Combipolar sensing in dual chamber pacing: is there still a need for bipolar leads in the atrium?

Bipolar leads have been shown to provide superior sensing conditions compared to unipolar leads as bipolar sensing is less susceptible to interference. However, the mechanical long-term integrity and longevity of bipolar leads is inferior to that of unipolar leads. A prospective randomized, multicenter study was performed to investigate a new atrial detection configuration called combipolar sensing. This new sensing concept is designed for the use of conventional unipolar leads in the atrium and the ventricle. While the atrial stimulation is unipolar, atrial sensing is accomplished in a bipolar way using the ventricular lead tip as the indifferent electrode. A modified dual chamber pacemaker provided with this sensing concept was implanted in 26 patients. At predischarge and at the 1- and 3-month follow-ups no significant differences in atrial sensing thresholds and P wave amplitudes were found between the unipolar and the combipolar sensing configuration at rest or during provocation. Myopotential inhibition could be demonstrated in 22 patients during unipolar sensing at sensitivity settings as "low" as 2 mV. In contrast, during combipolar sensing it could only be demonstrated in one patient once and only at the highest atrial sensitivity of 0.5 mV. Combipolar atrial sensing is feasible under normal conditions and during provocation. Myopotential interference is negligible. Thus, combipolar sensing offers comparable atrial sensing to bipolar without the disadvantages of a bipolar lead.

Peak endocardial acceleration-based clinical testing of the "BEST" DDDR pacemaker. European PEA Clinical Investigation Group.

The peak endocardial acceleration (PEA, unit g) shows a near correlation with myocardial contractility during the isometric systolic contraction of the heart (dP/dtmax), with sympathetic activity and, thus, with physiological heart rate modulation. The (Biomechanical Endocardial Sorin Transducer (BEST) sensor is incorporated in the tip of a pacing lead and measures PEA directly near the myocardium. In an international study, the lead was implanted with the dual chamber pacemaker Living-1 (Sorin) in 105 patients. The behavior of the PEA signal was tested under conditions of physical and mental stress and during daily life activities by 24-hour recordings of PEA (PEA Holter) at 1 to 2 months and approximately 1 year after implantation. Implantation of the BEST lead was performed without complications in all patients. The sensor functioned properly in the short- and long-term in 98% of patients. Although PEA values differed from patient to patient, the values closely reflected the variations in sympathetic activity due to physical and mental stress in each patient. During exercise and during daily life activities a close correlation between PEA and heart rate was observed among patients with normal sinus rhythm. Peak endocardial acceleration allows a nearly physiological control of the pacing rate.

Automatic adjustment of pacemaker stimulation output correlated with continuously monitored capture thresholds: a multicenter study. European Microny Study Group.

Pacing threshold is affected by many factors. A pacing system able to confirm capture at each beat and automatically adjust its output close to the actual pacing threshold is highly desirable. This study evaluates the safety and efficacy of the Autocapture function of the Pacesetter Microny SR+. One hundred thirteen patients were recruited from 16 centers in 7 European countries and followed up for 1 year. All pacemakers were implanted with Pacesetter's low polarization, bipolar leads. The key feature of Autocapture is the immediate delivery of a 4.5 V safety backup pulse 62.5 ms after any ineffective ongoing low output pulse. Holter recordings confirmed total reliability of this feature without any exit block. The measured evoked response (ER) signal was stable over time. Acute and chronic pacing thresholds measured by VARIO and Autocapture tests correlated (r > 0.79) over the period of the study. The incidence of backup pulses was 1.1% during pacing. With Autocapture programmed ON, the overall total current consumption was 4.1 microA for VVI and 5.0 microA for VVIR pacing. This study proved that the Autocapture safely and reliably regulates the pacemaker's output according to the prevailing threshold thus providing maximum patient safety and prolonging service life.

La función autocaptura en marcapasos VVIR: experiencia del estudio multicéntrico / Autocaptura function in a VVIR pacemaker: a multicentre clinical experience

La función de autocaptura verifica la captura latido a latido. La búsqueda automática del umbral de estimulación, ajusta el potencial de salida 0.3 V. por encima del valor medido. Ante la pérdida de captura de un estímulo, el sistema emite un segundo impulso de 4.5 V. a los 65 mseg. para conseguir captura, evitando con ello pausas del ritmo cardíaco. La función de Autocaptura nos oferece por elo una estimulación segura de bajo consumo. El sistema ha sido incorporado a un marcapasos VVIR de 12,8 gr. de peso y 5.9 cm3 de volumen, de estimulación unipolar y detección bipolar. Presentamos la experiencia de un estudio multicéntrico que incluye 113 pacientes, 57 hombres y 56 hombres y 56 mujeres. La edad media fue de 76 anos (45-93). La indicación ECG fue de fibrilación auricular con pobre respuesta ventricular en el 84 "por ciento" de los casos y de bloqueo A-V en el restante 16 "por cento". Se han revisado los protocolos de 112 controles de alta hospitalaria, 107 de 30 dias, 94 de 3 meses y 49 de 6 meses. En todos los casos se ha practicado un registro Holter de 24 horas al mes de la implantación. El valor medio de umbral de estimulación en el momento de la implatacióon fue de 0.6 V, a 1 mes de 1.3 V., a los 3 meses de 1.3 V. y a los 6 meses de 1.2 V. Los valores medios de onda R intrínseca / onda R evocada fueron en la implantación de 14.7/10.2 mV., al mes 16.8/10.0 mV., a los 3 meses 16.5/10.2 mV. y a los 6 meses 17.5/10.2 mV. Se ha calculado un consumo un consumo medio de 3.9 +ou- mA. con lo que la longevidad del generador resulta de entre 7 y 8 anos. El análisis latido a latido de 3.7 millones de estímulos de los registros Holter, nos confirma que cada pérdida de captura ha sido detectada y seguida de un estímulo de segurid efectivo. Conclusión: La función Autocaptura posee la habilidad de cambiar automaticament el potencial de salida en consonancia con el umbral de estimulación, y por ello nos permite ofrecer una terapia de estimulación segura y fiable con bajo consumo energético.

Three-year experience with a stylet for lead extraction: a multicenter study.

INTRODUCTION: The extraction of chronically implanted and infected pacemaker and defibrillator leads is an important issue. This article describes the experience gathered between 1990 and 1994 by seven European centers regarding a locking stylet that is uniformly applicable for a wide variety of internal pacing coil diameters. This interventional locking stylet for lead extraction has an outer diameter of 0.4 mm (0.016 inches). The stylet consists of a hollow shaft in which an inner traction wire is embedded. At the tip of the inner traction wire an anchoring mechanism, which can be opened by retraction, is applied. Removal attempts were made for 150 leads, 110 in ventricular and 40 in atrial positions. RESULTS: Complete removal was possible in 122 cases (81%). Partial removal was possible in 18 cases (12%). Failure to remove the lead with the extraction stylet was experienced in 10 cases (7%). In seven patients, the leads were removed by cardiothoracic surgery; 3 defective leads were left in place. There were no serious complications associated with the procedure. None of the patients died. CONCLUSION: The experience with this extraction stylet for lead removal has shown good results. Despite a low complication rate thus far, each case for lead removal should be judged on the individual basis of benefit-to-risk ratio.

Comparison of threshold values between steroid and nonsteroid unipolar membrane leads.

The aim of this study was to evaluate whether steroid membrane leads can reduce pacing thresholds and thereby save energy as compared to nonsteroid membrane leads. The study was a random sample, double blind test consisting of 90 patients between 49-94 years of age admitted to seven hospitals in Europe for pacemaker implantation. The two leads compared in this study had contoured activated carbon tips covered with ion exchange membranes. The leads were identical except that 30 micrograms of dexamethasone was dissolved in the ion exchange membrane of one of the leads. Normal lead implant procedures were used. Follow-up procedures were conducted at 2 weeks and 1, 3, 6, and 12 months after lead implantation. The pulse generator was programmed to an amplitude of 2.5 or 5 V and a duration of 0.5 msec. The stimulation threshold was measured using the VARIO function. The threshold was measured a total of three times in order to determine the presence of microdislocations. At the 2- and 4-week follow-ups, the stimulation threshold was significantly lower for the steroid leads than for the membrane leads without steroid (0.54 +/- 0.19 vs 0.76 +/- 0.25 V, P = 0.0005; and 0.59 +/- 0.19 vs 0.74 +/- 0.26 V, P = 0.005), but after 3 months, the threshold values were almost the same for both leads.

Direct current application: easy induction of ventricular fibrillation for the determination of the defibrillation threshold in patients with implantable cardioverter defibrillators.

For the determination of the defibrillation threshold, the induction of ventricular fibrillation is mandatory. However, in severely damaged hearts it is sometimes difficult to induce ventricular fibrillation by rapid stimulation or alternating current. Only rapid nonclinical ventricular tachycardias may result, and their cardioversion threshold may be different from the defibrillation threshold. Therefore, it was the purpose of this study to test the potential of direct current (DC) application to rapidly induce ventricular fibrillation in patients with an implanted cardioverter defibrillator. The defibrillation threshold had to be determined in 13 patients (9 with coronary heart disease, 4 with dilative cardiomyopathy, ejection fraction 35%) during and 2 weeks after the implantation of a cardioverter defibrillator. DC was applied 37 times by a commercially available 9-V DC battery via a bipolar catheter for about 3 seconds. Ventricular fibrillation was induced 23 times (62%) and rapid nonclinical ventricular tachycardias were induced six times (16%). In one patient clinical ventricular tachycardia was observed. In seven instances (19%) sinus rhythm remained. In 12 of the 13 patients, ventricular fibrillation could be induced by DC. Thus, the induction of ventricular fibrillation by DC application may serve as an additional tool to induce ventricular fibrillation, determining the defibrillation threshold in implantable cardioverter defibrillator patients.

[A noncardiac pulmonary edema following aortocoronary bypass surgery. Diagnosis and therapy based on a case report]. / Ein nichtkardiales Lungenödem nach aorto-koronarer Bypassoperation. Klinik, Diagnostik und Therapie anhand einer Kasuistik.

Noncardiac pulmonary edema can occur not only after cardiac surgery with cardiopulmonary bypass but also after noncardiac operations. This so-called transfusion-related acute lung injury (TRALI) has been attributed to the transfusion of homologous blood and plasma. In the presence of normal left ventricular function an acute increase in pulmonary capillary permeability leads to massive protein-rich pulmonary edema, reduced pulmonary function, and intravascular hypovolemia. This may be caused by leukocyte antibodies. Signs and diagnostic and therapeutic procedures are discussed with reference to a case report.

Catecholamines and the renin-angiotensin-aldosterone system during treatment with felodipine ER or hydrochlorothiazide in essential hypertension.

The neurohumoral responses after 10 mg of felodipine extended release (ER), a new dihydropyridine calcium antagonist, and 25 mg of hydrochlorothiazide (HCTZ) were compared in a randomized, double-blind, crossover trial in 28 mild to moderate hypertensives. Antihypertensive drugs were gradually discontinued. Felodipine ER, 10 mg was given once daily for 2 weeks; after another washout period of 1 week, patients were switched to 25 mg of HCTZ once daily and vice versa. Blood pressure (BP) was measured at baseline, 2.5 h after medication, and after 2 weeks of treatment (24 h postdosing) using an oscillometric device. Felodipine ER and HCTZ both lowered BP effectively. However, felodipine ER was superior in reducing systolic and diastolic BP during the short term and medium term. Treatment with felodipine ER over 2 weeks increased sympathetic outflow as indicated by elevated plasma norepinephrine levels, whereas plasma epinephrine was mainly unaffected, as were plasma renin and aldosterone levels. On the other hand, 25 mg of HCTZ increased plasma renin and aldosterone, but left catecholamines unchanged. Despite persistent increased sympathetic activity, the reduction in BP in this study was more pronounced after felodipine ER as compared to HCTZ. The lack of a difference between heart rates under both medications after 2 weeks of treatment suggests a resetting of the baroreflex by felodipine ER and furthermore that the increased norepinephrine levels may not be clinically relevant, but demonstrate the maintained baroreflex activity. HCTZ, in doses as low as 25 mg, is still capable of stimulating the renin-angiotensin-aldosterone system.

Effects of felodipine ER and hydrochlorothiazide on blood rheology in essential hypertension--a randomized, double-blind, crossover study.

The haemorheological effects of felodipine extended release (ER), a new dihydropyridine calcium antagonist, were compared with hydrochlorothiazide (HCTZ) in 28 mild to moderate hypertensives (18 men and 10 women, aged 30-70 years) in a randomized, double-blind, crossover trial. Antihypertensive drugs were gradually discontinued. Felodipine Er, 10 mg, was given once daily for 2 weeks, and after another wash-out period of 1 week, patients were switched to 25 mg HCTZ, once daily, and vice versa. Whole blood viscosity (BV) at three different shear stresses, haematocrit (Hct), plasma viscosity (PV), red blood cell (RBC) aggregation, RBC deformability, and fibrinogen were measured under standardized conditions 2.5 h after medication, and after 2 week of treatment (24 h post-dosing). Felodipine ER improved BV acutely, but not during treatment over a 2-week period. By contrast, HCTZ did not affect BV, but decreased RBC deformability 2.5 h after medication intake. After 2 weeks of treatment, the negative effect on RBC deformability had increased slightly. Furthermore, fibrinogen and PV were significantly elevated at this stage. In summary, felodipine ER did not improve blood rheology over a 2-week treatment period in this study. HCTZ exhibited marginal but significant negative effects on fibrinogen, PV and indices of RBC deformability, but not on RBC aggregation.

Comparison of once daily felodipine 10 mg ER and hydrochlorothiazide 25 mg in the treatment of mild to moderate hypertension.

The efficacy of extended release felodipine 10 mg (ER) o.d., a new dihydropyridine calcium antagonist, and 25 mg hydrochlorothiazide (HCTZ) o.d. have been compared in a randomized, double-blind, crossover trial in 28 mildly to moderately hypertensive subjects (supine diastolic blood pressure, BP, greater than or equal to 95 mm Hg and less than or equal to 110 mm Hg on three separate occasions). Both drugs significantly reduced systolic and diastolic BP in the sitting position felodipine from 157.1/93.8 mm Hg at baseline to 133/78.9 mm Hg 2.5 h after medication and to 138/82.7 mm Hg after 2 weeks of treatment, and HCTZ from 156/95.6 mm Hg to 147/88.4 mm Hg 2.5 h after medication and to 149/89.5 mm Hg also after 2 weeks. A decrease of the same magnitude in standing systolic and diastolic BP was observed after both treatment regimens with the exception of diastolic BP 2.5 h after dosing with HCTZ, which was not significantly lower. At all times (2.5 h and 2 weeks), the reduction in systolic and diastolic BP was greater after felodipine compared to HCTZ. Heart rate was significantly increased after felodipine in both the sitting and standing positions, and both 2.5 h following medication and after 2 weeks of treatment. The difference between the regimens was significant only 2.5 h after dosing. Overall, felodipine 10 mg ER o.d. was superior to 25 mg HCTZ o.d. in lowering BP.

Efficacy and safety of intravenous amiodarone in acute refractory arrhythmias.

Few data are available on intravenous amiodarone therapy in refractory arrhythmias. This retrospective study in 50 patients (14 with supraventricular and 36 with ventricular tachyarrhythmias) revealed a favorable effect of intravenous amiodarone in the treatment of life-threatening arrhythmias with an overall success rate of 76%. In the subgroup of patients with ventricular fibrillation and concomitant severe congestive heart failure success rate was low (25%, 2/8), whereas effectiveness in patients with ventricular tachycardias was high (greater than 90%) and proved to be independent of left ventricular function. If patients with recurrent ventricular fibrillation were excluded from the analysis, successful treatment with intravenous amiodarone was achieved in 90%, even in those patients with severely compromised myocardium.