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Coronary Revascularization Before Transcatheter Aortic Valve Replacement: It Is Safe, But Is It Necessary? Free Access

Editorial Comment

J Am Coll Cardiol Intv, 13 (22) 2614–2616
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Introduction

The prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis varies widely, from 80% in extreme high-risk trials to only 15% in more recent low-risk trials (1–3). Given the higher risk of mortality in patients with CAD, guidelines suggest that revascularization with coronary artery bypass grafting be considered in patients undergoing surgical aortic valve replacement (4). Therefore, it is not surprising that the early trials of transcatheter aortic valve replacement (TAVR) required coronary angiography before consideration of TAVR, and percutaneous coronary intervention (PCI) of proximal and mid lesions in major coronary arteries was strongly recommended.

In this issue of JACC: Cardiovascular Interventions, Faroux et al. (5) reported a series of 1,197 patients (1,705 lesions) with a mean age of 81 years treated with PCI during the TAVR workup. Ninety-four percent of PCIs were performed before TAVR, at a median of 41 days, and 5.6% were performed at the time of TAVR. One-half of the patients had multivessel disease, and lesion morphology was often complex; 50% of the lesions were calcified, and 46% involved bifurcations. Despite an advanced mean age of 81 years and complexity of disease, PCI success was achieved in 97%. At a median 2-year follow-up, target vessel failure occurred in only 3.3% and was predicted by baseline comorbidities and incomplete revascularization. Higher than expected use of bare-metal stents suggests operators did not want to use prolonged dual antiplatelet therapy and may have stopped dual antiplatelet therapy before TAVR in the early experience, given the higher rate of vascular and bleeding complications. Or perhaps the fact that patients were enrolled starting in 2007 reflects the drug-eluting stent thrombosis scare that occurred at the time this registry began. Importantly, stent thrombosis occurred in only 5 patients (0.4%) at a median of 48 days post-TAVR, and clinically apparent restenosis was infrequent at 2.3%. However, overall major adverse cardiac and cardiovascular events occurred in about one-third of patients, with acute coronary syndrome in 8.4% and death in 28.7% (cardiac death in 8.8%) likely reflecting age and comorbidities.

Although the investigators state “these findings provide further reassuring information regarding the early safety of pre-TAVR PCI,” there were no data provided regarding rates of death, myocardial infarction (MI) or coronary artery bypass grafting after PCI. We assume these patients would not have made it into the TAVR registry, so this is a potential limitation of the registry. Despite this, the high success rates and low complication rates in high-risk patients are encouraging.

Therefore, PCI can be safely performed in the aortic stenosis patient, but is it necessary? Physicians initially had concerns about ischemia and cardiac collapse with the necessary rapid pacing, difficulty passing or deploying first-generation TAVR valves, vascular injury, and bleeding with large-bore access. Also, initial studies only enrolled elderly high-risk patients with a high prevalence of coronary disease, so it made sense to require angiography and revascularization. Moreover, it became readily apparent that cannulating coronary arteries through TAVR struts can make subsequent PCI challenging, particularly when using supra-annular valves or when a second valve was placed to treat aortic insufficiency (6). Thus, revascularization pre-TAVR made sense. With additional clinical experience and improvement in devices and techniques, the risks of acute ischemia and hemodynamic collapse while performing TAVR are now minimal in most cases. Coronary protection techniques including stenting of ostial left main and right coronary arteries and BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR) have been utilized to prevent potentially catastrophic peri-procedural complications in patients whose anatomy is at high risk for acute coronary obstruction with TAVR (7).

Whether PCI before TAVR offers clinical benefit in patients with CAD remains unclear. To date, there have been no randomized trials addressing this issue. A meta-analysis of 11 cohort studies enrolling 5,580 patients (mean age 82.4 years) found no difference in 30-day all-cause mortality (odds ratio [OR]: 1.30 [0.85 to 1.98]), stroke (OR: 0.7 [0.36 to 1.45]), MI (OR: 2.71 [0.55 to 12.23]), acute kidney injury (OR: 0.7 [0.46 to 1.06]), as well as no difference in 1-year all-cause mortality (OR: 1.19 [0.92 to 1.52]), in patients who underwent TAVR with and without PCI (8). However, as seen in many observational registries, sicker patients may have been treated, so potential benefits may not be apparent. But because we are now performing TAVR in intermediate- and low-risk patients that may live for several more decades, some have suggested that it is even more important to revascularize these patients before TAVR if coronary access is impeded by the transcatheter aortic valve.

However, in addition to development of techniques to improve acute ischemic complications, clinical experience with performing coronary angiography and interventions has grown significantly over the past decade. Techniques to improve success of cannulating coronary ostia and interventions have been refined, including using guide catheters with smaller curves (e.g., engaging the left coronary artery with a JL3 or EBU 3 from a radial approach or JL3.5/EBU 3.5 from a femoral approach), remote wiring and using guide extension catheters, and using the appropriate cells within the transcatheter valve (Figure 1) to access the coronary ostia (9).

Figure 1
Figure 1

Coronary Access With Self-Expanding Transcatheter Aortic Valve

Red dot represents the location of the coronary ostium in relation to the valve frame, and the red line represents the annular plane (9). The red x’s depict the closest diamonds that can be used to access the coronary ostium. An optimally positioned Evolut-R (Medtronic, Galway, Ireland) (A) would make coronary access potentially easier than one with a higher implant (B).

Whether revascularization before TAVR is necessary is still uncertain. Several trials addressing the use of intracoronary physiological testing in the aortic stenosis patient (Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation [NOTION-3]; NCT03058627; and Functional Assessment In TAVI [FAITAVI]; NCT03360591) or to determine the timing of revascularization (Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention [TAVI PCI]; NCT04310046) are planned. Unfortunately, these will not directly assess the clinical benefits of revascularization.

Our current state of abilities to perform PCI after TAVR is challenging, but promising. However, it is imperative that all interventionalists learn these adaptations to coronary angiography and interventions as more patients who are living longer after TAVR develop clinically significant CAD. These techniques are particularly important to know when patients with prior TAVR present with acute coronary syndromes, ST-segment elevation MI and cardiogenic shock in order to provide timely and life-saving care.

Author Relationship With Industry

Both authors have reported that they have no relationships relevant to the contents of this paper to disclose.

References

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Footnotes

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.