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Background: 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). Methods: 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. Results: 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. Conclusions: 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.

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BACKGROUND: Mitral 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. METHODS: Patients 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. RESULTS: From 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). CONCLUSIONS: Impella-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 INFORMATION: Trial Name: The Global cVAD Study (cVAD) ClinicalTrial.govIdentifier:NCT04136392 URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

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Background: Patients with complex coronary artery disease, as defined by high SYNTAX scores, undergoing percutaneous coronary intervention (PCI) have poorer outcomes when compared with patients with lower SYNTAX I scores. This study aimed to assess if mechanical circulatory support using Impella mitigates the effect of the SYNTAX I score on outcomes after high-risk percutaneous coronary intervention (HRPCI). Methods: Using data from the PROTECT III study, patients undergoing Impella-assisted HRPCI between March 2017 and March 2020 were divided into 3 cohorts based on SYNTAX I score-low (≤22), intermediate (23-32), and high (≥33). Procedural and clinical outcomes out to 90 days were compared between groups. Multivariable regression analysis was used to assess the impact of SYNTAX I score on major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days. Results: A total of 850 subjects with core laboratory-adjudicated SYNTAX I scores were identified (low: n = 310; intermediate: n = 256; high: n = 284). Patients with high SYNTAX I scores were older than those with low or intermediate SYNTAX I scores (72.7 vs 69.7 vs 70.1 years, respectively; P < .01). After adjustment for covariates, high SYNTAX I score remained a significant predictor of 90-day MACCE (hazard ratio [HR], 2.14; 95% CI, 1.42-3.69; P < .01 vs low), whereas intermediate SYNTAX I score was not (HR, 0.92; 95% CI, 0.47-1.77; P = .80 vs low). These findings persisted after adjustment for post-PCI SYNTAX I score. Conclusions: A high SYNTAX I score was associated with higher rates of 90-day MACCE in patients who underwent Impella-assisted HRPCI. Further research is needed to understand the patient and procedural factors driving this finding.

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Background: Anemia is prevalent among patients with cardiovascular disease and is associated with adverse outcomes. However, data regarding the impact of anemia in high-risk percutaneous coronary intervention (HRPCI) are limited. Objectives: This study aimed to evaluate the impact of anemia in patients undergoing Impella-supported HRPCI in the PROTECT III study. Methods: Patients undergoing Impella-supported HRPCI in the multicenter PROTECT III study were assessed for anemia based on baseline hemoglobin levels according to World Health Organization criteria. Patients were stratified into three groups, namely, no anemia, mild anemia, and moderate or severe anemia. Major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 30 and 90 days, and major bleeding events were compared across groups. Results: Of 1,071 patients with baseline hemoglobin data, 37.9% had no anemia, 43.4% had mild anemia, and 18.7% had moderate or severe anemia. Anemic patients were older and more likely to have comorbidities. Anemia was associated with higher MACCE rates at 30 days (moderate to severe, 12.3%; mild, 9.8%; no anemia, 5.4%; p = 0.02) and at 90 days (moderate to severe, 18.7%; mild, 14.6%; none, 8.3%; p = 0.004). These differences persisted after adjustment for potential confounders at 30 and 90 days, and sensitivity analysis excluding dialysis showed similar results. Major bleeding at 30 days was also higher in anemic patients (5.5% vs. 1.2%, p = 0.002). Conclusion: Baseline anemia in Impella-supported HRPCI is common and independently associated with MACCE and major bleeding, emphasizing its significance as a prognostic factor. Specific management strategies to reduce anemia-associated MACCE risk after HRPCI should be examined. Clinical Trial Information Trial Name: The Global cVAD Study (cVAD)ClinicalTrial.gov Identifier: NCT04136392URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

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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.

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The benefit of mechanical circulatory support with Impella (Abiomed, Inc., Danvers, Massachusetts) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared with historical data (PROTECT II) but lack a direct comparison with the HR-PCI cohort without Impella support. We retrospectively identified patients meeting the PROTECT III inclusion criteria for HR-PCI and compared this group (non-Impella cohort [NonIMP]) with the outcomes data from the PROTECT III registry (Impella cohort). Baseline differences were balanced using inverse propensity weighting. The coprimary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 patients at great risk did not receive Impella support; 200 patients had 90-day event ascertainment and were included in the inverse propensity weighting analysis and compared with 504 patients in the Impella cohort 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 less in NonIMP at 90 days (7.5% vs 13.8%, p = 0.033). Periprocedural vascular complications, bleeding, and transfusion rate did not differ 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 showed similar MACE in-hospital but fewer MACE at 90 days, whereas there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for patients with HR-PCI.

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Coronary artery disease (CAD) is a major cause of morbidity and mortality in the United States, and as strides have been made in its management, outcomes have continued to improve. Management has evolved from expectant management to coronary artery bypass graft surgery and thrombolysis, to more recently percutaneous intervention with stenting and medical management in select cases. Here, we describe a case of a complex patient with severe triple-vessel disease who was deemed a poor surgical candidate for coronary artery bypass graft surgery and would instead undergo high-risk percutaneous intervention with the placement of nine drug-eluting stents.

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Contemporary medical practices allow complete percutaneous coronary intervention (PCI) in a considerable number of patients who previously would have been considered too 'high-risk' for such procedures. The use of mechanical circulatory support (MCS) devices during these high-risk PCIs (HR-PCIs) is thought to reduce the potential risk for major adverse events during and after revascularization. The intra-aortic balloon pump (IABP), veno-arterial extracorporeal membrane oxygenation (V-A ECMO), and the Impella are the most common MCS devices in use. This review aims to summarize the clinical evidence for each of these devices and the potential mechanisms for the improvement in patient outcomes in HR-PCI. The IABP use has rapidly declined in recent years due to no evidence of benefit in HR-PCI and cardiogenic shock. The V-A ECMO results in low rates of major adverse cardiac and cerebrovascular events (MACCEs) but higher rates of acute kidney injury and increased need for transfusions. In initial studies, Impella resulted in a reduced need for repeat interventions and reduced rates of hypotension, but no benefit in mortality. However, MACCE rates with Impella have gradually declined over the last 10 years, reflecting increased operator experience and technical improvements. Thus, a large, randomized trial is needed to assess the efficacy of Impella in HR-PCI with contemporary standards of care. There is currently no individual parameter that can identify patients who would benefit from MCS use in elective HR-PCI. To address this gap, we propose an algorithm that combines anatomical complexity, comorbidities, and clinical presentation to accurately identify candidates for MCS-assisted HR-PCI.

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PURPOSE OF REVIEW: This review will focus on the indications of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) and then analyze in detail all MCS devices available to the operator, evaluating their mechanisms of action, pros and cons, contraindications, and clinical data supporting their use. RECENT FINDINGS: Over the last decade, the interventional cardiology arena has witnessed an increase in the complexity profile of the patients and lesions treated in the catheterization laboratory. Patients with significant comorbidity burden, left ventricular dysfunction, impaired hemodynamics, and/or complex coronary anatomy often cannot tolerate extensive percutaneous revascularization. Therefore, a variety of MCS devices have been developed and adopted for high-risk PCI. Despite the variety of MCS available to date, a detailed characterization of the patient requiring MCS is still lacking. A precise selection of patients who can benefit from MCS support during high-risk PCI and the choice of the most appropriate MCS device in each case are imperative to provide extensive revascularization and improve patient outcomes. Several new devices are being tested in early feasibility studies and randomized clinical trials and the experience gained in this context will allow us to provide precise answers to these questions in the coming years.

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Complex percutaneous coronary intervention (PCI) procedures have been routinely performed in non-surgical centres in the UK for more than two decades. These procedures follow strict guidelines and recommendations by the British Cardiovascular Intervention Society to ensure a more effective running of PCI programs. Even more so, expected guiding principles necessary for the safe optimisation of complex PCI procedures have also been created.  An 81-year-old male was admitted with non-ST-elevation myocardial infarction (NSTEMI) and severely impaired left ventricle ejection fraction (LVEF; 26% according to the cardiac MRI report). Angiogram findings revealed severe multiple-vessel coronary artery disease affecting the following arteries: right coronary artery (RCA), left anterior descending artery (LAD), left circumflex artery (LCx), and intermediate artery (IM). There was also severe disease in the distal left main stem (LMS) bifurcation extending to the ostia of the LAD, LCx, and IM branches. Following a multidisciplinary meeting, the patient underwent Impella-supported high-risk PCI (complex PCI) using the DK crush technique with no peri- and post-procedure complication and a significant LV function improvement (45-49%). This is the first known case of this procedure performed at the Royal Cornwall Hospital in Treliske (RCHT), Truro, Cornwall. This case report highlights that when the decision to choose between coronary artery bypass graft (CABG) and PCI is not straightforward following an individualised risk-stratification scoring system analysis and in the setting of patient comorbidities, a high-risk PCI supported with the Impella device is a suitable alternative with promising short-term and long-term outcomes.

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BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

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BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

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INTRODUCTION: Impella devices have emerged as a critical tool for temporary mechanical circulatory support (TMCS) in the management of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (PCI). The purpose of this review is to examine the history of the different Impella devices, their hemodynamic profiles, and how the data supports their use. AREAS COVERED: This review covers the development and specifications of the Impella 2.5, Impella CP, Impella 5.0/Left Direct (LD), Impella RP, and Impella 5.5 devices. This review also covers the clinical trials that illuminate the Impella devices' use in their appropriate clinical contexts. These studies examine the effectiveness of Impella devices and have begun to yield promising results, demonstrating improved survival rates when compared to the historically high mortality rates associated with CS. It is important to weigh the benefits of Impella devices in light of their contraindications. A literature search was conducted by searching the PubMed database for reviews, meta-analyses, and clinical trials pertinent to Impella devices. EXPERT OPINION: Impella devices are a crucial tool for management of patients undergoing high-risk PCI and those with CS. There is evidence that early Impella implantation is beneficial in the treatment of patients presenting with CS. Further randomized controlled trials are needed to better elucidate the benefits of Impella devices in various clinical settings.

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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).

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BACKGROUND: The use of Impella support is increasingly adopted to "protect" patients with severe coronary artery disease (CAD) and left ventricle (LV) dysfunction undergoing percutaneous coronary intervention (PCI). AIMS: To evaluate the impact of Impella-protected (Abiomed, Danvers, Massachusetts, USA) PCIs on myocardial function recovery. METHODS: Patients with significant LV dysfunction undergoing multi-vessel PCIs with pre-intervention Impella implantation were evaluated by echocardiography before PCI and at median follow up of 6 months: global and segmental LV contractile function were assessed by LV ejection fraction (LVEF) and wall motion score index (WMSI), respectively. Extent of revascularization was graded using the British Cardiovascular Intervention Society Jeopardy score (BCIS-JS). Study endpoints were LVEF and WMSI improvement, and its correlation with revascularization. RESULTS: A total of 48 high surgical risk (mean EuroSCORE II 8) patients with median LVEF value of 30%, extensive wall motion abnormalities (median WMSI 2.16), and severe multi-vessel CAD (mean SYNTAX score 35) were included. PCIs brought a significant reduction of ischemic myocardium burden with BCIS-JS decrease from mean value of 12 to 4 (p < 0.001). At follow-up, WMSI reduced from 2.2 to 2.0 (p = 0.004) and LVEF increased from 30% to 35% (p = 0.016). WMSI improvement was proportional to the baseline impairment (R - 0.50, p < 0.001), and confined to revascularized segments (from 2.1 to 1.9, p < 0.001). CONCLUSIONS: In patients with extensive CAD and severe LV dysfunction, multi-vessel Impella-protected PCI was associated to an appreciable contractile recovery, mainly determined by regional wall motion improvement in revascularized segments.

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BACKGROUND: Percutaneous coronary intervention in high-risk patients (HRPCI) is associated with increased risk of complications. Mechanical circulatory support devices, including intra-aortic balloon pump (IABP) may bridge patient safely throughout the procedure. AIM: We aimed to describe hemodynamic effects of larger (MEGA) compared to standard (STRD) volume IABP or no balloon control group (CTRL) during HRPCI. METHODS: In this single-center, open-label randomized controlled trial HRPCI were randomly assigned to three groups according to planned hemodynamic support: MEGA, STDR and CTRL in a 1:1:1 scheme. Screening failure patients formed registry (REG). We analyzed data from pulmonary artery catheter especially cardiac output and cardiac power output (CPO) with Fick method and pulmonary artery wedge pressure (PCWP), as well as left ventricle systolic pressure (LVSP) with PIGTAIL catheter. We also calculated endocardial viability ratio (EVR) and analyzed pressure tracings from the IABP console. We compared baseline and on-support values. Final hemodynamic analysis was done on per-treatment basis, including REG patients. RESULTS: A total of 47 patients were analyzed (16 MEGA, 10 STRD and 21 CTRL). Compared to CTRL we found significant increase from baseline to on-support value for cardiac output and CPO in the MEGA, but not in the STRD group. The change in EVR (increase) and in LVSP (decrease) was significant equally in MEGA and STRD vs. CTRL group, but PCWP did not change significantly for both balloons vs. CTRL. Diastolic augmented pressure with IABP was higher in MEGA than STRD and was positively correlated with systolic unloading. CONCLUSIONS: We observed more favorable hemodynamic effects of larger compared to standard volume balloon.

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Background: Coronary artery bypass grafting is the standard of care for patients with obstructive left main (LM) coronary disease. In poor surgical candidates, high-risk percutaneous coronary artery intervention (PCI) is an alternative. Methods: We investigated a retrospective cohort of patients who underwent LM PCI from January 2010 to March 2014 (n = 89). Obstructive LM disease was defined as 50% angiographic obstruction of luminal flow, and the primary endpoint was inhospital mortality. Ventricular assist device (VAD) was defined as the use of either intra-aortic balloon pump (IABP) or Impella 2.5 devices before, during, or following PCI. Results: A total of 89 patients with LM PCI were divided into those with (n = 39) and without (n = 50) VAD support. The former group was further divided into those with support from either Impella 2.5 (n = 28) or IABP (n = 11). Age, race, and gender did not differ between patients who received unassisted LM-PCI from those with VAD support (P = 0.142, 1.0, and 0.776, respectively). The angiographic stenosis of atherosclerotic lesions in LM, proximal left anterior descending artery, and other native/surgical coronary vessels was similar between the groups. The duration of hospitalization was significantly longer for patients with VAD support compared to those without (7.19 ± 6.89 vs. 2.78 ± 3.39, P < 0.001). The incidence of cardiogenic shock and inhospital mortality was significantly higher in the VAD group (P = 0.009 and 0.001, respectively). Overall, inhospital mortality was 9% (8/89). The IABP and Impella 2.5 groups had mortality proportions of 46% (5/11) and 11% (3/28), respectively; P = 0.028. For all patients, inhospital mortality was higher for those with versus without cardiogenic shock (56% or 5/9 vs. 4% or 3/80; P < 0.001), and for those with versus without left ventricular systolic function <40% (17% vs. 2%;P < 0.025). Conclusion: In a selected group of patients with LM disease, unsupported PCI appears to be a feasible and safe procedure. In high-risk patients, the use of Impella 2.5 appears to be superior to IABP in LM PCI resulting in favorable short-term outcomes.

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The use of mechanical circulatory support devices in cardiovascular practice has risen exponentially over the past decade. These devices are currently used for hemodynamic support in patients with cardiogenic shock, high-risk percutaneous coronary intervention, left ventricular unloading, protection of kidneys, and right ventricular failure. The Impella (Abiomed) percutaneous microaxial flow pump devices are rapidly gaining popularity. However, despite their increasing use, there are limited randomized clinical trials (RCTs) to support the benefits of the therapy and growing concern regarding complication rates. Vascular problems, including bleeding and acute limb ischemia, are associated with the devices, but published reports also highlight risks for cardiac perforations, mitral chordae rupture, and stroke. In this review, we summarize the history, mechanism of action, previously published RCT data, and upcoming RCTs on these devices.

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BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) offers hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (PCIs). However, long-term outcomes associated with VA-ECMO have not previously been studied. AIM: To explore long-term outcomes in high-risk cases undergoing PCI supported by VA-ECMO. METHODS: In the present observational cohort study, 61 patients who received VA-ECMO-supported high-risk PCI between April 2012 and January 2020 at the Sixth Medical Center of Chinese People's Liberation Army General Hospital were enrolled. The endpoint characteristics such as all-cause mortality, repeated cardiovascular diseases, and cardiac death were examined. RESULTS: Among 61 patients, three failed stent implantation due to chronic total occlusions with severely calcified lesions. One patient showed VA-ECMO intolerance because of high left ventricular afterload. PCI was successfully performed in 57 patients (93.4%). The in-hospital mortality was 23.0%, and the overall survival was 45.9%, with a median follow-up period of 38.6 (8.6-62.1) mo. CONCLUSION: VA-ECMO can be used as a support in patients undergoing high-risk PCI as it is associated with favorable long-term patient survival.

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BACKGROUND: The best timing to perform percutaneous coronary interventions (PCI) in patients undergoing TAVI is unknown. Most PCI are performed before TAVI, because of concerns about potential ischemic complications during valve implantation. In this study we aimed to compare short-and long-term outcomes of patients undergoing PCI before or after TAVI. METHODS: Patients undergoing TAVI and PCI from 2010 to 2021 were analyzed. PCI was defined as high-risk when involving unprotected left main, proximal left anterior descending, proximal dominant right coronary artery or 3-vessel disease. The primary endpoint was the cumulative incidence of any TAVI procedural complication and in-hospital adverse events (VARC-3 criteria). RESULTS: Out of 1162 patients, 144 underwent PCI, 68% after TAVI, 78.4% of which were at high-risk. The primary endpoint occurred in 28.4% of patients in PCI pre-TAVI group vs 21.4% in PCI post-TAVI group (p = 0.403) and in 34.4% vs 17.3% of patients respectively among high-risk patients (p = 0.075). A higher rate of stroke was observed in the PCI pre-TAVI group regardless of the PCI complexity (6.5% vs 0.0%, p = 0.031; 9.3% vs 0.0% p = 0.025 in the high-risk group). At 24 months, MACCE-free survival was lower in patients who underwent PCI before TAVI (84.4% vs 97.9%, adjusted HR 10.16, 95% CI 1.19-86.57, p = 0.019; and 84.4% vs 97.3%, adjusted HR 7.34 95% CI 0.78-62.28 p = 0.082 in the high-risk group). CONCLUSIONS: PCI performed after TAVI does not expose patients to higher risks of peri-procedural hazards and provides a trend towards favourable clinical outcome at mid-to-long term.

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