Clinical Surveillance of a Tined, Bipolar, Steroid-Eluting, Silicone-Insulated Ventricular Pacing Lead

Since 1990, 1,068 Medtronic 5024 bipolar, silicone-insulated, tined, steroid-eluting ventricular leads have been implanted at the Mayo Clinic (Rochester, MN) and Midelfort Clinic (Eau Claire, WI). Implantation data were favorable: median pacing thresholds of 0.5 V at 0.5 ms, median R wave of 13.4 mV, and median impedance of 593 omega. Of the 2.1% acute lead-related complications (dislodgment, microdislocation, diaphragmatic pacing, and undersensing), 1.2% necessitated reoperation. This rate is lower than that in most published series of other leads. During a median follow-up of 23 months (up to 76 months), 12 (1.1%) chronic lead-related complications (high thresholds, loss of capture, and undersensing) and no instances of definite or suspected lead material failure occurred. This rate is much lower than that in studies of other leads. Thus, the 5024 lead combines the reliability of silicone insulation with a low rate of chronic complications that is probably the result of its steroid elution. No evidence of failure of lead material has appeared up to 6 years after implantation.     

Clinical Surveillance of an Active Fixation, Bipolar, Polyurethane Insulated Pacing Lead, Part I: The Atrial Lead

Since 1989, 168 Telectronics model 330–801 active fixation, polyurethane insulated atrial leads (Accufix) have been implanted at the Mayo Clinic. There were four (2.4%) acute lead related complications, (i.e., perforation, microdislodgment, and pericarditis). Over a median follow-up time of 7.6 months (up to 2.7 years), there were 14 (8.3%) chronic complications, including 1 instance (0.6%) of definite lead failure. Most of these complications were early (within the first month) and transient. Four patients (2.4%) required reoperation for chronic complications. During follow-up, 23% of the examined patients had high pacing thresholds, most at about 3 months after implantation, necessitating high-output programming. The exact mechanism and natural history of this phenomenon should be further investigated.     

Clinical Surveillance of an Active Fixation, Bipolar, Polyurethane Insulated Pacing Lead, Part II: The Ventricular Lead

Since 1989, 72 Telectronics 330–201 active fixation, polyurethane insulated ventricular leads (Accufix) have been implanted at the Mayo Clinic. There were four (5.6%) acute lead related complications (perforation, microdislodgment, and macrodislodgment), three of which led to early reoperation. Over a follow-up time of up to 2.7 years (median 9.4 months), there were six (8.3%) chronic lead related complications but no failures of lead material. Most of these complications developed during the first month, and half of them were transient, with documented improvement later. Two patients (2.6%) required reoperation for chronic complications. At follow-up examination of the pacing thresholds, usually performed about 3 months after implantation, 14.3% of the examined patients had high pacing thresholds necessitating high-output programming. The mechanisms and later evolution of this phenomenon should be further evaluated.     

Short- and Long-Term Results with an Active-Fixation, Bipolar, Polyurethane-Insulated Atrial Pacing Lead

Since 1989, 136 Medtronic 4058 and 4058M bipolar atrial screw-in leads have been implanted at the Mayo Clinic. Early lead related complications included dislodgment in 4 (2.9%). Over a median follow-up time of 14.4 months (1 day to 3.3 years), there were 11 lead related complications (undersensing, failure to capture, diaphragmatic pacing, and gross lead dislodgment). Chronic complications resulted in reoperations in four patients (2.9%). Of 77 patients in whom pacing thresholds were measured between 2 and 4 months after implantation, 9 (11.7%) and 2 (2.6%) had high pacing thresholds and very high thresholds, respectively. The Kaplan-Meier estimate of the probability of 1-year complication-free lead survival was 93.5%. There were no lead material failures. We conclude that the 4058/4058M lead implanted in the atrial position has favorable acute and chronic performance data, with a tendency toward high pacing thresholds at 3 months. The cause of this phenomenon and its course over time should be further evaluated.     

Bipolar Tined Polyurethane Ventricular Lead: A Four-Year Experience

With the advent of polyurethane as an insulating material for permanent pacemaker leads, concern has arisen over the integrity and long-term durability of polyurethane-insulated pacing leads. Specific concern has arisen over particular bipolar tined polyurethane ventricular leads. We have assessed our 4-year experience with this lead. This experience involves two groups of patients, those with leads manufactured before a certain date and those with leads manufactured at a later date. In the first group (judged to be at increased risk) the failure rate was 8.8%, and in the second group (judged not to be at increased risk) the rate was 3.9%. Lead failure occurred at an average of 17.5 months in the first group. Adequate follow-up on the second group is not available to determine whether or not the failure rate may eventually be as high as that in the early group. Actuarial analysis suggests that survivorship free of lead failure is probably not significantly different in the two groups. This experience points out the need for determining lead failure rates, identifying optimal lead design and configuration, and establishing a lead registry or mechanism by which the integrity of various pacing leads can be evaluated.     

Unsatisfying Results in Long-Term Atrial Pacing with a Bipolar Active Fixation Atrial Lead

A high dislodgment rate during long-term atrial pacing using the unipolar sickle-shaped active fixation lead was recently reported; therefore, the long-term results of atrial pacing in 118 consecutive patients with the bipolar sickle-shaped active fixation lead (Biotronik FH60-BP) were evaluated. Between January 1989 and September 1993, 87 leads (74%) were inserted for dual chamber pacing and 31 leads (26%) for atrial pacing only. At the time of implantation, the bipolar atrial electrogram had a mean voltage of 4.4 ± 1.6 mV, whereas the acute atrial threshold was 0.72 ± 0.38 V and 1.46 ± 0.67 ml at 0.5-msec pulse duration and mean resistance 506 ± 79 Ω. Early lead dislodgment (< 1 month after implantation) occurred in 9 patients (7.6%). During a mean follow-up of 21.8 months (median 20.9 months), late dislodgment (> 1 month after implantation) occurred in 6 patients (5.1%) after a mean interval of 7.9 months (range 3–14 months). Due to the unacceptably high late dislodgment rate, which to date remains unexplained, new implants of this lead are not recommended.     

Comparison of Electrical Characteristics Between a Steroid-Eluting Single-Pass VDD Lead and a Standard Steroid-Eluting Ventricular Lead

Compared to regular ventricular leads, single-pass VDD leads have two additional floating electrodes proximal to the ventricular tip, which enables them to detect atrial signals. Because of the latter, VDD leads are thicker than ventricular leads, which could affect ventricular pacing. The purpose of the present study was to compare ventricular pacing of a steroid-eluting single-pass VDD lead (CapSure VDD, Medtronic; n = 107) with the same steroid-eluting regular lead (CapSure SP, Medtronic; n = 39) implanted in the ventricle; both leads were connected to the same types of pacemakers. At implantation, pacing thresholds were measured at 0.5-ms pulse duration and impedance by means with the PSA. At discharge, as well as after 1 and 3 months, pulse duration thresholds were determined at 2.5 V pulse amplitude and impedance by telemetry. At implantation, pacing thresholds and impedance were not different in the VDD (0.38 ± 0.16 V; 691 ± 122 Ω) and ventricular lead group (0.44 ± 0.17 V; 648 ± 150 Ω). During follow-ups, no differences in pulse duration threshold were detected between the two groups neither at discharge (VDD = 0.05 ± 0.03 ms; ventricular 0.05 ± 0.02 ms), nor after 1 (VDD = 0.05 ± 0.02 ms; ventricular 0.08 ± 0.07 ms) and 3 months (VDD = 0.06 ± 0.03 ms; ventricular 0.09 ± 0.10 ms). There were also no significant differences for impedance at discharge (VDD = 675 ± 113 Ω; ventricular = 594 ± 113 Ω), after 1 (VDD = 678 ± 131 Ω,; ventricular = 627 ± 112 Ω) and 3 months (VDD = 652 ± 99 Ω; ventricular = 628 ± 105 Ω). Pacing thresholds and impedance were neither significantly different at implantation nor during follow-ups between patients with steroid-eluting VDD leads and patients with an equivalent ventricular lead indicating that the thicker VDD lead does not affect ventricular pacing.     

Five-Year Follow-Up of a Bipolar Steroid-Eluting Ventricular Pacing Lead

Steroid-eluting pacing leads are known to attenuate the threshold peaking early after implantation. Long-term performance, however, is not yet settled. The lead design tested in this prospective study combines a 5.8-mm2 tip of microporous platinum-iridium with elution of 1.0 mg of dexamethasone sodium phosphate and tines for passive fixation (model 5024, Medtronic Inc.). In 50 patients (mean age 69 +/- 10 years), the electrode was implanted in the right ventricular apex. Follow-up was performed on days 0, 2, 5, 10, 28, 90, 180 and every 6 months thereafter for 5-years postimplant. At each visit, pacing thresholds were determined as pulse duration (ms) at 1.0 V and as the minimum charge (microC) delivered for capture. Lead impedance (omega) was telemetered at 2.5 V-0.50 ms, and sensing thresholds (mV) were measured in triplicate using the automatic sensing threshold algorithm of the pacemaker implanted (model 294-03, Intermedics Inc.). On the day of implantation, mean values were 0.10 +/- 0.03 ms, 0.12 +/- 0.03 microC, 758 +/- 131 omega, and 13.1 +/- 1.8 mV, respectively. Beyond 1-year postimplant, pacing thresholds did not vary significantly. Sensing thresholds and lead impedance values were stable during long-term follow-up. Five years after implantation, mean values were 0.23 +/- 0.11 ms, 0.24 +/- 0.07 microC, 670 +/- 139 omega, and 11.6 +/- 3.1 mV for pulse width and charge threshold, lead impedance, and sensing threshold, respectively, and all leads captured at 1.0 V with the longest pulse duration available (1.50 ms). It is concluded that the bipolar steroid-eluting tined ventricular lead showed stable stimulation thresholds, lead impedance values, and sensing thresholds for 5 years after implantation.     

Appraisal of Pacing Lead Performance from the Danish Pacemaker Register

The Danish Pacemaker Register was established in January 1982, and the 11 implanting centers in Denmark report to the Register on a continuous basis by use of the European Pacemaker Patient Identification Card proposed by the European Working Group on Cardiac Pacing. As of May 1994, the Register contained data on 18,053 lead implants performed in Denmark, i.e., 1,253 (7%) lead implants before 1982, and all the 16,800 initial lead implants since 1982 on 17,020 generators in 15,366 patients for a total of 12,188 (67,5%) ventricular unipolar, 3,178 (17.6%) ventricular bipolar, 1,316 (7.3%) atrial unipolar, and 1,371 (7.6%) atrial bipolar leads. Preformed J shaped leads were used in 3.5% of the atrial implants and active fixation in < 8%. Lead failure was defined as need for replacement or abandonment of the lead due to pacing or sensing problems with the exception of lead displacement. The 10-year survival rate for unipolar atrial and ventricular leads was 95.8%± 2.1% (2 standard errors) and 97.1 %± 0.6%, respectively, as compared to a 4-year survival rate of 91.5%± 4.6% and 91.6%± 1.7% for bipolar atrial and ventricular leads, and an 8-year survival rate for bipolar ventricular leads of 75.1%± 5.0%. The 5-year survival rate for the bipolar Medtronic model 4012 lead was 85.8%± 8.1% and 67.4%± 7.3% for the bipolar Siemens model 1010T lead, indicating a poor performance. The Siemens lead models 105T and 1050T seem to be performing like the model 101OT. The 5-year survival rate for the bipolar Telectronics model 284 lead was 88.4%± 6.2%. The data from the Danish Pacemaker Register confirm the previous reported good survival of unipolar pacing leads irrespective of the chamber paced, and demonstrate that the bipolar Medtronic 4012 lead, the bipolar Telectronics 284 lead, and especially the bipolar Siemens 1010T, 105T, and 1050T models are unreliable leads that need careful monitoring and appropriate replacement.     

Chronic Steroid-Eluting Lead Performance: A Comparison of Atrial and Ventricular Pacing

It is generally believed that atrial pacing leads have higher stimulation thresholds and long-term complication rates than ventricular leads, and this is one of the factors limiting the use of dual chamber pacing. A study was undertaken to compare atrial and ventricular bipolar tined steroid-eluting leads in two designs: the Medtronic CapSure SP and the Telectronics Encor Dec. There were 123 pairs of leads: 81 CapSure SP and 42 Encor Dec. Bipolar atrial and ventricular stimulation thresholds, electrograms. and pacing impedance were measured using the Telectronics META DDDR pulse generator immediately postimplantation, and at 1, 3, and 6 months for all leads and at 12, 18, and 24 months for the CapSure SP. The only major lead complication was a 2% atrial lead dislodgment rate. All leads demonstrated low stimulation thresholds, with the CapSure SP leads having lower values than comparable Encor Dec leads. All leads had a mean range of 0.53–0.89 V at all testing periods with P < 0.05 for atrial leads only. There were no differences in electrogram size between manufacturers and no instances of atrial and ventricular undersensing. Pacing impedance was about 100 Ω higher for the Encor Dec leads (P < 0.05, atrial leads only), suggesting that these leads will result in lower pacing energy losses provided the pulse generators are at identical settings. More than 90% of patients could be paced chronically in the atrium and ventricle at 2.5 V, but for chronic 1.6-V pacing, the CapSure SP leads were superior. In conclusion, atrial and ventricular steroid-eluting leads of both manufacturers gave excellent stimulation threshold results allowing low energy dual chamber pacing.     

A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead

A multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar tined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The probability of a 4012 lead failure by Kaplan-Meier analysis was 20.9% at 6 years after implantation. Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with the previous impedance measurements. Of the 95 definite lead failures, 16 (16.8%) were associated with symptoms similar to those experienced before pacemaker placement. The observed failure rate is unacceptable, and strong consideration should be given to replacing the 4012 pacing lead in pacemaker-dependent patients and closely monitoring nondependent patients.     

Clinical Experience with Passive-Fixation Coradial Bipolar Endocardial Pacing Leads

Bipolar, transvenous, passive-fixation leads (ThinLine(tm) Sulzer Intermedics Inc., Angleton, TX, USA) incorporating coradial individually coated conductor coils, and a redundant external 55D polyurethane insulation sheath were developed. The diameter of the new leads (< 5 FT) is in the range of available unipolar leads and is considerably smaller than conventional bipolar pacing leads. From January 9, 1994 to November 12, 1996, 1,536 model 432–04 (523 atrial) and 430–10 (1,013 ventricular) leads were implanted in 1,068 patients at 50 US and 5 Canadian centers to evaluate their safety and efficacy. The study included a general phase, with follow-ups at 1, 3, 6, 12, 18, and 24 months; and a randomized intensive phase with collection of more data and additional 2- and 6-week follow-ups. Capture and sensing thresholds, lead impedance, and handling characteristics were evaluated. Clinical events were monitored and performance was compared to that of two commercially available conventional (coaxial) leads: Sulzer Intermedics models 432–03 (atrial) and 430–07 (ventricular). During a total of 17,530 device months, there were two lead failures, no lead related deaths, 32 explants, 37 complications, and no unexpected adverse device effects. Capture thresholds were lower than those for coaxial controls with identical electrodes, sensing was comparable, lead impedances were within clinically acceptable ranges, and investigators found overall handling characteristics good to excellent. ThinLine coradial bipolar leads are safe and effective for cardiac pacing and sensing.     

Experimental and Clinical Study of a New Permanent Myocardial Atrial Sutureless Pacing Lead

A new permanent lead has been developed for atrial epicardial use. Early clinical evaluation (26 human implants) following thorough canine studies indicates that the new lead is safe, effective, and reliable. Canine thresholds and P-wave amplitudes as a function of implant time are similar to those of transvenous alrial "J" leads. Human thresholds at implant are higher than canine, but change less with time. Implant and acute repositioning were found to be easy. There have been no lead-related operations.     

Multicenter Experience With a Bipolar Tined Polyurethane Ventricular Lead

A multicenter study was undertaken to determine the failure rate of a specific bipolar tined polyurethane ventricular pacing lead, the Medtronic 4004/4004M pacing lead. Seven centers in the United States and Canada implanted 586 Medtronic 4004/4004M pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The Kaplan-Meier estimate of the percentage of 4004/4004M lead failures within 4 years after implantation was 14.1% (95% confidence interval: 8.5%–19.3%). Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with previous impedance measurements. The observed rate of failure is unacceptable, and strong consideration should be given to replacing the 4004/4004M pacing lead in pacemaker dependent patients and closely monitoring nondependent patients.     

Sixteen Failures in a Single Model of Bipolar Polyurethane-insulated Ventricular Pacing Lead: A 44-Month Experience

During a 44-month period, 105 Medtronic model 6972-58 polyurethane-insulated, bipolar ventricular pacing leads were implanted, of which 16 failed clinically at a mean of 20.5 months post-implant. Pacing dysfunction presented as either intermittent or complete loss of sensing and/or capture and, rarely, oversensing. Thirteen of the 16 patients were asymptomatic, and problems were detected in 11 instances during routine telephonic surveillance. At the time of lead replacement, low or widely fluctuating lead resistance values and high current drain were uniformly observed. The single lead capable of total extraction revealed rupture of both internal and external insulation. A brief summary of the currently much-discussed "polyurethane controversy" is presented, and the issue of patient management is discussed.     

"In-Line" Bipolar, Steroid-Eluting, High Impedance, Epimyocardial Pacing Lead

Recent advances in electrode surface designs have eliminated traditional threshold differences between endo- and epicardial pacing leads. Since the epicardial approach offers the potential of direct left ventricular pacing and the transvenous approach may not be feasible or warranted in all instances, more advanced leads are being designed to optimize epicardial pacing capabilities. This study was conducted to evaluate a bipolar epimyocardial lead. Six immature canines (age 3 months) were instrumented. The lead (Medtronic mode! 10389) is a single-pass, "in-line" bipolar electrode with low current drain and high impedance, with an intramyocardial steroid-eluting cathode and nonsteroid epicardial anode. Twelve ventricular leads were implanted (two per animal) and the animals followed for 6 months with weekly analysis of pacing and sensing capabilities. Results at explant were compared with implant values and showed no significant differences between sensed R waves or in R wave slew rates in unipolar or bipolar modes. Explant lead impedances remained high in both modes: bipolar, 1658 ± 331; and unipolar, 1327 ± 308 Ω (P < 0.05). Chronic voltage (V) threshold at 0.5 ms showed no significant change from implant values during the study: unipolar, 0.3 ± 0.06 versus 1.0 ± 0.8; and bipolar, 0.4 ± 0.06 versus 1.6 ± 1.2. Histologic review showed negligible fibrous reaction at the electrode-tissue interface. This study introduces a high impedance, low threshold, "in-line" bipolar pacing lead design capable of stable chronic pacing with implant facilitated by a single suture technique.     

Programmable Polarity: Effects on Pacing and Sensing of Bipolar Steroid-Eluting Leads

Presently available bipolar pacemakers connected to bipolar leads allow the programming of polarity to either bipolar or unipolar configuration. The bipolar configuration improves sensing because of its lack of oversensing. In respect to the pacing impulse, it may be beneficial to program the bipolar to unipolar configuration, because the unipolar pacing configuration seems to lead to lower pacing thresholds. The aim of the study was to investigate the effects of the two configurations on pacing and sensing in 11 patients with a new ventricular steroid-eluting lead (Encor Dec 033–301. Telectronics Inc.) connected to the same types of VVI(R) pacemakers. Follow-up was 12 months after implantation. Pacing was assessed by pulse duration thresholds at 0.8-, 1.6-, and 2.5-V pulse amplitude and by pacing impedance. Parameters for sensing included sensing thresholds, R wave amplitudes, and amplitude of intrinsic deflection. Pulse duration thresholds were similar for the two configurations. At implantation, pacing impedance was significantly higher with bipolar (672 ± 60 Ω) than with unipolar pacing configuration (626 ± 82 Ω, P < 0.005). The difference lasted until 1 month after implantation (bipolar: 670 ± 49 Ω: unipolar: 630 53 Ω, P < 0.01). No significant differences were detected after 3 (bipolar: 683 ± 63 Ω; unipolar: 662 ± 70 Ω) and 12 months (bipolar: 658 ± 64 Ω: unipolar: 660 ± 63 Ω) between the 2 configurations. Although intrinsic deflections of ventricular electrograms were different, mean R wave amplitudes were similar in unipolar and bipolar configuration. Pacing and sensing characteristics of unipolar and bipolar configuration were similar for the studied bipolar pacing lead. Pacing impedance was initially higher for bipolar than for unipolar configuration and equilibrated within 3 months after implantation.     

Initial Experience with a Co-Radial Bipolar Pacing Lead

A new type of endocardial bipolar pacing lead has been designed to overcome the potential drawbacks of the conventional coaxial bipolar pacing had. We prospectively evaluated the new co-radial bipolar pacing leads (Intermedics Thin Line), which are thinner (5 Fr vs 6—8 Fr) than standard coaxial bipolar leads. X-ray visibility and lead handling were subjectively assessed (excellent, good, adequate, or poor) at implant; lead impedance, sensitivity threshold, and pacing threshold were measured at implant, then at 1, 3. 6, 12, and 18 months. The results were as follows: 103 patients (51 M; age 63.8 ± 17.4 years) received 71 atrial (A) and 89 ventricular (V) leads. X-ray visibility was excellent in 59/103; good in 23/103; adequate in 11/103; and poor in 10/103. Overall handling was excellent in 56/71 A and 69/89 V; good in 11/71 A and 18/89 V; adequate in 3/71 A and 1/89 V; poor in 1/71 A and 1/89 V. There were two perioperative complications. At implant: impedance in A and V were 370.1 ± 74.7 and 501.5 ± 124.4 Ω, sensing thresholds in A and V were 3.0 ± 1.5 and 9.9 ± 5.0 mV, pacing thresholds at 0.45 ms in A and V were 0.59 ± 0.21 and 0.41 ± 0.15 volt, respectively. At 1, 3, 6. 12, and 18 months of follow-up: no pacing lead related complications were reported; pacing lead characteristics remained outstanding and stable. This new lead appears to have significant clinical advantages over the conventional coaxial bipolar pacing lead. Long-term follow-up is required to confirm its reliability and chronic performance characteristics.     

Comparison of Lead Complications with Polyurethane Tined, Silicone Rubber Tined, and Wedge Tip Leads: Clinical Experience with 822 Ventricular Endocardial Leads

Lead-related complications have been prospectively studied for 602 unipolar tined endocardial ventricular pacemaker leads implanted over a five-year period. No differences were noted in overall complication rates between 238 polyurethane insulated leads (4.2%) and 364 silicone rubber insulated leads (3.6%). Comparing the total series of 602 tined leads to a retrospective survey of 220 wedge tip leads, a marked reduction in dislodgements (0.3% vs. 7.7%, P<0.001) and reoperations (2.0% vs. 15.0%, P<0.001) was found using tined leads. We conclude that tined ventricular leads are far superior to wedge tip leads with respect to lead complications.     

The Effect of Biphasic Defibrillation on the Immediate Pacing Threshold of a Dedicated Bipolar, Steroid-Eluting Lead

It is apparent that pacing threshold increases following an ICD shock, although the degree of change observed is dependent on the method used to assess pacing and the lead design used. We previously demonstrated a rise in postshock pacing threshold using a lead with integrated bipolar pacing in which the distal shocking coil also serves as the pacing anode. In this study, we sought to investigate whether the postshock pacing threshold increased significantly in an endocardial, steroid-eluting lead with dedicated bipolar pacing electrodes. Twenty patients (16 men, 4 women; median age 73, ejection fraction [EF] 0.17-0.58) were studied during pectoral ICD implantation (Medtronic active can model 7221Cx or 7223Cx with model 6932-65 lead). The diastolic pulse width pacing threshold at 1 or 2 V was determined. Pacing rate was set > or = 100/min at twice diastolic threshold output to assess pacing immediately following the first DFT test shock. For subsequent shocks, the output was adjusted to establish postshock thresholds as 1, 2, 3, or 4 times the diastolic threshold. The postshock threshold was defined as the output yielding 100% capture > or = 2.5 seconds following a shock. In 8 of 20 patients (ratio 0.40 +/- 0.11), a rise in the post-shock threshold was shown by failure of consistent capture when pacing at 2 times diastolic threshold > or = 2.5 seconds after a DFT test shock. Two of these patients failed at 3 times threshold, but none failed at 4 x threshold. Five of 12 patients with successful capture of 2 times threshold failed to capture at threshold. The postshock threshold increased by a mean factor of 2.83 +/- 0.83 in the group of patients with a threshold rise. Following ICD shock in an active can, steroid-eluting lead system with dedicated bipolar pacing, the post-shock threshold increases significantly. Our studies suggest a need for postshock pacing to be set at least 4 x threshold regardless of the lead design.