Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial.

INTRODUCTION: Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). METHODS: The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). RESULTS: The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. CONCLUSION: During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.

Computed tomography is better than echocardiography in predicting balloon-expandable transcutaneous implantation valve size in a real-world clinical practice single-center study.

AIMS: Transcatheter aortic valve replacement (TAVR) has become the standard of care for selected patients with severe aortic stenosis. Multidetector computed tomography (MDCT) and transoesophageal 2D/3D (two-dimensional/three-dimensional) echocardiography (ECHO) are used for aortic annulus (AA) sizing. The aim of this study was to compare the accuracy of AA sizing by ECHO versus MDCT for Edwards Sapien balloon expandable valve in a single center. METHODS AND RESULTS: Data from 145 consecutive patients with TAVR (Sapien XT or Sapien S3) were analyzed retrospectively. A total of 139 (96%) patients had favorable outcomes after TAVR (at most mild aortic regurgitation and only one valve implanted). The 3D ECHO AA area and area-derived diameter were smaller than the corresponding MDCT parameters (464 ± 99 vs. 479 ± 88 mm2 , p < .001, and 24.2 ± 2.7 vs. 25.0 ± 5.5 mm, p = .002, respectively). The 2D ECHO annulus measurement was smaller than both the MDCT and 3D ECHO area-derived diameters (22.6 ± 2.9 vs. 25.0 ± 5.5 mm, p = .013, and 22.6 ± 2.9 vs. 24.2 ± 2.7 mm, p < .001, respectively) but larger than the minor axis diameter of the AA derived from MDCT and 3D ECHO by multiplanar reconstruction (p < .001). The 3D ECHO circumference-derived diameter was also smaller than the MDCT circumference-derived diameter (24.3 ± 2.5 vs. 25.0 ± 2.3, p = .007). The sphericity index by 3D ECHO was smaller than that by MDCT (1.2 ± .1 vs. 1.3 ± .1, p < .001). In up to 1/3 of the patients, 3D ECHO measurements would have predicted different (generally smaller) valve size than was the valve size implanted with favorable result. The concordance of the implanted valve size with the recommended size based on preprocedural MDCT and 3D ECHO AA area was 79.4% versus 61% (p = .001), and for the area-derived diameter, the concordance was 80.1% versus 61.7% (p = .001). 2D ECHO diameter concordance was similar to MDCT (78.7%). CONCLUSIONS: 3D ECHO AA measurements are smaller than MDCT measurements. If 3D ECHO-based parameters alone are used to size the Edwards Sapien balloon expandable valve, then the selected valve size would have been smaller than the valve size implanted with favorable result in 1/3 of the patients. MDCT preprocedural TAVR assessment should be the preferred method over 3D ECHO in routine clinical practice to determine Edwards Sapien valve size.

Myocardial injury in stress echocardiography: Comparison of dobutamine, dipyridamole and dynamic stressors-single center study.

OBJECTIVES: In stress echocardiography (SE), dipyridamole (DIP) and dynamic stress (ExSE) are reported as being safer than dobutamine stress echocardiography (DSE). We investigated whether these commonly used stressors cause myocardial injury, measured by high sensitivity troponin T (hsTnT). METHODS: One hundred and thirty five patients (DSE n = 46, ExsE n = 46, DIP n = 43) with negative result of SE were studied. The exclusion criteria were known ischaemic heart disease (IHD), baseline wall motion abnormalities, left ventricle systolic dysfunction/regional wall motion abnormalities, septum/posterior wall ≥13 mm, diabetes/pre-diabetes, baseline hsTnT level ≥14 ng/L, baseline blood pressure ≥160/100 mmHg, peak pulmonary pressure ≥45mmHg, eGFR <1ml/s/1.73m2 , more than mild to moderate valvular disease and dobutamine side effects. HsTnT was measured before and 180 minutes after the test. RESULTS: All patients had low pre-test probabilities of having obstructive IHD. HsTnT increased in DSE, less so in ExSE, and was unchanged in the DIP group (∆hsTnT 9.4 [1.5-58.6], 1.1 [-0.9-15.7], -0.1 [-1.4-2.1] ng/L, respectively, p<0.001). In DSE, the ∆hsTnT was associated with peak dobutamine dose (r = 0.30, p = 0.045), test length (r = 0.43, p = 0.003) and atropine use (p<0.001). In ExSE, the hsTnT increase was more likely in females (p = 0.012) and the elderly (>65 years) (r = 0.32, p = 0.03); no association was found between atropine use (p = 0.786) or test length and ∆hsTnT (r = 0.10, p = 0.530). CONCLUSIONS: DSE is associated with myocardial injury in patients with negative SE, no injury was observed in DIP and only mild case in ExSE. Whether myocardial injury is causative of the higher reported adverse event rates in DSE remains to be determined.

4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation.

BACKGROUND: The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk. OBJECTIVES: This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS: This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA2DS2-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. CONCLUSIONS: In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study).

Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. OBJECTIVE: To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. STUDY DESIGN: The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2DS2VASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. CONCLUSION: The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.

[The user´s reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2]. / Uzivatelské výstupy z národního registru katetrových implantací aortální chlopne (Czech TAVI Registry): moznosti analytických výstupu zalozených na databázovém systému TrialDB2.

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.

The effect of cholesteryl ester transfer protein inhibition on lipids, lipoproteins, and markers of HDL function after an acute coronary syndrome: the dal-ACUTE randomized trial.

AIMS: The effects of cholesteryl ester transfer protein (CETP) inhibition on lipids, inflammation, and markers of high-density lipoprotein (HDL) function, following an acute coronary syndrome (ACS), are unknown. METHODS AND RESULTS: The dal-ACUTE study randomized 300 patients (1 : 1) to dalcetrapib 600 mg/day or placebo within 1 week of an ACS. The primary endpoint was per cent change in HDL-cholesterol (HDL-C) after 4 weeks. Secondary endpoints included apolipoprotein levels, markers of HDL function, and inflammation. Dalcetrapib treatment increased HDL-C and apolipoprotein A1 by 33.7 and 11.8%, respectively (both P < 0.001) and total cholesterol efflux by 9.5% (P = 0.003) after 4 weeks, principally via an increase in non-ATP-binding cassette transporter (ABC) A1-mediated efflux, without statistically significant changes in pre-ß1-HDL levels. The increase in total efflux with dalcetrapib correlated most strongly with increases in apolipoprotein A1 and HDL-C (r = 0.46 and 0.43, respectively) rather than the increase in pre-ß1-HDL (r = 0.32). Baseline and on-treatment ABCA1-mediated efflux correlated most strongly with pre-ß1-HDL levels; in contrast, non-ABCA1-mediated efflux correlated better with apolipoprotein A1 and HDL-C levels. CONCLUSIONS: High-density lipoprotein raised through CETP inhibition with dalcetrapib improves cholesterol efflux, principally via a non-ABCA1-mediated pathway. While HDL-C was increased by one-third, apolipoprotein A1 and total efflux were increased only by one-tenth, supporting the concept of dissociation between improvements in HDL function and HDL-C levels, which may be of relevance to ongoing trials and the development of therapeutic interventions targeting HDL.

ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial.

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 <12 h of symptom onset were randomized in 4 high-volume radial centers. The primary endpoint was the cumulative incidence of major bleeding and vascular access site complications at 30 days. The rate of net adverse clinical events (NACE) was defined as a composite of death, myocardial infarction, stroke, and major bleeding/vascular complications. Access site crossover, contrast volume, duration of intensive care stay, and death at 6 months were secondary endpoints. RESULTS: The primary endpoint occurred in 1.4% of the radial group (n = 348) and 7.2% of the femoral group (n = 359; p = 0.0001). The NACE rate was 4.6% versus 11.0% (p = 0.0028), respectively. Crossover from radial to femoral approach was 3.7%. Intensive care stay (2.5 ± 1.7 days vs. 3.0 ± 2.9 days, p = 0.0038) as well as contrast utilization (170 ± 71 ml vs. 182 ± 60 ml, p = 0.01) were significantly reduced in the radial group. Mortality in the radial and femoral groups was 2.3% versus 3.1% (p = 0.64) at 30 days and 2.3% versus 3.6% (p = 0.31) at 6 months, respectively. CONCLUSIONS: In patients with STEMI undergoing primary PCI by operators experienced in both access sites, the radial approach was associated with significantly lower incidence of major bleeding and access site complications and superior net clinical benefit. These findings support the use of the radial approach in primary PCI as first choice after proper training. (Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention [PCI] [STEMI-RADIAL]; NCT01136187).

Acute myocardial infarction complicated by shock: outcome analysis based on initial electrocardiogram.

OBJECTIVES: To assess the relation between initial ECG findings, presence of risk factors, coronary angiography findings, and clinical outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (CS). DESIGN: Data from a total of 5572 acute myocardial infarction patients admitted to the four tertiary hospitals during a period of 3 years were analyzed. CS on admission was present in 358 patients (6.4%). They were divided into four groups based on the admission ECG: ST-segment elevation (STEMI), ST-segment depression (STDMI), bundle branch block (BBBMI), and other ECG acute myocardial infarction. RESULTS: CS developed most frequently among BBBMI patients (in 12.1% of all BBBMIs, p < 0.001 vs. STEMI), followed by STEMI (6.7%), STDMI (4.4%), and other ECG acute myocardial infarction (2.3%). The risk of CS development was similar in patients with left bundle branch block (LBBB) (13.3%) and right bundle branch block (RBBB) (11.2%). The one-year mortality was highest among RBBBMI patients (66.7%, p < 0.001), followed by LBBBMI (48.6%), other ECG (47.1%), STEMI (41.7%), and STDMI patients (38.1%). CONCLUSIONS: RBBB on admission ECG is associated with the highest risk of CS development, frequent left main coronary artery affection, and unsuccessful revascularization. It is also an independent predictor of one-year mortality.

Comparison of outcomes in ST-segment depression and ST-segment elevation myocardial infarction patients treated with emergency PCI: data from a multicentre registry.

BACKGROUND: Traditionally, acute myocardial infarction (AMI) has been described as either STEMI (ST-elevation myocardial infarction) or non-STEMI myocardial infarction. This classification is historically related to the use of thrombolytic therapy, which is effective in STEMI. The current era of widespread use of coronary angiography (CAG), usually followed by primary percutaneous coronary intervention (PCI) puts this classification system into question. OBJECTIVES: To compare the outcomes of patients with STEMI and ST-depression myocardial infarction (STDMI) who were treated with emergency PCI. METHODS: This multicentre registry enrolled a total of 6 602 consecutive patients with AMI. Patients were divided into the following subgroups: STEMI (n = 3446), STDMI (n = 907), left bundle branch block (LBBB) AMI (n = 241), right bundle branch block (RBBB) AMI (n = 338) and other electrocardiographic (ECG) AMI (n = 1670). Baseline and angiographic characteristics were studied, and revascularisation therapies and in-hospital mortality were analysed. RESULTS: Acute heart failure was present in 29.5% of the STDMI vs 27.4% of the STEMI patients (p < 0.001). STDMI patients had more extensive coronary atherosclerosis than patients with STEMI (three-vessel disease: 53.1 vs 30%, p < 0.001). The left main coronary artery was an infract-related artery (IRA) in 6.0% of STDMI vs 1.1% of STEMI patients (p < 0.001). TIMI flow 0-1 was found in 35.0% of STDMI vs 66.0% of STEMI patients (p < 0.001). Primary PCI was performed in 88.1% of STEMI (with a success rate of 90.8%) vs 61.8% of STDMI patients (with a success rate of 94.5%) (p = 0.012 for PCI success rates). In-hospital mortality was not significantly different (STDMI 6.3 vs STEMI 5.4%, p = 0.330). CONCLUSION: These data suggest that similar strategies (emergency CAG with PCI whenever feasible) should be applied to both these types of AMI.

Primary angioplasty in acute myocardial infarction with right bundle branch block: should new onset right bundle branch block be added to future guidelines as an indication for reperfusion therapy?

AIMS: The current guidelines recommend reperfusion therapy in acute myocardial infarction (AMI) with ST-segment elevation or left bundle branch block (LBBB). Surprisingly, the right bundle branch block (RBBB) is not listed as an indication for reperfusion therapy. This study analysed patients with AMI presenting with RBBB [with or without left anterior hemiblock (LAH) or left posterior hemiblock (LPH)] and compared them with those presenting with LBBB or with other electrocardiographic (ECG) patterns. The aim was to describe angiographic patterns and primary angioplasty use in AMI patients with RBBB. METHODS AND RESULTS: A cohort of 6742 patients with AMI admitted to eight participating hospitals was analysed. Baseline clinical characteristics, ECG patterns, coronary angiographic, and echocardiographic data were correlated with the reperfusion therapies used and with in-hospital outcomes. Right bundle branch block was present in 6.3% of AMI patients: 2.8% had RBBB alone, 3.2% had RBBB + LAH, and 0.3% had RBBB + LPH. TIMI flow 0 in the infarct-related artery was present in 51.7% of RBBB patients vs. 39.4% of LBBB patients (P = 0.023). Primary percutaneous coronary intervention (PCI) was performed in 80.1% of RBBB patients vs. 68.3% of LBBB patients (P< 0.001). In-hospital mortality of RBBB patients was similar to LBBB (14.3 vs. 13.1%, P = 0.661). Patients with new or presumably new blocks had the highest (LBBB 15.8% and RBBB 15.4%) incidence of cardiogenic shock from all ECG subgroups. Percutaneous coronary intervention was done more frequently (84.8%) in patients with new or presumably new RBBB when compared with other patients with blocks (old RBBB 66.0%, old LBBB 62.3%, new or presumably new LBBB 73.0%). In-hospital mortality was highest (18.8%) among patients presenting with new or presumably new RBBB, followed by new or presumably new LBBB (13.2%), old LBBB (10.1%), and old RBBB (6.4%). Among 35 patients with acute left main coronary artery occlusion, 26% presented with RBBB (mostly with LAH) on the admission ECG. CONCLUSION: Acute myocardial infarction with RBBB is frequently caused by the complete occlusion of the infarct-related artery and is more frequently treated with primary PCI when compared with AMI + LBBB. In-hospital mortality of patients with AMI and RBBB is highest from all ECG presentations of AMI. Restoration of coronary flow by primary PCI may lead to resolution of the conduction delay on the discharge ECG. Right bundle branch block should strongly be considered for listing in future guidelines as a standard indication for reperfusion therapy, in the same way as LBBB.

Routine upfront abciximab versus standard periprocedural therapy in patients undergoing primary percutaneous coronary intervention for cardiogenic shock: The PRAGUE-7 Study. An open randomized multicentre study.

BACKGROUND: The outcome of acute myocardial infarction (AMI) complicated with cardiogenic shock is poor. The aim of this study was to analyse, whether upfront abciximab administration could improve the outcomes of cardiogenic shock. METHODS: This multicentre open trial randomized 80 patients with AMI complicated by cardiogenic shock expected to undergo primary PCI into group A (routine upfront-pre-procedural-abciximab bolus followed by 12-h abciximab infusion) and group B (standard therapy). The study primary objective was 30-day combined outcome (death/reinfarction/stroke/new severe renal failure). RESULTS: PCI was technically successful in 90% (A) versus 87.5% (B) patients. Abciximab was used in 100% (A) versus 35% (B). The primary endpoint occurred in 17 group A patients (42.5%) and 11 group B patients (27.5%, P = 0.24). Ejection fraction among survivors after 30 days was 44 ± 11% (A) versus 41 ± 12% (B, P = 0.205). Major bleeding occurred in 17.5% (A) versus 7.5% (B, P = 0.310). No differences (A versus B) were found in TIMI-flow and MBG after PCI. CONCLUSIONS: This study did not show any benefit from routine pre-procedural abciximab when compared with a selective abciximab use during the intervention in patients with cardiogenic shock undergoing primary PCI. However, small sample size of the trial preclude any definitive conclusion, a larger prospective, randomized, multicentered trial is needed.

Role of ischemia-modified albumin in estimating the extent and scope of cardiac ischemia in patients with ST elevation myocardial infarction.

Ischemia-modified albumin (IMA) is a laboratory biomarker of cardiac ischemia. Our study aims to determine whether IMA can estimate or represent to any degree the extent of myocardial ischemia. We expect that the higher the marker of cardiac necrosis (maximum value after serial measurements) the greater the preceding cardiac ischemia, indicated by IMA in patients diagnosed with STEMI prior to direct percutaneous coronary intervention (PCI). We studied 216 patients indicated for direct PCI with a diagnosis of ST elevation myocardial infarction. Biochemical analysis of IMA was carried out using the albumin cobalt binding (ACB®) test. We also obtained relevant values for markers of myocardial necrosis (CK, CK-MB, cTnT). In all patients, there was an increased level of IMA prior to the procedure (116 ± 16.9 kU/l); also raised were levels of CK (17.32 µkat/l), CK-MB (4.85 µkat/l) and cTnT (2.97 µg/l) taken as the maximum values obtained after serial measurements at 12, 18, and 24 h after the procedure. We observed that there was no significant association between increase in IMA and cTnT (R2 = 0.0068, p = 0.483). This was also the case for CK-MB (R2 = 0.0011, p = 0.637). IMA does not estimate the extent of ischemia in patients with ST elevation myocardial infarction. However, its absence can be used qualitatively to rule out cardiac ischemia.

Bland-White-Garland syndrome in adults: sudden cardiac death as a first symptom and long-term follow-up after successful resuscitation and surgery.

Two cases (a 23-year-old man and a 33 year-old-woman) with Bland-White-Garland (BWG) syndrome (an anomalous origin of the left coronary artery from the pulmonary artery) are presented. Their first symptom was survived sudden cardiac death. Both patients underwent surgical repair. One patient received an implantable defibrillator because of serious structural changes in the left ventricle and symptomatic non-sustained ventricular tachycardia; the second patient is free of therapy. During long-term follow-up (10.5 and 4.5 years, respectively), ventricular tachyarrhythmias did not recur. Both cases show good long-term prognosis in resuscitated adult patients after surgical repair for BWG syndrome regardless of the presence of structural changes.

Transcatheter closure of a chronic iatrogenic arteriovenous fistula between the carotid artery and the brachiocephalic vein with an Amplatzer duct occluder in combination with a carotid stent.

We report an original method of transcatheter closure of an arteriovenous fistula using the combination of an Amplatzer PDA occluder and a carotid stent. The fistula was between the left carotid artery and the brachiocephalic vein. The patient had significant left-to-right shunt and was highly symptomatic. Due to the large orifice and pseudoaneurysmatic enlargement of the fistula, we had to use a large Amplatzer PDA occluder and the protruding part of the PDA device disk had to be covered with a carotid stent. The fistula was completely closed. The patient stopped having symptoms and, 2 years after the procedure, the effect persists.

The percutaneous closure of a large pseudoaneurysm of the ascending aorta with an atrial septal defect Amplatzer occluder: two-year follow-up.

Pseudoaneurysm of the ascending aorta is a high-risk complication following cardiac surgery. The present report describes excellent two-year follow-up results after the percutaneous closure of a very large pseudoaneurysm with an Amplatzer atrial septal defect occluder. The original cavity in the anterior mediastinum with maximal diameter 15 cm remained as only a small scar. The patient was without serious health problems both early and after two years.