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46 result(s) for "Cuculi, Florim"
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Cardiovascular magnetic resonance by non contrast T1-mapping allows assessment of severity of injury in acute myocardial infarction
Current cardiovascular magnetic resonance (CMR) methods, such as late gadolinium enhancement (LGE) and oedema imaging (T2W) used to depict myocardial ischemia, have limitations. Novel quantitative T1-mapping techniques have the potential to further characterize the components of ischemic injury. In patients with myocardial infarction (MI) we sought to investigate whether state-of the art pre-contrast T1-mapping (1) detects acute myocardial injury, (2) allows for quantification of the severity of damage when compared to standard techniques such as LGE and T2W, and (3) has the ability to predict long term functional recovery. 3T CMR including T2W, T1-mapping and LGE was performed in 41 patients [of these, 78% were ST elevation MI (STEMI)] with acute MI at 12-48 hour after chest pain onset and at 6 months (6M). Patients with STEMI underwent primary PCI prior to CMR. Assessment of acute regional wall motion abnormalities, acute segmental damaged fraction by T2W and LGE and mean segmental T1 values was performed on matching short axis slices. LGE and improvement in regional wall motion at 6M were also obtained. We found that the variability of T1 measurements was significantly lower compared to T2W and that, while the diagnostic performance of acute T1-mapping for detecting myocardial injury was at least as good as that of T2W-CMR in STEMI patients, it was superior to T2W imaging in NSTEMI. There was a significant relationship between the segmental damaged fraction assessed by either by LGE or T2W, and mean segmental T1 values (P < 0.01). The index of salvaged myocardium derived by acute T1-mapping and 6M LGE was not different to the one derived from T2W (P = 0.88). Furthermore, the likelihood of improvement of segmental function at 6M decreased progressively as acute T1 values increased (P < 0.0004). In acute MI, pre-contrast T1-mapping allows assessment of the extent of myocardial damage. T1-mapping might become an important complementary technique to LGE and T2W for identification of reversible myocardial injury and prediction of functional recovery in acute MI.
Safety and efficacy of super-high pressure OPN balloon in patients with in-stent restenosis - an intra-coronary imaging-based observational study
Patients with in-stent restenosis have an increased risk of recurrence of major adverse cardiovascular events. Achievement of an adequate acute luminal gain is essential to minimize such recurrence. We compared the effect of utilization of Super-high pressure OPN balloon in patients with In-stent restenosis. This is an investigator-initiated single-centre observational study done at SRIHER, India. The primary outcome was procedural success, defined by intravascular ultrasound (IVUS). In addition, we intended to study the in-hospital clinical outcomes. We studied 30 patients, with 73.4% male and a median age of 66.5 years. Diabetes was present in 83%, hypertension in 60%, and chronic kidney disease in 20%. Left ventricular dysfunction (EF < 45%) was observed in 43.3%. In-stent restenosis (ISR) cases presented as chronic coronary syndrome (43.3%), NSTEMI (36.7%), and unstable angina (20%). Among 49 lesions, 48.97% were in the LAD, followed by the RCA (28.57%), LCx (20.4%), and LM (2.04%). OPN was used for pre-dilatation in 14 patients and post-dilatation in 13 patients while it was used for both pre- and post-dilatation in 3 patients. Regarding final treatment, drug-eluting stents (DES) was used in 21 cases (36 lesions), a covered stent in 1 case (2 lesions), drug-coated balloons (DCB) in 6 cases (9 lesions), and plain old balloon angioplasty (POBA) in 2 cases (2 lesions). Procedural success was obtained in all but one patients. ( n  = 47 lesions) One patient had coronary perforation that was managed by a covered stent. At a median follow-up of 31 months (IQR-22), 4 (13.3%) patients had died; 1 due to potential stent thrombosis and 3 due to non-cardiovascular causes, and there was no MI or repeat revascularization. In our image-guided study, we found that OPN usage may be a safe and effective in patients with ISR lesions leading to a very good acute luminal gain.
Rotational Atherectomy Combined With Super High‐Pressure Noncompliant Balloon in Severe or Recurrent In‐Stent Restenosis
Background In-stent restenosis (ISR) and recurrent ISR (Re-ISR) remain significant challenges of percutaneous coronary intervention (PCI), especially in complex lesions where conventional therapies are less effective. Rotational atherectomy (RA) combined with super high-pressure noncompliant (NC) balloons represents a potential strategy for addressing severe ISR or Re-ISR. Objectives and Methods This study investigated the procedural success and safety as well as clinical outcomes of RA combined with super high-pressure NC balloons in patients with severe or Re-ISR. Consecutive patients treated for severe or Re-ISR between January 2020 and September 2024 were retrospectively analyzed. The primary endpoint was major adverse cardiovascular events (MACEs) at follow-up, including target vessel myocardial infarction (TV-MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). Periprocedural complications were also recorded. Results Out of 13 treated patients, 6 (46%) patients experienced periprocedural events, including 3 (23%) Type A dissections, 2 (15%) Type B dissections, and 1 (8%) Ellis Grade I perforation. 9 (70%) patients were treated with drug-coated balloons (DCBs), 1 (8%) of which had crossover to stenting and 2 (15%) had hybrid strategy with DCB and stenting combined. At a median follow-up of 13months, 4 (31%) patients had MACE, comprising 1 (8%) TV-MI by TLR, 2 (15%) clinically driven TLR, and 1 (8%) TVR. Secondary outcomes included 1 (8%) case of hospitalization for heart failure (HF) and 1 (8%) COVID-19-related death. Conclusions RA combined with super high-pressure NC balloons for the treatment of severe ISR or Re-ISR is associated with a significant risk of periprocedural complications. However, the midterm outcomes suggest this strategy might be effective in managing severe or Re-ISR. Trail Registration ClinicalTrials.gov identifier: NCT06075602
Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial
BackgroundThe randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.MethodsEight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints.ResultsOne-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).ConclusionsThe clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group.Clinical Trial Registrationwww.clinicaltrials.gov; number, NCT01574534
Manual compression versus MANTA device for access management after impella removal on the ICU
To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24–69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01–0.50; p  = 0.001), and there was no significant difference in vascular complications between the two groups ( p  = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.
Mitigating the risk of flow deterioration by deferring stent optimization in STEMI patients with large thrombus burden: Insights from a prospective cohort study
Objectives It is uncertain, if omitting post-dilatation and stent oversizing (stent optimization) is safe and may decrease the risk for distal thrombus embolization (DTE) in STEMI patients with large thrombus burden (LTB). Background In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) with stenting, (DTE) and flow deterioration are common and increase infarct size leading to worse outcomes. Methods From a prospective registry, 74 consecutive STEMI patients with LTB undergoing pPCI with stenting and intentionally deferred stent optimization were analyzed. Imaging data and outcomes up to 2 years follow-up were analyzed. Results Overall, 74 patients (18% females) underwent deferred stent optimization. Direct stenting was performed in 13 (18%) patients. No major complications occurred during pPCI. Staged stent optimization was performed after a median of 4 (interquartile range (IQR) 3; 7) days. On optical coherence tomography, under-expansion and residual thrombus were present in 59 (80%) and 27 (36%) cases, respectively. During deferred stent optimization, we encountered no case of flow deterioration (slow or no-reflow) or side branch occlusion. Minimal lumen area (mm 2 ) and stent expansion (%) were corrected from 4.87±1.86mm to 6.82±2.36mm ( p <0.05) and from 69±18% to 91±12% ( p <0.001), respectively. During follow-up, 1 patient (1.4%) required target lesion revascularization and 1 (1.4%) patient succumbed from cardiovascular death. Conclusions Among STEMI patients with LTB, deferring stent optimization in the setting of pPCI appears safe and potentially mitigates the risk of DTE. The impact of this approach on infarct size and clinical outcomes warrants further investigation in a dedicated trial.
“Burying” covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency
Covered coronary stent (CS) implantation is associated with a high risk for in-stent restenosis (ISR) and stent thrombosis (ST). We describe the outcomes after overstenting (\"burying\") CS using contemporary drug-eluting stents (DES). We analyzed short- and long-term outcomes of consecutive patients who had had a CS implanted, which was consecutively covered (\"buried\") with a third-generation DES. CSs were primarily post-dilated and then covered with a longer DES overlapping the proximal and distal edges of the CS. To ensure optimal stent expansion and appositions, all lesions were post-dilated using adequately sized non-compliant balloons. Between 2015 and 2020, 23 patients (mean age 67 ± 14 years, 74% males) were treated using this novel approach. Reasons for implanting CS included treatment of coronary aneurysms (n = 7; 30%), coronary perforations (n = 13; 57%), and aorto-ostial dissections (n = 3; 13%). All CSs were successfully deployed, and no peri-procedural complications occurred. The median time of follow-up was 24.5 (interquartile range [IQR] 11.7-37.9) months. All patients had a 1-month follow-up (FU) and 19/23 (83%) patients had 12-month FU (FU range 1-60 months). No probable or definite STs occurred, and no cardiovascular deaths were observed. Among patients undergoing angiographic FU (11/23 [48%]), 1/23 showed angiographically significant ISR 6 months post CS implantation. Burying a coronary CS under a DES appears to be a safe and promising strategy to overcome the limitations of the currently available CS devices, including a relatively high risk for target lesion failure due to ISR and ST.
Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon
Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions. Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization. From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a \"DCB only\" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed. In complex coronary lesions, a \"DCB only\" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.
Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial
Background A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist‘s toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. Methods The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. Discussion Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. Trial registration number ClinicalTrials.gov Identifier: NCT04470934.
Circulating endothelial progenitor cells predict coronary artery disease severity
Circulating endothelial progenitor cells (EPCs) may play an important role in the body's defense against atherosclerosis. Previous studies have shown an association between EPC numbers and the presence of traditional coronary artery disease (CAD) risk factors. The relationship between EPC numbers and the severity of atherosclerosis is, however, not known. EPC counts were measured by quantitative cell culture in 122 patients undergoing diagnostic cardiac catheterization. The association between patients' EPC count and the presence of multivessel CAD and traditional cardiac risk factors was assessed using logistic regression analysis. The median age of the study population was 58 years; 37% had multivessel CAD, 29% had diabetes, and 14% had myocardial infarction this admission. EPC counts did not vary significantly with most established cardiac risk factors but were lower in diabetics versus nondiabetics and trended toward lower numbers in older patients. EPC count was the second strongest predictor of multivessel CAD, after patient age. Patients with multivessel disease had significantly lower EPC counts than those without (median, 3 vs 13; P < .0088). For every 10 colony forming unit increase in EPCs, a patient's likelihood for multivessel CAD declined by 20% ( P < .001). This study demonstrates an inverse relationship between circulating EPCs and CAD severity, independent of traditional risk factors. If confirmed in ongoing studies, this may represent an important new diagnostic and therapeutic target for coronary disease treatment.