Mechanische Kreislaufunterstützung bei Patienten im akuten kardiogenen Shock

Objectives Cardiogenic shock (CS) as the final stage of Heart failure (HF) is present in approximately 25% of cases and is associated with high mortality. Temporary mechanical circulatory support (MCS) is widely used for CS therapy. In our research, we investigated and compared different temporary MCS concepts based on microaxial intraaortic impeller pumps. Methods The data of all patients who received MCS with a temporary microaxial left ventricular impeller pump in the German Heart Center Berlin (DHZB) since 01/2016 were collected retrospectively and used for a database establishment. The obtained data were analyzed in regard to different clinical aspects and published. This dissertation summarizes and describes the results of three major publications. Results The results of the pilot study demonstrated a 43% survival in 28 patients on isolated impeller pump support, as well as 44% in 9 CS patients on combination of v a ECLS and Impella. Preoperative cardiopulmonary resuscitation (CPR) and an arterial pH 7.45 were associated with poor outcomes. In the second study, 70 patients were supported with Impella 5.0/5.5®. The overall 30 day survival was 51%. An increase in arterial lactate (OR 1.217 per 1 mmol/L; p=0.015) and CPR before implantation (OR 16.74; p=0.009) were identified as predictors of 30 day mortality on Impella support. A cut-off of 8 mmol/L for preoperative lactate showed a specificity of 0.944 and a sensitivity of 0.294 (OR 7.083, CI 1.422 35.28; p=0.017) for 30 day mortality. Based on these data, an algorithm for optimal short-term MCS therapy was developed and thereafter applied as a standardized operational procedure at the DHZB. In my third analysis we compared the percutaneously implanted Impella CP® and larger surgical Impella 5.0/5.5®. In unadjusted cohorts the 30 day survival was significantly higher in the Impella 5.0/5.5® group (58% vs. 36%, p=0.021). After propensity score adjustment for relevant preoperative demographic and hemodynamic parameters, the 30 day survival was similar between the groups (OR 1.23, 95% CI [0.34-4.18], p=0.744). Preoperative lactate levels above 8 mmol/L and CPR before implantation were associated with poor outcomes in both cohorts (OR 10.7, 95% CI [3.45-47.34], p<0.001; OR 13.2, 95% CI [4.28-57.89], p<0.001). Based on these results the selection algorithm from the second study was amended to include the use of percutaneous impeller pumps. Conclusions A total of 203 patients treated with different MCS devices were analyzed. Our studies demonstrated that temporary MCS with microaxial impeller pumps is a feasible treatment in CS patients. In cases with preoperative CPR or lactate levels ≥ 8 mmol/L an advanced treatment concept with a combination of Impella and v a ECLS should be pursued. An algorithm based on these parameters may prove useful for optimal patient selection and to identify optimal temporary MCS in CS patients.Ziele Kardiogener Schock (KS) als Endstadium der Herzinsuffizienz (HI) tritt in ungefähr 25% der Fälle auf und ist mit einer hohen Sterblichkeit assoziiert. Temporäre mechanische Kreislaufunterstützung (MKU) wird in der Therapie des KS eigesetzt. In unseren Studien wurden verschiedene Konzepte für temporäre MKU auf der Basis der mikroaxialen int-raaortalen Impellerpumpe untersucht und verglichen. Methoden Die Daten von allen im Deutschen Herzzentrum Berlin (DHZB) seit 01/2016 zur mecha-nischen Kreislaufunterstützung mit einem temporären linksventrikulären mikroaxialen Impellersystem versorgten Patienten*innen wurden retrospektiv in einer Datenbank ge-sammelt, analysiert und publiziert. Diese Dissertation ist eine Zusammenfassung der Ergebnisse der drei wichtigsten Pub-likationen. Ergebnisse Die Ergebnisse der Pilotstudie zeigten ein Überleben von 43% bei 28 Patienten*innen unter isolierter mikroaxialer Impellerpumpentherapie, sowie 44% bei 9 Patienten*innen mit Kombination von v-a ECLS und Impella. Präoperative kardiopulmonale Reanimati-on (KPR) sowie ein arterieller pH 7,45 waren mit einem schlechteren Überleben assoziiert. In der zweiten Studie wurden 70 Patienten*innen isoliert mit Impella 5.0/5.5® behandelt. Das 30-Tage-Überleben betrug 51%. Ein präoperativer Anstieg des arteriellen Laktatwertes (OR 1.217 pro 1 mmol/l; p=0.015) sowie KPR (OR 16.74; p=0.009) wurden als Prädiktoren für die 30-Tage-Mortalität identifiziert. Ein arterielles Laktat von 8 mmol/l wies hierbei eine Spezifität von 0.944 und eine Sensitivität von 0.294 (OR 7.083, CI 1.422–35.28; p=0.017). Auf der Basis dieser Daten wurde ein Algorithmus für die Behandlung des KS mittels temporärer MKU entwickelt und folglich im DHZB im Rahmen einer SOP festgelegt. In meiner dritten Analyse haben wir die perkutan implantierbaren Impella CP und die größeren chirurgischen Impella 5.0/5.5® Systeme verglichen. Das nicht adjustierte 30-Tage-Überleben war signifikant höher in der Impella 5.0/5.5® Kohorte (58% vs. 36%, p=0.021). Nach der Propensity-Score-Adjustierung waren die Kohorten ähnlich (OR 1.23, 95% CI [0.34-4.18], p=0.744). Ein präoperativer Laktatwert über 8 mmol/L sowie präoperative KPR gingen mit einer erhöhten Mortalität einher (OR 10.7, 95% CI [3.45-47.34], p<0.001; OR 13.2, 95% CI [4.28-57.89], p<0.001). Der Algorithmus aus der zweiten Studie wurde auf der Basis neuer Ergebnisse um die Anwendung der perkutan implantierbaren Impellerpumpen erweitert. Schlussfolgerung Insgesamt wurden von mir 203 Patienten*innen mit verschiedenen MKU-Systemen ana-lysiert. Unsere Studien haben gezeigt, dass mikroaxiale Impellerpumpen eine effektive Therapie im KS darstellen. Präoperative KPR sowie Laktatwerte ≥ 8 mmol/L sollten eine erweiterte Therapie bestehend aus einer Kombination von einer Impellerpumpe und v-a ECLS nach sich ziehen. Ein Algorithmus basierend auf diesen Erkenntnissen kann helfen eine optimale temporäre MKU-Therapie auszuwählen

Left Ventricular Unloading in v-a ECLS Patients

The v-a ECLS is an effective approach for mechanical circulatory support, however, it is associated with several disadvantages. An increased afterload generated by a pump outflow leads to a left ventricular (LV) distension, pulmonary congestion, and lung edema on one hand and impairs myocardial perfusion on the other. In this chapter, we will discuss the rationality as well as different techniques for LV unloading during v-a ECLS support

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices:the EUROMACS analysis

OBJECTIVES: The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). METHODS: A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. RESULTS: Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P = 0.012]. CONCLUSIONS: Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients

Endovascular treatment of an anastomotic outflow graft pseudoaneurysm of the descending aorta after implantation of a left ventricular assist device

Introduction: Outflow graft (OG) obstruction is a dangerous complication that may occur for various reasons after the implantation of the left ventricular assist device (LVAD). Case Report: In this study, we describe the case of a 67‐year‐old patient on LVAD support who developed a late pseudoaneurysm of the OG anastomosis (to the descending aorta) causing OG stenosis at the level of the anastomosis. The patient was treated with a customized fenestrated endovascular stent graft placed into the descending aorta and stent implantation into the OG.ISSN:0886-0440ISSN:1540-819

Surgical treatment of outflow graft kinking complicated by external obstruction with a fibrin mass in a patient with LVAD

Background Outflow graft (OG) obstruction is a dangerous complication that may occur for various reasons after left ventricular assist device (LVAD) implantation. Case Summary We describe the case of a 51‐year‐old patient on LVAD support who developed significant OG kinking and external OG obstruction due to a fibrin mass causing severe stenosis. Both the OG kinking and external obstruction were eliminated via a left lateral thoracotomy.ISSN:0886-0440ISSN:1540-819

Management of increased systemic flow requirements in patients with left ventricular assist devices

ISSN:2304-1021ISSN:2225-319

Percutaneous mitral valve repair assisted by a catheter-based circulatory support device in a heart transplant patient

Background: Systemic infections and chronic graft rejection represent common causes of mortality and morbidity in heart transplant patients. In severe cases, cardiogenic shock (CS) may occur and require hemodynamic stabilization with temporary mechanical circulatory support (tempMCS). Under these devastating circumstances, treatment of sequelae of left ventricular dysfunction, such as secondary mitral regurgitation (MR) is challenging, especially when surgical repair is deemed futile. In nontransplant patients, interventional mitral valve repair strategies such as the MitraClip system (Abbott Cardiovascular) have been used to successfully treat secondary MR and allow for weaning from tempMCS. Case summary: We report about the first patient in whom profound CS after heart transplantation was stabilized with tempMCS followed by interventional elimination of secondary MR.ISSN:0886-0440ISSN:1540-819

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis

OBJECTIVES: The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). METHODS: A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. RESULTS: Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P=0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P=0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P<0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P=0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P=0.012]. CONCLUSIONS: Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients

Propensity score-based analysis of 30-day survival in cardiogenic shock patients supported with different microaxial left ventricular assist devices

Background and methods Microaxial left ventricular assist devices are used increasingly for treating cardiogenic shock. We compared the short-term outcome of patients supported with different microaxial devices for cardiogenic shock. A retrospective propensity score-adjusted analysis was performed in cardiogenic shock patients treated with either the Impella CP (n = 64) or the Impella 5.0/5.5 (n = 62) at two tertiary cardiac care centers between 1/14 and 12/19. Results Patients in the Impella CP group were significantly older (69.6 ± 10.7 vs. 58.7 ± 11.9 years, p = .001), more likely in INTERMACS profile 1 (76.6% vs. 50%, p = .003) and post-C-reactive protein (CPR) (36% vs. 13%, p = .006). The median support time was 2.0 days [0.0, 5.3] in the CP group vs. 8.5 days [4.3, 15.8] in the 5.0/5.5 group (p < .001). The unadjusted 30-day survival was significantly higher in the Impella 5.0/5.5 group (58% vs. 36%, p = .021, odds ratio [OR] for 30-day survival on Impella 5.0/5.5 was 3.68 [95% confidence interval [CI]: [1.46–9.90]], p = .0072). After adjustment, the 30-day survival was similar for both devices (OR: 1.23, 95% CI: [0.34–4.18], p = .744). Lactate levels above 8 mmol/L and preoperative CPR were associated with a significant mortality increase in both cohorts (OR: 10.7, 95% CI: [3.45–47.34], p < .001; OR: 13.2, 95% CI: [4.28–57.89], p < .001, respectively). Conclusion Both Impella devices offer a similar effect with regard to survival in cardiogenic shock patients. Preoperative CPR or lactate levels exceeding 8 mmol/L immediately before implantation have a poor prognosis on Impella CP and Impella 5.0/5.5.ISSN:0886-0440ISSN:1540-819