Current and Future Challenges in Mechanical Circulatory Support

Heart failure has become one of the fastest growing cardiovascular diagnoses, with estimates as high as 500 000 new cases per year.1,2 This growth is in part a result of the reductions in death from acute coronary syndromes, increased use of implantable cardioverter defibrillators, and improved survival with most cardiovascular interventions, which have led to this continued increase in the number of patients who develop progressive heart failure (HF). The estimated number of people in the United States with the diagnosis of HF may exceed 7 million, based on the estimated average prevalence of 2.6%,3,4 and a census of >300 million population (Figure 1).5,6 HF is clearly age related,1,–,4 with prevalence as low as 0.5% in those 65 years of age.2 This is an important demographic, because it is estimated that the number of people >65 years of age will double in the next 20 to 30 years.4,–,7 HF is not a homogeneous condition. Based primarily on data from recent hospital registries8,9 and other studies,10 nearly half of all patients have HF with preserved systolic function, and the other half have varying degrees of severity of HF with reduced systolic function. Although the prevalence of HF is higher in males at <70 years of age, overall HF is equally common in men and women. Unfortunately, the average survival of patients with either preserved or reduced systolic function is only 40% at 5 years after diagnosis,10,11 and may be as high as 80% when it reaches a refractory stage.12 One study of 3500 patients in Minnesota suggested that there is …

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Cost-effectiveness analysis in cardiac surgery: A review of its concepts and methodologies

Brief Report Cardiomems (CMEMS) have been demonstrated to reduce hospitalizations in symptomatic HF. The purpose of our study is to describe our experience of CMEMS in our 27 left ventricular assist device (LVAD) patients. We found that there was a 56% reduction in HF hospitalizations at 6 mo and up to 29% reduction in HF hospitalizations at 12 mo pre- and post-CMEMS placement. Further investigation is warranted in a large cohort with a particular focus on the effects on the hemocompatibility LVAD complications. Brief Communication Left ventricular assist devices are the standard of care for the treatment of patients with advanced heart failure (HF). Despite this therapy, nearly 20% of patients have residual HF symptoms resulting in increased morbidity, mortality, and decrease in quality of life. The CardioMEMS (CMEMS) pulmonary artery (PA) sensor allows for frequent collection of hemodynamic information and has been proven to reduce HF hospitalizations in chronic HF patients.1,2 Data regarding efficacy in the LVAD population is limited to small case series. We describe our single-center experience using the CMEMS system in this patient population. We performed a retrospective study of 27 LVAD patients who underwent placement of the CMEMS device between August 2018 and January 2020 at Ascension St. Vincent Data was extracted through the electronic medical record systems. Patients were selected based on high-risk features such as frequent hospitalizations pre CMEMS implant. Baseline characteristics and outcome analysis including HF hospitalizations occurring in the 1 y pre- and 6 mo and 1 y post-CMEMS implantation in these patients were collected. All implants were performed after LVAD placement without interruption of anticoagulation, with the majority (89%) performed by the right internal jugular approach without interruption of anticoagulation. Technique was similar among implanting cardiologists including gaining access with an 11 French Terumo sheath and either a 260 cm Cardiomems guidewire or 300 cm Steelcore to selectively engage the appropriately sized vessel in the left PA. A hand injection of a mixture of ~10 mL of iodinated contrast and normal saline was then used under fluoroscopy for vessel identification, followed by re-engagement of the vessel with the wire and the implant then performed as described by the IFU. At the time of implant, goal PADP was set for the patient, and subsequent PA pressure data was then used to adjust diuretics, guideline-directed medical therapy, or speed adjustments in a stepwise fashion at the discretion of the patient’s primary cardiologist or CMEMS implanter. Baseline demographics were collected and included a mean age of 56 with 71% male with all with end-stage HF with LVAD support with HM3 (55%), HM2 (9%), and HVAD (36%) with 43% as a bridge to transplant. There was no significant difference in pulmonary vascular resistance between LVAD recipients with and without CMEMS. As seen in Figure 1, there was a 58% reduction in HF hospitalizations at 6 mo and up to 29% reduction in HF hospitalizations at 12 mo pre- and post-CMEMS placement. When HF hospitalization was further delineated by primary or secondary diagnosis, this reduction was even more marked (64% at 6 mo and 47% at 1 y, respectively). The procedure was remarkably safe in this anticoagulated, continuous flow population, with only 3% of patients developing scant hemoptysis that resolved without any intervention.Figure 1.: Primary endpoint of HF hospitalizations.Major limitations to these observations exist including the limited number of patients examined in a retrospective and single-center nature. Additionally, patients were selected for PA sensor implant at the discretion of their primary cardiologist and influenced by factors such as adherence to treatment recommendations and monitoring, distance traveled to LVAD center and other clinical characteristics that may introduce significant bias. Hospitalizations remain a large burden for LVAD patients, with some reports of >70% of patients needing hospitalization within the first-year postimplant.3,4 Elevated filling pressures may not only lead to HF hospitalizations but also lead to hemocompatibility related adverse events that may further complications associated with LVADs contributing to morbidity5,6 further hospitalizations. If the signal of reduced hospitalization for HF as both a primary and secondary diagnosis can be replicated in a larger population, PA sensor monitoring may present a safe and unique opportunity to decrease morbidity in a population that often struggles with the adverse events associated with LVAD therapy. Further investigation is required to examine the generalizability of these findings and whether other adverse events such as right ventricular failure, hemocompatibility related adverse events, or infection are truly impacted by more intensive hemodynamics monitoring.

Recurrent orthostatic syncope due to left atrial and left ventricular collapse after a continuous-flow left ventricular assist device implantation

Discussions in Cardiothoracic Treatment and Care: Mechanical Circulatory Support Left Ventricular Assist Device Therapy for Patients With Advanced Heart Failure

Serum albumin is an independent predictor of morbidity, including deep sternal wound infections, and mortality following cardiac surgery and left ventricular assist device (LVAD) implantation.1, 2 Preoperative hypoalbuminemia in patients being evaluated for LVAD implementation may be due to malnutrition and frailty, hepatic dysfunction due to both right and left heart failure, the cardiorenal syndrome, and systemic inflammation. Patients with hypoalbuminemia may potentially benefit from LVAD implantation since the combination of nutritional support and the reversal of heart failure may restore serum albumin to normal levels. On the other hand, the co-morbidities associated with hypoalbuminemia may increase perioperative morbidity and mortality and decrease long-term survival. Furthermore, patients with hypoalbuminemia undergoing LVAD implantation may not recover sufficiently to be considered candidates for heart transplantation. In view of the increasing costs associated with LVAD therapy,3 the known increased morbidity and mortality in patients with hypoalbuminemia, and the uncertainty of the option for heart transplantation, should patients with moderate and severe serum hypoalbuminemia undergo LVAD therapy? In this edition of the Journal, Critsinelis et al4 sought to determine short- and-long term survival in patients with low preoperative serum albumin levels who underwent continuous-flow LVAD implantation. In 526 patients who had undergone LVAD implantation at their center, 186 patients (35.4%) had moderate hypoalbuminemia (2.5-3.5 g/dL) and 18 (3.4%) had severe hypoalbuminemia (<2.5 g/dL). Patients with preoperative hypoalbuminemia were more likely to receive LVAD implementation for destination therapy, were more likely to have required preoperative circulatory support, had significantly lower preoperative hemoglobin levels and platelet counts, significantly higher white blood cell counts, and higher liver function enzyme levels. Hypoalbuminemia patients also had a higher incidence of postoperative morbidity, including infections and sepsis, gastrointestinal bleeding, neurological dysfunction, acute kidney injury, and an increased incidence of hospital readmissions. Preoperative hypoalbuminemia was also associated with significantly decreased early and long-term survival following LVAD implementation. However, hypoalbuminemia prior to LVAD implementation did not affect the success of bridge to transplantation and did not significantly affect survival after heart transplantation. Furthermore, there was no association between body mass index (BMI) and outcomes with LVAD implantation which suggests that the co-morbidities associated with hypoalbuminemia, and not preoperative BMI, are responsible for the increased morbidity and mortality associated with hypoalbuminemia. Patients with hypoalbuminemia, but with normal pre-albumin levels and a normal central venous pressure, had no difference in survival compared to patients with normal albumin levels. Should LVAD therapy be denied to patients with preoperative hypoalbuminemia? The answer lies in what co-morbidities responsible for preoperative hypoalbuminemia can be reversed following initiation of LVAD therapy. Reversing the sequelae of low cardiac output may improve appetite and absorption of nutrients, improve hepatic function, and reduce systemic inflammation. Critsinelis et al did not assess the effects of perioperative nutritional supplementation on perioperative morbidity and mortality in their patients. Furthermore, they limited their assessment to measuring only preoperative serum albumin levels. Hence, we do not know whether patients who had a significant increase in serum albumin levels post LVAD implantation had better short- and long-term survival. While deceased preoperative serum albumin levels are a marker for increased perioperative morbidity and decreased short- and long-term survival following LVAD implantation, the data from this study suggest that serum albumIn alone cannot be used to exclude patients for LVAD support who may be potential candidates for heart transplantation. These patients will require more aggressive perioperative nutritional supplementation and continued therapy for underlying co-morbidities in addition to LVAD support. Only then can we determine whether LVAD implementation can improve long- and short-time survival in patients with hypoalbuminemia.

Six million adults in the United States are living with heart failure (HF), with 915 000 cases diagnosed annually.1 Improvements in medical and device therapy will only increase the number of patients who reach the refractory or advanced HF stage of the disease. In fact, 5% to 25% of all patients with HF are considered to have advanced HF, which is characterized by ongoing symptoms and exceedingly high mortality risk despite guideline-directed medical therapy.1,2 Left ventricular assist devices (LVADs) have become an effective therapeutic option to improve survival and quality of life in patients with advanced HF.3–7 The majority of LVAD implantations are performed in advanced HF patients who are hospitalized and dependent on inotropic agents, patients with progressive hemodynamic decline, and those in cardiogenic shock.3 The introduction of continuous-flow technology and newer pump designs has dramatically changed the outlook of end-stage HF, with 1-year survival rates nearing 90% for patients awaiting heart transplantation and 75% for transplant ineligible patients,3–6 marked improvement in symptoms, functional capacity, and quality of life.7 See Article by Stewart et al The success of LVAD therapy has raised interest in implanting LVADs in a broader population of symptomatic, ambulatory advanced HF patients who are not yet inotrope dependent. Such interest is further substantiated by the fact that ambulatory patients with advanced HF have greater survival, shorter length of stay, and lower incidence of severe right ventricular failure.3,5,8 However, before we can expand the indication for an LVAD to this population, a few questions should be be addressed: First, is there equipoise between adverse events and the expected gain in survival and functional capacity? Adverse events related to the use of LVAD technology have decreased over time,3–6 …

Transcatheter Aortic Valve Replacement in Patients With Left Ventricular Assist Devices and Aortic Regurgitation—Single Institution Retrospective Analysis

Rescuing the right ventricle: A conceptual framework to target new interventions for patients receiving a durable left ventricular assist device

Survival of the Unfittest: A case of End-Stage Heart Failure and advanced esophageal cancer managed successfully with an implantable Left Ventricular Assist Device (LVAD) and aggressive chemoradiation therapy

Risk Assessment in Critically Ill Patients Awaiting Transplantation: a Step Forward

Heart Failure is an epidemic with a current prevalence of over 5.8 million patients in the USA and almost 23 million patients worldwide, with high associated mortality risks. The severe shortage of donor organs for cardiac transplants and increasing number of heart failure patients has led to the increasing popularity of left ventricular assist device (LVAD) therapy for treatment of end-stage heart failure patients. This paper describes our initial clinical experience with LVAD therapy of heart failure patients at our clinic. Ten patients (eight males and two females) with a mean age of 48 years (range, 14-68 years) were implanted with LVADs as bridge to transplantation (BT) or destination therapy (DT) at our clinic between January 2015 and October 2017. Preliminary results were very promising with 0% 30-day mortality rates and no major surgical complications or LVAD thrombosis. Such results of LVAD implantation in Kuwait indicate the feasibility of establishing De Novo LVAD programs in low volume LVAD centers (≤10 implants/year) with promising results and offer a new era of hope for treating advanced heart failure patients.

Secondary mitral regurgitation (SMR) worsens outcomes in advanced heart failure. Transcatheter edge-to-edge repair (TEER) and left ventricular assist device (LVAD) implantation represent advanced treatment options for patients with persistent symptoms despite guideline-directed medical therapy (GDMT). A scoping review using a PICO framework identified contemporary studies published up to 2025 involving adults with advanced heart failure (NYHA III-IV, INTERMACS 1-7) and ≥moderate SMR. Outcomes included mortality, heart failure hospitalizations, functional status, mitral regurgitation reduction, ventricular remodeling, complications, and quality of life. Nine studies including over 2,000 patients were analyzed (mean age 60-72 years; LVEF 15-33%). TEER was associated with lower mortality and fewer heart failure hospitalizations compared with GDMT in selected patients. LVAD recipients generally had more advanced disease (predominantly INTERMACS 1-3) with higher early mortality but substantial functional improvement. TEER achieved MR ≤ 2 + in 84-99% of patients with low procedural complication rates (1-9%), whereas LVAD therapy demonstrated greater functional improvement but higher device-related complications. TEER is associated with improved outcomes in selected patients with advanced heart failure and SMR, while LVAD therapy remains essential for patients with end-stage disease requiring durable circulatory support.

Sodium Glucose Co-trasporter-2 Inhibitors Initiation In Patients With Advanced Heart Failure Supported With Left Ventricular Assist Device