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.

Screening of Fabry disease in patients with an implanted permanent pacemaker.

BACKGROUND: Anderson-Fabry disease (AFD) is an X-linked inherited lysosomal disease caused by a defect in the gene encoding lysosomal enzyme α-galactosidase A (GLA). Atrio-ventricular (AV) nodal conduction defects and sinus node dysfunction are common complications of the disease. It is not fully elucidated how frequently AFD is responsible for acquired AV block or sinus node dysfunction and if some AFD patients could manifest primarily with spontaneous bradycardia in general population. The purpose of study was to evaluate the prevalence of AFD in male patients with implanted permanent pacemaker (PM). METHODS: The prospective multicentric screening in consecutive male patients between 35 and 65 years with implanted PM for acquired third- or second- degree type 2 AV block or symptomatic second- degree type 1 AV block or sinus node dysfunction was performed. RESULTS: A total of 484 patients (mean age 54 ± 12 years at time of PM implantation) were enrolled to the screening in 12 local sites in Czech Republic. Out of all patients, negative result was found in 481 (99%) subjects. In 3 cases, a GLA variant was found, classified as benign: p.Asp313Tyr, p.D313Y). Pathogenic GLA variants (classical or non-classical form) or variants of unclear significance were not detected. CONCLUSION: The prevalence of pathogenic variants causing AFD in a general population sample with implanted permanent PM for AV conduction defects or sinus node dysfunction seems to be low. Our findings do not advocate a routine screening for AFD in all adult males with clinically significant bradycardia.

Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in patients with dilated cardiomyopathy and heart failure without late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) high-risk markers - CRT-REALITY study - Study design and rationale.

BACKGROUND: Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to advances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients. METHODS: Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation. DISCUSSION: If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. CLINICALTRIALS: gov, NCT04139460.

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).

Simple electrophysiological predictor of QRS change induced by cardiac resynchronization therapy: A novel marker of complete left bundle branch block.

BACKGROUND: QRS complex shortening by cardiac resynchronization therapy (CRT) has been associated with improved outcomes. OBJECTIVE: We hypothesized that the absence of QRS duration (QRSd) prolongation by right ventricular mid-septal pacing (RVP) may indicate complete left bundle branch block (cLBBB). METHODS: We prospectively collected 12-lead surface electrocardiograms (ECGs) and intracardiac electrograms during CRT implant procedures. Digital recordings were edited and manually measured. The outcome measure was a change in QRSd induced by CRT (delta CRT). Several outcome predictors were investigated: native QRSd, cLBBB (by using Strauss criteria), interval between the onset of the QRS complex and the local left ventricular electrogram (Q-LV), and a newly proposed index defined by the difference between RVP and native QRSd (delta RVP). RESULTS: One hundred thirty-three consecutive patients were included in the study. Delta RVP was 27 ± 25 ms, and delta CRT was -14 ± 28 ms. Delta CRT correlated with native QRSd (r = -0.65), with the presence of ECG-based cLBBB (r = -0.40), with Q-LV (r = -0.68), and with delta RVP (r = 0.72) (P < .00001 for all correlations). In multivariable analysis, delta CRT was most strongly associated with delta RVP (P < .00001), followed by native QRSd and Q-LV, while ECG-based cLBBB became a nonsignificant factor. CONCLUSION: Baseline QRSd, delta RVP, and LV electrical lead position (Q-LV) represent strong independent predictors of ECG response to CRT. The absence of QRSd prolongation by RVP may serve as an alternative and more specific marker of cLBBB. Delta RVP correlates strongly with the CRT effect on QRSd and outperforms the predictive value of ECG-based cLBBB.

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).

The variability of automated QRS duration measurement.

AIMS: Previous studies have demonstrated substantial variability in manual assessment of QRS complex duration (QRSd). Disagreements in QRSd measurements were also found in several automated algorithms tested on digitized electrocardiogram (ECG) recordings. The aim of our study was to investigate the variability of automated QRSd measurements performed by two commercially available electrocardiographs. METHODS AND RESULTS: Two GE MAC 5000 (GE-1 and GE-2) electrocardiographs and two Mortara ELI 350 (Mortara-1 and Mortara-2) electrocardiographs were used in the study. Participants for the study were recruited from patients hospitalized in the department of cardiology of a university hospital. Participants underwent up to four recording sessions within a single day with a different electrocardiograph at each session when two to four immediately successive ECG recordings were undertaken. In 76 patients, 683 ECGs were recorded; the mean QRSd was 109.0 ± 26.1 ms. The QRSd difference ≥10 ms between the first and second intra-session ECG was found in 7, 3, 20, and 14% of ECG pairs for GE-1, GE-2, Mortara-1, and Mortara-2, respectively. No inter-session difference in QRSd was found within both manufacturers. In individual patients, Mortara calculated the mean QRSd to be longer by 7.3 ms (95% CI: 6.2-8.5 ms, P < 0.0001) with a 2.1-times (95% CI: 1.9-2.4) greater standard deviation of the mean QRSd (7.1 vs. 3.3 ms, P < 0.001). CONCLUSION: Electrocardiographs from two manufacturers measured QRSd values with a systematic difference and a significantly different level of precision. This may have important clinical implications in selection of suitable candidates for cardiac resynchronization therapy.

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.

Assessment of optimal right ventricular pacing site using invasive measurement of left ventricular systolic and diastolic function.

AIMS: Right ventricular apical pacing has a detrimental effect on left ventricular (LV) function. More optimal pacing site may be found by invasive measurement of LV mechanical performance during pacing from different RV pacing sites. We aimed to investigate the effect of RV pacing lead location on invasive indices of LV mechanical performance. METHODS AND RESULTS: Patients undergoing catheter ablation for persistent atrial fibrillation were enrolled. Single-site endocardial pacing from the lateral LV region was periodically switched to pacing from the mapping catheter navigated to different RV sites within the three-dimensional electroanatomical RV map. SystIndex, DiastIndex, and PPIndex were defined as the ratio of LV dP/dtmax, LV dP/dtmin, and arterial pulse pressure during RV pacing to corresponding values from adjacent periods of LV pacing. Haemodynamic data were analysed in 18 RV segments created by dividing RV horizontally (basal, mid, and apical portion), vertically (inferior, mid, and superior portion) and frontally (septum and free wall). Eight patients (58 ± 7 years; 2 females; 26 ± 4 RV pacing sites per patient) were enrolled into the study. Compared with LV pacing, the best RV pacing values of SystIndex and DiastIndex were achieved in basal-mid-septal segment (+6.9%, P = 0.02 and +3.4%, P = 0.36, respectively) while the best PPIndex was obtained in superior-mid-septal segment of RV (+4.5%, P = 0.02). All indices were fairly concordant showing significant improvement of haemodynamics during RV pacing in the direction from free wall to septum, from apex to base, and from inferior to superior segments. CONCLUSION: The best LV mechanical performance was achieved by RV septal pacing in the non-apical mid-to-superior segments.

Small left atrium and mild mitral regurgitation predict super-response to cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) can result in profound reverse remodelling. The goal of this study was to identify factors predictive of such beneficial response. METHODS AND RESULTS: Super-response to CRT was defined as normalization or near normalization of left ventricular systolic function without recognized reversible causes of heart failure. In a retrospective study, we compared baseline demographic, electrocardiogram, and echocardiographic characteristics of super-responders (n = 21) with a population of unselected consecutive cardiac CRT patients (Control 1, n = 330) and another sex-, age-, and aetiology-matched control group (Control 2, n = 43). Compared with Control 1, super-responders had significantly smaller left ventricular end-diastolic diameter (65.4 ± 6.4 vs. 73.4 ± 9.3 mm, P = 0.0001), higher ejection fraction (0.25 ± 0.05 vs. 0.22 ± 0.04, P = 0.004), smaller degree of mitral regurgitation (MR; mean value 1.9 ± 0.9 vs. 2.6 ± 0.8, P = <0.0001), and smaller left atrium (LA; 42.8 ± 4.6 vs. 50.0 ± 6.5 mm, P < 0.0001). Septal flash and inter-ventricular mechanical dyssynchrony were both more frequent among super-responders than in Control 2 subjects (93.8 vs. 69.8%; P = 0.01, and 93.8 vs. 62.8%; P = 0.01, respectively). In a multivariate analysis, smaller LA diameter and milder MR remained independent predictors of super-response. CONCLUSION: Super-response to cardiac CRT was associated with less advanced left-sided structural involvement as described by echocardiography. In particular, smaller LA and milder MR were independent predictors of pronounced reverse remodelling.

The hemodynamic effect of right ventricle (RV), RT3DE targeted left ventricle (LV) and biventricular (BIV) pacing in the early postoperative period after cardiac surgery.

BACKGROUND: Congestive heart failure negatively impacts the prognosis in patients after cardiac surgery. The aim of our study was to assess the value of targeted cardiac resynchronization therapy (CRT) within 72 hours after cardiac surgery in patients with mechanical dyssynchrony, who had an ejection fraction ≤ 35%, QRS ≥150 ms or between 120 and 150 ms. METHODS: A prospective randomized trial based on three-dimensional echocardiography (RT3DE) and optimized sequential dual-chamber (DDD ) pacing in patients after cardiac surgery. DDD epicardial pacing (Medtronic coaxial epicardial leads 6495) was provided by a modified Medtronic INSYNC III Pacemaker (Medtronic Inc., Minneapolis, MN, USA). SUMMARY OF RESULTS: The study included 21 patients with ischemic heart disease (HD) or valvular HD (16 men, 5 women, average age 69 years) with left ventricle (LV) dysfunction after cardiac surgery . Patients with biventricular (BIV) (CO 6.7 ± 1.7 L/min, CI 3.5 ± 0.8 L/min/m(2) ) and LV (CO 6.2 ± 1.5 L/min, CI 3.2 ± 0.7 L/min/m(2) ) pacing had statistically significantly higher CO and CI than patients with right ventricular (RV) (CO 5.4 ± 1.4 L/min, CI 2.8 ± 0.6 L/min/m(2) ) pacing (BIV vs RV P ≤ 0.001; LV vs RV P ≤ 0.05; BIV vs LV P ≤ 0.05). CONCLUSIONS: RT3DE targeted and optimized CRT in the early postperative period after cardiac surgery provided better hemodynamic results than RV pacing.

Catheter ablation of electrical storm in patients with structural heart disease.

AIMS: Electrical storm (ES) adversely affects prognosis of patients and may become a life-threatening event. Catheter ablation (CA) has been proposed for the treatment of ES. Our goal was to evaluate the efficacy of CA ablation both in acute and long-term suppression of ES. METHODS AND RESULTS: Fifty consecutive patients with coronary artery disease (38), idiopathic dilated cardiomyopathy (5), arrhythmogenic right ventricular cardiomyopathy (6), and/or with combined aetiology (1) underwent CA for ES. Mean left ventricular ejection fraction (LVEF) was 29 ± 11%. All patients underwent electroanatomical mapping, and CA was performed to abolish all inducible ventricular arrhythmias. The ES was suppressed by CA in 84% of patients. During the follow-up of 18 ± 16 months, 24 patients had no recurrences of any ventricular tachycardia (VT; 48%). Repeated procedure was necessary to suppress the recurrent ES in 13 cases (26%). Statistical analysis revealed that low LVEF (22 ± 3 vs. 31 ± 12%; P < 0.001), increased LVend-diastolic diameter (72 ± 9.1 vs. 64 ± 8.9 mm; P = 0.0135), and renal insufficiency (P < 0.001) were the univariate predictors of early mortality or necessity for heart transplantation. Recurrence of ES despite previous CA procedure was associated with a higher risk of death or heart transplant during follow-up (P < 0.05). CONCLUSION: Catheter ablation is effective in acute suppression of ES and often represents a life-saving therapy. In the long term, it prevents recurrences of any VT in about half of the treated patients.

Catheter ablation of arrhythmic storm triggered by monomorphic ectopic beats in patients with coronary artery disease.

BACKGROUND: Frequent episodes of polymorphic ventricular tachycardias/ventricular fibrillation (VT/VF) in patients with coronary artery disease can be triggered by monomorphic ventricular premature beats (VPBs) and thus, amenable to catheter ablation. The goal of this study was to review single-center experience in catheter ablation of electrical storm caused by focally triggered polymorphic VT/VF. METHODS: Catheter ablation of electrical storm due to focally triggered polymorphic VT/VF was performed in nine patients (mean age, 62+/-7 years; two females). All patients had previous myocardial infarction (interval of 3 days to 171 months). Mean left ventricular ejection fraction was 27+/-6 percent. All patients presented with repeated runs of polymorphic VT/VF triggered by monomorphic VPBs. RESULTS: Based on mapping data, the ectopic beats originated from scar border zone on interventricular septum (n=5), inferior wall (n=3), and lateral wall (n=1). Catheter ablation was performed to abolish the triggering ectopy and to modify the arrhythmogenic substrate by linear lesions within the infarct border zone. The ablation procedure was acutely successful in eight out of nine patients. During the follow-up of 13+/-7 months, two patients died due to progressive heart failure. One patient had late recurrence of electrical storm due to ectopic beats of different morphology and was successfully reablated. CONCLUSION: Electrical storm due to focally triggered polymorphic VT/VF may occur either in subacute phase of myocardial infarction or substantially later after index event. Catheter ablation of ectopic beats triggering these arrhythmias can successfully abolish electrical storm and become a life-saving procedure.

Life-threatening arrhythmia caused by primary aldosteronism.

BACKGROUND: Arrhythmias are one of the typical complications of primary aldosteronism (PA), is commonly characterized by hypertension and hypokalemia. CASE REPORT: In this report, we present 3 cases of subjects in whom primary aldosteronism manifested with life-threatening arrhythmias. In 2 subjects, after excluding organic heart disease, an implantable cardioverter defibrillator was inserted and, only after the second episode of polymorphic ventricular tachycardia accompanied with low plasma potassium levels, the diagnosis of primary aldosteronism was made. CONCLUSIONS: It is important to include diagnosis of primary aldosteronism in the diagnostic work-up of hypertensive subjects without any structural cardiovascular impairment who present with malignant arrhythmia and hypokalemia. Appropriate treatment of primary aldosteronism may avoid insertion of an implantable cardioverter defibrillator.

The relationship between right ventricular pacing voltage and QRS complex duration.

Compared to the natural electrical activation of the myocardium through the His-Purkinje system, right ventricular pacing is associated with prolonged QRS complex duration, thereby impeding the synchronicity of contractions. In left ventricular pacing, a higher pacing voltage decreases the QRS complex duration. The aim of our study was to describe the relation between the right ventricular pacing voltage and the QRS complex duration. Fourteen patients (73.6 +/- 7.6 years) with AV block and implanted pacemakers were paced at a frequency of 100 bpm with various pacing voltages. A signal-averaged QRS vector length was calculated at each degree of pacing voltage. The changes in the QRS complex duration were measured as a relative shift of the terminal region of the vectorcardiographic QRS complex (end-shift) and its most prominent peak (peak-shift) using the cross-correlation method. The nonlinear relationship between stimulation voltage and QRS duration was observed with the highest impact of stimulation voltage changes near the threshold value. The fourfold increase in the stimulation voltage above the threshold caused QRS complex shortening by 3.7 +/- 2.1 ms (range 0.19-7.76 ms). Similar peak- and end-shift responses to altered stimulation energy demonstrated that the acceleration of depolarization occurred in the initial portion of the QRS complex. Older electrodes exhibited smaller and more linear changes in the QRS complex duration.

Optimization of right ventricular lead position in cardiac resynchronisation therapy.

BACKGROUND: The benefit of biventricular pacing (BiV) may be substantially affected by optimal lead placement. AIM: To evaluate the importance of right ventricular (RV) lead positioning on clinical outcome of BiV. METHODS AND RESULTS: A total of 99 patients with symptomatic heart failure and implantation of BiV system were included. Position of the left-ventricular (LV) lead was selected based on timing of local endocardial signal within the terminal portion of the QRS complex. RV lead was preferably positioned at the midseptum (n=74, RVS group) where the earliest RV endocardial signal was recorded. A subgroup of patients had RV lead placed in the apex (n=25, RVA group). NYHA class, maximum oxygen-uptake (VO(2)max), LV end-diastolic diameter (LVEDD, mm) and ejection fraction were assessed every third month. A trend towards greater improvement in NYHA class and significant increase in VO(2)max was present in the RVS group. Moreover, a significant decrease in LVEDD (DeltaLVEDD) was observed in the RVS group only (-3.4+/-6.5 mm versus +1.7+/-6.4 mm in RVA group at 12 months, p=0.004). No significant correlation between the degree of DeltaLVEDD and QRS narrowing induced by BiV was found. LVEDD reduction was predominantly present in dilated cardiomyopathy. CONCLUSIONS: Midseptal positioning of the RV lead appears to promote reverse LV remodelling during cardiac resynchronisation therapy.

Surgical ablation of post-infarction ventricular tachycardia guided by mapping in sinus rhythm: long term results.

OBJECTIVE: Some patients after myocardial infarction have an increased risk of malignant ventricular tachyarrhythmias (VTA) or sudden cardiac death. The aim of the study was to evaluate long-term results of surgical ablation of an arrhythmogenic substrate guided by simplified intraoperative mapping of pathological ventricular electrograms during sinus rhythm. METHODS: The study population consisted of 77 patients (9 women; mean age 62.4+/-8.5 years) with previous Q-wave myocardial infarction and at least one documented episode of sustained VT/VF more than one month after the last infarction. The left ventricular ejection fraction was 31.3+/-8.8%. All but eight patients had clinical indication for concomitant coronary artery bypass surgery. All underwent preoperative electrophysiologic study. Intraoperative epicardial and endocardial mapping during sinus rhythm was performed using a multielectrode with 16 bipolar electrodes in combination with a multichannel recording system. Myocardial regions revealing fractionated, low amplitude signals lasting > or =130 ms were surgically excised or cryoablated. All surviving patients were restudied within one to two weeks after surgery using identical programmed electrical stimulation protocol. RESULTS: Five (6.5%) patients died in the perioperative (30-days) period. In the remaining cohort, inducibility of any sustained VTA after surgical procedure was observed in 21 subjects (29.2%). An implantable cardioverter-defibrillator (ICD) was implanted in these patients. Recurrence of sustained VTA was documented during follow-up period in two patients who were noninducible after the surgery (at the month 10 and 22, respectively), and both received ICD as well. No patient died of sudden cardiac death. In 14 ICD patients, no significant VTA was documented during the mean follow-up of 37.3+/-23.2 months. Altogether, 61 from the 72 patients surviving the surgery (84.7%) remained free of spontaneous recurrences of VTA during the follow-up. CONCLUSIONS: Surgical ablation of an arrhythmogenic substrate guided by simplified intraoperative mapping in normothermic heart during sinus rhythm appears to be both safe and efficacious procedure that prevents recurrences of VTA in a substantial proportion of patients.

Technical aspects of implantation of LV lead for cardiac resynchronization therapy in chronic heart failure.

The goal of this study was to analyze total procedural and fluoroscopic time during initial experience with implantation of LV lead in a single center, and to assess the performance of electrophysiologically-guided approach for cannulation of the coronary sinus (CS) in a subsequent period. Over an initial period of 29 months, a total of 46 attempts to implant biventricular pacing system were revised. During the first phase, only one type of LV electrode was available for three implanters (11 attempts). The second phase covered their early experience with other stylet-controlled LV leads (10 attempts). Additional LV leads including the over-the-wire design were available in the third phase and 25 attempts were done by he most experienced implanter. In a period of advanced experience, 92 implant procedures performed by four implanters using an electrophysiologically-guided approach to CS cannulation were revised. In the first period, success rates for different phases reached 70%, 90%, and 96%, respectively. Significant decrease in both procedural and fluoroscopic times was achieved with increased experience (Phase I: 247.1 +/- 104.5 minutes and 31.2 +/- 34.3 minutes, Phase II: 219.4 +/- 85.6 minutes, and 22.9 +/- 19.1 minutes, Phase III: 116.4 +/- 89.9 minutes and 6.6 +/- 4.4 minutes, respectively, P < 0.05). Advanced experience with electrophysiologically-guided approach to CS cannulation allowed achievement of this target within a reasonable amount of time (15.4 +/- 16.3 minutes) and with minimum fluoroscopic time (2.1 +/- 2.9 minutes). In conclusion, both individual learning curve and technical advances significantly influence success rate, procedural, and fluoroscopic times for biventricular system implantation. Electrophysiologically-guided approach makes cannulation of the CS a highly reproducible procedure that requires minimum fluoroscopic time.

Catheter ablation of ventricular tachycardia following myocardial infarction using three-dimensional electroanatomical mapping.

One challenge encountered during catheter ablation of postinfarction ventricular tachycardia (VT) is the inducibility of multiple VT morphologies associated with variable hemodynamic instability. The clinical usefulness and safety of a three-dimensional electroanatomical mapping in guiding radiofrequency (RF) catheter ablation of VT, used in parallel with a multichannel recording system, was studied in 28 men (mean age = 63.8 +/- 10.6 years, mean left ventricular ejection fraction = 28% +/- 9%). Three-dimensional voltage maps of the left ventricle were obtained in sinus rhythm with annotation of areas of fractionated or late potentials, zones of slow conduction and/or dense scar with no pacing capture at 10 mA. RF lesions were created either in sinus rhythm or during hemodynamically stable VT within reconstructed critical zones of the circuit. A total of 82 VTs were induced (mean = 2.9 +/- 1.0/patient). Hemodynamically unstable clinical VTs were induced in 5 patients, and clinical or nonclinical unstable VT in 14. Clinical VT was rendered noninducible in 24/28 (85.7%) patients, and monomorphic VT was eliminated in 16/28 (57.1%) patients. The mean procedural time was 258 +/- 82 minutes, and fluoroscopic exposure 13.5 +/- 8.8 minutes. During a mean follow-up period of 10.6 +/- 6.4 months, catheter ablation was repeated in 6 patients for VT recurrences. No significant complications occurred except for a transient cerebral ischemic attack in one patient. In conclusion, electroanatomical mapping assisted the successful and safe catheter ablation of both mappable and nonmappable VTs in a significant proportion of patients after myocardial infarction.