A cost-effectiveness analysis of remote monitoring after pacemaker implantation for bradycardia in Japan.

BACKGROUND: Although remote monitoring (RM) after pacemaker implantation is common, its cost-effectiveness has not been fully investigated. Therefore, we assessed the cost-effectiveness of RM compared with conventional follow-up (CFU) in Japanese patients with pacemakers. METHODS: A Markov model was constructed to analyze costs and quality-adjusted life years after pacemaker implantation. The target population was Japanese patients implanted with a dual-chamber pacemaker for bradycardia. Transition probabilities (e.g. atrial fibrillation, stroke, and device trouble) were obtained from literature and expert sources. Additionally, stroke risk was determined according to anticoagulation and CHADS2 scores. We used a 10-year horizon with sensitivity analyses for significant variables. RESULTS: Compared to CFU, RM was more effective; however, it was also more expensive. When the range of the Japanese willingness-to-pay threshold was considered to be ¥5,000,000, RM was at least cost-neutral relative to the CFU in all elderly patients with pacemakers for bradycardia. The cost-effectiveness of RM relative to CFU could be higher for patients with high CHADS2 scores, especially in patients with a CHADS2 score ≥ 3. Scenario analyses changing the interval between visits to an in-office evaluation in the CFU also demonstrated the same conclusions. In particular, when the interval between office visits was 1 year for the CFU, the RM could be more cost-effective. CONCLUSIONS: This study demonstrated that RM can be a cost-effective option for Japanese patients, especially those with high CHADS2 scores and long-term intervals between office visits.

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing.

AIMS: Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. METHODS AND RESULTS: We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. CONCLUSION: According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

Use and Outcomes of Dual Chamber or Cardiac Resynchronization Therapy Defibrillators Among Older Patients Requiring Ventricular Pacing in the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator Registry.

Importance: Frequent right ventricular (RV) pacing can cause and exacerbate heart failure. Cardiac resynchronization therapy (CRT) has been shown to be associated with improved outcomes among patients with reduced left ventricular ejection fraction who need frequent RV pacing, but the patterns of use of CRT vs dual chamber (DC) devices and the associated outcomes among these patients in clinical practice is not known. Objective: To assess outcomes, variability in use of device type, and trends in use of device type over time among patients undergoing implantable cardioverter defibrillator (ICD) implantation who were likely to require frequent RV pacing but who did not have a class I indication for CRT. Design, Setting, and Participants: This retrospective cohort study used the National Cardiovascular Data Registry (NCDR) ICD Registry. A total of 3100 Medicare beneficiaries undergoing first-time implantation of CRT defibrillator (CRT-D) or DC-ICD from 2010 to 2016 who had a class I or II guideline ventricular bradycardia pacing indication but not a class I indication for CRT were included. Data were analyzed from August 2018 to October 2019. Exposures: Implantation of a CRT-D or DC-ICD. Main Outcomes and Measures: All-cause mortality, heart failure hospitalization, and complications were ascertained from Medicare claims data. Multivariable Cox proportional hazards models and Fine-Gray models were used to evaluate 1-year mortality and heart failure hospitalization, respectively. Multivariable logistic regression was used to evaluate 30-day and 90-day complications. All models accounted for clustering. The median odds ratio (MOR) was used to assess variability and represents the odds that a randomly selected patient receiving CRT-D at a hospital with high implant rates would receive CRT-D if they had been treated at a hospital with low CRT-D implant rates. Results: A total of 3100 individuals were included. The mean (SD) age was 76.3 (6.4) years, and 2500 (80.6%) were men. The 1698 patients (54.7%) receiving CRT-D were more likely than those receiving DC-ICD to have third-degree atrioventricular block (828 [48.8%] vs 432 [30.8%]; P < .001), nonischemic cardiomyopathy (508 [29.9%] vs 255 [18.2%]; P < .001), and prior heart failure hospitalizations (703 [41.4%] vs 421 [30.0%]; P < .001). Following adjustment, CRT-D was associated with lower 1-year mortality (hazard ratio [HR], 0.70; 95% CI, 0.57-0.87; P = .001) and heart failure hospitalization (subdistribution HR, 0.77; 95% CI, 0.61-0.97; P = .02) and no difference in complications compared with DC-ICD. Hospital variation in use of CRT was present (MOR, 2.00), and the use of CRT in this cohort was higher over time (654 of 1351 [48.4%] in 2010 vs 362 of 594 [60.9%] in 2016; P < .001). Conclusions and Relevance: In this cohort study of older patients in contemporary practice undergoing ICD implantation with a bradycardia pacing indication but without a class I indication for CRT, CRT-D was associated with better outcomes compared with DC devices. Variability in use of device type was observed, and the rate of CRT implantation increased over time.

Assessment of injury current during leadless pacemaker implantation.

BACKGROUND: Leadless pacemakers are an established treatment option for bradyarrhythmias. Similar to conventional transvenous pacemakers, satisfying pacing values during implantation are targeted for optimal long-term device function. The objective is to investigate the role of a local injury current (IC) in leadless pacemaker implantations. METHOD: The IC, sensing value, capture threshold and impedance were collected in 30 consecutive patients receiving a leadless pacemaker. RESULTS: 39 EGMs were recorded from 30 patients (including 9 device repositions). An IC was detected in 15 cases (38%). At implantation, the presence of an IC was associated with a significantly lower sensing (7.1 ± 3.7 mV vs 12.0 ± 4.0 mV; P = 0.004) and a higher capture threshold (median threshold 1.13 V at 0.24 ms [0.50-2.00] vs 0.50 V at 0.24 ms [0.25-0.75]; P = 0.002) and with a 26 fold higher likelihood of device repositioning compared to the absence of an IC (OR 26.3 [2.79-248], P < 0.001). Patients with an IC in their final implant position had a lower sensing (9.3 ± 4.4 mV vs 13.6 ± 4.7 mV at implantation, P = 0.04), while the initially similar capture threshold was lower after 24 h in the IC group. After 2 weeks, all parameters were similar between the two groups. CONCLUSIONS: Our study shows that an IC can readily be observed during leadless pacemaker implantation associated with a lower sensing and a higher capture threshold at implantation but with similar to even better values during follow-up.

Cardiac Pacing Training in Africa: Endorsed by the Africa Heart Rhythm Association (AFHRA): JACC International.

The field of pacing in Africa has evolved in an uncoordinated way across the continent with significant variation in local expertise, cost, and utilization. There are many countries where pacemaker services do not meet one-hundredth of the national demand. Regional, national, and institutional standards for pacemaker qualification and credentials are lacking. This paper reviews the current needs for bradycardia pacing and evaluates what standards should be set to develop pacemaker services in a resource-constrained continent, including the challenges and opportunities of capacity building and training as well as standards for training programs (training prerequisites, case volumes, program content, and evaluation).

Permanent pacemaker implantation in pediatric heart transplant recipients: A systematic review and evidence quality assessment.

Bradyarrhythmias are a common complication following pediatric OHT and may require permanent pacemaker implantation (PPM). The purpose of this study was to investigate the incidence, predictors, and outcomes of children undergoing PPM implantation following OHT. A PRISMA-compliant systematic literature review was performed using the PubMed database and the Cochrane Library (end-of-search date: January 27, 2019). The Newcastle-Ottawa scale and the Joanna Briggs Institute tool were used to assess the quality of cohort studies and case reports, respectively. We analyzed data from a total of 11 studies recruiting 7198 pediatric patients who underwent heart transplant. PPM implantation was performed in 1.9% (n = 137/7,198; 95% CI: 1.6-2.2) of the patients. Most patients underwent dual-chamber pacing (46%, 95% CI: 32.6-59.7). Male-to-female ratio was 1.3:1. Mean patient age at the time of OHT was 10.1 ± 6.3. Overall, biatrial anastomosis was used in 62.2% (95% CI: 52.8-70.6) of the patients. The bicaval technique was performed in the remaining 37.8% (95% CI: 29.4-47.1). Sinus node dysfunction was the most frequent indication for PPM implantation (54.4%; 95% CI: 42.6-65.7) followed by AV block (45.6%; 95% CI: 34.3-57.3). The median time interval between OHT and PPM implantation ranged from 17 days to 12.5 years. All-cause mortality was 27.9% (95% CI: 18.6-39.6) during a median follow-up of 5 years. PPM implantation is rarely required after pediatric OHT. The most common indication for pacing is sinus node dysfunction, and patients undergoing biatrial anastomosis may be more likely to require PPM.

Novel technologies for heart rate assessment during neonatal resuscitation at birth - A systematic review.

BACKGROUND: 6.5-9 million newborns worldwide require resuscitation at birth annually. During neonatal resuscitation, inaccurate or slow heart rate (HR) assessments may significantly increase risk of infant mortality or morbidity. Therefore fast, accurate, and effective HR assessment tools are critical for neonatal resuscitation. OBJECTIVE: To systematically review the literature about accuracy, latency, and efficacy of technologies for HR assessment during neonatal resuscitation. METHODS: Adhering to PRISMA guidelines, PubMed, EMBASE, and Google Scholar databases were systematically searched to identify studies related to technologies for HR assessment, which could be used to guide neonatal resuscitation. RESULTS: Forty-six studies evaluating HR assessment technologies for neonatal resuscitation were identified. In total, 16 studies (3/16 randomized trials and 13/16 observational studies) compared two or more HR assessment technologies to measure accuracy, latency, and efficacy. Of the trials, 1/3 had a low risk of bias while 2/3 had high risks. All observational studies had high risks of bias. Most studies considered infants not requiring resuscitation, constituting indirect evidence and lower certainty in the context of neonatal resuscitation. Two trials reported faster times to HR assessment using electrocardiogram with a mean(SD) 66(20) versus 114(39) s and a median(IQR) 24(19-39) versus 48(36-69) s (both p < 0.001), compared to pulse oximetry. CONCLUSION: While electrocardiography is faster to assess HR at birth and more reliable to detect HR changes compared to other recommended technologies, practice should not exclusively rely on ECG. While novel technologies could support HR assessment, no studies validate their clinical efficacy during neonatal resuscitation.

Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany.

Aim: This study evaluated the occurrence and associated costs of pacemaker complications in Germany from 2010 to 2013. Patients & methods: Patients with a de novo or replacement implantation of a single or dual chamber pacemaker between 2010 and 2013 were followed for 12 months post-implant using German health insurance claims data. A case-control analysis was performed using propensity score matching to estimate the costs of complications. Results: Out of 12,922 implanted patients, 12.0% had a complication in the year following the implant. Complications related to lead and pocket were found in 10.2% of all implanted patients; infections occurred in 1.7% patients. Healthcare costs up to 36 months post complication were on average €4627 higher than for pacemaker patients without a complication. Conclusion: Pacemaker complications are common and represent a burden for patients and healthcare systems generating substantial costs. Most of the pacemaker complications involved the pacing lead or pacemaker pocket.

Health care cost analysis of enhanced pacing modalities in bradycardia patients: Portuguese case study on the results of the MINERVA trial.

INTRODUCTION: The MINERVA trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduces progression to permanent atrial fibrillation (AF) in patients with paroxysmal or persistent AF and bradycardia who need cardiac pacing, compared to standard dual-chamber pacing (DDDR). It was shown that AF-related health care utilization was significantly lower in the DDDRP + MVP group than in the control group. Cost analysis demonstrated significant savings related to this new algorithm, based on health care costs from the USA, Italy, Spain and the UK. OBJECTIVE: To calculate the savings associated with reduced health care utilization due to enhanced pacing modalities in the Portuguese setting. METHODS: The impact on costs was estimated based on tariffs for AF-related hospitalizations and costs for emergency department and outpatient visits in Portugal. RESULTS: The MINERVA trial showed a 42% reduction in AF-related health care utilization thanks to the new algorithm. In Portugal, this represents a potential cost saving of 2323 euros per 100 patients in the first year and 17118 euros over a 10-year period. Considering the number of patients who could benefit from this new algorithm, Portugal could save a total of 75369 euros per year and 555410 euros over 10 years. Additional savings could accrue if heart failure and stroke hospitalizations were considered. CONCLUSION: The combination of atrial preventive pacing, atrial antitachycardia pacing and an algorithm to minimize the detrimental effect of right ventricular pacing reduces recurrent and permanent AF. The new DDDRP + MVP pacing mode could contribute to significant costs savings in the Portuguese health care setting.

Evidence for reduced susceptibility to cardiac bradycardias in South Asians compared with Caucasians.

OBJECTIVES: To investigate ethnic differences in susceptibility to bradycardias in South Asian and white European patients in the UK by determining rates of permanent pacemaker (PPM) implantation for sinus node dysfunction (SND) and atrioventricular block (AVB) in each ethnic group. METHODS: We carried out a retrospective cohort study into new PPM implantation during the period from 1 May 2006 to 31 March 2014, in patients of South Asian and Caucasian ethnicity resident in Leicestershire, UK. Numbers of individuals at risk in each ethnic group were derived from UK National Census data of 2011. Crude, and age-standardised incidence rates and risk ratios per 1000 population of PPM implantation were calculated for Caucasians and South Asians. RESULTS: During the study period, 4883 individuals from the Leicestershire population of 980 328 underwent PPM implantation, a cumulative implantation rate of 4.98/1000 population. The population cumulative PPM implantation rate for SND was 1.74/1000, AVB 2.83/1000 and other indications 0.38/1000 population. The crude incidence in Caucasians (6.15/1000 population) was higher than in South Asians (1.07/1000 population) and remained higher after age standardisation (5.60/1000 vs 2.03/1000, P<0.001). The age-standardised cumulative PPM implantation rates were lower in South Asians for both SND (0.53/1000 in South Asians; 1.97/1000 in Caucasians, P<0.001) and AVB (1.30/1000 in South Asians; 3.17/1000 in Caucasians, P<0.001). Standardised risk ratios (95% CI) for PPM implantation in South Asians compared with Caucasians for all pacing indications, SND and AVB were 0.36 (95% CI 0.36 to 0.37), 0.27 (95% CI 0.27 to 0.28) and 0.41 (95% CI 0.41 to 0.42), respectively. CONCLUSIONS: Rates of PPM implantation are lower in South Asians residing in the UK, compared with Caucasians. This observation raises the possibility of lower inherent susceptibility to bradycardias in South Asians compared with Caucasians. Studies aimed at identifying underlying mechanisms, including possible genetic differences, are warranted.

Economics of Home Monitoring for Apnea in Late Preterm Infants.

BACKGROUND: Apnea of prematurity affects a small proportion but large absolute number of late preterm infants, with out-patient management variably utilized despite relative clinical equipoise and potential for improved cost-effectiveness. METHODS: Over a 5-y period, from 2009 to 2013, infants born at ≥34 weeks gestational age at a level IIIB academic center in Boston, Massachusetts, with discharge-delaying apnea, bradycardia, and desaturation (ABD) events were identified. In-patient costs for discharge-delaying ABD events were compared with hypothetical out-patient management. Out-patient costs took into account 4-10 d of in-patient observation for ABD events before caffeine initiation, 3-5 d of additional in-patient observation before discharge, daily caffeine until 43 weeks corrected gestational age, home pulse oximetry monitoring until 44 weeks corrected gestational age, and consideration of variable readmission rates ranging from 0 to 10%. RESULTS: A total of 425 late preterm and term infants were included in our analysis. Utilization of hypothetical out-patient management resulted in cost savings per eligible patient ranging from $2,422 to $62, dependent upon variable periods of in-patient observation. Sensitivity analysis demonstrated few instances of decreased relative cost-effectiveness. CONCLUSIONS: Out-patient management of discharge-delaying ABD events in a late preterm and term population was a cost-effective alternative to prolonged in-patient observation.

Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation.

BACKGROUND: The optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited. OBJECTIVES: To determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions. SELECTION CRITERIA: We included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² <= 40%) and a random-effects model when heterogeneity was moderate or substantial (I² > 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables. MAIN RESULTS: We included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non-paroxysmal atrial fibrillation. We generally assessed the included studies as having low or unclear risk of bias across multiple domains, with reported outcomes generally lacking precision due to low event rates. Evidence showed that RFCA was superior to antiarrhythmic drugs in achieving freedom from atrial arrhythmias (RR 1.84, 95% CI 1.17 to 2.88; 3 studies, 261 participants; low-quality evidence), reducing the need for cardioversion (RR 0.62, 95% CI 0.47 to 0.82; 3 studies, 261 participants; moderate-quality evidence), and reducing cardiac-related hospitalisation (RR 0.27, 95% CI 0.10 to 0.72; 2 studies, 216 participants; low-quality evidence) at 12 months follow-up. There was substantial uncertainty surrounding the effect of RFCA regarding significant bradycardia (or need for a pacemaker) (RR 0.20, 95% CI 0.02 to 1.63; 3 studies, 261 participants; low-quality evidence), periprocedural complications, and other safety outcomes (RR 0.94, 95% CI 0.16 to 5.68; 3 studies, 261 participants; very low-quality evidence). AUTHORS' CONCLUSIONS: In people with non-paroxysmal atrial fibrillation, evidence suggests a superiority of RFCA to antiarrhythmic drugs in achieving freedom from atrial arrhythmias, reducing the need for cardioversion, and reducing cardiac-related hospitalisations. There was uncertainty surrounding the effect of RFCA with significant bradycardia (or need for a pacemaker), periprocedural complications, and other safety outcomes. Evidence should be interpreted with caution, as event rates were low and quality of evidence ranged from moderate to very low.

Clinical and genetic predictors of major cardiac events in patients with Anderson-Fabry Disease.

BACKGROUND: Anderson-Fabry Disease (AFD) is an X linked lysosomal storage disorder caused by mutations in the α-galactosidase A gene. Some mutations are associated with prominent and, in many cases, exclusive cardiac involvement. The primary aims of this study were to determine the incidence of major cardiac events in AFD and to identify clinical and genetic predictors of adverse outcomes. METHODS AND RESULTS: We studied 207 patients with AFD (47% male, mean age 44 years, mean follow-up 7.1 years). Fifty-eight (28%) individuals carried mutations that have been previously associated with a cardiac predominant phenotype. Twenty-one (10%) developed severe heart failure (New York Heart Association functional class (NYHA) ≥3), 13 (6%) developed atrial fibrillation (AF), 13 (6%) received devices for the treatment of bradycardia; there were a total of 7 (3%) cardiac deaths. The incidence of the primary endpoint (a composite of new onset AF, NYHA ≥ 3 symptoms, device insertion for bradycardia and cardiac death) was 2.64 per 100 person-years (CI 1.78 to 3.77). Age (HR 1.04, CI 1.01 to 1.08, p=0.004), Mainz Severity Score Index score (HR 1.05, CI 1.01 to 1.09, p=0.012) and QRS duration (HR 1.03, CI 1.00 to 1.05, p=0.020) were significant independent predictors of the primary endpoint. The presence of a cardiac genetic variant did not predict the primary end point. CONCLUSIONS: AFD is associated with a high burden of cardiac morbidity and mortality. Adverse cardiac outcomes are associated with age, global disease severity and advanced cardiac disease but not the presence of cardiac genetic variants.

Effects of enhanced pacing modalities on health care resource utilization and costs in bradycardia patients: An analysis of the randomized MINERVA trial.

BACKGROUND: Many patients who suffer from bradycardia and need cardiac pacing also have atrial fibrillation (AF). New pacemaker algorithms, such as atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), have been specifically designed to reduce AF occurrence and duration and to minimize the detrimental effects of right ventricular pacing. The randomized MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that DDDRP + MVP pacing modality reduced permanent AF in bradycardia patients as compared with standard dual-chamber pacing (DDDR). OBJECTIVE: The aim of this study was to estimate the cost savings due to lower AF-related health care utilization events based on health care costs from the United States and the European Union. METHODS: Dual-chamber pacemaker patients with a history of paroxysmal or persistent AF were randomly assigned to receive DDDR (n = 385) or the advanced features (DDDRP + MVP; n = 383). We used published health care costs from the United States and the European Union (Italy, Spain, and the United Kingdom) to estimate the costs associated with AF-related hospitalizations and emergency visits. RESULTS: The rate of AF-related hospitalizations was significantly lower in the DDDRP + MVP group than in the conventional pacemaker group (DDDR group; 42% reduction; incidence rate ratio 0.58). Similarly, a significant reduction of 68% was observed for AF-related emergency department visits (incidence rate ratio 0.32; P < .001). As a consequence, DDDRP + MVP could potentially reduce health care costs by 40%-44%. Over a ten-year period, the cost savings per 100 patients ranged from $35,702 in the United Kingdom to $121,831 in the United States. CONCLUSION: New pacing algorithms such as DDDRP + MVP used in the MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial successfully reduced AF-related health care utilization, resulting in significant cost savings to payers.

Arrhythmic burdens in patients with tetralogy of Fallot: a national database study.

BACKGROUND: Tetralogy of Fallot (TOF) is a common cyanotic congenital heart disease with increasingly recognized late morbidity. OBJECTIVE: The purpose of this study was to explore the long-term outcome by using a national database of Taiwan, a country with national health insurance and easily accessible medical care. METHODS: Data on TOF patients were retrieved from database records from 2000 to 2010. Complications and therapies were identified by their respective codes. RESULTS: We identified 4781 TOF patients (prevalence 0.63/1000 in pediatric patients and 0.06/1000 in adult patients). Arrhythmias were identified in 219 patients (8.3% for adult patients and 2.8% for pediatric patients): 160 tachycardia and 59 bradycardia (4 with tachy-bradycardia syndrome). The occurrence of arrhythmias was associated with higher mortality (excluding cardiac surgical death, 15.6% vs 8.6%, P = .001). Patients with atrial fibrillation were the oldest (median age 44.3 years), followed by those with tachy-bradycardia syndromes (32.4 years) and atrial flutter (31.5 years). The incidence of nonperioperative tachycardia increased with age (1.4%, 1.7%, 3.3%, 5.2%, 10.2%, and 16.9% in age group 0-9, 10-19, 20-29, 30-39, 40-49, and ≥50 years, respectively). Tachycardia therapy (ablation and implantable cardioverter-defibrillator) was administered in 20.4% (annually 2.4%) of patients with nonperioperative tachycardia. In the subgroup born 2000-2010 with complete postnatal data, mortality was 15.1% (296/1960), and 1-, 5-, and 10-year survival was 0.911, 0.826, and 0.788, respectively. Risk of atrioventricular block requiring a pacemaker was 0.6%. CONCLUSION: Arrhythmias are common in TOF patients and increase mortality risk. Medical needs because of tachycardia often appear late in adulthood.

Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.

AIMS: Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). METHODS AND RESULTS: In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004). CONCLUSION: In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF. CLINICALTRIALSGOV IDENTIFIER: NCT00262119.

Assessment and treatment of patients with acute unstable bradycardia.

Bradycardia is a slow heart rate that can lead to cardiac arrest or occur after initial resuscitation following cardiac arrest. This article provides information on acute unstable bradycardia and common arrhythmias. It focuses on the assessment of patients with acute bradycardia and how the presence or absence of adverse clinical features, in conjunction with an arrhythmia, dictates the necessity and choice of treatment.

Long term quality-of-life in patients with bradycardia pacemaker implantation.

BACKGROUND: Health-related quality of life (HRQoL) values shortly after pacemaker (PM) implantation for bradycardia have been established, however little is known about long-term HRQoL. METHODS: Using the generic SF-36 and the PM specific Aquarel questionnaire, HRQoL was repeatedly measured during a 7.5 year follow-up period in 881 bradycardia PM recipients included in the large scale nationwide Dutch FOLLOWPACE study. HRQoL over time, corrected for age, gender, diabetes, hypertension, heart failure, cardiovascular disease and AV-synchrony, was assessed with a linear mixed model. RESULTS: Increased scores both on overall SF-36 and on all SF-36 subscales were observed shortly after implantation. Although scores on SF-36 gradually declined over time, scores remained improved over the measured pre-implantation values. Also, scores for almost all subscales remained increased throughout the 7.5 year observation period, except for physical functioning which showed a gradual decline several years after the initial rise. Additionally, higher scores on all Aquarel scales were observed after implantation. Scores on the arrhythmias and chest discomfort subscales improved and remained stable throughout follow-up (FU), whereas the dyspnea at exertion subscale showed a gradual decline during FU to reach pre-implantation values at 5 years. CONCLUSIONS: Increased HRQoL is observed not only shortly after PM implantation, but also after long-term FU. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00135174; http://www.clinicaltrials.gov/ct2/show/NCT00135174.

Management of arrhythmias in the perioperative setting.

Perioperative arrhythmias are a common complication of surgery, with incidence ranging from 4% to 20% for noncardiothoracic procedures, depending on the type of surgery performed. The immediate postoperative period is a dynamic time and is associated with many conditions conducive to the development of postoperative arrhythmias. The presence of postoperative atrial fibrillation is associated with increased morbidity, ICU stay, length of hospitalization, and hospital costs. The associated burdens are expected to rise in the future, given that the population undergoing cardiac surgery is getting older and sicker. Thousands of patients undergo major surgery each year and a major complication of these procedures is the occurrence of perioperative arrhythmia. It is imperative for clinicians to be up-to-date on current management of these arrhythmias.