6
November 2021 | Issue 63
Advertorial
Issue 63 | November 2021
Advertorial
THIS ADVERTORIAL IS SPONSORED BY iVASCULAR
Chronic total occlusion: The last frontier in the cath lab Treatment of a chronic total occlusion (CTO)—a complete obstruction of the coronary artery that has persisted for more than three months—is one of the major challenges in the cath lab. A CTO consists of a proximal and distal cap, separated by an occluded segment, and due to the complexity involved in CTO percutaneous coronary intervention (PCI), the approach is seen as being so challenging that some have described it as the last frontier in interventional cardiology. In this advertorial, sponsored by iVascular, Cardiovascular News considers the challenges of treating CTOs, and details the features of the Navitian microcatheter, which has been designed specifically for the treatment of complex lesions and CTOs.
T
he literature has suggested a varying in procedural success. In such complex prevalence of CTOs in coronary scenarios, microcatheters are essential tools and artery disease patients, with data high-quality performance is required.” pointing towards an incidence rate of Deployment of a microcatheter is one of the anywhere up to 30% of cases,1 with an essential techniques for successful CTO PCI, even greater prevalence in diabetic or and the device can be used for a number of heart failure patients.2 Furthermore, functions, including to increase the support of a 13% of cases exhibit more than one guidewire, to advance through tortuous vessels, CTO. Historically, the vast majority of Roberto Garbo to gain access to side branches, facilitating patients with a CTO are not treated using a parallel wiring, and plaque modificiation.3 percutaneous technique largely due to increased failure In their 2018 paper in Vessel Plus,4 Lazzaro Paraggio rates, technical complexity, cost and procedure length— and Francesco Burzotta (Institute of Cardiology, with medical management or coronary artery bypass Università Cattolica del Sacro Cuore, Rome, Italy) grafting (CABG) having been the favoured approaches document the important functions of microcatheters in the bulk of cases. in the successful deployment of PCI for CTOs. They However, this balance is gradually shifting, as percutaneous approaches continue to develop, and as new techniques, devices, and knowledge enter the field. Significant advances have been made in recent years that have led to increases in the success rate of PCI for CTO—advancing from close to 70% to more than 90%—which potentially open out the percutaneous option to a wider subset of patients. This picture is summed up by EuroCTO board member Roberto Garbo (Maria Pia Hospital, Turin, Italy) who tells Cardiovascular News: “CTOs are the most complex coronary interventions, in which operator expertise and dedicated devices play a fundamental role
CTOs are the most complex coronary interventions, in which operator expertise and dedicated devices play a fundamental role in procedural success.”
note that the key role of the microcatheter in CTO procedures can be summarised in three essential steps. Namely, these are: to safely place the CTO guidewire just in front of the lesion, to increase support and precision, and to allow guidewire exchange once the lesion has been crossed. “All these steps could be used even in complex PCI procedures when a CTO-dedicated guidewire is used to cross a heavily calcified and/or narrowed lesion as explained before or when a workhorse guidewire should be manipulated more precisely which facilitates torque in the tip response,” Paraggio and Burzotta write. Finally, they add that microcatheters could be very useful in reducing guidewire kinking and prolapse while trying to cross a lesion immediately after a large side branch.
Navitian: A new entrant in the microcatheter market
As approaches to CTO PCI have developed, so has microcatheter technology. The latest entrant to the evolving coronary microcatheter market is Navitian from iVascular. iVascular is a fast-growing company founded in 2010 in Barcelona, Spain with the aim of developing advanced medical devices and therapies for the treatment of cardiovascular system disorders. Thanks to know-how and investment in technology, iVascular has achieved the vertical integration of all the processes of their products. Navitian has been designed specifically with complex lesions and CTOs in mind. The Navitian coronary microcatheter has a single lumen from the proximal end to the distal end, and it is used for support, passage of a guidewire and for the delivery of contrast media or saline solution. Features that have been targeted for CTOs in particular include a unique proprietary braiding technology, intended to optimise the pushability of the device and featuring a high penetration capacity, with low profiles and external conical transition to cross the most challenging lesions. Furthermore, the tip of the Navitian device is completely adaptable thanks to its design, which features a c-cut radiopaque marker and radiopaque charged polymers, which are intended to aid the visibility of the device. The distal body of the catheter is coated with a
proprietatry hydrophilic coating, Hydrax plus, which is durable and helps with catheter navigation through tortuous arteries and is designed to facilitate excellent trackability. The useful length of the catheter can be 135cm or 150cm, for antegrade and retrograde approach respectively. The product is compatible with 0.014” guidewires can support a maximum pressure of 2070kPa (300psi) with the distal end open.
The performance of Navitian was really good both in antegrade and retrograde, the overall performance of the device in terms of profile, crossability and support was at high-quality level.” On the right and below, Garbo describes real case experience using the Navitian microcatheter in both antegrade and retrograde approaches. He describes the performance of the device as being at a “highquality level”. “The performance of Navitian was really good both in antegrade and retrograde, the overall performance of the device in terms of profile, crossability and support was at high-quality level,” Garbo says. “In the retrograde approach, after balloon dilatation over stent struts, the Navitian 150 easily crossed the septal giving us good feedback for the rest of the procedure.” References 1. Lombardi W, Banerjee S. Chronic Total Occlusions [Internet]. The Cardiology Advisor. 2021 [cited 27 September 2021]. Available from: https://www. thecardiologyadvisor.com/home/decision-support-in-medicine/cardiology/ chronic-total-occlusions/ 2. Konstantinidis N, Werner G, Deftereos S et al. Temporal Trends in Chronic Total Occlusion Interventions in Europe. Circulation: Cardiovascular Interventions. 2018;11(10). 3. Vemmou E, Nikolakopoulos I, Xenogiannis I et al. Recent advances in microcatheter technology for the treatment of chronic total occlusions. Expert Review of Medical Devices. 2019;16(4):267-273. 4. Paraggio L, Burzotta F, Aurigemma C et al. Usefulness of chronic total occlusion devices and techniques in other complex lesion subsets. Vessel Plus. 2019.
Navitian: Simplifying complex CTO cases
Two case studies involving the use of the Navitian microcatheter were recently presented at the EuroCTO congress (17–18 September; Florence, Italy) demonstrating the performance of the device in challenging CTO cases. Presented by Roberto Garbo, board member of EuroCTO club, details of the cases are presented below.
Case 1: Complex calcified CTO supported by a new microcatheter Patient profile: Patient is a 74-year-old male, whose risk factors include diabetes and hypertension. In December 2020 he presented with effort angina, and an exercise test was positive at a low threshold. Lesion: Mid left anterior descending (LAD) CTO (Figure 1) with diffuse disease was scheduled for treatment on 26 March 2021. Procedure: The LAD/diagonal branch presented with a severely calcified CTO, which was treated using the antegrade approach. The first soft polymeric wire (Fielder XTR) was advanced (Figure 2), with a subsequent step-up using Navitian (Gaia 2nd) and then a final successful crossing with Fielder XTR (wire de-escalation technique). Navitian showed very good behaviour in this case (Figure 3). Garbo’s conclusion: “In this complex antegrade CTO case, Navitian microcatheter had very good performance in crossing the calcified CTO lesion.”
Figure 2: Fielder XTR is advanced
Chronic total occlusion (CTO) in focus
Case 2: Complex RCA CTO from antegrade to retrograde approach achieved with Navitian
A CTO is defined as the complete obstruction of a coronary artery, exhibiting TIMI 0 or TIMI 1 flow, with an occlusion duration of three months or more. The prevalence has been described as high as 30%, and 13% of cases exhibit more than one CTO.
Patient profile: The patient is a 64-year-old male, with risk factors including a history of smoking, hypertension and dislipidaemia. In December 2020 he presented an anterior non-ST segment elevation myocardial infarction (NSTEMI).
Benefits of Navitian Optimal pushability due to a unique design with a proprietary braiding technology High penetration capacity with low profiles to cross the most challenging lesions Excellent visibility due to a c-cut radiopaque marker and radiopaque charged polymers Excellent trackability due to a proprietary hydrophilic coating Hydrax plus Antegrade and retrograde approach: 135 and 150cm
Figure 1: Presence of the mid-LAD CTO is detected
Figure 3: The final case result
Lesion: Right coronary artery (RCA) CTO post-stent was detected. In February 2021 he presented with angina for minimal effort, so an RCA CTO PCI was scheduled for 26 March 2021. Procedure: An antegrade approach with intravascular ultrasound (IVUS) guidance for entry failed due to calcification at the proximal cap. A retrograde approach was needed, which was attempted using Navitian 150cm and Sion black (Asahi). This achieved good crossing in the septal branch over a stented LAD. The connection between the two wires (ante and retro) was obtained with the Reverse CART technique. Garbo’s conclusion: “The performance of Navitian was really good both in antegrade and retrograde, the overall performance of the device in terms of profile, crossability and support was at highquality level. In retrograde approach, after balloon dilatation over stent struts, the Navitian 150 easily crossed the septal giving us good feedback for the rest of the procedure.”
Figure 1: RCA CTO post-stent
Figure 2: Navitian 150 and Sion black are advanced into the lesion
Figure 3: Crossing the septal branch using Navitian
Figure 4: Reverse CART procedure is employed
Figure 5: External view of the Navitian microcatheter in use
Figure 6: The final case result
7