New guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) have downgraded the use of embolic protection devices during saphenous vein graft intervention from Class I (should be used) to Class IIa (reasonable to use). Timir K Paul (Department of Internal Medicine, University of Tennessee at Nashville, Nashville, USA) discusses why he supports this change in recommendation.
The recently published ACC/AHA 2021 guidelines on coronary revascularisation have downgraded the recommendation on the use of embolic protection devices during saphenous vein graft intervention from Class I to Class IIa.1 This guideline update comes three years after the European Society of Cardiology (ESC) 2018 guidelines on revascularisation had updated with the same recommendations in this regard.2
This updated recommendation is based on three studies, arguably the most impactful of which was the meta-analysis published in Circulation: Cardiovascular Interventions, in which myself and colleagues demonstrated that the routine use of an embolic protection device during percutaneous coronary intervention (PCI) to a saphenous vein graft does not provide benefit in the contemporary interventional era and may even increase the risk of periprocedural myocardial infarction (MI).3 During an initial interview in Cardiovascular News in January 2018, I suggested that “until further evidence from randomised trials, current guideline recommendations on embolic protection devices during saphenous vein graft PCI would change to class IIa”. 4 During a later commentary in September 2018, I then proposed that the USA should follow Europe’s lead and change guidelines on embolic protection in saphenous vein graft intervention. 5
The 2011 ACC/AHA and older ESC guidelines give the use of embolic protection devices a class I indication for saphenous vein graft intervention when technically feasible.6 The guideline recommendations are based on only one randomised controlled trial that was published in 2002 and only has 30-day outcomes data.7 The embolic protection device that was used in this trial is not used anymore and there is no study comparing the current filter wire embolic protection device with control. Subsequently several studies published in this regard have shown conflicting results. A large National Cardiovascular Data Registry (NCDR) CathPCI registry showed no benefits in routine use of embolic protection devices during saphenous vein graft intervention, rather a slightly higher incidence of periprocedural complications noted in the embolic protection device group.8 Moreover, in the recent era, no-reflow and periprocedural MI during saphenous vein graft intervention has decreased likely due to the use of more potent pharmacotherapy and pre-treatment with dual antiplatelet therapy (DAPT), as well as less bulky and highly deliverable balloons and stents. Thus, the role of the routine use of embolic protection devices in saphenous vein graft intervention has been questioned in the contemporary era. Another observational registry study by Ahmad Shoaib et al, including 20,642 patients (n=17,730 without embolic protection devices, n=2,912 with embolic protection devices), revealed that embolic protection device use was associated with similar in-hospital, 30-day and one-year mortality and in-hospital major adverse cardiovascular events, but higher adjusted risk for the periprocedural no-reflow or slow-flow phenomenon.9
Reviewing results from eight studies, my colleagues and I identified 52,893 patients who had undergone saphenous vein graft intervention—of whom, 11,506 had undergone intervention with an embolic protection device and 41,387 had undergone intervention without embolic protection.3 There were no significant differences between the groups in the rate of all-cause mortality, major adverse cardiovascular events, target vessel revascularisation, late MI, or periprocedural MI. Surprisingly, when a fixed-effect model was used, contrary to the expected benefit of the use of embolic protection devices, was associated with 1.5-fold higher periprocedural MI (p<0.0001) compared with the use of no embolic protection device. This result questions the necessity of routine use of embolic protection devices during saphenous vein graft intervention as the main goal is to reduce no reflow and prevent periprocedural MI. The results of this study show no difference in clinical outcomes with or without embolic protection devices during saphenous vein graft PCI. The authors recommended that randomised controlled trials are needed in the current era to evaluate long-term outcomes with routine use of embolic protection devices and meanwhile, current guideline recommendations on embolic protection devices use should be revisited. However, I do not anticipate that there will be any randomised trials on embolic protection devices in the current era.
Regardless of embolic protection device use, the periprocedural events rate remained approximately 10% across the studies indicating that their use was not always successful. The use of embolic protection devices increases the procedure time and complexity and in approximately 50% of cases it cannot be used due to vessel size, anatomic location, and lesion complexity. Even if embolic protection devices can be used, it may not completely seal the distal vessel and can be unsuccessful in preventing distal embolisation. Additionally, embolic protection device use is associated with procedural complications including vessel perforation, dissection and device entrapment. Although there is no evidence from randomised trials, several simpler techniques such as direct stenting, under-sizing stents with higher stent/lesion length ratio, keeping higher activated clotting time and aggressive use of periprocedural microvascular vasodilator therapy has been proven beneficial in observational studies in preventing no reflow phenomenon without using embolic protection devices.
With the updated guidelines, physicians are not mandated to use embolic protection devices in saphenous vein graft intervention in every case. However, if the treating physician’s clinical judgement indicates that the use of an embolic protection device would be beneficial in certain cases then they should use it. Embolic protection devices in saphenous vein graft PCI can still be useful in selected higher risk patients. This guideline change would reduce significant healthcare costs due to shorter procedural time, reduced contrast volume, decreased procedural related complications and ultimately eliminating device related costs, as well as protecting physicians from unnecessary litigation. Despite these factors, it is likely that there will still be a lot of criticism on this guideline change from the operators who routinely use embolic protection devices in saphenous vein graft intervention.
References:
1) Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Dec 7:S0735-1097(21)06158-1. doi: 10.1016/j.jacc.2021.09.006. Epub ahead of print. PMID: 34895950.
2) 2018 ESC/EACTS Guidelines on myocardial revascularization. The Task Force on myocardial revascularization of the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal (2018) 00, 1–96. doi:10.1093/eurheartj/ehy394.
3) Paul TK, Bhatheja S, Panchal HB, Zheng S, Banerjee S, Rao SV, Guzman L, Beohar N, Zhao D, Mehran R, Mukherjee D. Outcomes of saphenous vein graft intervention with and without embolic protection device: A Comprehensive Review and Meta-Analysis. Circ Cardiovasc Interv. 2017;10:e005538. DOI: 10.1161/CIRCINTERVENTIONS.117.005538. PMID: 29246912.
4) BIBA Medical Staff. Cardiovascular News 2018. https://bit.ly/2zB5mux (date accessed 28 September 2018)
5) https://cardiovascularnews.com/the-us-should-follow-europes-lead-and-change-guidelines-on-embolic-protection-in-saphenous-vein-grafting/?hilite=timir+paul. Accessed January 2022.
6) Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK and Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124:e574-e651.
7) Baim DS, Wahr D, George B, Leon MB, Greenberg J, Cutlip DE, Kaya U, Popma JJ, Ho KKL, Kuntz RE and Investigators SvgAFoERST. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation. 2002;105:1285-90.
8) Brennan JM, Al-Hejily W, Dai D, Shaw RE, Trilesskaya M, Rao SV, Brilakis ES, Anstrom KJ, Messenger JC, Peterson ED, Douglas PS and Sketch MH. Three-Year Outcomes Associated With Embolic Protection in Saphenous Vein Graft Intervention: Results in 49 325 Senior Patients in the Medicare-Linked National Cardiovascular Data Registry CathPCI Registry. Circulation: Cardiovascular Interventions. 2015;8:e001403-e001403.
9) Shoaib A, Kinnaird T, Curzen N, Ludman P, Smith D, Khoo CW, Kontopantelis E, Rashid M, Mohamed M, Nolan J, Zaman A, Mamas MA; British Cardiovascular Intervention Society; National Institute for Cardiovascular Outcomes Research. Outcomes Following Percutaneous Coronary Intervention in Saphenous Vein Grafts With and Without Embolic Protection Devices. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2286-2295. doi: 10.1016/j.jcin.2019.08.037. PMID: 31753300.
