Safety and Effectiveness of Coronary Sinus Reducer in the Therapy of Refractory Angina Pectoris-Mid-Term Results of the Real-Life Cohort.

Background: Despite continuous improvements in revascularization techniques, refractory angina without potential revascularization options remains a relevant clinical issue with significant impact on the patient's quality of life. Recently, a novel device, the Coronary Sinus Reducer (CSR), has been introduced into clinical practice as a therapeutic option for patients with disabling angina pectoris. In this single-center, observational study, we evaluated the mid-term (3-month) safety and efficacy of the CSR in a real-world cohort. Methods: The study population consisted of 55 patients with refractory angina without potential revascularization options, who were predominantly men (87.3%) with a high cardiovascular risk factor burden and advanced angina (baseline CCS angina class 3.15 ± 0.6). In terms of procedure safety, all patients underwent successful device deployment with only one periprocedural complication. Results: At the 3-month follow-up, we observed a statistically significant improvement in angina control measured CCS class and SAQ-7 total questionnaire along with increased abolition of physical limitation-6-MWT (233.3 ± 107.1 vs. 305.2 ± 126.8; p < 0.0001). Additionally, we observed significant improvement in terms of quality of life measurements SF-36, the EQ-5D-5L questionnaire, and the EQ-VAS. Conclusions: Our real-world data suggest that CSR implantation is a relatively safe procedure and appears to be particularly effective in relieving angina symptoms and improving quality of life in subjects with refractory angina.

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.

Pulmonary thromboembolism in 102 consecutive patients with chronic atrial fibrillation. Diagnostic value of echocardiography.

BACKGROUND: Little is known about the incidence and diagnosis of pulmonary thromboembolism (PE) in patients with chronic permanent atrial fibrillation (CAF). Also it has not been established if echocardiography, a diagnostic tool useful in clinical evaluation of both diseases, is of value in diagnosis of PE in CAF patients. AIM: To establish the prevalence of PE among patients suffering from CAF without or with poorly controlled anticoagulation as well as to evaluate the possibility to detect PE and to assess the diagnostic role of echocardiography. METHODS: Prevalence of PE in a population of 102 patients (52 males and 50 females at the mean age of 68 years, range 32-88 years) admitted to hospital between January and December 2004 with diagnosis of CAF was studied retrospectively. Echocardiography-based original algorithm of PE diagnosis in such patients was analysed. RESULTS: Among 102 patients with CAF, 20 (19%) cases of PE were diagnosed, including 12 with acute PE (APE) and 8 suffering from chronic thromboembolic pulmonary hypertension (CTEPH). Patients with CAF and APE as well as with CAF and CTEPH had increased right ventricular dimension (p=0.0002 and p=0.001, respectively), higher tricuspid pressure gradient (p=0.005 and p=0.001, respectively) and shorter pulmonary artery acceleration time (p=0.00006 and p=0.0004, respectively) estimated in echocardiography as compared to patients with CAF but without PE. Subjects with CAF and PE had also significantly decreased left ventricular dimension and better left ventricular performance. CONCLUSIONS: A relatively high incidence of PE among patients with CAF not treated with anticoagulants or with poorly controlled anticoagulation therapy was noted. The important value of a diagnostic algorithm employing echocardiography in a diagnosis of clinically significant APE and CTEPH in this group of patients was also shown.