A Prospective Randomized Trial of Defibrillation Thresholds from the Right Ventricular Outflow Tract and the Right Ventricular Apex

Background: Right ventricular outflow tract (RVOT) pacing has been suggested to improve hemodynamics and to help prevent pacing-induced cardiomyopathy. Pacing from the RVOT is feasible and equivalent in terms of sensing and stimulation threshold. However, physicians have been reluctant to use RVOT pacing because of concerns that defibrillation efficacy might be adversely affected. To date, there have been no randomized-controlled trials published comparing the defibrillation threshold in leads implanted in the RVOT and the right ventricular apex (RVA).
Objective: The purpose of this study was to compare defibrillation thresholds (DFT) in the RVOT and RVA. Ventricular sensing and stimulation thresholds were also compared.
Methods: This prospective, randomized, multicenter study included 87 patients (70 males, age 69 ± 11 years). At implantation, the patient's ventricular implantable cardioverter-defibrillator (ICD) lead position was randomized to either the RVOT or RVA. A four-shock Bayesian up-down method was used to determine the DFT. Patients were followed for 3 months postimplant.
Results: DFTs were not significantly different in leads implanted in the RVOT (median 8.8 J [6.28, 12.9] vs. 7.9 J [6.20, 12.6], P = 0.65). Threshold and impedance measurements were stable in both RVOT and RVA groups from implant to follow-up. All ICD leads remained stable chronically at the 3-month follow-up.
Conclusion: DFTs in leads placed in the RVOT and RVA are comparable. RVOT ICD lead placement is safe and exhibits similar lead stability, threshold, and impedance measurements as the traditional RVA location.     

Right ventricular outflow tract pacing: practical and beneficial. A 9-year experience of 460 consecutive implants

BACKGROUND: Pacing from the right ventricular apex (RVA) in patients with ventricular dysfunction has been identified as a possible contributor to deterioration of ventricular function. Therefore, alternative pacing sites such as the right ventricular outflow tract (RVOT) are receiving intensified scrutiny. An unresolved question is whether technical, procedural, and stability issues are comparable for the RVA and the RVOT. METHODS: This report details 460 consecutive ventricular pacing lead implants with the primary intended site in the RVOT. Patients were evaluated for success, complication rates, and followed-up for stability of pacing parameters. The total patient implant population included 300 male and 170 female patients with a mean age of 70.6 years. Ten patients were excluded from the analysis, since there was a primary indication and intention to implant in the RVA, leaving a total of 460 patients for analysis. The indications for pacing were symptomatic bradycardia due to any cause and/or Mobitz II or complete heart block. There was no clinical evidence of heart failure in 420 patients. In 40 patients with heart failure, the indication for pacing was cardiac resynchronization therapy using the RVOT as an alternate site when pacing from a branch vein of the coronary sinus was not possible. Outcome information was obtained from the implanter's clinic. RESULTS: The overall success rate in the RVOT was 84% over the total 9-year period with a 92% success rate in the last 4(1/2) years, using the RVOT technique described. At 20 months in a subgroup comparison of RVOT and RVA implants, there was no significant difference in pacing threshold, R-wave sensing, or pacing lead impedance. Dislodgment occurred in only 1 of 460 patients. Reasons for failure to implant in the RVOT include inability to find a stable position with adequate pacing and sensing thresholds (related to anatomy, scarred myocardium, pulmonary hypertension, tricuspid regurgitation), hemodynamic instability limiting time for implant, and a learning curve. Long-term stability and lead performance were excellent, and certain acute and chronic complications of RV pacing did not occur.     

Right Ventricular Outflow Tract Septal Pacing: Long-Term Follow-Up of Ventricular Lead Performance

Background: The detrimental effects of right ventricular apical pacing on left ventricular function has driven interest in selective site pacing, predominantly on the right ventricular outflow tract (RVOT) septum. There is currently no information on long-term ventricular lead electrical performance from this site.
Methods: A total of 100 patients with ventricular lead placement on the RVOT septum undergoing pacemaker implantation for bradycardia indications were analyzed retrospectively. Lead positioning was confirmed with the use of fluoroscopy. Long-term (1 year) follow-up was obtained in 92 patients. Information on stimulation threshold, R-wave sensing, lead impedance, and lead complications were collected.
Results: Lead performance at the RVOT septal position was stable in the long term. Ventricular electrical parameters were acceptable with stable long-term stimulation thresholds, sensing, and impedance for all lead types. One-year results demonstrated mean stimulation threshold of 0.71 ± 0.25 V, mean R wave of 12.4 ± 6.05 mV, and mean impedance values of 520 ± 127 Ω. There were no cases of high pacing thresholds or inadequate sensing.
Conclusions: This study confirms satisfactory long-term performance with leads placed on the RVOT septum, comparable to traditional pacing sites. It is now time to undertake studies to examine the long-term hemodynamic effects of RVOT septal 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.     

Compatibility of automatic threshold tracking pacemakers with previously implanted pacing leads in children

The Autocapture function controls and optimizes the amplitude of the pacing pulse and saves energy. The manufacturer recommends using a special low polarization, low threshold bipolar Pacesetter lead for the Autocapture function. The purpose of this study was to evaluate the compatibility of Autocapture with previously implanted pacing leads. The study included 15 patients (mean age 13.6 +/- 3.4 years) who needed pulse generator replacement and received the VVIR pacemaker Regency SR+ or the DDDR pacemakers Affinity DR or Integrity DR with the Autocapture function. The new pulse generators connected to previously implanted ventricular leads. At the time of implantation the pacing threshold was 1.0 +/- 0.35 V at 0.5 ms, the lead impedance was 580 +/- 80 omega, and the spontaneous R wave amplitude was 7.89 +/- 4.89 mV. The polarization signal (PS) was 3.8 +/- 3.04 mV, and evoked response (ER) was 8.15 +/- 4.57 mV at the predischarge testing. Follow-up telemetry was done at months 1, 3, 6, 12, and 18. The follow-up duration was 9.4 +/- 5 months (range 1-18 months). If the results of PS and ER measurements were acceptable for autocapture, it turned on at the 1-month visit. In six (40%) patients the results were found acceptable for autocapture function. Age, lead impedance, pacing threshold, intrinsic R wave measurement, lead age, fixation mechanism, and ER measurements were not statistically different in Autocapture suitable and not suitable groups. The main reason not to activate Autocapture had been increased PS. Any significant fluctuations were not observed in pacing threshold, lead impedance, ER, and PS during follow-up. In conclusion, previously implanted pacing leads may be compatible with the Autocapture function.     

Active Fixation Atrial Leads: Randomized Comparison of Two Lead Designs

Active fixation leads have reduced the incidence of lead dislodgement in patients with permanent pacemakers. However, theoretic concern that the tissue trauma associated with a myocardial screw-helix may increase the chronic pacing threshold of active compared to passive fixation leads has remained. Whether active fixation leads with a stimulating electrode that is independent of the fixation mechanism are associated with a lower chronic pacing threshold than leads utilizing a screw-helix for both fixation and stimulation is unknown. The present prospective, randomized study compared the acute and chronic atrial pacing and sensing characteristics of two unipolar active fixation leads, one utilizing a screw-helix for both fixation and electrical stimulation, the other with an active porous tip electrode and an electrically inactive helix. Patients were randomized to receive either a Medtronic 6957J lead with an electrically active myocardial screw-helix or a Cordis 329-101P lead with an inactive helix and a porous tip electrode. The baseline characteristics of the groups were comparable. At implantation, the 329-101P lead had a lower mean voltage threshold than the 6957J lead (0.61 +/- 0.16 V vs 1.05 +/- 0.34 V, P = 0.0004). There were no significant differences in atrial electrogram amplitude, slew rate, or lead impedance between the groups. At 6 weeks follow-up, there were no differences in the mean threshold voltage (1.85 +/- 0.36 vs 1.93 +/- 0.69 V), impedance (528 +/- 81 vs 530 +/- 118 ohms), or atrial electrogram amplitude (2.63 +/- 0.50 vs 2.42 +/- 0.95 mV) between the two leads. At long-term follow-up (mean 16.2 +/- 2.8 months, range 13.1-20.0 months) there were no significant differences in voltage threshold (1.65 +/- 0.61 vs 1.97 +/- 0.64 V), impedance (565.5 +/- 81.6 vs 617.7 +/- 146.7 ohms), or atrial electrogram amplitude (2.79 +/- 0.75 vs 3.10 +/- 1.53 mV). Thus, these results suggest that active fixation leads in the atrium with an electrode that is independent of the fixation mechanism do not provide chronic stimulation thresholds or electrogram amplitudes that are superior to those obtained with leads utilizing a myocardial screw-helix as both the active electrode and the fixation device.     

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.     

Automatic threshold tracking activation without the intraoperative evaluation of the evoked response amplitude. AUTOCAP Investigators

Automatic threshold tracking (Autocapture) controls the amplitude of the pacing pulse and adjusts it to the actual pacing threshold. The algorithm is based on the proper detection of the evoked response (ER) amplitude after the pacing pulse. For this reason an intraoperative evaluation of ER and polarization is recommended. The aims of the study were to evaluate the ER signal and polarization and the performance of automatic threshold tracking without any intraoperative testing of the ER signal. In addition, the ER amplitude was correlated with the pacing threshold, pacing impedance, spontaneous R wave amplitude, and with the clinical data. The study included 60 patients who received the VVIR pacemaker Regency connected to the Membrane E 1450/1452 pacing lead (St. Jude-Pacesetter). At implantation, a pacing threshold < 0.7 V at 0.5 ms was achieved in all patients. ER and polarization were assessed for the first time at hospital predischarge testing. Follow-up measurements were conducted at month 1, 3, and 6. The ER amplitude at hospital discharge was 8.4 +/- 4.2 mV and increased to 9.4 +/- 4.8 mV at the 6-month follow-up. The pacemaker recommended not to program automatic threshold tracking on in one patient permanently and in three patients intermittently. The ER amplitudes were not differently distributed in men compared with women or in right-sided compared to left-sided implants. The correlation between age and the evoked response was r = 0.15. The correlation between ER amplitude and pacing threshold was r = -0.08, with pacing impedance r = 0.02, and with R wave amplitude r = 0.44. In conclusion, despite no operative evaluation of the ER amplitude being performed, the mean ER amplitude was about 9 mV at 6-month follow-up. Automatic threshold tracking could be programmed on in 93% of the patients throughout the time. Neither the clinical data nor the conventional electrical parameters help to predict patients who will have low ER amplitude or to optimize the ER signal at implantation.     

Rapid decline in acute stimulation thresholds with steroid-eluting active-fixation pacing leads

BACKGROUND AND AIM: There is an increasing use of active-fixation leads for cardiac pacing, yet concerns remain regarding initial high stimulation thresholds. The aim was to perform a detailed analysis of pacing parameters at the time of implantation to determine when lead repositioning should be considered. METHODS: We performed a prospective observational study of consecutive new pacemaker implants. Detailed analysis of pacing parameters was collected at 2-minute intervals for 10 minutes, and at day 1 and week 8 following implant. RESULTS: Ninety-four patients underwent implantation of 79 dual-chamber and 15 single-chamber pacemakers using active-fixation leads in both chambers. An initial threshold of >1 V was demonstrated in 45/94 (48%) ventricular leads (mean threshold 1.5 +/- 0.3 V). This declined rapidly to 0.9 +/- 0.3 V at 4 minutes (P < 0.01), 0.7 +/- 0.3 V at 10 minutes (P < 0.01), and 0.6 +/- 0.3 V at day 1 (P < 0.01). At day 1, 43/45 leads were <1 V. There were 79 atrial leads. An initial threshold of >1 V (mean 1.7 +/- 0.6 V) was demonstrated in 41/79 (52%) leads falling significantly to 1.1 +/- 0.5 V at 4 minutes (P < 0.01), 0.9 +/- 0.4 V at 10 minutes (P < 0.01), and 0.6 +/- 0.2 V at day 1 (P < 0.01). At 10 minutes, 32 of 41 leads demonstrated a threshold of <1 V with all leads <1 V at day 1. Thresholds were maintained medium term. CONCLUSIONS: Active-fixation leads are commonly associated with initially high thresholds that fall rapidly. An initial threshold of 2 V should be provisionally accepted and retested at 4 minutes. The majority will have a threshold of <1 V the following day. A failure of a high threshold to decline at 4 minutes requires lead repositioning.     

The Right Ventricular Outflow Tract as an Alternative Permanent Pacing Site: Long-Term Follow-Up

The long-term characteristics of the right ventricular outflow tract have been assessed as an alternative permanent pacing site to the right ventricular apex. Thirty-three consecutive patients requiring ventricular pacing were randomized to be paced from one of the two sites. Pacing was performed using a screw-in lead, and a programmable pacemaker was used to facilitate threshold testing. There was no significant difference in the lead positioning time or any acute implant measurement (e.g., threshold at 0.5 msec 0.4 +/- 0.2 V for both sites, P = 0.99). Chronic measurements were also comparable during follow-up (mean 73 months) with a mean threshold at most recent follow-up of 0.15 +/- 0.2 msec (apex) and 0.13 +/- 0.21 msec (outflow tract) at 5 V, P = 0.81. There was only one pacing related complication, a lead dislodgment (outflow tract) in a pacemaker twiddler. Overall, both sites were highly satisfactory.     

右室心尖部与右室流出道起搏近期效果比较

目的评价右心室流出道（RVOT）起搏和右心室心尖部（RVA）起搏对心脏同步性和心功能的影响。方法 41例病态窦房结综合征、高度及完全房室传导阻滞病人根据心室起搏电极植入部位的不同,分为RVOT起搏组（21例）和RVA起搏组（20例）。分别于术前和术后3、12个月通过超声心动图分别对病人左心室舒张末内径（LVEDD）,左心室收缩末内径（LVESD）、左心室射血分数（LVEF）、室间隔和左心室后壁之间的运动延迟（SP-WMD）、心室间机械延迟时间（IVMD）等指标进行观察随访。结果术后3、12个月时,RVOT起搏组的LVEDD、LVESDI、VMD和SPWMD均明显小于RVA起搏组,LVEF均明显高于RVA起搏组（t=2.14-12.61,P〈0.05）。结论 RVOT起搏较RVA起搏更有利于双心室电激动的同步性,且对心功能的不良影响较小。     

Comparison of mid-term clinical experience with steroid-eluting active and passive fixation ventricular electrodes in children

Although active fixation ventricular leads seem to have advantages over passive fixation leads, this study compares the follow-up results of active and passive fixation leads in children. We evaluated the implantation and follow-up data of 41 children with active (Accufix II DEC, group 1) (n = 20) or passive (Membrane E, group 2) (n = 21) fixation, steroid-eluting ventricular leads. All but one of the patients in group 1 completed the 12-month follow-up. The mean follow-up period in group 2 was 10.4 +/- 2.9 months (range 3-12 months, median 12 months). In both groups the mean pacing threshold was measured as 0.51 +/- 0.09 V versus 0.48 +/- 0.15 V (P > 0.05) at 0.5-ms pulse width, mean R wave amplitude as 9.9 +/- 2.5 mV versus 9.4 +/- 3.2 mV (P > 0.05), and mean impedance as 557 +/- 92 omega versus 664 +/- 160 omega (P < 0.05), respectively, at implantation. After the first week of pacing, mean threshold values in group 1 were significantly lower than those of group 2 (P < 0.01 and P < 0.05, respectively). During the follow-up period, lead impedance measurements did not show a significant difference between the two groups. In one patient from group 1, the lead (by unscrewing) was removed easily because of pacemaker pocket infection. No lead dislodgement or helix deformation occurred in group 1. Nevertheless, in one patient from group 2, the lead was extracted at 4-month postimplantation because of lead displacement. We conclude that the steroid-eluting active fixation lead (Accufix II DEC) have advantages of easier implantation and lower acute and chronic stimulation thresholds compared to the passive fixation lead (Membrane E). Therefore, Accufix II DEC is superior to Membrane E, and it is a better first choice in children with an implanted single chamber ventricular pacemaker.     

High Pacing Impedances: Are You Overtorquing Your Leads?

BACKGROUND: Variations in measured pacing impedances that occur at the time of lead implantation remain largely unexplained and may be due to the morphology of the tissue-lead interface. METHODS: An endocardial pacing lead was implanted under direct endoscopic visualization and parameters were measured for defined stages of implantation into multiple sites within the right atrium of in vitro swine hearts (n = 6, 38 implants), in vivo swine hearts (n = 2, 10 implants), and an in vitro human heart (n = 1, 15 implants). RESULTS: Steady increases in impedance values up to 2 turns fully fixed (2TF) were associated with minimal tissue distortion in all implants. Overtorquing of the in vitro swine implants resulted in severe distortion at the tissue-lead interface demonstrating either tissue wrapping (24 implants) or tissue coring (14 implants). Impedance and threshold values remained elevated (953 +/- 282 Omega, 7.86 +/- 3.0 V; both P < 0.05 vs 2TF) during tissue distortion/wrapping, while tissue-cored implants were associated with significant decreases (552 +/- 187 Omega, 6.2 +/- 2.2 V; both P < 0.05 vs 2TF). P-wave amplitudes demonstrated no significant changes or correlation to tissue distortion. Importantly, both swine in vivo and human in vitro data demonstrated similar trends compared with the swine in vitro data. CONCLUSIONS: In this study, one is able to directly observe and correlate the degree of distortion at the tissue-lead interface with measured electrical parameters. Instantaneous impedance values obtained during fixation serve as a superior indicator of an acceptable lead implantation, and should therefore be carefully monitored during implantation.     

Long-term performance of active-fixation pacing leads: a prospective study

BACKGROUND: Despite the increasingly widespread use of active-fixation leads, long-term clinical follow-up of pacing lead outcomes is lacking. The aim was to analyze pacing parameters over a 2-year follow-up. We performed a prospective observational study of consecutive new pacemaker implants using the 1488T St. Jude (100) and the Medtronic 5076 (100) active-fixation leads. Detailed analysis of pacing parameters was collected at implant, day 1, and 1, 3, 6, 12, 18, and 24 months. METHODS AND RESULTS: One hundred patients underwent implantation of 100 dual-chamber pacemakers. Initial pacing parameters in the ventricle were threshold 0.7 +/- 0.2 V, R wave 12.0 +/- 6.5 mV, and impedance 879 +/- 224 Omega. Threshold increased significantly from day 1 (0.7 +/- 0.2 V) to month 1 (0.9 +/- 0.6 V, P < 0.01) and remained stable over the long term. Four of the 100 patients had a threshold >2 V (mean 3.3 +/- 0.9 V) all between day 1 and month 3. For all patients, R wave remained stable, but impedance declined significantly from day 1 (879 +/- 184 Omega) to month 1 (677 +/- 122 Omega, P < 0.01). There were no ventricular lead complications. Initial pacing parameters in the atrium were threshold 0.9 +/- 0.3 V, P wave 3.3 +/- 2.4 mV, and impedance 606 +/- 144 Omega. Threshold remained stable over the long-term follow-up. One of 100 patients had a rise in threshold >2 V (2.2 V) between day 1 and month 1. No patients underwent lead repositioning. Sensing and impedance remained stable over the long term. Patient follow-up was completed in 94% (6 unrelated deaths). There was an 8% incidence of atrial fibrillation. CONCLUSION: Active-fixation leads are generally associated with stable long-term pacing parameters.     

Right Ventricular Septal Pacing: The Success of Stylet-Driven Active-Fixation Leads

Background: The detrimental effects of right ventricular (RV) apical pacing on left ventricular function has driven interest in alternative pacing sites and in particular the mid RV septum and RV outflow tract (RVOT). RV septal lead positioning can be successfully achieved with a specifically shaped stylet and confirmed by the left anterior oblique (LAO) fluoroscopic projection. Such a projection is neither always used nor available during pacemaker implantation. The aim of this study was to evaluate how effective is the stylet-driven technique in septal lead placement guided only by posterior-anterior (PA) fluoroscopic view.
Methods: One hundred consecutive patients with an indication for single- or dual-chamber pacing were enrolled. RV septal lead positioning was attempted in the PA projection only and confirmed by the LAO projection at the end of the procedure.
Results: The RV lead position was septal in 90% of the patients. This included mid RV in 56 and RVOT in 34 patients. There were no significant differences in the mean stimulation threshold, R-wave sensing, and lead impedance between the two sites . In the RVOT, 97% (34/35) of leads were placed on the septum, whereas in the mid RV the value was 89% (56/63).
Conclusions: The study confirms that conventional active-fixation pacing leads can be successfully and safely deployed onto the RV septum using a purposely-shaped stylet guided only by the PA fluoroscopic projection. (PACE 2010; 49–53)     

Septal lead implantation for the reduction of paced QRS duration using passive-fixation leads

In 120 consecutive patients with standard pacing indications, we tested the feasibility of RV septal lead implantation technique guided by surface ECG and the degree to which this technique reduces paced QRS duration compared to RV apical stimulation when passive-fixation leads are used. During implantation, an ECG was recorded with a paper speed of 100 mm/s using the orthogonal Frank leads, and QRS was measured from the earliest to the latest deflection in any of the Frank leads. Pace-mapping of the septum was performed until QRS was minimal. The lead was attached, where QRS, pacing threshold, lead impedance, and EGM amplitude provided the best compromise. An average of 3.7 +/- 2.5 attempts (range 1-18, median 7) was needed until a final implantation site was found. There were no technical problems during implantation. QRS could be reduced by 5-55 ms (mean delta QRS 19 +/- 11 ms) in 83 (69%) of 120 patients. In 22 (18%) patients, QRS was identical with apical and septal pacing, and in 15 (13%) patients, QRS was 5-20 ms (10 +/- 4) longer despite septal stimulation. Average QRS was significantly shorter during septal pacing compared with apical pacing (151 +/- 20 vs 162 +/- 23 ms, P < 0.001). There was a tendency towards greatest QRS reduction when the high septum was stimulated (22 +/- 11 ms reduction) as compared with mid- (18 +/- 11 ms) or apical parts of the RV septum (16 +/- 10 ms). QRS reduction was most likely if apical QRS width was > 170 ms (P = 0.0002), and there was an inverse correlation between apical QRS and delta QRS (r = 0.53, P < 10(-7)). During a mean follow-up of 14 months, there was no pacing or sensing problem and no lead dislodgment occurred.     

Benefits of Smaller Electrode Surface Area (4 mm2) on Steroid-Eluting Leads

The purpose was to test whether a reduction of pacemaker electrode surface area below 8 mm2 improves leads that elute steroid from the electrode tip to the surrounding myocardium. A standard-sized 8 mm2 lead with 1 mg dexamethasone was implanted in 12 patients and a lead with 4 mm2 electrode surface area and 0.5 mg dexamethasone in ten patients. Pacing threshold, impedance, and sensing threshold were measured at implantation and after 1, 4, and 12 weeks. Pacing thresholds were similar for both groups and were always less than or equal to 0.8 V at 0.5 msec pulse duration in all patients. Impedance was significantly higher (P less than 0.05) for the 4 mm2 lead (implantation: 726 +/- 119 ohms; 1 week: 596 +/- 71 ohms; 4 weeks: 624 +/- 68 ohms; 12 weeks: 643 +/- 56 ohms) than for the 8 mm2 lead (implantation: 422 +/- 43 ohms; 1 week: 402 +/- 48 ohms; 4 weeks: 439 +/- 57 ohms; 12 weeks: 449 +/- 61 ohms). R wave amplitudes did not differ between both groups; no sensing failure occurred at 5 mV sensitivity. Compared to the 8 mm2 lead the reduction of surface area to 4 mm2 did not influence pacing threshold, but resulted in a higher pacing impedance. The amount of pacing energy was lower in the smaller-sized electrode. For clinical impact, low pacing threshold and high impedance leads are the condition to implant pulse generators with smaller battery capacity.     

Pectoral cardioverter defibrillators: comparison of prepectoral and submuscular implantation techniques

The purpose of this study was to compare the two techniques of pectoral ICD implantation, prepectoral and submuscular, performed by an electrophysiologist in the catheterization laboratory with use of general or local anesthesia in 45 consecutive patients. Over a period of 30 months, we implanted pectoral transvenous ICDs in 43 men and 2 women, aged 59 +/- 12 years, with use of general (n = 20) or local (n = 25) anesthesia in the catheterization laboratory. Patients had coronary (n = 30) or valvular (n = 4) disease, cardiomyopathy (n = 10) or no organic disease (n = 1), a mean left ventricular ejection fraction of 31%, and presented with ventricular tachycardia (n = 40) or fibrillation (n = 5). One-lead ICD systems (18 Endotak, 10 Transvene/8 Sprint, 2 EnGuard) were used in 38 patients, 2-lead (5 Transvene, 1 EnGuard) systems in 6 patients, and 1 atrioventricular lead ICD system in 1 patient. The prepectoral technique was employed in 29 patients with adequate subcutaneous tissue, while the submuscular technique was used in 16 patients who had a thin layer of subcutaneous tissue. The defibrillation threshold averaged 9-10 J in both groups and there were no differences in pace/sense thresholds. All implants were entirely transvenous with no subcutaneous patch. Biphasic ICD devices were employed in all patients. Active or hot can devices were used in 39 patients. There were no complications, operative deaths, or infections. Patients were discharged at a mean of 3 days. All devices functioned well at predis-charge testing. Over 14 +/- 8 months, 20 patients received appropriate device therapy (antitachycardia pacing or shocks). No late complications occurred. One patient died at 3 months of pump failure; there were no sudden deaths. In conclusion, for exclusive pectoral implantation of transvenous ICDs, electrophysiologists should master both prepectoral and submuscular techniques. One can thus avoid potential skin erosion or need for abdominal implantation in patients with a thin layer of subcutaneous tissue. Finally, there are no differences in pacing or defibrillation thresholds between the two techniques.     

Dual Chamber Pacing with a Single-Lead DDD Pacing System

The successful application of single-lead VDD pacing during the last few years has generated the idea of single-lead DDD pacing. Preliminary data from several single-lead VDD studies attempting to pace the atrium by a floating atrial dipole are unsatisfactory, causing an unacceptably high current drain of the device. We studied the feasibility as well as the short- and long-term stability of atrioventricular sequential pacing, using a new single-pass, tined DDD lead. In eight consecutive patients (age 73+/-16 years) with symptomatic higher degree AV block and intact sinus node function, this new single-pass DDD lead was implanted in combination with a DDDR pacemaker. Correct VDD and DDD function was studied at implantation; at discharge; and at 1, 3, and 6 months of follow-up. At implant, the atrial stimulation threshold was 0.6+/-0.1 V/0.5 ms. During follow-up, the atrial pacing thresholds in different every day positions averaged 2.1+/-0.5 V at discharge, 2.9+/-0.5 V at 1 month, 3.8+/-0.4 V at 3 months, and 3.4+/-0.4 V at 6 months (pulse width always 0.5 ms). The measured P wave amplitude at implantation was 4.5+/-2.2 mV; during follow-up the telemetered atrial sensitivity thresholds averaged 2.1+/-0.3 mV. Phrenic nerve stimulation at high output pacing (5.0 V/0.5 ms) was observed in three (38%) patients at discharge and in one (13%) patient during follow-up; an intermittent unmeasurable atrial lead impedance at 3 and 6 months follow-up was documented in one (13%) patient. This study confirms the possibility of short- and long-term DDD pacing using a single-pass DDD lead. Since atrial stimulation thresholds are still relatively high compared to conventional dual-lead DDD pacing, further improvements of the atrial electrodes are desirable, enabling lower pacing thresholds and optimizing energy requirements as well as minimizing the potential disadvantage of phrenic nerve stimulation.     

Acute and Chronic Cycle Length Dependent Increase in Ventricular Pacing Threshold

Several factors have been shown to influence ventricuJar pacing threshold in humans, including pacing lead location (endocardial vs epicardial), lead maturation, and antiarrhythmic agents. To determine whether ventricuJar pacing rate has a significant influence on acute and chronic pacing thresholds, we measured pacing thresholds in 16 patients receiving an implantafaleantitachycardia pacemaker cardioverter defibrillator (Cadence?). Ventricular pacing thresholds were determined using the device programmer at cycle lengths of GOO, 400, and 300 msec at the time of implantation; prior to hospital discharge at 3-14 days; and during follow-up outpatient visits at 6-8 weeks, 3 months, and 6 months to 1 year. Eleven patients had an epicardial lead system and five an endocardial lead system. Eleven patients were being treated with antiarrhythmic drug therapy. Device output ranged from 1-10 V and was adjustable in 1-V increments (pulse width was held constant at 1 msec). A cycle length dependent increase in pacing threshold (defined as a ≤ 1-V increase in threshold at 400 or 300 msec relative to 600 msecj was observed in 10/16 patients during 12/72 pacing trials at 400 msec, and in 15/16 patients during 31/67 trials at 300 msec. In trials in which an increase in pacing threshold occurred, the magnitude of the increase at 400 msec relative to 600 msec was only 1 V in all 12 trials, but at 300 msec the increase ranged from 4–9 V in 7/31 (23%) trials. There was an equal percentage (67%) of patients demonstrating a cycle length dependent increase in threshold with measurements made at the time of device implantation and at the 6 month to 1 year follow-up period. Two-way analysis of variance showed a significant effect of cycle length and time from implantation on mean pacing thresholds at the three cycle lengths. In conclusion, a cycle length dependent increase in pacing threshold occurred in virtually all patients during follow-up of up to 12 months and, thus, its presence was independent of lead location, presence of antiarrhythmic agents, and the state of lead maturation. These findings suggest that pacing thresholds measured at rates just above the sinus rate may not always apply to the faster rates utilized for antitachycardia pacing and indicates the need for threshold measurement at the designed pacing rate.