Search

Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions., Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated., Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed., Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials., Competing Interests: AA-T has received consulting and speaker fees from SIS Medical. MB has received consulting and speaker fees from Abbott Vascular, Abiomed, Amarin, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Daichii, MedAlliance, Mundipharma, Novartis, OmPharma and SIS Medical. FC has received consulting and speaker fees from Abbott Vascular, Abiomed, Boston Scientific and SIS Medical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Madanchi, Attinger-Toller, Gjergjizi, Majcen, Cioffi, Epper, Gnan, Koch, Zhi, Cuculi and Bossard.)

Background and Objectives: The adoption of optical coherence tomography (OCT) in percutaneous coronary intervention (PCI) is limited by need for real-time image interpretation expertise. Artificial intelligence (AI)-assisted Ultreon™ 2.0 software could address this barrier. We used eye tracking to understand how these software changes impact viewing efficiency and accuracy., Methods: Eighteen interventional cardiologists and fellows at McMaster University, Canada, were included in the study and categorized as experienced or inexperienced based on lifetime OCT use. They were tasked with reviewing OCT images from both Ultreon™ 2.0 and AptiVue™ software platforms while their eye movements were recorded. Key metrics, such as time to first fixation on the area of interest, total task time, dwell time (time spent on the area of interest as a proportion of total task time), and interpretation accuracy, were evaluated using a mixed multivariate model., Results: Physicians exhibited improved viewing efficiency with Ultreon™ 2.0, characterized by reduced time to first fixation (Ultreon™ 0.9 s vs. AptiVue™ 1.6 s, p  = 0.007), reduced total task time (Ultreon™ 10.2 s vs. AptiVue™ 12.6 s, p  = 0.006), and increased dwell time in the area of interest (Ultreon™ 58% vs. AptiVue™ 41%, p  < 0.001). These effects were similar for experienced and inexperienced physicians. Accuracy of OCT image interpretation was preserved in both groups, with experienced physicians outperforming inexperienced physicians., Discussion: Our study demonstrated that AI-enabled Ultreon™ 2.0 software can streamline the image interpretation process and improve viewing efficiency for both inexperienced and experienced physicians. Enhanced viewing efficiency implies reduced cognitive load potentially reducing the barriers for OCT adoption in PCI decision-making., Competing Interests: MS, NP, and TS have received honoraria from Abbott Vascular. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Cioffi, Pinilla-Echeverri, Sheth and Sibbald.)

Background: The magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce., Methods: We analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years., Results: In total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61-64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling., Conclusion: In contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases., Competing Interests: MB has received speaker and/or consultant fees from Abbott Vascular, Amgen, AstraZeneca, Abiomed, Amgen, Bayer, Daiichi Sankyo, Mundipharma, and SIS Medical. RK has received institutional grants from Abbott, Biosense Webster, Biotronik, Boston Scientific, Medtronic, and SIS Medical and serves as a consultant for Biosense Webster and Biotronik. FC has received speaker and consulting fees from Abbott Vascular, Abiomed, and SIS Medical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Bossard, Madanchi, Avdijaj, Attinger-Toller, Cioffi, Seiler, Tersalvi, Kobza, Schüpfer and Cuculi.)

Cardiogenic shock (CS) remains a leading cause of hospital death. However, the use of mechanical circulatory support has fundamentally changed CS management over the last decade and is rapidly increasing. In contrast to extracorporeal membrane oxygenation as well as counterpulsation with an intraaortic balloon pump, ventricular unloading by the Impella™ device actively reduces ventricular volume as well as pressure and augments systemic blood flow at the same time. By improving myocardial oxygen supply and enhancing systemic circulation, the Impella device potentially protects myocardium, facilitates ventricular recovery and may interrupt the shock spiral. So far, the evidence supporting the use of Impella™ in CS patients derives mostly from observational studies, and there is a need for adequate randomized trials. However, the Impella™ device appears a promising technology for management of CS patients. But a profound understanding of the device, its physiologic impact and clinical application are all important when evaluating CS patients for percutaneous circulatory support. This review provides a comprehensive overview of the percutaneous assist device Impella™. Moreover, it highlights in depth the rationale for ventricular unloading in CS and describes practical aspects to optimize care for patients requiring hemodynamic support., Competing Interests: MB has received speaker fees from Abbott Vascular, Abiomed, and SIS Medical. FC has received speaker and/or consultant fees from Abbott Vascular, Abiomed, Boston Scientific, and SIS Medical. RK has received institutional grants from Abbott, Biosense-Webster, Biotronik, Boston, Medtronic, SIS Medical, and consultant fees from Biosense-Webster and Biotronik. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Attinger-Toller, Bossard, Cioffi, Tersalvi, Madanchi, Bloch, Kobza and Cuculi.)

In the last decades, transcatheter aortic valve replacement (TAVR) revolutionized the treatment of symptomatic severe aortic stenosis. The efficacy and safety of TAVR were first proven in inoperable and high-risk patients. Then, subsequent randomized clinical trials showed non-inferiority of TAVR as compared to surgical aortic valve replacement also in intermediate- and low-risk populations. As TAVR was progressively studied and clinically used in lower-risk patients, issues were raised questioning its opportunity in a younger population with a longer life-expectancy. As long-term follow-up data mainly derive from old studies with early generation devices on high or intermediate surgical risk patients, results can hardly be extended to most of currently treated patients who often show a low surgical risk and are treated with newer generation prostheses. Thus, in this low-risk younger population, decision making is difficult due to the lack of supporting data. The aim of the present review is to revise current literature regarding TAVR in younger patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Bocchino, Angelini, Alushi, Conrotto, Cioffi, Tersalvi, Senatore, Pedrazzini, De Ferrari and Biasco.)

During the Coronavirus Disease 2019 worldwide pandemic, patients with heart failure are a high-risk group with potential higher mortality if infected. Although lockdown represents a solution to prevent viral spreading, it endangers regular follow-up visits and precludes direct medical assessment in order to detect heart failure progression and optimize treatment. Furthermore, lifestyle changes during quarantine may trigger heart failure decompensations. During the pandemic, a paradoxical reduction of heart failure hospitalization rates was observed, supposedly caused by patient reluctance to visit emergency departments and hospitals. This may result in an increased patient mortality and/or in more complicated heart failure admissions in the future. In this scenario, different telemedicine strategies can be implemented to ensure continuity of care to patients with heart failure. Patients at home can be monitored through dedicated apps, telephone calls, or devices. Virtual visits and forward triage screen the patients with signs or symptoms of decompensated heart failure. In-hospital care may benefit from remote communication platforms. After discharge, patients may undergo remote follow-up or telerehabilitation to prevent early readmissions. This review provides a comprehensive appraisal of the many possible applications of telemedicine for patients with heart failure during Coronavirus disease 2019 and elucidates practical limitations and challenges regarding specific telemedicine modalities., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Tersalvi, Winterton, Cioffi, Ghidini, Roberto, Biasco, Pedrazzini, Dauw, Ameri and Vicenzi.)