Multicenter Clinical Evaluation of a New SSIR Pacemaker

A multicenter clinical evaluation of Sorin Swing 100, a new SSIR pacemaker with a gravimetric sensor, was performed by seven different centers enrolling a total of 89 patients, 56 men and 33 women, mean age 73.1 years, for pacemaker implantion (73 patients) or pacemaker replacement (16 patients). Pacing mode was VVIR in 73 patients and AAIR in 16. The behavior of pacing rate was evaluated 3 months after the implant by performing a 24-hour Holter monitor, an exercise stress test, and tests for the assessment of mechanical external interference (MEI). A physiological behavior of the paced rate was always observed during Holter monitoring. In 52 completely paced patients mean diurnal, nocturnal, and maximal heart rate were, respectively, 74.9 ± 5.7 ppm, 58.1 ± 5.8 ppm, and 113.4 ± 12.7 ppm; a paced rate exceeding 100 ppm was reached on the average 5.6 times/Holter monitor. In all but two patients the sleep rate (55 ppm) was reached during the night or long resting time. During exercise stress test a direct correlation between the increase in pacing rate and the increase in workload was observed; the mean maximal heart rate reached in 49 completely paced patients was, respectively, 102.8 ± 9 ppm in 17 patients who accomplished stage 1, 116.2 ± 13.6 ppm in 28 patients who accomplished stage 2, and 133 ± 6.7 ppm in 10 patients who accomplished stage 3 of the Bruce protocol. MEI testing never increased the pacing rate over the noise rate (10 ppm over the basic rate). In only seven patients the results obtained suggested to change the nominal set up of the pacemaker. Our experience clearly indicates that Swing 100 is an effective, reliable, and easy to use SSIR pacemaker. The availability of the sleep rate allows a more physiological pattern of pacing rate and can lead to significant energy saving.     

A New Approach to the Prevention of Endless Loop Tachycardia in DDD and VVD Pacing

Endless loop tachycardia (ELT) is a possible complication in dual chamber pacing; it is usually prevented by programming the atrial refractory period (PVARP) longer than the retrograde ventriculoatrial (VA) conduction interval; this in some patients limits the upper rate. In 15 patients with a DDD (nine patients) or a single-pass lead VDD pacemaker (six patients) and retrograde atrial activation, telemetric recording documented a significant difference in amplitude of antegrade, and retrograde atrial potentials (VDD 1.21 ± 0.32 mV vs 0.56 ± 0.23 mV, P = 0.008; DDD 2.7 ± 1 vs 1.8 ± 1 mV, P - 0.038; Student's t-test for paired data). In 3/15 patients ELT stopped after programming of atrial sensitivity to a value. greater than the retrograde P wave amplitude; in 11/15 patients this occurred at a sensing value lower than or equal to retrograde P wave amplitude with a high pass band filter operating. One patient required PVARP lengthening. Holter monitoring showed no more ELTs. In most patients with a DDD or single-pass lead VDD pacemaker with widely programmable sensing amplitude and Hi/Low bandpass filters. individual programming of atrial channel sensitivity prevents ELT without affecting the PVARP and, consequently, upper rate limit.     

Value of Automatic Processing and Reliability of Stored Data in an Implanted Pacemaker: Initial Results in 59 Patients

Stored data in implantable pacemakers have rarely been used as a diagnostic tool because of the complexity. Our group bas developed software called AIDA, providing an automatic interpretation of data stored in memories of the Chorus (ELA medical) pacemaker. We com pared the results of AIDA analysis to surface ECG Holter interpretation in 59 patients (age 75 ± 9 years). In 33 cases, neither AIDA nor the Holter found any anomaly. Eleven patients demonstrated episodes of supraventricular tachycardia (SVT), confirmed by AIDA in ten patients; AIDA failure was due to nonsustained episodes of SVT not inducing mode switch. Loss of atrial sensing, pacemaker-mediated tachycar dia, and ventricular extrasystoles were detected by AIDA in ten patients. Traditional Holter missed three cases. This initial study confirms that stored pacemaker data, automatically interpreted can provide reli able information over a 24-hour period.     

A New Algorithm for Closed-Loop Stimulation: A Feasibility Study

PIERAGNOLI, P., et al .: A New Algorithm for Closed-Loop Stimulation: A Feasibility Study. Closed-loop stimulation (CLS) is a physiological system for adaptive rate pacing based on monitoring and processing of the intracardiac impedance. The "standard" CLS algorithm (SCLS) requires continuous ventricular pacing. A new, enhanced CLS algorithm (ECLS) provides rate modulation during sensed and paced ventricular depolarizations. The aim of this study was to validate ECLS and to compare its effectiveness with that of SCLS. Ten patients received Inos²⁺ CLS pulse generators. SCLS and ECLS were uploaded to the device and evaluated in a randomized, crossover fashion at 30 and 45 days after pacemaker implantation. At each follow-up visit, ambulatory and posture tests were performed. Heart rate (HR) during daily activity was evaluated based on 24-hour Holter recordings. During all phases of the ambulatory test, both algorithms provided physiologically appropriate rates in all patients. The proportion of sensed ventricular events was significantly higher in ECLS (93.9%) than in SCLS (0.7%). The proportion of paced ventricular events during 24 hours was substantially lower with ECLS (25.7%) than with SCLS (98.4%). Postural changes did not influence HR with either algorithm. The Holter recordings indicated prompt, safe, and effective rate modulation appropriate to patient activity. In conclusion, analysis of these clinical data demonstrated the safety and effectiveness of the ECLS algorithm. Moreover, with this algorithm the ventricle is paced only when required, which may be expected to retard battery depletion and retain the natural ventricular activation pattern whenever possible. (PACE 2003; 26[Pt. II]:229–232)     

Evaluation of Rate-Responsive Pacemakers by Transesophageal Holter Monitoring of Spontaneous Atrial Rate

BONGIORNI, M.G., ET AL.: Evaluation of Rate-Responsive Pacemakers by Transesophageal Holter Monitoring of Spontaneous Atrial Rate. One of the most important problems in rate responsive (RR) pacing is the clinical experimental evaluation of the reliability of various sensors. In particular, it is difficult to test their sensitivity and specificity during daily activity of the patients. Atrial rate, when present and normal, is the most physiological marker of metabolic requirements, but sometimes it is impossible to analyze the P wave in ventricular paced rhythm during routinely performed tests (e.g., ergometric test and 24-hour Holter monitoring). During various physical activities, we monitored atrial electrograms on an esophageal lead on the first channel of a standard Holter tape recorder; on the second channel a surface ECG lead was recorded. We selected 10 patients with high grade heart block and normal sinus node function paced in RR-VVI mode. RR pacing was obtained using various sensors (body activity, blood temperature, spike-T interval, minute ventilation). The good quality of recording allowed an easy evaluation of atrial and ventricular rates. In four cases an appropriate increase in heart rate was documented; sensitivity threshold and/or rate response slope were reprogrammed when indicated. The pacing rate of one patient did not parallel the atrial rate during walking only. In three cases, we observed a delay in the ventricular rate increase, with ventricular rate decreasing at peak exercise despite further atrial rate increase. In the last two patients, we observed inappropriate pacing response; pacing rate increased later and to a lower level than the atrial one. This new method is applied easily and appears reliable to evaluate the response of RR pacemakers to individual metabolic needs. Its applicability is, however, limited by the need for a normal sinus node function. In conclusion, transesophageal atrial rate recording is a useful tool for the clinical evaluation of RR pacemakers, and it can be proposed as a new method for testing new sensors.     

非小细胞肺癌表皮生长因子受体基因主要突变类型快速简便的检测方法

背景与目的:肺癌组织中表皮生长因子受体(epidermal growth factor receptor,EGFR)基因突变是靶向药物EGFR酪氨酸激酶抑制剂(tyrosine kinase inhibitor,TKI)治疗有效的一个重要相关因素及预测指标.目前临床上需要一种简单、敏感、可靠的方法来检测EGFR基因的突变,从而指导TKI类药物的最佳应用.本研究旨在进一步了解中国非小细胞肺癌(non-small cell lung cancer,NSCLC)患者EGFR基因突变的特点,并针对常见的特异性突变,寻找一种方便、准确、快捷的检测方法.方法:手术切除的NSCLC冰冻组织标本50例,对照为正常肺组织16例.分别提取肿瘤组织、正常肺组织DNA,PCR法扩增肿瘤组织DNA中EGFR基因外显子18～21,提纯后测序,确定有无突变存在.针对常见特异性突变设计突变特异引物,应用该引物扩增肿瘤组织及正常对照肺组织DNA,观察有无特异条带出现,并与直接测序结果相比较,观察是否存在一致性.结果:50例NSCLC组织中共检出突变15例,突变率30%,均为杂合子突变,其中外显子19突变的6例(12%),外显子21突变的9例(18%);外显子19的突变类型均为缺失突变del E746-A750;外显子21的突变类型为替代突变,8例为L858R,1例为L861Q.应用特异引物扩增已在直接测序中验证的存在特异突变的肺癌组织DNA,均显示出阳性条带;相反,对于16个正常对照肺组织DNA和在直接测序中未发现有突变的肺癌组织DNA,应用该特异引物扩增后,均无阳性条带出现.结论:本研究结果表明中国NSCLC患者EGFR基因突变的主要类型为外显子19的缺失突变和外显子21的替代突变,应用突变特异PCR检测肺癌组织中的常见EGFR基因突变类型,是一种简单、特异、准确、经济、省时省力的方法,可在临床中推广应用.     

Atrioventricular Interval Optimization in the Right Atrial Appendage and Interatrial Septum Pacing: A Comparison Between Echo and Peak Endocardial Acceleration Measurements

PADELETTI, et al. : Atrioventricular Interval Optimization in the Right Atrial Appendage and Interatrial Septum Pacing: A Comparison Between ECHC and Peak Endocardial Acceleration. Interatrial septum pacing (IASP) reduces interatrial conduction time and consequently may interfere with atrioventricular delay (AVD) optimization. We studied 14 patients with an implanted BEST Living system device able to measure peak endocardial acceleration (PEA) signal. The aims of our study were to compare the (1) optimal AVD (OAVD) in right atrial appendage pacing (RAAP) and IASP, and (2) OAVD derived by the PEA signal versus OAVD derived by Echo/Doppler evaluation of the left ventricular filling time (LVFT) and cardiac output (CO). Measurements were performed in DDD VDD modes Eight patients (group A) had RAAP and six patients (group B) had IASP. In group A, OAVD measured by LVFT, CO, and PEA was 185 ± 23 ms , 177 ± 19 ms , and 192 ± 23 ms in DDD and 147 ± 19 ms , 135 ± 27 ms , and 146 ± 20 ms in VDD, respectively. OAVD measured by LVFT, CO, and PEA was significantly longer in DDD mode than in VDD (P < 0.01, P < 0.01, P < 0.001 ). In group B, OAVD measured by LVFT, CO, and PEA was 116 ± 19 ms , 113 ± 10 ms , and 130 ± 30ms in DDD and 106 ± 16 ms , 96 ± 15 ms , and 108 ± 26 ms in VDD, respectively. No statistical differences were observed between DDD and VDD. Significant correlations between OAVDs PEA derived and OAVDs LVFT and CO derived were observed (r = 0.71, r = 0.69, respectively ). When new techniques of atrial stimulation, as IASP, are used an OAVD shorter and similar in VDD and DDD has to be considered. The BEST Living system could provide a valid method to ensure, in every moment, the exact required OAVD to maximize atrial contribution to CO.     

Did the role of the neurologist in the emergency department change during the COVID-19 pandemic? Evidence from an Italian nationwide survey

Neurological Sciences - This study aims to assess whether the role of neurologists in the emergency department changed during the coronavirus (COVID)-19 pandemic. Data from an Italian national...     

Pharmacokinetics, coagulation factor consumption and clinical efficacy in patients being switched from full-length FVIII treatment to B-domain-deleted r-FVIII and back to full-length FVIII

Summary.  Concerns have been raised regarding pharmacokinetic performance, efficacy and safety of B-domain-deleted recombinant FVIII (BDD rFVIII). The objective of this study was to perform a retrospective survey of half-life measurements, efficacy and safety in patients with severe haemophilia A, switching treatment from full-length factor VIII (FL FVIII) to BDD rFVIII and then back to FL FVIII. We hypothesized that half-life of FVIII would be equal regardless of product and that total factor consumption and bleeding frequency would be indistinguishable. We report on inhibitor development and outcome following surgery. Patients with severe haemophilia A, exposed to BDD rFVIII were identified from a database. A retrospective analysis of laboratory data and medical notes was undertaken. No significant difference was detected between the half-life measurements during the switch from FL FVIII (T/2 median 9.15 h, range 6.4–22) to BDD rFVIII (T/2 median 9.7, range 4.7–16.8) and back to FL FVIII (T/2 median 9.0, range 5.0–19.5). There was no significant difference in coagulation factor usage (BDD rFVIII median 4803 IU kg⁻¹ year⁻¹, range 659–11 304; FL FVIII median 5349, range 1691–10 146), nor bleeds. Eleven received BDD rFVIII to cover surgical procedures, with no reports of excess bleeding. Thirty-three patients received significant exposure to BDD rFVIII and one developed a low titre inhibitor. BDD rFVIII was found to be equivalent to other FVIII products in terms of pharmacokinetics, clinical efficacy and safety in this study group.     

Radiofrequency Ablation of Atrial Flutter and Atrial Tachycardias in Patients with Permanent Indwelling Catheters

The presence of chronic indwelling leads in the area targeted for RF ablation may pose a technical challenge and reduce the chance of success of the ablation. In addition, application of lesions in close proximity to pacemaker leads or other permanent catheters could affect their function. Fourteen patients referred for RF ablation of atrial flutter/fibrillation and atrial tachycardia, who had a permanent dual chamber pacemaker (10 patients), ICD (1 patient), or both (3 patients) were studied to assess the safety, efficacy, and effects of the ablative procedure on device function. Lead impedance, R and P wave amplitude, and pacing threshold of the defibrillator and pacemaker were measured before and after ablation. The procedure was successful in all patients. In one patient who underwent both atrial flutter and atrial fibrillation ablation, the atrial pacing threshold increased from 1.0 preablation to 2.0 V postablation. No P wave was detectable after ablation. In another patient, the P wave amplitude went from 4.0 to 2.0 mV postablation. In both patients the device converted to the power reset mode. No changes were observed in the remaining patients. Postablation defibrillator testing showed no malfunction. Follow-up reinterrogation of the devices revealed no alterations. In conclusion: (1) RF ablation of atrial flutter and/or tachycardia is feasible even in patients with multiple chronic atrial and ventricular indwelling catheters; and (2) RF applications in close proximity of defibrillator and pacing catheters does not appear to alter their function unless lesions are produced in the area surrounding the distal pacing electrode.