Comparison of a Unipolar Defibrillation System with a Dual Lead System Using an Enlarged Defibrillation Anode

The unipolar system for transvenous defibrillation, consisting of a single right ventricular lead as the cathode and the device shell as anode, has been shown to combine low de- fibrillation thresholds (DFTs) and simple implantation techniques. We compared the defibrillation efficacy of this system with the defibrillation efficacy of a dual lead system with a 12-cm long defibrillation anode placed in the left subclavian vein. The data of 38 consecutive patients were retrospectively analyzed. The implantation of an active can system was attempted in 20 patients (group 1), and of the dual lead system in 18 patients (group 2). Both groups had comparable demographic data, cardiac disease, ventricular function, or clinical arrhythmia. The criterion for successful implantation was a DFT of > 24 J. This criterion was met in all 18 patients of group 2, The active can system could not be inserted in 3 of the 20 group 1 patients because of a DFT > 24 J. In these patients, the implantation of one (n = 2) or two (n = 1) additional transvenous leads was necessary to achieve a DFT ≤ 24). The DFTs of the 17 successfully implanted group 1 patients were not significantly different from the 18 patients in group 2 (12.3 ± 5.7 f vs 10.8 ± 4.8 J). The defibrillation impedance was similar in both groups (50.1 ± 6.1 ± 48.9 ± 5.2 Ω). In group 1, both operation duration (66.8 ± 17 min vs 80.8 ± 11 min; P < 0.05) and fluoroscopy time (3.3 ± 2.1 min vs 5.7 ± 2.9 min; P < 0,05) were significantly shorter. Thus, the active can system allows reliable transvenous defibrillation and a marked reduction of operation duration and fluoroscopy time. The dual lead system, with an increased surface area defibrillation anode, seems to he a promising alternative for active can failures.     

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.     

Determinants of Nonthoracotomy Biphasic Defihrillation

The clinical variables affecting DFT for ICD systems are not completely determined, especially with regard to biphasic shocking devices. To distinguish which factors correlate with DFT, we examined data from patients who were enrolled in the Ventak P2/Endotak protocol. A total of 284 patients were enrolled in the study. Two patients had a DFT > 25 J and did not receive the device; 154 did not undergo stepdown to failure DFT testing. The remaining 128 patients had formal DFT testing and were suitable for analysis. Variables available for analysis included age, body surface area (BSA), LVEF, gender, lead configuration, primary arrhythmia, primary cardiac disease, and use of cardioactive medication. Data were evaluated using regression analysis, fitting DFT (range, 1–25 J, mean 11 ± 5 J) as a function of each variable. As a univariate predictor, BSA was found to be significant in predicting DFT, but accounted for only 9% of the total variation on the DFT (P < 0.01, r = 0.3). This study suggests that DFT using a biphasic shocking waveform is modestly influenced by the BSA of the patient. Other specific factors, including LVEF, do not predict DFT.     

Placement of a defibrillation lead in the left subclavian vein from the right cephalic vein

This case report highlights the feasibility and stability of transvenous placement of a second defibrillation lead in the left subclavian vein from a right cephalic vein approach. This was undertaken in a right-sided implant of an active can cardioverter defibrillator to lower defibrillation thresholds that would have otherwise precluded implant.     

Effects of a Thin-Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation

SCHUCHERT, A., et al. : Effects of a Thin‐Sized Lead Body of a Transvenous Single Coil Defibrillation Lead on ICD Implantation. In the interest of patients receiving implantable cardioverter defibrillators (ICDs), the clinical benefits of newer and thinner transvenous defibrillation leads have to be determined. The aims of this study were to evaluate the ICD procedure duration and the frequency of lead dislocation at the 3‐month follow‐up of a new defibrillation lead with a thin‐sized lead body and its conventionalsized predecessor. The thin‐sized single coil defibrillation lead (Kainox RV, Biotronik; lead body 6.7 Fr) was implanted in 61 patients and the conventional‐sized defibrillation lead (SPS, Biotronik; lead body 7.8 Fr) in 60 patients. Both leads were connected to a left‐sided, prepectorally implanted Phylax ICD (Biotronik) with active housing. The lead implantation time and total procedure duration were determined. Lead implantation time was defined as the time from lead insertion to the end of the pacing measurements. The total procedure duration spanned skin incision to closure. The incidence of lead repositioning during the lead implantation time and during ventricular fibrillation conversion testing was also assessed. The frequency of lead dislocations was recorded at the 3‐month follow‐up. Mean lead implantation time and total procedure duration of the thin‐sized lead (23 ± 22 minutes 76 ± 37 minutes ) were not statistically different from the time needed for the conventional‐sized lead (22 ± 20 minutes 81 ± 34 minutes ). The number of lead repositionings during the lead implantation time was similar (thin‐sized lead: 1.4 ± 2.4 ; conventional‐sized lead: 1.1 ± 1.9 ). An additional lead repositioning was not necessary during ventricular fibrillation conversion testing in 93.4% of the patients with thin‐sized and in 94.4% with conventional‐sized leads (not significant). At the 3‐month follow‐up, there were four (6.6%) lead dislocations in the thin‐sized and four (6.7%) in the conventional‐sized lead group. In conclusion, the downsized lead body of the new defibrillation lead influenced neither ICD procedure duration nor the incidence of lead dislocation during follow‐up.     

Internal Cardiac Defibrillation: Single and Sequential Pulses and a Variety of Lead Orientations

A sequential pulse system for internal cardiac defibrillation incorporating catheter and patch electrodes with two current pathways has been shown to reduce defibrillation threshold in comparison to the single pulse technique. The relative advantage of the sequential pulse over the single pulse technique with other lead systems is not known. We compared defibrillation thresholds using sequential and single pulses delivered to a variety of lead orientations with the same electrode surface areas, when possible. Defibrillation threshold totals determined in halothane-anesthetized open-chest pigs averaged: For the single pulse shock passed between (1) superior vena cava (SVC) and left ventricular apical patch (LVA), 27.2 +/- 9.1 joules (J) and (2) LV epicardial patch (LVE) to right ventricular epicardial (RVE) patch leads, 16.5 +/- 2.1 J; and for the sequential pulse shock with two pulses passed between: (1) the SVC to RV intracavitary apex (RVA) and a quadripolar catheter in the coronary sinus to the RVA, 11.6 +/- 1.0 J; (2) the SVC to LVA and the LVE to RVE, 9.6 +/- 1.3 J and (3) the SVC to RVA and the LVE to RVA, 8.9 +/- 0.4 J. Defibrillation thresholds for sequential pulse shocks were all significantly lower than either of the defibrillation thresholds for single pulse shocks (p less than 0.001). We conclude that the sequential pulse system provides a substantial reduction in defibrillation threshold over the single pulse regardless of the lead system when the surface area and pulse characteristics are controlled. Sequential pulse technique may be valuable in the design of an implantable automatic defibrillator.(ABSTRACT TRUNCATED AT 250 WORDS)     

Unipolar Electrode System for an Implantable Defibrillator: New Experimental Approaches

Chez le chien normal nous avons étudié le seuil de défibrillation après induction de fibrillation ventriculaire par un courant alternatif. Après une période de fibrillation soutenue de 10 secondes, des chocs d'énérgie progressivement croissante sont delivrés. Le systèeme d'éléctrode endocavitaire est capable d'une configuration unipolaire ou bipolaire; l'électrode distale se situe è l'apex du ventricule droit. Les résultats suggèrent que pour une capacité optimale de 9-20 uF, les chocs unipolaires (3-10j) sont plus éfficaces que les chocs bipolaires (10-30j). En plus, des arrythmies diverses telles que la tachycardie ventriculaire rapide, le rythme idioventriculaire accéleré et le bloc AV transitoire sont frequemment observées. Nous concluons que: (1) un défibrillateur endocardique unipolaire et implantable semble faisable; (2) il devrait incorporer des circuits appropriés pour le traitement des arrythmies observées après choc.     

Implantation of a Subcutaneous Lead Array in Combination with a Transvenous Defibrillation Electrode via a Single Infraclavicular Incision

Occasional patients have excessive defibrillation energy requirements despite appropriate transvenous defibrillation lead position and modification of defibrillation waveform and configuration. Preliminary data suggest that use of subcutaneous defibrillation electrode arrays with nonthoracotomy systems is associated with a substantial reduction in defibrillation threshold. The current operative approach to subcutaneous lead array implantation involves the use of a separate left chest incision. We present two cases in which implantation of a subcutaneous lead array in combination with a transvenous defibrillation electrode was performed via a single infraclavicular incision and associated with a reduction in defibrillation threshold. Such an approach simplifies implantation and avoids the potential morbidity of the additional incision required of a left lateral chest approach.     

Nonthoracotomy Implantation of Cardioverter Defibrillators: Preliminary Experience with a Defibrillation Lead Placed at the Right Ventricular Outflow Tract

Although morbidity and mortality associated with defibrillator implantation using a nonthoracotomy approach have decreased as compared with a thoracotomy approach, dfifihrillation thresholds have been higher and fewer patients satisfied implan t criteria. It may be possible to improve on the success of nonthoracotomy defibrillator implantation by the placement of a right ventricular (HV) outflow defibrillation lead. Implnntable car-dioverter defibrillator implantation data of 30 consecutive patients with clinical VT or VF were reviewed. Three defibrillation leads were routinely used. When either pacing threshold at the RV apex ivas inadequate (n - 2) or 18-J shocks were not successful in terminating VF in 3 of 4 trials (n = 8). the RV apex lead was positioned to the HV outflow tract attaching to the septum. Defibrillation testing was first performed with the RV apex lead in combination with CS, SVC. and/or subcutaneous leads. Twenty patients satisfied implant criteria with a defibrillation threshold of 13.5 ± 3.6 J. In 7 of the 10 patients, whose RV lead was repositioned to the RV outflow tract, this lead in combination with SVC, CS, or subcutaneous leads produced successful defibrillation at < 18 J or in 3 of 4 trials. This approach improved the overall success of nonthoracotomy implantation of defibrillators from 69% to 90%, After a follow-up of 27 ± 6 months, there was no dislodgment of the HV outflow tract defibrillation leads. Conclusions: This article reports the preliminary observation that placement of defibrillation leads to the RV outflow tract in humans was possible and without dislodgment. RV outflow tract offers an alternative for placement of defibrillation leads, which may improve on the success of nonthoracotomy defibrillator implantation.     

Bidirectional Defibrillation Using Implantable Defibrillators: A Prospective Randomized Comparison Between Pectoral and Abdominal Active Generators

SANDSTEDT, B., et al. : Bidirectional Defibrillation Using Implantable Defibrillators: A Prospective Randomized Comparison Between Pectoral and Abdominal Active Generators. The objective of this study was to compare the effects of active abdominal and pectoral generator positions on DFTs in a bidirectional tripolar ICD system. Twenty-five consecutive patients had ICD systems implanted under general anesthesia. A transvenous single lead bipolar defibrillation system and an active 57-cc test emulator in the abdominal and pectoral positions were used in the same patient. A randomized, alternating stepdown protocol was used starting at 15 J with 3-J decrements until failure. The mean implantation time was  114 ± 23 minutes  , the mean arrhythmia duration was  14.5 ± 1.5 seconds  , and the mean recovery time was  5.4 ± 1.1 minutes  . The mean DFTs in the abdominal and pectoral positions were  10.9 ± 5.1  and  9.7 ± 5.2 J  , respectively (NS), the mean intraindividual DFT difference (abdominal minus pectoral) was  −0.89 ± 4.15 J  (  range −9.5 to + 5.8 J  ). The 95% confidence interval showed a  −2.60 to + 0.82 J  mean difference (NS). The DFT was < 15 J in 72% and 88% of the patients and the defibrillation impedance was  41 ± 3  and  44 ± 3 Ω  , abdominal versus pectoral positions. There was no difference in DFT between active abdominal and pectoral generator bidirectional tripolar defibrillation. The pectoral position may be considered the primary option, but in cases of high DFTs the abdominal site should be considered an alternative to adding a subcutaneous patch. In some patients, the anatomy may favor an abdominal position. Possible differences in the long-term functionality on the leads are not yet well known and need to be further evaluated.     

The Left Subclavian Vein as an Alternative Site for Implantation of the Second Defibrillation Lead

The optimal placement for the second defibrillation lead in a twolead system has never been addressed. We retrospectively reviewed the data of 33 patients with an average age of 59.2 years (range 41–78 years), predominantly mala (n = 29), who underwent implantation of a cardioverter defibrillator (ICD) for treatment of ventricular tachycardia (n = 19) or ventricular fibrillation (n = 14). In all patients an attempt was made to implant an endovenous ICD device (leads only, no subcutaneous patch). In group I (n = 18) the defibrillation anode, a separate unipolar lead, was placed in the common position, the superior vena cava. In group II (n =15) the lead was placed in the left subclavian vein. At least two consecutive shocks reverting ventricular fibrillation at energies ±24J were required for implantation of the ICD device. All shocks were monophasic. The success rate of endovenous defibrillation was significantly higher in group II than in group I (67% vs 28%, P < 0.05). Thus, it could be demonstrated that the position of the defibrillation anode can influence the defibrillation efficacy in transvenous ICD systems. Prospective randomized trials are needed to investigate the optimal position for the second defibrillation electrode, which may gain increasing importance as soon as dual chamber ICDs become available.     

Effects of Respiration Phase on Ventricular Defibrillation Threshold in a Hot Can Electrode System

The impedance of defibrillation pathways is an important determinant of ventricular defibrillation efficacy. The hypothesis in this study was that the respiration phase (end-inspiration versus end-expiration) mayalter impedance and/or defibrillation efficacy in a "hot can" electrode system. Defibrillation threshold (DFT) parameters were evaluated at end-expiration and at end-inspiration phases in random order by a biphasic waveform in ten anesthetized pigs (body weight: 19.1 ±2.4 kg; heart weight: 97 ± 10g). Pigs were intubated with a cuffed endotracheal tube and ventilated through a Drager SAVrespirator with tidal volume of 400–500 mL. A transvenous defibrillation lead (6 cm long, 6.5 Fr) was inserted into the right ventricular apex. A titanium can electrode (92-cm² surface area) was placed in the left pectoral area. The right ventricular lead was the anode for the first phase and the cathode for the second phase. The DFT was determined by a "down-up down-up" protocol. Statistical analysis was performed with a Wilcoxon matched pair test. The median impedance at DFT for expiration and inspiration phases were 37.8 ±3.1 Ω and 39.3 ± 3.6 Ω, respectively (P = 0.02). The stored energy at DFT for expiration and inspiration phases were 5.7 ± 1.9 J and 6.0 ± 1.0 J, respectively (P = 0.594). Shocks delivered at end-inspiration exhibited a statistically significant increase in electrode impedance in a "hot can" electrode system. The finding that DFT energy was not significantly different at both respiration phases indicates that respiration phase does not significantly affect defibrillation energy requirements.     

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.     

Effects of Polarity on Defibrillation Thresholds Using a Biphasic Waveform in a Hot Can Electrode System

The polarity of a monophasic and biphasic shocks have been reported to influence DFTs in some studies. The purpose of this study was to evaluate the effect of the first phase polarity on the DFTofa biphasic shock utilizing a nonthoracotomy "hot can" electrode configuration which had a 90-μF capacitance. We tested the hypothesis that anodal first phase was more effective than cathodal ones for defibrillation using biphasic shocks in ten anesthetized pigs weighing 38.9 ± 3.9 kg. The lead system consisted of a right ventricular catheter electrode with a surface area of 2.7 cm² and a left pectoral "hot can" electrode with 92.9 cm² surface area. DFT was determined using a repeated "down-up" technique. A shock was tested 10 seconds after initiation of ventricular fibrillation. The mean delivered energy at DFT was 11.2 ± 1.7 J when using the right ventricular apex electrode as the cathode and 11.3 ± 1.2 J (P = NS) when using it as the anode. The peak voltage at DFT was also not significantly different (529.0 ± 41.3 and 531.8 ± 28.6 V, respectively). We concluded that the first phase polarity of a biphasic shock used with a nonthoracotomy "hot can" electrode configuration did not affect DFT.     

Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead

GRADAUS, R., et al. : Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead. Dual-chamber ICDs are increasingly used to avoid inappropriate shocks due to supraventricular tachycardias. Additionally, many ICD patients will probably benefit from dual chamber pacing. The purpose of this pilot study was to evaluate the intraoperative performance and short-term follow-up of an innovative single pass right ventricular defibrillation lead capable of bipolar sensing and pacing in the right atrium and ventricle. Implantation of this single pass right ventricular defibrillation lead was successful in all 13 patients (  age 63 ± 8 years  ; LVEF  0.44 ± 0.16  ; New York Heart Association [NYHA]  2.4 ± 0.4  , previous open heart surgery in all patients). The operation time was  79 ± 29  minutes, the fluoroscopy time  4.7 ± 3.1  minutes. No perioperative complications occurred. The intraoperative atrial sensing was  1.7 ± 0.5 mV  , the atrial pacing threshold product was  0.20 ± 0.14 V/ms  (  range 0.03–0.50 V/ms  ). The defibrillation threshold was  8.8 ± 2.7 J  . At prehospital discharge and at 1-month and 3-month follow-up, atrial sensing was  1.9 ± 0.9, 2.1 ± 0.5, and 2.7 ± 0.6 mV  , respectively, (  P = NS, P < 0.05, P < 0.05  to implant, respectively), the mean atrial threshold product  0.79, 1.65, and 1.29 V/ms  , respectively. In two patients, an intermittent exit block occurred in different body postures. All spontaneous and induced ventricular arrhythmias were detected and terminated appropriately. Thus, in a highly selected patient group, atrial and ventricular sensing and pacing with a single lead is possible under consideration of an atrial pacing dysfunction in 17% of patients.     

The Economic Impact of Transvenous Defibrillation Lead Systems

The purpose of this study was to compare implant charges and convalescence for transvenous and epicardial defibrillation systems. Hospital stay, intensive care utilization, professional fees, and hospital bills were compared in 44 patients who underwent implantation of a cardiac defibrillator between September 1991 and May 1993. Twenty-five consecutive patients received an epicardial lead system, while 19 consecutive patients underwent implantation of the entire transvenous defibrillation system in the electrophysiology laboratory. There were no significant differences between the two groups in mean age or left ventricular ejection fraction. There was a significant reduction in postoperative hospital convalescence from 7.2 ± 2.0 days with epicardial systems to 3.1 ± 1.5 days with transvenous systems (P < 0.001). Postoperative intensive care unit stay was significantly reduced with transvenous systems compared with epicardial systems (0.1 ± 0.2 vs 1.5 ± 0.9 days; P < 0.001). Hospital charges were also significantly reduced with the transvenous lead system implants. Mean implant charges were lower with transvenous systems; $32,090 ±$2,620 vs $38,307 ±$2,701 (P < 0.001); convalescence charges were lower: $5,861 ±$5,010 vs $12,447 ±$4,969 (P < 0.001); the total hospital bill was also significantly lower with transvenous systems: $53,459 ±$12,588 vs $71,981 ±$16,172 (P < 0.001). Professional fees for implantation ($4,131 ±$1,724 vs $6,100 ± 0, P < 0.001), convalescence care ($1,258 ±$960 vs $2,846 ±$1,770; P < 0.001), and total professional fees ($12,925 ±$4,772 vs $15,731 ±$4,055, P < 0.05) were lower in the transvenous defibrillation group. In conclusion, transvenous defibrillation lead systems are associated with significantly shorter postoperative recovery and significantly lower hospital and professional charges.     

Rise in Chronic Defibrillation Energy Requirements Necessitating Implantable Defibrillator Lead System Revision

The chronic defibrillation energy requirement (DER) is believed to remain clinically stable in patients with defibrillators. Six patients (two with an epicardial and four with a nonthoracotomy system) were identified with a rise in their chronic DER, which eliminated a 10-J safety margin, thus necessitating a defibrillator lead system revision. The mean increase in DER was 14.7 ± 4 J and was discovered at a mean of 16.0 ± 18 months (range 2-41) following implantation. Management included placement of a defibrillator with a biphasic waveform, placement of an additional defibrillation electrode, or both. At 2 months following revision of the defibrillation system, a 10-J DER safety margin was present in each patient. In some patients, there is a progressive increase in the chronic DER with elimination of a 10-J safety margin necessitating revision of the defibrillation system. Routine reevaluation of the chronic DER, therefore, is necessary to identify these patients.     

Implantation of Active Can Implantable Defibrillators in the right Pectoral Region

Routinely the active can ICD is placed in the left side pectoral position, which theoretically gives optimal conditions for a low defibrillation threshold. Some patients, bowever, demand a right pectoral position, which possibly could result in a bigger defibrillation threshold. A right pectoral position was used in 3 of 85 active can ICDs implanted in our institution from 1994. the DFT was 12 J in two and 18 f in one patient. Thus, right pectoral implantation is feasible and offers an alternative approach in selected patients.     

Factors affecting the frequency of subcutaneous lead usage in implantable defibrillators

Subcutaneous leads (SQ) add complexity to the defibrillation system and the implant procedure. New low output devices might increase the requirement for SQ arrays, although this might be offset by the effects of active can and biphasic technology. This study sought to assess the impact of these technologies on SQ lead usage, and to determine if clinical variables could predict the need for an SQ lead. Patients receiving nonthoracotomy systems (n = 554) at our institution underwent step-down-to-failure DFT testing with implant criteria of a 10-J safety margin. SQ leads were used only after several endovascular configurations failed. Use of biphasic waveforms significantly lowered the frequency of use of SQ leads from 48% to 3.7% (P < 0.000001). SQ leads were required in 4.4% of patients with cold can devices and 2.6% of patients with active can devices (P = NS). There was no increase in SQ lead usage with low energy (< 30-J delivered energy) devices. Clinical variables (including EF, heart disease, arrhythmia, and prior bypass) did not predict the need for an SQ lead. The implant DFT using SQ arrays (14.5 +/- 6.5 J) was not significantly lower than that for SQ patches (16.6 + 6.0 J). We conclude that biphasic waveforms significantly reduce the need for SQ leads. Despite this reduction, 3.7% of implants still use an SQ lead to achieve adequate safety margins. The introduction of lower output devices has not increased the need for SQ leads, and when an SQ lead is required, there is not a significant difference in the implant DFT of patches versus arrays. Clinical variables cannot predict which patients require SQ leads.     

Transvenous Single Lead Atrial Defibrillation: Efficacy and Risk of Ventricular Fibrillation in an Ischemic Canine Model

Transvenous atrial defibrillation with multiple atrial lead systems has been shown to be effective in models without the potential for ventricular arrhythmias. The specific aim of this study was to evaluate the efficacy and safety of transvenous single lead atrial defibrillation in a canine model of ischemia cardiomyopathy. Ten dogs had ischemia cardiomyopathy induced by repeated intracoronary micmsphere injections. The mean LV ejection fraction decreased from 71%± 9% to 38%± 14% (P = 0.003). Spontaneous atrial fibrillation (AF) developed in four dogs, and in six AF was induced electrically. Atrial defibrillation thresholds (ADFTs) were determined with synchronous low energy shocks using a transvenous tripolar lead with two defibrillation coils (right ventricle, superior vena cava) and an integrated sensing lead (RV coil vs electrode tip). The ADFTs derived by logistic regression were compared at 50% and 90% probability of success (ED₅₀, ED₉₀): ED₅₀ was 2.4 ±1.7 J and 2.9 ±2.1 J, respectively, for 5- and 10-ms monophasic shocks, and 1.8 ± 0.9 J and 2.1 ± 1.3 J, respectively, for 5- and 10-ms biphasic shocks. Immediately after 3 of 2,179 (0.1%) synchronized shocks, ventricular fibrillation (VF) developed. VF was induced in 3 of 1,062 (0.3%) shocks with integrated sensing (RV coil vs electrode tip) compared to 0 of 1,117 shocks when a separate bipolar RV sensing electrode was used for synchronization. In our canine model of ischemic cardiomyopathy, low energy atrial defibrillation via a transvenous single lead system was highly effective. However, there was a small but definite risk of VF induction, which seemed to be greater when an integrated as opposed to a true bipolar RV sensing was used.