Introduction

Transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis. With the expansion of its indications to include low-risk and intermediate-risk patients,^1,2 TAVR procedural volumes have surged, significantly surpassing surgical aortic valve replacements.³ The increasing demand for TAVR has posed major challenges to the accessibility of the procedure, exerting substantial pressure on the health care system.⁴ To address TAVR accessibility issues, there is a growing call to expand its availability to facilities without onsite cardiac surgery (CS) capabilities. Proponents of this proposal underscore the reduced complications from TAVR requiring cardiac surgery and the established risk of death in the waiting period before the procedure.

European and American guidelines strongly advocate for onsite CS before performing TAVR.^1,2 These guidelines emphasize that onsite CS further facilitates patient-centered evaluation through a multidisciplinary heart team. There are also several other compelling reasons supporting this recommendation:

First, in randomized trials that demonstrated TAVR's noninferiority to surgery, nearly all TAVR procedures were done in centers with onsite CS, following a thorough heart team assessment. Therefore, before considering the transition to non-onsite CS centers, it is imperative that new prospective studies, preferably randomized trials, establish the noninferiority of TAVR compared with surgery in this specific scenario. Meta-analyses of retrospective studies⁵ do not provide sufficiently solid evidence to support the expansion of TAVR to centers without onsite CS. This pooled analysis cited in support of allowing TAVR without onsite CS has notable methodological concerns: it consists of a few retrospective studies with many patients receiving TAVR a decade ago, lacks individual patient data, has a limited sample size, and the outcomes were not assessed using VARC-2 (Valve Academic Research Consortium-2) criteria.⁶

Second, although the risk of severe complications, including those needing urgent surgery post-TAVR, has decreased over time, drawing simple parallels between TAVR-related and percutaneous coronary interventions (PCI)-related complication is misleading.^7,8 Indeed, major complications requiring surgical salvage after TAVR remain more frequent (1% to 4% vs <1%), and are more fatal than those associated with PCI.^7,9 Importantly, the success of these emergent surgeries relies on timely interventions and surgical team expertise.⁷ Although inoperable patients might not undergo emergent surgery due to concerns about the potential futility of the procedure, in the case of low-intermediate risk patients, most complications are potentially eligible for surgical correction with a 1-year survival as high as 87%.¹⁰

Third, even more critical than addressing periprocedural complications is the pivotal role of the cardiac surgeon within the heart team throughout the evaluation and selection of candidates and procedural planning for TAVR. In particular, when considering younger patients for TAVR, the discussion becomes more complex, involving considerations of the lifetime management strategy and the optimal timing for TAVR or surgery. Such discussions should be carefully deliberated among the heart team members, including imaging experts, anesthesiologists, and other specialists with expertise in heart valve surgery, and shared with the patient to align the decision with their preferences. The intricacies of this process especially apply to patients with concomitant coronary artery disease, anatomical risk factors, multivalve disease, and valve-in-valve procedures. The expertise required to ensure the highest quality of care cannot be certain at this time in centers without onsite CS, where patients with heart valve disease are relatively uncommon compared with those with heart failure or coronary artery disease. Indeed, in previous studies, patients who underwent TAVR in non-onsite CS centers had more comorbidities and advanced heart disease than those undergoing intervention in centers with surgical backup.^9,11 This raises concerns regarding the accuracy of the selection process and the risk of futile procedures.

Fourth, the outcomes of TAVR are closely linked to the volume of procedures performed by operators and centers.¹² It is noteworthy that only 14% of hospitals without onsite cardiac surgery had a TAVR volume exceeding 50 cases per year in previous studies.¹² Additionally, TAVR centers have already developed their expertise in patient screening and procedural techniques, which can be challenging to replicate in centers with lower procedural volume. Thus, expanding TAVR to centers without surgical backup might lead to more TAVR procedures performed at low-volume centers with limited experience. Current recommendations emphasize the need to maintain adequate procedural volume to optimize TAVR outcomes.²

Fifth, extending TAVR to centers without surgical backup will not fully address waiting list issues. Although limited access to high-volume centers with onsite CS partly drives the growing waitlist, health care system–imposed TAVR procedure limits, like in the United Kingdom, play a larger role.^4,13,14

There are other strategies that could address waiting list issues while maintaining established optimal patient care:

First, embracing the minimalist approach for TAVR—full percutaneous access, local anesthesia or conscious sedation rather than general anesthesia, single femoral arterial access, left ventricular pacing rather than separate transvenous pacing, and limited or no use of the intensive care unit.^15,16 This approach reduces length of stay, allows same-day discharge for some patients, and maximizes TAVR centers’ capacity.¹⁷ Second, early diagnosis and prompt intervention in TAVR patients can reduce waiting list impact on the acuity of clinical presentation of aortic stenosis. Delays lead to worsened clinical presentations, extended hospital stays, and increased resource use.¹⁸ Educational campaigns for general physicians, encouraging heart auscultation at every visit, and promoting patient education for prompt consultation in the presence of symptoms might lead to earlier patient referrals. Lastly, streamlining access to initial TAVR evaluations at referral centers without surgical backup, with results shared virtually with experts at TAVR sites, may further lower the wait time for the procedure.¹⁹ These strategies could effectively meet the increasing demand, allowing centers to accommodate a growing volume of TAVR procedures and reduce waiting lists without compromising the safety of the procedure as well as maintaining high standards of care.²⁰

We recognize the potential value in considering the expansion of TAVR to select centers without onsite CS, especially for patients in remote areas with limited access to heart valve centers and deemed unsuitable for surgery by the heart team. However, this possibility needs to be assessed in adequately powered prospective clinical trials.

In conclusion, specialized heart valve centers with onsite CS provide the highest quality of care for patients undergoing TAVR, offering not only excellent management of potential life-threatening complications, but also optimal patients evaluation and selection, comprehensive procedural planning, expert intraprocedural management, and thorough postprocedural care. Adopting a simplistic approach to TAVR without considering the potential risks and complexities associated with TAVR without surgical backup could lead to poorer outcomes and jeopardize the ongoing success of this revolutionary procedure.

Footnotes