Alexander Rusanov

A 15-Year Experience With Permanent Pacemaker and Defibrillator Lead and Patch Extractions

BACKGROUND The value of extraction of infected or hazardous epicardial and endocardial pacemaker and internal cardioverter defibrillator (ICD) leads is well established. Recent reviews including all leads and patches are lacking. This review describes experience with open and percutaneous techniques, including all lead types and indications. METHODS With Institutional Review Board approval, we reviewed charts of all adults and children undergoing extraction of permanent pacemaker and ICD leads and patches by a single operator between 1993 and 2008. RESULTS Overall, 145 leads and 7 patches were removed from 79 patients. Dwell time averaged 56.2 months. The commonest indications for extraction were infection (73.4%) or risk of lead fracture (20.3%). Most leads (84.2%) were extracted percutaneously. Removal was complete for 131 leads (86.2%) and partial in 14. Incomplete lead removal was rarely associated with clinical complications. Minor complications occurred in 6 patients (7.6%) and major complications occurred in 3 (3.8%). The major complication rate was 16.7% for the open group and 1.5% in the percutaneous group. CONCLUSIONS Pacemaker and ICD infections generally respond to antibiotics, complete hardware removal, and a hardware free interval. However, these principles cannot always be invoked, and the risk of complications is likely to increase when hardware cannot be completely removed or when a hardware-free interval is unsafe or inadvisable. Percutaneous lead extraction is superior to open extraction in terms of safety and comfort, but epicardial extraction techniques remain critically important in selected patients.

Hidden in plain sight: bias towards sick patients when sampling patients with sufficient electronic health record data for research

BackgroundTo demonstrate that subject selection based on sufficient laboratory results and medication orders in electronic health records can be biased towards sick patients.MethodsUsing electronic health record data from 10,000 patients who received anesthetic services at a major metropolitan tertiary care academic medical center, an affiliated hospital for women and children, and an affiliated urban primary care hospital, the correlation between patient health status and counts of days with laboratory results or medication orders, as indicated by the American Society of Anesthesiologists Physical Status Classification (ASA Class), was assessed with a Negative Binomial Regression model.ResultsHigher ASA Class was associated with more points of data: compared to ASA Class 1 patients, ASA Class 4 patients had 5.05 times the number of days with laboratory results and 6.85 times the number of days with medication orders, controlling for age, sex, emergency status, admission type, primary diagnosis, and procedure.ConclusionsImposing data sufficiency requirements for subject selection allows researchers to minimize missing data when reusing electronic health records for research, but introduces a bias towards the selection of sicker patients. We demonstrated the relationship between patient health and quantity of data, which may result in a systematic bias towards the selection of sicker patients for research studies and limit the external validity of research conducted using electronic health record data. Additionally, we discovered other variables (i.e., admission status, age, emergency classification, procedure, and diagnosis) that independently affect data sufficiency.

Optimized temporary biventricular pacing acutely improves intraoperative cardiac output after weaning from cardiopulmonary bypass: A substudy of a randomized clinical trial

OBJECTIVE Permanent biventricular pacing benefits patients with heart failure and interventricular conduction delay, but the importance of pacing with and without optimization in patients at risk of low cardiac output after cardiac surgery is unknown. We hypothesized that pacing parameters independently affect cardiac output. Accordingly, we analyzed aortic flow measured with an electromagnetic flowmeter in patients at risk of low cardiac output during an ongoing randomized clinical trial of biventricular pacing (n = 11) versus standard of care (n = 9). METHODS A substudy was conducted in all 20 patients in both groups with stable pacing after coronary artery bypass grafting, valve surgery, or both. Ejection fraction averaged 33% ± 15%, and QRS duration was 116 ± 19 ms. Effects were measured within 1 hour of the conclusion of cardiopulmonary bypass. Atrioventricular delay (7 settings) and interventricular delay (9 settings) were optimized in random sequence. RESULTS Optimization of atrioventricular delay (171 ± 8 ms) at an interventricular delay of 0 ms increased flow by 14% versus the worst setting (111 ± 11 ms, P < .001) and 7% versus nominal atrioventricular delay (120 ms, P < .001). Interventricular delay optimization increased flow 10% versus the worst setting (P < .001) and 5% versus nominal interventricular delay (0 ms, P < .001). Optimized pacing increased cardiac output 13% versus atrial pacing at matched heart rate (5.5 ± 0.5 vs 4.9 ± 0.6 L/min, P = .003) and 10% versus sinus rhythm (5.0 ± 0.6 L/min, P = .019). CONCLUSIONS Temporary biventricular pacing increases intraoperative cardiac output in patients with left ventricular dysfunction undergoing cardiac surgery. Atrioventricular and interventricular delay optimization maximizes this benefit.

Temporary biventricular pacing decreases the vasoactive-inotropic score after cardiac surgery: A substudy of a randomized clinical trial

OBJECTIVE Vasoactive medications improve hemodynamics after cardiac surgery but are associated with high metabolic and arrhythmic burdens. The vasoactive-inotropic score was developed to quantify vasoactive and inotropic support after cardiac surgery in pediatric patients but may be useful in adults as well. Accordingly, we examined the time course of this score in a substudy of the Biventricular Pacing After Cardiac Surgery trial. We hypothesized that the score would be lower in patients randomized to biventricular pacing. METHODS Fifty patients selected for increased risk of left ventricular dysfunction after cardiac surgery and randomized to temporary biventricular pacing or standard of care (no pacing) after cardiopulmonary bypass were studied in a clinical trial between April 2007 and June 2011. Vasoactive agents were assessed after cardiopulmonary bypass, after sternal closure, and 0 to 7 hours after admission to the intensive care unit. RESULTS Over the initial 3 collection points after cardiopulmonary bypass (mean duration, 131 minutes), the mean vasoactive-inotropic score decreased in the biventricular pacing group from 12.0 ± 1.5 to 10.5 ± 2.0 and increased in the standard of care group from 12.5 ± 1.9 to 15.5 ± 2.9. By using a linear mixed-effects model, the slopes of the time courses were significantly different (P = .02) and remained so for the first hour in the intensive care unit. However, the difference was no longer significant beyond this point (P = .26). CONCLUSIONS The vasoactive-inotropic score decreases in patients undergoing temporary biventricular pacing in the early postoperative period. Future studies are required to assess the impact of this effect on arrhythmogenesis, morbidity, mortality, and hospital costs.

Hemodynamic Stability During Biventricular Pacing After Cardiopulmonary Bypass

OBJECTIVE To assess the stability of cardiac output, mean arterial pressure, and systemic vascular resistance during biventricular pacing (BiVP) optimization. DESIGN Substudy analysis of data collected as part of a randomized controlled study examining the effects of optimized temporary BiVP after cardiopulmonary bypass (CPB). SETTING A single-center study at a university-affiliated tertiary care hospital. PARTICIPANTS Cardiac surgery patients at risk of left ventricular failure after CPB. INTERVENTIONS BiVP was optimized immediately after CPB. Atrioventricular delay (7 unique settings) was optimized first, followed by the left ventricular pacing site (3 unique settings) and then the interventricular delay (9 unique settings). Each setting was tested twice for 10 seconds each time. Vasoactive medication and fluid infusion rates were held constant. MEASUREMENTS AND MAIN RESULTS Aortic flow velocity and radial artery pressure were digitized, recorded, and averaged over single respiratory cycles. Least squares and linear regression/Wilcoxon analyses were applied to the first 7 patients studied. Subsequently, curvilinear analysis was applied to 15 patients. Changes in mean arterial pressure and systemic vascular resistance were statistically insignificant or too small to be meaningful by least squares analysis. During interventricular synchrony optimization, cardiac output and mean arterial pressure decreased (mean changes -5.7% and -2.5%, respectively; with standard errors 2.3% and 1.5%, respectively), whereas SVR increased (mean change 3.1% with standard error 3.4%). Only the change in cardiac output was statistically significant (p = 0.043). Curvilinear fits to data for 15 patients demonstrated progressive hemodynamic stability over the total testing period. CONCLUSION BiVP optimization may be done safely in patients after CPB. With continuous monitoring of mean arterial pressure and cardiac output, the procedure results in no harmful hemodynamic perturbation.

Salvage of a Failing Bifurcated Bipolar Epicardial Lead With Conductor Fracture

Cardiac rhythm abnormalities in children are often managed by using epicardial pacing systems. Lead failure poses a serious problem in pacemaker-dependent patients. We describe a lead repair that was not intuitive and avoided repeat thoracotomy in a pacemaker-dependent patient with lead fracture.

EliIE: An open-source information extraction system for clinical trial eligibility criteria

Objective To develop an open-source information extraction system called Eligibility Criteria Information Extraction (EliIE) for parsing and formalizing free-text clinical research eligibility criteria (EC) following Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) version 5.0. Materials and Methods EliIE parses EC in 4 steps: (1) clinical entity and attribute recognition, (2) negation detection, (3) relation extraction, and (4) concept normalization and output structuring. Informaticians and domain experts were recruited to design an annotation guideline and generate a training corpus of annotated EC for 230 Alzheimers clinical trials, which were represented as queries against the OMOP CDM and included 8008 entities, 3550 attributes, and 3529 relations. A sequence labeling-based method was developed for automatic entity and attribute recognition. Negation detection was supported by NegEx and a set of predefined rules. Relation extraction was achieved by a support vector machine classifier. We further performed terminology-based concept normalization and output structuring. Results In task-specific evaluations, the best F1 score for entity recognition was 0.79, and for relation extraction was 0.89. The accuracy of negation detection was 0.94. The overall accuracy for query formalization was 0.71 in an end-to-end evaluation. Conclusions This study presents EliIE, an OMOP CDM-based information extraction system for automatic structuring and formalization of free-text EC. According to our evaluation, machine learning-based EliIE outperforms existing systems and shows promise to improve.

An Interoperable Similarity-based Cohort Identification Method Using the OMOP Common Data Model Version 5.0

Cohort identification for clinical studies tends to be laborious, time-consuming, and expensive. Developing automated or semi-automated methods for cohort identification is one of the “holy grails” in the field of biomedical informatics. We propose a high-throughput similarity-based cohort identification algorithm by applying numerical abstractions on electronic health records (EHR) data. We implement this algorithm using the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), which enables sites using this standardized EHR data representation to avail this algorithm with minimum effort for local implementation. We validate its performance for a retrospective cohort identification task on six clinical trials conducted at the Columbia University Medical Center. Our algorithm achieves an average area under the curve (AUC) of 0.966 and an average Precision at 5 of 0.983. This interoperable method promises to achieve efficient cohort identification in EHR databases. We discuss suitable applications of our method and its limitations and propose warranted future work.

Effect of atrioventricular conduction prolongation on optimization of paced atrioventricular delay for biventricular pacing after cardiac surgery.

OBJECTIVES Atrioventricular conduction prolongation (AVCP) in cardiac pacing is measurable and results primarily from delayed atrial conduction. Noninvasive methods for measuring atrial conduction are lacking. Accordingly, AVCP was used to estimate atrial conduction and investigate its role on the paced atrioventricular delay (pAVD) during biventricular pacing (BiVP) optimization. DESIGN Retrospective analysis of data collected as part of a randomized controlled study of temporary BiVP after cardiopulmonary bypass. SETTING Single-center study at university-affiliated tertiary care hospital. PARTICIPANTS Cardiac surgical patients at risk of left ventricular failure after cardiopulmonary bypass. INTERVENTIONS Temporary BiVP was optimized immediately after cardiopulmonary bypass. Vasoactive medication and fluid infusion rates were held constant during optimization. MEASUREMENTS AND MAIN RESULTS For each patient the AVCP and the pAVD producing the optimum (highest) cardiac output (OptCO) and mean arterial pressure (OptMAP) were determined. Patients were stratified into long- and short-AVCP groups. Overall AVCP (mean ± standard deviation) was 64 ± 28 ms. For the short-AVCP group (<64 ms, n = 3), AVCP, OptCO, and OptMAP were 40 ± 11, 120 ± 0, and 150 ± 30 ms, respectively, and for the long-AVCP group (>64 ms, n = 4), these same parameters were 89 ± 10, 218 ± 44, and 218 ± 29 ms. OptCO and OptMAP were significantly less in the short-AVCP group (p = 0.015 and p = 0.029, respectively). CONCLUSIONS AVCP varies widely after cardiopulmonary bypass, affecting optimum pAVD. Failure to correct for this can result in the selection of inappropriately short and potentially deleterious pAVDs, especially when nominal pAVD is used, causing BiVP to appear ineffective.

Clinical validation of a real-time data processing system for cardiac output and arterial pressure measurement during intraoperative biventricular pacing optimization.

Biventricular pacing (BiVP) improves cardiac output (CO) and mean arterial pressure (MAP) after cardiopulmonary bypass (CPB) in selected patients at risk for acute left heart failure after cardiac surgery. Optimization of atrioventricular delay (AVD) and interventricular delay (VVD) to maximize the hemodynamic effect of pacing requires rapid and accurate data processing. Conventional post hoc data processing (PP) is accurate but time-consuming, and infeasible in the intraoperative setting. We created a customized, real-time data processing (RTP) system to improve data processing efficiency, while maintaining accuracy. Biventricular pacing optimization was performed within 1 hour of the conclusion of CPB in 10 patients enrolled in the Biventricular Pacing After Cardiac Surgery trial. Cardiac output, measured by an electromagnetic flow meter, and arterial pressure were recorded as AVD was randomly varied across seven settings and VVD across nine settings. Post hoc data processing values calculated by two observers were compared to RTP-generated outputs for CO and MAP. Interexaminer reliability coefficients were generated to access the dependability of RTP. Interexaminer reliability coefficient values ranged from 0.997 to 0.999, indicating RTP is as reliable as PP for optimization. Real-time data processing is instantaneous and therefore is more practical in a clinical setting than the PP method. Real-time data processing is useful for guiding intraoperative BiVP optimization and merits further development.