Impella 5.5 Support for Delayed Surgical Ventricular Septal Defect Repair-A Paradigm Shift?

BACKGROUND: Ventricular septal defects (VSDs) remain a rare but life-threatening complication of myocardial infarction. Although the incidence has decreased due to better treatment options, the mortality rate remains high. The timing of VSD repair remains critical to outcome. The use of mechanical circulatory support is rarely described in the literature, although it may help to delay repair to allow tissue stabilization. While Impella is currently considered contraindicated due to the potential worsening of the right-to-left shunt and possible systemic embolization of necrotic debris, there is no comprehensive evidence for this. Therefore, we aimed to analyze whether the use of Impella 5.5 as a first choice for patients undergoing VSD repair should be considered for discussion. METHODS: This retrospective study analyses four consecutive patients who underwent delayed ventricular septal repair after prior implantation of Impella 5.5 (Abiomed Inc., Danvers, Massachusetts, United States). RESULTS: A total of 75% of patients (n = 3) presented with acute right heart failure prior to implantation with a mean systolic pulmonary artery pressure of 64 ± 3.0 mmHg. Implantation was performed under local anesthesia in three cases. The mean time to surgery was 9.8 ± 3.1 days. All patients remained on the Impella 5.5 device postoperatively. Weaning from Impella 5.5 was successful in 75% (n = 3). The mean length of stay in the intensive care unit was 22.3 ± 7.5 days. CONCLUSION: Preoperative implantation of the Impella 5.5 device is a safe and feasible option for patients undergoing VSD repair. Outcomes may be improved by performing Impella implantation under local anesthesia and continuing Impella support after VSD repair. However, it is important to note that these patients represent a high-risk cohort and the mortality rate remains high.

Impact of pulmonary hypertension on short-term outcomes in patients undergoing surgical aortic valve replacement for severe aortic valve stenosis.

OBJECTIVES: In patients with left heart disease and severe aortic stenosis (AS), pulmonary hypertension (PH) is a common comorbidity and predictor of poor prognosis. Untreated AS aggravates PH leading to an increased right ventricular afterload and, in line to right ventricular dysfunction. The surgical benefit of aortic valve replacement (AVR) in elderly patients with severe AS and PH could be limited due to the multiple comorbidities and poor outcomes. Therefore, we purposed to investigate the impact of PH on short-term outcomes in patients with moderate to severe AS who underwent surgical AVR in our heart center. METHODS: In this study we retrospectively analyzed a cohort of 99 patients with severe secondary post-capillary PH who underwent surgical AVR (AVR + PH group) at our heart center between 2010 and 2021 with a regard to perioperative outcomes. In order to investigate the impact of PH on short-term outcomes, the control group of 99 patients without pulmonary hypertension who underwent surgical AVR (AVR group) at our heart center with similar risk profile was accordingly analyzed regarding pre-, intra- and postoperative data. RESULTS: Atrial fibrillation occurred significantly more often (p = .013) in patients who suffered from PH undergoing AVR. In addition, the risk for cardiac surgery (EUROSCORE II) was significantly higher (p < .001) in the above-mentioned group. Likewise, cardiopulmonary bypass time (p = .018), aortic cross-clamp time (p = .008) and average operation time (p = .009) were significantly longer in the AVR + PH group. Furthermore, the in-hospital survival rate was significantly higher (p = .044) in the AVR group compared to the AVR + PH group. Moreover, the dialysis rate was significantly higher (p < .001) postoperatively in patients who suffered PH compared to the patients without PH undergoing AVR. CONCLUSION: In our study, patients with severe PH and severe symptomatic AS who underwent surgical aortic valve replacement showed adverse short-term outcomes compared to patients without PH.

Impact of Chronic Kidney Disease and Dialysis on Outcome after Surgery for Infective Endocarditis.

Infective endocarditis (IE) carries a heavy burden of morbidity and mortality in chronic kidney disease (CKD) and hemodialysis (HD) patients. We investigated the risk factors, pathognomonic profile and outcomes of surgically treated IE in CKD and HD patients. We preoperatively identified patients with CKD under hemodialysis (HD group) and compared them with patients without hemodialysis (Non-HD group). Furthermore, we divided the cohort into four groups according to the underlying stage of CKD, with a subsequent outcome analysis. Between 2009 and 2018, 534 Non-HD and 58 HD patients underwent surgery for IE at our institution. The median age was 65.1 [50.6-73.6] and 63.2 [53.4-72.8] years in the Non-HD and HD groups, respectively (p = 0.861). The median EuroSCORE II was 8.0 [5.0-10.0] vs. 9.5 [7.0-12.0] in the Non-HD vs. HD groups (p = 0.004). Patients without CKD had a mortality rate of 5.6% at 30 days and 15.5% at 1 year. Mortality rates proportionally rose with the severity of CKD. Among HD patients, 30-day and 1-year mortality rates were 38.1% and 75.6%, respectively (p < 0.001). Staphylococcus aureus IE was significantly more frequent in the HD group (p = 0.006). In conclusion, outcomes after surgery for IE correlated with the severity of the underlying CKD, with HD patients exhibiting the most unfavorable results. Pre-existing CKD and staphylococcus aureus infection were independent risk factors for 1-year mortality.

Acute stroke in patients undergoing coronary artery bypass grafting surgery in acute coronary syndrome: Predictors and outcomes.

OBJECTIVES: Coronary artery bypass grafting (CABG) surgery in patients with acute coronary syndrome (ACS) remains a high-risk procedure and is associated with adverse outcomes. The risk factors of acute stroke in the above-mentioned patients stay unclear and some appropriate data is lacking in the literature. Thus, we aimed to investigate the predictors of acute stroke in patients undergoing CABG surgery in ACS. METHODS: The retrospective single-centre cohort analysis was conducted. All patients (n = 1344) who suffered from acute coronary syndrome and underwent CABG procedure at the University hospital Cologne from June 2011 until October 2019 were included in our study. In order to find the risk factors of acute stroke after bypass surgery, patients were divided into two groups (non-stroke group (n = 1297) and stroke group (n = 47)). In order to even above-mentioned groups propensity score matching (PSM) analysis was performed (non-stroke group (n = 46) and stroke group (n = 46). RESULTS: Duration of cardiopulmonary bypass (p = .015) and cross clamp time (p = .006) were significantly longer in patients who suffered stroke. Perioperative myocardial infarction was significantly higher (p = .030) in the stroke group. Likewise, the duration of intensive care unit stay (p < .001) and in-hospital stay (p < .001) were significantly longer in patients with stroke. However, the mortality rate did not differ significantly (p = .131) between above-mentioned groups. Univariate and multivariate analysis showed cardiogenic shock (p = .003), peripheral vascular disease (PVD, p = .025) and previous stroke (p = .045) as relevant independent predictors for acute stroke after CABG procedure in patients with ACS. CONCLUSION: Based on our findings, acute stroke after bypass surgery in patients with ACS is associated with increased mortality and adverse outcomes. Cardiogenic shock, peripheral vascular disease and previous stroke were independent predictors of stroke after CABG procedure. Therefore, preoperative evaluation of potential risk factors may be crucial to improve postoperative results.

Implanting Impella 5.5 under Local Anesthesia.

BACKGROUND: Surgically implanted Impella 5.5. delivers full cardiac support and left ventricular unloading for patients with heart failure. So far, the Impella device is implanted under general anesthesia (GA). MATERIAL AND METHODS: A total of n = 3 critically ill patients presented with acute heart failure in need of cardiac support. All patients suffered cardiogenic shock of varying etiology. Due to hemodynamically unstable conditions, GA was avoided. All implantations were performed solely under local anesthesia (LAS) without any regional anesthesia. RESULTS: All implantations were performed successfully under LAS with 60 mL of mepivacaine of 2% solution and ropivacaine of 1% solution (50:50 ratio). All devices were placed from the right axillary artery. One patient needed hematoma evacuation several days after surgery. No other Impella-related complication was observed. CONCLUSION: A surgical implantation of the Impella 5.5 device under LAS is feasible and safe. Despite the small number of cases, no disadvantage can be described at the present moment. Our series should encourage physicians to perform the procedure under LAS.

Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial.

BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1ß and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.

Preoperative Statin Therapy for Atrial Fibrillation and Renal Failure after Cardiac Surgery.

BACKGROUND: Performing cardiac surgery in patients with cardiovascular risk factors incorporates a steady risk for the development of postoperative complications. Perioperative statin intake was associated with an improvement of perioperative outcomes in these patients. However, the European Association for Cardio-Thoracic Surgery guidelines regarding the perioperative statin treatment were changed recently due to large studies reporting about relevant adverse effects related to statin therapy. METHODS: All relevant databases were searched including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the metaRegister of Controlled Trials. Various registries were screened (National Research Register, the ClinicalTrials.gov, and gray literature) with search on online conference indices of relevant scientific meetings. No language restrictions were applied. RESULTS: We identified 10 randomized controlled studies summarizing 3,468 participants undergoing various kinds of cardiac surgical procedures. All included studies presented with marked differences regarding study design. Pooled analysis indicated that statin pretreatment was associated with a formally reduced incidence of postoperative atrial fibrillation (AF) (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.39-1.00; p = 0.05) but with an increased incidence of renal failure (OR 1.20, 95% CI 1.01-1.44; p = 0.04) compared with control. Substantial heterogeneity was observed among studies reporting about AF. CONCLUSION: Current but sparse evidence reveals that statin pretreatment is associated with a higher rate of postoperative renal failure compared with control therapy but is ineffective to substantially reduce postoperative AF. Given the relevant heterogeneity among included studies, statin pretreatment cannot be generally recommended.

Major Bleeding after Surgical Revascularization with Dual Antiplatelet Therapy.

OBJECTIVE: Patients with acute coronary syndrome are treated with dual antiplatelet therapy containing acetylsalicylic acid (ASA) and P2Y12 antagonists. In case of urgent coronary artery bypass grafting this might be associated with increasing risks of bleeding complications. METHODS: Data from 1200 consecutive urgent operations between 2010 and 2018 were obtained from our institutional patient database. For this study off-pump surgery was excluded. The primary composite end point major bleeding consisted of at least one end point: transfusion ≥ 5 packed red blood cells within 24 hours, rethoracotomy due to bleeding, chest tube output >2000 mL within 24 hours. Demographic data, peri-, and postoperative variables and outcomes were compared between patients treated with mono antiplatelet therapy, ASA + clopidogrel (ASA-C) +ticagrelor (ASA-T) or +prasugrel (ASA-P) < 72 hours before surgery. Furthermore, we compared patients with dual antiplatelet therapy with ASA monotherapy. RESULTS: From 1,086 patients, 475 (44%) received dual antiplatelet therapy. Three-hundred seventy-two received ASA-C (77.7%), 72 ASA-T (15%), and 31 ASA-P (6.5%). Major bleeding (44 vs. 23%, p < 0.0001) was more frequently in patients receiving dual therapy with higher rates of massive drainage loss within 24 hours (23 vs. 11%, p < 0.0001) of mass transfusion (34 vs. 16%, p < 0.0001) and rethoracotomy (10 vs. 5%, p = 0.002) when compared with ASA. In this analysis, ASA-T and ASA-P were not associated with higher bleeding complications compared with ASA-C. CONCLUSION: Dual antiplatelet therapy is associated with higher rates of major bleeding. Further studies should examine the difference in the prevalence of major bleeding complications in the different dual antiplatelet therapy regimes in patients requiring urgent surgery.

Central vs peripheral venoarterial ECMO in postcardiotomy cardiogenic shock.

OBJECTIVES: Central or peripheral venoarterial extracorporeal membrane oxygenation (va ECMO) is widely used in postcardiotomy cardiogenic shock (PCS). Available data suggest controversial results for both types. Our aim was to investigate PCS patients treated with either peripheral (pECMO) or central ECMO (cECMO) concerning their outcome. METHODS: Between April 2006 and October 2016, 156 consecutive patients with va ECMO therapy due to PCS were identified and included in this retrospective analysis. Patients were divided into cECMO and pECMO groups. Statistical analysis of risk factors concerning 30-day mortality of the mentioned patient cohort was performed using IBM SPSS Statistics. RESULTS: Fifty-six patients received cECMO and 100 patients were treated with pECMO due to PCS. In the group of cECMO peripheral vascular disease was significantly more present (cECMO 19 [34%] vs pECMO 14 [14%]; P < .01). On-site ECMO complications occurred significantly more frequent in patients treated with cECMO (cECMO 44 [79%] vs pECMO 54 [54%] g/dL; P < 0.01). More often cECMO patients required a second look operation due to mediastinal bleeding (cECMO 52 [93%] vs pECMO 61 [61%] g/dL; P < .01). Thirty-day mortality was comparable with nearly 70% in both cohorts (cECMO 39 [70%] vs pECMO 69 [69%]; P = .93). CONCLUSION: Patients supported by cECMO or pECMO due to refractory PCS did not show significant differences in 30-day mortality, despite a lower incidence of on-site ECMO complications and re-exploration in pECMO patients. PCS itself is associated with high mortality and peripheral cannulation might help to save resources compared with central cannulation.

Higher incidence of perivalvular abscess determines perioperative clinical outcome in patients undergoing surgery for prosthetic valve endocarditis.

BACKGROUND: Cardiac surgery for prosthetic valve endocarditis (PVE) is associated with substantial mortality. We aimed to analyze 30-day and 1-year outcome in patients undergoing surgery for PVE and sought to identify preoperative risk factors for mortality with special regard to perivalvular infection. METHODS: We retrospectively analyzed data of 418 patients undergoing valve surgery for infective endocarditis between January 2009 and July 2018. After 1:1 propensity matching 158 patients (79 PVE/79 NVE) were analyzed with regard to postoperative 30-day and 1-year outcomes. Univariate and multivariable analyses were performed to identify potential risk factors for mortality. RESULTS: 315 patients (75.4%) underwent surgery for NVE and 103 (24.6%) for PVE. After propensity matching groups were comparable with regard to preoperative characteristics, clinical presentation and microbiological findings, except a higher incidence of perivalvular infection in patients with PVE (51.9%) compared to NVE (26.6%) (p = 0.001), longer cardiopulmonary bypass (166 [76-130] vs. 97 [71-125] min; p < 0.001) and crossclamp time (95 [71-125] vs. 68 [55-85] min; p < 0.001). Matched patients with PVE showed a 4-fold increased 30-day mortality (20.3%) in comparison with NVE patients (5.1%) (p = 0.004) and 2-fold increased 1-year mortality (PVE 29.1% vs. NVE 13.9%; p = 0.020). Multivariable analysis revealed perivalvular abscess, sepsis, preoperative AKI and PVE as independent risk factors for mortality. Patients with perivalvular abscess had a significantly higher 30-day mortality (17.7%) compared to patients without perivalvular abscess (8.0%) (p = 0.003) and a higher rate of perioperative complications (need for postoperative pacemaker implantation, postoperative cerebrovascular events, postoperative AKI). However, perivalvular abscess did not influence 1-year mortality (20.9% vs. 22.3%; p = 0.806), or long-term complications such as readmission rate or relapse of IE. CONCLUSIONS: Patients undergoing surgery for PVE had a significantly higher 30-day and 1-year mortality compared to NVE. After propensity-matching 30-day mortality was still 4-fold increased in PVE compared to NVE. Patients with perivalvular abscess showed a significantly higher 30-day mortality and perioperative complications, whereas perivalvular abscess seems to have no relevant impact on 1-year mortality, the rate of readmission or relapse of IE.