Predictors of improved quality of life 1 year after pacemaker implantation.

BACKGROUND: Patient's health-related quality of life (HRQoL) of pacemaker (PM) patients has increasingly become an important issue of health care evaluation. Currently, knowledge of pacing performance and technology is more or less outlined. However, determinants of poor or good HRQoL of paced patients require further elucidation. OBJECTIVES: The purpose of this study is to determine the HRQoL 1 year after PM implantation and predictors of differences in HRQoL between pre- and post-PM implantation. METHODS: We quantified the mean differences between HRQoL before implantation (baseline) and 1 year later, assessed with the generic Medical Outcomes Survey 36-Item Short-Form Survey and EuroQol (EQ5D), and the PM patient-specific AQUAREL (Assessment of QUality of life And RElated events) questionnaires, in 501 consecutively included patients in the Dutch multicenter longitudinal FOLLOWPACE cohort study. Multivariable linear regression modeling was then performed to determine predictive factors of the HRQoL 1 year after implantation. RESULTS: The HRQoL of the patients increased markedly in the first year after implantation. Seventy percent of the patients considered their health improved, whereas 11% experienced a complete recovery in HRQoL. The most important predictors for improved HRQoL after 1 year were HRQoL at baseline, age, presence of cardiac comorbidities, and atrial fibrillation with slow ventricular response as indication for chronic pacing. CONCLUSION: In most patients receiving a PM, HRQoL increased in the first year after PM implantation. Knowledge of the predictors of this increase may aid physicians to timely differentiate between patients who most likely will benefit most from PM implantation in terms of HRQoL.

Poor health-related quality of life of patients with indication for chronic cardiac pacemaker therapy.

BACKGROUND: Studies on health-related quality of life (HRQoL) of patients awaiting pacemaker (PM) implantation are scarce, or executed in specific patient subgroups (regarding age or specific cardiac rhythm disorders). The purpose of this study was to systematically assess the HRQoL in a large unselected cohort of patients with a conventional indication for PM therapy. METHODS: Pre-PM implantation HRQoL (measured with the SF-36 questionnaire, completed at hospital admission) of 818 consecutive Dutch patients included in the FOLLOWPACE study was compared with the HRQoL in a sample of the general Dutch population, and with several cohorts of patients with other conditions. Linear regression analysis was performed to analyze determinants of this HRQoL. RESULTS: Almost all SF-36 subscale scores were substantially and significantly lower in the PM patients compared to the general population, with P-values < 0.001 in all SF-36 subscales except for "pain" and "general health perception." In the PM patients, presence of comorbidities, gender, and age were significantly associated with the overall physical component summary score (mean 38.8 +/- 27 standard deviation) whereas the overall mental component summary score (46.8 +/- 27.0) was associated with gender and age. CONCLUSION: The HRQoL of patients before first PM implantation is significantly lower than that of a general population and also various other patient populations. Physicians should be aware of this unfavorable condition and keep the time interval between the diagnosis of a cardiac rhythm disorder requiring PM implantation and the implantation procedure as short as possible.

No evidence of automatic atrial overdrive pacing efficacy on reduction of paroxysmal atrial fibrillation.

AIMS: Paroxysmal atrial fibrillation (PAF) is frequently encountered in pacemaker patients, most commonly in sick sinus syndrome. The combination of site-specific pacing in conjunction with an overdrive algorithm combined with antiarrhythmic drugs on the incidence of PAF in patients with a conventional indication for pacing is unknown. METHODS AND RESULTS: Patients with pacemaker indication and PAF received a DDDR-pacemaker, which included an automatic atrial overdrive (AO) algorithm. The atrial lead was implanted in either the right atrial appendage (RAA) (n = 83) or the right low-atrial septum (LAS) (n = 94). The algorithm was switched on or off in a 3 month, single blind crossover design and antiarrhythmic drugs were kept stable. A control group of 96 patients (LAS, n = 14; RAA, n = 84) without PAF served as controls to assess any proarrhythmic effect of overdrive pacing. Atrial fibrillation (AF) burden defined as cumulative time in mode switch was not reduced during automatic AO from either the RAA or from the LAS. The reduction was not effective both for AF of short (<24 h) and long (> or =24 h) duration. There was no atrial proarrhythmia induced by the overdrive algorithm in the control group. CONCLUSIONS: We could not demonstrate a reduction of AF burden defined as cumulative time in AF by the AO algorithm, in patients who are paced for standard indications and PAF, neither from the RAA nor from the LAS.

A technique of lead insertion for low atrial septal pacing.

BACKGROUND: Pacing in the low right atrial septum (LAS) appears superior to right atrial appendage or free wall stimulation for the prevention of paroxysmal atrial fibrillation. However, insertion of active fixation lead in the low right atrial septal position is difficult and time consuming, inhibiting application of this pacing method in daily practice. METHODS: The technique of handling and positioning of a new "over the wire" lead system is presented with emphasis on electrocardiographic P wave pattern and fluoroscopic landmarks. RESULTS: The initial results demonstrate an acute implantation and short-term success of LAS pacing of >90% in the first 100 patients without major complications. Pacing thresholds at 3 and 6 months were fully comparable with that of the conventional atrial pacing, whereas impedance and atrial sensing signals were significantly higher at 3 and 6 months follow-up. CONCLUSION: These favorable initial results justify recommanding chronic LAS pacing with the active fixation atrial lead and providinge guidelines and fluoroscopic landmarks for the implantation. Insertion of the atrial active fixation lead positioned with the Locatortrade mark tool strongly supports the implantation procedure.

Electrical characteristics of low atrial septum pacing compared with right atrial appendage pacing.

AIM: The study was designed to compare the electrical characteristics of atrial leads placed in the low atrial septum (LAS) with those placed in the right atrial appendage (RAA) associated with dual chamber pacing. METHODS: In 86 patients an active-fixation (St. Jude Medical's Tendril DX model 1388T) atrial lead was positioned in RAA and in 86 patients the same model atrial lead was placed in the LAS. Pacing thresholds, sensing thresholds, impedances and the Far Field paced R-Wave (FFRW) amplitude and timing were compared at 6 weeks and at 3 and 6 months. RESULTS: The pacing threshold did not differ between groups. Sensed voltage of the P-wave was higher in the LAS compared with the RAA at 3 and 6 months (P=0.004). Impedance was higher in the LAS at 6 weeks and 3 months (P=0.002) but this difference was no longer significant at 6 months (P=0.05). The atrial sensed FFRW voltage was significantly higher in the LAS position compared with the RAA at 3 and 6 months follow-up (P=0.0002). FFRW voltage>1 mV was seen in 87% of the RAA pacing group and in 94% of the LAS pacing group (P=ns). The time between the ventricular pacing stimulus and the sensed FFRW in the atrium, (V spike-FFRW) in RAA was longer than in LAS at all follow-up measurements (P=0.006). CONCLUSIONS: The electrical characteristics of LAS pacing makes this alternative position in the atrium safe and feasible. Though statistical differences were found in P-wave sensing (LAS higher voltage than in the RAA) and FFRW sensing was higher in the LAS compared with the RAA this did not interfere with the clinical applicability of the LAS as alternative pacing site.

Clinical and angiographic safety and efficacy trial with a new coronary stent: the RESTOR study of the R Stent.

The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a significant single, de novo coronary lesion (average reference vessel diameter 2.84 +/- 0.54 mm, average lesion length 10.53 +/- 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin greater than or equal to 100 mg/day. The angiographic success rate (< 30% diameter stenosis post-procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic follow-up at 6 months. Minimal lumen diameter pre-/post-procedure and at follow-up was 0.98 +/- 0.37, 2.64 +/- 0.38 and 1.85 +/- 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.