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.

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.

Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome. Mid-term outcomes (2 years).

Introduction: Acute coronary syndrome (ACS) is a well-known risk factor for adverse clinical outcomes in percutaneous coronary intervention (PCI). Therefore, evaluation of coronary stents in this challenging clinical scenario can provide unique information on device safety and efficacy. Bioresorbable scaffolds (BRS) were designed to overcome long-term complications related to permanent vessel caging with a permanent metallic drug-eluting stent (DES). Aim: We designed this study to evaluate the mid-term safety and efficiency of the Magmaris BRS in comparison to the leading new-generation ultrathin DES Ultimaster in the ACS population. Material and methods: We present a retrospective analysis of 2-year follow-up data. The primary outcomes consisted of death from cardiac causes, myocardial infarction, and in-stent thrombosis. The second main study endpoint was defined as target-lesion failure (TLF). Results: The study population consisted of two cohorts, the first of 193 patients treated with Magmaris implantation and the second of 169 patients treated with Ultimaster implantation. At the 2-year follow-up, there were no significant differences in both study cohorts in terms of primary outcome (5.1% vs. 11%; p = 0.051), and TLF (5.6% vs. 8%, p = 0.41). Conclusions: Treatment with a second-generation BRS (Magmaris) versus a novel second-generation DES (Ultimaster) in non-ST-elevation acute coronary syndrome (NSTE-ACS) was associated with similar rates of target lesion failure at 2-year follow-up.

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR).

BACKGROUND: Coronary calcifications represent a challenging subset for the interventional cardiologist performing percutaneous coronary intervention (PCI) and are well-established risk factors for adverse outcomes. Adequate plaque modification prior to stent implantation is critical to achieve an optimal outcome following PCI. Recently, a novel orbital atherectomy device has been introduced into clinical practice to modify calcified plaques. We evaluated the mid-term safety and efficacy of OA in a high-risk "all-comers" population. METHODS: We evaluated 96 consecutive patients with severely calcified coronary lesions who underwent PCI facilitated by the orbital atherectomy device. RESULTS: In-hospital MACCE was 5.2% without target lesion revascularization. At 6-month follow-up, the MACCE rate was 10.4% with a concomitant TLR rate of 1%. CONCLUSIONS: Our mid-term data showed good safety and efficacy of orbital atherectomy as a plaque-modifying tool in an all-comers cohort with severely calcified coronary lesions.

Safety and efficacy of a novel calcified plaque modification technique - Shockwave Intravascular Lithotripsy - in patients with coronary artery disease: Mid-term outcomes.

BACKGROUND: Coronary interventions in calcified lesions are associated with a higher rate of adverse clinical events. Initial aggressive plaque modification along with post-implantation optimization is pivotal for achieving a favorable outcome of percutaneous coronary intervention (PCI). Recently, the Shockwave C2 Intravascular Lithotripsy (S-IVL) System, a novel acoustic wave-based device designed to modify calcified plaque, has been introduced into clinical practice. AIMS: We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions. METHODS: We retrospectively analyzed a total of 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria - the presence of a calcified resistant lesion (defined by inadequate non-compliant balloon catheter inflation) or a significantly underexpanded stent (more than 20% of reference diameter). The study had two primary endpoints - successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously underexpanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure. RESULTS: In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At 6-month follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%. CONCLUSION: Our mid-term data confirm acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in a cohort of 131 consecutive patients with severely calcified coronary lesions.

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.

Comparison of Orbital Atherectomy and Rotational Atherectomy in Calcified Left Main Disease: Short-Term Outcomes.

BACKGROUND: Coronary calcifications, particularly in left main disease (LMD), are independently associated with adverse outcomes of percutaneous coronary intervention (PCI). Adequate lesion preparation is pivotal to achieve favorable short- and long-term outcomes. Rotational atherectomy devices have been used in contemporary practice to obtain adequate preparation of the calcified lesions. Recently, novel orbital atherectomy (OA) devices have been introduced to clinical practice to facilitate the preparation of the lesion. The objective of this study is to compare the short-term safety and efficacy of orbital and rotational atherectomy for LMD. METHODS: we retrospectively evaluated a total of 55 consecutive patients who underwent the LM PCI supported by either OA or RA. RESULTS: The OA group consisted of 25 patients with a median SYNTAX Score of 28 (26-36). The Rota group consisted of 30 patients with a median SYNTAX Score of 28 (26-33.1) There were no statistical differences in MACCE between the RA and OA subpopulations when recorded in-hospital (6.7% vs. 10.3% p = 0.619) as well as in a 1-month follow-up after the procedure (12% vs. 16.6% p = 0.261). CONCLUSION: OA and RA seem to be similarly safe and effective strategies for preparating the lesion in the high-risk population with calcified LMD.

Shockwave intravascular lithotripsy as a novel strategy for balloon undilatable heavily calcified chronic total occlusion lesions.

BACKGROUND: The successful percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) improves the long-term outcome in patients with coronary artery disease (CAD). Heavy calcification remains one of the strongest predictors of an unfavorable outcome of PCI. In this case series study, shockwave intravascular lithotripsy (S-IVL)-a novel balloon-based coronary system facilitating modification of calcified coronary lesions was evaluated. METHODS: The study population consisted of five heavily calcified, undilatable-CTOs lesions treated with S-IVL selected out of all consecutive CTO-PCI patients performed at two high-volume cardiac centers. RESULTS: The registry included 5 patients successful CTO - S-IVL procedures with an average J-CTO of 2.6 points. In the short-term follow-up period, including the first 30 days, no cases of acute in-stent thrombosis, target lesion failure, or major adverse cardiac and cerebrovascular events were noted. CONCLUSIONS: The present data suggest that this approach can be safe and useful in the treatment of complex calcified CTO lesions.

Rota-Lithotripsy as a Novel Bail-Out Strategy for Highly Calcified Coronary Lesions in Acute Coronary Syndrome.

BACKGROUND: Heavily calcified lesions in acute coronary syndrome (ACS) still represent a challenging subset for percutaneous coronary intervention (PCI). Rota-lithotripsy-a marriage of rotational atherectomy and intravascular lithotripsy-has recently been introduced to clinical practice as a novel therapeutic option. METHODS: This study is among the to present the 6-month clinical outcomes of rota-lithotripsy when performed in the ACS setting. The study cohort consisted of 15 consecutive ACS patients who underwent a rota-lithotripsy-PCI due to the presence of a highly calcified, undilatable lesion. RESULTS: The procedural success ratio reached 100%. During the 6-month follow-up, in two of the patients, instances of MACE (major adverse cardiac events) occurred, including one fatal event. Additionally, during the observation period, one target lesion failure, due to subacute stent thrombosis, was identified. CONCLUSIONS: Rotational atherectomy with the subsequent use of shockwave intravascular lithotripsy appears to be a safe and effective therapeutic bail-out option for the management of highly calcified coronary artery lesions. Despite, these initial favorable outcomes, carrying out a large number of studies with long-term observations is still necessary in order to establish the potential benefits and shortcomings of rota-lithotripsy.