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Coronary Artery Disease: HELP
Articles by Evan Shlofmitz
Based on 25 articles published since 2008
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Between 2008 and 2019, Evan Shlofmitz wrote the following 25 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 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.

2 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.

3 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.

4 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.

5 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.

6 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.

7 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.

8 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.

9 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.

10 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.

11 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.

12 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.

13 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.

14 Article State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. 2017

Barbato, Emanuele / Shlofmitz, Evan / Milkas, Anastasios / Shlofmitz, Richard / Azzalini, Lorenzo / Colombo, Antonio. ·Cardiovascular Research Center, Aalst OLV Hospital, Aalst, Belgium. ·EuroIntervention · Pubmed #28844031.

ABSTRACT: Since the first balloon angioplasty by Andreas Grüntzig 40 years ago, interventional cardiology has witnessed the introduction of countless tools and techniques that have significantly contributed to broadening the application of percutaneous coronary interventions (PCI) in unprecedented anatomic settings. Heavily calcified, fibrotic coronary stenosis has traditionally represented a very challenging scenario for PCI, and a very common indication for surgical revascularisation. This was mostly due to the difficulty in adequately dilating these lesions and/or to the inability to deliver and implant stents appropriately, which is often associated with high rates of procedural complications and suboptimal long-term clinical outcomes. Thanks to dedicated cutting and scoring balloons and to atherectomy devices, the treatment of most fibrotic and heavily calcified stenoses has become feasible and safe. Interventional cardiologists have learned how best to apply these tools through better patient and lesion selection, and also as a result of improved technology and techniques. In this review, we describe a 40-year-long journey that has evolved from the initial stand-alone debulking strategy to the currently applied coronary plaque modification, with the main objective of optimising drug-eluting stent delivery and implantation, translating into significantly improved patient outcomes.

15 Article Safety of orbital atherectomy in patients with left ventricular systolic dysfunction. 2017

Shlofmitz, Evan / Meraj, Perwaiz / Jauhar, Rajiv / Sethi, Sanjum S / Shlofmitz, Richard A / Lee, Michael S. ·Northwell Health, Manhasset, New York. · UCLA Medical Center, Los Angeles, California. · St. Francis Hospital-The Heart Center, Roslyn, New York. ·J Interv Cardiol · Pubmed #28722196.

ABSTRACT: OBJECTIVES: We evaluated the angiographic and clinical outcomes in patients with severely calcified lesions and systolic dysfunction who underwent orbital atherectomy (OA). We hypothesized that OA would provide similar outcomes in patients with systolic dysfunction compared with patients with preserved systolic function. BACKGROUND: Systolic dysfunction is associated with an increased risk of adverse clinical events after percutaneous coronary intervention (PCI). The effects of OA in patients with systolic dysfunction are unknown. METHODS: Our analysis retrospectively analyzed 438 patients (n = 69 with EF ≤ 40%) who underwent OA. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days. RESULTS: There were no significant differences between patients with preserved versus reduced systolic function in terms of dissections (0.9% vs. 1.6%, P = 0.51), perforation (0.3% vs. 3.2%, P = 0.07), or no reflow (0.3% vs. 3.2%, P = 0.07). Patients with systolic dysfunction had higher rates of the composite of 30-day MACCE (1.1% vs. 8.7%, P = 0.002) and the individual end points of death (0.3% vs. 7.2%, P < 0.001), and myocardial infarction (0.5% vs. 4.3%, P = 0.03). The rates of target vessel revascularization (0% vs. 0%, P = 1), stroke (0.3% vs. 0%, P > 0.9), and stent thrombosis (0.8% vs. 1.4%, P = 0.5) were low in both groups and did not differ. CONCLUSION: Plaque modification with OA was safe and well tolerated in patients with systolic dysfunction. In this high-risk cohort, adverse clinical outcomes occurred more frequently than in a lower risk population.

16 Article Outcomes of patients with myocardial infarction who underwent orbital atherectomy for severely calcified lesions. 2017

Lee, Michael S / Shlofmitz, Evan / Lluri, Gentian / Kong, Jeremy / Neverova, Natalya / Shlofmitz, Richard. ·Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA. Electronic address: mslee@mednet.ucla.edu. · Department of Cardiology, Northwell Health, Manhasset, NY, USA. · Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA. · Cardiology Department, St. Francis Hospital-The Heart Center, Roslyn, NY, USA. ·Cardiovasc Revasc Med · Pubmed #28529094.

ABSTRACT: OBJECTIVES: This study analyzed the outcomes of patients who presented with non-ST-elevation myocardial infarction (NSTEMI) and subsequently underwent orbital atherectomy for severe coronary artery calcification (CAC). BACKGROUND: Patients who present with NSTEMI have increased risk for death and recurrent MI after percutaneous coronary intervention (PCI). Patients with severe CAC have worse outcomes after PCI.Orbital atherectomy modifies calcified plaque, facilitating stent delivery and optimizing stent expansion. There are no data on these patients who present with NSTEMI who undergo orbital atherectomy. METHODS: Of the 454 consecutive real-world patients who underwent orbital atherectomy in our retrospective multicenter registry, 51 patients (11.2%) presented with NSTEMI. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30days. RESULTS: Patients with NSTEMI had a higher prevalence of chronic kidney disease, lower mean ejection fraction, and required more vessels to be treated. The primary endpoint was similar in patients who presented with and without NSTEMI (2.0% vs. 2.2%, p=0.9), as were the 30-day rates of death (2.0% vs. 1.2%, p=0.67), MI (0% vs. 1.2%, p=0.42), target vessel revascularization (0% vs. 0%, p>0.91), and stroke (0% vs. 0.2%, p=0.72). The rates of angiographic complications and stent thrombosis rate were low in both groups. CONCLUSIONS: Despite having worse baseline characteristics, patients who presented with NSTEMI and subsequently underwent orbital atherectomy had similar clinical outcomes compared with patients without NSTEMI.

17 Article Comparison of Rotational Atherectomy Versus Orbital Atherectomy for the Treatment of Heavily Calcified Coronary Plaques. 2017

Lee, Michael S / Park, Kyung Woo / Shlofmitz, Evan / Shlofmitz, Richard A. ·Division of Cardiology, UCLA Medical Center, Los Angeles, California. Electronic address: mslee@mednet.ucla.edu. · Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. · Department of Cardiology, Northwell Health, Manhasset, New York. · Cardiology Department, St. Francis Hospital-The Heart Center, Roslyn, New York. ·Am J Cardiol · Pubmed #28258729.

ABSTRACT: We evaluated the outcomes of patients with severe coronary artery calcification (CAC) who underwent rotational atherectomy (RA) and orbital atherectomy (OA). Severe CAC increases the complexity of percutaneous coronary intervention (PCI) because of the difficulty in optimizing stent expansion, leading to worse clinical outcomes. Both devices are effective treatment strategies for severe CAC. No comparisons have been performed to evaluate the clinical outcomes after RA and OA. The outcomes of 67 patients with severe CAC who underwent RA from July 2012 to June 2015 and 60 patients who underwent OA from February 2014 to September 2016 were evaluated. The primary end point was the rate of 30-day major adverse cardiac and cerebrovascular events, comprising cardiac death, myocardial infarction, target vessel revascularization, and stroke. The primary end point was similar in the RA and OA groups (6% vs 6%, p >0.9), as were the individual end points of death (0% vs 2%, p = 0.8), myocardial infarction (6% vs 4%, p = 0.7), target vessel revascularization (0% vs 0%, p >0.9), and stroke (0% vs 0%, p >9). Procedural success was achieved in all patients. Angiographic complications were uncommon in both groups. No patient had stent thrombosis. In conclusion, both RA and OA are safe and effective for the treatment of severe CAC as they provided similar clinical outcomes at short-term follow-up.

18 Article Orbital atherectomy treatment of severely calcified coronary lesions in patients with impaired left ventricular ejection fraction: one-year outcomes from the ORBIT II study. 2017

Lee, Michael S / Martinsen, Brad J / Shlofmitz, Richard / Shlofmitz, Evan / Lee, Arthur C / Chambers, Jeffrey. ·UCLA Medical Center, Los Angeles, CA, USA. ·EuroIntervention · Pubmed #28191873.

ABSTRACT: AIMS: Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challenging. The ORBIT II study demonstrated the safety and efficacy of orbital atherectomy (OA) in patients with severe CAC. Microparticulate liberated during OA may disturb the coronary microcirculation. In the present study, we evaluated OA treatment in patients with left ventricular systolic dysfunction. METHODS AND RESULTS: Patients were grouped by left ventricular ejection fraction (LVEF): 26-40% (n=33), 41-50% (n=90), and >50% (n=314). Procedural success was similar (LVEF 26-40%: 90.9%, LVEF 41-50%: 88.9%, LVEF >50%: 88.4%). Rates of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target vessel revascularisation, were similar in the LVEF 26-40%, 41-50%, and >50% groups, respectively, at 30 days (9.1%, 7.8%, 11.5%) and one year (18.2%, 19.1%, 16.0%). Although the 30-day cardiac death rate was 0% in patients with left ventricular dysfunction, one-year cardiac death was higher compared with patients with preserved left ventricular systolic function. CONCLUSIONS: No patient with left ventricular systolic dysfunction experienced cardiac death at 30 days suggesting that OA was well tolerated without haemodynamic complication. However, one-year cardiac death was higher in patients with left ventricular systolic dysfunction, consistent with previous studies demonstrating the association between reduced left ventricular function and increased mortality after PCI.

19 Article Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy. 2017

Lee, Michael S / Shlofmitz, Evan / Lluri, Gentian / Shlofmitz, Richard A. ·UCLA Medical Center, Los Angeles, California. · Northwell Health, Manhasset, New York. · St. Francis Hospital-The Heart Center, Roslyn, New York. ·J Interv Cardiol · Pubmed #28116818.

ABSTRACT: OBJECTIVES: We evaluated the clinical outcomes of elderly patients who underwent orbital atherectomy for the treatment of severe coronary artery calcification (CAC) prior to stenting. BACKGROUND: Percutaneous coronary intervention (PCI) of severe CAC is associated with worse clinical outcomes including death, myocardial infarction (MI), and target vessel revascularization (TVR). The elderly represents a high-risk group of patients, often have more comorbid conditions, and have worse outcomes after PCI compared to younger patients. Clinical trials and a large multicenter registry have demonstrated the safety and efficacy of orbital atherectomy for the treatment of severe CAC. Clinical outcomes of elderly patients who undergo orbital atherectomy are unknown. METHODS: Of the 458 patients, 229 were ≥75 years old (elderly) and 229 were <75 years old (younger). The primary endpoint was rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, MI, TVR, and stroke. RESULTS: The primary endpoint was similar in the elderly and younger groups (2.2% vs. 2.2%, P = 1), as were the individual endpoints of death (2.2% vs. 0.4%, P = 0.1), MI (0.9% vs. 1.3%, P = 0.65), TVR (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P = 0.32). The rates of angiographic complications and stent thrombosis were similarly low in both groups. CONCLUSIONS: The elderly represented a sizeable number of patients who underwent orbital atherectomy. It is a safe and effective treatment strategy for elderly patients with severe CAC as the clinical outcomes were similar to their younger counterparts. A randomized trial should further clarify the role of orbital atherectomy in these patients.

20 Article Impact of Impaired Renal Function in Patients With Severely Calcified Coronary Lesions Treated With Orbital Atherectomy. 2017

Lee, Michael S / Shlofmitz, Evan / Lluri, Gentian / Shlofmitz, Richard A. ·UCLA Medical Center, 100 Medical Plaza Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #28089999.

ABSTRACT: OBJECTIVES: We evaluated the clinical outcomes of patients with chronic kidney disease (CKD) who underwent orbital atherectomy for severe coronary artery calcification (CAC) prior to stent implantation. BACKGROUND: Percutaneous coronary intervention (PCI) of lesions with severe CAC is associated with increased rates of adverse clinical events. Patients with CKD are at increased risk for atherosclerotic cardiovascular disease, including vascular calcification, and have worse outcomes after PCI. METHODS: Of the 456 consecutive real-world patients in our retrospective multicenter registry with severe CAC who underwent orbital atherectomy, 88 patients (19.3%) had CKD (creatinine ≥1.5 mg/dL). The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular event (MACCE), defined as death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke. RESULTS: The CKD group had a higher prevalence of diabetes mellitus and hypertension as well as a lower mean left ventricular ejection fraction. The primary endpoint was similar in the CKD and non-CKD groups (3.4% vs 1.9%; P=.40), as were 30-day rates of death (2.2% vs 1.1%; P=.30), MI (1.1% vs 0.5%; P=.40), TVR (0% vs 0%; P>.99), and stroke (0% vs 0.3%; P>.99). Angiographic complications and stent thrombosis rates were low and did not differ between the two groups. CONCLUSION: Despite higher-risk baseline characteristics, patients with CKD had no significant differences in MACCE. Orbital atherectomy represents a reasonable treatment strategy for the treatment of severe CAC in patients with CKD. A prospective randomized trial with long-term follow-up is needed to identify the optimal treatment for these patients.

21 Article Gender-Based Differences in Outcomes After Orbital Atherectomy for the Treatment of De Novo Severely Calcified Coronary Lesions. 2016

Lee, Michael S / Shlofmitz, Evan / Mansourian, Pejman / Sethi, Sanjum / Shlofmitz, Richard A. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #27801655.

ABSTRACT: OBJECTIVES: We evaluated the relationship between gender and angiographic and clinical outcomes in patients with severely calcified lesions who underwent orbital atherectomy. BACKGROUND: Female gender is associated with increased risk of adverse clinical events after percutaneous coronary intervention (PCI). Severe coronary artery calcification increases the complexity of PCI and increases the risk of adverse cardiac events. Orbital atherectomy is effective in plaque modification, which facilitates stent delivery and expansion. Whether gender differences exist after orbital atherectomy is unclear. METHODS: Our analysis retrospectively analyzed 458 consecutive real-world patients (314 males and 144 females) from three centers who underwent orbital atherectomy. The primary endpoint was the major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of death, myocardial infarction (MI), target-vessel revascularization (TVR), and stroke, at 30 days. RESULTS: The primary endpoint of MACCE was low and similar in females and males (0.7% vs 2.9%; P=.14). The individual endpoints of death (0.7% vs 1.6%; P=.43), MI (0.7% vs 1.3%; P=.58), TVR (0% vs 0%; P>.99), and stroke (0% vs 0.3%; P=.50) were low in both groups and did not differ. Angiographic complications were low: perforation (0.8% vs 0.7%; P>.90), dissection (0.8% vs 1.1%; P=.80), and no-reflow (0.8% vs 0.7%; P>.90). CONCLUSION: Plaque modification with orbital atherectomy was safe and provided similar angiographic and clinical outcomes between females and males. Randomized trials with longer-term follow-up are needed to support our results.

22 Article Outcomes in Diabetic Patients Undergoing Orbital Atherectomy System. 2016

Lee, Michael S / Shlofmitz, Evan / Nguyen, Heajung / Shlofmitz, Richard A. ·UCLA Medical Center, Los Angeles, California. mslee@mednet.ucla.edu. · Northwell Health, Manhasset, New York. · UCLA Medical Center, Los Angeles, California. · St. Francis Hospital-The Heart Center, Roslyn, New York. ·J Interv Cardiol · Pubmed #27489020.

ABSTRACT: OBJECTIVES: We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non-diabetic patients. BACKGROUND: Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported. METHODS: Our retrospective multicenter registry included 458 consecutive real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days. RESULTS: Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non-diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30-day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups. CONCLUSION: Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non-diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer-term follow-up are needed to determine the ideal treatment strategy for diabetics.

23 Article Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy. 2016

Lee, Michael S / Shlofmitz, Evan / Kaplan, Barry / Alexandru, Dragos / Meraj, Perwaiz / Shlofmitz, Richard. ·Division of Interventional Cardiology, UCLA Medical Center, Los Angeles, California. · Division of Cardiology, Northwell Health, Manhasset, New York. · Division of Cardiology, St. Francis Hospital, Roslyn, New York. ·J Interv Cardiol · Pubmed #27358246.

ABSTRACT: OBJECTIVES: We evaluated the safety and efficacy of orbital atherectomy in real-world patients with severe coronary artery calcification (CAC). BACKGROUND: The presence of severe CAC increases the complexity of percutaneous coronary intervention as it may impede stent delivery and optimal stent expansion. Atherectomy may be an indispensable tool for uncrossable or undilatable lesions by modifying severe CAC. Although the ORBIT I and II trials report that orbital atherectomy was safe and effective for the treatment of severe CAC, patients with kidney disease, recent myocardial infarction, long diffuse disease, severe left ventricular dysfunction, and unprotected left main disease were excluded. METHODS: This retrospective study included 458 consecutive patients with severe CAC who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at 3 centers. RESULTS: The primary endpoint of major adverse cardiac and cerebrovascular events at 30 days was 1.7%. Low rates of 30-day all-cause mortality (1.3%), myocardial infarction (1.1%), target vessel revascularization (0%), stroke (0.2%), and stent thrombosis (0.9%) were observed. Angiographic complications were low: perforation was 0.7%, dissection 0.9%, and no-reflow 0.7%. Emergency coronary artery bypass graft surgery was performed in 0.2% of patients. CONCLUSION: In the largest real-world study of patients who underwent orbital atherectomy, including high-risk patients who were not surgical candidates as well as those with very complex coronary anatomy, acute and short-term adverse clinical event rates were low. A randomized clinical trial is needed to identify the ideal treatment strategy for patients with severe CAC.

24 Article Percutaneous Coronary Intervention in Severely Calcified Unprotected Left Main Coronary Artery Disease: Initial Experience With Orbital Atherectomy. 2016

Lee, Michael S / Shlofmitz, Evan / Kaplan, Barry / Shlofmitz, Richard. ·Division of Interventional Cardiology, UCLA Medical Center, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #27031936.

ABSTRACT: OBJECTIVE: We report the clinical outcomes of patients who underwent percutaneous coronary intervention (PCI) with orbital atherectomy for severely calcified unprotected left main coronary artery (ULMCA) disease. BACKGROUND: Although surgical revascularization is the gold standard for patients with ULMCA disease, not all patients are candidates for this. PCI is increasingly used to treat complex coronary artery disease, including ULMCA disease. The presence of severely calcified lesions increases the complexity of PCI. Orbital atherectomy can be used to facilitate stent delivery and expansion in severely calcified lesions. The clinical outcomes of patients treated with orbital atherectomy for severely calcified ULMCA disease have not been reported. METHODS: From May 2014 to July 2015, a total of 14 patients who underwent PCI with orbital atherectomy for ULMCA disease were retrospectively evaluated. The primary endpoint was major cardiac and cerebrovascular event (cardiac death, myocardial infarction, stroke, and target-lesion revascularization) at 30 days. RESULTS: The mean age was 78.2 ± 5.8 years. The mean ejection fraction was 41.8 ± 19.8%. Distal bifurcation disease was present in 9 of 14 patients. Procedural success was achieved in all 14 patients. The 30-day major adverse cardiac and cerebrovascular event rate was 0%. One patient had coronary dissection that was successfully treated with stenting. No patient had perforation, slow flow, or thrombosis. CONCLUSIONS: Orbital atherectomy in patients with severely calcified ULMCA disease is feasible, even in high-risk patients who were considered poor surgical candidates. Randomized trials are needed to determine the role of orbital atherectomy in ULMCA disease.

25 Article Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study. 2016

Lee, Michael S / Shlofmitz, Evan / Shlofmitz, Richard / Sahni, Sheila / Martinsen, Brad / Chambers, Jeffrey. ·UCLA Medical Center, 100 Medical Plaza, Suite 630, Los Angeles, CA 90095 USA. mslee@mednet.ucla.edu. ·J Invasive Cardiol · Pubmed #26984932.

ABSTRACT: OBJECTIVES: The ORBIT II trial reported excellent outcomes in patients with severely calcified coronary lesions treated with orbital atherectomy. Severe calcification of the left main (LM) artery represents a complex coronary lesion subset. This study evaluated the safety and efficacy of coronary orbital atherectomy to prepare severely calcified protected LM artery lesions for stent placement. METHODS: The ORBIT II trial was a prospective, multicenter clinical trial that enrolled 443 patients with severely calcified coronary lesions in the United States. The major adverse cardiac event (MACE) rate through 2 years post procedure, defined by cardiac death, myocardial infarction (CK-MB >3x upper limit of normal with or without a new pathologic Q-wave) and target-vessel revascularization, was compared in the LM and non-left main (NLM) groups. RESULTS: Among the 443 patients, a total of 10 underwent orbital atherectomy of protected LM artery lesions. At 2 years, there was no significant difference in the 2-year MACE rate in the LM and NLM groups (30.0% vs 19.1%, respectively; P=.36). Cardiac death was low in both groups (0% vs 4.4%, respectively; P=.99). Myocardial infarction occurred within 30 days in both groups (10.0% vs 9.7%, respectively; P=.99). Severe dissection, perforation, persistent slow flow, and persistent no reflow did not occur in the LM group. Abrupt closure occurred in 1 patient in the LM group. CONCLUSIONS: Orbital atherectomy for patients with heavily calcified LM coronary artery lesions is safe and feasible. Further studies are needed to assess the safety and efficacy of orbital atherectomy in patients with severely calcified LM artery lesions.