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.

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 2­4), 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•7­4•0] vs contemporary 2•6% [1•7­4•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.

Combined transcatheter aortic valve and tricuspid valve-in-valve implantation in a patient with a mitral mechanical prosthesis.

Despite progressively uncommon in Western countries, rheumatic heart disease still portrays a significant global burden. In elderly or high-surgical risk patients, plurivalvular disease may require a complex percutaneous approach. Transcatheter aortic valve implantation (TAVI) in patients with previous monoleaflet mitral prosthesis is challenging due to interference between the aortic valve and the rigid mitral mechanical prosthesis "ring." Prior cases report the use of CoreValve or Edwards Sapien aortic valves in patients with adequate mitro-aortic distance. Performing a second major procedure, such as tricuspid valve-in-valve (TVIV), sequentially during a single percutaneous intervention, increases treatment complexity. An 83-year-old woman with rheumatic heart disease, with previous implantation of a Bjork-Shiley monoleaflet mitral prosthesis, and Carpentier-Edwards 29 tricuspid bioprosthesis presented with decompensated heart failure due to severe aortic stenosis and tricuspid bioprosthesis stenosis. After HeartTeam discussion, the patient was deemed as inoperable due to a prohibitive surgical risk. As an alternative, a TAVI (Navitor FlexNav) and a transcatheter TVIV replacement (Edwards Sapiens 3 Ultra) were discussed and proposed, with both techniques being performed sequentially in a single procedure. TAVI in a patient with a previous monoleaflet mitral mechanical prosthesis and TVIV may be a feasible approach in inoperable patients with plurivalvular disease.

Patient-reported outcome measures in knee injuries rehabilitation: A protocol for intervention.

Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the main cause of disability in 4 of 6 regions in 2017, with an increase in the associated burden and the impact they have on today's society. One of these conditions is related to the knee, which is associated with complex and vulnerable injuries associated with ligaments, menisci, and cartilage. After surgery, there is a reflex inhibition of motor neurons and immobilization, there is rapid atrophy and weakness in the different associated muscles, affecting proprioception, strength and muscle function, compromising quality of life. The aim of this article is to describe a protocol for a rehabilitation program after surgery for people with knee injuries. An experimental study will be carried out with 75 patients, with control and experimental groups. In both groups, initial measurements will be compared with measurements after the program, at different times. It is hoped that this study will generate significant information on rehabilitation intervention for people with knee injuries.

Association Between the Magnitude of Glycemic Control and Body Weight Loss With GLP-1 Receptor Agonists and Risk of Atherosclerotic Cardiovascular Disease: A Systematic Review and Meta-analyses of Randomized Diabetes Cardiovascular Outcomes Trials.

PURPOSE: Reduction of major atherosclerotic cardiovascular events (MACE) has not been consistent among different glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to assess the association between the magnitude of glycemic control, body weight loss, and reductions in systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) achieved through GLP-1 RA therapy and MACE. METHODS: Electronic databases (MEDLINE, CENTRAL, SCOPUS) were searched through March 2023. Studies were eligible if they were cardiovascular outcome trials (CVOTs) comparing GLP-1 RAs versus placebo in T2DM patients. The outcome of interest was 3-point MACE - cardiovascular death, myocardial infarction, or stroke. Random-effects meta-regression analyses evaluated the associations between reductions of HbA1c, body weight, SBP and LDL-C and reduction of MACE. RESULTS: Overall, 8 CVOTs were included (60079 patients, 30693 with GLP-1 RAs). Reductions of HbA1C were associated with the reduction of 3P-MACE (Log RR -0.290 [95% CI -0.515;-0.064], p = 0.012), with an estimated RR reduction of 25% for each 1% absolute reduction in HbA1C levels. Body weight loss was associated with the reduction of 3P-MACE (Log RR -0.068 [95% CI -0.135;-0.001], p = 0.047), with an estimated RR reduction of 7% for each 1 kg reduction in body weight. Reductions of SBP (Log RR -0.058 [95% CI -0.192;0.076], p = 0.396) and LDL-C (Log RR -0.602 [95% CI -4.157;2.953], p = 0.740) were not associated with the reduction of 3P-MACE. CONCLUSIONS: In T2DM patients, more potent GLP-1 RAs in reducing HbA1c and body weight were associated with greater reductions of MACE.

Interventional cardiology in cancer patients: A position paper from the Portuguese Cardiovascular Intervention Association and the Portuguese Cardio-Oncology Study Group of the Portuguese Society of Cardiology.

The field of Cardio-Oncology has grown significantly, especially during the last decade. While awareness of cardiotoxicity due to cancer disease and/or therapies has greatly increased, much of the attention has focused on myocardial systolic disfunction and heart failure. However, coronary and structural heart disease are also a common issue in cancer patients and encompass the full spectrum of cardiotoxicity. While invasive percutaneous or surgical intervention, either is often needed or considered in cancer patients, limited evidence or guidelines are available for dealing with coronary or structural heart disease. The Society for Cardiovascular Angiography and Interventions consensus document published in 2016 is the most comprehensive document regarding this particular issue, but relevant evidence has emerged since, which render some of its considerations outdated. In addition to that, the recent 2022 ESC Guidelines on Cardio-Oncology only briefly discuss this topic. As a result, the Portuguese Association of Cardiovascular Intervention and the Cardio-Oncology Study Group of the Portuguese Society of Cardiology have partnered to produce a position paper to address the issue of cardiac intervention in cancer patients, focusing on percutaneous techniques. A brief review of available evidence is provided, followed by practical considerations. These are based both on the literature as well as accumulated experience with these types of patients, as the authors are either interventional cardiologists, cardiologists with experience in the field of Cardio-Oncology, or both.

Prevalence of musculoskeletal disorders among dental students: A systematic review and meta-analysis.

Objectives: This study aimed to determine the prevalence of work-related musculoskeletal disorders (WMSDs) in dental students and analyze the potential associated risk factors. Methods: This review was registered in PROSPERO with the number CRD42022349864. We performed a meta-analysis calculating event rates with relative 95% confidence intervals for each body region. Two investigators systematically searched Cochrane, Pubmed, Scopus, and EBSCO databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results: Sixteen studies, with 3761 dental students, were included. The highest 7-day prevalence was in the lower back (27.2%; 95% CI 20-35), neck (27%; 95% CI 19.1-35.8), and upper back (24.2%; 95% CI 17.2-32). Yearly occurrence was mainly in the neck (51%; 95% CI 41-61), followed by shoulders (45.3%; 95% CI 37.6-53.1) and lower back (42%; 95% CI 34.1-50.2) and a fraction of these reported that symptoms in lower-back (15.2%; 95% CI 12.1-18.5), neck (13.9%; 95% CI 10.6-17.5) and shoulders (12.2%; 95% CI 8.7-16.3) affected work or normal activities. Associated contributing factors include female sex, poor posture habits, inadequate ergonomics knowledge, sedentary lifestyle, high physical activity levels, poor quality of life, and smoking. In contrast, engaging in physical exercise has positively impacted mitigating the risk of musculoskeletal disorders. Conclusions: WMSDs have a high prevalence among dental students, particularly in the cervicothoracic, lumbar, and shoulder regions, having a significant impact since training years. Further research with a multidimensional approach with psychosocial and physical assessments is recommended to understand this issue thoroughly.

Coronary artery disease and its management in TAVI.

OBJECTIVE: Aortic stenosis and coronary artery disease (CAD) are frequently associated. The preprocedural evaluation and indications for treatment in patients undergoing transcatheter aortic valve intervention (TAVI) remain controversial. This study sought to 1) determine the prevalence and angiographic characteristics of CAD in TAVI candidates, along with revascularization patterns, and 2) to evaluate the impact of the presence and complexity of CAD, as well as angiography-guided percutaneous coronary intervention, on prognosis after TAVI. METHODS: Single-center retrospective study from a prospectively collected institutional registry that included all patients that underwent TAVI between 2009 and 2018 and pre TAVI coronary angiography (CA) in our institution in the context of pre-procedure work-up. A multivariate analysis was performed to determine the effect of CAD and PCI on 2-year mortality. RESULTS: A total of 379 patients were included: 55 patients (14.5%) presented with normal coronary arteries, 120 (31.6%) with non-obstructive CAD, and 204 (53.8%) with obstructive CAD (the mean SxS was 8.2). Ultimately, 110 patients (29%) underwent PCI. Two-year survival after TAVI was decreased in patients with complex coronary lesions (SS > 22), while it was not affected by the overall presence of non-obstructive CAD, obstructive CAD, residual SxS, or pre-TAVI PCI of angiographically significant lesions (OR 0.631, 95%CI 0.192-1.406). CONCLUSION: In our population, the overall presence and management of obstructive CAD did not appear to impact mortality at 2 years after TAVI. Survival was decreased in patients with baseline complex coronary anatomies.

Effectiveness and Safety of P2Y12 Inhibitor Pretreatment for Primary PCI in STEMI: Systematic Review and Meta-analysis.

ABSTRACT: Dual antiplatelet therapy with aspirin and P2Y12 inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) has been shown to be associated with better outcomes. Yet, there is uncertainty regarding the optimal timing for its initiation. We performed a systematic review and meta-analysis of evidence on pretreatment with P2Y12 inhibitors in combination with aspirin in patients with STEMI undergoing primary percutaneous coronary intervention (PCI). We performed a systematic search of electronic databases PubMed, CENTRAL, and Scopus until April 2022. Studies were eligible if they compared P2Y12 inhibitor upstream administration with downstream use in patients with STEMI submitted to PCI. Studies with patients receiving fibrinolysis or medical therapy only were excluded. Outcomes were assessed at the shortest follow-up available. Of 2491 articles, 3 RCT and 16 non-RCT studies were included, with a total of 79,300 patients (66.1% pretreated, 66.0% treated with clopidogrel). Pretreatment was associated with reduction in definite stent thrombosis (odds ratio [OR] 0.61 [0.38-0.98]), all-cause death (OR 0.77 [0.60-0.97]), and cardiogenic shock (OR 0.60 [0.48-0.75]). It was also associated with a lower incidence of thrombolysis in myocardial infarction flow <3 pre-PCI (OR 0.78 [0.67-0.92]). However, incidence of recurrent MI was not significantly reduced (OR 0.93 [0.57-1.52]). Regarding safety, pretreatment was not associated with a higher risk of major bleeding events (OR 0.83 [0.75-0.92]). Pretreatment with dual antiplatelet therapy, including a P2Y12 inhibitor, was associated with better pre-PCI coronary perfusion, lower incidence of definite stent thrombosis, cardiogenic shock, and, possibly, all-cause mortality with no sign of potential harm encountered.

Spontaneous Cervical Spondylodiscitis With Retropharyngeal Abscess and Bacteremia: A Case Report.

Retropharyngeal abscess is a deep neck infection, rarely reported in adults. Nevertheless, when it occurs, it is mostly in immunocompromised patients and it can have life-threatening complications such as airway obstruction. On the other hand, more insidious complications can develop, such as mediastinitis, spinal osteomyelitis, and epidural abscess which represent an emergency medical condition when the patient develops neurologic symptoms. All must be diagnosed early and treated promptly. Spinal infection is an ancient disease, yet, morbidity remains significant despite developments in surgical and radiologic methods and the discovery of antibiotics. Management frequently involves a combination of these to achieve the best results.  The aim of this case report, as a research design, is to describe scientific observations that we encountered in a clinical setting, expand our knowledge, and highlight the role of the interprofessional team in evaluating and managing these conditions.

Cholesteryl hemiazelate identified in CVD patients causes in vitro and in vivo inflammation.

Oxidation of PUFAs in LDLs trapped in the arterial intima plays a critical role in atherosclerosis. Though there have been many studies on the atherogenicity of oxidized derivatives of PUFA-esters of cholesterol, the effects of cholesteryl hemiesters (ChEs), the oxidation end products of these esters, have not been studied. Through lipidomics analyses, we identified and quantified two ChE types in the plasma of CVD patients and identified four ChE types in human endarterectomy specimens. Cholesteryl hemiazelate (ChA), the ChE of azelaic acid (n-nonane-1,9-dioic acid), was the most prevalent ChE identified in both cases. Importantly, human monocytes, monocyte-derived macrophages, and neutrophils exhibit inflammatory features when exposed to subtoxic concentrations of ChA in vitro. ChA increases the secretion of proinflammatory cytokines such as interleukin-1ß and interleukin-6 and modulates the surface-marker profile of monocytes and monocyte-derived macrophage. In vivo, when zebrafish larvae were fed with a ChA-enriched diet, they exhibited neutrophil and macrophage accumulation in the vasculature in a caspase 1- and cathepsin B-dependent manner. ChA also triggered lipid accumulation at the bifurcation sites of the vasculature of the zebrafish larvae and negatively impacted their life expectancy. We conclude that ChA behaves as an endogenous damage-associated molecular pattern with inflammatory and proatherogenic properties.

Upstream anticoagulation in patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis.

BACKGROUND AND AIM: Parenteral anticoagulation is recommended for all patients presenting with ST-segment elevation myocardial infarction (STEMI) during primary percutaneous coronary intervention (PPCI). Whether upstream anticoagulation improves clinical outcomes is not well established. We conducted a systematic review and meta-analysis of contemporary evidence on parenteral anticoagulation timing for STEMI patients. METHODS: We performed a systematic search of electronic databases (PubMed, CENTRAL, and Scopus) until December 2022. Studies were eligible if they (a) compared upstream anticoagulation with administration at the catheterization laboratory and (b) enrolled patients with STEMI undergoing PPCI. Efficacy outcomes included in-hospital or 30-day mortality, in-hospital cardiogenic shock (CS), and TIMI flow grade pre- and post-PPCI. Safety outcome was defined as in-hospital or 30-day major bleeding. RESULTS: Overall, seven studies were included (all observational), with a total of 69,403 patients. Upstream anticoagulation was associated with a significant reduction in the incidence of in-hospital or 30-day all-cause mortality (OR 0.61; 95% CI 0.45-0.81; p < 0.001) and in-hospital CS (OR 0.68; 95% CI 0.58-0.81; p < 0.001) and with an increase in spontaneous reperfusion (pre-PPCI TIMI > 0: OR 1.46; 95% CI 1.35-1.57; p < 0.001). Pretreatment was not associated with an increase in major bleeding (OR 1.02; 95% CI 0.70-1.48; p = 0.930). CONCLUSIONS: Upstream anticoagulation was associated with a significantly lower risk of 30-day all-cause mortality, incidence of in-hospital CS, and improved reperfusion of the infarct-related artery (IRA). These findings were not accompanied by an increased risk of major bleeding, suggesting an overall clinical benefit of early anticoagulation in STEMI. These results require confirmation in a dedicated randomized clinical trial.

Predictive value of a positive stress single-photon emission computed tomography or stress cardiac magnetic resonance for ruling in obstructive coronary artery disease in a real-world setting.

INTRODUCTION AND OBJECTIVES: Randomized controlled trials comparing stress cardiac magnetic resonance (CMR) and single-photon emission computed tomography (SPECT) suggest similar diagnostic accuracy for detecting obstructive coronary artery disease (CAD). There are few data on whether this remains true in routine clinical practice. The aim of this study was to assess clinical and angiographic characteristics of patients undergoing invasive coronary angiography (ICA) after stress CMR or SPECT, and to compare their positive predictive value with published results from the CE-MARC trial. METHODS: In this retrospective tertiary-center analysis, we included 429 patients undergoing ICA after a positive stress CMR or positive SPECT performed within the previous 12 months. Obstructive CAD was defined as any coronary artery stenosis ≥50% in a vessel compatible with the ischemic territory on stress testing. RESULTS: Of the total 429 patients, 356 (83%) were referred after a positive SPECT, and 73 (17%) after a positive stress CMR. Patients did not differ according to age, cardiovascular risk factors, previous revascularization or left ventricular dysfunction, but patients with SPECT were more frequently male (p=0.046). The prevalence of obstructive CAD was similar in patients with positive SPECT vs. positive stress CMR (76.1% vs. 80.8%, respectively, p=0.385). The positive predictive values of both techniques were similar to those reported in the CE-MARC trial. CONCLUSION: In this tertiary center analysis, stress CMR and SPECT showed similar positive predictive values, comparable to those reported in the CE-MARC trial. This finding supports the emerging adoption of CMR in clinical practice for the diagnosis and management of CAD.

Antitumoral and Antimicrobial Activities of Block Copolymer Micelles Containing Gold Bisdithiolate Complexes.

Gold(III) bisdithiolate complexes have been reported as potential antimicrobial and antitumoral agents. The complex [Au(cdc)2]- (cdc=cyanodithioimido carbonate) displayed antimicrobial and outstanding antitumor activity against the ovarian cancer cells A2780 and A2780cisR, which are sensitive and resistant to cisplatin, respectively. However, poor water solubility may hamper its clinical use. Block copolymer micelles (BCMs) may solubilize hydrophobic drugs, improving their bioavailability and circulation time in blood. Aiming to provide water solubility, prolonged availability, and enhanced therapeutic indexes, BCMs loaded with [Au(cdc)2]- were synthesized and characterized. The BCM-[Au(cdc)2] micelles were prepared with a loading efficiency of 64.6% and a loading content of 35.3 mg [Au(cdc)2]-/gBCM. A hydrodynamic diameter of 77.31 ± 27.00 nm and a low polydispersity index of 0.18 indicated that the micelles were homogenous and good candidates for drug delivery. Cytotoxic activity studies against A2780/A2780cisR cells showed that BCM-[Au(cdc)2] maintained relevant cytotoxic activity comparable to the cytotoxicity observed for the same concentration of gold complexes. The Au uptake in A2780 cells, determined by PIXE, was ca. 17% higher for BCMs-[Au(cdc)2] compared to [Au(cdc)2]-. The BCMs-[Au(cdc)2] presented antimicrobial activity against S. aureus Newman and C. glabrata CBS138. These results evidenced the potential of BCM-[Au(cdc)2] for drug delivery and its promising anticancer and antimicrobial activities.

Coronary sinus Reducer device for the treatment of refractory angina: A multicenter initial experience.

INTRODUCTION: The coronary sinus Reducer (CSR) device has emerged as a complementary therapy in patients with severe angina refractory to optimal medical therapy and not amenable to revascularization. Our aim was to assess the safety and efficacy of the CSR in a real-world setting. METHODS: Twenty-six patients with refractory angina (RA) and evidence of myocardial ischemia attributable to the left coronary artery considered unsuitable for revascularization were treated with the CSR at two centers between May 2017 and July 2019. Safety endpoints were procedural success and complications. Efficacy endpoints, assessed at six-month follow-up, were reduction in CCS class, improvement in quality of life (QoL) assessed using the short version of the Seattle Angina Questionnaire (SAQ-7), and reduction in antianginal therapy. RESULTS: Twenty-three patients had end-stage coronary artery disease without revascularization targets and three had microvascular disease without epicardial stenosis. Procedural success was achieved in 23 patients, with two device/procedure-related complications and one anatomically-related failure to deliver the device. A total of 24 patients had the device implanted and entered the efficacy analysis. Eighteen patients (75.0%) had a reduction of at least one CCS class, 41.7% had a reduction of at least two classes, and 16.7% became asymptomatic, with a mean reduction in CCS class of 1.3±0.2 (p=0.001) at six-month follow-up. All SAQ-7 domains improved, notably physical limitation (p=0.001), angina frequency (p=0.005) and QoL (p=0.006). There was a mean reduction in anti-ischemic drugs from 3.4±1.1 to 2.9±1.2 (p=0.010). CONCLUSION: In this real-world, multicenter experience, implantation of the CSR was associated with improvement in angina and QoL in patients with RA.