Ventricular Assist Device Therapy Research Articles

(816) - Best Practices to Manage Right Ventricular Dysfunction in Patients with Left Ventricular Assist Device Therapy

(816) - Best Practices to Manage Right Ventricular Dysfunction in Patients with Left Ventricular Assist Device Therapy

Phase-of-care mortality assessment in cardiogenic shock due to end-stage heart failure

End-stage heart failure-related cardiogenic shock (HF-CS) is associated with high risk of short-term mortality, but the causes and mode of death in HF-CS have not been described. This study aimed to (i) describe the causes/modes of death in patients with HF-CS based on the phases-of-care (Rescue-Optimization-Stabilization-Exit therapy), analogous to the phase-of-care mortality analysis, and (ii) assess the impact of the introduction of a standardized team-based care. We included 120 consecutive patients with HF-CS who underwent temporary mechanical circulatory support. The introduction of standardized team-based care reduced mortality at six months (36/63 (57%) vs 17/57 (30%), p=0.003), but did not alter the distribution of phase-of-care mortality. There were fewer deaths following heart transplantation/left ventricular assist device therapy with standardized team-based care (6% vs 28%, p=0.067) may be clinically relevant.

Low Mean Perfusion Pressure Indexed to Body Surface Area is a Powerful Predictor of Poor Outcomes After Heart Transplantation in Patients With High Pre-Transplant Venous Pressure: A Clinical Study With Physiological Insights From Mathematical Modelling of Biventricular Heart Failure

The deleterious consequences of chronically elevated venous pressure in patients with profound right ventricular or biventricular dysfunction are well known, including renal and hepatic dysfunction, and volume overload. The only option for these patients, if they fail optimal medical treatment, is a heart transplant, as they are not candidates for left ventricular assist device therapy. Mean perfusion pressure (MPP) is important in the outcomes of critically ill patients with high venous pressure. The question arises whether MPP is important for the outcomes of heart transplants in patients with elevated pre-transplant venous pressure. Medical management of heart failure patients with reduced ejection fraction involves lowering the systemic afterload with vasodilators while awaiting a transplant. We hypothesised that when venous pressure is elevated prior to transplant, a substantial reduction in systemic arterial elastance (Ea) through vasodilation may significantly decrease MPP, resulting in compromised end-organ function and consequent unfavourable outcomes after heart transplantation. This study aims to investigate whether a low MPP serves as a risk factor for adverse outcomes in heart transplant recipients with high venous pressure. A retrospective analysis was conducted on 250 heart transplant recipients undergoing isolated heart transplantation at a single institution from October 2012 to March 2020. Right atrial pressure (RAP) of more than 15 mmHg was considered high. Additionally, Ea calculated as the ratio of end-systolic pressure to stroke volume, and MPP calculated as the difference between mean arterial pressure and RAP were considered in our analysis. The outcomes of transplantation were measured in terms of 90-day mortality and survival up to 7 years. High RAP was a significant risk factor for short-term and medium-term survival if Ea was low (<2.7 mmHg/mL, the median value). This group had 39.39% in-hospital mortality compared to 14.49% for RAP<15 mmHg (p∼0.005). When Ea was high, this difference in survival was not evident: 8% for RAP<15 mmHg vs 4.8% for RAP>15 mmHg (p∼0.550). This effect was mediated through a lower MPP, and the mortality due to lower MPP increased strikingly with higher body surface area (BSA). A negative correlation was observed between MPP indexed to BSA (MPPI) and the Model for End-Stage Liver Disease score (r∼-0.3580, p<0.0001) as well as creatinine (r∼-0.3551, p<0.0001). MPPI less than 40 mmHg/m2 was associated with poorer short-term (23.2% for MPPI<40 mmHg/m2 vs 7.1% for MPPI>40 mmHg/m2, p∼0.001) and medium-term survival. The impact of high RAP and low Ea on survival was evident even on medium-term follow-up; only 30% survival at 7 years follow-up for high RAP and low Ea vs 75% for RAP<15 mmHg (p∼0.0033). The acceptable blood pressure during vasodilator therapy in patients with high RAP needs to be higher, especially in those with higher BSA. MPPI less than 40 mmHg/m2 is a risk factor for survival, in the short and medium-term, after heart transplantation.

Patients’ and physicians’ beliefs and attitudes towards integrating personalized risk estimates into patient education about left ventricular assist device therapy

BackgroundPersonalized risk (PR) estimates may enhance clinical decision making and risk communication by providing individualized estimates of patient outcomes. We explored stakeholder attitudes toward the utility, acceptability, usefulness and best-practices for integrating PR estimates into patient education and decision making about Left Ventricular Assist Device (LVAD). Methods and ResultsAs part of a 5-year multi-institutional AHRQ project, we conducted 40 interviews with stakeholders (physicians, nurse coordinators, patients, and caregivers), analyzed using Thematic Content Analysis. All stakeholder groups voiced positive views towards integrating PR in decision making. Patients, caregivers and coordinators emphasized that PR can help to better understand a patient’s condition and risks, prepare mentally and logistically for likely outcomes, and meaningfully engage in decision making. Physicians felt it can improve their decision making by enhancing insight into outcomes, enhance tailored pre-emptive care, increase confidence in decisions, and reduce bias and subjectivity. All stakeholder groups also raised concerns about accuracy, representativeness and relevance of algorithms; predictive uncertainty; utility in relation to physician's expertise; potential negative reactions among patients; and overreliance. ConclusionStakeholders are optimistic about integrating PR into clinical decision making, but acceptability depends on prospectively demonstrating accuracy, relevance and evidence that benefits of PR outweigh potential negative impacts on decision making quality.

Trust criteria for artificial intelligence in health: normative and epistemic considerations

Rapid advancements in artificial intelligence and machine learning (AI/ML) in healthcare raise pressing questions about how much users should trust AI/ML systems, particularly for high stakes clinical decision-making. Ensuring that...

Revisiting Pulmonary Hypertension in the Era of Temporary Mechanical Circulatory Support – Literature Review and Case-Based Discussion

Pulmonary arterial hypertension (PAH) is characterized by persistently increased pressure in the pulmonary arteries. New defining criteria for the different hemodynamic types of pulmonary hypertension (PH) that occur with left heart disease have been proposed by the task force on PH. After consideration of the changes in the general definition of PH in left heart disease, the proposed hemodynamic definition was: (1) isolated postcapillary PH: pulmonary artery wedge pressure >15 mm Hg and mean pulmonary arterial pressure (mPAP) >20 mm Hg and pulmonary vascular resistance (PVR) <3 Woods units (WU); and (2) combined post- and precapillary PH: pulmonary artery wedge pressure >15 mm Hg, mPAP >20 mm Hg, and PVR ≥3 WU. Secondary PH is initially reversible, but eventually, it can become fixed because of the remodeling process of the pulmonary vascular system. Limitations in defining both the time for and amount of reversibility lack clarity. We discuss a case of PH as a framework to better understand these key principles in addressing patients' candidacy for heart or heart-lung transplantation. We performed a literature search for all available contemporary data with the following terms: "pulmonary hypertension," "reversal," "Impella 5.5," "temporary mechanical support," and "LVAD" using the National Library of Medicine - PubMed and PubMed Central between 2019 and 2023. A total of 14 published papers were found with these search. From these, 3 addressed the issue of PH and reversibility in the setting of LHD after durable LVAD placement. No papers were found using Impella 5.5 and PH during this timeframe. Given the paucity of data in the field regarding temporary mechanical circulatory support and pulmonary hypertension, we present a case-based discussion to guide the reader in understanding the potential impact of this method in patients with WHO Class 2 Pulmonary hypertension. A 49-year-old woman with a medical history of acute on chronic biventricular systolic and diastolic heart failure, American College of Cardiology stage D, Stevenson profile C, New York Heart Association class IV (ejection fraction 18%) secondary to nonischemic cardiomyopathy after cardiac resynchronization therapy, pulmonary hypertension, bilateral deep vein thrombosis, and segmental pulmonary embolism presented for heart transplant evaluation. Her cardiac output and central hemodynamics were measured, and she was found to have a pulmonary artery (PA) pressure of 78/38 with a mean PA pressure of 51, pulmonary capillary wedge pressure (PCWP) 30, transpulmonary pressure gradient (TPG) 21, thermodilution cardiac output (CO) 3.35 L/min, and cardiac input (CI) 1.75 L/min/m2. Her PVR was 6.2 WU. Provocative pharmacologic testing for reversibility of PH was performed using sodium nitroprusside, which resulted in a blood pressure of 83/57 (92), heart rate 92/min, and PA pressure of 71/31, with a mean PA pressure of 44 PCWP 22, TPG 22, CO 4.8 L/min, and CI of 2.48 L/min/m2 with a PVR of 4.5 WU. Following this, the patient underwent Impella 5.5 placement through the right axillary artery to optimize afterload reduction and improve end-organ perfusion. Post-Impella hemodynamics on milrinone 0.5 mcg/kg/min demonstrated the following: blood pressure 90/66 (74), heart rate 53/min, and PA pressure of 56/29, with a mean PA pressure of 38, PCWP 24, TPG 14, CO 6 L/min, and CI of 2.9 L/min/m2 with a PVR of 2.3 WU. Left ventricular assist device support with Impella 5.5 is associated with a reduction in mPAP and PVR over weeks to months and thus plays a crucial role as a bridge to transplant. Our case and this review highlights the characteristics of PH resulting from heart failure with reduced ejection fraction and discusses the important clinical issues related to the treatment of these patients. We have shown that left ventricular assist device therapy with Impella 5.5 can effectively reduce left-sided filling pressures and lead to PH improvement. We demonstrate the potential benefits of Impella 5.5 in the management of patients with WHO 2 PH and cardiogenic shock with impaired hemodynamics.

A prospective, observational multicenter registry of heart failure patients in Germany: preliminary results of the ongoing H2-registry

Abstract Background Heart failure (HF) is a highly prevalent condition affecting 1-2% of the adult population in Europe. Despite pioneering improvements in HF treatment during the last two decades, hospitalization and mortality rates remain relatively high. Gathering real-world data on HF populations is crucial especially in the light of newly emerging therapeutic approaches. Purpose The H2-registry was set up in 2021 to provide up-to-date, real-world data on a contemporary cohort of hospitalized HF patients in Germany using a standardized set of outcome measures. Methods The ongoing H2-registry represents a prospective, investigator-initiated, multicenter observational registry. Inpatients ≥18 years of age with a present diagnosis of chronic or acute HF are recruited in secondary and tertiary hospitals throughout Germany. Patients are excluded if they present in any kind of shock during index hospitalization, or if they previously underwent heart transplantation or ventricular assist device therapy. Routine follow-up (FU) is conducted every 6 months. A standardized set of variables according to the International Consortium of Health Outcome Measurements (ICHOM) including a pre-defined selection of questionnaires to collect patient-reported outcome measures (PROMs) is used to objectively monitor the course of disease. Results Until the reference date 12/31/22, a total of 2,190 patients were included in ten active study centers. Mean age was 72 years, 36.8% were female, and mean left-ventricular ejection fraction (LVEF) was 43.4% (38.1% had an LVEF of ≤ 40%). In-hospital mortality at index case was 1.3%. Within the cohort with completed 6-month FU comprising of 976 patients, all-cause mortality was 11.3% (110). In addition, 24.2% (209) in the survival cohort had at least one HF-related re-hospitalization. Numbers for all-cause mortality and re-hospitalizations at 12-month FU were 21.3% (71) and 32.8% (86), respectively. Evaluations of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores showed a significant improvement overall and in all sub-categories (p &amp;lt; 0.001) at 6- and 12-month FU. Conclusions The H2-registry currently represents the largest ongoing prospective registry of HF inpatients in Germany. Our preliminary data highlights the pronounced mortality risk and healthcare burden in this cohort. However, HF-related therapies initiated during the course of a hospitalization have the potential to significantly improve patients’ quality of life. In the near future, it its foreseeable that the actively recruiting H2-registry based on ICHOM-standards will markedly contribute to the collection of real-world data on HF patients.

Abstract 13703: Left Ventricular Assist Device Therapy in “Cold and Dry” Patients

Introduction: Patients who suffer from end-stage HF and have low PCWP are referred to as “cold and dry” patients and are an understudied minority, where the benefit derived from LVAD therapy is unclear. We therefore conducted a retrospective analysis to evaluate functional outcomes and quality of life after LVAD in patients with low versus high PCWP on pre-LVAD hemodynamics. Methods: Adults receiving LVADs between 2006 and 2017 were identified from the INTERMACS database. Outcomes include assessment of functional status with 6-minute walk test (6MWT) distance and quality of life measures, with KCCQ and EuroQol questionnaire scores pre- and post-LVAD, stratified by pre-LVAD PCWP. Median follow up was 364±41 days. Results: Study sample comprised 10310 patients who received LVAD from 2006 to 2017. Mean age was 57 ± 13, 8113 (79%) were male, and the mean PCWP prior to LVAD implantation was 25 ± 9.19 mmHg. The patients were separated into a high (PCWP &gt;15 mmHg) and a low (PCWP&lt;15 mmHg) group based on pre-LVAD hemodynamics. For patients with PCWP &lt;15 mmHg, mean age was 58.1±12.4, 1191 (74%) were males, LVEDD was 6.7±1 cm, and mean PCWP was 11±3.2 mmHg (Table 1). When compared to patients with high PWCP, those with a PCWP &lt;15 mmHg showed less improvement in quality of life questionnaire scores, including EuroQol (+0.11 vs +0.17, p=0.001) and KCCQ (+26 vs +31, p=0.03), and functional capacity with 6MWT distance (+194 feet vs +340 feet, p=0.02) after LVAD (Figure 1). Conclusions: In patients with end-stage HF and low PCWP, LVADs are associated with less improvement in functional capacity and quality of life when compared to patients with high PCWP.

Contemporary Left Ventricular Assist Device Therapy as a Bridge or Alternative to Transplantation.

Left ventricular assist devices (LVADs), which were introduced as a bridge to heart transplantation, are now an established alternative to heart transplantation (HT) for patients with advanced heart failure. These devices have undergone significant technological advancements over the years, and contemporary LVADs prolong life substantially in patients dependent on inotropic therapy or in those with severe ambulatory advanced heart failure with a median survival that exceeds 5 y, and most patients benefit from a doubling in functional capacity, even among those intended as destination therapy because of ineligibility for transplantation. Other intended goals for LVAD implantation consist of (1) bridge to remission or recovery and (2) bridge to transplant or candidacy for transplant. In the former situation, few selected patients underwent LVAD implantation, facilitating myocardial remission to recovery that allowed explantation. Among those bridged to transplantation, survival in the intended goal was excellent, with 80% success at 5 y (with a 50% rate of transplantation). In this review, we provide a brief historical background on the evolution of LVADs and discuss outcomes with contemporary pumps, immunological and infection-related impact of such devices, impact of bridging in HT, and use of devices for facilitating myocardial recovery and remission. Furthermore, we discuss implications of HT allocation policies, with a specific focus within the United States, and outline future perspectives and novel device in development.

Association of pre–left ventricular assist device defibrillator shocks for ventricular arrhythmia with clinical outcomes after left ventricular assist device implantation

Implantable cardioverter-defibrillation (ICD) shocks after left ventricular assist device therapy (LVAD) are associated with adverse clinical outcomes. Little is known about the association of pre-LVAD ICD shocks on post-LVAD clinical outcomes and whether LVAD therapy affects the prevalence of ICD shocks. The purpose of this study was to determine whether pre-LVAD ICD shocks are associated with adverse clinical outcomes post-LVAD and to compare the prevalence of ICD shocks before and after LVAD therapy. Patients 18 years or older with continuous-flow LVADs and ICDs were retrospectively identified within the University of Pittsburgh Medical Center system from 2006-2020. We analyzed the association between appropriate ICD shocks within 1 year pre-LVAD with a primary composite outcome of death, stroke, and pump thrombosis and secondary outcomes of post-LVAD ICD shocks and ICD shock hospitalizations. Among 309 individuals, average age was 57 ± 12 years, 87% were male, 80% had ischemic cardiomyopathy, and 42% were bridge to transplantation. Seventy-one patients (23%) experienced pre-LVAD shocks, and 69 (22%) experienced post-LVAD shocks. The overall prevalence of shocks pre-LVAD and post-LVAD were not different. Pre-LVAD ICD shocks were not associated with the composite outcome. Pre-LVAD ICD shocks were found to predict post-LVAD shocks (hazard ratio [HR] 5.7; 95% confidence interval [CI] 3.42-9.48; P <.0001) and hospitalizations related to ICD shocks from ventricular arrhythmia (HR 10.34; 95% CI 4.1-25.7; P <.0001). Pre-LVAD ICD shocks predicted post-LVAD ICD shocks and hospitalizations but were not associated with the composite outcome of death, pump thrombosis, or stroke at 1 year. The prevalence of appropriate ICD shocks was similar before and after LVAD implantation in the entire cohort.

Widening care gap in VAD therapy

The removal of the HeartWare ventricular assist device (HVAD) due to pump malfunctions and inferior outcomes compared to HeartMate 3 (HM3) in adults has created a care gap for younger patients. It is unclear if the reported HVAD survival differs by age and if the initial experience with HM3 can bridge the gap. Using the Society of Thoracic Surgeons (STS) Intermacs and Pedimacs registries, durable ventricular assist device (VAD) implants between September 2012 and December 2021 were identified. Young adults (YA) were defined as <40years old in Intermacs. Patients were excluded if they had an isolated right VAD (RVAD) or were implanted as destination therapy (DT). Survival analysis by Kaplan-Meier (KM) and competing outcomes curveswas performed, and 1-year survival is reported. The Intermacs cohort consisted of YA (n=1226; HVAD 818; HM3 408) with a median age of YA of 32.07 (26.66-36.27) yearsand weight (wt) of83.2 (68-104.2) kg. Most had cardiomyopathy (CM) (92.2%). The Pedimacs cohort was 668patients (median age 9.47 [1.82-14.23] years, wt 27.2 [10-57.05]kg), and most also had CM (70.5%). Device breakdown includedHVAD (n=326), Berlin EXCOR(n=277), and HM3 (n=65). HVAD survival differed by age in adults, with YA fairing better than adults >40 years old (88.8%vs79.4% at 1year, p<0.0001). YA survival was also better compared to Pedimacs patient (88.9%vs83.7%, p=0.0002), but when competing events were analyzed, mortality was similar to YA (9.2% vs9.6%, p=0.1) with a higher proportion of patient undergoing transplant at 1 year in Pedimacs (74% vs31.3%, p<0.0001). Survival by device differed between HVAD and HM3 in YA (88.8% vs94.4%, p=0.0025). This difference in device survival was not seen in all children (83.7% vs87.3%, p=0.21), including those ≥25kg. Adverse event profiles also differed across the groups with adults seeing less adverse events with the HM3, but the same was not found (including stroke) in the pediatric cohort. Survival outcomes for patients between 10 and 25kg were similar with the HVAD compared to the Berlin Heart EXCOR(p=0.4290), with similarities in stroke risk. The removal of the HVAD device may result in a care gap in younger patient whose survival outcomes do not mirror that of older adults. The HM3 can fill a portion of this gap with good survival, but there remains a subset of pediatric patients that, based on initial HM3 use, will no longer have access to intracorporeal support and therefore, despite reasonable outcomes with the Berlin Heart EXCOR,will not be able to be discharged home. Lastly, it is essential that future changes to the availability of devices take into account the various patient populations that utilize the device to avoid unintended consequences of access inequality.

Considerations of Left Ventricular Assist Device Therapy in the United States’ Prison System

Left ventricular assist device therapy for advanced heart failure is contraindicated if a patient lives in an unsafe environment and recent guidelines declare that “legal history is pertinent for determining personal constraints or financial responsibilities due to parole requirements, pending charges, and possible imprisonment,” implying that incarceration would be a contraindication. International guidelines and precedent in the United States establish that medical care for incarcerated persons should match access in the community. We present a case example and practical considerations for advanced heart failure programs faced with the challenge of partnering with patients with heart failure who may be incarcerated and their correctional health systems in the care of their chronic condition. We encourage the heart failure community to not let incarceration be a contraindication to left ventricular assist device therapy.

Gastrointestinal bleeding on continuous-flow left ventricular assist device therapy.

While technological advances in the field of continuous-flow left ventricular assist device (CF-LVAD) are constantly being made, CF-LVAD recipients are still subjected to a relatively high rate of LVAD-related adverse events, with post-LVAD gastrointestinal bleeding (GIB) being the most common one. GIB is associated with a significant impairment in quality of life, multiple hospital admissions, blood transfusion requirements and possibly death. Furthermore, of those patients who bled once, many will experience recurrent GIB events, which further aggravates their discomfort. While some medical and endoscopic treatment options are available, evidence regarding their benefit remains largely equivocal, with all related studies based on data from registries rather than clinical trials. Although having a major impact on LVAD recipients, an effective and validated pre-implant screening options to predict GIB events post-implant are scarce. This review focuses on the aetiology, incidence, risk factors, treatment options and the effect of new generation devices on post-LVAD GIB.

P46: Rationale and Design of a Patient Empowerment Pilot: Self-Administered 6MWT Improve to Outcomes and Timely Utilization of Ventricular Assist Devices

Background: Ventricular assist devices (VAD) are life-saving therapy for appropriately selected end-stage heart failure patients. Although life-prolonging, VAD implantation may accompany considerable lifestyle changes, need for caregiver support, and risk of complications. Furthermore, early evaluation of VAD therapy is important to minimize the exacerbation of cardiac dysfunction. Therefore, shared decision-making through a timely evaluation for VAD therapy is imperative to minimize discrepancies between patient goals and clinical outcomes. The 6-minute walk test (6MWT) is a validated measure to predict morbidity and mortality in advanced heart failure patients, but it can be costly and time-consuming to perform routinely in the clinic. The Timed Walk App is a smartphone application that allows patients to perform a self-directed 6MWT, providing clinicians and patients with opportunities for shared decision-making and a larger database of objective clinical data for VAD evaluation. This study aims to address whether the usage of the Timed Walk App by heart failure patients can improve the clinical outcomes and timely utilization of VAD therapy. Methods: Patients referred to the University of Florida Heart Failure Clinic with an ejection fraction of less than 30% will be considered for study inclusion. Eligible patients will be educated on using the Timed Walk App to self-administer the 6MWT. Patients will be instructed to perform the 6MWT every 15 days and at least once a month. The demographic information, heart failure etiology, and biomarkers of illness severity will be obtained from the electronic medical record. For enrolled patients with VAD implantation, the following data will be collected: time between referral and LAD implantation, hospital length of stay, and incidence of adverse events post-VAD. Quality of life (QOL) assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ-5D will be performed at one-, three-, six-, and twelve-month intervals post-VAD. Data collected will be compared to a retrospective propensity-matched cohort in a weighted 3:1 fashion [Figure]. Results: In comparison to standard clinical assessments, we will analyze whether the use of the Timed Walk App improves: 1) likelihood of implantation 2) time from referral to VAD 3) implant length of stay 4) incidence of post-implant adverse events and 5) patient-reported QOL and perception of care. Conclusion: This study aims to explore whether the patient-directed monitoring of heart failure progression using the Timed Walk App promotes timely and appropriate utilization of VAD therapy. Findings are expected to inform future studies exploring the usage of smartphone applications to facilitate shared decision-making in advanced heart failure patients to improve the quality of life and clinical outcomes of VAD therapy.

P80: Adding Intra-Aortic Balloon Pump Counter-Pulsation To Vasodilator Therapy Results In Better Organ Perfusion In Patients With Biventricular Heart Failure Awaiting A Heart Transplant

Background: Significant right ventricular dysfunction with elevated central venous pressure is associated with poor survival in heart failure patients with reduced ejection fraction (HFrEF). Heart transplant is often the only option for this group of patients, as they are not candidates for left ventricular assist device therapy. Medical management of HFrEF involves lowering the systemic afterload with vasodilators. While this therapy is very effective in isolated left ventricular dysfunction, in patients with biventricular dysfunction and high venous pressure, vasodilation can lead to low organ perfusion pressure, resulting in organ dysfunction. Organ perfusion pressure is calculated as the difference between mean arterial pressure and central venous pressure. We hypothesized that combining intra-aortic balloon pump (IABP) counter-pulsation with vasodilator therapy might be a good clinical option for stabilizing these patients while awaiting a heart transplant. Methods: To understand the hemodynamics of vasodilator and IABP therapy in biventricular heart failure, we used a closed-loop multiscale model of the entire cardiovascular system, including a one-dimensional model of the arterial tree coupled with a lumped model of the heart and IABP counter-pulsation. In addition, a baroreceptor model was also used to capture the physiological changes secondary to ventricular dysfunction realistically. Results: Our mathematical model accurately captures the features of the aortic pressure waveform with IABP support (Figure 1) and the hemodynamic consequences of the onset of right ventricular dysfunction (Table 1). Biventricular dysfunction leads to lower cardiac output and organ perfusion pressure when compared with isolated left ventricular dysfunction. Vasodilation during biventricular dysfunction increases the cardiac output but reduces the organ perfusion pressure further. IABP counter-pulsation increases cardiac output along with higher mean arterial pressure and hence higher organ perfusion pressure. The best results are seen when vasodilators are used in conjunction with IABP, where a “sweet spot” of maximal increase in cardiac output with the best possible organ perfusion pressure is obtained, and this combined additive effect of IABP counter-pulsation and vasodilation is also reflected across the renal vasculature (Table 1). Conclusion: Vasodilation with high venous pressure can lead to low organ perfusion pressure and consequent organ dysfunction. Fine-tuning IABP counter-pulsation and vasodilator seems to confer a substantial hemodynamic benefit in this setting.Figure 1. Simulated aortic pressure waveform with IABP support

Predictors and clinical implications of residual mitral regurgitation following left ventricular assist device therapy

BackgroundCorrection of mitral regurgitation (MR) at the time of left ventricular assist device (LVAD) implantation remains controversial. There is conflicting evidence regarding the clinical impact of residual MR, and studies...

Value of implant-based telemonitoring in the high-risk population of ventricular assist device patients

Abstract Funding Acknowledgements Type of funding sources: None. Background Telemonitoring of heart failure (HF) patients is an evolving field. Prior studies presented promising results. However, the relevance of telemonitoring in the specific cohort of end-stage HF patients on ventricular assist device (VAD) therapy has not been analysed yet. Purpose This study aimed to evaluate the benefit of daily implant-based multiparameter-telemonitoring in high-risk HF-patients on VAD therapy with an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization defibrillator (CRT-D) including telemonitoring function. Beyond that, patients’ outcome and complication rates were evaluated. Methods A total of 30 end-stage HF-patients (65 ± 10 years, 89 % male) with a VAD and an ICD or a CRT-D with telemonitoring function were included in this observational single center study. Long-term follow-up data (4.28 ± 2.62 years) were assessed. Results All patients (n=30, 100%) received daily ICD or CRT-D telemonitoring. In the majority of patients (73%, n=22) the telemedical center had to take actions a mean of 3 times. Most events (84%, n=45) were identified within 24 hours. An acute alert due to sustained ventricular arrhythmias (VAs) occurred in 13 patients (65%) with 46% of them (n=6) requiring a shock delivery. Eight patients (62%) were hospitalized due to symptomatic VAs. Inadequate shocks were recognized in 3 patients (23%). In 12 patients (92%) immediate medication adjustments were recommended. Relevant lead problems were revealed in 13 patients (43%) with 6 patients (46%) undergoing consecutive lead revisions. Device-reprogramming was recommended in 50% of all VAD-patients (n=15). Compared to HF-patients without remote monitoring, daily telemonitoring significantly reduced the number of in-hospital device controls by 44% (p&amp;lt;0.01). Conclusions Daily implant-based-telemonitoring increased patient safety as it allowed for pre-emptive interventions and an immediate detection of cardiac arrhythmias and device/lead problems. Even in this high-risk HF-patient population, telemonitoring significantly reduced the number of in-hospital device-controls. Further studies are warranted to confirm these initial observations.

Blood flow kinetic energy is a novel marker for right ventricular global systolic function in patients with left ventricular assist device therapy.

Right ventricular (RV) failure remains a major concern in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation. We aimed to measure the kinetic energy of blood in the RV outflow tract (KE-RVOT) - a new marker of RV global systolic function. We also aimed to assess the relationship of KE-RVOT to other echocardiographic parameters in all subjects and assess the relationship of KE-RVOT to hemodynamic parameters of RV performance in HF patients. Fifty-one subjects were prospectively enrolled into 4 groups (healthy controls, NYHA Class II, NYHA Class IV, LVAD patients) as follows: 11 healthy controls, 32 HF patients (8 NYHA Class II and 24 Class IV), and 8 patients with preexisting LVADs. The 24 Class IV HF patients included 21 pre-LVAD and 3 pre-transplant patients. Echocardiographic parameters of RV function (TAPSE, St', Et', IVA, MPI) and RV outflow color-Doppler images were recorded in all patients. Invasive hemodynamic parameters of RV function were collected in all Class IV HF patients. KE-RVOT was derived from color-Doppler imaging using a vector flow mapping proprietary software. Kruskal-Wallis test was performed for comparison of KE-RVOT in each group. Correlation between KE-RVOT and echocardiographic/hemodynamic parameters was assessed by linear regression analysis. Receiver operating characteristic curves for the ability of KE-RVOT to predict early phase RV failure were generated. KE-RVOT (median ± IQR) was higher in healthy controls (55.10 [39.70 to 76.43] mW/m) than in the Class II HF group (22.23 [15.41 to 35.58] mW/m, p < 0.005). KE-RVOT was further reduced in the Class IV HF group (9.02 [5.33 to 11.94] mW/m, p < 0.05). KE-RVOT was lower in the LVAD group (25.03 [9.88 to 38.98] mW/m) than the healthy controls group (p < 0.005). KE-RVOT had significant correlation with all echocardiographic parameters and no correlation with invasive hemodynamic parameters. RV failure occurred in 12 patients who underwent LVAD implantation in the Class IV HF group (1 patient was not eligible due to death immediately after the LVAD implantation). KE-RVOT cut-off value for prediction of RV failure was 9.15 mW/m (sensitivity: 0.67, specificity: 0.75, AUC: 0.66). KE-RVOT, a novel noninvasive measure of RV function, strongly correlates with well-established echocardiographic markers of RV performance. KE-RVOT is the energy generated by RV wall contraction. Therefore, KE-RVOT may reflect global RV function. The utility of KE-RVOT in prediction of RV failure post LVAD implantation requires further study.

Infections in Patients With Left Ventricular Assist Devices: Current State and Future Perspectives.

Mechanical circulatory support is increasingly being used as bridge-to-transplant and destination therapy in patients with advanced heart failure. Technologic improvements have led to increased patient survival and quality of life, but infection remains one of the leading adverse events following ventricular assist device (VAD) implantation. Infections can be classified as VAD-specific, VAD-related, and non-VAD infections. Risk of VAD-specific infections, such as driveline, pump pocket, and pump infections, remains for the duration of implantation. While adverse events are typically most common early (within 90 days of implantation), device-specific infection (primarily driveline) is a notable exception. No diminishment over time is seen, with event rates of 0.16 events per patient-year in both the early and late periods postimplantation. Management of VAD-specific infections requires aggressive treatment and chronic suppressive antimicrobial therapy is indicated when there is concern for seeding of the device. While surgical intervention/hardware removal is often necessary in prosthesis-related infections, this is not so easily accomplished with VADs. This review outlines the current state of infections in patients supported with VAD therapy and discusses future directions, including possibilities with fully implantable devices and novel approaches to treatment.

A Systematic Review and Physiology of Pulmonary Artery Pulsatility Index in Left Ventricular Assist Device Therapy.

Right heart failure is a major complication following left ventricular assist device (LVAD) implantation. Pulmonary artery pulsatility index (PAPi) has been evaluated as a haemodynamic marker for right heart failure, but PAPi is dependent on pulmonary vascular resistance. We conducted a systematic review to assess the relationship between PAPi and right heart failure and death in patients undergoing LVAD implantation; and examined the relationship between PAPi cut-off and pulmonary vascular resistance. We searched PubMed, EMBASE, CENTRAL and manually screened retrieved references to identify all clinical studies reporting PAPi in adult patients with a durable LVAD. Eligibility criteria were prespecified and two reviewers independently screened and extracted data; the Newcastle-Ottawa Scale was used to assess quality of non-randomized studies. This study was prospectively registered on PROSPERO (CRD42021259009). From 283 unique records, we identified 16 studies reporting haemodynamic assessment in 20,634 adult patients with an implanted durable LVAD. Only 2 studies reported on mortality and in both, a lower PAPi was significantly associated with death. Fifteen studies reported right heart failure data and in ten studies a lower PAPi was significantly associated with right heart failure. Six studies reported on PAPi cut-offs ranging from 0.88 to 3.3; and the cut-offs were directly related to pulmonary vascular resistance (r = 0.6613, p = 0.019). Lower PAPi was associated with right heart failure and death following LVAD implantation, but a single PAPi cut-off cannot be defined, as it is dependent on pulmonary vascular resistance.