High-risk PCI Research Articles

The use of veno-arterial extra corporeal membrane oxygenation for hemodynamics support during high-risk percutaneous coronary intervention

BackgroundComplex coronary artery disease still a major health problem, whether high-risk PCI on V-A ECMO or not is a better choice.Aim and objectivesThe study is designed to assess the outcomes of using V-A ECMO on high-risk PCI procedures.Patients and methodsA prospective interventional study performed on patients with viable ischemic myocardium who refused CABG, syntax score>22, excluding scarred myocardium. V-A ECMO (Fem-Fem configuration) will be initiated during elective high-risk PCI procedure, compared to patients who underwent high-risk PCI refusing ECMO, also excluding patients suffering from acute decompensated heart failure.ResultsThis is a case-control study where total of 20 patients were identified, 10 patients underwent high-risk PCI on V-A ECMO support, (Control group) 10 patients underwent high-risk PCI without V-A ECMO; our study showed a statistically significant higher SYNTAX score in group 1 than that in group 2, p value 0.025, no statistically significance difference between the number of cases with left main lesions, unprotected LM and MVD between group 1 and group 2, average ECMO duration of 2.5 h, 6 patients on awake ECMO, and statistically non-significant difference between NYHA class between group 1 and group 2. Also our study showed no statistically difference between LV EF before and after PCI in both groups; in group 1, eight patients had complete revascularization in one session while in group 2 only seven patients had complete revascularization; one patient in group 1 had VT while in group 2, one patient had VF and another one suffered of asystole; group 1 patients all discharged home within 1 week while group 2 had two mortalities during PCI.ConclusionECMO can be successfully used to facilitate elective high-risk PCI minimizing risk of cardiovascular complications.

Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS)—A Pilot Trial

Background: The decision-making process to use percutaneous mechanical circulatory support in the context of elective high-risk percutaneous coronary intervention (HRPCI) is complex and evolving. The aim of this study is to evaluate the left ventricular end-diastolic pressure (LVEDP) as a parameter to identify patients that may benefit from a protected HRCPI (pHRPCI) procedure. Methods: Overall, 62 patients (pHRPCI n = 31 vs. non-pHRPCI n = 31) with a complex coronary artery disease and a left ventricular ejection fraction (LVEF) ≤35% were included. The primary endpoint was defined as a change in LVEDP and its correlation with laboratory measurements. The secondary safety endpoint was a composite of the incidence of major in-hospital adverse cardiac and cerebrovascular events (MACCE). Results: Baseline characteristics were similar, including age (pHRPCI 72.8 ± 8.8 vs. non-pHRPCI 75.0 ± 10.4; p = 0.408), male (pHRPCI 83.9% vs. non-pHRPCI 96.8; p = 0.195), pre-PCI Syntax Score (pHRPCI 33.9 ± 13.1 vs. non-pHRPCI 35.4 ± 12; p = 0.643), post-PCI Syntax Score (pHRPCI 7.4 ± 6.2 vs. non-pHRPCI 9.6 ± 8.4; p = 0.239) and baseline LVEDP between the groups (pHRPCI 18.5 ± 10.5 mmHg vs. non-pHRPCI 15.7 ± 8.1 mmHg; p = 0.237). There was a trend to a lower LVEF in the pHRPCI group (26.4 ± 6.7% vs. 29.4 ± 5%; p = 0.051). The primary endpoint analysis revealed a significant change in LVEDP (pHRPCI −4.7 ± 9 mmHg vs. non-pHRPCI +3.1 ± 7.5 mmHg; p < 0.001) that did not correlate with changes in creatinine (p = 0.285), NT-proBNP (p = 0.383) or troponin (p = 0.639) concentrations within 24 h. Overall, low rates of in-hospital (pHRPCI 6.5% vs. non-pHRPCI 3.2%; p = 0.999) and 90-days (pHRPCI 12.9% vs. non-pHRPCI 12.9%; p = 0.999) MACCE were observed in both groups. Conclusions: Protected HRPCI leads to a significant reduction in LVEDP without influencing biomarkers of myocardial damage. There was no difference in MACCE rates between the groups.

Safety and complications associated with the use of protamine in percutaneous coronary intervention.

There is a paucity of data on the use of protamine after PCI. The purpose of this study was to assess the incidence of thrombotic complications of protamine after high-risk PCI. The authors conducted a retrospective analysis of 168 patients. All patients received protamine intra- or immediately post-index PCI. Baseline characteristics and procedural characteristics including heparin dosing, protamine dosing, and bleeding and thrombotic complications were evaluated. The primary outcome was the incidence of acute stent thrombosis (ST), subacute ST, and 'other' thrombotic complications. Secondary outcomes included mortality within 24 hours and within 30 days of the index procedure. A total of 168 patients were included. The majority of patients received dual anti-platelet therapy prior to the index procedure (85%). The average procedure time was 202 ± 103 minutes, and an average of 2.59 (± 1.38) stents were deployed. An average protamine dose of 32mg was administered, and the median dose was 20mg (IQR 20). Seventy-three (43%) had a coronary perforation and five (3%) had access site related bleeding requiring transfusion. Four (2%) patients had acute ST, no patients experienced subacute ST, and 2 (1%) patients developed non-coronary arterial thrombosis. Eight (5%) died within 24 hours of their PCI and 14 (8%) patients died within 30 days after PCI. In our cohort, administration of protamine was well tolerated in the majority of patients, however, 3.6% of patients did experience coronary or peripheral arterial thrombosis warranting caution when using protamine in these challenging scenarios.

High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study.

The Magenta Elevate is a 9-F, self-expanding, catheter-mounted pump delivered sheathed through a commercially available 10-F femoral introducer over the wire to the left ventricle (LV), providing temporary hemodynamic support up to an equivalent of normal cardiac output. The authors sought to assess the feasibility and outcomes of Elevate-supported high-risk percutaneous coronary intervention (HR-PCI) in a first-in-human study and study the hemodynamic impact of high-output support during prolonged interventional left main coronary artery (LM) occlusions. In this study, 14 patients underwent Elevate-supported HR-PCI, with 8 patients undergoing 20 prolonged (39 ± 16 seconds) balloon occlusions of an unprotected LM. Systolic and diastolic aortic pressures, mean arterial pressure (MAP), and diastolic aorto-left ventricular pressure difference (dΔPAoLV) were determined before and during inflations. There were no major device-related adverse events (primary safety endpoint) and no mortality at 30days. During prolonged LM occlusions, the following changes were observed: There was a significant drop in systolic aortic pressure (-35mmHg [-46 to-23mmHg]; P< 0.0001) accompanied by a significant increase in diastolic pressure (7mmHg [4 to 10mmHg]; P< 0.0055). MAP, which showed a small decrease (-7mmHg [-13 to-2mmHg]; P< 0.001) and dΔPAoLV (-2mmHg [-5 to 4mmHg]; P = 0.51) remained in the normal range. Ventriculo-arterial uncoupling occurred in 13 of 20 LM balloon occlusions. In this first-in-human study, use of the Magenta Elevate low-profile, high-output catheter during HR-PCI was safe and provided substantial cardiac support. During prolonged interventional LM occlusions, the system unloaded the LV, maintaining a normal MAP and dΔPAoLV.

TCT-582 Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS): A Pilot Trial

TCT-582 Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS): A Pilot Trial

Right Ventricular Dysfunction in Patients Undergoing High-Risk PCI with Impella

Right ventricular dysfunction (RVD) is an important prognostic factor in several cardiac conditions, including acute and chronic heart failure. The impact of baseline RVD on clinical outcomes of patients undergoing high-risk percutaneous coronary intervention (HRPCI) supported by Impella is unknown. Patients from the single-arm, multicenter PROTECT III study of Impella-supported HRPCI were stratified based on the presence or absence of RVD. RVD was quantitatively assessed by an echocardiography core laboratory and was defined as fractional area change < 35%, tricuspid annular plane systolic excursion < 17 mm or pulsed-wave Doppler S-wave of the lateral tricuspid annulus < 9.5 cm/s. Procedural outcomes, 90-day major adverse cardiac and cerebrovascular events (MACCE: the composite of all-cause mortality, myocardial infarction, stroke/TIA, and repeat revascularization), and 1-year mortality were assessed. Of the 239 patients who underwent RV function assessment, 124 were found to have RVD. Lower left ventricular ejection fraction, higher blood urea nitrogen levels, and more severe RV dilation were independently associated with RVD. The incidence of hypotensive episodes during PCI, the proportion of patients requiring prolonged Impella support, the completeness of revascularization, and the rate of in-hospital mortality did not differ significantly between patients with vs without RVD. However, 90-day MACCE rates were higher in those with RVD, and RVD was a robust predictor of 1-year mortality in multivariable Cox-regression analyses. In patients undergoing HRPCI with Impella, RVD was associated with more advanced biventricular failure. The use of Impella support during HRPCI facilitated effective revascularization, even in those with concomitant RVD. Nevertheless, RVD was associated with unfavorable long-term prognoses.

Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS) - Pilot Trial Interim Analysis

Evaluation of LVEDP Change During High-Risk PCI With and Without Impella Support (ELVIS) - Pilot Trial Interim Analysis

In-Hospital Safety and Effectiveness of Non-Emergent, MCS-Supported High-Risk PCI Procedures: A Comprehensive Propensity-Score Matched Analysis of Contemporary, Large-Scale Claims Dataset

In-Hospital Safety and Effectiveness of Non-Emergent, MCS-Supported High-Risk PCI Procedures: A Comprehensive Propensity-Score Matched Analysis of Contemporary, Large-Scale Claims Dataset

High-risk PCI facilitated by levosimendan infusion and Impella CP support in ACS cohort-pilot study.

High-risk PCI facilitated by levosimendan infusion and Impella CP support in ACS cohort-pilot study.

Awake VA-ECMO in cardiogenic shock, single centre experiences

Abstract Funding Acknowledgements None. Background/Introduction "Awake" V-A ECMO when the patient is fully awake, breathing spontaneously, without deep sedation. Advantages of awake VA-ECMO include reduced sedative side effects, early active movements, reduced muscle mass loss, increased interaction with the family and medical staff, description of their symptoms, and more exact information than sedative patients so that early detection of complications. Purpose and Methods Present a series of 15 patients with cardiac support by awake VA-ECMO, techniques, parameters, complications, and treatment results. Results Enrolled in this study, including 15 patients: 04 NSTEMI (very high-risk PCI), 09 Myocarditis, 02 electrical storm; Age 53,2 ± 19,5. The local anesthesia, mild sedation when the patient is anxious; performed vascular access with DSA system. The duration from the patient's admission to ECMO was 3,8 ± 2,9 (day) and awake VA-ECMO 3,1 ± 2,5 (day) (min to max: 1 – 6). The CO of ECMO: 1,6 ± 1,2 (l/ph); 03 patients with continuous renal replacement therapy. A patient with acute thrombosis of the lower extremity had successful percutaneous thrombectomy; fifteen patients were successfully weaned from ECMO (100%), no patient death in 7 days, and 02 patient deaths in 30 days. Conclusion Awake VA-ECMO can be performed safety on the cardiac patient when waiting for recovery or management.

The effect of standardization of insertion and removal of percutaneous left ventricular assist device

BackgroundThe effect of standardizing an insertion and removal protocol for pVAD devices has not been previously described. ObjectivesWe sought to evaluate clinical outcomes in patients who underwent pVAD insertion pre- and post-protocol standardization. MethodsAll patients who underwent pVAD insertion that remained in place at index procedure completion between January 2017 and September 2023 at a single academic center for both high-risk PCI and cardiogenic shock indications were included in the study. The primary outcome was the incidence of limb ischemia and major bleeding before and after the protocol initiation. Secondary outcomes included in-hospital and 30-day MACCE rate (death, myocardial infarction, stroke, emergent CABG), and how often the operators followed the protocol. ResultsA total of 89 patients had pVAD left in place (29 pre-protocol initiation and 60 post-protocol initiation). There was a significant decrease in incidence of limb ischemia post-protocol initiation compared to pre (17.2 % vs 1.7 %, p = 0.01) but no difference in bleeding incidence (13.8 % vs 20.0 %, p = 0.47). Adherence increased in all components of the protocol except for right heart catheterization. ConclusionStandardization of an insertion and removal protocol for pVAD devices led to a statistically significant decrease in limb ischemia in a high-risk patient population.

Scrutinizing the Role of Venoarterial Extracorporeal Membrane Oxygenation: Has Clinical Practice Outpaced the Evidence?

The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for temporary mechanical circulatory support in various clinical scenarios has been increasing consistently, despite the lack of sufficient evidence regarding its benefit and safety from adequately powered randomized controlled trials. Although the ARREST trial (Advanced Reperfusion Strategies for Patients with Out-of-Hospital Cardiac Arrest and Refractory Ventricular Fibrillation) and a secondary analysis of the PRAGUE OHCA trial (Prague Out-of-Hospital Cardiac Arrest) provided some evidence in favor of VA-ECMO in the setting of out-of-hospital cardiac arrest, the INCEPTION trial (Early Initiation of Extracorporeal Life Support in Refractory Out-of-Hospital Cardiac Arrest) has not found a relevant improvement of short-term mortality with extracorporeal cardiopulmonary resuscitation. In addition, the results of the recently published ECLS-SHOCK trial (Extracorporeal Life Support in Cardiogenic Shock) and ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) discourage the routine use of VA-ECMO in patients with infarct-related cardiogenic shock. Ongoing clinical trials (ANCHOR [Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock, NCT04184635], REVERSE [Impella CP With VA ECMO for Cardiogenic Shock, NCT03431467], UNLOAD ECMO [Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO, NCT05577195], PIONEER [Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI, NCT04045873]) may clarify the usefulness of VA-ECMO in specific patient subpopulations and the efficacy of combined mechanical circulatory support strategies. Pending further data to refine patient selection and management recommendations for VA-ECMO, it remains uncertain whether the present usage of this device improves outcomes.

Change in left ventricular function and outcomes following high-risk percutaneous coronary intervention with Impella-guided hemodynamic support.

High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown. We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year. Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% (n = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p = 0.48). In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes.

Observational, multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL): efficacy and safety outcomes

Abstract Introduction Impella (Abiomed, Danvers, MA, USA) is the smallest and the least invasive mechanical circulatory support device used in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCI). Data regarding the efficacy and safety of Impella in the real-life setting are urgently needed. Purpose The main goal of the IMPELLA-PL registry is to evaluate the efficacy and safety of Impella in patients with CS and undergoing HR-PCI, identify independent predictors of in-hospital and 12-month outcomes and compare it with other registries. Methods IMPELLA-PL is a national, multicentre, retrospective registry including consecutive patients treated with Impella for CS and high-risk PCI in 20 Polish interventional cardiological centres from January 2014 until December 2021, with 12-month follow-up until December 2022. The main efficacy and safety endpoints included (i) in-hospital mortality, (ii) 12-month mortality, (iii) 12-month rate of major adverse cardiovascular events (MACE) following hospital discharge, evaluated according to the prespecified definitions. Results A total of 308 patients were enrolled in the registry: 55 had CS (56.4%) and 253 underwent HR-PCI (43.6%). In the CS group, in-hospital mortality rate was 76.4%, 12-month mortality rate was 80.0% and post-discharge MACE rate was 9.1%. Device-related complications included access site bleeding (30.9%), limb ischaemia (12.7%) and haemolysis (10.9%). In the HR-PCI group, in-hospital mortality rate was 8.3%, 12-month mortality rate was 18.2% and MACE rate post-discharge was 22.5%. Device-related complications included access site bleeding (14.6%), limb ischaemia (2.4%) and haemolysis (1.6%). The independent predictors of 12-month mortality included atrial fibrillation (OR 3.50, 95% CI 1.38-8.95), chronic kidney disease (OR 2.77, 95% CI 1.06-7.26). Conclusions The mortality and complications rate in patients with CS remains high, despite the use of Impella, and higher than reported in other registries. The mortality and complications rate in patients undergoing HR-PCI is acceptable and consistent with other registries.

Abstract 18211: Does Frailty Matter in High Risk PCI

Background: There are limited data depicting the relationship between frailty and in-hospital outcomes for high-risk PCI. Methods: The Cath-PCI registry (2018 - 2020) was used to examine the association of frailty as defined by the Canadian Study of Health and Aging (CSHA) frailty index and in-hospital complications for patients undergoing PCI. We conducted a logistic regression analysis for in-hospital mortality. Results: The sample size was 1,316,390 individuals aged ≥ 65 years undergoing PCI. The frailty distribution was: 78,921 not frail (6.0%), 892,695 pre-frail (67.8%), 284,444 frail (21.6%), and 60,330 severely frail (2.2%). The median age of patients who were frail was 76 years, 39.4% were female, and 87.2% were white. In-hospital rates for any bleeding stratified by frailty status were: not frail: 1.0%, pre-frail: 1.5%, frail 3.3%, severely frail 8.9%. The adjusted odds ratio (aOR) regarding in-hospital mortality among PCI patients at high bedside mortality risk for pre-frail, 2.58 (95% CI: 1.42 - 1.80) for frail, and 5.14 (95% CI: 4.56 - 5.80) for severely frail. The adjusted association for in-hospital mortality across sub-groups stratified by frailty status was: left main PCI ~ pre-frail aOR 1.44 (95% CI: 1.01 - 2.05), frail aOR 2.18 (95% CI: 1.53 - 3.11) and severely frail aOR 3.98 (95% CI: 2.79 - 5.70). While the aORs for chronic total occlusion were ~ pre-frail 1.57 (95% CI: 0.97 - 2.52), frail 2.31 (95% CI: 1.43 - 3.75) and severely frail 6.04 (5.40 - 6.75) and cardiogenic shock ~ pre-frail 1.33 (95% CI: 1.08 - 1.64), frail 1.54 (95% CI: 1.25 - 1.90) and severely frail 2.44 (1.99 - 3.00). Conclusions: Contemporary PCI is commonly performed on frail patients. Frailty is associated with higher risk of mortality across high-risk PCI categories; however, severe frailty depicts a distinct and exceptionally high-risk cohort.

Abstract 17708: Cardiac Nut-Cracker: Paroxysmal Left Main Coronary Compression by Inducible Pulmonary Trunk Dilatation in Pulmonary Hypertension

Case Presentation: A 56yo woman with a 12-year history of idiopathic pHTN and severe RV dysfunction presented with worsening exertional angina (CCS III). Perfusion imaging demonstrated a large apical-septal defect, corresponding to an 80% eccentric stenosis of the LMCA on angiography ( Fig 1AB ) due to compression on ostium and shaft by a severely dilated pulmonary trunk ( Fig 1C ). Right heart catheterization revealed pulmonary artery pressures (PAPs) of 90/40/68mmHg. Operative risk for CABG was deemed prohibitive, thus the patient underwent high-risk PCI of the LMCA under IV conscious sedation. Initial angiography confirmed a patent LMCA with minimal longitudinal compression. Opening PAPs (102/37/64mmHg) with supplemental oxygen (FiO 2 /PaO 2 0.76/168mmHg) were similar to preop findings ( Fig 1D ). To replicate her symptomatology, supplemental oxygen was discontinued, resulting in rapid worsening of LMCA compression with severe reduction in LMCA cross-sectional area at room air conditions (FiO 2 /PaO 2 0.21/70mmHg), with corresponding suprasystemic PAP (122/44/73mmHg) ( Fig 1E) . Under IVUS guidance, a preselected stent was deployed producing complete LMCA patency without evidence of dynamic compression; minimal stent areas were unchanged at supraphysiologic and physiologic conditions: 19 vs 20mm 2 , FiO 2 0.73 vs 0.21 ( Fig 1F ). Discussion: LMCA stenosis from extrinsic compression of the vessel by an enlarged pulmonary artery is a rare etiology of acute coronary syndromes. Treatment options include PCI, CABG, reimplantation, or PA reduction plasty. While preop imaging clearly demonstrated LMCA compression by a dilated PA, during PCI true and dynamic severity of LMCA compression was revealed only under “normoxic conditions” (FiO 2 0.21). This paroxysmal “nut-cracker” phenomenon from inadvertent reversal of dynamic LMCA compression highlights the importance of normoxia in making the diagnosis of such anomalies in susceptible individuals with pHTN.

TCT-480 Severe Aortic Stenosis and Concomitant Complex, High-Risk PCI: Current Management and Survival in Large Volume Centers

TCT-480 Severe Aortic Stenosis and Concomitant Complex, High-Risk PCI: Current Management and Survival in Large Volume Centers

TCT-145 Relationship Between Preprocedural Blood Pressure and Outcomes in Patients Undergoing Impella-Supported High-Risk PCI: Insights From the cVAD PROTECT III Study

TCT-145 Relationship Between Preprocedural Blood Pressure and Outcomes in Patients Undergoing Impella-Supported High-Risk PCI: Insights From the cVAD PROTECT III Study

TCT-241 Clinical Characteristics and Outcomes of Impella-Supported High-Risk PCI in Patients Turned Down for Coronary Artery Bypass Graft Surgery: Insights From the cVAD PROTECT III Study

TCT-241 Clinical Characteristics and Outcomes of Impella-Supported High-Risk PCI in Patients Turned Down for Coronary Artery Bypass Graft Surgery: Insights From the cVAD PROTECT III Study

TCT-770 Women Undergoing High-Risk PCI Have Better 12-Month Survival Despite Higher Complexity of Coronary Artery Disease: Insights From the IMPELLA-PL Registry

TCT-770 Women Undergoing High-Risk PCI Have Better 12-Month Survival Despite Higher Complexity of Coronary Artery Disease: Insights From the IMPELLA-PL Registry