Intravascular imaging in the diagnosis and management of patients with suspected intracoronary pathologies: A CJC White Paper.

Intravascular imaging has become an integral part of the diagnostic and management strategies for intracoronary pathologies. This White Paper summarizes 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 non-obstructive coronary disease (MINOCA). Findings are presented following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system in an expert consensus process involving a diverse Writing group and vetted by a Review group. Expert consensus was achieved around nine 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 as well as 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 presenting with MINOCA 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 of this White Paper will help to guide the utilization of intravascular imaging towards those situations in which the balance of efficacy, safety and cost are most optimal.

Assessment of Coronary Stenoses for Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis of Randomized Trials.

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.

Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial infarction cases with large thrombus burden.

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.

Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons.

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.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

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.

The impact of colchicine on patients with acute and chronic coronary artery disease.

Inflammation plays a central role in coronary artery disease (CAD), and recent data have shown that anti-inflammatory drugs have the potential to reduce ischemic events in CAD patients. Colchicine is an ancient anti-inflammatory drug that targets neutrophil and inflammasome activities. It has been prescribed for decades for different rheumatological conditions. Given the important role of inflammation in the development of cardiovascular disease, there has been considerable interest in studying colchicine's potential to limit the progression of atherosclerosis among afflicted patients. In fact, there is a growing body of randomized data suggesting that use of low-dose colchicine reduces the risk of ischemic events in patients with CAD, particularly repeated revascularizations, new myocardial infarctions and strokes. This review article summarizes background information-including possible side effects and contraindications-as well as the current evidence backing up the use of colchicine in patients with established CAD.

Does artificial intelligence enhance physician interpretation of optical coherence tomography: insights from eye tracking.

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.

Mitigating the risk of flow deterioration by deferring stent optimization in STEMI patients with large thrombus burden: Insights from a prospective cohort study.

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 (mm2) 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.

Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.

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 > 180o arc and > 0.5 mm thickness, and/or nodular calcification with > 90o 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.

Direct Oral Anticoagulants Versus Vitamin K Antagonists for the Treatment of Left Ventricular Thrombi-Insights from a Swiss Multicenter Registry.

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.

Trajectories of Cardiac Function Following Treatment With an Impella Device in Patients With Acute Anterior ST-Elevation Myocardial Infarction.

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.

Contexte: La décharge du ventricule gauche (VG) à l'aide de la pompe microaxiale percutanée Impella est de plus en plus employée chez les patients qui présentent un infarctus du myocarde avec élévation du segment ST (STEMI) et un choc cardiogénique manifeste. Dans ce contexte, l'évolution de la fonction et des dimensions cardiaques après le congé de l'hôpital demeure incertaine. Nous avons cherché à caractériser les variations des paramètres échocardiographiques au fil du temps chez les patients ayant subi un STEMI antérieur aigu traités au moyen d'un dispositif Impella. Méthodologie: À partir d'un registre prospectif actif, nous avons extrait les dossiers de patients consécutifs ayant subi un STEMI antérieur aigu et pris en charge au moyen d'un dispositif Impella. Une échocardiographie transthoracique a été effectuée durant l'hospitalisation de référence puis à la première visite de suivi ambulatoire. Les facteurs prédictifs de la réponse, définis comme une augmentation absolue ≥ 10 % de la fraction d'éjection ventriculaire gauche (FEVG) au moment du suivi, ont été recherchés. Résultats: Au total, 66 patients (89,4 % d'hommes, âgés de 64,3 ± 11,6 ans) ayant subi un STEMI antérieur ont été traités au moyen d'un dispositif Impella pendant les 24 premières heures de l'hospitalisation, entre 2014 et 2022. Le taux de mortalité hospitalière était de 24 %. Des hémorragies majeures et des complications vasculaires ayant nécessité une intervention chirurgicale sont survenues chez 24 % et 11 % des patients, respectivement. Au début de l'étude, la FEVG moyenne était de 34 % ± 12 %. Lors du suivi, les survivants affichaient une augmentation significative de la FEVG (p < 0,0001), alors que les dimensions du VG, les paramètres diastoliques et les mesures de la taille et de la fonction du ventricule droit étaient demeurés stables. Globalement, 28 patients affichaient une augmentation absolue de la FEVG ≥ 10 % lors du suivi. D'après l'analyse univariée, la créatininémie initiale était le seul facteur prédictif important de la réponse. Conclusions: Parmi les patients ayant subi un STEMI antérieur nécessitant un support mécanique hémodynamique au moyen d'un dispositif Impella, une augmentation durable de la fonction ventriculaire gauche, sans signe de remodelage indésirable, a été observée chez la majorité des survivants. Ce signal justifie une évaluation plus approfondie dans le cadre d'essais cliniques conçus à cet effet.

"Burying" covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency.

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.

Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon.

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.

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.

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.

Pushing the Boundaries: Drug-Coated Balloons to Treat a Calcified and Thrombotic Lesion in Acute Coronary Syndrome.

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.

Manual compression versus MANTA device for access management after impella removal on the ICU.

To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24-69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01-0.50; p = 0.001), and there was no significant difference in vascular complications between the two groups (p = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.

Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds-Insights From an All-Comer Registry.

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.

Ventricular Unloading Using the ImpellaTM Device in Cardiogenic Shock.

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.

Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker.

PURPOSE: The miniaturized transcatheter pacing system (TPS) implant is performed using a 27 Fr sheath. Achieving femoral vein access hemostasis after sheath removal is of utmost importance. Feasibility and clinical effectiveness of double device-based suture-mediated closure technique (DualPerclose) were evaluated. METHODS: Patients undergoing TPS positioning and treated with DualPerclose technique at our institution were considered. Feasibility of the DualPerclose technique included the rates of effective initial device suture fixation and effective hemostasis after sheath removal. Clinical efficacy considered intraprocedural and periprocedural bleeding events as well as midterm access site vascular injury assessed at 3 months using lower limb vascular ultrasonography. Data on all follow-up major adverse events were also collected. RESULTS: All patients (n = 83 patients; mean age 82.3 ± 7.1 years, 67.5% male gender, 85.5%, with structural heart disease, mean left ventricular ejection fraction 54.0 ± 9.6%, renal impairment in 31.3%) who underwent TPS positioning between November 2015 and February 2020 were considered. TPS positioning was successful in all patients. In 82 patients, the DualPerclose approach was utilized: 13 patients (15.8%) required > 2 devices to obtain effective fixing of 2 sutures; complete immediate hemostasis was achieved in 80 patients (97.6%). One (1.2%) severe groin-related bleeding event occurred. At midterm, 1 (1.2%) mildly symptomatic arteriovenous fistula was diagnosed (conservative treatment). Over a median follow-up of 22 (IQR 10-35.5) months, 14 (17.1%) major adverse events were recorded, including 1 loss of capture requiring TPS replacement and 5 deaths. CONCLUSION: Femoral vein access closure using dual Perclose Proglide devices during TPS is feasible and clinically effective.

Etiology and device therapy in complete atrioventricular block in pediatric and young adult population: Contemporary review and new perspectives.

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.