How Reliable is Atrial Sensing in Single-Lead VDD Pacing: Comparison of Three Systems

This study evaluated the reliability of atrial sensing, expressed as AV synchronous stimulation, in three VDD systems with the atrial sensitivity (AS) programmed to a conventional value with a 2:1 safety margin compared to most-sensitive values. We studied 34 sex- and age-matched patients with 3 VDD systems: 14 with Unity 292–07, 10 with Saphir 600, and 10 with Thera VDD (5 model 8948 and 5 model 8968i). Two 24-hour Hollers were performed on consecutive days. The AS was programmed in a randomized order to its most-sensitive value or to a 2:1 safety margin. All other parameters were programmed identically. The patients underwent a myopotential oversensing test and a daily life activity protocol. A beat-to-beat analysis of the Holters was performed to determine AV synchrony. For the entire group AV synchrony with conventional AS was 98.63%± 2.57%, compared to 99.80%± 0.43% with most-sensitive values (p = 0.002). There was no difference between the three systems with conventional AS. With the most-sensitive AS, AV synchrony was: Unity 99.99%± 0.03%, Saphir 99.42%± 0.60% (P = 0.002), Thera 99.81 %± 0.35% (ns). In the Saphir system with an atrial blanking period of 150 ms, ventricular far-field sensing could be demonstrated in 5 of 10 patients. This reduced the percentage of AV synchrony due to an unwanted mode-switch to a nontracking mode. Myopotential oversensing was not detected in any patient. Conclusion: The VDD systems tested under identical conditions showed reliable P wave sensing at the most-sensitive atrial sensing setting without myopotential oversensing. Ventricular far-field sensing reduced AV synchrony and must be avoided by appropriate refractory periods.     

Impact of Programmed Sensitivity Safety Factor on Atrial Sensing in Children

The relationship between the pacemaker sensitivity safety factor (PSSF) and atrial under- or oversensing as documented by 24-hour Holter monitoring was examined. Our study comprised 78 transvenous fixed atrial leads implanted between 1983–1995 in 71 children. Overall, 210 Holter reports identified 143 (68%) Holters with normal atrial sensing function, 31 (15%) with undersensing, 32 (15%) with oversensing, and 4 (2%) with both problems. From 161 Holter reports in which the PSSF was available, the incidence of undersensing at a PSSF of 2.0 (range 1.5–2.4) was 25% (14/57). There was a dramatic decline in undersensing when the PSSF was 3 (3%) compared to a FSSF < 3 (21 %) (P < 0.001). A PSSF cut-off point of 2.0 best predicted occurrence of undersensing with a sensitivity of 79% and a specificity of 67%. Other variable were also examined by multiple logistic regression analysis, but only PSSF remained highly associated with undersensing (odds ratio [OR] = 0.6, P = 0.03). In contrast, PSSF did not have a significant role in predicting oversensing, but presence of sick sinus syndrome (OR = 10.5) or unipolar lead (OR = 5.6) were significantly associated with oversensing (P = 0.0001). The majority of undersensing problems can be avoided by routinely allowing for at least a threefold or more programmed sensitivity margin. Other factors may increase the risk of oversensing, regardless of the PSSF.     

First Experience with an Automatic Sensing Algorithm in Single-Lead VDD Stimulation

An "Autosensing" algorithm available in SSI(B) and DDD(R) pacemakers automatically adapts the device's sensitivity to changing intracardiac signals. The atrial sensing function of this algorithm was tested for the first time with a VDD pacing system in which large variations of the atrial signal may occur because the atrial electrodes float in the atrial blood pool. Methods: 15 patients with a VDD pacing system were studied (Unity 292–07, lead 425; Sulzer Intermedics). The atrial sensing threshold was measured, and the atrial sensitivity was programmed with a 2:1 safety margin. The autosensing algorithm and sensitivity profile were temporarily activated, and an ambulatory ECG with continuous marker annotation was recorded. All patients underwent a 30-minute daily life activities protocol. A beat-to-beat analysis of the ambulatory ECG was correlated with the changes in atrial sensitivity. Results: The algorithm changed the baseline sensitivity from 0.57 ± 0.23 mV during the test to 0.39 ± 0.20 mV after the final rest period (P < 0.05). During the test 12.6 ± 10.2 adaptations of the sensitivity occurred (range 0–33). In eight patients atrial undersensing occurred in 4.4%± 7.5% of the cycles (4–458 unsensed P waves]. In these patients, the algorithm continuously adjusted the sensitivity towards more sensitive values, operating 19.1 ± 18.3 changes compared with 5.4 ± 7.3 changes in patients without undersensing (P = 0.009). Oversensing did not occur. Conclusion: The autosensing algorithm effectively optimized atrial sensitivity in VDD pacing. In patients with atrial undersensing the algorithm continuously remained near the most sensitive settings, thus reacting as intended. A faster sensitivity adjustment of the system would be desirable.     

Long-Term Stability of P Wave Sensing in Single Lead VDDR Pacing: Clinical Versus Subclinical Atrial Undersensing

Optimal function of a single lead P wave synchronous rate adaptive ventricular pacing system (VDDR) requires reliable P wave sensing over time and during daily activities. The stability of P wave sensing and the incidence of sensitivity reprogramming in a single pass lead with a diagonally arranged bipole was assessed in 30 patients with complete atrioventricular block over a follow-up period of 12 ± 1 months (range 6 months to 3 years). Atrial sensing was assessed during clinic visits, by physical maneuvers (postural changes, breathing, Valsalva maneuver, walking and isometric exercise), maximum treadmill exercise and Holter recordings. P wave amplitude at implantation was 1.21 ± 0.09 (0.5–3.6) mV, and the atrial sensing threshold remained stable over the entire period of follow-up. Using an atrial sensitivity based on twice the sensing threshold at 1 month, P wave undersensing was found in 2, 4, 3, and 7 patients during clinic visit, physical maneuvers, exercise, and Holter recordings, respectively. Atrial sensitivity reprogramming was performed in three patients based on the correction of undersensing during physical maneuvers. Although eight patients had atrial undersensing on Holter recordings, the number of undersensed P waves was small (total 101 beats or 0.013%± 0.001% of total ventricular beats) and no patient was symptomatic. One patient had intermittent atrial undersensing at the highest sensitivity, but the VDDR mode was still functional most of the time. No patient had myopotential interference at ihe programmed sensitivity. One patient developed chronic atrial fibrillation and was programmed to the VVIR mode. Thus, single lead VDDR pacing is a stable pacing mode in 97% of patients. Because of the large variability of P wave amplitude, the use of a sensitivity margin at least three times the atrial sensitivity threshold will maximize atrial sensing and minimize the need for atrial sensitivity reprogramming (1/30 patients). Physical maneuvers and exercise tests are effective means for rapid assess ment of the adequacy of P wave sensing.     

Comparative Evaluation of Acute and Long-Term Clinical Performance of Two Single Lead Atrial Synchronous Ventricular (VDD) Pacemakers: Diagonally Arranged Bipolar Versus Closely Spaced Bipolar Ring Electrodes

Floating P wave sensing can be derived from bipolar atrial electrodes with different electrode configurations, although the relative clinical efficacy of these methods of atrial sensing has not been studied. We evaluated 32 sex and age matched patients with advanced AV block who received A V synchronous pacers using either a single lead with diagonally arranged bipole (Unity VDDR, Model 292, Intermedics Inc.) or closely spaced bipolar complete ring electrodes (Them VDD, Model 8948, Medtronic Inc.). The total surface area of the atrial electrodes were 17.2 and 25 mm², and the highest programmable atrial sensitivities were 0.1 and 0.25 mV, respectively. Atrial electrogram amplitude and sensing threshold were evaluated at implant and at each follow-up clinic visit (1, 3, and 6 months), Stability of atrial sensing was assessed during physical maneuvers, treadmill exercise test, and Holier recording. Atrial electrogram amplitude at implantation was higher in the Them VDD (2.08 ± 0.79 vs 1,45 ± 0.59 mV in Unity VDDR; P < 0.05), but the value of atrial sensing threshold was lower during follow-up than Unity VDDR. P wave undersensing was additionally observed with both pacemakers during physical maneuvers and exercise testing (6%-19% of patients). Two and four patients had atrial undersensing on Holter in the Unity VDDR and Them VDD, respectively, and the percentage P wave undersensing were 0.88%± 2.41% versus 3.63%± 8.16%, respectively. Reprogramming of the atrial sensitivity in the Unity VDDR and the use of investigational software allowing 0.18 mV atrial sensitivity to be programmed in the Them VDD substantially reduced the percentage of P wave undersensing on Holter to 0.46%± 1.67% and 0.10%± 0.24%, respectively. Beginning at discharge with a programmed atrial sensitivity level at least twice the sensing margin, the mean atrial sensitivity level was reprogrammed from 0.29 to 0.26 mV for Unity VDDR and 0.33 to 0.24 mV for Them VDD at 6 months. There was no incidence of atrial oversensing. Despite differences in atrial amplitudes at implantation between the diagonally arranged bipole and closely spaced full ring single lead systems, the clinical performances of atrial sensing were similar at an appropriately high atrial sensitivities. The absence of atrial oversensing suggests that single pass VDD pacemakers should probably be programmed at the highest available atrial sensitivity to ensure adequate P wave sensing as guided by physical maneuvers and Holter recording to minimize the need of subsequent reprogramming.     

Discrimination between ventricular and supraventricular tachycardia by dual chamber cardioverter defibrillators: importance of the atrial sensing function

Although the addition of atrial sensing in dual chamber ICDs may improve the ability of the device to discriminate between supraventricular (SVT) and ventricular tachycardia (VT), atrial sensing errors may also negatively affect tachycardia classification. This prospective study evaluated the incidence of atrial sensing errors in a dual chamber ICD and their impact on VT/SVT discrimination. In 145 patients, a dual chamber ICD (Defender) was implanted. Analysis of 1,241 tachycardia episodes stored during a mean follow-up of 14+/-8 months revealed atrial sensing errors in 817 (66%) episodes. Upon expert review, device-based classification was confirmed in 509 (98%) of 522 SVT episodes. No false device-based SVT classification was related to atrial sensing errors. Of 719 episodes classified as VT by the device, 645 (90%) were confirmed. There were 74 episodes of false-positive VT detection. Of these, 63 were related to atrial sensing errors: atrial undersensing in 58 (92%) and atrial oversensing in 5 (8%) episodes. Atrial sensing errors led to incorrect VT/SVT discrimination in 51 (4%) of 1,241 episodes. Only the occurrence of paroxysmal atrial fibrillation and abdominal site of device implantation showed a significant influence on false VT/SVT discrimination. Atrial sensing errors are frequently encountered in dual chamber ICDs. Due to the VT/SVT discrimination algorithm, atrial sensing errors only led to misclassification in 4 % of all episodes, mainly due to atrial undersensing. No VT underdetection due to atrial oversensing occurred.     

Should Unipolar Leads Be Implanted in the Atrium? A Holter Electrocardiographic Comparison of Threshold Adapted Unipolar and High Sensitive Bipolar Sensing

The accuracy ofatrial sensing plays a central role in dual chamber pacing. Recent Holter electrocardiographic studies showed a high incidence of atrial malsensing. We investigated the efficacy of bipolar atrial sensing at high sensitivity compared to threshold adapted unipolar sensing. One h undred consecutive patients with identical dual chamber pacemakers and bipolar atrial leads were investigated. Mean and individual range of 40 unipolar and bipolar telemetered atrial potentials were calculated; sensing threshold was determined by a semiautomatic sensing test. Oversensing was investigated with the help of a muscle provocation test. Twenty-four-hour Holter monitoring was performed at the highest bipolar sensitivity as well as at a unipolar sensitivity of half the measured sensing threshold. Mean atrial potential was significantly lower during bipolar mode compared to the unipolar sensing configuration, 3.66 ± 1.75 versus 3.85 ± 1.62 mV, P = 0.02. The bipolar atrial potentials showed a higher individual range than the unipolar signals, 2.44 ± 2.62 versus 1.79 ± 0.92 mV, P < 0.01. Sensing threshold did not differ significantly, 2.76 ± 1.33 versus 2.67 ± 1.29 mV. Mean oversensing threshold was 1.21 mV at unipolar configuration, whereas oversensing could not be provoked at a bipolar sensitivity of 0.5 mV. The incidence of atrial undersensing was significantly higher at threshold adapted unipolar sensing compared to bipolar sensing at highest atrial sensitivity, 35% versus 22%, P = 0.04. Oversensing did not occur at bipolar sensing, but was observed in 56% of patients at unipolar mode. Thirty-two percent of patients showed both atrial undersensing and over- sensing at the unipolar sensing configuration. The muscle provocation test reached a sensitivity of 89% and a specificity of 95% in prediction of atrial oversensing during daily life. In conclusion, unipolar atrial potentials are more stable than bipolar ones. On the other hand, bipolar atrial sensing is less prone to the perception of myopotentials. Programming a high bipolar sensitivity significantly improves atrial sensing. Th us, bipolar leads should generally be implanted in the atrium.     

Efficacy and Safety of Bipolar Sensing with High Atrial Sensitivity in Dual Chamber Pacemakers

In dual chamber pacemakers, atrial sensing performance is decisive for maintenance of AV synchrony. Particularly, the efficacy of mode switching algorithms during intermittent atrial tachyarrhythmias depends on the sensitive detection of low potential amplitudes. Therefore, a high atrial sensitivity of 0.18 mV, commonly used in single lead VDD pacemakers, was investigated for its efficacy and safety in DDD pacing. Thirty patients received dual chamber pacemakers and bipolar atrial screw‐in leads for sinus node syndrome or AV block; 15 patients suffered from intermittent atrial fibrillation. Pace makers were programmed to an atrial sensitivity of 0.18 mV. Two weeks, 3, 9, and 15 months after implantation, P wave sensing threshold and T wave oversensing thresholds for the native and paced T wave were determined. The myopotential oversensing thresholds were evaluated by isometric contraction of the pectoral muscles. Automatic mode switch to DDIR pacing was activated when the mean atrial rate exceeded 180 beats/min. The patients were followed by 24‐hour Holter monitoring. Two weeks after implantation, mean atrial sensing threshold was 1.81 ± 0.85 mV (range 0.25–2.8 mV) without significant differences during further follow‐up. Native T wave sensing threshold was < 0.18 mV in all patients. In 13% of patients, paced T waves were perceived in the atrial channel at the highest sensitivity. This T wave sensing could easily be avoided by programming a postventricular atrial refractory period exceeding 300 ms. Myopotential oversensing could not be provoked and Holter records showed no signs of sensing dysfunction. During a 15‐month follow‐up, 1,191 mode switch events were counted by autodiagnostic pacemaker function. Forty‐two of these events occurred during Holter monitoring. Unjustified mode switch was not observed. In DDD pacemakers, bipolar atrial sensing with a very high sensitivity is efficient and safe. Using these sensitivity settings, activation of the mode switch algorithm almost completely avoids fast transmission of atrial rate to the ventricle during atrial fibrillation.     

R wave undersensing caused by an algorithm intended to enhance sensing specificity in an implantable cardioverter defibrillator

This article reports on a case of ventricular undersensing despite normal R wave amplitudes during sinus rhythm in an ICD patient. Undersensing of ventricular signals was noted without any evidence of lead dislocation or variation in signal amplitude. Undersensing was due to an exceptionally small R wave signal width and a feature of the Biotronik sensing algorithm designed to avoid oversensing. This algorithm, intended to enhance the sensing specificity of the device, requires registration of two consecutive points above the maximum programmed sensitivity for a ventricular sense event. After modifying the algorithm to a single point registration undersensing disappeared.     

The Effect of Bipole Tip-to-Ring Distance in Atrial Electrodes upon Atrial Tachyarrhythmia Sensing Capability in Modern Dual-Chamber Pacemakers

Introduction: Accurate atrial arrhythmia discrimination is important for dual chamber pacemakers and defibrillators. The aim was to assess the accuracy of atrial arrhythmia recording using modern devices and relate this to atrial tip-to-ring (TTR) distance.
Methods: One hundred eighty-two patients (72 ± 9 years, 55% male) with paroxysmal atrial fibrillation were enrolled and were included in the study if they had an atrial fibrillation (AF) burden of 1–50% during a monitoring phase. Seventy-nine patients fulfilled these criteria and were followed for at least 5 months. Electrodes were classified as having short (<10 mm), medium (10–12), or long (13–18) atrial TTR spacing.
Results: Two thousand eight hundred eighty-three detailed onset reports were analyzed; 730 (25%) demonstrated aberrant sensing. Six percent were due to farfield R wave oversensing (FFRWO) and 19% due to undersensing, sometimes occurring in the same patient and study phase. FFRWO was significantly reduced with short TTR electrodes (P < 0.05). Undersensing due to sensitivity fallout was 18% (short), 24% (medium), and 17% (long) (P = ns). Undersensing due to pacemaker blanking was 11% (short), 11% (medium), and 12% (long) (P = ns). Active fixation electrodes did not show any difference from passive fixation.
Conclusion: Atrial electrodes with a short TTR (<10 mm) significantly reduce FFRWO without increasing undersensing and should be used routinely in patients with paroxysmal atrial tachyarrhythmias. However, 20% of atrial tachyarrythmia episodes were incorrectly classified as terminated by these modern devices due to undersensing. Clinicians should be wary of using device-derived endpoints that rely on AF episode number or duration as these may be falsely increased or reduced, respectively. (PACE 2010; 85–93)     

Programmed Atrial Sensitivity: A Critical Determinant in Atrial Fibrillation Detection and Optimal Automatic Mode Switching

Automatic mode switching (AMS) prevents tracking of paroxysmal atria] fibrillation (AF) in dual chamber pacing. The correct detection of AF can be affected by the programmed atrial sensitivity (AS). We prospectively studied the relationship between AS, AF under-sensing, an d AMS, using unfiltered bipolar in tracardiac atrial electrogram s recorded from 17 patients during sinus rhythm (SR) and in AF. Overall, 780 rhythms were recorded and replayed onto three dual chamber pacemaker models using different AMS algorithms (Thera DR 7940, Marathon DDDB 294–09, and Meta DDDH 1254), and the ventricular responses were measured. AS was randomly programmed in steps from the highest available AS to half of the mean atrial P wave amplitude (PWA), and the percentage of appropriate AMS responses (defined as a ventricular pacing rate at the expected AMS mode) were recorded. AMS efficacy was related to the programmed AS settings in an exponential manner. At low AS settings, a higher percentage of tests were associated with absence of, or with intermittent AMS and tracking of AF, whereas at higher AS, oversensing of noise during SR occurred. An optimal AS measured approximately 1.3 mV, representing about one-third of the PWA measured during SR, although oversensing of SR and undersensing of AF continued to occur in 14% of tests and time, respectively, due to the high variation in PWA during AF. Thus, a fixed AS cannot eliminate AF undersensing without inviting noise oversensing, suggesting the need for automatic adjustments of AS, or the use of a rate-limiting algorithm to prevent rate oscillation during intermittent AF sensing. In conclusion, AMS functions of existing pacemakers were significantly limited by the undersensing of AF and oversensing of noise. Proper adjustment of the AS is important to enable effective AMS during AF.     

Inhibition of Bradycardia Pacing Caused by Far-Field Atrial Sensing in a Third-Generation Cardioverter Defibrillator with an Automatic Gain Feature

The diagnostic accuracy of implantable Cardioverter defibrillators may be improved by automatically adjusting gain algorithms, which in general reduce the likelihood of oversensing while maintaining the ability to detect the low amplitude signals associated with ventricular fibrillation. We present a patient with a third-generation device who developed prolonged ventricular asystole arising as a complication of the automatic gain feature. During asystole the device automatically increased sensitivity in order to prevent undersensing of ventricular fibrillation, which in this case resulted in far-field sensing of atrial activity and inhibition of ventricular pacing.     

Reliability of an Automatic Sensing Algorithm

Automatic adaptation of the atrial sensitivity was evaluated in 18 patients with dual chamber pacemakers (Intermedics, Inc., Relay) in the unipolar mode. After atrial sensitivity was stabilized in the upright position, patients underwent a 1.0 W/kg body weight exercise for 5 minutes. A 24-hour Holter EGG was recorded, and the maximum and minimum atrial sensitivity values reached were stored in the memory of the pulse generator. In a second series of 12 patients, Holter ECGs were recorded twice, starting with the same sensitivity but with automatic adaptation alternately switched "on" or "off." Results of the exercise test: mean atrial sensitivity declined from 2.30 ± 0.77 mV to 2.03 ± 0.68 mV. There was no change in five patients, a slight increase in two patients, and lowering of the atrial sensitivity was observed in 11 patients, the difference ranging from 0.2 to 1.0 mV. A total of two P waves in two patients were missed by the atrial amplifier. The minimum and maximum sensitivity reached during Holter monitoring averaged 2.31 ± 0.67 mV versus 1.72 ± 0.71 mV (difference 0-1.7 mV). Normal pacemaker function was found in six patients, including one patient without any intrinsic atrial activity. Malsensing of less than five P waves occurred in four patients. More than 50 sensing defects resulted from ectopic atrial beats (four patients). We observed atrial oversensing in three cases; one patient showed atrial over- and undersensing. The comparison between fixed and variable sensitivity did not reveal any superiority of automatic adaptation. Conclusion: earlier findings of atrial signal variation during daily life are confirmed. Although quite reliable during exercise studies, automatic adaptation of atrial sensitivity is not able to compensate for sudden changes in atrial electrogram or to sufficiently suppress extracardiac noise.     

Bipolar ventricular far-field signals in the atrium

In an attempt to evaluate the prevalence and predisposing factors of bipolar ventricular far-field oversensing, 57 patients were studied who had a Medtronic dual chamber pacemaker implanted (models 7940: n = 6; 7960i: n = 41; 401: n = 3; 8968i: n = 7) and bipolar atrial leads with a dipole spacing from 8.6 to 60 mm attached to various parts of the atrial wall (lateral/anterior: n = 30; appendage: n = 10; atrial septum: n = 10; floating: n = 7). Median bipolar sensing threshold for P waves was 4.0 mV (2.8-4.0 mV, lower and upper quartile) with standard leads and 0.35 (0.25-1.4) mV with single pass (VDD) devices. At the highest sensitivity available, 43 of 50 DDD pacemakers but only two of seven VDD systems detected intrinsic R waves in the atrium (P < 0.01). Ventricular far-field oversensing occurred at 0.5 mV in 28 (56%) and at 1.0 mV in 16 of 50 DDD units (32%), respectively, and there was one observation in a septal implant at a sensitivity of even 2.8 mV. With ventricular pacing, VDD systems were as susceptible to far-field signals as DDD pacemakers. Outside the postventricular blanking period (100 ms), evoked R waves were detected by 27 of 57 systems (47%) at maximum atrial sensitivity, by 10 (18%) at 0.5 mV, and by 2 (4%) at a setting of 1.0 up to 1.4 mV, respectively. There was no definite superiority of any lead position, there was a trend in favor of the atrial free wall for better intrinsic R wave rejection, but just the opposite was the case for paced ventricular beats. Bipolar signal discrimination tended to be higher with short tip-to-ring spacing (1 7.8 mm) but the difference to larger dipole lengths (30-60 mm) was not significant in terms of the R to P wave ratio and the overall far-field susceptibility. In summary, bipolar ventricular far-field oversensing in the atrium is common with short postventricular blanking times and high atrial sensitivity settings that may be warranted for tachyarrhythmia detection and mode switching. A potentially more discriminant effect of shorter dipole lengths (< or = 10 mm) remains to be tested.     

Morphology-Enhanced Atrial Event Classification Improves Sensing in Pacemakers

BACKGROUND: In atrial-based pacing, appropriate therapy and reliable diagnostics depend on detection and discrimination of atrial signals. Accurate classification of atrial events is mainly confounded by oversensing of ventricular far-field R-wave signals (FFRW), but attempts to reject FFRWs by manipulating atrial sensitivity and/or postventricular atrial blanking period (PVAB) may result in undersensing (especially of atrial fibrillation, AF) or in 2:1 atrial flutter detection. The objective of this study is therefore to evaluate if such methods can be improved by morphology-enhanced atrial event classification (MORPH). METHODS: Twenty-four-hour ambulatory atrial electrograms were recorded from continuous telemetry of digital pacemakers. Half of the recording was used for collecting two individual morphology parameters that discriminated P-waves from FFRWs in every patient (learning phase). The other half was used to test the MORPH algorithm against traditional methods (classification phase). RESULTS: In 44/48 patients, data were suitable for analysis. Average P and FFRW amplitudes were 1.96 mV versus 0.61 mV (P < 0.001). The interval between ventricular events and FFRW oversensing (VA interval) averaged at 14 ms during sensing and at 118 ms during pacing in the ventricle. Compared to nominal ("Factory") settings, the MORPH algorithm improved the sensitivity for P-wave recognition from 97.2% to 99.2%, the specificity from 91.9% to 99.96%, and the accuracy from 95.3% to 99.4% (P < 0.01 for all). CONCLUSIONS: By improving atrial signal discrimination, morphology analysis of atrial electrograms allows for high atrial sensitivity settings, and potentially improves the reliability of atrial arrhythmia diagnostics in heart rhythm devices.     

Experience with a dual chamber implantable defibrillator

An implantable defibrillator with dual chamber pacing may have advantages for pacing, sensing, and detection of brady- and tachyarrhythmias. This study evaluates the safety and performance of a dual chamber implantable cardioverter defibrillator that incorporates an algorithm to discriminate supraventricular from ventricular arrhythmias. The 300 patients in this study had the device implanted for the following indications: ventricular tachycardia (47%), sudden cardiac death survivorship (51%), and prophylactic implants (2%). Patients received dual chamber pacing for accepted bradyarrhythmic (51.7%) or investigational indications. During a mean follow-up period of 1.7 months a total of 1,092 arrhythmia episodes in 96 patients were fully documented in the device memory: 66 patients experienced a total of 796 ventricular tachyarrhythmia episodes and 42 experienced a total of 296 supraventricular episodes. The device appropriately detected 100% of sustained ventricular tachyarrhythmias while reducing the inappropriate detection of supraventricular tachyarrhythmias by 72% compared to single chamber rate only detection. The positive predictive value was 90.5% for ventricular tachyarrhythmia detection in episodes that exceeded the tachycardia detection rate. Adverse events observed in at least 2% of the patients were incisional pain (22%), inappropriate ventricular detection (7%), atrial lead dislodgement (4%), atrial oversensing/undersensing (3%), hematoma (3%), incessant ventricular tachyarrhythmia (2%), and pneumothorax (2%). There were 13 deaths, none of which were attributed to device failure. The Gem DR is safe and effective for the detection and treatment of ventricular tachyarrhythmias. The dual chamber detection algorithm appropriately recognized supraventricular tachycardia with rapid ventricular rates 72% of the time while maintaining 100% detection of sustained ventricular tachyarrhythmias.     

Comparison of Myopotential Interference in Unipolar-Bipolar Programmable DDD Pacemakers

Myopotential interference (MPI) can inhibit or trigger single and dual chamber unipolar pacemakers while bipolar pacemakers are resistant. Twenty units of two different models of dual chamber pacemaker, each capable of being programmed to single chamber or dual chamber and unipolar or bipolar function were tested to provoke myopotential interference. No patient had evidence of myopotential interference at any sensitivity setting in the bipolar configuration either in atrium or in ventricle. All patients (20/20) interfered with pacemaker function at the highest atrial or ventricular sensitivity settings in the unipolar configuration. T wave sensing occurred at the 0.25 mV sensitivity setting in four patients in pacemaker model 925, in both bipolar and unipolar configurations. Twenty-five percent of patients had myopotential interference at the unipolar atrial sensing threshold and did not allow a setting which would reject myopotential interference while providing satisfactory atrial sensing. Twenty percent (2/10) had myopotential caused ventricular inhibition at the least sensitive ventricular channel setting in model 240G so that myopotential interference could not be avoided in that unit no matter how large the electrogram.     

Impact and Prevention of Far-Field Sensing in Fallback Mode Switches

BORDACHAR, P., et al.: Impact and Prevention of Far-Field Sensing in Fallback Mode Switches. Far-field oversensing (FFOS) promoted by high atrial sensitivity and short atrial refractory periods induces false positive mode switches. We evaluated the incidence of ventricular FFOS in a population of DDD paced patients. Methods: One hundred thirty-seven patients (   71 ± 10   years, 76 men) implanted with a Talent DR pacemaker were studied. Before discharge, an analysis of internal data stored in the memories of the PM was performed by the specific software incorporated in the programmer in parallel with a 24-hour Holter recording. Data were validated by a panel of experts. One and 4 months follow-up was based only on the data stored in the PM memories. Results: Pacing indications were atrioventricular block   (n = 75)   , sinus node dysfunction   (n = 57)   , and other   (n = 5)   . Sustained far-field oversensing was observed in 12/137 patients (9%). Out of a total of 3,511 triggered mode switch episodes, FFOS accounted for 20% and 7% of a 311 days cumulative time in mode switch. Inappropriate mode switch episodes induced by far-field were more numerous but shorter than episodes prompted by atrial arrhythmias. Atrial sensitivity was increased in eight patients, successfully in four. Reprogramming of the atrial refractory period   (156 ± 11 ms)   was successful in five of six patients. Conclusions: A 9% rate of ventricular FFOS was observed in an unselected population, easily and automatically diagnosed using the internal memory function and the automatic analysis provided by the programmer. Prolongation of the atrial refractory period was more effective than resetting of the atrial sensitivity in eliminating FFOS. (PACE 2003; 26[Pt. II]:206–209)     

VDD(R) Pacing: Short- and Long-Term Stability of Atrial Sensing with a Single Lead System

Background: Recent studies have shown that the atrial signal can reliably be sensed for VDD(R) pacing via atrial floating electrodes incorporated in a single-pass lead. However, there remains concern about the long-term stability of atrial sensing and proper VDD function under real-life conditions. This study investigated the long-term reliability of atrial sensing and atrioventricular synchronous pacing using a new single lead VDD(R) pacing system. Methods and Results: In 20 consecutive patients (ages 71 ± 14 years) with normal sinus node function and high-degree heart block, a single lead VDD(R) pacemaker (Unity(tm), Intermedics) was implanted, Atrial sensing was studied at implantation, at discharge, and at 1, 3, 6, 12, and 18 months of follow-up. At implant, the measured P wave amplitude was 2.3 ± 1.2 mV. By telemetry, the atrial sensing threshold was 0.79 ± 0.41 mV at discharge, 0.75 ± 0.43 mV at 1 month, 0.73 ± 0.43 mV at 3 months, 0.76 ± 0.41 mV at 6 months, 0.79 ± 0.41 mV at 12 months, and 0.77 ± 0.35 mV at 18 months of follow-up (P = NS). Appropriate VDD pacing was assessed by the percentage of correct atrial synchronization (PAS = atrial triggered ventricular paced complexes ± total number of ventricular paced complexes) during repeated Holters. PAS was 99.99%± 0.01 % at 1 month, 99.99%± 0.02% at 3 months, and 99.98%± 0.05% at 12 months of follow-up (P = NS). No atrial oversensing with inappropriate ventricular pacing was observed, neither during isometric arm exercise testing nor spontaneously during Holier monitoring. Conclusion: The long-term stability of atrial sensing with almost 100% correct atrial synchronous tracking and the lack of inappropriate pacing due to atrial oversensing make the new Unity VDD(R) system a highly reliable single lead pacing system. In view of the lower costs and the ease of single lead implantation, this system may offer an interesting alternative to DDD pacemakers in patients with normal sinus node function.     

High rate atrial tachyarrhythmia detections in implantable pulse generators: low incidence of false-positive detections. The PA Clinical Trial Investigators

Some newer pulse generators have enhanced diagnostic features that provide information on the frequency, date, time of onset, and duration of atrial and/or ventricular tachyarrhythmias. However, the sensitivity and specificity of device-based atrial tachyarrhythmia detections may vary and depend, in part, on lead position and selected programming parameters. The prevalence of inappropriate detections of paroxysmal atrial fibrillation (PAF) was investigated in 97 patients who received a Thera DR pacemaker 3 months prior to a planned AV node ablation. Patients were randomized to no atrial or to rate adaptive atrial pacing therapy and followed for 3 months. Following a total AV node ablation, patients were randomized to DDDR versus VDD pacing and followed for 1 year. The high rate atrial episode diagnostic feature was used for detection of PAF and the diagnostic data were retrieved during follow-up visits. Criteria were developed to identify oversensing due to near-field P wave detections, far-field R wave detections, or competitive atrial pacing as causes of false-positive atrial tachyarrhythmia detections. A total of 1,636 detections of PAF were recorded in patients preablation. Only 48 episodes (2.9%) were characterized as false-positive detections; 25 episodes (1.5%) were classified as oversensing, and 23 episodes (1.4%) were classified as competitive atrial pacing. A total of 3,061 detections of PAF were recorded postablation. Only four episodes (0.1%) were classified as oversensing. Thus, the diagnostic atrial tachyarrhythmia detection feature in newer pacemakers is an effective method for evaluating the time course of PAF in patients with implantable pulse generators.