VDD(R) Pacing: Short- and Long-Term Stability of Atrial Sensing with a Single Lead System

Background: Recent studies have shown that the atrial signal can reliably be sensed for VDD(R) pacing via atrial floating electrodes incorporated in a single-pass lead. However, there remains concern about the long-term stability of atrial sensing and proper VDD function under real-life conditions. This study investigated the long-term reliability of atrial sensing and atrioventricular synchronous pacing using a new single lead VDD(R) pacing system. Methods and Results: In 20 consecutive patients (ages 71 ± 14 years) with normal sinus node function and high-degree heart block, a single lead VDD(R) pacemaker (Unity(tm), Intermedics) was implanted, Atrial sensing was studied at implantation, at discharge, and at 1, 3, 6, 12, and 18 months of follow-up. At implant, the measured P wave amplitude was 2.3 ± 1.2 mV. By telemetry, the atrial sensing threshold was 0.79 ± 0.41 mV at discharge, 0.75 ± 0.43 mV at 1 month, 0.73 ± 0.43 mV at 3 months, 0.76 ± 0.41 mV at 6 months, 0.79 ± 0.41 mV at 12 months, and 0.77 ± 0.35 mV at 18 months of follow-up (P = NS). Appropriate VDD pacing was assessed by the percentage of correct atrial synchronization (PAS = atrial triggered ventricular paced complexes ± total number of ventricular paced complexes) during repeated Holters. PAS was 99.99%± 0.01 % at 1 month, 99.99%± 0.02% at 3 months, and 99.98%± 0.05% at 12 months of follow-up (P = NS). No atrial oversensing with inappropriate ventricular pacing was observed, neither during isometric arm exercise testing nor spontaneously during Holier monitoring. Conclusion: The long-term stability of atrial sensing with almost 100% correct atrial synchronous tracking and the lack of inappropriate pacing due to atrial oversensing make the new Unity VDD(R) system a highly reliable single lead pacing system. In view of the lower costs and the ease of single lead implantation, this system may offer an interesting alternative to DDD pacemakers in patients with normal sinus node function.     

Single-Lead VDD Pacing System

A single pass ventricular lead with a dual chamber electrode system, designed for VDD pacing, was implanted in 17 patients (11 men, 6 women, aged 53 to 86 years, mean 74) for symptomatic bradycardia due to second-or third-degree AV block and normal sinus node function. Bipolar atrial electrodes, diagonally displaced along the lead axis and positioned within the right atrial cavity, are used to detect atrial activity that is then differentially processed within the pacemaker. P wave amplitude (amp) derived from a PSA-DAA device at implant was 1.38 +/- 0.28 mV. P wave signal amp derived from telemetered atrial electrograms was 1.29 +/- 0.22 mV at predischarge (n = 17), 1.31 +/- 0.24 mV at 3 months (n = 15), 1.30 +/- 0.24 mV at 6 months (n = 8), 1.51 +/- 0.34 mV at 9 months (n = 4), and 1.35 +/- 0.35 mV at 12 months (n = 2); and the far-field QRS signal measured at predischarge was of negligible voltage (0.17 +/- 0.07 mV). The susceptibility of the atrial sensor system to interference was noted with chest wall stimulation and only at higher sensitivities (0.1 to 0.3 mV) and not with isometric arm exercise. Intact VDD pacing function at rest and during exercise was established using Holter and periodic ECG monitoring. Postoperative complications included one lead displacement and one pocket hematoma. Three patients died postimplant of causes unrelated to pacemaker function. Advantages of the single-lead VDD pacing include: (1) elimination of second atrial sensing lead; (2) superior atrial sensing performance; (3) effective resistance to myopotential and far-field signal interference; and (4) stability of postimplant atrial signal amplitude.     

Long-Term Reliability of Single Lead Atrial Synchronous Pacing Systems Using Closely Spaced Atrial Dipoles: Five-Year Experience

To assess the long-term capability of single atrioven ticular (AV) lead VDD pacing systems using close atrial dipoles to assure reliable atrial guided pacing, the safety and efficacy of 86 VDD units implanted in 73 patients at a single center since November 1988 was reviewed. All patients suffered from advanced AV block with normal sinoatrial function. Sixty five patients received a LEM/CCS Twinal 30/30S system, four patients received a Vitatron-Saphir system, and four patients received a Medtronic Thera VDR 8348 system. All patients underwent provocative tests in search of myopotential interference, and Holter recordings; in a group of patients who underwent pacemaker replacement a comparison was made between implant and replacement measurements. The mean follow-up duration was 27.3 months. A high percentage of successfully VDD paced patients and a low incidence of pacemaker malfunction, regularly solved by pacemaker reprogramming, was reported. Atrial signal amplitudes comparable to those measured at implant were found at replacement in all patients. These data support the long-term reliability of single AV lead VDD pacing systems with closely spaced atrial dipoles, as well as stable atrial sensing by floating bipolar atrial electrodes and effective atrial synchronous ventricular pacing over time.     

Efficacy of single lead VDD pacing in patients with impaired and normal left ventricular function

Atrial synchronous ventricular pacing seems to be the best pacing mode for patients with advanced AV block and impaired LV function. The long-term follow-up of single lead VDD pacing was studied in 33 patients with impaired LV function and compared to 42 patients with normal LV function. All patients received the same VDD lead and VDDR pacemaker. The lead model with 13-cm AV spacing between the atrial and ventricular electrode was implanted in 89% of the patients. Follow-ups were 1, 3, 6, and 12 months after implantation. The percentage of atrial sensing and the P wave amplitude were determined at each follow-up. Minimal P wave amplitude at implantation was 2.0 +/- 1.4 mV in patients with impaired and 1.7 +/- 0.9 mV with normal LV function (not significant). At the 12-month follow-up, 33 patients with normal and 23 patients with depressed LV function remained paced in the VDD mode. The remaining patients died in five (impaired LV function) and seven cases (normal LV function) or their pacemakers were programmed to the VVI/VVIR pacing mode in four (impaired LV function) and three cases (normal LV function). P wave amplitude did not differ in the two groups (e.g., at month 12: impaired: 1.17 +/- 0.42 mV; normal: 1.09 +/- 0.49 mV). The atrial sensitivity was programmed in most patients to sensitive settings with no differences between the two groups (e.g., at month 12: impaired: 0.13 +/- 0.06 mV; normal: 0.13 +/- 0.05 mV). The diagnostic counters indicated nearly permanent atrial sensing (e.g., at month 12: impaired: 99.3 +/- 2.2%; normal: 99.0 +/- 1.0 mV). In conclusions, single lead VDD pacing restored AV synchronous ventricular pacing in patients with normal and with impaired LV function indicating that it could be an alternative to DDD pacemakers, but not to dual-chamber pacing.     

Far-field QRS complex sensing: prevalence and timing with bipolar atrial leads

Sensing of far-field QRS complex through the atrial pacemaker lead may cause a number of pacemaker function disturbances, most of which are rarely seen with modern pulse generators. However, certain pulse generator algorithms will still be jeopardized by far-field QRS complex sensing. Intracardiac electrograms with markers were obtained by telemetry in 30 patients following implantation of a permanent bipolar atrial lead and a DDDR pulse generator. The occurrence and timing of far-field QRS complex sensing was studied at different atrial amplifier sensitivity settings. With paced ventricular complexes, QRS sensing was documented in all 30 cases at the maximum atrial sensitivity (0.1 mV). The median QRS complex sensing threshold was 0.3 mV, and the sensing window at high atrial sensitivities was 67-202 ms following the ventricular pacing impulse. In one case, QRS complex sensing was seen up to an atrial sensitivity of 1.5 mV. In 12 of 13 patients with 1:1 AV conduction, atrial sensing of spontaneously conducted ventricular complexes was seen (median sensing threshold 0.2 mV; the sensing window was -23 to 114 ms relative to the ventricular amplifier sensing event). Far-field QRS complex sensing was also found in all 12 patients in whom ventricular fusion complexes were obtained (median sensing threshold 0.2 mV; the window of sensing was 64-187 ms after the ventricular pacing impulse). Constant or intermittent QRS complex sensing via the atrial bipolar lead was thus universally demonstrable. It occurred in only a minority (20%) of patients at a sensitivity of 0.5 mV or less. Knowledge regarding the timing of the oversensing as related to the atrial sensitivity setting may aid in the design of algorithms of future pacemakers and cardioverter defibrillators.     

Usefulness of Echocardiography to Predict Inappropriate Atrial Sensing in Single-Lead VDD Pacing

Reliable atrial sensing is the prerequisite for restoration of atrioventricular synchrony in patients with single-lead VDD pacing systems. To determine echocardiographic variables associated with inappropriate atrial sensing, 21 consecutive patients with symptomatic second- or third-degree AV block and normal sinus node function were studied. Prior to implantation echocardiographic measurements of end-systolic and end-diastolic dimensions and volumes of the right atrium and right ventricle were performed. All patients underwent implantation of a Medtronic Thera VDD(d) pacemaker with a bipolar Medtronic Capsure electrode. A minimal amplitude of the unfiltered atrial electrocardiogram of > or =0.5 mV was required for permanent lead position and the atrial sensitivity was programmed below the lowest recorded value. Appropriate atrial sensing (atrial triggered ventricular paced complexes/total number of ventricular paced complexes) was assessed during 24-hour Holter monitoring and treadmill exercise testing 3 to 6 weeks after implantation. Inappropriate atrial sensing (<95% correct atrial synchronization during Holter registration and/or <97.5% during exercise testing) was present in nine patients. Right atrial volumes and the right ventricular end-diastolic volume was significantly higher, as compared to patients without inappropriate sensing (12 patients). The right atrial and diastolic volumes had the highest correlation with correct atrial sensing r = 0.83, P<0.0001). Using a postdefined cut-off value of > or =80 mL for the end-diastolic right atrial volume, sensitivity and specificity for inappropriate sensing was 100% and 92%, respectively. These findings show that preimplant echocardiography can identify patients with inappropriate sensing during VDD pacing, in whom DDD pacing should be considered.     

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.     

Differential Bipolar Sensing of a Dual Chamber Pacemaker

Differential bipolar sensing was evaluated in 10 consecutive patients with symptomatic heart block managed with dual chamber pacing. During pacemaker implantation atrial and ventricular electrograms were recorded using unipolar (UP) and differential bipolar (DBP) sensing amplifiers. The mean peak-to-peak amplitudes of the UP and DBP atrial electrograms were 3.3 +/- 1.2 mV and 4.2 +/- 1.2 mV, respectively. The difference was statistically significant (p less than 0.05). The mean peak-to-peak amplitudes of the ventricular electrograms were, respectively, 6.8 +/- 1.5 mV and 7.5 +/- 1.4 mV (p less than 0.01). Within 6 weeks after pacemaker implantation, patients visited the outpatient clinic. Isometric exercise tests were performed during UP and DBP sensing of the pacing system. Myopotential sensing in the ventricle occurred in nine patients during UP sensing and in none of the patients during DBP sensing (p less than 0.01) at a sensitivity setting of 0.5 mV. In addition, chest wall stimulation was performed to assess the effects of far-field signals on the ventricular sensing circuit of the pulse generator. Chest wall stimuli inhibited ventricular output during UP sensing in all 10 patients, whereas during DBP sensing inhibition of the ventricular channel occurred in three patients and then only at high output (greater than 8 V) settings. The susceptibility of the pacing system to crosstalk was also determined. However, neither during UP sensing nor during DBP sensing could cross-stimulation or cross-inhibition be demonstrated. In conclusion, DBP sensing is superior to UP sensing in terms of myopotential and far-field sensing.(ABSTRACT TRUNCATED AT 250 WORDS)     

Variation in P Wave Amplitude Immediately After Pacemaker Implantation: Possible Mechanism and Implications for Early Programming

The P wave amplitude (PWA) plays an important role in determining atrial sensing capabilities. To assess early PWA change, we compared the unipolar PWA in 43 patients at the time of atrial lead placement, measured by a pacing systems analyzer, to the unipolar PWA recorded at the end of pacemaker surgery, from telemetered atrial endocardial electrograms. Individual PWA varied from a decrease of 5.2 mV to an increase of 2 mV (-63% to 267%). In 33 patients with active fixation leads, the implant PWA was 1.96 +/- 0.99 mV versus 2.4 +/- 1.4 mV after surgery. In 11 patients with passive fixation leads, the implant PWA was 2.8 +/- 1.9 mV versus 1.9 +/- 0.8 mV after surgery. The PWA change, measured as the difference between the postsurgical and implant PWA was 0.43 +/- 0.8 mV in active versus -0.86 +/- 1.6 mV in the passive fixation lead groups (P less than 0.05). Considerable change in individual P wave amplitude can therefore occur very early after pacemaker implantation. The direction differs significantly between active (predominantly positive) and passive fixation groups (predominantly negative). These data suggest that an adequate margin of safety is important when initially programming atrial sensitivity, particularly when using passive fixation leads.     

Initial Clinical Experience with a Single Pass VDDR Pacing System

Although ventricular rate adaptive pacing (VVIR) improves exercise capacity and cardiac output compared to constant rate ventricular pacing (WI), this pacing mode does not provide benefit of atrioventricular (AV) synchrony. We evaluated the use of a custom-built VDDR pacing system using a single pass, ventricular lead, which detects end cavity P wave using a pair of diagonally arranged atrial bipolar (DAB) electrodes. In the VDDR mode, AV synchrony is enabled and the P wave rate is used in conjunction with an accelerometer based activity sensor for rate adaptive pacing. A VDDR pacemaker was implanted in three patients with complete AV block (mean age 63 ± 1 year) and the mean implantation time was 29 minutes. Mean P wave amplitude was 2.4 mV (1.2–4.2 mV) at implantation and telemeter P wave amplitude was stable over a follow-up of 6 months. At a sensitivity of 0.2 mV, stable P wave sensing was observed during breathing maneuvers, arm swinging, my potential induction, and Holter recording. Paired exercise tests performed in the VDDR and VVIR modes showed higher cardiac output at rest, during exercise, and in the recovery period in the VDDR pacing mode. Thus VDDR pacing using a single pass lead is superior to VVIR pacing by enabling P synchronous ventricular pacing without adding to the complexity of implantation.     

European clinical experience with a dual chamber single pass sensing and pacing defibrillation lead

Dual chamber ICDs are increasingly implanted nowadays, mainly to improve discrimination between supraventricular and ventricular arrhythmias but also to maintain AV synchrony in patients with bradycardia. The aim of this study was to investigate a new single pass right ventricular defibrillation lead capable of true bipolar sensing and pacing in the right atrium and integrated bipolar sensing and pacing in the right ventricle. The performance of the lead was evaluated in 57 patients (age 61 +/- 12 years; New York Heart Association 1.9 +/- 0.6, left ventricular ejection fraction 0.38 +/- 0.15) at implant, at prehospital discharge, and during a 1-year follow-up. Sensing and pacing behavior of the lead was evaluated in six different body positions. In four patients, no stable position of the atrial electrode could intraoperatively be found. The intraoperative atrial sensing was 2.3 +/- 1.6 mV and the atrial pacing threshold 0.8 +/- 0.5 V at 0.5 ms. At follow-up, the atrial sensing ranged from 1.5 mV to 2.2 mV and the atrial pacing threshold product from 0.8 to 1.7 V/ms. In 11 patients, an intermittent atrial sensing problem and in 24 patients an atrial pacing dysfunction were observed in at least one body position. In 565 episodes, a sensitivity of 100% and a specificity of 96.5% were found for ventricular arrhythmias. In conclusion, this single pass defibrillation lead performed well as a VDD lead and for dual chamber arrhythmia discrimination. However, loss of atrial capture in 45% of patients preclude its use in patients depending on atrial pacing.     

The Influence of Endocardial Electrode Fixation Status on Acute and Chronic Atrial Stimulation Threshold and Atrial Endocardial Electrogram Amplitude

The endocardial atrial electrogram or "P wave amplitude" (PWA) and pacemaker atrial stimulation thresholds are important parameters determining correct pacing system function. Pacemaker lead fixation mechanism and lead age may negatively influence these parameters. Therefore, we compared acute and chronic PWA and atrial stimulation thresholds in 33 patients with permanent transvenous atrial screw-in leads, follow-up 647 days +/- 297 days; and in 31 patients with nonscrew leads, follow-up 855 days +/- 512 days (P = ns). Results: The PWA differed between the two lead types acutely (1.97 mV +/- 0.8 mV for screw-in versus 2.48 mV +/- 1.1 mV for nonscrew-in leads; P less than 0.05), but not chronically (2.21 mV +/- 0.8 mV vs 2.2 mV +/- 1.2 mV; P = ns). Acute and chronic atrial pacing thresholds did not differ between groups. We also analyzed an early interim PWA in a subgroup of patients (mean 31 days after implantation). The nonscrew fixation group interim PWA was 1.76 mV +/- 0.9 mV versus 2.7 mV +/- 1.2 mV at implant (P less than 0.001). The screw-in lead interim PWA was 2.04 mV +/- 0.9 mV versus 1.97 mV +/- 0.7 mV at implant (P = ns). Conclusions: (1) A significantly higher endocardial PWA occurs at the time of lead implantation in nonscrew versus screw-in lead groups, but the chronic PWA does not differ between the two groups. (2) A transient but marked early (mean approximately 31 days) attenuation of the PWA occurs only with nonscrew-in leads. (3) Atrial threshold stimulation energies do not differ between the two lead groups acutely or during follow-up.     

Effects of body position and exercise on evoked response signal for automatic threshold activation

The Autocapture function controls and optimizes the output of the ventricular pulse amplitude automatically. For this reason an automatic test has to be performed during follow-up to measure the evoked response signal and lead polarization for the calculation of the appropriate evoked response sensitivity setting. The aim of the study was to assess whether body position and exercise influence the evoked response and polarization. Both parameters were determined in the supine and upright position and subsequently during supine and upright symptom-limited ergometry. The study included 14 patients with the VVIR pacemaker Regency SR+ who had received the ventricular pacing leads Membrane E 1450 T (n = 8), CapSure Z 5034 (n = 4), or SX 60 (n = 2). The evoked response signal was 7.4 +/- 3.3 mV during supine and increased to 9.7 +/- 5.6 mV (+35%) during upright position (P < 0.05). The exercise tests were terminated at 105 +/- 36 W (supine) and 110 +/- 34 W (upright). There was a gradual insignificant decrease of the evoked response during each exercise test with a mean decrease of -1.1 +/- 0.9 mV (-15%; supine) and -1.6 +/- 2.1 mV (-16%; upright). The evoked response increased within 5 minutes during recovery to the initial values. Polarization remained unchanged during both tests. The pacemaker did not recommend activating autocapture in four patients who all had received high-ohmic pacing leads. In conclusions, the measurement of the evoked response in supine position seems to represent the worst case. Physical activities did not effect autocapture function in patients with the recommended lead, but the pacemaker did not always recommend Autocapture activation in some patients with high-ohmic pacing leads.     

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.     

Experience with a Low Profile Bipolar, Active Fixation Pacing Lead in Pediatric Patients

Continued miniaturization of permanent pacing systems has promoted use of this technology in younger and smaller pediatric patients. Intermedics ThinLine 438-10 active fixation pacing leads (4.5 Fr lead body) were implanted in 26 patients (17 males/9 females; 9.9 +/- 6.9 years). Twenty of 26 patients received dual chamber systems, 6 of 26 patients single lead systems. Each patient has been followed 3 months. Pacemaker analysis at implant and 6 months later evaluated pulse width thresholds at 2.5 V (atrial 0.07 +/- 0.02 vs 0.13 +/- 0.02 ms [P = 0.01]; ventricular 0.08 +/- 0.04 ms vs 0.20 +/- 0.04 ms [P = 0.01]); sensing thresholds (atrial 4.1 +/- 0.41 mV vs 4.0 +/- 4.2 mV [P = NS]; ventricular 9.7 +/- 0.72 vs 9.3 +/- 0.94 mV [P = NS]); and impedance (atrial 345 +/- 12 vs 370 +/- 120 O [P = 0.04]; ventricular 412 +/- 17 vs 458 +/- 190 O [P < 0.01]). One volt lead failed with exit block at approximately 6 weeks. The youngest (9 months to 5 years) and smallest (6.5-18.0 kg) ten patients have each shown by venography to have at least mild venous stenosis at the lead(s) insertion site; five patients demonstrated collateral formation around asymptomatic obstruction, with no thrombus formation. The Intermedics 438-10 ThinLine pacing lead has demonstrated good and stable early postimplant electrical parameters. Angiographic evaluation in our smaller patients has shown evidence for asymptomatic venous obstruction.     

P Wave Recognition and Atrial Stimulation with Fractally Iridium Coated VDD Single Pass Leads

The bottleneck of VDD systems is the reliable detection of the small atrial signals by a floating atrial electrode. Fractally iridium coated electrodes offer excellent sensing and pacing performance. In this study, the performance of such a floating atrial lead in P wave sensing and synchronous ventricular stimulation was examined. Atrial pacing was also used as a test of atrial wall contact. Patients and Methods : A fractally iridium coated VDDlead was implanted in 18 patients. In 15 patients it was interfaced with a VDD pacemaker and in 3 patients with a DDD system depending on the P wave amplitude measured acutely (≥ 2 mV). Simultaneous recordings of the surface ECG and pacemaker telemetry were used to analyze P wave amplitudes and AV synchrony in different body positions, and during normal and deep breathing. Additionally, exercise tests based on daily life activities and 24-hour ECG monitoring were performed to test the pacemaker function. Results : During implantation P wave amplitudes were 1.86 mV ± 1.08 mV (range 0.5–4.9 mV) and during follow-up (6.6 ± 5.6 weeks) 0.18–3.8 mV. Holter recordings revealed reliable P wave sensing at a sensitivity setting of 0.5 mV (95.5%). P wave sensing was further improved by a higher atrial sensitivity. AV synchronous pacing ± 99.9% was achieved in all patients. In 7 patients the atrial electrode could be positioned close to the atrial wall enabling atrial stimulation thresholds at an average of 4.3 volts. Conclusion : This fractally iridium coated VVD lead allowed consistent and reliable P wave sensing at an atrial sensitivity as low as 0.5 mV in selected patients.     

The influence of high versus normal impedance ventricular leads on pacemaker generator longevity

As pacemaker generator longevity is dependent on current consumption and resistance of the pacing lead, the use of a high impedance pacing lead theoretically results in an extension of battery longevity. Therefore, the effect of high versus standard impedance ventricular leads on generator longevity was studied. In 40 patients (21 women, age 73 +/- 13 years) with a standard dual chamber pacemaker indication, a bipolar standard impedance ventricular lead was implanted in 20 patients, the remaining patients received a bipolar high impedance lead in a randomized fashion. All patients received identical pacemaker generators and atrial leads. The estimated longevity of the generator was calculated automatically by a programmed pacemaker algorithm. After a mean follow-up of 39 +/- 4.8 months, no significant differences were observed with respect to mean pacing and sensing thresholds of the atrial and ventricular leads in both groups. However, the high impedance leads displayed a significantly higher impedance and a significantly lower current drain as compared to standard impedance leads (1,044 +/- 139 vs 585 +/- 90 Omega, and 2.2 +/- 0.4 vs 4.3 +/- 1.1 mA). The extrapolated generator longevity was significantly longer in the high impedance lead group, as compared to the standard impedance lead group (107.3 +/- 8.5 vs 97.6 +/- 9.0 months; P = 0.02). In conclusion, implantation of a high impedance lead for ventricular pacing results in a clinically relevant extension of generator longevity.     

Septal His-Purkinje Ventricular Pacing in Canines: A New Endocardial Electrode Approach

Ventricular activation sequences and cardiac performance are influenced by pacing sites. Stimulation of or close to the specialized a trioventricular (AV) conduction system optimizes paced ventricular function compared to alternative epi- or endocardial muscle conduction sites. This study reports a new endocardial electrode implant approach to approximate septal His-Purkinje ventricular pacing. Five 6-month-old beagles were used, A custom, platinum-iridium, exposed helical screw electrode (Medtronic, Inc.), 4.5-mm long, with a 17.8-mm² surface area, was designed with a polyurethane covered 4 filar MP35N nickle conductor lead. An 8 French sheath (USCI, Inc.) was modified as introducer to permit simultaneous implant intracardiac pressure and electrogram recordings. Following a thoracotomy, the introducer was inserted through the right atrial appendage and advanced to record optimal His-bundle electrogram while maintaining atrial pressure along the septal tricuspid valve annulus. After electrode implant, ECG demonstrated narrow paced QRS morphology. Mean implant values showed sensed R wave 6,3 mV, slew rate 0.65 V/sec, pacing impedance 319 ohms, and threshold 0.9 V/3.3 mA at 0.5-msec output. Necropsy showed implant above the tricuspid annulus with electrode extension into and contained within the proximal ventricular septum. This study demonstrates that an endocardial septal approach to His-Purkinje ventricular pacing to optimize paced ventricular function is feasible with a new electrode design and precise septal implant technique. Alternative introducer designs may permit tranvenous application of this approach.     

Reliability of single-lead VDD atrial sensing and pacing during exercise

If atrial sensing ability of a single-lead VDD pacemaker is well accepted at rest, the detection quality by atrial floating electrodes remains less recognized during exercise. The aim of this study was to verify, during treadmill test and a continous telemetry, the atrial tracking performance using four different leads technologies. From November 1994 to July 1997, 21 patients (71.3 +/- 6.3 years old, 7 female, cardiopathy: 57%) were paced for isolated high degree (permanent: 13, paroxystic: 8) AV block. The implanted devices were the Vitatron Saphir/Brillant lead (13 patients), Intermedics Unity/425/04-13 lead (5 patients), Pacesetter Addvent (2 patients), and Biotronik Eikos (1 patient). The acute atrial signal amplitude was 1.66 +/- 0.75 mV. The treadmill test used the chronotropic assessment exercise protocol after pacemaker reprogramming to detect atrial undersensing (AV delay < or = 120 ms, no hysteresis, no flywheel, upper rate increase). The mean delay was 31.1 weeks (range 1-100). The testing duration was 6.1 +/- 2.3 minutes, the number of steps was 3.3 +/- 1.3 per patient, and the peak exercise rate was 135 +/- 19 beats/min. At rest, complete atrial tracking was complete in 90% of the patients, and during testing in only 23.8% of the patients, while AV synchronization > 95% was present in 57.1%, > 90% in 71.4%, and > 85% in 90.4% of patients (Vitatron 13/13, Intermedics 3/5, Biotronik 1/1, and Pacesetter 1/2). During the recovery period synchronization was always > 95%. The mean P wave amplitude at rest was 1.1 +/- 0.5 mV; during the first step, 1.04 +/- 0.61 mV; second step, 0.94 +/- 0.53 mV; third step, 0.82 +/- 0.58 mV; fourth step, 0.67 +/- 0.39 mV; and during recovery, 1.13 +/- 0.67 mV. The mean P wave decrease signal at peak of exercise is 0.21 mV (from -1.31 to +0.5). In fact, P wave variations have several patterns: a decrease was measured in 7 patients, an increase in 2 patients, and no significant change in 7 patients. Single-lead VDD P wave identification during exercise was almost accurate. However, often there was progressive lowering of atrial sensing with transient loss of AV synchrony.     

Implantation strategy of the atrial dipole impacts atrial sensing performance of single lead VDD pacemakers

Intermittent atrial undersensing is observed in a considerable percentage of patients with single lead VDD pacemakers. Analyzing the 2-year data of the Saphir Multicenter Follow-Up Study, the authors investigated predictors for the occurrence of undersensing. The study included 194 patients with high degree AV block who received a VDD pacemaker system with an identical sensing amplifier. Placement strategy of the atrial dipole was left to the discretion of the implanting physician. At the final position, atrial potential amplitudes were measured during deep and shallow respiration. Atrial dipole position was determined by intraoperativefluoroscopy subdividing the right atrium in a high, mid, and low portion. Undersensing was defined by evidence of at least one not sensed P wave during Holter monitoring or exercise testing and by the presence of 0.1-0.2 mV amplitudes in the P wave amplitude histogram of the pacemaker. Incidence of undersensing was 25.8%; 9.3% of patients showed frequent (> 5%) or symptomatic undersensing. Patients with undersensing were older (76.6 +/- 10.6 vs 64.2 +/- 14.8 years), showed a lower minimum of intraoperative atrial potential amplitude (P(min) 0.86 +/- 0.64 vs 1.43 +/- 0.77 mV), a wider range of potential amplitude (deltaP 1.71 +/- 1.44 vs 0.94 +/- 0.84 mV), and a higher incidence of dipole placement in the low right atrium (50.0% vs 11.1 %, P < 0.001 for all comparisons). In a multivariate regression analysis, patient age > 66 years, Pmin < 0.6 mV, > 1.3 mV and atrial dipol placement in the lowright atrium were independently predictive for undersensing. Minimal atrialpotential amplitude, range of potential amplitude, and atrial dipole position influence atrial sensing performance in single lead VDD pacing. Thus, implantation guidelines should reflect these rules to improve the outcome of VDD pacemaker recipients.