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Intravascular imaging has become an integral part of the diagnostic and management strategies for intracoronary pathologies. In this White Paper we summarize current evidence and its implications on the use of intravascular imaging in interventional cardiology practice. The areas addressed are planning and optimization of percutaneous coronary intervention, management of stent failure, and evaluation of ambiguous coronary lesions and myocardial infarction with nonobstructive coronary disease. The findings presented followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system in an expert consensus process that involved a diverse writing group vetted by a review group. Expert consensus was achieved around 9 statements. Use of intravascular imaging in guiding percutaneous revascularization is supported by high-quality evidence, particularly for lesions with increased risk of recurrent events or stent failure. Specific considerations for intravascular imaging guidance of intervention in left main lesions, chronic occlusion lesions, and in patients at high risk of contrast nephropathy are explored. Use of intravascular imaging to identify pathologies associated with stent failure and guide repeat intervention, resolve ambiguities in lesion assessment, and establish diagnoses in patients who present with myocardial infarction with nonobstructive coronary disease is supported by moderate- to low-quality evidence. Each topic is accompanied by clinical pointers to aid the practicing interventional cardiologist in implementation of the White Paper findings. The findings presented in this White Paper will help to guide the use of intravascular imaging toward situations in which the balance of efficacy, safety, and cost are most optimal., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Evidence regarding the comparative efficacy of the different methods to determine the significance of coronary stenoses in the catheterization laboratory is lacking. We aimed to compare all available methods guiding the decision to perform percutaneous coronary intervention (PCI). We searched Medline, Embase, and CENTRAL until October 5, 2023. We included trials that randomized patients with greater than 30% stenoses who were considered for PCI and reported major adverse cardiovascular events (MACE). We performed a frequentist random-effects network meta-analysis and assessed the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. We included 15 trials with 16,333 participants with a mean weighted follow-up of 34 months. The trials contained a median of 49.3% (interquartile range: 32.6%, 100%) acute coronary syndrome participants. Quantitative flow ratio (QFR) was associated with a decreased risk of MACE compared with coronary angiography (CA) (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.56 to 0.82, high certainty), fractional flow reserve (FFR) (RR 0.73, 95% CI 0.58 to 0.92, moderate certainty), and instantaneous wave-free ratio (iFR) (RR 0.63, 95% CI 0.49 to 0.82, moderate certainty), and ranked first for MACE (88.1% probability of being the best). FFR (RR 0.93, 95% CI 0.82 to 1.06, moderate certainty) and iFR (RR 1.07, 95% CI 0.90 to 1.28, moderate certainty) likely did not decrease the risk of MACE compared with CA. Intravascular imaging may not be associated with a significant decrease in MACE compared with CA (RR 0.85, 95% CI 0.62 to 1.17, low certainty) when used to guide the decision to perform PCI. In conclusion, a decision to perform PCI based on QFR was associated with a decreased risk of MACE compared with CA, FFR, and iFR in a mixed stable coronary disease and acute coronary syndrome population. These hypothesis-generating findings should be validated in large, randomized, head-to-head trials., Competing Interests: Declaration of competing interest Marc-André d'Entremont is a Canadian Institutes of Health Research Canada Graduate Scholarship Doctoral awardee. Sanjit Jolly reports receiving grants or contracts from Boston Scientific and consultation and advisory fees from Penumbra, Teleflex, and Abiomed. Gregg W. Stone has received speaker honoraria from Medtronic, Pulnovo, Abiomed, Amgen, Boehringer Ingelheim (Ingelheim, Germany); has served as a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Cardiomech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, Cardiac Success, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia BioPharma, Oxitope, HighLife, Elixir, Remote Cardiac Enablement, Aria; and has equity/options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, BioStar (Waltham, Massachusetts) family of funds, SpectraWave, Orchestra® Biomed, Aria, Valfix, Xenter. Dr. Stone's employer, Mount Sinai Hospital, receives research grants from Shockwave, Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc., Phillips, Biosense-Webster, Vascular Dynamics, Pulnovo, and V-wave. The remaining authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Patients with acute myocardial infarction (AMI) and large thrombus burden (LTB) still represent a challenge. Afflicted patients have a high morbidity and mortality. Aspiration thrombectomy is often ineffective in those cases. Mechanical thrombectomy devices (MTDs), which are effective for management of ischemic strokes, were recently CE-approved for treatment of thrombotic coronary lesions. Real-world data about their performance in AMI cases with LTB are scarce. This study sought to summarize our early experience with a novel MTD device in this context., Methods: We analyzed consecutive patients from the prospective OPTIMISER registry (NCT04988672), who have been managed with the NeVa™ MTD (Vesalio, USA) for AMI with LTB at a tertiary cardiology facility. Outcomes of interest included, among others, periprocedural complications, target lesion failure (TLF), target lesion revascularization (TLR) and target vessel myocardial infarction (TV-MI)., Results: Overall, 15 patients underwent thrombectomy with the NeVa™ device. Thrombectomy was successfully performed in 14 (93%) patients. Final TIMI 3 flow was achieved in 13 (87%) patients, while 2 (13%) patients had TIMI 2 flow. We encountered no relevant periprocedural complications, especially no stroke, stent thrombosis or vessel closure. After a mean follow-up time of 26 ± 2.9 months, 1 (7%) patient presented with TLR due to stent thrombosis (10 months after treatment with the MTD and stenting)., Conclusions: In AMI patients with LTB, the deployment of the novel NeVa™ MTD seems efficient and safe. Further randomized trials are warranted to assess whether the use of the NeVa™ device in cases with LTB improves procedural and clinical outcomes., (© 2024. The Author(s).)

Objectives: Despite the introduction of improved drug eluting stents (DES), the rate of repeat revascularization procedures following percutaneous coronary interventions (PCI) in coronary chronic total occlusions (CTO) remains high. By leaving vessels uncaged and limiting length of stented segments, drug-coated balloons (DCB) represent an appealing alternative to DES for CTO-PCI. Since data supporting the use of DCBs in CTO-PCI is scarce, we compared the outcomes of patients undergoing CTO-PCI involving DCBs vs DES only., Methods: From 2 prospective registries, outcomes of patients undergoing CTO-PCI involving DCBs and those undergoing PCI with DES only were compared. Outcomes included major adverse cardiac and cerebrovascular events (MACCE) and cardiovascular death (CV-death)., Results: Overall, 157 patients were studied; 112 (71%) underwent CTO-PCI involving DCBs and 45 (29%) were treated with DES only. Mean J-CTO score was 1.84 ± 0.7. Most CTO-lesions involved the right coronary artery, 88 (56%), and 26 (17%) cases were in-stent occlusions. In the DCB group, 46 (41%) lesions were treated with DCBs alone. Mean lengths of the stented segments in the DCB vs DES cohorts were 59 ± 28 mm vs 87 ± 37 mm (P less than .001), respectively. After 12 months, the MACCE rate was higher in the DES only vs DCB group (26% vs 11%, P=.03). Length of the stented segment was an independent predictor for MACCE (HR 1.15 [95% CI, 1.05-1.26] per 10-mm stent length)., Conclusions: Revascularization of CTO lesions involving DCBs appears safe and potentially lowers MACCE rates compared to treatment with DES alone. Importantly, using DCBs for CTO treatment may reduce total stent length, which determines PCI outcomes.

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.)

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., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Calcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively., Methods: Retrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180 o arc and > 0.5 mm thickness, and/or nodular calcification with > 90 o arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %., Results: 50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events., Conclusion: Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications., Competing Interests: Declaration of competing interest Authors have the following disclosures relevant to this manuscript: The OPN NC Registry was supported by an AFP grant through Hamilton Health Sciences. Dr. Pinilla-Echeverri has served as a consultant and speaker, received research grant support, and served on the Advisory Board for Abbott Vascular; has served on the Advisory Board for Philips; has served as a consultant for Conavi, Amgen, Bayer, and Novartis. Dr. Bossard has served as consultant and speaker fees for Abbott Vascular, Abiomed, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Dachii Sankyo, Novartis, SIS Medical and Vifor. Dr. Chavarria has served as a consultant and speaker for Abbott Vascular. Dr. Dutra has served as a consultant for Abbott Vascular. Dr. Attinger has served as a speaker for SIS Medical. Dr. Sibbald has served as a consultant for Abbott Vascular. Dr. Cuculi has received consulting and speaker fees from Abiomed, Boston Scientific, SIS Medical and Abbott Vascular. Dr. Sheth has served as a consultant, served on the Speakers Bureau, received research grant support, and served on the Advisory Board for Abbott Vascular. Dr. Hillani, Dr. Cioffi, Dr. Guerrero, Dr. Madanchi and Ellen Kossmann have nothing to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Current guidelines recommend vitamin K antagonists (VKAs) for the treatment of a left ventricular thrombus (LVT). However, direct oral anticoagulants (DOACs) show superior safety and efficacy compared with VKAs in most thromboembolic disorders. Nevertheless, DOACs remain poorly investigated for the treatment of LVT. To describe the thrombus resolution rate and clinical efficacy of DOACs versus VKAs in patients with LVT, we analyzed consecutive patients with confirmed LVT from a multicenter echocardiography database. Echocardiograms and clinical end points were evaluated independently. The thrombus resolution rate and clinical outcomes were compared according to the underlying anticoagulation regimen. In total, 101 patients were included (17.8% women, mean age 63.3 ± 13.2 years), 50.5% had recently experienced a myocardial infarction. The mean left ventricular ejection fraction was 36.6 ± 12.2%. DOACs versus VKAs were used in 48 and 53 patients, respectively. The median follow-up was 26.6 (interquartile range 11.8;41.2) months. Among patients receiving VKAs compared with DOACs, the thrombus resolved more rapidly within the first month in those taking VKAs (p = 0.049). No differences were seen between the 2 groups with respect to major bleedings, strokes, and other thromboembolic events. In each group, LVT recurred in 3 of the subjects (a total of 6) after discontinuation of anticoagulation. In conclusion, DOACs appear to be a safe and effective alternative to VKAs for the treatment of LVTs, but the rate of thrombus dissolution within 1 month after initiation of anticoagulation appears to be higher with VKAs. A sufficiently powered randomized trial is required to definitively define the role of DOACs in the treatment of LVT., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: 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)., Methods: 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., Results: 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., Conclusions: 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.

Background: Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population., Methods: From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE)., Results: Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died., Conclusions: For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials., Competing Interests: Declaration of competing interest AAT has received consulting and speaker fees from SIS Medical. RK has received institutional grants from Abbott, Biosense-Webster, Biotronik, Boston-Scientific, Medtronic, SIS Medical and act as a consultant for Biosense-Webster, Biotronik and Medtronic. MB has received consulting and speaker fees from Abbott Vascular, Abiomed and SIS Medical. FC has received consulting and speaker fees from SIS Medical, Abiomed and Abbott Vascular. All other authors have no conflicts of interest to declare., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular (LV) unloading via the percutaneous micro-axial Impella pump is increasingly used in patients with anterior ST-segment elevation myocardial infarction (STEMI) and overt cardiogenic shock. In this context, the evolution of cardiac function and dimensions beyond hospital discharge remains uncertain. We aimed to characterize echocardiographic changes over time in patients with acute anterior STEMI treated with an Impella device., Methods: From an ongoing prospective registry, consecutive patients with acute anterior STEMI managed with an Impella device were extracted. Transthoracic echocardiography was performed at index hospitalization and at first outpatient follow-up. Predictors of response, defined as a ≥ 10% absolute increase in left ventricular ejection fraction (LVEF) at follow-up, were sought., Results: A total of 66 patients (89.4% male, aged 64.3 ± 11.6 years) with anterior STEMI were treated with an Impella device in the first 24 hours of hospitalization, from 2014 to 2022. In-hospital mortality was 24%. Major bleeding and vascular complications requiring surgery occurred in 24% and 11% of patients, respectively. At baseline, mean LVEF was 34% ±12%. At follow-up, survivors showed a significant increase in LVEF ( P < 0.0001), whereas LV dimensions, diastolic parameters, and measures of right ventricular dimension and function remained stable. Overall, 28 patients had a ≥ 10% absolute increase in LVEF at follow-up. Baseline creatinine was the only significant predictor of response at univariate analysis., Conclusions: Among patients with anterior STEMI requiring mechanical hemodynamic support with an Impella device, the majority of survivors showed a sustained increase in LV function, without evidence of adverse remodelling. This signal warrants further investigation in dedicated trials., (© 2022 The Authors.)

BACKGROUND Use of drug-coated balloons (DCB) is an important research topic. Many companies are quickly developing new, cutting-edge technologies and means to deliver drugs. Moreover, interest is growing in use of sirolimus-coated balloons, a promising technology in the "leaving nothing behind" era. This, in combination with interest in lesion preparation and intravascular imaging, creates a promising future for DCB for years to come. CASE REPORT A 72-year-old patient presented with NSTEMI. Coronary angiography showed a subtotal stenosis of the right coronary artery (RCA). PCI was performed on the native RCA and, given the patient's failure to adhere to the drug regimen, he was treated with a metal-free PCI strategy. After using a novel lesion preparation technique with cutting balloon and high-pressure non-compliant balloon, a novel Sirolimus DCB was used. Final angiography and OCT run showed good luminal gain despite diffuse dissections. To assess vascular healing, we performed coronary angiography 5 weeks later, which demonstrated an excellent result, with absence of residual dissection and further luminal gain compared to the index procedure. CONCLUSIONS The use of a novel lesion preparation technique (cutting balloon and high-pressure highly non-compliant balloon) in combination with guidance by intravascular imaging and the use of a new sirolimus-coated balloon may attract attention in the interventional cardiology community and stimulate discussion on lesion preparation and use of drug-coated balloons.

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.)

Background: 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., Methods: 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., Results: 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., Conclusions: 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.

Complete atrioventricular block (CAVB) is a total dissociation between the atrial and ventricular activity, in the absence of atrioventricular conduction. Several diseases may result in CAVB in the pediatric and young-adult population. Permanent right ventricular (RV) pacing is required in permanent CAVB, when the cause is neither transient nor reversible. Continuous RV apical pacing has been associated with unfavorable outcomes in several studies due to the associated ventricular dyssynchrony. This study aims to summarize the current literature regarding CAVB in the pediatric and young adult population and to explore future treatment perspectives., (© 2021 Wiley Periodicals LLC.)

Background: Early studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes., Aims: To evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS., Methods: We did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT)., Results: Overall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3-77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years., Conclusions: Treatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR., Competing Interests: Competing interests: MM, GMC, AA-T, MW, FM, TS, LV, ST and RK report no conflicts of interest. MB has received consulting and speaker fees from Amgen, Astra Zeneca, Bayer and Mundipharma. FC has received consulting and speaker fees from SIS Medical and Abbott Vascular., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Inflammation plays a pivotal role in coronary artery disease (CAD). The anti-inflammatory drug colchicine seems to reduce ischemic events in patients with CAD. So far there is equipoise about its safety and impact on mortality. Methods and Results To evaluate the utility of colchicine in patients with acute and chronic CAD, we performed a systematic review and meta-analysis. MEDLINE, EMBASE, Cochrane CENTRAL and conference abstracts were searched from January 1975 to October 2020. Randomized trials assessing colchicine compared with placebo/standard therapy in patients with CAD were included. Data were combined using random-effects models. The reliability of the available data was tested using trial sequential analyses . Of 3108 citations, 13 randomized trials (n=13 125) were included. Colchicine versus placebo/standard therapy in patients with CAD reduced risk of myocardial infarction (odds ratio [OR] 0.64; 95% CI, 0.46-0.90; P =0.01; I 2 41%) and stroke/transient ischemic attack (OR 0.50; 95% CI, 0.31-0.81; P =0.005; I 2 0%). But treatment with colchicine compared with placebo/standard therapy had no influence on all-cause and cardiovascular mortality (OR 0.96; 95% CI, 0.65-1.41; P =0.83; I 2 24%; and OR 0.82; 95% CI, 0.55-1.22; P =0.45; I 2 0%, respectively). Colchicine increased the risk for gastrointestinal side effects ( P <0.001). According to trial sequential analyses, there is only sufficient evidence for a myocardial infarction risk reduction with colchicine. Conclusions Among patients with CAD, colchicine reduces the risk of myocardial infarction and stroke, but has a higher rate of gastrointestinal upset with no influence on all-cause mortality.

Acute heart failure (AHF) is a major cause of unplanned hospitalisations in the elderly and is associated with high mortality. Its prevalence has grown in the last years due to population aging and longer life expectancy of chronic heart failure patients. Although international societies have provided guidelines for the management of AHF in the general population, scientific evidence for geriatric patients is often lacking, as these are underrepresented in clinical trials. Elderly have a different risk profile with more comorbidities, disability, and frailty, leading to increased morbidity, longer recovery time, higher readmission rates, and higher mortality. Furthermore, therapeutic options are often limited, due to unfeasibility of invasive strategies, mechanical circulatory support and cardiac transplantation. Thus, the in-hospital management of AHF should be tailored to each patient's clinical situation, cardiopulmonary condition and geriatric assessment. Palliative care should be considered in some cases, in order to avoid unnecessary diagnostics and/or treatments. After discharge, a strict follow-up through outpatient clinic or telemedicine is can improve quality of life and reduce rehospitalisation rates. The aim of this review is to offer an insight on current literature and provide a clinically oriented, patient-tailored approach regarding assessment, treatment and follow-up of elderly patients admitted for AHF., (Copyright and License information: Journal of Geriatric Cardiology 2021.)

Acute heart failure (AHF) is a frequent medical condition that needs immediate evaluation and appropriate treatment. Patients with signs and symptoms of volume overload mostly require intravenous loop diuretics in the first hours of hospitalization. Some patients may develop diuretic resistance, resulting in insufficient and delayed decongestion, with increased mortality and morbidity. Urinary sodium measurement at baseline and/or during treatment has been proposed as a useful parameter to tailor diuretic therapy in these patients. This systematic review discusses the current sum of evidence regarding urinary sodium assessment to evaluate diuretic efficacy in AHF. We searched Medline, Embase, and Cochrane Clinical Trials Register for published studies that tested urinary sodium assessment in patients with AHF., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

BACKGROUND It is challenging to distinguish between acute coronary syndrome (ACS) and myocardial injury due to alternative causes (eg myopericarditis, coronary vasospasm, and pulmonary embolism), as they often share similar presentations, especially in young patients. Coronary computerized tomography angiography (CCTA) is increasingly recognized as a fast and safe diagnostic tool for rapid assessment of the coronary anatomy among patients with a low to intermediate cardiovascular risk profile and/or atypical chest pain. However, its utility among patients with possible ACS is still debated. CASE REPORT A 36-year-old man presented to our institution with intermittent pleuritic chest pain and malaise over the preceding 7 days. He was a smoker and his father had ACS at the age of 45 years. The patient had unspecific electrocardiographic changes and elevated troponin values. The initial transthoracic echocardiogram indicated a normal ejection fraction without any wall motion abnormalities. Presuming a very low chance of coronary artery disease due to his age and atypical symptoms, we ordered a CCTA, which identified a thrombotic lesion in the right coronary artery (RCA). An invasive coronary angiography, including an optical coherence tomography, confirmed the presence of a thrombotic lesion located at the level of the proximal RCA, which was consequently treated with 1 drug-eluting stent. CONCLUSIONS Physicians should always eliminate underlying coronary artery disease among patients with unclear myocardial injury, irrespective of a patient's presentation, age, and estimated cardiovascular risk. In this context, CCTA represents a safe and simple tool to rapidly assess the coronary anatomy, especially in younger patients.

Treatment of ST represents a challenge. The presence of large amounts of thrombus combined with stent optimization increase the risk of distal embolization. A two-step strategy of stent implantation and deferred stent optimization might be appropriated. We hereby present three clinical cases of ST successfully treated with a two-step approach., Competing Interests: GM Cioffi and M Madanchi report no conflicts of interest. M. Bossard has received consulting and speaker fees from Amgen, Astra Zeneca, Bayer, and Mundipharma. F Cuculi has received consulting and speaker fees from SIS Medical and Abbott Vascular., (© 2021 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.)

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.)

Inhibition of platelet function by means of dual antiplatelet therapy (DAPT) is the cornerstone of treatment of acute coronary syndrome (ACS). While preventing ischemic recurrences, inhibition of platelet function is clearly associated with an increased bleeding risk, a feared complication that may lead to significant morbidity and mortality. Since bleeding risk management is intrinsically associated with therapeutic adjustments undertaken during the whole clinical history of patients with acute coronary syndrome, single decisions taken from the very first day to years of follow-up might be decisive. This review aims at providing a clinically oriented, patient-tailored approach in reducing the risk and manage bleeding complications in ACS patients treated with DAPT. The steps in clinical decision making from the day of ACS to follow-up are analyzed. New treatment strategies to enhance the safety of DAPT are also described.

Intratympanic gentamicin therapy is a useful alternative treatment for refractory Meniere's disease and is generally well tolerated. Visual disturbances as side effects of this treatment are rarely reported in the literature. In this report we describe the case of a 52-year-old woman with refractory Meniere's disease who developed binocular vertical diplopia following intratympanic gentamicin therapy. Spontaneous resolution of diplopia occurred within 2 weeks. The development of diplopia should be discussed as a potential complication with patients undergoing intratympanic gentamicin therapy., Learning Points: Meniere's disease is an inner ear disorder which can cause vertigo and hearing loss.As medical treatment sometimes fails, other therapeutic options should be considered.Gentamycin chemical labyrinthectomy can be administered as an alternative treatment, but the development of diplopia should be discussed as a potential side effect., Competing Interests: Conflicts of Interests: The Authors declare that there are no competing interests.

Background: Pulmonary vein isolation (PVI) is becoming the therapy of choice for symptomatic paroxysmal drug-refractory atrial fibrillation (AF). The most frequently reported complications are vascular complications (1.4%). Bleeding complications of the central nervous system have rarely been described. We report a case of spontaneous spinal bleed after PVI., Case Summary: A 68-year-old woman with a 2-year history of highly symptomatic paroxysmal AF (EHRA 3) was referred for a PVI redo procedure. A high-density mapping showed pulmonary vein reconnection of all pulmonary veins successfully isolated by radiofrequency ablation. During the entire procedure, the patient had sinus rhythm with an ACT around 300 s. No intraprocedural and peri-procedural complications occurred. Four hours after haemostasis, the anticoagulation clotting time (ACT) was 110 s and rivaroxaban (20 mg) was reinitiated. In the following hours, the patient developed fluctuating neurological lower limb symptoms. A lumbar magnetic resonance imaging showed a subdural spinal haematic collection with an associated epidural component from L3 to S2 exerting compression over the dural sheath. A conservative treatment approach was adopted with progressive recovery of sensorial and motor deficits. After 5 months, the patient still presented residual lower limb motor deficits necessitating the support of a walking stick., Discussion: We describe the first case of a spontaneous spinal bleeding following PVI. Given the gradual diffusion of PVI to treat AF in more clinically complex patients with a larger range of comorbidities, particular consideration should be given to seek predisposing bleeding factors in order to assess the risk for neurological complications., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

We present the case of a young woman complaining of aspecific symptoms of malaise and dyspnea admitted to our Cardiology Department for investigations. Two-dimensional (2D)/3D transthoracic echocardiography showed an echogenic, sessile mass adhering to the midsegment of the posterior interventricular septum. The patient refused transesophageal echocardiography. For further investigation, a cardiac magnetic resonance imaging was performed, which raised suspicion of a benign tumor. Ultimately, the patient underwent uncomplicated cardiac surgery with total excision of the mass. Histopathology examination revealed a capillary hemangioma., Competing Interests: There are no conflicts of interest., (Copyright: © 2019 Journal of Cardiovascular Echography.)