Durable VAD Research Articles

Extending the window in clinical decision making: the role for Impella 5.5 in cardiogenic shock

Abstract Background Acute decompensated heart failure (HF) refractory to medical management deteriorates quickly to cardiogenic shock, ultimately requiring mechanical circulatory support (MCS). These devices aim to provide circulatory support as a bridge to advanced therapies. We report patient outcomes with the latest minimally invasive temporary MCS device: Impella 5.5 with SmartAssist. Methods All patients who underwent Impella 5.5 implantation between January 2020 and December 2023 were analyzed. Duration of Impella support and peri-implant parameters were collected from electronic medical records. ANOVA was performed and utilized a p-value of <0.05 as significant for statistical analysis. Results During our review period, a total of 99 patients were supported with Impella 5.5 in the setting of cardiogenic shock. 92 were bridged to heart transplant (BTT), of which 17 also received combined kidney transplantation. Two underwent durable VAD implantation (BTVAD), and 3 had native heart recovery (BTR) and explant. Two patients died, yielding a survival rate of 98%. For BTT group, the median age was 60 years (52-65) at implant and a median BMI of 27 kg/m² (24-31) with a mean support duration of 29 days (SD ±24). Baseline GFR was 49 mL/min/1.73m² (35-65). In the BTVAD group, the median BMI was 43 kg/m² (39-46) with an average duration of support of 22 days (SD ±8) with a GFR of 55 mL/min/1.73m² (38-73). The BTR group had a median BMI of 29 kg/m² (27-30) with an average duration of support of 15 days (SD ±7) and a lower baseline GFR of 36 mL/min/1.73m² (26 – 37) compared to BTT or BTVAD. The two patients that died were supported for an average of 42 days (SD ±9.2) and expired due to non-candidacy in the setting of newly detected prostate cancer in one patient and multi-organ failure in another. All BTVAD and BTT patients did not have a stroke or major vascular complications before terminal therapy. Conclusion Our center highlights the role of early Impella 5.5 placement in the stabilization of patients in cardiogenic shock, thereby providing both patients and providers time for decision-making while optimizing end-organ perfusion beyond the accepted duration of 14 days.Impella Data - Entire CohortImpella Data - Stratified by Outcome

Effect of RVAD Cannulation Length on Right Ventricular Thrombosis Risk: An In Silico Investigation

Left ventricular assist devices (LVADs) have been used off-label as long-term support of the right heart due to the lack of a clinically approved durable right VAD (RVAD). Whilst various techniques to reduce RVAD inflow cannula protrusion have been described, the implication of the protrusion length on right heart blood flow and subsequent risk of thrombosis remains poorly understood. This study investigates the influence of RVAD diaphragmatic cannulation length on right ventricular thrombosis risk using a patient-specific right ventricle in silico model validated with particle image velocimetry. Four cannulation lengths (5, 10, 15 and 25 mm) were evaluated in a one-way fluid–structure interaction simulation with boundary conditions generated from a lumped parameter model, simulating a biventricular supported condition. Simulation results demonstrated that the 25-mm cannulation length exhibited a lower thrombosis risk compared to 5-, 10- and 15-mm cannulation lengths due to improved flow energy distribution (25.2%, 24.4% and 17.8% increased), reduced stagnation volume (72%, 68% and 49% reduction), better washout rate (13.0%, 11.6% and 9.1% faster) and lower blood residence time (6% reduction). In the simulated scenario, our findings suggest that a longer RVAD diaphragmatic cannulation length may be beneficial in lowering thrombosis risk; however, further clinical studies are warranted.

Mechanical circulatory support in pediatric myocarditis: Support strategies and outcomes in a nationally representative cohort

Myocarditis is a common cause of pediatric heart failure which may require mechanical circulatory support (MCS). The purpose of this study is to describe MCS strategies used in a nationwide cohort of pediatric patients with myocarditis, identify trends over time, and compare outcomes between MCS strategies. This study utilized the Kids' Inpatient Database (KID), a national sample of administrative discharge data. KID admissions from 2003-2016 were queried using ICD-9/10 codes to identify those with a diagnosis of myocarditis. MCS outcomes were compared using logistic regression. Of 5,661 admissions for myocarditis, MCS was used in 424 (7.5%), comprised of extracorporeal membrane oxygenation (ECMO) in 312 (73.6%), including 32 (10.2%) instances of extracorporeal cardiopulmonary resuscitation (ECPR), temporary ventricular assist devices (tVAD) in 28 (6.6%), durable VAD (dVAD) in 42 (9.9%) and combination MCS in 42 (9.9%). MCS use increased over time (p=0.031), but MCS strategies did not significantly change. Mortality was high in the MCS group (28.3%). There was no difference in odds of death in the VAD only or combination MCS group compared to the non-ECPR ECMO group (p=0.07 and p=0.65, respectively). MCS is used in 1 in 13 pediatric myocarditis cases, and MCS use is increasing over time with ECMO remaining the most frequently used modality. Mortality remains high in patients that receive MCS but does not differ between those receiving VAD or combination MCS as compared to non-ECPR ECMO on unadjusted analysis. Further prospective analysis is required to evaluate the relative effectiveness of MCS modalities in this disease.

Abstract 18803: Extended Duration Impella Support: A Review of 107 Patients Successfully Supported With Impella 5.5 Device at a Single Institution

Introduction: Impella 5.5 is an FDA-approved microaxial, continuous flow pump intended to provide left ventricular hemodynamic support for 14 days. We report 107 consecutive patients supported with this device, many for extended durations. Methods: The outcomes of consecutive patients supported with Impella 5.5 at an academic hospital from March 2021 to June 2023 are included. Results: 107 patients required 112 Impella 5.5 devices. The majority of patients had a heart failure etiology of NICMP (57, 53%), followed by ICMP (36, 34%), post cardiotomy shock (6, 5%), other (4, 4%), planned post cardiotomy cardiac protection (3, 3%), and congenital heart disease (1, 1%). 60 patients (56%) were SCAI D, 30 patients (28%) SCAI E, and 17 patients (16%) were SCAI C. The majority patients (70,65%) were Intermacs 2. The majority of Impella 5.5 devices were placed as a bridge to decision (55 patients, 51%), followed by BTT (28 patients, 26%), BTR (16 patients, 15%), Bridge to LVAD (7 patients, 7%), and one patient (1%) device was placed for post cardiotomy cardiac protection. 11 patients required interval escalation to concomitant VA-ECMO. Patients requiring ECPELLA were placed on PVA ECMO after an average of 22 days of impella support, and average time of support on ECPELLA was 5.4 days. All patients transitioned to cardiac replacement therapy. Among patients with explant data, 43 supported for < 2 weeks, 38 for 2-4 weeks, and 17 for > 4 weeks. Longest duration of support was 92 days. Of patients reaching a primary endpoint, 42 were transplanted (39%), 21 patients died (20%), 18 patients received durable VAD (17%), 12 were discharged without transplant or VAD (11%), 10 were transferred while on support (9%) and 4 patients are still supported (4%). With respect to complications, 5 patients suffered from strokes, 3 pump thrombosis, 2 had fiber optic cable malfunctions, 2 had purge line leaks, and there were 3 patients with a broken optical sensor, and 2 arterial (brachial and axillary) thrombus. Conclusion: The Impella 5.5 device is a left ventricular support device placed most frequently to successfully stabilize patients undergoing evaluation for advanced therapies who were failing despite inotropic therapy.

P102: Hemodynamic Ramp Studies in Continuous Flow Ventricular Assist Device in Fontan Patients: A Case Series

Purpose: There is limited experience in patients with single ventricle physiology using the Heartmate III (HM3). With a growing population of failing Fontan patients and long wait times for cardiac transplantation, the need for an appropriate strategy for durable mechanical support is increasing. Determination of the best strategies to optimize the HM3 device in Fontan circulation has not yet been elucidated. Methods: A retrospective case series of three patients with failing Fontan on VAD who underwent ramp studies by cardiac catheterization were reviewed with the intent of optimizing hemodynamics. Results: All patients had hypoplastic left heart syndrome, completed Fontan, and were on durable VAD. Patient 1 was a 19y male on a Heartware at 2640 rpm. Initial hemodynamics with a PCWP of 25 mmHg and Fontan pressure of 25 mmHg. Increase in RPM to 2900 bpm showed no change in Fontan pressure and decrease in PCWP to 20 mmHg. No change on adjustment back to 2700 RPM though improvement noted in tricuspid regurgitation in echocardiogram. Patient 2 was a 13y male on HM 3 at 5000 rpm with PCWP 15 mmHg and Fontan 19 mmHg. Tricuspid regurgitation on echocardiogram improved from moderate to mild and final VAD speed was 5200 RPM. Patient 3 was a 12y male on HM3 at 5100 rpm with PCWP of 15 mmHg and Fontan 18 mmHg. Increase up to 5500 RPM with no change in PCWP and Fontan at 17mmHg. Final speed at 5200 RPM with PCWP of 14mmHg and Fontan 17 mmHg. Conclusions: Significant hemodynamic changes on catheterization ramp study were not found. Increase in support from the VAD was made due to clinical indications and echocardiographic assessment of atrioventricular valve regurgitation. Hemodynamic data was useful in reassuring that changes made to the device were not detrimental to the patient. Further data on ramp studies and indications for changes in device speed will be useful in the care of these patients.

P66: Incidence of DVT formation in patients requiring temporary mechanical circulatory support for cardiogenic shock

Background: After the 2018 UNOS organ allocation change, temporary mechanical circulatory support (tMCS) has increased in managing acute decompensated heart failure (ADHF) as a bridge to transplant, recovery, or durable VAD. However, patients supported with tMCS are more prone to complications. Deep venous thrombosis (DVT) is one of the most common complications in this patient population. DVT is associated with an increased risk of pulmonary embolism, stroke, chronic venous insufficiency, and increased length of hospital stays. We aimed to identify the incidence of DVT in ADHF patients supported with tMCS. Method: We performed a retrospective review of patients with ADHF who had undergone heart or heart/kidney transplantation between January 2021 and November 2022 at Mayo Clinic in Florida. Patient data were extracted from the electronic health record after IRB approval as exempt for retrospective chart review was obtained. Our primary outcome was DVT during the transplant, diagnosed by venous duplex ultrasonography. Results: 93 patients with ADHF were found during our review period, of which 46 (49%) developed a DVT. The median age was 60 years (53 – 67), with 65% male. All but one DVT was in the upper extremity. Within the DVT population, 75% were hypertensive (p <.001), 64% were diabetic (p =.003), 78% had hyperlipidemia (p<.001), and had elevated mean creatinine of 2.16 vs. 1.55 (p =.04). A total of 44 patients required tMCS, of these, 26 patients developed DVT (59%) which was statistically significant compared to 18 that did not develop DVT while on tMCS, p =.04. The combination of support was as follows: 27 axillary Impella 5.5 alone, 5 VA ECMO without LV vent, 1 VA ECMO with IABP vent, 4 VA ECMO with Impella 5.5 vent, and 7 intra-aortic balloon pumps only. Ischemic cardiomyopathy was not a significant risk for DVT, p =.372. The median ejection fraction was 25% (15 -55). The median LOS was 48 days (31 – 74). Patients with DVT were found to have a significantly lower BMI, 26.4 vs 29.3 (p =.002), as well as a significantly shorter cardiopulmonary bypass time of 187min vs. 296 min (p <.001). Conclusions: We found increased rates of DVT in patients utilizing all forms of tMCS with ADHF. Factors influencing the development of DVT may relate to an overall increased inflammatory state, evidenced by our data showing significant differences in rates of hypertension, diabetes, hyperlipidemia, worse renal function, and sarcopenia. Chronicity of disease, time in the hospital, and the need for more procedures may also influence DVT risk in patients awaiting transplantation or LVAD.

P61: Novel use of newer intravascular ambulatory systemic ventricular assist devices as a bridging strategy for cardiogenic shock with pulmonary hypertension in patients with complex congenital cardiac conditions

Background: Cardiogenic shock [CS] in patients with failing systemic ventricles is associated with high mortality. Suitable patients maybe successfully bridged using newer intravascular ambulatory left ventricular assist devices [Impella 5.5, Abiomed, Danvers, MA] as a bridge to transplantation. We report our successful experience with two such patients. Methods: Between January 2022 and January 2023, 2 patients underwent trans-axillary artery placement of LV Impella 5.5 for CS as a bridge to heart transplant. Both these patients had previously undergone a Senning operation for transposition of the great arteries, and presented with failing systemic ventricle with pulmonary hypertension. Results: Two patients [patient 1: 36 years, patient 2: 38 years] presented to our unit with cardiogenic shock. They underwent trans-axillary artery placement of LV Impella 5.5 into the systemic ventricle for CS as a bridge to decision for high pulmonary vascular resistance [PVR]. Heart and lung transplantation was considered, but the patients declined and opted to pursue strategy for heart transplant alone. Following 30 and 50 days on impella 5.5 support in patients 1 and 2 respectively, along with intravenous diuretics and milrinone 0.25mcg/kg/min, there was reversal of pulmonary hypertension [Table-1]. Both patients underwent successful redo-sternotomy and heart transplantation. Second patient required 48-hours of extra-corporeal membrane oxygenator [ECMO] support for primary graft dysfunction, increased immunosuppression for grade 2 rejection, and temporary renal replacement therapy. Both patients recovered and were discharged home. Conclusions: We report successful outcomes in these two patients who had previously undergone complex congenital heart surgery, and had presented to us in cardiogenic shock with failing systemic ventricles and severe pulmonary hypertension, which hitherto would have precluded cardiac transplantation alone. Utilization of Impella 5.5 for cardiogenic shock in these patients facilitated successful reversal of pulmonary hypertension and therefore, a successful cardiac transplantation without resorting to durable VAD placement or heart-lung transplantation in this difficult cohort of patients. Furthermore, impella 5.5 placement helped avoid femoral ECMO completely, with its inherent problems of immobility, bleeding, infections, limb ischemia, and muscle wasting, and greatly facilitated early ambulation and rehabilitation while awaiting a suitable organ. Table 1. - Pre transplant hemodynamics in both patients PAS PAD PAM PCWP TPG PVR RA CI CO PA Sat P1 Baseline 80 50 60 38 22 10 22 1.1 2.2 34% P1 Day-30 impella 45 20 28 18 10 2 7 2.7 5 59% P2 Baseline 88 50 64 41 23 4.8 18 3 4.7 58% P2 Day-50 impella 57 26 36 16 20 2.5 7 4 7.3 74% PAS/D/M: pulmonary artery systolic/diastolic/mean pressures; PCWP: pulmonary capillary wedge pressure; TPG: trans pulmonary gradient; RA: right atrial pressure. All in mmHg. PVR: pulmonary vascular resistance in wood units CI: cardiac index in liters/minute/square meter body surface area; CO: cardiac output in liters/minute; PA sat: pulmonary artery oxygen saturation

TOP4: Measuring patient alcohol intake pre and post-LVAD implant – what’s in a number?

Background: Our center routinely screens advanced heart failure patients for unhealthy alcohol use as part of their initial evaluation. One assessment tool utilized is the phosphatidylethanol (PEth) blood concentrations in the blood. PEth is a biomarker that measures the presence of ethanol with a half-life of 4-10 days and a window of detection of 2-4 weeks. The detection window can be longer in patients with excessive alcohol intake. Based on literature reviews, PEth values can be classified as: Light or no Consumption (<20 ng/mL), Significant Consumption (20–199 ng/mL), or Heavy Consumption (>200 ng/mL). Utilizing the PEth testing, we sought to determine: did preop PEth level correlate with alcohol consumption reported during evaluation; did PEth level increase immediately after implant due to blood transfusions and did random PEth screenings six months after implant correlate with preop values and patient reported alcohol intake. The literature suggests that alcohol consumption increases risk of GI bleeds which contributes to patient morbidity while on left ventricular assist device (LVAD) therapy. We sought to determine if elevated PEth levels in patients post-implant were associated with any bleeding after implant. Method: PEth levels were collected in 16 Heartmate 3 LVAD patients within 24 hours of LVAD implant, three business days after LVAD implant and 90 days after LVAD implant. Test was determined to be negative when PEth value was <20ng/ml. The study period was from March 2022 – October 2022. Results: Of the 16 patients, only 2 had positive PEth screening pre-implant for durable VAD. The 2 patients who were positive pre-implant had confirmed alcohol use during their pre-implant psychosocial assessment. Interestingly, 1 patient had positive PEth 3 days post implant and associated subarachnoid hemorrhage and surgical bleeding. This patient PEth level pre-implant was negative and he was hospitalized the entire pre-operative period suggesting that the blood he received at implant may have been the cause of this positive PEth. Of the 16 patients, a total of 6 were identified as having any bleeding post-operatively and none of those six patients had a positive PEth pre-implant. Conclusion: PEth levels are helpful in assessing alcohol intake in our LVAD patients pre/post-implant. PEth provides clinicians with an objective measurement for further discussions with patients about their alcohol intake and how alcohol use can have negative impacts on survival post-VAD. There is little evidence from our small study to suggest that blood transfusions can cause elevated PEth levels. Our data suggests PEth can provide clinicians with an objective measurement to assess patient alcohol intake. PEth assists the clinical team in addressing the amount of alcohol consumption as PEth values >20ng/ml are associated with moderate consumption and >200ng/dl indicate heavy drinking patterns. Further studies are needed for validation.

(797) Implantation from Short Term MCS to Durable VAD: Single Center Experience

(797) Implantation from Short Term MCS to Durable VAD: Single Center Experience

(643) The New Heart Allocation System Change and DCD Heart Availability: Effects on Durable VAD Patients

(643) The New Heart Allocation System Change and DCD Heart Availability: Effects on Durable VAD Patients

Abstract 14482: Clinical Impact of Advances of Short-Term Mechanical Circulatory Support Devices and Therapeutic Strategies in Patients With Cardiogenic Shock

Introduction: Although revised US adult heart allocation system has provided the opportunity of urgent heart transplantation and improved clinical outcomes in urgent patients, it may not offer select temporary mechanical circulatory support (MCS) patients the opportunity and adequate time to recover to the point of waitlist removal. Severe donor shortages have increased the need for assessment of reversibility of cardiac function. Advances of MCS devices may provide the longer time to assess the appropriate therapeutic strategy. Hypothesis: The aim of this study was to evaluate the impact of bridge-to-decision (BTD) strategies which used recently developed short-term MCS devices strategies. Methods: We retrospectively reviewed the medical records of 108 patients who received BTD strategies from January 2017 to February 2022. Results: Etiology of cardiogenic shock were myocarditis (35.2 %), idiopathic cardiomyopathy (26.0 %) and ischemic cardiomyopathy (30.5 %). Ninety-three (86.1%) had been used any temporary MCS prior to BTD strategy using short-term MCS devices, including intra-aortic balloon pumping, peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) and low-flow percutaneous VAD. Sixty-five (60.2 %) had been inserted extracorporeal centrifugal-flow pump VAD (CF-VAD group), twenty-eight (25.9 %) had high-flow percutaneous VAD (P-VAD group) including with ECMO (ECPELLA) (50 %), and fifteen (13.9 %) had extracorporeal pulsatile-flow pump VAD (PF-VAD group). Duration of short-term MCS support was 42.5±44.1 days. Twenty-five (23.1 %) needed the conversion to other pumps. Forty-eight (40.7%) were withdrawn for recovery of cardiac function (mean duration to decision; 27.7±23.8 days), other forty-eight (40.7 %) were implanted durable implantable VAD for no-recovery of cardiac function (mean duration to decision; 48.4±40.7 days). Twenty patients (18.5 %) died. Clinical prognosis was comparable in three groups (P=0.943). Conclusions: BTD strategies using recently developed short-term MCS devices provided relatively long-term support duration to decision for definitive therapy, and showed favorable clinical outcomes. However, conversion or exchange to other pumps was needed for long-term support.

Heart transplantation after total artificial heart bridging-Outcomes over 15 years.

Data are limited on outcomes after heart transplantation in patients bridged-to-transplantation (BTT) with a total artificial heart (TAH-t). The UNOS database was used to identify 392 adult patients undergoing heart transplantation after TAH-t BTT between 2005 and 2020. They were compared with 11014 durable left ventricular assist device (LVAD) BTT patients and 22348 de novo heart transplants (without any durable VAD or TAH-t BTT) during the same period. TAH-t BTT patients had increased dialysis dependence compared to LVAD BTT and de novo transplants (24.7%vs. 2.7%vs. 3.8%) and higher levels of baseline creatinine and total bilirubin (all p<.001). After transplantation, TAH-t BTT patients were more likely to die from multiorgan failure in the first year (25.0%vs. 16.1%vs. 16.1%, p=.04). Ten-year survival was inferior in TAH-t BTT patients (TAH-t BTT 53.1%, LVAD BTT 61.8%, De Novo 62.6%, p<.001), while 10-year survival conditional on 1-year survival was similar (TAH-t BTT 66.8%, LVAD BTT 68.7%, De Novo 69.0%, all p>.20). Among TAH-t BTT patients, predictors of 1-year mortality included higher baseline creatinine and total bilirubin, mechanical ventilation, and cumulative center volume <20 cases of heart transplantation involving TAH-t BTT (all p<.05). Survival after TAH-t BTT is acceptable, and patients who survive the early postoperative phase experience similar hazards of mortality over time compared to de novo transplant patients and durable LVAD BTT patients.

In Search for the Right Partner. First Multicenter Results of the Hybrid VAD Procedure cfLVAD and Durable Paracorporeal RVAD

<h3>Purpose</h3> Continuous-flow durable left ventricular assist devices (cfLVAD) has become routine treatment for severe heart failure nowadays. Fully implantable cfLVAD are safe, reduce mortality and allow for high patient comfort. However, right ventricular (RV) failure (early or late after cfLVAD) remains a crucial limitation and is associated with high morbidity and mortality. Temporary RVAD fails to reverse RV-Failure in 9-42%. RV-Failure prediction models exhibit heterogeneous derivation and validation methodologies with insufficient power of prognosis of RV-Failure. Results of cf-BIVAD are limited and application remains "off-label-use" while pulsatile paracorporeal RVAD treatment is approved with excellent data. Pulsatile RVAD flow is precise, physiological and prevents lung hyperperfusion. The purpose of this national multi-center trial was to evaluate the results of the durable Hybrid VAD strategy using 3rd generation continuous flow left ventricular assist devices (cf-LVAD) and a paracorporeal pulsatile right ventricular Assistent device (RVAD). <h3>Methods</h3> We retrospectively analyzed 10 consecutive patients (8 male, 80%; 43.1 ± 17.9 years) who underwent permanent cfLVAD and durable pulsatile RVAD implantation (Berlin Heart EXCOR) subsequently for end-stage heart failure and impaired right heart function. The durable RVAD implantation was performed on CPB and beating heart with a sternotomy approach. Bridge-to-transplantation (BTT) was intended in all cases. The procedure was performed one-staged in 50% of all cases. <h3>Results</h3> INTERMACS class on cfLVAD at time of pulsatile RVAD implantation was class I in 9 (90%) and class II in 1 case (10%) with temporary MCS in 9 cases (90%) using ECLS in 7 (77.8%) and temporary RVAD in 2 patients (22.2%). Upon follow up survival was 70% with 5 (50%) patients transplanted, 2 patients on ongoing hybrid support and 3 patients deceased. Time on hybrid-device was 140.3 ± 122.1 days. <h3>Conclusion</h3> Intention to treat heart failure with cfLVAD alone is comprehensive and sensible if applicable. There is a need for bail-out strategy for early/late RV-Failure beyond temporary RVAD. With our initial results we here provide the very first evidence of the Hybrid VAD support with promising results. Hybrid VAD procedure is associated with good survival (70%) allowing for sufficient preparation for heart transplant (BTT).

Characteristics and Outcomes of Patients Supported with Impella Percutaneous VAD Device at Pediatric Institutions: Action Collaborative Experience

<h3>Purpose</h3> We describe Advanced Cardiac Therapies Improving Outcomes Network (ACTION) pediatric multicenter experience with Impella® percutaneous ventricular assist device (PVAD) support for management of cardiogenic shock. <h3>Methods</h3> Retrospective review of patients supported with a Impella PVAD 15 pediatric centers participating in ACTION Collaborative from 10/2014 to 09/2021. Only patients supported with Impella PVAD alone were included. Demographics, device, and outcomes data was reviewed and reported using descriptive statistics. <h3>Results</h3> Total of 47 patients met the inclusion criteria. Median age was 16.1 years (range 6.38,34.4), weight 65.0 kg (range 29.6,124), and BSA 1.75 m² (range 1.05,2.52). PVAD was used most often for transplant graft dysfunction (40.4%) followed by dilated cardiomyopathy/myocarditis (31.9%), end stage congenital heart disease (14.9%) and others (12.5%). INTERMACS Profile 1 was reported in 42.6%, Profile 2 in 42.6%, and Profile 3 in 10.6%. Strategies for support included bridge to recovery (55.3%), bridge to transplant (23.4%) and bridge to decision (19.1%). Ten patients (21.3%) were bridged to durable VAD support. Impella CP was used in 64% cases, 5.0 in 18% and 5.5 in 18%. Nine (19%) patients had >1 device implanted. Anticoagulation was achieved with unfractioned heparin in 91% and a direct thrombin inhibitors in 9%. Median duration of support was 5.5 days (range 1,116) on CP device, 27 days (range 6,64) on 5.5 device and 21.5 days (range 8,143) on 5.0 device. Most common device complications included hemolysis (39.0%), major bleeding (15.3%), device malfunction (13.6%), renal failure (8.5%), arterial non-CNS thrombus (5.1%), and cardiac arrhythmia (3.2%). There were no neurological events. A positive clinical outcome was achieved in 85% of patients (77% survived to explant; 8% alive on device). <h3>Conclusion</h3> This study reports the Impella PVAD pediatric multi center experience for support of cardiogenic shock, with overall low morbidity and satisfactory survival benefit for a high-risk population. This device should be considered as part of the mechanical support armamentarium used in management of cardiogenic shock. Further investigation into optimal patient selection and support environment is needed to optimize its use in pediatric institutions and minimize adverse events.

Systemic Right Ventricle Mechanical Support with Impella 5.5 as a Bridge to Cardiac Transplantation

<h3>Introduction</h3> A 39-year-old man with Senning atrial switch for dextro-transposition of the great arteries (d-TGA) presented with systemic right ventricle (RV) failure and cardiogenic shock. He had Impella 5.5 percutaneous mechanical support for his systemic RV and received cardiac transplantation 42 days later. To our knowledge, this has not been previously reported in the literature. <h3>Case Report</h3> A 39-year-old man with Senning atrial switch for d-TGA and long-standing systemic RV dysfunction on heart failure medical and resynchronization therapy was transferred for cardiogenic shock. Diuresis was unsuccessfully attempted with a furosemide drip, so inotropes and evaluation for advanced heart failure therapies were initiated. His condition initially improved, but on hospital day 8, he had a ventricular fibrillation cardiac arrest, requiring cardiopulmonary resuscitation and emergent femoral intra-aortic balloon pump (IABP) placement. Right heart catheterization showed cardiac index of 2.16 L/min/m^2 on milrinone, dobutamine, and IABP. He continued to clinically deteriorate. After multidisciplinary discussions, an axillary Impella 5.5 device was placed under fluoroscopic and TEE guidance. The device could not be rotated posteriorly away from the RV free wall due to the opposing posterior orientation of the atrioventricular valve and anterior course of the innominate artery (figure). However, there was significant hemodynamic improvement and no arrhythmias, so device was secured. He was listed for heart transplantation as UNOS Status 2. Forty-two days after Impella placement, a suitable donor heart became available. He underwent successful transplant with initial biopsy showing no rejection. He was discharged on post-operative day 12 and continues to do well as an outpatient. <h3>Summary</h3> Impella 5.5 device implantation in the systemic RV is a feasible strategy for patients with d-TGA and atrial switch awaiting durable VAD or transplant.

Outcomes of a multidisciplinary shock team utilizing an integrated medical/surgical strategy: The Penn Medicine Shock Model

Background Cardiogenic shock (CS) is associated with poor prognosis, with mortality rates in excess of 40-50%. Multidisciplinary shock teams have been created to facilitate early diagnosis and appropriate escalation of support. However, there are varying approaches to implementation, resulting in variable outcomes. We describe our team's approach and outcomes over 18 months. Shock team Approach : The Penn Medicine Cardiogenic Shock Team (PMCST) was established in November 2019 and consists of physicians from Interventional Cardiology, Electrophysiology, Cardiac Surgery, and Intensive Care. The team is led by an Advanced Heart Failure Cardiologist and Cardiothoracic Surgeon, who activate other members of the team by phone for expedited decision-making. The multidisciplinary team evaluates referred patients for a potentially treatable insult and/or an appropriate exit strategy to avoid futile device placement. Accepted patients are then categorized for treatment/escalation of support according to three pathways: 1) acute myocardial infarction (AMI) shock, 2) hemodynamic (non-AMI) shock, 3) post-cardiotomy shock. All PMCST calls are maintained in a data registry. Results Between November 2019 and April 2021, the team received a total of 197 shock calls. Majority of the calls (93%) came from 20 local referring centers and 139 patients (70%) were accepted. Approximately half (53%) were admitted to the Cardiothoracic Intensive Care Unit. Temporary mechanical support devices were used in 84 patients (61%). Intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) were the most frequently used single platforms (IABP 29%, ECMO 23%), but the majority of patients (36%) received multiple devices. Escalation of mechanical support was required in 32 patients (38%). Combined Impella and ECMO was the most commonly implemented escalation platform (25%). In total, 39 patients (46%) were evaluated for advanced therapies, with 6 patients (7%) proceeding to durable VAD or transplant. Overall survival rate was 68%. Discussion The PMCST multidisciplinary approach utilizes an integrated medical/surgical team strategy with leadership by Advanced Heart Failure and Cardiothoracic Surgery. This approach prioritizes ongoing community partnership for early recognition and appropriate utilization of therapy, and represents a successful strategy towards implementation of timely, but not futile, mechanical support and advanced therapies. Cardiogenic shock (CS) is associated with poor prognosis, with mortality rates in excess of 40-50%. Multidisciplinary shock teams have been created to facilitate early diagnosis and appropriate escalation of support. However, there are varying approaches to implementation, resulting in variable outcomes. We describe our team's approach and outcomes over 18 months. : The Penn Medicine Cardiogenic Shock Team (PMCST) was established in November 2019 and consists of physicians from Interventional Cardiology, Electrophysiology, Cardiac Surgery, and Intensive Care. The team is led by an Advanced Heart Failure Cardiologist and Cardiothoracic Surgeon, who activate other members of the team by phone for expedited decision-making. The multidisciplinary team evaluates referred patients for a potentially treatable insult and/or an appropriate exit strategy to avoid futile device placement. Accepted patients are then categorized for treatment/escalation of support according to three pathways: 1) acute myocardial infarction (AMI) shock, 2) hemodynamic (non-AMI) shock, 3) post-cardiotomy shock. All PMCST calls are maintained in a data registry. Between November 2019 and April 2021, the team received a total of 197 shock calls. Majority of the calls (93%) came from 20 local referring centers and 139 patients (70%) were accepted. Approximately half (53%) were admitted to the Cardiothoracic Intensive Care Unit. Temporary mechanical support devices were used in 84 patients (61%). Intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) were the most frequently used single platforms (IABP 29%, ECMO 23%), but the majority of patients (36%) received multiple devices. Escalation of mechanical support was required in 32 patients (38%). Combined Impella and ECMO was the most commonly implemented escalation platform (25%). In total, 39 patients (46%) were evaluated for advanced therapies, with 6 patients (7%) proceeding to durable VAD or transplant. Overall survival rate was 68%. The PMCST multidisciplinary approach utilizes an integrated medical/surgical team strategy with leadership by Advanced Heart Failure and Cardiothoracic Surgery. This approach prioritizes ongoing community partnership for early recognition and appropriate utilization of therapy, and represents a successful strategy towards implementation of timely, but not futile, mechanical support and advanced therapies.

Outcomes of Patients with SCAD Complicated by Cardiogenic Shock Bridged with Temporary Mechanical Circulatory Support to Heart Transplant and Durable LVAD

<h3>Purpose</h3> Cardiogenic shock (CS) is a rare but potentially fatal presentation of spontaneous coronary artery dissection (SCAD). SCAD is often associated with abnormalities in other vascular beds. The safety and outcomes of patients with SCAD-CS on temporary MCS (TCMS) devices as a bridge to heart transplant (HT) and durable left ventricular assist device (LVAD) is unknown. We sought to characterize the outcomes of this unique population. <h3>Methods</h3> A comprehensive search of MEDLINE/PubMed identified 33 relevant publications meeting inclusion criteria. Data on patient characteristics, safety, and clinical outcomes was extracted. <h3>Results</h3> A cohort of 37 patients from a total of 33 case reports and series were identified. Most were female with an average age of 36 ± 6 years. SCAD-CS was the presenting manifestation in 16% of patients, while others progressed to CS later in their course. Revascularization was performed by CABG and PCI in 42% and 31% of patients, respectively. TMCS use included IABP (57%), VA-ECMO (31%), Impella (16%), surgically placed temporary VAD (8%), and biventricular support device (3%). Escalation to VA-ECMO or surgically placed temporary VAD was required in 7 patients (6 on IABP; 1 on Impella). Non-fatal TMCS complications included hemolysis (n=1, Impella) and bleeding with femoral artery dissection (n=1, VA-ECMO). Fatal complications included death from hemorrhagic shock due to accidental decannulation (n=1, VA-ECMO). Overall survival to discharge was 86%. Fourteen percent of patients received HT and 8.1% received durable LVAD. Complications related to HT include RV failure/death from a marginal donor allograft (n=1), acute graft rejection (n=1), and CMV viremia (n=1). Complications of durable VAD included pump thrombosis requiring pump exchange and HT (n=1). Other causes of death unrelated to TMCS included cardiac arrest (n=1), rupture of the right common iliac artery (n=1), and LV wall rupture (n=1). There was great variability in post-discharge outcome reporting. <h3>Conclusion</h3> Little is known about the appropriate management of SCAD-CS. To our knowledge, no prior studies have reported on outcomes of patients with SCAD-CS bridged with TMCS to HT and durable LVAD. Our data suggests acceptable outcomes in this subset of patients. Larger scale prospective studies are warranted to validate this data.

Mechanical Circulatory Support in Pediatric Myocarditis: Utilization and Patient Outcomes

<h3>Purpose</h3> Myocarditis is a common cause of pediatric heart failure and may require treatment with mechanical circulatory support (MCS). The purpose of this study is to describe the frequency of MCS use in pediatric myocarditis, types of MCS used, and outcomes of patients who receive MCS. <h3>Methods</h3> This study utilized the administrative Kids' Inpatient Database (KID), a nationally representative sample of discharge data. Five years of KID admissions (2003, 2006, 2009, 2012 and 2016) were queried using ICD-9/10 codes to identify those with a diagnosis of myocarditis. MCS strategies and outcomes were calculated and compared using logistic regression. <h3>Results</h3> Of 5,661 admissions for myocarditis, MCS was used in 194 (3.4%). ECMO was used in 82 (42.3%), a temporary ventricular assist device (tVAD) in 38 (19.6%), a durable VAD (dVAD) in 53 (27.3%) and combination MCS (cMCS) in 22 (11.3%). Half of admissions (n=2854, 50.4%), occurred in patients age 13-18 years, however teenagers were less likely than children <13 years to require MCS (2.7% vs 4.2%, p=0.008). Overall, 336 (5.9%) patients died and 94 (1.7%) patients underwent transplant. Mortality (22.3% vs 5.4%), stroke (16.4% vs 3.5%), significant bleeding (7.8% vs 1.1%), arrhythmia (49.7% vs 23.6%), and renal failure (35.3% vs 7.1%) were higher in patients treated with MCS (p<0.0001 for all). There was no significant difference in mortality between patients receiving dVAD, tVAD or cMCS when compared to ECMO. There was a significantly higher rate of transplant in patients who received any other MCS type compared to ECMO (p≤0.0005 for all). MCS use was associated with significantly longer admissions (28.2 vs 3.8 days, p<0.0001) and significantly higher charges (median $887,799 vs $57,157, p<0.0001). <h3>Conclusion</h3> MCS is used in 1 in 30 pediatric myocarditis cases and patients who require MCS have higher morbidity and mortality. ECMO is the most commonly used MCS modality in pediatric myocarditis but there is no significant difference in mortality based on MCS modality.

Clinical Outcomes Associated with Acute Mechanical Circulatory Support Utilization in Heart Failure Related Cardiogenic Shock

<h3>Purpose</h3> We sought to define clinical, hemodynamic, metabolic, and both drug and device treatment parameters associated with clinical outcomes among heart failure patients presenting with cardiogenic shock (HF-CS) patients using data from the Cardiogenic Shock Working Group (CSWG) Registry. HF-CS is increasingly common however most studies have focused exclusively on acute myocardial infarction related CS. <h3>Methods</h3> HF-CS patients were selected from the multi-center CSWG registry were divided into 3 outcome cohorts assessed at hospital discharge: mortality, heart replacement therapy (HRT: durable VAD or heart transplant), or native heart survival (NHS: without heart replacement therapy). Clinical characteristics, hemodynamic and laboratory parameters, drug therapies, acute mechanical circulatory support device (AMCS) utilization, and Society of Cardiovascular Angiography and Intervention (SCAI) stages were compared across the 3 outcome cohorts. <h3>Results</h3> Of the 712 HF-CS patients identified, 180 (25.3%) died during their hospitalization, 277 (38.9%) underwent HRT, and 255 (35.8%) experienced NHS without HRT. Patients who died had the highest right atrial pressure and heart rate and the lowest mean arterial pressure of the 3 outcome groups (<i>p</i><0.01 for all). BiV congestion was most common among patients who died, while isolated left-ventricular congestion was most common among patients who underwent HRT. Lactate, BUN, serum creatinine, and AST were highest in HF-CS patients experiencing in-hospital death. In-hospital mortality increased with deteriorating SCAI stages (stage B: 0%, stage C: 10.7%, stage D: 29.4%, stage E: 54.5%, p <0.001), and with the use of AMCS devices (IABP: 23%, Impella: 45.3%, or ECMO: 54.7%, p<0.001). <h3>Conclusion</h3> In patients with HF-CS biventricular profile, surrogates of end-organ dysfunction, increased SCAI staging and the use of AMCS devices were all associated with a higher probability of in-hospital mortality.

Outcomes of ECMO versus VAD in Children with Congenital Heart Disease as a Bridge to Transplant in Recent Era: Analysis from United Network for Organ Sharing Database

<h3>Purpose</h3> To compare the clinical characteristics, risk factors, and overall survival (waitlist and post-transplant) outcomes in children with congenital heart disease (CHD) bridged to transplantation with either a VAD vs. ECMO vs. no-mechanical circulatory support (MCS). <h3>Methods</h3> The study included 2899 primary heart transplantations in children <18 years with CHD between 2010 and 2019 from the UNOS database. Patients who had ECMO or VAD at listing or while listed were included and their waitlist and post-transplant outcomes compared with CHD patients who did not require MCS. <h3>Results</h3> Of all, 466(16%) had ECMO and 200(7%) VAD at the time of listing or while listed (Figure-1 A-B). There was an increasing VAD utilization trend during the last decade over ECMO (<i>p</i><0.01). The 90 days post-MCS survival was better with the use of VAD compared to ECMO (67% vs. 49%, p<.01) (Figure-2). More patients in the VAD group (70%) were transplanted compared to ECMO (47%), the transplantability rate was decreased with older age (odds ratio (OR), 0.91; 0.95% confidence interval (CI), 0.86-0.95), lower BMI (OR, 0.93; 95% CI, 0.89-0.98) and lower albumin < 3g/dL (OR, 0.6; 95% CI, 0.53-0.7). Multivariate model predicted that lower BMI (OR, 1.12; 95% CI, 1.06-1.18), pre-transplant ECMO (OR, 2.19; 95% CI, 1.39-3.45), and higher bilirubin (OR, 1.15; 95% CI, 0.97-1.36) decreased 1-year post-transplant survival. Patients transplanted with VAD had better 1-year survival than ECMO (88% vs. 70%, p=0.01) (Figure-3). <h3>Conclusion</h3> Waiting list survival of children with CHD supported by durable VAD is better compared to ECMO support. The long-term posttransplantation outcomes of CHD patients supported by VAD is similar to non-MCS patients and better than ECMO supported patients. The transition from ECMO to VAD while listed results in similar outcomes to VAD-first, so every effort should be made to select CHD patients eligible for VAD as a bridge to transplantation.