Ventriculo-arterial uncoupling with an impella assisted HVAD: The p-D LVAD.

This paper presents the novel use of a temporary percutaneous ventricular assist device (pVAD) in a 51-year-old man with an implanted durable left ventricular assist device (d-LVAD). The pre-existing left ventricular assist device was unable to successfully unload the left ventricle, and the addition of the temporary pVAD achieved successful unloading as well as a decrease in pulmonary artery pressures without compromising the function of the right ventricle allowing safe UNOS listing for orthotopic heart transplantation.

Biventricular catheterization combined with pressure-volume loop monitoring provides insight into the dynamic effects of left ventricular assist devices ramp on right ventricular function.

Ramp studies are utilized for speed optimization of continuous flow left ventricular assist devices (CF-LVADs). We here report the utility of combined left and right heart catheterization during a ramp study to ensure a comprehensive understanding of the hemodynamic implications on both ventricles. Pressure-volume loop (PV loop) monitoring uncovered compromised systolic and mildly compromised right ventricular function with increasing LVAD speeds, despite improvement in left ventricular unloading. These findings informed patient management and highlight the potential utility of PV loop monitoring as an adjunct to left and right heart catheterization during ramp studies of next-generation LVADs.

Vasopressors independently associated with mortality in acute myocardial infarction and cardiogenic shock.

BACKGROUND: Increasing vasopressor dose is associated with increasing mortality in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS). It is unknown whether the use of vasopressors is independently harmful or if their use is secondary to decreasing intrinsic cardiac power output (CPO). Mechanical circulatory support (MCS) devices enhance CPO. We sought to evaluate the independent impact of increasing vasopressor dose on survival in the National Cardiogenic Shock Initiative (NCSI). METHODS: The NCSI is a single arm prospective trial evaluating outcomes associated with the use of MCS using Impella in patients with AMICS. Early initiation of MCS placement before percutaneous coronary intervention (PCI) and rapid de-escalation of vasopressors guided by systematic use of invasive hemodynamic measures led to 70% in-hospital survival for the first 300 patients enrolled from July 2016 to December 2019 in 57 U.S. sites. RESULTS: Hemodynamic measures were obtained immediately after MCS and PCI. Survival curves were constructed based on CPO and use of vasopressors. For patients with CPO ≤0.6 W, survival was 77.3%, 45.0%, and 35.3% when 0, 1, or ≥ 2 vasopressors were used (p = 0.02). Similarly, for patients with CPO >0.6 W survival was 81.7%, 72.6%, and 56.8%, respectively (p = 0.01). Logistic regression analysis demonstrated that increasing vasopressor requirements were independently associated with increasing mortality (p = 0.02). CONCLUSION: Increasing vasopressor requirement is associated with increased mortality in AMICS independent of underlying CPO. Methods to decrease the need for vasopressors may enhance survival in AMICS.

Outcomes of mechanical circulatory support for acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Mechanical circulatory support (MCS) with the Impella device (Abiomed, Danvers, MA) has been associated with higher in-hospital mortality than intra-aortic balloon pump (IABP) in the Premier Healthcare Database and National Cardiovascular Data Registry. METHODS: The objective of this retrospective cohort study was to describe trends and outcomes of Impella usage in acute myocardial infarction complicated by cardiogenic shock (AMICS) treated with MCS (Impella or IABP) using real-world observational data from the National Inpatient Sample (NIS) including hospitalizations for AMICS managed with MCS between January 2012 to December 2017. The primary outcomes included in-hospital mortality, transfusion, acute kidney injury, stroke, total costs, and length of stay. Propensity score matching was performed with hierarchical models using risk factor and Elixhauser comorbidity variables. RESULTS AND CONCLUSION: We identified 54,480 hospitalizations for AMICS managed with MCS including 5750 (10.5%) utilizing Impella. Throughout the study period, Impella usage increased yearly to 19.9% of AMICS cases in 2017. After propensity score matching, Impella was associated with higher in-hospital mortality (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.41-2.13) and transfusions (OR 1.97, 95% CI 1.40-2.78) than IABP, without association with acute kidney injury or stroke. Impella use was associated with higher hospital costs (mean difference $22,416.80 [95% CI $17,029-27,804]). Impella usage for AMICS increased significantly from 2012 to 2017 and was associated with increased in-hospital mortality and costs. Randomized controlled trials are urgently needed to assess the safety and efficacy of Impella.

Characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock during COVID-19.

OBJECTIVES: To evaluate characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) during the coronavirus disease 2019 (COVID-19) pandemic. BACKGROUND: The COVID-19 pandemic has created challenges in delivering acute cardiovascular care. Quality measures and outcomes of patients presenting with AMICS during COVID-19 in the United States have not been well described. METHODS: We identified 406 patients from the National Cardiogenic Shock Initiative (NCSI) with AMICS and divided them into those presenting before (N = 346, 5/9/2016-2/29/2020) and those presenting during the COVID-19 pandemic (N = 60, 3/1/2020-11/10/2020). We compared baseline clinical data, admission characteristics, and outcomes. RESULTS: The median age of the cohort was 64 years, and 23.7% of the group was female. There were no significant differences in age, sex, and medical comorbidities between the two groups. Patients presenting during the pandemic were less likely to be Black compared to those presenting prior. Median door to balloon (90 vs. 88 min, p = 0.38), door to support (88 vs. 78 min, p = 0.13), and the onset of shock to support (74 vs. 62 min, p = 0.15) times were not significantly different between the two groups. Patients presented with ST-elevation myocardial infarction more often during the COVID-19 period (95.0% vs. 80.0%, p = 0.005). In adjusted logistic regression models, COVID-19 period did not significantly associate with survival to discharge (odds ratio [OR] 1.09, 95% confidence interval [CI] 0.54-2.19, p = 0.81) or with 1-month survival (OR 0.82, 95% CI 0.42-1.61, p = 0.56). CONCLUSIONS: Care of patients presenting with AMICS has remained robust among hospitals participating in the NCSI during the COVID-19 pandemic.

Timing of mechanical circulatory support during primary angioplasty in acute myocardial infarction and cardiogenic shock: Systematic review and meta-analysis.

OBJECTIVES: We aim to define whether the timing of microaxial left ventricular assist device (IMLVAD) implantation might impact on mortality in acute myocardial infarction (AMI) cardiogenic shock (CS) patients who underwent primary percutaneous coronary intervention (PPCI). BACKGROUND: Despite the widespread use of PPCI, mortality in patients with AMI and CS remains high. Mechanical circulatory support is a promising bridge to recovery strategy, but evidence on its benefit is still inconclusive and the optimal timing of its utilization remains poorly explored. METHODS: We compared clinical outcomes of upstream IMLVAD use before PPCI versus bailout use after PPCI in patients with AMI CS. A systematic review and meta-analysis of studies comparing the two strategies were performed. Effect size was reported as odds ratio (OR) using bailout as reference group and a random effect model was used. Study-level risk estimates were pooled through the generic inverse variance method (random effect model). RESULTS: A total of 11 observational studies were identified, including a pooled population of 6759 AMI-CS patients. Compared with a bailout approach, upstream IMLVAD was associated with significant reduction of 30-day (OR = 0.65; 95% confidence interval [CI] = 0.51-0.82; I2 = 43%, adjusted OR = 0.54; 95% CI = 0.37-0.59; I2 = 3%, test for subgroup difference p = 0.30), 6-month (OR = 0.51; 95% CI = 0.27-0.96; I2 = 66%), and 1-year (OR = 0.56; 95% CI = 0.39-0.79; I2 = 0%) all-cause mortality. Incidence of access-related bleeding, acute limb ischemia and transfusion outcomes were similar between the two strategies. CONCLUSION: In patients with AMI-CS undergoing PPCI, upstream IMLVAD was associated with reduced early and midterm all-cause mortality when compared with a bailout strategy.

Unmasking of a significant left main stenosis in a patient with high left ventricular pressures.

As identification of left main (LM) stenoses has prognostic and therapeutic relevance, a precise anatomic and/or functional characterization of angiographically intermediate LM stenoses, by using intravascular ultrasound (IVUS) and fractional flow reserve (FFR) respectively, is crucial (1). However, increased left ventricular (LV) pressures might affect FFR measurements (2). Here we describe the case of a patient with chronic coronary syndrome and severe LV dysfunction in whom coronary angiography revealed an intermediate LM stenosis and catheterization identified an increased LV end-diastolic pressure. FFR measurement showed disproportionally higher FFR values compared with the minimal luminal area assessed by IVUS. When cardiac output was artificially augmented by using Impella for assisting percutaneous coronary intervention, the value of FFR measurement turned out proportional to what expected for the degree of anatomical stenosis. This discrepancy between anatomic and functional measurement may be a sign of coronary autoregulation dysfunction and therefore could help to identify high-risk patients in whom the use of a mechanical support device is more beneficial during percutaneous revascularization.

Outcomes of bailout percutaneous ventricular assist device versus prophylactic strategy in patients undergoing nonemergent percutaneous coronary intervention.

OBJECTIVES: To compare in-hospital outcomes of bailout support to prophylactic support with percutaneous ventricular assist devices (pVAD) for high-risk nonemergent percutaneous coronary intervention (HRPCI). BACKGROUND: Prophylactic support with pVAD for a HRPCI is used in patients felt to be at risk for hemodynamic collapse during PCI. An alternative strategy of bailout pVAD support in the event of hemodynamic collapse is also entertained. METHODS: We compared the outcomes of patients entered in the cVAD database who underwent Impella Protected PCI (ProPCI group) with patients from the cVAD and USpella databases receiving bailout Impella support for hemodynamic collapse during HRPCI (Bailout group). RESULTS: A total of 1,028 patients supported with Impella pVAD were entered into the cVAD database as of July 2019 and were included in this analysis. Of those 971 were in the ProPCI group and 57 in the Bailout group. Patients in the Bailout group were more often female (50.9%vs. 27.2%, p = .0002) with higher median baseline left ventricular ejection fraction (LVEF) (40%vs. 30%, p < .0001) and with lower prevalence of both heart failure (42.1%vs. 56.9%, p = .0385) and left main disease (40.0%vs. 56.1%, p = .0250) compared to the ProPCI group. Unadjusted and adjusted in-hospital mortality was significantly higher in the Bailout group (49.1%vs. 4.3%, and 57.8%vs. 4.4%, p < .0001 for both). CONCLUSIONS: In our study population, the bailout group was associated with significant increased mortality compared to ProPCI group. Female gender was more frequently observed in patients requiring bailout pVAD. Further investigation is warranted in order to generalize the findings of our study.

Mechanical circulatory support in acute myocardial infarction and cardiogenic shock: Challenges and importance of randomized control trials.

BACKGROUND: Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with significant morbidity and mortality. METHODS: We provide an overview of previously conducted studies on the use of mechanical circulatory support (MCS) devices in the treatment of AMI-CS and difficulties which may be encountered in conducting such trials in the United States. RESULTS: Well powered randomized control trials are difficult to conduct in a critically ill patient population due to physician preferences, perceived lack of equipoise and challenges obtaining informed consent. CONCLUSIONS: With growth in utilization of MCS devices in patients with AMI-CS, efforts to perform well-powered, randomized control trials must be undertaken.

A safe and simple method for axIABP placement using a left axillary-radial technique.

In patients with severe heart failure, a percutaneous axillary intraaortic balloon pump (axIABP) may permit ambulation while awaiting destination therapy. Traditionally, an "axillary-femoral" approach has been used with femoral access for axillary angiography during insertion. We describe an "axillary-radial" technique for axIABP insertion and removal using the left radial artery.

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

Axillary Impella insertion under regional nerve block: A case report.

Percutaneous coronary interventions with the Impella (Abiomed, MA) catheter-based, micro-axial mechanical left ventricular assist device is a safe option for patients undergoing higher risk interventions. However, severe peripheral arterial disease limits vascular access for Impella insertion. Upper extremity arterial access has been traditionally obtained under general anesthesia. We present the first case, to our knowledge, of using peripheral nerve blocks for Impella 3.5 CP insertion into the axillary artery.

Novel technique of performing multivessel PCI through an Impella sheath.

A 69-year-old woman with diabetes was found to have multi-vessel coronary artery disease and underwent 5-vessel coronary artery bypass grafting. Patient had persistent cardiogenic shock postoperatively despite intra-aortic balloon pump and escalating pressor requirements. Electrocardiogram showed new ischemic changes and the patient was urgently taken to the catheterization lab for coronary angiography and placement of an Impella CP for higher degree of hemodynamic support via the left femoral artery. Due to limitations in vascular access the Impella CP sheath was utilized for vascular access for diagnostic angiography and coronary intervention concurrently with ongoing Impella CP support. The first obtuse marginal had severe proximal disease and was treated with percutaneous coronary intervention (PCI) with a drug eluting stent. To our knowledge, this case is the first in which successful diagnostic angiography as well as multi-vessel PCI was performed via an Impella sheath while concurrently using the percutaneous mechanical circulatory support system of the Impella CP. Multiple guide catheters and a pigtail catheter were successfully passed via the Impella CP sheath to perform PCI. This novel method of vascular access could be an important tool to use in high-risk patients with limitations in access sites and decrease potential bleeding complications by limiting the number of arterial punctures.

A contemporary and complete treatment solution for a high-risk patient with critical aortic stenosis, left ventricular thrombus, severe left ventricular dysfunction, and calcified left main stem disease.

The combination of severe coronary disease, significant valvular dysfunction and impaired ventricular function pose patients at a very high procedural risk. In addition, the presence of left ventricular thrombus can complicate ventricular instrumentation increasing embolic risk. Contemporary techniques and devices have now become available to overcome these challenges to reduce risk and allow safer, more efficient procedures. We describe the feasibility of using Impella CP™ with cerebral protection to facilitate complete revascularisation and percutaneous valve replacement in a patient with critical aortic stenosis, severe left ventricular (LV) impairment, LV thrombus and a calcified left main stem disease.

Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative.

BACKGROUND: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). METHODS: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS. RESULTS: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure. CONCLUSION: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.

Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative.

OBJECTIVE: The 'Detroit Cardiogenic Shock Initiative' is a single-arm, multicenter study to assess the feasibility of early mechanical circulatory support (MCS) in patients who present with acute myocardial infarction complicated by cardiogenic shock (AMICS) who undergo percutaneous coronary intervention. METHODS: Between July 2016 and February 2017, 4 metro Detroit sites participated in the study. The centers agreed to treat patients with AMICS using a mutually agreed-upon protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those from the 'SHOCK' trial with an additional exclusion criteria being use of intra-aortic balloon pump counter pulsation prior to MCS. RESULTS: A total of 41 consecutive patients were included. Patients had an average age of 65 ± 14 years, 71% were male and 59% of patients were admitted to the hospital in cardiogenic shock. Prior to receiving MCS, 93% of patients were on vasopressors or inotropes, 15% of patients had a witnessed out of hospital cardiac arrest, 27% of patients had an in-hospital cardiac arrest, and 17% were under active cardiopulmonary resuscitation while MCS was being implanted. In accordance to the protocol recommendation, 66% of patients had a MCS device inserted prior to PCI. Right heart catheterization and hemodynamic monitoring was performed in 83% of patients. Door to support times averaged 83 ± 58 minutes and 71% of patients were able to reduce the levels of inotropes and vasopressors within the first 24-hours of their index procedure. Pre-procedure cardiac power output (CPO) was 0.57 W and post-procedure CPO was 0.95 W, a 67% increase (p < 0.001). Survival to explant for the entire cohort was 85% a significant improvement from institutional historical controls (85% vs 51% p < 0.001) and survival to discharge was 76%. CONCLUSION: Centers who adopted a regional shock protocol emphasizing the delivery of early MCS with invasive hemodynamic monitoring can achieve rapid door to support times and can improve survival in patients who present with AMICS. Larger national studies will be needed to further validate this pilot feasibility study.

A team-based approach to patients in cardiogenic shock.

Cardiogenic shock is a common clinical condition with high in-hospital mortality. Early application of appropriate interventions for cardiogenic shock-including medical therapies, revascularization, temporary hemodynamic support devices, and durable mechanical circulatory support-may improve outcomes. The number and complexity of therapies for cardiogenic shock are increasing, making time-dependent decision-making more challenging. A multidisciplinary cardiogenic shock team is recommended to guide the rapid and efficient use of these available treatments. © 2015 Wiley Periodicals, Inc.

First-in-human robotic percutaneous coronary intervention for unprotected left main stenosis.

The safety and feasibility of robotically-assisted percutaneous coronary intervention (PCI) for simple coronary lesions has been demonstrated. The CorPath robotic system (Corpath 200, Corindus, Waltham, MA) consists of a robotic arm mounted on the cardiac catheterization table that consists of a drive housing a single-use sterile cassette, which is connected to the guiding catheter. While sitting in the nonsterile, radiation-shielded cockpit, the operator remotely controls delivery and removal of coronary guidewires, angioplasty balloons, and stents. The database for the ongoing PRECISION registry was queried at a single center and results of unprotected left main robotic PCI procedures are reported. Of 102 robotic PCI procedures performed at this center, 6 were unprotected left main lesions (age 69 ± 14 years; 67% male). All 6 subjects underwent successful PCI (fluoroscopy time 26.8 ± 11.4 min;1.8 stents and 2.2 vessels treated/patient) with three requiring hemodynamic support (two with percutaneous left ventricular assistance using the Impella 2.5 (Abiomed, Danvers, MA) and one with intraaortic balloon pump counterpulsation). This report demonstrates the feasibility of performing robotically assisted unprotected left main PCI with or without hemodynamic support. © 2016 Wiley Periodicals, Inc.

"Shock and Go?" extracorporeal cardio-pulmonary resuscitation in the golden-hour of ROSC.

OBJECTIVES: The feasibility and outcomes of 35 consecutive patients subjected to eCPR in the tertiary cardiology center were investigated. BACKGROUND: While conventional cardiopulmonary-resuscitation (cCPR) often times achieves only mediocre outcomes extracorporeal cardiopulmonary-resuscitation (eCPR) increasingly shifts into the focus of interest. However, the scientific evidence for eCPR is sparse, particularly in the cardiological setting. METHODS: Retrospective chart analysis of 35 patients treated with eCPR between 01/2014 and 10/2015. RESULTS: The duration of cCPR until initiation of eCPR was 73.8 ± 37.6 min and resulted in an initial pH of 6.9 ± 0.2 and serum lactate level of 14.5 ± 4.8 mmol/L. About 62% (n = 22) of the patients suffered from out of hospital cardiac arrest (OHCA), 85% (n = 30) of the overall events were witnessed and bystander-CPR performed in 77% (n = 27) of cases. Cause of arrest was dominated by acute myocardial infarction (AMI, 71%), initial rhythm to a lesser degree by ventricular fibrillation/tachycardia (VF/VT, 57%). Almost all patients (n = 33, 94%) experienced return of spontaneous circulation (ROSC) after establishing extracorporeal life support (ECLS). In all 57% patients were successfully weaned from ECLS. Survival to discharge was 31% with predominantly good cerebral performance category (CPC 1-2). Survivors were more likely to receive bystander-CPR (P = 0.03) and the duration of cCPR until initiation of eCPR was significantly shorter (P = 0.004). CONCLUSIONS: Our data proves the exceptional level of efficiency of eCPR particularly when Bystander-CPR has been initiated and there is a short duration of cCPR. © 2016 Wiley Periodicals, Inc.