Variability of cardiac output as determined by impedance cardiography in pacemaker patients.

Hemodynamic assessment of pacemaker patients is necessary for gauging responses to changes in programming or other conditions affecting circulation. Impedance cardiography permits noninvasive determinations of cardiac output at short intervals but data regarding variability of this method in patients with pacemakers is unavailable. Thirty-eight patients with pacemakers (24 with DDD and 14 with VVI devices) and 6 normal subjects were studied. Each patient was studied in the supine position and repeated impedance measurements were obtained. Fourteen patients were studied during sinus rhythm, 24 were studied during DDD pacing, and 32 patients were studied during VVI pacing. Variability was assessed by methods that analyzed both serial measurements and variability between 2 consecutive and nonconsecutive measurements. The mean indexes and coefficients of variation of 2 and serial measurements in sinus rhythm and DDD were 4%; in VVI it was 6%. The precision of impedance cardiography in all pacing modes, as demonstrated by analysis of variability, indicates that detected changes of stroke volume and cardiac output > 7% on serial (2 and more) measurements, performed by the same operator and during the same session, represent true hemodynamic alterations with 95% confidence. The precision of impedance cardiography demonstrated may be comparable or superior to other frequently used techniques, and the data obtained are valuable both investigationally and clinically.

Long-term follow-up of pacemaker lead systems: establishment of standards of quality.

The functional details of all 5,405 pacemaker leads implanted on Montefiore Medical Center were contemporaneously recorded between 1960 and May 31, 1993. Some models have been observed for as long as 24 years. Ventricular leads with more than 50 and atrial leads with more than 30 implanted units have been continually and repeatedly subjected to actuarial cumulative survival rate (CSR) analysis during which clinical decisions, such as continued lead implantation, cessation of use, or early withdrawal from service, were made. CSR evaluation for many lead models by the Mantel-Haenszel method allowed comparison of the performance of contemporaneous lead models with older and new technologies. No effect on lead longevity, durability, on mode of end of lead service, lead removal independent of function (e.g., for infection), materials, or physiological failure was found due to an operator or anatomical route of venous access. Multifilar silicone rubber insulated leads have longevity (CSR) superior to monofilar silicone rubber leads. The cumulative survival of silicone rubber insulated monofilar models 6901, 6907, continuous lead (CL), 4 mm, and 2 mm was 79%-91%, 20 years after implantation. Multifilar silicone rubber insulated models 6961 and 4116 had a cumulative survival of 99%-100%, 15 years after implantation. Among multifilar polyurethane insulated leads, distinct longevity differences exist between formulations and contemporaneous models that are normally similar, yielding a bimodal longevity distinction; model 6971 (ventricular) has 95% CSR and 6991U (atrial) has 94% CSR, 10 years after implantation. Both performed less well than other contemporaneous models, which approximate 100% CSR. The 10-year CSR for leads implanted between 1960-1975 (Era 1) is 98.7%, and the 10-year CSR of leads implanted between 1981-1985 (Era 3) is 99.4%. Comparison of individual lead models, and all leads of specific eras, allows development of survival expectations and standards of quality for comparison between contemporaneous lead models and different eras of manufacture. As the highest available lead CSR sets the standard, statistical deviation of a model from the best performance of a specific era should be considered as an indication of reduced quality.

The clinical relevance of electromyopotential oversensing in current unipolar devices.

UNLABELLED: Electromyopotential oversensing of unipolar pacemakers was first appreciated 20 years ago, but its prevalence in present day devices is less well defined. Thirty-four pacemaker patients, only two with symptoms suggestive of oversensing, were evaluated in unipolar settings to assess the frequency of provocation of oversensing in one or, if present, both pacing channels. The sensing threshold of each patient, whenever possible, was recorded as well. RESULTS: Atrial oversensing occurred in 11/18 patients (61%), all at sensitivities in the 0.4-1.0 mV range. Ventricular oversensing was noted in 13/33 patients (39%), with all but one programmed to settings of 1.25 mV or more sensitive (i.e. < 1.25 mV). Twenty six of 26 patients amenable to testing had ventricular sensing thresholds of at least 4.0 mV or more. Of the 15 patients amenable to atrial sensing threshold testing, 4 had a threshold of 1.0 mV or < 1.0 mV, 6 had thresholds between 1.0-2.0 mV, and 5 sensed at settings > 2.0 mV. CONCLUSION: Electromyopotential oversensing remains a relevant issue in current day unipolar pacemakers. Most patients do not describe symptoms related to electromyopotential interference, yet such interference is frequently provoked. Oversensing is common at high sensitivities typically utilized for atrial sensing, but quite unusual at settings necessary for adequate ventricular sensing. Programming unipolar devices to unnecessarily high sensitivities should be avoided or serious consequences may result.