High-risk Percutaneous Coronary Intervention Research Articles

TCTAP C-089 High Risk Percutaneous Coronary Intervention in Old Age, LCx CTO and LM Bifurcation Lesion – How We Succeeded

TCTAP C-089 High Risk Percutaneous Coronary Intervention in Old Age, LCx CTO and LM Bifurcation Lesion – How We Succeeded

Long-Term Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention Among Medicare Beneficiaries.

Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left main). Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N = 29,407) compared with non-CTO PCIs (N = 522,315). We then evaluated similar outcomes between CTO PCIs and high-risk non-CTO PCIs (N = 53,662). We excluded patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction. Patients undergoing CTO PCI were more likely to be younger and male. CTO PCI was associated with a higher risk of in-hospital events compared with non-CTO PCI (7.0% vs 4.2%; P < .001) and high-risk non-CTO PCI (7.0% vs 6.5%; P = .008). In addition, CTO PCI was associated with a slightly higher risk of long-term repeat revascularization compared with non-CTO PCI (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.05-1.13). However, compared with high-risk non-CTO PCIs, CTO PCIs were associated with a slightly lower risk of long-term major adverse cardiovascular events (aHR, 0.87; 95% CI, 0.84-0.90) and readmission (aHR, 0.87; 95% CI, 0.84-0.90). In this study, CTO PCI was associated with higher risk of both in-hospital and out-of-hospital events but a slightly lower risk of long-term events compared with high-risk non-CTO PCIs. These findings shed light on the complexity of various PCI procedures that can inform clinicians and patients of expected outcomes.

Hemodynamic support for high-risk percutaneous coronary interventions – patient selection

Hemodynamic support for high-risk percutaneous coronary interventions – patient selection

Effect of Race on Clinical Outcomes Following Hemodynamically Supported High-Risk Percutaneous Coronary Intervention.

Effect of Race on Clinical Outcomes Following Hemodynamically Supported High-Risk Percutaneous Coronary Intervention.

Feasibility Testing of the RT Cardiac Systems Percutaneous Mechanical Circulatory Support Device.

RT Cardiac Systems (RTCS, Raleigh, NC) is developing an intravascular percutaneous mechanical circulatory support (pMCS) device drive system for use during high-risk percutaneous coronary intervention and emergent cardiogenic shock. The proprietary pMCS device (US patent 10,780,206) consists of a miniaturized axial flow pump with an integrated motor connected via a short flexible drive system. This novel flexible drive system creates a flexible pump that is advantageous for percutaneous placement and conforming to anatomy. This design also has the benefit of not requiring a continuous external lubrication source. In this article, we present engineering development and feasibility testing of the prototype pMCS system. Computational fluid dynamics (CFD) modeling was performed to evaluate candidate blade set designs (impeller leading and trailing edges, diffuser) and predict hydrodynamic performance and hemolysis risk. Bench testing of candidate lip seal designs (radial interference, durometer, and seal angle) was evaluated for leak rate. Two 16Fr prototype devices were then fabricated and tested in a static mock flow loop. Experimental testing demonstrated 3 L/min flow against 110 mmHg and 4 L/min flow against 80 mmHg, which matched the CFD-predicted hydrodynamic performance. These results demonstrate feasibility of the engineering design and performance of the prototype devices.

CRT-100.61 Clinical Predictors of Impella Dependence During High-Risk Percutaneous Coronary Intervention

CRT-100.61 Clinical Predictors of Impella Dependence During High-Risk Percutaneous Coronary Intervention

CRT-700.34 Short-Term Outcomes Among Aortic Valve Stenosis Patients Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention

CRT-700.34 Short-Term Outcomes Among Aortic Valve Stenosis Patients Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention

CRT-700.05 Impella Utilization in High-Risk Percutaneous Coronary Intervention Mitigates the Risks of Procedural and Clinical Adverse Events Independent of Left Ventricular Ejection Fraction: The Protect III Study

CRT-700.05 Impella Utilization in High-Risk Percutaneous Coronary Intervention Mitigates the Risks of Procedural and Clinical Adverse Events Independent of Left Ventricular Ejection Fraction: The Protect III Study

Left Main Percutaneous Coronary Revascularization.

Left main (LM) coronary artery disease accounts for approximately 4-6% of all percutaneous coronary interventions (PCIs). There has been mounting evidence indicating the non-inferiority of LM PCI as a revascularization option, particularly for those with a low SYNTAX score. The EXCEL and NOBEL trials have shaped current guidelines. The European Society of Cardiology assigned a class 2a (level of evidence B) for isolated LM disease involving the shaft and ostium and a class IIb (level of evidence B) for isolated LM disease involving the bifurcation or additional two- or three-vessel disease and a SYNTAX score <32. However, data on the use of a single stent or an upfront two-stent strategy for distal LM disease are conflicting, wherein the EBC Main trial reported similar outcomes with a stepwise provisional approach and the DKCRUSH-V trial reported better outcomes with an upfront two-stent strategy using the 'double-kissing' crush technique. Although several studies have noted better immediate results with image-guided PCI, there are few data on outcomes in LM disease specifically. In fact, the uptake of imaging in the aforementioned landmark trials was only 40%. More importantly, the role of mechanical circulatory support (MCS) has been less well studied in LM PCI. Indiscriminate use of MCS for LM PCI has been noted in clinical practice. Trials evaluating the benefit of MCS in high-risk PCI demonstrated no benefit. This review highlights contemporary trials as they apply to current practice in LM PCI.

Clinical outcomes in patients undergoing complex, high-risk percutaneous coronary intervention and haemodynamic support with intra-aortic balloon versus Impella pump: Real-life single-centre preliminary results.

Patients and mechanical circulatory support assortment, as well as periprocedural and post-procedural clinical outcomes in complex high-risk percutaneous coronary interventions (PCIs) underpinned by percutaneous left ventricular assist devices (pLVAD) are the subject of debate. The study aimed to identify differences between patients qualified for complex high-risk PCIs with an intra-aortic balloon pump (IABP) or Impella pump support and to compare peri- and post-procedural clinical outcomes. The presented analysis is a single-center study, which comprised consecutive patients undergoing complex high-risk PCIs performed with the pLVAD, either IABP or Impella. Patients included in the current analysis were recruited between January 2018 and December 2021. There were 28 (56%) patients in the Impella group and 22 (44%) in the IABP group. The primary endpoints included overall mortality and major adverse cardiovascular events (MACE) such as all-cause mortality, myocardial infarction, revascularization, and cerebrovascular events. Patients from the IABP group were significantly older, had higher left ventricular ejection fraction (LVEF), and less frequent history of PCI, while the in-hospital risk of death assessed by EuroSCORE II remained similar in the Impella and IABP groups (median interquartile range [IQR] 2.8 [2-3.8] vs. 2.5 [1.8-5.2]; P = 0.73). Patients undergoing complex high-risk PCIs with pLVAD support presented similar results during the follow-up, assessed by log-rank estimates in terms of MACE (P = 0.41) and mortality rate (P = 0.65). The use of pLVAD devices in patients undergoing complex high-risk PCIs, with reduced left ventricular ejection fraction, is a promising treatment option for patients disqualified from surgery by cardiac surgeons.

Impella-supported high-risk percutaneous coronary intervention complicated by a stuck pump and somersault in the aorta.

Impella-supported high-risk percutaneous coronary intervention complicated by a stuck pump and somersault in the aorta.

386 IMPACT OF REVASCULARIZATION COMPLETENESS ON ONE-YEAR OUTCOMES OF IMPELLA-SUPPORTED PCI IN ACUTE CORONARY SYNDROME: A SINGLE-CENTER EXPERIENCE

Abstract Background The use of mechanical circulatory support in high-risk percutaneous coronary intervention (HRPCI) has grown over the past decade. We aimed to evaluate the impact of coronary revascularization extent on one-year outcomes of Impella-supported HRPCI in the setting of acute coronary syndrome (ACS). Methods We performed a single-center retrospective study including all patients who underwent coronary angiography supported by Impella at our institution. Patients undergoing HRPCI in the setting of ACS with Impella-assistance were identified for the analysis. Revascularization extent was assessed using the British Cardiovascular Intervention Society (BCIS) jeopardy score revascularization index (RI). Patients were classified into two groups according to the completeness of revascularization in high RI (RI&amp;gt;0.75) and low RI (RI&amp;lt;0.75). The primary study endpoint was survival free from major adverse cardiac and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke, heart failure hospitalization) at one-year follow-up. Results Among fifty patients enrolled in the study, forty ACS patients (mean age 69.2±9 years) were identified for the analysis. At coronary angiography, 76.3% had multivessel disease, and the mean BCIS-JSPRE-PCI score was 10.2±2.1. After Impella-supported PCI, BCIS-JSPOST-PCI score was 2.1±2.0 (p&amp;lt;0.01) and RI&amp;gt;0.75 was reached in 89.2% of cases (mean RI 0.8±0.2). In-hospital mortality was 20.5% without a statistical difference between high and low RI (p=0.1). Within 12 months, time-to-MACCE was statistically higher in patients with high RI as compared to low RI (288.2 vs. 189.8 days, p&amp;lt;0.05) (Figure). Conclusions Our single-center experience suggests a more extensive revascularization, aiming for a positive impact on outcomes, when a Impella-protected strategy is performed in the setting of acute coronary syndromes.

136: EVALUATION OF OUTCOMES IN THE MANAGEMENT OF UNFRACTIONATED HEPARIN IN IMPELLA HEART PUMPS.

Introduction: The Impella® is a percutaneous ventricular assist device indicated for the management of cardiogenic shock or hemodynamic support in high-risk percutaneous coronary intervention. An Impella® requires anticoagulation with unfractionated heparin (UFH) and monitoring to prevent bleeding or thrombotic events. Available methods for monitoring include activated clotting time (ACT), activated partial thromboplastin time (aPTT), and anti-Xa, but the ideal method of monitoring UFH with Impella® is not identified. This study evaluates concomitant ACT and aPTT values for 36 hours after Impella® implantation to determine if either predicts bleeding or thrombotic events. Methods: This single center study included adult patients with an Impella® anticoagulated with UFH. The primary outcome was evaluated with receiver operating characteristic (ROC) curve using concomitant ACT and aPTT values to determine the impact on bleeding and thrombotic events. A linear regression was used to correlate concomitant ACT and aPTT values. Secondary outcomes included intensive care unit (ICU) and hospital length of stay, need for renal replacement therapy, and in-hospital mortality. Results: Of 50 patients included, 15 (30%) had a bleeding event and 15 (30%) had a thrombotic event. The duration of Impella® implant was 56 hours (IQR 28, 78), with 59% of bleeding events occurring while the Impella® was in place and 55% of thrombotic events occurring after device removal. For events that occurred during the 36 hours evaluated, the area under the ROC curve did not exceed 0.85 for the ACT and aPTT for bleeding or thrombotic events. Linear regression of concomitant ACT and aPTT showed an r2 of 0.4255. Median ICU and hospital length of stay were 10 and 11.5 days, respectively, 17 (34%) patients required renal replacement therapy and the in-hospital mortality rates were 36%. Conclusions: ACT and aPTT values show poor correlation in patients with an Impella® and neither demonstrated greater predictability on bleeding or thrombotic events during hospitalization. Patients demonstrated similar mortality rates when compared to previously published literature.

177: SAFETY AND EFFECTIVENESS OF AN ANTI-XA-BASED UNFRACTIONATED HEPARIN PROTOCOL FOR IMPELLA DEVICES

Introduction: Impella® devices are used as a short-term form of mechanical circulatory support in patients with cardiogenic shock or high-risk percutaneous coronary intervention (PCI). Anticoagulation protocols in this population are not well established. The purpose of this study was to evaluate thrombotic and bleeding complications when using an unfractionated heparin (UFH) protocol with a reduced initial dose of 6 units/kg/hour targeting an anti-Xa goal of 0.3-0.5 units/mL. Methods: This single-center, retrospective study included patients on Impella® support who received an UFH purge solution and/or an intravenous UFH infusion. The primary outcome was overall composite bleeding including major or minor bleeding or bleeding requiring medical attention. Secondary outcomes included thrombotic events and systemic UFH exposure. Results: Forty-one patients met criteria for inclusion. Anti-Xa values were in therapeutic range 46% of the time while on Impella support (interquartile range 16.6-75), with a median IV UFH dose of 6 units/kg/hour. The overall bleeding rate was 29.2% (12 total events), of which six were minor bleeds and two were major bleeds. Rates of thrombosis were low with two events during the study period. Conclusions: Use of a modified UFH protocol to target an anti-Xa goal of 0.3-0.5 units/mL prevented thromboembolic events, demonstrating the efficacy of this strategy. The majority of bleeding events were minor with no cases of fatal bleeding or intracranial hemorrhage. Based on this study, an anti-Xa goal of 0.3-0.5 units/mL with an initial rate of 6 units/kg/hr may be a useful approach to minimize heparin exposure while preventing thrombotic complications.

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement

463 WOVEN CORONARY ARTERY AN INCIDENTAL FINDING

Abstract Introduction Woven coronary artery is a rare congenital vascular anomaly, namely a coronary segment divided into many independent thin channels, which intertwine around the coronary axis for several centimeters, and then re-anastomose distally in a single lumen. The etiology of woven coronary arteries is unknown; however, it is commonly considered a benign condition which only rarely results into myocardial ischemia and acute coronary events Clinical case A 47-year-old man, with history of hypertension and drug addiction, presented to the emergency department due to dyspnea (NYHA IV). The chest x-ray showed bilateral pneumonia with pleural effusion, and depressed left ventricular ejection fraction of 32% with antero-lateral ipokinesia and moderate mitral regurgitation was shown at echocardiography. The electrocardiogram showed right bundle branch block. Troponin levels were elevated, denoting myocardial injury and possibly an acute coronary syndrome; therefore the patient was referred to invasive coronary angiography. The coronary angiogram showed the aspect of“woven coronary artery” both in the right (more frequent) and in the circumflex coronary (Figure 1). As in this case, woven coronary is usually incidentally diagnosed during coronary angiography, in fact the anomaly could not explain this clinical scenario. Sometimes woven coronary can be confounded with dissections, recanalized thrombus and chronic total occlusion with bridging collaterals. In the current case the vessels presented a thrombolysis in myocardial infarction (TIMI) flow grade 3 and there was no coronary occlusion; moreover, the simultaneous multivessel presence of this suggestive angiographic aspect makes the hypothesis of a congenital anomaly more likely. Conclusion Woven coronary artery is a rare vascular anomaly, usually benign. Intravascular imaging, which was not performed in this case, may be helpful in equivocal circumstances to avoid unnecessary and potentially high-risk percutaneous coronary intervention.

Optimized patient selection in high-risk protected percutaneous coronary intervention.

Percutaneous mechanical circulatory support (pMCS) is increasingly used in patients with poor left-ventricular (LV) function undergoing elective high-risk percutaneous coronary interventions (HR-PCIs). These patients are often in critical condition and not suitable candidates for coronary artery bypass graft surgery. For the definition of HR-PCI, there is a growing consensus that multiple factors must be considered to define the complexity of PCI. These include haemodynamic status, left-ventricular ejection fraction, clinical characteristics, and concomitant diseases, as well as the complexity of the coronary anatomy/lesions. Although haemodynamic support by percutaneous LV assist devices is commonly adopted in HR-PCI (protected PCI), there are no clear guideline recommendations for indication due to limited published data. Therefore, decisions to use a nonsurgical, minimally invasive procedure in HR-PCI patients should be based on a risk-benefit assessment by a multidisciplinary team. Here, the current evidence and indications for protected PCI will be discussed.

What is known in pre-, peri-, and post-procedural anticoagulation in micro-axial flow pump protected percutaneous coronary intervention?

Interest in the use of percutaneous left ventricular assist devices (p-LVADs) for patients undergoing high-risk percutaneous coronary intervention (PCI) is growing rapidly. The Impella™ (Abiomed Inc.) is a catheter-based continuous micro-axial flow pump that preserves haemodynamic support during high-risk PCI. Anticoagulation is required to counteract the activation of the coagulation system by the patient's procoagulant state and the foreign-body surface of the pump. Excessive anticoagulation and the effect of dual antiplatelet therapy (DAPT) increase the risk of bleeding. Inadequate anticoagulation leads to thrombus formation and device dysfunction. The precarious balance between bleeding and thrombosis in patients with p-LVAD support is often the primary reason that patients' outcomes are jeopardized. In this chapter, we will discuss anticoagulation strategies and anticoagulant management in the setting of protected PCI. This includes anticoagulant therapy with unfractionated heparin, direct thrombin inhibitors, DAPT, purge blockage prevention by bicarbonate-based purge solution, and monitoring by activated clotting time, partial thromboplastin time, as well as anti-factor Xa levels. Here, we provide a standardized approach to the management of peri-interventional anticoagulation in patients undergoing protected PCI.

Specific clinical vignettes in high-risk protected percutaneous coronary intervention.

There are several cardiac- and patient-related factors that come into play when considering patients for protected percutaneous coronary intervention (PCI). Cardiac factors include complexity/location of coronary lesions, the degree of left or right ventricular impairment, the presence of valvular lesions, and ventricular arrhythmias. Patient related factors include comorbidities that would render the patient at a higher risk of death should cardiogenic shock ensue during the procedure. Comorbidities include chronic lung disease (chronic obstructive airways disease, asthma, pulmonary fibrosis), renal or liver impairment, other cardiovascular diseases (such as previous cerebrovascular accident or transient ischemic attack, peripheral arterial disease, carotid stenosis), diabetes, frailty and advanced age. Here, we present three very different cases where left ventricular support was deemed appropriate to reduce peri-procedural risk and optimize outcomes.

Optimal bail-out and complication management strategies in protected high-risk percutaneous coronary intervention with the Impella.

Despite the routine use of percutaneous mechanical circulatory support (pMCS) with the Impella heart pump, vascular and bleeding complications may occur during removal with or without pre-closure. To safely close the large-bore access (LBA), post-hoc selection of the appropriate treatment of vascular complications is critical to patient recovery and survival. Femoral artery access is typically utilized for LBA, and percutaneous axillary artery access is a common alternative, especially in the instance of severe peripheral artery disease. Optimization of patient outcomes and efficiency of pMCS can be achieved with adequate arterial access using state-of-the-art techniques. Impella removal techniques with or without pre-closure will be addressed as well as the management of large-bore femoral access complications. In addition, treatment strategies to manage patient deterioration during a protected high-risk percutaneous coronary intervention will be provided.