Equipment Entrapment/Loss During Chronic Total Occlusion Percutaneous Coronary Intervention

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Background. There is limited data on equipment loss or entrapment during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Methods. We analyzed the baseline clinical and angiographic characteristics and outcomes of equipment loss/entrapment at 43 US and non-US centers between 2017 and 2023.

Results. Equipment loss/entrapment was reported in 40 (0.4%) of 10 719 cases during the study period. These included guidewire entrapment/fracture (n = 21), microcatheter entrapment/fracture (n = 11), stent loss (n = 8) and balloon entrapment/fracture/rupture (n = 5). The equipment loss/entrapment cases were more likely to have moderate to severe calcification, longer lesion length, higher J-CTO and PROGRESS-CTO complications scores, and use of the retrograde approach compared with the remaining cases. Retrieval was attempted in 71.4% of the guidewire, 90.9% of the microcatheter, 100% of the stent loss, and 100% of the balloon cases, and was successful in 26.7%, 30.0%, 50%, and 40% of the cases, respectively.  Procedures complicated by equipment loss/entrapment had higher procedure and fluoroscopy time, contrast volume and patient air kerma radiation dose, lower procedural (60.0% vs 85.6%, P < .001) and technical (75.0% vs 86.8%, P = .05) success, and higher incidence of major adverse cardiac events (MACE) (17.5% vs 1.8%, P < .001), acute myocardial infarction (7.5% vs 0.4%, P < .001), emergency coronary artery bypass graft (2.5% vs 0.1%, P = .03), perforation (20.0% vs 4.9%, P < .001), and death (7.5% vs 0.4%, P < .001).

Conclusions. Equipment loss is a rare complication of CTO PCI; it is more common in complex CTOs and is associated with lower technical success and higher MACE.

Equipment loss and entrapment is a rare yet potentially life-threatening complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).^1-9 Retrieval attempts can lead to further complications.^10,11 Given the increasing complexity of CTO PCI cases,^12,13 operators need to be prepared to address this complication. Treatment depends on the type of equipment, its location, the angiographic characteristics of the lesion, and other procedural complications.^14-16 Various retrieval techniques have been reported in the literature that can be employed in such scenarios.^17-29 We analyzed a large, multicenter CTO PCI registry to determine the baseline characteristics and outcomes of CTO PCIs complicated by equipment loss/entrapment.

We investigated the baseline clinical and angiographic characteristics as well as procedural outcomes of CTO PCIs complicated by equipment loss at between 2017 and 2023 at 43 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). The management and collection of the study data was done through REDCap (Research Electronic Data Capture) electronic data capture tools hosted at the Minneapolis Heart Institute Foundation.30,31 Approval for the study was obtained from the institutional review board of each participating center.

Coronary CTOs were defined as coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow for a duration of at least 3 months. Estimation of the occlusion duration was clinically based on the first onset of angina, prior history of myocardial infarction (MI) in the target vessel territory, or comparison with a prior angiogram.

Assessment of calcification was performed through angiography; calcification was classified as mild (spots), moderate (involving ≤ 50% of the reference lesion diameter), or severe (> 50% of the reference lesion diameter).^32,33CTOs were defined based on the definition of CTO Academic Research Consortium: absence of antegrade flow through the lesion with a presumed or documented duration of at least 3 months.³⁴ Successful CTO revascularization with achievement of less than 30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow was considered technical success. The achievement of technical success without any in-hospital major adverse cardiac events (MACE) prior to hospital discharge was considered procedural success. In-hospital MACE included the following: 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).³⁵ The Japanese CTO (J-CTO) score was calculated according to the description by Morino et al,³⁶ the PROGRESS-CTO score according to Christopoulos et al,³⁷ the new PROGRESS-CTO complication scores (acute MI, MACE, mortality, and pericardiocentesis) according to Simsek et al,³⁸ and the PROGRESS-CTO perforation score according to Kostantinis et al.³⁹ To calculate the estimated glomerular filtration rate, the Modification of Diet in Renal Disease (MDRD) 4-variable equation was used: (estimated glomerular filtration rate [eGFR] = 175 × SerumCreatinine^−1.154 × age^−0.203 × 1.212 [if African American] × 0.742 [if female]).⁴⁰

Statistical analysis. 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) unless otherwise specified and were compared using the independent-samples t-test for normally distributed variables and the Mann-Whitney U test for non-parametric variables, as appropriate.

To address potential confounding factors, we conducted propensity score matching analysis. The analysis included a comprehensive set of 23 variables, encompassing baseline clinical (age, gender, diabetes mellitus, dyslipidemia, smoking, hypertension, family history of premature coronary artery disease, prior PCI, prior CABG, prior MI, congestive heart failure, cerebrovascular disease, peripheral arterial disease) and angiographic (target vessel, proximal cap ambiguity, good distal landing zone, vessel diameter, lesion length, side branch at proximal cap, distal cap at bifurcation, interventional collaterals, moderate/severe calcification, and moderate/severe tortuosity) parameters. The missing values for those 25 variables were 6.9%. To create and analyze 5 multiply imputed datasets, multiple imputation was used. Using the default settings of the mice 3.15.0 package, incomplete variables were imputed under fully conditional specification.⁴¹

The Within approach was used for propensity score matching, as this approach has been shown to introduce less bias than the Across approach.⁴² The optimal pair matching method was employed, with a matching ratio of 1:20. Covariate balance in matched groups was assessed using standardized difference, which was less than 0.1 for all covariates. In each of the imputed results, logistic regression analysis was performed to evaluate the effect of the equipment entrapment/loss on technical success and MACE, and the pool() function of the mice package was used to pool the results.

All statistical analyses were performed using R Statistical Software, version 4.2.2 (R Foundation for Statistical Computing). A P-value less than .05 was considered statistically significant.

Of 10 719 CTO PCIs performed between 2017 and 2023 in the PROGRESS-CTO registry, 40 (0.4%) were complicated by equipment loss/entrapment: 21 guidewire entrapment/fractures, 11 microcatheter entrapment/fractures, 8 stent losses, and 5 balloon entrapments/fractures/ruptures (Figure 1).

The baseline clinical and angiographic characteristics of the equipment loss/entrapment cases are shown in Table 1. They all had similar baseline characteristics, except for higher prevalence of prior MI, and were more likely to be men. Table 2 shows the angiographic characteristics of the study lesions. CTOs complicated by equipment loss/entrapment were more likely to have moderate to severe calcification and had larger lesion diameter and higher J-CTO and PROGRESS-CTO complications scores.

The procedural techniques used for CTO PCIs complicated by equipment loss/entrapment are shown in Table 3. Equipment loss/entrapment cases more often required retrograde crossing (65.0% vs 29.0%, P < .001); they also required more stents, and higher procedure and fluoroscopy time, contrast volume, and air kerma radiation dose.  

Guidewire entrapment/fracture. Table 4 describes 21 cases with guidewire-related complications (entrapment [n = 4], fracture [n = 7], entrapment and fracture [n = 10]). The most common causes of guidewire entrapment or fracture were aggressive pulling of the entrapped guidewire, guidewire over-rotation, severe lesion calcification, guidewire deformation, atherectomy over a kinked guidewire, and guidewire jailing during stenting. Retrieval was attempted in 71.4% of the cases and was successful in 26.7% (Figure 2). Retrieval techniques used for guidewire entrapment or fracture were forceful pulling, snaring, guidewire twirling, advancement of balloon/guide extension over the entrapped guidewire, and balloon inflation; the most used technique was the advancement of a microcatheter over the entrapped guidewire. Technical success was achieved in 12 cases (57.2%), while complications included 3 cases with perforation, one with acute MI, and one with unplanned revascularization, and 3 cases resulted in death (2 of these cases led to emergency surgery/CABG and 1 required pericardiocentesis).

Microcatheter entrapment/fracture. Table 5 describes 11 cases with microcatheter-related complications (fracture [n = 8], entrapment and fracture [n = 3]). The main causes of microcatheter entrapment/fracture were microcatheter over-rotation and coronary calcification. Retrieval was attempted in 90.9% and was successful in 30.0% (Figure 2). Snaring and wiring around microcatheter and balloon inflation were the retrieval techniques used. Technical success was achieved in 10 cases (90.9%); one case required pericardiocentesis, and one each was complicated by acute MI, perforation, access complications, and bleeding.

Stent loss. Eight cases of stent loss are described in Table 6. Stent loss was mainly caused by poor vessel preparation prior to attempting stent delivery, forceful withdrawal of the stent inside the guide catheter, coronary tortuosity and calcification, attempting to deliver equipment via a collateral during the retrograde approach, and stent advancement through a previously deployed stent. Retrieval was attempted in all (100%) stent loss cases and was successful in 50% (Figure 3).  The main retrieval techniques used were snaring, guidewire twirling, and the small balloon technique. Technical success was achieved in 7 cases (87.5%), while 5 cases also had perforation, of which 2 resulted in acute MI; 1 was also complicated by access site injury and bleeding.

Balloon entrapment/fracture/rupture. Table 6 presents the 5 cases with balloon-related complications (balloon shaft fracture, balloon rupture, and lithotripsy balloon entrapment). Retrieval was attempted in 100% of the balloon cases and was successful in 40% (Figure 3).  Snaring and wiring next to the entrapped balloon and balloon inflation were the retrieval techniques used. All cases were technically successful, but one patient required emergency cardiac surgery, one had acute MI, one had perforation, and one had access site injury and bleeding.

Overall outcomes. The in-hospital outcomes of CTO PCIs complicated by equipment loss or entrapment are shown in Figure 1. Compared with the remaining cases, equipment loss/entrapment cases had lower technical (75.0% vs 86.8%, P = .05) and procedural (60.0% vs 85.6%, P < .001) success, and higher incidence of MACE (17.5% vs 1.8%, P < .001), in-hospital mortality (7.5% vs 0.4%, P < .001), acute MI (7.5% vs 0.4%, P < .001), emergency CABG (2.5% vs 0.1%, P = .03), and perforation (20.0% vs 4.9%, P < .001) (Table 7).  In propensity score analysis that matched patients using 23 variables, equipment entrapment/loss was associated with similar technical success (OR: 0.51, 95% CI: 0.23-1.15, P = .10) but higher in-hospital MACE (OR: 11.6, 95% CI: 3.36-40.04, P < .001).

The major findings of our study regarding equipment entrapment or loss during CTO PCI are as follows:

1. Equipment entrapment/loss is infrequent (0.4% of all CTO PCI cases),
2. Equipment entrapment/loss is more likely to occur in complex CTOs and when retrograde crossing is used,
3. Equipment retrieval is attempted in most (84.4%) but is successful in few (36.8%) cases, and
4. Equipment entrapment/loss is associated with lower success and higher risk for in-hospital MACE.

In a study of 2361 CTO PCIs performed between 2015 and 2020, device entrapment occurred in 1.5% of the cases, with guidewires being the most commonly entrapped equipment.² A meta-nalysis of 3482 patients from 26 studies reported 1.2% incidence of wire fracture and equipment entrapment in retrograde CTO PCI.⁴³ The EuroCTO club reported 0.6% risk of wire entrapment in 175 patients that were treated with the retrograde approach between 2005 and 2007.⁴⁴ Use of the retrograde approach was high in equipment loss/entrapment cases in our study: 65.0% vs 29.0%, P < .001. Although most studies have shown higher risk of complications with the retrograde approach,⁴⁵ Gasparini et al reported that the incidence of device entrapment did not significantly differ between antegrade and retrograde CTO PCI.²¹

Similar to prior studies, severe calcification is associated with higher risk of device entrapment or fracture, which is likely related to equipment deformation during advancement.^21,46-48 The combination of tortuosity and calcification may further increase the risk.

If a guidewire becomes entrapped, forceful withdrawal should be avoided, as it may lead to deformation or fracture that can be challenging to treat.^14,16 Instead, a microcatheter or balloon should be advanced over the entrapped guidewire before attempting withdrawal, as this maneuver increases and concentrates the pull force at the site of entrapment. Also, if the guidewire fractures, complete separation of the distal part (without wire unraveling) is more likely. Treatment of guidewire fracture depends upon the location of fracture and upon whether unraveling has occurred: if the remaining wire segment is entirely located within the coronary tree, it can often be covered with drug-eluting stents. If the wire fragment protrudes into the aorta or if unraveling occurs, surgical extraction may be required, even though it carries high mortality.¹⁴ Retrieval was successful in only 26.7% of cases in our study.

Microcatheter entrapment is uncommon but is more likely to occur in heavily calcified lesions and may lead to microcatheter tip fracture. Tip fracture is more common with certain microcatheters, such as the Caravel (Asahi), and less common with more supportive microcatheters, such as the Mamba and Mamba Flex (Boston Scientific),⁴⁹ that have an integrated tip (as opposed to being built separately and then glued together). The latter microcatheters are, therefore, preferred when treating heavily calcified and tortuous lesions. Microcatheter over-rotation should be avoided.^14,24 Technical success was high in cases of microcatheter entrapment or fracture (90.9%), while retrieval success was low (30.0%). Avoiding aggressive manipulation, especially when a lesion is highly calcified, could help prevent this complication. Five of 6 microcatheter entrapments in the study by Gasparini et al²¹ vs  4 of 11 in our study occurred during retrograde CTO PCI.

Stent loss is often due to poor lesion preparation and may occur during attempts to withdraw a stent inside the guide catheter or a guide catheter extension. The key question when stent loss occurs is whether to attempt retrieval or not. Deploying or crushing the lost stent within the coronary artery is often a faster and safer approach,¹⁴ although it might not always be possible (eg, in cases of stent-vessel mismatch or risk of side branch occlusion, respectively). Stent retrieval was attempted in all stent loss cases in our study and was successful in 50%. Retrieval attempts can sometimes lead to complications, such as dissection or perforation.⁵⁰ Sometimes the lost stent can be difficult to visualize; intravascular imaging may be helpful in these cases.¹⁵  In a metanalysis of 71 655 PCIs published between 1991 and 2012, stent loss occurred in 1.3% of cases, with 19% of these cases developing further complications.⁵¹

Like guidewire entrapment, balloon entrapment and fracture can sometimes require emergency surgery for removal, as it occurred with a lithotripsy balloon in 1 patient from our study. Gasparini et al described technical success in all 6 balloon entrapment cases in their study²¹ vs 2 successful cases out of 5 in our series. If the balloon shaft kinks during advancement, the balloon should be discarded and a new one used instead, as fracture can occur at the kink site. If balloon fracture occurs, further management depends upon whether a segment of the balloon is inside the guide catheter; if this is the case, then another balloon can be advanced alongside the balloon fragment and inflated at high pressure, followed by withdrawal of the guide along with the balloon fragment. Alternatively, a snare can be used for balloon fragment withdrawal.^52,53

The following measures may help reduce the risk of equipment loss/entrapment:

1. Refraining from direct stenting
2. Ensuring good vessel preparation prior to stent delivery
3. Avoiding forceful stent advancement
4. Minimizing balloon inflation pressure
5. Avoiding big and acute bends or loops during attempts for retrograde crossing of a collateral artery
6. Refraining from applying force when encountering resistance
7. Avoiding the use of small guide catheters when treating complex lesions
8. Refraining from orbital atherectomy within recently placed stents, 
9. Preventing interlocking of the antegrade microcatheter/balloon/stent with the retrograde microcatheter or balloon by maintaining a secure distance between them.¹⁴

In our study, cases complicated by equipment entrapment or loss had lower procedural (60.0% vs 85.6%, P < .001) and technical (75.0% vs 86.8%, P = .05) success and higher incidence of complications. In a study of 2361 CTO PCIs, 8.3% of the CTO PCIs that were complicated by device entrapment had intraprocedural MI, 2.8% developed tamponade requiring pericardiocentesis, and 2.8% required emergency surgery.² Therefore, equipment entrapment/loss carries a high risk for additional complications in both CTO and non-CTO PCI,^3,5,7,8 highlighting the importance of prevention.

Study limitations. The PROGRESS-CTO is an observational registry with all inherent limitations. The absence of independent adjudication for clinical events and the lack of core laboratory assessment for the study angiograms might have led to underreporting of equipment loss/entrapment. The low occurrence of equipment loss/entrapment may introduce a class imbalance, as non-events outnumber events by a high degree. The procedures reported in the registry were performed at centers with experienced CTO PCI operators, potentially limiting the generalizability of the results to centers with limited CTO PCI experience.

Equipment loss or entrapment is an infrequent complication of CTO PCIs that is associated with high rates of complications, including mortality. Prevention is key.

From the ¹Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; ²Texas Health Presbyterian Hospital, Dallas, Texas, USA; ³University Hospitals, Case Western Reserve University, Cleveland, Ohio, USA; ⁴Henry Ford Cardiovascular Division, Detroit, Michigan, USA; ⁵WellSpan York Hospital, York, Pennsylvania, USA; ⁶Massachusetts General Hospital, Boston, Massachusetts, USA; ⁷Oklahoma Heart Institute, Tulsa, Oklahoma, USA; ⁸Division of Cardiology, Department of Medicine, University of Washington, Seattle, Washington, USA; ⁹Selcuk University, Konya, Turkey; ¹⁰Medical Center of the Rockies, Loveland, Colorado, USA; ¹¹Tristar Hospitals, Tennessee, USA; ¹²Biruni University Medical School, Istanbul, Turkey; ¹³Cleveland Clinic, Cleveland, Ohio, USA; ¹⁴Meshalkin Novosibirsk Research Institute, Novosibirsk, Russia; ¹⁵St. Vincent Hospital, Indianapolis, Indiana, USA; ¹⁶St. Boniface General Hospital, Winnipeg, Manitoba, Canada.

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; the Joseph Durda Foundation; Ms. Marilyn and Mr. William Ryerse; Mr. Greg and Mrs. Rhoda Olsen. 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.

Disclosures: Dr Choi serves on the Medtronic advisory board. Dr. Poommipanit is a consultant for Asahi Intecc, and Abbott Vascular. Dr Alaswad is a consultant and speaker for Boston Scientific, Abbott Cardiovascular, Teleflex, and Cardiovascular Systems Inc. Dr Basir is a consultant for Abbott Vascular, Abiomed, Cardiovascular Systems, Inc (CSI), Chiesi, and Zoll. Dr Davies receives speaking honoraria from Abiomed, Asahi Intec, Boston Scientific, Medtronic, Teleflex, and Shockwave Medical, and serves on advisory boards for Abiomed, Avinger, Boston Scientific, Medtronic, and Rampart. Dr Jaffer has done sponsored research for Canon, Siemens, Shockwave, Teleflex, Mercator, and Boston Scientific; has been a consultant for Boston Scientific, Siemens, Magenta Medical, IMDS, Asahi Intecc, Biotronik, Philips, and Intravascular Imaging, Inc.; has equity interest in Intravascular Imaging Inc. and DurVena; and has the right to receive royalties through Massachusetts General Hospital licensing arrangements with Terumo, Canon, and Spectrawave. Dr Khatri has received personal honoraria for proctoring and speaking from Abbott Vascular, Medtronic, Terumo, and Shockwave Medical. Dr Azzalini received consulting fees from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, Reflow Medical, and Cardiovascular Systems, Inc. Dr Sandoval receives consulting/speaker honoraria from Abbott Diagnostics, Roche Diagnostics, Zoll, and Philips; is an associate editor for JACC Advances; and holds patent 20210401347. Dr Burke receives consulting and speaker honoraria from Abbott Vascular and Boston Scientific. Dr Brilakis receives consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor, Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, IMDS, Medicure, Medtronic, Siemens, Teleflex, and Terumo; research support from Boston Scientific, GE Healthcare; is the owner of Hippocrates LLC; and is a shareholder of MHI Ventures, Cleerly Health, and Stallion Medical.  The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute, 920 E 28th Street #300, Minneapolis, MN 55407, USA. Email: esbrilakis@gmail.com; X: @esbrilakis; @m1chaella_alex

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