Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation.

INTRODUCTION: Data on peri-operative management of direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations remain limited. This study aimed to evaluate a standardized DOAC management regime consisting of interruption of a single dose prior to implantation and reinitiation within 6-24 h; also, patient clinical characteristics associated with this approach were identified. METHOD: Consecutive patients undergoing standard TPS implantation procedures from two Swiss tertiary centers were included. DOAC peri-operative management included the standardized approach (Group 1A) or other approaches (Group 1B). RESULTS: Three hundred and ninety-two pts (mean age 81.4 ± 7.3 years, 66.3% male, left ventricular ejection fraction 55.5 ± 9.6%) underwent TPS implantation. Two hundred and eighty-two pts (71.9%) were under anticoagulation therapy; 192 pts were treated with DOAC; 90 pts were under vitamin-K antagonist. Patients treated with DOAC less often had structural heart disease, diabetes mellitus, and advanced renal failure. The rate of major peri-procedural complications did not differ between groups 1A (n = 115) and 1B (n = 77) (2.6% and 3.8%, p = 0.685). Compared to 1B, 1A patients were implanted with TPS for slow ventricular rate atrial fibrillation (AF) (p = 0.002), in a better overall clinical status, and implanted electively (<0.001). CONCLUSIONS: Standardized peri-procedural DOAC management was more often implemented for elective TPS procedures and did not seem to increase bleeding or thromboembolic adverse events.

Multimodality Imaging Evaluation to Detect Subtle Right Ventricular Involvement in Patients with Acute Myocarditis and Preserved Left Ventricular Ejection Fraction.

Background: Evaluation of the right ventricle (RV) in patients with acute myocarditis (MY) remains challenging with both 2D transthoracic echocardiography (TTE) and cardiovascular magnetic resonance (CMR). We examined the incremental diagnostic value of CMR feature tracking (FT) to evaluate RV involvement in patients with myocarditis. Methods: We enrolled 54 patients with myocarditis and preserved left ventricle (LV) ejection fraction (EF). The CMR protocol included T2-weighted images for edema detection and late gadolinium enhancement (LGE) images. Global longitudinal strain (GLS) of the left ventricle (LV) and RV free wall strain (CMR-FWS) were obtained with CMR-FT. We identified 34 patients (62%) with inferior and lateral segment (IL-MY) involvement and 20 (38%) noIL-MY in case of any other myocardial segment involved. Here, 20 individuals who underwent CMR for suspected cardiac disease, which was not confirmed thereafter, were considered as the control population. Results: TTE and CMR showed normal RV function in all patients without visible RV involvement at the LGE or T2-weighted sequences. At CMR, LV-GLS values were significantly lower in patients with MY compared to the control group (median -19.0% vs. -21.0%, p = 0.029). Overall, CMR RV-FWS was no different between MY patients and controls (median -21.2% vs. -23.2 %, p = 0.201) while a significant difference was found between RV FWS in IL-MY and noIL-MY (median -18.17% vs. -24.2%, p = 0.004). Conclusions: CMR-FT has the potential to unravel subclinical RV involvement in patients with acute myocarditis, specifically in those with inferior and lateral injuries that exhibit lower RV-FWS values. In this setting, RV deformation analysis at CMR may be effectively implemented for a comprehensive functional assessment.

Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker.

PURPOSE: The miniaturized transcatheter pacing system (TPS) implant is performed using a 27 Fr sheath. Achieving femoral vein access hemostasis after sheath removal is of utmost importance. Feasibility and clinical effectiveness of double device-based suture-mediated closure technique (DualPerclose) were evaluated. METHODS: Patients undergoing TPS positioning and treated with DualPerclose technique at our institution were considered. Feasibility of the DualPerclose technique included the rates of effective initial device suture fixation and effective hemostasis after sheath removal. Clinical efficacy considered intraprocedural and periprocedural bleeding events as well as midterm access site vascular injury assessed at 3 months using lower limb vascular ultrasonography. Data on all follow-up major adverse events were also collected. RESULTS: All patients (n = 83 patients; mean age 82.3 ± 7.1 years, 67.5% male gender, 85.5%, with structural heart disease, mean left ventricular ejection fraction 54.0 ± 9.6%, renal impairment in 31.3%) who underwent TPS positioning between November 2015 and February 2020 were considered. TPS positioning was successful in all patients. In 82 patients, the DualPerclose approach was utilized: 13 patients (15.8%) required > 2 devices to obtain effective fixing of 2 sutures; complete immediate hemostasis was achieved in 80 patients (97.6%). One (1.2%) severe groin-related bleeding event occurred. At midterm, 1 (1.2%) mildly symptomatic arteriovenous fistula was diagnosed (conservative treatment). Over a median follow-up of 22 (IQR 10-35.5) months, 14 (17.1%) major adverse events were recorded, including 1 loss of capture requiring TPS replacement and 5 deaths. CONCLUSION: Femoral vein access closure using dual Perclose Proglide devices during TPS is feasible and clinically effective.

A patient-centered multidisciplinary cardiac rehabilitation program improves glycemic control and functional outcome in coronary artery disease after percutaneous and surgical revascularization.

BACKGROUND: Cardiac rehabilitation (CR) is strongly associated with all-cause mortality reduction in patients with coronary artery disease (CAD). The impact of CR on pathological risk factors, such as impaired glucose tolerance (IGT) and functional recovery remains under debate. The aim of the present study is to determine whether CR had a positive effect beside physical exercise improvement on pathological risk factors in IGT and diabetic patients with CAD. METHODS: One hundred and seventy-one consecutive patients participating in a 3-month CR from January 2014 to June 2015 were enrolled. The primary endpoint was defined as an improvement of peak workload and VO2-peak; glycated hemoglobin (HbA1c) reduction was considered as secondary endpoint. RESULTS: Euglycemic patients presented a significant improvement in peak workload compared to diabetic patients (from 5.75 ± 1.45 to 6.65 ± 1.84 METs vs. 4.8 ± 0.8 to 4.9 ± 1.4 METs , p = 0.018). VO2-peak improved in euglycemic patients (VO2-peak from 19.3 ± 5.3 to 22.5 ± 5.9 mL/min/kg, p = 0.003), while diabetic patients presented only a statistically significant trend (VO2-peak from 16.9 ± 4.4 to 18.0 ± 3.8 mL/min/kg, p < 0.056). Diabetic patients have benefited more in terms of blood glucose control compared to IGT patients (HbA1c from 7.7 ± 1.0 to 7.4 ± 1.1 compared to 5.6 ± 0.4 to 5.9 ± 0.5, p = 0.02, respectively). CONCLUSIONS: A multidisciplinary CR program improves physical functional capacity in CAD setting, particularly in euglycemic patients. IGT patients as well as diabetic patients may benefit from a CR program, but long-term outcome needs to be clarified in larger studies.

[Sex and gender medicine: the foundation of gender medicine]. / "Sex and gender medicine": il principio della medicina di genere.

"Sex and gender medicine" is the original name of gender medicine. It is important to define medical concepts without ignoring key terminology. The purpose of "sex and gender medicine" is to focus on both sex and gender differences, to analyze how these two sides of the human being overlap and, finally, to improve their medical understanding. On the one hand sex, besides defining male and female, refers to the biological differences among humans, animals, tissues and cells. On the other, the concept of gender is applicable only to humans, and includes identity, roles and relations in the society. However, despite its 20 years of history, gender medicine is still little known. Biological differences among cardiovascular diseases are ignored. Symptoms and their expressions, which may be different in women, are often described as "atypical" because of the masculine vision of the heart attack and pain. Similarly, anxious syndrome is often conceived as the first reason to explain chest discomfort in women. In reality, prejudices and vagueness around women still dominate prevention and medical treatment. Our objective is to distinguish the concepts of sex and gender in order to understand the best way to face differences and medical knowledge in both.

Post procedural risk assessment in patients undergoing trans aortic valve implantation according to the age, creatinine, and ejection fraction-7 score: Advantages of age, creatinine, and ejection fraction-7 in stratification of post-procedural outcome.

BACKGROUND: Post-procedural risk stratification based on renal function after trans aortic valve implantation (TAVI) was assessed by means of a modified age, creatinine, and ejection fraction (ACEF) score using the lowest glomerular filtration rate (GFR), obtained within 1 week after valve implantation. We refer to the score as ACEF-7 score. METHODS: The Zurich- and Cardiocentro Ticino TAVI-Cohorts comprised of 424, and 137 patients, who were not on hemodialysis and had already survived the first post-procedural week. Zurich patients were stratified into tertiles of ACEF-7 score (ACEF-7Low ≤ 2.45 (n = 138), ACEF-7Mid 2.46-4.38 (n = 142), and ACEF-7High ≥ 4.39 (n = 144) and compared for survival using KM curves. Euroscore II, Society of Thoracic Surgeons (STS), and ACEF were also calculated at baseline in all patients and assessed for prognostic significance in predicting the primary outcome of 1-year all-cause mortality using univariate and multivariate Cox regression models. Results were then confirmed in the Cardiocentro cohort. RESULTS: Six months (18.1% vs. 6.3% vs. 2.9% P < 0.001) and 1-year all-cause mortality (24.3% vs. 12.7% % vs. 5.8%, P < 0.001), as well as the composite of death or rehospitalization (35% vs. 20% vs. 11% P < 0.001) occurred significantly more frequently in the ACEF-7High compared to the other groups. Both Euroscore II and STS score were not predictors of mortality in our cohort. In a multivariate Cox regression model corrected for gender, Acute Kidney Injury, and baseline ACEF score, the ACEF-7 score was an independent predictor of 1-year all-cause mortality as a per point increment HR 1.512 [95% CI 1.227-1.862, P < 0.001] and as ACEF-7High (≥4.39); HR 5.541 [1.694-18.120]). In addition, the ACEF-7 tertiles showed a significant (P = 0.02) net reclassification improvement of 16% when compared to baseline tertiles of ACEF score, when assessing 1-year all-cause mortality. CONCLUSION: Post-procedural risk stratification using the simple ACEF-7 score significantly better predicted long-term outcome than commonly used risk-scores. Practical implications could include contrast sparing and renal protection in high-risk patients, emphasizing the importance of preventative measures.

Radiological exposure of patients undergoing transcatheter aortic valve implantation in contemporary practice.

BACKGROUND: Radiological exposure associated with transcatheter aortic valve implantation (TAVI) is unknown and might impact on broadening indications to lower risk patients. Radiological exposure of TAVI patients and its predictors are herein reported. METHODS: Radiological exposure derived from exams/procedures performed within 30 days preceding/following TAVI were acquired and converted into effective-dose. Total effective-dose was defined as the sum of each single dose derived from diagnostic/therapeutic sources. Univariable and multivariable analyses were performed to recognize correlates of exposure. RESULTS: Seventy-five patients aged 82.6 ±â€Š6.0 years with a median Euroscore II 3.6 [IQR 1.93-6.65] were analysed. Median total effective-dose was 41.39 mSv [IQR 27.93-60.88], with TAVI accounting for 47% of it. Age (coefficient -0.031, 95% CI -0.060 to -0.002; P = 0.031) and previous history of cerebrovascular accidents (CVA; coefficient -0.545; 95% CI -1.039 to -0.010; P = 0.046) resulted as inversely correlated to total effective-dose (log-transformed), whereas left ventricular ejection fraction (LVEF) less than 50% (coefficient 0.430, 95% CI 0.031-0.828; P = 0.035) was directly associated. CONCLUSION: Multiple radiological sources are responsible for the observed exposure, with TAVI being the prominent source. Age is inversely related to the radiological exposure.

Echocardiographic-fluoroscopic fusion imaging for transcatheter mitral valve repair guidance.

The echocardiographic-fluoroscopic fusion imaging is a new imaging system which has recently become available, with the proposal to facilitate catheters and device navigation during catheter-based structural heart disease interventions. Several reports have described the early developments and the first clinical experiences, but literature focusing on the practical applications of fusion imaging technology to mitral valve transcatheter interventions, and on its potential advantages and current limitations, is still limited. In this review, we, therefore, describe the role of this novel imaging system during Mitraclip, Cardioband, and paravalvular leak closure interventions. The technical principles and the fluoroscopic anatomy of the interatrial septum and mitral valve are also described.

[Inhibitors of PCSK9]. / Inhibiteurs de la PCSK9.

Observational data show a consistent association between elevated low density lipoproteins (LDL-C) and cardiovascular disease (CVD). Reduction of LDL-C reduces the risk of CVD as has been shown by many trials. Statins are currently the most effective drugs for lowering LDL-C, but can present side effects which might limit the prescribed dosage and prevent patients from reaching the recommended LDL levels. Although treated with statins important residual cardiovascular event risk remains in patients in primary and secondary prevention for CVD. The discovery of protein convertase subtilisin kexin 9 antibodies is a very promising new hypolipidemic treatment and the aim of this review is to explain their mechanism of action and to discuss safety and efficacy results of some phase III studies.

Les données d'observation montrent une association cohérente entre une élévation des lipoprotéines de basse densité (LDL-C) et les maladies cardiovasculaires (MCV). Les statines sont actuellement les médicaments les plus efficaces pour abaisser le LDL-C, mais elles peuvent présenter des effets secondaires qui pourraient limiter les patients d'atteindre les niveaux de LDL-C recommandés. Bien que traités par les statines, un important risque résiduel d'événement cardiovasculaire reste chez les patients en préventions primaire et secondaire. La découverte des anticorps contre la protéase convertase subtilisine / kexine 9 est un nouveau traitement antilipémique très prometteur et le but de cet examen est d'expliquer leur mécanisme d'action et de discuter les données de sécurité et d'efficacité de quelques études de phase III.

Echocardiographic-Fluoroscopic Fusion Imaging in Transseptal Puncture: A New Technology for an Old Procedure.

In an era of catheter-based structural heart disease and left-side electrophysiologic interventions, transseptal puncture (TSP) is probably the most common transcatheter procedure. Experienced interventional cardiologists and electrophysiologists may safely perform TSP using fluoroscopic guidance alone. However, at present TSP is usually the first step in complex percutaneous catheter-based structural heart disease procedures and necessitate a precise site-specific TSP. Thus, in these procedures most interventional cardiologists perform TSP under fluoroscopic and two- or three-dimensional transesophageal echocardiographic guidance. The EchoNavigator system may provide a solution by fusing fluoroscopic and transesophageal echocardiographic images. In this review, the authors describe advantages and limitations of this new imaging system in guiding TSP and suggest specific echocardiographic-fluoroscopic fusion imaging perspectives that may facilitate TSP, making it potentially easier and safer.

Evaluation of a protocol for same-day discharge after radial lounge monitoring in a southern Swiss referral percutaneous coronary intervention centre.

AIMS: The aim of the study was to retrospectively evaluate safety and patient satisfaction of same-day discharge after elective radial coronary angiography/percutaneous coronary intervention (PCI) after the implementation of a radial lounge facility. METHODS: All patients admitted to our radial lounge with a planned same-day discharge after an uncomplicated coronary angiography/PCI, having a co-living caregiver, were day enrolled in the study. Rates of same-day discharge, unplanned overnight stay, and in-hospital and first complications [death, myocardial infarction (MI), unplanned coronary angiography, access site hematoma, bleedings requiring hospitalization] were analysed; satisfaction was also evaluated through a questionnaire. RESULTS: From February 2015 to January 2016, 312 patients with a mean age of 66.6 ±â€Š10.8 years were admitted to the radial lounge (coronary angiography, n = 232; PCIs, n = 80). Of them, 245 (78.5%) were discharged the same day. Mean radial lounge monitoring was 6:35 h (interquartile range 5:30-7:30 h). No episodes of death/MI/unplanned coronary angiography were observed both in same-day discharged and postponed patients. Reasons to postpone discharge were: PCI deemed to need prolonged monitoring in 31, patient's preference in 14, femoral shift in 13, surgery in four, chest pain in four, and bleeding in one. At day 1, 11 access site hematoma and one hospitalization for access site bleeding were reported. Patients reported complete satisfaction in 97% of cases. Unplanned overnight stay was common among PCIs patients (RR 6.2, 95% CI 3.9-9.9, P < 0.001). CONCLUSION: A low rate of minor complications was observed in elective radial coronary angiography and PCIs showing the feasibility and safety of the development of an institutional protocol for same-day discharge after the implementation of a radial lounge facility.

Prevention of Contrast-Induced Acute Kidney Injury by Furosemide With Matched Hydration in Patients Undergoing Interventional Procedures: A Systematic Review and Meta-Analysis of Randomized Trials.

OBJECTIVES: The objective of this meta-analysis of randomized trials was to evaluate if the administration of furosemide with matched hydration using the RenalGuard System reduces contrast-induced acute kidney injury (CI-AKI) in patients undergoing interventional procedures. BACKGROUND: CI-AKI is a serious complication following angiographic procedures and a powerful predictor of unfavorable early and long-term outcomes. METHODS: Online databases were searched up to October 1, 2016, for randomized controlled trials. The primary outcome was the incidence of CI-AKI, and the secondary outcomes were need for renal replacement therapy, mortality, stroke, and adverse events. RESULTS: A total of four trials (n = 698) published between 2011 and 2016 were included in the analysis and included patients undergoing percutaneous coronary procedures and transcatheter aortic valve replacement. RenalGuard therapy was associated with a lower incidence of CI-AKI compared with control treatment (27 of 348 [7.76%] patients vs. 75 of 350 [21.43%] patients; odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.19 to 0.50; I2 = 4%; p < 0.00001) and with a lower need for renal replacement therapy (2 of 346 [0.58%] patients vs. 12 of 348 [3.45%] patients; OR: 0.19; 95% CI: 0.05 to 0.76; I2 = 0%; p = 0.02). No major adverse events occurred in patients undergoing RenalGuard therapy. CONCLUSIONS: The main finding of this meta-analysis is that furosemide with matched hydration by the RenalGuard System may reduce the incidence of CI-AKI in high-risk patients undergoing percutaneous coronary intervention or transcatheter aortic valve replacement. However, further independent high-quality randomized trials should elucidate the effectiveness and safety of this prophylactic intervention in interventional cardiology.

Predictors of disagreement between prospectively ECG-triggered dual-source coronary computed tomography angiography and conventional coronary angiography.

AIMS: To identify causes of misinterpretation in second generation, dual-source coronary computed tomography angiography (CCTA). METHODS: A retrospective re-interpretation was performed on 100 consecutive CCTA studies, previously performed with a 2×128 slice dual-source CT. Results were compared with coronary angiography (CA). CCTA and CA images were interpreted by 2 independent readers. At CCTA vessel diameter, image quality, plaque characteristics and localization (bifurcation vs. non) were described for all segments. Finally, aortic contrast-to-noise ratio (CNR) and the total Agatston calcium score were quantified. Agreement between CCTA and CA was assessed with the Kappa statistic after categorizing the stenosis severity at significant (≥50%) and critical (≥70%) cut-offs, and independent predictors of disagreement were determined by multivariable logistic regression, including patient characteristics such as body mass index (BMI), heart rate (HR), age and gender. RESULTS: Per-segment sensitivity and specificity at ≥50% and ≥70% stenosis was of 83-95%, and 73-97%, respectively. There was a substantial agreement between CCTA and CA (kappa-50%=0.78, SE=0.03; kappa-70%=0.72, SE=0.03). Worse motion-related quality score, smaller vessel diameter, calcification within the segment of interest and LAD location were independent predictors of disagreement at 50% stenosis. The same factors, excluded LAD location, in addition to bifurcation-location of the coronary lesion predicted misdiagnosis at 70% stenosis. HR per se and BMI did not predict disagreement. CONCLUSION: According to the literature a substantial agreement between CCTA and CA was found. However, discrepancies exist and are mainly related with motion-related degradation of image quality, specific vessel anatomy and plaque characteristics. Awareness of such potential limitations may help guiding interpretation of CCTA.

Combined Left Atrial Appendage Closure and Pacemaker Implant through a Single Right Femoral Vein Access.

Left atrial appendage (LAA) closure is indicated in patients with atrial fibrillation (AF) and high bleeding as well as thromboembolic risks. A subgroup of these patients may also present an indication for a single-chamber permanent pacemaker due to symptomatic low-rate AF or when "ablate and pace" strategy is indicated for rate control. A miniaturized wireless transcatheter pacing system (TPS) is now available as a single-chamber permanent pacemaker. This case presents how combined LAA closure and permanent pacemaker implant, by means of TPS, is feasible through a single femoral venous access.

PCSK9 inhibitors: an overview on a new promising lipid-lowering therapy.

Atherosclerosis is characterized by cholesterol deposition in the arterial intima, with subsequent plaque formation and arterial disease. Low-density lipoprotein cholesterol (LDL-C) plays the most important role in the atherogenesis process, which is the substrate of cardiovascular disease and is the leading cause of death worldwide. Several studies show that a strict control of risk factors, particularly the reduction of LDL-C levels, is a cornerstone in primary and secondary prevention of coronary heart disease. Statins are currently the most effective drugs for lowering LDL-C, but the discovery of proprotein convertase subtilisin kexin 9 (PCSK9) has opened up new therapeutic options in lipid management. PCSK9 reduces LDL-receptors' recycling resulting in a decrease of LDL-C receptors on the surface of hepatocytes and an increase of LDL-C levels in plasma. Obviously, inhibition of PCSK9 has been associated with an increase of LDL-C receptors with subsequent lowering of plasma levels of LDL-C. The clinical development of monoclonal antibodies against PCSK9 has been achieved through phase I and II studies, and nowadays there are many ongoing phase III trials with promising preliminary results. The aim of this review is to update the evidence for PCSK9 monoclonal antibodies, such as evolocumab, alirocumab and bococizumab, in LDL-C management and to discuss their therapeutic perspectives based on the most recent clinical studies, with attention to side-effects.

Cardiac Remodeling, Circulating Biomarkers and Clinical Events in Patients with a History of Atrial Fibrillation. Data from the GISSI-AF Trial.

PURPOSE: Atrial fibrillation (AF) is the most common arrhythmia and has an increasing impact on public health because of its morbidity and mortality. Clinical and diagnostic tests to predict the recurrence of arrhythmia and clinical events before AF becomes permanent are still an open issue. METHODS: 307 out of 1442 patients in sinus rhythm, at high risk of recurrence of AF enrolled in the GISSI-AF study, participated in a substudy with echocardiographic and biohumoral evaluation at baseline and at 12-month follow-up. The relations between biomarker concentrations and echocardiographic parameters with study endpoints in 1 year, were analysed by a stepwise multivariable Cox model (entry criteria p < 0.5 and stay criteria p < 0.2). RESULTS: The echocardiographic variables, cardiac markers and clinical variables considered in the statistical model indicated a higher concentration of NT-proBNP at baseline as the strongest factor related to time of first AF recurrence (HR 1.42; 95 %CI 1.23-1.46), first CV hospitalization (HR 1.58; 95 %CI 1.31-1.92) and increasing duration of recurrent AF (OR 2.16; 95 %CI 1.52-3.08). Valsartan treatment was not related to clinical events. CONCLUSIONS: In patients in sinus rhythm with a history of AF a higher concentration of NT-proBNP at baseline was the strongest independent risk factor for first AF recurrence and its duration, and for the first hospital admission for cardiovascular reasons.