Dedicated Bifurcation Stents

Bifurcations still remain one of the most challenging lesions to be treated in the modern PCI era. They are associated with lower procedural success rates, higher rates of periprocedural complications, and complicated long-term outcomes. Their incidence is assessed to be approximately 15–20%. There is still debate on how should they be treated—one-stent versus two-stent techniques, whether there is a need for obligatory proximal optimization or kissing balloons. Multiple clinical trials have tested different PCI strategies. We will cover theoretical basics of treating bifurcations and describe different types of dedicated bifurcation stents—Nile PAX, Nile SIR, BiOSS Expert, BiOSS LIM, Stentys Tryton, and Axxess Plus. We will discuss the data from studies comparing these bifurcation devices and will show our own experience and results working with these devices. There will be a discussion, tips, and tricks treating bifurcation lesions with dedicated devices—most common pitfalls and how to deal with them

The role of periprocedural hemodynamic variables during carotid stenting for the mid-term general mortality in advanced age patients

Introduction: Carotid stenting may produce significant bradycardia and/or hypotension. This may have negative short- and long-term effects for the elderly high-risk patients. Their cerebral hemodynamics is with exhausted adaptive capacity because of the multiple cardiovascular risk factors, advanced age, and significant stenosis. Aim: This was a retrospective study aimed at finding whether periprocedural hypoperfusion or hypotension at the time of carotid stenting had any significance for the acute neurological outcome and mid-term general mortality in advanced-age patients who were at high risk for surgical endarterectomy. Materials and methods: We studied 138 consecutive patients with significant carotid stenosis from January 2015 to July 2019. The mean (SD) age was 67.41 (10.70) years. The mean follow-up period was 31 months (922 days). The patients were hemodynamically monitored periprocedurally according to a local protocol. Vasopressors were added if a prolonged hypotension was measured. Statistical data were analyzed using SPSS IBM v. 19 (p=0.05, CI 95%). Results: The male patients were 94 (68%). The number of patients with hypotension periprocedurally or in the first 6 hours post-procedure was 55 (42%). The mean blood pressures were 135/83 mmHg before, 116/76 mmHg during, and 121/73 mmHg after the procedure. Kaplan-Maier analysis showed no significant differences in the mid-term general mortality rate between patients with and patients without transitory hypotension. There wasn’t any difference in the postprocedural neurological outcome either. Conclusions: The presence of hypotension during carotid stenting was not linked to a negative neurological outcome. It also did not increase mid-term all-cause mortality in elderly patients (mean age, 67 years). The finding could be attributed to the relatively brief period of hypotension, the prompt administration of vasopressors, or the prevention of brain edema and hyper-reperfusion during carotid stenting in terms of elevated blood pressure; however, this remains to be determined

Brave Dreams: An overestimated study, crippled by recruitment failure and misleading conclusions

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External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry.

THEMIS is a double-blind, randomized trial of 19,220 patients with diabetes mellitus and stable coronary artery disease (CAD) comparing ticagrelor to placebo, in addition to aspirin. The present study aimed to describe the proportion of patients eligible and reasons for ineligibility for THEMIS within a population of patients with diabetes and CAD included in the Reduction of Atherothrombosis for Continued Health (REACH) registry. The THEMIS eligibility criteria were applied to REACH patients. THEMIS included patients ≥50 years with type 2 diabetes and stable CAD as determined by either a history of previous percutaneous coronary intervention, coronary artery bypass grafting, or documentation of angiographic stenosis of ≥50% of at least one coronary artery. Patients with prior myocardial infarction or stroke were excluded. In REACH, 10,156 patients had stable CAD and diabetes. Of these, 6515 (64.1%) patients had at least one exclusion criteria. From the remaining population, 784 patients did not meet inclusion criteria (7.7%) mainly due to absence of aspirin treatment (7.2%), yielding a 'THEMIS-eligible population' of 2857 patients (28.1% of patients with diabetes and stable CAD). The main reasons for exclusion were a history of myocardial infarction (53.1%), use of oral anticoagulation (14.5%), or history of stroke (12.9%). Among the 4208 patients with diabetes and a previous PCI, 1196 patients (28.4%) were eligible for inclusion in the THEMIS-PCI substudy. In a population of patients with diabetes and stable coronary artery disease, a sizeable proportion appear to be 'THEMIS eligible.' http://www. gov identifier: NCT01991795.The THEMIS trial was funded by AstraZeneca. The REACH registry was sponsored by Sanofi, Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan) and is endorsed by the World Heart Federation.S

Mezinárodní lidskoprávní závazky postkomunistických zemí: případy České republiky a Slovenska

Monografie pojednává o motivacích států k uzavření a plnění smluv o lidských právech a dále se zabývá jednotlivými oblastmi "života" mezinárodních lidskoprávních smluv od jejich uzavírání, ratifikace, uplatnění výhrad, přes implementaci v domácí legislativě až po jejich aplikaci v každodenní praxi vnitrostátních soudů.Monografie pojednává o motivacích států k uzavření a plnění smluv o lidských právech a dále se zabývá jednotlivými oblastmi "života" mezinárodních lidskoprávních smluv od jejich uzavírání, ratifikace, uplatnění výhrad, přes implementaci v domácí legislativě až po jejich aplikaci v každodenní praxi vnitrostátních soudů.The monograph deals with the motivation of states to accept and fulfill the international HR treaties and concentrates in the examples of the Czech republic and Slovakia to the particular aspects of the "life" of the treaties from their acceptance, ratification, reservations, through their implementation in the domestic legislation to "everyday" application before domestic courts

Polymer-based or polymer-free stents in patients at high bleeding risk

Background: polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. Methods: in an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. Results: a total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). Conclusions: among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)

Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries

Aims Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. Methods and results A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. Conclusion Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encourage

World Federation for Interventional Stroke Treatment (WIST) multispecialty training guidelines for endovascular stroke intervention

Introduction: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. Aim: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. Material and methods: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency – rather than time-based – guidelines for operator training, taking into consideration trainees’ previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. Results: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. Conclusions: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted