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

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.

Roadmap towards an institutional Impella programme for high‐risk coronary interventions

“…Patients undergoing Impella‐assisted PCI should be treated in high‐volume centres with 24 h availability of cardiac surgery and by multidisciplinary teams of experienced operators, to ensure procedural and long‐term success. Details of the technical aspects of these procedures are beyond the scope of this manuscript and have been recently summarized 30–34 . Here, we focus on three crucial procedural aspects that facilitate Impella‐assisted complex PCI: (i) checklist at catheterization laboratory arrival, (ii) large‐bore access and closure techniques, and (iii) completeness of revascularization.…”

“…Details of the technical aspects of these procedures are beyond the scope of this manuscript and have been recently summarized. [30][31][32][33][34] Here, we focus on three crucial procedural aspects that facilitate Impella-assisted complex PCI: (i) checklist at catheterization laboratory arrival, (ii) large-bore access and closure techniques, and (iii) completeness of revascularization. We strongly advocate to develop a checklist to be completed at catheterization laboratory arrival, confirming the patient's informed consent, reviewing patient indications and contraindications, recent laboratory data, and LVEF.…”

Letter by Moroni et al Regarding Article, “Feasibility and Safety of High-Risk Percutaneous Coronary Intervention Without Mechanical Circulatory Support”

“…We read with interest the article by Khalid et al, 1 who reported on the feasibility and safety of high-risk percutaneous coronary intervention (PCI) without mechanical circulatory support. The authors are to be praised for their results (procedural success was observed in 98.2%, while 30-day mortality was only 1.6%).…”

“…However, we would like to make several comments and offer a different interpretation of their global study findings. First, the high-risk PCI criteria mentioned by the Interventional Council of the American College of Cardiology 2 and referenced as inclusion criteria by Khalid et al 1 have not been widely adopted or prospectively validated. Second, adherence to such high-risk criteria was not complete, as in the study by Khalid et al 1 acute coronary syndromes (which are associated with higher morbidity and mortality) were excluded.…”

Ten-year trends of clinical outcomes after percutaneous coronary intervention: a Korean nationwide longitudinal cohort study

“…Among AMI types, the prevalence of non-ST-elevation myocardial infarction (NSTEMI) is increasing compared with that of ST-elevation myocardial infarction (STEMI) 5 6. Moreover, PCI is increasingly being used in high-risk patients, including elderly patients, cardiogenic shock with the use of mechanical circulatory support devices and patients with multiple clinical comorbidities 7–9…”