Moderate or severe aortic regurgitation is common after TAVR and an adverse prognostic indicator of short- and long-term survival. Incidence of moderate or severe AR is higher with use of the CoreValve. Mild AR may be associated with increased long-term mortality. Therefore, every effort should be made to minimize AR by a comprehensive pre-procedural planning and meticulous procedural execution.
Background:
Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS.
Methods:
Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality.
Results:
In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%,
P
=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%,
P
<0.01) and peripheral vascular complications (9.8% versus 3.8%,
P
=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results.
Conclusions:
In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS.
Clinical Trial Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT03313687.
Background:
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. The aim of this study was to evaluate if left ventricular unloading in cardiogenic shock patients treated with VA-ECMO was associated with lower mortality.
Methods:
Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading (using an Impella) at 16 tertiary-care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity-score-matched cohort.
Results:
Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio 0.79, 95% confidence interval 0.63-0.98, p=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading; e.g. severe bleeding in 98 (38.4%) vs. 45 (17.9%), access-site related ischemia in 55 (21.6%) vs. 31 (12.3%), abdominal compartment in 23 (9.4%) vs. 9 (3.7%) and renal replacement therapy in 148 (58.5%) vs. 99 (39.1%).
Conclusions:
In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in cardiogenic shock patients treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in cardiogenic shock patients treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.
Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC.
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