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© 2021 European Society of Cardiology. All rights reserved. Published by the Czech Society of Cardiology.

Purpose: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). Results: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01–2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91–6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. Conclusions: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Toto odborne stanovisko reprezentuje nazor výse uvedených odborných spolecnosti a bylo vytvořene v souladu s vědeckými a lekařskými poznatky dostupnými v době připravy publikace. Cilem tohoto dokumentu je pomahat lekařům při volbě nejlepsiho diagnostickeho a lecebneho postupu pro každeho pacienta s daným onemocněnim, přicemž je posuzovan jak vliv na klinicke výsledky, tak poměr přinosu a rizika daneho postupu. Definitivni rozhodnuti týkajici se konkretniho pacienta vsak musi ucinit osetřujici lekař po konzultaci s pacientem a tento dokument v žadnem připadě nenahrazuje individualni odpovědnost každeho lekaře. Obsah tohoto dokumentu byl publikovan pouze pro nekomercni a edukacni ucely.

Narodni registr kardiovaskularnich intervenci (NRKI) je prospektivni multicentrický registr, který shromažďujeme data o vsech provedených perkutannich koronarnich intervencich (PCI) ze vsech PCI center v Ceske republice, a to prospektivně od roku 2005. V obdobi let 2005-2017 je patrný mirný (cca 14%) narůst poctu osetřených nemocných a poctu provedených PCI. Podil mužů a žen se zasadně neměni (70 : 30), stoupa průměrný vět nemocných, a to vice u mužů nežli u žen. Podil PCI pro AKS je dlouhodobě kolem 50 %, přicemž primarni PCI v akutni fazi STEMI podstupuje rocně kolem 6 000 nemocných - ani pocet těchto výkonů do roku 2018 neklesa. Nejcastěji intervenovanou tepnou je RIA a pote ACD, narůsta pocet intervenci kmene leve věncite tepny. Potěsitelným faktem je dominantni podil transradialniho přistupu k PCI (75 %) a zcela dominujici podil lekových stentů (nad 95 % v roce 2018). Objektivizovana jsou data o celkove mortalitě nemocných (30denni a 1rocni), přicemž dominantni roli hraje klinicka manifestace onemocněni (STEMI vs. NSTE-AKS vs. chronicka ICHS) a věk nemocných.

Autoři originalniho textu ESC:Juhani Knuuti,William Wijns,Antti Saraste et al.,jmenem autorů pracovni skupiny European Society of Cardiology (ESC) The Task Force for the diagnosis,management of chronic coronary syndromes of the European Society of Cardiology (ESC).© 2020 European Society of Cardiology. All rights reserved. Published by the Czech Society of Cardiology

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

ný clanek představuje přistup Ceske asociace intervencni kardiologie k invazivni lecbě srdecnich onemocněni během koronavirove pandemie. Primarni angioplastika zůstava metodou volby pro lecbu pacientů s infarktem myokardu s elevacemi useku ST (STEMI) i pro nemocne s infarktem myokardu be elevaci useku ST (NSTEMI) a trvajici ischemii, bez ohledu na znalost přitomnosti koronaviru u těchto pacientů v době výkonu. Ostatni nemocni, kteři potřebuji katetrizacni lecbu srdecni nemoci, by měli být vysetřeni alespoň 48 hodin před přijetim do zdravotnickeho zařizeni na přitomnost COVID-19. Přiznivý průběh pandemie v Ceske republice umožňuje v soucasnosti katetrizacnim laboratořim postupný navrat k obvykle urovni kvality a dostupnosti invazivni lecby. © 2020, CKS.

Autoři prezentuji soucasně dostupne informace týkajici se alergických reakci po katetrizacnim uzavěru defektů siňoveho septa. Popisuji patogenezi reakce, možne typy nežadoucich alergických komplikaci a jejich management.

Autoři originalniho textu ESC/EATCS: Franz-Josef Neumann,Miguel Sousa-Uva jmenem Pracovni skupiny pro revaskularizaci myokardu Evropske kardiologicke spolecnosti (ESC),European Association for Cardio-Thoracic Surgery (EACTS) s přispěnim European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Aims In the randomized GRAFFITI trial, surgeons drew their strategy based on coronary angiography. When patients were randomized to fractional flow reserve (FFR)-guidance, surgeons were informed of the FFR values and asked to redraw their strategy. The aim of this study was to investigate the changes induced by FFR knowledge. Methods and results The intended and performed strategy (before and after FFR) were compared. Among 172 patients, 84 with 300 lesions were randomized to the FFR-guided group. The intended strategy was to bypass 236 stenoses:108 with a venous and 128 with an arterial graft. After disclosing FFR, a change in strategy occurred in 64 lesions (21.3%) of 48 (55%) patients. Among 64 lesions for which the intended strategy was medical therapy, 16 (25%) were bypassed after disclosing FFR. The number of procedures with >1 venous graft planned was significantly reduced from 37 to 27 patients (p = .031). The proportion of on-pump surgery was significantly reduced from 71 to 61 patients (p = .006). The rates of clinical events at 1 year were similar between patients with or without at least one change in strategy. Discussion FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Background The trial collected prospective data from physiology measurements of borderline lesions in five Czech, one Japan and one Argentinian cathlabs. The main purposes were to analyze diagnostic agreement between FFR (fractional flow reserve) and iFR (instantaneous wave free ratio) examinations and to find possible explanations for discrepant results. Methods FFR and iFR examinations were analyzed using Philips-Volcano console and coronary flow reserve (CFR) was analyzed by using Combomap machine Philips-Volcano. Hyperemia for FFR and CFR measurements was induced by intracoronary administration of adenosine. We used CFR as a truth for comparison between FFR and iFR, because CFR has higher impact on patients prognosis than pressures indices. Results Data were collected from February 2016 to June 2019 and the database includes 1.789 examinations from 1.492 patients (282 of them, 15.8%, with ACS). CFR were measured in 343 lesions in 293 patients. (ACS 31.2%). Overall correlation between FFR and iFR is high (R=0.86 p Conclusion The FFR/iFR discrepancy occurred in almost one quarter of examinations. Correlation between CFR and iFR is better than between CFR and FFR. High flow is probably one of the main reason for FFRp/iFRn type of discrepancy. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Czech Health Research Council

The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype.The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST).We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients.Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)

Tato prace podava přehled soucasneho stavu metody katetrizacnich implantaci pulmonalni chlopně. Provedeni výkonu je spojenes vysokou proceduralni uspěsnosti a přiznivými parametry okamžite a trvale redukce gradientu v RVOT a nizkým výskytempostproceduralni regurgitace. Diky mensi invazivitě se stala bezpecnou a ucinnou katetrizacni alternativou chirurgicke lecbydysfunkce RVOT konduitu. S dostupnosti nových typů implantovatelných chlopni lze ocekavat dalsi rozsiřeni indikaci teto metodyi pro pacienty, u kterých neni pro nevhodnou morfologii v teto chvili možne výkon provest.

Guidelines summarize and evaluate available evidence. The final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate.

U nezanedbatelne casti nemocných s významnou aortalni stenozou je prokazan nizký transvalvularni aortalni gradient. V klinicke praxi rozeznavame tři hlavni subtypy aortalni stenozy s nizkým gradientem: 1. klasický typ s nizkou ejekcni frakci leve komory, 2. paradoxni typ se zachovanou ejekcni frakci leve komory a 3. aortalni stenozu s normalnim průtokem a nizkým gradientem. K rozliseni mezi "skutecně" významnou aortalni stenozou a pseudostenozou je někdy třeba využit dalsi diagnosticke postupy a metody, jako je dobutaminova zatěžova echokardiografie a výpocetni tomografie. U pacientů s nizkým gradientem, ale potvrzenou významnou aortalni stenozou je intervence chlopenni vady i přes zvýsene operacni riziko považovana za indikovanou a je spojena s lepsim dlouhodobým přeživanim.

Prvni transkatetrova implantace aortalni chlopně (TAVI) v Ceske republice byla provedena v roce 2008 a od te doby je vice než 90 % vsech výkonů TAVI provedených v Ceske republice zahrnuto do online vedeneho Ceskeho registru TAVI. Patnact set třicet dva výkonů TAVI provedených od roku 2008 do konce cervna 2016 u pacientů se symptomatickou a významnou aortalni stenozou a vysokým rizikem (median logistickeho EuroSCORE 18,2 a věku 80 let) bylo spojeno s přiznivými výsledky, co se týce bezpecnosti (nemocnicni mortalita 3,9 %, významna paravalvularni aortalni regurgitace po TAVI 1,0 %) a ucinnosti (index plochy aortalniho usti před TAVI versus po TAVI byl 0,4 cm2/m2 versus 1,0 cm2/m2). U větsiny pacientů (83,7 %) byla indikovana TAVI kvůli vysokemu operacnimu riziku, ktere posoudil kardiotým, a 71,9 % pacientů bylo propustěno do domaciho osetřovani.

Kazuistika popisuje podani kangreloru pacientce, ktere byla provedena perkutanni koronarni intervence s implantaci stentu bezprostředně po miniinvazivnim kardiochirurgickem výkonu (plastika mitralni a trikuspidalni chlopně). Důvodem podani parenteralniho protidestickoveho leku byly obavy z krvaceni a nemožnost peroralniho přijmu.

Background: We tested whether the level of endothelial dysfunction assessed by digital tonometry, and expressed as reactive hyperemia index (RHI), is related to occurrences of a discrepancy between...

Aims The aim of this study was to assess prospectively the clinical benefits of fractional flow reserve (FFR) in guiding coronary artery bypass grafting (CABG). Methods and results GRAFFITI is a single-blinded, prospective, multicentre, randomised controlled trial of FFR-guided versus angiography-guided CABG. We enrolled patients undergoing coronary angiography, having a significantly diseased left anterior descending artery or left main stem and at least one more major coronary artery with intermediate stenosis, assessed by FFR. Surgical strategy was defined based on angiography, blinded to FFR values prior to randomisation. After randomisation, patients were operated on either following the angiography-based strategy (angiography-guided group) or according to FFR, i.e., with an FFR ≤0.80 as cut-off for grafting (FFR-guided group). The primary endpoint was graft patency at 12 months. Between March 2012 and December 2016, 172 patients were randomised either to the angiography-guided group (84 patients) or to the FFR-guided group (88 patients). The patients had a median of three [3; 4] lesions; diameter stenosis was 65% (50%; 80%), FFR was 0.72 (0.50; 0.82). Compared to the angiography-guided group, the FFR-guided group received fewer anastomoses (3 [3; 3] vs 2 [2; 3], respectively; p=0.004). One-year angiographic follow-up showed no difference in overall graft patency (126 [80%] vs 113 [81%], respectively; p=0.885). One-year clinical follow-up, available in 98% of patients, showed no difference in the composite of death, myocardial infarction, target vessel revascularisation and stroke. Conclusions FFR guidance of CABG has no impact on one-year graft patency, but it is associated with a simplified surgical procedure. ClinicalTrials.gov Identifier: NCT01810224.

Katetrizacni uzavěr ouska leve sině (left atrial appendage closure, LAAC) představuje alternativni přistup v prevenci cevnich mozkových přihod (CMP) u pacientů s fibrilaci sini (FS). Udajů ve prospěch teto formy "lokalni" prevence tromboembolie u pacientů s vysoce rizikovým skore CHA2DS2-VASc stale přibýva. Uzavěr ouska leve sině by se mohl stat významnou alternativou u pacientů s limitacemi/kontraindikaci k antikoagulacni lecbě. Udaje ze dvou hlavnich randomizovaných klinických studii prokazaly užitecnost a bezpecnost zařizeni WATCHMAN LAAC v prevenci CMP u pacientů s FS jako plnohodnotne lecebne strategie. Přes celkovou ucinnost vsech dnes použivaných mechanických okluderů (dokumentovanou prospektivnimi multicentrickými studiemi) může jednoznacný přinos jejich použiti omezovat: (a) 1-3% incidence rezidualni tamponady; (b) nedosaženi uplneho, tedy 100% uzavřeni u třetiny pacientů; (c) embolizacni komplikace vcetně embolizace okluderu. Pro zlepseni výsledků byly zkonstruovany nove generace těchto zařizeni s cilem dosahnout: (i) meně traumatickeho implantacniho výkonu; (ii) přesnějsiho umistěni a zakryti usti ouska leve sině (left atrial appendage, LAA). Tento clanek shrnuje opodstatněni výkonu, klinicke udaje, zařizeni, techniky implantace i lekove režimy v dalsim sledovani pacientů.Zavěrem je třeba konstatovat, že potřebujeme dalsi udaje a studie k prokazani principu LAAC, zvlastě v nove eře lecby přimými peroralnimi antikoagulancii.

BackgroundThe COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. ObjectiveWe analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. MethodsMASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score≤3 and intermediate-to-high (IHBR) for score>3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n=1270) LBR and 44% (n=1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p=0.047) driven by cardiac death (1.7% vs. 0.7%, p=0.029) with similar rates of MI (1.8% vs. 1.1%, p=0.17), TLR (1.5% vs. 1.6%, p=0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p=0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p=0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p Conclusion Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

OBJECTIVES: The authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings.\ud \ud BACKGROUND: In tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested.\ud \ud METHODS: Angiographically intermediate tandem and/or diffuse lesions were entered into the international, multi-center iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared.\ud \ud RESULTS: Mean age was 67+/-12 years (81% male). Paired pre-and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93+/-0.05; observed actual iFR was 0.92+/-0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4+/-0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (-0.18+/-0.05 lesion/vessel; p = 0.0001) and length (-4.4+/-1.0 mm/vessel; p < 0.0001).\ud \ud CONCLUSIONS: In tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback altered revascularization procedural planning in nearly one-third of patients.

Background The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization. Methods The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014–May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization. Results A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12). Conclusion The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. Clinicaltrials.gov identifier NCT02183454 .

Introduction Veno-arterial extracorporeal life support (ECLS) is increasingly being used to treat rapidly progressing or severe cardiogenic shock. However, it has been repeatedly shown that increased afterload associated with ECLS significantly diminishes left ventricular (LV) performance. The objective of the present study was to compare LV function and coronary flow during standard continuous-flow ECLS support and electrocardiogram (ECG)-synchronized pulsatile ECLS flow in a porcine model of cardiogenic shock. Methods Sixteen female swine (mean body weight 45 kg) underwent ECLS implantation under general anesthesia and artificial ventilation. Subsequently, acute cardiogenic shock, with documented signs of tissue hypoperfusion, was induced by initiating global myocardial hypoxia. Hemodynamic cardiac performance variables and coronary flow were then measured at different rates of continuous or pulsatile ECLS flow (ranging from 1 L/min to 4 L/min) using arterial and venous catheters, a pulmonary artery catheter, an LV pressure-volume loop catheter, and a Doppler coronary guide-wire. Results Myocardial hypoxia resulted in declines in mean cardiac output to 1.7±0.7 L/min, systolic blood pressure to 64±22 mmHg, and LV ejection fraction (LVEF) to 22±7%. Synchronized pulsatile flow was associated with a significant reduction in LV end-systolic volume by 6.2 mL (6.7%), an increase in LV stroke volume by 5.0 mL (17.4%), higher LVEF by 4.5% (18.8% relative), cardiac output by 0.37 L/min (17.1%), and mean arterial pressure by 3.0 mmHg (5.5%) when compared with continuous ECLS flow at all ECLS flow rates (P

Clinical benefit of invasive functionally guided revascularization has been mostly investigated and proven for percutaneous coronary intervention. It has never been prospectively evaluated whether a systematic fractional flow reserve (FFR) assessment is also beneficial in guiding coronary artery bypass graft surgery (CABG). The objective of the GRAft patency after FFR-guided versus angiography-guIded CABG (GRAFFITI) trial was to compare an FFR-guided revascularization strategy to the traditional angiography-guided revascularization strategy for patients undergoing CABG. Patients were enrolled with significantly diseased left anterior descending or left main stem and at least one major coronary artery with angiographically intermediate stenosis (30-90% diameter stenosis) that was assessed by FFR. Thereafter, while the FFR values were kept concealed, cardiac surgeons decided their intended procedural strategy based on the coronary angiography alone. At this point, patients underwent 1:1 randomization to either an FFR-guided or an angiography-guided CABG strategy. In case the patient was randomized to angiography-guided arm, cardiac surgeons kept their intended procedural strategy, i.e., CABG was guided solely on the basis of the coronary angiography. In case the patient was randomized to the FFR-guided arm, FFR values were disclosed to the surgeons who revised the surgical protocol according to the functional significance of each coronary stenosis. The primary endpoint of the trial was the rate of graft occlusion at 12 months, assessed by coronary computed tomography or coronary angiography. The secondary endpoints were (1) length of postoperative hospital stay; (2) changes in surgical strategy depending upon FFR results (in FFR-guided group only); and (3) rate of major adverse cardiac and cerebrovascular events, i.e., composite of death, myocardial infarction, stroke, and any revascularization during the follow-up period. This study is the first prospective randomized trial investigating potential clinical benefits, associated with FFR-guided surgical revascularization. info:eu-repo/semantics/publishedVersion

Objectives To evaluate the first experience of real-time instantaneous wave–free ratio (iFR) measurement by clinicians. Background The iFR is a new vasodilator-free index of coronary stenosis severity, calculated as a trans-lesion pressure ratio during a specific period of baseline diastole, when distal resistance is lowest and stable. Because all previous studies have calculated iFR offline, the feasibility of real-time iFR measurement has never been assessed. Methods Three hundred ninety-two stenoses with angiographically intermediate stenoses were included in this multicenter international analysis. Instantaneous wave–free ratio and fractional flow reserve (FFR) were performed in real time on commercially available consoles. The classification agreement of coronary stenoses between iFR and FFR was calculated. Results Instantaneous wave–free ratio and FFR maintain a close level of diagnostic agreement when both are measured by clinicians in real time (for a clinical 0.80 FFR cutoff: area under the receiver operating characteristic curve [ROCAUC] 0.87, classification match 80%, and optimal iFR cutoff 0.90; for a ischemic 0.75 FFR cutoff: iFR ROCAUC 0.90, classification match 88%, and optimal iFR cutoff 0.85; if the FFR 0.75-0.80 gray zone is accounted for: ROCAUC 0.93, classification match 92%). When iFR and FFR are evaluated together in a hybrid decision-making strategy, 61% of the population is spared from vasodilator while maintaining a 94% overall agreement with FFR lesion classification. Conclusion When measured in real time, iFR maintains the close relationship to FFR reported in offline studies. These findings confirm the feasibility and reliability of real-time iFR calculation by clinicians., Graphical Abstract

Background Heart failure with preserved or mildly reduced ejection fraction (HFpEF) is common and, to date, therapeutic options are limited. Increased left atrial pressure is a key contributor to the symptoms associated with HFpEF, particularly during physical activity. We report the 30-day outcome of patients treated with a novel device intended to lower left atrial pressure by creating an 8 mm permanent shunt in the atrial septum. Methods and results Eleven patients were enrolled in the pilot trial. Key inclusion criteria were: EF >45%; baseline PCWP ≥15 mmHg (rest), or ≥ 25 mmHg (exercise); and ≥1 hospitalization for heart failure within the past 12 months, or persistent NYHA class III/IV for at least 3 months. Mean age, LVEF, and NYHA class were 70 ± 12 years, 57 ± 9%, and 3.2 ± 0.4, respectively. Most patients had significant co-morbidities. The interatrial septal device (IASD) device was implanted using percutaneous trans-septal access via the femoral vein. The device was successfully implanted in all patients. At 30 days, LV filling pressures were significantly reduced by 5.5 mmHg (19.7 ± 3.4 vs. 14.2 ± 2.7; P = 0.005), and NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient. No patient developed pulmonary hypertension. Two serious adverse events occurred; heart failure re-hospitalization, and implant malposition successfully treated with a new device. Conclusion Contemporary management of HFpEF patients is confounded by the lack of effective therapies. The use of a device-based approach to reduce left atrial pressure provides a novel means to improve haemodynamic and symptomatic status in HFpEF patients and warrants further investigation.

Objectives This study sought to compare radial and femoral approaches in patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PCI) by high-volume operators experienced in both access sites. Background The exact clinical benefit of the radial compared to the femoral approach remains controversial. Methods STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. A total of 707 patients referred for STEMI

Detection and reduction of inducible myocardial ischemia is a key moment in management of patients with stable coronary artery disease. It has been shown that coronary angiography as well as non-invasive stress testing fails to inform about true hemodynamic significance of individual stenosis in certain subsets of coronary anatomies. Intervention of non-significant lesion is associated with worse prognosis than optimal medical treatment. Using invasive measurement of myocardial fractional flow reserve (FFRmyo) for decision to perform or defer percutaneous coronary intervention was superior to angiographical guidance. Revascularization of functionally significant lesions and medical management of non-significant ones is the base of concept of functional revascularization and FFRmyo may be a tool, which provides information needed for such clinical decision.

To assess the gender differences in correlation lipoprotein(a) concentration with the extent of coronary artery disease in patients with established coronary artery disease.Blood lipids and lipoprotein(a) concentrations were measured in 351 consecutive patients (256 men and 95 women) who underwent coronary angiography between January and May 2010, and who had established coronary atherosclerosis (angiography score1). A modified angiographic Gensini Score was used.Mean angiographic score was 19.6 in men and 15.0 in women. Men had lower mean high-density lipoprotein cholesterol level than women (1.05 vs. 1.18 mmol/l) and lower mean apolipoprotein A level (1.41 vs. 1.53 g/l). Mean lipoprotein(a) level was higher in men than women (307.1 vs. 282.7 mg/l). Significant inverse correlation between high-density lipoprotein cholesterol and apoA with angiographic score was identified in women (r = -0.23, p = 0.028 and r = -0.26, p = 0.025), but not in men. Lipoprotein(a) level correlated significantly with angiographic score only in men (r = 0.168, p = 0.0185).Gender differences were identified in patients with established coronary atherosclerosis in the relation of blood lipids and lipoprotein(a) levels with the extent of coronary artery disease.

OBJECTIVE To assess long-term results after deferring coronary intervention (percutaneous coronary intervention (PCI)) of an intermediate lesion with a value of myocardial fractional flow reserve (FFR) > or = 0.75 in a 'real life' patient population with no respect to results of stress tests (if performed) or coronary disease extent. METHODS PCI of an intermediate lesion was deferred in a group of 85 consecutive patients (54 men, 61+/-10 years) on the basis of the result of FFR > or = 0.75 (mean FFR, 0.89+/-0.06%). FFR was measured in 111 stenoses (mean diameter stenosis, 54+/-8%, left anterior descending coronary artery, 65 (58%), left circumflex coronary artery, 24 (22%), right coronary artery, 22 (20%). Multi-vessel disease (defined as visually assessed diameter reduction of more than 50% in at least two arteries of more than 1.5 mm diameter, supplying at least two of the three major coronary artery perfusion territories) was present in 67% of patients (one-vessel disease, 28 patients (33%), two-vessel disease, 39 patients (46%), three-vessel disease, 18 patients (21%). Recorded events during follow-up were as follows: all-cause death, cardiac death, non-fatal myocardial infarction, ischemia-driven target lesion transcatheter revascularization (TLR) and coronary artery bypass graft (CABG). Angina class (Canadian Cardiovascular Society (CCS) classification) and the need for anti-anginal drugs were recorded. RESULTS Follow-up was completed in 85 patients (100%). Mean duration of follow-up was 22.6+/-6.6 months (range 4-33 months). Events occurred in 11 patients (13%). Seven patients died; this included two cardiac deaths. A non-fatal myocardial infarction occurred in one patient, one patient needed TLR and three patients underwent CABG. Estimated 33 month cardiac-event-free survival (Kaplan-Meier) was 91+/-4%. Angina class decreased [1.6+/-1.2 compared with 0.8+/-0.8 (P < 0.0001)] without difference with respect to the use of anti-anginal drugs (1.7+/-0.8 compared with 1.7+/-0.9, P = NS). CONCLUSIONS Deferring coronary interventions of intermediate stenosis based on FFR measurement is safe with respect to long-term follow-up, irrespective of the extent of coronary artery disease.

Fabry disease (alpha-galactosidase A deficiency) is an X-linked recessive lysosomal storage disease in which left ventricular hypertrophy (LVH) is common, and if severe, may mimic hypertrophic obstructive cardiomyopathy. Alcohol-induced percutaneous transluminal septal myocardial ablation (PTSMA) has been used as a safe and effective method to alleviate LVH obstruction in patients with hypertrophic obstructive cardiomyopathy (HCM). We describe a case of a classically affected Fabry 53-year-old male with symptomatic HCM (NYHA class III with exertional angina) who was treated with PTSMA. The procedure safely and effectively alleviated symptomatic left ventricular outflow tract obstruction at long-term follow-up, and the patient's NYHA classification was reduced to NYHA class I to II.

Background: In tandem and diffuse disease, offline analysis of continuous instantaneous wave-free ratio (iFR) pullback measurement has been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the real-time online analysis approach (iFR Scout)

Assessment of the treatment procedures and their results is increasingly important in current medicine. The emphasis is put on an effective use of the health technologies (HTA). Unlike randomised studies, which involve strictly selected groups of patients who meet inclusion and exclusion criterias, the multicentre clinical registries provide a real-life picture of the treatment safety and effectiveness. Well prepared registries involve both research database and a friendly user interface enabling collection of parametric and easily analyzable data. Although there are some technological aspects aiming to ensure a maximum quality of entered data, cooperation with the users and data managers is essential. Such a registry, otherwise meaningful, must provide answers to previously defined medical hypotheses. Regular feedback to users (so called benchmarking or reporting) is considered to be of key importance. The Czech TAVI Registry (CTR) is a good example of reaching all of the above defined criterias. This registry contains data of approximately 95 % of all transcatheter aortic valve implantations (TAVI) performed in the Czech Republic. It is based on a general system aimed at the design of clinical trials, namely the TrialDB2 (a database system for clinical registries developed by the Institute of Biostatistics and Analyses at the Masaryk University (IBA MU). CTR has been run as an English-language version under the auspices of the Czech Society of Cardiology and represents one of the top-quality registries maintained by IBA MU. This paper presents the currently available database systems and some reports from this particular registry.

BACKGROUND: Implantation of coronary stents after predilatation is a standard approach in the treatment of most coronary lesions. Stenting without predilatation could be a possible alternative way of treating a certain subset of patients. OBJECTIVE: To identify a group of patients suitable for this optional method, to evaluate their immediate clinical and angiographic outcomes and to test the feasibility and safety of this new therapeutic concept. METHODS: Ninety selected patients with 91 lesions were treated by implantation of coronary stents without predilatation. RESULTS: The mean duration of this procedure was 12.3 +/- 9.1 min and the fluoroscopic time was 3.6 +/- 2.9 min. The stenoses before and after this procedure were 77 +/- 10 and 5 +/- 9%, respectively. Predilatation, postdilatation or implantation of an additional stent was necessary for seven patients. Primary success rate was 92% with an excellent immediate clinical and angiographic outcome. No major complications occurred during direct stenting. CONCLUSION: Direct stenting is feasible using commercially available stents and could be performed for about 20% of patients for whom coronary intervention is indicated. The proper selection of lesions is of crucial importance. Lesions eligible for direct stenting should be without visible calcifications and on vessels without proximal tortuosity. This procedure proved to be safe and successful in this series of coronary interventions.

Heart failure with preserved or mildly reduced ejection fraction (HFpEF) is common and, to date, therapeutic options are limited. Increased left atrial pressure is a key contributor to the symptoms associated with HFpEF, particularly during physical activity. We report the 30-day outcome of patients treated with a novel device intended to lower left atrial pressure by creating an 8 mm permanent shunt in the atrial septum.Eleven patients were enrolled in the pilot trial. Key inclusion criteria were: EF45%; baseline PCWP ≥15 mmHg (rest), or ≥ 25 mmHg (exercise); and ≥1 hospitalization for heart failure within the past 12 months, or persistent NYHA class III/IV for at least 3 months. Mean age, LVEF, and NYHA class were 70 ± 12 years, 57 ± 9%, and 3.2 ± 0.4, respectively. Most patients had significant co-morbidities. The interatrial septal device (IASD) device was implanted using percutaneous trans-septal access via the femoral vein. The device was successfully implanted in all patients. At 30 days, LV filling pressures were significantly reduced by 5.5 mmHg (19.7 ± 3.4 vs. 14.2 ± 2.7; P = 0.005), and NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient. No patient developed pulmonary hypertension. Two serious adverse events occurred; heart failure re-hospitalization, and implant malposition successfully treated with a new device.Contemporary management of HFpEF patients is confounded by the lack of effective therapies. The use of a device-based approach to reduce left atrial pressure provides a novel means to improve haemodynamic and symptomatic status in HFpEF patients and warrants further investigation.

Lipoprotein (a) [Lp(a)], together with other serum lipoproteins have an important role in the pathogenesis of coronary heart disease. The objective of the study was to assess the association between plasma levels of Lp(a) with the extent of angiographically defined coronary artery disease (CAD).A total of 518 consecutive patients (66 % males) underwent coronary angiography in connection with lipids and lipoprotein determinations between 1st January and 31st May 2010. Most of the patients were treated with lipid lowering therapy (77 % statins). Modified angiographic Gensini Score (GS) and adjusted angiographic score (AS) were used to reflect the extent of coronary atherosclerosis.Both GS and AS angiographic scores correlated significantly with age, male gender, statin therapy and inversely with left ventricular ejection fraction (p0.05-0.01 for all). The results showed significant inverse correlation of HDL cholesterol levels with GS and AS (r=-0.16, p0.001), and apolipoprotein A levels with GS and AS (r=-0.20, p0.0001) and a positive correlation of Lp(a) levels with angiographic score (r=0.13, p0.01) and with adjusted angiographic score (r=0.16, p0.01). Regression analysis showed only Lp(a) concentration was an independent lipid factor that correlated with the extent of CAD.Only Lp(a) levels correlated with the extent of coronary artery disease as assessed with coronary angiography in patients treated with lipid lowering therapy.

Background Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS. Methods The trial was stopped prematurely after enrollment of one hundred and fifty-six patients with ACS that were randomized at admission to fluvastatin 80 mg (N = 78) or placebo (N = 78). Study medication was administered immediately after randomization and then once daily for 30 days; all patients were then encouraged to continue in open-label statin therapy and at the end of one-year follow-up 75% in the fluvastatin group and 78% in the placebo group were on statin therapy. Results We did not demonstrate any difference between groups in the level of C-reactive protein, interleukin 6, and pregnancy-associated plasma protein A on Day 2 and Day 30 (primary endpoint). Fluvastatin-therapy, however, significantly reduced one-year occurrence of major adverse cardiovascular events (11.5% vs. 24.4%, odds ratio (OR) 0.40, 95% CI 0.17-0.95, P = 0.038). This difference was caused mainly by reduction of recurrent symptomatic ischemia (7.7% vs. 20.5%, OR 0.32, 95% CI 0.12-0.88, P = 0.037). Conclusions This study failed to prove the effect of fluvastatin given as first-line therapy of ACS on serum markers of inflammation and plaque instability. Fluvastatin therapy was, however, safe and it may reduce cardiovascular event rate that supports immediate use of a statin in patients admitted for ACS. Trial registration NCT00171275