Defibrillator generator replacements in patients with left ventricular assist device support: The risks of hematoma and infection.

BACKGROUND: The majority (89%) of left ventricular assist device (LVAD) patients have an implantable cardioverter-defibrillator (ICD) in place. Due to the advances of modern-day LVAD therapy, more patients are on support for longer. This inevitably leads to more LVAD patients facing ICD generator battery depletion. Until now, there are insufficient data regarding periprocedural risks of generator replacements in a high-risk group like the LVAD cohort. METHODS: A retrospective, single-center analysis of pocket-related outcomes of all ICD generator replacements in LVAD and Non-LVAD patients between January 2014 and December 2018. The primary outcome was the combined endpoint of clinically significant pocket hematoma and/or cardiac implantable electronic device (CIED) infection in the first 6 months after ICD generator exchange. The clinically significant hematoma was defined as hematoma requiring reoperation, prolongation of hospitalization, or interruption of anticoagulation. The cumulative incidence function was calculated for the primary endpoint. RESULTS: Two hundred seventy-seven patients underwent ICD generator exchange in our clinic in this time. Of these, 251 patients had a complete 6-month follow-up regarding clinically significant pocket hematomas and pocket infections. One hundred ninety patients had no LVAD, and 61 patients were on LVAD support. The rate of the primary combined endpoint clinically significant pocket hematoma and/or CIED infection was 3.5 times higher in LVAD patients compared to the non-LVAD cohort (event rate 39.14 vs 11.07 per 100 patient-years, p = 0.048). Clinically significant pocket hematomas necessitating revision occurred nearly 4 times more often in the LVAD group (p = 0.042). Pocket device infection rates were around 16 times higher in LVAD patients compared to non-LVAD patients (p = 0.002). CONCLUSIONS: Compared to Non-LVAD patients, LVAD patients exhibit a relevant higher rate of clinically significant pocket hematoma and CIED infection after ICD generator exchange. This information should additionally be considered in the decision-making process regarding the indication for ICD generator exchange.

Mechanical unloading by miniature axial flow pumps in late cardiac allograft failure due to acute rejection.

Allograft failure secondary to rejection commonly requires a multimodal treatment, ultimately including mechanical circulatory support. A few case reports have demonstrated the use of Impella-devices due to its assumed favorable safety profile in this fragile cohort. However, this treatment option does not play a role in choice of anti-rejective therapy in clinical routine up to date. We summarize our institutional experiences and literature mini-review on Impella-based treatment strategies in allograft rejection after heart transplantation. In all seven cases, three from our institution and four reported in the literature, Impella-based therapies led to hemodynamic stabilization in allograft failure secondary to rejection. Adverse events included hemolysis, non-fatal bleeding and in one patient a relevant aortic valve insufficiency occurred. All patients showed an improvement of allograft function. Two patients died in context of severe immunosuppression or late secondary organ failure. Based on the limited available data, we propose that Impella-mediated mechanical unloading represents a valuable option for hemodynamic stabilization in severe allograft failure due to rejection, enabling an initiation of causal therapy and thereby potentially representing an opportunity to prevent mortality. Furthermore, we hypothesize it might add to the traditional therapeutic approaches by facilitating recovery by decompressing the myocardium in allograft rejection.

Efficacy of quadruple treatment on different types of pre-operative anaemia: secondary analysis of a randomised controlled trial.

In patients with pre-operative anaemia undergoing cardiac surgery, combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12 and oral folic acid reduces allogeneic blood product transfusions. It is unclear if certain types of anaemia particularly benefit from this treatment. We performed a post-hoc analysis of anaemic patients from a randomised trial on the 'Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery'. We used linear regression analyses to examine the efficacy of a combination anaemia treatment compared with placebo on the following deficiencies, each representing a part of the combination treatment: ferritin and transferrin saturation; endogenous erythropoietin; holotranscobalamine; and folic acid in erythrocytes. Efficacy was defined as change in reticulocyte count from baseline to the first, third and fifth postoperative days and represented erythropoietic activity in the immediate peri-operative recovery phase. In all 253 anaemic patients, iron deficiency was the most common cause of anaemia. Treatment significantly increased reticulocyte count in all regression analyses on postoperative days 1, 3 and 5 (all p < 0.001). Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 (95%CI -0.14 to -0.02) and -0.14 (95%CI -0.23 to -0.06), respectively. Quadruple anaemia treatment was effective regardless of the cause of anaemia and its effect manifested early in the peri-operative recovery phase. The more pronounced a deficiency was, the stronger the subsequent boost to erythropoiesis may have been.