Transseptal puncture in left atrial appendage closure guided by 3D printing and multiplanar CT reconstruction.

BACKGROUND: The presented study investigates the application of bi-arterial 3D printed models to guide transseptal puncture (TSP) in left atrial appendage closure (LAAC). AIMS: The objectives are to (1) test the feasibility of 3D printing (3DP) for TSP guidance, (2) analyse the distribution of the optimal TSP locations, and (3) define a CT-derived 2D parameter suitable for predicting the optimal TSP locations. METHODS: Preprocedural planning included multiplanar CT reconstruction, 3D segmentation, and 3DP. TSP was preprocedurally simulated in vitro at six defined sites. Based on the position of the sheath, TSP sites were classified as optimal, suboptimal, or nonoptimal. The aim was to target the TSP in the recommended position during the procedure. Procedure progress was assessed post hoc by the operator. RESULTS: Of 68 screened patients, 60 patients in five centers (mean age of 74.68 ± 7.64 years, 71.66% males) were prospectively analyzed (3DP failed in one case, and seven patients did not finally undergo the procedure). In 55 patients (91.66%), TSP was performed in the optimal location as recommended by the 3DP. The optimal locations for TSP were postero-inferior in 45.3%, mid-inferior in 45.3%, and antero-inferior in 37.7%, with a mean number of optimal segments of 1.34 ± 0.51 per patient. When the optimal TSP location was achieved, the procedure was considered difficult in only two (3.6%) patients (but in both due to complicated LAA anatomy). Comparing anterior versus posterior TSP in 2D CCT, two parameters differed significantly: (1) the angle supplementary to the LAA ostium and the interatrial septum angle (160.83° ± 9.42° vs. 146.49° ± 8.67°; p = 0.001), and (2) the angle between the LAA ostium and the mitral annulus (95.02° ± 3.73° vs. 107.38° ± 6.76°; p < 0.001), both in the sagittal plane. CONCLUSIONS: In vitro TSP simulation accurately determined the optimal TSP locations for LAAC and facilitated the procedure. More than one-third of the optimal TSP sites were anterior.

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.

Randomized comparison of 9-month stent strut coverage of biolimus and everolimus drug-eluting stents assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction. Long-term (5-years) clinical follow-up (ROBUST trial).

BACKGROUND: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. METHODS: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. RESULTS: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm² vs. 0.9 mm²; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). CONCLUSIONS: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years.

Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation.

AIMS: The management of congestion is one of the key treatment targets in heart failure. Assessing congestion is, however, difficult. The purpose of this study was to investigate the safety and dynamic response of a novel, passive, inferior vena cava (IVC) sensor in a chronic ovine model. METHODS AND RESULTS: A total of 20 sheep divided into three groups were studied in acute and chronic in vivo settings. Group I and Group II included 14 sheep in total with 12 sheep receiving the sensor and two sheep receiving a control device (IVC filter). Group III included an additional six animals for studying responses to volume challenges via infusion of blood and saline solutions. Deployment was 100% successful with all devices implanted; performing as expected with no device-related complications and signals were received at all observations. At similar volume states no significant differences in IVC area normalized to absolute area range were measured (55 ± 17% on day 0 and 62 ± 12% on day 120, p = 0.51). Chronically, the sensors were completely integrated with a thin, reendothelialized neointima with no loss of sensitivity to infused volume. Normalized IVC area changed significantly from 25 ± 17% to 43 ± 11% (p = 0.007) with 300 ml infused. In contrast, right atrial pressure required 1200 ml of infused volume prior to a statistically significant change from 3.1 ± 2.6 mmHg to 7.5 ± 2.0 mmHg (p = 0.02). CONCLUSION: In conclusion, IVC area can be measured remotely in real-time using a safe, accurate, wireless, and chronic implantable sensor promising to detect congestion with higher sensitivity than filling pressures.

Contrast-induced acute kidney injury and its contemporary prevention.

The complexity and application range of interventional and diagnostic procedures using contrast media (CM) have recently increased. This allows more patients to undergo procedures that involve CM administration. However, the intrinsic CM toxicity leads to the risk of contrast-induced acute kidney injury (CI-AKI). At present, effective therapy of CI-AKI is rather limited. Effective prevention of CI-AKI therefore becomes crucially important. This review presents an in-depth discussion of CI-AKI incidence, pathogenesis, risk prediction, current preventive strategies, and novel treatment possibilities. The review also discusses the difference between CI-AKI incidence following intraarterial and intravenous CM administration. Factors contributing to the development of CI-AKI are considered in conjunction with the mechanism of acute kidney damage. The need for ultimate risk estimation and the prediction of CI-AKI is stressed. Possibilities of CI-AKI prevention is evaluated within the spectrum of existing preventive measures aimed at reducing kidney injury. In particular, the review discusses intravenous hydration regimes and pre-treatment with statins and N-acetylcysteine. The review further focuses on emerging alternative imaging technologies, alternative intravascular diagnostic and interventional procedures, and new methods for intravenous hydration guidance; it discusses the applicability of those techniques in complex procedures and their feasibility in current practise. We put emphasis on contemporary interventional cardiology imaging methods, with a brief discussion of CI-AKI in non-vascular and non-cardiologic imaging and interventional studies.

The role of central autonomic nervous system dysfunction in Takotsubo syndrome: a systematic review.

INTRODUCTION: Takotsubo syndrome (TTS), also known as stress cardiomyopathy or "broken heart" syndrome, is a mysterious condition that often mimics an acute myocardial infarction. Both are characterized by left ventricular systolic dysfunction. However, this dysfunction is reversible in the majority of TTS patients. PURPOSE: Recent studies surprisingly demonstrated that TTS, initially perceived as a benign condition, has a long-term prognosis akin to myocardial infarction. Therefore, the health consequences and societal impact of TTS are not trivial. The pathophysiological mechanisms of TTS are not yet completely understood. In the last decade, attention has been increasingly focused on the putative role of the central nervous system in the pathogenesis of TTS. CONCLUSION: In this review, we aim to summarize the state of the art in the field of the brain-heart axis, regional structural and functional brain abnormalities, and connectivity aberrancies in TTS.

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).

Primary percutaneous coronary intervention is appropriate in transient ST-elevation myocardial infarction.

INTRODUCTION: Reperfusion therapy by primary percutaneous coronary intervention (PPCI) is generally indicated in patients suffering from acute myocardial infarction (MI) with ST-segment elevation (STEMI). Prior to hospital admission, full ST-segment resolution (fSTR) may occur. Optimal management of such patients with transient STEMI (TSTEMI) is potentially challenging. Our aim was to evaluate the hypothesis that in TSTEMI patients, patency of infarct related artery (IRA) is achieved before PPCI, and to compare the outcome of TSTEMI and STEMI patients during a prolonged follow-up. MATERIAL AND METHODS: Three hundred consecutive adult STEMI patients were referred to catheterization laboratory. In all patients, standard 12 lead ECGs were obtained both at the time of the first medical contact, and on catheterization laboratory admission. RESULTS: TSTEMI occurred in 20 patients (6.7%). Despite fSTR (isoelectric ST segment), occluded IRA was found in 5 of these patients (25%). Pre-PPCI TIMI flow grade 2 was found in 6 TSTEMI patients (30%). Troponin T value at 24 h after symptom onset was lower in the TSTEMI group (1.8±2.5 mg/L vs. 3.6±3.5 mg/L, P=0.008). These patients also had a lower value of brain natriuretic peptide (156.3±119.5 ng/L vs. 438.5±429.0 ng/L, P<0.001) and higher left ventricular ejection fraction (59.9±6.3% vs. 51.6±10.2%, P<0.001). All patients were followed for a median of 5.6 years during which the overall survival did not differ between the TSTEMI and STEMI groups. CONCLUSION: Primary PCI is strongly recommended in TSTEMI patients because of a relatively high incidence of occluded infarct related arteries. The rate of patients with TSTEMI is relatively low.

Percutaneous coronary intervention of chronic total occlusion - to whom, when and why.

Chronic total occlusion is characterised by total discontinuation of a blood flow in coronary vessel present for at least three months. Typical finding involves filling of the distal arterial segments by collateral flow. Well developed collaterals usually provide sufficient supply to preserve myocardial viability, but frequently are not capable of preventing excercise ischemia in the occluded territory. Percutaneous intervention of a CTO is focused on ischemia reduction, improvement of excercise capacity and quality of life. A succesful recanalization of a CTO leads to an improvement of left ventricular systolic function. Patients presenting with acute coronary syndromes and a coincident CTO in non-infarct related artery show worse short and long-term outcomes as compared to patients without a CTO. Technolocigal and procedural evolvement over past decades with implementation of novel techniques used by experienced operators lead to a substantial succes rate imprevement with acceptable complications rate in contemporary CTO interventions.

Patent foramen ovale from the point of view of interventional cardiology.

The link between patent foramen ovale (PFO) and paradoxical embolization, which may be cause of so-called “cryptogenic” ischemic stroke, has been known for more than 100 years. The catheteriziation closure of PFO as a secondary preventive treatment is performed in a greater extent since the end of the last century. The results of the first epidemiological and randomised clinical trials comparing antiagregation or anticoagulant therapy with the PFO closure did not show a clear benefit of any of these approaches. In 2017, major randomized clinical trials were published that demonstrated the benefit of PFO catheter closure compared to drug therapy alone. In this summary article we describe the diagnostic procedure of patients with PFO undergoing paradoxical embolization, indications and selections of a suitable patient for catheter closure of PFO, the procedure itself and subsequent clinical follow-up of these patients.

Amiodarone induced pulmonary toxicity.

Amiodarone is one of the more frequently used drugs in the treatment of supraventricular and ventricular arrhythmias. Many adverse effects, more or less serious, are associated with its administration. Amiodaron-induced pulmonary toxicity (AIPT) is quite rare but represents one of the most severe adverse effects with high mortality. We present an 80 years old patient, who used amidorane due to paroxysmal atrial fibrillation for several years. Within 3 months, he was repeatedly hospitalized for a bilateral pneumonia. Eventually, AIPT was diagnosed. Early diagnosis, proper therapy of AIPT and changed antiarrhythmic therapy has significantly improved the clinical status of our patient. In this case we demonstrate typical clinical presentations of AIPT as well as the most common diagnostic procedures and recommended treatment methods. Finally, some other commonly used therapeutical options for supraventricular arrhythmias are mentioned. Future options are outlined.

First zero contrast PCI guided by intracoronary ultrasound in the Czech Republic.

Contrast induced nephropathy is associated with worse clinical outcome in patients undergoing coronary intervention. The most profound risk factor is advanced chronic renal insufficiency. Due to the increasing number of coronary interventions on severally ill patients, there is a need of modern therapeutic approach that could reduce the volume of contrast media to minimum or even zero. Herein, the authors present a case report of a 68-year-old patient with chronic kidney disease, who required elective coronary intervention (PCI) due to a significant lesion of the left anterior descending coronary artery. During this intervention, maximum emphasis was given on reduction of contrast media. To the best of our knowledge, this was the first similar intervention performed in the Czech Republic. Minimum contrast PCI guided by the intracoronary ultrasound, i.e. the IVUS-guided zero-contrast PCI may serve as a potential alternative to standard, angiography-guided PCI.

Myocardial infarction or broken heart syndrome?

Takotsubo or broken heart syndrome represents a rare type of cardiomyopathy, often imitating acute myocardial infarction. It is a sudden transient cardiac syndrome that typically involves left ventricular apical akinesis with preserved motility of basal heart segments. In contrast to acute myocardial infarction, the pathology is fully reversible in the majority of patients. In the present casereport, we discuss 78yearsold female referred to our department for typical symptomatology of acute myocardial infarction. Coronary angiography revealed significant stenosis on the left anterior descending coronary artery, but ventriculography disclosed apical dysfunction and clinical course of the disease result in the diagnosis of Takotsubo cardiomyopathy. Until recently, normal or nonobstructive coronary angiography represented one of the mean diagnostic features of Takotsubo cardiomyopathy. In 2018, new diagnostic criteria were introduced, importantly modifying our approach to the Takotsubo diagnostics with omitting a coronary lesion as an exclusion criterium of the Takotsubo cardiomyopathy.

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).

OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up.

AIMS: To assess the possible merits of optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. All patients were scheduled for nine months of follow-up angiography and OCT study. OCT guidance led to post-pPCI optimization in 29% of cases (59% malapposition and 41% dissections). No complications were found related to the OCT study. OCT analysis at nine months showed significantly less in-segment area of stenosis (6% [-11, 19] versus 18% [3, 33]; p=0.0002) in favor of the OCT-guided group. The rate major adverse cardiovascular events were comparable at nine months in both groups (3% in the OCT group versus 2% in the angio-guided group; p=0.87). CONCLUSIONS: This study demonstrates the safety of OCT guidance during pPCI. The use of OCT optimized stent deployment in 1/3 of patients in this clinical scenario and significantly reduced in-segment area of stenosis at nine months of follow-up. Whether such improvements in OCT endpoints will have a positive impact on late clinical outcomes, they demand both a larger and longer-term follow-up study.

Radial artery neointimal hyperplasia after transradial PCI-Serial optical coherence tomography volumetric study.

AIMS: Transradial catheterization (TRC) is a dominant access site for coronary catheterization and percutaneous coronary interventions (PCI) in many centers. Previous studies reported higher intimal thickness of the radial artery (RA) wall in patients with a previous history of TRC. In this investigation the aim was to assess the intimal changes of RA using the optical coherence tomography (OCT) intravascular imaging in a serial manner. METHODS AND RESULTS: 100 patients with the diagnosis of non-ST-elevation myocardial infarction (nSTEMI) treated by PCI were enrolled (6 patients were excluded from this analysis because of occluded RA at follow-up [2 patients] and insufficient quality of OCT images [4 patients]). An 54mm long OCT run of the RA was performed immediately after the index PCI and repeated 9 months later. Volumetric analyses of the intimal layer and lumen changes were conducted. Median intimal volume at baseline versus 9 months was 33.9mm3 (19.0; 69.4) versus 39.0mm3 (21.7; 72.6) (p<0.001); and median arterial lumen volume was 356.3mm3 (227.8; 645.3) versus 304.7mm3 (186.1; 582.7) (p<0.001). There was no significant difference in the effect of any clinical factor on the RA volume changes. CONCLUSIONS: OCT volumetric analyses at baseline and 9 months showed a significant increase in the radial artery intimal layer volume and a decrease in lumen volume after transradial PCI. No significant factors affecting this process were identified.

Relationship of long-term prognosis to MMP and TIMP polymorphisms in patients after ST elevation myocardial infarction.

The influence of polymorphisms in the large group of MMP and TIMP genes on clinical outcomes in patients after ST elevation myocardial infarction (STEMI) treated with primary PCI was analysed. In total, 550 consecutive Caucasian patients with STEMI were included in the present study, with a median of 32 months. We analysed 19 polymorphisms in the genes coding MMP and TIMP genes. The MMP-1 -519A/G and -422A/T polymorphisms are associated with combined endpoint after myocardial infarction. The hazard ratio for AT variant of MMP-1 -422A/T was 1.75 (p < 0.001); the variants with at least one A allele of MMP-1 -519A/G have less risk of combined endpoint. The TT variants of -1562C/T MMP-9 and at least one T allele of +92C/T MMP-13 were considered in a trend to affect disease progression and long-term survival after myocardial infarction. According to reclassification analysis NRI and IDI, long-term risk stratification using MMP-1 -422A/T and -519A/G polymorphisms gives additional information to the commonly used GRACE risk score. Patient stratification after myocardial infraction (MI) according to risk genotypes of MMP-1 polymorphisms could have important clinical implications for identification of patients at risk and therapeutic strategies.

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.

Short sheath benefit in radial artery injury after PCI - optical coherence tomography serial study.

BACKGROUND AND AIMS: Transradial catheterization is the predominant access site for coronary catheterization and percutaneous coronary interventions (PCI). Previous studies have reported a high incidence of radial artery (RA) injury. The aim of this investigation was to evaluate the incidence of RA injury using last generation optical coherence tomography (OCT) intravascular imaging in a serial manner. METHODS: 100 patients with a diagnosis of non-ST-elevation myocardial infarction (nSTEMI) treated by PCI were enrolled. OCT of RA was performed immediately after the index PCI. OCT was repeated 9 months later. RESULTS: There were 11 patients with RA injuries (11.0%) at baseline, including 3 patients with RA medial dissection and 8 patients with intimal tears. In the follow-up OCT data, the number of RA injuries was 10 (10.0%), including 7 patients with RA medial dissection and 3 patients with intimal tear. All injuries were clinically asymptomatic and there was no finding of vessel perforation. There was no significant difference between the baseline and follow-up procedure in terms of number of injuries. CONCLUSION: The study showed no significant difference between baseline and follow-up RA injury incidence. There was a higher risk of radial injury for repeated catheterization in women. The conclusion is that radial catheterization is a very safe procedure in terms of radial artery damage. This is evidenced by considerably fewer injuries compared to published studies. The use of the short radial sheath (7 cm in this study) is protective and reduces the incidence of radial injury.

The value of novel invasive hemodynamic parameters added to the TIMI risk score for short-term prognosis assessment in patients with ST segment elevation myocardial infarction.

BACKGROUND: We compared the prognostic capacity of conventional and novel invasive parameters derived from the slope of the preload recruitable stroke work relationship (PRSW) in STEMI patients and assessed their contribution to the TIMI risk score. METHODS: Left ventricular end-diastolic pressure (EDP), ejection fraction (EF), pressure adjusted maximum rate of pressure change in the left ventricle (dP/dt/P), aortic systolic pressure to EDP ratio (SBP/EDP) and end-diastolic volume adjusted stroke work (EW), derived from the slope of the PRSW relationship, were obtained during the emergency cardiac catheterization in 523 STEMI patients. The predictive power of the analyzed parameters for 30-day and 1-year mortality was evaluated using C-statistics and reclassification analysis was adopted to assess the improvement in TIMI score. RESULTS: The highest area under the curve (AUC) values for 30-day mortality were observed for EW (0.872(95% confidence interval 0.801-0.943)), SBP/EDP (0.843(0.758-0.928)) and EF (0.833(0.735-0.931)); p<0.001 for all values. For 1-year mortality the best predictive value was found for EW (0.806(0.724-0.887) and EF (0.793(0.703-0.883)); p<0.001 for both. The addition of EDP, SBP/EDP ratio and EW to TIMI score significantly increased the AUC according to De Long's test. For 30-day mortality, increased discriminative power following addition to the TIMI score was observed for EW and SBP/EDP (Integrated Discrimination Improvement was 0.086(0.033-0.140), p=0.002 and 0.078(0.028-0.128), p=0.002, respectively). CONCLUSIONS: EW and SBP/EDP are prognostic markers with high predictive value for 30-day and 1-year mortality. Both parameters, easily obtained during emergency catheterization, improve the discriminatory capacity of the TIMI score for 30-day mortality.