Objectives. The use of a microaxial flow pump (mAFP) to support high-risk percutaneous coronary intervention (HRPCI) in patients with cardiogenic shock (CS) is well established. A high-flow, surgically implanted mAFP (Impella 5.5, Abiomed/Johnson & Johnson MedTech) is increasingly used in patients with CS, yet little is known about the outcomes in HRPCI. The authors aimed to describe the outcomes, patient and procedural characteristics of Impella 5.5-supported HRPCI in a high-volume center. Methods. The authors identified all adult patients who underwent Impella 5.5-supported percutaneous coronary intervention (PCI) at Providence St. Vincent Medical Center from January 1, 2021, to December 31, 2024. Patient demographics and clinical data were abstracted from the medical record. Categorical data were reported as frequency and percentage. Continuous variables represented by intervals were summarized using mean and SD or median and IQR. Results. Of the 34 patients identified, 31 were male, and the mean age was 62.9 (± 9.7) years. All patients had a maximal CS stage of C-E. The mean left ventricular ejection fraction was 24.3%. Unprotected left main was treated in 50% of the study cohort, and 94% of the patients required multivessel PCI. The mean SYNTAX score was 35.9 (± 10.8) and the residual SYNTAX score was 7.4 (± 5.9). Major adverse cardiac and cerebrovascular events occurred in 41% of the patients. The 90-day all-cause mortality was 38%. Conclusions. Impella 5.5 is feasible to support HRPCI in patients with severe multivessel coronary artery disease, severe heart failure, and CS with acceptable short- and intermediate-term patient outcomes.

Severe coronary artery calcification (CAC) complicates high-risk percutaneous coronary intervention (HRPCI), particularly in patients with impaired left ventricular function. Atherectomy may facilitate lesion preparation, but its use in high-risk settings is limited. We therefore aimed to assess the impact of CAC severity and atherectomy on outcomes in Impella-supported HRPCI. In the PROTECT III study (NCT04136392), 1015 of 1237 patients had data on CAC severity and atherectomy. Patients were grouped as severe CAC without atherectomy (n=298), severe CAC with atherectomy (n=326), and no severe CAC (n=400). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/TIA, or repeat revascularization) at 30- and 90-days. Secondary endpoints included 1-year mortality, PCI-related complications, and hemodynamic instability. Patients with severe CAC had higher baseline SYNTAX scores and more left main disease. Atherectomy was associated with slightly longer procedural times, but not increased periprocedural complications or hemodynamic instability. At 90 days, MACCE was highest in the untreated severe CAC group (16.1% vs. 12.6% vs. 9.2%; overall log-rank p=0.048). One-year mortality was also highest in this group (23.7%; p=0.02). However, CAC severity and atherectomy use were not independent predictors of outcomes. Sensitivity analysis excluding patients with atherectomy but no severe CAC showed higher mortality risk in untreated severe CAC cases (adjHR: 0.59; overall p=0.026). In conclusion, Severe CAC is common in patients undergoing Impella-supported HRPCI and is associated with worse outcomes. Atherectomy was safe but its benefit remains uncertain. These findings highlight the prognostic relevance of CAC and the potential role of calcium modification in HRPCI.

BACKGROUND:A novel optical coherence tomography (OCT)-based physiology assessment technique, virtual flow reserve (VFR), has been demonstrated to perform as a reliable surrogate for invasive physiology. OBJECTIVES:The authors sought to examine the performance of post-percutaneous coronary intervention (PCI) VFR as a predictor of 2-year clinical outcomes independent from the OCT-based minimal stent area (MSA). METHODS:The ILUMIEN IV (Optical Coherence Tomography [OCT] Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI) trial prospectively recruited 2,487 patients with diabetes or high-risk coronary lesions randomizing to OCT- vs angiography-guided drug-eluting stent implantation. All patients with single-lesion treatment who had a final OCT imaging available underwent retrospective post-PCI VFR analysis offline. Of 2,128 eligible patients, VFR analysis was successfully performed in 2,057 (96.6%). Independent OCT predictors for the primary endpoint of 2-year target vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization, were evaluated by multivariable analysis. RESULTS:The median post-PCI VFR was 0.90 (Q1-Q3: 0.86-0.92), with a significant difference in VFR observed between the angiography- and OCT-guided groups (0.89 [Q1-Q3: 0.86-0.92] vs 0.90 [Q1-Q3: 0.87-0.92]; P < 0.001). By multivariable analysis, both MSA (per 1 mm2) and VFR (per 0.1 mm Hg/mm Hg) were independent predictors of 2-year TVF. Overall, MSA, proximal edge dissection and VFR independently predicted both TVF and target lesion failure. CONCLUSIONS:Post-PCI OCT-based VFR assessment is predictive of 2-year clinical outcomes independent of MSA. Online VFR analysis can provide operators with an immediate assessment of post-PCI physiology in addition to OCT anatomy, providing incremental value in assessing procedural success and informing on clinical prognosis (ILUMIEN IV [Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI]; NCT03507777).

Prevention, prompt diagnosis, and rapid treatment are crucial for improving outcomes of complications that occur during percutaneous coronary intervention (PCI). The authors summarize studies on PCI complications published between January 1, 2023, and May 1, 2024, including coronary dissection, no reflow, perforation, and equipment loss/entrapment.

BACKGROUND:Coronary bifurcation lesions (CBL) are associated with lower procedural success, worse postprocedural outcomes, and greater unplanned repeat revascularization. We sought to better understand the impact of Impella support in patients undergoing percutaneous coronary intervention (PCI) of CBLs. METHODS:We used data from the cVAD PROTECT III study (NCT04136392), an FDA-audited, single-arm study of patients undergoing high-risk PCI with Impella support, to examine the outcomes of patients undergoing PCI of CBLs. Patients with a Medina classification of 1.1.1, 1.0.1, or 0.1.1 were considered to have a true CBL, and were compared to patients with nontrue CBLs and/or no CBLs. The primary outcome was the rate of CEC-adjudicated major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days. Cox proportional hazards regression models were adjusted for age, sex, left main disease, and triple vessel disease. RESULTS:Of 1,044 patients, 523 had at least one true CBL treated. Baseline characteristics were comparable between groups except for age which was higher in patients with CBLs. Patients with CBLs had a significantly higher pre-PCI SYNTAX scores and number of treated lesions, more left main disease and triple vessel disease, and longer procedure duration. There was no difference in post-PCI SYNTAX score, PCI-related complications, or failure to achieve angiographic success. After adjustment for potential confounders, patients with CBLs had similar rates of 90-day MACCE. CONCLUSIONS:While patients with CBLs undergoing Impella-supported high-risk PCI had higher complexity, there were similar rates of PCI-related complications and 90-day MACCE. TRIAL REGISTRATION:Trial Name: The Global cVAD Study (cVAD), ClinicalTrial.gov Identifier: NCT04136392, URL:https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Access site bleeding remains a persistent challenge in patients with Impella CP catheters (Abiomed).1Ancona M.B. Montorfano M. Masiero G. et al.Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy.Eur Heart J Acute Cardiovasc Care. 2021; 10: 999-1006https://doi.org/10.1093/ehjacc/zuab051Crossref PubMed Scopus (16) Google Scholar,2Iannaccone M. Albani S. Giannini F. et al.Short term outcomes of Impella in cardiogenic shock: a review and meta-analysis of observational studies.Int J Cardiol. 2021; 324: 44-51https://doi.org/10.1016/j.ijcard.2020.09.044Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar Strategies for management include sheath manipulation, manual pressure, mattress suture placement, or preprocedural placement of Perclose suture-mediated closure devices (Abbott Vascular).3Van Edom C. Gramegna M. Baldetti L. et al.Management of bleeding and hemolysis during percutaneous microaxial flow pump support: a practical approach.J Am Coll Cardiol Intv. 2023; 16: 1707-1720https://doi.org/10.1016/j.jcin.2023.05.043Crossref Scopus (6) Google Scholar,4Saleem D. Sethi S.S. Parikh S.A. et al.Preclose cinching "C-stitch" to aid hemostasis after Impella insertion.J Soc Cardiogr Angiogr Interv. 2022; 1100447https://doi.org/10.1016/j.jscai.2022.100447Abstract Full Text Full Text PDF Scopus (0) Google Scholar Despite these maneuvers, bleeding around the repositioning sheath can occur, often leading to premature device removal. In this report, we describe the "sideclose" technique, a novel strategy to achieve hemostasis with the placement of an additional Perclose while maintaining an Impella CP uninterrupted. The sideclose is a 2-person technique that begins with an Impella CP in place, the 14F peel-away sheath removed and the 9F to 13F tapered repositioning sheath within the vessel (Figure 1A). First, the sideport of the repositioning sheath is wired with a 0.035-inch J-wire (Figure 1B). While holding pressure at the arteriotomy site, the repositioning sheath is withdrawn over the Impella shaft while carefully maintaining the position of the Impella catheter. The backend of the 0.035-inch J-wire is pulled through the repositioning sheath (Figure 1C). A Perclose device is then placed over the 0.035-inch J-wire alongside the Impella shaft, in order to suture closed a portion of the arteriotomy (Figure 1D, E). Next, the Impella repositioning sheath is gently readvanced into the now smaller arteriotomy to achieve hemostasis (Figure 1F). A 65-year-old man with a history of end-stage renal disease, multivessel coronary artery disease, and an ejection fraction of 20% was admitted with decompensated heart failure and severe aortic stenosis. He underwent urgent transcatheter aortic valve replacement with a 26-mm SAPIEN 3 prosthesis via a 14F eSheath (Edwards Lifesciences). A single Perclose suture had been deployed prior to the introduction of the eSheath. Immediately after valve deployment, the patient became hypotensive and required cardiopulmonary resuscitation. Echocardiogram showed left ventricular standstill with no evidence of tamponade, coronary occlusion, or aortic dissection. The eSheath was removed and an Impella CP was placed. The patient stabilized within 20 minutes of the initiation of mechanical support but had persistent bleeding from the groin site, despite Impella sheath manipulation and tightening of the preclose suture. The sideclose technique was performed, resulting in immediate hemostasis. The patient stabilized in the intensive care unit; the Impella was removed the following day without complication by tightening the initially placed preclose suture. No additional closure or compression devices were required. The sideclose technique can be performed immediately after Impella CP placement or at an interval, with or without the existence of preclose sutures, and does not require the interruption of mechanical circulatory support. During sideclose, care must be taken to maintain the position of the Impella catheter while the repositioning sheath is withdrawn and readvanced. Possible complications or concerns with the technique include inadvertent movement of the Impella catheter, iatrogenic femoral artery stenosis or occlusion due to the additional suture, femoral artery injury, or failure to achieve hemostasis. It is theoretically possible for the Perclose needles to puncture the Impella catheter and cause damage to the device; to avoid this, we recommend positioning the Perclose squarely alongside the Impella with needles aligned at the 12-o'clock position (Figure 1D). Heavily diseased, calcified, or narrow caliber femoral vessels would likely not be well suited to this technique. Further study of this technique is required to refine the method and establish its clinical utility. Along with meticulous vascular access techniques, preclose strategies and careful attention to sheath angle and positioning, the sideclose technique may be useful and definitive in managing bleeding at the Impella arteriotomy site. Ethan Korngold reports consulting and honoraria for Abbott Vascular and Edwards Lifesciences. Jason Wollmuth reports consulting and honoraria for Abbott Vascular and Abiomed. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Coaxial trapping of guide extension catheters within a coronary artery allows for maximal support in delivering equipment; however, use of this technique within the left main coronary artery has been avoided due to concerns surrounding hemodynamic instability and vessel injury. We describe our initial experience with impromptu coaxial trapping of guide extension catheters within the left main coronary artery using the dual access rapid trap (DART) technique. Coaxial trapping of guide extension catheters within the left main coronary artery using DART enabled successful equipment delivery across balloon-uncrossable lesions. This case demonstrates that DART is a safe and effective method for equipment delivery across balloon-uncrossable lesions and may aid operators in safely solving complex cases.

BACKGROUND Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). OBJECTIVES The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. METHODS We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization.RESULTS From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 +/- 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs-21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex.CONCLUSIONS In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392) (J Am Coll Cardiol Intv 2023;16:1721-1729) (C) 2023 Published by Elsevier on behalf of the American College of Cardiology Foundation.

BACKGROUND:Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI).OBJECTIVES:The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study.METHODS:We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization.RESULTS:From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex.CONCLUSIONS:In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392).

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

•A significant LVEF improvement is noted in HRPCI patients who survive to 90 ​​days.•HRPCI patients with complete revascularization show the highest improvement in LVEF.•Significant heart failure and angina improvement is observed in normal baseline LVEF patients.•This is the largest study to date looking at LVEF changes 30 ​​days after PCI.

In patients at high risk for haemodynamic instability during percutaneous coronary intervention (PCI), practitioners are increasingly opting for prophylactic mechanical circulatory support, such as the Impella® heart pump (Abiomed, Danvers, MA, USA). Though Impella-supported high-risk PCI (HRPCI) ensures haemodynamic stability during the PCI procedure, access-related complication rates have varied significantly in published studies. Reported variability in complication rates relates to many factors, including anticoagulation practices, access and closure strategy, post-procedure care and variations in event definitions. This article aims to outline optimal strategies to minimize vascular and bleeding complications during Impella-supported HRPCI based on previously identified clinical, procedural and postprocedural risk factors. Practices to reduce complications include femoral skills training, standardized protocols to optimize access, closure, anticoagulation management and post-procedural care, as well as the application of techniques and technological advances. Protocols integrating these strategies to mitigate access-related bleeding and vascular complications for Impella-supported procedures can markedly limit vascular access risk as a barrier to appropriate large-bore mechanical circulatory support use in HRPCI.