ABSTRACT
BACKGROUND: Comprehensive data on patients at high risk of sudden cardiac death (SCD) in emerging countries are lacking. The aim was to deepen our understanding of the SCD phenotype and identify risk factors for death among patients at high risk of SCD in emerging countries. METHODS: Patients who met the class I indication for implantable cardioverter-defibrillator (ICD) implantation according to guideline recommendations in 17 countries and regions underrepresented in previous trials were enrolled. Countries were stratified by the WHO regional classification. Patients were or were not implanted with an ICD at their discretion. The outcomes were all-cause mortality and SCD. RESULTS: We enrolled 4222 patients, and 3889 patients were included in the analysis. The mean follow-up period was 21.6 ± 10.2 months. There were 433 (11.1%) instances of all-cause mortality and 117 (3.0%) cases of SCD. All-cause mortality was highest in primary prevention (PP) patients from Southeast Asia and secondary prevention (SP) patients from the Middle East and Africa. The SCD rates among PP and SP patients were both highest in South Asia. Multivariate Cox regression modelling demonstrated that in addition to the independent predictors identified in previous studies, both geographic region and ICD use were associated with all-cause mortality in patients with high SCD risk. Primary prophylactic ICD implantation was associated with a 36% (HR = 0.64, 95% CI 0.531-0.802, p < 0.0001) lower all-cause mortality risk and an 80% (HR = 0.20, 95% CI = 0.116-0.343, p < 0.0001) lower SCD risk. CONCLUSIONS: There was significant heterogeneity among patients with high SCD risk in emerging countries. The influences of geographic regions on patient characteristics and outcomes were significant. Improvement in increasing ICD utilization and uptake of guideline-directed medical therapy in emerging countries is urgent. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02099721.
Subject(s)
Defibrillators, Implantable , Humans , Risk Factors , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/prevention & control , Africa , Middle EastABSTRACT
BACKGROUND: In primary prevention (PP) patients the utilization of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D) remains low in many geographies, despite the proven mortality benefit. PURPOSE: The objective of this analysis was to examine the mortality benefit in PP patients by guideline-indicated device type: ICD and CRT-D. METHODS: Improve sudden cardiac arrest was a prospective, nonrandomized, nonblinded multicenter trial that enrolled patients from regions where ICD utilization is low. PP patient's CRT-D or ICD eligibility was based upon the 2008 ACC/AHA/HRS and 2006 ESC guidelines. Mortality was assessed according to guideline-indicated device type comparing implanted and nonimplanted patients. Cox proportional hazards methods were used, adjusting for known factors affecting mortality risk. RESULTS: Among 2618 PP patients followed for a mean of 20.8 ± 10.8 months, 1073 were indicated for a CRT-D, and 1545 were indicated for an ICD. PP CRT-D-indicated patients who received CRT-D therapy had a 58% risk reduction in mortality compared with those without implant (adjusted hazard ratio [HR]: 0.42, 95% confidence interval [CI]: 0.28-0.61, p < .0001). PP patients with an ICD indication had a 43% risk reduction in mortality with an ICD implant compared with no implant (adjusted HR: 0.57, 95% CI: 0.41-0.81, p = .002). CONCLUSIONS: This analysis confirms the mortality benefit of adherence to guideline-indicated implantable defibrillation therapy for PP patients in geographies where ICD therapy was underutilized. These results affirm that medical practice should follow clinical guidelines when choosing therapy for PP patients who meet the respective defibrillator device implant indication.
Subject(s)
Cardiac Resynchronization Therapy , Defibrillators, Implantable , Heart Failure , Cardiac Resynchronization Therapy Devices , Heart Failure/diagnosis , Heart Failure/therapy , Humans , Primary Prevention , Prospective Studies , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: Steroid-eluting (SE) electrodes suppress local inflammation and lower pacing capture thresholds (PCT); however, their effectiveness on quadripolar left ventricular (LV) leads in the cardiac vein is not fully studied. We evaluated the effectiveness of SE on all four LV pacing electrodes in human subjects enrolled in the Medtronic Attain® Performa™ quadripolar LV lead study. METHODS: A total of 1,097 subjects were included in this evaluation. At each follow-up visit (1, 3, 6, and 12 months), LV PCT and pacing impedance were measured using either manual or automated testing methods. Summary statistics for PCT and impedance values were obtained for implant and each scheduled follow-up visit for all lead models. RESULTS: Average extended bipolar (LV electrode to right ventricular Coil) PCTs for the four LV SE pacing electrodes (LV1, LV2, LV3, and LV4) on the three shapes of the quadripolar LV leads were 1.06 ± 0.97 V, 1.38 ± 1.26 V, 1.51 ± 1.33 V, and 2.25 ± 1.63 V, respectively, at 0.5-ms pulse width. PCTs remained low and stable throughout the 12-month follow-up period. CONCLUSION: This clinical trial demonstrated that SE on all LV pacing electrodes is associated with low and stable PCTs for all quadripolar LV lead electrodes, resulting in multiple viable vectors for LV pacing. The large number of available vectors facilitates basal pacing, avoidance of PNS, and potentially prolongs generator longevity due to lower PCTs.
ABSTRACT
BACKGROUND: Despite available evidence that implantable cardioverter defibrillators (ICDs) reduce all-cause mortality among patients at risk for sudden cardiac death, utilization of ICDs is low especially in developing countries. OBJECTIVE: To summarize reasons for ICD or cardiac resynchronization therapy defibrillator implant refusal by patients at risk for sudden cardiac arrest (Improve SCA) in developing countries. METHODS: Primary prevention (PP) and secondary prevention (SP) patients from countries where ICD use is low were enrolled. PP patients with additional risk factors (syncope, ejection fraction < 25%, nonsustained ventricular tachycardia [NSVT], or frequent premature ventricular complexes) were further categorized as "1.5 PP patients." Candidates who declined implantation were asked for reasons for refusal. Baseline factors that may have influenced the implant decision were examined using logistic regression. RESULTS: Among 3892 patients, the implant refusal rate was 46.5% among PP patients (n = 2700), and 10.3% among SP patients (n = 1192). The most common refusal reason was inability to pay for the device (53.8%), followed by not believing in the benefits of the ICD (19.4%). Among PP ICD candidates, those with no syncope, no NSVT, no premature ventricular contractions, shorter QRS duration, no atrial arrhythmias, and no left bundle branch block were more likely to refuse implant. Among SP candidates, a history of cardiovascular surgery and no sinus node dysfunction were significant predictors of ICD refusal. Additionally, countries had significant differences in patient refusal rates among PP and SP groups. CONCLUSION: Implant refusal among PP patients is high in many countries. Increased reimbursement and better awareness of the benefits of an ICD could increase their utilization.
Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Developing Countries , Treatment Refusal/statistics & numerical data , Female , Humans , Male , Middle Aged , Primary Prevention , Prospective Studies , Risk Factors , Secondary PreventionABSTRACT
AIMS: This study aims to demonstrate that primary prevention (PP) patients with one or more additional risk factors are at a similar risk of life-threatening ventricular arrhythmias when compared with secondary prevention (SP) patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy-defibrillator (CRT-D) implant. The study evaluates the benefits of therapy for high-risk patients in countries where defibrillation therapy for PP of SCA is underutilized. METHODS: Enrolment will consist of 4800 ICD-eligible patients from Asia, Latin America, Eastern Europe, the Middle East, and Africa. Upon enrolment, patients will be categorized as SP or PP. Primary prevention patients will be assessed for additional risk factors: syncope/pre-syncope, non-sustained ventricular tachycardia, frequent premature ventricular contractions, and low left ventricular ejection fraction. Those PP patients with one or more risk factors will be categorized as '1.5' patients. Implant of an ICD/CRT-D will be left to the patient and/or physician's discretion. The primary endpoint will compare the appropriate ICD therapy rate between SP and 1.5 patients. The secondary endpoint compares mortality between 1.5 implanted and non-implanted patients. CONCLUSION: The Improve SCA study will investigate a subset of PP patients, believed to be at similar risk of life-threatening ventricular arrhythmias as SP patients. Results may help clinicians identify and refer the highest risk PP patients for ICDs, help local societies expand guidelines to include PP of SCA utilizing ICDs, and provide additional geographical-relevant evidence to allow patients to make an informed decision whether to receive an ICD. TRIAL REGISTRATION: NCT02099721.
Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Resynchronization Therapy , Death, Sudden, Cardiac/prevention & control , Developed Countries , Electric Countershock , Primary Prevention/methods , Secondary Prevention/methods , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/mortality , Arrhythmias, Cardiac/physiopathology , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy Devices , Death, Sudden, Cardiac/epidemiology , Defibrillators, Implantable , Electric Countershock/adverse effects , Electric Countershock/instrumentation , Humans , Patient Selection , Primary Prevention/instrumentation , Prospective Studies , Research Design , Risk Assessment , Risk Factors , Secondary Prevention/instrumentation , Time Factors , Treatment OutcomeABSTRACT
The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess 'real world' efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013. Data was available for 510 patients: median age 68 years (range 20-91), median CHA2DS2-VASc score was 2 and median HAS-BLED score was 2. The average follow-up duration of 315 days (range: 1-1,096). The overall discontinuation rate was 16% after a median 252 days of treatment with dabigatran. There were 17 (3.3%) patients with minor bleeding, 2 (0.4%) had major bleeding episodes. 20 patients (3.9%) developed dyspepsia which was the most common side effect. The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial. None of the patients had an ischaemic stroke, 1 (0.2%) patient had a haemorrhagic stroke. Out of 510 patients, 158 patients (31%) were switched to dabigatran from warfarin. This showed that patients frequently preferred the dabigatran due to convenience when given a choice to switch from warfarin. We report one of the largest registry of Asian patients. Reassuringly, we found that our cohort had a low rate of rate of ischaemic stroke, low rates of side effects and bleeding with the drug.
Subject(s)
Antithrombins/administration & dosage , Atrial Fibrillation/drug therapy , Benzimidazoles/administration & dosage , Stroke/prevention & control , beta-Alanine/analogs & derivatives , Adult , Aged , Aged, 80 and over , Antithrombins/adverse effects , Atrial Fibrillation/complications , Benzimidazoles/adverse effects , Dabigatran , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Retrospective Studies , Stroke/etiology , beta-Alanine/administration & dosage , beta-Alanine/adverse effectsABSTRACT
BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction. OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months. METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system. RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%. CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.
ABSTRACT
BACKGROUND: Observational studies suggest that conventional right ventricular apical pacing may have a deleterious effect on left ventricular function. In this study, we examined whether biventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia and a normal ejection fraction. METHODS: In this prospective, double-blind, multicenter study, we randomly assigned 177 patients in whom a biventricular pacemaker had been successfully implanted to receive biventricular pacing (89 patients) or right ventricular apical pacing (88 patients). The primary end points were the left ventricular ejection fraction and left ventricular end-systolic volume at 12 months. RESULTS: At 12 months, the mean left ventricular ejection fraction was significantly lower in the right-ventricular-pacing group than in the biventricular-pacing group (54.8+/-9.1% vs. 62.2+/-7.0%, P<0.001), with an absolute difference of 7.4 percentage points, whereas the left ventricular end-systolic volume was significantly higher in the right-ventricular-pacing group than in the biventricular-pacing group (35.7+/-16.3 ml vs. 27.6+/-10.4 ml, P<0.001), with a relative difference between the groups in the change from baseline of 25% (P<0.001). The deleterious effect of right ventricular apical pacing occurred in prespecified subgroups, including patients with and patients without preexisting left ventricular diastolic dysfunction. Eight patients in the right-ventricular-pacing group (9%) and one in the biventricular-pacing group (1%) had ejection fractions of less than 45% (P=0.02). There was one death in the right-ventricular-pacing group, and six patients in the right-ventricular-pacing group and five in the biventricular-pacing group were hospitalized for heart failure (P=0.74). CONCLUSIONS: In patients with normal systolic function, conventional right ventricular apical pacing resulted in adverse left ventricular remodeling and in a reduction in the left ventricular ejection fraction; these effects were prevented by biventricular pacing. (Centre for Clinical Trials number, CUHK_CCT00037.)
Subject(s)
Bradycardia/therapy , Cardiac Pacing, Artificial/methods , Stroke Volume , Ventricular Dysfunction, Left/etiology , Ventricular Remodeling , Aged , Atrioventricular Block/complications , Bradycardia/etiology , Bradycardia/physiopathology , Cardiac Pacing, Artificial/adverse effects , Cardiac Volume , Double-Blind Method , Echocardiography, Three-Dimensional , Female , Humans , Male , Pacemaker, Artificial , Prospective Studies , Quality of Life , Sick Sinus Syndrome/complications , Ventricular Dysfunction, Left/prevention & control , Ventricular Dysfunction, Left/therapy , Ventricular Function, LeftABSTRACT
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. OBJECTIVES: The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and low ventricular ejection fraction <25%) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. METHODS: A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n = 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n = 1913) and those without any 1.5PP criteria (n = 783). The decision to undergo ICD implantation was left to the patient and/or physician. The Cox proportional hazards model was used to compute hazard ratios. RESULTS: Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30%) to that in patients with SP indications (hazard ratio 0.47; 95% confidence interval 0.38-0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95% confidence interval 0.46-0.97) (P = .03). There was a 49% relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. CONCLUSION: These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.
Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable/statistics & numerical data , Primary Prevention/methods , Risk Assessment/methods , Tachycardia, Ventricular/therapy , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Female , Global Health , Humans , Incidence , Male , Middle Aged , Prognosis , Prospective Studies , Risk Factors , Survival Rate/trends , Tachycardia, Ventricular/complicationsABSTRACT
BACKGROUND: Deleterious effect on left ventricular (LV) function was observed with conventional right ventricular apical (RVA) pacing. Preliminary data suggested that biventricular pacing (BiV) may be superior to RVA pacing in patients with LV systolic dysfunction. However, the optimal pacing mode and site(s) for patients with normal LV systolic function remain controversial. METHODS: The Pacing to Avoid Cardiac Enlargement (PACE) trial is a prospective, multicenter, randomized, double blinded, parallel, controlled study aiming to determine if BiV pacing is better than conventional RVA pacing in preserving LV systolic function and preventing remodeling in patients with LV ejection fraction (EF) > or = 45% indicated for pacing. This study targets to recruit 200 patients from various centers in Asia, all of whom will receive BiV pacemaker implantation before being randomized to either atrial-based RVA or BiV pacing for 1 year. Their echocardiographic parameters including LV volumes, left ventricular ejection fraction (LVEF), and dyssynchrony index by tissue Doppler imaging, exercise capacity, quality of life assessment, neurohormone levels, and clinical events will be assessed before and after pacing. The primary endpoints are changes in LV end-systolic volume and LVEF 1 year after pacing. It is designed with 90% power to detect a 5% difference in the LVEF after 1 year of pacing. The enrollment began in 2006. It is expected to conclude at the end of 2008. CONCLUSION: The PACE trial will determine whether atrial-based BiV pacing can preserve LV systolic function and prevent LV adverse remodeling induced by conventional RVA pacing in patients with normal LV systolic function and standard pacing indication.
Subject(s)
Cardiac Pacing, Artificial/methods , Cardiomegaly/prevention & control , Randomized Controlled Trials as Topic/methods , Asia/epidemiology , Cardiomegaly/epidemiology , Cardiomegaly/physiopathology , Double-Blind Method , Follow-Up Studies , Humans , Multicenter Studies as Topic/methods , Prospective Studies , Research Design , Ventricular Function, Left/physiologyABSTRACT
BACKGROUND: The Asian population with atrial fibrillation (AF) have a higher risk of stroke than the caucasian population and a higher risk of intracranial bleeding when anticoagulated with warfarin. There are few real-world studies comparing the efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among Asian patients to assess its outcomes of ischemic stroke and hemorrhagic stroke. METHODS: A retrospective cohort study of 1000 patients on dabigatran and warfarin from 2009 to 2013. RESULTS: Data were available for 500 patients on dabigatran and 500 patients on warfarin. The average follow-up duration was 315 ± 280 days in the dabigatran group and 355 ± 232 in the warfarin group. The time in therapeutic range (TTR) was 53.2% in the warfarin-treated group, with 32.8% of patients in the subtherapeutic international normalized ratio range of <2. None of the patients in the dabigatran group had ischemic cerebrovascular accident (CVA) compared to 4 (0.8%) patients in the warfarin group, hazard ratio (HR) 0.13, P = .3. There was 1 (0.2%) patient in both dabigatran and warfarin groups with hemorrhagic CVA (HR 1.16, P = .92). There were 3 (0.6%) patients with major bleeding in the dabigatran group compared to 2 (0.4%) patients in the warfarin group (HR 1.57, P = .59). CONCLUSION: There were similar rates of efficacy for outcomes of ischemic CVA, hemorrhagic CVA, and bleeding when comparing dabigatran with warfarin. Our study shows that despite similar efficacy, suboptimal TTR rates and inconveniences with warfarin demonstrate that NOACs are preferred for stroke prevention in AF.
Subject(s)
Antithrombins/therapeutic use , Atrial Fibrillation/drug therapy , Dabigatran/therapeutic use , Stroke/prevention & control , Warfarin/adverse effects , Aged , Antithrombins/administration & dosage , Asian People , Cohort Studies , Dabigatran/administration & dosage , Female , Humans , Male , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: The normal sinus pacemaker complex is an extensive structure within the right atrium. We hypothesized that patients with sinus node disease (SND) would have evidence of diffuse atrial abnormalities. METHODS AND RESULTS: Sixteen patients with symptomatic SND and 16 age-matched controls were studied. The following were evaluated: effective refractory periods (ERPs) from the high and low lateral right atrium (RA), high septal RA, and distal coronary sinus (CS); conduction time along the CS and lateral RA; P-wave duration; and conduction at the crista terminalis. Electroanatomic mapping was performed to define the sinus node complex and determine regional conduction velocity, double potentials, fractionated electrograms, regional voltage, and areas of electrical silence. Patients with SND demonstrated significant increase in atrial ERP at all right atrial sites, increased atrial conduction time along the lateral RA and CS, prolongation of the P-wave duration, and greater number and duration of double potentials along the crista terminalis. Electroanatomic mapping demonstrated the sinus node complex in SND to be more often unicentric, localized to the low crista terminalis at the site of the largest residual voltage amplitude. There was significant regional conduction slowing with double potentials and fractionation associated with areas of low voltage and electrical silence (or scar). CONCLUSIONS: SND is associated with diffuse atrial remodeling characterized by structural change, conduction abnormalities, and increased right atrial refractoriness. There was a change in the nature of sinus pacemaker activity with loss of the normal multicentric pattern of activation, caudal shift of the pacemaker complex, and abnormal and circuitous conduction around lines of conduction block.
Subject(s)
Arrhythmias, Cardiac/pathology , Atrial Function, Right , Heart Atria/pathology , Sinoatrial Node/physiopathology , Action Potentials , Aged , Arrhythmias, Cardiac/physiopathology , Atrial Fibrillation/etiology , Atrial Fibrillation/pathology , Atrial Fibrillation/physiopathology , Cardiac Pacing, Artificial , Electrocardiography , Female , Heart Atria/physiopathology , Heart Conduction System/physiopathology , Humans , Male , Middle Aged , Neural ConductionABSTRACT
BACKGROUND: The objective of this study was to describe the electrophysiological characteristics, anatomic distribution, and long-term outcome after focal ablation (RFA) of pulmonary vein (PV) atrial tachycardia (AT). Both atrial fibrillation (AF) and AT may be due to a rapidly firing focus in the PVs. Whether these represent two aspects of the same process is unknown. METHODS AND RESULTS: Twenty-seven patients with 28 PV(16%) ATs of a consecutive series of 172 undergoing RFA for focal AT are reported. The mean age was 39+/-16 years, with symptoms for 9+/-14 years resistant to 1.7+/-0.8 medications. AT occurred spontaneously or with isoproterenol in all patients and was not inducible with PES in any. The distribution of PV ATs was right superior PV, 11; left superior PV, 11; left inferior PV, 5; and right inferior PV, 1; 26of 28 foci (93%) were ostial. RFA was successful in 28 of 28 PV ATs acutely. RFA was focal in 25 of 28, with PV isolation of a single target vein in 3. There were 4 recurrences at a mean of 3.3 months. Repeat RFA was performed in all 4 and successful in 3 of 4. All but one recurrence occurred from the same site. Long-term success was achieved in 26 of 27 (96%) patients at mean follow-up of 25+/-22 months. No patients have had subsequent development of AF or AT from a different site. CONCLUSIONS: PV AT has a distribution similar to PV AF, with a propensity to upper veins. However, the majority of foci are ostial, and only a small percentage occur from deep in the PV. Focal RFA is associated with high long-term success, with freedom from both AT from other sites and from AF. PV AT is a localized process and therefore may be different from PV AF.
Subject(s)
Catheter Ablation , Electrocardiography , Pulmonary Veins/physiopathology , Tachycardia/diagnosis , Tachycardia/physiopathology , Adolescent , Adult , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Child , Electrophysiologic Techniques, Cardiac , Female , Follow-Up Studies , Humans , Male , Middle Aged , Recurrence , Reoperation , Tachycardia/surgery , Treatment OutcomeABSTRACT
OBJECTIVES: The study was done to characterize the electrocardiographic and electrophysiologic features of focal atrial tachycardia originating at the mitral annulus (MA). BACKGROUND: Though the majority of left atrial tachycardias originate around the ostia of the pulmonary veins, only isolated reports have described focal tachycardia originating from the MA. METHODS: Seven patients of a consecutive series of 172 patients undergoing radiofrequency ablation for focal atrial tachycardia are reported. Electrophysiologic study involved catheters positioned along the coronary sinus (CS), crista terminalis (CT), His bundle, and a mapping/ablation catheter. RESULTS: All seven patients had tachycardia foci originating from the superior region of the MA in close proximity to the left fibrous trigone and mitral-aortic continuity. These foci demonstrated a characteristic P-wave morphology and endocardial activation pattern. The P-wave morphology in the precordial leads typically showed a biphasic pattern, with an inverted component followed by an upright component. The P-wave was consistently of low amplitude in the limb leads. Earliest endocardial activity occurred at the His bundle region in all seven patients. In general, CS activation was proximal to distal, and mid-CT activation was earlier than high or low CT. Ablation was successful at the superior aspect of the MA in all patients. CONCLUSIONS: The MA is an unusual but important site of origin for focal atrial tachycardia, with a propensity to be localized to the superior aspect. It can be suspected as a potential anatomic site of tachycardia origin from analysis of P-wave morphology and the atrial endocardial activation sequence map. Using mapping targeted to anatomic structures achieved a high success rate for ablation.
Subject(s)
Echocardiography , Electrophysiology , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Tachycardia, Ectopic Atrial/diagnostic imaging , Tachycardia, Ectopic Atrial/physiopathology , Adult , Aged , Catheter Ablation , Female , Follow-Up Studies , Heart Conduction System/diagnostic imaging , Heart Conduction System/physiopathology , Heart Conduction System/surgery , Humans , Male , Middle Aged , Mitral Valve/surgery , Outcome Assessment, Health Care , Severity of Illness Index , Tachycardia, Ectopic Atrial/surgery , Time FactorsABSTRACT
BACKGROUND: The Medtronic Attain Performa quadripolar leads provide 16 pacing vectors with steroid on every electrode. This includes a short bipolar configuration between the middle 2 electrodes. OBJECTIVE: A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries. METHODS: Cardiac resynchronization therapy with defibrillator candidates were enrolled (mean age 68 years; 71% men). All implanted subjects were followed at 1, 3, and 6 months postimplant. Pacing capture threshold (PCT) values were measured at each visit. Adverse events were reported upon occurrence. RESULTS: Of 1124 subjects in whom a left ventricular (LV) lead was attempted, 1097 (97.6%) were successfully implanted with an Attain Performa lead. Thirty-six LV lead-related complications were reported (the 6-month LV lead-related complication-free survival rate was 96.9%). Phrenic nerve stimulation (PNS) occurred in 81 subjects (7.2%), with only 3 (0.3%) requiring surgical intervention. At 6 months, the mean PCT at the programmed vector was (1.1 ± 0.8) V and 94.4% of subjects had a PCT of ≤2.5 V. All 16 programming polarities were used in at least 1 patient, and short bipolar configurations were used in 17% of subjects. CONCLUSION: This large multicenter study demonstrated a high success rate for the implantation of Attain Performa quadripolar LV leads with a low complication rate. The PCT was low and stable over time. A low rate of postimplantation PNS was observed, and cases of PNS were readily resolved with reprogramming. Nonstandard vectors were often used for LV pacing.
Subject(s)
Cardiac Catheters/adverse effects , Cardiac Resynchronization Therapy Devices/adverse effects , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/methods , Defibrillators, Implantable , Equipment Design , Female , Follow-Up Studies , Heart Failure/physiopathology , Heart Failure/therapy , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Left ventricular (LV) lead implantation for cardiac resynchronization therapy (CRT) is associated with lead dislodgement rates ranging from 3% to 10%, and some implant approaches to prevent dislodgement may contribute to suboptimal CRT response. We report our early human experience with an LV lead with a side helix for active fixation to the coronary vein wall. OBJECTIVES: To assess the feasibility and safety of the Model 20066 LV lead and to evaluate the implant procedure. METHODS: The Model 20066 is a 4-F bipolar steroid eluting lead that has a small exposed side helix and can be delivered using a guidewire or stylet. At the desired vein location, the lead body is rotated clockwise until the helix is fixated. This study was a single-arm, prospective, nonrandomized trial that enrolled 40 patients from 4 centers who met standard indications for CRT. RESULTS: The lead was successfully implanted in 39 of 40 (98%) patients. In 38 of 40 (95%) patients, the implanters were successful at implanting at a predetermined target site. There were no Model 20066 LV lead dislodgements reported within 12 months of follow-up. The electrical performance of the tip and ring electrodes was stable through the 12-month follow-up visit and similar to other LV leads. Overall lead handling was rated as acceptable for all implants. CONCLUSION: This new LV lead specifically designed with an active fixation mechanism for stability and precise placement was successfully and safely deployed in the coronary vasculature.
Subject(s)
Cardiac Resynchronization Therapy/methods , Coronary Vessels/surgery , Electrodes, Implanted , Adult , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Coronary Vessels/physiopathology , Equipment Design , Equipment Failure , Feasibility Studies , Female , Follow-Up Studies , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Treatment OutcomeABSTRACT
Treatment with thalidomide is associated with vascular thrombosis. The effect of thalidomide on platelet activation is unclear, although the use of aspirin is justified for thromboprophylaxis. A study on platelet activation markers was done among multiple myeloma patients receiving thalidomide therapy with warfarin as thromboprophylaxis. Strict criteria and procedure were set to avoid misinterpretation of platelet activation other than due to the thalidomide's effect. Blood specimen pre and post thalidomide therapy were used for flow cytometric analysis. Platelet surface P-selectin, CD62P expression and PAC-1 (antibody that recognizes conformational change of the GPIIb/IIIa complex) were examined by using three-colour flowcytometer. Increased expression marker for PAC-1 was observed after 4 weeks of thalidomide treatment (Pâ<â0.05) indicating one aspect of platelet activation activity seen in these patients. The mechanism of thrombosis by thalidomide is probably multifactorial and one of them is likely through platelet activation. Further study on the affected pathway/s in the platelet activation process would confirm the exact mechanism of thalidomide-induced thrombosis and potential extended usage of this drug in future.
Subject(s)
Antibodies, Monoclonal/metabolism , Immunosuppressive Agents/adverse effects , Multiple Myeloma/drug therapy , Thalidomide/adverse effects , Thrombosis/genetics , Aged , Antibodies, Monoclonal/immunology , Anticoagulants/therapeutic use , Blood Platelets/drug effects , Blood Platelets/immunology , Blood Platelets/pathology , Female , Gene Expression , Humans , Male , Middle Aged , Multiple Myeloma/immunology , Multiple Myeloma/pathology , P-Selectin/genetics , P-Selectin/immunology , P-Selectin/metabolism , Platelet Activation/drug effects , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Platelet Glycoprotein GPIIb-IIIa Complex/immunology , Thrombosis/chemically induced , Thrombosis/immunology , Thrombosis/pathology , Warfarin/therapeutic useSubject(s)
Cardiac Resynchronization Therapy/methods , Heart Failure/therapy , Adult , Aged , Echocardiography/methods , Electrocardiography/methods , Female , Heart Failure/diagnostic imaging , Heart Failure/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Registries , Treatment Outcome , Ventricular Remodeling/physiologyABSTRACT
Coronary sinus perforation is a relatively uncommon but much feared complication that may occur during the placement of left ventricular pacing lead. Coronary sinus perforation, especially in the presence of an obstructive flap, usually indicates the need to abandon the implantation attempt, as there are difficulties in crossing the obstructive flap as well as uncertainty of whether the lead is in the true lumen or into the pericardial space. We describe our experience in successfully placing the left ventricular lead safely despite the problems arising from these circumstances.
Subject(s)
Coronary Vessels/injuries , Electrodes, Implanted/adverse effects , Heart Ventricles/surgery , Pacemaker, Artificial/adverse effects , Prosthesis Implantation/adverse effects , Prosthesis Implantation/methods , Wounds, Penetrating/etiology , Aged , Humans , Male , Treatment OutcomeABSTRACT
We report the case of an accessory pathway in a left inferoposterior diverticulum. The pathway masqueraded as a true left lateral pathway due to the direction of activation over a coronary sinus to left atrium connection. The patient had undergone four prior failed ablation attempts at other institutions using both a transseptal and retrograde approach.