scholarly journals Left ventricle unloading and valvular integrity following microaxial mechanical circulatory support: a two year follow-up study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Hatzis ◽  
H Ahrens ◽  
K Karatolios ◽  
B Markus ◽  
D Divchev ◽  
...  

Abstract Background Although the use of mechanical circulatory support (MCS) systems may improve the outcome of patients with cardiogenic shock (CS) due to myocardial infarction, little is known about its effect on the long-term structural integrity of left-ventricular (LV) valves as well as on the development of LV- architecture. Methods 84 consecutive patients were monitored over 2 years having received microaxillar MCS device (ImpellaTM CP or 2.5) for complete coronary revascularization followed by optimal medical treatment. Results 62 patients were treated for severe cardiogenic shock and compared with 22 patients receiving short-term microaxillar MCS for high risk percutaneous coronary interventions (PCI). 24 patients of the total population received Impella CP (14F motor pump) and the remaining 60 patients received Impella 2.5 (12F motor pump). Beside a significant increase in LV-ejection fraction after 2 years (p≤0.03 vs. pre implantation) in total cohort, we observed a statistically significant decrease in LV-dilation (p<0.001) and the severity of mitral valve regurgitation (p=0.007) in the 2 year follow-up period suggesting an improved LV-architecture. Neither the duration of support, nor the size of the MCS device or the indication for its use revealed any devastating impact on aortic or mitral valve integrity. Conclusions These findings indicate that beside complete revascularization and optimal medical treatment, microaxillar transvalvular MCS device supports the restoration of LV-architecture without detrimental long-term effects on the structural integrity of LV valves regardless of the size of the device or the duration of support. Funding Acknowledgement Type of funding source: None

2021 ◽  
Vol 10 (6) ◽  
pp. 1273
Author(s):  
Georgios Chatzis ◽  
Styliani Syntila ◽  
Harald Schuett ◽  
Christian Waechter ◽  
Holger Ahrens ◽  
...  

Although the use of microaxilar mechanical circulatory support systems may improve the outcome of patients with cardiogenic shock (CS), little is known about its effect on the long-term structural integrity of left ventricular (LV) valves as well as on the development of LV-architecture. Therefore, we aimed to study the integrity of the LV valves and architecture and function after Impella support. Thus, 84 consecutive patients were monitored over two years having received ImpellaTM CP (n = 24) or 2.5 (n = 60) for refractory CS (n = 62) or for high-risk percutaneous coronary interventions (n = 22) followed by optimal medical treatment. Beside a significant increase in LV ejection fraction after two years (p ≤ 0.03 vs. pre-implantation), we observed a statistically significant decrease in LV dilation (p < 0.001) and severity of mitral valve regurgitation (p = 0.007) in the two-year follow-up period, suggesting an improved LV architecture. Neither the duration of support, nor the size of the Impella device or the indication for its use revealed any devastating impact on aortic or mitral valve integrity. These findings indicate that Impella device is a safe means of support of LV-function without detrimental long-term effects on the structural integrity of LV valves regardless of the size of the device or the indication of support.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
M Karami ◽  
E Eriksen ◽  
DM Ouweneel ◽  
WK Lagrand ◽  
JPS Henriques

Abstract Funding Acknowledgements Type of funding sources: None. Background The role of percutaneous mechanical circulatory support (pMCS) in cardiogenic shock (CS) is still a subject of debate. The IMPRESS in Severe Shock trial is still the largest RCT on the effectiveness of pMCS in CS patients. We performed a follow-up at 5-years of the IMPRESS in Severe Shock trial to assess differences in long-term clinical outcome and functional status between pMCS and intra-aortic balloon pump (IABP) treated patients. Methods The IMPRESS in Severe Shock trial (NTR3450) is an investigator-initiated, multicentre, randomized, open-label trial. Between June 2012 and September 2015, a total of 48 patients with severe CS from AMI with ST-segment elevation undergoing immediate revascularisation were randomized to pMCS with the Impella CP (n = 24) or IABP (n = 24). The trial design and primary end-point results (30-day all-cause mortality) have been previously published. For the 5-year assessment, all-cause mortality and the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) were evaluated. MACCE consisted of death, myocardial re-infarction, repeat PCI, CABG and stroke. In survivors, a structured interview was conducted and follow-up echocardiography was obtained. Data were analysed according to the intention-to-treat principle. Results Long-term follow-up was performed 5.5 years (IQR 5.3-6.5) after initial randomization and completed for all patients regarding mortality status. Five-year mortality was 50% (n = 12/24) in the pMCS group and 63% (n = 15/24) in the IABP group (RR 0.87, 95% CI 0.47-1.59, p = 0.65). After 6 months, only 3 additional deaths occurred, all in the IABP group. MACCE occurred in 12/24 (50%) of the pMCS patients versus 19/24 (79%) of the IABP patients (p = 0.07) (Figure 1). Myocardial re-infarction occurred in 1 pMCS patient and in 2 IABP patients, repeat PCI in 3 IABP patients, CABG in 1 IABP patient and stroke in 2 pMCS patients and in 2 IABP patients. Among 5-year survivors, follow-up interview was successfully conducted in 11/12 (92%) pMCS and 7/9 (78%) IABP patients. All patients except for one were in NYHA class I or II (pMCS n = 10 [91%] and IABP n = 7 [100%], p = 1.00) and none of the patients had residual angina complaints. Echocardiography was obtained in 10/12 (83%) pMCS and 6/9 (67%) IABP patients. There were no differences in LVEF between the two groups (pMCS 52 ±11% vs. IABP 48 ±10%, p = 0.53). Conclusions In this randomized trial of patients with CS after AMI, there was no difference in long-term 5-year mortality between pMCS (by Impella CP) and IABP treated patients, supporting previously published 30-day and 6-month data. Interestingly, we did observe a not significantly different (p = 0.07) higher occurrence of MACCE in the IABP group. Abstract Figure. Kaplan Meier Impella vs. IABP: MACCE


Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 87
Author(s):  
Khalil Jawad ◽  
Alex Koziarz ◽  
Maja-Theresa Dieterlen ◽  
Jens Garbade ◽  
Christian D. Etz ◽  
...  

Background: Peripartum cardiomyopathy (PPCM) is a rare, life-threatening form of heart disease, frequently associated with gene alterations and, in some cases, presenting with advanced heart failure. Little is known about ventricular assist device (VAD) implantation in severe PPCM cases. We describe long-term follow-up of PPCM patients who were resistant to medical therapy and received mechanical circulatory support or heart transplant. Methods and results: A total of 13 patients were included with mean follow-up of eight years. Mean age of PPCM onset was 33.7 ± 7.7 years. All patients were initially treated with angiotensin-converting enzyme inhibitors and beta-blockers, and four received bromocriptine. Overall, five patients received VADs (three biventricular, two isolated left ventricular) at median 27 days (range: 3 to 150) following childbirth. Two patients developed drive line infection. Due to the short support time, none of those patients had a stroke or VAD thrombosis. In total, five patients underwent heart transplantation, of which four previously had implanted VADs. Median time to transplantation from PPCM onset was 140 days (range: 43 to 776), and time to transplantation from VAD implantation were 7, 40, 132, and 735 days, respectively. All patients survived until most recent follow up, with the exception of one patient who died following unrelated abdominal surgery two years after PPCM recovery. Conclusions: In patients with severe, life-threatening PPCM refractory to medical management, mechanical circulatory support with or without heart transplantation is a safe therapeutic option.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Haurand ◽  
S Bueter ◽  
C Jung ◽  
M Kelm ◽  
R Westenfeld ◽  
...  

Abstract Background Percutaneous left ventricular assist devices such as the Impella pump, are used to hemodynamically stabilize patients with cardiogenic shock (CS) caused by acute myocardial infarction (AMI) until cardiac function has recovered after revascularization. Whether Impella mechanical circulatory support (MCS) is effective in stabilizing patients with CS not caused by AMI has so far not been thoroughly investigated. Purpose The aim of this study is to analyze whether MCS with Impella is effective to stabilize patients with non-AMI related CS compared to patients with AMI related CS. Method We retrospectively analyzed 106 patients with CS and Impella support in the years from 2011 to 2018. Efficacy to stabilize the patient was assessed by laboratory values such as lactate, hemodynamic parameters and clinical scores. The difference in mortality was calculated with the Log-Rank-Test, comparing Kaplan-Meier curves. Results 36 patients suffered from non-AMI CS and in 70 patients CS was caused by AMI. Regarding the clinical scores and hemodynamic parameters, both groups were severely ill, with no significant difference in APACHE II score, with a mean score of 17.9 in the non-AMI group compared to 20.5 in the AMI-group (p=0.103), the SOFA score (mean score of 6.3 in non-AMI group vs 6.8 in AMI group, p=0.467) and cardiac index (mean CI of 1.9 l/min/m2 in non-AMI group vs 2.2 l/min/m2 in AMI group, p=0.176). There was a comparable mean decrease in lactate levels in both groups 48 hours after initiation of MCS, from initially 4.1 mmol/l to 1.7 mmol/l (p&lt;0.001) in the non-AMI group and from initially 3.6 mmol/l to 2.2 mmol/l (p=0.025) in the AMI group. The non-ACS group exhibited a trend of lower mortality compared to the AMI group, with 47% in the non-AMI group and 57% in the AMI group (p=0.067). In multivariate analysis, age, lactate levels, cardiopulmonary resuscitation, low platelets and higher doses of inotropes and vasopressors were independent predictors for mortality. An upgrade to LVAD was performed for 22% of the non-AMI group and for 6% of the AMI group (p=0.020). Conclusion Impella support is effective to hemodynamically stabilize patients with non-AMI related CS. Therefore, MCS can be used as bridge to recovery or enables further treatment options as upgrade to longterm mechanical support devices. Funding Acknowledgement Type of funding source: None


Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 747
Author(s):  
Rafal Berger ◽  
Hasan Hamdoun ◽  
Rodrigo Sandoval Boburg ◽  
Medhat Radwan ◽  
Metesh Acharya ◽  
...  

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.


2019 ◽  
Vol 57 (1) ◽  
pp. 183-188 ◽  
Author(s):  
Charles-Henri David ◽  
Astrid Quessard ◽  
Ciro Mastroianni ◽  
Guillaume Hekimian ◽  
Julien Amour ◽  
...  

Abstract OBJECTIVES Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates of 50–80%. Although veno-arterial extracorporeal membrane oxygenation has been used as mechanical circulatory support in patients with PCCS, it is associated with a high rate of complications and poor quality of life. The Impella 5.0 and Impella Left Direct (LD) (Impella 5.0/LD) are minimally invasive left ventricular assist devices that provide effective haemodynamic support resulting in left ventricular unloading and systemic perfusion. Our goal was to describe the outcome of patients with PCCS supported with the Impella 5.0/LD at La Pitié-Salpêtrière Hospital. METHODS We retrospectively reviewed consecutive patients supported with the Impella 5.0/LD for PCCS between December 2010 and June 2015. Survival outcome and in-hospital complications were assessed. RESULTS A total of 29 patients (63 ± 14 years, 17% women) with PCCS were supported with the Impella 5.0/LD. At baseline, 69% experienced chronic heart failure, 66% had dilated cardiomyopathy and 57% had valvular disease. The mean EuroSCORE II was 22 ± 17 and the ejection fraction was 28 ± 11%. Most of the patients underwent isolated valve surgery (45%) or isolated coronary artery bypass grafting (38%). The mean duration of Impella support was 9 ± 7 days. Weaning from the Impella was successful in 72.4%, and 58.6% survived to discharge. Recovery of native heart function was observed in 100% of discharged patients. Survival to 30 days and to 1 year from Impella implant was 58.6% and 51.7%, respectively. CONCLUSIONS The Impella 5.0 and the Impella LD represent an excellent treatment option for critically ill patients with PCCS and are associated with favourable survival outcome and native heart recovery.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Toru Kondo ◽  
Naoki Shibata ◽  
shingo kazama ◽  
Yuki Kimura ◽  
Hideo Oishi ◽  
...  

Background: In cardiogenic shock refractory to medical treatment, choosing and changing mechanical circulatory support to stabilize hemodynamics until cardiac recovery or next treatment is a strategic cornerstone for improving the outcome. We aimed to clarify the differences in treatment course and outcome between Impella 5.0 and extracorporeal left ventricular assist device (eLVAD) in patients with cardiogenic shock refractory to medical therapy or other mechanical circulatory support. Methods: We performed a retrospective medical record review of consecutive patients who were treated with Impella 5.0 or eLVAD as a bridge to decision (BTD) at our medical center from December 2011 to January 2020. Results: A total of 26 patients (median age 40 years, 16 males) were analyzed. Of seven patients managed with Impella 5.0, one patients used Impella CP and four patients used peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) before Impella 5.0 implantation. On the other hand, of 19 patients managed with eLVAD, 11 patients used VA-ECMO before eLVAD implantation. In patients managed with Impella 5.0, Impella 5.0 was removed successfully in two patients (29%) and four patients (71%) underwent the operation for durable LVAD. In patients managed with eLVAD, eLVAD was successfully removed in three patients (16%), nine patients (47%) required durable LVAD, and seven patients (37%) died during eLVAD management. The period between implantation of Impella 5.0 or eLVAD to durable LVAD surgery was significantly shorter with Impella 5.0 (58 [38 - 95] vs. 235 [126 - 318] days, p=0.001). During durable LVAD implantation, cardiopulmonary bypass time was significantly shorter and a significantly smaller amount of red blood cells transfusion was required with Impella 5.0 (149 [125 - 182] vs. 192 [170 - 250] minutes, p=0.042; 7.0 [5.0 - 9.5] vs. 15.0 [10.0- 2.0] units, p=0.019, respectively). There were 4 massive stroke events in eLVAD, but no massive stroke events in Impella 5.0. In Impella 5.0. Conclusions: Impella 5.0 facilitates smoother management as a BTD and reduces surgical invasiveness during durable LVAD implantation. Impella 5.0 would be a more effective option for success to cardiac recovery or next therapy than eLVAD.


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