Temporary Right Ventricular Assist Device Support for Acute Right Heart Failure: A Single-Center Experience.

INTRODUCTION: Severe right ventricular (RV) failure is associated with significant morbidity and mortality. Although right ventricular assist devices (RVADs) are increasingly used for refractory RV failure, there is limited data on their short- and long-term outcomes. Therefore, we undertook this study to better understand our experience with temporary RVADs. METHODS: We conducted a retrospective review of all RVADS performed from 2017 to 2021. Patients supported with surgical RVADs, the Protek Duo device, and the Impella RP device were included. Patients were stratified by the type of RVAD and by etiology of RV failure. Survival was assessed by the Kaplan-Meier method and multivariable Cox proportional hazards regression models. RESULTS: From 2017 to 2021, 42 patients underwent RVAD implantation: 32 with a Protek Duo, 6 with an Impella RP, and 4 with a surgical RVAD. Majority of patients were already supported with an alternate form of mechanical support. Most patients had impaired renal function, decreased hepatic function, and lactic acidosis at the time of cannulation. The median duration of RVAD support was 8.5 [5-19] d. Survival to decannulation was 68.4%, to discharge was 47.4%, and to 1-y was 40.2%. Multivariable analysis identified elevated total bilirubin levels to be associated with 30-d mortality while increased hemoglobin levels were protective. After RVAD cannulation, the median number of pressors and inotropes was lower (P < 0.01) and the lactic acidosis was less (P < 0.01). CONCLUSIONS: In conclusion, RVAD support is associated with lower lactate levels, and decreased number of vasoactive medications, but is associated with significant morbidity and mortality.

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.

A single healthcare experience with Impella RP.

OBJECTIVES: To understand the predictors of survival and indications for Impella RP in a single healthcare experience. BACKGROUND: The Impella RP can be used to temporarily support patients with right ventricular (RV) dysfunction after left ventricular assist device (LVAD) placement or myocardial infarction (MI). However, recent postmarket approval data have raised concerns of higher than expected mortality with this device. METHODS: A retrospective chart review and analysis of all patients that underwent Impella RP placement in the Emory Healthcare system between January 2016 and December 2018 were performed. Patients were classified according to the indication. RESULTS: A total of 39 patients underwent Impella RP placement. Six patients were post-LVAD, 9 were implanted for massive pulmonary embolism with persistent shock, 8 for postcardiac surgery RV failure (non-LVAD), 11 for RV failure post-MI, and 5 for new or worsening nonischemic cardiomyopathy. The worst survival was noted in MI-related cardiogenic shock group and in patients who presented with cardiac arrest (3/12). All observed deaths were due to persistent refractory shock. There was no device related death. Survival improved during the last year of experience compared to the first 2 years. CONCLUSION: This study supports the selective use of the Impella RP, with a higher than national reported survival rate (49% vs. 28.6%). Indication appears to be an important factor determining survival.

Initial experience with Impella RP in a quaternary transplant center.

Right ventricular failure is one of the most common complications encountered after left ventricular assist device implantation and heart transplantation. It has been reported to have an incidence up to 30%. It increases morbidity and short-term mortality. Impella RP is a small pump that can provide up to 4L/min of flow. We analyzed all the patients with right ventricular failure that were treated with Impella RP in our institution. The Impella RP was implanted percutaneously in the catheterization laboratory guided by fluoroscopy. Overall, 7 patients required the implantation of an Impella RP due to right ventricular failure: 2 after long-term LVAD, 3 presented with acute right ventricular failure immediately after LVAD implantation, and 2 needed it after heart transplantation. Regarding complications, we report 2 patients with hemolysis. Hemodynamic parameters as well as end-organ perfusion and inotropic requirements improved after the insertion of the Impella. Overall, 30-day survival is 58%. Median time of support was 9 (5-19) days. RV failure is one of the most challenging complications after LVAD implantation and heart transplantation. The major challenge is the timing of implantation. The minimally invasive nature of the Impella RP facilitates de-escalation of treatment and paves the road to recovery. Impella RP proved useful in facilitating ECMO wean. Used in a prompt manner alongside the ease of implantation and the minimal rate of complications, Impella RP seems to be an appropriate device to tackle RV failure providing enough flow to allow for recovery or escalation decision-making.

Impella RP in hemodynamically unstable patients with acute pulmonary embolism.

Over the last years, different case reports/studies have demonstrated that in patients with acute pulmonary embolism (PE) and refractory shock mechanical circulatory support (MCS) with Impella RP® (Abiomed, Inc, Danvers, Mass) increases the chances of survival, significantly unloading the right ventricle and improving both the cardiac output and the mean pulmonary artery pressure. We reviewed the medical literature about the use of Impella RP in patients with acute PE and refractory shock using PubMed (MEDLINE), Scopus, Cochrane library, and Google Scholar databases. The final research was conducted in July 2019. The results evidenced that available data are currently scant to definitively assess the real role Impella RP® in patient with acute PE and refractory shock. However, preliminary data seems to be very promising. Further larger studies are needed to confirm the safety and efficacy of MCS in these patients. A multidisciplinary assessment, using the PERT team, must be performed case by case to determine the need of MCS.

Mechanical circulatory support for acute right ventricular failure in the setting of pulmonary embolism.

BACKGROUND: Right ventricular (RV) failure due to pulmonary embolism (PE) increases morbidity and mortality and contributes to prolonged hospital length of stay and higher costs of care. RV mechanical circulatory support (MCS) including Impella RP devices have been increasingly used in hemodynamically compromised PE patients who are refractory to intravascular volume expansion and inotropic therapy. However, effectiveness and safety of Impella RP, in hemodynamically unstable PE patients is unknown. METHODS: We included consecutive patients who presented to Detroit Medical Center between November 3, 2015 and October 2, 2017 with acute PE and had evidence of hemodynamic compromise indicating Impella RP. RESULTS: Total of five cases were identified. All patients met the shock definition due to massive or submassive PE and therefore received Impella RP on admission. Cardiac index was improved from mean of 1.69/min/m2, (0.88-2.15 L/min/m2 ), to 2.5 L/min/m2 (range 1.88-3.4), after 24 h of treatment. Similarly, mean heart rate reduced to 92 beats per minute (79-105), and mean systolic blood pressure increased to 140 mmHg (115-179). No significant changes were found in renal function, hemoglobin and platelets level during device use. One patient experienced hemoglobin drop from 13.7 to 7.3 g/dL but did not require blood transfusion. All patients survived to discharge. CONCLUSION: In patients with PE and RV shock, Impella RP device resulted in immediate hemodynamic benefit with reversal of shock and favorable survival to discharge.

Impella RP in the Treatment of Right Ventricular Failure: What We Know and Where We Go.

Temporary mechanical circulatory support devices for the treatment of acute right ventricular failure represent crucial tools for clinical practice. Right ventricular failure presents specific treatment issues, and dedicated percutaneous devices are less in number compared to the left ventricle. Current data and insights on mechanical circulatory support for the right ventricle come mostly from the context of cardiac surgery, predominantly the setting of acute right ventricular failure after left ventricular assist device implantation. The Impella RP (Abiomed, Danvers, MA) is a minimally invasive temporary device that has gained application for the percutaneous treatment of right ventricular failure with positive clinical results. Even though treatment indications are clear, technical and management issues still are relevant because of the limited scientific data available. Appropriate positioning and repositioning, interaction with right ventricular valvular apparatus, anticoagulation management, weaning, and patient mobilization are examples of the open challenges. In line with the positive initial experience with this device, future research efforts should be focused on the improvement of device limitations and on providing additional data that might drive optimal clinical management.

Use of a Percutaneous Right Ventricular Assist Device to Manage Right Ventricular Failure in Inferior STEMIs.

Acute right heart failure is a complication of inferior ST-elevation myocardial infarctions. Given the further hemodynamic instability that results from right-sided failure, a treatment option is needed to help bridge toward cardiac recovery. We present a case of using a right ventricular assist device in a patient who had marked improvement in cardiac function after an instance of acute right heart failure.

Shunting Across a Latent Patent Foramen Ovale (PFO) in a Patient With Right Ventricular (RV) Infarction Improved With Impella.

The right-to-left shunt (RTLS) through a latent patent foramen ovale (PFO) is a rare complication of right ventricle myocardial infarction (MI). Though a rare complication, the development of refractory hypoxemia after right ventricular MI should always alert clinicians to consider the possibility of shunting across PFO. Right-sided Impella (Impella RP) can be considered in such patients, which helps to decrease the elevated right heart pressure reducing the shunt, thereby providing a bridge to recovery.

CT and chest radiography in evaluation of mechanical circulatory support devices for acute heart failure.

Acute heart failure and cardiogenic shock are a major cause of morbidity and mortality in patients who have had recent cardiac surgery, myocardial infarct or pulmonary hypertension. The use of percutaneous mechanical circulatory support (MCS) devices before organ failure occurs can improve outcomes in these patients. Imaging plays a key role in identifying appropriate positioning of MCS devices for supporting ventricle function. These devices can be used for left ventricle, right ventricle or biventricular support. Fluoroscopy, angiography and echocardiography are used for implanting these devices. Radiographs and CT can identify both intra- and extra-cardiac complications. The cardiothoracic imager will see increasing use of these devices and familiarity with their normal appearance and complications is important. CRITICAL RELEVANCE STATEMENT: Chest radiographs and CT are useful for assessing the position of the mechanical cardiac support device used for treatment of acute heart failure. CT can identify cardiac and extra-cardiac complications associated with these devices. KEY POINTS: IABP upper/distal marker should be 2-3 cm distal to the ostia of the left subclavian artery. Inlet of Impella CP should be 3.5 cm below the aortic valve. The Impella 5.5 does not have a pigtail portion. The inlet should be about 5 cm below the aortic annulus. Impella RP inlet port should be in the right atrium or inferior vena cava, the pigtail portion should be positioned in the main pulmonary artery. Protek Duo inflow is in the right atrium or right ventricle. The outflow is in the main pulmonary artery.

Paradoxical Shock and Management of a Post-percutaneous Mechanical Thrombectomy Device in a Morbidly Obese Patient With a Submassive Pulmonary Embolism.

A submassive pulmonary embolism (PE) is a type of PE where the pulmonary artery is partially obstructed. It is categorized as an intermediate risk when compared to massive PE, which presents as a complete obstruction of the pulmonary artery, therefore placing it in the high-risk category. In either case, if not promptly assessed and treated, it can prove to be fatal. We report the case of a morbidly obese middle-aged female who presented with a submassive PE. Based on the evaluation of the patient's pre-existing conditions, risk factors, clinical severity, imaging, and lab findings, it was concluded that percutaneous mechanical thrombectomy (PMT) was essential to promptly alleviate the clot burden. Following the procedure, it was observed that the patient became hemodynamically unstable, accompanied by hypoxemia and respiratory acidosis. With the assistance of pressors and later the placement of a right ventricular Impella device, the patient was successfully stabilized and, several days later, discharged from the hospital. This report explores the potential factors that may have contributed to the patient's hemodynamic instability and acute right ventricular failure after the PMT procedure. These factors can be attributed to pre-existing changes in the right ventricle (RV) as a result of morbid obesity, as well as possible associations with obstructive sleep apnea or obesity hypoventilation syndrome. Furthermore, it is important to highlight that patients exhibiting submassive PE can be considered suitable candidates for PMT, with careful consideration of the patient's medical history, clinical severity of symptoms, and diagnostic findings. It is worth noting that PMT intervention in this patient demonstrated a favorable outcome.

Impella RP for Patients with Acute Right Ventricular Failure and Cardiogenic Shock: A Subanalysis from the IMP-IT Registry.

The use of percutaneous right ventricular assist devices (pRVADs) to support patients with right ventricular (RV)-predominant cardiogenic shock (CS) refractory to optimal medical therapy is increasing progressively, and the Impella RP is the first FDA-approved pRVAD in such a clinical scenario. The aim of the present study is to report the outcomes of patients treated with Impella RP in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry, a multicenter registry that evaluated the trends in use and clinical outcomes of the Impella in the setting of CS and high-risk percutaneous coronary intervention in Italy. A total of 15 patients who received Impella RP were enrolled. In 40% of the patients, the main cause was ST-segment elevation myocardial infarction. A total of 40% of patients required biventricular support with a left Impella. Device-related complications were reported in 46.7% of patients. Overall, the in-hospital mortality was 46.7%, whereas the one-year mortality was 53.3%. The composite rate of all-cause death, heart failure (HF) hospitalization, left ventricular assist device (LVAD) and heart transplant at one year was 60%. The Impella RP has favorable survival outcomes in RV-predominant cardiogenic shock. However, the device-related complications are frequent and should be carefully weighed when considering escalation to Impella RP.

Comprehensive evaluation of Impella RP® in right ventricular failure.

Right ventricular failure has a high morbidity and mortality in patients suffering from advanced heart failure, pulmonary hypertension, acute myocardial infarction after cardiac surgery and in left ventricular assist device patients. The Impella RP® catheter is a mechanical circulatory device, positioned from a venous femoral percutaneous access and passing through the tricuspid and pulmonary valves, reaches the pulmonary artery. Impella RP (Abiomed Inc., MA, USA) acts as a direct right ventricle bypass and it provides a flow up to 4.4 liters per minute, unloading the right ventricle. The main contraindications are: thrombi in the vena cava, right atrium and ventricle and pulmonary artery; mechanical tricuspid or pulmonary prostheses. In this review, the principles of operations, clinical applications and results of Impella RP are summarized and evaluated.

Right ventricular failure is a severe medical condition characterized by a sudden or a progressive reduction of the function of the right heart. This condition, if left untretated, leads to low blood pressure, reduced oxygen supply to other organs as brain, liver and kidneys, and eventually death. The right ventricular failure can be the consequence of a heart attack or a progressive disease of the heart, such as chronic heart failure, inflammatory diseases or inherited conditions. When medical therapy fails, the function of the right ventricle (RV) can be temporarily replaced by a mechanical device. Impella RP^® is a mechanical device, inserted into the heart without the need of a surgical operation, that bypasses the RV and ensures an adequate blood flow. Impella RP, while replaces the right ventricular function, allows time for the right ventricular recovery. When and if the RV recovers, Impella RP can be removed. As all the medical devices, Impella RP can be associated to adverse effects, mainly bleeding and damage of cardiac structures.

Use of Impella RP for Acute Right Ventricular Failure Post-Pericardiectomy.

Surgical pericardiectomy is the accepted treatment for patients with constrictive pericarditis. Right ventricular failure in patients that undergo pericardiectomy is a frequent complication due to sudden volume overload. Impella RP is used to bypass the right ventricle and tackle the transient right ventricular failure. It is implanted percutaneously and provides enough support to achieve haemodynamical stability and recover end-organ function. We report the case of a patient that developed acute right ventricular failure in the early postoperative period of a pericardiectomy. He underwent the implantation of an Impella RP in the setting of acute right ventricular failure and was successfully explanted after 6 days of support.

Impella RP Versus Pharmacologic Vasoactive Treatment in Profound Cardiogenic Shock due to Right Ventricular Failure.

The aim was to translationally compare a pharmacologic strategy versus treatment with the Impella RP in profound RV cardiogenic shock (CS). The pigs were allocated to either vasoactive therapy with norepinephrine (0.10 µg/kg/min) for the first 30 min, supplemented by an infusion of milrinone (0.4 µg/kg/min) for additional 150 min, or treatment with the Impella RP device for 180 min. Total RV workload (Pressure-volume-area × heart rate*103(mmHg/min)) remained unaffected upon treatment with the Impella RP and increased in the vasoactive group (CS 179[147;228] to norepinephrine 268[247;306](p = 0.002 compared to Impella RP) and norepinephrine + milrinone 366[329;422] (p = 0.002 compared to Impella RP). A trend towards higher venous cerebral oxygen saturation was observed with norepinephrine than Impella RP (Impella RP 51[47;61]% vs norepinephrine 62[57;71]%; p = 0.07), which became significantly higher with the addition of milrinone (Impella RP 45[32;63]% vs norepinephrine + milrinone 73[66;81]%; p = 0.002). The Impella RP unloaded the failing RV. In contrast, vasoactive treatment led to enhanced cerebral venous oxygen saturation.

Clinical use of percutaneous mechanical circulatory assistance in a patient with end-stage right-sided heart failure and massive tricuspid insufficiency due to congenital heart disease: first-in-the-world case report.

BACKGROUND: Due to improvement in the management of patients with congenital heart disease (CHD), the likelihood of their survival to adulthood is increasing. A relevant population suffers end-stage right ventricular failure (RVF) in their 3rd-4th decade of life. Hence, heart transplantation is still gold standard of treatment of end-stage heart failure, mechanical circulatory assistance has become a valuable tool in the bridging to heart transplant or definitive therapy. Use of implantable short-term or long-term devices is reported by others. However, within this clinical context, presence of significant tricuspid regurgitation (TR) or CHD is used as exclusion criteria for insertion of a percutaneous right ventricular circulatory support. CASE SUMMARY: We described a 36-year-old patient diagnosed with Ebstein's anomaly and severe TR who is admitted to hospital due to RVF refractory to standard medical treatment. After case presentation to the heart team, an Impella RP device insertion was scheduled, in spite of the presence of TR or CHD after evaluation of pulmonary valve competency and 3D reconstruction with virtual device implantation. During support, the patient improved clinically and haemodynamically. Due to device displacement to the right ventricle, it was bedside explanted after 30 days of support. After mechanical unloading during 30 days patients' right ventricle recovered partially, permitting patient to improve his functional class. DISCUSSION: Although TR and CHD are exclusion criteria for the implantation of the Impella RP device, we report clinical experience in patient with Ebstein's anomaly and severe TR supported with percutaneous device as bridge to heart transplantation during 30 days.

The First Case of Impella RP Use in Acute Right Ventricular Failure From Air Embolism.

BACKGROUND: Air embolism can cause the following catastrophic complications that must be avoided: cardiogenic shock (from right heart failure), obstructive shock, myocardial infarction, stroke, RVOT obstructions, and pulmonary embolism. Currently there is a paucity of data on Impella RP use in rare causes of acute right ventricle (RV) failure, especially if caused by air embolism. CASE REPORT: We report a case of a patient with acute RV failure due to air embolism who recovered from temporary use of Impella RP. DISCUSSION: This case highlights the utility of right-sided mechanical support (MCS) devices for acute RV failure.

Central Venous Pressure and Clinical Outcomes During Left-Sided Mechanical Support for Acute Myocardial Infarction and Cardiogenic Shock.

Background: Right ventricular failure (RVF) is associated with increased mortality among patients receiving left ventricular mechanical circulatory support (LV-MCS) for cardiogenic shock and requires prompt recognition and management. Increased central venous pressure (CVP) is an indicator of potential RVF. Objectives: We studied whether elevated CVP during LV-MCS for acute myocardial infarction complicated by cardiogenic shock is associated with higher mortality. Methods: Between January 2014 and June 2019, we analyzed hemodynamic parameters during Impella LV-MCS from 28 centers in the United States participating in the global, prospective catheter-based ventricular assist device (cVAD) study. A total of 132 patients with a documented CVP measurement while on Impella left-sided support for cardiogenic shock were identified. Results: CVP was significantly higher among patients who died in the hospital (14.0 vs. 11.7 mmHg, p = 0.014), and a CVP >12 identified patients at significantly higher risk for in-hospital mortality (65 vs. 45%, p = 0.02). CVP remained significantly associated with in-hospital mortality even after adjustment in a multivariable model (adjusted OR 1.10 [95% CI 1.02-1.19] per 1 mmHg increase). LV-MCS suction events were non-significantly more frequent among patients with high vs. low CVP (62.11 vs. 7.14 events, p = 0.067). Conclusion: CVP is a single, readily accessible hemodynamic parameter which predicts a higher rate of short-term mortality and may identify subclinical RVF in patients receiving LV-MCS for cardiogenic shock.

Impella RP as a bridge to cardiac transplant for refractory late right ventricular failure in setting of left ventricular assist device.

Right ventricular (RV) failure remains a major complication after surgical implantation of a left ventricular assist device (LVAD). While the use of a percutaneous RV assist device has been described as a short-term bridge to recovery in end-stage heart failure patients with early post-operative RV failure after index LVAD implant, management of refractory late RV failure remains challenging in these patients. We report the first successful case of extended Impella RP use as a safe and effective bridge to orthotopic heart transplant in an LVAD patient with refractory, haemodynamically significant late RV failure. The Impella RP provided support for 37 days. Haemodynamically intolerant arrhythmia precluded use of inotropic support. No adverse complications related to percutaneous Impella RP support were seen. We also review potential considerations for mechanical circulatory support strategies in this setting: central RV assist device cannulation requires sternotomy incision that can impact subsequent cardiac surgeries, while percutaneous Protek Duo insertion requires adequate vessel size and patency. With an LVAD in situ, veno-arterial extracorporeal membrane oxygenation was not considered for isolated RV support in this case. The patient is currently over 6 months post-orthotopic heart transplant.

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. RESULTS: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). CONCLUSIONS: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.