Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet ...therapy.
The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate.
BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up.
Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration.
The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.
Dynamic three-dimensional-cardiac magnetic resonance (3D-CMR) perfusion proved highly diagnostic for the detection of angiographically defined coronary artery disease (CAD) and has been used to ...assess the efficacy of coronary stenting procedures. The present study aimed to relate significant coronary lesions as assessed by fractional flow reserve (FFR) to the volume of myocardial hypoenhancement on 3D-CMR adenosine stress perfusion imaging and to define the inter-study reproducibility of stress inducible 3D-CMR hypoperfusion.
A total of 120 patients with known or suspected CAD were examined in two CMR centres using 1.5 T systems. The protocol included cine imaging, 3D-CMR perfusion during adenosine infusion, and at rest followed by delayed enhancement (DE) imaging. Fractional flow reserve was recorded in epicardial coronary arteries and side branches with ≥2 mm luminal diameter and >40% severity stenosis (pathologic FFR < 0.75). Twenty-five patients underwent an identical repeat CMR examination for the determination of inter-study reproducibility of 3D-CMR perfusion deficits induced by adenosine. Three-dimensional CMR perfusion scans were visually classified as pathologic if one or more segments showed an inducible perfusion deficit in the absence of DE. Myocardial ischaemic burden (MIB) was measured by segmentation of the area of inducible hypoenhancement and normalized to left ventricular myocardial volume (MIB, %). Three-dimensional CMR perfusion resulted in a sensitivity, specificity, and diagnostic accuracy of 90, 82, and 87%, respectively. Substantial concordance was found for inter-study reproducibility Lin's correlation coefficient: 0.98 (95% confidence interval: 0.96-0.99).
Three-dimensional CMR stress perfusion provided high diagnostic accuracy for the detection of functionally significant CAD. Myocardial ischaemic burden measurements were highly reproducible and allowed the assessment of CAD severity.
Abstract This study assessed the clinical utility and feasibility of concomitant of combined left atrial appendage (LAA) closure and positioning of miniaturized pace-maker (Micra TPS). All ...consecutive patients undergoing VVI-PM implant from November 2015 to October 2016 were considered. VVI-PM implant was conducted either using transvenous approach or by positioning Micra TPS. In selected patients with concomitant contraindication to OAC, Micra TPS was combined with LAA occlusion ( combined approach ), performed in general anesthesia and guided by multi-modality imaging; procedural and follow-up data of these specific patients were registered. Sixty patients were treated with VVI-PM implant . Six (10.0%) patients presented OAC contraindication, of which 4 (6.7%) were eligible for the combined procedure ; 2 of 4 of these patients presented chronic hemodialysis-dependent renal failure. The combined approach was successful in all 4 patients without intra-or peri-procedural complications. No adverse events linked to the combined approach occurred during mid-term follow-up (7.5, IQR 5.0-7.9 months). In conclusion, VVI-PM indication and concomitant contraindication to OAC is not uncommon; in selected patients combined LAA closure and positioning of Micra TPS may be a feasible therapeutic option.
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.
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.
From February 2015 to January 2016, 312 patients with a mean age of 66.6 ± 10.8 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).
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.
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.
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.
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.
Seventy-five patients aged 82.6 ± 6.0 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.
Multiple radiological sources are responsible for the observed exposure, with TAVI being the prominent source. Age is inversely related to the radiological exposure.
Aims
The time course of atherosclerosis burden in distinct vascular territories remains poorly understood. We longitudinally evaluated the natural history of atherosclerotic progression in two ...different arterial territories using high spatial resolution magnetic resonance imaging (HR-MRI), a powerful, safe, and non-invasive tool.
Methods and results
We prospectively studied a cohort of 30 patients (mean age 68.3, n = 9 females) with high Framingham general cardiovascular disease 10-year risk score (29.5%) and standard medical therapy with mild-to-moderate atherosclerosis intra-individually at the level of both carotid and femoral arteries. A total of 178 HR-MRI studies of carotid and femoral arteries performed at baseline and at 1- and 2-year follow-up were evaluated in consensus reading by two experienced readers for lumen area (LA), total vessel area (TVA), vessel wall area (VWA = TVA − LA), and normalized wall area index (NWI = VWA/TVA). At the carotid level, LA decreased (−3.19%/year, P = 0.018), VWA increased (+3.83%/year, P = 0.019), and TVA remained unchanged. At the femoral level, LA remained unchanged, VWA and TVA increased (+5.23%/year and +3.11%/year, both P < 0.01), and NWI increased for both carotid and femoral arteries (+2.28%/year, P = 0.01, and +1.8%/year, P = 0.033).
Conclusion
The atherosclerotic burden increased significantly in both carotid and femoral arteries. However, carotid plaque progression was associated with negative remodelling, whereas the increase in femoral plaque burden was compensated by positive remodelling. This finding could be related to anatomic and flow differences and/or to the distinct degree of obstruction in the two arterial territories.
A substantial proportion of patients experiencing ST-segment elevation myocardial infarction (STEMI) have a late presentation. There is a lack of temporal trends drawn from large real-word scenarios ...in these patients.
All STEMI patients included in the AMIS Plus registry from January 1997 to December 2017 were screened and patient-related delay was assessed. STEMI patients were classified as early or latecomers according to patient-related delay (≤ or> 12hours, respectively).
A total of 27 231 STEMI patients were available for the analysis. During the study period, the prevalence of late presentation decreased from 22% to 12.3% (P <.001). In latecomer STEMI patients, there was a gradual uptake of evidence-based pharmacological treatments (rate of P2Y12 inhibitors at discharge, from 6% to 90.6%, P <.001) and a marked increase in the use of percutaneous coronary intervention (PCI), particularly in 12- to 48-hour latecomers (from 11.9%-87.9%; P <.001). In-hospital mortality was reduced from 12.4% to 4.5% (P <.001). On multivariate analysis, PCI had a strong independent protective effect on in-hospital mortality in 12- to 48-hour latecomers (OR, 0.29; 95%CI, 0.15-0.55).
During the 20-year study period, there was a progressive reduction in the prevalence of late presentation, a gradual uptake of main evidence-based pharmacological treatments, and a marked increase in PCI rate in latecomer STEMI patients. In-hospital mortality was reduced to a third (to an absolute rate of 4.5%); in 12- to 48-hour latecomers, this reduction seemed to be mainly associated with the increasing implementation of PCI.
Una proporción relevante de pacientes con infarto de miocardio con elevación del segmento ST (IAMCEST) tiene una presentación tardía (> 12 h tras el inicio de los síntomas). El objetivo de este estudio fue evaluar las tendencias temporales en estos pacientes.
Se incluyó a todos los pacientes con IAMCEST del registro AMIS Plus entre enero de 1997 y diciembre de 2017 (27.231 pacientes) y se clasificaron como de presentación temprana o tardía según el retraso en la demanda de atención médica (≤ o> 12 h, respectivamente).
Se observó una disminución en la prevalencia de presentación tardía del 22 al 12,3% (p <0,001). En los pacientes con IAMCEST y presentación tardía hubo un marcado aumento en la prescripción de inhibidores del P2Y12 (del 6 al 90,7%; p <0,001) y en la tasa de intervención coronaria percutánea (ICP), particularmente en los pacientes con presentación entre 12 y 48 h (del 11,9 al 87,9%; p <0,001). La mortalidad hospitalaria se redujo del 12,4 al 4,5% (p <0,001). En el análisis multivariado, en los pacientes con presentación entre 12 y 48 h, la ICP tuvo un fuerte efecto protector independiente sobre la mortalidad hospitalaria (OR = 0,29; IC95%, 0,15-0,55).
Durante el periodo de 20 años del estudio, los pacientes con IAMCEST y presentación tardía mostraron una reducción en su prevalencia, una gradual aceptación del tratamiento farmacológico basado en la evidencia y un marcado incremento en la proporción de ICP. En pacientes con IAMCEST y presentación tardía, la mortalidad hospitalaria se redujo a un tercio (hasta el 4,5%); en los pacientes con presentación entre 12 y 48 h, esta reducción parece estar asociada principalmente con un aumento de la tasa de ICP.
PDF
