Early Postoperative Increase in Defibrillation Threshold with Nonthoracotomy System in Humans

The stability of the defibrillation threshold (DFT) early after implantation of an implantable cardioverter defibrillator was evaluated in 15 patients. All but one patient had a three lead nonthoracotomy system using a subcutaneous patch, a right ventricular endocardial lead, and a lead in coronary sinus (n = 5) or superior vena cava (n = 9). Shocks were delivered using simultaneous in nine, sequential in three, and single pathway (coronary sinus not used) in one patient. DFTs were measured at implant (n = 15), 2–8 days postoperation (postop, n = 15), and 4–6 weeks later (n = 8). The DFT was defined as the lowest energy shock that resulted in successful defibrillation. The DFT was assessed with output beginning at 18 joules or 2–4 joules above the implant DFT. All shocks were delivered in 2- to 4-joule increments or decrements. DFTs were significantly higher postoperatively than DFTs at implant (22.7 ± 7.0 J vs 16.9 ± 3.9 J; P < 0.05), Eight of 15 patients had DFT determined at all three study periods. In these patients, DFT increased at postop (22.8 ± 8.3 J vs 16.4 ± 3.9 J at implant: P < 0.05) and returned to baseline at 4–6 weeks (16 ± 7.1) vs 16.4 ± 3.9 J at implant; P = N.S.). Thus, in patients with a multilead nonthoracotomy system, a DFT rise was observed early after implant. The DFT appears to return to baseline in 4–6 weeks. These results have important implications for programming energy output after implantable cardioverter defibrillator implantation.     

Prospective Randomized Comparison of Biphasic Waveform Tilt Using a Unipolar Defibrillation System

Background: A unipolar defihrillation system using a single right ventricular (RV) electrode and the active shell or container of an implantable cardioverter defibrillator situated in a left infraclavicular pocket has been shown to be as efficient in defibrillation as an epicardial lead system. Additional improvements in this system would have favorable practice implications and could derive from alterations in pulse waveform shape. The specific purpose of this study is to determine whether defibrillation efficacy can be improved further in humans by lowering biphasic waveform tilt. Methods: We prospectively and randomly compared the defibrillation efficacy of a 50% and a 65% tilt asymmetric biphasic waveform using the unipolar defibrillation system in 15 consecutive cardiac arrest survivors prior to implantation of a presently available standard transvenous defibrillation system. The RV defibrillation electrode has a 5-cm coil located on a 10.5 French lead and was used as the anode. The system cathode was the active 108 cm² surface area shell (or “CAN”) of a prototype titanium alloy pulse generator placed in the left infraclavicular pocket. The defibrillation pulse derived from a 120-μF capacitor and was delivered from RV ± CAN, with RV positive with respect to the CAN during the initial portion of the cycle. Defibrillation threshold (DFT) stored energy, delivered energy, leading edge voltage and current, pulse resistance, and pulse width were measured for both tilts examined. Results: The unipolar single lead system, RV ± CAN, using a 65% tilt biphasic pulse resulted in a stored energy DFT of 8.7 ± 5.7 J and a delivered energy DFT of 7.6 ± 5.0 J. In ail 15 patients, stored and delivered energy DFTs were < 20 J. The 50% tilt biphasic pulse resulted in a stored energy DFT of 8.2 ± 5.4 J and a delivered energy DFT of 6.1 ± 4.0 J;P = 0.69 and 0.17, respectively. As with the 65% tilt pulse, all 15 patients had stored and delivered energy DFTs < 20 J. Conclusion: The unipolar single lead transvenous defibrillation system provides defibrillation at energy levels comparable to that reported with epicardial lead systems. This system is not improved by use of a 50% tilt biphasic waveform instead of a standard 65% tilt biphasic pulse. (PACE 1995; 18:1369–1373)     

Prospective Evaluation of Defibrillation Threshold and Postshock Rhythm in Young ICD Recipients

Background: Adaptation of implantable cardioverter defibrillator (ICD) systems to the needs of pediatric and congenital heart patients is problematic due to constraints of vascular and thoracic anatomy. An improved understanding of the defibrillation energy and postshock pacing requirements in such patients may help direct more tailored ICD therapy. We describe the first prospective evaluation of defibrillation threshold (DFT) and postshock rhythm in this population. Methods: We prospectively studied patients ≤60 kg at time of ICD intervention. DFTs were obtained using a binary search protocol with three VF inductions. Postshock pacing was programmed using a stepwise protocol, lowering the rate prior to each VF induction. Results: Twenty patients were enrolled: 11 had channelopathy, five congenital heart disease, and four cardiomyopathy. The median age was 16 years, median weight 48 kg. Twelve patients had a transvenous high‐voltage coil; eight had pericardial +/? subcutaneous coil(s). Median DFT was 7 J (range 3–31 J); 19/20 patients had DFT ≤15 J and all patients <25 kg had DFT ≤9 J (n = 6). There was no difference in DFT between patients with transvenous versus pericardial +/? subcutaneous coils (median 7 J vs 6 J, P = 0.59). No patient with normal atrioventricular conduction prior to defibrillation required postshock pacing (n = 16). There were no adverse events. Conclusions: These data suggest that many pediatric ICD patients have low DFTs and adequate postshock escape rhythm. This may help determine appropriate parameters for future design of pediatric‐specific ICDs. (PACE 2012;35:1487–1493)     

The Effect of Dofetilide on Ventricular Defibrillation Thresholds

Introduction: High defibrillation threshold (DFT) with an inadequate defibrillation safety margin remains an infrequent but troubling problem associated with defibrillator implantation. Dofetilide is a selective class III antiarrhythmic drug that reduces DFTs in a canine model. We hypothesized that dofetilide would reduce DFTs in humans, obviating the need for complex lead systems.
Methods and Results: Sixteen consecutive patients with DFTs ≥20 J delivered energy at implant-received dofetilide therapy and underwent follow-up DFT testing acutely following drug loading and/or chronically (128 ± 94 days). Amiodarone was discontinued in four patients at implantation. With dofetilide, DFTs decreased from 28 ± 4 J to 19 ± 7 J (P < 0.0001), resulting in a safety margin of 15 ± 8 J for the implanted devices. Five patients subsequently had spontaneous arrhythmias terminated successfully with shocks.
Conclusion: Dofetilide reduces DFTs sufficiently to prevent the need for more complex lead systems. This strategy should be considered when an inadequate defibrillation safety margin is present.     

Comparison of Simultaneous Versus Sequential Defibrillation Pulsing Techniques Using a Nonthoracotomy System

The defibrillation threshold (DFT) using simultaneous (SIML) versus sequential (SEQ) pathways for shock delivery was compared in 16 patients with an implanted cardioverter defibrillator. All patients had three-lead nonthoracotomy systems (NTL) using a left chest subcutaneous patch, a right ventricular endocardial lead, and a lead in the coronary sinus (n = 5) or superior vena cava (n = 11). The DFT were determined 2–44 days (17 ± 17 days) after implantation. The DFT was defined as the lowest energy shock that resulted in successful defibrillation. The first pathway tested was SIML in 12 and SEQ in 4 patients with output beginning at or above the intraoperative DFT, routinely 18 J. The second pathway was tested beginning 2–4 J above the DFT of the first tested pathway. All shocks were delivered in 2–4 J decrement or increment steps. The SEQ pathway shocks resulted in a significantly lower DFT than SIML pathway shocks (14 ± 6 vs 18 ± 6 J; I < 0.01). There was no difference in the time delay after ventricular fibrillation initiation before shock delivery for the successful defibrillation between SIML versus SEQ pathways (7 ± 2 secs for both pathways). In 7 of 16 patients, defibrillation using SEQ pathway resulted in a > 5 J lowering of DFT, while only one patient had > 5 J lowering of DFT using SIML shocks (P <0.05). These results have important implications for selecting the optimal pathway for implantable cardioverter defibrillator therapy with a multilead NTL system.     

Initial Single-Center Experience with an Advanced Third-Generation Investigational Defibrillator

The CPI PRxII is a recently approved, multitiered implantable cardioverter defibrillator (ICD) that delivers high and low energy biphasic shocks, antitachycardia (ATP) and bradycardia pacing, and stores 2.5 minutes of electrograms from the widely spaced shocking electrodes. The PRxII was implanted in 58 patients at Yale-New Haven Hospital between December 1993 and January 1995. At implant, mean biphasic defibrillation threshold (DFT) in patients with testing to failure was 10 J (1–20). All 36 patients who were candidates for a new transvenous system underwent successful nonthoracotomy implantation. Based on noninvasive predischarge EPS results, 30 patients had ≥ 1VT zone: 21 patients had ATP, 9 others had first shock ≤ 5 J. During follow-up, 13 patients had been treated for 379 events (range, 1–127). Of 340 events in a zone with ATP, 97% responded to ATP, 3% required shock. First programmed shock converted all events in a VF zone. Details, including RR intervals, were available for ail events in 15 of 17 patients receiving appropriate or inappropriate therapy or diverted shocks. One hundred eleven of 148 available electrograms confirmed VT by morphology, rate, and/or presence of AV dissociation. In nine patients, electrogram data altered therapy through diagnosis of inappropriate or diverted therapy, guidance of detection enhancements, or diagnosis of previously unrecognized VTs. We conclude the PRxII achieves low DFTs that obviate the need for thoracotomy and effectively treats ventricular arrhythmias with ATP and shock, with programming guided by noninvasive electrophysiology. Multiple stored electrograms from widely spaced shocking electrodes greatly enhance diagnostic capabilities, facilitating effective treatment.     

Transesophageal Defibrillation: Animal Studies and Preliminary Clinical Observations

Ventricular fibrillation (VF) that fails to respond to transthoracic defibrillation leaves the clinician with few alternatives. The purpose of this study was to develop a technique of rescue defibrillation by use of transesophageal electrodes. Fourteen anesthetized dogs (20 30 kg) were investigated in this study. Two electrodes (300 mm²) were mounted 8 cm apart on an esophageal probe and inserted approximately 40 cm from the mouth. VF was induced using AC current delivered to the myocardium. Defibrillation was then performed between the distal electrode (anode) and anterior skin patch (cathode). After 15 seconds of induced VF, transesophageal and transthoracic defibrillation thresholds (DFTs) were determined in random order. The esophageal DFT (90 ± 15 joules) tended to be lower than the transthoracic DFT (115 ± 35 joules), though this difference was not statistically significant. One dog could not be defibrillated by transthoracic defibrillation but responded to transesophageai defibrillation. Esophageal electrodes were also useful for arrhythmia discrimination and ventricular pacing (pacing threshold of 38 ± 5 mA at a pulse duration of 2.5 msec). Following transesophageal DFT determination, in ten dogs (total energy of 600 ± 150 joules), acute esophageal histopathology demonstrated mild to severe focal injury to the mucosa and/or muscular layers. However, esophagi in four chronic dogs (total energy of 470 ± 110 joules) showed no gross evidence of macosal damage, perforation, or stricture 4 weeks following defibrillation. Histopathology showed only focal myocyte atrophy and repair. As a last resort, transesophageal defibrillation was performed in the emergency room on four patients with out-of-hospital refractory VF who failed > 6 high energy transthoracic shocks. Transesophageal defibrillation successfully terminated VF in each patient in spite of ≥ 50 minutes of cardiac arrest, however, none of the patients survived the initial resuscitation, Jn conclusion, transesophageal defibrillation is as effective as transthoracic defibrillation in a canine model and safe up to a total energy of 600 joules. Preliminary clinical trials suggest that this method results in conversion from VF when trunsthoracic defibrillation fails.     

The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series

Background: Conventional insertion of implantable cardioverter‐defibrillator (ICD) includes an evaluation of the defibrillation threshold (DFT). Implanting an ancillary defibrillation lead in the azygos vein has been introduced as a therapeutic option in patients with “high” DFT. This study reports the efficacy and stability of azygos defibrillation coils implanted for elevated DFTs. Methods: This is a retrospective review of seven consecutive patients with right and left pectoral, single‐ and dual‐chamber, and biventricular ICDs and elevated DFTs, in whom an azygos defibrillation coil was introduced. Results: Addition of an azygos defibrillator lead achieved a satisfactory safety margin during single energy defibrillation efficacy testing in four out of seven patients, with success at maximum device output in two patients. No satisfactory safety margin was achieved in the remaining patient, despite the further addition of a subcutaneous defibrillation coil. No change in lead position was observed over a mean radiographic follow‐up of 8 months. No complications were noted during a mean follow‐up of 14 months, including no deaths, and no ICD shocks. Conclusion: Implanting a defibrillation coil into the azygos vein is feasible and safe. In a majority of patients with failed defibrillation efficacy testing, adding an azygos coil achieves success on repeat testing. Therefore, this technique is one option for lowering the defibrillation threshold in patients who fail DFT testing of their ICD.     

A Prospective, Randomized Evaluation of a Nonthoracotomy Implantable Cardioverter Defibrillator Lead System

Nonthoracotomy lead systems for ICDs have been developed that obviate the need for a thoracotomy and reduce the morbidity and mortality associated with implantation. However, an adequate DFT cannot be achieved in some patients using transvenous electrodes alone. Thus, a new subcutaneous "array" electrode was designed and tested in a prospective, randomized trial that compared the DFT obtained using monophasic shock waveforms with a single transvenous lead alone that has two defibrillating electrodes, the transvenous lead linked to a subcutaneous/submuscular patch electrode, and the transvenous lead linked to the investigational array electrode. There were 267 patients randomized to one of the three nonthoracotomy ICD lead systems. All had DFTs that met the implantation criterion of ≤ 25 J. The resultant study population was 82% male and 18% female, mean age of 63 ± 11 years. The indication for ICD implantation was monomorphic VT in 70%, VF in 19%, monomorphic VT/VF in 6%, and polymorphic VT in 4% of the patients, respectively. The mean LVEF was 0.33 ± 0.13. The mean DFT obtained with the transvenous lead alone was 17.5 ± 4.9 J as compared to 16.9 ± 5.5 J with the lead linked to a patch electrode (P = NS), and 14.9 ± 5.6 with the lead linked to the array electrode (array versus lead alone, P = 0.0001; array versus lead/patch, P = 0.007). The results of this investigation suggest that the subcutaneous array may be superior to the standard patch as a subcutaneous electrode to lower the DFT and increase the margin of safety for successful nonthoracotomy defibrillation.     

Comparative Reproducibility of Defibrillation Threshold and Upper Limit of Vulnerability

The upper limit of vulnerability (ULV) is the strength at or above which VF is not induced when a stimulus is delivered during the vulnerable phase of the cardiac cycle. Previous studies have demonstrated a statistically significant correlation between the ULV and the defibrillation threshold (DFT) in groups of patients. However, the correlation between ULV and DFT may not be close in individual patients. This imperfect correlation may be due to physiological factors or to limitations of the measuremen t methods. The reproducibility of either DFT or ULV has not been studied critically. The purpose of this study was to compare the reproducibility of clinically applicable methods for determination of DFT and ULV. We prospectively studied 25 patients with a transvenous implantable cardioverter defibrillator (Medtronic 7219D) at postoperative electrophysiological study. DFT was defined as the lowest energy that defibrillated after 10 seconds of VF. The ULV was defined as the lowest energy that did not induce VF with three shocks at 0, 20. and 40 ms before the peak of the T wave in ventricular paced rhythm at a cycle length of 500 ms. Both the DFT and the ULV were determined twice for biphasic pulses using a three-step, midpoint protocol. There was no significant difference between the two determinations of DFT (10.1 ± 5.9 J vs 10.4 ± 5.8 J), the two determinations of ULV (13.4 ± 6.8 J vs 13.8 ± 6.6) or the DFT-ULV Pearson correlation coefficients for each determination (0.84, P < 0.001 vs 0.75, P < 0,001). To analyze reproducibility, Lin concordance coefficients for second determination versus first determination were constructed for both ULV and DFT. This coefficient is similar to the Pearson correlation coefficient, but measures closeness to the line of identity rather than the line of regression. The Lin concordance coefficient for ULV was higher than that for DFT (0.93, 95% CI 0.85–0.97 vs 0.64, 95% Cl 0.33–0.82; P < 0.01). For paired comparison of defibrillation efficacy under different experimental conditions, the sample sizes required to detect differences of 2 J, 3 J, and 4 J (80% power, P < 0.05) were 52, 24, and 15 for DFT versus 15, 8, and 6 for ULV. We conclude that a simple, clinically applicable method for determination of ULV is more reproducible than the single point DFT. Measured correlations between the ULV and single point are limited by the reproducibility of the DFT measurement.     

Initial Experience with a New Transvenous Defibrillation System

The clinical efficacy and safely of a new bidirectional transvenous defibrillation endocardial lead system (ELS) was studied in 39 patients with ventricular tachycardia (VT) or fibrillation (VF). There were 28 patients with coronary disease and 11 patients with nonischemic VT/VF. Fourteen patients received the ELS combined with antitachycardia pacing devices (Ventak PRx 1700, CPI) and 25 patients with the Ventak P or P2 (CPI). Implantation of the ELS was attempted in 47 patients. Intraoperatively, the mean defibrillation threshold (DFT) was > 25 joules in five patients and no reliable ELS position was found in three other patients. These eight patients underwent thoracotomy and epicardial leads implantation. The mean DFT was ≤ 20 jouJes in all 39 patients and the mean DFT was 18 joules. During the mean follow-up of 8 ± 2 months two patients (5%) died suddenly. Complications occurred in two patients (5%).     

Defibrillation Threshold Testing in Patients with Hypertrophic Cardiomyopathy

Introduction: Implantable cardioverter‐defibrillators (ICDs) decrease sudden cardiac death in patients with hypertrophic cardiomyopathy (HCM). One of the vital aspects of ICD implantation is the demonstration that the myocardium can be reliably defibrillated, which is defined by the defibrillation threshold (DFT). We hypothesized that patients with HCM have higher DFTs than patients implanted for other standard indications. Methods: We retrospectively reviewed the medical records of patients implanted with an ICD at the University of Maryland from 1996 to 2008. All patients with HCM who had DFTs determined were included. Data were compared to selected patients implanted for other standard indications over the same time period. All patients had a dual‐coil lead with an active pectoral can system and had full DFT testing using either a step‐down or binary search protocol. Results: The study group consisted of 23 HCM patients. The comparison group consisted of 294 patients. As expected, the HCM patients were younger (49 ± 18 years vs 63 ± 12 years; P < 0.00001) and had higher left ventricular ejection fractions (66% vs 32%; P < 0.000001). The average DFT in the HCM group was 13.9 ± 7.0 Joules (J) versus 9.8 ± 5.1 J in the comparison group (P = 0.0004). In the HCM group, five of the 23 patients (22%) had a DFT ≥ 20 J compared to 19 of 294 comparison patients (6%). There was a significant correlation between DFT and left ventricle wall thickness in the HCM group as measured by echocardiography (r = 0.44; P = 0.03); however, there was no correlation between DFT and QRS width in the HCM group (r = 0.1; P = NS). Conclusions: Our results suggest that patients with HCM have higher DFTs than patients implanted with ICDs for other indications. More importantly, a higher percentage of HCM patients have DFTs ≥ 20 J and the DFT increases with increasing left ventricle wall thickness. These data suggest that DFT testing should always be considered after implanting ICDs in HCM patients. (PACE 2010; 1342–1346)     

Late Retesting of System Performance in ICD Patients Without Spontaneous Shocks

One hundred five implantable cardioverter defibrillator (ICD) patients (71 ± 9 years of age, 83% men) without spontaneous ICD discharges for ≥ 12 months were tested to assess high voltage (HV) circuit integrity and the system's ability to recognize and terminate ventricular fibrillation (VF). Indications for ICD implantation were sustained ventricular tachycardia (VT) (35%), cardiac arrest (27%), and inducible VT (38%). Eighty-two percent of the patients had coronary artery disease (CAD), and the mean left ventricular ejection fraction (LVEF) was 36%± 13%. Results: One hundred patients had inducible VF and five did not. Testing led to ICD reprogramming in 50 (49%) patients. Two (1.9%) patients required ICD replacement: (1) a 45-year-old patient with a Ventritex 110 ICD implanted for 13 months interfaced with a CPI 0062 lead implanted for 46 months could not be defibrillated internally (impedance nonmeasurable); (2) an 82-year-old patient with a 23-month-old Medtronic 7219 ICD interfaced with 6936 and 6933 leads whose defibrillation threshold (DFT) had doubled since implantation (24 J from 12 J). Lead fractures were found in both cases (proximal coil of the 0062, and subcutaneously in the 6933). Based on DFT determinations, the first shock output was programmed lower in 37 patients and higher in 10 patients. Shock pulse width was changed in one patient and the ventricular refractory period in another. No programming changes were made in 54 (51%) patients. Conclusions: (1) Late testing of HV circuit integrity in ICD patients without an ICD shock in ≥ 12 months identifies previously unsuspected HV lead fractures; (2) chronic DFT testing resulted in HV output reprogramming in one-half of the patients.     

"Tuned" Defibrillation Waveforms Outperform 50/50% Tilt Defibrillation Waveforms: A Randomized Multi-Center Study

Introduction: A superior performance of a tuned waveform based on duration using an assumed cardiac membrane time constant of 3.5 ms and of a 50/50% tilt waveform over a standard 65/65% tilt waveform has been documented before. However, there has been no direct comparison of the tuned versus the 50/50% tilt waveforms.
Methods: In 34 patients, defibrillation thresholds (DFTs) for tuned versus 50/50% tilt waveforms in a random order were measured by using the optimized binary search method. High voltage lead impedance was measured and used to select the pulse widths for tuned and 50/50% tilt defibrillation waveforms.
Results: Delivered energy (7.3 ± 4.6 J vs 8.7 ± 5.3 J, P = 0.01), stored energy (8.2 ± 5.1 J vs 9.7 ± 5.6 J, P = 0.01), and delivered voltage (405.9 ± 121.7 V vs 445.0 ± 122.6 V, P = 0.008) were significantly lower for the tuned than for the 50/50% tilt waveform. In four patients with DFT ≥15 J, the tuned waveform lowered the mean energy DFT by 2.8 J and mean voltage DFT by 45 V. For all patients, the mean peak delivered energy DFT was reduced from 29 J to 22 J (24% decrease). Multiple regression analysis showed that a left ventricular ejection fraction <20% is a significant predictor of this advantage.
Conclusion: Energy and voltage DFTs are lowered with an implantable cardioverter defibrillator that uses a tuned waveform compared to a standard 50% tilt biphasic waveform.     

Short Biphasic Pulses from 90 Microfarad Capacitors Lower Defibrillation Threshold

For defibrillation between right ventricular and retropectoral patch electrodes using truncated exponential pulses, the stored energy defibrillation threshold (DFT) is lower for short pulses from small 60-μF capacitors than for conventional pulses from 120-μF capacitors, but 60-μF pulses frequently require higher voltages than are currently used. The goal of this study was to determine if DFT could be reduced by intermediate size 90-μF capacitors. This study compared biphasic waveform DFTs for 120μF-65% tilt pulses, 90μF-65% tilt pulses, and 90 μF-50% tilt pulses in 20 patients at defibrillator implantation. The 90μF-50% tilt pulses were selected because their duration is half that of 120μF-65% tilt pulses. The stored energy DFT for 90 μF-50% tilt pulses (9.1 ± 4.3 J) was less than both the DFT for 120 μF-65% tilt pulses (12.0 ± 5.5 J, P < 0.005) and the DFT for 90μF-65% tilt pulses (11.6 ± 5.8 J, P < 0.005). There was no significant difference between the latter two values. The voltage DFTs for 90 μF-50% pulses (436 ± 113 V) and 120 μF-65% tilt pulses (436 ± 104 V) were not statistically different; the voltage DFT for 90 μF-65% tilt pulses was higher than for either of the other two pulses (490 ± 131, P < 0.005). The DFT was 20 } or greater in three patients for both 120 μF-65% tilt pulses and 90 μF-65% tilt pulses, but it was 16 J or less in all patients for 90 μF-50% tilt pulses. When pathways were dichotomized by the median resistance of 71 Ω, 90 μF-50% tilt pulses significantly reduced DFTs compared to 120 μF-65% tilt pulses for higher resistance pathways (9.2 ± 4.0 J vs 13.0 ± 6.2 J, P = 0.002), but not lower resistance pathways (9.0 ± 4.8 J vs 10.9 ± 4.6 J, P = NS). For the electrode configuration tested, biphasic 90 μF-50% tilt pulses reduce stored energy DFT in comparison with 120 μF-65% tilt pulses without increasing voltage DFT. However, 90 μF-65% tilt pulses provide no benefit.     

Defibrillation Thresholds and Perioperative Mortality Associated with Endocardial and Epicardial Defihrillation Lead Systems

Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads (87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The mean DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation. This could be due to patient characteristics, a less invasive implant procedure, and absence of concomitant cardiac surgery.     

Influence of Anodal Electrode Position on Transvenous Defibrillation Efficacy in Humans: A Prospective Randomized Comparison

Nonthoracotomy lead systems for implantable cardioverter defibrillators (ICDs) have reduced operative mortality and morbidity as compared to epicardial lead systems but are usually associated with higher defibrillation thresholds (DFTs). The purpose of this prospective randomized trial was to investigate if the second defibrillation electrode in the left subclavian vein can increase defibrillation efficacy and decrease DFT as compared to the superior vena cava (SVC) position in nonthoracotomy lead systems for ICDs. Seventeen patients (mean age; 49.9 ± 11.3 years, mean ejection fraction; 46.1%± 15.8%) were implanted with an investigational unipolar electrode (Medtronic 13001) used as the defibrillation anode. DFT testing was started in the SVC (n = 10, group A) or the left subclavian vein (n = 7, group B), and repeated in the alternative position starting at the DFT of the initial position. Fifteen patients were eligible for analysis (group A: n = 9, group B: n = 6). With the electrode in the SVC, ventricular fibrillation could be successfully terminated in 9 out of 15 patients (60%). In the left subclavian vein the success rate was 100% (P < 0.01). Mean DFT in the SVC was 13.0 ± 5.2 J and in the left subclavian vein 10.2 ± 4.9 J. DFTs in the left subclavian vein were either lower (group A: n = 5/9, group B: n = 5/6) or equal to the results in the SVC position (P < 0.001). Thus, the left subclavian vein appears to be a superior alternative for positioning of the defibrillation anode as compared to the SVC for nonthoracotomy lead systems using two separate leads.     

Intracardiac Emergency Defibrillation for Refractory Ventricular Fibrillation During Implantation of Cardioverter Defibrillators with Nonthoracotomy Lead Systems

Implantable cardioverter defibrillators (ICDs) are being implanted in increasing numbers. At inlraoperative defibrillation threshold tests refractory ventricular fibrillation (VF) requiring emergency open chest resuscitation is a major concern during impiantation of nonthoracotomy ICD lead systems. A new method of high energy endocardial/extrathoracic defibrillotion via the implanted ICD transvenous defibrillation electrode (TDE) was used to terminate refractory VF. During implantation of ICD with TDE in 20 patients refractory VF occurred in two patients. The arrhythmia was terminated with endocardial/extrathoracic defibrillation in both cases, and no complications were observed.     

A Patch in the Pectoral Position Lowers Defibrillation Threshold

Implantable pacemaker cardioverter defibrillators are now available with biphasic waveforms, which have been shown to markedly improve defibrillation thresholds (DFTs). However, in a number of patients the DFT remains high. Also, DFT may increase after implantation, especially if antiarrhythmic drugs are added. We report on the use of a subcutaneous patch in the pectoral position in 15 patients receiving a transvenous defibrillator as a method of easily reducing the DFT. A 660-mm² patch electrode was placed beneath the generator in a pocket created on the pectoral fascia. The energy required for defibrillation was lowered by 56% on average, and the system impedance was lowered by a mean of 25%. This maneuver allowed all patients to undergo a successful implant with adequate safety margin.     

Effect of Biphasic Waveform Pulse on Endocardial Defibrillation Efficacy in Humans

Several clinical studies have proved increased defibrillation efficacy for implantable cardioverter defibrillators with biphasic pulse waveforms compared to monophasic pulse waveforms. This difference in defibrillation efficacy depends on the type of defibrillation lead system used. The influence of biphasic defibrillation pulse waveforms on the defibrillation efficacy of purely endocardial defibrillation lead systems has not yet been sufficiently examined, we, therefore studied 30 consecutive patients with drug refractory ventricular tachyarrhythmias during the implantation of a cardioverter defibrillator. After implanting an endocardial "integrated" sensing/defibrillation lead we performed a prospective randomized comparison of the defibrillation efficacy of monophasic and biphasic defibrillation waveform pulses. For endocardial defibrillation with the biphasic waveform the mean defibrillation threshold was 12.5 ± 4.9 joules and for the monophasic waveform 22.2 ± 5.6 joules (P < 0.0001). There was a decrease in the required defibrillation energy of biphasic defibrillation in 29/30 patients. Thus considering purely endocardial defibrillation a statistically significant and clinically relevant increase in defibrillation efficacy can be demonstrated for biphasic defibrillation waveform pulses.