Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis.

BACKGROUND: The recent introduction of leadless pacemakers (PMs) was aimed to eliminate transvenous lead- and pocket-related complications. While the initial results with the leadless PMs seem promising, the nonrandomized nature, limited implant experience of operators, and short follow-up period of these studies preclude a simple comparison to transvenous PMs. OBJECTIVES: The objective of this study was to provide a balanced comparison of leadless and transvenous single-chamber PM therapies through a propensity score-matched analysis. METHODS: Leadless patients from 3 experienced leadless implant centers were propensity score-matched to VVI-R patients from a contemporary prospective multicenter transvenous PM registry. The primary outcome was device-related complications that required invasive intervention during mid-term follow-up. Separate analyses including and excluding PM advisory-related complications were performed. RESULTS: A total of 635 patients were match-eligible (leadless: n = 254; transvenous: n = 381), of whom 440 patients (median age 78 years; interquartile range 70-84 years; 61% men) were successfully matched (leadless: n = 220 vs transvenous: n = 220). The complication rate at 800 days of follow-up was 0.9% (95% confidence interval [CI] 0%-2.2%) in the leadless group vs 4.7% (95% CI 1.8%-7.6%) in the transvenous group when excluding PM advisory-related complications (P = .02). When including these PM advisory-related complications, the complication rate at 800 days increased to 10.9% (95% CI 4.8%-16.5%) in the leadless group vs 4.7% (95% CI 1.8%-7.6%) in the transvenous group (P = .063). CONCLUSION: This study reveals favorable complication rates for leadless compared to transvenous single-chamber pacing therapy at mid-term follow-up in a propensity score-matched cohort. When including PM advisory-related complications, this advantage is no longer observed.

Risk of heart failure- and cardiac death gradually increases with more right ventricular pacing.

BACKGROUND: Right ventricular pacing (RVP) is associated with an increased risk of heart failure (HF) events. However, the extent and shape of this association is hardly assessed. OBJECTIVE: We quantified whether the undesired effects of RVP are confirmed in an unselected population of first bradycardia pacemaker recipients. Furthermore, we studied the shape of the association between RVP and HF death and cardiac death. METHODS: Cumulative percentage RVP (%RVP) was measured in 1395 patients. Using multivariable Cox regression analysis with %RVP as time-dependant co-variate we evaluated the association between %RVP and HF- and cardiac death, both unadjusted and adjusted for confounders, including age, gender, pacemaker-indication, cardiac disease, HF at baseline, diabetes, hypertension, atrio-ventricular synchrony, usage of beta-blocking drugs, anti-arrhythmic medication, HF medication, and prior atrial fibrillation/flutter. Non-linear associations were evaluated with restricted cubic splines. RESULTS: During a mean follow-up of 5.8 (SD 1.1) years 104 HF deaths and 144 cardiac deaths were observed. %RVP was significantly associated with HF- and cardiac death in both unadjusted (p<0.001 and p<0.001, respectively) and adjusted analyses (p=0.046 and p=0.009, respectively). Our results show a linear association between %RVP and HF- and cardiac death. We observed a constant increase of 8% risk of HF death per 10% increase in RVP. A model incorporating various non-linear transformations of %RVP using restrictive cubic splines showed no improved model fit over linear associations. CONCLUSION: This long-term, prospective study observed a significant, though linear association between %RVP and risk of HF death and/or cardiac death in unselected bradycardia pacing recipients.

Prognosis of the bradycardia pacemaker recipient assessed at first implantation: a nationwide cohort study.

OBJECTIVE: Pacing technology and care have improved notably over the past decade, justifying an update on the long-term prognosis and pre-implantation determinants of prognosis of bradycardia pacemaker (PM) recipients. DESIGN: Prospective cohort study. SETTING: 23 Dutch pacemaker centres PATIENTS: Pre-implantation characteristics of 1517 patients receiving a first bradycardia PM between 2003-2007 were studied in relation to survival. INTERVENTIONS: None; patients were followed up during routine clinical practice. MAIN OUTCOME MEASURES: Cause and time to death. RESULTS: At the end of a mean follow-up of 5.8 (SD 1.1) years, 512 patients (33%) died, mostly of non-cardiac cause (67%). There were two PM related deaths. Survival rates were 93%, 81%, 69%, and 61% after 1, 3, 5 and 7 years, respectively. PM recipients without concomitant cardiovascular disease at implantation showed survival rates comparable to age and sex matched controls. Predictors at time of implantation associated with cardiac mortality were: age, coronary artery disease (CAD), diabetes, heart failure, valve disease, and the indication for PM implantation. Predictors for all cause mortality were: male gender, age, body mass index, CAD, cardiac surgery, diabetes, heart failure, and maintained atrioventricular synchrony. CONCLUSIONS: A pre-implantation history of heart failure, CAD, and diabetes are the most important predictors for worse prognosis in PM recipients. Without baseline heart disease, survival rates equal that of the general population, suggesting that the prognosis of contemporary PM recipients is mainly determined by comorbid diseases and a bradycardia pacing indication as such does not influence survival. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00135174.

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.

Incidence and predictors of pacemaker reprogramming: potential consequences for remote follow-up.

AIMS: Remote follow-up (FU) enables to cope with the expanding number of pacemaker (PM) FU. Although remote FU offers comparable monitoring options to in-office FU, reprogramming of device settings is not available, thereby imposing a potentially important restriction to the applicability of remote FU.  The aim of this study was to assess in a large cohort of bradycardia PM recipients, the incidence of PM reprogramming during long-term FU and its predictors, to judge the possibilities for remote FU. METHODS AND RESULTS: Between 2003 and 2010 all in-office FU of 1517 bradycardia PM recipients included in the FOLLOWPACE study were recorded. Only 24.5% of all 13 258 recorded FU visits >3 months after implantation were visits-with-reprogramming (VWRs), occurring in 1158 patients (79%). Fifty percent of patients were free of reprogramming at 9 months, and 29% at 24 months. Using multivariable binary logistic regression analysis, the following patient characteristics were predictive for frequent PM reprogramming, defined as >3 VWRs during 3 year FU: age, a history of atrial arrhythmias, PM complication <3 months after implantation, congestive heart failure, PM indication, and lead fixation method. This model had a receiver operating characteristic area of 0.66 (95% confidence interval 0.61-0.71). CONCLUSION: This study observed a low proportion of VWR (∼25%) during a mean FU of 5.3 years; however, those patients at high risk for PM reprogramming cannot easily be predicted. The vast majority of patients (>80%) do not need frequent reprogramming, suggesting a potential benefit of using remote FU to reduce the number of unnecessary in-office visits.

Pacemaker follow-up: are the latest guidelines in line with modern pacemaker practice?

AIMS: Guidelines regarding pacemaker (PM) follow-up (FU) are not precisely defined. The study aim is to describe long-term routine in-hospital FU, evaluate compliance to guidelines, and assess the portion of visits-with-an-action (VWA). METHODS AND RESULTS: The multicentre prospective FOLLOWPACE study collected data in the period 2003-2010, regarding FU of 1517 patients with a first PM for bradycardia indications in 23 Dutch hospitals. A total of 15 472 visits were analysed with a median FU of 4.9 years, adding up to 6750 patient years. The median time to the first three visits was 35, 127, and 303 days, respectively. Thereafter the median interval between visits was 180 days. Most patients had 2 FU/year, 22% had 1 FU/year, and 18% had >3 FU/year. Seventy-three percent of patients with single-chamber PMs had at least 1 FU/year, whereas 36% of patients with dual-chamber PMs received at least 2 FU/year. During the first year, 52% of visits were VWA, as opposed to 17% after 6 years. Battery status was assessed in 98%, and stimulation and sensing thresholds in 90% and 77% of visits, respectively. Reprogramming markedly declined from ≈ 60% in the first FU visit to 10-20% after the fifth visit. CONCLUSION: Although the measurements during PM FU are according to guidelines, the frequency of FU is not. Moreover, in the vast majority of performed FU, PM programming is left unchanged. This suggests that a large portion of FU visits is redundant, such that their frequency after the first year can be diminished, or replaced by remote FU.

Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.

BACKGROUND: Today quantitative information about the type of complications and their incidence during long-term pacemaker (PM) follow-up is scarce. OBJECTIVE: To assess the incidence and determinants of short- and long-term complications after first pacemaker implantation for bradycardia. METHODS: A prospective multicenter cohort study (the FOLLOWPACE study) was conducted among 1517 patients receiving a PM between January 2003 and November 2007. The independent association of patient and implantation-procedure characteristics with the incidence of PM complications was analyzed using multivariable Cox regression analysis. RESULTS: A total of 1517 patients in 23 Dutch PM centers were followed for a mean of 5.8 years (SD 1.1), resulting in 8797 patient-years. Within 2 months, 188 (12.4%) patients developed PM complications. Male gender, age at implantation, body mass index, a history of cerebrovascular accident, congestive heart failure, use of anticoagulant drugs, and passive atrial lead fixation were independent predictors for complications within 2 months, yielding a C-index of 0.62 (95% confidence interval 0.57-0.66). Annual hospital implanting volume did not additionally contribute to the prediction of short-term complications. Thereafter, 140 (9.2%) patients experienced complications, mostly lead-related complications (n = 84). Independent predictors for long-term complications were age, body mass index, hypertension, and a dual-chamber device, yielding a C-index of 0.62 (95% confidence interval 0.57-0.67). The occurrence of a short-term PM complication was not predictive of future PM complications. CONCLUSIONS: Complication incidence in modern pacing therapy is still substantial. Most complications occur early after PM implantation. Although various patient- and procedure-related characteristics are independent predictors for early and late complications, their ability to identify the patient at high risk is rather poor. This relatively high incidence of PM complications and their poor prediction underscores the usefulness of current guidelines for regular follow-up of patients with PM.

Long-term outcome of cardiac pacing in octogenarians and nonagenarians.

AIMS: The number of patients >80 years receiving pacemakers (PMs) is increasing. Little is known about survival and complications in this specific subgroup. We aim to determine predictors of long-term survival. METHODS AND RESULTS: Pacemaker-related complications and death occurring in patients receiving a first PM for conventional bradycardia indications were systematically documented (the FollowPace registry). This report describes 481 patients ≥80 years during a mean follow-up of 5.8 (SD 1.2) years. Within 2 months 54 PM complications occurred in 47 patients (9.8%). During follow-up, 35 adverse PM events were reported in 33 patients (6.9%). Complication rates in patients ≥80 years were comparable with those for patients <80 years. Survival rates were 86, 75, and 49% after 1, 2, and 5 years, respectively, and were comparable with survival for age- and sex-matched controls from the general Dutch population. Most patients died of non-cardiac causes. Age at the time of implantation, male gender, the presence of congestive heart failure, coronary pathology, and diabetes mellitus were independent predictors of all-cause mortality. CONCLUSION: This large study of long-term cardiac pacing for bradycardia in octogenarians and nonagenarians showed a cumulative 5-year survival of ~50%, which compares with that of age- and sex-matched controls. These data suggest a beneficial impact of bradycardia pacing, restoring life expectancy to previous levels. The occurrence of PM complications during long-term follow-up is not infrequent with 18.1% of patients experiencing a PM-related complication during a mean of 5.8 years follow-up. The complication rate was not higher than in younger PM patients.