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Background: Achieving bi‐directional conduction block, as assessed by differential pacing and change in activation along tricuspid annulus (TA), across the cavo‐tricuspid isthmus (CTI), is considered a satisfactory end point during catheter ablation of atrial flutter (AFL). Aim: To assess role of subclinical conduction by observing polarity reversal of local bipolar signals from RS to QR pattern lateral to the line of ablation, in predicting recurrence of CTI dependant AFL after ablation in patients with bidirectional conduction block. Method and Results: Of 683 patients undergoing ablation of CTI dependent AFL, 73 (10.6%) patients underwent redo flutter ablation and were evaluated further. The mean age was 60.8 years and 51% were males. Evidence of bidirectional block by differential pacing and change is activation along multipolar catheter and reversal of local bipolar signals from RS to QR pattern lateral to the line of ablation, during the 1st and subsequent procedure, were studied. 60% patients had confirmed bidirectional block of which 71% had lack of voltage reversal, at the end of 1st procedure. All patients with bidirectional block with lack of reversal of bipolar signals, after the first procedure had recurrence of AFL whereas only 3/11 (27%) people with bidirectional block and with absence of subclinical conduction had recurrence of AFL. Conclusion: Achieving bidirectional conduction block is not sufficient to prevent recurrence of AFL after CTI ablation. Reversal of local bipolar signals, from RS to QR pattern along with achieving bidirectional conduction delay would reduce recurrence of AFL, post ablation. [ABSTRACT FROM AUTHOR]

A gene mutation on chromosome seven appears to be one cause of a heart arrhythmia called Wolff-Parkinson-White syndrome, according to a study of two families with 31 members who have the syndrome. The mutation is located at 7q34-q36 and affects the gamma2 regulatory subunit of AMP-activated protein kinase.

Aims: To explore possible associations that may explain the greater benefit from cardiac resynchronization therapy (CRT) reported amongst women.Methods and Results: In an individual-patient data meta-analysis of five randomized controlled trials, all-cause mortality and the composite of all-cause mortality or first hospitalization for heart failure (HF) were compared among 794 women and 2702 men assigned to CRT or a control group. Multivariable analyses were performed to assess the impact of sex, QRS duration, HF aetiology, left ventricular end-diastolic diameter (LVEDD), and height on outcome. Women were shorter, had smaller LVEDD, more often left bundle branch block, and less often ischaemic heart disease, but QRS duration was similar between sexes. Women tended to obtain greater benefit from CRT but sex was not an independent predictor of either outcome. For all-cause mortality, QRS duration was the only independent predictor of CRT benefit. For the composite outcome, height and QRS duration, but not sex, were independent predictors of CRT benefit. Further analysis suggested increasing benefit with increasing QRS duration amongst shorter patients, of whom a great proportion were women.Conclusions: In this individual-patient data meta-analysis, CRT benefit was greater in shorter patients, which may explain reports of enhanced CRT benefit among women. Further analyses are required to determine whether recommendations on the QRS threshold for CRT should be adjusted for height. (ClinicalTrials.gov numbers: NCT00170300, NCT00271154, NCT00251251). [ABSTRACT FROM AUTHOR]

Abstract: Background/objective: We compared health‐related quality of life (HRQoL) in patients randomized to escalated therapy and those randomized to ablation for ventricular tachycardia in the VANISH trial. Methods: HRQoL was assessed among VANISH patients at baseline and 3‐, 6‐, and 12‐month follow‐up visits. Four validated instruments were used: the SF‐36, the implanted cardioverter defibrillator (ICD) Concerns questionnaire (ICDC), the Hospital Anxiety and Depression Scale (HADS), and the EuroQol five dimensions questionnaire (EQ‐5D). Linear mixed‐effects modeling was used for repeated measures with SF‐36, HADS, ICDC, and EQ‐5D as dependent variables. In a second model, treatment was subdivided by amiodarone use prior to enrollment. Results: HRQoL did not differ significantly between those randomized to ablation or escalated therapy. On subgroup analysis, improvement in SF‐36 measures was seen at 6 months in the ablation group for social functioning (63.5–69.3, P = 0.03) and energy/fatigue (43.0–47.9, P = 0.01). ICDC measures showed a reduction in ICD concern in the ablation group at 6 months (10.4–8.7, P = 0.01) and a reduction in ICD concern in the escalated therapy group at 6 months (10.9–9.4, P = 0.04). EQ‐5D measures showed a significant improvement in overall health in ablation patients at 6 months (63.4–67.3, P = 0.04). Conclusion: Patients in the VANISH study randomized to ablation did not have a significant change in quality of life outcomes compared to those randomized to escalated therapy. Some subgroup findings were significant, as those randomized to ablation showed persistent improvement in SF‐36 energy/fatigue and ICD concern, and transient improvement in SF‐36 social functioning and EQ‐5D overall health. [ABSTRACT FROM AUTHOR]

Background: The VANISH trial (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease) compared the effectiveness of escalated antiarrhythmic drug therapy to catheter ablation in patients with prior myocardial infarction, an implanted defibrillator, and ventricular tachycardia (VT). The effectiveness of these interventions in patients on sotalol versus amiodarone was compared.Methods and Results: Analysis was conducted based on whether patients had recurrent VT, despite amiodarone (amio-refractory) or nonamiodarone drugs (sotalol-refractory). Outcomes included death, VT storm, appropriate implantable cardioverter defibrillator shock, and any ventricular arrhythmia. At baseline, 169 (65.2%) were amio-refractory, and 90 (34.7%) were sotalol-refractory (1 patient on procainamide rather than sotalol). Amio-refractory patients had more renal insufficiency (23.7% versus 10%; P=0.0008), worse New York Heart Association class (82.3% II/III versus 65.5%; P=0.0003), and lower ejection fraction (29±9.7% versus 35.2±11%; P<0.0001). Within the amio-refractory group, ablation resulted in reduction of any ventricular arrhythmia compared with escalated drug therapy (hazard ratio, 0.53; 95% confidence interval, 0.31-0.9), P=0.020). Sotalol-refractory patients had trends toward higher mortality and VT storm with ablation, with no effect on implantable cardioverter defibrillator shocks. Within the escalated drug therapy arm, amio-refractory patients had a higher rate of the composite outcome (hazard ratio, 1.94; 95% confidence interval, 1.14-3.29; P=0.0144) and a trend to higher mortality (hazard ratio, 2.40; 95% confidence interval, 0.93-6.22; P=0.07), whereas mortality was not different between amio- and sotalol-refractory patients within the ablation treatment group.Conclusions: Patients with amio-refractory VT have a higher rate of ventricular arrhythmia and mortality than those with sotalol-refractory VT and derive greater benefit of catheter ablation than for patients with sotalol-refractory VT who are switched to amiodarone.Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT00905853. [ABSTRACT FROM AUTHOR]

BACKGROUND: Clinical trials have established the average benefit of cardiac resynchronization therapy (CRT), but estimating benefit for individual patients remains difficult because of the heterogeneity in treatment response. Accordingly, we created a multivariable model to predict changes in quality of life (QoL) with and without CRT. METHODS AND RESULTS: Patient-level data from 5 randomized trials comparing CRT with no CRT were used to create a prediction model of change in QoL at 3 months using a partial proportional odds model for no change, small, moderate, and large improvement, or deterioration of any magnitude. The C statistics for not worsening or obtaining at least a small, moderate, and large improvement were calculated. Among the 3614 patients, regardless of assigned treatment, 33.3% had a deterioration in QoL, 9.2% had no change, 9.2% had a small improvement, 13.5% had a moderate improvement, and the remaining 34.9% had a large improvement. Patients undergoing CRT were less likely to have a decrement in their QoL (28.2% versus 38.9%; P<0.001) and more likely to have a large QoL improvement (38.7% versus 30.6%; P<0.001). A partial proportional odds model identified baseline QoL, age, and an interaction of CRT with QRS duration as predictors of QoL benefits 3 months after randomization. C statistics of 0.65 for not worsening, 0.68 for at least a small improvement, 0.69 for at least a moderate improvement, and 0.73 for predicting a large improvement were observed. CONCLUSIONS: There is marked heterogeneity of treatment benefit of CRT that can be predicted based on baseline QoL, age, and QRS duration. [ABSTRACT FROM AUTHOR]

Aims: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with symptomatic heart failure and QRS prolongation but there is uncertainty about which patient characteristics predict short-term clinical response.Methods and Results: In an individual patient meta-analysis of three double-blind, randomized trials, clinical composite score (CCS) at 6 months was compared in patients assigned to CRT programmed on or off. Treatment-covariate interactions were assessed to measure likelihood of improved CCS at 6 months. MIRACLE, MIRACLE ICD, and REVERSE trials contributed data for this analysis (n = 1591). Multivariable modelling identified QRS duration and left ventricular ejection fraction (LVEF) as predictors of CRT clinical response (P < 0.05). The odds ratio for a better CCS at 6 months increased by 3.7% for every 1% decrease in LVEF for patients assigned to CRT-on compared to CRT-off, and was greatest when QRS duration was between 160 and 180 ms.Conclusions: In symptomatic chronic heart failure patients (NYHA class II-IV), longer QRS duration and lower LVEF independently predict early clinical response to CRT. [ABSTRACT FROM AUTHOR]

Background: The RAFT (Resynchronization in Ambulatory Heart Failure Trial) demonstrated that cardiac resynchronization therapy (CRT) reduced both mortality and heart failure hospitalizations in patients with functional class II or III heart failure and widened QRS. We examined the influence of CRT on ventricular arrhythmias in patients with primary versus secondary prophylaxis defibrillator indications.Methods and Results: All ventricular arrhythmias among RAFT study participants were downloaded and adjudicated by 2 blinded reviewers with an overreader for disagreements and committee review for remaining discrepancies. Incidence of ventricular arrhythmias among patients randomized to CRT-D versus implantable cardioverter defibrillator (ICD) were compared within the groups of patients treated for primary prophylaxis and for secondary prophylaxis. Of 1798 enrolled patients, 1764 had data available for adjudication and were included. Of these, 1531 patients were implanted for primary prophylaxis, while 233 patients were implanted for secondary prophylaxis; 884 patients were randomized to ICD and 880 to CRT-D. During 5953.6 patient-years of follow-up, there were 11 278 appropriate ICD detections of ventricular arrhythmias. In the primary prophylaxis group, CRT-D significantly reduced incidence ventricular arrhythmias in comparison to ICD (hazard ratio, 0.86; 95% confidence interval, 0.74-0.99; P=0.044). This effect was not seen in the secondary prophylaxis group (hazard ratio, 1.14; 95% confidence interval, 0.82-1.58; P=0.45). CRT-D was not associated with significant differences in overall ventricular arrhythmia burden in either group.Conclusions: CRT reduced the rate of onset of new ventricular arrhythmias detected by ICDs in patients without a history of prior ventricular arrhythmias. This effect was not observed among patients who had prior ventricular arrhythmias.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251. [ABSTRACT FROM AUTHOR]

Background: Whether adding cardiac resynchronization therapy (CRT-D) to an implanted cardioverter-defibrillator alters the risk of atrial fibrillation or other atrial tachyarrhythmias (AF/AT), or if postimplantation AF/AT modulate the benefits of CRT-D, remain unknown.Methods and Results: We studied 972 Resynchronization/Defibrillation in Ambulatory Heart Failure Trial (RAFT) participants without permanent AF, who were randomized to CRT-D (n=495) versus nonresynchronization defibrillator (implanted cardioverter-defibrillator; n=477) within the predefined stratum eligible for an atrial lead. Occurrence of postrandomization AF/AT was prospectively assessed, and Cox models were used to test the independent association between the postrandomization AF/AT and the RAFT primary composite outcome of all-cause mortality or hospitalization for heart failure. Over 41 (±19) months, postrandomization AF/AT occurred in 216 (45.3%) patients randomized to implanted cardioverter-defibrillator and 249 (50.3%) randomized to CRT-D. After adjusting for competing risk of death, randomization to CRT-D increased risk of postrandomization AF/AT (hazard ratio, 1.20; 95% confidence interval, 1.00-1.42; P=0.045). Postrandomization AF/AT, which remained paroxysmal in 69.5%, did not reduce biventricular pacing percentage. In adjusted models, postrandomization AF/AT was not associated with the primary outcome (hazard ratio, 1.04; 95% confidence interval, 0.84-1.30). However, AF/AT was associated with a borderline decreased risk of mortality (hazard ratio, 0.75; 95% confidence interval, 0.58-1.00) but increased risk of heart failure hospitalization (hazard ratio, 1.43; 95% confidence interval, 1.08-1.90).Conclusions: In RAFT, nearly half of the patients developed postrandomization AF/AT, and those randomized to CRT-D had borderline significant higher risk. Postrandomization AF/AT was associated with risk of heart failure hospitalization, but not with the primary composite outcome.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251. [ABSTRACT FROM AUTHOR]

Background: Studies of cardiac resynchronization therapy in addition to an implantable cardioverter defibrillator in patients with mild to moderate congestive heart failure had not been shown to reduce mortality until the recent RAFT trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial). We performed a meta-analysis including the RAFT trial to determine the effect of cardiac resynchronization therapy with or without an implant able defibrillator on mortality. Methods: We searched electronic databases and other sources for reports of randomized trials using a parallel or crossover design. We included studies involving patients with heart failure receiving optimal medical therapy that compared cardiac resynchronization therapy with optimal medical therapy alone, or cardiac resynchronization therapy plus an implantable defibrillator with a standard implantable defibrillator. The primary outcome was mortality. The optimum information size was considered to assess the minimum amount of information required in the literature to reach reliable conclusions about cardiac resynchronization therapy. Results: Of 3071 reports identified, 12 studies (n = 7538) were included in our meta- analysis. Compared with optimal medical therapy alone, cardiac resynchronization therapy plus optimal medical therapy significantly reduced mortality (relative risk [RR] 0.73, 95% confidence interval [CI] 0.62-0.85). Compared with an implantable defibrillator alone, cardiac resynchronization therapy plus an implantable defibrillator significantly reduced mortality (RR 0.83, 95% CI 0.72-0.96). This last finding remained significant among patients with New York Heart Association (NYHA) class I or II disease (RR 0.80, 95% CI 0.67-0.96) but not among those with class III or IV disease (RR 0.84, 95% CI 0.69-1.07). Analysis of the optimum information size showed that the sequential monitoring boundary was crossed, which suggests no need for further clinical trials. Interpretation: The cumulative evidence is now conclusive that the addition of cardiac resynchronization to optimal medical therapy or defibrillator therapy significantly reduces mortality among patients with heart failure. [ABSTRACT FROM AUTHOR]

Background: Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter–defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients. Methods: We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure. Results: We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD–CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD–CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD–CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P=0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001). Conclusions: Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.) N Engl J Med 2010;363:2385-95. [ABSTRACT FROM AUTHOR]

Background: The need for pacing support in typical ICD patients is unknown.Objective: This study sought to determine whether atrial pacing with ventricular backup pacing is equivalent to ventricular backup pacing only in implantable cardioverter-defibrillator (ICD) patients.Methods: We randomized 1,030 patients from 84 sites with indications for ICDs, with sinus rhythm, and without symptomatic bradycardia to atrial pacing with ventricular backup at 60 beats/min (518) or ventricular backup pacing at 40 beats/min (512). The primary end points were time to death, heart failure hospitalization (HFH), and heart failure-related urgent care (HFUC).Results: Follow-up was 2.4 ± 0.8 years when the trial was stopped for futility. There were 355 end point events (103 deaths, 252 HFH/HFUC) in 194 patients favoring ventricular backup pacing (event-free rate 77.7% vs. 80.3% for atrial pacing at 30 months; hazard ratio 1.14, upper confidence bound 1.59, prespecified noninferiority threshold 1.21), therefore equivalence between pacing arms was not demonstrated. Overall HFH/HFUC rates were slightly higher during atrial pacing (event-free rate 85.4% vs. 86.4% for ventricular backup pacing). Exploratory analyses revealed that the difference in HFH/HFUC rates was largely seen in patients with a PR interval ≥230 ms. There were no differences between groups for atrial fibrillation, ventricular tachycardia/ventricular fibrillation, quality of life, or echocardiographic measurements. Fewer patients in the atrial pacing group were reported to develop an indication for bradycardia pacing (3.7% vs. 7.3%, P = .0053).Conclusion: Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated.Clinical Trials Identifier: NCT00281099. [ABSTRACT FROM AUTHOR]

Background: Cardiac arrest due to ventricular arrhythmia in the absence of a reversible cause or contraindication has been a class I indication for insertion of an implantable cardioverter defibrillator since 1998. We compared and contrasted the use of implantable cardioverter defibrillator therapy in Canada and the United States among adults who survived a cardiac arrest. Method: Data on hospital separations from April 1, 1994 through March 31, 2003 were obtained from the Health Person-Oriented Information Database maintained by Statistics Canada and from the US National Hospital Discharge Survey on all patients with a primary diagnosis of cardiac arrest, ventricular fibrillation or ventricular flutter for the same 9-year period. We excluded all records of patients with a secondary diagnosis of acute myocardial infarction. Results: In Canada, 3793 patients survived to discharge after a cardiac arrest; 628 (16.6%) of these were implanted with a cardioverter defibrillator before discharge. The implant rate rose steadily from 5.4% in 1994/95 to 26.7% in 2002/03. In the United States, 23 688 (30.2%) of 78 538 such survivors received an implantable cardioverter defibrillator before discharge. Logistic regression analysis indicated that sex, age, fiscal year, the hospital's teaching status, hospital size and patient history of heart failure were positive predictors of implantable cardioverter defibrillator implantation. Age, renal failure, liver failure and cancer were negative predictors of receiving an implantable cardioverter defibrillator. Interpretation: The rate of use of implantable cardioverter defibrillator therapy for cardiac arrest survivors in Canada is increasing, but still is lower than the rate in the United States. [ABSTRACT FROM AUTHOR]

Circumferential lesions to the pulmonary vein (PV) ostia to cause conduction block at the junction of the PV and left atrium could offer a new approach during catheter ablation of patients with paroxysmal (focal) atria! fibrillation. Diode laser can deliver energy through diffusing or ring fiber tips. In three pigs weighing between 60 and 65 kg, transseptal puncture was performed and a fiberoptic balloon catheter with a collapsed profile of 10 Fr was advanced through a sheath under fluoroscopic guidance to the ostium of the right and left PVs. The balloon was inflated with a 3-cc mixture of D2O (deuterium oxide) and contrast to deliver circumferential lesions with a 15-mm diameter × 3-mm ring width of light. Applications consisted of 3.2 to 3.8 W/cm for 120 seconds; the animals were sacrificed 3 hours after ablation for pathological examination. Photonic energy was delivered successfully to the ostium of five of the five targeted PVs, and was well tolerated hemodynamically in each animal without ectopy. Gross inspection revealed endocardial lesions at the ostium of four of five PVs, confined to the atrium in each and circumferential in three of five PVs. Microscopically, transmural coagulation necrosis of the atrium was present at the ostium of three of five PVs, and extended into the myocardial sleeves of two PVs. Photonic energy delivery using a fiberoptic balloon catheter can create circumferential lesions to the PV ostia, suggesting that this new form of energy delivery may be therapeutically advantageous for pulmonary vein ablation with need to pursue chronic studies. [ABSTRACT FROM AUTHOR]

The heart rate (HR)-minute ventilation (VE) relationship has been shown to be nonlinear and can be expressed as two distinct straight lines. This study is to assess the correlation of the initial HR-VE slope to clinical parameters. Maximum treadmill exercise tests were performed in 100 healthy volunteers (age 19-77 years) using a ramp protocol in which work-rate increases linearly with exercise. Breath-by-breath VO2, VCO2, and VE were measured, and HR and RP were monitored throughout the exercise. The HR-VE curve demonstrated nonlinearity with a breakpoint determined by a change point analysis. This breakpoint was significantly higher than that of the anaerobic threshold. The VE at the HR-VE breakpoint was 56.4 ± 19.4 and VE at the VE-VO2 and VCO2-VO2 breakpoints were 48.0 ± 18.3 (P < 0.0001) arid 40.1 ± 16.5 (P < 0.0001). respectively. The HR at this HR-VE breakpoint was 77.7 ± 12.9% of the HR range. The first slope. S1 (1.76 ± 0.64) was steeper than the second slope, S2 (0.66 ± 0.39). Although there was a gender difference for S1, the best clinical predictor on a stepwise multiple regression analysis was body surface area (BSA) which explained 47% of the variance. It was concluded that nonlinearity of the HR-VE curve can be expressed as two straight lines. The breakpoint is beyond the anaerobic threshold and can be estimated to be approximately 75% of the maximal predicted HR. RSA is the only clinical parameter that significantly predicts the initial slope of the HR-VE curve. This can be of great importance in the programming of rate-adaptive pacemakers using a VE. [ABSTRACT FROM AUTHOR]

Although morbidity and mortality associated with defibrillator implantation using a nonthoracotomy, approach have decreased as compared with a thoracotomy approach. defibrillation thresholds have been higher and fewer patients satisfied implant criteria. It may be possible to improve on the success of nonthoracotomy defibrillator implantation by the placement of a right ventricular (RV) outflow defibrillation lead. Implantable cardioverter defibrillator implantation data of 30 consecutive patients with clinical VT or VF were reviewed. Three defibrillation leads were routinely used. When either pacing threshold at the RV apex was inadequate (n = 2) or 18-f shocks were not successful in terminating VF in 3 of 4 trials (n = 8), the RV apex lead was positioned to the RV outflow tract attaching to the septum. Defibrillation testing was first performed with the RV apex lead in combination with CS, SVC, and/or subcutaneous leads. Twenty patients satisfied implant criteria with a defibrillation threshold of 13.5 + 3.6 J. In 7 of the 10 patients, whose RV lead was repositioned to the HV outflow tract, this lead in combination with SVC, CS, or subcutaneous leads produced successful defibrillation at ≤ 18 f or in 3 of 4 trials. This approach improved the overall success of nonthoracotomy implantation of defibrillators from 69% to 0%. After a follow-up of 27 ± 6 months, there was no dislodgment of the RV outflow tract defibrillation leads. Conclusions: This article reports the preliminary observation that placement of defibrillation leads to the HV outflow tract in humans was possible and without dislodgment. RV outflow tract offers an alternative for placement of defibrillation leads, which may improve on the success of nonthoracotomy defibrillator implantation. [ABSTRACT FROM AUTHOR]