The in-ear region as a novel anatomical site for ECG signal detection: validation study on healthy volunteers.

PURPOSE: Early detection of cardiac arrhythmias is a major opportunity for mobile health, as wearable devices nowadays available can detect single-lead electrocardiogram (ECG). The study aims to validate the in-ear region as a new anatomical site for ECG signal detection and looks towards designing innovative ECG wearable devices. METHODS: We performed ECG using KardiaMobile device (AliveCor®) on 35 healthy volunteers. First, ECG was detected by standard modality using both hands. Then, ECG was detected using the left in-ear region instead of the right hand. All the recorded ECGs were analyzed by the device and by two cardiologists in blind testing. RESULTS: We successfully collected 70 ECGs performed on 35 volunteers (male 54%, age 39.1 ± 10.7 years; BMI 22.9 ± 2.89 kg/m2) with no differences observed by KardiaMobile in ECG reports detected in the two different modalities. All the ECGs were reported as normal by the device and the two cardiologists. Moreover, linear regression analysis showed good correlation between the amplitude (mV) of P (r = 0.76; r2 = 0.57; p < 0.0001) and QRS waves (r = 0.81; r2 = 0.65; p < 0.0001), the intervals (ms) of PR (r = 0.91; r2 = 0.83; p < 0.0001; LOA - 0.60-0.41; CC = 0.91), QRS (r = 0.78; r2 = 0.61; p < 0.0001; LOA - 0.49-0.43; CC = 0.78), QT (r = 0.85; r2 = 0.71; p < 0.0001; LOA - 1.31-1.20; CC = 0.85), and heart rate (r = 0.94; r2 = 0.89; p < 0.0001; LOA - 7.82-7.76; CC = 0.94) detected in two different modalities. CONCLUSION: The in-ear region is a reliable novel anatomical site for ECG signal detection in normal healthy subjects. Further studies are needed to validate this new ECG detection modality also in case of cardiac arrhythmias and to support the development of new wearable devices.

Performance and clinical comparison between left ventricular quadripolar and bipolar leads in cardiac resynchronization therapy: Observational research.

AIM: To evaluate Attain Performa (Medtronic, Dublin, Ireland) quadripolar lead performance in clinical practice and, secondarily, to compare its long term clinical outcomes vs bipolar leads for left ventricular (LV) pacing. METHODS AND RESULTS: We retrospectively analyzed clinical, procedural and follow-up data of 215 patients implanted with a quadripolar lead. One hundred and twenty one patients implanted with bipolar lead were selected to compare long-term clinical outcomes. The quadripolar lead was implanted in the target vein in 196 patients (91%) without acute dislodgements. In 50% of patients the chosen final pacing configuration at implant would not have been available with bipolar leads. A dedicated quadripolar pacing vector was chosen more frequently when the LV tip location was apical than otherwise (65.6% vs 42.7%, p=0.003). After a median follow-up of 14 months, the LV pacing threshold was less than 2.5V at 0.4ms in 98 patients (90%) with a safety margin between phrenic nerve and LV pacing threshold >3V in 97 patients (89%). We observed a slight trend toward a lower risk of heart failure worsening and a lower incidence of ventricular arrhythmias and pulmonary congestion in patients implanted with quadripolar leads compared with the control group. CONCLUSION: Quadripolar leads improve the management of phrenic nerve stimulation at no trade-off with pacing threshold and lead stability. Quadripolar leads seems to be associated with a lower incidence of VT/VF and pulmonary congestion, when compared with bipolar leads, but further investigations are necessary to confirm that this positive effect is associated with better LV reverse remodeling.

Risk of arrhythmia in type I myotonic dystrophy: the role of clinical and genetic variables.

OBJECTIVE: To examine the association between the presence of arrhythmia in type 1 myotonic dystrophy (DM1) and clinical-genetic variables, evaluating their role as predictors of the risk of arrhythmia. METHODS: 245 patients with genetically proven DM1 underwent clinical and non-invasive cardiological evaluation. Severity of muscular involvement was assessed according to the 5 point Muscular Disability Rating Score (MDRS). Data were analysed by univariate and multivariate models. RESULTS: 245 patients were examined and cardiac arrhythmias were found in 63 subjects, 40 of whom required a device implant. Statistical analyses revealed that men had more than double the risk of developing arrhythmias compared with women (p = 0.018). Addition of each year of age caused an increased risk of arrhythmia equal to 3% (p = 0.030). Subjects with MDRS 5 had a risk of arrhythmia 12 times higher than patients with MDRS 1-2 (p<0.001). Although all of these variables were significantly associated with cardiac rhythm dysfunction, they had a low sensitivity for the prediction of arrhythmic risk CONCLUSION: Male sex, age and muscular disability were strongly associated with the development of arrhythmia in DM1. However, all of these variables were weak predictors of arrhythmic risk. These results suggest that other factors may be involved in the development of cardiac conduction abnormalities in DM1.

Techniques for transvenous leads extraction.

The number of implanted cardiac pacing and defibrillating devices is currently increasing, leading to an increasing number of device-related complications, due to either malfunction or infection. Removal of the whole system, including the leads, was proven to be the most effective therapy. At present the importance of transvenous lead extraction is consequently increased. In order to remove pacing and implantable cardioverter defibrillators (ICD) leads, they have to be made free from any binding site from the entry in the vein to the tip. Different techniques, including mechanical dilation, powered dilation and intravascular approaches have been developed over the last years and are currently available. Results reported in the literature show a significant success rate (ranging between 90% and 98% of the leads) and a reduced incidence of serious complications (1% to 3% in different series) in selected centres. The extraction procedures are complex and life-threatening complications may always occur, suggesting the need of trained and experienced operators as well as the availability of a surgical standby. At present indications to removal are restricted to infection or to damage of the leads inducing serious risk for the patients; the availability of a more effective and safe technique will probably spread indications to most of abandoned leads.

Management of cardiac device infections: A retrospective survey of a non-surgical approach combining antibiotic therapy with transvenous removal.

Pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) have become life-saving therapeutic tools for patients with cardiac arrhythmia. Complications include thrombosis, embolism and infections at a highly variable rate. Surgical removal of the infected device has been perceived as the only way to guarantee a successful outcome and to reduce the high risk of mortality. Recently, a transvenous extraction method has been developed to remove infected intracardiac leads without sternotomy. This survey was designed to evaluate the outcome of an approach combining antibiotic therapy with non-surgical transvenous complete removal for the management of cardiac device infections (CDIs). We reviewed case-histories of 121 patients (105 with PM and 16 with ICD infections). The aim of our retrospective survey was to ascertain that a non-invasive transvenous complete removal of the infected devices is safe and effective when associated with appropriate antibiotic therapy starting 10 days before the procedure and extending to at least three weeks after. The infected devices were successfully removed in all patients with a non-surgical transvenous technique. The infections were most frequently caused by coagulase-negative staphylococci (70%), Staphylococcus aureus (14%), and Gram-negative rods (12%). Polymicrobial infections were documented in 19 patients and represent 16% of all device-related infections. The removal of the devices was done during antibiotic therapy, administered for a median of 26 days (range 23 to 45 days). Neither fatalities nor relapse of infections were recorded in the patient population during the one-year follow-up visits. According to our experience, CDIs can be treated with antibiotic therapy and non-surgical removal of the entire infected device, thus allowing a successful reimplantation. This procedure prevents recurrent infections and operative mortality.

Comparative assessment of right, left, and biventricular pacing in patients with permanent atrial fibrillation.

AIMS: Left ventricular (LV) and biventricular (BiV) pacing are potentially superior to right ventricular (RV) apical pacing in patients undergoing atrioventricular (AV) junction ablation and pacing for permanent atrial fibrillation. METHODS AND RESULTS: Prospective randomized, single-blind, 3-month crossover comparison between RV and LV pacing (phase 1) and between RV and BiV pacing (phase 2) performed in 56 patients (70+/-8 years, 34 males) affected by severely symptomatic permanent atrial fibrillation, uncontrolled ventricular rate, or heart failure. Primary endpoints were quality of life and exercise capacity. Compared with RV pacing, the Minnesota Living with Heart Failure Questionnaire (LHFQ) score improved by 2 and 10% with LV and BiV pacing, respectively, the effort dyspnoea item of the Specific Symptom Scale (SSS) changed by 0 and 2%, the Karolinska score by 6 and 14% (P<0.05 for BiV), the New York Heart Association (NYHA) class by 5 and 11% (P<0.05 for BiV), the 6-min walked distance by 12 (+4%) and 4 m (+1%), and the ejection fraction by 5 and 5% (P<0.05 for both). BiV pacing but not LV pacing was slightly better than RV pacing in the subgroup of patients with preserved systolic function and absence of native left bundle branch block. Compared with pre-ablation measures, the Minnesota LHFQ score improved by 37, 39, and 49% during RV, LV, and BiV pacing, respectively, the effort dyspnoea item of the SSS by 25, 25, and 39%, the Karolinska score by 39, 42, and 54%, the NYHA class by 21, 25, and 30%, the 6-min walking distance by 35 (12%), 47 (16%), and 51 m (19%) and the ejection fraction by 5, 10, and 10% (all differences P<0.05). CONCLUSIONS: Rhythm regularization achieved with AV-junction ablation improved quality of life and exercise capacity with all modes of pacing. LV and BiV pacing provided modest or no additional favourable effect compared with RV pacing.

An evaluation of the strategy of maintenance of sinus rhythm by antiarrhythmic drug therapy after ablation and pacing therapy in patients with paroxysmal atrial fibrillation.

AIMS: Permanent atrial fibrillation develops in many patients after ablation and pacing therapy. We compared a strategy that initially allowed patients to remain in atrial fibrillation with a strategy that initially attempted to restore and maintain sinus rhythm. METHODS AND RESULTS: In this multicentre randomized controlled trial, 68 patients affected by severely symptomatic paroxysmal atrial fibrillation were assigned, after successful atrioventricular junction ablation and pacing treatment, to antiarrhythmic drug therapy with amiodarone, propafenone, flecainide or sotalol and were compared with 69 patients assigned, after successful AV junction ablation and pacing treatment, to no antiarrhythmic drug therapy. The patients were followed-up for 12 to 24 months (mean 16+/-4). The drug arm patients had a 57% reduction in the risk of developing permanent atrial fibrillation (21% vs 37%, P=0.02). Evaluation after 12 months revealed similar quality of life scores and echocardiographic parameters in the two groups, but the drug arm patients had more episodes of heart failure and hospitalizations (P=0.05). The outcome was similar between the 40 patients who developed permanent atrial fibrillation and the 97 who did not. CONCLUSION: Conventional antiarrhythmic therapy reduces the risk of development of permanent atrial fibrillation after ablation and pacing therapy. The present data do not support the concept that the development of permanent atrial fibrillation is related to an adverse outcome when a perfect control of heart rate is obtained by ablation and pacing.

Which strategy is "best" after myocardial infarction? The Beta-blocker Strategy plus Implantable Cardioverter Defibrillator Trial: rationale and study design.

The Beta-blocker Strategy plus Implantable Cardioverter Defibrillator (BEST-ICD) Trial is a multicenter prospective randomized trial that started in June 1998, in 95 centers in Italy and Germany. The trial will test the hypothesis whether, in high-risk post myocardial infarction (MI) patients already treated with beta blockers, electrophysiologic study (EPS)-guided therapy (including the prophylactic implantation of implantable cardioverter defibrillator [ICD] in inducible patients) will improve survival compared with conventional therapy. Patients eligible for the study are survivors of recent MI (> or = 5 and < or = 21 days), aged < or = 80 years, with left ventricular ejection fraction < or = 35% and > or = 1 of the following additional risk factors: (1) ventricular premature beats > or = 10/hour; (2) decreased heart rate variability (standard deviation of unusual RR intervals < 70 msec); and (3) presence of ventricular late potentials. Furthermore, all enrolled patients must be able to tolerate at least 25 mg of metoprolol per day. These patients constitute about 9% of all patients with recent MI and are expected to have a 2-year all-cause mortality > 25% of which 50% is anticipated to be from sudden death. The main criteria of exclusion from the study are (1) a history of sustained ventricular arrhythmia; (2) documentation of nonsustained ventricular tachycardia during the screening phase; and (3) the need for myocardial revascularization and contraindications or intolerance to beta-blocker therapy. Eligible patients will be randomized to 2 different therapeutic strategies: conventional strategy or EPS/ICD strategy. Patients allocated to the EPS/ICD strategy will undergo further risk stratification, and electrophysiologically inducible patients (approximately 35%) will receive prophylactic ICDs, in addition to the conventional therapy, whereas noninducible patients will be only conventionally treated. The primary endpoint of the study will be death from all causes. By hypothesizing a 30% reduction in the 2-year mortality (from 20% to 14%) in the EPS/ICD group compared with conventionally treated patients, 1,200 patients will have to be included. A triangular, 2-sided sequential design with preset boundaries, for a 5% significance level and 90% power to detect a reduction in 2-year mortality from 20% to 14%, will be used to permit early termination of the trial if the strategy is found to be efficacious, no difference, or inefficacious.

Prospective, randomized study of atrioventricular ablation and mode-switching, dual chamber pacemaker implantation versus medical therapy in drug-resistant paroxysmal atrial fibrillation. The PAF study. Paroxysmal Atrial Fibrillation.

We performed a prospective randomized 6-month evaluation of the clinical effects of atrioventricular junctional ablation together with placement of a DDDR mode-switching pacemaker vs pharmacological treatment in 43 patients with intolerable paroxysmal atrial fibrillation not controlled with antiarrhythmic drugs. Ablation and pacemaker treatment were highly effective and superior to drug therapy in controlling symptoms and improving quality of life. However, discontinuation of drug therapy exposed patients to further recurrences of paroxysmal atrial fibrillation and the risk of developing permanent atrial fibrillation.

Incessant nonreentrant atrioventricular nodal tachycardia due to multiple nodal pathways treated by radiofrequency ablation of the slow pathways.

In patients with dual AV nodal physiology, simultaneous anterograde fast and slow pathway conduction resulting in an unusual form of nonreentrant AV nodal tachycardia has been observed. We describe the case of a young patient with an incessant form of complex supraventricular tachycardia who underwent electrophysiologic evaluation, which showed simultaneous conduction via multiple AV nodal pathways that caused a unique form of incessant nonreentrant AV nodal tachycardia. Radiofrequency ablation of the spatially closed intermediate and slow pathways effectively treated the tachycardia. The electrophysiologic determinants of simultaneous conduction through the multiple nodal pathways and the apparently different behavior of the fast pathway before and after ablation are discussed.

Radiographic assessment of atrial dipole position in single pass lead VDD and DDD pacing. The Multicenter Study Group.

Atrial electrode position was determined by radiographic analysis in 160 patients paced in single-lead VDD for second- or third-degree A-V block, implanted > 1 year with Phymos single pass leads and Phymos 3D pacemakers. The packing lead features an atrial dipole with a 30-mm electrode interspace. In 44% of patients, the upper atrial electrode was positioned within a band of 20 mm centered at the level of the superior vena caval insertion (junctional area) and was in the inferior vena cava or in the atrium in 35% and 21% of cases, respectively. In spite of these different dipole locations, all patients had stable atrium-driven pacing at routine follow-up visits. With the electrode in the junctional area, unipolar stimulation of up to 5 V for 1 ms resulted in stable atrial capture in 63% and 59% of the patients in supine and upright positions, respectively. With the electrode in the atrium, corresponding success rates were 45% and 54%. In the atrium, however, the prevalence of diaphragmatic stimulation was significantly lower than at the junction (10% vs 42% in supine position; 21% vs 47% upright). Though atrial sensing function proved adequate in a wide range of positions, these results suggest that the Phymos lead atrial dipole should be positioned within the atrium, as close as possible to the atrial wall, to maximize the number of VDD patients who might benefit from single-lead DDD pacing.

Assessment of atrioventricular junction ablation and DDDR mode-switching pacemaker versus pharmacological treatment in patients with severely symptomatic paroxysmal atrial fibrillation: a randomized controlled study.

BACKGROUND: The purpose of the study was to evaluate the effect of AV junction ablation and pacemaker implantation on quality of life and specific symptoms in patients with paroxysmal atrial fibrillation (AF) not controlled by drugs. METHODS AND RESULTS: We performed a multicenter, randomized, 6-month evaluation of the clinical effects of AV junction ablation and DDDR mode-switching pacemaker (Abl+Pm) versus pharmacological treatment in 43 patients with intolerable, recurrent paroxysmal AF of three or more episodes in the previous 6 months not controlled with three or more antiarrhythmic drugs. Before completion of the study, 3 patients in the drug group withdrew because of the severity of their symptoms and 1 patient assigned to the Abl+Pm group in whom the ablation procedure failed. At the end of the 6 months, the 21 patients of the Abl+Pm group who completed the study showed, in comparison with the 18 of the drug group, lower scores in the Living with Heart Failure Questionnaire (-51%, P=.0006), palpitations (-71%, P=.0000), effort dyspnea (-36%, P=.04), exercise intolerance score (-46%, P=.001), and easy fatigue (-51%, P=.02). The scores for rest dyspnea, chest discomfort, and NYHA functional classification were also lower (-56%, -50%, and -17%, respectively) in the Abl+Pm group, although not significantly. At the end of the study, palpitations were no longer present in 81% of the Abl+Pm group and in 11% of the drug group (P=.0000). AF was documented in 31 of 122 visits (25%) in the Abl+Pm group and in 9 of 107 examinations (8%) in the drug group (P=.0005); chronic AF developed in 5 (24%) and 0 (0%) in the two groups, respectively (P=.04). CONCLUSIONS: In patients with paroxysmal AF not controlled by pharmacological therapy, Abl+Pm treatment is highly effective and superior to drug therapy in controlling symptoms and improving quality of life. The discontinuation of drug therapy exposes patients to further recurrences of paroxysmal AF and the risk of developing permanent AF.

Is local myocardial contractility related to endocardial acceleration signals detected by a transvenous pacing lead?

The availability of sensors monitoring cardiac function parameters may offer many interesting new applications in cardiac pacing. A microaccelerometer sensor (BEST, Biomechanical Endocardial Sorin Transducer) located at the tip of a pacing lead (PL) has been developed by Sorin Biomedica. The signal detected by the accelerometer, peak endocardial acceleration (PEA), was shown to reflect cardiac contractility and to be related to the dP/dt signal. Whether the PEA detected by the BEST sensor in different cardiac locations is the expression of local acceleration forces or reflects the whole heart contractility has not yet been demonstrated in humans. Endocardial acceleration and PEA were evaluated in five patients (4 males, 1 female, mean age 68 years) who underwent cardiac catheterization. Sinus rhythm was present in four patients and chronic atrial fibrillation was present in one. The BEST PL was introduced through the left subclavian vein and PEA signals were recorded: (1) at the apex of the right ventricle (RV), (2) within the coronary sinus (CS), (3) at the right atrial appendage (RAA), and (4) floating in the right atrium. The PEA signals were recorded simultaneously with surface ECG, intracardiac electrograms, and RV pressure. At each recording site, PEA signals with significant amplitude were always recorded during the preejection period, during the isovolumic contraction phase, independently of the recording site and cardiac rhythm. The PEA amplitude was higher in the RV (mean value 1.32 g) and it decreased in the RAA and CS (0.75 and 0.45 g, respectively). The same behavior of PEA was observed during sinus rhythm or atrial fibrillation. The amplitude and the timing of the PEA signals detected by the BEST accelerometer were independent of the recording site and atrial rhythm; they appeared to be strictly related to the global ventricular contractility. These results suggest that the BEST could be used either as an effective sensor in closed loop pacing systems, or primarily as a diagnostic hemodynamic sensor.