Numerical methods for hemolysis and thrombus evaluation in the percutaneous ventricular assist device.

BACKGROUND: A percutaneous ventricular assist device (pVAD) is an effective method to treat heart failure, but its complications, mainly hemolysis and thrombus formation, cannot be ignored. Accurate evaluation of hemolysis and thrombus formation in pVAD is essential to guide the development of pVAD and reduce the incidence of complications. METHODS: This study optimized the numerical model to predict hemolysis and thrombus formation in pVAD. The hemolysis model is based on the power law function, and the multi-component thrombus prediction model is improved by introducing the von Willebrand factor. RESULTS: The error between the numerical simulation and the hydraulic performance experiment is within 5%. The numerical results of hemolysis are in good agreement with those of in vitro experiments. Meanwhile, the thrombus location predicted by the numerical model is the same as that found in the in vivo experiment. CONCLUSION: The numerical model suggested in this study may therefore accurately assess the possible hemolytic and thrombotic dangers in pVAD, making it an effective tool to support the development of pVAD.

TriVAD: Successful use of Impella 5.5 and Protek Duo CentriMag RVAD following Heartware HVAD thrombosis as a bridge to heart transplant.

INTRODUCTION: Pump thrombosis remains a feared complication following placement of durable left ventricular assist devices (LVAD) and can be particularly detrimental to individuals being bridged to heart transplantation. Complications associated with this malfunction not only increase morbidity related to right heart failure, hemolysis, and other organ failure, but may ultimately jeopardize a patient's heart transplant candidacy. Additionally, reoperation for durable ventricular device replacement not only poses additional surgical risks to patients but can potentially complicate or even prohibit transplantation in the future. CASE REPORT: This case report describes a novel configuration of temporary, groin-free, percutaneously-deployed biventricular mechanical circulatory devices to support a patient with biventricular failure due to partial LVAD thrombosis. DISCUSSION/CONCLUSION: The use of less invasive mechanical support measures, such as the approach described here, may help patients achieve adequate hemodynamic support while allowing them to remain ambulatory and facilitate successful bridging to heart transplantation.

[Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device].

Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering. Test setups, clinical conditions, failure modes, effects analysis, and evaluation models have been investigated. A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed. This study offers valuable insights into standardizing their reliability evaluation in clinical settings.

Percutaneous ventricular assist device for higher-risk percutaneous coronary intervention in surgically ineligible patients: Indications and outcomes from the OPTIMUM study.

BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

Glimpse into the future.

Randomized studies attempting to prove benefit of mechanical circulatory support in cardiogenic shock have failed to reduce the risk of death. Further, both registry and randomized data suggest increased rates of serious complications associated with these devices. This last review in the supplement discusses current evidence and provides a perspective on how the scientific community could advance cardiogenic shock research focused on mechanical circulatory support.

Safety and Efficacy of a Percutaneously Inserted Ventricular Support Device Purge Solution Heparin 25 U/mL.

BACKGROUND: The Impella is a percutaneous ventricular assist device (pVAD) that provides temporary hemodynamic support to patients with cardiogenic shock or for protected percutaneous coronary intervention. The manufacturer recommends a 50-U/mL concentration of heparin purge solution (or 25 U/mL as an alternative), with systemic heparin to maintain therapeutic anticoagulation during device support. Concomitant use of systemic heparin with the purge solution may increase the risk of bleeding. OBJECTIVES: The primary objective of this study was to describe the prevalence of thrombosis and bleeding using a less-concentrated heparin purge solution (25 U/mL) in combination with systemic heparin therapy. METHODS: This was a retrospective observational cohort study of patients who required at least 12 hours of pVAD support and received 25-U/mL concentration of heparin purge solution between January 1, 2014, and May 31, 2017. The primary end points were the rate of thrombotic and bleeding events. Secondary end points included the percentage of time within the therapeutic activated partial thromboplastin time (aPTT) range. Descriptive statistics were utilized for data analysis. RESULTS: Of the 161 patients screened, 100 met inclusion criteria; 63% of patients experienced a bleeding event, with Bleeding Academic Research Consortium (BARC) type 3a being the most common. Median percentages of subtherapeutic and supratherapeutic aPTT values were similar between the bleeding and nonbleeding groups. Two patients experienced thrombotic events. CONCLUSION AND RELEVANCE: Based on our findings, the device thrombosis rate was 2% and the rate of major bleeding (BARC 3a and higher) was 35%. This study provides descriptive outcomes data of a lower-concentration heparin purge solution.

Temporal trends of survival and utilization of mechanical circulatory support devices in patients with in-hospital cardiac arrest secondary to ventricular tachycardia/ventricular fibrillation.

BACKGROUND: Pulseless ventricular tachycardia/ventricular fibrillation (VT/VF) is the initial rhythm in a third of in-hospital cardiac arrest patients. Mechanical circulatory support (MCS) device use remains poorly understood in this population. METHODS: We conducted an observational analysis of temporal trends in the utilization of MCS in VT/VF IHCA between January 2008 and December 2014 utilizing the Nationwide Inpatient Sample (NIS) database. Using multivariable analysis, we assessed factors associated with MCS use and survival to discharge. RESULTS: Among 151,628 hospitalizations with VT/VF IHCA, 14,981 (9.9%) received MCS. Intra-aortic balloon pump (IABP) was the most commonly used MCS (9.1%). From 2008 to 2014, there was significant increase in the utilization of MCS (8.7-11%; ptrend < 0.0001). On multivariable analysis, there was 12-fold increase and three-fold increase in the utilization of PVAD and ECMO respectively; however, there was no significant change in the use of IABP. Over the seven-year sample period, there was significant increase in the overall survival to hospital discharge (35.4-43.5%; ptrend < 0.0001). Survival to hospital discharge increased in both MCS and non-MCS groups. CONCLUSION: There was significant increase in utilization of MCS after VT/VF IHCA during the study period. IABP was the most commonly utilized MCS. The survival to hospital discharge increased in the overall study population including both MCS and non-MCS groups. Future studies are needed to identify patient population most likely to benefit from the use of MCS after VT/VF IHCA.

The effect of standardization of insertion and removal of percutaneous left ventricular assist device.

BACKGROUND: The effect of standardizing an insertion and removal protocol for pVAD devices has not been previously described. OBJECTIVES: We sought to evaluate clinical outcomes in patients who underwent pVAD insertion pre- and post-protocol standardization. METHODS: All patients who underwent pVAD insertion that remained in place at index procedure completion between January 2017 and September 2023 at a single academic center for both high-risk PCI and cardiogenic shock indications were included in the study. The primary outcome was the incidence of limb ischemia and major bleeding before and after the protocol initiation. Secondary outcomes included in-hospital and 30-day MACCE rate (death, myocardial infarction, stroke, emergent CABG), and how often the operators followed the protocol. RESULTS: A total of 89 patients had pVAD left in place (29 pre-protocol initiation and 60 post-protocol initiation). There was a significant decrease in incidence of limb ischemia post-protocol initiation compared to pre (17.2 % vs 1.7 %, p = 0.01) but no difference in bleeding incidence (13.8 % vs 20.0 %, p = 0.47). Adherence increased in all components of the protocol except for right heart catheterization. CONCLUSION: Standardization of an insertion and removal protocol for pVAD devices led to a statistically significant decrease in limb ischemia in a high-risk patient population.

Predicting survival after Impella implantation in patients with cardiogenic shock: The J-PVAD risk score.

AIMS: Impella has become a new option for mechanical circulatory support in patients with cardiogenic shock (CS); however, prognostic models for patients after Impella are lacking. We aimed to identify the factors that predict in-hospital mortality in patients with CS requiring Impella and develop a new risk prediction model. METHODS AND RESULTS: We utilized the J-PVAD registry, which includes all cases where Impella was implanted in Japan. Two-thirds of the patients in the J-PVAD registry were randomly assigned to the derivation cohort (n = 1701), and the other third was assigned to the validation cohort (n = 850). A backward stepwise logistic regression model was developed to identify factors associated with in-hospital mortality. In the derivation cohort, 956 patients were discharged alive, and 745 patients (43.8%) died during hospitalization. Among 29 candidate variables, 12 were independently associated with in-hospital mortality and were applied as components of the risk model, including age, sex, body mass index, fulminant myocarditis aetiology, cardiac arrest in hospital, baseline veno-arterial extracorporeal membrane oxygenation use, mean arterial pressure, lactate, lactate dehydrogenase, total bilirubin, creatinine, and albumin levels. The comparison of predicted and observed in-hospital mortality according to the 7th quantiles using the J-PVAD risk score showed good calibration. The area under the curve for the J-PVAD risk score was 0.76 (95% confidence interval 0.73-0.78). In the validation cohort, the J-PVAD risk score showed good calibration and discrimination ability. CONCLUSIONS: The J-PVAD risk score can be calculated using variables easily obtained in routine clinical practice. It helps the accurate stratification of mortality risk and facilitates clinical decision-making.

Predictors of left ventricular ejection fraction in high-risk percutaneous coronary interventions.

Revascularization completeness after percutaneous coronary intervention (PCI) is associated with improved long-term outcomes. Mechanical circulatory support [intra-aortic balloon pump (IABP) or Impella] is used during high-risk PCI (HR-PCI) to enhance peri-procedural safety and achieve more complete revascularization. The relationship between revascularization completeness [post-PCI residual SYNTAX Score (rSS)] and left ventricular ejection fraction (LVEF) in HR-PCI has not been established. We investigated LVEF predictors at 90 days post-PCI with Impella or IABP support. Individual patient data (IPD) were analyzed from PROTECT II (NCT00562016) in the base case. IPD from PROTECT II and RESTORE-EF (NCT04648306) were naïvely pooled in the sensitivity analysis. Using complete cases only, linear regression was used to explore the predictors of LVEF at 90 days post-PCI. Models were refined using stepwise selection based on Akaike Information Criterion and included: treatment group (Impella, IABP), baseline characteristics [age, gender, race, New York Heart Association Functional Classification, LVEF, SYNTAX Score (SS)], and rSS. Impella treatment and higher baseline LVEF were significant predictors of LVEF improvement at 90 days post-PCI (p ≤ 0.05), and a lower rSS contributed to the model (p = 0.082). In the sensitivity analysis, Impella treatment, higher baseline LVEF, and lower rSS were significant predictors of LVEF improvement at 90 days (p ≤ 0.05), and SS pre-PCI contributed to the model (p = 0.070). Higher baseline LVEF, higher SS pre-PCI, lower rSS (i.e. completeness of revascularization), and Impella treatment were predictors of post-PCI LVEF improvement. The findings suggest potential mechanisms of Impella include improving the extent and quality of revascularization, and intraprocedural ventricular unloading.

Inpatient outcomes of mechanical circulatory support devices and heart transplantation in hypertrophic cardiomyopathy.

INTRODUCTION: The pathophysiology of HCM presents unique challenges for the management of cardiogenic shock and the use of mechanical circulatory support devices (MCSD). However, outcomes investigations for MCSD and HT in HCM patients is limited to case reports. The present study investigated MCSD and HT outcomes in HCM patients in a large retrospective cohort. METHODS: The National Inpatient Sample (2016-2019) was used for the retrospective analysis of patients hospitalized for MCSD and HT using ICD-10 codes. Patients with implantation of more than one device category were excluded. These patients were divided into two cohorts, with and without HCM, and compared in terms of in-hospital mortality, trends in mortality rates, hospitalization costs and mean length of stay. RESULTS: Among 267,780 patients hospitalized for MCSD and HT, 1155 patients had underlying HCM. Underlying HCM was associated with increased odds of mortality in patients receiving left ventricular assist devices (LVAD) (OR 3.4, 95% CI 1.03-11.2, p = 0.04) and temporary MCSD (OR 2.5, CI 1.8-3.6, p < 0.001). HCM was not associated with increased mortality in patients hospitalized for HT (OR 0.67, CI 0.15-2.85, p = 0.6). Patients with HCM undergoing MCSD and HT had a longer mean length of stay (22.1 vs 13.2 days, p = 0.004), and higher mean hospitalization charges ($830,103 vs $460,383, p < 0.0001) as compared to non-HCM patients. CONCLUSION: Underlying HCM is associated with increased in-hospital mortality in patients undergoing LVAD and temporary MCSD placement. Further prospective studies are required to expand our understanding of prognosis among HCM patients undergoing MCSD and establish management guidelines.

Left Ventricular Outflow Obstruction From Mechanical Circulatory Support in Critical Aortic Stenosis: A Cautionary Tale.

We submit a cautionary tale of a patient with critical aortic stenosis presenting with acute myocardial infarction and cardiogenic shock, who underwent balloon aortic valvuloplasty, insertion of a transvalvular left percutaneous ventricular assist device and high-risk percutaneous coronary intervention, with a post-operative course complicated by outflow obstruction from the device itself. (Level of Difficulty: Intermediate.).

Prognosis in Patients With Cardiogenic Shock Who Received Temporary Mechanical Circulatory Support.

Background: Temporary mechanical circulatory support (MCS) is often used in patients with cardiogenic shock (CS), and the type of MCS may vary by cause of CS. Objectives: This study sought to describe the causes of CS in patients receiving temporary MCS, the types of MCS used, and associated mortality. Methods: This study used a nationwide Japanese database to identify patients receiving temporary MCS for CS between April 1, 2012, and March 31, 2020. Results: Of 65,837 patients, the cause of CS was acute myocardial infarction (AMI) in 77.4%, heart failure (HF) in 10.9%, valvular disease in 2.7%, fulminant myocarditis (FM) in 2.5%, arrhythmia in 4.5%, and pulmonary embolism (PE) in 2.0% of cases. The most commonly used MCS was an intra-aortic balloon pump alone in AMI (79.2%) and in HF (79.0%) and in valvular disease (66.0%), extracorporeal membrane oxygenation with intra-aortic balloon pump in FM (56.2%) and arrhythmia (43.3%), and extracorporeal membrane oxygenation alone in PE (71.5%). Overall in-hospital mortality was 32.4%; 30.0% in AMI, 32.6% in HF, 33.1% in valvular disease, 34.2% in FM, 60.9% in arrhythmia, and 59.2% in PE. Overall in-hospital mortality increased from 30.4% in 2012 to 34.1% in 2019. After adjustment, valvular disease, FM, and PE had lower in-hospital mortality than AMI: valvular disease, OR: 0.56 (95% CI: 0.50-0.64); FM: OR: 0.58 (95% CI: 0.52-0.66); PE: OR: 0.49 (95% CI: 0.43-0.56); whereas HF had similar in-hospital mortality (OR: 0.99; 95% CI: 0.92-1.05) and arrhythmia had higher in-hospital mortality (OR: 1.14; 95% CI: 1.04-1.26). Conclusions: In a Japanese national registry of patients with CS, different causes of CS were associated with different types of MCS and differences in survival.

Use of an argatroban systemic infusion and purge solution in a patient with a percutaneous ventricular assist device with suspected heparin-induced thrombocytopenia.

PURPOSE: Thrombocytopenia can occur when using an Impella percutaneous ventricular assist device (pVAD), and heparin-induced thrombocytopenia (HIT) is often suspected. Data on heparin- and anticoagulant-free purge solutions in these devices are limited. Previous case reports have described argatroban-based purge solutions, both with and without systemic argatroban, at varying concentrations in patients with known or suspected HIT. SUMMARY: A 33-year-old male was transferred to our institution and emergently initiated on life support with venoarterial extracorporeal membrane oxygenation (ECMO), an Impella pVAD, and continuous venovenous hemofiltration to receive an urgent aortic valve replacement. Over the next several days, the patient's platelet count declined with a nadir of 17 × 103/µL on hospital day 13. The patient's 4T score for probability of HIT was calculated as 4. All heparin products were discontinued on hospital day 15, and the patient was initiated on systemic infusion with argatroban 1,000 µg/mL at a rate of 0.2 µg/kg/min with a purge solution of argatroban 0.05 mg/mL. The systemic infusion remained at a rate of 0.2 µg/kg/min, and the total argatroban dose was, on average, less than 0.25 µg/kg/min. On hospital day 21, the patient was transferred to another institution. CONCLUSION: Systemic infusion and a purge solution with argatroban were used in a patient with an Impella pVAD with multisystem organ dysfunction and suspected HIT. The patient achieved therapeutic activated partial thromboplastin times without adjustment of the systemic argatroban infusion and did not experience bleeding or thrombosis. Further studies concerning the safety and effectiveness of argatroban-based purge solutions in patients with pVADs are needed.

Can we have a rationalized selection of intra-aortic balloon pump, Impella, and extracorporeal membrane oxygenation in the catheterization laboratory?

Cardiac assistance represents an emerging issue in cardiovascular medicine. The evolution of invasive cardiology techniques is making the catheterization laboratory one of the main hospital sites where implantation of percutaneous ventricular assistance devices (PVADs) is discussed and performed. Among available PVADs, intra-aortic balloon pump (IABP), Impella, and extracorporeal membrane oxygenation (ECMO) are the most popular and offer completely different levels and ways to assist critical patients. The main settings calling for PVAD consideration in the catheterization laboratory are clinically indicated high-risk patients (CHIP) undergoing percutaneous coronary intervention (PCI) and patients with cardiogenic shock or refractory cardiac arrest. In CHIP, PVAD serves the purpose of preventing hemodynamic collapse during PCI. This may also allow more extensive revascularizations and higher quality revascularization plans (imaging use, debulking, stent result optimization). IABP or Impella are more commonly selected whereas ECMO is seldom considered as a third option for highly selected patients. The "elective" nature of CHIP-PCI should allow careful procedure planning (peripheral artery disease assessment, access site selection and management) in order to minimize vascular/bleeding complications. Cardiogenic shock is still associated with high mortality rates, and PVAD theoretically offers further recovery chances. The lack of benefit observed with systematic IABP use is currently prompting consideration of the roles of Impella and ECMO. Prolonged assistance is often needed. Thus, team decisions and shared protocols for PVAD selection have to be promoted, taking into consideration available resources and operators' skills. In this paper, we critically review the available data in the field and highlight the possible decisionmaking hubs that catheterization-laboratory teams may consider in order to rationalize PVAD selection.

Mechanical Left Ventricular Unloading in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) increases left ventricular (LV) afterload, potentially provoking LV distention and impairing recovery. LV mechanical unloading (MU) with intra-aortic balloon pump (IABP) or percutaneous ventricular assist device (pVAD) can prevent LV distension, potentially at the risk of more complications, and net clinical benefit remains uncertain. OBJECTIVES: This study aims to determine the association between MU and outcomes for patients undergoing VA-ECMO. METHODS: The authors queried the Extracorporeal Life Support Organization registry for adults receiving peripheral VA-ECMO from 2010 to 2019 and stratified them by MU with IABP or pVAD. The primary outcome was in-hospital mortality; secondary outcomes included on-support mortality and complications during VA-ECMO. RESULTS: Among 12,734 VA-ECMO patients, 3,399 (26.7%) received MU: 2,782 (82.9%) IABP and 580 (17.1%) pVAD. MU patients were older (age 56.3 vs 52.7 years) and, before extracorporeal membrane oxygenation, more often required >2 vasopressors (41.7% vs 27.2%) and had respiratory (21.1% vs 15.9%), renal (24.6% vs 15.8%), and liver failure (4.4% vs 3.1%) (all P < 0.001). MU patients had lower in-hospital mortality (56.6% vs 59.3%, P = 0.006), which persisted in multivariable modeling (adjusted OR [aOR]: 0.84; 95% CI: 0.77-0.92; P < 0.001). MU was associated with more cannula site bleeding (aOR: 1.25; 95% CI: 1.11-1.40; P < 0.001) and hemolysis (aOR: 1.27; 95% CI: 1.03-1.57; P = 0.02). Compared to pVAD, MU patients with IABP had similar mortality (aOR: 0.80; 95% CI: 0.64-1.01; P = 0.06) and less medical bleeding (aOR: 0.45; 95% CI: 0.31-0.64; P < 0.001), cannula site bleeding (aOR: 0.72; 95% CI: 0.54-0.96; P = 0.03), and renal injury (aOR: 0.78; 95% CI: 0.62-0.98; P = 0.03). CONCLUSIONS: Among adults receiving VA-ECMO, MU was associated with lower in-hospital mortality despite increased complications including hemolysis and cannulation site bleeding. Compared to pVAD, MU with IABP was associated with similar mortality and lower complication rates.

Hemolysis during short-term mechanical circulatory support: from pathophysiology to diagnosis and treatment.

INTRODUCTION: Despite advances in heart failure therapies and percutaneous coronary interventions, survival for cardiogenic shock remains poor. Percutaneous ventricular assist devices (pVAD) are increasingly used, but current evidence remains conflicting. The Impella is an example of such a device, based on a catheter mounted micro-axial continuous flow pump, that has been rapidly adopted in routine practice. An important aspect of postimplantation care is the prevention of complications. Hemolysis is one of the most frequent complications seen with this device. AREAS COVERED: In this review, we discuss the pathophysiology, diagnosis and treatment of hemolysis in patients supported with a pVAD. A practical algorithm for rapid identification of hemolysis and the underlying cause is presented, allowing for early treatment and prevention of further complications. EXPERT OPINION: Hemolysis remains a threat to patients supported with any mechanical circulatory support device. Prevention as well as treatment demands for sufficient knowledge about the device, the optimal position, and hemodynamics. Future studies should try to clarify some of the elements that are still unclear, such as optimal anticoagulation, the location of pentoxifylline, or extracorporeal removal of free hemoglobin. This could help to optimize outcomes in clinical practice as well as future studies.

Left Ventricular Support for Unprotected Left Main Coronary Artery Interventions (The Dayton Heart and Vascular Impella Registry).

Background: Coronary artery bypass grafting is the standard of care for patients with obstructive left main (LM) coronary disease. In poor surgical candidates, high-risk percutaneous coronary artery intervention (PCI) is an alternative. Methods: We investigated a retrospective cohort of patients who underwent LM PCI from January 2010 to March 2014 (n = 89). Obstructive LM disease was defined as 50% angiographic obstruction of luminal flow, and the primary endpoint was inhospital mortality. Ventricular assist device (VAD) was defined as the use of either intra-aortic balloon pump (IABP) or Impella 2.5 devices before, during, or following PCI. Results: A total of 89 patients with LM PCI were divided into those with (n = 39) and without (n = 50) VAD support. The former group was further divided into those with support from either Impella 2.5 (n = 28) or IABP (n = 11). Age, race, and gender did not differ between patients who received unassisted LM-PCI from those with VAD support (P = 0.142, 1.0, and 0.776, respectively). The angiographic stenosis of atherosclerotic lesions in LM, proximal left anterior descending artery, and other native/surgical coronary vessels was similar between the groups. The duration of hospitalization was significantly longer for patients with VAD support compared to those without (7.19 ± 6.89 vs. 2.78 ± 3.39, P < 0.001). The incidence of cardiogenic shock and inhospital mortality was significantly higher in the VAD group (P = 0.009 and 0.001, respectively). Overall, inhospital mortality was 9% (8/89). The IABP and Impella 2.5 groups had mortality proportions of 46% (5/11) and 11% (3/28), respectively; P = 0.028. For all patients, inhospital mortality was higher for those with versus without cardiogenic shock (56% or 5/9 vs. 4% or 3/80; P < 0.001), and for those with versus without left ventricular systolic function <40% (17% vs. 2%;P < 0.025). Conclusion: In a selected group of patients with LM disease, unsupported PCI appears to be a feasible and safe procedure. In high-risk patients, the use of Impella 2.5 appears to be superior to IABP in LM PCI resulting in favorable short-term outcomes.

Percutaneous Ventricular Assist Device Fracture in the Right Ventricle and its Retrieval.

Mechanical circulatory support devices are used to offer short-term support for patients with cardiogenic shock. However, these devices are not without complications, and the risk and management of each must be closely considered. We discuss an infrequent complication of the percutaneous right heart pump and review complications reported to the U.S. Food and Drug Administration. (Level of Difficulty: Intermediate.).