Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study.

BACKGROUND: The oral anticoagulant dabigatran offers an effective alternative to vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), yet patient preference data are limited. The prospective observational RE-SONANCE study demonstrated that patients with AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy. This pre-specified sub-study aimed to assess the impact of country and age on patients' perceptions of dabigatran or VKA therapy in AF. METHODS: RE-SONANCE was an observational, prospective, multi-national study (NCT02684981) that assessed treatment satisfaction and convenience in patients switching from VKAs to dabigatran (Cohort A), or newly diagnosed with AF receiving dabigatran or VKAs (Cohort B), using the PACT-Q questionnaire. Pre-specified exploratory outcomes: variation in PACT-Q2 scores by country and age (< 65, 65 to < 75, ≥ 75 years) (both cohorts); variation in PACT-Q1 responses at baseline by country and age (Cohort B). RESULTS: Patients from 12 countries (Europe/Israel) were enrolled in Cohort A (n = 4103) or B (n = 5369). In Cohort A, mean (standard deviation) PACT-Q2 score increase was highest in Romania (convenience: 29.6 [23.6]) and Hungary (satisfaction: 26.0 [21.4]) (p < 0.001). In Cohort B, mean (standard error) increase in PACT-Q2 scores between dabigatran and VKAs was highest in Romania (visit 3: 29.0 [1.3]; 24.5 [0.9], p < 0.001). Mean PACT-Q2 score increase by age (all p < 0.001) was similar across ages. PACT-Q1 responses revealed lowest expectations of treatment success in Romania and greatest concerns about payment in Estonia, Latvia, and Romania, but were similar across ages. CONCLUSIONS: Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe. TRIAL AND CLINICAL REGISTRY: Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.

Patient perception of anticoagulant treatment for stroke prevention (RE-SONANCE study).

Objective: We evaluated atrial fibrillation (AF) patients' perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications. Methods: The RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30-45 and 150-210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3. Results: The main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (p<0.001 for all) for treatment convenience (mean change V1 vs V2=20.72; SD=21.50; V1 vs V3=24.54; SD=22.85) and treatment satisfaction (mean change V1 vs V2=17.60; SD=18.76; V1 vs V3=21.04; SD=20.24). In cohort B, mean PACT-Q2 scores at V2 and V3 were significantly higher (p<0.001 for all) for dabigatran versus a VKA for treatment convenience (V2=18.38; SE =0.51; V3=23.34; SE=0.51) and satisfaction (V2=15.88; SE=0.39; V3=19.01; SE=0.41). Conclusions: Switching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.

Impact of percutaneous patent foramen ovale closure on migraine headaches in patients with history of ischemic neurological events.

INTRODUCTION: Observational studies have shown that migraine has been associated with patent foramen ovale (PFO). Whilst studies investigating PFO closure for the treatment of migraine have been neutral, there is some evidence that symptoms of migraine may improve if the PFO was closed after ischemic stroke. AIM: To establish whether closure of PFO in patients with stroke or transient ischemic attack (TIA) is associated with reduction in the severity of co-existent migraine headaches. MATERIAL AND METHODS: Patients with ischemic stroke or TIA, PFO suitable for percutaneous closure and migraine, were given migraine severity questionnaires prior to PFO closure. These were followed up at 6 and 12 months after closure with the same questionnaire. The primary endpoint was change in migraine severity using the Migraine Severity Scale (MIGSEV). Migraine episode frequency, disability (using the MIDAS scale), and pain intensity were also assessed. RESULTS: Sixty-two patients were included in the analysis. MIGSEV scores reduced from 7 (7-8) at baseline to 4 (3.25-6) at 6-month follow-up, and 3 (0-4) at 12-month follow-up (p < 0.001). Other measures of migraine headache were also improved at both 6- and 12-month follow-up. Twenty-four (38%) patients were rendered migraine free at 12 months. CONCLUSIONS: PFO closure for stroke or TIA prevention in patients with migraine was associated with a reduction in markers of migraine headache severity.

Early stage of atherosclerosis in aortocoronary saphenous vein grafts: intravascular ultrasound study

Abstract Introduction: Angiographically visible plaques in patent vein grafts are usually detected years after surgery. Our aim was to examine early plaque formation in vein grafts. Methods: Bypass angiography and intravascular ultrasonography (IVUS) examination were performed on 77 aortocoronary saphenous vein grafts (SVGs) implanted in 36 patients during the first 2 years after CABG. In each graft, a good quality 25 mm ultrasound image was analyzed. We measured: plaque area, lumen area, external elastic membrane (EEM) area, graft area and wall area. For the comparative assessment of SVGs, the index plaque area/EEM area was calculated. Data were analyzed for the following 4 time periods: I - 0-4 months (22 grafts), II - 5-8 months (23 grafts), III - 9-12 months (19 grafts) and IV - 13-16 months (13 grafts) after CABG. Student's t and Fisher-Snedecor tests were used for the purpose of statistical analysis in this retrospective study. Results: In period I, plaque formation (neointimal) was observed in 10 grafts (45%), with a mean plaque area of 1.59 mm., in 6 grafts (26%) in period II, with a mean plaque area of 1.03 mm. and in 15 grafts (71%) in period III, with a mean plaque area of 1.41 mm., and in all (100%) grafts in period IV, with mean plaque area of 2,3 mm.. Average index plaque area/EEM area in periods I, II, III and IV were 0.12, 0.08, 0.13 and 0.22. We have showed a significant plaque increase between periods II and IV(P=0.038). Conclusion: IVUS showed plaque in about 40% of venous grafts during the first year after CABG. Between 13-16 months plaque was visible in all studied grafts.

Early Stage of Atherosclerosis in Aortocoronary Saphenous Vein Grafts: Intravascular Ultrasound Study.

INTRODUCTION: Angiographically visible plaques in patent vein grafts are usually detected years after surgery. Our aim was to examine early plaque formation in vein grafts. METHODS: Bypass angiography and intravascular ultrasonography (IVUS) examination were performed on 77 aortocoronary saphenous vein grafts (SVGs) implanted in 36 patients during the first 2 years after CABG. In each graft, a good quality 25 mm ultrasound image was analyzed. We measured: plaque area, lumen area, external elastic membrane (EEM) area, graft area and wall area. For the comparative assessment of SVGs, the index plaque area/EEM area was calculated. Data were analyzed for the following 4 time periods: I - 0-4 months (22 grafts), II - 5-8 months (23 grafts), III - 9-12 months (19 grafts) and IV - 13-16 months (13 grafts) after CABG. Student's t and Fisher-Snedecor tests were used for the purpose of statistical analysis in this retrospective study. RESULTS: In period I, plaque formation (neointimal) was observed in 10 grafts (45%), with a mean plaque area of 1.59 mm., in 6 grafts (26%) in period II, with a mean plaque area of 1.03 mm. and in 15 grafts (71%) in period III, with a mean plaque area of 1.41 mm., and in all (100%) grafts in period IV, with mean plaque area of 2,3 mm.. Average index plaque area/EEM area in periods I, II, III and IV were 0.12, 0.08, 0.13 and 0.22. We have showed a significant plaque increase between periods II and IV(P=0.038). CONCLUSION: IVUS showed plaque in about 40% of venous grafts during the first year after CABG. Between 13-16 months plaque was visible in all studied grafts.

Risk factors and prognostic role of an electrical storm in patients after myocardial infarction with an implanted ICD for secondary prevention.

INTRODUCTION: The aim of our study was to determine the risk factors for electrical storm (ES) and to assess the impact of ES on the long-term prognosis in patients after myocardial infarction (MI) with an implantable cardioverter-defibrillator (ICD) for secondary prevention of sudden cardiac death (SCD). MATERIAL AND METHODS: We retrospectively analyzed 416 patients with coronary artery disease after MI who had an implanted ICD for secondary prevention of SCD. Fifty (12%) patients had one or more incidents of an electrical storm - the ES (+) group. We matched the reference group of 47 patients from 366 ES (-) patients. RESULTS: We analyzed 3,408 episodes of ventricular arrhythmias: 3,148 ventricular tachyarrhythmic episodes in the ES (+) group (including 187 episodes of ES) and 260 in the ES (-) group. Multivariate logistic regression showed that inferior wall MI (RR = 3.98, 95% CI: 1.52-10.41) and the absence of coronary revascularization (RR = 2.92, 95% CI: 1.18-7.21) were independent predictors of ES (p = 0.0014). During 6-year observation of 97 patients, there were 39 (40%) deaths: 25 (50%) subjects in the ES (+) group and 14 (30%) in the ES (-) group (p = 0.036). Independent predictors of death were: the occurrence of ES (HR = 1.93), older age (HR = 1.06), and lower left ventricular ejection fraction (HR = 0.95) (for all p < 0.001). CONCLUSIONS: Electrical storm in patients after MI with ICD for secondary prevention is a relatively common phenomenon and has a negative prognostic significance. Myocardial infarction of the inferior wall and the absence of coronary revascularization are predisposing factors for the occurrence of an ES.

Andersen-Tawil syndrome: Clinical presentation and predictors of symptomatic arrhythmias - Possible role of polymorphisms K897T in KCNH2 and H558R in SCN5A gene.

BACKGROUND: Andersen-Tawil syndrome (ATS) is rare channelopathy caused by KCNJ2 mutation and probably KCNJ5. It is characterized by arrhythmias, neurological symptoms, and dysmorphic features. The present study retrospectively examined the characteristics of 11 unrelated families with ATS. METHODS: This study consisted of 11 probands positive for KCNJ2 variants and 33 family members (mean age 30.0±17.3 years, female n=31). Additional genetic screening of 3 LQTS genes (KCNQ1, KCNH2, SCN5A) was performed in 9 families. Predictors of arrhythmias [premature ventricular beats>2000/24h, biventricular and polymorphic ventricular tachycardia (VT)], syncope, and/or cardiac arrest (CA) were evaluated. RESULTS: In KCNJ2 mutation carriers vs non-carriers (n=25 vs n=19) significant differences were observed in U-wave manifestations in V2-V4, Tpeak-Tend duration, QTUc duration (p<0.0001), dysmorphic features, and neurological symptoms. Compared to asymptomatic carriers (n=9), in those with arrhythmias and/or syncope and/or CA (n=16) micrognathia (p=0.004), periodic paralysis (p=0.019), palpitation (p=0.005), U-wave n V2-V4 (p=0.049) were more frequent; QTU (p=0.045) and Tpeak-Tend (p=0.014) were also longer (n=9). In the subgroup of carriers with syncope and/or cardiac arrest (n=10, 90% women), K897T-KCNH2 polymorphism (p=0.02), periodic paralysis (p=0.004), muscle weakness (p=0.04), palpitations (p=0.04), arrhythmias (biventricular VT, p=0.003; polymorphic VT, p=0.009) were observed more frequently. Tpeak-Tend duration was longer (p=0.007) and the percentage of patients with premature ventricular contraction >2000/24h was higher (p=0.005). CONCLUSION: A higher risk of arrhythmia, syncope, and/or CA is associated with the presence of micrognathia, periodic paralysis, and prolonged Tpeak-Tend time. Our findings suggest that K897T may contribute to the occurrence of syncope.

Neointima development in externally stented saphenous vein grafts.

INTRODUCTION: The main limitation of coronary artery bypass grafting (CABG) is rapid neointimal hyperplasia leading to graft failure. AIM: To assess plaque formation in saphenous vein grafts (SVG) covered by an external Dacron stent in comparison with the classical technique. MATERIAL AND METHODS: In the study group vein grafts covered by external stent mesh made of Dacron were implanted. An intravascular ultrasonography (IVUS) study was performed in 35 aorto-coronary SVG covered by an external Dacron stent and in 64 normal SVG during the first year after CABG. In each SVG 25 mm of good quality IVUS image, volumes of lumen, plaque (neointima), outer border of the vein graft (external SVG) and adventitia were calculated in three time periods: 0-130 days, 130-260 days and 260-390 days. RESULTS: Between the first and second time period, lumen volume (mm3) was reduced from 10.33 ±4.4, to 6.80 ±2.23 in the second period and 5.69 ±1.26 in the third one. This effect was much less marked in normal grafts. The corresponding lumen volume (mm3) was: 10.90 ±3.9, 9.15 ±2.94 and 8.92 ±2.93 in consecutive time periods. Plaque volume (mm3) did not change in control grafts during the course of the study, but it increased very significantly in stented grafts from 0.86 ±1.24 in the first period to 2.70 ±1.58 in the second and 3.29 ±2.66 in the third one. CONCLUSIONS: The experimental technique of implanting SVG covered with an external elastic Dacron stent seems to be inferior to traditional ones. This is probably due to the more complicated process of vein implantation and higher micro-injury occurrence during the surgery.

Patients with atrial fibrillation and low risk of stroke: do they really need anticoagulation?

Atrial fibrillation (AF) significantly increases the risk of thromboembolic events, in particular the risk of stroke. Anticoagulation therapy has been shown to reduce this risk; therefore, the treatment should be lifelong. However, the risk in patients with nonvalvular AF is not equally distributed, and there is a population of patients at low risk. According to the current guidelines, the decision on the need of anticoagulation is primarily dependent on whether the patient is at low risk. The CHA2DS2-VASc is currently the most commonly recommended scheme for assessing thromboembolic risk in patients with nonvalvular AF. In a large group of nontreated patients with a CHA2DS2-VASc of 0 (1 in women), the annual risk of stroke was 0.49%; ischemic stroke, 0.43%; bleeding, 1.08%; intracranial bleeding, 0.15%; and death, 3.87%. In patients on warfarin, the frequency of ischemic stroke was similar. Patients with a CHA2DS2-VASc of 0 (1 in women) are low-risk patients who do not benefit from anticoagulation. The low-risk group is also defined as patients younger than 65 years of age without structural cardiovascular disease, regardless of sex. They represent from 6% to 10% of patients with nonvalvular AF. Thromboembolic risk in patients with a score of 1 (2 in women) is much more controversial, as reflected by several recently published cohort studies. In a Swedish study, the risk was found to be low, while in Danish and Taiwanese studies-as significantly higher. Another analysis has shown that the use of vitamin K antagonists is appropriate when the risk of stroke is higher than 1.7%/year. Owing to a lower risk of intracranial bleeding, anticoagulation with nonvitamin K antagonist oral anticoagulants may be considered already at an annual risk of stroke exceeding 0.9%. Patients at low risk do not require chronic anticoagulation.

[Catheter ablation--when possible, whether effective? When implantable cardioverter defibrillator?]. / Ablacja--kiedy mozliwa, czy skuteczna? Kiedy kardiowerter-defibrylator serca?

There are important gender differences in cardiac electrophysiology that may affect effectiveness of cardiac arrhythmias invasive treatment. Women present to catheter ablation later, with more symptoms, and after having failed more antiarrhythmic drugs. Catheter ablation of supraventricular tachycardias and atrial fibrillation (AF), except for long lasting AF, appears equally effective in the two genders. However, female gender predicted a higher risk of complications, with vascular access complications being the most frequent events. The role of implantable cardioverter defibrillators (ICD) in women with heart failure for the primary prevention of sudden cardiac death has not been well established. Women are underrepresented in primary prevention implantable ICD trials, and data on the benefit of ICD therapy in this subgroup are controversial. Further studies are needed to define the population of women who may benefit most from ICD therapy.

[National Consultant in Cardiology Experts' Group Guidelines on dealing with patients implanted with some St. Jude Medical Riata and Riata ST leads]. / Zalecenia zespolu ekspertów Konsultanta Krajowego w dziedzinie kardiologii dotyczace postepowania z wybranymi elektrodami St. Jude Medical Riata i Riata ST.

In December 2010 St. Jude Medical informed about higher incidence of silicone insulation abrasion in implantable cardioverter-defibrillator leads Riata/Riata ST. The manifestation of this phenomenon is the externalisation of conductors outside the body of the lead, which is visible in a fluoroscopy. The abrasion could also involve an insulation under high-voltage coil and in the worst case could result in a short circuit within high voltage part of the system. The incidence of this phenomenon varies from part of to several dozen percent according to published papers and becomes higher in a longer follow-up. The highest probability of malfunction in 8 F single coil and the lowest in 7 F dual-coil leads is observed. For the needs of this guidelines all Riata/Riata ST leads were divided into: functioning, damaged but active (visible externalisation but electrically functioning), malfunctioning. In the last case the lead should be removed and a new one implanted (class of indication I) ,although only implantation of a new lead with abandoning malfunctioning one is allowed and should be considered (IIa). In patients with functioning lead extraction with a new lead implantation may be considered during elective replacement only in high risk patients (IIb). In case of damaged but active lead its extraction with the implantation of a new lead during elective replacement of the device should be considered in high risk population (IIa) and may be considered in other patients (IIb). The final decision related to Riata/Riata ST should be individualised and undertaken in co-operation with the patient after detailed assessment of the risk related to each treatment option.

Role of left atrial speckle tracking echocardiography in predicting persistent atrial fibrillation electrical cardioversion success and sinus rhythm maintenance at 6 months.

PURPOSE: We assessed the value of left atrium speckle tracking imaging (STI) indices, and clinical and other echocardiographic parameters in persistent atrial fibrillation (AF) patients to predict the efficacy of electrical cardioversion (EC) and sinus rhythm (SR) maintenance at 6 months. MATERIAL/METHODS: Eighty persistent AF patients planned to receive EC, underwent echocardiography including STI. After 24h, patients with successful EC were examined to predict SR maintenance. After 6 months patients with no AF recurrence in electrocardiogram (ECG) underwent 7-day ECG to exclude silent AF. Every AF>1 min was a recurrence. RESULTS: SR restored in 61 patients, 19 unsuccessful. Prior use of statins (68.8% vs. 42.1%, p=0.03) was the only factor, determined later by univariate analysis to be a significant EC success predictor (OR=1.09, CL ± 95% 1.001-1.019, p<0.03). Both groups received similar antiarrhythmics and had similar echocardiographic parameters. After 6 months, SR was maintained in 19 patients (31.1%, Group I); AF recurrences were registered in 42 patients (68.8%, Group II). In Group I, only the mitral valve deceleration time (MVDT) 224.18 ± 88.13 vs. 181.6 ± 60.6 in Group II, p=0.04) and the dispersion of time to peak longitudinal strain (dTPLS) (86.0 ± 68.3 vs. 151.8 ± 89.6, p=0.03) differed significantly. The univariate analysis revealed dTPLS as a significant predictor of SR maintenance. CONCLUSION: High EC efficacy and frequent AF recurrences were observed. The dispersion of time to the maximal longitudinal strain (LS) of left atrial segments facilitated prediction of SR maintenance. The value of 7-day ECG monitoring for detection of arrhythmia after 6 months was limited.

Differentiation of arrhythmia originating from the right or left ventricular outflow tract based on the QRS morphology of premature ventricular beats and duration of repolarisation.

BACKGROUND: Premature ventricular beats (PVBs) and monomorphic ventricular tachycardia originating from the right ventricular outflow tract (RVOT) are the most frequent forms of idiopathic ventricular arrhythmias, but arrhythmia originating from the left ventricular outflow tract (LVOT) may be found in about 10% of these patients. AIM: To compare electrocardiographic (ECG) patterns and duration of repolarisation after PVBs originating from the left and right superior part of the interventricular septum which were successfully treated with radiofrequency catheter ablation. METHODS: We studied 62 patients who did not receive antiarrhythmic drug treatment before ablation, including 50 patients with RVOT arrhythmia (21 males, mean age 42 ± 14 years, left ventricular ejection fraction [LVEF] 61 ± 6%) and 12 patients with LVOT arrhythmia (3 males, mean age 41 ± 17 years, LVEF 59 ± 9%). Pre-ablation 24-h Holter ECG recordings were analysed for the total number of PVBs. In addition, we evaluated ectopic beat QRS duration, prematurity index and duration of repolarisation (QT interval, JT interval and TpeakTend values uncorrected for the heart rate) based on ten random daytime PVBs during a period of stable sinus rhythm at a rate of 60-70 bpm. RESULTS: The study groups did not differ by age, LVEF, heart rate and the number of PVBs. RVOT arrhythmia was characterised by a lower prematurity index (0.59 ± 0.11 vs. 0.72 ± 0.09, p = 0.001) and a lower R/S ratio in leads V1-V3 (p < 0.01 for each lead). QRS duration of right-sided PVBs was shorter compared to that of left-sided PVBs (147 ± 13 vs. 166 ± 13 ms, p = 0.002), QT and JT intervals were similar (QT: 422 ± 32 vs. 429 ± 27 ms, p = 0.35; JT: 272 ± 27 vs. 266 ± 27 ms, p = 0.31), and TpeakTend was shorter in RVOT arrhythmia (100 ± 10 vs. 110 ± 6 ms, p = 0.01). Combination of R > S in lead V3 and TpeakTend-PVB > 110 ms identified LVOT arrhythmia with a sensitivity of 75% and specificity of 96%. CONCLUSIONS: Ventricular arrhythmias originating from the left or right superior part of the interventricular septum are not only characterised by different ECG patterns of ventricular ectopic beats but also show significant differences in the repolarisation phase.

Prediction of infarct size by speckle tracking echocardiography in patients with anterior myocardial infarction.

BACKGROUND: Speckle tracking echocardiography (STE) is based on tracing of pixel groups in grayness scale for the quantitative measurement of myocardium strain and myocardium strain rate. Recent data suggest that evaluation of STE could be a tool for myocardial function assessment similar to MRI. AIM: To assess the predictive value of STE for the evaluation of infarct size in patients with anterior ST-elevation myocardial infarction (STEMI). MATERIALS AND METHODS: We enrolled 39 patients with the first anterior wall STEMI (mean age 59±10 years, 29 men). All patients were treated with a primary percutaneous coronary intervention, and the time from the symptom onset to reperfusion was 298±195 min. Left ventricular ejection fraction assessed in three-dimensional echocardiography was 47±9%. On the day of discharge, STE was performed to determine the average global value of peak longitudinal strain (GLS) of 16 myocardial segments. The average value of the peak longitudinal strain for nine segments supplied by the left anterior descending artery anterior wall global longitudinal strain was assessed separately. Infarct size was assessed 3 months after STEMI by MRI using late gadolinium enhancement, and a large infarct was defined as at least 20% left ventricle myocardium covered by the scar. RESULTS: According to the results of MRI, we defined two groups: 22 patients with a large infarct (≥20%, group A) and 17 patients with a small infarct (<20%, group B). There were no differences between both groups in the demographics and cardiovascular risk factors. There was a significant correlation between GLS and the degree of myocardium injury assessed by MRI (r=0.62, P=0.001). The correlation was higher for anterior wall global longitudinal strain (r=0.68, P=0.001). With the receiver operating characteristic curve, the cut-off point for GLS was calculated (-12.3), which defined a large infarct with 82% sensitivity and 87% specificity (area under the curve=83). For segments supplied by the left anterior descending artery, the cut-off value for the prediction of a large infarct was -11.5 (sensitivity 90%, specificity 73%, area under the curve=84). CONCLUSION: STE seems to be a very promising tool in the prediction of infarct size in patients with anterior STEMI.