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result(s) for
"Kalmucki, Piotr"
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Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial
2016
ObjectiveFunctional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR.Methods36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant.ResultsThere was 1 major adverse event within 30 days—a death (not device related)—occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study.ConclusionsThe modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.
Journal Article
Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation
by
Kałmucki, Piotr
,
Witte, Klaus K
,
Siminiak, Tomasz
in
Carillon
,
Clinical outcomes
,
Clinical trials
2023
It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are 2 broad groups: those with proportional FMR who respond less favorably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown.
We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device.
This is a pooled analysis from 3 trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n = 74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n = 39;35%).
At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r = 0.17; change in LVESV r = 0.14).
Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large-scale trial.
[Display omitted]
Journal Article
Management of Calcified Coronary Lesions-A Review of Plaque Modification Methods
by
Kałmucki, Piotr
,
Siminiak, Tomasz
,
Baszko, Artur
in
Angioplasty
,
Atherosclerosis
,
Atherosclerotic plaque
2025
Coronary artery disease remains the leading cause of cardiovascular morbidity and mortality worldwide, affecting millions of individuals each year. Coronary artery calcification is a common finding in patients with advanced atherosclerosis and represents an important determinant of procedural success during percutaneous coronary intervention. Severe calcifications are associated with increased procedural complexity and elevated complication rates due to challenging lesion preparation, suboptimal stent expansion, and less favorable long-term clinical results. This review summarizes the present understanding of vascular calcification mechanisms, discusses relevant diagnostic imaging modalities, and describes current plaque modification techniques used to optimize procedural outcomes. Methods such as rotational, orbital, and laser atherectomy, as well as specialized balloon technologies and intravascular lithotripsy, are discussed with regard to their mechanisms of action, clinical effectiveness, and safety profiles. Particular emphasis is placed on the integration of advanced imaging for precise lesion assessment, improved patient selection, and the use of combination strategies in complex cases. Finally, emerging technologies and future directions are highlighted, with the goal of enhancing procedural safety, device deliverability, and treatment outcomes in the evolving field of interventional cardiology.
Journal Article
Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial
2024
Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure.
The SELECT trial was a randomised, double-blind, multicentre, placebo-controlled, event-driven phase 3 trial in 41 countries. Adults aged 45 years and older, with a BMI of 27 kg/m2 or greater and established cardiovascular disease were eligible for the study. Patients were randomly assigned (1:1) with a block size of four using an interactive web response system in a double-blind manner to escalating doses of once-weekly subcutaneous semaglutide over 16 weeks to a target dose of 2·4 mg, or placebo. In a prespecified analysis, we examined the effect of semaglutide compared with placebo in patients with and without a history of heart failure at enrolment, subclassified as heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, or unclassified heart failure. Endpoints comprised MACE (a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death); a composite heart failure outcome (cardiovascular death or hospitalisation or urgent hospital visit for heart failure); cardiovascular death; and all-cause death. The study is registered with ClinicalTrials.gov, NCT03574597.
Between Oct 31, 2018, and March 31, 2021, 17 604 patients with a mean age of 61·6 years (SD 8·9) and a mean BMI of 33·4 kg/m2 (5·0) were randomly assigned to receive semaglutide (8803 [50·0%] patients) or placebo (8801 [50·0%] patients). 4286 (24·3%) of 17 604 patients had a history of investigator-defined heart failure at enrolment: 2273 (53·0%) of 4286 patients had heart failure with preserved ejection fraction, 1347 (31·4%) had heart failure with reduced ejection fraction, and 666 (15·5%) had unclassified heart failure. Baseline characteristics were similar between patients with and without heart failure. Patients with heart failure had a higher incidence of clinical events. Semaglutide improved all outcome measures in patients with heart failure at random assignment compared with those without heart failure (hazard ratio [HR] 0·72, 95% CI 0·60–0·87 for MACE; 0·79, 0·64–0·98 for the heart failure composite endpoint; 0·76, 0·59–0·97 for cardiovascular death; and 0·81, 0·66–1·00 for all-cause death; all pinteraction>0·19). Treatment with semaglutide resulted in improved outcomes in both the heart failure with reduced ejection fraction (HR 0·65, 95% CI 0·49–0·87 for MACE; 0·79, 0·58–1·08 for the composite heart failure endpoint) and heart failure with preserved ejection fraction groups (0·69, 0·51–0·91 for MACE; 0·75, 0·52–1·07 for the composite heart failure endpoint), although patients with heart failure with reduced ejection fraction had higher absolute event rates than those with heart failure with preserved ejection fraction. For MACE and the heart failure composite, there were no significant differences in benefits across baseline age, sex, BMI, New York Heart Association status, and diuretic use. Serious adverse events were less frequent with semaglutide versus placebo, regardless of heart failure subtype.
In patients with atherosclerotic cardiovascular diease and overweight or obesity, treatment with semaglutide 2·4 mg reduced MACE and composite heart failure endpoints compared with placebo in those with and without clinical heart failure, regardless of heart failure subtype. Our findings could facilitate prescribing and result in improved clinical outcomes for this patient group.
Novo Nordisk.
Journal Article
Evaluation of radiological risk during coronary angioplasty procedures: comparison of transradial and transfemoral approaches
2017
Increasing operator experience and newer available interventional cardiology devices require reassessment of radiological risk related to percutaneous coronary interventions (PCI). We aimed at comparison of radiological risk and procedural data of PCIs performed by radial (RA) and femoral (FA) approach in real life patients. Detailed retrospective analysis of 1500 consecutive PCIs with the use of radial or femoral access was performed. Comparison between RA and FA groups included procedural time (PT), fluoroscopy time (FT), radiation dose and contrast volume usage. There was no significant differences between RA and FA procedures in FT (12.6 ± 13.5 vs. 11.7 ± 9.5 min), X-ray dose generated during PCI (805.9 ± 615.9 vs. 792.2 ± 633.9 mGy) and use of contrast medium (145.2 ± 62.2 vs. 152.5 ± 64.2 ml). Mean total PT was shorter in RA (43.7 ± 24.5 min) than in FA group (47.2 ± 30.13 min, p < 0.02). Patients’ age positively correlated with FT (r = 0.14, p < 0.05) and PT (r = 0.07, p < 0.05) in RA but not in FA group (r = 0.05; r = −0.06, respectively). Despite younger age, PCIs in males needed higher usage of contrast medium (151.7 ± 69.2 vs. 139.1 ± 49.3 ml; p < 0.001), and higher X-ray dose (887.0 ± 660.4 vs. 657.8 ± 515.2 mGy; p < 0.001). Age significantly correlated with PT only in female (r = 0.093, p < 0.05) but not in male patients (r = 0.015). We conclude that fluoroscopy times, X-ray dose and use of contrast medium were similar in RA and FA, but mean total procedural time was significantly shorter in RA than in FA group. However, older patients in RA group needed longer fluoroscopy and procedural times to complete PCI and this was not seen in FA.
Journal Article
Bipolar irrigated radiofrequency ablation of resistant ventricular tachycardia with a septal intramural origin: the initial experience and a description of the method
by
Iwachów, Piotr
,
Kochman, Karol
,
Baszko, Artur
in
Alcohol
,
Bipolar RF ablation
,
Cardiac arrhythmia
2016
Key Clinical Message Bipolar radiofrequency (RF) ablation is effective in treatment of ventricular tachycardia originating from thick interventricular septum. The RF generator and CARTO system can be used to precisely and safely perform ablation. Standard ablation catheter can be used with indifferent ablation electrode connected to the electrode receptacle in RF generator with custom‐made cable. Bipolar radiofrequency (RF) ablation is effective in treatment of ventricular tachycardia originating from thick interventricular septum. The RF generator and CARTO system can be used to precisely and safely perform ablation. Standard ablation catheter can be used with indifferent ablation electrode connected to the electrode receptacle in RF generator with custom‐made cable.
Journal Article
Stent loss in the radial artery - surgical vs. interventional approach - report of two cases
2015
Stent loss during coronary angioplasty is a complication that can be managed in various manners; however, transradial access limits the options available. We describe two coronary interventions complicated by stent dislodgement, initially managed by pulling the stent back to the radial artery. Both stents were unwillingly lost on different levels in radial arteries. The first case was managed with a direct radial artery cut-down because distal location made it a quick and straightforward procedure. In the second case a partially deployed stent was lost in the proximal part of the radial artery. It was rewired, deployed, and post-dilated with a larger balloon. This enabled continuation of the procedure using the same access. Both cases were asymptomatic during 24 months of follow-up. It is crucial to avoid leaving artificial bodies in arteries supplying vital organs because stent-related thrombosis or stenosis may seriously compromise blood flow. Removing the stent via the introducer sheath should be considered the optimal treatment. Unfortunately it is common that a partially expanded stent will not pass through the sheath. The superficial location of the distal radial artery segment facilitates surgical cut-down with local anaesthesia. When dislodgement occurs in deeper segments of the radial artery, the benefits from cut-down seem to be less because the procedure might take more time and be more difficult - as in the presented case in which we decided to rewire and fully expand the stent in situ. Retrieval of the stent at all costs might have led to further complications; hence stent deployment may be a good alternative to retrieval in such cases.
Journal Article
Methods and Techniques Stent loss in the radial artery – surgical vs. interventional approach – report of two cases
2015
Stent loss during coronary angioplasty is a complication that can be managed in various manners; however, transradial access limits the options available. We describe two coronary interventions complicated by stent dislodgement, initially managed by pulling the stent back to the radial artery. Both stents were unwillingly lost on different levels in radial arteries. The first case was managed with a direct radial artery cut-down because distal location made it a quick and straightforward procedure. In the second case a partially deployed stent was lost in the proximal part of the radial artery. It was rewired, deployed, and post-dilated with a larger balloon. This enabled continuation of the procedure using the same access. Both cases were asymptomatic during 24 months of follow-up. It is crucial to avoid leaving artificial bodies in arteries supplying vital organs because stent-related thrombosis or stenosis may seriously compromise blood flow. Removing the stent via the introducer sheath should be considered the optimal treatment. Unfortunately, it is common that a partially expanded stent will not pass through the sheath. The superficial location of the distal radial artery segment facilitates surgical cut-down with local anaesthesia. When dislodgement occurs in deeper segments of the radial artery, the benefits from cut-down seem to be less because the procedure might take more time and be more difficult - as in the presented case in which we decided to rewire and fully expand the stent in situ. Retrieval of the stent at all costs might have led to further complications; hence stent deployment may be a good alternative to retrieval in such cases.
Journal Article