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Original Contribution

Equipment Utilization in Chronic Total Occlusion Percutaneous Coronary Interventions: Update From the PROGRESS-CTO Registry

Spyridon Kostantinis, MD1;  Bahadir Simsek, MD1;  Judit Karacsonyi, MD, PhD1; Athanasios Rempakos, MD1;  Khaldoon Alaswad, MD2;  Farouc A. Jaffer, MD, PhD3;  Jaikirshan J. Khatri, MD4;  Paul Poommipanit, MD5;  Rhian E. Davies, DO6; Stephane Rinfret, MD7;  William Nicholson, MD7;  Wissam Jaber, MD7;  James W. Choi, MD8;  Mitul P. Patel, MD9;  Michael Koutouzis, MD10;
Ioannis Tsiafoutis, MD10;  Sevket Gorgulu, MD11;  Taral N. Patel, MD12;  Brian K. Jefferson, MD12;  Jimmy L. Kerrigan, MD13;  Basem Elbarouni, MD14;  Nidal Abi Rafeh, MD15; Omer Goktekin, MD16;  Ahmed M. ElGuindy, MD17;  Salman Allana, MD1;  Olga C. Mastrodemos, BA1;  Bavana V. Rangan, BDS, MPH1; Yader Sandoval, MD1;  M. Nicholas Burke, MD1;  Emmanouil S. Brilakis, MD, PhD1

February 2023
1557-2501
J INVASIVE CARDIOL 2023;35(2):E61-E69. doi: 10.25270/jic/22.00322

Watch the accompanying author interview here.


Abstract

Background. Guidewires and microcatheters are critical to the success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods. We examined equipment utilization in 11,202 CTO-PCIs performed in 10,952 patients at 42 United States (US) and non-US centers between 2012 and 2022. Results. Antegrade-only crossing was attempted in 7628 CTO-PCIs (68%) and the retrograde approach was used in 3574 CTO-PCIs (32%). The median number of guidewires used during antegrade wiring increased with lesion complexity from 3 (interquartile range [IQR], 2-4) for J-CTO score of 0 to 5 (IQR, 4-7) for J-CTO score of 5 (P<.001). Antegrade-only procedures had higher technical (90% vs 79%; P<.001) and procedural success (89% vs 77%; P<.001) compared with retrograde procedures. In antegrade-only cases, Pilot 200 (28%; Abbott Vascular) and Fielder XT (24%; Asahi Intecc) were the most frequently used guidewires, while Corsair (21%; Asahi Intecc) and Turnpike Spiral (20%; Vascular Solutions) were the most commonly used microcatheters. In retrograde cases, Sion (32%; Asahi Intecc) was the most common guidewire used, followed by Sion Black (22%; Asahi Intecc), Pilot 200 (22%), and Suoh 03 (19%; Asahi Intecc), while Corsair (16%) and Turnpike LP (11%) were the most commonly used microcatheters. The most successful guidewire for collateral crossing was the Sion (32%), followed by Sion Black (15%) and Suoh 03 (11%). Conclusion. Polymer-jacketed guidewires are the most commonly used guidewires for antegrade wiring, while non-polymer-jacketed, torquable guidewires are the most frequently used guidewires for retrograde techniques. Turnpike and Corsair are the most commonly used microcatheters in CTO-PCI.

J INVASIVE CARDIOL 2023;35(2):E61-E69.

Key words: chronic total occlusion, equipment, guidewire, microcatheter, percutaneous coronary intervention


Chronic total occlusion (CTO) lesions have been associated with relatively low procedural success rates, reflecting the high complexity of those lesions.1-4 However, advances in guidewire and microcatheter technology and the evolution of crossing techniques have increased the success and efficiency of CTO percutaneous coronary intervention (PCI) in recent years.5-8 We examined a contemporary international multicenter registry to determine guidewire and microcatheter utilization patterns in CTO-PCI over time.

Methods

We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 11,202 CTO-PCIs performed in 10,952 patients between 2012 and 2022 at 42 United States (US) and non-US centers. Data collection was recorded in a dedicated online database (PROGRESS CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; Clinicaltrials.gov identifier, NCT02061436). Study data were collected and managed using REDCap (Research Electronic Data Capture) electronic data-capture tools hosted at the Minneapolis Heart Institute Foundation.9,10 The study was approved by the institutional review board of each center.

Coronary CTOs were defined as coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3-month duration. Estimation of the duration of occlusion was clinical, based on the first onset of angina, prior history of myocardial infarction (MI) in the target-vessel territory, or comparison with a prior angiogram. A procedure was defined as retrograde if an attempt was made to cross the lesion through a collateral vessel or bypass graft supplying the target vessel distal to the lesion. Technical success was defined as successful CTO revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow. Procedural success was defined as the achievement of technical success without any in-hospital major adverse cardiac event (MACE). In-hospital MACE included any of the following adverse events prior to hospital discharge: death; MI; recurrent symptoms requiring urgent repeat target-vessel revascularization with PCI or coronary artery bypass graft (CABG) surgery; tamponade requiring either pericardiocentesis or surgery; and stroke. MI was defined using the Third Universal Definition of Myocardial Infarction (type 4a MI).11 The Japanese CTO (J-CTO) score was calculated as described by Morino et al,12 the PROGRESS-CTO score as described by Christopoulos et al,13 and the PROGRESS-CTO MACE score as described by Simsek et al.14

Categorical variables were expressed as percentages and were compared using the Pearson’s Chi-square test. Continuous variables are presented as mean ± standard deviation or as median (interquartile range [IQR]) unless otherwise specified and were compared using the Student’s t test for normally distributed variables and the Wilcoxon rank-sum test for non-parametric variables, as appropriate. Temporal trends were tested for significance with linear contrast analysis (for continuous variables) and with the Cochran-Armitage test (for categorical variables). All statistical analyses were performed using JMP, version 16.0 (SAS Institute). A P-value of <.05 was considered to indicate statistical significance.

Results

Of the 11,202 CTO-PCIs attempted in 10,952 patients, antegrade-only crossing was performed in 7628 CTO-PCIs (68%) and the retrograde approach was used in 3574 CTO-PCIs (32%). The clinical and angiographic characteristics and procedural outcomes of the study patients are presented in Table 1 and Table 2, respectively.

The mean patient age was 64 ± 10 years and 81% were men. The prevalence of diabetes, hypertension, dyslipidemia, congestive heart failure, prior MI, prior PCI, and prior CABG was high.

The right coronary artery was the most common target vessel overall (53%), followed by the left anterior descending artery (26%) and the left circumflex (19%). Lesions in the retrograde group were longer (30 mm [IQR, 22-50] vs 20 mm [IQR, 15-30]; P<.001) and more likely to have unfavorable characteristics, such as a side branch at the proximal cap, a blunt or stumpless proximal cap, moderate or severe calcification, and/or moderate or severe proximal tortuosity. The mean J-CTO score was 2.4 ± 1.3 and was higher among retrograde cases compared with antegrade-only cases (3.1 ± 1.1 vs 2.0 ± 1.2; P<.001). The mean PROGRESS-CTO MACE score was 2.4 ± 1.6 and was also higher among retrograde cases compared with antegrade-only cases (3.9 ± 1.2 vs 1.7 ± 1.3; P<.001).

Technical and procedural success were 86% and 85%, respectively. Antegrade-only procedures had higher technical success (90% vs 79%; P<.001) and procedural success (89% vs 77%; P<.001) compared with retrograde procedures. Retrograde CTO-PCIs required longer procedure time and fluoroscopy time, higher air kerma radiation dose, and more contrast volume. The overall incidence of MACE was 2% and was higher in the retrograde group (3.5% vs 1.3%; P<.001).

The median number of guidewires used during antegrade wiring increased with lesion complexity from 3 (IQR, 2-4) for J-CTO score of 0 to 5 (IQR, 4-7) for J-CTO score of 5 (P<.001) (Figure 1A). In antegrade-only cases, Pilot 200 (28%; Abbott Vascular), Fielder XT (24%; Asahi Intecc), and Gaia second (13%; Asahi Intecc) were the most frequently used guidewires (Figure 2A). Compared with 2017-2019, the use of the Pilot 200, Fielder XT, Gaia second, and Gaia third guidewires (Asahi Intecc) decreased, with an increase in the use of the Gladius Mongo (Asahi Intecc) from 4% in 2017-2019 to 22% in 2020-2022 (Table 3 and Figure 2B). The guidewires most frequently used to successfully cross the lesion during antegrade wiring were the Pilot 200 (16%), Fielder XT (12%), and Fielder XT-A (7%; Asahi Intecc).

The most commonly used microcatheters for antegrade-only cases were the Corsair (21%; Asahi Intecc) and Turnpike Spiral (20%; Vascular Solutions) (Figure 2C). The use of Turnpike (Vascular Solutions) and Turnpike Spiral microcatheters decreased over time, whereas the use of Finecross (Terumo) increased (Table 3 and Figure 2D).

The median number of guidewires used during the retrograde approach increased with lesion complexity from 6 (IQR, 4-10) for J-CTO score of 0 to 10 (IQR, 8-13) for J-CTO score of 5 (P<.001) (Figure 1B). In retrograde cases, Sion (32%; Asahi Intecc) was the most commonly used guidewire, followed by Sion Black (22%; Asahi Intecc), Pilot 200 (22%), and Suoh 03 (19%; Asahi Intecc) (Figure 3A). The use of Sion Black increased from 19% in 2017-2019 to 43% in 2020-2022, with a similar increase in the use of the Gladius Mongo guidewire (from 8% to 30%) during the same time period (Table 3 and Figure 3B). The retrograde guidewires that most often successfully crossed the CTO lesion were the Pilot 200 (17%), Gaia third (13%), and Gladius Mongo (10%). The most successful guidewires for collateral crossing were the Sion (32%), followed by the Sion Black (15%) and Suoh 03 (11%).

The most frequently used microcatheters for retrograde cases were the Corsair (16%) and the Turnpike LP (11%; Vascular Solutions) (Figure 3C). The use of Corsair and Turnpike LP microcatheters decreased over time, whereas the use of Corsair Pro XS (Asahi Intecc) increased (Table 3 and Figure 3D). In retrograde cases with successful microcatheter collateral crossing, the microcatheters that more commonly crossed the collateral were the Corsair (36%), Turnpike LP (25%), and Caravel (13%; Asahi Intecc).

Kostantinis Equipment Utilization in CTO-PCI Fig 1
Figure 1. Median number of guidewires used according to J-CTO score for (A) antegrade-only approach and (B) retrograde approach.
Kostantinis Equipment Utilization in CTO-PCI Fig 2
Figure 2. (A) Most commonly used guidewires for antegrade wiring. (B) Temporal trends on guidewires for antegrade wiring. (C) Most commonly used microcatheters for antegrade wiring. (D) Temporal trends on microcatheters for antegrade wiring.
Kostantinis Equipment Utilization in CTO-PCI Fig 3
Figure 3. (A) Most commonly used guidewires for retrograde approach. (B) Temporal trends on guidewires for retrograde approach. (C) Most commonly used microcatheters for retrograde approach. (D) Temporal trends on microcatheters for retrograde approach.
Kostantinis Equipment Utilization in CTO-PCI Tab 1
Table 1.
Kostantinis Equipment Utilization in CTO-PCI Tab 2
Table 2.
Kostantinis Equipment Utilization in CTO-PCI Tab 3
Table 3.

Discussion

The main findings of our study are the following: (1) higher lesion complexity is associated with use of more guidewire types; (2) polymer-jacketed guidewires are the most commonly used guidewires for antegrade wiring, with an increase in the use of the Gladius Mongo over time; (3) non-polymer-jacketed torquable guidewires are the most commonly used guidewires for retrograde techniques, with an increase in the use of Sion Black, Suoh 03, and Gladius Mongo over time; and (4) torquable microcatheters are the most commonly used microcatheters in CTO-PCI.

Outcomes of CTO-PCI have improved, likely due to advancements in equipment and techniques as well as due to increasing operator expertise.5,6 As previously described, antegrade wiring is the most widely used CTO crossing technique, whereas retrograde and antegrade dissection and re-entry are often required for more complex CTOs.15-17 In our study, high lesion complexity (higher J-CTO score) was associated with the utilization of more guidewire types in both antegrade and retrograde cases.

Guidewire choice for antegrade crossing depends on proximal cap morphology.18,19 For tapered proximal caps, most operators recommend the use of a polymer-jacketed, low penetration force, tapered guidewires, such as the Fielder XT, with subsequent escalation to polymer-jacketed guidewires with higher penetration force.18,19 If there is a blunt proximal cap, the use of stiff, intermediate, or high-penetration-force guidewires (such as the Pilot 200 and Gladius Mongo) or a composite-core guidewire (such as the Gaia series) may be required for antegrade wiring.18,19 However, after proximal cap crossing, de-escalation to less-penetrating guidewires is recommended to minimize the risk for distal vessel injury.20,21 In our study, Pilot 200 (28%), Fielder XT (24%), and Gaia second (13%) were the most frequently used guidewires for antegrade wiring.

The retrograde crossing strategy differs from the standard antegrade approach in that the lesion is approached from the distal vessel with a guidewire advanced through either a bypass graft or through a collateral channel (septal or epicardial), followed by placement of a microcatheter at the distal CTO cap.22-25 In our study, Sion (32%) was the most commonly used guidewire for collateral crossing, whereas final retrograde crossing was more frequently achieved with the Pilot 200 wire (17%) and the Gaia third wire (13%). The Sion wire, which is highly torquable, soft, and has excellent shape, can facilitate collateral crossing, but a stiffer wire is often needed for crossing the CTO lesion.20,21 In our study, the use of Sion Black (soft, polymer-jacketed wire), Gladius Mongo (stiff, polymer-jacketed wire), and the Suoh 03 (very soft tip for epicardial collaterals) for retrograde approach increased over time (Table 3 and Figure 3B).

The use of a microcatheter significantly increases the success and efficiency of CTO-PCI and should be routinely used for enabling easy guidewire exchange, supporting the guidewire, and increasing the penetrating power of the guidewire during both antegrade and retrograde wire manipulation.18,19 As compared with over-the-wire balloons, microcatheters have a flexible tip to increase penetrability, a wider lumen to help with wire manipulation, and a radio-opaque marker at the tip allowing better assessment of distance of the CTO lesion from the microcatheter.20,26

In our study, the most commonly used microcatheters for antegrade crossing were larger, torquable microcatheters, such as Corsair (21%) and Turnpike Spiral (20%). These microcatheters have a braid/coil construction that provides flexibility and facilitates torque transmission.21,27

In retrograde cases with successful microcatheter collateral crossing, the microcatheters that most commonly crossed the collateral were the Corsair (36%), Turnpike LP (25%), and Caravel (13%). The Corsair microcatheter is a septal dilator useful for both antegrade but especially for retrograde CTO-PCI, while the Turnpike LP and Caravel are smaller microcatheters that facilitate advancement through small and tortuous collaterals.21,28 In our study, the use of Corsair Pro XS microcatheter for the retrograde approach increased over time (Table 3 and Figure 3D).

Study limitations. First, PROGRESS-CTO is an observational retrospective study without long-term follow-up for all patients. Second, there was no core-laboratory assessment of the study angiograms or clinical event adjudication. Third, we only recorded the total number of guidewires and the different guidewire types used, but not the actual number of guidewires per type of guidewire or the sequence of guidewire use. Fourth, the use of various guidewires and microcatheters was at the discretion of the operator; thus, selection bias may be present. Fifth, the procedures were performed at dedicated, high-volume CTO centers by skilled and experienced operators, and these results may not be reproducible by less-experienced operators, limiting the generalizability of our findings to centers with limited CTO-PCI experience.

Conclusion

Higher lesion complexity is associated with the number of guidewire types used for both antegrade and retrograde crossing. Polymer-jacketed guidewires are the most commonly used guidewires for antegrade wiring, while torquable guidewires are the most frequently used guidewires for retrograde techniques. Torquable microcatheters are the most commonly used microcatheters in CTO-PCI. Over time, the types of wires and microcatheters have changed, with the introduction of new equipment.

Acknowledgments. The authors are grateful for the philanthropic support of our generous anonymous donors, and the philanthropic support of Drs Mary Ann and Donald A. Sens, Mrs Diane and Dr Cline Hickok, Mrs Wilma and Mr Dale Johnson, Mrs Charlotte and Mr Jerry Golinvaux Family Fund, the Roehl Family Foundation, and the Joseph Durda Foundation. The generous gifts of these donors to the Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease (CCAD) helped support this research project.

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From 1Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota; 2Henry Ford Cardiovascular Division, Detroit, Michigan; 3Massachusetts General Hospital, Boston, Massachusetts; 4Cleveland Clinic, Cleveland, Ohio; 5University Hospitals, Case Western Reserve University, Cleveland, Ohio; 6Wellspan York Hospital, York, Pennsylvania; 7Emory University Hospital Midtown, Atlanta, Georgia; 8Texas Health Presbyterian Hospital, Dallas, Texas; 9UCSD Medical Center, La Jolla, California; 10Red Cross Hospital of Athens, Athens, Greece; 11Biruni University Medical School, Istanbul, Turkey; 12Tristar Centennial Medical Center, Nashville, Tennessee; 13Saint Thomas Heart Hospital, Nashville, Tennessee; 14St Boniface General Hospital, Winnipeg, Manitoba, Canada; 15North Oaks Health System, Hammond, Louisiana; 16Memorial Bahcelievler Hospital, Istanbul, Turkey; and 17Aswan Heart Center, Magdi Yacoub Foundation, Cairo, Egypt.

Study data were collected and managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at the Minneapolis Heart Institute Foundation (MHIF), Minneapolis, Minnesota.9,10 REDCap is a secure, web-based application designed to support data capture for research studies, providing: (1) an intuitive interface for validated data entry; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for importing data from external sources.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Alaswad reports consultant and speaker for Boston Scientific, Abbott Cardiovascular, Teleflex, and CSI. Dr Jaffer reports sponsored research by Canon, Siemens, Shockwave, Teleflex, Mercator, Boston Scientific; consultant for Boston Scientific, Siemens, Magenta Medical, IMDS, Asahi Intecc, Biotronik, Philips, Intravascular Imaging; equity interest in Intravascular Imaging, Inc, DurVena; licensing arrangements between Massachusetts General Hospital and Terumo, Canon, and Spectrawave, for which he has the right to receive royalties. Dr Khatri reports personal honoria for proctoring and speaking from Abbott Vascular, Asahi Intecc, Terumo, and Boston Scientific. Dr Poommipanit reports consultant fees from Asahi Intecc and Abbott Vascular. Dr Davies reports speaking honoraria from Abiomed, Asahi Intecc, Boston Scientific, Medtronic, Siemens Healthineers, and Shockwave. Dr Rinfret reports consultant work for Abbott Vascular, Abiomed, Boston Scientific, SoundBite Medical, Teleflex. Dr Nicholson reports proctor fees and speakers’ bureau and advisory board income from Abbott Vascular, Boston Scientific, and Asahi Intecc; intellectual property with Vascular Solutions. Dr Jaber reports proctoring and/or consulting fees from Abbott and Medtronic. Dr Patel reports consulting honoraria from Abbott, Medtronic, Terumo, Cardiovascular Systems, Inc. Dr Kerrigan reports income from Abiomed, Asahi Intecc, Biotronik, Cordis, iSchemaView, Inc, Osprey Medical, Penumbra, Philips, and Teleflex. Dr Abi-Rafeh reports proctor and speaker honoraria from Boston Scientific and Abbott Vascular. Dr ElGuindy reports consulting honoraria from Medtronic, Boston Scientific, Asahi Intecc, Abbott; proctorship fees from Medtronic, Boston Scientific, Asahi Intecc, Terumo; educational grants from Medtronic. Dr Sandoval previously served on the advisory boards for Roche Diagnostics and Abbott Diagnostics without personal compensation and has also been a speaker without personal financial compensation for Abbott Diagnostics. Dr Burke reports consulting and speaker honoraria from Abbott Vascular and Boston Scientific. Dr Brilakis reports consulting/speaker honoraria from Abbott Vascular, American Heart Association (Associate Editor, Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Elsevier, GE Healthcare, IMDS, InfraRedx, Medicure, Medtronic, Opsens, Siemens, and Teleflex; research support from Boston Scientific, GE Healthcare; owner of Hippocrates, LLC; shareholder in MHI Ventures, Cleerly Health, and Stallion Medical. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted November 18, 2022.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Director of the Center for Complex Coronary Interventions, Minneapolis Heart Institute, Chairman of the Center for Coronary Artery Disease at the Minneapolis Heart Institute Foundation, 920 E 28th Street #300, Minneapolis, MN 55407. Email: esbrilakis@gmail.com


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