Mechanical Circulatory Support Options Research Articles

Bridge to Life: Current Landscape of Temporary Mechanical Circulatory Support in Heart-Failure-Related Cardiogenic Shock.

Acute heart failure (HF) presents a significant mortality burden, necessitating continuous therapeutic advancements. Temporary mechanical circulatory support (MCS) is crucial in managing cardiogenic shock (CS) secondary to acute HF, serving as a bridge to recovery or durable support. Currently, MCS options include the Intra-Aortic Balloon Pump (IABP), TandemHeart (TH), Impella, and Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO), each offering unique benefits and risks tailored to patient-specific factors and clinical scenarios. This review examines the clinical implications of recent advancements in temporary MCS, identifies knowledge gaps, and explores promising avenues for future research and clinical application. Understanding each device's unique attributes is crucial for their efficient implementation in various clinical scenarios, ultimately advancing towards intelligent, personalized support strategies.

Fully Magnetically Levitated Durable Biventricular Assist Device Insertion

Durable mechanical circulatory support options for patients with biventricular failure are limited. One emerging strategy is the use of two fully magnetically levitated durable ventricular assist devices (HeartMate 3s) in a biventricular configuration. The use of a HeartMate 3 as a right ventricular assist device (RVAD) requires several complex technical modifications. Here, we provide step-wise detailed figures and a comprehensive description of bilateral HeartMate 3 insertion, with a particular focus on right atrial inflow cannulation for the RVAD. Potential pitfalls and solutions are also described.

Abstract 13015: Sex Disparities in Outcomes of Adults With Cardiogenic Shock Using Impella; a Propensity-Matched Analysis

Introduction: Impella use is one of the mechanical circulatory support options in patients with cardiogenic shock (CS). While recent studies have associated a 47.3% short-term mortality in Impella support for CS, there is a lack of data on sex disparities in its use. We, therefore, conducted a retrospective analysis to analyze its impact. Hypothesis: We assessed the hypothesis that females and males have different outcomes following the use of Impella for CS. Methods: We explored the 2016-2020 National Inpatient sample for adults with CS and Impella use. Propensity matching was conducted for multiple patient and hospital characteristics. The differences in males and females for various complications were analyzed. Results: Our study initially found 57630 cases that matched our selection, with 41455(71.9%) males and 16175(28.1%) females. After propensity matching, Females showed a higher mean age (64.31 vs. 62.82 years, p<0.01), with a higher mean Charlson Comorbidity Index (CCI) score (4.50 vs. 4.25, p<0.01), but a shorter hospitalization ( 15.31 vs. 16.64 days). In addition, females showed higher odds of central line-associated bloodstream infection (CLABSI) (aOR 2.576, 95% CI 1.147-5.788, p=0.022), pulmonary embolism (PE) (aOR 1.544, 95% CI 1.077-2.213, p=0.018), respiratory failure/arrest (aOR 1.124, 95% CI 1.001-1.262, p=0.048) than males, while having lower odds of acute kidney injury (AKI) (aOR 0.727, 95% CI 0.648-0.815, p<0.01). No differences in stroke, sepsis, or death events were found between them. Conclusions: In conclusion, there are differences in outcomes between males and females following use of Impella for CS, as females expressed higher odds of CLABSI, PE, respiratory failure/arrest, and lower odds of AKI than males. Future randomized studies in clinical settings and addressing for limitations of our study (such as drug use and duration of various comorbidities) are warranted to improve outcomes between the two cohorts.

Percutaneous Management of High-Risk Pulmonary Embolism.

Acute pulmonary embolism (PE) leads to an abrupt increase in pulmonary vascular resistance and right ventricular afterload, and when significant enough, can result in hemodynamic instability. High-risk PE is a dire cardiovascular emergency and portends a poor prognosis. Traditional therapeutic options to rapidly reduce thrombus burden like systemic thrombolysis and surgical pulmonary endarterectomy have limitations, both with regards to appropriate candidates and efficacy, and have limited data demonstrating their benefit in high-risk PE. There are growing percutaneous treatment options for acute PE that include both localized thrombolysis and mechanical embolectomy. Data for such therapies with high-risk PE are currently limited. However, given the limitations, there is an opportunity to improve outcomes, with percutaneous treatments options offering new mechanisms for clot reduction with a possible improved safety profile compared with systemic thrombolysis. Additionally, mechanical circulatory support options allow for complementary treatment for patients with persistent instability, allowing for a bridge to more definitive treatment options. As more data develop, a shift toward a percutaneous approach with mechanical circulatory support may become a preferred option for the management of high-risk PE at tertiary care centers.

Incidence and severity of thrombocytopenia associated with use of intravascular microaxial ventricular assist devices for treatment of cardiogenic shock.

The use of temporary mechanical circulatory support (MCS) for patients with refractory cardiogenic shock has increased over the past decade. Impella devices (intravascular microaxial ventricular assist devices [VADs]) have become common MCS options but reportedly cause thrombocytopenia. Limited published data regarding the incidence or severity of microaxial VAD-associated thrombocytopenia exists. The goal of this study was to determine the incidence, timing, and severity of thrombocytopenia in a microaxial VAD population. A retrospective multicenter review of electronic medical records identified all patients implanted with microaxial VAD at three US academic teaching hospitals between June 2015 and August 2017. Patients were excluded for short-term procedural microaxial VAD use during percutaneous coronary intervention. Sixty-four patients underwent microaxial VAD insertion (95% for left-sided support) during the observed time period. Support was in place for a median duration of 5.2 (interquartile range [IQR]: 2.4-10.0) days. Within 7 days postinsertion, 98.5% of patients developed thrombocytopenia (platelet count <150,000/μl) and 81.3% of patients experienced a>50% platelet decrease. Average platelet count nadir was 68,200/μl or 63.9% from baseline occurring on median day 3.8 (IQR: 2.4-5.4). Twenty-four patients (38.1%) were tested for heparin-induced thrombocytopeniaby the heparin-dependent antibody (HDA) test. All HDAs were either negative or had serotonin release assay negative confirmation. Postdevice removal, platelet counts returned to baseline or >150,000/μl in 63% of patients by Day 5. Microaxial VAD-associatedthrombocytopenia is common. Practitioners should consider this when evaluating supported patients for other causes of thrombocytopenia. Platelet counts return to preimplantation levels within days of device removal.

Right heart failure after left ventricular assist device: From mechanisms to treatments.

Left ventricular assist device (LVAD) therapy is a lifesaving option for patients with medical therapy-refractory advanced heart failure. Depending on the definition, 5-44% of people supported with an LVAD develop right heart failure (RHF), which is associated with worse outcomes. The mechanisms related to RHF include patient, surgical, and hemodynamic factors. Despite significant progress in understanding the roles of these factors and improvements in surgical techniques and LVAD technology, this complication is still a substantial cause of morbidity and mortality among LVAD patients. Additionally, specific medical therapies for this complication still are lacking, leaving cardiac transplantation or supportive management as the only options for LVAD patients who develop RHF. While significant effort has been made to create algorithms aimed at stratifying risk for RHF in patients undergoing LVAD implantation, the predictive value of these algorithms has been limited, especially when attempts at external validation have been undertaken. Perhaps one of the reasons for poor performance in external validation is related to differing definitions of RHF in external cohorts. Additionally, most research in this field has focused on RHF occurring in the early phase (i.e., ≤1 month) post LVAD implantation. However, there is emerging recognition of late-onset RHF (i.e., > 1 month post-surgery) as a significant cause of morbidity and mortality. Late-onset RHF, which likely has a unique physiology and pathogenic mechanisms, remains poorly characterized. In this review of the literature, we will describe the unique right ventricular physiology and changes elicited by LVADs that might cause both early- and late-onset RHF. Finally, we will analyze the currently available treatments for RHF, including mechanical circulatory support options and medical therapies.

Transinnominate Impella 5.5 insertion as a bridge to transplantation in a pediatric patient in refractory cardiogenic shock.

Transinnominate Impella 5.5 insertion as a bridge to transplantation in a pediatric patient in refractory cardiogenic shock.

Mechanical Circulatory Support: Primer for Consultant Specialists.

Mechanical life support therapies exist in many forms to temporarily replace the function of vital organs. Generally speaking, these tools are supportive therapy to allow for organ recovery but, at times, require transition to long-term mechanical support. This review will examine nonrenal extracorporeal life support for cardiac and pulmonary support as well as other mechanical circulatory support options. This is intended as a general primer and overview to assist nephrologist consultants participating in the care of these critically ill patients who often experience acute renal injury as a result of cardiopulmonary shock and from their exposure to mechanical circulatory support.

Predictors of Mechanical Circulatory Support in Fulminant Acute Myocarditis

<h3>Purpose</h3> Fulminant acute myocarditis (FAM) is rare but with high acute mortality. Mechanical circulatory support (MCS) may be needed to bridge to recovery or heart transplantation. We aim to determine predictors of MCS and evaluate long-term outcomes. <h3>Methods</h3> Observational prospective study of patients admitted to a third-level hospital with FAM between 2007 and 2021. FAM was defined as an acute myocardial inflammation in endomyocardial biopsy (EMB) or magnetic resonance, with hemodynamic instability and left or right ventricular dysfunction. We performed multivariate logistic regression analysis to determine predictors of need of MCS. Survival was analyzed with Kaplan-Meier curves and the log rank. <h3>Results</h3> We included 71 patients with a diagnosis of FAM by EMB (53) or magnetic resonance (15). Mean age was 42 years and mean left ventricular ejection fraction (LVEF) was 27%. In EMB the most frequent finding was lymphocytic myocarditis (79.6%). 58 patients received treatment with corticosteroids. 43 patients needed MCS: veno-arterial ECMO (11), Impella (1), left (1) or biventricular Centrimag (14) and Intraortic balloon pump (16). Univariate predictors of MCS were ST segment deviation in ECG, lower LVEF, need for inotropes, positive troponines, need for mechanical ventilation (MV), higher heart rate and lower blood pressure. In the multivariate analysis only ST segment deviation (OR 13.9, p = 0.026) remained significant, but mechanical ventilation (OR 4.488, p = 0.076) and initial LVEF (OR 0.926, p = 0.059) showed a trend to predict MCS. Survival of patients who needed MCS support was worse (with 5 patients needing heart transplant), but those who survived the acute phase showed good recovery of the LVEF at discharge and last follow-up (figure). <h3>Conclusion</h3> In patients with FAM with hemodynamic instability, the presence of ST segment deviation, lower LVEF and MV predict the need to refer to a center with options for MCS

Bedside Ultrasound of Internal Jugular Vein for Right Ventricular Function Assessment

<h3>Purpose</h3> Assessing right ventricular (RV) function is important in critically ill heart failure patients and candidacy for mechanical circulatory support options. In addition, diastolic heart failure and fluid overload are the earliest manifestations of rejection and coronary vasculopathy in heart transplant (HTx) recipients. Echocardiographic measurements can be difficult to obtain due to body habitus and poor ultrasound windows. Using ultrasound (POCUS) to assess dynamic changes in internal jugular vein (IJV) dimension could be a quick and reproducible method for bedside RV function assessment. <h3>Methods</h3> Patients scheduled to undergo right heart catheterization (RHC) as their standard of care were prospectively enrolled. While supine, the IJV was imaged at the apex of the sternocleidomastoid. Using M-mode on a portable ultrasound machine, maximum (Dmax) and minimum (Dmin) anteroposterior diameters were measured during normal breathing. Respiratory variation in diameter (RVD) was then calculated using the following equation [(Dmax - Dmin)/Dmax] and expressed as a percentage. RHC was then performed within one hour. <h3>Results</h3> A total of 92 heart failure patients were enrolled with mean age 58 and mean BMI 30.3. IJV dimensions could be assessed in all patients irrespective of BMI. Poor right ventricular (RV) function (right ventricular stroke work index -RVSWI) of <5 g/m/beat/m² was associated with low RVD (16% vs 34%, p = 0.001). An IJV RVD of < 15% had 82% specificity for RVSWI < 5 (ROC AUC 0.774). When using pulmonary artery pulsatility pressure (PAPi), an RVD of <15% had 79% specificity for a PAPi ≤ 2. When combined with a Dmin of 1cm, the specificity increased to 87% (Odds ratio 3.75, p=0.016). 21 of these assessments were in HTx patients, showing similar correlation. A Dmax >1.1cm or RVD <20% individually had specificity of 80% for RAP >=10 mmHg (both with ROC AUC > 0.800). Again, RVSWI <5 was associated with low RVD (19% vs 41%, p = 0.02). In the 14 biopsies performed in HTx patients, 4 were noted with >= 2R acute cellular rejection and all 4 of these had an RAP >=8mmHg, Dmax >1cm and RVD <20% (p<0.01). <h3>Conclusion</h3> Less dynamic IJV diameter variation on POCUS correlates with poor RV function and may be an early indicator of rejection in HTx patients. This assessment can be easily done at bedside regardless of body habitus, with great specificity and can be helpful in the diagnostic management of these patients.

ELSO Interim Guidelines for Venoarterial Extracorporeal Membrane Oxygenation in Adult Cardiac Patients.

ELSO Interim Guidelines for Venoarterial Extracorporeal Membrane Oxygenation in Adult Cardiac Patients.

Dry Field Closure of Large-Bore Access With Iliac Artery Angioplasty Through the Ipsilateral Sheath: The Single-Access Dry-Closure Technique.

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Meanwhile, the interventional community has gradually shifted from an open surgical to endovascular closure. However, vascular access complications and bleeding still remain a significant risk. Various techniques involving an additional access site have been described to allow for endovascular bailout of potential complications. However, these by themselves create an additional burden to procedural morbidity. Furthermore, the weight of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the "second arterial access" strategy. For that reason, we propose an alternative strategy, the "single-access dry-closure" technique, which provides vascular access control without the additional burden and risk of a second arterial access. This involves the use of low-pressure iliac artery occlusive angioplasty, delivered through the ipsilateral sheath during the endovascular closure. We hereby describe the steps, advantages and disadvantages of this novel technique. We also include the description of multiple technical variations depending on the use of one or two preclosed Proglide devices. This novel approach seems to be a safe, effective, simple, fast and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. It also lowers contrast volume and radiation exposure while improving the overall set-up and operator ergonomics.

Short-term use of \u201cECMELLA\u201d in the context of fulminant eosinophilic myocarditis with cardiogenic shock

BackgroundEosinophilic myocarditis (EM) is a rare form of myocarditis. Clinical presentation is various, includes cardiogenic shock and can often be fatal. Diagnosis is based on myocardial eosinophilic infiltration in endomyocardial biopsy. Mechanical circulatory support (MCS) is often required in patients suffering from severe cardiogenic shock. Among the available MCS options the “ECMELLA” concept, a combination of left ventricular venting by Impella® device and extracorporeal life support (ECLS) is possibly able to provide the necessary time frame for diagnostics and initiation of anti-inflammatory medication in patients with fulminant myocarditis.Case presentationWe report a case of a 38‐year‐old woman who was presented to us in severe cardiogenic shock, quickly requiring hemodynamic support by an Impella CP® device. Further dramatic hemodynamic deterioration accompanied by multi-organ dysfunction required escalation of MCS via ECLS as veno‐arterial extracorporeal membrane oxygenation (VA-ECMO). After histopathological diagnosis of EM, our patient was put on immunosuppressive therapy with prednisolone. Recovery of both right and left ventricular function allowed explanation of VA-ECMO on day 4 and further hemodynamic improvement allowed removal of the Impella® device on day 9. The patient was discharged after 7 weeks with fully restored cardiac function and in a good neurological state.ConclusionsIn severe cardiac shock due to fulminant EM the ECMELLA concept as bridge-to-recovery seems to be a valid option to provide the required time for diagnostics and specific therapy.

Currently Available Options for Mechanical Circulatory Support for the Management of Cardiogenic Shock.

Cardiogenic shock (CS) is a complex condition with a high risk for morbidity and mortality. Mechanical circulatory support (MCS) devices were developed to support patients with CS in cases refractory to treatment with vasoactive medications. Current devices include intra-aortic balloon pumps, intravascular microaxial pumps, percutaneous LVAD, percutaneous RVAD, and VA ECMO. Data from limited observational studies and clinical trials show a clear difference in the level of hemodynamic support offered by each device. However, at this point, there are insufficient clinical trial data to guide MCS selection and, until ongoing clinical trials are completed, use of the right device for the right patient depends largely on clinical judgment.

Right Heart Failure After Left Ventricular Assist Device Placement: Medical and Surgical Management Considerations.

Durable left ventricular assist device therapy is an increasingly accepted surgical therapy for advanced heart failure refractory to guideline-directed medical therapy. Right heart failure is a known and frequent complication after durable left ventricular assist device implantation and remains an important clinical challenge. Medical management of right heart failure after left ventricular assist device therapy focuses on improving right ventricular contractility and optimizing right ventricular preload and afterload. Mechanical circulatory support options include surgical and percutaneous devices options as well as the total artificial heart or heart transplantation. Early institution of therapy is necessary to reduce the morbidity and mortality.

Patient size parameters to guide use of the Impella device in pediatric patients.

To define patient and ventricular size parameters to guide Impella device (Abiomed, Inc., Danvers, MA) placement for mechanical circulatory support (MCS) in small pediatric patients (10-30 kg). There are few options for MCS in children, and there are no data on minimum patient size requirements for placement of the Impella 2.5 device. This was a multicenter study of echocardiographic and magnetic resonance imaging (MRI) derived dimensions of the left ventricle (LV) length and ascending aorta used to define minimum size parameters that are necessary for the placement of the Impella catheter. Data were collected from 44 cardiac MRIs conducted in healthy pediatric patients and 39 echocardiograms performed in pediatric patients with cardiomyopathy prior to surgical ventricular assist device (VAD) placement. The Impella 2.5 catheter is 7.5 cm from the pigtail to the aortic annulus marker, thus requiring an LV apical length of 7.5 cm to allow the device to function in an unconstrained fashion. In the cohort of patients undergoing consideration for VAD placement, a minimum LV length of 7.5 cm corresponded to a height of 122 cm, weight of 23 kg, and body surface area (BSA) of 0.89 m2 . In the MRI cohort, this corresponded to a height of 121 cm, weight of 23.9 kg, and BSA of 0.89 m2 . MCS with Impella devices is feasible in pediatric patients. This study defines anthropomorphic and anatomic measurements to guide providers in patient selection for MCS using the Impella devices.

SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019.

The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It is clear that there are varying degrees of cardiogenic shock but there is no robust classification scheme to categorize this disease state. A multidisciplinary group of experts convened by the Society for Cardiovascular Angiography and Interventions was assembled to derive a proposed classification schema for cardiogenic shock. Representatives from cardiology (interventional, advanced heart failure, noninvasive), emergency medicine, critical care, and cardiac nursing all collaborated to develop the proposed schema. A system describing stages of cardiogenic shock from A to E was developed. Stage A is "at risk" for cardiogenic shock, stage B is "beginning" shock, stage C is "classic" cardiogenic shock, stage D is "deteriorating", and E is "extremis". The difference between stages B and C is the presence of hypoperfusion which is present in stages C and higher. Stage D implies that the initial set of interventions chosen have not restored stability and adequate perfusion despite at least 30 minutes of observation and stage E is the patient in extremis, highly unstable, often with cardiovascular collapse. This proposed classification system is simple, clinically applicable across the care spectrum from pre-hospital providers to intensive care staff but will require future validation studies to assess its utility and potential prognostic implications.

Cardiac Support Devices

Mechanical circulatory support (MCS) involves the use of intra-aortic balloon pump (IABP), short-term percutaneous ventricular assist devices, long-term surgically implanted continuous-flow ventricular assist devices (cf-LVADs), and extracorporeal membrane oxygenation (ECMO) for the treatment of acute and chronic heart failure and cardiogenic shock. IABP is increasingly recognized as an important adjunct in the postoperative treatment arsenal for those patients with severely reduced left ventricular systolic function. Short-term percutaneous options for the treatment of acute right and left heart failure include both the Impella and Tandem Heart, whereas the Centrimag is often used in the surgical setting for acute cardiogenic shock and heart failure. Long-term surgical MCS options include the total artificial heart and the cf-LVADs HeartWare and Heartmate II. ECMO is frequently used for the treatment of acute cardiogenic shock and may be placed peripherally via a percutaneous approach or with central cannulation. ECMO is also increasingly used in the setting of acute cardiac life support, known as extracorporeal life support. Key words: cardiac critical care, extracorporeal membrane oxygenation, long-term ventricular assist device, mechanical circulatory support, short-term ventricular assist device

Cardiogenic Shock and Short-Term Mechanical Circulatory Support Options in the Current Era: Focus on Adverse Events

Background In the absence of robust evidence from randomized controlled trials, clinicians treating cardiogenic shock (CS) often make decisions on short-term Mechanical Circulatory Support (s-t MCS) based on individual center or clinical team preferences. We sought to investigate whether description of device-related adverse events (AE) could help identify targets to advance the field. Methods Our institution's CS database was queried for CS patients who underwent placement of s-t MCS based on predefined criteria, between Jan 2014 - Mar 2017. Patients who needed Intra-Aortic Balloon Pump, central cannulation or had a post-cardiotomy CS were excluded from the analysis. We identified 61 who required s-t MCS with Impella, peripheral Veno-Arterial Extra-Corporeal Membrane Oxygenation (VA-ECMO) or combination of these devices as a sequela of escalating support strategy. Results Of the total patients, 23 (37.7%) were treated with Impella, 10 (16.4%) with VA-ECMO and the remaining 28 (45.9%) with combinations of devices. Groups were of similar demographics and CS etiology. Severity of CS pre-MCS revealed no differences in vital signs, number of vasoactive agents used, left ventricular ejection fraction, use of mechanical ventilation and CPR. The VA-ECMO compared with Impella and Combination groups had higher baseline lactate (11.1 vs 4.9 vs 5.3; p=0.002) and lower baseline pH (7.05 vs 7.27 vs 7.27; p=0.004) pre-MCS. The mean length of support was similar between Impella and VA-ECMO groups, however it was longer in the Combination vs Impella group (p=0.001). Major AE are shown in the Table . The mean ICU stay was 15 days and did not differ among the groups. Exchange to durable LVAD was performed in 6 patients: 3/23 (Impella) and 3/28 (Combination) group. The overall survival to hospital discharge was 43% and did not differ between the groups (p=0.2). Conclusions Despite significant advances in the technology of s-t MCS options, morbidity and mortality remain high and the device-related AE could provide practical quality improvement targets for CS programs.

Cardiogenic Shock: Recent Developments and Significant Knowledge Gaps.

Patients with cardiogenic shock (CS) continue to have high rates of morbidity and mortality. We aimed to describe current principles in the management of CS including coronary revascularization, medical management, mechanical circulatory support, and supportive care. Revascularization is still recommended, but trials have not found a benefit in the revascularization of nonculprit artery lesions. New mechanical circulatory support options are available, but optimal use remains uncertain. Overall improvement in outcomes appears to have plateaued. There remain substantial knowledge gaps about the management of CS. The ideal timing and selection criteria for mechanical support remain under-developed. There has been little systematic study to inform medical management or supportive care of this patient population. A more expansive research focus is necessary to improve the care of CS.