Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures.

The aim of the present single-center, nonrandomized, retrospective study was to assess the safety and long-term efficacy of percutaneous left atrial appendage closure (LAAC) procedures and to compare the different LAAC devices and therapeutic regimes in this respect.Medical data of 136 patients (pts) (mean age, 72.5 ± 7.6 years; score for atrial fibrillation stroke risk estimation [CHA2DS2-VASc], 4.6 ± 1.6; and score for estimation of major bleeding risk for patients on anticoagulant therapy [HAS-BLED], 2.6 ± 0.9) who underwent percutaneous LAAC procedures in Gottsegen National Cardiovascular Center from January 2010 to January 2020 were analyzed.The rates of outpatient cardiac mortality, ischemic brain event, and major bleeding were 3.8, 1, and 1.9/100 pt years, respectively. The rate of successful device deployment was 96.4%. There was one case of procedural mortality (0.7%), one case of device dislocation (0.7%), one case of ischemic stroke (0.7%), and one case of myocardial infarction (0.7%). Two cases of pericardial tamponades (1.5%) and four cases of major femoral complications (3%) occurred. Although the implantation success of different occluder types was similar, significant differences were found concerning procedural characteristics. Patients on single antiplatelet therapy (SAPT) in the first 3 months after the LAAC procedure did not suffer from stroke or embolic events.The present study confirmed the safety and effectivity of percutaneous LAAC. Robust relative stroke risk reduction and less pronounced but significant bleeding risk reduction were observed. Device implantation success was high. The perioperative complication rate was relatively low. The results of long-term observations regarding ischemic events confirmed the safety of using a simplified antithrombotic regime after LAAC in pts with high bleeding risk.

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.

OBJECTIVES: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. BACKGROUND: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). METHODS: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. RESULTS: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). CONCLUSIONS: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.

[The first 200 transcatheter aortic valve implantations in the Gottsegen Gyorgy Institute of Cardiology, Hungary]. / Az elso 200 transzkatéteres aortabillentyu-implantáció a Gottsegen György Országos Kardiológiai Intézetben.

INTRODUCTION: Transcatheter aortic valve implantation is a therapeutic alternative for contraindicated and high surgical risk patients with severe symptomatic aortic stenosis. This intervention is part of daily routine in the Institute of the authors. AIM: In the present work the results of the first 200 patients are discussed. METHOD: Until January, 2016, 200 patients (female 55%, mean age 79.9 years, average EuroSCORE 19.3%, left ventricular ejection fraction 54%, peak gradient 81.2 mmHg, mean aortic gradient 50.9 mmHg) underwent transcatheter aortic valve implantation. RESULTS: The procedure was performed with 99% success rate. Complications were evaluated according to VARC 2 definitions. Mortality was 5% at one month and 17.4% at one year. Cardiac mortality was 13.6 at one year. Cerebrovascular complications were 5% within one year, and 95% of patients were in NYHA I or II functional classes at one year. CONCLUSION: These findings are consistent with worldwide results. Orv. Hetil., 2016, 157(45), 1786-1792.

[Percutaneous left atrial appendage closure after resolution of left atrial appendage thrombi with dabigatran]. / Percutan bal pitvari fülcsezárás dabigatrannal való fülcsethrombus feloldását követoen.

The "gold standard" of the prevention of atrial fibrillation related thromboembolic events is anticoagulation therapy with oral vitamin K antagonists. A certain proportion of high-risk patients with atrial fibrillation are not receiving effective antithrombotic therapy because of problems associated with its use. Resolution of subsequent left atrial appendage thrombi is quite a great challenge in patients who are not tolerating "standard" antithrombotic drugs. According to the knowledge of the authors, this is the first report of a patient with non-valvular persistent atrial fibrillation and high stroke risk, who was intolerant to "standard" anticoagulant therapy and had persistent left atrial appendage thrombi following the use of a wide variety of "standard" anticoagulants. Successful resolution of left atrial appendage thrombi with dabigatran and successful percutaneous left atrial appendage closure were performed in this case.

Ventricular septal rupture caused by myocardial bridge, solved by interventional closure device.

Myocardial bridging is a common coronary anomaly, which is generally described as a benign phenomenon. However, a growing number of studies consider this anomaly a relevant pathophysiological phenomenon with serious pathological consequences. Here we report on the case of an 88-year-old woman suffering from myocardial infarction and ventricular septal rupture, lacking any recognizable coronary disease except for a myocardial bridge causing the systolic compression of the left anterior descending coronary artery. A wide range of diagnostic procedures, including coronarography, echocardiography, and magnetic resonance imaging were used. The septal rupture was finally closed by using a percutaneous closure device. This event indicates that myocardial bridges - at least in some cases - may have notable clinical relevance.

Treatment of three-vessel disease in light of the results of the FAME-3 study / A háromér-betegség kezelése a FAME-3 vizsgálat eredményeinek tükrében

Previous randomized clinical studies have shown the superiority of coronary artery bypass grafting over percutaneous coronary intervention in the treatment of severe multivessel disease mainly because of a reduced need for repeat revascularization but, in some, a mortality benefit and reduced rate of myocardial infarction were shown among those undergoing surgery. The late breaker multicentric, randomized FAME (Fractional Flow Reserve Versus Angiography in Multivessel Evaluation)-3 study, involving 1500 patients, sought to determine whether fractional flow reserve guided percutaneous coronary intervention with implantation of new-generation drug-eluting stents was non -inferior to present-day coronary bypass surgery with respect to the composite of all-cause death, myocardial infarction, stroke and repeat revascularization at one year. The authors who were particularly active in the FAME-3 trial describe the study setting, the characteristics of the patient population, the procedures, and the results. The FAME-3 study failed to show the non-inferiority of percutaneous coronary intervention to bypass surgery in the treatment of three vessel disease using the predetermined margin. The authors present a detailed analysis of the possible reasons and some important secondary results. These include a lack of significant difference between the two arms with respect to `hard end points' and the significantly higher perioperative morbidity of the surgical group. Albeit our clinical practice should be based on the analysis of the primary end point, informing patients and shared decision making must include these secondary results when individual revascularization strategies are planned.

Transcatheter aortic valve replacement ­ 10 years experience at Gottsegen György National Cardiovascular Center in Hungary / Tíz év tapasztalatai a transzkatéteres aortamubillentyu-implantációval a Gottsegen György Országos Kardiovaszkuláris Intézetben.

Összefoglaló. Bevezetés: A transzkatéteres aortamubillentyu-beültetés (TAVI) az idos, súlyos aortastenosisban szenvedo, multimorbid, magas mutéti kockázattal rendelkezo betegek esetében javasolt a szívsebészeti aortamubillentyu-beültetés alternatívájaként. Célkituzés: Jelen munkánkban az intézetünkben elindult TAVI-program elso 10 éve alatt elvégzett 463, TAVI-n átesett beteg rövid és hosszú távú eredményeit tekintjük át és értékeljük. Külön vizsgáljuk az elso 200 beteg és az utánuk következo 263 beteg eredményeit. Módszer: 2008. november 11. és 2018. december 31. között 463 betegnél végeztünk TAVI-t. Betegeink átlagéletkora 79,6 év, átlagos logisztikus EuroSCORE-értékük 19,0%, átlagos STS-score-értékük pedig 5,2% volt. A beavatkozás elott az esetek 72%-ában NYHA III-as vagy IV-es funkcionális stádiumban voltak. A beavatkozások 92,8%-át transfemoralis behatolásból végeztük. Az aortabillentyun mért átlagos gradiens 50 Hgmm, a billentyuarea 0,55 cm2 volt. Az esetek mintegy 2%-ában az aortabillentyu-bioprotézis restenosisa miatt "valve-in-valve" beavatkozást végeztünk. Eredmények: A TAVI után a 30 napos halálozás 5,2%, az 1 éves pedig 16,4% volt. A TAVI-t követoen kialakult szövodményeket a VARC-2 kritériumrendszere alapján értékeltük. A beavatkozás után 2,2%-ban fordult elo major stroke. A leggyakoribb szövodmény, a posztoperatív pacemakerimplantáció (19,9%) aránya szignifikánsan csökkent a késobb TAVI-n átesett 263 beteg esetében (26,5% vs. 14,8% [p = 0,002]). A vérzéses szövodmények aránya a percutan beavatkozások bevezetésével szignifikánsan emelkedett ugyan (10% vs. 20,2% [p = 0,016]), de ez nem járt a mortalitás emelkedésével. Következtetés: Az eredmények alapján elmondhatjuk, hogy a TAVI intézetünkben is biztonságos alternatívát jelent a magas mutéti rizikóval rendelkezo, súlyos, tünetes aortastenosisban szenvedo betegek esetében. Orv Hetil. 2022; 163(6): 229-235. INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is an alternative treatment to surgical aortic valve replacement for elderly, high surgical risk patients. OBJECTIVE: The aim of this study was to evaluate the short- and long-term outcomes of those 463 patients who underwent TAVI during the first 10 years in our TAVI program. We compare the first 200 patients' results with the further 263 patients' results. METHOD: Between 11th November 2008 and 31st December 2018, 463 patients underwent TAVI. The average age of the patients was 79.6 years, the average logistic EuroSCORE was 19.0%, the average STS score was 5.2%. 72% of the patients were in NYHA III or IV stage before TAVI. 92% of TAVIs were performed from femoral arteries. Average mean gradient was 50.0 mmHg and aortic valve area was 0.55 cm2, respectively. In 2% of the cases, "valve-in-valve" intervention was performed because of the restenosis of former aortic valve prosthesis. RESULTS: 30-day mortality was 5.2% and the 1-year mortality was 16.4% after TAVI. Post-TAVI complications were evaluated according to the VARC-2 definitions. Major stroke occurred in 2.2% after TAVI. The most common complication was pacemaker implantation (19.9%), but their incidence was significantly reduced between the 2 groups (26.5% vs. 14.8% [p = 0.002]). The incidence of vascular access site complications was significantly higher between the 2 groups (10% vs. 20.2% [p = 0.016]), but it did not affect the mortality. CONCLUSION: Based on our results, TAVI is a safe alternative treatment for patients with severe, symptomatic aortic stenosis in our institute as well. Orv Hetil. 2022; 163(6): 229-235.

Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: The applicability of resting indices to guide noninfarct-related artery revascularization in ST-elevation myocardial infarction is unknown. METHODS: We analyzed the correlation and prognostic value of fractional flow reserve (FFR) and resting distal coronary to aortic pressure ratio (Pd/Pa) in all patients of the Compare-Acute trial in whom, after successful primary percutaneous coronary intervention, the noninfarct-related artery was interrogated by both and treated medically. The treating cardiologist was blinded to these values. The primary end point was the composite of target vessel (interrogated noninfarct-related artery) related nonfatal target vessel myocardial infarction and target vessel repeat revascularization at 36 months. RESULTS: Five hundred seventeen patients (665 vessels) were included. On receiver-operating characteristic analysis, the optimal Pd/Pa cut off for FFR≤0.80 was 0.905 (C statistic: 0.894). The diagnostic accuracy of Pd/Pa was 80.15% (95% CI, 76.91%-83.12%) with respect to FFR. During the 36-month follow-up, 130 target vessel revascularization and 14 target vessel myocardial infarction occurred. FFR and Pd/Pa had a diagnostic accuracy to predict these events of 62.86% (95% CI, 59.06%-66.54%) and 56.84% (95% CI, 52.98%-60.64%), respectively (P=0.20). When they were discrepant, FFR was significantly better than Pd/Pa in identifying which vessels could be safely deferred (P=0.048). CONCLUSIONS: Immediately after successful primary percutaneous coronary intervention, resting Pd/Pa has a diagnostic accuracy of 80% with respect to FFR measured in the noninfarct-related artery. FFR is not significantly superior in predicting target vessel myocardial infarction and target vessel revascularization during 36 months of follow-up but, in case FFR and Pd/Pa are discrepant, FFR is superior in identifying which nonculprit vessels can be safely deferred. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01399736.

Elevated Fasting Glucose and C-Reactive Protein Levels Predict Increased All-Cause Mortality after Elective Transcatheter Aortic Valve Implantation.

Surgical aortic valve replacement in the elderly is now being supplanted by transcatheter aortic valve implantation (TAVI). Scoring systems to predict survival after catheter-based procedures are understudied. Both diabetes (DM) and underlying inflammatory conditions are common in patients undergoing TAVI, but their impact remains understudied in this patient group. We examined 560 consecutive TAVI procedures and identified eight pre-procedural factors: age, body mass index (BMI), DM, fasting blood glucose (BG), left-ventricular ejection fraction (EF), aortic valve (AV) mean gradient, C-reactive protein levels, and serum creatinine levels and studied their impact on survival. The overall mortality rate at 30 days, 1 year and 2 years were 5.2%, 16.6%, and 34.3%, respectively. All-cause mortality was higher in patients with DM (at 30 days: 8.9% vs. 3.1%, p = 0.008; at 1 year: 19.7% vs. 14.9%, p = 0.323; at 2 years: 37.9% vs. 32.2%, p = 0.304). The presence of DM was independently associated with increased 30-day mortality (hazard ratio [HR] 5.38, 95% confidence interval [CI], 1.24-23.25, p = 0.024). BG levels within 7-11, 1 mmol/L portended an increased risk for 30-day and 2-year mortality compared to normal BG (p = 0.001 and p = 0.027). For each 1 mmol/L increase in BG 30-day mortality increased (HR 1.21, 95% CI, 1.04-1.41, p = 0.015). Reduced EF and elevated CRP were each associated with increased 2-year mortality (p = 0.042 and p = 0.003). DM, elevated BG, reduced EF, and elevated baseline CRP levels each are independent predictors of short- and long-term mortality following TAVI. These easily accessible screening parameters should be integrated into risk-assessment tools for catheter-based aortic valve replacement candidates.

The prognostic value of immediate post-TAVI hemodynamic evaluation is superior to aortography and transoesophageal echocardiography in predicting patient survival.

BACKGROUND: Although post-TAVI PAR is commonly seen, its exact evaluation, grading and the true impact on patients' survival are still debated. This single center study aimed to evaluate the effect of post transcatheter aortic valve implantation (TAVI) paravalvular aortic regurgitation (PAR) on patients' survival. The outcome was evaluated by the three most commonly used techniques just after TAVI in the interventional arena. METHODS: 201 high risk patients with severe symptomatic aortic stenosis underwent TAVI with the self-expandable system. The severity of post-TAVI PAR was prospectively evaluated by aortography and transesophageal echocardiography (TEE) using a four-class scheme and hemodynamic evaluation by calculation of the regurgitation index (RI). Median follow up time was 763 days. RESULTS: Post-TAVI PAR results of the three different modalities were concordant with each other (all p < 0.001). Patients with grade 0-I PAR by aortography had better long term outcomes compared to those who had grade II-III PAR (unadjusted HR 1.77 [95% CI, 1.04-3.01], p = 0.03). Although in multivariate analysis neither aortography nor TEE were shown to be significant predictors of survival, hemodynamic assessment using the exact RI result was a significant predictor of survival and its effect was found to be linear (adjusted HR 0.72 [95% CI, 0.52-0.98] for 10% point increase in RI, p = 0.03595). CONCLUSIONS: Among the three modalities that are frequently used to evaluate the outcome, post-TAVI RI showed the highest added predictive value for survival.

[Percutaneous closure of left atrial appendage in non-valvular atrial fibrillation--international and Hungarian experiences]. / A bal pitvari fülcse perkután zárása nonvalvularis pitvarfibrillációban--nemzetközi és hazai tapasztalatok.

In patients with non-valvular atrial fibrillation, efficacy of stroke prevention with oral anticoagulant therapy has been proved. Despite their high risk for thromboembolic events, there are substantial numbers of patients who are not candidates for long-term oral anticoagulant therapy, therefore the interest in alternative treatment strategies are in focus these days. The most common place within the heart for thrombus formation in patients with non-valvular atrial fibrillation is the left atrial appendage. Two devices specifically designed for percutaneous left atrial appendage closure are currently available in Europe: the WATCHMAN LAA system (Atritech, Inc) and the AMPLATZER Cardiac Plug (AGA Medical Corporation). Although present trial results (PLAATO, PROTECT AF) suggest that LAA closure may be performed at acceptable safety and it may reduce the long-term stroke risk, available data are still very limited. At present these procedures may be an acceptable alternative in selected high-risk patients with non-valvular atrial fibrillation who are not or suboptimal candidates for oral anticoagulant therapy. On 28. January, 2010 we performed the first three successful percutaneous left atrial appendage closure procedures in Gottsegen György Hungarian Institute of Cardiology in Hungary.

[Emergency care of patients with myocardial infarction: from the onset of symptoms until opening the vessel]. / Szívinfarktus miatt kezelt betegek sürgosségi ellátása: a panasz kezdetétol az ér megnyitásáig.

Introduction and aim: The authors analyse emergency care data for 6878 patients treated for acute myocardial infarction (AMI) using data from the Hungarian Myocardial Infarction Registry (HUMIR) and the National Ambulance Service (NAS). Method: Patients received treatment between 01/01/2017 and 31/12/2018, and all patients underwent percutaneous coronary intervention (PCI): 47.5% of patients had ST-elevation myocardial infarction (STEMI) and 3614 patients (52.5%) had non-ST-elevation myocardial infarction. The time between the beginning of the complaint and notification of NAS was regarded as the patient delay (PD). The time from the notification of NAS until arrival on the scene (M1), that of the on-site care (M2) and of the transport from the scene to the hospital (M3) were recorded. In-hospital care was evaluated from admission until opening the vessel ("door to balloon time"). The results were also broken down by counties. The median values and the quartiles (Q1, Q3) were given when the time was reported. Results: Patient delay in both types of infarction was unfavourably long: 101 minutes for STEMI and 687 minutes for NSTEMI. Immediate ambulance action was recorded in 58.7% for STEMI patients and 43.7% for NSTEMI patients. In both types of myocardial infarction, the median M1 time was 13 minutes, on-site care (M2) was 23 minutes, and M3 time was 30 minutes. In patients treated for STEMI, the time from hospital admission until opening the infarct-related artery was 37 minutes, and the total ischemic time was 243 minutes. In 9.5% of STEMI patients, the infarct-related artery was opened within 2 hours, in 49.1% within 4 hours, and in 88.1% within 12 hours. Significant differences were found between the counties for each of the periods examined. Conclusions: The PD is currently the biggest problem in providing optimal care timely for myocardial infarction patients. There are significant regional differences in rescue times, and further analysis is needed to investigate the causes. Orv Hetil. 2020; 161(12): 458-467.

The Natural History of Nonculprit Lesions in STEMI: An FFR Substudy of the Compare-Acute Trial.

OBJECTIVES: The aim of this study was to determine the prognostic value of fractional flow reserve (FFR) in non-infarct-related arteries (IRAs) in ST-segment elevation myocardial infarction (MI). BACKGROUND: Patients with ST-segment elevation MI often present with multivessel disease. The treatment of non-IRAs is debated. The applicability of FFR has not been widely proved. METHODS: Outcomes were analyzed in all patients in the Compare-Acute (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial in whom, after successful primary percutaneous coronary intervention, non-IRAs were interrogated using FFR and treated medically. The treating cardiologist was blinded to the FFR value. The primary endpoint was the composite of cardiovascular mortality, target vessel-related (non-IRA with FFR measurement at primary percutaneous coronary intervention) nonfatal MI, and target vessel revascularization: major adverse cardiac events (MACE) at 24 months. RESULTS: A total of 751 patients (963 vessels) were included. Target non-IRAs with MACE had lower FFR compared with those without (0.78 vs. 0.84, respectively; p < 0.001). The median FFR of non-IRAs with TVR was lower than that of those without (0.79 vs. 0.85, respectively; p < 0.001). The difference was significant in all vessels. The median FFR of target non-IRAs with MI was lower than that of those without (0.79 vs. 0.84, respectively; p = 0.016). The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (<0.80) compared with the others (0.80 to 0.87 and ≥0.88). CONCLUSIONS: In patients with ST-segment elevation MI with multivessel disease, FFR measured in the medically treated non-IRA immediately after successful primary percutaneous coronary intervention shows a nonlinear and inverse risk continuum of MACE. Importantly, worsening prognosis is demonstrated around the cutoff of 0.80.

Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events.

BACKGROUND: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. METHODS AND RESULTS: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). CONCLUSIONS: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.

[The first percutaneous aortic valve implantation in Hungary]. / Az elsô perkután aortabillentyû-beültetés Magyarországon.

Aortic valve replacement can produce dramatic benefit in the setting of symptomatic aortic stenosis. The potential for morbidity and mortality associated with thoracotomy, cardiopulmonary bypass, and aortotomy has fostered a search for alternatives. Early experience with transcatheter endovascular aortic valve implantation demonstrated feasibility and efficacy, but the procedure was difficult to reproduce. However, equipment, techniques, and experience have evolved rapidly. Balloon-expandable and self-expanding prostheses and percutaneous femoral artery and open left ventricular apical access have found favor, each with potential advantages and disadvantages. Procedural success rates and clinical outcomes continue to improve. Current studies suggest that morbidity and mortality rates of percutaneous aortic valve implantations are much better in comparison to conventional surgery in selected high-risk patients. On November 11, 2008, in the Gottsegen György Hungarian Institute of Cardiology we performed the first two successful percutaneous aortic valve implantations in Central and Eastern Europe, following a more than one-year preparation period. After seven days the patients were discharged in very good conditions.

[Transient left ventricular apical akinesis with systolic dysfunction after physical exercise: a form of tako-tsubo syndrome]. / Fizikai terhelés indukálta reverzíbilis csúcsi akinézis szisztolés diszfunkcióval: a tako-tsubo-szindróma egyik formája.

A 43-year-old woman with mild hypertension and type-2 diabetes mellitus was presented to the coronary care unit because of ongoing chest pain and associated dyspnea after physical exercise. On arrival, her ECG disclosed ST-segment elevations in the precordial leads. The emergent cardiac catheterization failed to demonstrate coronary artery disease. The prompt performed transthoracic echocardiogram demonstrated systolic dysfunction with apical ballooning. Akinetic segments were irrespective of coronary artery anatomy. Laboratory tests revealed only slightly elevated cardiac enzymes: we observed a significant discrepancy between the extent of akinesis and the minimal increase in cardiac necroenzymes. The patient was medically managed and discharged in stable condition, with follow-up at 4 weeks demonstrating nearly total recovery of cardiac function and total resolution of wall motion disorder. Her clinical presentation is consistent with that of tako-tsubo cardiomyopathy, a syndrome that is characterized by transient apical regional wall motion abnormalities in the absence of epicardial coronary artery disease. Main precipitating factor is thought to be the cathecolamin excess due to emotional or physical stress, subarachnoid hemorrhage, phaeochromocytoma or cocaine use. The authors report the first physical exercise induced tako-tsubo syndrome in the Hungarian medical literature.

Thallium-201 myocardial SPECT in left bundle branch block: diagnosis of myocardial ischemia with a disease-specific reference database.

BACKGROUND: The aim of this study was to assess the value of a myocardial perfusion single photon emission computed tomography (SPECT) reference file for patients with left bundle branch block (LBBB). METHODS AND RESULTS: Tl-201 stress-redistribution myocardial perfusion SPECT studies of patients with complete, permanent LBBB were reviewed retrospectively. To develop a reference database, 18 patients with a low likelihood of coronary artery disease (CAD) were selected. Left ventricular regional average and standard deviation (SD) values of the reference file images were calculated. The diagnostic performance was tested on perfusion images of 49 patients with LBBB, undergoing both scintigraphic and coronary angiographic evaluation, and was compared with a commercial quantitative analysis system using a general reference database. The LBBB reference file performed significantly better in detecting epicardial CAD than did the general reference database (receiver operating characteristic area under the curve 0.835 +/- 0.06 vs 0.580 +/- 0.08, p < .01). Disease localization also was improved significantly in the territory of the left anterior descending and of the right coronary arteries. CONCLUSIONS: The use of a reference file of patients with LBBB and a low likelihood of CAD aids the detection and the localization of myocardial ischemia on Tl-201 myocardial SPECT images of this patient group.

[Drug-eluting coronary stents]. / Gyógyszerkibocsátó coronariastentek.

The first method of percutaneously treating a diseased vessel was developed by Dotter and Judkins in 1964. Andreas Grüntzig performed the first coronary angioplasty in 1977. In 1985 Palmaz et al. implanted the first balloon-mounted stent in a peripheral artery. Puel and Sigwart implanted the first human coronary stent in March 1986; it was a self-expanding mesh-like device. Schatz et al. applied some small modifications to the original Palmaz stent, which resulted in the first coronary stent available on the market, called Palmaz-Schatz stent. In 1987 Sigwart was the first to suggest the use of coronary stents in acute vessel occlusions during unsuccessful PTCA. Using the device it became possible to cover the intimal flap and to prevent elastic recoil. Because of the high incidence of subacute stent thromboses and the bleeding complications (aggressive anticoagulation regimens) these times the coronary stents were implanted only in order to avoid emergency CABG surgery. In 1993 BENESTENT and STRESS trials have proved that elective stent implantation can significantly reduce the incidence of restenosis. The dual antiplatelet therapy and the high pressure stent implantation technique dramatically reduced the incidence of subacute stent thrombosis. The treatment of coronary artery disease has undergone revolutionary changes in the past decade but remained the leading cause of mortality in the developed world. The most important limitation of PCI has been in-stent restenosis, which occurs in 20-40% of stent implantations. Clinically it results in recurrent ischemic episodes most often requiring repeat revascularisation (rePCI or CABG). With the use of drug-eluting stents the incidence of in-stent restenosis can be reduced dramatically, based on the currently available clinical trials it remains below 10%.

[Experiences with the first, Hungarian autologous bone marrow cell transplantation in acute myocardial infarction]. / Akut szívizom-infarctusban végzett elso magyar autológ csontveloi o'ssejt transzplantációk során szerzett tapasztalataink.

Intracoronary transfer of autologous bone marrow cells promotes recovery of left ventricular systolic function in patients with acute myocardial infarction. Although the exact mechanisms of stem cell therapy are still intensely debated, the concept of stem cell therapy has already been introduced into the clinical practice--at least as an adjunctive therapy in clinical trials. In this article the authors report their experiences about the first Hungarian phase I. trial in bone marrow stem cell transplantation after acute myocardial infarction. So far, four patients with acute ST elevation myocardial infarction were eligible and recruited into the trial. All patients received purified, autologous bone marrow stem cells into the re-opened infarct related artery via a second catheterisation. The primary end point of the study is ejection fraction, which is measured by cardiac MRI at the beginning and 6 months after recruitment. So far, cell transfer did not increase the risk of adverse clinical events or proarrhythmic effects.