Notes: This study evaluated a newly developed automatic capture verification scheme for implantable cardioverter defibrillators (ICDs) regarding discrimination of capture, fusion, and noncapture beats, with an emphasis on fusion detection. The algorithm uses evoked response detection based on a sensing vector from right ventricular shocking coil to Can. Patients undergoing ICD implant or replacement were enrolled in this study. An external system was used for pacing and data acquisition. To provoke ventricular fusion beats, VVI patients were paced close to the rate of their intrinsic rhythm and DDD patients were paced close at their intrinsic PR interval. Surface ECG and wideband filtered intracardiac electrograms were recorded for off-line analysis. Each paced beat was independently classified visually by surface ECG and by the automatic detection algorithm. The algorithm performance was then evaluated by comparing the classification results. Twenty-seven patients (22 males, 5 females; 63.8 ± 12.5 years) were analyzed. Device and lead demographics were: 18 DDD/9 VVI; 16 dedicated bipolar, 11 integrated bipolar leads; 18 acute, 9 chronic (3.7 ± 2.0 years) leads. In total, 2064 beats were analyzed, including 1,477 fusion beats and 587 capture beats. Fusion detection sensitivity and specificity were 99.5% and 99.0%, respectively. Seven true-fusion beats (0.5%) were classified as capture and 6 capture beats (1.0%) were identified as fusions. Capture or fusion beats were never detected as non-capture beats. It is concluded that the algorithm was effective in detecting fusion beats. It could potentially be used in ICD applications that need accurate fusion detection.

Notes: BINNER, L., et al.: Autocapture Enhancements: Unipolar and Bipolar Lead Compatibility and Bipolar Pacing Capability on Bipolar Leads. Beat-by-beat Autocapture maximizes device longevity by minimizing stimulus amplitude while assuring patient safety. Currently, Autocapture permits use of only bipolar leads. The authors have devised a detection method that operates with unipolar and bipolar leads and covers all pacing and sensing combinations (but bipolar pace and sense simultaneously). This new detection method for unipolar sensing uses the integral of the negative portion of the unipolar evoked response as a robust capture detection feature. When using bipolar leads, the method provides the flexibility of bipolar or unipolar pacing. In this study, unipolar ventricular intracardiac electrograms (EGMs) were recorded in 71 patients, 73.7 ± 9.9 years of age; 9 with high polarization, 62 with low polarization. High polarization had polished platinum or activated carbon electrodes. Low polarization had TiN, platinized platinum, or IrOx electrodes. The intracardiac EGMs were recorded 544 ± 796 days after implant. The pacemakers performed an automatic capture threshold test while the intracardiac EGM signals were recorded in a programmer. These digitized signals were saved for off-line analysis. The unipolar evoked response was calculated at up to six (depending on capture threshold) pacing voltages and the polarization integral at 4.5 V and at loss of capture. An automatic calibration algorithm determined if the signal-to-noise ratio was adequate for Autocapture operation. Autocapture was possible with 60 of 62 of the low polarizations, and with 6 of 9 of the high polarizations. The average values from the data collected were: average unipolar evoked response - 4.1 ± 2.1  mV , average peak negative voltage - 10.0 ± 3.7  mV , average polarization 0.3 ± 0.34 mV, and average signal-to-noise ratio (unipolar evoked response/polarization) 38 ± 71. In all cases the algorithm correctly determined the appropriateness of using Autocapture with the electrodes tested and the unipolar evoked response threshold to be used. (PACE 2003; 26[Pt. II]:221–224)

Notes: CANDINAS, R., et al.: Impact of Fusion Avoidance on Performance of the Automatic Threshold Tracking Feature in Dual Chamber Pacemakers: A Multicenter Prospective Randomized Study. The Autocapture algorithm enables automatic capture verification on a beat-by-beat basis by recognizing the evoked response signal following each pacemaker stimulus. The algorithm intends to increase patient safety while decreasing energy consumption. However, the occurrence of fusion beats, particularly during dual chamber pacing, may limit the energy saving effect of Autocapture. The aim of this multicenter, prospective, randomized study was to evaluate the impact of the Fusion Avoidance (FA) algorithm on the incidence of fusion beats. Thirty-eight patients (mean age 69 ± 13 years) with intrinsic AV conduction who were implanted with an Affinity DR were studied. After programming a PV/AV delay of 120/190 ms, patients were randomized to FA On or Off. Each group was further randomized with respect to activation of the AutoIntrinsic Conduction Search (AICS) algorithm. The total number of beats, ventricular paced beats, fusion beats, backup pulses, and threshold searches were analyzed from 24-hour Holter recordings. The number of total beats was comparable in both FA groups. The number of total ventricular paced beats, fusion beats, backup pulses, and threshold searches were significantly reduced in the FA On group (% reduction: 68% P 〈 0.001, 75% P 〈 0.01, 95% P 〈 0.01, and 94% P 〈 0.05, respectively). The number of ventricular paced beats with full capture was significantly reduced when AICS was activated (P 〈 0.05). In conclusion, the FA algorithm substantially reduces the amount of ventricular paced beats, fusion beats, unnecessary backup pulses and threshold searches, and therefore, provides added benefits in energy saving obtained by Autocapture.

Notes: SPERZEL, J., et al.: Reduction of Pacing Output Coupling Capacitance for Sensing the Evoked Response. Sensing of the intracardiac evoked response (ER) after a pacing stimulus has been used in implantable pacemakers for automatic verification of capture. Reliable detection of ER is hampered by large residual afterpotentials associated with pacing stimuli. This led to the development of various technological solutions, like the use of triphasic pacing pulses and low polarizing electrode systems. This study investigated the effect of reducing the coupling capacitance (CC) in the pacemaker output circuitry on the magnitude of afterpotential, and the ability to automate detection of ventricular evoked response. A CC of 2.2 μF and four different blanking and recharge time settings were clinically tested to evaluate its impact on sensing of the ventricular ER and pacing threshold. Using an automatic step-down threshold algorithm, 54 consecutive patients, aged 70 ± 10 years with acutely (n = 27) or chronically (n = 27) implanted ventricular pacing leads were enrolled for measurement testing. Routine measurements, using a standard pacing system analyzer (PSA), were (mean ± SD) impedance 569 ± 155 Ω, R wave amplitude baseline to peak 9.8 ± 3.7 mV and threshold 0.9 ± 0.7 V at 0.4-ms pulse width. This new capture verification scheme, based on a CC of 2.2 μF and recharge/blanking timing setting of 10/12 ms, was successful in 52 patients which is equivalent to a success rate of 96%. In a subgroup of 26 patients implanted with bipolar ventricular leads (10 chronic, 16 acute), data were collected in unipolar (UP) and bipolar (BP) pace/sense configurations. Also, ER signals were recorded with two different band-pass filters: a wider band (WB) of 6–250 Hz and a conventional narrow band (NB) of 20–100Hz. WB sensing from UP lead configuration yielded statistically significant larger signal to artifact ratios (SAR) than the other settings (P 〈 0.01). A dedicated unipolar ER sensing configuration using a small output capacitor and a wider band-pass filter enables adequate automatic capture verification, without any restrictions on pacing lead models or pacing/sensing configurations.

Notes: CARLSSON, J., et al.: Prospective Randomized Comparison of Two Defibrillation Safety Margins in Unipolar, Active Pectoral Defibrillator Therapy. Various techniques are used to establish defibrillation efficacy and to evaluate defibrillation safety margins in patients with an ICD. In daily practice a safety margin of 10 J is generally accepted. However, this is based on old clinical data and there are no data on safety margins using current ICD technology with unipolar, active pectoral defibrillators. Therefore, a randomized study was performed to test if the likelihood of successful defibrillation at defibrillation energy requirement (DER) +5 J and +10 J is equivalent. Ninety-six patients (86 men; age 61.0 ± 10.3 years; ejection fraction 0.341 ± 0.132 ; coronary artery disease [n = 65],dilated cardiomyopathy [n = 18], other [n = 13]) underwent implantation of an active pectoral ICD system with unidirectional current pathway and a truncated, fixed tilt biphasic shock waveform. The defibrillation energy requirement (DER) was determined with the use of a step-down protocol (delivered energy 15, 10, 8, 6, 4, 3, 2 J). The patients were then randomized to three inductions of ventricular fibrillation at implantation and three at predischarge testing with shock strengths programmed to DER + 5 J at implantation and + 10 J at predischarge testing or vice versa. The mean DER in the total study population was7.88 ± 2.96 J. The number of defibrillation attempts was 288 for +5 J and 288 for +10 J. The rate of successful defibrillation was 94.1% (DER + 5 J) and 98.9% (DER + 10 J;P 〈 0.01for equivalence). Charge times for DER + 5 J were significantly shorter than for DER + 10 J (3.65 ± 1.14vs5.45 ± 1.47 s; P 〈 0.001). A defibrillation safety margin of DER + 5 J is associated with a defibrillation probability equal to the standard DER + 10 J. In patients in whom short charge times are critical for avoidance of syncope, a safety margin of DER + 5 J seems clinically safe for programming of the first shock energy. (PACE 2003; 26[Pt. I]:613–618)

Notes: BORIANI, G., et al.: Evaluation of a Dual Chamber Implantable Cardioverter Defibrillator for the Treatment of Atrial and Ventricular Arrhythmias. Eighty-nine patients with a documented history of atrial tachyarrhythmias or fibrillation (AF) received a cardioverter defibrillator designed to selectively differentiate and treat atrial and ventricular arrhythmias. Twenty-two patients received a coronary sinus lead and, therefore, could use a separate shock vector for selective treatment of atrial tachyarrhythmias/AF. The device is designed to treat tachyarrhythmias with antitachycardia pacing (ATP) and/or shock therapy using an atrial and/or a ventricular shock vector. Patients underwent induction and shock termination of atrial or dual tachyarrhythmias (AF/VF) to verify proper device function and to measure the arrhythmia detection time with enhancements and preventive algorithms programmed On and Off, respectively. Detection time for 329 VF inductions was 2.41 ± 0.64  seconds with enhancements On and 2.29 ± 0.47 with enhancements Off (NS). At implant or predischarge, 283 AF and/or AF/VF (121 atrial and 162 atrial/ventricular fibrillation) were induced. Shock conversion efficacy was 89.8% with AF conversion energies ranging from 0.9 to 27 J. Thirteen of the 23 patients had atrial shock conversions using the separate shock vector with an average conversion energy of 1.9 ± 1.4  J . (range 0.5–5 J). During follow-up the efficacy of ATP on atrial tachyarrhythmias was 59% and the efficacy of delivered shocks on AF was 85%. This new dual chamber cardioverter defibrillator appropriately detected and classified atrial arrhythmias, and shock therapy for AF was highly effective. The detection algorithm differentiated atrial tachyarrhythmia/AF and did not delay VF detection. The separate shock vector converted induced AF with energies ranging from 0.6 to 5 J. (PACE 2003; 26[Pt. II]:461–465)

Notes: AutoCapture™ based on the evoked response can be confounded by electrode polarization. In this study, polarization was measured in human subjects who had chronic atrial leads. The aim of the study was to determine whether electrode polarization can be measured using a time integral atrial evoked-response integral (AERI) of the negative portion of the atrial paced ER evoked-response signal and to determine whether high-polarization atrial leads unsuitable for AutoCapture™ can be identified a priori. Atrial intracardiac-electrogram (IEGM) signals from 39 patients with implanted pacemakers were recorded and analyzed. The signals were recorded during conventional atrial-threshold searches. A total of 221 atrial-capture thresholds were recorded, ranging from 0.25 to 2.75 V with a mean of 0.79 V. Each evoked response was evaluated using the AERI in a 36 ms window following the 0.4 ms atrial stimulus. The polarization was estimated as a linear function of stimulus voltage using the evoked-response signal integral of captured beats identified on the IEGM. The 221 threshold-search datasets were obtained using leads with eight different electrode materials. Polarization could be measured using AERI as a function of stimulus voltage. Furthermore, this polarization measure can be used to identify high-polarization leads, which are ill suited for the atrial AutoCapture™ algorithm.

Notes: Background: This study was conducted to evaluate the clinical performance of the ventricular automatic capture feature as implemented in the Insignia I Ultra pacemaker system (Guidant) utilizing a variety of ventricular leads Currently, the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). The ability of a pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s and is only available today in conjunction with a specific low polarization lead system. Methods: One hundred and five patients were enrolled from 17 European centers utilizing 31 different types of ventricular leads were followed through their 3-month follow-up visit. There were no restrictions on the type of ventricular leads used. Results: The average mean difference between the commanded autothreshold test (0.652 + 0.335 V) and the manual threshold test (0.651 + 0.335 V) was 0.001 + 0.49 (P 〈 0.0001). The average mean difference between the ambulatory autothreshold test (0.696 + 0.322 V) and the commanded autothreshold test (0.682 + 0.315 V) was 0.002 + 0.74 (P 〈 0.0001). Holter recordings confirmed that there were no loss of capture incidences without a backup pulse being delivered. In addition, the mean number of backup pulses delivered in a 24-hour period was less than 0.1% of the total number of paced beats. Conclusions: This study provided that the automatic capture feature while using a variety of leads accurately determines the ventricular stimulation threshold and safely delivers a backup pulse when required.

Notes: Background: Aim of this invasive study was to characterize and quantify changes in left ventricular (LV) systolic function due to sequential biventricular pacing (BV) as compared to right atrial triggered simultaneous BV (BV0), LV, and right ventricular (RV) pacing in patients with congestive heart failure (CHF). Methods: In 22 CHF patients, all in sinus rhythm, temporary multisite pacing was performed prior to implantation of a permanent system. LV systolic function was evaluated invasively by the maximum rate of LV pressure increase (dP/dtmax). Sequential BV pacing was performed with preactivation of either ventricle at 20–80 ms. Results: In comparison to RV pacing, LV and BV0 pacing increased dP/dtmax by 33.9 ± 19.3% and 34.0 ± 22.6%, respectively (P 〈 0.001). In 9 patients, optimized sequential BV pacing further improved dP/dtmax by 8.5 ± 4.8% compared to BV0 (range 3.3–17.1, P 〈 0.05). In 10 patients exhibiting a PR interval ≤200 ms, LV pacing was either superior (n = 6) or equal to BV0 pacing (n = 4). In these 10 patients, LV pacing yielded a 7.4 ± 8.0% higher dP/dtmax than BV0 pacing (P 〈 0.05). Conclusions: Using sequential BV pacing, generally with LV preactivation, moderate improvements in LV systolic function can be achieved in selected patients. Baseline PR interval may aid in the selection of the optimum cardiac resynchronization therapy (CRT) mode, favoring LV pacing in patients with a PR interval ≤200 ms.

Notes: Introduction: Pulmonary vein stenosis (PVS) is a potential complication of pulmonary vein isolation (PVI) using radiofrequency energy. The aim of our study was the evaluation of the severity and long-term outcome of primary angioplasty and angioplasty with pulmonary vein stenting for PVS. Methods and Results: Twelve patients with 15 PVS (greater than 70% stenosis) were prospectively evaluated. Primary dilation of the stenosis was performed because of clinical symptoms (10 patients) and/or the lung perfusion scans showed a significant perfusion defect (11 patients). Magnetic resonance imaging and lung perfusion scans performed before, directly after, during 3-month, and 6-month follow-up. In the stenting group additional multislice CT-scans directly after, during 6-month, and 12-month follow-up were performed.Within 2 months after primary balloon angioplasty, the PV size parameters were significantly reduced (P 〈 0.001) with recurrence of PVS in 11 of 15 PVs (73%). Pulmonary vein stenting in 8 patients and 11 PVs resulted in no vein stenosis during 12-month follow-up. Normalization of lung perfusion was noted in 8 of 12 patients. We observed 2 patients with hemoptysis during PV dilation, as severe complications with potential life-threatening character. Conclusion: PVS stenting seems to be superior to balloon angioplasty and effective at least over a period of 12 months in treating acquired PVS after pulmonary vein isolation.