Feasibility and Safety of High-Risk Percutaneous Coronary Intervention Without Mechanical Circulatory Support

Author:

Khalid Nauman1ORCID,Rogers Toby1ORCID,Torguson Rebecca2,Zhang Cheng1,Shea Corey1,Shlofmitz Evan1ORCID,Chen Yuefeng1,Musallam Anees1,Wermers Jason P.1ORCID,Case Brian1,Hashim Hayder1,Ben-Dor Itsik1,Bernardo Nelson L.1,Satler Lowell1,Waksman Ron1ORCID

Affiliation:

1. Section of Interventional Cardiology, MedStar Washington Hospital Center, DC (N.K., T.R., C.Z., C.S., E.S., Y.C., A.M., J.P.W., B.C., H.H., I.B.-D., N.L.B., L.S., R.W.).

2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, NY (R.T.).

Abstract

Background: Recommendations to broaden the use of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remain controversial with the absence of robust evidence from randomized clinical trials and the risk of device-related complications. This investigation examined whether performing high-risk PCI without elective MCS is feasible and safe. Methods: We performed a single-center, retrospective analysis for patients meeting contemporary high-risk PCI criteria as defined by the Interventional Council of the American College of Cardiology. These criteria include unprotected left main disease, last remaining conduit, left ventricular ejection fraction <35%, three-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Clinical, procedural, and major in-hospital and 30-day cardiovascular outcomes were assessed. Results: The analysis included a cohort of 1680 patients (2887 lesions) with stable coronary artery disease who met high-risk PCI criteria and were treated from 2003 to 2018. The study population comprised 75% men and 68% whites. Mean age was 69.16±11.19 years. Conventional cardiovascular risk factors among our cohort were as follows: hypertension, 91%; hypercholesterolemia, 91%; diabetes, 44%; and cigarette smoking, 14%. Intravascular ultrasound was performed on 53% of the lesions. Rescue MCS was required in 0.8% of the patients. Procedural success was observed in 98.2% of the patients, while the 30-day mortality rate was 1.6%. The incidence of major complications was as follows: all-cause mortality, 1.6%; cardiac death, 0.8%; acute renal failure, 4.6%; stroke, 0.2%; and major bleeding, 1.1%. Conclusions: High-risk PCI as defined by the professional societies without elective MCS is feasible and safe in the majority of patients, challenging the current recommendations and practice. A randomized trial comparing unprotected versus protected high-risk PCI for these broad recommendations is warranted to best ascertain which patients would benefit from MCS.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Reference22 articles.

1. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: Executive Summary

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3. Zuckerman BD. US Food and Drug Administration letter concerning premarket application for Impella 2.5. 2015. Accessed September 29 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003A.pdf.

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5. National Cardiovascular Data Registry. NCDR CathPCI Registry Data Coder’s Dictionary v5.0. 2019. Accessed September 29 2020. https://cvquality.acc.org/docs/default-source/pdfs/2019/01/10/pci-v5-0-data-dictionary-coders-rtd-07242018-uploaded-jan-10-2019.pdf?sfvrsn=b95981bf_2.

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