Wearable Devices for Remote Monitoring of Heart Rate and Heart Rate Variability-What We Know and What Is Coming.

Heart rate at rest and exercise may predict cardiovascular risk. Heart rate variability is a measure of variation in time between each heartbeat, representing the balance between the parasympathetic and sympathetic nervous system and may predict adverse cardiovascular events. With advances in technology and increasing commercial interest, the scope of remote monitoring health systems has expanded. In this review, we discuss the concepts behind cardiac signal generation and recording, wearable devices, pros and cons focusing on accuracy, ease of application of commercial and medical grade diagnostic devices, which showed promising results in terms of reliability and value. Incorporation of artificial intelligence and cloud based remote monitoring have been evolving to facilitate timely data processing, improve patient convenience and ensure data security.

Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

AIMS: There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. METHODS AND RESULTS: The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. CONCLUSION: The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. CLINICAL TRIALS.GOV IDENTIFIER: NCT02270840.

Coronary Sinus Lead Positioning.

Although cardiac resynchronization therapy improves morbidity and mortality in patients with cardiomyopathy, heart failure, and electrical dyssynchrony, the rate of nonresponders using standard indications and implant techniques is still high. Optimal coronary sinus lead positioning is important to increase the chance of successful resynchronization. Patient factors such as cause of heart failure, type of dyssynchrony, scar burden, coronary sinus anatomy, and phrenic nerve capture may affect the efficacy of the therapy. Several modalities are under investigation. Alternative left ventricular lead implantation strategies are occasionally required when the transvenous route is not feasible or would result in a suboptimal lead position.

Reduced appropriate implantable cardioverter-defibrillator therapy after cardiac resynchronization therapy-induced left ventricular function recovery: a meta-analysis and systematic review.

AIMS: For patients undergoing cardiac resynchronization therapy (CRT) with implantable cardioverter-defibrillator (ICD; CRT-D), the effect of an improvement in left ventricular ejection fraction (LVEF) on appropriate ICD therapy may have significant implications regarding management at the time of ICD generator replacement. METHODS AND RESULTS: We conducted a meta-analysis to determine the effect of LVEF recovery following CRT on the incidence of appropriate ICD therapy. A search of multiple electronic databases identified 709 reports, of which 6 retrospective cohort studies were included (n = 1740). In patients with post-CRT LVEF ≥35% (study n = 4), the pooled estimated rate of ICD therapy (5.5/100 person-years) was significantly lower than patients with post-CRT LVEF <35% [incidence rate difference (IRD): -6.5/100 person-years, 95% confidence interval (95% CI): -8.8 to -4.2, P < 0.001]. Similarly, patients with post-CRT LVEF ≥45% (study n = 4) demonstrated lower estimated rates of ICD therapy (2.3/100 person-years) compared with patients without such recovery (IRD: -5.8/100 person-years, 95% CI: -7.6 to -4.0, P < 0.001). Restricting analysis to studies discounting ICD therapies during LVEF recovery (study n = 3), patients with LVEF recovery (≥35 or ≥45%) had significantly lower rates of ICD therapy compared with patients without such recovery (P for both <0.001). Patients with primary prevention indication for ICD, regardless of LVEF recovery definition, had very low rates of ICD therapy (0.4 to 0.8/100-person years). CONCLUSION: Recovery of LVEF post-CRT is associated with significantly reduced appropriate ICD therapy. Patients with improvement of LVEF ≥45% and those with primary prevention indication for ICD appear to be at lowest risk.

Novel Technique to Prevent Phrenic Nerve Injury During Pulmonary Vein Isolation Using Preprocedural Imaging.

INTRODUCTION: Phrenic nerve (PN) injury is one of the major complications of pulmonary vein isolation (PVI). Pace mapping for PN capture is routinely used to identify areas with high risk for injury along the anterior border of the right pulmonary veins (PVs). Our aim was to evaluate the feasibility of using preprocedural imaging to identify areas where no PN capture is possible along the anterior border of the right PVs, thus avoiding the need for pace mapping during PVI. METHODS AND RESULTS: It was hypothesized that PN capture along the anterior border of the right PVs does not occur in the area where the right and left atria overlap. Three-dimensional segmentation of both atria was performed on preprocedural magnetic resonance and computed tomography angiograms in 40 patients before undergoing PVI. The area of overlap between the right and left atria was delineated. Image registration was performed during the procedure. Using pacing, regions with and without PN capture were marked along the anterior border of the right PVs. A total of 361 points were tested for PN stimulation (9 ± 4 points/patient). PN capture occurred in 97 out of the 189 points (51%) in the area with no overlap between the right and left atria. No PN capture occurred in the area of overlap (172 points, P< 0.001). CONCLUSION: Delineation of the area of overlap between the right and left atria derived from preprocedural imaging reliably identifies regions where PN pace capture does not occur. Testing for PN stimulation before ablation may not be necessary in these regions.

How to Perform a Completely Fluoroless Ablation.

Radiation exposure related to electrophysiology catheter ablation procedures carries small but non-negligible stochastic and deterministic effects on health. Lead aprons can also place considerable pressure on the spinal column, resulting in potentially detrimental consequences. Fortunately, however, advancements in tools used for arrhythmia mapping and ablation have made it feasible to reduce or essentially eliminate the need for fluoroscopy, with no impact on the efficacy or safety of such procedures, as demonstrated by several long-term outcome studies. In this review, we describe our stepwise approach to safely and efficiently perform a completely fluoroless ablation.

Hidden in Plain Sight-An Unusual Case of Acute-onset Persistent Dyspnea.

Pacemaker (PM) syndrome is an uncommon complication after PM or defibrillator implant in patients with long-standing persistent atrial fibrillation. We present a case where an unexpected and unrecognized improvement in a comorbid condition paradoxically led to worsened symptoms, ie, acute-onset persistent dyspnea, in a patient with a single-chamber implantable cardiac defibrillator. A careful review of clinical data led to diagnosis and successful treatment.

Usefulness of electroanatomical mapping during transseptal endocardial left ventricular lead implantation.

AIM: Failure rate to implant left ventricular (LV) lead transvenously is 4-8% in cardiac resynchronization therapy (CRT) patients. Epicardial lead placement is an alternative method and if not applicable case reports and small series showed the feasibility of endocardial LV lead implantation. Electroanatomical mapping might be a useful tool to guide this procedure. METHODS AND RESULTS: Four patients had undergone endocardial LV lead implantation after unsuccessful transvenous implantation or epicardial LV lead dysfunction using the transseptal approach. Electroanatomical mapping was used to mark the location of the transseptal puncture. This location point guided the mapping catheter from the subclavian access and facilitated positioning of the LV lead at the adjacent latest activation area of the left ventricle detected by activation mapping. Endocardial active fixation LV leads were successfully implanted in all patients with stable electrical parameters immediately after implantation and over a mean follow-up of 18.3 months (lead impedance 520 ± 177 vs. 439 ± 119 Ω and pacing threshold 0.8 ± 0.2 V, 0.5 ms vs. 0.6 ± 0.1 V, 0.5 ms, respectively). Patients were maintained on anticoagulation therapy with a target international normalized ratio of 3.5-4.5 and did not show any thromboembolic, haemorrhagic events, or infection. Echocardiography showed significant improvement of LV systolic function with marked improvement of the functional status. CONCLUSIONS: Electroanatomical mapping is a useful technical tool to guide endocardial LV lead implantation. It helps to identify the location of the transseptal puncture and the use of activation mapping might facilitate location of the optimal lead positions during CRT.

Exercise-induced Brugada pattern and ventricular tachycardia during Capecitabine treatment.

We report the case of a 59-year-old female patient with no previous cardiovascular disease treated for Breast cancer with Capecitabine. Shortly after starting treatment, she developed recurrent angina. An exercise stress echocardiogram was performed, which induced a type 1 Brugada pattern 12 s of a non-sustained pleomorphic ventricular tachycardia ensued.

Tracing the European course of cardiac resynchronization therapy from 2006 to 2008.

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

Successful cardiac resynchronization therapy after heart transplantation.

We describe a case of a 56-year-old male patient, who developed refractory dilated cardiomyopathy 5 years after heart transplantation. An atriobiventricular pacemaker was implanted when indication criteria of cardiac resynchronization therapy (CRT) were seen. The intraventricular dyssynchrony was significant before CRT, while synchronous contraction was demonstrated later with the beneficial reverse remodelling of the left ventricle. Resynchronization therapy resulted in significant improvement of the patient's clinical parameters. The success of this therapy points out the possible role of CRT in the treatment of chronic allograft failure after heart transplantation.

Electrical atrial fibrillation induction affects the characteristics of induced arrhythmia.

Several methods are being used to induce atrial fibrillation (AF) in experimental investigations, which may affect the electrophysiologic parameters of the induced arrhythmia. The aim of our study was the investigation of temporal characteristics of AF during and after electrical induction. Direct current and high-frequency stimulation was used for induction in bipolar biatrial, right and left atrial appendage configurations in 6 dogs. Atrial and ventricular electrical activity was recorded near the bundle of His. Seven statistical parameters were calculated to analyze the temporal characteristics of electrical activity of both chambers. The induction method affected 5 atrial and no ventricular electrophysiologic parameters during stimulation, and the effect disappeared after ceasing induction, during the induced transient or persistent AF. Electrical stimulation affects the properties of the induced arrhythmia during the induction; thus, the investigation of AF is recommended only after ceasing the induction to avoid bias.

Diagnostic Accuracy of a Novel Mobile Phone Application for the Detection and Monitoring of Atrial Fibrillation.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults, associated with significant morbidity, increased mortality, and rising health-care costs. Simple and available tools for the accurate detection of arrhythmia recurrence in patients after electrical cardioversion (CV) or ablation procedures for AF can help to guide therapeutic decisions. We conducted a prospective, single-center study to evaluate the accuracy of Cardiio Rhythm Mobile Application (CRMA) for AF detection. Patients >18 years of age who were scheduled for elective CV for AF were enrolled in the study. CRMA finger pulse recordings, utilizing an iPhone camera, were obtained before (pre-CV) and after (post-CV) the CV. The findings were validated against surface electrocardiograms. Ninety-eight patients (75.5% men), mean age of 67.7 ± 10.5 years, were enrolled. No electrocardiogram for validation was available in 1 case. Pre-CV CRMA readings were analyzed in 97 of the 98 patients. Post-CV CRMA readings were analyzed for 92 of 93 patients who underwent CV. One patient left before the recording was obtained. The Cardiio Rhythm Mobile Application correctly identified 94 of 101 AF recordings (93.1%) as AF and 80 of 88 non-AF recordings (90.1%) as non-AF. The sensitivity was 93.1% (95% confidence interval [CI] = 86.9% to 97.2%) and the specificity was 90.9% (95% CI = 82.9% to 96.0%). The positive predictive value was 92.2% (95% CI = 85.8% to 95.8%) and the negative predictive value was 92.0% (95% CI = 94.8% to 95.9%). In conclusion, the CRMA demonstrates promising potential in accurate detection and discrimination of AF from normal sinus rhythm in patients with a history of AF.

Left Ventricular Lead Location and Long-Term Outcomes in Cardiac Resynchronization Therapy Patients.

OBJECTIVES: The authors aimed to evaluate the association of left ventricular (LV) lead location and long-term outcomes in MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy). BACKGROUND: There is limited data on the association of lead location with long-term clinical outcomes in patients with cardiac resynchronization therapy with defibrillator (CRT-D). METHODS: The LV lead location was classified in 797 patients with CRT-D, in 569 patients with left bundle branch block (LBBB), in 228 patients with non-LBBB, and in 505 patients with an implantable cardioverter-defibrillator (ICD) only. Leads were classified into apical (n = 83) and non-apical (n = 486); with the non-apical LV leads further categorized into anterior (n = 99) and posterior/lateral (n = 387) within LBBB. All-cause mortality and heart failure (HF) events were assessed using Kaplan-Meier and Cox analyses. RESULTS: In CRT-D patients with LBBB and posterior/lateral LV lead location, there was an association with a significant reduction in long-term all-cause mortality (hazard ratio [HR]: 0.54, 95% confidence interval [CI]: 0.37 to 0.79; p = 0.001), and HF events (HR: 0.44, 95% CI: 0.33 to 0.60; p < 0.001) compared to an ICD only, accompanied with better LV reverse remodeling. CRT-D patients with LBBB and an anterior LV lead location were shown to be associated with a significant reduction in HF events compared to an ICD only (anterior HR: 0.50, 95% CI: 0.30 to 0.82; p = 0.006); however, no association with mortality reduction was observed from CRT-D versus an ICD only. CRT-D was not associated with improved outcomes in non-LBBB patients, regardless of LV lead location. CONCLUSIONS: In mild HF patients with LBBB and an implanted CRT-D, lateral/posterior, and anterior LV lead locations are similarly associated with reduction in the risk of HF or death events compared to ICD alone. Mortality benefit derived from CRT-D is associated only with patients with lateral/posterior LV lead location. An apical LV lead location should be avoided due to the early risk of death whenever possible. (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy [MADIT-CRT], NCT00180271; Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry [MADIT-CRT-PAR], NCT01294449; and MADIT-CRT Long-Term International Follow-Up Registry - Europe, NCT02060110).

Stabilization of the coronary sinus electrode position with coronary stent implantation to prevent and treat dislocation.

INTRODUCTION: Coronary sinus (CS) leads used for cardiac resynchronization have undergone development in the last years. However, dislocation rate remained high (5-9%). The aim of this study was to investigate the effectiveness and safety of stent implantation in a CS side vein to stabilize the left ventricular lead position after postoperative or intraoperative dislocation of the electrode. METHODS AND RESULTS: Thirty-six patients (age: 64 +/- 9.7 years, 19 primary, 17 ischemic cardiomyopathy, NYHA class III: 30, IV: 6) were treated with stenting. The procedure was performed because of postoperative dislocation in seven patients, while dislocation was observed during the implantation in 29 cases. The electrode was repositioned into the desired position and a bare metal coronary stent was introduced via another guide wire. The stent was deposited at 5- to 15-mm proximal to the tip of the electrode with a pressure of 6 to 14 atmospheres. Control angiography showed no blood flow compromise in any of the side branches or in the coronary sinus. Control echocardiography did not show pericardial effusion due to stenting. During follow-up (11.5 +/- 5.5, 2-23 months), left ventricular pacing threshold increased from 2.2 to 5.6 V in one patient, but dislocation was not found by fluoroscopy. Clinically important pacing threshold increase was not detected in the other cases. Impedance measurements did not suggest lead insulation failure. CONCLUSION: Stent implantation to stabilize the left ventricular lead position seems to be a useful and safe procedure in the treatment of patients with complicated coronary sinus anatomy or lead instability.

[Resynchronization therapy of heart failure]. / Szívelégtelenség reszinkronizációs kezelése.

Heart failure has a high prevalence and it has a poor prognosis despite the advances in pharmacological treatment. Cardiac resynchronization therapy with biventricular pacemaker has a clinically proven efficacy in the treatment of heart failure with intraventricular dyssynchrony. Conventionally the therapy is indicated in severe drug refractory heart failure (NYHA III-IV) with optimal drug treatment, increased QRS duration (> or = 120 ms), echocardiographic parameters (left ventricular ejection fraction at most 35%). Implementation of new methods (tissue doppler echocardiography, CT, MRI, electroanatomical mapping) can help to select potentially responding patients. Individual optimization of therapy can be performed with non-invasive and invasive methods, the efficacy can be improved even in responding patients. Due to the outstanding efficiency widening the indications is a must. Currently, the efficacy is being investigated in mild heart failure and patients with narrow QRS. Several other questions (transvenous or surgical implantation, need of an implantable defibrillator) will be answered in future trials.

Short-term effect of rate control on plasma endothelin levels of patients with tachyarrhythmias.

Radiofrequency catheter ablation or modification of the atrio-ventricular junction is an effective therapy of drug refractory supraventricular tachyarrhythmias (ST). Higher endothelin (ET) levels were observed during nonsustained STs. We aimed to examine the effect of sustained STs and the applied rate-control therapy on plasma ET levels. Twenty-two patients (12 men; mean age, 64.4 +/- 13.2 years; ejection fraction, 41.8 +/- 11.2%; New York Heart Association (NYHA) class I: 3 cases, NYHA II: 11 cases, and NYHA III: 8 cases) suffering of atrial fibrillation (n = 11), atrial flutter (n = 7), atrial paroxysmal tachycardia (n = 3), or sinus tachycardia (n = 1) were studied, having coronary artery disease (n = 8), dilative cardiomyopathy (n = 5), or no underlying diseases (n = 9). All groups went under catheter ablation (same protocol, duration: 35 +/- 10.3 mins; rate before ablation, 100-170/min in every case; after ablation, 70-80/min in Groups I and II and 70-90/min in Group III). A pacemaker (PM) was implanted 2 months before ablation in Group I (n = 9) and during ablation in Group II (n = 7). No PM was implanted in Group III (n = 6). A control group (n = 13; 7 men; mean age, 66.15 +/- 6.7 years) with sinus rhythm got a PM without ST and ablation. Blood samples were collected from the cubital vein immediately before (control), and 5 mins and 24 hrs after ablation. Plasma ET-1 and big ET-1 levels were measured after immunoprecipitation with Western blot analysis. There were no differences between plasma ET-1 levels in the ST groups and the control group (Groups I, II, and III vs. control group: 0.66 +/- 0.04 fmol/ml, 0.93 +/- 0.12 fmol/ml, and 0.68 +/- 0.05 fmol/ml vs. 0.50 +/- 0.05 fmol/ml, respectively; P < 0.05). Comparing the control, 5-min, and 24-hr samples, ET-1 levels decreased significantly after supraventricular tachycardia ablation in Groups I and III (control vs. Group I, 5 mins and 24 hrs: 0.66 +/- 0.04 fmol/ml vs. 0.50 +/- 0.04 fmol/ml and 0.29 +/- 0.05 fmol/ml; control vs. Group III, 24 hrs: 0.68 +/- 0.05 vs. 0.34 +/- 0.05 fmol/ml; P < 0.05). No plasma big ET-1 changes were measured in any of the groups. The rapid decrease of ET levels after catheter ablation suggests that a high ventricular rate can be a trigger of ET production. PM implantation procedure seems to interfere with the ET decrease in ST patients.

Coronary Sinus Lead Positioning.

Although cardiac resynchronization therapy improves morbidity and mortality in patients with cardiomyopathy, heart failure, and electrical dyssynchrony, the rate of nonresponders using standard indications and implant techniques is still high. Optimal coronary sinus lead positioning is important to increase the chance of successful resynchronization. Patient factors such as cause of heart failure, type of dyssynchrony, scar burden, coronary sinus anatomy, and phrenic nerve capture may affect the efficacy of the therapy. Several modalities are under investigation. Alternative left ventricular lead implantation strategies are occasionally required when the transvenous route is not feasible or would result in a suboptimal lead position.

Changes of endothelin-1 and big endothelin-1 levels and action potential duration during myocardial ischemia-reperfusion in dogs with and without ventricular fibrillation.

Myocardial ischemia-reperfusion is associated with increased production of endothelin-1 (ET-1). Moreover, exogenous ET-1 has arrhythmogenic properties. Our aim was to investigate the correlation between endogenous ET-1, big ET-1 levels and epicardial monophasic action potential duration during myocardial ischemia-reperfusion in anesthetized dogs. Thirty-minute myocardial ischemia was followed by a 90-minute reperfusion period in 18 mongrel dogs. The total incidence of ventricular fibrillation (VF) during ischemia and reperfusion was 11.1% and 33.3%, respectively. During ischemia, the monophasic action potential duration at 90% repolarization (MAPD90) decreased significantly (control versus ischemia, 30 minutes, 224.7 +/- 7.1 ms versus 173.8 +/- 7.6 ms; P < 0.05), while during reperfusion a significant prolongation of MAPD90 was observed (ischemia, 30 minutes versus reperfusion, 30 minutes, 173.8 +/- 7.6 ms versus 249.7 +/- 9.9 ms, P < 0.05). During reperfusion ET-1 and big ET-1 levels increased significantly in the coronary sinus and femoral artery (control versus reperfusion, 90 minutes: coronary sinus ET-1, 15.1 +/- 1.4 fmol/mL versus 22.3 +/- 1.1 fmol/mL; big ET-1, 14.7 +/- 1.9 fmol/mL versus 27.4 +/- 2.3 fmol/mL; P < 0.05). The ET-1 concentration increased to a higher level during ischemia in dogs with VF compared with dogs surviving ischemia-reperfusion (non-VF versus VF: control, 15.1 +/- 1.3 versus 15.2 +/- 1.3; ischemia, 30 minutes, 17.6 +/- 1.2 fmol/mL versus 22 +/- 1.6 fmol/mL; P < 0.05), demonstrating a trend of correlation between endothelin levels and development of VF (P = 0.07). ET-1 and big ET-1 levels increased during reperfusion and in the VF group during ischemia; however, there was no correlation between endothelin levels and MAPD90.