News Article | February 23, 2017
LA JOLLA, CA - February 22, 2017 - The MagnaSafe Registry, a new multicenter study led by scientists at The Scripps Research Institute (TSRI), has demonstrated that appropriately screened and monitored patients with standard or non-MRI-conditional pacemakers and defibrillators can undergo MRI at a field strength of 1.5 tesla without harm. These devices are not presently approved by the U.S. Food and Drug Administration (FDA) for MRI scanning. The researchers observed no patient deaths, device or lead failures, losses of pacing function or ventricular arrhythmias in 1,500 patients who underwent MRI using a specific protocol for device interrogation, device programming, patient monitoring and follow-up designed to reduce the risk of patient harm from MRI effects. The research will be published as an Original Article in the February 23, 2017 issue of The New England Journal of Medicine. The use of MRI poses potential safety concerns for patients with an implanted cardiac device. These concerns are a result of the potential for magnetic field-induced cardiac lead heating, which could result in cardiac injury and damage to an implanted device. As a result, it has long been recommended that patients with a pacemaker or defibrillator not undergo MRI scanning, even when MRIs are considered the most appropriate diagnostic imaging method for their care. Despite the development of devices designed to reduce the potential risks associated with MRI, a large number of patients have devices that have not been shown to meet these criteria and are considered "non-MRI-conditional." At least half these patients are predicted to have the need for MRI after a device has been implanted. Researchers established the MagnaSafe Registry to determine the frequency of cardiac device-related events among patients with non-MRI-conditional devices, as well as to define a simplified protocol for screening, monitoring and device programming before MRI. "Given the great clinical demand for MRI for patients with a standard pacemaker or defibrillator, we wanted to determine the risk," said study leader Dr. Robert Russo, an adjunct professor at TSRI and director of The La Jolla Cardiovascular Research Institute. In the MagnaSafe Registry, researchers at 19 U.S. institutions tested 1,000 cases with a non-MRI-conditional pacemaker (one not approved for use in an MRI) and 500 cases of patients with a non-MRI-conditional implantable cardioverter defibrillator (ICD), a device that can shock the heart in response to a potentially fatal cardiac rhythm. They scanned regions other than the chest, such as the brain, spine or extremities--where MRI is traditionally the best option for imaging. The researchers tested the devices at an MRI field strength of 1.5 tesla, a standard strength for MRI scanners and reprogrammed some devices according to a prespecified protocol for the MRI examination. "If the patient was not dependent upon their pacemaker, the device was turned off," explained Russo. "If they could not tolerate having the device turned off, it was set to a pacing mode that did not sense cardiac activity. The reason was that the pacemaker could sense the electrical activity (radiofrequency energy) from the MRI scanner and the function of the device could be inhibited, which could be catastrophic if you depend upon your pacemaker for your heartbeat." Russo and his co-investigators did observe adverse effects in a small group of patients. Six patients had a brief period of atrial fibrillation, and in six additional cases pacemaker partial reset (a loss of stored patient information) was noted. But in no cases did the researchers observe device failure or a failure in the leads that connect the device to the heart when the protocol was followed. "One ICD generator could not be interrogated after MRI and required immediate replacement; the device had not been appropriately programmed per protocol before the MRI," explained Russo. These findings led the researchers to conclude that "device removal and replacement seem unlikely to be safer than proceeding with scanning for patients with a pacemaker or an ICD who require a nonthoracic MRI," provided a protocol similar to the MagnaSafe protocol was followed. "Patients with a standard or non-MRI-conditional pacemaker can undergo clinically indicated MRI without harm if a protocol such as the 'MagnaSafe' protocol used in this study is followed and patients are screened and monitored as described," said Russo. The researchers also noted that their results may not be predictive of findings with all device and lead combinations, higher MRI field strengths, patients younger than 18 years of age and MRI examinations of the chest or cardiac resynchronization devices (those designed to increase the function of a failing heart). The researchers plan to follow up by studying the risk for patients in need of a chest scan at scanner field strength of 1.5 tesla, as well as an MRI of any anatomic area at a higher field strength (3.0 tesla). The study, "Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator," also included authors from the University of California, San Diego; Scripps Memorial Hospital; the University of California, Los Angeles; Providence St. Joseph Medical Center; the University of Arizona; Intermountain Medical Center; Inova Heart and Vascular Institute; Allegheny General Hospital; Abington Memorial Hospital; Yale University School of Medicine; Providence Heart Institute; Oklahoma Heart Institute; the University of Mississippi Medical Center; the Medical College of Wisconsin; Bassett Medical Center; Carnegie Hill Radiology; Methodist DeBakey Heart and Vascular Center and Baptist Health. The study was supported by grants from St. Jude Medical, Biotronik, Boston Scientific and the Hewitt Foundation for Medical Research, and by philanthropic gifts from Mr. and Mrs. Richard H. Deihl, Evelyn F. and Louis S. Grubb, Roscoe E. Hazard, Jr. and the Shultz Steel Company. The Scripps Research Institute (TSRI) is one of the world's largest independent, not-for-profit organizations focusing on research in the biomedical sciences. TSRI is internationally recognized for its contributions to science and health, including its role in laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. An institution that evolved from the Scripps Metabolic Clinic founded by philanthropist Ellen Browning Scripps in 1924, the institute now employs more than 2,500 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists--including two Nobel laureates and 20 members of the National Academies of Science, Engineering or Medicine--work toward their next discoveries. The institute's graduate program, which awards PhD degrees in biology and chemistry, ranks among the top ten of its kind in the nation. In October 2016, TSRI announced a strategic affiliation with the California Institute for Biomedical Research (Calibr), representing a renewed commitment to the discovery and development of new medicines to address unmet medical needs. For more information, see http://www. .
Gurbel P.A.,Inova Heart and Vascular Institute |
Jeong Y.-H.,Gyeongsang National University |
Navarese E.P.,Inova Heart and Vascular Institute |
Tantry U.S.,Inova Heart and Vascular Institute
Circulation Research | Year: 2016
The pivotal role that platelets play in thrombosis and resultant ischemic event occurrences in patients with high-risk coronary artery disease is well established. This role provides the fundamental basis for the current wide implementation of dual antiplatelet therapy with aspirin and a P2Y12 receptor inhibitor. The development of user friendly point-of-care methods to assess platelet reactivity to adenosine diphosphate has increased the frequency of platelet function testing in clinical practice. Recent large observational studies have established an independent relation between the results of point-of-care platelet function testing and clinical event occurrence in patients undergoing coronary artery stenting. However, prospective, randomized trials have failed to demonstrate that personalized antiplatelet therapy based on point-of-care assessment of platelet function is effective in reducing ischemic event occurrences. Important limitations were associated with these trials. In addition, the concept of a therapeutic window of P2Y12 receptor reactivity with an upper threshold associated with ischemic event occurrence and a lower threshold associated with bleeding has also been proposed. In the absence of strong prospective evidence to support personalized antiplatelet therapy, clinical decision making about antiplatelet therapy rests on the large body of observational data and the fundamental importance of platelet physiology in catastrophic event occurrence in patients with high-risk coronary artery disease. © 2016 American Heart Association, Inc.
Ad N.,Inova Heart and Vascular Institute |
Henry L.,Inova Heart and Vascular Institute |
Hunt S.,Inova Heart and Vascular Institute
European Journal of Cardio-thoracic Surgery | Year: 2011
Objective: Surgical ablation procedures that use the Cox-Maze procedure lesion set were shown to be very effective. However, many surgeons are reluctant to perform the procedure, especially in high-risk patients such as those with reduced left ventricular (LV) function. This study explored the potential impact of the Cox-Maze III/IV procedure on patients with low ejection fraction (EF<40%) and symptoms of heart failure experiencing atrial fibrillation (AF) who present for cardiac surgery. Methods: A prospective study whereby patients with persistent or long-standing persistent AF who had surgical ablation were followed. Echocardiograms (echo) were obtained; patients with preoperative EF <40% were included. Health-related quality of life (HRQL-SF-12) and AF symptom severity were obtained at baseline and follow-up. Rhythm was captured by electrocardiogram (EKG) and 24-h Holter. Results: In the past 5 years, 482 patients had surgical ablation (424 full Cox-Maze) of whom 44 patients met the inclusion criteria; however, two patients did not have an available follow-up echo, leaving 42 patients for analysis. Mean age was 61.1 ± 12.9 years, and additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 7.5 ± 3.1. There was one operative death, there were no strokes or transient ischemic attacks (TIAs) at follow-up, and EF improved from 30 ± 5.0% to 45 ± 13.0% at a mean of 1.5 ± 11.3 months, postoperatively. The return to NSR at time of follow-up echo was 86% (35/40). The physical functioning HRQL scores improved (37.0 ± 12.3 to 46.8 ± 9.1, p=0.02) at 12 months (population norm. =38.1 ± 9.9) with a significant improvement in symptom severity. Kaplan-Meier event-free survival at 24 months was 87% (confidence interval (CI): 80.4-91.6) (events considered were redo valve replacement, ventricular assist device or death). Conclusions: This is a unique study assessing a high-risk group of patients. Surgical ablation in patients with low EF can be performed in a safe and effective way without added operative risk. Given the potential long-term clinical advantages of a successful surgical ablation in patients with low EF and heart failure, we believe that surgical ablation should be considered in such patients when they present to surgery. © 2010.
Shlobin O.A.,Inova Heart and Vascular Institute |
Nathan S.D.,Inova Heart and Vascular Institute
Expert Review of Respiratory Medicine | Year: 2011
Interstitial lung diseases (ILDs) may be complicated by the development of pulmonary hypertension (PH), which is associated with worse functional impairment and a poorer prognosis. This article reviews the current state of knowledge on the prevalence, pathogenesis, diagnosis and prognosis of ILD-related PH. Whether the treatment of ILD-related PH changes clinical outcomes is currently unknown, but the current studies are summarized and the authors' perspective is offered. © 2011 Expert Reviews Ltd.
Mentz R.J.,Duke University |
O'Connor C.M.,Inova Heart and Vascular Institute
Nature Reviews Cardiology | Year: 2016
Acute heart failure (AHF) is a complex syndrome characterized by worsening heart failure (HF) symptoms that requires escalation of therapy. Intrinsic cardiac abnormalities and comorbid conditions, including lung and renal disease, and sleep-disordered breathing, can contribute to the development of AHF. In this Review, we summarize and discuss the literature on the clinical evaluation and underlying pathophysiology of AHF. Important features of AHF evaluation include identification of precipitating factors to the disease, and assessment of circulatory-renal limitations associated with use of HF medications, prior HF hospitalizations, congestion and perfusion profiles, and end-organ dysfunction. The pathophysiological contributions of endothelial dysfunction, neurohormonal activation, venous congestion, and myocardial injury to the development of AHF are also discussed. These potential causative mechanisms provide a framework for clinicians to evaluate and manage patients with AHF and highlight possible future targets for therapies designed to improve clinical outcomes. © 2015 Macmillan Publishers Limited. All rights reserved.
A systematic review of minimally invasive surgical treatment for atrial fibrillation: A comparison of the Cox-Maze procedure, beating-heart epicardial ablation, and the hybrid procedure on safety and efficacy
Je H.G.,Inova Heart and Vascular Institute |
Shuman D.J.,Inova Heart and Vascular Institute |
Ad N.,Inova Heart and Vascular Institute
European Journal of Cardio-thoracic Surgery | Year: 2015
There is a growing trend to perform off-bypass surgical ablation for atrial fibrillation (AF) because it is perceived to be safer and more effective than the Cox-Maze procedure with cardiopulmonary bypass (CPB) support. In this systematic review, we compared three minimally invasive stand-alone surgical ablation procedures for AF: the endocardial Cox-Maze procedure, epicardial surgical ablation and a hybrid epicardial surgical and catheter-based endocardial ablation procedure (hybrid procedure). Relevant studies were identified in MEDLINE and the Cochrane Database of Systematic Reviews according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. From 565 initial studies, 37 were included in this review. The total number of patients across all studies was 1877 (range 10-139). Two studies reported on endocardial Cox-Maze procedures (n = 145), 26 reported on epicardial surgical ablation (n = 1382) and 9 reported on hybrid surgical ablation (n = 350). For minimally invasive Cox-Maze, epicardial and hybrid groups, operative mortality rates were 0, 0.5 and 0.9%, perioperative permanent pacemaker insertion rates were 3.5, 2.7 and 1.5%, incidence of conversion to median sternotomy was 0, 2.4 and 2.5%, and reoperation for bleeding was 1.0, 1.5 and 2.2%, with mean length of stay (days) of 5.4, 6.0 and 4.6, respectively. At 12 months, rates of sinus rhythm restoration were 93, 80 and 70%, and sinus restoration without anti-arrhythmic medications was 87, 72 and 71%, for Cox-Maze, epicardial and hybrid procedures, respectively. Of the three procedures, the minimally invasive Cox-Maze procedure with CPB support was most effective for the treatment of stand-alone AF and had important safety advantages in conversion to sternotomy and major bleeding. The minimally invasive Cox-Maze procedure with CPB support also demonstrated the potential for a higher success rate 12 months following the procedure. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
Ad N.,Inova Heart and Vascular Institute
The Journal of thoracic and cardiovascular surgery | Year: 2012
Despite growing awareness of the clinical significance of atrial fibrillation (AF) and observational data demonstrating the safety and efficacy of surgical therapy, AF ablation is variably performed among patients with AF undergoing cardiac surgery. We examined the national trends of surgical ablation and perioperative outcomes for stand-alone surgical ablation of AF. Using the Society of Thoracic Surgeons Adult Cardiac Surgery Database, 91,801 (2005-2010) surgical AF ablations were performed of which 4893 (5.3%) were stand-alone procedures. The outcomes of 854 propensity-matched pairs having "on" versus "off" cardiopulmonary bypass stand-alone ablation were compared. The percentage of patients with preoperative AF increased from 2005 to 2010 (from 10.0% to 12.2%). Overall, 40.6% of patients with AF underwent concomitant surgical ablation-a significant decline of 1.6% from 2005 to 2010. The number of stand-alone surgical ablations increased significantly from 552 to 1041 cases (2005-2010). Overall, the stand-alone group had a mean age of 60 years, 71% were men, and 80% were treated "off" cardiopulmonary bypass. The "on" cardiopulmonary bypass group had significantly more pulmonary disease, diabetes, and congestive heart failure. Overall, the operative mortality and stroke rate was 0.7% for each. After propensity matching, the "off" cardiopulmonary bypass group underwent significantly fewer reoperations for bleeding and had a lower incidence of prolonged ventilation and shorter hospitalization. New pacemaker implantation was low, without group differences. The prevalence of AF in patients undergoing cardiac surgery has increased, as has the number of stand-alone surgical ablations. The treatment of concomitant disease declined slightly. Isolated surgical ablation is safe, performed "on" or "off" cardiopulmonary bypass. These results support consideration of surgical AF ablation as an alternative to percutaneous ablation for patients with lone AF. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
Speir A.,Inova Heart and Vascular Institute
The Journal of heart valve disease | Year: 2013
The study aim was to determine the health-related quality of life (HRQL) in conjunction with clinical outcomes following aortic valve replacement (AVR) surgery. In these times of healthcare change, quality measures of the success of a procedure go beyond clinical outcomes, with patient reports of HRQL considered important. All patients who had undergone AVR surgery were followed prospectively through the authors' valve registry and the local Society of Thoracic Surgery (STS) database. The HRQL (Short-Form 12 and Minnesota Living with Heart Failure Questionnaire) was collected preoperatively, and at six and 12 months after surgery. Since 2005, a total of 459 patients have undergone isolated AVR surgery. The mean age, ejection fraction and STS risk score were 65.8 +/- 13.6 years, 57.7 +/- 11.0%, and 2.8 +/- 3.5 (range: 0.4-47.9), respectively. The median (IQR) length of hospital stay was 5 (3-7) days. Compared to the STS national norms, all clinical outcomes were excellent. A Kaplan-Meier analysis showed the two year cumulative survival as 92.0%. After 12 months the physical and mental HRQL had improved significantly, surpassing age and heart disease norms (p < 0.001 and p = 0.02, respectively). Multivariate analysis determined that a higher 12-month physical HRQL was predicted by a lower STS risk score (B = -1.3, p < 0.001) and a lower perioperative morbidity (B = -5.5, p = 0.02) after adjustment for baseline HRQL, age, and gender. In a subset of patients classified as 'symptomatic', as determined by higher MLHF scores, the HRQL scores were increased to age norms and surpassed the heart disease norms. Patients who undergo AVR can expect excellent clinical and HRQL outcomes, with greater benefits the earlier the surgery is carried out. The tracking of HRQL is valuable in understanding the success of a procedure from the patients' perspective.
Ad N.,Inova Heart and Vascular Institute |
Holmes S.D.,Inova Heart and Vascular Institute
Journal of Thoracic and Cardiovascular Surgery | Year: 2014
Objective One of the challenges that exists when discussing the Cox maze procedure for atrial fibrillation (AF) with patients is predicting the success for a given patient. The purpose of the present study was to develop a scoring system using well-established clinical factors to predict the probability of sinus rhythm (SR) after surgery. Methods The data from patients 1 and 2 years postoperatively were analyzed using logistic regression to predict SR, including the most accepted variables associated with failure (age, left atrium size, AF duration, AF type). Regression models were applied using hypothetical patients to examine the predicted probability of SR. Results The predictors of 1-year SR were a shorter AF duration and greater surgeon experience performing surgical ablation. The predictors at 2 years were a shorter AF duration and smaller left atrium. The 1-year prediction model applied to hypothetical data found a 1-cm increase in left atrial size associated with a 0.4% reduction in SR probability, a 5-year increase in AF duration associated with a 0.8% reduction, and a reduction by 50 cases of surgeon experience associated with a 1.0% reduction. The 2-year model found a 1-cm increase in left atrial size associated with a 1.0% reduction in SR probability, a 5-year increase in AF duration associated with a 0.8% reduction, and a reduction by 50 cases of experience associated with a 0.2% reduction. Conclusions Our findings are the first step in establishing a risk scoring system to better predict the outcomes after surgical ablation for AF and improve the ability to discuss the risk and benefits with patients. © 2014 by The American Association for Thoracic Surgery.
Hunt S.,Inova Heart and Vascular Institute
Journal for healthcare quality : official publication of the National Association for Healthcare Quality | Year: 2011
Improving outcomes is a central theme in the national healthcare reform discussions and the ongoing debate centers on ways to limit escalating costs while maintaining excellent patient outcomes. Facilities need to be able to make sense of their "numbers," implement appropriate change in practice, evaluate the impact of this change, and understand what the new numbers are really conveying to the public. The need for a dynamic, longitudinal data system that allows rapid response to new insights and discoveries must be available on a local level. Atrial fibrillation, an electrical conduction disorder of the heart that carries significant morbidity with its onset, is a chronic condition that currently affects over 2 million people in the United States. Our institute has performed over 450 surgeries for atrial fibrillation and is one of the few facilities nationwide that offers surgery for atrial fibrillation. As an exemplar, we describe our experience with the establishment of a database process that links hospital databases together as well as creates a patient's longitudinal record of follow-up that includes later events, interventions, and outcomes out to 5 years. Furthermore, we discuss how these data have changed our practice and go beyond the reporting of just numbers. © 2011 National Association for Healthcare Quality.