Characteristics and Outcome in Cardiogenic Shock according to Vascular Access Site for PCI.

BACKGROUND: The optimal vascular access site for percutaneous coronary interventions (PCI) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains uncertain. While observational data favor transradial access (TRA) due to lower complication rates and mortality, transfemoral (TFA) PCI offers advantages such as shorter access and procedure times, along with quicker escalation to mechanical circulatory support (MCS). In this study, we aimed to investigate factors associated with a transfemoral approach and compare mortality rates between TRA and TFA in AMI-CS patients undergoing PCI. METHODS: Data from a nationwide registry of AMI-CS patients undergoing PCI (2017-2021) were analyzed. We compared patient demographics, procedural details, and outcomes between TRA and TFA groups. Logistic regression identified access site factors and radial-to-femoral cross-over predictors. Propensity score matched (PSM) analysis examined the impact of access site on mortality. RESULTS: Of 1562 patients, 45% underwent TRA PCI, with an increasing trend over time. TFA patients were more often female, had a history of coronary artery bypass grafting (CABG), lower blood pressure, higher resuscitation and intubation rates, and elevated lactate levels. After PSM, 30-day mortality was lower in TRA (33% vs. 46%, p <0.001). Predictors for cross-over included left coronary artery interventions, multivessel PCI, and MCS initiation. CONCLUSION: Significant differences exist between TRA and TFA PCI in AMI-CS. TFA was more common in patients with worse hemodynamics and was associated with higher 30-day mortality compared to TRA. This mortality difference persisted in the propensity score matched analysis.

Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction.

AIMS: This study aimed to give contemporary insight into the use of Impella and venoarterial extracorporeal membrane oxygenation (VA-ECMO) in acute myocardial infarction-related cardiogenic shock (AMICS) and into associated outcomes, adverse events, and resource demands. METHODS AND RESULTS: This nationwide observational cohort study describes all AMICS patients treated with Impella (ABIOMED, Danvers, MA, USA) and/or VA-ECMO in 2020-2021. Impella and/or VA-ECMO were used in 20% of all AMICS cases (n = 4088). Impella patients were older (34% vs. 13% >75 years, p < 0.001) and less frequently presented after an out-of-hospital cardiac arrest (18% vs. 40%, p < 0.001). In-hospital mortality was lower in the Impella versus VA-ECMO cohort (61% vs. 67%, p = 0.001). Adverse events occurred less frequently in Impella-supported patients: acute haemorrhagic anaemia (36% vs. 68%, p < 0.001), cerebrovascular accidents (4% vs. 11%, p < 0.001), thromboembolisms of the extremities (5% vs. 8%, p < 0.001), systemic inflammatory response syndrome (21% vs. 25%, p = 0.004), acute kidney injury (44% vs. 53%, p < 0.001), and acute liver failure (7% vs. 12%, p < 0.001). Impella patients were discharged home directly more often (20% vs. 11%, p < 0.001) whereas VA-ECMO patients were more often discharged to another care facility (22% vs. 19%, p = 0.031). Impella patients had shorter hospital stays and lower hospital costs. CONCLUSION: This is the largest, most recent European cohort study describing outcomes, adverse events, and resource demands based on claims data in patients with Impella and/or VA-ECMO. Overall, adverse event rates and resource consumption were high. Given the current lack of beneficial evidence, our study reinforces the need for prospectively established, high-quality evidence to guide clinical decision-making.

Characteristics, Treatment Strategies and Outcome in Cardiogenic Shock Complicating Acute Myocardial Infarction: A Contemporary Dutch Cohort.

Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is associated with high morbidity and mortality. Our study aimed to gain insights into patient characteristics, outcomes and treatment strategies in CS patients. Patients with CS who underwent percutaneous coronary intervention (PCI) between 2017 and 2021 were identified in a nationwide registry. Data on medical history, laboratory values, angiographic features and outcomes were retrospectively assessed. A total of 2328 patients with a mean age of 66 years and of whom 73% were male, were included. Mortality at 30 days was 39% for the entire cohort. Non-survivors presented with a lower mean blood pressure and increased heart rate, blood lactate and blood glucose levels (p-value for all <0.001). Also, an increased prevalence of diabetes, multivessel coronary artery disease and a prior coronary event were found. Of all patients, 24% received mechanical circulatory support, of which the majority was via intra-aortic balloon pumps (IABPs). Furthermore, 79% of patients were treated with at least one vasoactive agent, and multivessel PCI was performed in 28%. In conclusion, a large set of hemodynamic, biochemical and patient-related characteristics was identified to be associated with mortality. Interestingly, multivessel PCI and IABPs were frequently applied despite a lack of evidence.

The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: the Academic Medical Center intensive care unit experience.

OBJECTIVE: Cardiogenic shock remains an important therapeutic challenge, with high in-hospital mortality rates. Mechanical circulatory support may be beneficial in these patients. Since the efficacy of the intra-aortic balloon pump seems limited, new percutaneously placed mechanical left ventricular support devices, such as the Impella system, have been developed for this purpose. Our current purpose was to describe our experience with the Impella system in patients with ST-elevation myocardial infarction presenting in profound cardiogenic shock, who were admitted to our intensive care unit for mechanical ventilation. METHODS: From January 2004 through August 2010, a total of 34 ST-elevation myocardial infarction patients with profound cardiogenic shock were admitted to our intensive care unit and treated with either the Impella 2.5 or the Impella 5.0 device. Baseline and follow-up characteristics were collected retrospectively. MEASUREMENTS AND MAIN RESULTS: Within the study cohort, 25 patients initially received treatment with the Impella 2.5, whereas nine patients received immediate Impella 5.0 support. Eight out of 25 patients in the Impella 2.5 group were upgraded to 5.0 support. After 48 hrs, 14 of 25 patients in the 2.5 group were alive, five of whom had been upgraded. In the 5.0 group, eight out of nine patients were alive. After 30 days, six of 25 patients in the 2.5 group were alive, three of whom had been upgraded. In the 5.0 group, three of nine patients were alive at 30 days. CONCLUSIONS: In ST-elevation myocardial infarction patients with severe and profound cardiogenic shock, our initial experience suggests improved survival in patients who received immediate Impella 5.0 treatment, as well as in patients who were upgraded from 2.5 to 5.0 support, when compared to patients who received only Impella 2.5 support.

Outcome and Predictors for Mortality in Patients with Cardiogenic Shock: A Dutch Nationwide Registry-Based Study of 75,407 Patients with Acute Coronary Syndrome Treated by PCI.

It is important to gain more insight into the cardiogenic shock (CS) population, as currently, little is known on how to improve outcomes. Therefore, we assessed clinical outcome in acute coronary syndrome (ACS) patients treated by percutaneous coronary intervention (PCI) with and without CS at admission. Furthermore, the incidence of CS and predictors for mortality in CS patients were evaluated. The Netherlands Heart Registration (NHR) is a nationwide registry on all cardiac interventions. We used NHR data of ACS patients treated with PCI between 2015 and 2019. Among 75,407 ACS patients treated with PCI, 3028 patients (4.1%) were identified with CS, respectively 4.3%, 3.9%, 3.5%, and 4.3% per year. Factors associated with mortality in CS were age (HR 1.02, 95%CI 1.02-1.03), eGFR (HR 0.98, 95%CI 0.98-0.99), diabetes mellitus (DM) (HR 1.25, 95%CI 1.08-1.45), multivessel disease (HR 1.22, 95%CI 1.06-1.39), prior myocardial infarction (MI) (HR 1.24, 95%CI 1.06-1.45), and out-of-hospital cardiac arrest (OHCA) (HR 1.71, 95%CI 1.50-1.94). In conclusion, in this Dutch nationwide registry-based study of ACS patients treated by PCI, the incidence of CS was 4.1% over the 4-year study period. Predictors for mortality in CS were higher age, renal insufficiency, presence of DM, multivessel disease, prior MI, and OHCA.

Impella versus extracorporal life support in cardiogenic shock: a propensity score adjusted analysis.

AIMS: The mortality in cardiogenic shock (CS) is high. The role of specific mechanical circulatory support (MCS) systems is unclear. We aimed to compare patients receiving Impella versus ECLS (extracorporal life support) with regard to baseline characteristics, feasibility, and outcomes in CS. METHODS AND RESULTS: This is a retrospective cohort study including CS patients over 18 years with a complete follow-up of the primary endpoint and available baseline lactate level, receiving haemodynamic support either by Impella 2.5 or ECLS from two European registries. The decision for device implementation was made at the discretion of the treating physician. The primary endpoint of this study was all-cause mortality at 30 days. A propensity score for the use of Impella was calculated, and multivariable logistic regression was used to obtain adjusted odds ratios (aOR). In total, 149 patients were included, receiving either Impella (n = 73) or ECLS (n = 76) for CS. The feasibility of device implantation was high (87%) and similar (aOR: 3.14; 95% CI: 0.18-56.50; P = 0.41) with both systems. The rates of vascular injuries (aOR: 0.95; 95% CI: 0.10-3.50; P = 0.56) and bleedings requiring transfusions (aOR: 0.44; 95% CI: 0.09-2.10; P = 0.29) were similar in ECLS patients and Impella patients. The use of Impella or ECLS was not associated with increased odds of mortality (aOR: 4.19; 95% CI: 0.53-33.25; P = 0.17), after correction for propensity score and baseline lactate level. Baseline lactate level was independently associated with increased odds of 30 day mortality (per mmol/L increase; OR: 1.29; 95% CI: 1.14-1.45; P < 0.001). CONCLUSIONS: In CS patients, the adjusted mortality rates of both ECLS and Impella were high and similar. The baseline lactate level was a potent predictor of mortality and could play a role in patient selection for therapy in future studies. In patients with profound CS, the type of device is likely to be less important compared with other parameters including non-cardiac and neurological factors.

Improvement of sidestream dark field imaging with an image acquisition stabilizer.

BACKGROUND: In the present study we developed, evaluated in volunteers, and clinically validated an image acquisition stabilizer (IAS) for Sidestream Dark Field (SDF) imaging. METHODS: The IAS is a stainless steel sterilizable ring which fits around the SDF probe tip. The IAS creates adhesion to the imaged tissue by application of negative pressure. The effects of the IAS on the sublingual microcirculatory flow velocities, the force required to induce pressure artifacts (PA), the time to acquire a stable image, and the duration of stable imaging were assessed in healthy volunteers. To demonstrate the clinical applicability of the SDF setup in combination with the IAS, simultaneous bilateral sublingual imaging of the microcirculation were performed during a lung recruitment maneuver (LRM) in mechanically ventilated critically ill patients. One SDF device was operated handheld; the second was fitted with the IAS and held in position by a mechanic arm. Lateral drift, number of losses of image stability and duration of stable imaging of the two methods were compared. RESULTS: Five healthy volunteers were studied. The IAS did not affect microcirculatory flow velocities. A significantly greater force had to applied onto the tissue to induced PA with compared to without IAS (0.25 +/- 0.15 N without vs. 0.62 +/- 0.05 N with the IAS, p < 0.001). The IAS ensured an increased duration of a stable image sequence (8 +/- 2 s without vs. 42 +/- 8 s with the IAS, p < 0.001). The time required to obtain a stable image sequence was similar with and without the IAS. In eight mechanically ventilated patients undergoing a LRM the use of the IAS resulted in a significantly reduced image drifting and enabled the acquisition of significantly longer stable image sequences (24 +/- 5 s without vs. 67 +/- 14 s with the IAS, p = 0.006). CONCLUSIONS: The present study has validated the use of an IAS for improvement of SDF imaging by demonstrating that the IAS did not affect microcirculatory perfusion in the microscopic field of view. The IAS improved both axial and lateral SDF image stability and thereby increased the critical force required to induce pressure artifacts. The IAS ensured a significantly increased duration of maintaining a stable image sequence.

A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: should we change the guidelines?

Aims Intra-aortic balloon counterpulsation (IABP) in ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock is strongly recommended (class IB) in the current guidelines. We performed meta-analyses to evaluate the evidence for IABP in STEMI with and without cardiogenic shock. Methods and results Medical literature databases were scrutinized to identify randomized trials comparing IABP with no IABP in STEMI. In absence of randomized trials, cohort studies of IABP in STEMI with cardiogenic shock were identified. Two separate meta-analyses were performed respectively. The first meta-analysis included seven randomized trials (n = 1009) of STEMI. IABP showed neither a 30-day survival benefit nor improved left ventricular ejection fraction, while being associated with significantly higher stroke and bleeding rates. The second meta-analysis included nine cohorts of STEMI patients with cardiogenic shock (n = 10529). In patients treated with thrombolysis, IABP was associated with an 18% [95% confidence interval (CI), 16-20%; P < 0.0001] decrease in 30 day mortality, albeit with significantly higher revascularization rates compared to patients without support. Contrariwise, in patients treated with primary percutaneous coronary intervention, IABP was associated with a 6% (95% CI, 3-10%; P < 0.0008) increase in 30 day mortality. Conclusion The pooled randomized data do not support IABP in patients with high-risk STEMI. The meta-analysis of cohort studies in the setting of STEMI complicated by cardiogenic shock supported IABP therapy adjunctive to thrombolysis. In contrast, the observational data did not support IABP therapy adjunctive to primary PCI. All available observational data concerning IABP therapy in the setting of cardiogenic shock is importantly hampered by bias and confounding. There is insufficient evidence endorsing the current guideline recommendation for the use of IABP therapy in the setting of STEMI complicated by cardiogenic shock. Our meta-analyses challenge the current guideline recommendations.

Mechanical circulatory support in cardiogenic shock from acute myocardial infarction: Impella CP/5.0 versus ECMO.

BACKGROUND: Short-term mechanical circulatory support devices are increasingly used in cardiogenic shock after acute myocardial infarction. As no randomised evidence is available, the choice between high-output Impella or extra-corporeal membrane oxygenation (ECMO) is still a matter of debate. Real-life data are necessary to assess adverse outcomes and to help guide the treatment decision between the different devices. The purpose of this study was to compare characteristics and clinical outcomes of Impella CP/5.0 with ECMO support in patients with cardiogenic shock from myocardial infarction. METHODS: A retrospective, two-centre study was performed on all cardiogenic shock from myocardial infarction patients with Impella CP/5.0 or ECMO support, from 2006 until 2018. The primary outcome was 30-day mortality. Potential baseline imbalance between the groups was adjusted using inverse probability treatment weighting, and survival analysis was performed with an adjusted log-rank test. Secondarily, the occurrence of device-related complications (limb ischaemia, access site-related bleeding, access site-related infection) was evaluated. RESULTS: A total of 128 patients were included (Impella, N=90; ECMO, N=38). The 30-day mortality was similar for both groups (53% vs. 49%, P=0.30), also after adjustment for potential baseline imbalance between the groups (weighted log-rank P=0.16). Patients with Impella support had significantly fewer device-related complications than patients treated with ECMO (respectively, 17% vs. 40%, P<0.01). CONCLUSIONS: Patients treated with Impella CP/5.0 or ECMO for cardiogenic shock after myocardial infarction did not differ in 30-day mortality. More device-related complications occurred with ECMO compared to Impella support.

Pre-PCI versus immediate post-PCI Impella initiation in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: In selected patients with an acute myocardial infarction (AMI) complicated by Cardiogenic shock (CS), mechanical circulatory support with Impella may be beneficial, although conclusive evidence is still lacking. Nevertheless, it has been suggested that Impella initiation prior to primary PCI might improve survival. OBJECTIVE: To investigate the effect pre-PCI versus immediate post-PCI Impella initiation on short term mortality. METHODS: A prospective, single center, observational study, was performed including all patients with STEMI complicated by CS, treated with primary PCI and Impella. Thirty day mortality was compared between patients with Impella initiation pre-PCI and immediately post-PCI. RESULTS: A total of 88 patients were included. In the pre-PCI group (n = 21), admission heart rate was lower (84 versus 94 bpm, p = 0.04) and no IABP was implanted before Impella initiation, versus 17.9% in post-PCI group (n = 67), p = 0.04. Total 30-day all-cause mortality was 58%, and was lower in pre-PCI group, 47.6% versus 61.2% in the post-PCI group, however not statistically significant (HR 0.7, 95% CI 0.3-1.3, p = 0.21). Thirty-day cardiac mortality was significantly lower in the pre-PCI group, 19% versus 44.7% in the post-PCI group (HR 0.3, 95% CI 0.09-0.96, p = 0.042). CONCLUSION: Pre-PCI Impella initiation in AMICS patients was not associated with a statistically significant difference in 30-day all-cause mortality, compared to post-PCI Impella initiation.

Primary intra-aortic balloon support versus inotropes for decompensated heart failure and low output: a randomised trial.

AIMS: The haemodynamic effects of primary implantation of an intra-aortic balloon pump (IABP) versus inotropes in decompensated heart failure and low output (DHF-LO), but without an acute coronary syndrome, have not been investigated. We therefore aimed to investigate the effect of primary IABP implantation as compared to inotropes on haemodynamics in DHF-LO with no acute ischaemia. METHODS AND RESULTS: Patients (n=32) with DHF-LO despite IV diuretics were randomised to primary 50 mL IABP or inotropes (INO: enoximone or dobutamine). The primary endpoint was the improvement of organ perfusion assessed by ∆ mixed-venous oxygen saturation (SvO2) at 3 hours; secondary endpoints included ∆ cardiac power output (CPO), NT-proBNP proportional change, cumulative fluid balance and ∆ dyspnoea severity score, all at 48 hours. Data are presented as median (IQR). Patients were 60 (48-69) years old and 72% were male. Baseline SvO2 was 44 (39-53)%. ∆SvO2 was higher in the IABP group (+17 [+9; +24] vs. +5 [+2; +9]%, p<0.05). IABP patients had a higher ∆CPO, a greater relative reduction in NT-proBNP, a more negative cumulative fluid balance, and a greater reduction in dyspnoea severity score. There were no IABP-related serious adverse events (SAEs). Thirty-day mortality was 23% (IABP) vs. 44% (INO). CONCLUSIONS: Primary circulatory support by IABP showed a significant increase in improved organ perfusion assessed by SvO2.

Real-life use of left ventricular circulatory support with Impella in cardiogenic shock after acute myocardial infarction: 12 years AMC experience.

AIMS: Mortality in cardiogenic shock patients remains high. Short-term mechanical circulatory support with Impella can be used to support the circulation in these patients, but data from randomised controlled studies and 'real-world' data are sparse. The aim is to describe real-life data on outcomes and complications of our 12 years of clinical experience with Impella in patients with cardiogenic shock after acute myocardial infarction and to identify predictors of 6-month mortality. METHODS: We describe a single-centre registry from October 2004 to December 2016 including all patients treated with Impella for cardiogenic shock after acute myocardial infarction. We report outcomes and complications and identify predictors of 6-month mortality. RESULTS: Our overall clinical experience consists of 250 patients treated with Impella 2.5, Impella CP or Impella 5.0. A total of 172 patients received Impella therapy for cardiogenic shock, of which 112 patients had cardiogenic shock after acute myocardial infarction. The mean age was 60.1±10.6 years, mean arterial pressure was 67 (56-77) mmHg, lactate was 6.2 (3.6-9.7) mmol/L, 87.5% were mechanically ventilated and 59.6% had a cardiac arrest before Impella placement. Overall 30-day mortality was 56.2% and 6-month mortality was 60.7%. Complications consisted of device-related vascular complications (17.0%), non-device-related bleeding (12.5%), haemolysis (7.1%) and stroke (3.6%). In a multivariate analysis, pH before Impella placement is a predictor of 6-month mortality. CONCLUSIONS: Our registry shows that Impella treatment in cardiogenic shock after acute myocardial infarction is feasible, although mortality rates remain high and complications occur.

Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device - the role of anticoagulation.

BACKGROUND AND PURPOSE: It is unknown what the optimal anticoagulant level is to prevent thromboembolic stroke in patients with left ventricular assist device (LVAD) support. We aimed to evaluate the relation between coagulation status and the occurrence of thromboembolic stroke in HeartMate-II LVAD assisted patients. METHODS: Thirty-eight consecutive patients with a HeartMate-II LVAD were included. Coagulation status was classified according to INR and aPTT ratio at: 1) the moment of first thromboembolic stroke; and 2) during the two weeks preceding the first thromboembolic stroke to assess long-term coagulation status. In patients without stroke, coagulation status was determined just before heart transplant, VAD explantation or death, whichever came first, and at two weeks preceding these surrogate endpoints. Based on coagulation status, patients were divided in two groups: Group I (reference group) was defined as INR below 2 and aPTT ratio below 1.5; Group II (adequate anticoagulation) as INR above 2 or aPTT ratio above 1.5. Logistic regression analysis was performed to assess the odds ratio for developing stroke for patients with adequate anticoagulation compared to the reference Group. RESULTS: Thromboembolic stroke occurred in six (16 %) patients, none within 2 weeks after LVAD implantation. Considering coagulation status at the time of event, patients in coagulation Group II had no decreased risk for thromboembolic stroke (OR 0.78; 95 % CI 0.12-5.0). Results for coagulation status 2 weeks prior of event could not be calculated as all six strokes occurred in Group II. CONCLUSION: In our experience anticoagulation within predefined targets is not associated with a reduced thromboembolic stroke risk in patients with a HeartMate-II LVAD on antiplatelet therapy. However, no firm statement about the effect of either anticoagulant or antiaggregant therapy can be made based on our study. A larger randomized study is needed to support the hypothesis that there may be no additional benefit of coumarin or heparin therapy compared with antiplatelet therapy alone.

Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry.

BACKGROUND: Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. METHODS AND RESULTS: This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%. CONCLUSIONS: In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.

Long-term safety and sustained left ventricular recovery: long-term results of percutaneous left ventricular support with Impella LP2.5 in ST-elevation myocardial infarction.

AIMS: Mechanical left ventricular (LV) unloading may reduce infarct size when combined with primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI). The Impella LP2.5 is a novel percutaneous left ventricular assist device. Although the short-term safety and feasibility of this device have been demonstrated, the long-term effects are unknown. The purpose of the current study was to evaluate the long-term effects of the Impella LP2.5 support on the aortic valve and left ventricular ejection fraction (LVEF). METHODS AND RESULTS: In 2006, 10 patients with anterior STEMI received 3-day support with the Impella LP2.5 after PCI. The control group consisted of 10 comparable patients, treated according to routine care. For the current study, echocardiography was performed and adverse events were recorded. Mean duration of follow-up was 2.9±0.6 years in the Impella group and 3.0±0.3 years in the control group. No differences in aortic valve abnormalities and LVEF were demonstrated between the groups; nevertheless, LVEF increase from baseline was significantly greater in Impella-treated patients (23.6±8.9% versus 6.7±7.0%, P=0.008). CONCLUSIONS: Three-day support with the Impella LP2.5 is not associated with adverse effects on the aortic valve at long-term follow-up. LVEF was similar in both groups; however, recovery was significantly greater in the Impella group.

Percutaneous left ventricular assist devices for high-risk percutaneous coronary intervention.

Although coronary artery bypass grafting remains an important therapeutic option for patients with complex coronary artery disease, percutaneous coronary intervention strategies have become an established alternative. Nevertheless, treatment options for surgery-ineligible patients with complex coronary artery disease used to be limited, especially in patients with a reduced left ventricular function. Those patients are at high risk of profound hypotension and mortality, which may be adequately prevented by prophylactic placement of a percutaneous mechanical assist device. Although many devices have been developed and randomized evidence is still pending, the Impella LP2.5 device (Abiomed-Impella CardioSystems GmbH, Aachen, Germany) seems to be promising as it is easily applicable, carries a low complication rate and provides adequate circulatory support.

[The Impella system for mechanical support and myocardial recovery]. / Het beschadigde hart: ondersteuning en herstel met het Impella-systeem.

Mechanical circulatory support has become an increasingly important therapeutic option in the field of cardiology, both with regard to treatment of patients in cardiogenic shock and protection against haemodynamic instability during high-risk percutaneous coronary intervention (PCI). The intra-aortic balloon pump (IABP) is the current standard treatment for mechanical circulatory support. However, its efficacy seems limited, both in acute and elective settings. The Impella system is a new technique which may be a suitable alternative to IABP treatment. The Impella is a small micro-axial, catheter-mounted cardiac pump, which is inserted through the femoral artery. Safety and efficacy of Impella treatment have been demonstrated during elective high-risk PCI. In the setting of cardiogenic shock, mechanical support with the Impella may lead to partial recovery of left ventricular function, especially when Impella treatment is applied according to a carefully designed pre-specified protocol..

Sensor-augmented insulin pump therapy to treat hyperglycemia at the coronary care unit: a randomized clinical pilot trial.

BACKGROUND: The relationship between admission hyperglycemia and adverse outcome in myocardial infarction has been shown consistently. However, achieving and maintaining normoglycemia in ST elevated myocardial infarction (STEMI) patients has proven difficult. This study aimed to investigate the efficacy of sensor-augmented insulin pump (SAP) therapy to treat hyperglycemia. METHODS: In a randomized controlled pilot trial, we assigned 20 patients, 30-80 years old, admitted with STEMI and hyperglycemia (>or=140 mg/dL) to receive either 48 h of strict glycemic control with an subcutaneous insulin pump augmented with a continuous glucose monitor (SAP group) or to treatment according to standard practice (Control group) with glucose measured by blinded continuous glucose monitoring. The main outcome measure was proportion of time spent in hyperglycemia. RESULTS: The median treatment time was 47.0 h (interquartile range [IQR], 46.2-48.0 h) in the SAP group and 44.6 h (IQR, 22.0-48.6 h) in the Control group. The median proportion of time >or= 140 mg/dL was 14.6% (IQR, 10.5-18.5%) in the SAP group and 36.3% (IQR, 26.0-80.4%) in the control group (P = 0.006). The proportion of time