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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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Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Estados Unidos/epidemiología , Masculino , Femenino , Anciano , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/epidemiología , Factores de Riesgo , Medición de Riesgo/métodosRESUMEN
BACKGROUND: There are limited data on the clinical characteristics and outcomes of patients who require prolonged mechanical circulatory support (MCS) after Impella-supported high-risk percutaneous coronary intervention (HR-PCI). AIMS: The aim of this study is to describe the contemporary clinical characteristics, outcomes, and predictors associated with prolonged MCS support after assisted HR-PCI. METHODS: Patients enrolled in the prospective, multicentre, clinical endpoint-adjudicated PROTECT III study who had undergone HR-PCI using Impella were evaluated. Patient and procedural characteristics and outcomes for those who received prolonged MCS beyond the duration of their index procedure were compared to those in whom MCS was successfully weaned and explanted at the conclusion of the index PCI. RESULTS: Among 1,155 patients who underwent HR-PCI with Impella between 2017 and 2020 and had sufficient data to confirm the duration of Impella support, 16.5% received prolonged MCS (mean duration 25.2±31.1 hours compared with 1.8±5.8 hours for those who only received intraprocedural MCS). Patients receiving prolonged support presented with more urgent indications (e.g., acute coronary syndromes [ACS], lower ejection fraction [EF], elevated baseline heart rate and lower systolic blood pressure). Use of the Impella CP, intraprocedural complications, periprocedural complications and in-hospital mortality were all more common amongst the prolonged MCS group. Prolonged MCS was associated with increased rates of major adverse cardiovascular and cerebrovascular events, cardiovascular death, and all-cause mortality at 90-day follow-up. CONCLUSIONS: Patients receiving prolonged MCS after Impella-supported HR-PCI presented with more ACS, reduced EF and less favourable haemodynamics. Additionally, they were more likely to experience intraprocedural and periprocedural complications as well as increased in-hospital and post-discharge mortality.
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Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Cuidados Posteriores , Estudios Prospectivos , Alta del PacienteRESUMEN
BACKGROUND: Pathologic response at the time of surgery after neoadjuvant therapy for HER2 positive early breast cancer impacts both prognosis and subsequent adjuvant therapy. Comprehensive descriptions of the tumor microenvironment (TME) in patients with HER2 positive early breast cancer is not well described. We utilized standard stromal pathologist-assessed tumor infiltrating lymphocyte (TIL) quantification, quantitative multiplex immunofluorescence, and RNA-based gene pathway signatures to assess pretreatment TME characteristics associated pathologic complete response in patients with hormone receptor positive, HER2 positive early breast cancer treated in the neoadjuvant setting. METHODS: We utilized standard stromal pathologist-assessed TIL quantification, quantitative multiplex immunofluorescence, and RNA-based gene pathway signatures to assess pretreatment TME characteristics associated pathologic complete response in 28 patients with hormone receptor positive, HER2 positive early breast cancer treated in the neoadjuvant setting. RESULTS: Pathologist-assessed stromal TILs were significantly associated with pathologic complete response (pCR). By quantitative multiplex immunofluorescence, univariate analysis revealed significant increases in CD3+, CD3+CD8-FOXP3-, CD8+ and FOXP3+ T-cell densities as well as increased immune cell aggregates in pCR patients. In subsets of paired pre/post-treatment samples, we observed significant changes in gene expression signatures in non-pCR patients and significant decreases in CD8+ densities after treatment in pCR patients. No RNA based pathway signature was associated with pCR. CONCLUSION: TME characterization HER2 positive breast cancer patients revealed several stromal T-cell densities and immune cell aggregates associated with pCR. These results demonstrate the feasibility of these novel methods in TME evaluation and contribute to ongoing investigations of the TME in HER2+ early breast cancer to identify robust biomarkers to best identify patients eligible for systemic de-escalation strategies.