Mechanical Circulatory Support for High-Risk Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: This review will focus on the indications of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) and then analyze in detail all MCS devices available to the operator, evaluating their mechanisms of action, pros and cons, contraindications, and clinical data supporting their use. RECENT FINDINGS: Over the last decade, the interventional cardiology arena has witnessed an increase in the complexity profile of the patients and lesions treated in the catheterization laboratory. Patients with significant comorbidity burden, left ventricular dysfunction, impaired hemodynamics, and/or complex coronary anatomy often cannot tolerate extensive percutaneous revascularization. Therefore, a variety of MCS devices have been developed and adopted for high-risk PCI. Despite the variety of MCS available to date, a detailed characterization of the patient requiring MCS is still lacking. A precise selection of patients who can benefit from MCS support during high-risk PCI and the choice of the most appropriate MCS device in each case are imperative to provide extensive revascularization and improve patient outcomes. Several new devices are being tested in early feasibility studies and randomized clinical trials and the experience gained in this context will allow us to provide precise answers to these questions in the coming years.

Utilization of TandemHeart in cardiogenic shock: Insights from the THEME registry.

BACKGROUND: TandemHeart has been demonstrated to improve hemodynamic and metabolic complications in cardiogenic shock (CS). Contemporary outcomes have not been reported. OBJECTIVES: To evaluate the outcomes of the TandemHeart (LivaNova) in contemporary real-world use. METHODS: We analyzed baseline characteristics, hemodynamic changes, and outcomes of all patients treated with TandemHeart who were enrolled in the THEME registry, a multicenter, prospective, observational study. RESULTS: Between May 2015 and June 2019, 50 patients underwent implantation of the TandemHeart device. 22% of patients had TandemHeart implanted within 12 h, 32% within 24 h, and 52% within 48 h of CS diagnosis. Cardiac index (CI) was significantly improved 24 h after implantation (median change 1.0, interquartile range (IQR) (0.5-1.4 L/min/m2 ). In survivors, there was a significant improvement in CI (1.0, IQR (0.5-2.25 L/min/m2 ) and lactate clearance -2.3 (-5.0 to -0.7 mmol/L). The 30-day and 180-day survival were 74% (95% confidence interval: 60%-85%) and 66% (95% confidence interval: 51%-79%), respectively. Survival was similarly high in those in whom TandemHeart has been used as a bridge to surgery (85% 180-day survival). CONCLUSION: In a contemporary cohort of patients presenting in CS, the use of TandemHeart is associated with a 74% 30-day survival and a 66% 180-day survival.

Contemporary device management of cardiogenic shock following acute myocardial infarction.

Despite advances in the overall management of acute myocardial infarction (AMI), cardiogenic shock in the setting of AMI (CS-AMI) continues to be associated with poor patient outcomes. There are multiple devices that can be used in CS-AMI to support the failing circulation, although their utility in improving outcomes as compared with conventional pharmacotherapy of vasopressors and inotropes remains to be established. This contemporary review provides an update on the evidence base for each of these techniques. In CS-AMI, acute thrombotic occlusion of a major epicardial artery leads to hypoxia and myocardial ischaemia in the territory subtended by that vessel. The resultant regional dysfunction in myocardial contractility can severely compromise stroke volume and result in acute circulatory failure, systemic hypoperfusion, lactic acidosis, multi-organ failure and ultimately death.

Mechanical circulatory support in patients with cardiogenic shock not secondary to cardiotomy: a network meta-analysis.

To compare the efficacy and safety of different mechanical circulatory support (MCS) devices in CS. A total of 24 studies (7 randomized controlled trials-RCTs-and 17 non-RCTs) involving 11,117 patients were entered in a Bayesian network meta-analysis. The primary endpoint was 30-day mortality. Secondary endpoints were stroke and bleeding (requiring transfusion and/or intracranial and/or fatal). Compared with no MCS, extra-corporeal membrane oxygenation (ECMO) reduced 30-day mortality when used both alone (OR 0.37, 95% CrI 0.15-0.90) and together with the micro-axial pump Impella (OR 0.13, 95% CrI 0.02-0.80) or intra-aortic balloon pump (IABP) (OR 0.19, 95% CrI 0.05-0.63), although the relevant articles were affected by significant publication bias. Consistent results were obtained in a sensitivity analysis including only studies of CS due to myocardial infarction. After halving the weight of studies with a non-RCT design, only the benefit of ECMO + IABP on 30-day mortality was maintained (OR 0.22, 95% CI 0.057-0.76). The risk of bleeding was increased by TandemHeart (OR 13, 95% CrI 3.50-59), Impella (OR 5, 95% CrI 1.60-18), and IABP (OR 2.2, 95% CrI 1.10-4.4). No significant differences were found across MCS strategies regarding stroke. Although limited by important quality issues, the studies performed so far indicate that ECMO, especially if combined with Impella or IABP, reduces short-term mortality in CS. MCS increases the hazard of bleeding.

Right Heart Failure Management: Focus on Mechanical Support Options.

Millions of American adults suffer from right heart failure (RHF), a condition associated with high rates of hospitalization, organ failure, and death. There is a multitude of etiologies and mechanisms that lead to RHF, often in a feedforward spiral of decline. The management of advanced cases of RHF can be particularly difficult. For patients who are refractory to the medical optimization of volume status, hemodynamic and pharmacologic support, and rhythm control, mechanical therapies may be warranted. Currently available mechanical assist devices for RHF include venoarterial extracorporeal oxygenation and right ventricular assist devices, both surgical and percutaneous. Each advanced therapy has its own potential advantages and limitations, and often is appropriate in different clinical contexts. In this review, the authors describe the pathophysiology and medical therapies for RHF and then focus on the different types of advanced therapies that currently exist to help inform medical decision-making for this complicated patient cohort.

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

PURPOSE OF REVIEW: 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. RECENT FINDINGS: 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.

Tipless transseptal cannula concept combines improved hemodynamic properties and risk-reduced placement: An in silico proof-of-concept.

As a leading cause of death worldwide, heart failure is a serious medical condition in which many critically ill patients require temporary mechanical circulatory support (MCS) as a bridge-to-recovery or bridge-to-decision. In many cases, the TandemHeart system is used to unload the left heart by draining blood from the left atrium (LA) to the femoral artery via a transseptal multistage cannula. However, even though the correct positioning of the cannula is crucial for a safe treatment, the long cannula tip currently used in transseptal cannulas complicates positioning, making the cannula vulnerable to displacement during MCS. To overcome these limitations, we propose the development of a new tipless transseptal cannula with improved hemodynamic properties. We discuss the tipless cannula concept by comparing it to the common multistage cannula concept using computational fluid dynamics simulations and assess the flow field in the LA, the wall shear stresses (WSS), and the pressure loss. Across the two distinct time points of end-systole and end-diastole and two drainage flow rates of 3.5 and 5.0 L/min, we find a more homogeneous inlet flow pattern for the tipless cannula concept, accompanied by a remarkably reduced area of platelet-activating WSS (up to 10-times smaller area compared to the multistage cannula). Moreover, pressure loss is up to 14.5% lower in the tipless cannula concept, confirming overall improved hemodynamic properties of the tipless cannula concept. Finally, a diameter-dependent study reveals that lower WSS and pressure losses can be further reduced by large-lumen designs for any simulation setting. Overall, our results suggest that a tipless cannula concept remedies the crucial disadvantages of a long-tip multistage cannula by reducing the risk of misplacement, and it furthermore promotes optimized hemodynamics. With this successful proof-of-concept, we underscore the potential for and encourage the realization of further experimental investigations regarding the development of a tipless transseptal cannula for MCS.

Multimodal mechanical circulatory assist for perioperative biventricular failure.

A 61-year-old woman with acute myocardial infarction (MI), cardiogenic shock, and Impella CP support underwent emergency coronary artery bypass grafting. Postoperatively venous-arterial extracorporeal membrane oxygenation (va-ECMO) became necessary, followed by Impella 5.0 insertion on 7th postoperative day (POD), the addition of right ventricular support by TandemHeart due to inadequate flow of Impella system, which then allowed for va-ECMO weaning. Impella und TandemHeart were removed on 14th POD, 31st POD, respectively. Biventricular decompensation following MI was successfully treated by a sequence of different mechanical circulatory support systems allowing an adaptive weaning strategy.

Mechanical Circulatory Support During Catheter Ablation of Ventricular Tachycardia: Indications and Options.

Mapping of scar-related ventricular tachycardia (VT) in structural heart disease is fundamentally driven by identifying the critical isthmus of conduction that supports re-entry in and around myocardial scar. Mapping can be performed using activation and entrainment techniques during VT, or by substrate mapping performed in stable sinus or paced rhythm. Activation and entrainment mapping requires the patient to be in continuous VT, which may not be haemodynamically tolerated, or, if tolerated, may lead to adverse sequelae related to impaired end organ perfusion. Mechanical circulatory support (MCS) devices may facilitate haemodynamic stability and preserve end organ perfusion during sustained VT to permit mapping for long periods. Available options for haemodynamic support include an intra-aortic balloon pump (IABP), TandemHeart left atrial to femoral artery bypass system (CardiacAssist Inc., Pittsburgh, PA, USA), Impella left ventricle (LV) to aorta flow-assist system (Abiomed, Danvers, MA, USA), and extracorporeal membrane oxygenation (ECMO); the bypass and assist devices provide far better augmentation of cardiac output than IABP. MCS has potential key advantages including maintenance of vital organ perfusion, reduction of intra-cardiac filling pressures, reduction of LV volumes, wall stress, and myocardial consumption of oxygen, and improvement of coronary perfusion during prolonged periods of VT induction and/or mapping. Observational studies show MCS allows for longer duration of mapping, and increased likelihood of VT termination, without an increased risk of peri-procedural mortality or VT recurrence in follow-up, despite being used in a significantly sicker cohort of patients. However, MCS has increased risk of complications related to vascular access, bleeding, thromboembolic risk, mapping system interference, increase procedural complexity and increased cost. Acute haemodynamic decompensation occurs in ∼11% of patients undergoing VT ablation, and is associated with increased mortality. Prospectively identifying patients at risk of acute haemodynamic decompensation in the peri-procedural period may allow prophylactic MCS. Although observational studies of MCS in patients at high risk of haemodynamic decompensation are encouraging, its benefit needs to be proven in randomised trials. This review will summarise the indication for MCS, forms of MCS, procedural outcomes, complications and utility of MCS during VT ablation.

Mechanical circulatory support using modified TandemHeart ventricular assist device in neonates with CHD.

TandemHeart, an adult ventricular assist device, is also being used in children for mechanical circulatory support. In this case series, we describe our experience using TandemHeart ventricular assist device with a modified circuit to provide mechanical circulatory support in three neonates for multiple indications. TandemHeart ventricular assist device with a modified circuit can be used successfully to provide extracorporeal support to neonates with complex CHD.

Temporary Percutaneous Mechanical Circulatory Support in Advanced Heart Failure.

Cardiogenic shock is severe, refractory heart failure caused by significant myocardial dysfunction in the setting of adequate preload that is accompanied by systemic hypoperfusion. Progressive end-organ dysfunction is a hallmark of persistent cardiogenic shock and necessitates intervention to overcome altered hemodynamics and restore end-organ perfusion. Temporary percutaneous mechanical circulatory support is an established modality in the treatment of cardiogenic shock and is increasingly used in patients with cardiogenic shock as a bridge to recovery or further definitive therapy. This article reviews the current devices, their effects on left ventricular hemodynamics, and the evidence supporting their continued use.

Hemodynamic support with percutaneous devices in patients with heart failure.

The use of surgically implanted durable mechanical circulatory support (MCS) in high-risk patients with heart failure is declining and short-term, nondurable MCS device use is growing. Percutaneously delivered MCS options for advanced heart failure include the intra-aortic balloon pump, Impella axial flow catheter, TandemHeart centrifugal pump, and venoarterial extracorporeal membrane oxygenation. Nondurable MCS devices have unique implantation characteristics and hemodynamic effects. Algorithms and guidelines for optimal nondurable MCS device selection do not exist. Emerging technologies and applications will address the need for improved left ventricular unloading using lower-profile devices, longer-term ambulatory support, and the potential for myocardial recovery.

Removal of Impella® 2.5 while maintaining vascular access: a solution to a vascular quandary.

Cardiogenic shock (CS) in the setting of acute myocardial infarction is associated with high in-hospital mortality rates. Society guidelines provide a Class Ib recommendation for the use of hemodynamic support devices in patients with CS following ST-elevation myocardial infarction. Exchanging of hemodynamic support devices is often complicated by inability to maintain percutaneous vascular access upon device removal in the setting of anticoagulation. This report highlights one potential solution to the dilemma of maintaining vascular access following removal of an Impella® 2.5 mechanical support device to allow safe transition to a TandemHeart system in a patient with refractory CS.

Pharmacological Considerations during Percutaneous Treatment of Heart Failure.

Heart Failure (HF) remains a global health challenge, marked by its widespread prevalence and substantial resource utilization. Although the prognosis has improved in recent decades due to the treatments implemented, it continues to generate high morbidity and mortality in the medium to long term. Interventional cardiology has emerged as a crucial player in HF management, offering a diverse array of percutaneous treatments for both acute and chronic HF. This article aimed to provide a comprehensive review of the role of percutaneous interventions in HF patients, with a primary focus on key features, clinical effectiveness, and safety outcomes. Despite the growing utilization of these interventions, there remain critical gaps in the existing body of evidence. Consequently, the need for high-quality randomized clinical trials and extensive international registries is emphasized to shed light on the specific patient populations and clinical scenarios that stand to benefit most from these innovative devices.

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.

Percutaneous Right Ventricular Assist Device Using the TandemHeart ProtekDuo: Real-World Experience.

BACKGROUND: Acute right ventricular (RV) failure is challenging to treat and mechanical circulatory support devices are limited. The TandemHeart ProtekDuo (THPD; TandemLife) is a novel percutaneous RV assist device that can provide 4.0 liters per minute of blood flow through venovenous extracorporeal life support. It allows venous drainage from the right atrium and reinfusion of blood into the main pulmonary artery via internal jugular vein access. We aim to provide real-world insight into disease characteristics resulting in the use of THPD for mechanical support and enhance knowledge of best practice regarding clinical management weaning and removal/exit strategies. METHODS: We retrospectively collected data of consecutive patients who received a THPD device at our center for acute RV failure between August 2015 and February 2018. RESULTS: Eleven patients were diagnosed with acute RV failure and required placement of THPD. The hospital length of stay ranged from 12 to 223 days. The average length of support ranged from 11 to 154 days. We observed complications such as stroke (18.2%), sepsis (63.6%), massive gastrointestinal bleed (45.5%), and heparin-induced thrombocytopenia (54.5%). These patients received on average 85 units of blood products. Survival was 82% at 30 days and 72% at 180 days. Six of the patients were successfully weaned from the THPD devices and 1 patient required venovenous extracorporeal life support. CONCLUSIONS: This real-world experience, despite high morbidity, continues to suggest benefits of THPD for patients with severe acute RV failure.

Temporary Mechanical Circulatory Support as a Bridge to Heart Transplant or Durable Left Ventricular Assist Device.

Advanced heart failure refractory to medical therapy can result in patients presenting with progressively worsening hypoperfusion and cardiogenic shock. Temporary mechanical circulatory support is often necessary as a bridge to heart transplant or durable ventricular assist devices. These devices increase cardiac output. Several options are available for left ventricular support. With the exception of venoarterial extracorporeal membrane oxygenation, all other devices decrease left ventricular end-diastolic pressure. The choice of device should be driven by patient needs and the treating teams comfort. Timely identification of cardiogenic shock and use of shock teams are potential strategies that can help improve survival.

Delayed removal of a percutaneous left ventricular assist device for patients undergoing catheter ablation of ventricular tachycardia is associated with increased 90-day mortality.

PURPOSE: Assess if timing of removal of a percutaneous left ventricular assist device (pLVAD) after ventricular tachycardia (VT) ablation alters patient outcomes. METHODS: Sixty-nine patients underwent pLVAD support. Patients were divided into early (< 24 h, n = 43) and delayed (≥ 24 h, n = 26) removal groups after ablation. Factors for delayed pLVAD removal and predictors of 90-day mortality were analyzed. RESULTS: The delayed removal group had lower LVEF (27.1 ± 9.3% vs. 20.6 ± 5.4%, p = 0.002), greater percentage LVEF < 25% (58.1% vs. 84.6%, p = 0.02), and more VT storm (41.9% vs. 96.2%, p < 0.001). Ventricular fibrillation (VF) was induced in 9/69 (13%), with incidence higher in delayed removal group (27% vs. 5%, p = 0.002). VT storm (OR = 34.72, 95% CI, 4.30-280.33; p = 0.001), LVEF < 25% (OR = 3.95, 95% CI, 1.16-13.48; p = 0.03), and VF induced during ablation (OR = 9.25, 95% CI, 1.71-50.0; p = 0.01) were associated with delayed pLVAD removal in univariate analysis. Delayed pLVAD removal had a significantly higher 90-day mortality rate (2.3% vs 30.2%; p < 0.001). Univariate Cox proportional hazard regression analysis revealed delayed pLVAD removal was a significant predictor of 90-day mortality. CONCLUSIONS: Prolonged pLVAD insertion (≥ 24 h) after VT ablation was associated with VT storm, LVEF < 25%, and VF induced during ablation. Delayed pLVAD removal was a significant predictor of 90-day mortality in patients undergoing VT ablation.

Mechanical Circulatory Support in Acute Myocardial Infarction and Cardiogenic Shock.

Mechanical circulatory support devices are increasingly used for the treatment of acute myocardial infarction complicated by cardiogenic shock. These devices provide different levels of univentricular and biventricular support, have different mechanisms of actions, and provide different physiologic effects. Institutions require expert teams to safely implant and manage these devices. This article reviews the mechanism of action, physiologic effects, and data as they relate to the utilization of these devices.