Optical coherence tomography, intravascular ultrasound or angiography guidance for distal left main coronary stenting. The ROCK cohort II study.

OBJECTIVES: to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly. BACKGROUND: Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited. METHODS: ROCK II is a multicenter, investigator-driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS. RESULTS: A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascular-imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p = 0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found. CONCLUSIONS: Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.

Magnesium Bioresorbable Scaffold (BRS) Magmaris vs Biodegradable Polymer DES Ultimaster in NSTE-ACS Population-12-Month Clinical Outcome.

Background: Percutaneous coronary intervention (PCI) in the acute coronary syndrome (ACS) setting is associated with a greater probability of device failure. The currently ongoing development of new scaffold technologies has concentrated an effort on improving the PCI outcomes, including the use of new biodegradable materials. This pilot study evaluates the performance of a magnesium bioresorbable scaffold (Magmaris, Biotronik, Germany) in comparison to the sirolimus-eluting bioresorbable polymer stents (BP-SES) (Ultimaster, Terumo, Japan) in the NSTE-ACS setting. Methods: The population of this pilot comprised 362 patients assigned to one of two arms (193-Magmaris vs 169-Ultimaster). The data regarding the primary outcome comprised of death from cardiac causes, myocardial infarction, and stent thrombosis, along with target-lesion failure (TLF) and other clinical events was collected in the 1-yearfollow-up. Results: There were no statistically significant differences in clinical outcomes in the short term (30 days) or in the 1-yearfollow-up between both groups. Conclusion: At 12 months, there were no statistically significant differences between the Magmaris and Ultimaster for composed endpoints or the TLF.

Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi-institutional experience.

OBJECTIVE: We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions. BACKGROUND: The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods. METHODS: All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints. RESULTS: In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%. CONCLUSIONS: S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.

Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome-the initial report from the Magmaris-ACS registry.

OBJECTIVES: The Magmaris-ACS Registry is the first assessment of the Magmaris implantation in the acute coronary syndrome (ACS) population. BACKGROUND: Bioresorbable vascular scaffolds (BRS), the newest coronary stent technology, was developed to overcome the limitations of the metallic drug-eluting stents (DES). Current promising data of the Magmaris in patients with stable angina have encouraged to validate the second generation BRS in ACS indications. METHODS: The study population consisted of the consecutive patients who underwent PCI with the Magmaris BRS in the settings of ACS. Patients with ST-segment elevation myocardial infarction were excluded from enrolment. Baseline demographic and angiographic characteristics, as well as 30-day and 6-month clinical, follow up were prospectively analyzed. RESULTS: Fifty patients were enrolled at mean age 62.9 ± 8.4 years (unstable angina-52% and non-ST-segment myocardial infarction [NSTEMI]-48%). Treated fifty-one de novo lesions were located in LAD (37%), LCx (14%), and RCA (49%), respectively. Angiographic success in the target lesion was 100%. One case of recurrent ischemia was observed a day after the index procedure, due to the significant distal edge dissection a regular metallic DES overlapping Magmaris was implanted. No other in-hospital events occurred (procedural success 98%). Six-Month follow up showed none device-oriented endpoints such as cardiac mortality, target vessel myocardial infarction or target vessel revascularization. None early scaffold thrombosis was reported. CONCLUSION: The use of the Magmaris BRS in non-ST elevation ACS patient is associated with a procedural safety and promising early angiographic and clinical outcomes. Long-term follow-up and further evaluation in large prospective randomized controlled trials are needed.

Clinical aspects of myocardial fibrosis in adults with Ebstein's anomaly.

Heart failure and arrhythmia are common complications in adults with Ebstein's anomaly. They may result not only from hemodynamic alterations, but also from myocardial fibrosis. Late gadolinium enhancement (LGE) by CMR enables the evaluation of myocardial fibrosis. The aim of the study was to asses the presence of LGE and its relation to clinical outcome. We studied a group of 37 unoperated adults aged 43.0 ± 14.4 years with Ebstein's anomaly from the congenital heart disease outpatient clinic. Study protocol included: cardiopulmonary test, assessment of supraventricular arrhythmia (SVA), and CMR with evaluation of cardiac chambers' morphology and function, and presence of LGE. Variables following normal distribution were shown as mean ± SD if otherwise median (range) was applied. Fibrosis was found in 18 patients (48.6%) and was distributed as follows: 12 patients (32.4%) in the right atrium, 12 (32.4%) in the atrialized right ventricle, and 2 (5.4%) in the functional right ventricle. In patients with fibrosis, the tricuspid regurgitation fraction was bigger (48.3 ± 19.7 vs. 36.1 ± 22.6%, p = 0.048) and SVA was more frequent [12 (66.7%) vs. 6 (31.6%), p = 0.046] when compared to patients without fibrosis. However, exercise capacity did not differ between patients with and without LGE (peak VO2 24.0 ± 4.7 vs. 23.7 ± 4.4, p = 0.87). In adults with Ebstein's anomaly fibrosis estimated by LGE-CMR was localized in the right atrium and the right ventricle only. Volume overload resulting from tricuspid regurgitation might be a factor conducive to fibrosis. Myocardial fibrosis did not influence exercise capacity. Association between myocardial fibrosis and supraventricular arrhythmia was confirmed.

Transseptal puncture from the jugular vein and balloon cryoablation for atrial fibrillation in a patient with azygos continuation of an interrupted inferior vena cava.

AIMS: Inferior vena cava (IVC) interruption is a rare anatomic variant where the azygos vein (AV) drains the blood from the IVC to the upper part of the right atrium via the superior vena cava. Here, we report balloon cryoablation of the pulmonary veins (PVs) via superior access in a patient with atrial fibrillation. METHODS AND RESULTS: After the first failed ablation attempt due to IVC interruption, balloon cryoablation with a 28-mm Arctic Front Advance cryoballoon (Medtronic CryoCath LP, Quebec, Canada) via superior access was performed; it requires only a single transseptal puncture (TP), and the patient had optimal PV anatomy. Deflectable electrodes were inserted into the right ventricle and coronary sinus from the right femoral vein. The right internal jugular vein was accessed using an SL0 transseptal sheath and BRK needle. The TP was performed under transoesophageal echocardiographic guidance with a Safe Sept wire because the septum was stiff. All PVs were engaged: the left using an ablation catheter before balloon insertion and the inferior following a 'push-up' technique because of a leak above the veins. Cryothermal energy was delivered after checking for occlusion. The procedure lasted 210 min, fluoroscopy time was 78 min, and air-kerma dose was 194 mGy. During the 6-month follow-up, no episodes of atrial fibrillation were detected on several Holter recordings. CONCLUSIONS: Successful PV isolation in patients with AV continuation of an interrupted IVC can be safely performed using superior access with balloon cryoablation, after several modifications of standard equipment.

Two-Year Outcomes for Patients with Non-ST-Elevation Acute Coronary Syndrome Treated with Magmaris and Absorb Bioresorbable Scaffolds in Large-Vessel Lesions.

BACKGROUND: The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds-Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)-in patients with non-ST-elevation ACS. METHODS: The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. RESULTS: At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. CONCLUSION: Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS.

Comparison of diffusion-weighted with T2-weighted imaging for detection of edema in acute myocardial infarction.

BACKGROUND: Recent studies, performed with the use of a commercially available diffusion weighted imaging (DWI) sequence, showed that they are sensitive to the increase of water content in the myocardium and may be used as an alternative to the standard T2-weighted sequences. The aim of this study was to compare two methods of myocardial edema imaging: DWI and T2-TIRM. METHODS: The study included 91 acute and post STEMI patients. We applied a qualitative and quantitative image analysis. The qualitative analysis consisted of evaluation of the quality of blood suppression, presence of artifacts and occurrence of high signal (edema) areas. On the basis of edema detection in AMI and control (post STEMI) group, the sensitivity and specificity of TIRM and DWI were determined. Two contrast to noise ratios (CNR) were calculated: CNR1--the contrast between edema and healthy myocardium and CNR2--the contrast between edema and intraventricular blood pool. The area of edema was measured for both TIRM and DWI sequences and compared with the infarct size in LGE images. RESULTS: Edema occurred more frequently in the DWI sequence. A major difference was observed in the inferior wall, where an edema-high signal was observed in 46% in T2-TIRM, whereas in the DWI sequence in 85%. An analysis of the image quality parameters showed that the use of DWI sequence allows complete blood signal suppression in the left ventricular cavity and reduces the occurrence of motion artifacts. However, it is connected with a higher incidence of magnetic susceptibility artifacts and image distortion. An analysis of the CNRs showed that CNR1 in T2-TIRM sequence depends on the infarct location and has the lowest value for the inferior wall. The area of edema measured on DWI images was significantly larger than in T2-TIRM. CONCLUSIONS: DWI is a new technique for edema detection in patients with acute myocardial infarction which may be recommended for the diagnosis of acute injuries, especially in patients with slow-flow artifacts in TIRM images.

[Reversible dilated cardiomyopathy as an atypical form of takotsubo cardiomyopathy]. / Odwracalna kardiomiopatia rozstrzeniowa jako nietypowa postac kardiomiopatii takotsubo.

Stress-induced cardiomyopathy is characterized by transient regional left ventricular (LV) dysfunction that may involve, in different forms, midventricular, apical or basal segments. The authors describe a case of a 41-year-old woman with reversible, but global LV systolic dysfunction, complicated with apical thrombi. Clinical symptoms of dilated cardiomyopathy were preceded by persistent stressful workplace conditions. Ischemic, inflammatory, metabolic and endocrine causes of the disease were excluded. After 6 weeks, complete recovery of LV function in echocardiography and normal cardiac magnetic resonance imaging were observed, despite only modest doses of ramipril, carvedilol and diuretics. Six months later, as a result of another episode of emotional stress, she was hospitalized for typical takotsubo cardiomyopathy. Reversible global LV hypokinesis may be an atypical variant of stress-induced cardiomyopathy.

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds - magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort.

BACKGROUND: Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS -Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations. METHODS: We evaluated 2-years clinical outcomes after Magmaris BRS implantation in NSTE-ACS diabetic (n-72) and non-diabetic (n-121) cohorts. RESULTS: No significant differences between diabetic and non-diabetes cohorts were noticed in terms of Primary Outcome (cardiac death, myocardial infarction, stent thrombosis) (8.1% vs 3.3% p = 0.182) and Principal secondary outcome - TLF- target lesion failure (9.5% vs 3.3% p = 0.106) at 2-years follow-up. CONCLUSIONS: 2-years outcome suggests good safety and efficacy of the magnesium BRS (Magmaris) in NSTE- ACS and concomitant DM. Nevertheless, there is a strong need for large multicenter, randomized, prospective studies for a full assessment of this novel device in diabetic patients with ACS.

The Resorbable Magnesium Scaffold Magmaris in Acute Coronary Syndrome: An Appraisal of Evidence and User Group Guidance.

Bioresorbable scaffolds provide transient vessel support without the long-term limitations of permanent metallic drug-eluting stents. The sirolimus-eluting resorbable magnesium scaffold Magmaris is the only CE-marked metallic bioresorbable scaffold and provides short-term lumen support before being completely bioresorbed. To date, clinical trial results have demonstrated low adverse event rates in patients with simple coronary lesions. Seven European centers with large experience in Magmaris implantation, combined efforts in an informal collaboration to evaluate and appraise clinical data currently available regarding the performance of Magmaris in patients presenting with acute coronary syndromes, and to supply user-advice on patient selection and optimal implantation practice.

Transcoronary stem cell transfer and evolution of infarct-related artery atherosclerosis: evaluation with conventional and novel imaging techniques including Quantitative Virtual Histology (qVH).

Introduction: It has been suggested that infarct-related artery (IRA) atherosclerosis progression after stem cell transcoronary administration might represent a stem-cell mediated adverse effect. Aim: To evaluate, using conventional (quantitative coronary angiography, QCA, intravascular ultrasound - IVUS) and novel (quantitative virtual histology - qVH) tools, evolution of IRA atherosclerosis following transcoronary stem cell transfer. Material and methods: QCA, IVUS, VH-IVUS and qVH were performed in 22 consecutive patients (4 women) aged 59 years (data provided as median) undergoing a distal-to-stent infusion of 2.21 × 106 CD34+CXCR4+ autologous bone marrow cells via a cell delivery-dedicated perfusion catheter at anterior AMI day 7. Imaging was repeated at 12 months. This was a substudy of Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial (NCT00316381). Results: 18.2% subjects showed absence of distal-to-stent angiographic/IVUS atherosclerotic lesion(s) at baseline and no new lesion(s) at 12-months. In the remaining cohort, there were 28 lesions by QCA (32 by IVUS) at baseline and no new lesion(s) at follow-up. Three fibroatheromas evolved (2 to calcified fibroatheroma and 1 to a fibrocalcific lesion); other plaques maintained their stable (low-risk) phenotypes. Diameter stenosis of QCA-identified lesions was 29.5 vs. 26.5% (p = 0.012, baseline vs. 12-months). Gray-scale IVUS showed reduction in area stenosis (33.8 vs. 31.0%, p = 0.004) and plaque burden (66.27 vs. 64.56%, p = 0.009) at 12-months. Peak fibrotic plaque content increased from 70.41% to 75.0% (p = 0.004). qVH peak confluent necrotic core area and minimal fibrous cap thickness remained stable (0.64 vs. 0.59 mm2, p = 0.290, and 0.15 vs. 0.16 mm, p = 0.646). Conclusions: This study, using a range of classic and novel imaging techniques, indicates lack of any stimulatory effect of transcoronary stem cell transfer on coronary atherosclerosis. Whether, and to what extent, a moderate reduction in plaque burden and stenosis severity at 12-months results from optimized pharmacotherapy and/or stem cell transfer requires further elucidation.

Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice.

BACKGROUND: Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease (CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical and functional restoration. Nevertheless, following the initial encouraging reports, numerous concerns about the safety of BRS occurred. METHODS: In this study, a 1-year performance of 193 patients with magnesium BRS - Magmaris (Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS - Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting. RESULTS: The Magmaris, when compared to Absorb showed a significantly lower rate of primary endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis was observed. CONCLUSIONS: Data from the present study suggests encouraging safety a profile and more favorable clinical outcomes of Magnesium BRS in comparison to the polymer Absorb - BRS.

Very long-term follow-up of patients with coronary bifurcation lesions treated with bioresorbable scaffolds.

BACKGROUNDS: The data concerning the use of bioresorbable vascular scaffolds (BVS) in coronary bifurcation lesions are limited. AIMS: The objective of the study was to evaluate the early and very long-term clinical outcomes of bifurcation stenting with ABSORB BVS. METHODS: One hundred consecutive patients with coronary bifurcation lesions treated with BVS were included. A total of 124 BVS were implanted. Provisional side branch stenting was performed in 66 patients, distal main stenting in 14 patients, systematic T stenting in 2, and T with minimal protrusion (TAP) in 5 patients. Side branch ostial stenting was performed in additional 12 patients. RESULTS: The procedural success was achieved in 98% of patients. In long-term follow-up, the rate of cardiac death was 4.0%, target vessel myocardial infarction was 5.0%, and target vessel revascularization (TVR) was 11%. The cumulative incidence of definite/probable scaffold thrombosis (ST) was 2% at long-term follow-up. Comparison with the historical drug-eluting stents (DES) group revealed higher mortality and major adverse cardiac events rate in the ABSORB group. CONCLUSIONS: Stenting of coronary bifurcation lesions of low-to-moderate complexity with BVS was feasible with good acute performance and acceptable results. However, the risk of death and major adverse cardiovascular events was higher as compared with DES.

The 1-Year Safety and Efficacy Outcomes of Magmaris, Novel Magnesium Bioresorbable Vascular Scaffolds in Diabetes Mellitus Patients with Acute Coronary Syndrome.

BACKGROUND: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)-a novel magnesium-bioresorbable scaffold-is poorly investigated. METHODS: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. RESULTS: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. CONCLUSIONS: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM.

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents.

BACKGROUND: Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. RESULTS: There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively. CONCLUSION: Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.

Sex Differences in the Clinical Features and Outcomes of Patients with Acute Coronary Syndrome Treated with Two Generations (Absorb and Magmaris) of Bioresorbable Vascular Scaffolds.

BACKGROUND: Despite the developments in percutaneous coronary interventions (PCI), women are still more likely than men to have unfavorable outcomes after PCI performed in Acute Coronary Syndrome (ACS). The mechanisms of this phenomena are not fully understood. Potential benefits of bioresorbable scaffolds (BRS) may be particularly expressed in the female population. Nevertheless, the data available currently are inconsistent and limited. This study evaluated the gender-related differences in the short-term clinical outcomes in ACS patients treated with implantation of two generations of BRS (first generation, Absorb; second generation, Magmaris). METHODS: The study was divided into two arms. To the first one, we qualified 160 patients with ACS treated with PCI who received 210 Absorb scaffolds. The second arm was composed of 193 patients with ACS who underwent PCI with Magmaris implantation. RESULTS: There were no significant sex-related differences in primary endpoints (cardiovascular-death, myocardial infarction, in-stent thrombosis) or principal secondary endpoints (of target-lesion failure, scaffold restenosis, death from any reason, other cardiovascular events) in either generation of BRS in a 1-year follow-up. CONCLUSIONS: Both genders tended to have a similar outcome in routine clinical practice following BRS implantation due to ACS. The magnesium bioresorbable scaffold (Magmaris) early outcome seemed to be more favorable in comparison to the Absorb scaffold.

Long-term clinical follow-up of the resorbable magnesium scaffolds in acute coronary syndrome patients.

BACKGROUND: Research on the resorbable magnesium scaffolds (RMSs) has shown their safety and effectiveness in stable clinical conditions. It seems that this new therapeutic option could be promising for selected acute coronary syndrome (ACS) patients. AIMS: Our analysis aims to analyse the long-term performance of RMSs among ACS patients. METHODS: The study population consisted of consecutive ACS patients treated with the implantation of at least one RMS. The Magmaris ACS Registry was designed as a single-arm observational registry in the 'real-world' treatment practice setting. RESULTS: The study population consisted of 193 patients, predominantly male (78%), at a mean (SD) age of 64 (9) years and with the typical risk factors of ACS. Unstable angina (UA) was the indication for revascularisation in 32.1%, non-ST-segment myocardial infarction (NSTEMI) in 65.8% and ST-segment elevation myocardial infarction (STEMI) only in 2.1%. During the mean 24 months of follow-up, ten cases (5.2%) of target lesion failure (TLF) were diagnosed, of which five cases (2.6%) were clinically driven target lesion failure (CD-TLR), four cases (2.1%) of asymptomatic scaffold restenosis and one case (0.5%) of target vessel myocardial infarction (TV-MI). No cardiac deaths and 2 non-cardiac deaths (2.2%, both fatal strokes) were observed. No cases of scaffold thrombosis were observed during the median 24-month follow-up. CONCLUSIONS: The use of the RMSs in selected ACS patients is associated with procedural safety and promising early and long-term clinical efficacy and safety outcomes. Proper lesion selection is key to the long-term success of bioresorbable technology in this patient population.

Optimal medical therapy in patients with stable coronary artery disease in Poland: the ISCHEMIA trial experience.

Introduction: Optimal medical therapy (OMT) is the cornerstone of treatment for stable coronary disease with the ISCHEMIA trial showing similar outcomes using OMT with or without an initial invasive approach. Objectives: To describe OMT goal attainment in Polish ISCHEMIA participants compared with other countries. Patients and methods: Among 5179 trial participants, 333 were randomized in Poland. The median follow-up was 3.2 years. OMT targets were: not smoking, high-intensity statin therapy, low-density lipoprotein cholesterol (LDL-C) of less than 70 mg/dl, systolic blood pressure of less than 140 mm Hg, aspirin therapy, and ACEI / ARB, and ß-blocker therapy if indicated. Results: Compared with 36 other countries, at randomization, patients in Poland were older (67 [62­75] y vs 65 [58­71] y); P <⁠0.001), more often female (30% vs 22%; P = 0.002), with a longer history of angina (3 [1­9] y vs 1 [0­3] y; P <⁠0.001), and there were more cases of prior myocardial infarction (32% vs 18%; P <⁠0.01) and revascularization (PCI, 40% vs 19%; CABG, 11% vs 3%; P <⁠0.001 for both). The number of OMT goals attained increased from baseline to follow-up visits (5 [4­5] vs 6 [5­6]; P <⁠0.001) in Poland and other countries alike (P = 0.89 vs P = 0.14). In Poland, significant improvements were achieved regarding high-intensity statin therapy (27% vs 50%), LDL-C <⁠70 mg/dl (29% vs 65%), and systolic blood pressure of less than 140 mm Hg (63% vs 81%) (P <⁠0.001 for all), whereas not-smoking (89% vs 89%), aspirin (90% vs 88%), ACEI / ARB (93% vs 95%), and ß-blocker therapy (94% vs 90%) remained high. Conclusions: With regular surveillance and contemporary medical therapy, high OMT goal attainment was achievable among the participants of the ISCHEMIA trial in Poland relative to other countries. There is still room for improvement in LDL-C and blood pressure management.

[Effective treatment of recurrent infective endocarditis. Is it always in compliance with the guidelines?]. / Skuteczne leczenie nawracajacego infekcyjnego zapalenia wsierdzia. Czy zawsze zgodnie ze standardami?

We present a case of recurrent infective endocarditis (IE) in a 36-year-old man, localised on native congenital bicuspid aortic valve and an acquired membranous ventricular septal defect with vegetations extending to the right ventricle. Patient was successfully treated with standard therapy for IE due to staphylococci MSSA followed by aortic valve replacement and closure of ventricular septal defect.