Search

Objectives This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). Background Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. Methods The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Results SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p Conclusions Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

Background End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. Methods The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. Results Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm 2 , mean gradient 9.33 mm Hg) Conclusions Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.

Inferior vena cava (IVC) syndrome is commonly caused by deep vein thrombosis or a mass effect. We present an unusual case of IVC kinking and obstruction detected by echocardiography and confirmed by cardiac magnetic resonance and angiography. Management of marked tortuosity of the IVC secondary to a paralyzed hemidiaphragm is discussed. (Level of Difficulty: Beginner.), Graphical abstract, Inferior vena cava (IVC) syndrome is commonly caused by deep vein thrombosis or a mass effect. We present an unusual case of IVC kinking and…

Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up ( P =0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01675440.

Background Gait speed, as a measure of physical function and marker of frailty, is now routinely screened when evaluating patients with aortic stenosis (AS) for transcatheter aortic valve implantation (TAVI). Assessment of physical function is important to identify patients for whom TAVI may be futile and to assign patients to a procedural risk category. After TAVI, patients may exhibit physical resilience (improvement in physical function) or vulnerability (worsening). Characterizing the trajectory and clinical consequences of physical function after TAVI represent knowledge gaps in the field. Purpose Evaluate associations between physical resilience (improved gait speed) vs vulnerability (decline) after TAVI and subsequent death/hospitalization. Methods The REPRISE III trial compared a mechanically-expanded vs a self-expanding valve in 912 high/extreme risk patients with symptomatic AS. Patients (n=587) who underwent valve implantation and who had a gait speed recorded both pre- and 1-year post-TAVI were analyzed. Gait speed is based on the 5m walk test (slow: 5m in >6s, Results A clinically-meaningful improvement (≥0.1m/s), no change (±0.1m/s), or decline (≥0.1/ms) in gait speed 1 year after TAVI was observed in 39%, 36%, and 26% of patients, respectively. Among the 4 groups defined by pre- and 1-year post-TAVI gait speeds, 1 to 2 year mortality or hospitalization rates were: 6.6% (normal/normal), 20.9% (normal/slow), 8.0% (slow/normal), and 21.5% (slow/slow). Adjusted hazard ratios of the 2 models are shown (Table). Table. Outcome by Change in Gait Speed Death/Hospitalization P-value Death P-value Hospitalization P-value Adjusted HR [95% CI] Adjusted HR [95% CI] Adjusted HR [95% CI] Model 1: Baseline/1 year Gait Speed (Normal/Normal (n=150) [referent]) Normal/Slow (n=59) 3.82 [1.61, 9.08] Conclusion These data reveal there is marked heterogeneity in the trajectory of physical function after TAVI and that this trajectory–more so than baseline physical function–is clinically consequential. Identifying and optimizing factors associated with physical resilience after TAVI may improve outcomes. Acknowledgement/Funding Boston Scientific

Objectives We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis. Background The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli. Methods Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed. Results One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 ± 8 years, 5.4 ± 5%, and 8.2 ± 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 ± 0.6 m/s, mean AV gradient was 38 ± 13 mmHg, AV area was 0.79 ± 0.23 cm2 ; calcium score was 3,503 ± 1,970 Agatston units, and perimeter was 85 ± 4.3 mm. Device implantation was successful in all but one patient. Postprocedure mean AV peak velocity, AV mean gradient, and AV area were 1.9 ± 0.4 m/s, 7 ± 3 mmHg, and 2.6 ± 0.7 cm2 , respectively. New pacemaker requirement rate was 16%, and moderate paravalvular leak was present in six patients (3%), which improved to mild in three patients at 6-month follow-up. In-hospital, 30-day, 6-month, and 12-month survival rates were 98%, 96% (hospital discharge), 96% (30-day), 89% (6-month), and 83% (12-month). Conclusion These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.

Although mild to moderate mitral regurgitation is common in cardiac amyloidosis (CA), severe mitral regurgitation as the primary presenting finding is rare [(1)][1]. We present 3 such cases of patients with severe mitral regurgitation who on further workup were discovered to have CA [(2)][2] ([

Purpose: Access site complications following peripheral vascular intervention (PVI) are associated with prolonged hospitalization and increased mortality. Prediction of access site complication risk may optimize PVI care; however, there is no tool designed for this. We aimed to create a clinical scoring tool to stratify patients according to their risk of developing access site complications after PVI. Methods: The Society for Vascular Surgery’s Vascular Quality Initiative database yielded 27,997 patients who had undergone PVI at 131 North American centers. Clinically and statistically significant preprocedural risk factors associated with in-hospital, post-PVI access site complications were included in a multivariate logistic regression model, with access site complications as the outcome variable. A predictive model was developed with a random sample of 19,683 (70%) PVI procedures and validated in 8,314 (30%). Results: Access site complications occurred in 939 (3.4%) patients. The risk tool predictors are female gender, age > 70 years, white race, bedridden ambulatory status, insulin-treated diabetes mellitus, prior minor amputation, procedural indication of claudication, and nonfemoral arterial access site (model c-statistic = 0.638). Of these predictors, insulin-treated diabetes mellitus and prior minor amputation were protective of access site complications. The discriminatory power of the risk model was confirmed by the validation dataset (c-statistic = 0.6139). Higher risk scores correlated with increased frequency of access site complications: 1.9% for low risk, 3.4% for moderate risk and 5.1% for high risk. Conclusions: The proposed clinical risk score based on eight preprocedural characteristics is a tool to stratify patients at risk for post-PVI access site complications. The risk score may assist physicians in identifying patients at risk for access site complications and selection of patients who may benefit from bleeding avoidance strategies.

Patient-prosthesis mismatch (PPM) is common after aortic valve replacement but its significance is controversial. Though PPM has been linked to worse outcomes post SAVR, its impact after TAVR is still unclear. We present 3-year outcomes in REPRISE III by degree of PPM. In REPRISE III, 912 patients

High-degree atrioventricular (HD-AVB) block is frequently seen post transcatheter aortic valve replacement (TAVR) with right ventricular pacing induced cardiomyopathy being a potential long-term complication. A retrospective review of 59 patients (32 women, 27 men) who underwent permanent pacemaker

Current evidence shows that patients with acute ST-segment elevation myocardial infarction (STEMI) experience delay in primary percutaneous coronary intervention (PPCI) when they present to the hospital during off-hours (weekends and/or nights) compared with regular hours. We studied the impact of a

Many patients with inferior vena cava filters (IVCF) never have them retrieved and there are no well validated studies examining IVCF retrieval rates and clinical events in patients with abandoned IVCF. In this retrospective cohort study, we evaluate differences in the rates of venous

Immune checkpoint inhibitors (ICI) can manifest as toxicity in the form of autoimmune, breakthrough or immune-related adverse events. A 59-year-old woman presented with worsening dyspnea on exertion for 1 week. Her medical history was significant for non-small cell lung carcinoma treated with

A case of a 56-year-old woman with normal coronaries displays the side-to-side motion of the unengaged catheter followed by the rhythmic up-and-down, piston-like movements of the catheter tip after engagement.

CoreValve is widely used in transcatheter aortic valve replacement, but the impact of its deployment location on hemodynamics is unexplored despite a potential role in subsequent aortic and coronary artery pathologies. The objectives of this investigation were to perform fluid-structure interaction (FSI) simulations for a 29 mm CoreValve deployed in annular vs supra-annular locations, and characterize resulting hemodynamics including velocity and wall shear stress (WSS). Patient-specific geometry was reconstructed from computed tomography scans and CoreValve was deployed using a finite element approach. FSI simulations were then performed using a boundary conforming method and realistic boundary conditions. Results showed that CoreValve deployment location impacts hemodynamics in the ascending aorta and flow patterns in the coronary arteries. During peak-systole, annularly deployed CoreValve produced a jet-like flow structure impinging on the outer-curvature of the ascending aorta. Supra-annularly deployed CoreValve having a lateral tilt of 10° led to a more centered jet impinging further downstream. At mid-systole, valve leaflets of the annularly deployed CoreValve closed asymmetrically leading to disorganized flow patterns in the ascending aorta vs those from the supra-annular position. Supra-annularly deployed CoreValve also led to high-velocity para-valvular flow supplying the coronary arteries. CoreValve in the supra-annular position significantly (P

Purpose: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass graft surgery (CABG) in patients with unprotected left main or three-vessel coronary artery disease (LM-3VD) have excluded patients at high surgical risk. We compared clinical outcomes after PCI with drug-eluting stents to CABG in high surgical risk patients with LM-3VD. Methods: Patients with symptomatic LM-3VD who had Society of Thoracic Surgeons (STS)-predicted operative mortality > 5% and were undergoing either PCI with drug-eluting stents or CABG at a tertiary care center from January 2009 to December 2010 were enrolled in this nonrandomized prospective study. Results: Mean STS score was 14.5 ± 5.8% for PCI (n=83) vs. 13.6 ± 7.1% for CABG (n=187) (P=0.31). After mean follow-up of 37 months, incidence of the composite primary endpoint (death, myocardial infarction or stroke) was 42.2% for PCI and 39.6% for CABG (P=0.69, hazard ratio 1.3, 95% confidence interval 0.5-2.8). There were no differences in the individual components of the primary endpoint between PCI and CABG. Repeat revascularization was 30.1% for PCI vs. 9.6% for CABG (P=0.001). Major adverse cardiac and cerebrovascular event rates were similar between PCI and CABG, 50.6% vs. 42.2%, respectively (P=0.23). Patients in the PCI group were less likely than those in the CABG group to be discharged to a nursing home (12.1% vs. 47.1%, P 5%.

Study Objectives To estimate periprocedural bleeding risk before elective percutaneous coronary intervention (PCI) by using a point-of-care bleeding risk calculator and to document changes in anticoagulant use and bleeding complications after implementation of use of this calculator. Design Prospective observational pilot study with a historical control cohort. Setting Tertiary care medical center. Patients The pilot cohort consisted of 100 patients undergoing ad hoc PCI during elective cardiac catheterization procedures between January and May 2013, whose bleeding risk and accompanying PCI anticoagulant recommendations were determined by the use of a pre-PCI point-of-care bleeding risk calculator. The historical control cohort consisted of all patients who underwent elective PCI at the same facility between April 1, 2011, and March 31, 2012, before implementation of use of the bleeding risk calculator. Measurements and Main Results The pre-PCI bleeding risk calculator distinguished patients in the pilot cohort as high risk (score 12 or higher) or low risk (lower than 12) for bleeding after a PCI procedure. The primary outcome was bivalirudin use in the pilot cohort compared with its use in the historical control cohort. Implementation of the bleeding risk calculator significantly decreased bivalirudin use compared with bivalirudin use in the historical control cohort (87% in the control cohort vs 60% in the pilot cohort, p

ObjectivesThis study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS).MethodsPatients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up.ResultsAt 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (−38.2 mL; 95% CI −55.0 to –21.4; pConclusionsThe EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up.Trial registration numberNCT01940120.

Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option.The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year.We identified 394 matched pairs of IF and DA patients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p = 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p0.001) and at 1 year (30.4% vs 24.2%, p = 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p0.001).When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.

Excessive cardiac fibrosis, characterized by increased collagen-rich extracellular matrix (ECM) deposition, is a major predisposing factor for mechanical and electrical dysfunction in heart failure (HF). The human ventricular fibroblast (hVF) remodeling mechanisms that cause excessive collagen deposition in HF are unclear, although reports suggest a role for [Ca2+]i in fibrosis. Therefore, we determined the association of differences in cellular Ca2+ dynamics and collagen secretion/deposition between hVFs from failing and normal (control) hearts. Histology of left ventricle sections (Masson trichrome) confirmed excessive fibrosis in HF vs normal. In vitro, hVFs from HF showed increased secretion/deposition of soluble collagen in 48 hours of culture compared with control [85.9±7.4 μg/106 vs 58.5±8.8 μg/106 cells, P

Purpose: Coronary artery bypass graft is the standard treatment for unprotected left main disease; however, some patients are poor surgical candidates due to comorbidities. We assessed the safety and clinical outcome of elective, unprotected left main coronary artery stenting in nonsurgical patients. Methods: Between October 2004 and June 2006, 50 consecutive patients underwent elective, unprotected left main coronary artery stenting at our institution. Patients were followed for a median of 16 and 96 months and clinical outcomes monitored. Results: Median logistic euroSCORE was 28.6 (interquartile range: 14.6-43.4). Median baseline left ventricular ejection fraction (LVEF) was 50%. Procedural success rate was 100%. The rates of cerebrovascular accident, myocardial infarction, target vessel revascularization and cardiovascular death were 2%, 4%, 4% and 2%, respectively, at 30 days, 2%, 6%, 6% and 2% at 16 months, and 2%, 6%, 12% and 4% at 96 months. Major adverse cardiac and cerebrovascular event rate was 12% at 30 days, 16% at 16 months and 24% at 96 months. Median LVEF at 16 months was 55%, significantly improved from baseline (P

Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274)

Immune thrombocytopenic purpura (ITP), also known as idiopathic thrombocytopenic purpura, is an acquired immune-mediated disease of adults and children characterized by a transient or persistent decrease of platelets and, depending upon the degree of thrombocytopenia, an increased risk of bleeding. The use of standard treatments for acute myocardial infarction (AMI), such as antiplatelet agents and anticoagulants, pose serious problems in patients with ITP due to the potential higher risk of bleeding complications. There are no current guidelines available for management of ITP patients with AMI. In this brief review of the limited available literature, we discuss the proposed pathophysiological link between ITP and arterial thrombosis and the challenging medical and interventional treatment of these patients. (J Patient-Centered Res Rev.

Many new devices and techniques are being developed to attempt a reduction in embolic stroke risk for patients with atrial fibrillation who are either unable or unwilling to maintain long-term anticoagulation. One of these new devices (LARIAT®, SentreHEART Inc., Redwood City, California, USA) employs delivery of an epicardial suture to ligate the left atrial appendage after percutaneous pericardial and transseptal access. This series presents three clinical cases that demonstrate a serious and recurrent complication of left atrial laceration and cardiac tamponade shortly following delivery of an epicardial suture ligation to the left atrial appendage. Three clinical cases are described in detail with pre- and postprocedure angiography and echocardiography as well as illustrations reflecting the surgeon's findings on direct visualization of the left atrial lacerations postligation. Potential hypotheses of each injury are examined in light of the case timelines and findings at sternotomy. There was no suggestion that tamponade was related to pericardial or transseptal access, but rather a complication with device delivery. These three patients quickly progressed to clinical cardiac tamponade despite attempted drainage, stressing the importance of cardiovascular surgery backup, including a cardiopulmonary bypass pump, when delivering novel, percutaneous ligation devices for the left atrial appendage.

REPRISE III is the first large randomized comparison of 2 TAVR platforms: the mechanically-expanded Lotus valve (Boston Scientific, Marlborough, Massachusetts) and self-expanding CoreValve (CV) (Medtronic, Dublin, Ireland). In aortic stenosis patients with high/extreme surgical risk, Lotus was

Obstructive coronary artery disease (OCAD) is frequently found in the workup of severe aortic valve stenosis (AS), and bypass is routinely performed during surgical aortic valve replacement. Clinical equipoise remains for OCAD management prior to transcatheter aortic valve replacement (TAVR). A

The current guideline for optimal sizing in self-expanding (Medtronic Core, Evolut R and Pro) transcatheter aortic valve replacement (TAVR) is between 10-20% oversizing, measured by aortic valve perimetry equation applied to CT data. This recommendation is based on limited data to achieve the lowest

The 34 mm EVOLUT R (Medtronic, Minneapolis, MN) self-expanding transcatheter aortic valve replacement (TAVR) was designed to treat patients with larger annuli. We describe clinical and procedural outcomes with this prosthesis in the largest single-center experience to date. Clinical, demographic

Coronary artery ectasia (CAE) is a rare anomaly that can present at any age. Predisposing risk factors include Kawasaki disease in a younger population and atherosclerosis in an older generation. We present a unique case of a young woman diagnosed with multivessel CAE in the setting of acute

ObjectivesThis study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation.BackgroundTranscatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial.MethodsPatients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up.ResultsAt 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years.ConclusionsPatients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; NCT00209274)

Objective To report the efficacy and safety of the Outback® LTD® Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER). Background Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable. Methods A retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied. Results A total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication. Conclusion Use of Outback® LTD® Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown. © 2012 Wiley Periodicals, Inc.

To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency.In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio2.5.At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs20 cm). The 30-day major adverse event rate was 0.8%.The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.

Background— The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Methods and Results— Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0–10 days; 4.1% of strokes) and a late phase (11–365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (2 ), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. Conclusions— Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. Clinical Trial Registrations— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT01240902, NCT01531374.

Recent studies have suggested that fractional flow reserve (FFR) measurement can be avoided by using similar ranges of baseline mean coronary pressure (Pd) to mean aortic pressure (Pa) ratio (0.88-0.95). Further studies have suggested that too many significant coronary stenoses are misclassified based on these ranges. We hypothesized that with a certain range of baseline Pd/Pa, 100% positive predictive value (PPV) and negative predictive value (NPV) can be achieved to avoid misclassification.We retrospectively evaluated the pressure tracings of 555 consecutive intermediate coronary stenotic lesions that had undergone FFR measurement in the cardiac catheterization laboratory of a tertiary-care center. The baseline Pd/Pa was manually measured and correlated with final FFR. The operating test characteristics were calculated using an abnormal FFR of ≤0.80 as the criterion standard for the presence of hemodynamic, significant coronary stenosis.The area under the receiver-operating characteristics curve of baseline Pd/Pa for predicting FFR was 0.89, very similar to published results for instantaneous wave-free ratio and Pd/Pa. However, a significant number of lesions were mischaracterized (ie, using a baseline Pd/Pa of ≤0.88 to0.95, there were 22 misclassifications, with 6 false-positive and 16 false-negative results). At a Pd/Pa of ≤0.86, 100% PPV was achieved, and 100% NPV was achieved at1.00.A baseline Pd/Pa of ≤0.86 is associated with a PPV of 100%, which can avoid the misclassification errors seen in prior studies. This provides a more clinically useful application of baseline Pd/Pa.

Background and objective: We designed an algorithm to identify abdominal aortic aneurysm cases and controls from electronic health records to be shared and executed within the “electronic Medical Records and Genomics” (eMERGE) Network. Materials and methods: Structured Query Language, was used to script the algorithm utilizing “Current Procedural Terminology” and “International Classification of Diseases” codes, with demographic and encounter data to classify individuals as case, control, or excluded. The algorithm was validated using blinded manual chart review at three eMERGE Network sites and one non-eMERGE Network site. Validation comprised evaluation of an equal number of predicted cases and controls selected at random from the algorithm predictions. After validation at the three eMERGE Network sites, the remaining eMERGE Network sites performed verification only. Finally, the algorithm was implemented as a workflow in the Konstanz Information Miner, which represented the logic graphically while retaining intermediate data for inspection at each node. The algorithm was configured to be independent of specific access to data and was exportable (without data) to other sites. Results: The algorithm demonstrated positive predictive values (PPV) of 92.8% (CI: 86.8-96.7) and 100% (CI: 97.0-100) for cases and controls, respectively. It performed well also outside the eMERGE Network. Implementation of the transportable executable algorithm as a Konstanz Information Miner workflow required much less effort than implementation from pseudo code, and ensured that the logic was as intended. Discussion and conclusion: This ePhenotyping algorithm identifies abdominal aortic aneurysm cases and controls from the electronic health record with high case and control PPV necessary for research purposes, can be disseminated easily, and applied to high-throughput genetic and other studies.

Objectives This study aimed to compare the association of access site complications and the use of unfractionated heparin versus bivalirudin during subinguinal peripheral vascular intervention. Background Compared to unfractionated heparin, bivalirudin has been associated with fewer bleeding complications in patients undergoing percutaneous coronary intervention but more ischemic events. The safety and efficacy of direct thrombin inhibitors in peripheral vascular interventions is not well defined. Methods We compared the incidence of in-hospital access site complications and discharge status among patients in the multicenter, prospective Vascular Quality Initiative registry who underwent peripheral vascular intervention between August 2007 and January 2014 using bivalirudin or unfractionated heparin. Propensity score matching was used to obtain a balanced cohort of 1,524 patients in each treatment group. Results Patients treated with bivalirudin had a significantly lower incidence of access site hematomas (2.4% vs. 3.9%, P = 0.018), shorter post-procedural hospitalization (1.0 vs. 1.2 days, P