Temporal Trends in Patient Characteristics and Clinical Outcomes of TAVR: Over a Decade of Practice.

Background/Objective: Transcatheter aortic valve replacement (TAVR) is indicated for severe aortic stenosis patients with a prohibitive surgical risk. However, its use has been expanding in recent years to include intermediate- and low-risk patients. Thus, registry data describing changes in patient characteristics and outcomes are needed. The aim of this study was to analyse the temporal changes in patient profiles and clinical outcomes of all-comer TAVR. Methods: Baseline characteristics and VARC-3 outcomes of 1632 consecutive patients undergoing TAVR between 2008 and 2021 were analysed. Results: The annual rate of TAVR increased from 30 procedures in 2008-2009 to 398 in 2020-2021. Over the follow-up period, patient age decreased from 85 ± 4 to 80 ± 6.8 (p < 0.001) and the STS score decreased from 5.9% to 2.8% (p < 0.001). Procedural characteristics significantly changed, representing a shift into a minimally invasive approach: adoption of local anaesthesia (none to 48%, p < 0.001) and preference of transfemoral access (74% in 2011-2012 vs. 94.5% in 2020-2021, p < 0.001). The rates of almost all procedural complications decreased, including major vascular and bleeding complications, acute kidney injury (AKI) and in-hospital heart failure. There was a striking decline in rates of complete atrioventricular block (CAVB) and the need for a permanent pacemaker (PPM). PPM rates, however, remain high (17.8%). Thirty-day and one-year mortality significantly declined to 1.8% and 8.3%, respectively. Multivariable analysis shows that AKI, bleeding and stroke are strong predictors of one-year mortality (p < 0.001). Conclusions: The TAVR procedure has changed dramatically during the last 14 years in terms of patient characteristics, procedural aspects and device maturity. These shifts have led to improved procedural safety, contributing to improved short- and long-term patient outcomes.

A decade of follow-up: atrial fibrillation, pulmonary pressure, and the progression of tricuspid regurgitation.

BACKGROUND AND AIMS: Long-term data on atrial fibrillation (AF) impact on tricuspid regurgitation (TR) progression and its relation to pulmonary pressure are scant. We investigated this association in a study spanning over a decade. METHODS: Adults with echocardiographic evaluation before 2014, free of significant TR, were included. Patients were dichotomized by baseline AF, followed by stratification according to systolic pulmonary artery pressure (sPAP). The development of new significant TR and its impact on mortality were studied. RESULTS: Study population included 21 502 patients (median age 65, 40% female), 13% had baseline AF. During a median follow-up of 12 years, 11% developed significant TR. Compared with patients free of AF, patients with baseline AF were 3.5 and 1.3 times more likely to develop significant TR in a univariate and multivariate models, respectively (95% CI 3.27-3.91, 1.18-1.44, p < 0.001 for both). The risk of TR progression was higher in patients with permanent AF and those treated with rate control strategy (HR 1.95 and 2.01, respectively; p < 0.001 for both). The association of AF with TR progression was sPAP-related, being more pronounced among patients with normal sPAP than among those with elevated sPAP (HR 1.5 vs. 1.18; p for interaction < 0.001). TR progression was independently linked to a two-fold higher mortality risk, consistent regardless of baseline AF (p < 0.001). CONCLUSIONS: AF is an independent predictor of TR progression, especially in patients with normal sPAP. Subsequent research on strategies to prevent TR progression in this patient population are warranted.This analysis investigated the association of AF with TR progression, and the interaction of pulmonary arterial pressure with this link. Among patients with AF (Left), progression to significant TR is highly prevalent, with higher risk among patients with permanent AF and lower risk in those treated with rhythm control strategy. Pulmonary arterial pressure interacts with this association (Right), such that among patients with normal sPAP, the link between AF and TR progression is stronger, suggesting that the importance of proactive AF management in this sugroup of patients. TR has important implications on mortality, regardless of AF status (Middle).AF = Atrial Fibrillation; A-STR = Atrial Secondary TR; CIED = cardiac implantable electronic device; TR = Tricuspid Regurgitation; V-STR = Ventricular Secondary TR.

Cardiology department versus intensive care unit admission after successful uncomplicated transcatheter aortic valve replacement (TAVR).

BACKGROUND: Most patients after transcatheter aortic valve replacement (TAVR) are admitted directly to the cardiac intensive care unit (CICU) despite low complication rates. Reducing unnecessary CICU hospitalization reduces healthcare costs. This study aimed to compare the outcomes between patients admitted directly to the cardiology department (CD) and those admitted to CICU based on prespecified protocols. METHODS: Historical cohort study of all patients who underwent TAVR and were admitted directly to the CD according to a prespecified protocol (uncomplicated procedure, hemodynamically stable, without new conduction abnormalities) in 2017-2018, and the same number of patients meeting the same criteria who were admitted to the CICU in 2015-2016 before direct CD admission was initiated. Pacemaker implantation during the procedure was not considered a new conduction abnormality. In-hospital outcomes and 30-day post-discharge outcomes were compared. RESULTS: Overall, 260 patients (130 CICU + 130 CD) were included in the study. There was no in-hospital mortality in either group, and the post-procedure length of stay was shorter for patients admitted to CD (median and IQR: 2, 2-4 vs. 4, 3-5 days, p <0.001). There was no significant difference in 30-day emergency department visits between groups (CICU:13.9% vs. CD:16.2%, p = 0.602), rehospitalization rate (9.3%) was the same in both groups, and one patient from the CICU group died. Similar results were observed in multivariable analysis and after matching. CONCLUSION: Direct admission to the CD after TAVR, according to the proposed criteria, may be considered as a safe and less expensive alternative for stable patients after an uncomplicated TAVR procedure.

Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis.

BACKGROUND: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Low cardiorespiratory fitness is associated with elevated intraocular pressure among apparently healthy adults.

PURPOSE: To evaluate the association of cardiorespiratory fitness with elevated intraocular pressure (IOP) in healthy adults. METHODS: In this cross-sectional study, we evaluated 17,990 asymptomatic self-referred adults free of diabetes or cardiovascular disease who were screened in a preventive healthcare setting. All subjects underwent measurement of IOP and completed a maximal exercise stress test according to the Bruce protocol. Fitness was categorized into age and sex-specific quintiles according to the treadmill time and dichotomized to low (lowest quintile) and non-low fitness groups. Elevated IOP was defined as ≥ 21 mmHg. RESULTS: Median age was 45 (IQR 39-52) years and 12,073 (67%) were men. There were 3,351 (19%) subjects in the low fitness group. Median IOP was 14 mmHg (IQR 12-16) with elevated IOP documented in 188 (1%) subjects. Univariate binary logistic regression model demonstrated that compared with non-low fitness group, subjects in the low fitness group were 2.2 times more likely to have elevated IOP (95% CI 1.598-2.95, p<0.001). Multivariate binary logistic regression with adjustment to known cardiovascular risk factors (age, sex, hypertension, smoking, overweight, regular physical activity, low HDL cholesterol, high triglycerides, and fasting glucose levels) successfully demonstrated that lower fitness was independently and significantly associated with a 90% increased likelihood of elevated IOP (95% CI 1.37-2.61, p<0.001). Subgroup analysis revealed that the association was more pronounced among women compared with men (OR 3.8 vs. 1.6, p for interaction = 0.069). CONCLUSIONS: Low cardiorespiratory fitness is independently associated with increased IOP among apparently healthy adults.

Sixth monovalent XBB.1.5 vaccine elicits robust immune response against emerging SARS-CoV-2 variants in heart transplant recipients.

Continued circulation of severe acute respiratory syndrome coronavirus 2 has driven the selection of variants with improved ability to escape preexisting vaccine-induced responses, posing a persistent threat to heart transplant recipients (HTRs). The immunogenicity and safety of the updated XBB.1.5-containing monovalent vaccines are unknown. We prospectively enrolled 52 HTRs who had previously received a 5-dose ancestral-derived monovalent and bivalent messenger RNA (mRNA) vaccination schedule to receive the monovalent XBB.1.5 vaccine. Immunogenicity was evaluated using live virus microneutralization assays. The XBB.1.5 monovalent vaccine elicited potent and diverse neutralizing responses and broadened the reactivity spectrum to encompass newer strains, with the highest increase in neutralization activity being more pronounced against XBB.1.5 (15.8-fold) and JN.1 (13.3-fold) than against BA.5 (6.7-fold) and wild-type (4-fold). Notably, XBB.1.5 and JN.1 were resistant to neutralization by prevaccination sera. There were no safety concerns. Our findings support the updating of coronavirus disease 2019 vaccines to match antigenically divergent variants and exclude ancestral spike-antigen to protect HTRs.

Utilizing Human-Induced Pluripotent Stem Cells to Study Cardiac Electroporation Pulsed-Field Ablation.

BACKGROUND: Electroporation is a promising nonthermal ablation method for cardiac arrhythmia treatment. Although initial clinical studies found electroporation pulsed-field ablation (PFA) both safe and efficacious, there are significant knowledge gaps concerning the mechanistic nature and electrophysiological consequences of cardiomyocyte electroporation, contributed by the paucity of suitable human in vitro models. Here, we aimed to establish and characterize a functional in vitro model based on human-induced pluripotent stem cells (hiPSCs)-derived cardiac tissue, and to study the fundamentals of cardiac PFA. METHODS: hiPSC-derived cardiomyocytes were seeded as circular cell sheets and subjected to different PFA protocols. Detailed optical mapping, cellular, and molecular characterizations were performed to study PFA mechanisms and electrophysiological outcomes. RESULTS: PFA generated electrically silenced lesions within the hiPSC-derived cardiac circular cell sheets, resulting in areas of conduction block. Both reversible and irreversible electroporation components were identified. Significant electroporation reversibility was documented within 5 to 15-minutes post-PFA. Irreversibly electroporated regions persisted at 24-hours post-PFA. Per single pulse, high-frequency PFA was less efficacious than standard (monophasic) PFA, whereas increasing pulse-number augmented lesion size and diminished reversible electroporation. PFA augmentation could also be achieved by increasing extracellular Ca2+ levels. Flow-cytometry experiments revealed that regulated cell death played an important role following PFA. Assessing for PFA antiarrhythmic properties, sustainable lines of conduction block could be generated using PFA, which could either terminate or isolate arrhythmic activity in the hiPSC-derived cardiac circular cell sheets. CONCLUSIONS: Cardiac electroporation may be studied using hiPSC-derived cardiac tissue, providing novel insights into PFA temporal and electrophysiological characteristics, facilitating electroporation protocol optimization, screening for potential PFA-sensitizers, and investigating the mechanistic nature of PFA antiarrhythmic properties.

Echocardiography vs hemodynamic assessment of diastolic dysfunction.

OBJECTIVES: Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. RESULTS: Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). CONCLUSIONS: Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.

Modifiers of the Association between E/e' Ratio and Survival among Patients with No Apparent Structural or Functional Cardiac Abnormality.

BACKGROUND: The ratio between early mitral flow wave to early diastolic mitral annulus velocity (E/e' ratio) varies according to age and sex and is associated with mortality in heart failure. We sought to describe the association between E/e' and mortality in patients with no apparent structural or functional cardiac abnormality and explore possible modifiers of this association. METHODS: A retrospective study of 104,315 patients who underwent echocardiographic evaluation during 2009-2021 in the largest tertiary center in Israel. Patients with cancer, ventricular dysfunction, significant valvular or structural heart disease, or evidence of pulmonary hypertension were excluded. RESULTS: The final analysis included 32,836 patients with a median age of 56 (43-66) years, and 13,547 (41%) were female. The median E/e' was 8.3 (6.8-10.3), and 9,306 (28%) had an E/e' >10. During a median follow-up of 5.7 (3.3-8.5) years, 2,396 (7.3%) individuals died. E/e' >10 was associated with mortality (adjusted hazard ratio [HR] 1.16, 95% confidence interval [CI] 1.07-1.27, p<0.001). The mortality risk associated with E/e' >10 was significantly higher in those aged ≤70 (HR 1.26, 95% CI 1.12-1.42, p<0.001), males (HR 1.34, 95% CI 1.19-1.49, p<0.001), a normal left ventricular mass (HR 1.13, 95% CI 1.02-1.24, p = 0.017), and pulmonary artery pressure <30 mmHg (HR 1.18, 95% CI 1.06-1.30, p = 0.003). CONCLUSION: An elevated E/e' is associated with mortality, specifically in younger individuals, males, and those with a normal left ventricular mass and lower pulmonary artery pressure. This suggests that an elevated E/e' might be a marker of subclinical risk in these subgroups. Further studies are needed to identify whether an elevated E/e' is useful in shared decision-making regarding the management of cardiovascular risk factors.

Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.

BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Evaluation of coronary disease among patients undergoing transcatheter aortic valve implantation: propensity score matching analysis.

BACKGROUND: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of any > 70% proximal coronary lesions prior to TAVI. AIMS: To evaluate the outcomes of two diagnostic approaches for CCS clearance pre-TAVI and to determine the reduction in the need of invasive angiography (IA). METHODS: We investigated 2219 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural strategies for CCS assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results or mandatory IA. We preformed propensity score matching analysis using a 1:1 ratio. The final study cohort included 870 matched patients. Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented. RESULTS: Mean age of the study population was 82 ± 7, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (39% vs. 22%, p < 0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were similar between the two groups (0.3% vs. 0.7%, p value = 0.41), but spontaneous MI were significantly lower among the IA group (0% vs. 1.3%, p value = 0.03). Kaplan-Meier's survival analysis found that the cumulative probability of 1-year morality was similar between the two groups (p value log rank = 0.65). Cox regression analysis did not find association between CCS clearance strategy and outcome. CONCLUSIONS: In elderly patients, CTA-driven approach for CCS evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.

Mild renal impairment is associated with increased cardiovascular events and all-cause mortality following cancer diagnosis.

BACKGROUND: The association between mildly decreased renal function and cardiovascular (CV) outcomes in cancer patients remains unestablished. AIMS: We sought to explore this association in asymptomatic self-referred healthy adults. METHOD: We followed 25, 274 adults, aged 40-79 years, who were screened in preventive healthcare settings. Participants were free of CV disease or cancer at baseline. The estimated glomerular filtration rate (eGFR) was calculated according to the CKD Epidemiology Collaboration equation and categorized into groups [≤59, 60-69, 70-79, 80-89, 90-99, ≥100 (ml/min/1.73 m²)]. The outcome included a composite of death, acute coronary syndrome, or stroke, examined using a Cox model with cancer as a time-dependent variable. RESULTS: Mean age at baseline was 50 ±â€…8 years and 7973 (32%) were women. During a median follow-up of 6 years (interquartile range: 3-11), 1879 (7.4%) participants were diagnosed with cancer, of them 504 (27%) develop the composite outcome and 82 (4%) presented with CV events. Multivariable time-dependent analysis showed an increased risk of 1.6, 1.4, and 1.8 for the composite outcome among individuals with eGFR of 90-99 [95% confidence interval (CI): 1.2-2.1 P = 0.01], 80-89 (95% CI: 1.1-1.9, P = 0.01) and 70-79 (95% CI: 1.4-2.3, P < 0.001), respectively. The association between eGFR and the composite outcome was modified by cancer with 2.7-2.9 greater risk among cancer patients with eGFR of 90-99 and 80-89 but not among individuals free from cancer ( Pinteraction < 0.001). CONCLUSION: Patients with mild renal impairment are at high risk for CV events and all-cause mortality following cancer diagnosis. eGFR evaluation should be considered in the CV risk assessment of cancer patients.

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

BACKGROUND: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. AIM: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. METHODS: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. RESULTS: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. CONCLUSIONS: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Admission Serum Magnesium Levels Is Associated with Short and Long-Term Clinical Outcomes in COVID-19 Patients.

BACKGROUND: In the face of the global pandemic that the coronavirus disease 2019 (COVID-19) has created, readily available prognostic markers may be of great use. OBJECTIVE: To evaluate the association between serum magnesium (sMg) levels on admission and clinical outcomes in hospitalized COVID-19 patients. METHODS: We retrospectively analyzed all patients admitted to a single tertiary center with a primary de novo diagnosis of COVID-19. Patients were followed for a mean of 10 ± 7 months. Demographic, clinical and laboratory data were collected and compared between five groups of patients according to sMg quintiles on hospital admission. RESULTS: The cohort included 1522 patients (58% male, 69 ± 17 years old). A low sMg level (1st quintile) was associated with higher rates of diabetes and steroid use, whereas a high sMg level (5th quintile) was associated with dyslipidemia, renal dysfunction, higher levels of inflammatory markers and stay in the intensive care unit. All-cause in-hospital and long-term mortality was higher in patients with both low and high sMg levels, compared with mid-range sMg levels (2nd, 3rd and 4th quintiles; 19% and 30% vs. 9.5%, 10.7% and 17.8% and 35% and 45.3% vs. 23%, 26.8% and 27.3% respectively; p < 0.001 for all). After adjusting for significant clinical parameters indicating severe disease and renal dysfunction, only low sMg state was independently associated with increased mortality (HR = 1.57, p < 0.001). CONCLUSIONS: Both low and high sMg levels were associated with increased mortality in a large cohort of hospitalized COVID-19 patients. However, after correction for renal dysfunction and disease severity, only low sMg maintained its prognostic ability.

Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38†mm prospective trial.

BACKGROUND: The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization. RESULTS: A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ±â€…8.3, reference vessel diameter 2.88 mm ±â€…0.45, minimal lumen diameter 0.80 mm ±â€…0.41, and percent diameter stenosis 72.6% ±â€…13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%). CONCLUSION: Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).

Baseline renal function and the risk of cancer among apparently healthy middle-aged adults.

BACKGROUND: The association between mildly impaired renal function with all-site and site-specific cancer risk is not established. We aim to explore this association among apparently healthy adults. METHODS: We followed 25,073 men and women, aged 40-79 years, free of cancer or cardiovascular disease at baseline who were screened annually in preventive healthcare settings. The estimated glomerular filtration rate (eGFR) was calculated using the CKD Epidemiology Collaboration equation (CKD-EPI) and classified into four mutually exclusive groups: <60, 60-74, 75-89, ≥90 (mL/min/1.73 m²). The primary outcome was all-site cancer while the secondary outcome was site-specific cancer. Cancer data was available from a national registry. RESULTS: Mean age at baseline was 50 ± 8 years and 7973 (32 %) were women. During a median follow-up of 9 years (IQR 3-16) and 256,279 person years, 2045 (8.2 %) participants were diagnosed with cancer. Multivariable Cox model showed a 1.2 (95 %CI: 1.0-1.4 p = 0.05), 1.2 (95 %CI: 1.0-1.4 p = 0.02), and 1.4 (95 %CI: 1.1-1.7 p = 0.003) higher risk for cancer with eGFR of 75-89, 60-74, and < 60, respectively. Site-specific analysis demonstrated a 1.8 (95 %CI: 1.2-2.6 p = 0.004), 1.7 (95 %CI: 1.2-2.6 p = 0.004) and 2.2 (95 %CI: 1.3-3.6 p = 0.002) increased risk for prostate cancer with eGFR of 75-89, 60-74, and < 60, respectively. eGFR< 60 was associated with a 2.0 (95 %CI: 1.1-3.7 p = 0.03) and 3.7 (95 %CI: 1.1-13.1 p = 0.04) greater risk for melanoma and gynecological caner respectively. CONCLUSIONS: CKD stage 2 and worse is independently associated with higher risk for cancer incidence, primarily prostate cancer. Early intervention and screening are warranted among these individuals in order to reduce cancer burden.