Socio-economic effects and cost saving potential of remote patient monitoring (SAVE-HM trial).

OBJECTIVE: In the SAVE-trial we evaluated the safety, reliability and improvements of patient management using the BIOTRONIK Home Monitoring®-System (HM) in pacemaker (PM) and implanted cardioverter defibrillator (ICD) patients. DESIGN: 115 PM (Module A) and 36 ICD-patients (Module B) were recruited 3 months after implantation. PATIENTS: 65 patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up(FU) per year, whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU. In Module B 18 patients were randomised to HM-OFF and followed by standard outpatient clinic controls every 6 months; 18 patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year; unscheduled follow-ups were performed when necessary. RESULTS: The average follow-up period was 17.1 ± 9.2 months in Module A and 26.3 ± 8.6 months in Module B. In both modules, the number of FUs per year was significantly reduced (Module A HM-ON 0.29 ± 0.6 FUs/year vs HM-OFF 0.53 ± 0.5 FUs/year; p b 0.001; Module B HM-ON 0.87 ± 0.25 vs HM-OFF 1.73 ± 0.53 FU/year,p b 0.001). Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group (18.0 ± 41.3 and 22.4 ± 26.9 € respectively; p b 0.003). 93% of the unscheduled visits in Module B were clinically indicated,whereas 55% of the routine FUs were classified as clinically unnecessary. CONCLUSION: Remote home monitoring of pacemaker and ICD devices was safe, reduced overall hospital visits, and detected events that mandated unscheduled visits.

Initial experiences with a telemedicine framework for remote pacemaker follow-up.

According to international guidelines implanted cardiac pacemakers (PM) have to be checked periodically to ensure that they are working correctly. To spare a significant number of patients the burden of traveling to specialized PM clinics a telemedicine framework has been developed prototypically. A mobile, personal digital assistant (PDA) based PM follow-up unit provides the caregiver at the point-of-care with the necessary infrastructure to perform a basic PM follow-up examination remotely. In case of detected malfunction of the PM the patient is ordered to the hospital for further examination. The system has been evaluated in a clinical pilot trial on 44 patients with a total of 23 different PM models from 8 different manufacturers. The initial results indicate the potential of the concept to work as an efficient, manufacturer independent screening method with the ultimate goal to increase the safety, quality and efficiency of PM therapy.

Automated and manufacturer independent assessment of the battery status of implanted cardiac pacemakers by electrocardiogram analysis.

According to international standards, cardiac pacemakers have to indicate the status of their batteries upon magnet application by specific stimulation patterns. The purpose of this study has been to assess whether this concept can be used as a basis for automated and manufacturer independent examination of the depletion level of pacemakers in the framework of a collaborative telemedical pacemaker follow-up system. A prototype of such a system was developed and tested in a real clinical environment. Electrocardiograms (ECGs) were recorded during magnet application and automatically processed to extract the specific stimulation patterns. The results were used to assign each signal a corresponding pacemaker status: "ok," "replace" or "undefined," based on the expected behavior of the devices as specified by the manufacturer. The outcome of this procedure was compared to the result of an expert examination, resulting in a positive predictive value of 100% for the detection of ECGs indicating pacemaker status "ok." The method can, therefore, be utilized to quickly, safely and manufacturer neutrally classify cases into the categories "ok" and "needs further checking," which - in a telemedical setting - may be used to increase the efficiency of pacemaker follow-up procedures in the future.

Aborted sudden death in a patient with a structurally normal heart: the Brugada syndrome.

We report a 37-year-old man with documented aborted sudden death. After resuscitation, the patient showed no structural heart disease but the ECG showed a right bundle-branch block with a descending ST segment elevation in leads V(1) and V(2). After transient normalization of the ECG, the administration of ajmaline led to spontaneous development of the distinct descending ST segment elevation in the right precordial leads and therefore to the diagnosis of Brugada syndrome. The incidence of sudden cardiac death among these patients is high. The only treatment is an implantable cardioverter-defibrillator (ICD). The Brugada syndrome should therefore be borne in mind in the differential diagnosis of sudden death.

Perioperative ventricular dysrhythmias in patients with structural heart disease undergoing noncardiac surgery.

UNLABELLED: Noncardiac surgical patients with preoperative ventricular dysrhythmias and structural heart disease may be at increased risk of adverse cardiac outcome. We evaluated how anesthesia and surgery affect the course of ventricular dysrhythmias (premature ventricular beats [PVB] and repetitive forms of ventricular beats [RFVB]: couplets and nonsustained ventricular tachycardia) noted preoperatively in patients with structural heart disease and whether the frequency of ventricular dysrhythmias affects cardiac outcome. In a prospective study, 70 patients scheduled for noncardiac surgery with structural heart disease and RFVB on preoperative Holter electrocardiogram were continuously monitored intraoperatively and for 3 days postoperatively. Holter tracings were analyzed for rhythm, medians of total PVB and RFVB per hour. Preoperative RFVB recurred intraoperatively in 35% and postoperatively in 87% of patients. There was a significant intra- and postoperative decrease of total PVB per hour (P < 0.05) and RFVB per hour (P < 0.01). Frequency of ventricular dysrhythmias in the five patients suffering adverse outcome (unstable angina, n = 1; congestive heart failure, n = 4) did not significantly differ from those with good outcome. We conclude that in noncardiac surgical patients with structural heart disease and RFVB, the frequency of ventricular dysrhythmias is not associated with adverse cardiac outcome. IMPLICATIONS: Using continuous electrocardiogram monitoring, we investigated whether the frequency of perioperative ventricular dysrhythmias independently affects outcome in patients with structural heart disease undergoing noncardiac surgery. The incidence of perioperative dysrhythmia in patients with an adverse outcome (8%) did not differ from those with a good outcome.

Sensitivity and specificity of in situ bacterial chain reaction (BCR) in detecting sparse human tumor cells in peripheral blood.

We report here the development of bacterial chain reaction (BCR), a system using micro organisms as nanodevices to amplify and visualize signals from molecular bioprobes such as antibodies, binding proteins, lectins, and oligonucleotides. Unlike conventional enzyme-linked amplification systems in which the amount of enzyme is a constant parameter, in the BCR an enzyme (penicillinase) is used to trigger a proliferative chain reaction producing an exponential increase in enzyme. The detection limits and specificity of BCR were determined using a model system designed to detect and enumerate MCF-7 (a human breast adenocarcinoma cell line) cells disseminated at extremely low frequency (e.g., one tumor cell per million normal cells) among monocluclear cells (MNCs) of human peripheral blood. Results of testing 83 specimens of peripheral blood from presumably healthy donors showed 97.6% specificity. The system was capable of detecting tumor cells at a frequency of 2 x 10(-7).

A randomized controlled trial of a computer-based physician workstation in an outpatient setting: implementation barriers to outcome evaluation.

OBJECTIVE: A research prototype Physician Workstation (PWS) incorporating a graphical user interface and a drug ordering module was compared with the existing hospital information system in an academic Veterans Administration General Medical Clinic. Physicians in the intervention group received recommendations for drug substitutions to reduce costs and were alerted to potential drug interactions. The objective was to evaluate the effect of the PWS on user satisfaction, on health-related outcomes, and on costs. DESIGN: A one-year, two-period, randomized controlled trial with 37 subjects. MEASUREMENTS: Differences in the reliance on noncomputer sources of information, in user satisfaction, in the cost of prescribed medications, and in the rate of clinically relevant drug interactions were assessed. RESULTS: The study subjects logged onto the workstation an average of 6.53 times per provider and used it to generate 2.8% of prescriptions during the intervention period. On a five-point scale (5 = very satisfied, 1 = very dissatisfied), user satisfaction declined in the PWS group (3.44 to 2.98 p = 0.008), and increased in the control group (3.23 to 3.72, p < 0.0001). CONCLUSION: The intervention physicians did not use the PWS frequently enough to influence information-seeking behavior, health outcomes, or cost. The study design did not determine whether the poor usage resulted from satisfaction with the control system, problems using the PWS intervention, or the functions provided by the PWS intervention. Evaluative studies should include provisions to improve the chance of successful implementation as well as to yield maximum information if a negative study occurs.

Temperature-controlled slow pathway ablation for treatment of atrioventricular nodal reentrant tachycardia using a combined anatomical and electrogram guided strategy.

AIMS: Anatomical and electrogram-guided techniques have been used separately for slow pathway ablation in atrioventricular nodal reentrant tachycardia. The aims of the present study were to analyse electrogram characteristics of target sites and biophysical parameters using a combined anatomical and electrogram-guided technique for temperature-controlled radiofrequency catheter ablation of the slow pathway. METHODS AND RESULTS: Using a temperature-controlled (pre-selected 60 degrees C) catheter system, 53 patients with atrioventricular nodal reentrant tachycardia underwent slow pathway radiofrequency ablation. Mapping was started posteroseptally near the coronary sinus ostium and continued towards the midseptal area if needed. The longest and latest atrial electrograms with an atrioventricular ratio of < or = 0.5 were targeted. After a median of two pulses (mean 2.36 +/- 1.33), atrioventricular nodal reentrant tachycardia was rendered non-inducible in all patients without complications. Successful sites had longer atrial electrograms (78.8 +/- 9.8 vs 67.6 +/- 13.3 ms, P < 0.003) and larger ventricular electrogram amplitudes (92.4 +/- 51.2 vs 63.1 +/- 28.8 mV, P < 0.05) than the failed sites, but had a similar atrioventricular ratio, P-A interval and atrial electrogram amplitude. Overall, an atrial electrogram duration of > or = 70 ms was associated with effective radiofrequency delivery, with 86% sensitivity and 62% specificity. The achieved temperature maximum was 62.3 +/- 9.8 degrees C at successful and 58.8 +/- 9.0 degrees C at unsuccessful sites (ns). There was no significant difference between successful and unsuccessful applications with respect to power output, impedance and total delivery energy. During a pre-discharge study, three patients with inducible atrioventricular nodal reentrant tachycardia underwent a repeat ablation. During 12.3 +/- 2.5 (6-15) months of follow-up, three others had a clinical recurrence of atrioventricular nodal reentrant tachycardia. CONCLUSIONS: The combined approach for slow pathway ablation is highly effective, requiring a low number of radiofrequency pulses. Long atrial activation time seems to be the most powerful predictor of success. Similar catheter tip temperature levels during successful and unsuccessful radiofrequency applications indicate that suboptimal selection of target sites rather than ineffective heating due to poor catheter tissue coupling is responsible for unsuccessful energy delivery.

Temperature-controlled radiofrequency catheter ablation of manifest accessory pathways.

OBJECTIVES: The primary objectives of this study were to assess the feasibility of temperature-controlled radiofrequency catheter ablation of left and right sided manifest accessory pathways in patients with Wolff-Parkinson-White syndrome and to gain more insights into biophysical aspects of temperature-controlled catheter ablation in humans. BACKGROUND: The electrode-tissue interface temperature and other biophysical parameters are among important variables determining the efficacy and safety of radiofrequency ablation of accessory pathways. Experimental studies have shown that radiofrequency-induced tissue necrosis can be accurately predicted by monitoring of catheter tip temperature. METHODS: 38 consecutive patients (14 f, 24 m; aged 42 +/- 12 years) with anterograde conducting accessory pathways (left sided: n = 22; right sided: n = 16) underwent temperature-controlled radiofrequency ablation (HAT 200S, Dr Osypka, Germany). The electrode temperature was monitored via a thermistor embedded into a 4 mm catheter tip. Power output was adjusted automatically during energy delivery in a closed loop system (preselected temp.: 70.1 +/- 5.8 degrees C). RESULTS: Accessory pathway conduction was successfully abolished in all patients after the delivery of 2.3 +/- 2.1 radiofrequency pulses (range: 1-9, median: 2). Interruption of the accessory pathway as evidenced by loss of preexcitation occurred after 5.9 +/- 5.4 s. At the time of the interruption of the accessory pathway the catheter tip temperature measured 54.2 +/- 11.2 degrees C in patients with left and 44.9 +/- 5.0 degrees C in patients with right sided accessory pathways, respectively (P < 0.008). Higher temperature levels during left sided applications did not shorten the time it took for the effect to appear (left sided accessory pathway: 7.5 +/- 6.3 s, right sided accessory pathway: 3.7 +/- 2.9 s; ns). The catheter tip temperature was significantly higher during left compared to right sided applications after 5 (52.1 +/- 3.1 degrees C vs 47.2 +/- 4.3 degrees C) and 10 s (61.5 +/- 6.2 degrees C vs 52.7 +/- 4.2 degrees C) following initiation of the impulse (P < 0.005). Power output and delivered energy did not differ significantly at the time of accessory pathway abolition. Peak values of delivered power (45.1 +/- 10.9 W vs 41.3 +/- 10.6 W; P < 0.05) and total delivered energy (2452 +/- 1335 J vs 1392 +/- 762 J; P < 0.02) were significantly higher in the group of right sided pathways compared to left sided applications. The peak temperature measured 77.1 +/- 13 degrees C during effective and 69.9 +/- 14 degrees C during ineffective energy applications (P < 0.05). The time it took for the effect to appear was significantly longer in transiently effective pulses (10.4 +/- 7.2 s) compared to permanently effective applications (5.9 +/- 5.4 s; P < 0.02). Despite temperature control, an abrupt rise in impedance was observed in 10 of 89 (11%) energy applications. No procedure-related complications occurred. CONCLUSIONS: Temperature-controlled radiofrequency ablation of manifest accessory pathways is highly effective and safe. The temperature response is faster and significantly higher in left-sided energy applications compared to right-sided pulses. Peak temperature levels measured at the electrode tip are significantly higher during effective than ineffective pulses. Sudden rises in impedance are not completely prevented during temperature-controlled radiofrequency ablation of accessory pathway, although no procedure-related complications were noted in this patient cohort.

A randomized evaluation of a computer-based physician's workstation: design considerations and baseline results.

We are performing a randomized, controlled trial of a Physician's Workstation (PWS), an ambulatory care information system, developed for use in the General Medical Clinic (GMC) of the Palo Alto VA. Goals for the project include selecting appropriate outcome variables and developing a statistically powerful experimental design with a limited number of subjects. As PWS provides real-time drug-ordering advice, we retrospectively examined drug costs and drug-drug interactions in order to select outcome variables sensitive to our short-term intervention as well as to estimate the statistical efficiency of alternative design possibilities. Drug cost data revealed the mean daily cost per physician per patient was 99.3 cents +/- 13.4 cents, with a range from 0.77 cent to 1.37 cents. The rate of major interactions per prescription for each physician was 2.9% +/- 1%, with a range from 1.5% to 4.8%. Based on these baseline analyses, we selected a two-period parallel design for the evaluation, which maximized statistical power while minimizing sources of bias.

Recurrence and late block of accessory pathway conduction following radiofrequency catheter ablation.

INTRODUCTION: Many issues regarding the recurrence of accessory pathway conduction and the long-term outcome of late block of accessory pathway conduction are still unknown or controversial. METHODS AND RESULTS: Data from 217 patients who underwent an initially successful radiofrequency ablation of accessory pathways and 7 patients with late block of accessory pathway conduction following an initially unsuccessful ablation were analyzed. During a mean follow-up of 19 +/- 11 months, accessory pathway conduction resumed in 21 (10%) of 217 patients following an initially successful ablation and in 6 (86%) of 7 patients with late block of accessory pathway conduction (P < 0.01). After initially successful ablations, the recurrence rates of accessory pathway conduction at 1, 3, and 6 months were 5.9%, 7.4%, and 11.3%, respectively. A late electrophysiologic study at 6 months uncovered recurrence in only 1 of 124 asymptomatic patients, but failed to detect the late recurrence in 2 patients in whom the accessory pathway conduction resumed after more than 6 months. Multivariate analysis revealed that independent predictors for recurrence of accessory pathway conduction were concealed accessory pathway, presence of transient effect of radiofrequency pulse, and more than 5 pulses required for initial cure. Accessory pathway location, length of the tip electrode of the ablation catheter, and repeat radiofrequency pulses ("safety pulses") after effective pulses did not predict resumption of accessory pathway conduction. CONCLUSIONS: After initially successful ablation, the recurrence rates of accessory pathway conduction at 1, 3, and 6 months were 5.9%, 7.4%, and 11.3%, respectively. Late electrophysiologic testing had little prognostic value in asymptomatic patients following successful ablation. Application of "safety pulses" did not prevent recurrence. Late block of accessory pathway conduction did not predict long-term efficacy.

[Therapy of AV nodal reentry tachycardia with catheter ablation of the fast retrograde pathway]. / Therapie der AV-Knoten-Reentry-Tachykardie mittels Katheterablation der schnellen retrograden Leitungsbahn.

AV-nodal reentrant tachycardia (AVNRT) is a common cause of recurrent supraventricular tachycardia. Currently, catheter ablation of either slow or fast pathway are nonpharmacologic options for the treatment of patients with AVNRT. Radiofrequency (RF) catheter ablation of the fast pathway was attempted in 35 patients (aged 46.7 +/- 15 years; 12 m, 23 f) with recurrent AVNRT. RF energy (25-50 watt, 30-90 s) was delivered to the anterior right atrial septum. The catheter was placed posterior to the largest His bundle deflection. AV conduction was monitored during continuous pacing of the high right atrium while the RF current was applied. RF-ablation was acutely successful using a mean of 6.5 +/- 6.2 impulses in 31 patients. Late spontaneous block of the slow pathway occurred in one patient (pat. 17) with an unsuccessful initial attempt of fast pathway ablation. PQ and AH interval increased significantly after the ablation procedure (PQ: from 149 +/- 27 to 208 +/- 34 ms, AH: from 76 +/- 22 to 131 +/- 38 ms; p value: < 0.0001). Acute interruption of retrograde VA conduction was the result in 23 patients. Six patients (17%) had a recurrence of AVNRT during a follow-up period of 11.9 +/- 7.5 months. Five of 6 patients underwent a second successful procedure. Complete AV block occurred in 3 of the first 10 consecutive patients and in none of the subsequent 25 patients (overall incidence: 8.6%). Thus, RF ablation of the fast retrograde pathway is an effective method for the curative treatment of AVNRT.(ABSTRACT TRUNCATED AT 250 WORDS)

[The pro-arrhythmic effects of anti-arrhythmia agents]. / Proarrhythmische Effekte von Antiarrhythmika.

Proarrhythmia is defined as the provocation of new cardiac arrhythmias or the aggravation of preexisting arrhythmias by antiarrhythmic drugs. The possible types of manifestation of proarrhythmia are manifold. With respect to prognosis, drug-induced ventricular tachyarrhythmias seem to be of particular importance. Monomorphic ventricular tachycardia and ventricular tachycardias of the torsade de pointes type have to be distinguished. The former seem to be mainly based on reentrant mechanisms, while the later is supposed to result from triggered activity. Drug-induced monomorphic tachycardia is most often observed during therapy with drugs which slow conduction (class I agents, proarrhythmic potency: IC > IA > IB). Patients with depressed left ventricular function and previously documented life-threatening tachyarrhythmias are the most susceptible candidates. Torsade de pointes can be preferentially observed during therapy with antiarrhythmic drugs which prolong myocardial repolarization (i.e. class IA and class III agents). Electrolyte abnormalities and/or bradycardia are factors which often predispose to the development of this particular type of proarrhythmia. The physician who prescribes antiarrhythmic drugs must be aware of the different types and clinical manifestations of proarrhythmia. This is necessary to assess the degree of proarrhythmic risk and to determine the benefit/risk ratio before the start of drug therapy.

Atrioventricular nodal reentry tachycardia: electrophysiologic comparisons in patients with and without 2:1 infra-His block.

Patients with atrioventricular nodal reentry tachycardia (AVNRT) occasionally may demonstrate a 2:1 infra-His block during tachycardia. However, the electrophysiologic background of this phenomenon has not been established so far. In the present study we compared the electrophysiologic parameters of 10 consecutive patients with a transient 2:1 infra-His block during AVNRT of the common type (Group A) with those of 17 consecutive patients without this phenomenon during tachycardia (Group B). Transient 2:1 infra-His block occurred without termination of the tachycardia in all 10 patients of Group A. The tachycardia sustained despite intermittent or permanent conduction disturbance of the infrahisian tissue in 8 of these 10 patients. In comparison, the electrophysiologic parameters of 17 patients without 2:1 block during AVNRT of the common type (Group B) were analyzed. A significantly longer antegrade (318 +/- 58 ms vs. 259 +/- 50 ms) and retrograde (308 +/- 59 ms vs. 239 +/- 20 ms) AV conduction capacity could be demonstrated in these patients. The tachycardia cycle length did not differ significantly between the two groups, although the mean tachycardia cycle length was 48 ms longer in patients of Group B. These observations demonstrate an advanced conduction capacity in patients with a transient infra-His block during AVRNT of the common type. This study underlines that the reentry circuit in AVNRT is not necessarily dependent on infrahisian tissue.

[Torsade de pointes]. / Torsade de pointes.

Torsade de pointes (TDP) is a polymorphic ventricular tachycardia with a particular electrocardiographic pattern of continuously changing ("twisting") morphology of the QRS complex occurring in the setting of delayed myocardial repolarization (i.e., prolongation of the QT interval). TDP may develop in the setting of an idiopathic disorder (Jervell/Lange-Nielsen syndrome, Romano-Ward syndrome, sporadic long QT syndrome) or may be induced by pharmacologic agents which prolong the QT interval, as well as by other clinical circumstances under which repolarization is delayed (e.g., hypokalemia, hypomagnesemia, bradycardia) (acquired long QT syndrome). Since the treatment of TDP strongly differs from that of conventional ventricular tachycardia, correct diagnosis is critical as it guides the treating physician in selecting the appropriate mode of therapy. In this paper mainly the electrocardiographic criteria presently used for the correct identification of this unusual form of ventricular arrhythmia are presented. Additionally, the potential mechanisms and therapeutic modalities of TDP are discussed.

Frequency of magnetic resonance signal abnormalities of the brain in patients aged less than 50 years with idiopathic dilated cardiomyopathy.

Twenty patients with idiopathic dilated cardiomyopathy (IDC) aged less than 50 years (mean 41) and an age-matched group of 20 healthy volunteers were studied. All subjects were free of cerebrovascular symptoms and risk factors for stroke. Magnetic resonance imaging of the brain, extracranial Doppler ultrasonography, heart catheterization and echocardiography were performed. In patients with IDC, a higher frequency of ventricular enlargement (p less than 0.02), cortical atrophy (p less than 0.01) and white matter lesions (p less than 0.05) was observed. Cerebral infarcts were found in 4 patients (p less than 0.05) who showed clinically severe limitation of functional capacity (New York Heart Association class III or IV). The extent of cortical atrophy, and the duration of clinical evidence of IDC showed a significant correlation (p less than 0.04). The data indicate a high incidence of parenchymal abnormalities of the brain in young, neurologically asymptomatic patients with IDC.

Evaluation of the antihypertensive effect of lisinopril compared with nifedipine in patients with mild to severe essential hypertension.

For several reasons, increasing numbers of patients with hypertension are treated with angiotensin-converting enzyme inhibitors and calcium channel blockers. In a twenty-four week, double-blind, randomized, parallel study, the antihypertensive effect of lisinopril (20 to 80 mg qd) and nifedipine (20 to 80 mg bid) were compared in 21 patients. Fourteen patients received lisinopril (mean dose 35 mg), and 7 patients received nifedipine (mean dose 54 mg). By the end of week 12, 8 patients had responded (supine diastolic pressure less than or equal to 90 mg) to lisinopril and 5 to nifedipine. At the end of the study supine systolic/diastolic blood pressure was reduced from 172/104 to 149/92 mmHg with lisinopril and from 171/102 to 158/94 mmHg with nifedipine. No significant difference between the two treatments was detected. Three patients were reported to have at least one clinical adverse experience during the active treatment period, 1 in the lisinopril group and 2 in the nifedipine group. No serious clinical adverse experiences were recorded. In conclusion, lisinopril and nifedipine are both effective in reducing blood pressure in patients with mild to severe hypertension. Lisinopril qd and nifedipine slow release bid produce similar decreases in blood pressure after twelve weeks of therapy and the safety profiles of the two drugs are similar.