Clinical outcomes among patients with mitral valve regurgitation undergoing Impella-supported high-risk PCI.

BACKGROUND: Mitral valve regurgitation (MR) is associated with worse outcomes in patients undergoing percutaneous coronary intervention (PCI). We sought to evaluate outcomes of Impella-supported high-risk PCI (HRPCI) patients according to MR severity. METHODS: Patients from the PROTECT III study undergoing Impella-supported HRPCI were stratified into 4 groups according to MR severity: No or trace MR, mild MR, moderate MR, and severe MR. Immediate PCI-related complications, major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days and death at 1-year were assessed. RESULTS: From March 2017 to March 2020, 631 patients who underwent Impella-supported HRPCI in the PROTECT III study had evaluable MR severity at baseline. Patients with severe MR had lower body mass indices, lower left ventricular ejection fractions (LVEFs), and were more frequently diagnosed with heart failure. The incidence of immediate PCI-related complications was similar between groups. Unadjusted 90-day MACCE and 1-year mortality rates were numerically higher in patients with severe MR compared to the other study groups yet without reaching statistical significance. In multivariable analyses, there was no significant association between the presence of severe MR for 90-day MACCE or 1-year mortality compared with other degrees of MR (adj. HR = 1.71, 95% CI [0.73, 3.98], p = 0.21; adj. HR = 1.79, 95% CI [0.86, 3.74], p = 0.12, respectively). CONCLUSIONS: Impella-supported HRPCI patients with moderate or severe MR exhibited a higher prevalence of heart failure, lower LVEF, and longer hospital stays. Patients with severe MR showed numerically higher unadjusted rates of 90-day MACCE and 1-year mortality compared to other groups, however these differences did not reach statistical significance even after adjustment for potential confounders. CLINICAL TRIAL INFORMATION: Trial Name: The Global cVAD Study (cVAD) ClinicalTrial.govIdentifier:NCT04136392 URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Microvascular Obstruction in Patients With Anterior STEMI Treated With Supersaturated Oxygen.

Background: Supersaturated oxygen (SSO2) delivered into the left anterior descending coronary artery after percutaneous coronary intervention (PCI) for anterior ST-segment elevation myocardial infarction (STEMI) has been shown to reduce infarct size, but its effects on microvascular obstruction (MVO) are unknown. The aim of this study was to compare MVO in patients with anterior STEMI treated with SSO2 after successful primary PCI from 2 studies (the optimized SSO2 pilot and IC-HOT) with similar patients from 7 randomized trials who underwent primary PCI without SSO2 treatment. Methods: A total of 874 patients with anterior STEMI who underwent MVO assessment using cardiac magnetic resonance imaging within 10 days after primary PCI were included, of whom 90 patients (10.3%) were treated with SSO2. The primary end point was the extent of MVO as a continuous measure in a weighted multivariable model. The secondary end point was the presence of MVO. Results: SSO2 therapy was independently associated with a lower extent of MVO compared with no SSO2 therapy (coefficient, -1.35; 95% CI, -2.58 to -0.11; P = .03). SSO2 therapy was also associated with a borderline lower risk of any MVO (adjusted odds ratio, 0.56; 95% CI, 0.31-1.00; P = .051). Conclusions: In the present individual patient data pooled analysis from 9 studies, SSO2 therapy was associated with less MVO after successful primary PCI for anterior STEMI.

Implications of anemia in patients undergoing PCI with Impella-support: insights from the PROTECT III study.

Background: Anemia is prevalent among patients with cardiovascular disease and is associated with adverse outcomes. However, data regarding the impact of anemia in high-risk percutaneous coronary intervention (HRPCI) are limited. Objectives: This study aimed to evaluate the impact of anemia in patients undergoing Impella-supported HRPCI in the PROTECT III study. Methods: Patients undergoing Impella-supported HRPCI in the multicenter PROTECT III study were assessed for anemia based on baseline hemoglobin levels according to World Health Organization criteria. Patients were stratified into three groups, namely, no anemia, mild anemia, and moderate or severe anemia. Major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 30 and 90 days, and major bleeding events were compared across groups. Results: Of 1,071 patients with baseline hemoglobin data, 37.9% had no anemia, 43.4% had mild anemia, and 18.7% had moderate or severe anemia. Anemic patients were older and more likely to have comorbidities. Anemia was associated with higher MACCE rates at 30 days (moderate to severe, 12.3%; mild, 9.8%; no anemia, 5.4%; p = 0.02) and at 90 days (moderate to severe, 18.7%; mild, 14.6%; none, 8.3%; p = 0.004). These differences persisted after adjustment for potential confounders at 30 and 90 days, and sensitivity analysis excluding dialysis showed similar results. Major bleeding at 30 days was also higher in anemic patients (5.5% vs. 1.2%, p = 0.002). Conclusion: Baseline anemia in Impella-supported HRPCI is common and independently associated with MACCE and major bleeding, emphasizing its significance as a prognostic factor. Specific management strategies to reduce anemia-associated MACCE risk after HRPCI should be examined. Clinical Trial Information Trial Name: The Global cVAD Study (cVAD)ClinicalTrial.gov Identifier: NCT04136392URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Apoptotic Cells for Therapeutic Use in Cytokine Storm Associated With Sepsis- A Phase Ib Clinical Trial.

Background: Sepsis has no proven specific pharmacologic treatment and reported mortality ranges from 30%-45%. The primary aim of this phase IB study was to determine the safety profile of Allocetra™-OTS (early apoptotic cell) infusion in subjects presenting to the emergency room with sepsis. The secondary aims were to measure organ dysfunction, intensive care unit (ICU) and hospital stays, and mortality. Exploratory endpoints included measuring immune modulator agents to elucidate the mechanism of action. Methods: Ten patients presenting to the emergency room at the Hadassah Medical Center with sepsis were enrolled in this phase Ib clinical study. Enrolled patients were males and females aged 51-83 years, who had a Sequential Organ Failure Assessment (SOFA) score ≥2 above baseline and were septic due to presumed infection. Allocetra™-OTS was administered as a single dose (day +1) or in two doses of 140×106 cells/kg on (day +1 and +3), following initiation of standard-of-care (SOC) treatment for septic patients. Safety was evaluated by serious adverse events (SAEs) and adverse events (AEs). Organ dysfunction, ICU and hospital stays, and mortality, were compared to historical controls. Immune modulator agents were measured using Luminex® multiplex analysis. Results: All 10 patients had mild-to-moderate sepsis with SOFA scores ranging from 2-6 upon entering the study. No SAEs and no related AEs were reported. All 10 study subjects survived, while matched historical controls had a mortality rate of 27%. The study subjects exhibited rapid resolution of organ dysfunction and had significantly shorter ICU stays compared to matched historical controls (p<0.0001). All patients had both elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that gradually decreased following treatment. Conclusion: Administration of apoptotic cells to patients with mild-to-moderate sepsis was safe and had a significant immuno-modulating effect, leading to early resolution of the cytokine storm. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03925857. (https://clinicaltrials.gov/ct2/show/study/NCT03925857).

[TO BE A RESIDENT IN THE DEPARTMENT OF MEDICINE].

INTRODUCTION: Sir William Osler is considered to be one of the fathers of modern medicine who pioneered the practice of bedside teaching of clinical medicine for medical students and residents. Osler was well known as a diagnostician and outstanding therapist with a humanized approach and rare didactic capabilities. Medical training at Hadassah is built on the central tenets of Osler's approach, incorporating the tremendous advances in science and medicine. Training for residents in Internal Medicine is designed to develop a broad base of medical and, if possible, scientific knowledge, as well as skills and competencies to deliver a high standard of patient care. In the past 7 years, 28 residents have undergone specialist training in Internal Medicine B. Among them, 71% were Israeli medical school graduates; 36% were women;18% were recent immigrants to Israel; 78% were Jewish. Among Jewish residents, 32% were religiously observant. Besides the usual assignments of the internal medicine ward, the medical staff of Internal Medicine B excelled in diagnosis of hard to diagnose diseases as described in eleven cases. The diagnosis in some of those cases was a result of listening to the patient, education on clinical reasoning and the use advanced diagnostic tools. The basic unit of the residency is the clinical mission with an emphasis on exposure to novel modalities such as the use of bedside ultra sound along with dealing with end-of-life dilemmas, the management of complex situations and development of communication and interpersonal skills needed to work with close relatives and families facing critical times. The medical training in the internal ward is not just the sum of arbitrary care of the hospitalized patients, but a well-structured plan with gradually increasing demands. Over the past 7 years, residents in Internal Medicine B have achieved successful passing grades of 38/38 on the first attempt oral and written board examinations, a record that attests to the quality of the trainees and the training process. Hadassah has a long history of providing state-of-the-art patient care, and training young physicians to maintain this high standard - but the education process necessitates longstanding efforts and continuous striving for excellence.

Endarterectomy or Stenting in Severe Asymptomatic Carotid Stenosis.

BACKGROUND: Stroke is a major cause of death in the western world, and carotid endarterectomy has been shown to be effective in treating both symptomatic and asymptomatic carotid stenosis. Carotid stenting is a relatively new form of treatment for carotid stenosis and few studies have looked specifically at asymptomatic patients. OBJECTIVES: To retrospectively examine short- and long-term results in the treatment of asymptomatic carotid artery stenosis with surgery or stenting. METHODS: We retrospectively collected data of all patients with asymptomatic carotid stenosis treated by carotid artery stenting or carotid endarterectomy in our department from 2006-2007. The primary endpoints were stroke, myocardial infarction, or death during the periprocedural period; or any ipsilateral stroke, restenosis, or death within 4 years after the procedure. RESULTS: The study comprised 409 patients who were treated by either stenting or surgery. There was a low morbidity rate in both treatment groups with no significant difference in morbidity or mortality between the treatment groups in both in the short-term as well as long-term. CONCLUSIONS: Both treatment methods have a low morbidity and mortality rate and should be considered for patients with few risk factors and a long life expectancy. Treatment method should be selected according to the patient's individual risk factors and imaging data.