Performance and Integration of Smartphone Wireless ECG Monitoring into the Enterprise Electronic Health Record: First Clinical Experience.

INTRODUCTION: Patient initiated, remote cardiac monitoring has proved to be a significant advance in the diagnosis and management of arrhythmias. Further improvements in ease of use and access to results will further improve health outcomes and cost-effectiveness. Here we describe a proof-of-concept evaluation to assess the feasibility of successfully implementing a cloud-based management system using KardiaPro (KP) for remote electrocardiogram (ECG) monitoring to interface into EPIC, an enterprise electronic health record (EHR) system. METHODS: The KP management system was embedded using hypertext markup language (HTML) code directly into the EHR. Encrypted credentials and patient data were bundled with an application programming interface key allowing linkage of remote monitoring from patients' smartphones. During the time of implementation, a total of 322 patients and 32 179 ECGs were recorded. RESULTS: The KP-EHR interface provided full functionality, allowing detection, interpretation and documentation of atrial fibrillation (AF), flutter events, ventricular tachycardia, and complete heart block. Our study focused on KP's detection of AF, and 16.7% of tracings were classified as probable AF with only 2.3% of tracings not analyzed by the KP algorithm because of tracings that were too noisy or truncated. Enhanced management was facilitated with clinical information immediately accessible. Blinded physician ECG review validated the KP proprietary algorithm interpretation and ECGs. CONCLUSIONS: Direct integration of KP into EHR was successful and practical. It allows for historical, point of care and immediate retrieval of remote ambulatory monitoring data and documentation into the electronic health record. KP EHR integration warrants further study as it has the potential to improve cost-effectiveness and clinical diagnostic value, leading to improvements in delivery of patient care.

Inappropriate disabling of an ICD noise-detection algorithm in pacemaker-dependent patients.

SecureSense is an implantable cardioverter defibrillator algorithm that differentiates lead-related oversensing from ventricular tachycardia/ventricular fibrillation by continuous comparison between the near-field (NF) and the far-field (FF) electrogram. If lead noise is identified, inappropriate therapy is withheld. Undersensing on the FF channel could result in inappropriate inhibition of life-saving therapy. Thus, the device automatically switches SecureSense to passive mode if undersensing on the FF channel is suspected. We report here the first cases of inappropriate automatic SecureSense deactivation due to misdiagnosed FF undersensing in pacemaker-dependent patients. Physicians should be aware that SecureSense does not withhold an inappropriate therapy for sustained oversensing in pacemaker-dependent patients.

Early Diagnosis of Defibrillation Lead Dislodgement.

OBJECTIVES: This study sought to develop and evaluate an algorithm for early diagnosis of dislodged implantable cardioverter-defibrillator (ICD) leads. BACKGROUND: Dislodged defibrillation leads may sense atrial and ventricular electrograms (EGMs), triggering shocks in the vulnerable period that induce ventricular fibrillation (VF). METHODS: We developed a 2-step algorithm by using experimental lead dislodgements (LDs) at ICD implantation and a control dataset of newly implanted, in situ leads. Step 1 consisted of an alert triggered by abrupt decrease in R-wave amplitude and increase in pacing threshold. Step 2 withheld therapy based on ventricular EGM evidence of LD identified from experimental LD behavior. We estimated the algorithm's performance using a registry dataset of 3,624 new implantations and an atrial dislodgement dataset of 14 LDs at the atrium. RESULTS: In the registry dataset, the algorithm identified 20 of 21 radiographic LDs (95%) at a median of 11 days before clinical diagnosis. Step 1 had positive predictive values of 57% for radiographic LD and 77% for surgical revision. The false positive rate was 0.4% after step 1 and ≤0.2% after step 2. In the atrial dislodgement dataset, step 1 identified all 14 LDs; step 2 would have prevented inappropriate therapy in all 7 patients with stored EGMs at LD, including 2 patients with fatal, shock-induced VF. CONCLUSIONS: An ICD algorithm can facilitate early diagnosis of defibrillation LD. Additional data are needed to determine the safety of withholding shocks based on EGM evidence of LD.

Global and regional left ventricular strain indices in post-myocardial infarction patients with ventricular arrhythmias and moderately abnormal ejection fraction.

The aim of the study described here was to compare myocardial strains in ischemic heart patients with and without sustained ventricular tachycardia (VT) and moderately abnormal left ventricular ejection fraction (LVEF) to investigate which index could better predict VT on the basis of the analysis of global and regional left ventricular (LV) dysfunction. We studied 467 patients with previous myocardial infarction and LVEF >35%. Fifty-one patients had documented VT, and 416 patients presented with no VT. LV volumes and score index were obtained by 2-D echocardiography. Longitudinal, radial and circumferential strains were determined. Strains of the infarct, border and remote zones were also obtained. There were no differences in standard LV 2-D parameters between patients with and those without VT. Receiver operating characteristic values were -12.7% for global longitudinal strain (area under the curve [AUC] = 0.72), -4.8% for posterior-inferior wall circumferential strain (AUC = 0.80), 61 ms for LV mechanical dispersion (AUC = 0.84), -10.1% for longitudinal strain of the border zone (AUC = 0.86) and -9.2% for circumferential strain of the border zone (AUC = 0.89). In patients with previous myocardial infarction and moderately abnormal LVEF, peri-infarct circumferential strain was the strongest predictor of documented ventricular arrhythmias among all strain quantitative indices. Additionally, strain values from posterior-inferior wall infarctions had a higher association with arrhythmic events compared with global strain.

Non-Fluoroscopic Transseptal Catheterization During Electrophysiology Procedures using a Remote Magnetic Navigation System.

Transseptal punctures are commonly performed, and left atrial (LA) access is frequently lost during lengthy, complex electrophysiology (EP) procedures. We describe a new technique for non-fluoroscopic re-crossing the fossa ovalis using a new multielectrode transseptal sheath (TS) and a new remote magnetic catheter navigation system (RMNS) (CGCI System, Magnetecs) that uses 8 rapid external electromagnets for real-time navigation of a magnet-tipped electrode catheter across the initial transseptal puncture site in 5 patients undergoing left-sided ablation procedures. The three-dimensional (3D) position of a 8.5 Fr steerable TS with 5-ring 5-15-15-5-mm spaced distal electrodes (Agilis ES©, St Jude Medical), and site of fossal ovalis crossing were "shadowed landmarks" on a 3D electroanatomic mapping (EAM) system (EnSite/NavXTM, St Jude Medical). The TS-magnetic ablation catheter assembly was pulled-back to the inferior vena cava. EAM landmarks were used with RMNS-guided "manual" and "automated" catheter navigation modalities, until septal crossing was obtained. Transseptal re-crossing was successfully performed in all patients in 6.2±8.1 sec using the "automated" RMNS-guided technique and in 30.4±28.4 sec using the "manual" RMNS-guided technique (p=0.01) without complications. This new RMNS was safely and effectively used to perform non-fluoroscopic transseptal catheterization.

Dynamically shaped magnetic fields: initial animal validation of a new remote electrophysiology catheter guidance and control system.

BACKGROUND: To address some of the shortcomings of existing remote catheter navigation systems (RNS), a new magnetic RNS has been developed that provides real-time navigation of catheters within the beating heart. The initial experience using this novel RNS in animals is described. METHODS AND RESULTS: A real-time, high-speed, closed-loop, magnetic RNS system (Catheter Guidance Control and Imaging) comprises 8 electromagnets that create unique dynamically shaped ("lobed") magnetic fields around the subject's torso. The real-time reshaping of these magnetic fields produces the appropriate 3D motion or change in direction of a magnetized electrophysiology ablation catheter within the beating heart. The RNS is fully integrated with the Ensite-NavX 3D electroanatomic mapping system (St Jude Medical) and allows for both joystick and automated navigation. Conventional and remote navigational mapping of the left atrium were performed using a 4-mm-tip ablation catheter in 10 pigs. A multielectrode transseptal sheath allowed for additional motion compensation. Linear and circumferential radiofrequency lesion sets were performed; in a subset of cases, selective pulmonary vein isolation was also performed. Recording and fluoroscopic equipments were unaffected by the magnetic fields generated by Catheter Guidance Control and Imaging. Automated mode navigation was highly reproducible (96±8.4% of attempts), accurate (1.9±0.4 mm from target site), and rapid (11.6±3.5 seconds to reach targets). At postmortem examination, radiofrequency lesion depth was 78.5±12.1% of atrial wall thickness. CONCLUSIONS: A new magnetic RNS using a dynamically shaped magnetic field concept can reproducibly and effectively reach target radiofrequency ablation points within the pig left atrium. Validation of the system in clinical settings is under way.

Transient accelerated junctional rhythm late after para-Hisian accessory pathway cryoablation: a new phenomenon.

Transient junctional rhythm late after para-Hisian accessory pathway cryoablation occurred in two patients. Cryoablation was delivered using the 8 mm tip Freezor MAX™ catheter (Cryocath Technologies Inc., Montreal, Canada), 2 mm distal to the largest His potential. Transient symptomatic junctional rhythm occurred after 1 week. This benign, self-limiting rhythm is possibly caused by reversible cryoinjury to the His bundle periphery.

Catheter ablation of haemodynamically unstable or non-sustained ventricular tachycardia.

BACKGROUND: Ventricular tachycardia (VT) may be haemodynamically unstable or non-sustained, interfering with detailed activation mapping. Non-contact mapping permits beat-by-beat analysis of VT, projected upon a 3-dimensional reconstructed geometry of the cardiac chamber. Objective - The aim of the present study is to determine the utility of non-contact endocardial mapping to guide ablation of haemodynamically unstable VT or non-sustained VT. METHODS AND RESULTS: Eighteen VTs in 17 patients were induced (cycle length 336 +/- 58 ms) and mapped. Three patients were mapped during premature ventricular complexes (PVCs) because sustained VT could not be induced. Analysis of the archived non-contact activation maps was performed to identify the exit point and/or the diastolic pathway of theVT reentry circuit. The endocardial exit points (10 +/- 16 ms before QRS) were defined in 17/18 VTs (94%). A diastolic pathway was identified in 5/6 ischaemic VTs. The earliest activation sites were identified in all 3 patients with PVCs. Radiofrequency current was applied around the exit point or to create a line of block across the diastolic pathway. Catheter ablation was performed in 17/18 VTs, including 3 patients mapped using only PVCs. Ablation was successful in 16/18 VTs (89%) and in 1 5/17 patients (82%). Catheter ablation was not performed in one patient (peri-hisian VT) and was unsuccessful in one patient (mapped during PVCs). CONCLUSIONS: Non-contact endocardial mapping is useful to guide radiofrequency catheter ablation of untolerated or non-sustained VTs.

Radiofrequency catheter ablation and nerve growth factor concentration in humans.

BACKGROUND: In animal models, expression of nerve growth factor (NGF) is increased after necrotic myocardial injury. Whether radiofrequency (RF) catheter ablation increases NGF expression in humans is unclear. OBJECTIVES: The purpose of this study was to determine NGF concentrations in the aorta, coronary sinus, and peripheral veins before and after RF ablation in patients. METHODS: We sampled blood from aorta and either great cardiac vein (group 1, N = 18) or proximal (group 2, N = 20) coronary sinus before and after RF ablation. In group 3 (N = 21), peripheral venous blood was sampled before and after RF ablation and then up to postoperative day 7. In group 4 (N = 10), we sampled peripheral venous blood during diagnostic electrophysiologic study. The NGF concentration was determined by enzyme-linked immunosorbent assay. Transcardiac NGF concentration was the difference in NGF concentrations between coronary sinus and aorta. RESULTS: There was no change in transcardiac NGF concentrations in groups 1 and 2. In group 3, the NGF level did not change significantly from before the procedure (17.10 +/- 15.80 ng/mL) to immediately after the procedure (14.46 +/- 10.36 ng/mL). However, NGF levels increased significantly to 31.24 +/- 19.82 ng/mL (N = 21, P <.0001) on postoperative day 1, 26.23 +/- 16.89 ng/mL (N = 20, P <.001) on postoperative day 2, and 22.01 +/- 11.35 ng/mL (N = 16, P = .003) on postoperative day 3. NGF concentrations did not change significantly in group 4. CONCLUSION: RF ablation did not result in a detectable increase of transcardiac NGF concentration immediately after the procedure. However, the systemic NGF concentration increased significantly on postoperative days 1 to 3, suggesting that RF ablation resulted in increased NGF expression.

[Noncontact endocardial mapping to guide ablation for hemodynamically unstable or nonsustained ventricular tachycardia].

OBJECTIVE: To determine the feasibility and assess the validity of noncontact endocardial mapping to guide ablation of hemodynamically unstable or nonsustained ventricular tachycardia (VT). METHODS: Noncontact mapping permitted individual-beat analysis of ventricular arrhythmias. Three-dimensional electroanatomical mapping allowed detailed reconstruction of a chamber geometry and activation sequence. Eighteen hemodynamically unstable or nonsustained VTs were induced (cycle length: 336 ms +/- 58 ms) in 17 patients and mapped by noncontact mapping using an EnSite 3000 system performed for the guidance of catheter ablation. RESULTS: Three patients were mapped during premature ventricular complexes (PVCs) because sustained VT could not be induced. Analysis of the archived noncontact activation maps was performed to identify the exit site and/or the diastolic pathway of the VT reentry circuit. The endocardial exit sites 10 ms +/- 16 ms before QRS were defined in 9 right ventricular outflow tract (RVOT) and 5 ischemic VTs. The diastolic pathway was identified in 5 ischemic VTs. The earliest endocardial diastolic activity preceded the QRS onset by 60.1 ms +/- 42.6 ms. The earliest activation sites were identify in 3 patients with nonsustained VTs or PVCs. Radiofrequency current was applied around the exit site or to create a line of block across the diastolic pathway. Catheter ablation was performed in 17/18 (94%) VTs and 15/17 (88%) VTs was successfully ablated. Two (67%) of the three patients with non-sustained VTs were mapped and successfully ablated during PVCs. Catheter ablation was not performed in 1 patient (peri-Hisian VT) and was unsuccessful in 2 patients. CONCLUSION: Noncontact endocardial mapping is able to be used to guide ablation of untolerated or nonsustained VTs.