Publications by authors named "Tamaz Shaburishvili"

Article Synopsis
  • * The study included 51 patients and found a high safety rate, with 92.2% free from target lesion failure at 180 days and 90.2% at one year.
  • * The new DCB showed significantly better results in reducing in-stent late lumen loss compared to standard balloon angioplasty, indicating its superior efficacy for ISR treatment.
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  • This study evaluated the effectiveness and safety of a new procedure called splanchnic nerve ablation for managing fluid volume in patients with heart failure and preserved ejection fraction (HFpEF).* -
  • Conducted as a phase 2, double-blind, randomized trial involving 90 patients across 15 centers, the study compared the outcomes of the nerve ablation procedure to a sham control.* -
  • Results showed no significant differences in both the primary outcomes (reduction in pulmonary capillary wedge pressure) and safety events between the treatment and control groups, suggesting that the nerve ablation may not provide the expected benefits for these patients.*
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Aims: Loop diuretics may exacerbate cardiorenal syndrome (CRS) in heart failure (HF). Direct sodium removal (DSR) using the peritoneal membrane, in conjunction with complete diuretic withdrawal, may improve CRS and diuretic resistance.

Methods And Results: Patients with HF requiring high-dose loop diuretics were enrolled in two prospective, single-arm studies: RED DESERT (n = 8 euvolaemic patients), and SAHARA (n = 10 hypervolaemic patients).

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Objective: Splanchnic vasoconstriction augments transfer of blood volume from the abdomen into the thorax, which may increase filling pressures and hemodynamic congestion in patients with noncompliant hearts. Therapeutic interruption of splanchnic nerve activity holds promise to reduce hemodynamic congestion in patients with heart failure with preserved ejection fraction (HFpEF). Here we describe (1) the rationale and design of the first sham-controlled, randomized clinical trial of splanchnic nerve ablation for HFpEF and (2) the 12-month results of the lead-in (open-label) trial's participants.

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Background: Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP).

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  • TAVI is an effective treatment for severe aortic stenosis, but there's room for better technology focused on improving flow and durability.
  • This study tested the safety and feasibility of the DurAVR biomimetic transcatheter heart valve in patients with symptomatic severe aortic stenosis in a first-in-human trial.
  • Results showed successful implantation in all cases with minimal complications, favorable hemodynamics at 30 days and 1 year, and restoration of healthy blood flow patterns, indicating promising potential for the DurAVR valve.
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Background: Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access.

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Background: Synchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods.

Methods: Symptomatic patients with HFrEF despite guideline-directed therapy were enrolled.

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Background: Endovascular baroreflex amplification with the MobiusHD, a self-expanding stent-like device that is implanted in the internal carotid artery, was designed to reduce the sympathetic overactivity that contributes to progressive heart failure with reduced ejection fraction.

Methods: Symptomatic patients (New York Heart Association class III) with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) despite guideline directed medical therapy and n-terminal pro-B type natriuretic peptide (NT-proBNP) levels ≥400 pg/mL in whom carotid ultrasound and computed tomographic angiography demonstrated absence of carotid plaque were enrolled. Baseline and follow-up measures included 6-minute walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ OSS), and repeat biomarkers and transthoracic echocardiography.

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Background: Most approaches to the creation of an interatrial shunt require placement of a permanent implant to maintain patency.

Objectives: The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF).

Methods: This was a multicenter, uncontrolled study of patients with HFpEF/HFmrEF and NYHA functional class ≥II, ejection fraction >40%, and pulmonary capillary wedge pressure (PCWP) during supine exercise ≥25 mm Hg with PCWP-to-right atrial gradient ≥5 mm Hg.

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Background: Ablation of the right-sided greater splanchnic nerve (GSN) can reduce excessive splanchnic vasoconstriction, potentially improving the handling of volume shifts in patients with heart failure with preserved ejection fraction (HFpEF).

Objectives: The purpose of this study was to assess a novel catheter procedure of right-sided GSN ablation to treat HFpEF: splanchnic ablation for volume management.

Methods: This trial included 11 HFpEF patients (8 women, age 70 ± 8 years) with New York Heart Association functional class II or III symptoms, ejection fraction ≥50%, and elevated pulmonary capillary wedge pressure at rest or with exercise.

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Aims: Synchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra-abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device.

Methods And Results: The SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active-fixation leads on the inferior diaphragmatic surface.

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Aims: In heart failure (HF) with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention. Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial.

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Objectives: The goal of this study was to assess the safety and tolerability of omecamtiv mecarbil treatment during symptom-limited exercise in patients with ischemic cardiomyopathy and angina. These patients may have increased vulnerability to prolongation of the systolic ejection time.

Background: Omecamtiv mecarbil is a selective cardiac myosin activator that augments cardiac contractility in patients with systolic heart failure through a dose-dependent increase in systolic ejection time.

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Background: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome (time to cardiovascular death, aborted cardiac arrest, or hospitalization for management of heart failure) compared with patients receiving placebo. In a post hoc analysis, an ≈4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States, Canada, Brazil, and Argentina (the Americas).

Methods And Results: To better understand this regional difference in clinical outcomes, demographic characteristics of these populations and their responses to spironolactone were explored.

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Article Synopsis
  • A study was conducted to assess the effects of spironolactone on patients with heart failure and preserved left ventricular ejection fraction, involving 3,445 participants who were randomly assigned to receive either the drug or a placebo.
  • Over an average follow-up of 3.3 years, spironolactone did not significantly reduce the overall rates of serious cardiovascular events compared to the placebo, though it did lower hospitalizations for heart failure.
  • The treatment was associated with increased serum creatinine levels and a higher rate of hyperkalemia but did not result in more serious adverse events, suggesting a need for ongoing monitoring during treatment.
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Background: Treatment of Preserved Cardiac Function with an Aldosterone Antagonist (TOPCAT) is an ongoing randomized controlled trial of spironolactone versus placebo for heart failure with preserved ejection fraction (HFpEF). We sought to describe the baseline clinical characteristics of subjects enrolled in TOPCAT relative to other contemporary observational studies and randomized clinical trials of HFpEF.

Methods And Results: Between August 2006 and January 2012, 3445 patients with symptomatic HFpEF from 270 sites in 6 countries were enrolled in TOPCAT.

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Cangrelor is an intravenous antagonist of the P2Y(12) receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, cangrelor was not superior to clopidogrel in reducing the incidence of ischemic events in the cangrelor versus standard therapy to achieve optimal management of platelet inhibition (CHAMPION) trials. A prospectively designed platelet function substudy was performed in a selected cohort of patients to provide insight into the pharmacodynamic effects of cangrelor, particularly in regard to whether cangrelor therapy may interfere with the inhibitory effects of clopidogrel.

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Background: Despite increasing prevalence of heart failure (HF) in patients with preserved ejection fraction (PEF), there are no available therapies proven to reduce morbidity and mortality. Aldosterone, a potent stimulator of myocardial and vascular fibrosis, may be a key mediator of HF progression in this population and is therefore an important therapeutic target.

Objective: The TOPCAT trial is designed to evaluate the effect of spironolactone, an aldosterone antagonist, on morbidity, mortality, and quality of life in patients with HF-PEF.

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Background: Many patients with heart failure remain symptomatic and have a poor prognosis despite existing treatments. Decreases in myocardial contractility and shortening of ventricular systole are characteristic of systolic heart failure and might be improved by a new therapeutic class, cardiac myosin activators. We report the first study of the cardiac myosin activator, omecamtiv mecarbil, in patients with systolic heart failure.

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