Three-dimensional-guided and ICE-guided transseptal puncture for cardiac ablations: A propensity score match study.

INTRODUCTION: Transseptal puncture (TSP) is routinely performed for left atrial ablation procedures. The use of a three-dimensional (3D) mapping system or intracardiac echocardiography (ICE) is useful in localizing the fossa ovalis and reducing fluoroscopy use. We aimed to compare the safety and efficacy between 3D mapping system-guided TSP and ICE-guided TSP techniques. METHODS: We conducted a prospective observational study of patients undergoing TSP for left atrial catheter ablation procedures (mostly atrial fibrillation ablation). Propensity scoring was used to match patients undergoing 3D-guided TSP with patients undergoing ICE-guided TSP. Logistic regression was used to compare the clinical data, procedural data, fluoroscopy time, success rate, and complications between the groups. RESULTS: Sixty-five patients underwent 3D-guided TSP, and 151 propensity score-matched patients underwent ICE-guided TSP. The TSP success rate was 100% in both the 3D-guided and ICE-guided groups. Median needle time was 4.00 min (interquartile range [IQR]: 2.57-5.08) in patients with 3D-guided TSP compared to 4.02 min (IQR: 2.83-6.95) in those with ICE-guided TSP (p = .22). Mean fluoroscopy time was 0.2 min (IQR: 0.1-0.4) in patients with 3D-guided TSP compared to 1.2 min (IQR: 0.7-2.2) in those with ICE-guided TSP (p < .001). There were no complications related to TSP in both group. CONCLUSIONS: Three-dimensional mapping-guided TSP is as safe and effective as ICE-guided TSP without additional cost.

Patients' and family members' views on pacemaker reuse: An international survey.

INTRODUCTION: The reuse of cardiac implantable electronic devices may help increase access to these therapies in low- and middle-income countries (LMICs). No published data exist regarding the views of patients and family members in LMICs regarding this practice. METHODS AND RESULTS: An article questionnaire eliciting attitudes regarding pacemaker reuse was administered to ambulatory adult patients and patients' family members at outpatient clinics at Centro Nacional Cardiologia in Managua, Nicaragua, Indus Hospital in Karachi, Pakistan, Hospital Carlos Andrade Marín, and Hospital Eugenio Espejo in Quito, Ecuador, and American University of Beirut Medical Center in Beirut, Lebanon. There were 945 responses (Nicaragua - 100; Pakistan - 493; Ecuador - 252; and Lebanon - 100). A majority of respondents agreed or strongly agreed that they would be willing to accept a reused pacemaker if risks were similar to a new device (707, 75%), if there were a higher risk of device failure compared with a new device (584, 70%), or if there were a higher risk of infection compared to a new device (458, 56%). A large majority would be willing to donate their own pacemaker at the time of their death (884, 96%) or the device of a family member (805, 93%). Respondents who were unable to afford a new device were more likely to be willing to accept a reused device (79% vs. 63%, p < .001). CONCLUSIONS: Patients and their family members support the concept of pacemaker reuse for patients who cannot afford new devices.

Catheter ablation of the left and right atrial appendages without isolation in persistent atrial fibrillation.

BACKGROUND: Electrical isolation of the left atrial appendage (LAA) improves outcomes of patients with persistent atrial fibrillation (AF) but may increase the risk of thromboembolism. OBJECTIVE: The purpose of this study was to describe a method to map and ablate appendage drivers without complete electrical isolation. METHODS: One hundred thirteen patients underwent an ablation procedure for persistent AF. The procedure was performed during AF and consisted of pulmonary vein and posterior LA isolation as well as ablation of the LAA. The right atrium (RA) was targeted in patients with a right-to-left gradient in cycle length (CL). The end point of appendage ablation was CL slowing or AF termination but not complete isolation. RESULTS: Among the 113 patients (mean age 64.6 ± 8.6 years; ejection fraction 54% ± 13%; LA diameter 46 ± 6.5 mm), radiofrequency ablation terminated AF in 51 patients (45%). RA ablation was performed in 41 patients (36%) at the index or repeat procedure. The mean AF CL in the RA appendage (RAA) was shorter than that in the LAA (160 ± 32 ms vs 186 ± 29 ms; P < .01) in these patients. The most frequent target in the RA was the RAA (CLs approaching 50-60 ms). Discontinuing radiofrequency ablation upon AF termination or conduction slowing prevented LAA isolation. After a mean follow-up of 24 ± 15 months, 89 patients (78%) remained arrhythmia-free without antiarrhythmic medications. CONCLUSION: An ablation strategy guided by the AF CL addresses LAA drivers without complete electrical isolation and also helps identify the RAA as a source of persistent AF.

Warfarin for prevention of thromboembolism in atrial fibrillation: comparison of patient characteristics and outcomes of the "Real-World" Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry to the RE-LY, ROCKET-AF, and ARISTOTLE trials.

Randomized controlled trials (RCTs) examining warfarin use for stroke prevention in atrial fibrillation (AF) may not accurately reflect real-world populations. We aimed to determine the representativeness of the RCT populations to real-world patients and to describe differences in the characteristics of trial populations from trial eligible patients in a real-world setting. We hypothesized that a significant fraction of real-world patients would not qualify for the RE-LY, ROCKET-AF, and ARISTOTLE trials and that real-world patients qualifying for the studies may have more strokes and bleeding events. We compared the inclusion and exclusion criteria, patient characteristics, and clinical outcomes from RE-LY, ROCKET-AF, and ARISTOTLE against data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2), a regional network of six community- and academic-based anticoagulation clinics. Of the 1446 non-valvular AF patients in the MAQI2 registry taking warfarin, approximately 40-60% would meet the selection criteria used in RE-LY (788, 54.5%), ROCKET-AF (566, 39.1%), and ARISTOTLE (866, 59.9%). The most common reasons for exclusion from one or more trial were anemia (15.1%), other concurrent medications (11.2%), and chronic kidney disease (9.4%). Trial-eligible MAQI2 patients were older, more frequently female, with a higher rate of paroxysmal AF, and lower rates of congestive heart failure, previous stroke, and previous myocardial infarction than the trial populations. MAQI2 patients eligible for each trial had a lower rate of stroke and similar rate of major bleeding than was observed in the trials. A sizable proportion of real-world AF patients managed in anticoagulation clinics would not have been eligible for the RE-LY, ROCKET-AF, and ARISOTLE trials. The expected stroke risk reduction and bleeding risk among real-world AF patients on warfarin may not be congruent with published clinical trial data.

Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation: The Next Hurdle in Device Recycling.

OBJECTIVES: This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). BACKGROUND: Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. METHODS: A cleaning and sterilization protocol was developed that includes washing CIEDs in an enzymatic detergent, screw cap and set screw replacement, brushing, inspection, and sterilization in ethylene oxide. Validation testing was performed to assure compliance with accepted standards. RESULTS: With cleaning, the total mean bioburden for each of 3 batches of 10 randomly chosen devices was reduced from 754 to 10.1 colony-forming units. After sterilization with ethylene oxide, with 3 half-cycle and 3 full-cycle processes, none of the 90 biological indicator testers exhibited growth after 7 days. Through cleaning and sterilization, protein and hemoglobin concentrations were reduced from 99.2 to 1.42 µg/cm2 and from 21.4 to 1.03 µg/cm2, respectively. Mean total organic carbon residual was 1.44 parts per million (range 0.36 to 2.9 parts per million). Endotoxin concentration was not detectable at the threshold of <0.03 endotoxin units/ml or <3.0 endotoxin units/device. Cytotoxicity and intracutaneous reactivity tests met the standards set by the Association for Advancement of Medical Instrumentation and the International Organization for Standardization. CONCLUSIONS: CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10-6.

Postoperative Atrial Fibrillation: Incidence, Mechanisms, and Clinical Correlates.

Atrial fibrillation is the most commonly encountered arrhythmia after cardiac surgery. Although usually self-limiting, it represents an important predictor of increased patient morbidity, mortality, and health care costs. Numerous studies have attempted to determine the underlying mechanisms of postoperative atrial fibrillation (POAF) with varied success. A multifactorial pathophysiology is hypothesized, with inflammation and postoperative ß-adrenergic activation recognized as important contributing factors. The management of POAF is complicated by a paucity of data relating to the outcomes of different therapeutic interventions in this population. This article reviews the literature on epidemiology, mechanisms, and risk factors of POAF, with a subsequent focus on the therapeutic interventions and guidelines regarding management.

Nationwide Trends in Reported Incidence of Takotsubo Cardiomyopathy from 2006 to 2012.

Takotsubo cardiomyopathy (TC) is believed to be an increasingly diagnosed syndrome; however, data on its incidence are limited. The purpose of this study was to determine the reported incidence of TC in the United States and to examine its trend over several years. Data was obtained from the Nationwide Inpatient Sample, created by the Agency for Healthcare Research and Quality, for each of the years from 2006 to 2012. Hospital discharges with principal diagnosis of TC, identified using Internal Classification of Diseases, Ninth Revision, code 429.83, were included. We tabulated estimated total numbers of discharges, incidence per 100,000 persons, mean length of stay, inhospital death rates, and diagnoses stratified by age group and gender. The reported incidence of TC based on principal diagnosis at hospital discharge increased significantly over the study period, with 315 cases ± 43 (standard error) in 2006 and 6,230 cases ± 232 (standard error) in 2012 (p <0.001 for trend). Mean length of hospital stay was stable over the study period (3.4 days in 2006 vs 3.6 days in 2012; p = 0.74 for trend). The diagnosis was most frequent in patients aged 65 to 84 years (50% of all diagnoses in 2012), followed by those aged 45 to 64 years (39% of all diagnoses in 2012). Women accounted for >90% of diagnoses throughout the study period. In conclusion, the reported incidence of TC has increased significantly from 2006 to 2012, most likely because of increasing recognition of the syndrome.

Postoperative atrial fibrillation: incidence, mechanisms, and clinical correlates.

Atrial fibrillation is the most commonly encountered arrhythmia after cardiac surgery. Although usually self-limiting, it represents an important predictor of increased patient morbidity, mortality, and health care costs. Numerous studies have attempted to determine the underlying mechanisms of postoperative atrial fibrillation (POAF) with varied success. A multifactorial pathophysiology is hypothesized, with inflammation and postoperative ß-adrenergic activation recognized as important contributing factors. The management of POAF is complicated by a paucity of data relating to the outcomes of different therapeutic interventions in this population. This article reviews the literature on epidemiology, mechanisms, and risk factors of POAF, with a subsequent focus on the therapeutic interventions and guidelines regarding management.

Heart Rhythm Society members' views on pacemaker and implantable cardioverter-defibrillator reuse.

BACKGROUND: Reuse of cardiac implantable electronic devices (CIEDs) may help address the unmet need among patients in low- and middle-income countries (LMICs). METHODS: To examine Heart Rhythm Society (HRS) physicians' opinions regarding CIED reuse, an online survey eliciting attitudes toward CIED reuse was sent to all 3,380 HRS physician members. RESULTS: There were 429 responses (response rate 13%). A large majority of respondents agreed or strongly agreed that resterilization of devices for reimplantation in patients who cannot afford new devices may be safe (370, 87%) and, if proven to be safe, would be ethical (375, 88%). A total of 340 (81%) respondents would be comfortable asking their patients to consider donating their device, and 353 (84%) would be willing to reimplant a resterilized device if it were legal. The most commonly cited concerns about device reuse were infection (270, 64%) and device malfunction (125, 29%). Respondents from the United States and Canada had more favorable impressions of device reuse than respondents from other high-income countries (P < 0.05 for three of five positive statements regarding reuse), and were less likely to cite ethical concerns (P < 0.001). However, when responses from all high-income countries were compared with lower- and upper-middle income countries, there were no significant differences in the rates of approval. CONCLUSIONS: HRS survey respondents support the concept of CIED reuse for patients in LMICs who cannot afford new devices. Studies are needed to demonstrate the clinical efficacy and safety of this practice and to identify potential barriers to adoption among physicians.

Daily context matters: predictors of missed oral contraceptive pills among college and graduate students.

OBJECTIVE: The purpose of this study was to understand the relationship between daily contextual factors and oral contraceptive (OC) adherence among students who attend college or graduate school. STUDY DESIGN: Data on OC adherence, demographics, contextual factors, and side-effects were collected as part of the acceptability of the NuvaRing (Merck & Co, Whitehouse Station, NJ) vs OC study, in which students were assigned randomly to the contraceptive vaginal ring or to a low-dose OC. We performed bivariate and multivariable analyses to create an explanatory model for nonperfect OC adherence (missed at least 1 pill during 3 months of use). RESULTS: In a multivariable predictive model, missing a pill was associated positively with high perceived stress (odds ratio [OR], 3.16; P = .007), having ≥10 hours per week of paid employment (OR, 2.13; P = .075), and living with a partner (OR, 9.92; P = .040). CONCLUSION: Stressful and hectic lives contribute to poor OC adherence. When counseling women about contraception, clinicians should consider the influence of daily life on contraceptive adherence.

What will anesthesiologists be anesthetizing? Trends in neurosurgical procedure usage.

BACKGROUND: To anticipate future changes to the practice of neuroanesthesia, we examined the nationwide trends in frequently performed operative neurosurgery. METHODS: We used the Nationwide Inpatient Sample, a random sampling of approximately 20% of United States hospitals from 1993 to 2007. Eight categories of operative neurosurgery were developed, based on procedure codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). We tabulated total volume, mean length of stay, and inhospital mortality and calculated growth rates over the entire period, the most recent 5-year period, and the most recent 2-year period. We examined annual volumes from 1993 to 2007 for each neurosurgical category for the most common ICD-9-CM procedure code within each category. RESULTS: Intracranial endovascular procedures had the highest compound annual growth rate over the entire study period (32%), the most recent 4 years (29%), and the most recent 2 years (12%). Craniotomy for vascular surgery decreased over the entire period (-4.2%). Spinal fusion had the largest absolute increase over the study period (from 54,000 in 1993 to 350,000 in 2007). All categories except craniotomy for vascular surgery had decreased length of stay across the study period, with compound annual growth rates of -1.2% (ventricular and thecal shunt) to -6.6% (deep brain stimulation). Intracranial endovascular procedures had a much higher growth rate of length of stay than vascular surgery over the most recent 2-year (14% vs 1.0%) and 5-year periods (5.6% vs 1.5%). CONCLUSIONS: The highest volume trends in operative neurosurgery are for spinal fusion (increasing at a rate of approximately 12,000 procedures/y), craniotomy for tumors and other purposes (increasing at a rate of approximately 2,700 procedures/y), and a decrease in shunts (decreasing at a rate of approximately 3,000 per year). The data suggest that intracranial endovascular treatment remains relatively rare, but it is growing exponentially, and lengths of stay are increasing, whereas inhospital deaths are decreasing. The conclusions of this study are limited by the imprecise nature of the ICD-9-CM procedure codes, the categorization scheme we used, and by the sampling methods of the National Inpatient Sample.