptured sylvian temporal AVM. This AVM was localized in the superior surface of the temporal lobe, and its nidus was just beneath the cortical surface of this lobe. Because it was 5.1 cm at its largest diameter, had a deep drainage vein, and was localized adjacent to the Wernicke area, we classified it as a Spetzler-Martin grade IV AVM.4Despite the high-grade AVM, microsurgical treatment was the choice in this ruptured AVM and there was no increase in morbidity.

La declaración PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), publicada en 2009, se diseñó para ayudar a los autores de revisiones sistemáticas a documentar de manera transparente el porqué de la revisión, qué hicieron los autores y qué encontraron. Durante la última década, ha habido muchos avances en la metodología y terminología de las revisiones sistemáticas, lo que ha requerido una actualización de esta guía. La declaración prisma 2020 sustituye a la declaración de 2009 e incluye una nueva guía de presentación de las publicaciones que refleja los avances en los métodos para identificar, seleccionar, evaluar y sintetizar estudios. La estructura y la presentación de los ítems ha sido modificada para facilitar su implementación. En este artículo, presentamos la lista de verificación PRISMA 2020 con 27 ítems, y una lista de verificación ampliada que detalla las recomendaciones en la publicación de cada ítem, la lista de verificación del resumen estructurado PRISMA 2020 y el diagrama de flujo revisado para revisiones sistemáticas.The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.Full English text available from:www.revespcardiol.org/en

BACKGROUND:This review concerns the putative benefit of percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) for symptomatic patients with stable angina pectoris, or for asymptomatic persons in whom screening tests have revealed coronary heart disease (CHD; this entity has been newly designated chronic coronary syndrome, or CCS). Moreover, it addresses the question whether the indications for which PCI is now performed in Germany on patients with CCS are consistent with current scientific knowledge.METHODS:The pathophysiological concept of CHD and ischemia induction is discussed in the light of the scientific literature. This concept implies that PCI might be beneficial in the treatment of CCS. The benefit of PCI over OMT has now been evaluated in seven randomized trials (the so-called milestone trials). The current situation in Germany is presented here as well, on the basis of the available data.RESULTS:The pathophysiological concept of CHD implies that the particular coronary artery stenoses that are likely to give rise to a myocardial infarction (the so-called vulnerable plaques) cannot be identified prospectively with current methods. Moreover, a coronary artery stenosis will not necessarily cause myocardial ischemia. All of the randomized trials carried out to date that have compared OMT to PCI-plus-OMT in patients with CCS have led to the conclusion that PCI, because it focuses on individual coronary artery stenoses, cannot prolong survival or lower the incidence of myocardial infarction over the long term. This remains the case even if a single coronary artery stenosis is known to be causing moderate or severe myocardial ischemia (a conclusion of the ISCHEMIA trial). A PCI performed only because the coronary stenosis or stenoses meet certain morphological criteria, without any demonstration of a resulting functional disturbance, is generally detrimental to the health of the patient, with rare exceptions, and is inconsistent with the recommendations of current guidelines. The number of PCIs being performed in Germany at present is high compared to other countries; this arouses concern that the indications for it may be dubious in many cases.CONCLUSION:Current data imply that PCI for CCS does not improve outcomes in a large percentage of cases. A symptomatic benefit exists only in patients with frequent angina pectoris. The selection of CCS patients for PCI needs to be more strictly bound to the recommendations of current guidelines, particularly in Germany.

In the early 1990s, the idea of Transcatheter Aortic Valve Implantation (TAVI) emerged from clinicians by the insight that the long-term hemodynamic and clinical results of aortic balloon valvuloplasty to treat aortic stenonosis were not satisfying. Thus, Anderson and Cribier developed the balloon-expandable and Figulla and Laborde the self-expendable TAVI systems. Sceptical views by the surgical colleagues and the industry delayed the rapid development of this disruptive new therapy until 2002, when Alain Cribier demonstrated for the first time the proof of his concept. Bulky devices and paravalvular leakages in patients treated in terms of compassionate care resulted in high mortality rates. From 2005 onwards, the treatment of patients not at highest risk using smoother devices in clinical trials could demonstrate that the technology was equivalent to surgical aortic valve replacement. The transapical access route initiated the heart team approach with the surgical colleagues, however, this access route is presently expiring due to its greater trauma. The need to treat also aortic regurgitation is addressed by the “clipping technology” of JenaValve™. Ongoing clinical trials investigate an extended indication for TAVI at an earlier stage of aortic stenosis, or in reduced ejection fraction, and just demonstrated the safety and efficiency even in low surgical risk patients.

Unlike other intracardiac shunts, there is no known linear relationship between ostium secundum atrial septal defects (ASD) and development of pulmonary hypertension (PH). PH is observed in 8% to 10% of all ASD patients. Atrial septal defect–associated pulmonary hypertension (ASDAPH) is usually independent of the degree, duration of shunting, and defect size. Complete closure of ASD in these patients can be detrimental due to the potential risk for increase in pulmonary vascular resistance (PVR). Fenestrated closure allows for controlled residual shunt providing adequate cardiac output with a mechanism for decompression in the event of critical increase in PVR. After approval from institutional review boards and agencies protecting human subjects, 42 patients from 29 international centers underwent compassionate use of the Occlutech Fenestrated Atrial Septal Defect (FASD) device. Physician implanters reported outcomes via electronic survey. Follow-up data were available for 25 patients (72% female, n=18) from 18 centers. Symptomatic improvement was observed in a majority of the patients with reduction in New York Heart Association class III symptoms from 68% at baseline to 8% at long-term follow-up. Mean oxygen saturation improved from 93% at baseline to 97% at long-term follow-up (P=0.0066). Reduction in right atrial pressure and mean pulmonary arterial pressure were also noted. During follow-up, one patient had spontaneous occlusion of the fenestration requiring emergency stenting. No other major complications were observed. FASD implantation improves outcomes in patients with ASDAPH; however, further studies are required in a large cohort of patients to determine timing of intervention, optimal fenestration size, and long-term prognosis.

OBJECTIVES The authors investigated the development of pulmonary hypertension (PH), predictors of PH regression, and its prognostic impact on short, mid-, and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). BACKGROUND PH represents a common finding in patients with AS. Although TAVR is frequently associated with regression of PH, the predictors of reversible PH and its prognostic significance remain uncertain. METHODS In this study, 617 consecutive patients undergoing TAVR between 2009 and 2015 were stratified per baseline tertiles of pulmonary artery systolic pressure (PASP) as follows: normal (PASP <34 mm Hg), mild-to-moderate (PASP >= 34 mm Hg and <46 mm Hg), and severe PASP elevation (PASP >= 46 mm Hg). After TAVR, 520 patients with PH at discharge were stratified according to the presence or absence of PASP reduction. Primary outcome was all-cause mortality at 30 days, 1 year, and long-term follow-up at a maximum of 5.9 years. RESULTS In patients with both mild-to-moderate and severe PH at baseline, PASP decreased significantly at discharge (Delta PASP 3.0 +/- 9.3 mm Hg and 12.0 +/- 10.0 mm Hg, respectively) and 1 year (Delta PASP 5.0 +/- 9.7 mm Hg and 18.0 +/- 14.0 mm Hg, respectively). At a median follow-up of 370 days (interquartite range [IQR]: 84 to 500 days), the risk of all-cause mortality was similar among baseline PASP groups at all time intervals evaluated. After TAVR, a significant regression of PH was observed in 46% of patients. Contrarily, patients with residual PH had a higher risk of all-cause mortality at 30 days (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.74 to 6.99; p < 0.001), 1 year (HR: 3.12, 95% CI: 2.06 to 4.72; p < 0.001), and long-term (HR: 2.47, 95% CI: 1.74 to 3.49; p < 0.001). Left ventricular ejection fraction (LVEF) >40% (odds ratio [OR]: 3.56, 95% CI: 2.24 to 5.65; p < 0.001), baseline PASP >= 46 mm Hg (OR: 3.26, 95% CI: 2.07 to 5.12; p < 0.001), absence of concomitant tricuspid regurgitation (TR) >= moderate (OR: 0.53, 95% CI: 0.34 to 0.84; p < 0.001), and logistic EuroSCORE <25% (OR: 1.59, 95% CI: 1.04 to 2.45; p = 0.03) were independent predictors of PASP reduction. CONCLUSIONS In most patients with PH and AS, TAVR is associated with a significant early and late reduction of PASP. Patients with reversible PH after TAVR are at lower risk of all-cause mortality at early, mid-, and long-term follow-up. Therefore, the presence of PH should not preclude treatment with TAVR. (C) 2019 by the American College of Cardiology Foundation.

Infective endocarditis (IE) is still associated with a high morbidity and mortality. IE is characterized by bacterial biofilms of the endocardium, especially of the aortic and mitral valve leading to destruction of the valve. Current research demonstrate that about one quarter of the patients with