Publications by authors named "Stephen Ramee"

62 Publications

Clopidogrel resistance is common in patients undergoing vascular and coronary interventions.

Vascular 2022 Jan 2:17085381211059394. Epub 2022 Jan 2.

Section of Vascular/Endovascular Surgery, Department of Surgery, 81796Ochsner Medical Center-New Orleans, New Orleans, LA, USA.

Objectives: "Clopidogrel resistance," also defined as heightened platelet reactivity (HPR) while on clopidogrel therapy, may lead to a sub-optimal antiplatelet effect and a potential thrombotic event. There is limited literature addressing the prevalence of HPR in a large cohort of patients receiving either coronary or endovascular interventions.

Methods: In a large integrated healthcare system, patients with a P2Y12 reaction units (PRU) test were identified. HPR was defined as a PRU ≥ 200 during clopidogrel therapy. Vascular and coronary interventions were identified utilizing CPT codes, HPR prevalence was calculated, and Fischer's exact test was used to determine significance.

Results: From an initial cohort of 2,405,957 patients (October 2014 to January 2020), we identified 3301 patients with PRU tests administered. Of these, 1789 tests had a PRU ≥ 200 (HPR overall prevalence, 54%). We then identified 1195 patients who underwent either an endovascular or coronary procedure and had a PRU measurement. This corresponded to 935 coronary and 260 endovascular interventions. In the coronary cohort, the HPR prevalence was 54% (503/935). In the vascular cohort, the HPR prevalence was 53% (137/260); there was no difference between cohorts in HPR prevalence ( = 0.78).

Conclusion: "Clopidogrel resistance" or HPR was found to be present in nearly half of patients with cardiovascular disease undergoing intervention. Our data suggest HPR is more common in the cardiovascular patient population than previously appreciated. Evaluating patients for HPR is both inexpensive ($25) and rapid (< 10 min). Future randomized studies are warranted to determine whether HPR has a clinically detectable effect on revascularization outcomes.
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http://dx.doi.org/10.1177/17085381211059394DOI Listing
January 2022

Epidemiology, evaluation, and management of conduction disturbances after transcatheter aortic valve replacement.

Prog Cardiovasc Dis 2021 May-Jun;66:37-45

Ochsner Medical Center, New Orleans, LA, United States of America. Electronic address:

Aortic stenosis is the most common valvulopathy requiring replacement by means of the surgical or transcatheter approach. Transcatheter aortic valve replacement (TAVR) has quickly become a viable and often preferred treatment strategy compared to surgical aortic valve replacement. However, transcatheter heart valve system deployment not infrequently injures the specialized electrical system of the heart, leading to new conduction disorders including high-grade atrioventricular block and complete heart block (CHB) necessitating permanent pacemaker implantation (PPI), which may lead to deleterious effects on cardiac function and patient outcomes. Additional conduction disturbances (e.g., new-onset persistent left bundle branch block, PR/QRS prolongation, and transient CHB) currently lack clearly defined management algorithms leading to variable strategies among institutions. This article outlines the current understanding of the pathophysiology, patient and procedural risk factors, means for further risk stratification and monitoring of patients without a clear indication for PPI, our institutional approach, and future directions in the management and evaluation of post-TAVR conduction disturbances.
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http://dx.doi.org/10.1016/j.pcad.2021.06.004DOI Listing
August 2021

Elective Percutaneous Paravalvular Leak Closure Under Conscious Sedation: Procedural Techniques and Clinical Outcomes.

Cardiovasc Revasc Med 2020 10 5;21(10):1291-1298. Epub 2020 Mar 5.

John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA, United States of America. Electronic address:

Background: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays.

Methods: This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review.

Results: A total of 54 PVLs in thirty-seven patients were repaired (65% aortic & 35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72years, P<0.0001) but the two groups shared similar clinical risk factors (P>0.05). Average hospital stay was 1-2days (<1.5days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P=0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30days was 5.4% (two patients).

Conclusion: Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay.
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http://dx.doi.org/10.1016/j.carrev.2020.03.003DOI Listing
October 2020

Transaxillary TAVR Leads to Shorter Ventilator Duration and Hospital Length of Stay Compared to Transapical TAVR.

Curr Probl Cardiol 2021 Mar 22;46(3):100624. Epub 2020 May 22.

John Ochsner Heart and Vascular Center, New Orleans, LA.

There is an increasing need for alternative access in patients with prohibitive surgical risk who have unsuitable anatomy for transfemoral transcatheter aortic valve replacement (TAVR). Data on differences in periprocedural outcomes via alternative access sites are scarce. We performed a retrospective analysis of patients who underwent Transaxillary (TAX) or Transapical (TAP) TAVR at our center from 2012 to 2019. All data was summarized and displayed as mean ± SD for continuous variables and number of patients in each group. A propensity score was created for each patient in the dataset to determine the probability of axillary vs apical access. We adjusted for propensity score using multivariate logistic regression. A total of 102 patients underwent TAVR via alternative access: 28 patients (27%) via TAX and 74 patients (73%) via transapical (TAP) access. The average time to extubation in the TAX group was 5.3 ± 3.5 hours vs 9.1 ± 8.8 hours in the TAP patients (P = 0.03). None of the TAX patients required reintubation compared to 23% of TAP TAVR (P = 0.003). The average hospital length of stay for TAX was 2.4 ± 2.0 days compared to 6.9 ± 3.3 days (P < 0.0001) for TAP. TAX TAVR patients had significantly lower re-intubation rates, shorter time to extubation and in-hospital length of stay, but higher pacemaker implantation rates. TAX TAVR had improved periprocedural outcomes compared to TAP TAVR and remains the preferred TAVR alternative access.
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http://dx.doi.org/10.1016/j.cpcardiol.2020.100624DOI Listing
March 2021

Low risk TAVR: Long- term considerations and appropriate patient selection.

Prog Cardiovasc Dis 2020 May - Jun;63(3):377-382. Epub 2020 Apr 8.

John Ochsner Heart and Vascular Center, New Orleans, LA, USA.

Recent trials have shown impressive results in low-risk patients undergoing Transcatheter Aortic Valve Replacement (TAVR) with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days and have led to a Food and Drug Administration indication for TAVR in these patients. The long-term data on subclinical leaflet thrombosis, valve durability, effects of pacemaker implantation, right ventricular pacing, and progressive paravalvular leak is unclear. We describe clinical and procedural considerations for patient selection and introduce future potential procedural challenges. Finally, we discuss the importance of considering life expectancy and durability prior to TAVR in this low risk relatively young cohort and emphasize the importance of a heart team approach.
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http://dx.doi.org/10.1016/j.pcad.2020.04.002DOI Listing
August 2020

Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke.

Int J Stroke 2018 08 22;13(6):612-632. Epub 2018 May 22.

From the Department of Interventional Radiology (D.S.), The Reading Hospital and Medical Center, 6th and Spruce Sts., West Reading, PA 19612; Department of Radiology (B.B.), Erlanger Medical Center, Chattanooga, Tennessee; Departments of Medicine and Neurology (B.C.V.C.), Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia; Department of Radiology (J.S.C.), West Virginia University, Morgantown, West Virginia; Department of Diagnostic and Therapeutic Neuroradiology (C.C.), Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Toulouse, France; Department of Neurology (D.D.), Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Radiology (M.E.), University of Calgary, Calgary, Alberta, Canada; Department of Neurology (U.F.), Inselspital-Universitätsspital Bern, Bern, Switzerland; Department of Radiology (K.H.), Klagenfurt State Hospital, Klagenfurt am Wörthersee, Austria; Neuroendovascular Program, Department of Radiology (J.A.H.), Massachusetts General Hospital, Boston, Massachusetts; Cerebrovascular Center, Neurological Institute (M.S.H.), Cleveland Clinic, Cleveland, Ohio; Department of Radiology and Neuroradiology (O.J.), Klinik für Radiologie und Neuroradiologie, Kiel, Germany; Departments of Diagnostic Imaging, Neurology, and Neurosurgery (M.V.J.), Warren Alpert School of Medicine at Brown University, Rhode Island Hospital, Providence, Rhode Island; Department of Surgery (A.A.K.).

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http://dx.doi.org/10.1177/1747493018778713DOI Listing
August 2018

Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry®-Get With The Guidelines (GWTG)®.

Am Heart J 2017 Dec 12;194:16-24. Epub 2017 Aug 12.

Section of Cardiovascular Medicine, Yale University School of Medicine, Center for Outcomes Research and Evaluation, Yale New Haven Health System, New Haven, CT. Electronic address:

Background: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality.

Objective: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality.

Methods: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care.

Results: The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%).

Conclusion: The new ACTION Registry-GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models.
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http://dx.doi.org/10.1016/j.ahj.2017.08.004DOI Listing
December 2017

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

Eur Heart J 2018 04;39(15):1224-1245

Imperial College London, London, United Kingdom.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
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http://dx.doi.org/10.1093/eurheartj/ehx211DOI Listing
April 2018

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement.

J Am Coll Cardiol 2017 Apr;69(16):2067-2087

Imperial College London, London, United Kingdom.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
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http://dx.doi.org/10.1016/j.jacc.2017.02.038DOI Listing
April 2017

Echocardiographic Assessment of Degenerative Mitral Stenosis: A Diagnostic Challenge of an Emerging Cardiac Disease.

Curr Probl Cardiol 2017 Mar 10;42(3):71-100. Epub 2017 Jan 10.

Degenerative mitral stenosis (DMS) is characterized by decreased mitral valve (MV) orifice area and increased transmitral pressure gradient due to chronic noninflammatory degeneration and subsequent calcification of the fibrous mitral annulus and the MV leaflets. The "true" prevalence of DMS in the general population is unknown. DMS predominantly affects elderly individuals, many of whom have multiple other comorbidities. Transcatheter MV replacement techniques, although their long-term outcomes are yet to be tested, have been gaining popularity and may emerge as more effective and relatively safer treatment option for patients with DMS. Echocardiography is the primary imaging modality for evaluation of DMS and related hemodynamic abnormalities such as increased transmitral pressure gradient and pulmonary arterial pressure. Classic echocardiographic techniques used for evaluation of mitral stenosis (pressure half time, proximal isovelocity surface area, continuity equation, and MV area planimetry) lack validation for DMS. Direct planimetry with 3-dimensional echocardiography and color flow Doppler is a reasonable technique for determining MV area in DMS. Cardiac computed tomography is an essential tool for planning potential interventions or surgeries for DMS. This article reviews the current concepts on mitral annular calcification and its role in DMS. We then discuss the epidemiology, natural history, differential diagnosis, mechanisms, and echocardiographic assessment of DMS.
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http://dx.doi.org/10.1016/j.cpcardiol.2017.01.002DOI Listing
March 2017

Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.

J Am Coll Cardiol 2017 Feb 29;69(5):511-521. Epub 2016 Oct 29.

National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address:

Background: Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access.

Objectives: The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access.

Methods: A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%.

Results: Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge.

Conclusions: Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).
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http://dx.doi.org/10.1016/j.jacc.2016.10.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291753PMC
February 2017

The Rationale for Performance of Coronary Angiography and Stenting Before Transcatheter Aortic Valve Replacement: From the Interventional Section Leadership Council of the American College of Cardiology.

JACC Cardiovasc Interv 2016 12;9(23):2371-2375

Rush Medical College, Chicago, Illinois. Electronic address:

Transcatheter aortic valve replacement (TAVR) is an effective, nonsurgical treatment option for patients with severe aortic stenosis. The optimal treatment strategy for treating concomitant coronary artery disease (CAD) has not been tested prospectively in a randomized clinical trial. Nevertheless, it is standard practice in the United States to perform coronary angiography and percutaneous coronary intervention for significant CAD at least 1 month before TAVR. All existing clinical trials were designed using this strategy. Therefore, it is wrong to extrapolate current American College of Cardiology/American Heart Association Appropriate Use Criteria against invasive procedures in asymptomatic patients to the TAVR population when evaluating the quality of care by cardiologists or hospitals. In this statement from the Interventional Section Leadership Council of the ACC, it is recommended that percutaneous coronary intervention should be considered in all patients with significant proximal coronary stenosis in major coronary arteries before TAVR, even though the indication is not covered in current guidelines.
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http://dx.doi.org/10.1016/j.jcin.2016.09.024DOI Listing
December 2016

The Unknown Association of PPIs With Chest Pain in Patients With Known, Treated Coronary Artery Disease-A Diagnostic Dilemma.

Curr Probl Cardiol 2016 Jul - Aug;41(7-8):235-244. Epub 2016 Oct 12.

Patients with coronary artery disease (CAD) are destined to lifelong antiplatelet therapy in form of aspirin (acetylsalicylic acid) alone, or in combination with other P2Y2 inhibitors. Proton pump inhibitors (PPIs) are the preferred agents for the treatment and prophylaxis of gastrointestinal injury associated with nonsteroidal anti-inflammatory drug or acetylsalicylic acid or both, but recent data has raised questions about their association with negative cardiovascular events. We report 2 cases of patients with known CAD presented with chest pain mimicking angina pectoris that successfully resolved on discontinuation of the PPIs. One male and one female patient with known history of CAD receiving PPIs were referred to us with symptoms of refractory angina that was unresponsive to conventional optimized medical therapy. The angina was reported to be related to exertion in both the patients. Neither patient had a diagnosis of Prinzmetal angina or peptic ulcer disease; however, both patients reported a history of gastroesophageal reflux disease. Both patients were on dual antiplatelet therapy. No ischemic changes on the electrocardiogram were noted for either patient. Patient 1 had an exercise stress test that was negative for any inducible ischemia whereas patient 2 had no obstructive lesion seen on coronary angiography. Both patients reported to be symptom free after discontinuation of PPIs at 8 months of follow-up. It is our opinion that a relationship between PPIs and angina-like chest pain is plausible, as these 2 cases demonstrate the causative role of PPIs in precipitation of their symptoms. We postulate that this association should be considered in differential diagnosis of chest pain. In light of above findings we suggest that this is hypothesis generating and we are exploring the role of PPIs in patients with history of CAD and refractory angina-like symptoms despite complete revascularization.
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http://dx.doi.org/10.1016/j.cpcardiol.2016.10.001DOI Listing
February 2017

Predicting In-Hospital Mortality in Patients With Acute Myocardial Infarction.

J Am Coll Cardiol 2016 08;68(6):626-635

Saint-Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.

Background: As a foundation for quality improvement, assessing clinical outcomes across hospitals requires appropriate risk adjustment to account for differences in patient case mix, including presentation after cardiac arrest.

Objectives: The aim of this study was to develop and validate a parsimonious patient-level clinical risk model of in-hospital mortality for contemporary patients with acute myocardial infarction.

Methods: Patient characteristics at the time of presentation in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With the Guidelines) database from January 2012 through December 2013 were used to develop a multivariate hierarchical logistic regression model predicting in-hospital mortality. The population (243,440 patients from 655 hospitals) was divided into a 60% sample for model derivation, with the remaining 40% used for model validation. A simplified risk score was created to enable prospective risk stratification in clinical care.

Results: The in-hospital mortality rate was 4.6%. Age, heart rate, systolic blood pressure, presentation after cardiac arrest, presentation in cardiogenic shock, presentation in heart failure, presentation with ST-segment elevation myocardial infarction, creatinine clearance, and troponin ratio were all independently associated with in-hospital mortality. The C statistic was 0.88, with good calibration. The model performed well in subgroups based on age; sex; race; transfer status; and the presence of diabetes mellitus, renal dysfunction, cardiac arrest, cardiogenic shock, and ST-segment elevation myocardial infarction. Observed mortality rates varied substantially across risk groups, ranging from 0.4% in the lowest risk group (score <30) to 49.5% in the highest risk group (score >59).

Conclusions: This parsimonious risk model for in-hospital mortality is a valid instrument for risk adjustment and risk stratification in contemporary patients with acute myocardial infarction.
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http://dx.doi.org/10.1016/j.jacc.2016.05.049DOI Listing
August 2016

Acute Pulmonary Embolism: With an Emphasis on an Interventional Approach.

J Am Coll Cardiol 2016 Mar;67(8):991-1002

Structural and Valvular Heart Disease Program, Ochsner Medical Center, New Orleans, Louisiana.

Compared with recent advances in treatment of serious cardiovascular diseases, such as myocardial infarction and stroke, the treatment and outcome of acute pulmonary embolism (PE) have remained relatively unchanged over the last few decades. This has prompted several experts to call for the formation of multidisciplinary PE response teams with a more proactive approach to the treatment of PE. In the current document, we discuss the formation of such teams and describe the available treatment options beyond anticoagulation, with a focus on the interventional approach. Acknowledging the paucity of data to support widespread adoption of such techniques, we call for the collection of outcomes data in multicenter registries and support for randomized trials to evaluate interventional treatments in patients with high-risk PE.
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http://dx.doi.org/10.1016/j.jacc.2015.12.024DOI Listing
March 2016

A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery.

JACC Cardiovasc Interv 2015 Dec;8(14):1797-806

Columbia University Medical Center, New York, New York.

Objectives: The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.

Background: Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve compared with standard therapy, but the SAPIEN valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile SAPIEN XT system was developed to reduce these adverse events.

Methods: A total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography).

Results: Both overall and major vascular complications were higher at 30 days in patients undergoing TAVR with SAPIEN compared with SAPIEN XT (overall: 22.1% vs. 15.5%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value <0.002); no differences in the other major pre-specified endpoints were found.

Conclusions: In inoperable patients with severe, symptomatic AS, the lower-profile SAPIEN XT is noninferior to SAPIEN with fewer vascular complications and a lesser need for blood transfusion. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves; NCT01314313).
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http://dx.doi.org/10.1016/j.jcin.2015.08.017DOI Listing
December 2015

Cardiac Arrest: A Treatment Algorithm for Emergent Invasive Cardiac Procedures in the Resuscitated Comatose Patient.

J Am Coll Cardiol 2015 Jul;66(1):62-73

Structural and Valvular Heart Disease Program, Ochsner Medical Center, New Orleans, Louisiana.

Patients who are comatose after cardiac arrest continue to be a challenge, with high mortality. Although there is an American College of Cardiology Foundation/American Heart Association Class I recommendation for performing immediate angiography and percutaneous coronary intervention (when indicated) in patients with ST-segment elevation myocardial infarction, no guidelines exist for patients without ST-segment elevation. Early introduction of mild therapeutic hypothermia is an established treatment goal. However, there are no established guidelines for risk stratification of patients for cardiac catheterization and possible percutaneous coronary intervention, particularly in patients who have unfavorable clinical features in whom procedures may be futile and affect public reporting of mortality. An algorithm is presented to improve the risk stratification of these severely ill patients with an emphasis on consultation and evaluation of patients prior to activation of the cardiac catheterization laboratory.
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http://dx.doi.org/10.1016/j.jacc.2015.05.009DOI Listing
July 2015

Budd-Chiari syndrome after liver transplantation resulting from inferior vena cava occlusion at the suture line.

J Cardiol Cases 2015 Mar 6;11(3):73-77. Epub 2015 Jan 6.

Ochsner Medical Center, John Ochsner Heart and Vascular Institute, New Orleans, LA, USA.

A 64-year-old male with Budd-Chiari syndrome (BCS) due to inferior vena cava (IVC) occlusion after liver transplant presented with massive ascites and lower extremity edema. He was found to have chronic total occlusion of the supra-hepatic IVC with thrombosis in the infra-hepatic IVC, hepatic, renal, and iliac veins. Attempts to recanalize the occlusion by multiple operators failed. He was not a surgical candidate. The patient underwent venography of the IVC, and placement of a McNamara catheter for catheter-directed thrombolysis on the first day. The second day, he underwent right internal jugular access with contrast injections to mark the superior aspect of the occlusion via a Multipurpose catheter. An adult transseptal needle (Bard Electrophysiology Division C. R. Bard, Inc., Lowell, MA, USA) was used to create a tract through a 6 French Raabe Sheath and traverse the occlusion. A 10-mm Snare (Cook, Bloomington, IN, USA) cranially retracted the guidewire. Intravascular ultrasound was performed to further delineate the diameter of the IVC at the lesion before dilation with a 6.0 mm × 40 mm PTA balloon and a 10 mm × 29 mm Palmaz Stent (Cordis Corporation, Bridgewater, NJ, USA) deployment. The patient lost 24.6 kg in 2 weeks with resolution of ascites and pedal edema. < This case provides a unique approach to percutaneous intervention of inferior vena cava chronic total occlusion in the setting of Budd-Chiari syndrome post-liver transplant. There was use of an inferior and superior marker followed by use of transseptal needle to transverse the occlusion followed by balloon dilation and stent placement. While the disease and intervention have been described, the use of dual cranial/caudal markers and use of transseptal needle is unique to this particular case.>.
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http://dx.doi.org/10.1016/j.jccase.2014.08.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6279999PMC
March 2015

Anomalous right coronary artery: a case report.

Ochsner J 2014 ;14(2):287-91

John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA.

Background: Anomalous coronary arteries (ACAs) are rare but potentially life-threatening abnormalities of coronary circulation. Most variations are benign; however, some may lead to myocardial ischemia and/or sudden cardiac arrest.

Case Report: We present the case of a patient with a significant medical history of hypertension, hyperlipidemia, type 2 diabetes, obesity, and gastroesophageal reflux disease who presented to the emergency department with atypical chest pain. She underwent a cardiac catheterization that showed an anomalous right coronary artery originating near the anterior left coronary artery sinus and coursing between the pulmonary artery and aorta. The patient was deemed a poor surgical candidate, was discharged home on medical management with beta blocker therapy, and was instructed to restrict her physical activity.

Conclusion: Treatment of significant anomalies should be guided by the nature of the anomalous vessel. Symptomatic patients with ACAs have 3 treatment options: medical management, coronary angioplasty and stent deployment, or surgical correction. These treatment options remain controversial. Some clinicians advocate revascularization, but the long-term benefits of revascularization therapies have not yet been demonstrated.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4052602PMC
June 2014

Acute stroke intervention.

Curr Probl Cardiol 2014 Mar 11;39(3):59-76. Epub 2013 Nov 11.

Ischemic strokes will make up most (>80%) of the three-quarters of a million strokes that will occur in Americans this year. Reperfusion therapy is the fundamental strategy for the treatment of acute ischemic stroke. Reperfusion therapy may be accomplished noninvasively (intravenous thrombolysis) or invasively with catheter-based treatments (intra-arterial thrombolysis, thrombectomy, or angioplasty). Currently, a large majority of patients with acute ischemic stroke do not receive any form of reperfusion therapy owing to their delayed presentation (>3 hours) and lack of skilled man power for on-demand endovascular treatment. Paradoxically, improved success rates for reperfusion have been reported with the newer thrombectomy catheters, called "stentreivers." An option for broadening access for patients who need endovascular therapy would be to use interventional cardiologists with carotid stent experience who can help to provide 24 × 7 × 365 coverage.
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http://dx.doi.org/10.1016/j.cpcardiol.2013.11.004DOI Listing
March 2014

Transcatheter aortic valve implantation in surgically repaired double outlet right ventricle.

Congenit Heart Dis 2014 Sep-Oct;9(5):E153-7. Epub 2013 Jul 19.

Ochsner Clinic Foundation, Jefferson, La, USA.

A 52-year-old male patient, with a medical history of surgically repaired double outlet right ventricle presented with severe aortic stenosis (AS) and hepatitis C with cirrhosis, presented with New York Heart Association Class IV heart failure. During evaluation for a liver transplant, he was deemed a poor surgical candidate due to his aortic valve disease and cirrhosis with model for end-stage liver disease score of 14. Transthoracic echocardiogram showed severe AS with a mean gradient of 62 mm Hg and calculated aortic valve area of 0.74 cm(2) with a normal ejection fraction of 65%. The patient underwent transfemoral implantation of a 23-mm Edwards Sapien commercial heart valve with significant mean gradient reduction across the aortic valve from 62 to 13 mm Hg. The patient was observed in the coronary care unit and discharged home 2 days postprocedure with his clinical symptoms greatly improved.
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http://dx.doi.org/10.1111/chd.12114DOI Listing
June 2015

Multisociety Consensus Quality Improvement Guidelines for Intraarterial Catheter-directed Treatment of Acute Ischemic Stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

AJNR Am J Neuroradiol 2013 Apr;34(4):E0

Department of Interventional Radiology, Reading Hospital and Medical Center, 6th and Spruce Sts., West Reading, PA 19612, USA.

Purpose: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization.

Materials And Methods: Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of Neuro Interventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years.

Results: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days.

Conclusions: Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7964505PMC
April 2013

Multisociety consensus quality improvement guidelines for intraarterial catheter-directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

Catheter Cardiovasc Interv 2013 Aug 3;82(2):E52-68. Epub 2013 May 3.

Department of Interventional Radiology, Reading Hospital and Medical Center, West Reading, PA 19612, USA.

Purpose: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization.

Materials And Methods: Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years.

Results: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days.

Conclusions: Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures.
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http://dx.doi.org/10.1002/ccd.24862DOI Listing
August 2013

Carotid artery stenting: patient, lesion, and procedural characteristics that increase procedural complications.

Catheter Cardiovasc Interv 2013 Nov 9;82(5):715-26. Epub 2013 Aug 9.

Department of Cardiovascular Diseases, Ochsner Clinical School of the University of Queensland, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, Louisiana, 70121.

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.
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http://dx.doi.org/10.1002/ccd.24984DOI Listing
November 2013

Objective simulator-based evaluation of carotid artery stenting proficiency (from Assessment of Operator Performance by the Carotid Stenting Simulator Study [ASSESS]).

Am J Cardiol 2013 Jul 18;112(2):299-306. Epub 2013 Apr 18.

Center for Interventional Vascular Therapy, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.

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.
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http://dx.doi.org/10.1016/j.amjcard.2013.02.069DOI Listing
July 2013

Multisociety consensus quality improvement guidelines for intraarterial catheter-directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

J Vasc Interv Radiol 2013 Feb 28;24(2):151-63. Epub 2013 Jan 28.

Department of Interventional Radiology, Reading Hospital and Medical Center, West Reading, PA 19612, USA.

Purpose: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization.

Materials And Methods: Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years.

Results: In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days.

Conclusions: Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures.
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http://dx.doi.org/10.1016/j.jvir.2012.11.028DOI Listing
February 2013

Elective percutaneous intervention for intracranial atherosclerotic stenoses by interventional cardiologists.

Catheter Cardiovasc Interv 2012 Jul 10;80(1):121-7. Epub 2012 Jan 10.

Department of Cardiovascular Diseases, The John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, Louisiana 70121, USA.

Background: Current "best" medical therapy with anti-platelet and/or anti-thrombotic agents for symptomatic atherosclerotic intracranial (IC) disease is associated with high recurrence. IC catheter-based therapy (CBT) using balloon angioplasty with or without stent placement is an option for patients who have failed medical therapy. We sought to examine the outcomes of CBT for patients with symptomatic IC arterial disease managed by experienced interventional cardiologists.

Methods: We retrospectively studied 89 consecutive symptomatic patients with 99 significant (≥70% diameter) IC arterial stenoses who underwent CBT. CBT was performed by experienced interventional cardiologists with the consultative support of a neurovascular team. The primary endpoint was stroke and vascular death.

Results: Procedure success was achieved in 96/99 (97%) lesions and percent diameter stenosis was reduced from 91% ± 7.5% preprocedure to 19% ± 15% postprocedure (P < 0.001). The rate of in-hospital periprocedural stroke and all death was 3%. The primary endpoint of stroke and vascular death rate at 1 year was 5.7% (5/88) and at 2 years was 13.5% (11/81). The 2-year all-cause mortality was 11.3% (10/88).

Conclusions: For patients with symptomatic IC arterial stenosis who have failed medical therapy or are considered very high risk for stroke, CBT performed by experienced interventional cardiologists is safe and offers both high procedural success rates and excellent clinical outcomes at 1 year. CBT is an attractive option for this high-risk patient population considering the expected 12-15% rate of recurrent stroke at 1 year.
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http://dx.doi.org/10.1002/ccd.23439DOI Listing
July 2012
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