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Despite massive effort and investment in health information systems and technology, the promised benefits of electronic health records (EHRs) are far from fruition. The author presents the legislative programs that encourage the implementation of EHRs and explores the barriers hampering interoperability.

Importance: Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk. Use of TAVR for off-label indications has not been previously reported., Objective: To evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice., Design, Setting and Participants: Patients receiving commercially funded TAVR in the United States are included in the Transcatheter Valve Therapy Registry. A total of 23 847 patients from 328 sites performing TAVR between November 9, 2011, and September 30, 2014, were assessed for this study. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis. Data were linked with the Centers for Medicare & Medicaid Services for 15 397 patients to evaluate 30-day and 1-year outcomes., Exposure: Off-label use of TAVR., Main Outcomes and Measures: Frequency of off-label TAVR use and the association with in-hospital, 30-day, and 1-year adverse outcomes., Results: Among the 23 847 patients in the study (11 876 women and 11 971 men; median age, 84 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%). In-hospital mortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3% vs 4.7%; P < .001), as was 30-day mortality (8.5% vs 6.1%; P < .001) and 1-year mortality (25.6% vs 22.1%; P = .001). Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% CI, 1.04-1.55; P = .02), while adjusted 1-year mortality was similar in the 2 groups (hazard ratio, 1.11; 95% CI, 0.98-1.25; P = .11). The median rate of off-label TAVR use per hospital was 6.8% (range, 0%-34.7%; interquartile range, 3.4%-12.1%), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse cardiovascular events compared with the lowest tertile. However, this difference was not observed in adjusted 30-day or 1-year outcomes., Conclusions and Relevance: Approximately 1 in 10 patients in the United States have received TAVR for an off-label indication. After adjustment, 1-year mortality was similar in these patients to that in patients who received TAVR for an on-label indication. These results reinforce the need for additional research on the efficacy of off-label TAVR use.

The duration of support in patients with HeartMate II implantation as a bridge to transplant or as destination therapy is rising. As clinical experience continues to grow, physiologic changes contributing to pump malfunction are becoming apparent. Once malfunction is noted with increased power spikes, rises in lactate dehydrogenase and low-flow alarms, thrombosis of the pump is at risk. We describe outflow graft compression and offer an expeditious and definitive management strategy. Our novel management stenting strategy for outflow graft compression will continue to evolve as experience is gained., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

We present the primary report of a paediatric patient who had placement of the MitraClip device for severe functional mitral regurgitation. The patient was a 14-year-old boy with symptomatic end-stage non-compaction type cardiomyopathy secondary to a mitochondrial cytopathy. He had severe mitral regurgitation, tricuspid valve regurgitation, a severely dilated LV with apical non-compaction, severe LV dysfunction and severe pulmonary hypertension. Despite optimal medical therapy he developed progressive symptoms of congestive heart failure and he was not a candidate for an assist device or cardiac transplantation. Multimodality imaging with fluoroscopy, two-dimensional and three-dimensional transoesophageal echocardiography was used to guide the procedure. Two MitraClips were placed resulting in an adequate decrease in MR severity to no more than mild-moderate. Five months post MitraClip implantation, he has improved exercise tolerance. Transthoracic echocardiography showed mild to moderate mitral regurgitation and a decrease in left ventricular size. To our knowledge, this is the first reported paediatric patient to be offered this innovative procedure. Percutaneous edge-to-edge MV repair may prove to be a novel and effective palliation to consider in a subgroup of paediatric, adolescent and young adult patients. This case report describes some of the considerations specific to the paediatric patient.

More than a decade of war in the Middle East has pushed post-traumatic stress disorder (PTSD) to the forefront of public health concerns. The author defines the disorder and discusses risk factors, treatments, and the barriers to effective care.

Atrial fibrillation is prevalent and percutaneous left atrial appendage (LAA) closure is increasingly performed worldwide. This procedure is technically challenging and the success and procedural complexities depend on anatomy of the LAA and surrounding structures. These are readily depicted on cardiac computed tomography angiography (CCTA), which offers unique imaging planes. CCTA allows not only preplanning anatomic LAA assessment, but can also be used to evaluate for pre-existing LAA thrombus, and done postprocedure for surveillance for device-related thrombus, residual leak, and complications. In this article, we review the practical utility of CCTA for LAA closure., (Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

A 71-year-old man presented with New York Heart Association (NYHA) class IV heart failure. He had undergone transapical mitral valve replacement for mixed mitral stenosis and mitral regurgitation. At the 1 month follow-up, the patient reported symptom resolution. An echocardiogram revealed a low gradient and no regurgitation. Our case shows that with careful multidisciplinary evaluation, preoperative planning, and patient selection, percutaneous mitral intervention can become an alternative therapy for high-risk patients who cannot undergo conventional surgical therapy., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The comparative effectiveness of percutaneous closure of patent foramen ovale (PFO) plus medical therapy versus medical therapy alone for cryptogenic stroke is uncertain., Objectives: The authors performed the first pooled analysis of individual participant data from completed randomized trials comparing PFO closure versus medical therapy in patients with cryptogenic stroke., Methods: The analysis included data on 2 devices (STARFlex [umbrella occluder] [NMT Medical, Inc., Boston, Massachusetts] and Amplatzer PFO Occluder [disc occluder] [AGA Medical/St. Jude Medical, St. Paul, Minnesota]) evaluated in 3 trials. The primary composite outcome was stroke, transient ischemic attack, or death; the secondary outcome was stroke. We used log-rank tests and unadjusted and covariate-adjusted Cox regression models to compare device closure versus medical therapy., Results: Among 2,303 patients, closure was not significantly associated with the primary composite outcome. The difference became significant after covariate adjustment (hazard ratio [HR]: 0.68; p = 0.049). For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 (p = 0.043) and 0.58 (p = 0.044), respectively. In analyses limited to the 2 disc occluder device trials, the effect of closure was not significant for the composite outcome, but was for the stroke outcome (unadjusted HR: 0.39; p = 0.013). Subgroup analyses did not identify significant heterogeneity of treatment effects. Atrial fibrillation was more common among closure patients., Conclusions: Among patients with PFO and cryptogenic stroke, closure reduced recurrent stroke and had a statistically significant effect on the composite of stroke, transient ischemic attack, and death in adjusted but not unadjusted analyses., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral valve therapy requires an in-depth understanding of the mitral valve apparatus (annulus, leaflets, chordae tendinae, and papillary muscles) and the impact of various disease states. Adjacent structures (left atrium, left ventricular outflow tract, aortic valve, coronary sinus, and circumflex artery) must also be respected. This article reviews the anatomy and function of the normal and diseased mitral valve apparatus and the implications for catheter-based intervention., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Transcatheter mitral valve implantation (TMVI) represents a promising approach to treating mitral valve regurgitation in patients at increased risk of perioperative mortality. Similar to transcatheter aortic valve replacement (TAVR), TMVI relies on pre- and periprocedural noninvasive imaging. Although these imaging modalities, namely echocardiography, computed tomography, and fluoroscopy, are well established in TAVR, TMVI has entirely different requirements. Approaches and nomenclature need to be standardized given the multiple disciplines involved. Herein we provide an overview of anatomical principles and definitions, a methodology for anatomical quantification, and perioperative guidance., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement is being used with increasing frequency in patients with severe aortic stenosis who are otherwise deemed to be at high surgical risk. Aortic dissection is a rare complication of transcatheter aortic valve replacement and poses a unique management dilemma. We describe the treatment of an acute Stanford type A aortic dissection after transcatheter aortic valve replacement with a modified thoracic endovascular stent graft in a 95-year-old woman., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The Affordable Care Act, which recently survived a second Supreme Court challenge, has increased health care access without causing most of the disruption critics feared.

After killing more than 11,000 people in West Africa, the largest known outbreak of the deadly Ebola virus has largely subsided-but development of effective antiviral countermeasures remains a concern. Several experimental products show promise.

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Stem cell therapies offer great promise for a wide range of diseases and conditions. However, stem cell research-particularly human embryonic stem cell research-has also been a source of ongoing ethical, religious, and political controversy.

Objectives: This study sought to identify predictors of recurrent ischemic neurologic events within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial., Background: The CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using the STARFlex device was not superior to medical therapy in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO., Methods: The CLOSURE I trial is a multicenter, randomized trial of transcatheter PFO closure compared with medical therapy in patients who presented with cryptogenic stroke or TIA and had a PFO. We identified clinical predictors of recurrent ischemic stroke or TIA during 2 years of follow-up using Cox proportional hazards regression within the pooled intention-to-treat cohort., Results: In 909 patients, the incidence of recurrent events was 5.7% with 25 patients suffering a recurrent stroke and 30 a TIA. Patients who had a recurrent event had higher body mass index (30.2 ± 6.2 vs. 28.3 ± 5.8%; p = 0.03) and more frequently had diabetes (19.2% vs. 7.1%; p = 0.0016), hypertension (46.2% vs. 30.1%; p = 0.015), and ischemic heart disease (3.8% vs. 0.9%; p = 0.05). Diabetes (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.69 to 6.84; p = 0.0007), index TIA (HR vs. stroke: 2.13; 95% CI: 1.20 to 3.80; p = 0.01), and the detection of atrial fibrillation after study enrollment (HR: 4.85; 95% CI: 2.05 to 11.47; p = 0.0003) independently predicted recurrent ischemic neurologic events. Recurrent neurologic events were more frequent in subjects with RoPE (Risk of Paradoxical Embolism) score ≤5 than those with >5 (14.5% vs. 4.2%; p < 0.0001)., Conclusions: These findings suggest an alternative etiology to paradoxical embolism was frequently responsible for recurrent events within the CLOSURE I trial. (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) [CLOSURE I]; NCT00201461)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The MitraClip® system is a newer percutaneous device that has shown promising results but data on its safety and efficacy in low- and high-surgical risk populations continues to evolve. We performed a systematic review of the published studies reporting the safety and efficacy of MitraClip® implantation for treatment of moderate to severe and severe mitral regurgitation (MR)., Methods: Reviewers independently searched for relevant articles in Medline and abstracted clinical information based on pre-defined criteria and end-points. Patients were classified as low- or high-surgical risk for conventional mitral valve (MV) surgery based on Society of Thoracic Surgeons score, EuroSCORE, or surgeon discretion. Primary safety outcome was 30-day mortality and primary efficacy outcomes were freedom from death, ≥3+ MR, and requirement for MV surgery during follow-up., Results: Immediate and long-term outcomes of 16 studies, including 2980 patients (age 73.7 ± 0.6 years; 63.3% males) receiving the MitraClip®, were analyzed. Acute procedural success rate was 91.4% with a procedural mortality of 0.1%. Mortality at 30 days and long-term (310 days) follow-up was 4.2 and 15.8%, respectively and was significantly higher in the high-risk group (P = 0.003 and 0.019, respectively). Incidence of major procedural adverse outcomes was relatively low with blood transfusion accounting for most events. At follow-up, the number of patients with ≥3+ MR reduced from 96.3% to 14.7% (P < 0.001), and those with NYHA class III/IV reduced from 83.2% to 23.4% (P < 0.001)., Conclusion: MitraClip® implantation for moderate to severe or severe MR appears to be safe with a very low procedural mortality. There is significant improvement in functional outcomes although long-term mortality is high, especially in high surgical risk patients., (© 2013 Wiley Periodicals, Inc.)

The inability to reposition or retrieve balloon-expandable transcatheter aortic valves once they have been deployed requires implantation of the valve in the descending aorta or open surgical procedures to extract the valve. We describe the challenging transfemoral delivery of an Edwards Lifesciences Sapien valve wherein we had difficulty crossing the aortic valve and the guidewire position was compromised. We performed a transapical puncture to snare the guidewire and create a left ventricular to femoral wire rail, allowing us to deliver the transfemoral transcatheter valve, salvaging a situation where we would have been required to implant the valve in the descending aorta. We believe this is the first time this technique has been reported and represents an important method to facilitate delivery of transcatheter valves where guidewire support is insufficient or lost.

Objectives: The PRECISE multi-center study demonstrated the safety and feasibility of robotic-enhanced coronary intervention (PCI). We studied the learning curve associated with the robotic PCI approach., Methods: The CorPath 200 robotic system was used to perform clinically indicated PCI. The first 3 cases performed by each interventional cardiologist were considered early-experience cases and subsequent procedures were regarded as advanced-experience cases. We compared procedure efficiency, patient radiation exposure, and clinical outcomes in early and advanced-experience cases., Results: A total of 164 robotic-enhanced PCI procedures were performed, with 60 early-experience cases. Advanced-experience cases were associated with shorter procedure duration (51.3 ± 25.5 min vs. 42.2 ± 16.4 min, P = 0.008) and fluoroscopy time (12.9 ± 7.8 min vs. 10.1 ± 4.8 min, 0.009) as compared to early-experience cases., Conclusions: After performing 3 cases, interventionalists were able to complete robotic-enhanced PCI faster, with reduced radiation, and without compromising safety. The steep learning curve highlights the easy adoption of remote-control robotic technology for PCI.

Background: Patent foramen ovale (PFO) is associated with cryptogenic stroke (CS), although the pathogenicity of a discovered PFO in the setting of CS is typically unclear. Transesophageal echocardiography features such as PFO size, associated hypermobile septum, and presence of a right-to-left shunt at rest have all been proposed as markers of risk. The association of these transesophageal echocardiography features with other markers of pathogenicity has not been examined., Methods and Results: We used a recently derived score based on clinical and neuroimaging features to stratify patients with PFO and CS by the probability that their stroke is PFO-attributable. We examined whether high-risk transesophageal echocardiography features are seen more frequently in patients more likely to have had a PFO-attributable stroke (n=637) compared with those less likely to have a PFO-attributable stroke (n=657). Large physiologic shunt size was not more frequently seen among those with probable PFO-attributable strokes (odds ratio [OR], 0.92; P=0.53). The presence of neither a hypermobile septum nor a right-to-left shunt at rest was detected more often in those with a probable PFO-attributable stroke (OR, 0.80; P=0.45; OR, 1.15; P=0.11, respectively)., Conclusions: We found no evidence that the proposed transesophageal echocardiography risk markers of large PFO size, hypermobile septum, and presence of right-to-left shunt at rest are associated with clinical features suggesting that a CS is PFO-attributable. Additional tools to describe PFOs may be useful in helping to determine whether an observed PFO is incidental or pathogenically related to CS.

Occlusion of the left atrial appendage (LAA) may reduce the risk of stroke in patients with atrial fibrillation (AF). Trials comparing LAA occlusion to warfarin anticoagulation in patients with nonvalvular AF showed a reduction in hemorrhagic stroke, although an increase in safety events due to procedural complications. Long-term follow-up suggests possible superiority of LAA occlusion due to fewer strokes and bleeding events. The superior dosing and safety profiles of the novel oral anticoagulants raise the accepted threshold for safety and efficacy of LAA occlusion procedures, and underscore the need for randomized studies comparing LAA occlusion with these newer anticoagulants., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR)., Background: TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date., Methods: Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively., Results: From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60)., Conclusions: Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Studies have suggested that operator proficiency has a substantial effect on complication rates and procedural outcomes. Endovascular simulators have been used for training and have been proposed as an alternative to the conventional assessment of skills. The present study sought to validate simulation as an objective method for proficiency evaluation in carotid artery stenting. Interventional cardiologists classified as novice, intermediate, or experienced practitioners performed 3 simulated, interactive carotid stenting cases on an AngioMentor endovascular simulator. An automated algorithm scored the participants according to the technical performance, medical management, and angiographic results. A total of 33 interventional cardiologists (8 novices, 15 intermediates, and 10 experts) completed 82 simulated procedures. The composite scores for the case simulations varied significantly by operator experience, with better scores for the more experienced groups (p <0.0001). The metrics that discriminated between operator experience groups included fluoroscopy time, crossing the carotid lesion with devices other than a 0.014-in. wire before filter deployment, and incomplete coverage of the lesion by the stent. In conclusion, the results of the present study validate that a simulator with an automated scoring system is able to discriminate between levels of operator proficiency for carotid artery stenting. Simulator-based performance assessment could have a role in initial and ongoing proficiency evaluations and credentialing of interventional operators of high-risk endovascular procedures., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention., Background: Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice., Methods: Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only., Results: A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non-Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position., Conclusions: This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

By the end of 2012, states must figure out how they will provide exchanges for citizens to buy health care insurance. Much work remains to be done, including removing information barriers, to make health care accessible to all citizens by 2014.

Background: The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke., Methods: We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years., Results: A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events., Conclusions: In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).

The left atrial appendage (LAA) is the primary nonvalvular cause of cardioembolic stroke in patients with atrial fibrillation (AF). Warfarin and direct thrombin inhibitors such as dabigatran are presumed to prevent formation of LAA thrombus, and are first-line treatments to prevent ischemic stroke in AF. However, these medications carry many contraindications such as hemorrhage, and can interact with many drugs and supplements. Epicardial and endovascular techniques for occlusion of LAA are being explored, whether to mitigate the need for anticoagulation in patients at risk of bleeding or as a first-line therapy to reduce the risk of thromboembolic stroke. The purposes of this article are to 1) review the LAA structure and its potential contribution to ischemic stroke; 2) discuss the results of surgical and endovascular trials of LAA occlusion on risk of stroke and adverse events in AF patients; and 3) present early data on devices in development.

Background: Percutaneous coronary intervention (PCI) is used with increasing frequency in patients with diabetes and multivessel disease. This study investigated evolving revascularization strategies in the State of Washington., Methods: The Clinical Outcomes Assessment Program captures all revascularization in the State of Washington and was used to compare diabetic patients with multivessel disease undergoing first-time revascularization from 1999 to 2007. Categorical variables were compared with the chi-squared test and continuous variables were compared with the student's t-test. Results were risk-adjusted using a logistic regression., Results: A total of 11,602 patients with diabetes and multivessel disease underwent revascularization from 1999 to 2007 and were nearly equally divided between coronary artery bypass grafting (CABG) (51%) and PCI (49%). Patients undergoing CABG had a higher (p < 0.0001) prevalence of congestive heart failure, cerebrovascular disease, peripheral vascular disease, three-vessel coronary artery disease (CAD), and intraaortic balloon pump insertion, but a lower prevalence of female gender, cardiogenic shock, and emergency procedures. Patients undergoing CABG had more (p < 0.0001) three-vessel CAD and more complete revascularization (3.7 vs. 1.5 lesions treated). Short-term risk-adjusted mortality was equivalent. The prevalence of PCI increased from 34.1% in 1999 to 59.4% in 2007., Conclusions: PCI is applied with increasing frequency to patients with diabetes mellitus (DM) and multivessel disease. PCI is used most commonly in two-vessel CAD or with acute coronary syndromes with more limited and targeted revascularization. CABG is more commonly applied to extensive disease with more complete revascularization. Both the prevalence and percentage of patients undergoing PCI as primary therapy for multivessel disease with DM is increasing. A multidisciplinary approach may be warranted to ensure optimal outcomes., (© 2010 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to determine 5-year clinical status for patients treated with percutaneous left atrial appendage transcatheter occlusion with the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) system., Background: Anticoagulation reduces thromboembolism among patients with nonvalvular atrial fibrillation (AF). However, warfarin is a challenging medication due to risks of inadequate anticoagulation and bleeding. Thus, PLAATO was evaluated as a treatment strategy for nonwarfarin candidate patients with AF at high risk for stroke., Methods: Sixty-four patients with permanent or paroxysmal AF participated in this observational, multicenter prospective study. Primary end points were: new major or minor stroke, cardiac or neurological death, myocardial infarction, or requirement for cardiovascular surgery related to the procedure within 1 month of the index procedure. Patients were followed for up to 5 years., Results: Thirty-day freedom from major adverse events rate was 98.4% (95% confidence interval: 90.89% to >99.99%). One patient, who did not receive a PLAATO implant, experienced 2 events within 30 days (cardiovascular surgery, death). Treatment success was 100% 1 month after device implantation. At 5-year follow-up, there were 7 deaths, 5 major strokes, 3 minor strokes, 1 cardiac tamponade requiring surgery, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction. Only 1 event (cardiac tamponade) was adjudicated as related to the implant procedure. After up to 5 years of follow-up, the annualized stroke/transient ischemic attack (TIA) rate was 3.8%. The anticipated stroke/TIA rate (with the CHADS(2) scoring method) was 6.6%/year., Conclusions: The PLAATO system is safe and effective. At 5-year follow-up the annualized stroke/TIA rate in our patients was 3.8%/year, less than predicted by the CHADS(2) scoring system.

Background: This study analyzed and quantified perceptions that evolving percutaneous coronary intervention technologies changed referral patterns of patients with coronary artery disease and adversely impacted volumes, risk profiles, and outcomes of patients undergoing coronary artery bypass grafting surgery (CABG)., Methods: Washington State's prospective clinical registry was used to analyze volumes, risk profiles, and outcomes of all patients undergoing isolated CABG and percutaneous coronary intervention., Results: A total of 154,602 revascularization procedures were performed between 1999 and 2007. Total revascularizations procedures (percutaneous coronary intervention plus CABG) increased by 32% (from 14,084 in 1999 to 18,620 in 2007). Compared with 1999, by 2007 CABG volume decreased by 37%, while percutaneous coronary intervention volume increased by 71%. The ratio of percutaneous coronary intervention to CABG increased by 2.7-fold from 1.7:1 to 4.6:1 (p < 0.0001). Three time intervals were compared (1999-2000, 2001-2003, 2004-2007). For patients undergoing CABG, the prevalence of diabetes (28% to 36%), hypertension (66% to 76%), and three-vessel or left main disease (57% to 68%) increased significantly (p < 0.0001 for all). Female sex (28% to 24%), congestive failure (24% to 13%), and smoking (64% to 59%) decreased significantly (p < 0.0001 for all), whereas patients' age, low ejection fraction, and use of intraaortic balloon pump were unchanged. Although mortality (2.4% to 2.2%; p = 0.79), return to the operating room (3.4% to 3.6%; p = 0.41), and need for postoperative hemodialysis (1.2% to 1.0%; p = 0.44) were unchanged, the incidences of stroke (1.9% to 1.3%; p = 0.01), myocardial infarction (1.7% to 0.8%; p < 0.0001), transfusion (40% to 34%; p < 0.0001), and extubation within 6 hours (43% to 60%; p < 0.0001) improved significantly in the past 9 years., Conclusions: Despite significant reduction in both the volume and ratio of patients referred for surgical revascularization, risk profiles of patients undergoing isolated CABG in Washington State changed only modestly. Coronary artery bypass grafting mortality was not adversely affected, and morbidity was reduced.

Objectives: We sought to assess the prevalence of secondary right-to-left circulatory shunt (RLS) in patients undergoing transcatheter closure of patent foramen ovale (PFO) as detected by power M-mode transcranial Doppler (TCD) and intracardiac echocardiography., Background: Prevalence of residual RLS in late follow-up after PFO closure may be as high as 34%. Other cardiac and noncardiac sources of RLS may coexist and obscure PFO closure evaluation., Methods: Eighty-eight patients who underwent transcatheter PFO closure to prevent recurrent paradoxical cerebral embolism between June 2005 and December 2006 were evaluated for a secondary source of RLS. Before device deployment, a sizing balloon was inflated in the PFO tunnel and agitated saline contrast was injected into the inferior vena cava. Clinically significant secondary RLS was defined as >10 embolic tracks on TCD at rest or immediately after calibrated (40 mm Hg), sustained (10 s) respiratory strain, with corresponding negative color-flow Doppler. Late residual RLS was evaluated in all patients with TCD and transthoracic echocardiography (mean: 192 days; 95% confidence interval [CI]: 161 to 223 days)., Results: The sample (n = 84) was 59% female, age 49 +/- 14 years. Seventeen patients (20%; 95% CI: 11.7 to 28.8) had secondary RLS during balloon occlusion. At late follow-up (n = 66), 13 of 14 (93%) patients with secondary RLS and 23 of 52 (44%) patients without secondary RLS had residual RLS (p = 0.002)., Conclusions: This is the first report to systematically assess the prevalence of secondary RLS in patients undergoing PFO closure. Residual RLS detected by TCD may be due to secondary RLS, which may have implications for clinical outcomes.

Published mortality models for percutaneous coronary intervention (PCI), including the Clinical Outcomes Assessment Program (COAP) model, have not considered the effect of out-ofhospital cardiac arrest. The primary objective of this study was to determine if the inclusion of out-of-hospital cardiac arrest altered the COAP mortality model for PCI. The COAP PCI database contains extensive demographic, clinical, procedural and outcome information, including out-of-hospital cardiac arrest, which was added to the data collection form in 2006. This study included 15,586 consecutive PCIs performed in 31 Washington State hospitals in 2006. Using development and test sets, the existing COAP PCI logistic regression mortality model was examined to assess the effect of out-of-hospital arrest on in-hospital mortality. Overall, 2% of individuals undergoing PCI had cardiac arrest prior to hospital arrival. Among 8 hospitals with PCI volumes < 120 cases per year, 4 had cardiac arrest volumes that exceeded 10% of total volume, whereas none of the centers with > 120 cases per year did. In-hospital mortality was 19% in the arrest group and was 1.0% in remaining procedures (p < 0.0001). In the new multivariate model, out-of-hospital cardiac arrest was highly associated with mortality (odds ratio = 5.50; 95% confidence interval [CI] = 3.28-9.25). When evaluated in the test set, the new model had excellent discrimination (c-statistic = 0.89; 95% CI = 0.85-0.93). Out-of-hospital cardiac arrest is an important determinant of risk-adjusted in-hospital mortality for PCI, particularly for hospitals with low volumes and relatively high volumes of cardiac arrest cases.

Background: Recanalization of coronary chronic total occlusions (CTOs) remains a clinical challenge, particularly when standard guidewire attempts fail., Objectives: We sought to determine the safety and efficacy of a novel method that used high-frequency (20 kHz) vibration to fragment occlusive fibrous tissue and facilitate guidewire crossing into the distal vessel., Methods: A total of 125 patients with CTO, who failed at attempts of conventional guidewire recanalization after more than 5 min of fluoroscopy time, were enrolled in the study. The primary efficacy endpoint was the advancement of the CROSSER catheter through the occlusion and attainment of coronary guidewire positioning in the distal coronary lumen. The primary safety endpoint was the occurrence of death, myocardial infarction, clinical perforation, or target vessel revascularization within the first 30 days., Results: The average fluoroscopy time while delivering the CROSSER catheter was 12.4 min. CROSSER-assisted guidewire recanalization was achieved in 76 (60.8%) procedures and a final diameter stenosis <50% was obtained in 68 (54.4%) of cases. Major adverse events occurred in 11 (8.8%) patients, lower than the predefined objective performance criteria. Angina frequency and quality of life were improved in patients with successful guidewire recanalization., Conclusions: We conclude that high-frequency vibration using the CROSSER catheter is a safe and effective therapy for patients with CTO, which are refractory to standard guidewire recanalization., ((c) 2008 Wiley-Liss, Inc.)

Objective: Percutaneous mitral repair is rapidly developing as an alternative to cardiac surgery in select patients. The Evalve percutaneous E2E system uses the MitraClip to replicate the surgical suture-based approach. This procedure requires real-time echocardiographic guidance in a unique and significant collaboration between echocardiographer and interventionalist. transesophageal echocardiography (TEE) is used as the primary imaging modality to guide this procedure and is essential to its success., Methods: In EVEREST I, the US multicenter phase I safety and feasibility trial, 47 patients with 3 or 4+ mitral regurgitation (MR) were enrolled. The trial involved a standardized echocardiographic imaging protocol with a standardized anatomic-based vocabulary, predetermined standard TEE views, preprocedural strategy meetings, and display of echocardiographic aids to optimize communication and procedural efficiency during placement of the clip., Results: TEE guidance facilitated the creation of a double-orifice mitral valve in all 47 patients enrolled (100%), and 40 patients were discharged with 1 or more clips (85%). At discharge, successful placement of a clip and

The objective of the study was to assess differences in proportion of large right-to-left shunt (RLS) and atrial septal characteristics between migraineurs and non-migraineurs referred for transcatheter closure of patent foramen ovale (PF0). This retrospective study took place in a large metropolitan medical centre. The patients were migraineurs with aura (n=52), migraineurs without aura (n=19) and non-migraineurs (n=149). RLS was evaluated before closure using bilateral power m-mode transcranial Doppler at rest and after calibrated, sustained Valsalva manoeuvre, and graded with a validated 0-5 scale. Intracardiac echocardiography was used to assess atrial septal characteristics. Migraineurs had a higher proportion of large RLS (Grade IV or V) than nonmigraineurs at rest and after calibrated Valsalva (rest, p=0.04; Valsalva, p=0.01). Atrial septal characteristics were similar between groups. Migraine is associated with larger RLS at rest and strain; however migraine status does not predict PFO characteristics.

The purpose of the present study was to assess clinical outcomes and closure status after the transcatheter closure of patent foramen ovale. Two hundred thirty-seven consecutive patients (mean age 53 +/- 15 years; 48% men) who underwent patent foramen ovale closure for the prevention of recurrent stroke were evaluated. Primary end points were death, recurrent stroke, and residual right-to-left shunt (RLS). Closure status was monitored at 1, 6, 12, 24, 36, and 48 months after the index procedure by power M-mode transcranial Doppler and was defined by the number of embolic tracks detected after the release of a sustained, calibrated Valsalva maneuver. During a mean follow-up period of 568 +/- 364 days, the cumulative event rate for recurrent stroke (n = 8) was 3.4%, for an estimated event-free survival of 0.94 (SE 0.03). There was a significant difference in the estimated probability of recurrent stroke for patients grouped by age (< or =55 years 1.4% vs >55 years 6.6%, p = 0.03). There were 7 deaths (3.0%), 1 secondary to and 6 unrelated to recurrent strokes, and 3 surgical explantations (1.3%). Event-free survival, defined as freedom from death, stroke, or explantation, was 0.92 (SE 0.02). The magnitude of RLS was significantly less at late follow-up compared with baseline (grade 4.6 +/- 0.7 vs 1.8 +/- 1.6, p <0.001). Complete closure or minimal residual RLS (grade 0 to II) was achieved in 66% of patients. Device type (CardioSEAL or Amplatzer) did not affect the risk for adverse events or the presence of large residual RLS. In conclusion, transcatheter patent foramen ovale closure is associated with a low recurrent stroke rate in long-term follow-up.

Patent foramen ovale (PFO) has been linked to ischemic strokes of undetermined cause (cryptogenic strokes). PFO-a remnant of fetal circulation when the foramen ovale does not seal after birth-can permit microemboli to escape the pulmonary filter into the intracranial circulation, causing stroke. Coexistent atrial septal aneurysm, pelvic deep vein thrombosis and inherited clotting factor deficiencies could potentiate stroke risk in patients with PFO. Transcatheter PFO closure, a minimally invasive procedure, is one technique used to prevent recurrent cerebrovascular events. A connection between PFO and migraine headache has been conceptualized from retrospective evidence of reduced migraine frequency and severity after PFO closure; however, prospective randomized trials are needed to verify the efficacy of PFO closure on migraine prevention. In this review we discuss embryologic origins, diagnostic techniques and treatment options for prevention of paradoxical embolism thought to be related to PFO, and the relation of PFO to cryptogenic stroke and migraine.