Publications by authors named "Michael Jonas"

Aims: The interstitial space is the major compartment in which the excess fluid is located, forming peripheral congestion in acute decompensated heart failure (ADHF). The lymphatic system is responsible for the constant drainage of the compartment. In ADHF, the inefficiency of this system causes extravascular fluid accumulation, underscoring the crucial role of lymphatic system failure in ADHF's pathophysiology.

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  • Haemodynamic monitoring with implantable pressure sensors lowers heart failure hospitalizations and empowers patients to manage their treatment, potentially enhancing adherence and reducing healthcare provider workloads.
  • The VECTOR-HF I and IIa studies evaluate a patient self-management approach for heart failure, showing no serious complications and high adherence (91.4%) over a year, with significant reductions in hospitalizations and improvements in physical function and quality of life.
  • Interim results indicate that patient self-management using left atrial pressure monitoring is safe, feasible, and may lead to better outcomes for heart failure patients.
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  • * A study involving 315 patients found that after 1 year, only 4.9% experienced serious events like cardiac death or stent thrombosis, which was better than the pre-set safety target.
  • * The results indicate that a 1-month DAPT is sufficient for patients with stable angina, and some acute coronary syndrome patients had DAPT extended to 3 months, with very low rates of complications.
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  • The ridaforolimus-eluting stent (RES) system, known as EluNIR, uses a unique cobalt alloy and polymer to treat small coronary artery disease with a diameter of 2.25 mm.
  • The study assessed safety and effectiveness through a clinical trial involving 81 patients, with follow-ups at 30 days, 6 months, and 1 year, focusing on achieving low residual stenosis without major adverse events.
  • Results indicated a 98.8% success rate, low rates of complications (1.2% at 30 days and 2.5% at 1 year), and highlighted the EluNIR stent as a valuable option for treating this challenging type of coronary artery issue.*
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Background: The CHADS-VAS score is used to predict the risk of thromboembolic complications in patients with atrial fibrillation (AF). We hypothesized that the CHADS-VAS score can be used to predict mortality in patients undergoing coronary angiography.

Methods And Results: This was a prospective study of 990 patients undergoing coronary angiography.

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Background: Patients undergoing percutaneous coronary intervention (PCI) may experience rapid atherosclerotic plaque progression in nontreated vessels that is unlikely to result from natural de novo atherosclerosis. We hypothesize that intra-lesion bleeding plays a central role in this process. The aim of this study is to investigate the factors that may contribute to accelerated narrowing in coronary diameter.

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  • Diabetes mellitus (DM) increases the likelihood of neointimal hyperplasia (NIH) and restenosis after percutaneous coronary intervention (PCI), prompting a study to assess the link between DM severity and NIH after PCI.
  • The study involved patients with DM from the BLADE-PCI trial, focusing on those with recent HbA1c levels; results indicated that patients with uncontrolled DM (HbA1c ≥ 7.5%) had a higher mean percentage of NIH volume compared to those with controlled DM (HbA1c < 7.5%).
  • Despite these findings, no significant association was observed between higher HbA1c levels and increased NIH risk, leading to the conclusion that uncontrolled DM at PCI does
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Introduction: Impaired relaxation is the earliest manifestation of ischemic cascade. Risk factors and renal function abnormalities are associated with coronary disease and diastolic dysfunction as well. We aimed to study the association of noninvasive assessment of left ventricular filling pressures and renal function with mortality in high-risk patients undergoing coronary angiography.

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Background: The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions.

Methods: A prospective, multicenter, single-arm, open-label clinical trial.

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Introduction: Renal ischemia and reperfusion (IR) injury introduces cellular stress and is the main cause of acute kidney damage. Renal cells exposed to noxious stress induce the expression of the pleiotropic hormone leptin. As we have previously revealed a deleterious stress-related role for leptin expression, these results suggested that leptin is also involved in pathological renal remodeling.

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Aims: In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients.

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Background: Transcatheter aortic valve replacement (TAVR) provokes an early injury response, partially represented by dynamic changes in inflammatory markers. TAVR greatly benefits the elderly and we aimed to determine whether increased inflammatory markers post-TAVR in octagenerians were different than their younger counterparts and whether it was associated with adverse clinical outcomes.

Methods: Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVR from January 2010 to December 2021 were enrolled.

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  • The study assessed the safety and effectiveness of the SPAS device for positioning coronary stents during PCI procedures.
  • It involved 55 procedures that tackled various complex cases like calcified or occluded vessels, with positive feedback from 75.5% of the operators regarding their satisfaction and device performance.
  • Results indicated that the SPAS device is user-friendly, reliable, and demonstrated no adverse events, making it a promising tool for both standard and complex stenting.
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Objective: The aim of this study was to evaluate the mid-term efficacy of drug-coated balloons (DCB) in percutaneous coronary intervention (PCI) in two different pathophysiologic scenarios.

Background: There are different underlying pathological processes in coronary artery disease. Mid-term safety and efficacy of DCB approach is still limited.

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Background: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM.

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  • TAVI-related thrombocytopenia (TAVI-rTP) remains common, but recent research shows a decrease in severe cases over time.
  • The study analyzed 334 patients aged around 82 who underwent TAVI from 2010 to 2019, revealing a drop in significant platelet count reductions from 62% in earlier cases to 33% in more recent ones.
  • Patients with a reduction of 30% or more in platelet counts face higher risks of severe complications, including life-threatening bleeding and increased mortality within 30 days following the procedure.
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Objective: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.

Methods: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF.

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Removal of excess fluid in acute decompensated heart failure (ADHF) targets the intravascular space, whereas most fluid resides in the interstitial space. The authors evaluated an approach to interstitial decongestion using a device to enhance lymph flow. The device was deployed in sheep with induced heart failure (HF) and acute volume overload to create a low-pressure zone at the thoracic duct outlet.

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Gensini score (GS) provides valuable information on severity and prognosis of coronary artery disease (CAD).To evaluate the relationship between the severity of CAD determined by the GS and relation to ST-elevation myocardial infarction, non-ST segment elevation myocardial infarction (NSTEMI), unstable angina pectoris, chest pain (suspected angina syndrome on admission) and risk-factors for CAD and predictors of severity.Observational cross-sectional study.

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Objective: Transcatheter aortic valve implantation (TAVI) provokes early injury response, represented in part by dynamic changes in the inflammatory markers. The association of self-expanding valves (SEVs) and balloon-expandable valves (BEVs) with the consequent inflammatory response remains uncertain.

Materials And Methods: Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI: SEVs or BEVs, from January 2010 to December 2019 were enrolled.

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  • Anti-endothelial cell antibodies (AECA) are markers indicating endothelial dysfunction and are relevant for assessing prognosis in coronary artery disease.
  • A study involving 857 patients found that those with high AECA levels had a better overall health profile, with fewer instances of coronary artery disease and lower mortality rates over a 6-year follow-up.
  • The research results suggest that higher natural AECA levels may be linked to a reduced risk of significant coronary issues and better survival outcomes in patients undergoing coronary angiography.
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Background: Prior studies have proven the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with reduced left ventricular (LV) function. This study's aim was to investigate periprocedural inflammatory responses after TAVI.

Methods: Patients with severe symptomatic aortic stenosis and reduced LV function who underwent transfemoral TAVI were enrolled.

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Background: Chronic kidney disease (CKD) is associated with poorer outcomes following percutaneous coronary intervention (PCI) with drug-eluting stents. Drug-eluting balloons are used for in-stent restenosis and selected cases of de-novo coronary lesions. Little is known regarding the outcomes of individuals with CKD who undergo PCI with drug-eluting balloons.

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Background: Transcatheter aortic valve implantation related thrombocytopenia (TAVI-rTP) is an inevitable phenomenon. However, no study has been performed on TAVI-rTP in the current setting of extended clinical indications combined with technology improvements.

Methods: Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI, from January 2016 to December 2019 were enrolled.

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