Valvular complications following the Impella device implantation

Abstract

Background Despite clear clinical benefits, there is limited evidence regarding possible complications of the novel mechanical support device Impella. Aortic and mitral valve regurgitation or injury are rare but potential complications following implantation of the Impella device. Methods To evaluate valvular complications after the Impella device implantation, we have performed a comprehensive search of literature on multiple sites on this topic. Results and Conclusion Ten case reports and one observational retrospective study were identified, with a total number of 19 patients identified. This article aims to draw attention to potential periprocedural complications relating to the Impella, in particular iatrogenic aortic and mitral valve injuries. Moreover, we have summarized our recommendations emphasizing the need for careful management and meticulous follow‐up of these patients to avoid such potentially devastating complications.

Pseudoaneurysm Formation After “Preclose”-Assisted Impella Insertion in a Patient With Cardiogenic Shock

“…Placement and use of the Impella device bear potential risks. Risk factors for worse outcomes with Impella include older patients and female gender due to the higher likelihood of severe peripheral vascular disease and smaller arterial anatomy, respectively [ 3 , 4 ]. Additionally, diabetes mellitus and chronic kidney disease are associated with a negative impact on outcome.…”

“…Additionally, diabetes mellitus and chronic kidney disease are associated with a negative impact on outcome. According to several review articles and meta-analyses, the most common complications reported are major bleeding requiring blood product transfusion (15-20%), vascular access complications (about 15%), infection (about 13%), hemolysis (about 10%), vascular complications with a need of surgical repair (about 10%), limb ischemia (about 3-7%), stroke (about 4%) and bleeding requiring surgical intervention (about 2%) [ 3 , 4 , 9 ].…”

“…The use of temporary mechanical circulatory support (MCS) during high-risk percutaneous coronary intervention (PCI), such as intra-aortic balloon pump (IABP), Impella, and extracorporeal membrane oxygenation (ECMO) to increase stroke volume and/or reduce end-diastolic left ventricle pressure is an attractive option that may improve outcomes [ 1 - 3 ]. Of the MCS devices, the Impella is being increasingly used as an alternative to the IABP and ECMO for hemodynamic support in patients with CS and high-risk PCI due to its superior ability to augment cardiac output (CO) and reduce shock severity parameters, although it has yet to show significant effect on reducing 30-day mortality [ 1 , 4 ].…”

“…Iatrogenic aortic and mitral valve injuries are rare but potential complications following implantation of the Impella device. Additionally, vascular access complications such as hematoma or pseudoaneurysm (PA), limb ischemia, distal thrombus formation, stroke, and major bleeding have all been reported in literature [ 3 , 4 , 7 - 9 ]. In this case report, we examine the occurrence of an iatrogenic PA in the setting of Impella-assisted high-risk PCI in a patient with an acute anterior wall STEMI complicated by refractory CS.…”

Perioperative Management of Patients Receiving Short-term Mechanical Circulatory Support with the Transvalvular Heart Pump

“…14,37,38 Finally, aortic and mitral valve injury can occur during insertion or manipulation of left-sided devices, leading to clinically significant increases in aortic or mitral regurgitation. 39,40…”