The safety and feasibility of live-stream proctoring for CTO procedures.

OBJECTIVE: To assess the technical feasibility of a new method of educational training, based on audio-video (AV) communication between an interventional cardiologist and the cath lab staff members in one location and a remote expert proctor. METHODS: Overall, 9 patients underwent a percutaneous coronary intervention (PCI) targeting a chronic total occlusion (CTO) between June 2021 and January 2022 at a single Belgian center using the virtual proctoring approach. For this assessment, the strategic planning of the CTO PCI and all the decisions throughout the intervention were the responsibility of the proctor. The operator was guided via an AV link, by the proctor throughout the procedure. RESULTS: The operator performed each procedural step, guided by the remote proctor, who had continuous access to all relevant interventional details. No major adverse cardiac events (MACE) occurred during the index hospitalization or within 6 months follow-up. CONCLUSIONS: A new method of virtual proctoring based on live AV communication is feasible, even in the case of highly complex CTO PCI procedures. This strategy also appears safe and may provide the patient the benefit of incremental expertise. This approach is facilitated by advances in AV communication and allows physicians to share expertise irrespective of location. It could increase global interaction between colleagues and facilitate sharing of knowledge, which are both key aspects in the development of CTO PCI. This preliminary experience could serve as a basis for future large studies to study the potential role and benefits of virtual proctoring for complex CTO PCI procedures.

RailTracking: A Novel Technique to Overcome Difficult Anatomy During Transradial Approach.

OBJECTIVE: We aim to investigate the safety and efficacy of a new technique, "RailTracking," in the management of challenging transradial routes during percutaneous coronary interventions (PCI). BACKGROUND: The transradial access (TRA) currently represents the access site of choice in PCI, but complex anatomy could lead to complications and access-site crossover. The assisted-tracking techniques described in the past (such as balloon-assisted tracking and pigtail-assisted tracking) are based on the concept of a "guiding tapered tip" to improve trackability. The RailTracking technique creates a tapered catheter tip using a dedicated device. METHODS: We collected patient data from January 2021 to January 2022 in 2 high-volume centers using the RailTracking technique as a bail-out solution. A prospective analysis of the anatomical characteristics and outcomes of the study population was performed. RESULTS: Seventy-seven patients were included in the study. All patients presented with challenging anatomies; 35.1% of the patients (n = 27) had small radial arteries, 19.5% (n = 15) had significant radial tortuosity, 2.6% (n = 2) had significant brachial tortuosity, 2.6% (n = 2) had subclavian tortuosity, and 1.29% (n = 1) had a critical subclavian lesion. In addition, 38.9% presented with severe radial spasm. The procedural success rate of the RailTracking technique was 98.7% (76/77 patients). The only case of failure presented with calcifications and a critical lesion in the subclavian artery. However, no periprocedural vascular complications occurred. This new technique appears safe, with a radial artery occlusion rate of 3.89% (n = 3) at 1-month follow-up. CONCLUSION: The new RailTracking technique improves catheter crossing in challenging anatomies and seems safe and effective in cases of failure with currently available approaches.

Radial Artery Pseudoaneurysm Complicating Distal Transradial Access for Chronic Total Occlusion Recanalization.

We report a case of a distal radial access (dRA) pseudoaneurysm complicating a chronic total occlusion (CTO) percutaneous coronary intervention (PCI). After hospital discharge, the patient developed progressive pain and swelling at the access site and ultrasound revealed a distal radial artery pseudoaneurysm. This completely resolved conservatively with manual compression. This case highlights a potential vascular complication of the recently introduced dRA with its conservative management.

Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study.

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients.

OBJECTIVES: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). BACKGROUND: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. METHODS: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. RESULTS: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). CONCLUSIONS: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis.

The Last Broken Barrier: Retrograde Radial Artery Recanalization Prior to Transradial Coronary Interventions.

Transradial access has become the default vascular access for coronary procedures, since it has shown to reduce major bleeding, adverse cardiac events and mortality compared with transfemoral access. However, radial artery occlusion has been historically considered a formal contraindication for transradial coronary procedures. In this investigation, we report the feasibility and outcomes of radial artery occlusion recanalization from distal radial access prior to transradial angiography and intervention.

Device entrapment during percutaneous coronary intervention of chronic total occlusions: incidence and management strategies.

BACKGROUND: Equipment delivery in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can be challenging and it is associated with a higher risk of device entrapment. Data regarding the incidence of device entrapment during CTO PCI are lacking. AIMS: The aim of this study was to describe the incidence and procedural characteristics of device entrapment in patients undergoing PCI for CTOs and discuss management strategies for dealing with it. METHODS: Device entrapment was characterised in a large consecutive series of 2,361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020. RESULTS: Device entrapment occurred in 36 out of 2,361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalisation was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%), tamponade with urgent pericardiocentesis in 1 (2.8%) and emergency surgical removal of the entrapped device in 1 patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularisation. CONCLUSIONS: Device entrapment during CTO revascularisations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to achieve procedural success safely.

No-Reflow Complicating Chronic Total Occlusion Coronary Revascularization.

OBJECTIVES: To assess the incidence of no-reflow in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI), analyze possible causes and differential diagnoses, and identify useful management approaches. METHODS: In this multicenter observational study, all CTO-PCIs performed between January 2018 and April 2019 were reviewed to collect no-reflow complications, defined as Thrombolysis in Myocardial Infarction (TIMI) flow ≤1 in a patent epicardial artery. Patient clinical, anatomical, and procedural characteristics were analyzed. RESULTS: Out of 461 PCIs, two (0.43%) were complicated by no-reflow. In 1 case, PCI was performed on a long segment of the right coronary artery, after use of a dissection-re-entry technique by knuckle wiring. In the second patient, no-reflow developed after proximal left anterior descending coronary artery stenting, with a short subintimal tracking. Intravascular ultrasound was used to exclude complications in the epicardial vessel in both cases. Distal embolization seems the most plausible cause, and intracoronary adenosine effectively improved flow. Both patients had a type 4a myocardial infarction, asymptomatic in the first case, and associated with chest pain, electrocardiographic changes, and new regional wall-motion abnormality at echocardiography in the second case. CONCLUSIONS: No-reflow in CTO recanalization is rare, but associated with a high risk of periprocedural myocardial infarction, with incomplete protection from ischemia offered by the pre-existing collateral network.

Prevalence of inherited thrombophilia in patients with documented stent thrombosis.

BACKGROUND: Stent thrombosis (ST) is a multi-factorial process involving different mechanisms. The impact of inherited coagulation disorders in the genesis of ST has never been assessed. The aim of the present study was to evaluate the prevalence of G1691A Factor V Leiden mutation, G20210A Factor II (prothrombin) mutation and C677T homozygous methylenetetrahydrofolate reductase (MTHFR) polymorphism in patients with ST. METHODS AND RESULTS: The prevalence of the aforementioned gene variations was assessed in 127 patients: 50 admitted for ST and 77 previously treated with percutaneous coronary intervention not developing ST. A control cohort of 529 healthy volunteers was sampled from the same geographical area. Patients with ST were carriers of at least 1 gene variation in 28% of cases. The prevalence of G1691A Factor V Leiden mutation (odds ratio [OR]=0.64; 95% confidence interval [CI]: 0.04-10.5), G20210A Factor II mutation (OR=0.63; 95% CI: 0.12-3.28) and C677T MTHFR homozygous polymorphism (OR=1.13; 95% CI: 0.47-2.72) did not differ significantly among patients with or without ST. The logistic regression model did not show a significant association between gene variations and ST (OR=0.61; 95% CI: 0.24-1.60; P=0.32). CONCLUSIONS: A specific association between studied gene variations and ST has not been detected. The relatively high prevalence of at least 1 gene anomaly in such a rare subset of patients, and its consequences in term of secondary prevention therapy, suggests that screening for thrombophilia might be justifiable in cases of ST.