Multimodality imaging for the evaluation and management of patients with long-term (durable) left ventricular assist devices A Clinical Consensus Statement of the European Association of Cardiovascular Imaging (EACVI) of the ESC.

Left ventricular assist devices (LVADs) are gaining increasing importance as therapeutic strategy in advanced heart failure (HF), not only as bridge to recovery or to transplant, but also as destination therapy. Even though long-term LVADs are considered a precious resource to expand the treatment options and improve clinical outcome these patients, these are limited by peri-operative and post-operative complications, such as device-related infections, haemocompatibility-related events, device mispositioning and right ventricular failure. For this reason, a precise pre-operative, peri-operative and post-operative evaluation of these patients is crucial for the selection of LVADs candidates and the management LVADs recipients. The use of different imaging modalities offers important information to complete the study of patients with LVADs in each phase of their assessment, with peculiar advantages/disadvantages, ideal application and reference parameters for each modality. This clinical consensus statement sought to guide the use of multimodality imaging for the evaluation of patients with advanced HF undergoing LVADs implantation.

Acute aortic catastrophe caused by cardiovascular oncological manipulation by tyrosine kinase inhibitors with immune checkpoint blockades: a case report and literature review.

Background: Tyrosine kinase inhibitors targeting the vascular endothelial growth factor (VEGF) inhibitor pathway with immune checkpoint blockade have shown promising outcomes in managing metastatic renal cancer. However, they increase the risk of a person developing high blood pressure and cardiovascular complications. Case summary: In this study, we report the case of a 73-year-old woman on axitinib and pembrolizumab for her Stage 4 renal cell carcinoma. She presented with intractable chest pain and high systolic blood pressure, not responding to opiates. Her computed tomography angiography results showed an acute intra-mural haematoma with a rupture in the descending thoracic aorta. She underwent emergency thoracic endovascular aortic repair. Post-operatively, she recovered fully without any neurological or cardiovascular issues. Discussion: The severity of cardiovascular haemodynamic complications arising from the consumption of VEGF inhibitors and from immunotherapy and the lack of anti-hypertensive strategies to adequately manage such events require an unequivocal and urgent assessment of their cardiovascular safety. This case highlights the crucial role of cardiovascular oncology in managing such acute aortic catastrophes.

Understanding cardiac events in breast cancer (UCARE): pilot cardio-oncology assessment and surveillance pathway for breast cancer patients.

PURPOSE: In Ireland, over 3000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts. Specific services for cancer patients suffering from cancer therapy related cardiovascular toxicity have led to a higher incidence of safe anti-cancer treatment completion. Such services are not widely available in our jurisdiction, and the purpose of this trial is to remedy this situation. METHODS: This protocol describes a prospective, single arm, pilot feasibility study implementing a dedicated Cardio-Oncology assessment and surveillance pathway for patients receiving multimodal breast cancer treatment. It incorporates novel biomarker and radiomic surveillance and monitoring approaches for cancer-therapy related cardiac dysfunction into routine care for breast cancer patients undergoing adjuvant systemic chemotherapy. RESULTS: Declaration of results will via peer reviewed academic journals, and communicated directly to key knowledge users both nationally and internationally. This engagement will be critical to enable to healthcare services and policy sector make informed decisions or valuable changes to clinical practice, expenditure and/or systems development to support specialized Cardio-Oncology clinical pathways. All data is to be made available upon request. CONCLUSION: Dedicated cardio-oncology services have been recommended in recent literature to improve patient outcomes. Our protocol describes a feasibility study into the provision of such services for breast cancer.

Tricuspid valve and right-heart chamber remodelling in elderly subjects with secondary tricuspid regurgitation.

BACKGROUND: The prevalence of secondary tricuspid regurgitation (TR) increases with ageing, but the exact mechanisms and the pattern of tricuspid valve (TV) remodelling are yet to be defined. This knowledge is needed to guide patient selection for the evolving therapeutic options. We sought to explore the prevalence and predictors of secondary TR in the elderly, as well as the associated pattern of right-heart chamber and TV remodelling. METHODS: Consecutive older subjects (60-year-old or older) were prospectively enrolled and detailed analysis of right-heart chambers and TV was conducted (ClinicalTrials.gov ID: NCT05784883). TR severity was defined based on a multiparametric approach. RESULTS: Out of 213 patients (age, 67.1 ± 5.9 years, 52.6% female), 48.8% had mild and 15.5% had moderate-severe TR. The frequency of moderate-severe TR increased from 4.5% in those without to 32.9% in those with underlying abnormalities of the left/right heart. There was a significant trend of worsening right-heart chamber and TV remodelling across the three grades of TR severity (none-trace, mild, and moderate-severe; p-value for linear trend < 0.001). ROC curve-defined cut-points of TV remodelling parameters predicting moderate-severe TR were annular dilatation ≥3.75 cm (AUC: 0.74), tenting area ≥1.45 cm2 (AUC: 0.67), and leaflet length ≥2.25 cm (AUC: 0.61) with increasing frequency of moderate-severe TR from 7.2% through 64.7%, in those with none vs. all three criteria (p < 0.001). The most important correlate of the three TV remodelling parameters was right ventricular and atrial (RV and RA) dilatation. CONCLUSION: Rather than ageing per se, the presence of underlying cardiac abnormalities determines the frequency of moderate-severe TR. Progressive remodelling of right-heart chambers and TV geometry starts with the development of mild TR. TA dilatation, increased tenting, and leaflet elongation are three important correlates of the development of TR that parallel progressive RV and RA dilatation.Study Registration: ClinicalTrials.gov ID: NCT05784883.

Risk Prediction, Diagnosis and Management of a Breast Cancer Patient with Treatment-Related Cardiovascular Toxicity: An Essential Overview.

Breast cancer is amongst the most common invasive cancers in adults. There are established relationships between anti-cancer treatments for breast cancer and cardiovascular side effects. In recent years, novel anti-cancer treatments have been established, as well as the availability of multi-modal cardiac imaging and the sophistication of treatment for cardiac disease. This review provides an in-depth overview regarding the interface of breast cancer and cancer therapy-related cardiovascular toxicity. Specifically, it reviews the pathophysiology of breast cancer, the method of action in therapy-related cardiovascular toxicity from anti-cancer treatment, the use of echocardiography, cardiac CT, MRI, or nuclear medicine as diagnostics, and the current evidence-based treatments available. It is intended to be an all-encompassing review for clinicians caring for patients in this situation.

LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Redefining postoperative hypertension management in carotid surgery: a comprehensive analysis of blood pressure homeostasis and hyperperfusion syndrome in unilateral vs. bilateral carotid surgeries and implications for clinical practice.

Background: This study evaluates the implications of blood pressure homeostasis in bilateral vs. unilateral carotid surgeries, focusing on the incidence of postoperative hypertension, hyperperfusion syndrome, and stroke as primary outcomes. It further delves into the secondary outcomes encompassing major adverse cardiovascular events and all-cause mortality. Methods: Spanning two decades (2002-2023), this comprehensive retrospective research encompasses 15,369 carotid referrals, out of which 1,230 underwent carotid interventions. A subset of 690 patients received open carotid procedures, with a 10-year follow-up, comprising 599 unilateral and 91 bilateral surgeries. The Society for Vascular Surgery Carotid Reporting Standards underpin our methodological approach for data collection. Both univariate and multivariate analyses were utilized to identify factors associated with postoperative hypertension using the Statistical Package for the Social Sciences (SPSS) Version 22 (SPSS®, IBM® Corp., Armonk, N.Y., USA). Results: A marked acute elevation in blood pressure was observed in patients undergoing both unilateral and bilateral carotid surgeries (p < 0.001). Smoking (OR: 1.183, p = 0.007), hyperfibrinogenemia (OR: 0.834, p = 0.004), emergency admission (OR: 1.192, p = 0.005), severe ipsilateral carotid stenosis (OR: 1.501, p = 0.022), and prior ipsilateral interventions (OR: 1.722, p = 0.003) emerged as significant factors that correlates with postoperative hypertension in unilateral surgeries. Conversely, in bilateral procedures, gender, emergency admissions (p = 0.012), and plaque morphology (p = 0.035) significantly influenced postoperative hypertension. Notably, 2.2% of bilateral surgery patients developed hyperperfusion syndrome, culminating in hemorrhagic stroke within 30 days. Intriguingly, postoperative stage II hypertension was identified as an independent predictor of neurological deficits post-secondary procedure in bilateral CEA cases (p = 0.004), attributable to hyperperfusion syndrome. However, it did not independently predict myocardial infarction or mortality outcomes. The overall 30-day stroke rate stood at 0.90%. Lowest incidence of post operative hypertension or any complications were observed in eversion carotid endartrertomy. Conclusion: The study identifies postoperative hypertension as a crucial independent predictor of perioperative stroke following bilateral carotid surgery. Moreover, the study elucidates the significant impact of bilateral CEA on the development of post-operative hyperperfusion syndrome or stroke, as compared to unilateral CEA. Currently almost 90% of our carotid practice is eversion carotid endartrerectomy.

Systematic review of cardiovascular neurocristopathy-contemporary insights and future perspectives.

Introduction: Neural crest cells (NCCs) are multipotent and are attributed to the combination of complex multimodal gene regulatory mechanisms. Cardiac neural crest (CNC) cells, originating from the dorsal neural tube, are pivotal architects of the cardio-neuro-vascular domain, which orchestrates the embryogenesis of critical cardiac and vascular structures. Remarkably, while the scientific community compiled a comprehensive inventory of neural crest derivatives by the early 1980s, our understanding of the CNC's role in various cardiovascular disease processes still needs to be explored. This review delves into the differentiation of NCC, specifically the CNC cells, and explores the diverse facets of non-syndromic cardiovascular neurocristopathies. Methods: A systematic review was conducted as per the PRISMA Statement. Three prominent databases, PubMed, Scopus, and Embase, were searched, which yielded 1,840 studies. We excluded 1,796 studies, and the final selection of 44 studies formed the basis of this comprehensive review. Results: Neurocristopathies are a group of genetic disorders that affect the development of cells derived from the NC. Cardiovascular neurocristopathy, i.e., cardiopathy and vasculopathy, associated with the NCC could occur in the form of (1) cardiac septation disorders, mainly the aortico-pulmonary septum; (2) great vessels and vascular disorders; (3) myocardial dysfunction; and (4) a combination of all three phenotypes. This could result from abnormalities in NCC migration, differentiation, or proliferation leading to structural abnormalities and are attributed to genetic, familial, sporadic or acquired causes. Discussion: Phenotypic characteristics of cardiovascular neurocristopathies, such as bicuspid aortic valve and thoracic aortic aneurysm, share a common embryonic origin and are surprisingly prevalent in the general population, necessitating further research to identify the underlying pathogenic and genetic factors responsible for these cardiac anomalies. Such discoveries are essential for enhancing diagnostic screening and refining therapeutic interventions, ultimately improving the lives of individuals affected by these conditions.

Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is becoming the standard of care for severe symptomatic aortic stenosis (AS). Yet, some patients with AS are not indicated/eligible for TAVI. Several noninvasive, catheter-based or surgical alternatives exist, and other therapeutic options are emerging. AREAS COVERED: This review provides an overview of non-TAVI options for severe AS. Non-invasive, transcatheter, and alternative surgical strategies are discussed, emphasizing their backgrounds, techniques, and outcomes. EXPERT OPINION: Alternative therapies to TAVI, whether device-based or non-device-based, continue to evolve or emerge and provide either alternative treatments or a bridge to TAVI, for patients not meeting indications for, or having contraindications to TAVI.Although TAVI and SAVR are the current dominant therapies, there are still some patients that could benefit in the future from other alternatives.Data on alternative options for such patients are scarce. Many advantages and disadvantages arise when selecting a specific treatment strategy for individual patients.Head-to-head comparison studies could guide physicians toward better patient selection and procedural planning. Awareness of therapeutic options, indications, techniques, and outcomes should enable heart teams to achieve optimized patient selection. Furthermore, it can increase the use of these alternatives to optimize the management of AS among different patient populations.

ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

Association between three-year mortality after transcatheter aortic valve implantation and paravalvular regurgitation graded by videodensitometry in comparison with visual grading.

BACKGROUND: Estimation of regurgitant fraction by videodensitometry (VD-AR) of aortic root angiograms is a new tool for objective grading of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Stratification with boundaries at 6% and 17% has been proposed to reflect "none/trace", "mild" and "moderate or higher" PVR. OBJECTIVE: We sought to investigate the association of strata of VD-AR with 3-year mortality and to compare VD-AR with visual grading of angiograms. METHODS: We interrogated our database for patients undergoing transfemoral TAVI from 2008 to 2018. Vital status of the patients was obtained from population registers. To test differences in survival and estimate adjusted hazard ratios (HRs) we fitted Cox models. RESULTS: Our retrospective study included 699 patients with evaluable angiograms at completion of the TAVI procedure. Cumulative 3-year mortality was 35.0% in 261 (37.3%) patients with VD-AR < 6%, 33.9% in 325 (46.5%) patients with VD-AR between 6 and 17% (HR [95% confidence interval] 1.06 [0.80-1.42]; P = 0.684) and 47.2% in 113 (16.2%) patients with VD-AR > 17% (HR 1.57 [1.11-2.22]; P = 0.011). Visually, PVR was graded as "none/trace" in 470 (67.2%) patients, as "mild" in 219 (31.3%) and as "moderate" in 10 (1.4%). Both mild PVR and moderate PVR on visual grading were significantly associated with mortality (HRs 1.31 [1.12-1.54]; P = 0.001 and 1.92 [1.13-3.24]; P = 0.015; respectively). CONCLUSIONS: VD-AR > 17%, but not VD-AR 6-17%, was independently associated with mortality. Compared with subjective visual evaluation, VD-AR resulted in a smaller proportion of patients with PVR classified as prognostically relevant.

Tricuspid valve disease and cardiac implantable electronic devices.

The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.

Mechanism of balloon burst during transcatheter aortic valve replacement pre-dilatation: Image observation and validation by finite element analysis.

BACKGROUND: Balloon burst during transcatheter aortic valve replacement (TAVR) is serious complication. This study pioneers a novel approach by combining image observation and computer simulation validation to unravel the mechanism of balloon burst in a patient with bicuspid aortic valve (BAV) stenosis. METHOD: A new computational model for balloon pre-dilatation was developed by incorporating the element failure criteria according to the Law of Laplace. The effects of calcification and aortic tissue material parameters, friction coefficients, balloon types and aortic anatomy classification were performed to validate and compare the expansion behavior and rupture mode of actual balloon. RESULTS: Balloon burst was dissected into three distinct stages based on observable morphological changes. The mechanism leading to the complete transverse burst of the non-compliant balloon initiated at the folding edges, where contacted with heavily calcified masses at the right coronary sinus, resulting in high maximum principal stress. Local sharp spiked calcifications facilitated rapid crack propagation. The elastic moduli of calcification significantly influenced balloon expansion behavior and crack morphology. The simulation case of the calcific elastic modulus was set at 12.6 MPa could closely mirror clinical appearance of expansion behavior and crack pattern. Furthermore, the case of semi-compliant balloons introduced an alternative rupture mechanism as pinhole rupture, driven by local sharp spiked calcifications. CONCLUSIONS: The computational model of virtual balloons could effectively simulate balloon dilation behavior and burst mode during TAVR pre-dilation. Further research with a larger cohort is needed to investigate the balloon morphology during pre-dilation by using this method to guide prosthesis sizing for potential favorable outcomes.

A systematic review and meta-analysis of the efficacy and safety of Mavacamten therapy in international cohort of 524 patients with hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common heritable myocardial disorder worldwide. Current pharmacological treatment options are limited. Mavacamten, a first-in-class cardiac myosin inhibitor, targets the main underlying pathology of HCM. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of Mavacamten in patients with HCM. PRISMA flow chart was utilized using PubMed, SCOPUS, and Cochrane databases for all up-to-date studies using pre-defined keywords. Pre-specified efficacy outcomes comprised several parameters, including an improvement in peak oxygen consumption (pVO2) and ≥ 1 NYHA class, the need for septal reduction therapy (SRT), change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ), changes in biochemical markers and LVEF, along with peak left ventricular outflow tract gradient at rest and after Valsalva maneuver. Safety outcomes included morbidity and serious adverse events. This systematic review included five studies, four RCTs and one non-randomized control trial comprised a total of 524 (Mavacamten [273, 54.3%] vs placebo [230, 45.7%] adult (≥ 18 years) patients with a mean age of 56 years. The study. comprised patients with Caucasian and Chinese ethnicity and patients with obstructive (oHCM) and non-obstructive (nHCM) HCM. Most baseline characteristics were similar between the treatment and placebo groups. Mavacamten showed a statistically significant increase in the frequency of the primary composite endpoint (RR = 1.92, 95% CI [1.28, 2.88]), ≥ 1 NYHA class improvement (RR = 2.10, 95% CI [1.66, 2.67]), a significant decrease in LVEF, peak left ventricular outflow tract gradient at rest and after Valsalva maneuver. Mavacamten also showed a significant reduction in SRT rates (RR = 0.29, 95% CI [0.21, 0.40], p < 0.00001), KCCQ clinical summary scores (MD = 8.08, 95% CI [4.80, 11.37], P < 0.00001) troponin levels and N-terminal pro-B-type natriuretic peptide levels. However, there was no statistically significant difference between Mavacamten and placebo regarding the change from baseline peak oxygen consumption. Mavacamten use resulted in a small increase in adverse events but no statistically significant increment in serious adverse events. Our study showed that Mavacamten is a safe and effective treatment option for Caucasian and Chinese patients with HCM on the short-term. Further research is needed to explore the long-term safety and efficacy of Mavacamten with HCM. In addition, adequately powered studies including patients with nHCM is needed to ascertain befits of Mavacamten in those patients.

Emerging transcatheter heart valve technologies for severe aortic stenosis.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is the standard of care for selected patients with severe aortic stenosis, irrespective of the surgical risk. Over the last two decades of TAVI practice, multiple limitations were identified. In addition, the extension of TAVI into a wider patient spectrum created new challenges. AREAS COVERED: This review provides an overview of emerging transcatheter heart valves (THVs) beyond the approved contemporary THVs for the treatment of aortic stenosis. EXPERT OPINION: The incidence of degenerative aortic stenosis is expected to increase with more aging of the population. Therefore, TAVI needs to meet this increase in the number of patients indicated for aortic valve replacement alongside a wide and complex anatomical variability. An increasing number of Aortic THVs are available in the market. This includes upgraded iterations of contemporary devices and innovative devices developed by emerging manufacturers. The new devices aim for the reduction or elimination of undesirable outcomes like paravalvular leakage and conduction disturbances requiring permanent pacemaker implantation. Alternatively, emerging THVs should provide feasibility regarding yet unproven TAVI indications like Bicuspid aortic valve, aortic regurgitation, or very large anatomy. Furthermore, some of the emerging THVs are designed to tackle the long-term durability issue of biological valves.

Surgical Treatment of Patients with Sacroiliac Joint Syndrome: Comparative Study of Two Implants. / Operative Behandlung von Patienten mit Iliosakralgelenksyndrom: Vergleichsstudie zweier Implantate.

The treatment of patients with ISJ dysfunction is difficult due to the multifactorial causes of pain and various problems in clarification. Treatment includes physical therapy, corticosteroids, prolotherapy, radiofrequency denervation and sacroiliac joint fusion. A new option for the surgical treatment of ISG dysfunction is the Torpedo implant system. For a safe fusion, only 2 implants are needed, which are available in lengths of 30-50 mm. The new implant system has been tested in pilot studies for efficacy and biocompatibility with good results. For further documentation for the Torpedo implant system, a comparative study against the iFuse system was carried out.Two different implants were used: Group 1: Deltacor Torpedo, Group 2: iFuse implants (Si-Bone). The data generated during admission and subsequent check-ups (VAS, ODI, opioid use) were entered into an evaluation file set up for this purpose. Follow-up appointments were set at 1 month, 3, 6 and 12 months postoperatively.The data of 65 patients were evaluated comparatively. In all comparisons, only very small effect sizes were found with regard to the differences in the decrease in pain intensities, so that equivalent effectiveness of the two methods could initially be postulated from a clinical point of view. Most patients in both groups reported taking opioids to treat pain before surgery. According to the decrease in pain intensity, opioid treatment could be discontinued in some patients after the operation. After 12 months, the number of patients treated with opioids decreases to 23% in group 1 and to 17% in group 2. The success of the fusions with the two methods can also be proven by image documentation, from which the position of the implants can also be clearly recognised. In no case was there any loosening.Overall, the evaluation of this study allows the conclusion that both implant systems can be successfully used for the treatment of patients with ISJ syndrome. The present results should be confirmed in further comparative studies with the proposed evaluation methods.

Carvacrol-Loaded Phytosomes for Enhanced Wound Healing: Molecular Docking, Formulation, DoE-Aided Optimization, and in vitro/in vivo Evaluation.

Background: Despite recent advances in wound healing products, phytochemicals have been considered promising and attractive alternatives. Carvacrol (CAR), a natural phenolic compound, has been reported to be effective in wound healing. Purpose: This work endeavored to develop novel CAR-loaded phytosomes for the enhancement of the wound healing process. Methods: Molecular docking was performed to compare the affinities of the different types of phospholipids to CAR. Phytosomes were prepared by three methods (thin-film hydration, cosolvency, and salting out) using Lipoid S100 and Phospholipon 90H with three levels of saturation percent (0%, 50%, and 100%), and three levels of phospholipid molar percent (66.67%, 75%, and 80%). The optimization was performed using Design Expert where particle size, polydispersity index, and zeta potential were chosen as dependent variables. The optimized formula (F1) was further investigated regarding entrapment efficiency, TEM, 1H-NMR, FT-IR, DSC, X-RD, in vitro release, ex vivo permeation, and stability. Furthermore, it was incorporated into a hydrogel formulation, and an in vivo study was conducted to investigate the wound-healing properties of F1. Results: F1 was chosen as the optimized formula prepared via the thin-film hydration method with a saturation percent and a phospholipid molar percent of zero and 66.67, respectively. TEM revealed the spherical shape of phytosomal vesicles with uniform size, while the results of 1H-NMR, FT-IR, DSC, and X-RD confirmed the formation of the phytosomal complex. F1 demonstrated a higher in vitro release and a slower permeation than free CAR. The wound area of F1-treated animals showed a marked reduction associated with a high degree of collagen fiber deposition and enhanced cellular proliferation. Conclusion: F1 can be considered as a promising remedy for the enhancement of wound healing and hence it would be hoped to undergo further investigation.