High-risk Percutaneous Coronary Intervention Research Articles

Temporal modulation (early escalation and late de-escalation) of antiplatelet therapy in patients undergoing complex high-risk PCI: rationale and design of the TAILORED-CHIP trial.

Despite the use of conventional dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), the risk of adverse events remains high among patients with increased thrombotic risk. Until recently, the optimal antiplatelet strategy to balance the ischaemic and bleeding risks in patients who are undergoing complex high-risk PCI has been unclear. The TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP) trial is an investigator-initiated, multicentre, prospective randomised trial to evaluate the efficacy and safety of a time-dependent tailored antiplatelet therapy with an early (<6 months post-PCI) escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin) and a late (>6 months post-PCI) de-escalation (clopidogrel monotherapy) in patients undergoing complex high-risk PCI as compared with standard DAPT (clopidogrel plus aspirin for 12 months). Eligible patients had to have at least one high-risk anatomical or procedural feature or clinical characteristic associated with an increased risk of ischaemic or thrombotic events. The primary endpoint was the net clinical outcome, a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, or clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 12 months after randomisation. (ClinicalTrials.gov: NCT03465644).

Understanding long-term risk in Percutaneous Coronary Intervention (PCI) in the Australian contemporary era with a focus on defining Complex Revascularisation in High-Risk Indicated Patients (CHIP)

BackgroundComplex Revascularisation in High-Risk Indicated Patients (CHIP) is emerging in Percutaneous Coronary Intervention (PCI). We document the frequency and outcomes following CHIP PCI in the Australian population, to understand risk and guide clinical decision-making. We propose a scoring system to define CHIP procedures. MethodsPatients undergoing PCI from Melbourne Intervention Group registry between 2005 and 2018 were analysed. Patients were stratified based on the number of high-risk features defined as 1)presence of ≥3 patient factors including age > 75yo, COPD, diabetes, renal impairment (eGFR<60 mL/min/1.73 m2), PVD, and 2)LVEF<30 %, and/or 3)having one complex coronary anatomical feature such as LMCA PCI, ACC/AHA B2/C lesion PCI, presence of multi-vessel disease or CTO PCI. National Death Index linkage was performed for long-term mortality analysis. Outcomes were analysed according to 4 risk categories – low risk(score 0), intermediate risk(score 1), high-risk(score 2), and very high-risk(score 3). Results20,973patients were analysed. Majority of patients underwent intermediate-risk procedures(71.7 %), with low rates of high-risk(6.6 %), and very high-risk(0.2 %). Lesion success inversely correlates with risk; low-risk(99.4 %), intermediate-risk(95.1 %), high-risk(94.3 %), very high-risk(92.5 %),p < 0.001. In-hospital and 30-day death correlates with risk; low-risk(0.0 %/0.1 %), intermediate-risk(0.3 %/0.5 %), high-risk(1.5 %/2.9 %), very high-risk(2.4 %/7.1 %),p < 0.001. Long-term mortality correlates with risk; low-risk(12.3 %), intermediate-risk(15.8 %), high-risk(49.3 %), very high-risk(76.2 %),p < 0.001. On multivariate analysis, increasing risk correlates with long-term mortality; intermediate-risk(HR1.41), high-risk(HR6.42), and very high-risk(14.05). ConclusionIn the Australian practice, proportion of patients undergoing high and very high-risk PCI procedures are low. Despite good procedural success and in-hospital outcomes, long-term mortality is poor. Further research into appropriate patient selection, and direct comparison of CHIP PCI to those treated medically and surgically should be considered.

Percutaneous Coronary Intervention in High-Risk Patients

Ischemic heart disease (IHD) with severe coronary artery disease (SYNTAX score &gt;22 points) in combination with various comorbidities is often a reason for refusal of coronary artery bypass grafting in such patients. Thus, a new term has emerged, "high-risk percutaneous coronary intervention"; however, the criteria, indications and results of these interventions have not yet been sufficiently studied. Therefore, according to current clinical guidelines, the treatment tactics for this patient cohort is determined by the decision of a council, the so-called Heart Team. This analytical review summarizes the criteria for high-risk percutaneous coronary interventions based on the literature, and describes the effect of various comorbidities on the results of direct myocardial revascularization.

Optimizing elective high-risk PCI with ECMO support: the value of completely percutaneous use of VA-ECMO

Abstract Background Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a suitable manner to prevent hemodynamic deterioration during high-risk percutaneous coronary intervention (PCI). VA-ECMO is mainly surgically deployed under general anaesthesia. New developments now facilitate completely percutaneous insertion of VA-ECMO with only local anaesthesia, reducing operating team size and hospital costs. Purpose The aim of this study is to provide data on the outcomes of completely percutaneous use of VA-ECMO during high-risk PCI with local anaesthesia. Methods A retrospective single-centre registry was performed including all patients undergoing ECMO-assisted high-risk PCI, who were rejected for coronary artery bypass graft (CABG) as primary treatment option. Primary endpoint was the incidence of major adverse cardiac events (MACE), assessed during hospital admission and after discharge up to 90 days. Results Between January 2020 and February 2024, 34 patients undergoing ECMO-assisted high-risk PCI were included. The mean age of the population is 71.9 (± 8.4) and 27 (79.4%) patients are male. The mean left ventricular ejection fraction is 28.5 (± 11.1) percent and complexity indices were high, including STS mortality score: 4.1 (± 2.8), SYNTAX score I: 31.7 (± 9.4), SYNTAX score II: (PCI) 54.8 (± 10.8). Femoral artery was used for cannulation in 30 (88.2%) patients, of which one patient required an additional femoral backflow cannula due to prolonged ECMO support. Local anaesthesia in combination with preprocedural oral benzodiazepine was the preferred choice of anaesthesia (85.3%). Closure was predominantly performed with a percutaneous closure device (97.1%). Successful revascularization and procedural success were achieved in all patients. In-hospital MACE occurred in 2 (6.1%) patients. MACE occurred within 90 days in 5 (20.8%) patients after discharge. Conclusion High-risk PCI with completely percutaneous use of VA-ECMO with local anaesthesia is a novel concept, providing a suitable alternative to the standard surgical use of VA-ECMO with general anaesthesia.

Performance and safety of complex percutaneous coronary intervention in centres without on-site cardiac surgery: a multi-centre australian registry study.

Abstract Background Performing complex percutaneous coronary intervention (PCI) procedures in hospitals with no on-site cardiac surgery (NOSCS) remains controversial due to a lack of contemporary data and guideline support. Methods Victorian Cardiac Outcomes Registry data was analysed including all PCI cases in the state of Victoria, Australia, from 2014 to 2022. Patients were stratified by PCI at sites with on-site cardiac surgery (OSCS) or NOSCS. Complex PCI was defined as PCI to unprotected left main, bifurcation lesions, rotational atherectomy or intravascular lithotripsy use, severe left ventricular systolic dysfunction, chronic total occlusion, or vein graft PCI. The primary outcome was composite MACCE comprising all-cause mortality, stroke, non-fatal MI, emergency CABG, unplanned revascularisation, definite stent thrombosis and major bleeding (BARC 3 &amp; 5) at 30-days. Risk ratio for average treatment effect in the NOSCS cohort was estimated using inverse probability treatment weighting. Results 94,268 total PCI procedures (32.6% NOSCS) were analysed, including 12,459 complex PCI cases (28.7% NOSCS). Patients from NOSCS were younger (65.0 vs 67.4, p&amp;lt;0.001), less likely to have had previous PCI (29.5% vs 34.5%, p&amp;lt;0.001) or CABG (4.6% vs 8.0% p&amp;lt;0.001) and presented more frequently with acute coronary syndromes (NSTEMI [32.0% vs 28.0%, p&amp;lt;0.001; STEMI [23.3% vs 15.2%], p&amp;lt;0.001). A propensity weighted sample of 30,850 OSCS patients and 30,692 NOSCS patients demonstrated no difference in adjusted 30-day MACCE (risk ratio 0.93, 95% CI 0.87-1.01, p=0.051) for all PCI procedures. In a propensity-weighted subgroup of 3,638 OSCS and 3,576 NOSCS patients who underwent complex PCI, there was also no difference in adjusted 30-day MACCE (risk ratio 0.97, 95%CI 0.86-1.09, p=0.60). Unadjusted rates of CABG at 30-days were very low (0.1 vs 0.1%, p=1.00). Conclusion Patients undergoing PCI and complex PCI at NOSCS centres had comparable 30-day outcomes to those treated at OSCS centres. Newer percutaneous therapies such as intravascular lithotripsy and percutaneous left ventricular assist devices may further improve safety and efficacy of high-risk PCI in NOSCS centres as operator experience increases. Increasing PCI and complex PCI capabilities at NOSCS is likely to increase equitable treatment access for more patients.

Left ventricular unloading to facilitate ventricular remodelling in heart failure: A narrative review of mechanical circulatory support.

Heart failure represents a dynamic clinical challenge with the continuous rise of a multi-morbid and ageing population. Yet, the evolving nature of mechanical circulatory support offers a variety of means to manage candidates who might benefit from such interventions. This narrative review focuses on the role of the main mechanical circulatory support devices, such as ventricular assist device, extracorporeal membrane oxygenation, Impella and TandemHeart, in the physiological process of ventricular unloading and remodelling in heart failure, highlighting their characteristics, mechanism and clinical outcomes. The outcome measures described include physiological changes (i.e., stroke volume or preload and afterload), intracardiac pressure (i.e., end-diastolic pressure) and extracardiac pressure (i.e., pulmonary capillary wedge pressure). Overall, all the above mechanical circulatory support strategies can facilitate the unloading of the ventricular failure through different mechanisms, which subsequently affects the ventricular remodelling process. These physiological changes start immediately after ventricular assist device implantation. The devices are indicated in different but overlapping populations and operate in distinctive ways; yet, they have evidenced performance to a favourable standard to improve cardiac function in heart failure, although this proved variable for different devices, and further high-quality trials are vital to assess their clinical outcomes further. Both Impella and TandemHeart are indicated mainly in cardiogenic shock and high-risk percutaneous coronary intervention patients; at the time the literature was evaluated, both devices were found to yield a significant improvement in haemodynamics but not in survival. Nevertheless, the choice of device strategy should be based on individual patient factors, including indication, to optimize clinical outcomes.

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.

TCT-574 Safety and Efficacy of Percutaneous Ventricular Assist Device Versus Intra-Aortic Balloon Pump Supported High-Risk Percutaneous Coronary Intervention (HRPCI)

TCT-574 Safety and Efficacy of Percutaneous Ventricular Assist Device Versus Intra-Aortic Balloon Pump Supported High-Risk Percutaneous Coronary Intervention (HRPCI)

TCT-573 Illness Severity Among Patients Undergoing Percutaneous Ventricular Assist Device Versus Intra-Aortic Balloon Pump Supported High-Risk Percutaneous Coronary Intervention (HRPCI)

TCT-573 Illness Severity Among Patients Undergoing Percutaneous Ventricular Assist Device Versus Intra-Aortic Balloon Pump Supported High-Risk Percutaneous Coronary Intervention (HRPCI)

TCT-407 Clinical Characteristics and Outcomes of Impella-Supported High-Risk Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion: Insights From the cVAD PROTECT III Registry

TCT-407 Clinical Characteristics and Outcomes of Impella-Supported High-Risk Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion: Insights From the cVAD PROTECT III Registry

TCT-577 Impact of Left Ventricular Dysfunction on the Outcome of Patients Undergoing Microaxial Flow Pump–Supported High-Risk Percutaneous Coronary Intervention

TCT-577 Impact of Left Ventricular Dysfunction on the Outcome of Patients Undergoing Microaxial Flow Pump–Supported High-Risk Percutaneous Coronary Intervention

TCT-576 The Impact of Atherectomy in Severely Calcified Lesions in Patients With Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study

TCT-576 The Impact of Atherectomy in Severely Calcified Lesions in Patients With Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study

Clinical outcomes among patients with mitral valve regurgitation undergoing Impella-supported high-risk PCI

BackgroundMitral valve regurgitation (MR) is associated with worse outcomes in patients undergoing percutaneous coronary intervention (PCI). We sought to evaluate outcomes of Impella-supported high-risk PCI (HRPCI) patients according to MR severity. MethodsPatients from the PROTECT III study undergoing Impella-supported HRPCI were stratified into 4 groups according to MR severity: No or trace MR, mild MR, moderate MR, and severe MR. Immediate PCI-related complications, major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days and death at 1-year were assessed. ResultsFrom March 2017 to March 2020, 631 patients who underwent Impella-supported HRPCI in the PROTECT III study had evaluable MR severity at baseline. Patients with severe MR had lower body mass indices, lower left ventricular ejection fractions (LVEFs), and were more frequently diagnosed with heart failure. The incidence of immediate PCI-related complications was similar between groups. Unadjusted 90-day MACCE and 1-year mortality rates were numerically higher in patients with severe MR compared to the other study groups yet without reaching statistical significance. In multivariable analyses, there was no significant association between the presence of severe MR for 90-day MACCE or 1-year mortality compared with other degrees of MR (adj. HR = 1.71, 95% CI [0.73, 3.98], p = 0.21; adj. HR = 1.79, 95% CI [0.86, 3.74], p = 0.12, respectively). ConclusionsImpella-supported HRPCI patients with moderate or severe MR exhibited a higher prevalence of heart failure, lower LVEF, and longer hospital stays. Patients with severe MR showed numerically higher unadjusted rates of 90-day MACCE and 1-year mortality compared to other groups, however these differences did not reach statistical significance even after adjustment for potential confounders. Clinical trial informationTrial Name: The Global cVAD Study (cVAD)ClinicalTrial.govIdentifier:NCT04136392URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2

Pulsatile Left Ventricular Assistance in High-Risk Percutaneous Coronary Interventions: Short-Term Outcomes.

To document the real-world experience with the use of pneumatic pulsatile mechanical circulatory support (MCS) with the PulseCath iVAC2L during high-risk percutaneous coronary interventions (HR-PCIs). Background: The use of MCS in HR-PCIs may reduce the rate of major adverse cardiovascular events (MACEs) at 90 days. The PulseCath iVAC2L is a short-term pulsatile transaortic left ventricular (LV) assist device that has been in use since 2014. The iVAC2L Registry tracks its safety and efficacy in a variety of hospitals worldwide. Methods: The iVAC2L Registry is a multicenter, observational registry that aggregates clinical data from patients treated with the iVAC2L worldwide. A total of 293 consecutive cases were retrospectively collected and analyzed. Estimated rates of in-hospital clinical endpoints were described. All-cause mortality was used as the primary endpoint and other outcomes of interest were used as secondary endpoints. The rates obtained were reported and contextualized. Results: The in-hospital rate of all-cause mortality was 1.0%, MACE was 3.1%. Severe hypotension occurred in 8.9% of patients. Major bleeding and major vascular complications occurred in 1.0% and 2.1%, respectively. Acute myocardial infarction occurred in 0.7% of patients. Cerebrovascular events occurred in 1.4% of patients. Cardiac arrest occurred in 1.7% of patients. A statistically significant improvement in blood pressure was observed with iVAC2L activation. Conclusions: The results of the present study suggest that the iVAC2L is capable of improving hemodynamics with a low rate of adverse events. However, confirmatory studies are needed to validate these findings.

Feasibility and Effectiveness of Venoarterial Extracorporeal Membrane Oxygenation Plus Intra-Aortic Balloon Pump Assisted High-Risk Percutaneous Coronary Intervention in Complex Coronary Disease.

Mechanical circulatory support may facilitate high-risk percutaneous coronary intervention (PCI). This study aimed to assess the feasibility, safety and effectiveness of high-risk PCI under the support of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with intra-aortic balloon pump (IABP). We enrolled patients who received VA-ECMO plus IABP-assisted PCI procedures at our center from April 2012 to June 2018. Major adverse cardiac events (MACEs) included all-cause death, myocardial infarction, and target vessel revascularization. A total of 10 patients were included, with a mean age of 71 years, EuroSCORE II of 19.9%, and SYNTAX score of 39.8. Procedural success was achieved in nine (90%) patients. The mean duration of ECMO support was 1.5 hours, and 2.6 stents were implanted per patient. Major complications included contrast-induced nephropathy needing hemodialysis in one (10%) patient, significant hemoglobin drop requiring blood transfusion in two (20%) patients, pulmonary infection in one (10%) patient, and local surgical incision infection in one (10%) patient. The accumulative mortality rates for the nine patients with procedural success were 0, 22.2%, and 44.4% at 1, 3, and 5 years follow-up, respectively. However, cardiac death occurred in only one (11.1%) patient. In addition, two patients received repeat PCI or coronary artery bypass grafting within two years following the index procedure. The overall incidence rates of MACEs were 11.1%, 44.4%, and 66.7% at 1, 3, and 5 years follow-up, respectively. VA-ECMO plus IABP-assisted high-risk PCI was feasible in patients with complex coronary disease, with a high procedural success rate and acceptable mid-term clinical outcomes.

Mechanical Circulatory Support with Impella: Principles, Evidence, and Daily Practice.

The Impella (Abiomed, Danvers, MA, USA) microaxial pump is a percutaneous mechanical circulatory support (MCS) that has been shown to increase coronary perfusion, reduce myocardial oxygen demand, and improve peripheral organ perfusion. Therefore, indications for the Impella device include emergency use for cardiogenic shock (CS) and pre-emptive implantation during high-risk percutaneous coronary intervention (HR-PCI). However, despite their exponential use in cardiovascular practice over the past decade, there is limited randomized evidence to support the benefits of this therapy and growing concern regarding complication rates. In this review, we summarize the principles, evidence, and practical considerations of the most widely used Impella CP percutaneous left ventricular support in both CS and HR-PCI settings, moving from the historical background to current issues and future expectations for this device.

Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome

The appropriate follow-up surveillance strategy for patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) remains unknown. To assess clinical outcomes in patients with and without ACS who have undergone high-risk PCI according to a follow-up strategy of routine stress testing at 12 months after PCI vs standard care alone. The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented vs Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) trial was a randomized clinical trial that compared follow-up strategies of routine functional testing vs standard care alone 12 months after high-risk PCI. Patients were categorized as presenting with or without ACS. Patients were enrolled in the trial from November 2017 through September 2019, and patients were randomized from 11 sites in South Korea; data analysis was performed in 2022. Patients categorized as presenting with or without ACS were randomized to either a routine functional testing or standard care alone follow-up strategy 12 months after high-risk PCI. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years following randomization. Kaplan-Meier event rates through 2 years and Cox model hazard ratios (HRs) were generated, and interactions were tested. Of 1706 included patients, 350 patients (20.5%) were female, and the mean (SD) patient age was 64.7 (10.3) years. In total, 526 patients (30.8%) presented with ACS. Compared with those without ACS, patients with ACS had a 55% greater risk of the primary outcome (HR, 1.55; 95% CI, 1.03-2.33; P = .03) due to higher event rates in the first year. The 2-year incidences of the primary outcome were similar between strategies of routine functional testing or standard care alone in patients with ACS (functional testing: 16 of 251 [6.6%]; standard care: 23 of 275 [8.5%]; HR, 0.76; 95% CI, 0.40-1.44; P = .39) and in patients without ACS (functional testing: 30 of 598 [5.1%]; standard care: 28 of 582 [4.9%]; HR, 1.04; 95% CI, 0.62-1.74; P = .88) (P for interaction for ACS = .45). Although a landmark analysis suggested that the rates of invasive angiography and repeat revascularization were higher after 1 year in the routine functional testing group, the formal interactions between ACS status and either invasive angiography or repeat revascularization were not significant. Despite being at higher risk for adverse clinical events in the first year after PCI than patients without ACS, patients with ACS who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing at 12 months compared with standard care alone during follow-up. ClinicalTrials.gov Identifier: NCT03217877.

Standby extracorporeal membrane oxygenation: a better strategy for high-risk percutaneous coronary intervention.

The incidence of cardiac arrest (CA) during percutaneous coronary intervention (PCI) is relatively rare. However, when it does occur, the mortality rate is extremely high. Extracorporeal cardiopulmonary resuscitation (ECPR) has shown promising survival rates for in-hospital cardiac arrests (IHCA), with low-flow time being an independent prognostic factor for CA. However, there is no definitive answer on how to reduce low-flow time. This retrospective study, conducted at a single center, included 39 patients who underwent ECPR during PCI between January 2016 and December 2022. The patients were divided into two cohorts based on whether standby extracorporeal membrane oxygenation (ECMO) was utilized during PCI: standby ECPR (SBE) (n = 13) and extemporaneous ECPR (EE) (n = 26). We compared the 30-day mortality rates between these two cohorts and investigated factors associated with survival. Compared to the EE cohort, the SBE cohort showed significantly lower low-flow time (P < 0.01), ECMO operation time (P < 0.01), and a lower incidence of acute kidney injury (AKI) (P = 0.017), as well as peak lactate (P < 0.01). Stand-by ECMO was associated with improved 30-day survival (p = 0.036), while prolonged low-flow time (p = 0.004) and a higher SYNTAX II score (p = 0.062) predicted death at 30 days. Standby ECMO can provide significant benefits for patients who undergo ECPR for CA during PCI. It is a viable option for high-risk PCI cases and may enhance the overall prognosis. The low-flow time remains a critical determinant of survival.

Impella Versus Non-Impella for Nonemergent High-Risk Percutaneous Coronary Intervention

The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc., Danvers, MA) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared to historical data (PROTECT II) but lacks a direct comparison to the HR-PCI cohort without Impella support. We retrospectively identified patients meeting PROTECT III inclusion criteria for HR-PCI and compared this group (NonIMP) to the outcomes data from the PROTECT III registry (IMP). Baseline differences were balanced using inverse propensity weighting (IPW). The co-primary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 high-risk patients who did not receive Impella support; 200 patients had at 90-day event ascertainment and were included in the IPW analysis and compared with 504 patients in the IMP group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs. 4.8%, p=0.403) but lower in NonIMP at 90 days (7.5% vs. 13.8%, p=0.033). Periprocedural vascular complications, bleeding, and transfusion rate were not different between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs. 5.4%, p=0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort demonstrated similar MACE in-hospital but lower MACE at 90 days, while there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for HR-PCI patients.

Contrast-induced Nephropathy: Incidence and Reversibility in Patients Undergoing High-risk Percutaneous Coronary Intervention

Contrast-induced Nephropathy: Incidence and Reversibility in Patients Undergoing High-risk Percutaneous Coronary Intervention