Biomedical subjects
G Pioger
Publications and source records attributed to G Pioger.
Circadian variations in minute ventilation can be reproduced by a pacemaker sensor.
Special software allowing the memorization of 24-hour minute ventilation can be loaded into the memory of the Chorus RM, a DDDR pacemaker driven by minute ventilation. This feature was tested in the postimplant period in 13 patients. Measurements of minute ventilation, respiratory rate, and respiratory amplitude were analyzed according to prospectively defined diurnal and nocturnal time periods. Minute ventilation decreased by 39% (P < 0.001) from the diurnal to the nocturnal phase, while respiratory rate and amplitude decreased by 18% and 28%, respectively (P < 0.001 each). Thus, minute ventilation allowed discrimination between sleep and waking hours. This information could be utilized to modulate the backup rate of the pacemaker.
Automatic adaptation of the basic pacing rate in response to minute ventilation. Chorum French Investigational Group.
Rate responsive pacing based on minute ventilation (VE) correlates highly with metabolic demand. This type of sensing also recognizes extended periods of rest. The Chorum pacemaker includes a rate responsive algorithm that modulates the basic rate according to phases of activity versus sleep. Forty-six patients (mean age 78 +/- 15), received a Chorum pacemaker for atrioventricular block in 17 cases, sick sinus syndrome in 25, and mixed disorders in 4. Holter monitoring was performed to analyze to heart rate and to examine the circadian adaptation of the minimal pacing rate. The mean basic rate was programmed at 63 +/- 5 beats/min, and the sleep rate at 52 +/- 4 beats/min. Seventeen patients had spontaneous heart rates consistently above the programmed basic rate, and 6 had sustained supraventricular tachyarrhythmias. One-half of the patients had periods of pacing at the programmed sleep rate. The mean diurnal pacing rate was 68 +/- 5 beats/min compared to a mean nocturnal rate of 60 +/- 4 beats/min (P < 0.0001). The average time spent at the basic rate was 37 +/- 30 min (0-110) during daytime (4%), versus 242 +/- 153 min (20-477) at night (45%, P < 0.0001). No adverse effect was observed in this patient population. VE allows a reliable detection of the sleeping periods as well as an adjustment of the basic rate in accordance. Caution is advised in cases of bradycardia dependent tachyarrhythmias.
Measurement of minute ventilation with different DDDR pacemaker electrode configurations. Investigators of a Multicenter Study Evaluating the Chorus RM and Opus RM Pacemakers.
A rate responsive minute ventilation (VE) pacemaker was implanted in 49 patients (70.8 +/- 40.0 years). A Chorus RM 7034 pacemaker was implanted in 43 patients and an Opus RM 4534 in six patients. Four sensor configurations were compared: atrial configuration (bipolar atrial lead) in 34 patients; ventricular configuration (bipolar ventricular lead) in 6 patients; unipolar configuration (double unipolar leads) in 6 patients; and floating configuration (VDD single-pass lead) in 3 patients. The patients carried out 57 exercise tests in all with cardiopulmonary recording (CPX). Real VE and oxygen consumption (VO2) were recorded by the CPX, the VE measured by the sensor (VEsensor) was recorded in the pacemaker memory. The mean correlation between VE and VEsensor was 0.90 +/- 0.08 (P < 0.001) and between VO2 and VEsensor was 0.86 +/- 0.10 (P < 0.001). The mean correlation between VE and VEsensor by configuration type were as follows: atrial configuration = 0.89 +/- 0.08; ventricular configuration = 0.95 +/- 0.05; unipolar configuration = 0.87 +/- 0.14; and floating configuration = 0.88 +/- 0.05. In conclusion, VE may be reliably measured using different electrode configurations. A study conducted in a larger population should allow one to conclude that unipolar electrodes can be used in VDDR, AAIR, VVIR, or DDDR modes to measure VE.
Value of automatic processing and reliability of stored data in an implanted pacemaker: initial results in 59 patients.
Stored data in implantable pacemakers have rarely been used as a diagnostic tool because of the complexity. Our group has developed software called AIDA, providing an automatic interpretation of data stored in memories of the Chorus (ELA medical) pacemaker. We compared the results of AIDA analysis to surface ECG Holter interpretation in 59 patients (age 75 +/- 9 years). In 33 cases, neither AIDA nor the Holter found any anomaly. Eleven patients demonstrated episodes of supraventricular tachycardia (SVT), confirmed by AIDA in ten patients; AIDA failure was due to nonsustained episodes of SVT not inducing mode switch. Loss of atrial sensing, pacemaker-mediated tachycardia, and ventricular extrasystoles were detected by AIDA in ten patients. Traditional Holter missed three cases. This initial study confirms that stored pacemaker data, automatically interpreted can provide reliable information over a 24-hour period.
Ventricular protection against atrial arrhythmias in DDD pacing based on a statistical approach: clinical results.
Atrial arrhythmias (AA) are commonly encountered in DDD paced patients. Newer dual chamber pacemakers (PM) possess mode switching functions that convert pacing to an asynchronous mode when AAs are detected. The lack of a reliable mode switch leading to rapid, irregular ventricular responses may result from AA undersensing. To avoid this the DDDR PM Chorum 7234 Ela Medical AA diagnosis is based on a statistical approach: the PM constantly compares arrhythmic and sinus cycles and, based on "strong" and "weak" criteria, provides for rapid or slower mode switch. The aim of the study was to evaluate the efficiency and reliability of these two criteria. Thirty-one patients with a Chorum 7234 implanted for AV block (11), sinus dysfunction (10), both (5), or hypertrophic obstructive cardiomyopathy (5) were evaluated at 24 hours and 1 month using the internal memory (IM) of the PM, surface 24-hour Holter recordings, and exercise testing. Interrogation of the IM on the first day of study showed that 8 patients had mode switching episodes, based only on the strong criterion confirmed by the surface Holter recording. At 1 month, the IM revealed mode switching episodes in 12 patients, 6 of whom had used the weak criterion. No inappropriate mode switching episodes was recorded during exercise testing at the 1-month follow-up. These results confirm the reliability and efficiency of this algorithm as well as the requirement for a specific algorithm to compensate for transient loss of sensing during AA.
Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: formal monitoring of performance is still needed. BILITCH Registry and STIMAREC.
Formal Monitoring of Performance is Still Needed. In order to detect trends in the number of device or component failures that have occurred among permanent pacemaker systems since the 1970s, we reviewed the data of the five largest pacemaker manufacturers from the Bilitch Registry of permanent pacemaker pulse generators, the Stimarec failure registry, the general accounting office summaries of the United States Veterans Administration (VA) Registry of Pacemaker Leads, and the Implantable Lead Registry, from the Cleveland Clinic Lead registry, and the recalls and safety alerts issued by the United States Food and Drug Administration (FDA) over the last 20 years. The definition of failure followed the criterion, or criteria, developed within each registry and differed significantly between the registries. The 20-year period between 1976 and 1995 was divided into 5-year quartiles (QT): QT 1 = 1976-1980; QT2 = 1981-1985; QT3 = 1986-1990; and QT4 = 1991-1995. For pulse generators, the number of models with failures in each quartile in the Bilitch Registry were: QT 1 = 9; QT 2 = 11; QT3 = 17; QT4 = 13. In Stimarec, the number of units reported as having reached a dangerous condition were: QT1 = 710; QT2 = 212; QT3 = 114; QT4 = 310. From the FDA reports, the number of units included in recalls or safety alerts were: QT3 = 6,085; QT4 = 135,766. For permanent pacemaker leads, the numbers of failed or dangerous leads recorded in Stimarec were: QT3 = 16; QT4 = 32. In the VA Registry, the number of models having a below average survival was 2/92 (2.7%). In the Implantable Lead Registry, the number of models having a below average survival was 3/21 (14%). In the Cleveland Clinic series, 6/13 (46%) of lead models were recognized to have some failure involving the conductor, insulation, or connector. In the FDA reports, the number of leads involved in either recall or safety alert were: QT3 = 20,354; QT4 = 332,105. For programmers, the number of units involved either in a recall or safety alert were: QT3 = 11,124; QT4 = 3,528. In all of these series, each of the five largest manufacturers had some models or units involved in each time period. This review of programs has revealed: 1. The incidence of failures, recalls, or safety alerts did not decline over time; and 2. Despite changes in technology, formal monitoring of pacemaker systems is still warranted.