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Biomedical subjects

Johannes Sperzel

Publications and source records attributed to Johannes Sperzel.

At least 19 recordsLinked to original sources

Temporary third-degree atrioventricular block in a case of apical ballooning syndrome.

Apical ballooning is characterized by severe but reversible contractile dysfunction. The causative factor and the pathomechanism remain unknown. Several arrhythmias are reported to occur in apical-ballooning. We present a unique case of a 58-year-old man presenting with apical ballooning complicated by a prolonged third-degree atrioventricular block requiring the implantation of a pacemaker.

Cardiac Pacing, Artificial↗

Acute performance evaluation of a new ventricular automatic capture algorithm.

AIMS: This study evaluated the acute clinical performance of a new ventricular automatic capture algorithm developed to work with all lead types and pacing vectors. METHODS AND RESULTS: During regular pacemaker implant or replacement, AutoThreshold and manual threshold tests were performed in ventricular unipolar (UP) and bipolar (BP, if applicable) pacing using a customized external prototype INSIGNIA pacemaker. The success rate and accuracy of two different modes (commanded and ambulatory) of the automatic capture algorithm were used to evaluate the performance. Loss-of-capture events (two consecutive non-captured beats without backup pacing) were used to assess safety. Data of 53 patients (33 DDD/20 VVI) from four medical centres were analysed. Tested leads included 43 BP and 10 UP from nine manufacturers, and seven had electrodes with low polarization. The rate of successful commanded and ambulatory AutoThreshold tests was 96 and 94%, respectively, with an average absolute threshold difference compared with manual threshold of < 0.1 V at 0.4 ms (commanded 0.07 +/- 0.07 V and ambulatory 0.08 +/- 0.07 V). There was no significant difference in performance between UP/BP pacing, polarization, and lead type. No loss-of-capture event was observed. CONCLUSION: When successful, the ventricular automatic capture algorithm accurately determined pacing thresholds in either a UP or BP pacing configuration among all leads tested.

Adult↗

Patient Alert to detect ICD lead failure: efficacy, limitations, and implications for future algorithms.

AIMS: An algorithm that alerts implantable cardioverter-defibrillator (ICD) patients, in case of abnormal lead impedance (Patient Alerttrade mark, Medtronic), may help to recognize lead dysfunction. We aimed to determine the utility of Patient Alert for ICD lead-failure detection in a prospective study. METHODS AND RESULTS: Three hundred and sixty ICD patients were followed for 22+/-14 months. Patient Alert was active for pacing impedance <200 and >2000-3000 Omega, and high-voltage conductor impedance <10-20 and >200 Omega. Ten alert events and a total of 29 severe system complications occurred. Patient Alert detected three of 10 ICD lead failures, with a positive predictive value (PPV) of 77.8% for any severe system complication. Retrospective analysis identified 23 patients with a sensing integrity counter (SIC) >300 and revealed an additional four prior undetected lead defects. SIC detected ICD lead failure with 92.9% sensitivity and a PPV of 59.1%. Eight of nine patients with a false-positive SIC had an integrated bipolar lead. Patient Alert combined with SIC detected all ICD lead failures and 71.4% of all severe lead complications. CONCLUSIONS: Patient Alert, based on daily lead-impedance measurement, detected one-third of all ICD lead failures. Combined use with continuous lead integrity monitoring (SIC) increased sensitivity to 100%. Integrated bipolar leads may yield a false-positive SIC. Incorporating SIC and automated pace/sense threshold measurement may improve Patient Alert sensitivity for severe lead complications.

Aged↗

Asymptomatic recurrences of atrial fibrillation after pulmonary vein isolation.

AIMS: The purpose of this study was to determine the occurrence of asymptomatic episodes of atrial fibrillation (AF) and wrong AF perception after pulmonary vein isolation (PVI). We evaluated the success of ablation by using the following measurements: (i) clinical symptoms and duration of symptoms noticed by patients and (ii) synchronous event recording (ER). METHODS AND RESULTS: Eighty patients with paroxysmal AF underwent PVI and were provided repeatedly with a portable ER upon discharge and every 3 months for a year. The ER automatically detects arrhythmias by a detection algorithm and can also be manually triggered by the patient. In 46/80 patients (57.5%), episodes of AF were documented. Asymptomatic AF was detected in 21.3%. In 9/80 patients (11.3%), who reported clinical AF recurrence, no AF could be shown by ER. We compared patients' perception to have suffered AF episodes with the ERs and found a sensitivity of 75% and a specificity of 92%. CONCLUSION: Reliance on perception of AF by patients after PVI results in an underestimation of recurrence of the arrhythmia. We observed a maximal occurrence of silent AF or wrong perception of AF in 26/80 (32.6%) patients.

Analysis of Variance↗

Acute success and persistence of bidirectional conduction block in the cavotricuspid isthmus one month post cryocatheter ablation of common atrial flutter.

INTRODUCTION: Cryoablation is successful in the treatment of common atrial flutter. Long-term clinical success is mainly dependent on persistence of bidirectional conduction block (BCB) in the inferior cavotricuspid isthmus (CTI). Only few data on persistence of BCB post cryoablation with the reported technique are available. This prospective study aimed to test efficacy of cryo energy and persistence of BCB in the CTI 1 month post cryoablation. METHODS: Cryoablation of the CTI was performed in 50 consecutive patients (64 +/- 12 years, 40 males) with symptomatic common atrial flutter using a novel 9 Fr 8-mm-tip catheter. BCB in the CTI 30 minutes following the final cryoapplication was the ablation endpoint. Thirty days post ablation, persistence of BCB was controlled by repeat electrophysiological study (EPS). RESULTS: In all patients BCB was achieved with a mean of 9 (IQR 7-17.5) cryo applications and a mean cryo time of 2,378 seconds (IQR 1,680-3,474 seconds). In 5 of 50 patients, common atrial flutter recurred within 1 month post cryoablation. In 30 of 32 recurrence-free patients, persistence of BCB was verified. In 2 patients, resumption of isthmus conduction was detectable. Including relapses, 81.1% of patients (30/37) showed persistence of BCB. No patients reported pain during cryoapplication. No procedural complications were observed. CONCLUSIONS: Cryoablation of the CTI using a large-tip catheter is feasible and safe in the treatment of common atrial flutter. Acute and short-term success rates are comparable to those reported for radiofrequency (RF) ablation. Besides short-term clinical success, the persistence of BCB demonstrates efficacy of the cryoablation technique.

Adult↗

Reduction of RV pacing by continuous optimization of the AV interval.

BACKGROUND: In patients requiring permanent pacing, preservation of intrinsic ventricular activation is preferred whenever possible. The Search AV+ (SAV+) algorithm in Medtronic EnPulsetrade mark dual-chamber pacemakers can increase atrioventricular (AV) intervals to 320 ms in patients with intact or intermittent AV conduction. This prospective, multicenter study compared the percentage of ventricular pacing with and without AV interval extension. METHODS: Among 197 patients enrolled in the study, the percentage of ventricular-paced beats was evaluated via device diagnostics at the 1-month follow-up. Patient cohorts were defined by clinician assessment of conduction via a 1:1 AV conduction test at the 2-week follow-up. The observed percentage of ventricular pacing with SAV + ON and the predicted percentage of ventricular pacing with SAV + OFF were determined from the SAV + histogram data for the period between the 2-week and 1-month follow-up visits. RESULTS: Of 197 patients, 110 (55.8%) had intact 1:1 AV conduction, of which 109 had 1-month data. SAV + remained ON in 99/109 patients; 10 patients had intrinsic A-V conduction intervals beyond SAV + nominal and therefore SAV + disabled. The mean percentage of ventricular pacing in the 109 patients was SAV+ ON = 23.1% (median 3.7%) versus SAV + OFF = 97.2% (median 99.7%). In 87 patients without 1:1 AV conduction, SAV + was programmed OFF in 6, automatically disabled in 52, and remained ON in 29. In 8 of these patients, 80-100% reduction in ventricular pacing was observed with SAV + ON. CONCLUSION: The Search AV+ algorithm in the EnPulse pacemaker effectively promotes intrinsic ventricular activation and substantially reduces unnecessary ventricular pacing.

Aged↗

Contractile response and mitral regurgitation after temporary interruption of long-term cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) utilizing biventricular pacing (BVP) is a promising treatment modality for symptomatic patients with chronic left ventricular (LV) systolic dysfunction and intraventricular conduction delay. Clinical studies have shown short-term improvement in contractile function and mid-term improvement in clinical status with CRT. The objective of this study was to evaluate the haemodynamic consequences of temporary interruption of CRT after long-term stimulation. METHODS AND RESULTS: Twenty patients (16 men, 4 women) with LV dysfunction and New York Heart Association class III or IV heart failure, despite optimal medical therapy and a QRS interval of at least 120 ms, received a transvenous BVP system at the age of 66 (interquartile range, 61-69). Patients were studied after a median duration of 427 days (interquartile range, 281-563) of continuous CRT and again 72 h after cessation of BVP. Withdrawal of CRT resulted in a significant decline in maximal rate of LV systolic pressure rise from 711 mmHg/s (interquartile range, 640-816) to 442 mmHg/s (interquartile range, 389-582) (P=0.0001) and increases in mitral effective regurgitant orifice area from 4.8 mm(2) (interquartile range, 0.0-7.8) to 9.1 mm(2) (interquartile range, 5.7-13.3) (P=0.0001), mitral regurgitant volume from 7.8 mL (interquartile range, 0.0-11.5) to 16.0 mL (interquartile range, 10.7-20.8) (P=0.0001) and fraction from 13.8% (interquartile range, 0.0-19.2) to 27.7% (interquartile range, 14.6-34.0) (P=0.0002) determined by Doppler echocardiography. CONCLUSION: Cessation of long-term BVP leads to a decline in LV systolic performance and an increase in functional mitral regurgitation. These results indicate a sustained benefit of long-term CRT and support the notion to maintain CRT indefinitely.

Aged↗

Implantable dual-chamber defibrillator for the selective treatment of spontaneous atrial and ventricular arrhythmias: arrhythmia incidence and device performance.

INTRODUCTION: Atrial tachyarrhythmias are a common co-morbidity in patients with an ICD indication. Recently introduced ICD's are equipped to independently detect and treat atrial and ventricular tachyarrhythmias. The purpose of this prospective study was to evaluate the incidence and termination of spontaneous atrial and ventricular tachyarrythmias in patients with a history of atrial tachyarrhythmias. METHODS AND RESULTS: Ninety patients, 70% male with an ICD indication and history of atrial tachyarrhythmia (LVEF 45 +/- 6%, [AT/AF indication 55 +/- 10, AT/VT 45 +/- 16], 46% CAD) were enrolled and 89 were implanted with a VENTAK PRIZM AVT (Guidant). Spontaneous atrial and ventricular tachyarrhythmias were printed and evaluated during an average follow-up period of 272 +/- 72 days utilizing the stored intracardial electrogram function of the device. Nineteen patients (21%) presented had only atrial tachyarrhythmias, 32 patients (36%) had both atrial and ventricular tachyarrhythmias and 18 patients (20%) had only ventricular tachyarrhythmias. Patients with only atrial tachyarrhythmias had a total of 3274 atrial episodes; 2002 terminated spontaneously, 1264 were treated with ATP and 8 with shock therapy. ATP was successful in 735 (58%) of 1264 episodes. Patients with both atrial and ventricular tachyarrhythmias had 7277 documented atrial tachyarrhythmias, 5231 terminated spontaneously, 1153 of 2009 were terminated by ATP (57.4%) and 37 by shock therapy (20 patient controlled). Atrial tachyarrhythmias identified as atrial flutter (AT) by the atrial rhythm classification (ARC) algorithm had a higher ATP conversion success rate than episodes identified as atrial fibrillation (AF); 66.7% for AT and 26.4% for AF. Patients with only ventricular tachyarrhythmias had 690 documented episodes, 401 terminated spontaneously, 248 (85.8%) were terminated by ATP and 41 by shock. CONCLUSION: Seventy-seven percent of patients with an ICD indication had spontaneous atrial and/or ventricular tachyharrhythmias within the first 6 months after ICD implantation. ATP therapy terminated 58% of all atrial tachyarrhytmias and 66.7% of the atrial flutters. The dual chamber ICD detected, classified and terminated all ventricular tacharrhythmias appropriately.

Aged↗

Automatic measurement of atrial pacing thresholds in dual-chamber pacemakers: clinical experience with atrial capture management.

BACKGROUND: The Medtronic EnPulse pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES: The purpose of this study was to evaluate the clinical performance of ACM. METHODS: Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS: All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION: This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs.

Aged↗

Cryocatheter ablation of right ventricular outflow tract tachycardia.

INTRODUCTION: Cryocatheter techniques have been successfully applied to treat supraventricular tachycardia but there are no reports on their value in treating ventricular tachycardia (VT). We present our initial experience with cryocatheter ablation of right ventricular outflow tract (RVOT) tachycardia. METHODS AND RESULTS: Cryocatheter ablation was attempted in 14 patients (13 females, age 45.9 +/- 12.7 years) who were highly symptomatic due to frequent monomorphic ventricular extrasystole (VES) or nonsustained VT originating within the RVOT. A 9-Fr, 8-mm-tip cryocatheter was used for both mapping and ablation. Cryoablation was started after localizing the arrhythmic focus by pace and activation mapping. Ablation success, defined by complete disappearance of target VES/VT acutely and during a follow-up of 9.3 +/- 1.4 weeks, was achieved in 13 of 14 patients. Ablation was successful with local activation times of 35 +/- 4 ms, 5.8 +/- 3.3 applications, 18.8 +/- 7.5 minutes total cryo time, 9.4 +/- 4.2 minutes fluoroscopy time, and 66.9 +/- 26.1 minutes total procedure time, the latter two measures showing a reduction with number of patients treated. Three patients reported slight pain related to local pressure of the catheter on the RVOT wall. No pain was described related to delivery of cryothermal energy. CONCLUSIONS: Initial experience shows that focal VES/VT originating in the RVOT can be successfully treated using cryocatheter ablation. Acute and short term success rates, fluoroscopy times, and duration of procedure are comparable to conventional ablation techniques. A major advantage seems to be the virtual absence of ablation related pain.

Adult↗

Evaluation of fusion beat detection with a new ventricular automatic capture algorithm in ICDs.

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.

Algorithms↗

Evaluation of the atrial evoked response for capture detection with high-polarization leads.

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.

Aged↗

Invasive optimization of cardiac resynchronization therapy: role of sequential biventricular and left ventricular pacing.

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 (BV(0)), 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/dt(max)). Sequential BV pacing was performed with preactivation of either ventricle at 20-80 ms. RESULTS: In comparison to RV pacing, LV and BV(0) pacing increased dP/dt(max) by 33.9 +/- 19.3% and 34.0 +/- 22.6%, respectively (P < 0.001). In 9 patients, optimized sequential BV pacing further improved dP/dt(max) by 8.5 +/- 4.8% compared to BV(0) (range 3.3-17.1, P < 0.05). In 10 patients exhibiting a PR interval < or =200 ms, LV pacing was either superior (n = 6) or equal to BV(0) pacing (n = 4). In these 10 patients, LV pacing yielded a 7.4 +/- 8.0% higher dP/dt(max) than BV(0) 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 < or =200 ms.

Aged↗

Clinical performance of a ventricular automatic capture verification algorithm.

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.

Adult↗

Percutaneous pulmonary vein stenting for the treatment of severe stenosis after pulmonary vein isolation.

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.

Angioplasty, Balloon↗

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 form 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.

Aged↗

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.

Atrial Fibrillation↗

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 was 7.88 +/- 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 < 0.01 for equivalence). Charge times for DER + 5 J were significantly shorter than for DER + 10 J (3.65 +/- 1.14 vs 5.45 +/- 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.

Defibrillators, Implantable↗