Evaluating the efficacy and safety of temporary mechanical circulatory support devices in acute cardiogenic shock: A subgroup-specific systematic review.

OBJECTIVE: This systematic review aims to assess the comparative effectiveness and safety of temporary mechanical circulatory support (MCS) devices in various subgroups of patients with acute cardiogenic shock, providing insights for personalized clinical decision-making. METHODS: We conducted a comprehensive search across major databases to identify studies that reported on the use of temporary MCS devices like TandemHeart, Impella, and VA-ECMO in acute cardiogenic shock. Special attention was given to subgroup analyses based on etiologies of shock, patient demographics, and comorbid conditions. RESULTS: Our analysis revealed that while devices like TandemHeart and Impella offer significant hemodynamic support, their effectiveness and safety profiles vary across different patient subgroups. VA-ECMO demonstrated the highest flow rates and potential for mortality benefits but requires careful management due to associated risks. The lack of randomized controlled trials in specific patient subgroups highlights a gap in the current literature, underscoring the need for targeted research. CONCLUSION: The review underscores the necessity of a personalized approach in selecting temporary MCS devices for patients with acute cardiogenic shock, guided by specific patient characteristics and clinical scenarios. Future research should focus on addressing the identified evidence gaps through well-designed studies that provide robust subgroup-specific data, enabling clinicians to optimize treatment strategies and improve patient outcomes in this critical care context.

Transvenous Lead Extraction in the Left Ventricular Assist Device Patient.

The population of patients with advanced heart failure continues to increase steadily as does the need for mechanical circulatory support. Combination therapy with left ventricular assist devices (LVADs) and cardiovascular implantable electronic devices (CIEDs) is unavoidable. CIED complications in patients with LVADs are common and often necessitate device system revision and transvenous lead extraction. Despite this, management recommendations are limited, and guidelines are lacking.

Thromboembolic complications following implantation of durable left-ventricular assist devices.

INTRODUCTION: As the utilization of left-ventricular assist devices (LVADs) continues to rise and patients experience extended survival duration with these devices, the overall incidence of adverse events and complications has shown a notable increase. Among the major adverse events, thromboembolic complications are particularly significant. The aim of this study is to present our experience and assess the risk of thromboembolic complications after implantation of durable continuous-flow left-ventricular assist devices (CF-LVAD) in patients with end-stage heart failure. PATIENTS AND METHODS: From 2007 to 2022, 169 left ventricular continuous-flow durable mechanical assist devices were implanted at our institute. Three types of devices were employed: HeartMate II (n = 54, 32%), HeartMate 3 (n = 70, 41.4%), and Heart Ware (n = 45, 26.6%). The data were extracted from the EUROMACS register. RESULTS: Thromboembolic complication, pump thrombosis was observed in 11/169 patients (6.5%), with 2 patients experiencing stroke after embolism to the central nervous system. Among these cases, 10 patients (90.9%) were equipped with the Heart Ware device while 1 patient (9.1%) had the Heart Mate II device implanted. Nine patients received the durable device as a bridge to transplant therapy and two as a bridge to candidacy. The overall mean age of the patients was 47.6±10.2 years, with 2 women and 10 men. The pump thrombosis was managed through thrombolytic therapy, high-intensity heparin anticoagulation protocol, pump exchange, pump explantation, and early heart transplant. The combined hospital and long-term mortality rate was 4/11 patients (36.4%). CONCLUSION: Based on our experience, thromboembolic complications presenting primarily as pump thromboses, were a relatively common phenomenon experienced in association with the second-generation continuous-flow devices, but rarely seen with the third-generation devices. Thrombolysis followed by early heart transplantation proved to be a safe treatment option (Tab. 1, Ref. 14). Text in PDF www.elis.sk Keywords: durable mechanical assist device, durable left ventricular assist devices, outcomes, thromboembolic complications.

Atrial fibrillation increases thrombogenicity of LVAD therapy.

BACKGROUND: This study investigates the hypothesis that presence of atrial fibrillation (AF) in LVAD patients increases thrombogenicity in the left ventricle (LV) and exacerbates stroke risk. METHODS: Using an anatomical LV model implanted with an LVAD inflow cannula, we analyze thrombogenic risk and blood flow patterns in either AF or sinus rhythm (SR) using unsteady computational fluid dynamics (CFD). To analyze platelet activation and thrombogenesis in the LV, hundreds of thousands of platelets are individually tracked to quantify platelet residence time (RT) and shear stress accumulation history (SH). RESULTS: The irregular and chaotic mitral inflow associated with AF results in markedly different intraventricular flow patterns, with profoundly negative impact on blood flow-induced stimuli experienced by platelets as they traverse the LV. Twice as many platelets accumulated very high SH in the LVAD + AF case, resulting in a 36% increase in thrombogenic potential score, relative to the LVAD + SR case. CONCLUSIONS: This supports the hypothesis that AF results in unfavorable blood flow patterns in the LV adding to an increased stroke risk for LVAD + AF patients. Quantification of thrombogenic risk associated with AF for LVAD patients may help guide clinical decision-making on interventions to mitigate the increased risk of thromboembolic events.

Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock.

BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear. METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09). CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

Outcomes of outflow graft stenting in HeartMate 3 left ventricular assist devices: A systematic review and individual patient data meta-analysis.

PURPOSE: LVAD outflow graft stenosis continues to remain prevalent with a high complication rate. We sought to pool the existing evidence on indications, utilization patterns, and outcomes of transcatheter interventions for outflow graft stenosis in the HeartMate 3 LVAD. METHODS: An electronic search was performed to identify all studies in the English literature reporting on HeartMate 3 LVAD outflow graft stenting. Patient-level data were extracted for analysis. RESULTS: Thirteen published reports and one unpublished case comprising a total of 28 patients were included. Median patient age was 68.5 years [Interquartile range: 58, 71] and 25.9% (7/27) were female. Dyspnea [60.7% (17/28)] was the most common presenting symptom. Low flow alarms were present in 60% (15/25) of patients. Findings included external compression [35.7% (10/28)], graft twist [21.4% (6/28)], graft twist and external compression [14.3% (4.28)], intraluminal thrombus [10.7% (3/28)], graft twist and intraluminal thrombus [3.6% (1/28)], and pseudoaneurysm of outflow graft [3.6% (1/28)]. Median time from LVAD implantation to stenting was 2.1 years [1.4, 3]. Immediate flow normalization after stenting was observed in 85.7% (24/28). The 30-day mortality was 12% (3/25). Overall mortality was 12% (3/25) at a median follow-up of 3.9 months [1, 17]. CONCLUSION: Outflow graft stenting in the HeartMate 3 LVAD appears to be a reasonable treatment option for outflow graft stenosis, with low overall rates of complications and mortality. Further refinement of indications and approaches may improve outcomes.

Durable left ventricular assist device explantation following recovery in paediatric patients: Determinants and outcome after explantation.

OBJECTIVES: Myocardial recovery in children supported by a durable left ventricular assist device is a rare, but highly desirable outcome because it could potentially eliminate the need for a cardiac transplant and the lifelong need for immunosuppressant therapy and the risk of complications. However, experience with this specific outcome is extremely limited. METHODS: All patients < 19 years old supported by a durable left ventricular assist device from the European Registry for Patients with Mechanical Circulatory Support database were included. Participating centres were approached for additional follow-up data after explantation. Associated factors for explantation due to myocardial recovery were explored using Cox proportional hazard models. RESULTS: The incidence of recovery in children supported by a durable left ventricular assist device was 11.7% (52/445; median duration of support, 122.0 days). Multivariable analyses showed body surface area (hazard ratio 0.229; confidence interval 0.093-0.565; P = 0.001) and a primary diagnosis of myocarditis (hazard ratio 4.597; confidence interval 2.545-8.303; P < 0.001) to be associated with recovery. Left ventricular end-diastolic diameter in children with myocarditis was not associated with recovery. Follow-up after recovery was obtained for 46 patients (88.5%). Sustained myocardial recovery was reported in 33/46 (71.7%) at the end of the follow-up period (28/33; >2 year). Transplants were performed in 6/46 (11.4%) (in 5 after a ventricular assist device was reimplanted). Death occurred in 7/46 (15.2%). CONCLUSIONS: Myocardial recovery occurs in a substantial portion of paediatric patients supported with durable left ventricular assist devices, and sustainable recovery is seen in around three-quarters of them. Even children with severely dilated ventricles due to myocarditis can show recovery. Clinicians should be attentive to (developing) myocardial recovery. These results can be used to develop internationally approved paediatric weaning guidelines.

Plastic Surgery Involvement With Surgical Management of Infected Ventricular Assist Devices Decreased Lifetime Return to Operating Room and 90-Day Infectious Complications.

BACKGROUND: The use of left ventricular assist devices (LVADs) for patients with end-stage cardiac failure awaiting heart transplantation has become increasingly common. However, ventricular assist device-related infections remain a major problem complicating their long-term use. Retrospective review has previously shown a decrease in lifetime return to operating room (RTOR) with no change in 90-day complications when a muscle or omental flap is used for coverage after washout for infection. We wished to determine if early plastic surgery intervention led to a decreased length of stay for these patients. METHODS: Patients with LVAD readmitted for LVAD infection at a single institution from 2008 to 2021 were identified using a preexisting database. Patients were followed retrospectively for an average of 3.2 years. Patient demographics, preoperative diagnosis/disease state, type of ventricular assist device inserted, postoperative day of ventricular assist device infection onset, definitive device coverage, timing of coverage procedure after the initial washout for infection, type of flap used for coverage, 90-day complications after definitive coverage, and lifetime return to operating room for infection were reviewed. Comparison analysis with χ2 and analysis of variance testing was used to analyze outcomes. RESULTS: Of 568 patients admitted with an LVAD infection, 104 underwent operative debridement and closure by plastic and reconstructive surgery (PRS) or cardiothoracic surgery (CTS). Fifty-three underwent PRS closure, and 51 underwent CTS closure. There was an increased incidence of diabetes among the PRS group (P < 0.001); otherwise, there was no difference in baseline characteristics. There was increased RTOR over a lifetime with CTS closure compared with PRS (P = 0.03) and increased 90-day risk of infection (P = 0.007). Patients with PRS closure had an increased risk of postoperative hematoma (P = 046). Plastic and reconstructive surgery was typically consulted on hospital day 10. Both PRS and CTS closure patients were discharged on postoperative day 7, on average (P = 0.542). CONCLUSIONS: Plastic surgery involvement with surgical decision making and closure of infected LVAD devices has a decrease in lifetime RTOR and decreased 90-day complications related to infections. There may be a benefit to earlier PRS consultation for coverage assessment.

Management of incessant ventricular arrhythmias in a patient with left ventricular assist device: a case report.

BACKGROUND: The implantation of left ventricular assist devices (LVADs) as a bridge to transplantation or as destination therapy in end-stage heart failure patients is frequently complicated by the emergence of ventricular arrhythmias (VAs). These arrhythmias have been implicated in precipitating deleterious clinical outcomes, increased mortality rates and augmented healthcare expenditures. CASE PRESENTATION: We present a challenging case of a 49-year-old male with a history of dilated cardiomyopathy who received an LVAD. Post-implantation, the patient suffered from intractable VAs, leading to multiple rehospitalizations and hemodynamic deterioration. Despite exhaustive medical management and electrical cardioversion attempts, the patient's VAs persisted, ultimately necessitating prioritization for cardiac transplantation. DISCUSSION: This case highlights the challenges in managing VAs in LVAD patients and the importance of multidisciplinary collaboration. While pharmacological intervention is the initial strategy, catheter ablation may be considered in selected cases when medication is insufficient. In instances of intractable VAs, expeditious listing for heart transplantation as a high-priority candidate is advisable when feasible.

Evaluation of cardiac arrhythmia in pediatric patients with Left Ventricular Assist Device (L-VAD).

OBJECTIVE: Pediatric heart failure is an important cause of morbidity and mortality in childhood. Left ventricular assist devices (L-VAD) are used for bridging to transplantation in patients with indications for heart transplantation. PATIENTS AND METHODS: The children included in the study were patients who underwent implantation of an L-VAD due to advanced heart failure at Ege University Faculty of Medicine Hospital between January 2009 and January 2023. RESULTS: Of the 33 patients who underwent L-VAD implantation, 16 (48.5%) were female and 17 (51.5%) were male. The median age at surgery was 13 years (IQR, 9.5-15). The median weight was 44 kg (IQR, 25.65-52), the median height was 158 cm (IQR, 134.5-168.5), and the median body surface area was 1.37 m2 (IQR, 0.95-1.51). All patients who underwent L-VAD implantation had an echocardiographic diagnosis of dilated cardiomyopathy. The patients underwent a median of 16 (IQR, 9-21) ECGs, and the median number of 24-hour Holter ECGs obtained was 3 (IQR, 2-5). Arrhythmias that occurred after L-VAD implantation were classified as atrial and ventricular. Ventricular arrhythmia included ventricular tachycardia (VT) lasting for more than 30 seconds (sustained VT), VT lasting for less than 30 seconds (nonsustained VT), and ventricular fibrillation. Atrial arrhythmias included atrial flutter, atrial fibrillation, supraventricular tachycardia, and atrial ectopic tachycardia. During the follow-up, atrial or ventricular arrhythmias were observed in 11 (33%) patients. The most common rhythm disturbances before L-VAD implantation were ventricular arrhythmias, while after the surgery, atrial arrhythmias were found to be the most frequent. A total of 5 patients underwent cardioversion (n=2) or defibrillation (n=3) due to arrhythmia. CONCLUSIONS: In patients undergoing L-VAD implantation, rhythm disorders that could normally lead to hemodynamic instability are frequently encountered. In these rhythm disorders, medical therapy should be attempted before resorting to cardioversion or defibrillation, and subsequently, more aggressive treatment methods should be considered.

The Effects of Exercise on Cardiogenic Shock with an Intra-Aortic Balloon Pump: A Case Report. / Efeitos do Exercício em Choque Cardiogênico e Balão Intra-Aórtico: Um Relato de Caso.

This case report describes the exercise program on a hospitalized 54-year-old male patient with cardiogenic shock waiting for a heart transplant assisted by an intra-aortic balloon pump, a temporary mechanical circulatory support device. The temporary mechanical circulatory support device, an intra-aortic balloon pump, was placed in the left subclavian artery, enabling the exercise protocol. Measurements and values from Swan-Ganz catheter, blood sample, brain natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP), as well as the six-minute walk test (6MWT) and venous oxygen saturation (SvO2) were obtained before and after an exercise protocol. The exercise training protocol involved the use of an unloaded bed cycle ergometer once a day, for a maximum of 30 minutes, to the tolerance limit. No adverse events or events related to the dislocation of the intra-aortic balloon pump were observed during the exercise protocol. The exercise program resulted in higher SvO2 levels, with an increased 6MWT with lower Borg dyspnea scores (312 meters vs. 488 meters and five points vs. three points, respectively). After completing the ten-day exercise protocol, the patient underwent a non-complicated heart transplant surgery and a full recovery in the ICU. This study showed that exercise is a feasible option for patients with cardiogenic shock who are using an intra-aortic balloon pump and that it is well-tolerated with no reported adverse events.

O presente relato de caso descreve o programa de exercícios aplicado a um paciente do sexo masculino, de 54 anos, internado com choque cardiogênico, aguardando transplante cardíaco e assistido por balão intra-aórtico, um dispositivo de suporte circulatório mecânico temporário. O dispositivo de suporte circulatório mecânico temporário, um balão intra-aórtico, foi colocado na artéria subclávia esquerda, possibilitando o protocolo de exercícios. Antes e após um protocolo de exercícios, foram obtidos dados a partir de cateter de Swan-Ganz, amostra de sangue, peptídeo natriurético cerebral (NT-proBNP), proteína C reativa de alta sensibilidade (PCR-as), teste de caminhada de seis minutos (TC6min) e medição da saturação venosa de oxigênio (SvO2). O protocolo de treinamento físico envolveu a utilização de um cicloergômetro adaptado ao leito, sem carga, uma vez ao dia, por no máximo 30 minutos, até o limite da tolerância. Não foram observados eventos adversos tampouco relacionados ao deslocamento do balão intra-aórtico durante o protocolo de exercícios. O programa de exercícios resultou em maior SvO2 com aumento do TC6min e menores escores de dispneia de Borg (312 metros vs. 488 metros e cinco pontos vs. três pontos, respectivamente). Após completar o protocolo de exercícios de dez dias, o paciente foi submetido a uma cirurgia de transplante cardíaco sem complicações e recuperação total na UTI. O presente estudo demonstrou que o exercício é uma opção viável para pacientes com choque cardiogênico em uso de balão intra-aórtico e que é bem tolerado, além de não haver relatos de eventos adversos.

Perioperative interventions for the prevention of surgical wound infection in adult patients undergoing left ventricular assist devices implantation: A scoping review.

BACKGROUND: Surgical wound infection is the most frequent type of care health associated infection. Lack of knowledge about the prevention of surgical wound infection in patients undergoing left ventricular assist device implantation could significantly undermine the potential benefits of surgical intervention. OBJECTIVES: This study aimed to map the recommendations for adult patients undergoing left ventricular assist device implantation. DESIGN: This is a scoping review, being registered in the Open Science Framework under DOI https://doi.org/10.17605/OSF.IO/Q76B3 (https://osf.io/q76b3/). METHOD: Left ventricular assist device coordinators and nurse specialists in dermatology and stomatherapy conducted a scoping review in Scopus, The Cochrane Database of Systematic Reviews, Cumulative Index to Nursing and Allied Health Literature (CINAHL), limited to the period between 2015 and 2022. The results of this scoping review will be discussed and presented in separate articles. This paper will synthesize research evidence on the perioperative topic. RESULTS: The initial searches resulted in 771 studies. Sixty nine met the eligibility criteria and were included in the scoping review. Eight articles addressing the perioperative topic that answered the question of this article were included. CONCLUSION: Although this scoping review included heterogeneous, and scarce studies with left ventricular assist device patients. As such, there are many promising future research directions for this topic. IMPLICATIONS FOR CLINICAL PRACTICE: Infection surveillance should be an integral part of left ventricular assist device implantation programs in health care institutions. Velvet completely buried in subcutaneous tissues reduces transmission system infection. Triple tunnel method reduces transmission system infection risk.

Preliminary report of extracorporeal blood purification therapy in patients receiving LVAD: Cytosorb or Jafron HA330.

BACKGROUND: Left ventricular assist device (LVAD) candidates are at increased risk of immune dysregulation and infectious complications. To attenuate the elevated proinflammatory cytokine levels and associated adverse clinical outcomes, it has been postulated that extracorporeal blood purification could improve the overall survival rate and morbidity of patients undergoing LVAD implantation. METHODS: We retrospectively reviewed prospectively collected data of 15 patients who underwent LVAD implantation at our center between January 2021 and March 2022. Of these, 15 (100%) who received HeartMate 3™ (St. Jude Medical, Abbott, MN, USA) device were eligible. Intraoperatively, patients were single randomized 1:1:1 to three groups: group 1, patients who received Cytosorb therapy (n = 5; installed in the CPB circuit); group 2, patients who received Jafron HA330 (n = 5; installed in the CPB circuit); and control group 3, patients who did not receive filter (n = 5; usual care, neither Cytosorb nor Jafron during CPB). Baseline patient characteristics and intraoperative data were compared between the groups. Blood sample analyses were performed to assess the levels of inflammatory markers (IL-1, 6, 8; CRP, Leukocyte, Lactate, PCT, NT-proBNP, TNF-α) in both preoperative and postoperative data. RESULTS: Baseline patient characteristics were similar in all three groups. We found that IL1α; IL 6; IL8; Lactatedehydrogenase, PCT, pro-BNP, CRP; Leukocyte, and TNFα levels significantly increased with LVAD implantation and that neither Cytosorb nor Jafron influenced this response. In-hospital mortality and overall survival during follow-up were similar among the groups. CONCLUSION: Our preliminary results showed that hemoadsorption therapy using Cytosorb or Jafron hemoadsorption (HA) 330 may not be clinically beneficial for patients with advanced heart failure undergoing LVAD implantation. Large prospective studies are needed to evaluate the potential role of HA therapy in improving outcomes in patients undergoing LVAD implantation.

Special Considerations for Mechanical Circulatory Support or Device Therapy in Adult Congenital Heart Disease Heart Failure.

Heart failure has become the leading cause of mortality in adult congenital heart disease (ACHD) patients after the fifth decade of life. There is scanty evidence supporting the use of guideline-directed medical therapy in ACHD, especially in systemic right ventricle or single ventricle physiology. In complex patients, diagnosing heart failure and timely referral for advanced therapies are challenging. Mechanical circulatory support has been significantly developed over the past decade and has recently emerged as a feasible therapeutic option for these patients. This review summarizes current evidence of mechanical circulatory support in this population, its potential uses, and challenges.

Pseudomonas aeruginosa ventricular assist device infections: findings from ineffective phage therapies in five cases.

Left ventricular assist devices (LVAD) are increasingly used for management of heart failure; infection remains a frequent complication. Phage therapy has been successful in a variety of antibiotic refractory infections and is of interest in treating LVAD infections. We performed a retrospective review of four patients that underwent five separate courses of intravenous (IV) phage therapy with concomitant antibiotic for treatment of endovascular Pseudomonas aeruginosa LVAD infection. We assessed phage susceptibility, bacterial strain sequencing, serum neutralization, biofilm activity, and shelf-life of phage preparations. Five treatments of one to four wild-type virulent phage(s) were administered for 14-51 days after informed consent and regulatory approval. There was no successful outcome. Breakthrough bacteremia occurred in four of five treatments. Two patients died from the underlying infection. We noted a variable decline in phage susceptibility following three of five treatments, four of four tested developed serum neutralization, and prophage presence was confirmed in isolates of two tested patients. Two phage preparations showed an initial titer drop. Phage biofilm activity was confirmed in two. Phage susceptibility alone was not predictive of clinical efficacy in P. aeruginosa endovascular LVAD infection. IV phage was associated with serum neutralization in most cases though lack of clinical effect may be multifactorial including presence of multiple bacterial isolates with varying phage susceptibility, presence of prophages, decline in phage titers, and possible lack of biofilm activity. Breakthrough bacteremia occurred frequently (while the organism remained susceptible to administered phage) and is an important safety consideration.