p.47 抽出テキスト

CLINICAL STATEMENTS AND GUIDELINES

Circulation. 2025;151:e771–e862. DOI: 10.1161/CIR.0000000000001309 April 1, 2025 e817

Recommendation-Specific Supportive Text

1 The DanGer-SHOCK (Danish-German Cardiogenic

Shock) trial enrolled patients with STEMI and cardiogenic shock of <24 hours duration, defined as hypotension (SBP <100 mm Hg or vasopressor support), end-organ hypoperfusion (arterial lactate ≥2.5 mmol/L and/or SvO2 <55% with a normal PaO2), and LVEF <45%. Patients who were comatose (Glasgow Coma Scale score <8) after out-of-hospital cardiac arrest and patients with overt right ventricular failure were excluded.1 The study enrolled 360 patients at 14 specialized centers in Europe and randomized them to use of a microaxial flow pump or standard of care. Use of a microaxial flow pump significantly reduced the risk of all-cause mortality at 180 days by 26% (HR, 0.74 [95% CI, 0.55-0.99]; P =0.04; absolute risk reduction, 12.7%; number needed to treat =8) compared with standard of care. The absolute risk reduction seen in this trial is similar to the absolute risk reduction in 6-month mortality observed with emergency revascularization in patients with AMI and LV failure in the SHOCK (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock) trial.1,20 However, given the increased risks of serious complications like bleeding, limb ischemia, and renal replacement therapy with the microaxial flow pump seen in the DanGer Shock trial, the COR is based on the balance between these risks and the reduction in death. Additionally, the timing of microaxial flow pump placement was not dictated by the trial protocol; thus, the preferred timing of placement is unclear. Based on these results, use of a microaxial flow pump is reasonable to reduce mortality in patients with STEMI and cardiogenic shock who have clinical features consistent with the inclusion criteria of the DanGer-SHOCK trial. In particular, patients with STEMI who present with SCAI shock stages C, D, or E, who are noncomatose and have adequate peripheral vasculature to accommodate large-bore access are reasonable candidates for the microaxial flow pump. 2.	 Although randomized trial data are lacking, MCS

devices can be considered as a bridge to surgery for patients with mechanical complications of AMI when adequate clinical stabilization is required and may allow for further tissue stabilization at the injured site. A systemic review of patients treated with MCS as a bridge to surgical treatment of ventricular septal rupture yielded 111 studies (n=2440) with almost all patients receiving initial IABP support (n=2263).2 Of the 129 patients who underwent additional MCS device placement (77.5% of whom were on VA-ECMO), the lowest in-hospital mortality was observed in those treated with VA-ECMO (29.2%) when compared with those treated with an IABP alone (52.0%). However, 2 database analyses that were not included in the systematic review demonstrated higher in-hospital death with use of VA-ECMO in patients with post-AMI mechanical complications.3,4 Evaluation of the ECLS (Extracorporeal Life Support) Organizations Registry yielded 158 patients with post-AMI mechanical complications who underwent VA-ECMO.3 Survival to hospital discharge here was low at 37.3%, and complications related to VA-ECMO use occurred in 75.3% of patients. Evaluation of the National Inpatient Sample yielded 10 726 patients with post- STEMI mechanical complications, and the use of VA-ECMO was associated with increased inhospital mortality (OR, 2.80 [95% CI, 1.92-4.04]), while the use of an IABP was not associated with lower mortality.4 Both data sources included use of VA-ECMO at any time during the hospitalization for post-AMI mechanical complications, including use of VA-ECMO postsurgery, a cohort at highest risk of in-hospital mortality. 3.	 The IABP-SHOCK II (Intraaortic Balloon Pump

in Cardiogenic Shock II) trial randomized patients with AMI and severe or refractory cardiogenic shock in whom early revascularization was planned to IABP or no IABP.5 At 30 days and long-term follow-up, no differences were observed in the primary outcome of all-cause death or the secondary biomarker or measures of disease severity endpoints.6,7 VA-ECMO has not been shown to reduce death compared with medical therapy alone in patients with cardiogenic shock in the setting of MI but increases major bleeding and vascular complications.21 The ECMO-CS (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) trial randomized patients with rapidly deteriorating or severe cardiogenic shock to immediate or no immediate VA-ECMO.8 At 30 days, no differences were observed in the primary composite endpoint of all-cause death, resuscitated cardiac arrest, and implementation of another MCS device with results consistent in the 74 patients with cardiogenic shock related to MI and in the as-treated analysis. The ECLS-SHOCK (Extracorporeal Life Support in Infarct-Related Cardiogenic Shock) trial randomized patients with AMI and severe or refractory cardiogenic shock in whom early revascularization was planned to early ECLS or no ECLS.9 No differences were observed in the primary outcome of the 30-day mortality rate or secondary outcomes. Moderate or severe bleeding and peripheral vascular complications

Downloaded from http://ahajournals.org by on October 7, 2026