Mechanical Circulatory Assist Devices Research Articles

The utilization and mortality benefits of pulmonary artery catheterization in patients with cardiogenic shock

Abstract Introduction Pulmonary artery catheterization (PAC) can provide essential hemodynamic data to assist in managing critical patients with cardiogenic shock. The use of PAC has been controversial as clinical studies have shown a lack of benefit. However, with the recent widespread availability of mechanical circulatory assists devices, the application and benefits of PAC are expected to rise. Purpose To determine the impact of PAC on inpatient outcomes and the utilization of advanced heart failure devices in these patients. Methods The National Inpatient Sample from 2016 to 2018 was queried to identify patients with cardiogenic shock. Of these patients, we compared those who received invasive hemodynamic monitoring (IHM) with PAC to those who did not receive PAC. Patients under age 18 and those undergoing surgical or transcatheter cardiac procedures during the same admission were excluded. Multivariate logistic regression was used to select matched samples between groups accounting for patient/hospital demographics and medical comorbidities. The primary endpoint was a comparison of in-hospital mortality, length of hospitalization, and medical costs. The secondary endpoints compared the utilization of mechanical circulatory assists devices: percutaneous ventricular assist devices (pVAD), extracorporeal membrane oxygenation (ECMO), and left ventricular assist device (LVAD), and the incidence of post-PAC complications: pneumothorax, sepsis, and hemorrhage/hematoma. Results We identified a total of 279,619 patients admitted with cardiogenic shock, of these patients 25,166 (9%) received IHM with PAC. Patients who had PAC had decreased in-hospital mortality (22.3% vs 29.7%; p<0.001), increased length of hospitalization (12 days vs 9 days; p<0.001), and increased medical costs ($65,884 vs $47,983; p<0.001). Furthermore, in patients with PAC there was increased utilization of pVAD (4.5% vs 1.9%; p<0.001), ECMO (0.07% vs 0.01%; p<0.001), and LVAD (2.2% vs 0.3%; p<0.001). There was no difference in the prevalence of post-PAC complications between both groups. Conclusions The use of IHM with PAC was associated with improved mortality and utilization of mechanical circulatory assist devices in patients with cardiogenic shock without increasing risk for post-procedural complications. Therefore, the increased average duration and medical costs of hospitalization with PAC patients likely resulted from improved patient survival. Therefore, the present study indicated that IHM with PAC is safe and beneficial for patients with cardiogenic shock. Funding Acknowledgement Type of funding sources: None.

B-6 | Association between Mechanical Circulatory Device Use and In-Hospital Mortality in Admissions with Ventricular Tachycardia/Fibrillation and Non-Ventricular Tachycardia/Fibrillation Cardiac Arrest

Randomized clinical trials have not shown a mortality benefit with mechanical circulatory assist device (MCD) use in cardiogenic shock, however there is little data on MCD use in cardiac arrest. The purpose of this retrospective study is to identify if the use of MCD is associated with a lower in-hospital mortality in admissions with ventricular tachycardia/fibrillation (VT/VF) and non-VT/VF cardiac arrest.

E-20 | Trends in the Utilization of Mechanical Circulatory Devices in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention. 2016-2018

Short-term mechanical circulatory assist devices (MCDs) can provide hemodynamic support during high-risk percutaneous coronary intervention for chronic total occlusion (CTO-PCI). The aim of this study is to compare the utilization trends of Impella, IABP and ECMO in patients undergoing CTO-PCI.

The Use of Mechanical Circulatory Assist Devices for ACS Patients with Cardiogenic Shock and High-Risk PCI.

There has been a significant expansion of the use of mechanical circulatory support (MCS) devices for patient with acute coronary syndromes (ACS) with cardiogenic shock (CS) and in patients undergoing high-risk percutaneous interventions (PCI). The purpose of this review is to provide an overview of the indications and outcomes of these devices in high-risk cardiac patients. Early revascularization of the culprit-lesion is the immediate goal in ACS patients with CS and the use of pulmonary artery catheters has been associated with improved outcomes in patients with cardiogenic shock. The MCS devices that are used for myocardial support include the intra-aortic balloon pump (IABP), the left ventricle (LV) to aorta pumps, left atrium (LA) to arterial pumps, and right atrial (RA) to arterial pumps. This review provides an overview on the use of these devices in patients with ACS and CS and those undergoing high-risk PCI. Attention is focused on the IABP, the Impella (LV-aorta pump), the TandemHeart (LA-arterial pump), and veno-arterial extracorporeal membrane oxygenation (RA-arterial pump). The indications, evidence, and complications of each device are reviewed. Each device varies in its physiological effect on native heart function, complexity in insertion, and complications. The use of MCS devices for high-risk PCI and CS has increased in recent years and have demonstrated efficacy in supporting a vulnerable myocardium. Although recommendations can be made for use of each device in certain clinical scenarios, further evidence through registries and clinical trials is necessary to guide appropriate device utilization.

Mechanical Circulatory Assist Devices: Which Is the Best Device as Bridge to Heart Transplantation?

Heart transplantation is the recommended treatment method for patients with advanced heart failure that is refractory to clinical treatment. Due to the progressive severity of these patients and the impossibility of performing the transplant in a short term, there are mechanical circulatory assist devices that can offer necessary hemodynamic support and clinical stability in the period preceding the heart transplant surgery. The present study aims to address and describe the main devices used as bridges for heart transplantation, as well as to analyze their advantages and disadvantages. This work is a literature review, developed with scientific production in the period from 2010 to 2020, that focus on circulatory assist devices as a bridge for heart transplantation. These devices are characterized as a bridge for transplantation. Short-term or temporary devices are those used for hemodynamic support to stabilize the individual clinically in the presence of refractory cardiogenic shock. And long-term devices are indicated for stable patients with long-term strategic planning. According to the present study, it is possible to observe that there is a wide variety of devices available on the market, enabling the most appropriate choice according to the patient's need.

Mechanical Circulatory Assist Devices: Available Modalities and Review of Literature.

Despite advancements in the field interventional cardiology, the prognosis in patients who suffer from cardiogenic shock is poor. Over the years, the use of percutaneous mechanical circulatory support (MCS) devices has increased with the aim to improve short- and long-term outcomes. In this article, we aim to review the different modalities available for MCS devices and current literature comparing their uses.

P1710Risk of Mortality associated with use of mechanical support devices among comatose cardiac arrest patients

Abstract Background The impact of mechanical circulatory assist devices (MCS) has not been well studied in cardiac arrest survivors. We examined that association of MCS with risk of mortality among comatose cardiac arrest survivors Purpose Compare the survival between different MCS and non MCS groups Methods This is a retrospective cohort study of 1417 comatose adult cardiac arrest survivors that survived for at least 1 day post cardiopulmonary resuscitation. Cox proportional hazard models adjusted for demographics, resuscitation parameters, comorbidities and medications were used to compute hazard ratios for extracorporeal membrane oxygenation (ECMO), ECMO + Impella/intraaortic balloon pump (IABP), IABP and Impella associated with risk of short term 60 day mortality. Kaplan meier's curves were used to demonstrate cumulative survival rate. Results Among 1417 cardiac arrest survivors, MCS was used among 553 (39.1%) patients. After 60 days of follow up, mortality rate was 49.4% in non MCS group, 58.6% in IABP group, 22.9% in Impella group, 40.0% in ECMO only group, 50.0% in ECMO + Impella/IABP group. When compared with no MCS use, only Impella use was associated with decrease risk of short term mortality (HR 0.37; 95% CI 0.16–0.83, p=0.02) while there was no significant association of other forms of MCS with short term mortality. There was no significant association of any MCS with long term mortality. Kaplan-Meier curves demonstrate early benefit of Impella and very early benefit of ECMO (figure 1). Conclusions This is the first large study to report various types of MCS use among comatose cardiac arrest survivors and has shown an indication of benefit with Impella use only in first 60 days post cardiac arrest. Future prospective study may be needed to validate this association Acknowledgement/Funding None

Does the heart transplant have a future?

Summary Heart failure has remained the leading cause of death globally for the last 15 years—and its prevalence will continue to rise. Fifty years ago, heart failure management was enriched by the possibility of a heart transplant. Despite impressive improvements in medical treatment for heart failure, a heart transplant remains the most effective long-lasting treatment for advanced heart failure in terms of mortality and quality of life. However, donor and recipient characteristics have changed dramatically in recent years, leading to more complex decision-making regarding organ acceptance and to more demanding operations and postoperative management. With improving pathophysiological understanding in the last decades, today’s scientific interest still focuses on basic knowledge. How to retrieve and conserve organs to minimize ischaemic injury; how best to allocate them, considering the likelihood of success (developing a heart-allocation scoring system similar to that for lung allocation); how to match donor/recipient characteristics (ABO blood-group antigen compatibility versus incompatibility); and how to avoid graft failure, rejection and secondary morbidities such as malignomas and cardiac allograft vasculopathy after the heart transplant—all these factors remain fundamental challenges in today’s transplant medicine. The use of ex vivo perfusion (e.g. via the Organ Care System®, TransMedics, Andover, MA, USA) may play an important role in this change. Remarkably, there are huge regional divergences in current transplant practices: Whereas the number of transplants continues to rise in most Eurotransplant countries and other major transplant networks, there are some countries in which transplant numbers are static or even dropping (as in Germany). This difference results in wide variations across different countries as to how advanced heart failure is treated using mechanical circulatory-assist devices.

TCT-488 Risk of Mortality associated with use of mechanical support devices among comatose cardiac arrest patients

The impact of mechanical circulatory assist devices (MCS) has not been well studied in cardiac arrest survivors. We examined the association of MCS with risk of mortality among comatose arrest survivors. This is a retrospective cohort study of 1417 comatose adult cardiac arrest survivors that

Dispositivos de asistencia mecánica circulatoria

Un dispositivo de asistencia mecánica circulatoria o AMC, es una bomba con capacidad de dar soporte mecánico a un corazón en fallo cardiaco, facilitando el bombeo de la sangre desde las cavidades cardiacas hacia la circulación sistémica. Consideramos asistencia circulatoria a cualquier dispositivo o sistema utilizado para apoyar o sustituir la función cardiaca de forma temporal o, más raramente, permanente. Por norma general nos referimos a las asistencias ventriculares mecánicas y al corazón artificial total. ABSTRACT A mechanical circulatory assist devices (MCADs) , is a pump capable of giving mechanical support to a heart in heart failure, facilitating the pumping of blood from the cardiac cavities to the systemic circulation. We consider circulatory assistance to any device or system used to support or replace cardiac function temporarily or, more rarely, permanently. As a general rule, we refer to mechanical ventricular assist and total artificial heart.

Management of Patients on Mechanical Circulatory Assist Devices During Noncardiac Surgery.

Department of Anesthesiology, Perioperative and Pain Medicine, Division of Cardiothoracic Anesthesiology, Stanford Hospital & Clinics, Stanford, California The authors declare that they have nothing to disclose. Address Correspondence to: Vidya K. Rao, MD, MBA, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Cardiothoracic Anesthesiology, Stanford Hospital & Clinics, Stanford, CA 94305. E-mail: [email protected]

Калькулятор «Доступный прогноз» – способ качественной оценки выживаемости пациентов c сердечной недостаточностью с низкой фракцией выброса левого желудочка

A method for predicting one-year survival of patients with heart failure and reduced ejection fraction (HFrEF) is required to choose a management tactics and determine indications for high-tech care at the outpatient stage. To develop a method for proper prediction of survival of patients with HFrEF in outpatient clinics. This was a prospective study of 212 patients with functional class II-IV CHF of non-valvular origin and LV EF (Simpson) ≤35 % aged 18-70, including 176 (83 %) men and 36 (17 %) women who had given an informed consent to participate in the study. hospitalization to a specialized department for treatment of heart failure; best titration of tolerated doses and stabilization of the patient's condition; evaluation of status; laboratory and instrumental tests; outpatient follow-up by an HF specialist (visits, telephone contacts, therapy adjustment, and admission to a specialized HF department in case of decompensation); 200‑item database population; recording the composite endpoint (cardiovascular death, or implantation of a mechanical circulatory assist (MCA) device, or heart transplantation (HT) within 12 months). For 12 months, 135 (64 %) patients survived; a MCA device was implanted to 5 (2 %) patients; HT was performed for 21 (10 %) patients; and a fatal outcome was observed in 51 (24 %) patients. Therefore, 77 patients had the composite endpoint. A method for predicting survival was developed using a multiple logistic regression analysis. The developed proper method for survival prediction included the following parameters: age of HFrEF onset; frequency of respiratory movements; systolic blood pressure measured at 3-5 min of orthostasis; lymphocyte count, and red cell distribution width. An identified patient with a predicted survival less than one year should be as soon as possible forwarded to a selection panel for considering HT or MCA implantation as a «bridge» to HT. A predicted survival longer than one year is an indication for further outpatient management and considering cardioverter defibrillator implantation. The method for proper outpatient evaluation of survival prognosis for patients with HFrEF allows to predict the one-year survival using routine indexes, such as results of objective examination, case history, and blood count, without additional expenses.

Discussions in Cardiothoracic Treatment and Care: Mechanical Circulatory Support Left Ventricular Assist Device Therapy for Patients With Advanced Heart Failure

Discussions in Cardiothoracic Treatment and Care: Mechanical Circulatory Support Left Ventricular Assist Device Therapy for Patients With Advanced Heart Failure

361 - Effect of Prior Gastric Bypass Surgery on the Dose of Immunosuppression in Heart Transplant Recipients

Purpose: Since the use of Mechanical Circulatory Assist Devices has increased the options such as gastric bypass for the morbidly obese patient with stage D heart failure, there is minimal data available on the effects of gastric bypass surgery and the use of immunosuppression in the heart transplant population. The purpose of this case review is to evaluate the effect of two types of gastric bypass on the dosing of calcineurin inhibitors in the immediate post operative phase of heart transplantation. Methods: This was an observational case series using retrospective chart review of 4 patients within a 2 year time period who had undergone gastric bypass surgery prior to their heart transplant at a single center. The primary end points included: number of days until therapeutic dose of calcineurin inhibitor was achieved, and total daily dose of calcineurin inhibitor at discharge in a mg⋅kg−1 ratio. These findings were compared to other non-gastric bypass patients transplanted during the same period. Results: The time to reach therapeutic levels of tacrolimus (12–15) in the gastric bypass population was 15 days (19.5 for the sleeve gastrectomy and 10 for the Roux-en-Y patients. This compares to 11.4 days in the remaining non-gastric bypass patients during the same 2 year period. The average mg⋅kg−1 dosing in the Roux-en-Y patients was 0.015 mg⋅kg−1 and 0.2 in the sleeve gastrectomy patient, compared with 0.13 in the non-gastric bypass patients. Conclusions: Patients who underwent sleeve gastrectomy showed a trend towards higher dosing requirements of calcineurin inhibitors, specifically tacrolimus, in the immediate post transplant period. It was also noted that as the number of patients increased in whom we treated post transplant that had previously undergone gastric bypass, the uptitration of medications occurred at a more aggressive rate, which decreased the time to reach a therapeutic level.

Asistencia ventricular izquierda para terapia de destino: primera experiencia en septuagenarios

ObjectivesThe number of elderly patients suffering from congestive heart failure has increased dramatically in recent years. In the context of global stagnation of heart transplantation, comes the need for an alternative definitive therapy for these patients. Recently left ventricular assist devices (LVAD) have increased significantly, surpassing even the number of transplants worldwide. The technological development of new devices and the emergence of new surgical techniques arising from minimally invasive cardiac surgery have been part of this development. The purpose of this study was to review the first series of minimally invasive LVAD implants in septuagenarian patients. MethodsA prospective single-centre clinical trial was conducted on all patients greater than or equal to 70 years that required an LVAD implant (HVAD, HeartWare Inc.) as destination therapy for the years 2013 to 2015 in the Medizinische Hochschule Clinic in Hannover. The monitoring ended after two years. All patients were operated by a minimally invasive technique consisting of a “J” mini-sternotomy and a left lateral thoracotomy. ResultsA total of 14 patients were included (age 71.8 ± 1.5 years, all (100%) males, and 64.3% with ischaemic heart disease). It was a second operation for 50% of the cases, and 7.1% received a prior mechanical circulatory assist device (MCAD). All patients were operated on using extracorporeal circulation (ECC) for a mean time of 51 ± 8 min). The mean length of stay in ICU was 6.4 ± 5.2 days. Adverse events during the early post-operative period included, surgical re-intervention due to bleeding (7.1%), right ventricular failure (14.3%), and dialysis (14.3%). Survival rates were: 30 days: 85.7% 1 year: 78.6% 2 years: 70.7%. ConclusionsThe initial results show that minimally invasive implantation of LVAD can be performed effectively, safely, and with good results in septuagenarian patients as destination therapy. There were low levels of adverse events during a two year follow-up, showing that destination therapy can be performed even in patients in their seventies.

Safety and Feasibility of Laparoscopic Abdominal Surgery in Patients With Mechanical Circulatory Assist Devices.

Objectives Increasing number of mechanical circulatory assist devices (MCADs) are being placed in heart failure patients. Morbidity from device placement is high and the outcome of patients who require noncardiac surgery after, is unclear. As laparoscopic interventions are associated with decreased morbidity, we examined the impact of such procedures in these patients. Methods A retrospective review was conducted on 302 patients who underwent MCAD placement from 2005 to 2012. All laparoscopic abdominal surgeries were included and impact on postoperative morbidity and mortality studied. Results Ten out of 16 procedures were laparoscopic with 1 conversion to open. Seven patients had a HeartMate II, 2 had Total Artificial Hearts, and 1 had CentriMag. Four patients had devices for ischemic cardiomyopathy and 6 cases were emergent. Surgeries included 6 laparoscopic cholecystectomies, 2 exploratory laparoscopies, 1 laparoscopic colostomy takedown, and 1 laparoscopic ventral hernia repair with mesh. Median age of the patients was 63 years (range, 29-79 years). Median operative time was 123 minutes (range, 30-380 minutes). Five of 10 patients were on preoperative anticoagulation with average intraoperative blood loss of 150 mL (range, 20-700 mL). There were 3 postoperative complications; acute respiratory failure, acute kidney injury and multisystem organ failure resulting in death not related to the surgical procedure. Conclusion The need for noncardiac surgery in post-MCAD patients is increasing due to limited donors and due to more durable and longer support from newer generation assist devices. While surgery should be approached with caution in this high-risk group, laparoscopic surgery appears to be a safe and successful treatment option.

Abstract 19816: Recipient Body Mass Index and Role of Continuous Flow Mechanical Circulatory Assist Device in Patients Undergoing Heart Transplantation

Introduction: Extremes of body mass indices (BMI) at the time of heart transplantation (HT) have been associated with adverse post-transplant survival. Data is limited in evaluating the survival impact of continuous flow left mechanical circulatory support (CF-LMCS) devices across categories of BMI. Method: We performed post-hoc analysis of 17,480 patients (age: 53±12 years, 74.5% males, 4.1 years of median follow-up) undergoing HT from the United Network of Organ Sharing (UNOS) registry database. Patients were divided into following BMI categories: underweight (BMI <18.5 kg/m2), normal (BMI 18.5 to 24.9 kg/m2), overweight (BMI 25 to 29.9 kg/m2), mildly obese (BMI 30 to 34.9 kg/m2) and morbidly obese (BMI ≥35 kg/m2); Post-transplant survival was assessed for patients with and without CF-LMCS devices across these categories of BMI using Cox-proportional hazard analysis. Results: See Figure 1 and 2 Conclusion: At extremes of BMI, CF-LMCS devices had statistically non-significant association with post-HT survival. For those with BMI between 18.5 to 35 kg/m2, CF-LMCS devices offered survival advantage, suggesting that optimizing recipients' BMI within this range prior to undergoing HT may help improving their post-transplant survival.

Abstract 13861: Trends in Utilization of Mechanical Circulatory Assist Devices in Patients Presenting with ST Elevation Myocardial Infarction

Despite significant controversy about the efficacy, mechanical circulatory support (MCS) is often utilized in patients with cardiogenic shock after ST elevation myocardial infarction (STEMI). We aimed to characterize the trends and outcomes following the use of MCS devices in patients presenting with STEMI. Methods: We used the 2003-2011 US Nationwide Inpatient Sample for this study. All admissions with a principal diagnosis of STEMI were identified using standard ICD codes. MCS devices included intra aortic balloon pump or Impella and were identified using ICD procedure codes. Results: Of a total of 372984 admissions with STEMI, we identified 35685 (9.3%) cases that required MCS. Over the study duration, there was a significant increase in the utilization of MCS from 7.6% in 2003 to 10.5% in 2011 (Panel A). This increase in the use of MCS was accompanied by a significant increase in the incidence of cardiogenic shock in the study population (Panel A). Despite an increase in the overall cardiogenic shock incidence, there was a significant increase in the relative utilization of MCS in cardiogenic shock (Panel B) during the study duration. Of all the cardiogenic shock cases, utilization of MCS increased from 48.6% in 2003 to 57.4% in 2009, followed by a small decline to 54.7% in 2011. Among patients with cardiogenic shock, in-hospital mortality rate was 31.5% in patients with MCS as compared to 42.4% in those treated without MCS (p<0.001). Using multivariable hierarchical regression modeling, we found a significant reduction in adjusted in-hospital mortality with MCS, among patients with cardiogenic shock [OR (95% CI): 0.82 (0.77-0.88), p<0.001]. Conclusions: Over the last decade, there has been a significant increase in the utilization of MCS in patients with STEMI. In contrast to the results of the IABP trial, the use of MCS was associated with a significant reduction in in-hospital mortality in this real world nationwide experience.

Pearls and Pitfalls in Short‐Term Mechanical Circulatory Assist: How to Avoid and Manage Complications

In today's era, given the worsening risk profiles of patients undergoing cardiac surgery, the increasing number of complex cardiac surgeries, and the increasing number of patients undergoing thoracic organ transplantation, short-term mechanical circulatory assist (MCA) devices are indispensable. MCA devices are capable of supporting heart and lung function and have emerged as potentially lifesaving instruments, but may prove to be as hazardous as helpful due to their inherent tendency toward hemolysis, thromboembolism, and hemorrhage. Although MCA devices are being used regularly at some specialized centers, surgeries involving MCA are not as common as other routine cardiac surgeries, and even though professionals implanting and maintaining short-term MCAs are well acquainted with operating such devices, it is not uncommon to come across complications as a result of minor mistakes committed while dealing with them. Avoiding simple mistakes and taking proper precautions while implanting and maintaining these devices can prevent major catastrophes. We discuss commonly encountered problems and complications during the implantation and maintenance of short-term MCAs and offer reasonable and practical solutions. In addition, crucial issues such as anticoagulation, replacement of the device circuit, and management of the distal perfusion cannula are discussed. Continuous and efficient monitoring of the MCA device and the patient supported on MCA, together with anticipation and avoidance of complications, is key for successful short-term MCA support.

Right Ventricular Dysfunction: Lessons Learned From Mechanical Circulatory Assist Devices

Congestive heart failure represents a disease process of epidemic proportions in the United States, with 900,000 annual hospitalizations for New York Heart Association class III to IV symptoms. The inexorable deterioration of this group of patients has, until recently, been delayed by pharmacotherapy and by the use of automated implantable cardioverter defibrillators and cardiac resynchronization therapy. The authors propose that a major component of the downhill course of New York Heart Association class IV left heart failure is secondary to right heart failure and present the major predictors of right ventricular dysfunction. This, together with the limited availability of heart transplant donors, has led to the development of the left ventricular assist devices and the total artificial heart. Contrasting and comparing these devices have permitted insight into the importance of right ventricular function in the pathophysiology of heart failure, especially in the decision to proceed with left ventricular assist device placement, which is limited by right heart dysfunction or biventricular replacement with the total artificial heart.