Prosthesis Infolding Incidence and Short-Term Outcomes in Transcatheter Aortic Valve Implantation Using Evolut Self-Expandable Device: A Multicenter Study.

Transcatheter aortic valve implantation (TAVI) is an established treatment strategy in aortic valve disease. Infolding, as a nonuniform expansion of the prosthesis leading to introflection of part of the device circumference, is a complication specific to self-expandable prostheses. The aim of the study is to determine incidence, predictors, treatment strategy, and outcomes of infolding during Medtronic Evolut TAVI (Minneapolis, MN, US). Between January 2018 and March 2022, all patients treated with Evolut TAVI were included in a multicenter observational retrospective study. According to the occurrence of infolding, the enrolled cohort was divided into 2 groups; periprocedural characteristics and 30-day outcomes were compared. A total of 1,470 patients were included; 23 infolding cases (1.6%) were detected. Preprocedural imaging showed larger aortic anatomy and greater calcium burden in the infolding group. Infolding occurred mostly with Evolut Pro+ and size 34 mm and was diagnosed before full prosthesis release in 78.3%. The rate of moderate-to-severe paravalvular regurgitation was higher in the infolding group (21.7% vs 1.9%, p <0.001). Short-term follow-up showed greater all-cause and cardiovascular mortality (respectively, 4.3% vs 0.7% and 4.3% vs 0.6%, p <0.05) and higher rate of pacemaker implantation (33.3% vs 15.7%, p = 0.042) in case of infolding. High right cusp calcium score and resheathing maneuvers were independent predictors of infolding. In conclusion, prosthesis infolding is a TAVI complication burdened by worse cardiovascular outcomes. Prompt intraprocedural infolding diagnosis is pivotal, especially in case of great native valve calcium burden and resheathing maneuvers, to safely overcome this complication by prosthesis recapture or postdilation.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

In-vitro validation of coronary physiology assessment with 5 French guiding catheters.

BACKGROUND: The trans-radial approach for cardiac catheterization led to an increasing adoption of 5 French (F) catheters. We aim to evaluate reliability and reproducibility of coronary physiology assessment performed with 5F guiding catheter (GC). METHODS: Physiological measurements were performed in a coronary flow simulator, which provides two pulsatile flows, the baseline and hyperaemic flows. Two screws, positioned proximally and distally to the distal sensor of a pressure-temperature guidewire, were used to determine various combinations of stenoses and distal obstructions, simulating different pathophysiological conditions. For each setting, 5 measurements of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) were performed with 6F and 5F GCs. RESULTS: A total amount of 190 measurements were performed, 95 with 6F GC and 95 with 5F GC. Minimal differences between 6F and 5F GCs were detected for FFR [0.91 (IQR: 0.87-0.94) and 0.87 (IQR: 0.82-0.92) respectively, p < 0.001] and IMR (16.5 ± 8.8 and 15.4 ± 8.3 respectively, p = 0.001). Mean CFR was comparable between 6F and 5F GCs (3.6 ± 1.1 and 3.5 ± 0.7 respectively, p = 0.38). Misclassification rates were 1.0 %, 1.0 % and 0 % for FFR, CFR and IMR, respectively. According to Passing-Bablok analysis, an excellent agreement between 6F and 5F GCs was demonstrated for FFR and IMR, and a modest agreement for CFR. All measurements with 5F GC showed high reproducibility. CONCLUSIONS: In our in-vitro model, a complete physiological assessment including FFR, CFR and IMR resulted substantially comparable between 6F and 5F GCs. Further in-vivo analysis is required to support these findings.

Minimalistic Hybrid Approach for the Percutaneous Treatment of Coronary Chronic Total Occlusions: Midterm Follow-Up of an International Multicenter Cohort.

The minimalistic hybrid approach (MHA) is a recently proposed algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI), reducing the overall invasiveness of the procedure without impacting the acute results. However, data on midterm results are lacking. This study aimed to evaluate the midterm clinical outcomes of a multicenter international cohort of CTO PCI treated according to the MHA. Data from a consecutive series of patients with a CTO who underwent PCI according to the MHA between February 2019 and March 2022 were prospectively collected in 3 European centers and retrospectively analyzed. The main outcome was the first occurrence of a major adverse cardiac event (MACE), defined as a composite outcome of all-cause death, any myocardial infarction, and target vessel revascularization, at the last follow-up available. A total of 212 patients were included. The majority of the patients were symptomatic for angina (Canadian Cardiovascular Society class 2 or 3: 63.7%) at the time of the index procedure. The mean Japanese-CTO and CASTLE scores were 2.1 ± 1.2 and 2.0 ± 1.3, respectively. Technical success (CTO open with optimal flow) was achieved in 198 patients (93.9%) and procedural success (technical success without in-hospital MACEs) in 195 (91.9%). At the last follow-up available (median 677 days), the cumulative incidence rate of MACEs was 11.5%; in particular, all-cause death was 7.4%, any myocardial infarction was 4.3%, and unplanned target vessel revascularization was 6.5%. In conclusion, the midterm results of the MHA seem to be in line with contemporary results of other CTO PCI algorithms, thus potentially validating the MHA as a valuable alternative, provided that interventionalists are already expert CTO operators and accustomed to the definitions and peculiarities of MHA.

Prevalence of Collateral Typology in Coronary Chronic Total Occlusion and Its Impact on Percutaneous Intervention Performance.

The presence of collateral channels providing distal blood supply is a distinctive characteristic of chronic total occlusion (CTO) lesions. However, data about the distinct baseline and procedural characteristics of each collateral subset are scarce. Accordingly, we sought to explore the procedural aspects specific for each collateral typology (ipsilateral collaterals [ICs], contralateral collaterals [CCs] or mixed) in CTO-percutaneous coronary intervention (PCI). A retrospective analysis of our CTO-PCI registry was performed to investigate the prevalence, procedural characteristics, and outcomes specific for each CTO-PCI subset, defined according to the inter-arterial connection anatomy. A total of 209 cases were included. Of the included cases, 45 (22%) and 92 (44%) patients displayed solely IC or CC, respectively, whereas in 72 (34%) both IC and CC were present (mixed). The procedural success rate was high (91.1%) and comparable among the different groups, despite greater lesion complexity in the CC group. The most frequent target vessel was the left circumflex in the IC group (51% of cases) and the right coronary artery in the CC (63%) and mixed (57%) groups. Among the IC cases, 42% showed a poor collateral connection function (2% and 10% for the CC and mixed group, respectively), and 46% showed a suboptimal collateral recipient artery filling (21% and 20% for the CC and mixed group, respectively). Most of the IC cases were performed using a single access (96%). In conclusion, the success and complication rates were comparable among the collateral typology groups, irrespective of the differences in the baseline and procedural characteristics. Phenotyping CTO as hereby proposed might be helpful for targeted procedural considerations.

First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT.

Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747). Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001). Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. Funding: The study was funded by Elixir Medical.

DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.

BACKGROUND: Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent. METHODS: This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure. CONCLUSIONS: This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent. CONDENSED ABSTRACT: The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus.

Alternative (Transulnar or Distal Radial) Arterial Access for Chronic Total Occlusion Percutaneous Coronary Intervention (Subanalysis from the Minimalistic Hybrid Approach Algorithm Registry).

The transradial approach (TRA) has become the primary choice for percutaneous coronary intervention (PCI); however, it may not be always feasible because of clinical and/or technical challenges. Alternative forearm accesses, such as transulnar approach (TUA) and distal radial approach (dTRA) may allow maintaining a wrist approach for the procedure, avoiding the femoral artery. This issue is particularly relevant in patients who underwent multiple revascularizations, such as those with chronic total occlusion (CTO) lesions. This study aimed to evaluate whether the use of TUA and/or dTRA is comparable with TRA in CTO PCI using a minimalistic hybrid approach algorithm, which limits the number of accesses used to minimize vascular access complications. Patients with CTO PCI treated solely through a fully alternative approach (TUA and/or dTRA) were compared with those treated solely through a standard TRA approach. The primary efficacy end point was procedural success, whereas the primary safety end point was the composite of major adverse cardiac and cerebral events and vascular complications. Of 201 CTO PCIs attempted, 154 procedures were considered for analysis (standard, n = 104, alternative, n = 50). Alternative and standard groups demonstrated comparable rates of both procedural success (92% vs 94.2%, p = 0.70) and primary safety end point (4.8% vs 6.0%, p = 0.70). Of interest, 7 French guiding catheters were more frequently used in the alternative group (44% vs 26%, p = 0.028). In conclusion, CTO PCI after minimalistic hybrid approach by way of alternative forearm vascular accesses (dTRA and/or TUA) is feasible and safe to perform, compared with CTO PCI by way of standard TRA.

One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry.

BACKGROUND: Bioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events. AIMS: We aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine. METHODS: BIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes. RESULTS: Overall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391. CONCLUSIONS: The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.

Percutaneous treatment of left circumflex coronary artery injury related to mitral valve surgery: Case series and systematic review of the literature.

Left circumflex coronary artery (LCx) injury related to mitral valve surgery is a rare complication. The best treatment option is not defined, and percutaneous coronary intervention (PCI) may represent an effective treatment to avoid prolonged myocardial ischemia. To evaluate feasibility and efficacy of PCI treatment, all records of LCx injury related to mitral valve surgery and treated with PCI were included after a systematic PubMed searching. Moreover, we retrospectively analyzed our single-center PCI database and patients fulfilling the inclusion criteria were included. Patients undergoing transcatheter mitral valve intervention, non-mitral valve surgery, conservatively or surgically treated after LCx injury were excluded. Data about patient characteristics, procedural details, PCI success, and in-hospital mortality were collected. Fifty-six patients were included, 58.9% were male (n = 33) and the median age was 60.5 years (IQR = 21.75). The majority had left dominant or codominant coronary system (62.2%, n = 28 and 15.6%, n = 7, respectively). Clinical manifestations ranged from hemodynamic stability (21.1%, n = 8) to hemodynamic instability (42.1%, n = 16) and cardiac arrest (18.4%, n = 7). On ECG, 23.5% of patients (n = 12) presented ST-segment depression, 58.8% (n = 30) ST-segment elevation, 7.8% (n = 4) atrioventricular block, and 29.4% (n = 15) ventricular arrhythmias. Left ventricle dysfunction was present in 52.3% (n = 22) of patients and wall motion abnormalities in 71.4% (n = 30). PCI success rate was 82.1% (n = 46) and in-hospital mortality 4.5% (n = 2). LCx injury related to mitral surgery is a rare complication characterized by an increased risk of mortality. PCI seems a feasible treatment option, still burdened by suboptimal results, probably related to the technical challenges posed by the surgical failure.

A glimpse into the future of the percutaneous treatment of coronary chronic total occlusions.

Percutaneous coronary intervention (PCI) of coronary chronic total occlusion (CTO PCI) is one of the most challenging but rewarding procedures in the portfolio of interventional cardiologists. Several challenges, however, still must be overcome and many questions need to be answered. After coronary artery bypass graft (CABG), disease of the conduits and concomitant progression of atherosclerotic disease to CTO of the subtended native coronary vessels are common and associated with onset of new anginal symptoms and worsening of the prognosis. Which is the best strategy for these post-CABG CTOs? Furthermore, what is the role of physiology in the setting of CTO PCI? In the last decades, many researchers tried to demystify the complex maze but technical limitations and the demanding procedure itself, for both the patient and the operator, do not allow extensive investigation of its impact on clinical practice. Can we enhance periprocedural planning of CTO PCI with a more tailored and multidimensional evaluation? Analysis of coronary computed tomography angiography (CCTA) scans is getting more and more incorporated into the clinical routine and training of interventional cardiologists but mainly focuses on structural valvular disease. Nevertheless, with the appropriate expertise, a lot of information can be derived for coronary intervention to improve procedural planning and potentially outcomes. Finally, in the era of drug-eluting stent, is there a place for strategies that minimize metal implantation in the coronaries to further reduce late-onset adverse events in CTO PCI? This approach could be attractive in CTOs due to the higher risk of target vessel failure and revascularization shown in literature but, at the same time, more challenging due to the histological and anatomical complexity of the disease. In this review, we aim to tackle these questions and concomitantly provide a vision of potential future application of new techniques and technology in CTO PCI that could allow further advancement in this field.

Clinical implications of coronary microvascular dysfunction in patients with non-obstructive coronary artery disease and role of the thermodilution method.

More than 60% of patients undergoing coronary angiography present no coronary artery disease (CAD). Angina and myocardial ischemia are classically determined by epicardial vascular obstruction, but coronary microvascular dysfunction (CMD) may also represent a possible cause for these phenomena. Two endotypes of CMD have been recognized, with two different pathophysiological mechanisms: structural CMD, characterized by low coronary flow reserve (CFR) and high microvascular resistance (MVR) values; and functional CMD, characterized by low CFR and normal MVR values. According to the present data, almost half of patients with non-obstructive CAD have shown signs of CMD. For this reason, further investigations for microvascular function assessment should be considered when evaluating no-CAD patients complaining of angina or presenting signs of myocardial ischemia. The thermodilution method is currently becoming a widespread invasive technique due to its feasibility and high reproducibility for coronary physiology evaluation. Furthermore, a recently introduced technique - called continuous thermodilution - allows for direct measurement of absolute coronary flow and resistances. The role of this brand-new technique in the clinical scenario is however still to be fully investigated and its use is at present limited to research purposes only. Among no-CAD patients, both structural and functional CMD are related to a worse prognosis in term of mortality and major adverse cardiovascular events (MACE). In this review, we will discuss the present evidence supporting the definition, prevalence and clinical implication of the different forms of CMD and the technical aspects of its invasive assessment.

Applicability of the EXCEL Trial Criteria to an All-Comers Real-World Cohort of Unprotected Left Main Percutaneous Coronary Intervention.

The Evaluation of XIENCE versus EXCEL (Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial is the largest randomized study comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comer population of ULMD PCI would be eligible for the EXCEL trial and whether these patients show different long-term outcomes than the rest of the ULMD population. A total of 246 consecutive patients underwent ULMD PCI between January 2018 and December 2021 and were retrospectively analyzed. After application of the EXCEL trial inclusion and exclusion criteria, 98 patients (39%) were allocated to the "EXCEL-like" cohort and 148 to the "non-EXCEL-like." Baseline characteristics of the 2 groups were substantially comparable. The mean baseline SYNTAX score was lower in the EXCEL-like patients than the non-EXCEL-like group (20.1 ± 7.1 vs 23.0 ± 11.2, p = 0.025), with the latter also showing a higher degree of incomplete revascularization (residual SYNTAX score >8 : 11% vs 26%, p = 0.005). At 1 year, the cumulative major adverse cardiovascular and cerebral events rate was 7% for the EXCEL-like and 17% for the non-EXCEL-like patients, respectively (p = 0.03). At the last follow-up available, the significant difference in major adverse cardiovascular and cerebral events rate persisted (19% vs 37%, p = 0.02) and a significant difference in any unplanned revascularization was also shown (1.5% vs 13%, p = 0.04). In conclusion, in a contemporary real-world cohort of ULMD PCI, only a minority of patients could be enrolled in the EXCEL trial; the EXCEL-like patients, in our population, showed less clinical events at long-term follow-up than the cohort of patients who were ineligible for EXCEL, despite comparable baseline cardiovascular profiles; these findings may challenge a broad external applicability of the results of the EXCEL trial in routine clinical activity.

Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.

BACKGROUND: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. AIMS: We aimed to evaluate the safety and efficacy of the R-One system for PCI. METHODS: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. RESULTS: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. CONCLUSIONS: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

Feasibility, safety and predictors of a successful "blind wiring" antegrade approach in the percutaneous treatment of chronic coronary total occlusions.

BACKGROUND: Antegrade wiring using only antegrade guiding catheter without contralateral injection (defined as "blind antegrade wiring") may represent a valid initial treatment strategy for selected chronic coronary total occlusions (CTOs) due to the potentially lower risk of vascular complications. A careful selection of lesions eligible for this strategy as well as an accurate balance between the likelihood of success and failure is paramount. The aim of the study is to determine the rate of successful revascularization, the potential predictors of failure and the incidence of major complications, when using a "blind antegrade wiring" technique. METHODS: In this multicentric study, consecutive patients with CTO undergoing percutaneous coronary intervention (PCI) were retrospectively screened. All cases approached using "blind antegrade wiring" technique were included. RESULTS: Out of 155 consecutive CTO-PCIs, 94 involved initial "blind antegrade wiring" strategy. Successful revascularization by means of "blind antegrade wiring" technique was achieved in 73 (78%) patients. Final successful revascularization was obtained in 19 of the remaining 21 procedures with "blind antegrade wiring" failure using other techniques (by adding a second contralateral guiding catheter; 98% total successful revascularization). Logistic regression analysis identified higher J-CTO Score as the only predictor of "blind antegrade wiring" failure. One complication occurred (wire-based coronary perforation). CONCLUSIONS: "Blind antegrade wiring" may be considered as initial strategy for selected CTO-PCI, mainly for CTOs with low J-CTO Score. This strategy would allow in a substantial number of cases to avoid a priori dual injection, keeping it as secondary strategy in case of "blind antegrade wiring" failure.

24-Month Clinical Follow-Up and Mechanistic Insights From Intravascular Imaging Following Coronary Implantation of the Novel DynamX Bioadaptor Platform.

BACKGROUND/PURPOSE: Conventional stents "cage" the coronary arteries, impairing vascular function and physiology. The DynamX Bioadaptor is a cobalt­chromium platform with uncaging elements, designed to improve arterial pulsatility, vasomotion, compliance, and positive adaptive remodelling which may attenuate late clinical events associated with the caging of arteries through conventional stents. We present the first 24-month outcomes of this device. METHODS/MATERIALS: This European multicenter study enrolled 50 patients with 50 de novo lesions treated with the DynamX Bioadaptor. Clinical follow-up is scheduled until 36 months and imaging follow-up was performed at 9-12 months. RESULTS: 24-month endpoints were target lesion failure (2 cardiac deaths), myocardial infarction (1 non-target vessel myocardial infarction), target vessel revascularisation (n = 0), and definite or probable device thrombosis (n = 0). No endpoint events occurred beyond 9 months. Paired intravascular ultrasound analysis of 18 patients from a single center revealed a 0.22 mm2 increase in device cross-sectional area at 9-12 months. Pulsatility analysis showed an increase of in-device lumen area change by 46 % compared to the caged post-procedural configuration, reducing the compliance mismatch between the treated and not-treated vessel segments (segmental compliance). Likewise, vasomotion in response to nitroglycerin improved from 0.03mm2 post-procedure to 0.17mm2 at follow-up. CONCLUSIONS: 24-month clinical data demonstrate promising safety and efficacy of the DynamX Bioadaptor. Imaging data confirmed its unique capacity to improve arterial pulsatility, vasomotion, compliance and positive adaptive remodelling after "uncaging" which might have led to the promising clinical outcomes that need to be confirmed in larger studies.