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Coronary Artery Disease: HELP
Articles by Evan Shlofmitz
Based on 40 articles published since 2010
(Why 40 articles?)
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Between 2010 and 2020, Evan Shlofmitz wrote the following 40 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Review Second-Generation Drug-Eluting Resorbable Magnesium Scaffold: Review of the Clinical Evidence. 2020

Ozaki, Yuichi / Garcia-Garcia, Hector M / Shlofmitz, Evan / Hideo-Kajita, Alexandre / Waksman, Ron. ·Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. ·Cardiovasc Revasc Med · Pubmed #31662277.

ABSTRACT: Since October 8, 2013, the second-generation drug-eluting resorbable magnesium scaffold (RMS) has been used to treat coronary lesions. At present, the second-generation drug-eluting RMS is clinically available in Europe, some South American countries, and some Asian and African countries. Furthermore, patients are currently being enrolled in ongoing post-marketing trials. This device has the potential to be an alternative to drug-eluting stents in the future, but there is not yet sufficient evidence. This review provides the latest available evidence, comparison with other bioresorbable scaffolds, future perspectives, and discussion of clinical case reports with second-generation drug-eluting RMS. SUMMARY: Favorable outcomes have been reported after second-generation drug-eluting RMS implantation. More long-term clinical outcomes for this novel device are still required in the future.

2 Review Orbital Atherectomy: A Comprehensive Review. 2019

Shlofmitz, Evan / Shlofmitz, Richard / Lee, Michael S. ·MedStar Washington Hospital Center, 110 Irving Street, Suite 4B1, Washington, DC 20010, USA. · St. Francis Hospital- The Heart Center, 100 Port Washington Boulevard, Suite 105, Roslyn, NY 11576, USA. · UCLA Medical Center, 100 Medical Plaza Suite 630, Los Angeles, CA 90095, USA. Electronic address: mslee@mednet.ucla.edu. ·Interv Cardiol Clin · Pubmed #30832940.

ABSTRACT: Successful percutaneous coronary intervention (PCI) can be challenging in the presence of heavily calcified lesions. Severely calcified lesions are associated with worse clinical outcomes. Recognition of calcification is important before stenting to ensure adequate stent expansion can be attained. Orbital atherectomy is a safe and effective method to ablate calcified plaque. Lesion preparation through plaque modification with orbital atherectomy before stent implantation can help to optimize the results of PCI in these complex lesions.

3 Review Algorithmic Approach for Optical Coherence Tomography-Guided Stent Implantation During Percutaneous Coronary Intervention. 2018

Shlofmitz, Evan / Shlofmitz, Richard A / Galougahi, Keyvan Karimi / Rahim, Hussein M / Virmani, Renu / Hill, Jonathan M / Matsumura, Mitsuaki / Mintz, Gary S / Maehara, Akiko / Landmesser, Ulf / Stone, Gregg W / Ali, Ziad A. ·Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY 10032, USA; Department of Cardiology, St. Francis Hospital, 100 Port Washington Boulevard, Suite 105, Roslyn, NY 11576, USA; Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway 9th Floor, New York, NY 10019, USA. · Department of Cardiology, St. Francis Hospital, 100 Port Washington Boulevard, Suite 105, Roslyn, NY 11576, USA. · Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY 10032, USA. · CVPath Institute, 19 Firstfield Road, Gaithersburg, MD 20878, USA. · London Bridge Hospital, 2nd Floor, St Olaf House, London SE1 2PR, UK; Department of Cardiology, King's College Hospital, Denmark Hill, London, SE5 9RS, UK. · Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway 9th Floor, New York, NY 10019, USA. · Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY 10032, USA; Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway 9th Floor, New York, NY 10019, USA. · Department of Cardiology, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, Berlin 12200, Germany. · Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY 10032, USA; Department of Cardiology, St. Francis Hospital, 100 Port Washington Boulevard, Suite 105, Roslyn, NY 11576, USA; Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway 9th Floor, New York, NY 10019, USA. Electronic address: zaa2112@columbia.edu. ·Interv Cardiol Clin · Pubmed #29983145.

ABSTRACT: Intravascular imaging plays a key role in optimizing outcomes for percutaneous coronary intervention (PCI). Optical coherence tomography (OCT) utilizes a user-friendly interface and provides high-resolution images. OCT can be used as part of daily practice in all stages of a coronary intervention: baseline lesion assessment, stent selection, and stent optimization. Incorporating a standardized, algorithmic approach when using OCT allows for precision PCI.

4 Review Utility of intracoronary imaging in the cardiac catheterization laboratory: comprehensive evaluation with intravascular ultrasound and optical coherence tomography. 2018

Parviz, Yasir / Shlofmitz, Evan / Fall, Khady N / Konigstein, Maayan / Maehara, Akiko / Jeremias, Allen / Shlofmitz, Richard A / Mintz, Gary S / Ali, Ziad A. ·Division of Cardiology, Columbia UniversityMedical Center, New York, NY, USA. · Division of Cardiology, Columbia University Medical Center, New York, NY, USA. · Cardiovascular Research Foundation, New York, NY, USA. · St. Francis Hospital, Roslyn, NY, USA. ·Br Med Bull · Pubmed #29360941.

ABSTRACT: Background: Intracoronary imaging is an important tool for guiding decision making in the cardiac catheterization laboratory. Sources of data: We have reviewed the latest available evidence in the field to highlight the various potential benefits of intravascular imaging. Areas of agreement: Coronary angiography has been considered the gold standard test to appropriately diagnose and manage patients with coronary artery disease, but it has the inherent limitation of being a 2-dimensional x-ray lumenogram of a complex 3-dimensional vascular structure. Areas of controversy: There is well-established inter- and intra-observer variability in reporting coronary angiograms leading to potential variability in various management strategies. Intracoronary imaging improves the diagnostic accuracy while optimizing the results of an intervention. Utilization of intracoronary imaging modalities in routine practice however remains low worldwide. Increased costs, resources, time and expertise have been cited as explanations for low incorporation of these techniques. Growing points: Intracoronary imaging supplements and enhances an operator's decision-making ability based on detailed and objective lesion assessment rather than a subjective visual estimation. The benefits of intravascular imaging are becoming more profound as the complexity of cases suitable for revascularization increases. Areas timely for developing research: While the clinical benefits of intravascular ultrasound have been well validated, optical coherence tomography in comparison is a newer technology, with robust clinical trials assessing its clinical benefit are underway.

5 Review Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices. 2017

Shlofmitz, Evan / Martinsen, Brad J / Lee, Michael / Rao, Sunil V / Généreux, Philippe / Higgins, Joe / Chambers, Jeffrey W / Kirtane, Ajay J / Brilakis, Emmanouil S / Kandzari, David E / Sharma, Samin K / Shlofmitz, Richard. ·a Division of Cardiology , Columbia University Medical Center , New York , NY , USA. · b Cardiovascular Research Foundation , New York , NY , USA. · c Department of Clinical and Scientific Affairs , Cardiovascular Systems, Inc. , St. Paul , MN , USA. · d Division of Cardiology , UCLA Medical Center , Los Angeles , CA , USA. · e Duke Clinical Research Institute , Durham , NC , USA. · f Morristown Medical Center , Morristown , NJ , USA. · g Hôpital du Sacré-Coeur de Montréal , Université de Montréal , Montréal , Canada. · h Department of Engineering , Cardiovascular Systems, Inc ., St. Paul , MN , USA. · i Metropolitan Heart and Vascular Institute , Mercy Hospital , Minneapolis , MN , USA. · j Minneapolis Heart Institute , Abbott Northwestern Hospital , Minneapolis , MN , USA. · k Piedmont Heart Institute , Atlanta , GA , USA. · l Division of Cardiology , Mount Sinai Hospital , New York , NY , USA. · m Department of Cardiology , St. Francis Hospital-The Heart Center , Roslyn , NY , USA. ·Expert Rev Med Devices · Pubmed #28945162.

ABSTRACT: INTRODUCTION: The presence of severe coronary artery calcification is associated with higher rates of angiographic complications during percutaneous coronary intervention (PCI), as well as higher major adverse cardiac events compared with non-calcified lesions. Incorporating orbital atherectomy (OAS) for effective preparation of severely calcified lesions can help maximize the benefits of PCI by attaining maximal luminal gain (or stent expansion) and improve long-term outcomes (by reducing need for revascularization). Areas covered: In this manuscript, the prevalence, risk factors, and impact of coronary artery calcification on PCI are reviewed. Based on current data and experience, the authors review orbital atherectomy technique and best practices to optimize lesion preparation. Expert Commentary: The coronary OAS is the only device approved for use in the U.S. as a treatment for de novo, severely calcified coronary lesions to facilitate stent delivery. Advantages of the device include its ease of use and a mechanism of action that treats bi-directionally, allowing for continuous blood flow during treatment, minimizing heat damage, slow flow, and subsequent need for revascularization. The OAS technique tips reviewed in this article will help inform interventional cardiologists treating patients with severely calcified lesions.

6 Clinical Trial Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub-analysis. 2017

Shlofmitz, Evan / Martinsen, Brad / Lee, Michael / Généreux, Philippe / Behrens, Ann / Kumar, Gautam / Puma, Joseph / Shlofmitz, Richard / Chambers, Jeffrey. ·Cardiovascular Research Foundation, New York, New York. · Columbia University Medical Center, New York, New York. · Cardiovascular Systems, Inc., St. Paul, Minnesota. · UCLA Medical Center, Los Angeles, California. · Morristown Medical Center, Morristown, New Jersey. · Hôpital du Sacré-Coeur de Montréal, Montreal, Québec, Canada. · Emory University/Atlanta VA Medical Center, Atlanta, Georgia. · St. Francis Hospital, Roslyn, New York. · Metropolitan Heart and Vascular Institute, Minneapolis, Minnesota. ·J Interv Cardiol · Pubmed #28786143.

ABSTRACT: OBJECTIVES: We sought to assess the clinical outcomes when intravascular ultrasound (IVUS) was used prior to orbital atherectomy treatment (OA) versus angiography alone for lesion assessment. BACKGROUND: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with high rates of major adverse cardiac events (MACE). IVUS provides additional diagnostic information to optimize PCI. METHODS: ORBIT II was a single-arm study of 443 patients with de novo, severely calcified coronary lesions treated with OA before stent placement. Patients with IVUS imaging prior to OA (N = 35) were compared to patients without IVUS imaging for initial lesion assessment (N = 405). In this post-hoc sub-analysis procedural outcomes and the 3-year MACE rate were evaluated. RESULTS: The rates of severe angiographic complications were low in patients with and without IVUS imaging prior to OA. There was a significant reduction in the number of stents used in patients with IVUS imaging prior to OA (1.0 ± 0.2 vs 1.3 ± 0.6; P = 0.006) and increased post-OA mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs 1.2 ± 0.5 mm; P < 0.001). The 3-year MACE rate was similar in both groups (IVUS: 14.3% vs No IVUS: 24.2%; P = 0.26). CONCLUSIONS: There were significantly fewer stents placed, increased post-OA MLD, and similar 3-year MACE outcomes in patients with IVUS assessment of the degree of lesion calcification prior to OA as compared to patients with angiographic assessment of the degree of lesion calcification. Further studies are needed to determine the optimal integration of intravascular imaging with OA.

7 Article Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve? 2020

De Maria, Giovanni Luigi / Garcia-Garcia, Hector M / Scarsini, Roberto / Hideo-Kajita, Alexandre / Gonzalo López, Nieves / Leone, Antonio Maria / Sarno, Giovanna / Daemen, Joost / Shlofmitz, Evan / Jeremias, Allen / Tebaldi, Matteo / Bezerra, Hiram Grando / Tu, Shengxian / Lemos, Pedro A / Ozaki, Yuichi / Dan, Kazuhiro / Collet, Carlos / Banning, Adrian P / Barbato, Emanuele / Johnson, Nils P / Waksman, Ron. ·Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom (G.L.D.M., R.S., A.P.B.). · MedStar Washington Hospital Centre, Interventional Cardiology Department, Washington, DC (Y.O., H.M.G.-G., A.H.-K., E.S., K.D., R.W.). · Interventional Cardiology Department, Hospital Clinico San Carlos, Madrid, Spain (N.G.L.). · Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma (A.M.L.). · Interventional Cardiology Department, Uppsala University, Sweden (G.S.). · Interventional Cardiologist at Erasmus University Rotterdam, the Netherlands (J.D.). · Cardiac Catheterization Laboratory, St. Francis Hospital, Roslyn, NY (A.J.). · Department of Cardiology, University of Ferrara, Italy (M.T.). · University Hospitals of Cleveland, OH (G.B.). · Med-X Research Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T.). · Instituto do Coracao (InCor), Universidade de São Paulo, Brazil (P.A.L.). · Hospital Israelita Albert Einstein, Brazil (P.A.L.). · Cardiovascular Center Aalst, OLV Clinic, Belgium (C.C.). · Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.). · McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, TX (N.P.J.). ·Circ Cardiovasc Interv · Pubmed #32295416.

ABSTRACT: Fractional flow reserve is the current invasive gold standard for assessing the ischemic potential of an angiographically intermediate coronary stenosis. Procedural cost and time, the need for coronary vessel instrumentation, and the need to administer adenosine to achieve maximal hyperemia remain integral components of invasive fractional flow reserve. The number of new alternatives to fractional flow reserve has proliferated over the last ten years using techniques ranging from alternative pressure wire metrics to anatomic simulation via angiography or intravascular imaging. This review article provides a critical description of the currently available or under-development alternatives to fractional flow reserve with a special focus on the available evidence, pros, and cons for each with a view towards their clinical application in the near future for the functional assessment of coronary artery disease.

8 Article Impact of Intravascular Ultrasound on Outcomes Following PErcutaneous Coronary InterventioN in Complex Lesions (iOPEN Complex). 2020

Shlofmitz, Evan / Torguson, Rebecca / Zhang, Cheng / Craig, Paige E / Mintz, Gary S / Khalid, Nauman / Chen, Yuefeng / Rogers, Toby / Hashim, Hayder / Ben-Dor, Itsik / Garcia-Garcia, Hector M / Satler, Lowell F / Waksman, Ron. ·Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. · MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC; Cardiovascular Branch, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: Ron.Waksman@MedStar.net. ·Am Heart J · Pubmed #31951847.

ABSTRACT: BACKGROUND: Clinical data support the use of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) as being associated with improved outcomes. Nonetheless, global utilization of IVUS remains low. We hypothesize that, in the revascularization of complex lesions, IVUS use is associated with improved outcomes. METHODS: All patients with complex lesions treated with PCI at a single center from 2003 to 2016 were stratified by use of IVUS. Complex lesions were defined as follows: American College of Cardiology/American Heart Association type C lesions, in-stent restenosis, long lesions, bifurcations, severe calcification, left main lesions, and chronic total occlusions. The primary end point was the rate of major adverse cardiac events (MACE) at 1-year follow-up, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization. Inverse probability weighting was used in the adjusted analysis. RESULTS: A total of 6,855 patients were included in the final analysis, of whom 67.3% had IVUS and 32.7% had angiography alone. The primary end point occurred in 13.4% of patients treated with IVUS and 18.3% of patients treated with angiography alone (P < .001). Inverse probability weighting-adjusted 1-year MACE rates demonstrated significant reduction with IVUS for each complex lesion type. CONCLUSIONS: Among patients with complex lesions, the use of IVUS was associated with lower MACE 1 year after PCI than angiography alone was. Because of the increased procedural risk in complex lesions, routine utilization of IVUS-guided PCI should be considered in this subset of patients.

9 Article Initial Experience With GlideAssist to Facilitate Advancement of Orbital Atherectomy Prior to Plaque Modification of Severely Calcified Coronary Artery Lesions. 2019

Lee, Michael S / Shlofmitz, Evan / Rha, Seung-Woon / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #31671058.

ABSTRACT: OBJECTIVES: We report our initial experience with GlideAssist (Cardiovascular Systems, Inc) to facilitate advancement of the orbital atherectomy crown prior to plaque modification of severely calcified coronary artery lesions. BACKGROUND: Severe coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and is also associated with worse clinical outcomes compared with PCI of non-calcified vessels. Orbital atherectomy is an effective tool to modify calcified plaque prior to stenting. However, advancement of the orbital atherectomy crown may be technically challenging due to complex coronary anatomy. METHODS: From February 2018 to February 2019, GlideAssist was used in 13 patients at the University of California, Los Angeles Medical Center. The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events, which was the composite of death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: Reasons for use of GlideAssist included severe angulation/tortuosity (76.9%), ostial lesion (15.4%), and presence of previously implanted stent proximal to the calcified target lesion (7.7%). All patients who required GlideAssist had successful delivery of the crown to the calcified lesion. One patient experienced a major adverse cardiac and cerebrovascular event, which was due to periprocedural MI that was due to coronary dissection. The same patient experienced subacute stent thrombosis 13 days after the index PCI requiring TVR. No patient died or had a stroke. No other angiographic complication occurred. CONCLUSIONS: The GlideAssist function is a useful feature of the orbital atherectomy system to facilitate successful delivery of the crown in complex coronary anatomy.

10 Article Trends in Death Rate 2009 to 2018 Following Percutaneous Coronary Intervention Stratified by Acuteness of Presentation. 2019

Gajanana, Deepakraj / Weintraub, William S / Kolm, Paul / Rogers, Toby / Iantorno, Micaela / Ben-Dor, Itsik / Khalid, Nauman / Shlofmitz, Evan / Khan, Jaffar M / Chen, Yuefeng / Musallam, Anees / Kajita, Alexandre H / Hashim, Hayder / Satler, Lowell F / Torguson, Rebecca / Waksman, Ron. ·Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address: ron.waksman@medstar.net. ·Am J Cardiol · Pubmed #31547993.

ABSTRACT: Percutaneous coronary intervention (PCI) has evolved dramatically, along with patient complexity. We studied trends in in-hospital mortality with changes in patient complexity over the last decade stratified by clinical presentation. The study population included all patients presenting to the cardiac catheterization lab between January 2009 and July 2018. Expected in-hospital mortality was calculated using the National Cardiovascular Data Registry CathPCI risk scoring system. Yearly mean in-hospital mortality rates (%) were plotted and smoothed by weighted least squares regression for each presentation: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), and stable ischemic coronary artery disease (SI CAD). The overall cohort included 13,732 patients who underwent PCI during the study period, of whom 2,142 were for STEMI, 2,836 for NSTE-ACS, and 8,754 for SI CAD. Indications for PCI have changed over time, with more PCIs being performed for NSTE-ACS and STEMI than for SI CAD. NSTE-ACS and STEMI patients had a steady decrease in in-hospital mortality over time compared with SI CAD patients. Overall observed mortality continues to decrease in NSTE-ACS patients, with reduction in the observed mortality rate within the STEMI population to below expected since 2013. Patient complexity has not changed significantly. These results may be attributed to improved patient selection coupled with optimal pharmacotherapy with more robust therapies during procedure and hospitalization.

11 Article Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score. 2019

Shlofmitz, Evan / Généreux, Philippe / Chen, Shmuel / Dressler, Ovidiu / Ben-Yehuda, Ori / Morice, Marie-Claude / Puskas, John D / Taggart, David P / Kandzari, David E / Crowley, Aaron / Redfors, Björn / Mehdipoor, Ghazaleh / Kappetein, Arie Pieter / Sabik, Joseph F / Serruys, Patrick W / Stone, Gregg W. ·Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.). · New York-Presbyterian Hospital/Columbia University Medical Center (E.S., O.B.-Y., G.W.S.). · Morristown Medical Center, NJ (P.G.). · Hôpital du Sacré-Coeur de Montréal, Québec, Canada (P.G.). · Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France (M.-C.M.). · Mount Sinai Saint Luke's, NY (J.D.P.). · John Radcliffe Hospital, Oxford, United Kingdom (D.P.T.). · Piedmont Heart Institute, Atlanta, GA (D.E.K.). · Sahlgrenska University Hospital, Gothenburg, Sweden (B.R.). · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (A.P.K.). · UH Cleveland Medical Center, Cleveland, OH (J.F.S.). · Imperial College London, United Kingdom (P.W.S.). ·Circ Cardiovasc Interv · Pubmed #31495220.

ABSTRACT: BACKGROUND: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (P CONCLUSIONS: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

12 Article Update on Coronary Angiography-Based Physiology Technologies. 2019

Hideo-Kajita, Alexandre / Garcia-Garcia, Hector M / Shlofmitz, Evan / Campos, Carlos M. ·MedStar Health Research Institute - Medstar Cardiovascular Research Network (MHRI/MCRN), Hyattsville, Maryland - USA. · MedStar Washington Hospital Center, Washington, District of Columbia - USA. · Universidade de São Paulo - Faculdade de Medicina Hospital das Clinicas Instituto do Coração, São Paulo, SP - Brazil. · Hospital Israelita Albert Einstein - Cardiologia Intervencionista, São Paulo, SP - Brazil. ·Arq Bras Cardiol · Pubmed #31365603.

ABSTRACT: -- No abstract --

13 Article Efficacy and Safety of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin, Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization of Patients With Diabetes Mellitus. 2019

Waksman, Ron / Shlofmitz, Evan / Windecker, Stephan / Koolen, Jacques J / Saito, Shigeru / Kandzari, David / Kolm, Paul / Lipinski, Michael J / Torguson, Rebecca. ·MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address: Ron.Waksman@Medstar.net. · MedStar Washington Hospital Center, Washington, District of Columbia. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Catharina Hospital, Eindhoven, Netherlands. · Shonan Kamakura General Hospital, Kamakura, Japan; Sapporo Higashi Tokushukai Hospital, Sapporo, Japan. · Piedmont Heart Institute, Atlanta, Georgia. ·Am J Cardiol · Pubmed #31353004.

ABSTRACT: Patients with diabetes mellitus are prone to increased adverse outcomes after percutaneous coronary intervention, even with contemporary drug-eluting stents. Randomized controlled trials have demonstrated comparable clinical outcomes between an ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES) and a thin-strut durable-polymer everolimus-eluting stent (DP-EES) that has specific labeling for patients with diabetes. We aimed to evaluate the safety and efficacy of the BP-SES in patients with diabetes mellitus. To determine the performance of the BP-SES in diabetic patients, patient-level data from the BIOFLOW II, IV, and V randomized controlled trials were pooled. The primary end point was target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, and definite or probable stent thrombosis, at 1 year. Among 1,553 BP-SES and 791 DP-EES patients, 757 diabetic patients were identified. Of the diabetic patients included in this analysis (494 BP-SES vs 263 DP-EES), the proportion of insulin- and noninsulin-treated patients was similar between groups. The 1-year TLF rate in the diabetic population was 6.3% in the BP-SES group and 8.7% in the DP-EES group (hazard ratio 0.82, 95% confidence interval 0.047 to 1.43, p = 0.493). There were no significant differences, based on stent type or diabetes treatment regimen, in TLF hazards. In a patient-level pooled analysis of the diabetic population from randomized trials, 1-year clinical safety and efficacy outcomes were similar in patients treated with ultrathin BP-SES and thin-strut DP-EES.

14 Article Orbital Atherectomy Via Transradial Access: A Multicenter Propensity-Matched Analysis. 2019

Doshi, Rajkumar / Shlofmitz, Evan / Jauhar, Rajiv / Meraj, Perwaiz. ·Department of Internal Medicine, University of Nevada Reno School of Medicine, 1155 Mill St W1, Reno, NV 89502 USA. raj20490@gmail.com. ·J Invasive Cardiol · Pubmed #31303604.

ABSTRACT: AIMS: The main objective of this study was to assess the safety and feasibility of orbital atherectomy (OA) with transradial access compared with more traditional femoral access. METHODS: This multicenter, observational study included five tertiary-care centers. Out of the 39,870 who underwent percutaneous coronary intervention between January 2011 and January 2017, a total of 433 patients treated with coronary OA were identified and divided in two groups based on arterial access site. The co-primary outcomes of this study were major bleeding, associated blood transfusion, and safety outcomes. A propensity score was generated to match for baseline characteristics to avoid potential selection bias. RESULTS: Transradial access was associated with significantly reduced major bleeding and blood transfusion in both the unadjusted model (0.6% vs 4.4% [P=.02] and 0.6% vs 4.8% [P=.02], respectively) and the propensity-score matched model (0.8% vs 6.5% [P=.045 for both]). There were no differences in safety outcomes, contrast use, fluoroscopy time, or any other secondary outcomes. CONCLUSIONS: In this real-world, multicenter, observational study, OA via transradial access was both safe and feasible. Furthermore, transradial access was associated with reduced bleeding complications and associated blood transfusion when compared with femoral access.

15 Article Does an occluded RCA affect prognosis in patients undergoing PCI or CABG for left main coronary artery disease? Analysis from the EXCEL trial. 2019

Chen, Shmuel / Karmpaliotis, Dimitrios / Redfors, Björn / Shlofmitz, Evan / Ben-Yehuda, Ori / Crowley, Aaron / Mehdipoor, Ghazaleh / Puskas, John D / Kandzari, David E / Banning, Adrian P / Morice, Marie-Claude / Taggart, David P / Sabik, Joseph F / Serruys, Patrick W / Kappetein, A Pieter / Stone, Gregg W. ·Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA. ·EuroIntervention · Pubmed #31186220.

ABSTRACT: AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.

16 Article Clinical Outcomes of Atherectomy Prior to Percutaneous Coronary Intervention: A Comparative Assessment of Atherectomy in Patients With Obesity (COAP-PCI Subanalysis). 2018

Doshi, Rajkumar / Shlofmitz, Evan / Patel, Krunalkumar / Meraj, Perwaiz. ·Department of Cardiology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, 300 Community Drive, Manhasset, NY 11030 USA. PMeraj@northwell.edu. ·J Invasive Cardiol · Pubmed #30318482.

ABSTRACT: OBJECTIVES: The aim of this study was to investigate the safety and efficacy of atherectomy devices in obese patients with coronary artery calcification (CAC). BACKGROUND: Atherectomy is an important tool for lesion preparation in patients with CAC undergoing percutaneous coronary intervention (PCI). There have been no studies that compared the outcomes of orbital atherectomy (OA) and rotational atherectomy (RA) in obese patients. METHODS: A total of 35,590 patients from five tertiary-care hospitals who underwent PCI between January 2011 to April 2016 were identified. All adult patients with body mass index ≥30 kg/ m2 who had OA or RA prior to PCI were included in this analysis. A total of 91 patients were included in the OA arm and 131 patients in the RA arm prior to the matching. To remove potential selection bias, a propensity-score matched analysis was performed, and 69 patients were included in each group. RESULTS: The primary endpoint, composite of safety outcomes, did not occur in any patient of either group. The secondary endpoints - death on discharge (0.0% vs 1.5%; P=.48) and myocardial infarction (2.9% vs 6.4%; P=.42) - were similar between groups, as were individual outcomes including cardiogenic shock, bleeding complications, and congestive heart failure. Stroke, vascular complications, and the requirement for dialysis initiation did not occur in any of the patients. CONCLUSION: In this study assessing atherectomy in obese patients, OA and RA demonstrated comparable outcomes with complication rates within an acceptable range. It demonstrates that OA and RA can be safely performed in this high-risk patient subset with CAC.

17 Article Outcomes of Orbital Atherectomy in Severely Calcified Small (2.5 mm) Coronary Artery Vessels. 2018

Lee, Michael S / Shlofmitz, Evan / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #30068786.

ABSTRACT: OBJECTIVES: We evaluated the outcomes of plaque modification with orbital atherectomy followed by percutaneous coronary intervention (PCI) with small-diameter stents for severely calcified coronary arteries. BACKGROUND: PCI of severely calcified lesions is technically complex due to difficulties in predilating the lesion, delivering the stent, and achieving optimal stent expansion. PCI of small-diameter vessels is associated with an increased risk of adverse clinical events. METHODS: In our retrospective multicenter registry of 458 "all comers" with severe coronary artery calcification treated with orbital atherectomy, a total of 38 patients (8.3%) underwent stenting with a 2.5 mm diameter stent (small-vessel group) and 420 patients (91.7%) had a reference vessel diameter >2.5 mm (large-vessel group). The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events, which was the composite of death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: The small-vessel and large-vessel groups had similar rates of perforation (0.0% vs 0.7%; P=.80), dissection (2.6% vs 0.7%; P=.20), and no-reflow (0.0% vs 0.7%; P=.80). The primary endpoint was similar in both groups (0.0% vs 1.9%; P=.40), as were the rates of death (0.0% vs 1.4%; P=.40), MI (0.0% vs 1.2%; P=.50), TVR (0.0% vs 0.0%; P>.99), and stroke (0.0% vs 0.2%; P=.90). The small-vessel and large-vessel groups had similar rates of stent thrombosis (0.0% vs 1.0%; P=.70). CONCLUSIONS: Orbital atherectomy followed by stenting of small-diameter vessels appears to be feasible and safe. Further studies are needed to determine the ideal revascularization strategy for these patients.

18 Article Orbital Atherectomy of Severely Calcified Unprotected Left Main Coronary Artery Disease: One-Year Outcomes. 2018

Lee, Michael S / Shlofmitz, Evan / Park, Kyung Woo / Goldberg, Alec / Jeremias, Allen / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #29958177.

ABSTRACT: OBJECTIVE: We assessed the 1-year outcomes of patients who underwent orbital atherectomy for severely calcified unprotected left main coronary artery (ULMCA) disease. BACKGROUND: The standard of care for ULMCA is coronary artery bypass graft surgery. Percutaneous coronary intervention (PCI) is a reasonable option for the treatment for ULMCA disease, especially in patients who are not good candidates for surgical revascularization. Coronary artery calcification is associated with worse clinical outcomes in patients who undergo PCI. Modification of severely calcified plaque with orbital atherectomy facilitates stent delivery and expansion. Data on intermediate outcomes of patients with ULMCA disease who undergo orbital atherectomy are unknown. METHODS: We retrospectively evaluated 62 patients who underwent PCI with orbital atherectomy for ULMCA disease. The primary endpoint was the major cardiac and cerebrovascular event (MACCE) rate, which was the composite of cardiac death, myocardial infarction, target-lesion revascularization, and stroke at 1 year. RESULTS: Distal bifurcation disease was present in 71.0%, and a single-stent strategy was used in 90.5%. No patients experienced coronary perforation or no-reflow. Two patients experienced coronary dissection (3.2%). One patient experienced BARC-2 bleeding (1.6%). At 1 year, the MACCE rate was 11.3%, with cardiac death occurring in 1.6%, myocardial infarction in 8.1%, and target-lesion revascularization in 4.8%. Non-cardiac death occurred in 4.8%. No patient experienced stroke or stent thrombosis. CONCLUSION: Orbital atherectomy is an acceptable treatment option for patients with severely calcified ULMCA disease, especially if patients are deemed too high risk for surgical revascularization.

19 Article One-Year Outcomes of Orbital Atherectomy of Long, Diffusely Calcified Coronary Artery Lesions. 2018

Lee, Michael S / Shlofmitz, Evan / Lluri, Gentian / Park, Kyung Woo / Hollowed, John / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #29799426.

ABSTRACT: OBJECTIVES: The aim of this study was to determine the clinical outcomes of patients with long, diffusely calcified coronary artery lesions who underwent orbital atherectomy. BACKGROUND: The presence of severe coronary artery calcification increases the complexity of percutaneous coronary intervention. Orbital atherectomy of long, diffusely calcified lesions may increase the risk of periprocedural angiographic complications. Furthermore, the rate of ischemic complications, including target-vessel revascularization (TVR), in these long, calcified lesions is historically high. METHODS: In this retrospective multicenter registry, which included 458 real-world patients who underwent orbital atherectomy, a total of 154 patients (33.6%) required a total stent length of ≥50 mm (long-stent group). The primary endpoint was the 1-year major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of death, myocardial infarction, TVR, and stroke. RESULTS: The long stent group had a higher rate of perforation (1.9% vs 0.0%; P=.01) and dissection (2.6% vs 0.0%; P<.01). The primary endpoint was similar in the long and short groups (14.2% vs 11.5%, respectively; P=.40), as were the 1-year rates of death (2.6% vs 4.6%, respectively; P=.30), myocardial infarction (1.9% vs 1.6%, respectively; P=.80), TVR (9.7% vs 6.3%, respectively; P=.18), and stroke (1.3% vs 1.3%, respectively; P>.90). The stent thrombosis rate was similar in both groups (1.3% vs 1.3%; P>.90). CONCLUSIONS: Despite the higher angiographic complication rates, orbital atherectomy of long, diffusely calcified lesions was associated with acceptable rates of ischemic complications in this challenging lesion subset at 1-year follow-up.

20 Article Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study). 2018

Meraj, Perwaiz M / Shlofmitz, Evan / Kaplan, Barry / Jauhar, Rajiv / Doshi, Rajkumar. ·Department of Cardiology, Northwell Health, Hofstra Northwell Health School of Medicine, Manhasset, New York. ·J Interv Cardiol · Pubmed #29707807.

ABSTRACT: BACKGROUND: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

21 Article Multicenter Registry of Real-World Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy: 1-Year Outcomes. 2018

Lee, Michael S / Shlofmitz, Evan / Goldberg, Alec / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #29610442.

ABSTRACT: OBJECTIVES: We report the 1-year outcomes of real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. BACKGROUND: Percutaneous coronary intervention of heavily calcified lesions is technically challenging and associated with worse clinical outcomes. Modification of severely calcified coronary lesions with orbital atherectomy facilitates stent delivery and expansion. Although we previously reported the safety of orbital atherectomy at 30 days in all comers with severely calcified coronary lesions, including patients who were excluded from the ORBIT II trial, longer-term follow-up is unknown. METHODS: We retrospectively analyzed 458 all-comer patients who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at three centers. The primary endpoint was the 1-year major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of death, myocardial infarction, target-vessel revascularization, and stroke. RESULTS: One-year data were available for 453/457 patients (98.9%). At 1-year follow-up, the MACCE rate was 12.6%, death rate was 4.0%, myocardial infarction rate was 1.8%, target-vessel revascularization rate was 7.5%, stroke rate was 1.3%, and stent thrombosis rate was 1.3%. CONCLUSION: Orbital atherectomy is a valuable option for the treatment of severely calcified coronary arteries, including patients with very complex coronary anatomy and severe underlying comorbid conditions. Orbital atherectomy provided acceptable outcomes at 1 year and compared favorably to historical controls. A randomized trial with longer follow-up is needed to determine the optimal treatment strategy for patients with severely calcified coronary lesions.

22 Article Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. 2018

Lee, Michael S / Shlofmitz, Richard A / Shlofmitz, Evan / Srivastava, Pratyaksh K / Kong, Jeremy / Grines, Cindy / Revytak, George / Chambers, Jeffrey W. ·UCLA Medical Center, Los Angeles, CA, United States. Electronic address: mslee@mednet.ucla.edu. · St. Francis Hospital-The Heart Center, Roslyn, NY, United States. · Hofstra and Northwell Health Medical School, North Shore University Hospital, Manhassat, NY, United States. · UCLA Medical Center, Los Angeles, CA, United States. · Indiana University, Indianapolis, IN, United States. · Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, MN, United States. ·Cardiovasc Revasc Med · Pubmed #29454531.

ABSTRACT: OBJECTIVES: We assessed the safety and efficacy of orbital atherectomy to modify severely calcified coronary plaque prior to stent implantation in patients with small vessel (2.5mm) disease. BACKGROUND: Severe coronary artery calcification increases the risk of adverse clinical events during percutaneous coronary intervention (PCI). Patients who undergo PCI of small vessels have worse clinical outcomes including higher rates of perforation and dissection. The outcomes of orbital atherectomy of small diameter vessels (2.5mm) are unknown. METHODS: ORBIT II was a single-arm, multicenter trial which prospectively enrolled patients with severely calcified coronary lesions treated with orbital atherectomy prior to stenting in 49U.S. sites. The primary endpoint was the 3year rate of major adverse cardiac events, which was the composite of cardiac death, myocardial infarction, and target vessel revascularization. RESULTS: Of the 443 patients, 55 (12.4%) had reference vessel diameters (RVD) of 2.5mm and 388 (87.6%) had RVD >2.5. The rates of severe angiographic complications were similar in both groups. The primary endpoint was similar in both groups (30.6% vs. 22.5%, p=0.22), as were the rates of cardiac death (9.8% vs. 6.3%, p=0.33) and myocardial infarction (12.8% vs. 10.9%, p=0.67). Target vessel revascularization was numerically higher in the small vessel group (16.8% vs. 9.3%, p=0.13). CONCLUSIONS: Patients with small coronary vessel disease had comparable clinical outcomes compared to the larger diameter group following orbital atherectomy. Subsequent studies are required to establish the optimal revascularization approach for such patients with small coronary vessel disease burdened by heavily calcified lesions.

23 Article Impact of the Use of Intravascular Imaging on Patients Who Underwent Orbital Atherectomy. 2018

Lee, Michael S / Shlofmitz, Evan / Kong, Jeremy / Lluri, Gentian / Srivastava, Pratyaksh K / Shlofmitz, Richard. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #29378972.

ABSTRACT: OBJECTIVES: We assessed the impact of intravascular ultrasound (IVUS)/optical coherence tomography (OCT) on outcomes of patients who underwent orbital atherectomy. BACKGROUND: Intravascular imaging provides enhanced lesion morphology assessment and optimization of percutaneous coronary intervention (PCI) outcomes. Severe coronary artery calcification increases the complexity of PCI and is associated with worse clinical outcomes. Orbital atherectomy modifies calcified plaque, facilitating stent delivery and optimizing stent expansion. The impact of IVUS/OCT on clinical outcomes after orbital atherectomy is unknown. METHODS: Of the 458 consecutive real-world patients in our retrospective multicenter registry, a total of 138 patients (30.1%) underwent orbital atherectomy with IVUS/OCT. The primary safety endpoint was the rate of 30-day major adverse cardiac and cerebrovascular events, comprised of death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: The IVUS/OCT group and no-imaging group had similar rates of the primary endpoint (1.5% vs 2.5%; P=.48) as well as death (1.5% vs 1.3%; P=.86), MI (1.5% vs 0.9%; P=.63), TVR (0% vs 0%; P=NS), and stroke (0% vs 0.3%; P=.51). The 30-day stent thrombosis rates were low in both groups (0.7% vs 0.9%; P=.82). Emergent coronary artery bypass graft surgery was uncommonly performed in both groups (0.0% vs 0.9%; P=.25). CONCLUSION: Orbital atherectomy guided by intravascular imaging is feasible and safe. A large prospective randomized trial is needed to determine the clinical benefit of IVUS/OCT during PCI with orbital atherectomy.

24 Article Comparison of Heparin and Bivalirudin in Patients Undergoing Orbital Atherectomy. 2017

Lee, Michael S / Shlofmitz, Evan / Nayeri, Arash / Hollowed, John / Kong, Jeremy / Shlofmitz, Richard A. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #29086730.

ABSTRACT: OBJECTIVE: We compared the angiographic and clinical outcomes of heparin and bivalirudin in patients who underwent orbital atherectomy for severely calcified coronary lesions. BACKGROUND: Severely calcified coronary lesions are associated with increased ischemic complications. Orbital atherectomy modifies calcified plaque, thereby facilitating stent delivery and stent expansion. The ideal antithrombotic agent during orbital atherectomy is unknown. Previous studies reported that bivalirudin was associated with lower bleeding rates compared with heparin plus glycoprotein IIb/IIa inhibitors during percutaneous coronary intervention. METHODS: This retrospective multicenter analysis included 458 consecutive real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. Patients were stratified based on the antithrombotic agent that was used. The primary safety endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events, defined as death, myocardial infarction, target-vessel revascularization, and stroke. RESULTS: Heparin was used in 356/458 cases (77.2%) and bivalirudin was used in 102/458 cases (22.8%). The primary endpoint was similar in the heparin and bivalirudin groups (2% vs 3%; P=.55), as were the 30-day rates of death (1% vs 2%; P=.51), myocardial infarction (1% vs 1%; P=.90), target-vessel revascularization (0% vs 0%; P>.99), and stroke (0% vs 0%; P=.59). Angiographic complication, stent thrombosis, and major bleeding complication rates were similarly low in both groups. CONCLUSION: Both heparin and bivalirudin were safe and effective antithrombotic agents for patients who underwent orbital atherectomy. A randomized trial is needed to determine the antithrombotic agent of choice for orbital atherectomy.

25 Article Outcomes of Patients With a History of Coronary Artery Bypass Grafting Who Underwent Orbital Atherectomy for Severe Coronary Artery Calcification. 2017

Lee, Michael S / Shlofmitz, Evan / Nayeri, Arash / Hollowed, John / Shlofmitz, Richard A. ·UCLA Medical Center, 100 Medical Plaza Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #28974662.

ABSTRACT: OBJECTIVE: We assess the angiographic and clinical outcomes of patients with a history of coronary artery bypass graft (CABG) surgery who underwent orbital atherectomy for the treatment of severely calcified coronary lesions. BACKGROUND: The presence of severe coronary artery calcification (CAC) increases the complexity of percutaneous coronary intervention (PCI) and is associated with worse clinical outcomes. Patients with a history of CABG who undergo PCI often have comorbidities and are at higher risk for ischemic complications. METHODS: Of the 458 patients who underwent orbital atherectomy, 77 patients (17%) had a history of CABG and 381 (83%) did not. The primary endpoint was rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: The CABG group had a higher prevalence of hypertension, chronic renal insufficiency, history of PCI, and unstable angina. The primary endpoint was similar in the CABG and non-CABG groups (1% vs 2%; P=.56), as were the individual endpoints of cardiac death (0% vs 2%; P=.27), MI (1% vs 1%; P=.85), TVR (0% vs 0%; P>.99), and stroke (0% vs 0%; P=.65). The rates of angiographic complications and stent thrombosis were similarly low in both groups. CONCLUSION: Despite a higher-risk baseline profile, patients with a history of CABG had similar angiographic and clinical outcomes compared with patients who had no previous history of CABG. Further studies are needed to clarify the role of orbital atherectomy in these patients.

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