TAVR or SAVR First? A 62-Year-Old Man With Severe Aortic Stenosis

Both the recent European and American guidelines on the management of valvular heart disease emphasize patient age as a critical factor in selecting between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).^1,2 The American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend SAVR for young patients aged < 65 years or with a life expectancy > 20 years, while the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines suggest a threshold of < 75 years and low surgical risk for SAVR. Despite these recommendations, excellent clinical outcomes in the pivotal low-risk trials have led to the wider adoption of TAVR in younger and lower-risk patients,^3,4 and there has been a notable increase in TAVR utilization among individuals aged < 65 years, contrary to current guidelines. A 2015 to 2021 analysis stratifying therapies for isolated aortic stenosis (AS) according to guideline-recommended age groups found nearly equal use of TAVR and SAVR in younger patients aged < 65 years by 2021.⁵ Similarly, in a recent study of approximately 37,000 patients aged < 60 years undergoing aortic valve replacement from 2013 to 2021, the proportion of patients receiving TAVR increased significantly, with almost half opting for TAVR by 2021, compared to 22% during the study period.⁶

In the context of existing guidelines and emerging data, a hypothetical case of a 62-year-old man with severe AS raises the question of whether TAVR should be considered and reflects a broader trend where every patient with severe AS may potentially be offered or request TAVR.

THE LOW-RISK TRIAL PATIENT

Although evidence from randomized controlled trials (NOTION, PARTNER 3, Evolut Low Risk)^3,4,7 and nonrandomized prospective studies (LRT, LRT Bicuspid, Evolut Low Risk Bicuspid) suggest that TAVR has comparable outcomes to SAVR in low-risk patients,^8-10 it is important to note that these trials do not necessarily represent all-comer patients. They included highly selected patients who were at low risk for suboptimal outcomes after TAVR. Patients with certain high-risk features were excluded, such as those with complex coronary artery disease (multivessel disease or left main disease), mixed valve disease, severe left ventricular (LV) dysfunction (LV ejection fraction < 25%), hypertrophic obstructive cardiomyopathy, significant aortopathy requiring ascending aortic replacement, hemodynamic instability, and severe comorbidities (renal insufficiency, lung disease, liver disease, pulmonary hypertension), among others. Furthermore, around one-third of patients were rejected due to anatomic findings like unicuspid or bicuspid aortic valve anatomy, unsuitable aortic annulus dimensions, bulky calcified valve leaflets, prohibitive LV outflow tract (LVOT) calcification, porcelain aorta, and unfavorable femoral access. Patients in these trials had a mean age of 73 to 79 years^3,4,7 and few comorbidities, which may not reflect our 62-year-old patient. Considering the strict inclusion and exclusion criteria in randomized trials, extrapolating the results to younger patients is fraught with difficulty as those are not the patient populations that were studied.

TAVR OR SAVR FIRST?

Several clinical and anatomic considerations are critical when determining the suitability of TAVR versus SAVR. TAVR may be preferred over SAVR if the patient is at high surgical risk and has a short estimated life expectancy (< 15 years). In a 62-year-old patient at low surgical risk and an estimated life expectancy > 20 years, existing evidence suggests that SAVR would be the ideal first intervention if the following certain anatomic criteria are present, as these can significantly influence procedural success and long-term outcomes for both interventions.

Extreme Annular Dimensions

Large annuli outside instructions for use for commercially available transcatheter heart valves (THVs) can present challenges in achieving optimal THV sizing and performance. The feasibility of TAVR has been demonstrated in these patients,^11,12 but surgical options including stentless valve implantation offer more flexibility and should be the preferred option. Similarly, small annuli (with a THV prosthesis < 23 mm in diameter) are associated with an increased risk of severe prosthesis-patient mismatch, which independently predicts worse outcomes.¹³ TAVR explant is the only viable option for THV failure in these patients because redo TAVR does not address the underlying issue. If the estimated risk of prosthesis-patient mismatch is moderate to severe, SAVR with root enlargement should be preferred, with CT ­sizing further improving valve size selection and mitigating risk.¹⁴

Severe Annular and/or LVOT Calcification

This may pose challenges for TAVR, increasing risk of paravalvular leak (PVL) and/or annular rupture.^15,16 SAVR may be preferred in cases of extensive calcification to allow for thorough debridement and optimal prosthetic valve placement.

Noncalcified Aortic Valve

Commonly seen in younger patients with rheumatic AS, lack of calcification anchoring the THV may pose challenges for TAVR. Although dedicated THV platforms are currently being evaluated to address these challenges,¹⁷ SAVR should be preferred.

Bicuspid Aortic Valve

Frequently encountered in young AS patients, bicuspid aortic valve poses challenges for TAVR due to its unique morphology and associated aortopathy. Despite favorable outcomes for TAVR in selected patients with bicuspid AS in observational studies,^18-20 randomized trials comparing TAVR and SAVR are lacking. Careful patient selection is crucial and should consider factors such as calcified raphe and leaflet calcification, which may impact TAVR success. SAVR should be the preferred option, particularly with concomitant ­aortopathy that would warrant root replacement.

Lack of “Safe” Femoral Access

Recent low-risk trials have primarily focused on transfemoral candidates for TAVR,^3,4,7 with limited evidence for nontransfemoral TAVR. Although transfemoral access can be achieved in patients with suboptimal anatomy using techniques such as surgical cutdown and intravascular lithotripsy, SAVR should be preferred in such cases even if technically feasible.

Mixed Valve Disease

Mixed valve disease such as concomitant mitral stenosis and tricuspid regurgitation requires a comprehensive evaluation of each lesion that considers the severity, etiology, and hemodynamic consequences, as these may influence the choice and timing of intervention. Moderate or greater valvular dysfunction could warrant SAVR with concomitant valve surgery, but less severe dysfunction may be managed conservatively or addressed during a subsequent intervention, depending on the progression, clinical status, and surgical risk.

Complex Coronary Artery Disease

Complex coronary artery disease adds another layer of complexity and optimal revascularization strategies; either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) must be carefully considered in conjunction with aortic valve intervention to optimize outcomes. High SYNTAX scores, left main disease, or complex coronary lesions may favor SAVR with concomitant CABG to ensure complete revascularization and mitigate perioperative ischemic events. PCI can be considered if the patient has less extensive coronary artery disease or is at high surgical risk.

High Risk for Coronary Obstruction

With a low incidence (0.6%) and high mortality (40%-50% at 30 days) in native TAVR, coronary obstruction has been shown to be associated with low coronary artery height, narrow sinus width, cusp height greater than coronary height, virtual valve–to-coronary distance ≤ 4 mm, and culprit leaflet calcium volume.²¹ Risk mitigation strategies such as coronary protection and the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure have not yet been established in routine clinical practice,^22,23 and SAVR should be preferred when the risk of coronary obstruction is high.

LIFETIME MANAGEMENT CONSIDERATIONS

In addition to the previously mentioned factors, several considerations regarding lifetime management are becoming increasingly important and should be taken into account when determining the optimal first intervention in a 62-year-old patient with severe AS.

Current data comparing TAVR and SAVR are limited to 5 to 8 years,^7,24-29 leaving uncertainties about long-term outcomes such as mild PVL, conduction disturbances, and subclinical leaflet thrombosis. Although TAVR has seen improvements in outcomes compared to SAVR,^3,4,7 including reduced PVL rates, mild PVL remains a concern, especially in younger patients.^30,31 Similarly, new conduction disturbances are more common after TAVR, with conflicting evidence on their clinical impact.³² On the other hand, SAVR is associated with higher rates of postoperative atrial fibrillation, renal dysfunction, and bleeding complications,^3,4,7 the long-term impact of which is also not well defined.

The durability of TAVR valves in younger patients remains a major unknown and a key area of ongoing research. As discussed previously, these patients were excluded from randomized trials, leaving uncertainties about the long-term THV performance in this population. Additionally, younger patients typically lead more active lifestyles, which could subject the valve to greater hemodynamic stress and potentially affect its durability.³³ Although data comparing TAVR valve durability to surgical bioprosthetic valves are limited, current evidence suggests that the durability of TAVR valves is comparable to surgical valves in terms of structural valve degeneration.^7,24-29 Although there are no signals indicating premature failure of TAVR valves, it is challenging to guarantee a specific duration of valve durability; for example, it is difficult to promise a patient that a second procedure will be needed in 20 years due to a lack of long-term data in younger patients. We anticipate that 10-year data from the low-risk trials will be crucial to inform patient discussions, but waiting 10 years for definitive data may not be practical for many patients and physicians. Until there are further data to answer these questions, the guidelines will continue to recommend SAVR for younger patients aged < 65 years with longer life expectancy.

Several strategies come into play when considering the optimal approach to lifetime management, each with its own set of advantages and drawbacks. This is especially true regarding reintervention for THV failure in the 62-year-old man with severe AS and an estimated life expectancy > 20 years. An essential tenet of lifetime management is to minimize surgical interventions to a singular procedure throughout the patient’s lifespan, while prioritizing superior hemodynamic valve performance and avoiding surgery at advanced age (Figure 1).

Figure 1. Lifetime management strategies in a 62-year-old man with severe AS. AVR, aortic valve replacement; PPM, prosthesis-patient mismatch; SAV, surgical aortic valve; TAV, transcatheter aortic valve.

SAVR as Index Procedure

Given the available evidence and current guideline recommendations, SAVR as a first intervention may be the preferred strategy if the patient is not at high surgical risk, as surgery at a young age carries less risk and is associated with lower morbidity and mortality.

Mechanical valves. Current guidelines recommend mechanical prosthesis for patients aged < 50 (AHA/ACC) or 60 (ESC/EACTS) years. This could be an option for our patient considering the promise of “lifelong” durability and “no” reoperation, but patients frequently choose bioprosthetic over mechanical valves due to freedom from anticoagulation.

Redo SAVR. Although this is effective in addressing anatomic limitations associated with TAVR as second intervention, it contradicts the evolving principle of minimizing surgical interventions to just one during the patient’s lifetime. However, it facilitates TAVR to be considered as the third intervention, particularly in the context of advanced age.

TAV-in-SAV. This has emerged as the more favorable option if feasible, as multiple open heart surgeries may not be desirable for most patients. However, TAVR may not be feasible as the third intervention due to risk of prosthesis-patient mismatch, coronary obstruction, and impaired coronary access.^34-36

TAVR as Index Procedure

With the expansion of TAVR in younger patients with longer life expectancies, aortic valve reintervention for THV failure may be inevitable using the following options.

Redo TAVR. This is an attractive alternative to surgery for THV failure and may emerge as the preferred option for selected patients with optimal anatomy, as it eliminates the need for sternotomy altogether. However, TAVR may not be possible as the third intervention due to an even higher risk of prosthesis-patient mismatch, coronary obstruction, and impaired coronary access.^34-36

TAVR explant. This can be offered to patients who are surgical candidates but is a more technically complex operation than first-time SAVR and associated with significant mortality and morbidity.^37,38 Nonetheless, it facilitates TAVR to be considered as the third intervention at an advanced age if necessary.

Individualizing Care

Despite these considerations, discussions with patients often revolve around hypotheticals, as there isn’t a one-size-fits-all solution. These decisions must be individualized; lifetime management should be guided by the heart team, with an eye toward tailored care as our patient may need three interventions over his lifetime. One scenario that should be avoided is TAVR explant (TAVR-SAVR, SAVR-TAVR-SAVR, TAVR-TAVR-SAVR) in octogenarians due to the complexity of the surgical procedure in elderly patients with more comorbidities.

Increased confidence in a transcatheter approach, regardless of age, would be bolstered by durability data from ongoing studies, along with advancements in technologies and techniques for TAV-in-TAV procedures, including those focusing on leaflet modification and commissural alignment.^34,36

CONCLUSION

TAVR may be more appealing to many patients, but the long-term benefits of SAVR, particularly for the lifetime management of valvular heart disease, are evident in numerous cases. The existing gap in current evidence for younger patients underscores the need for more balanced and informed decision-making, particularly in this demographic representing a small proportion of patients in current trials. Despite the absence of ongoing trials dedicated to young patients for TAVR, there is a growing trend among younger patients leaning toward TAVR, aligning with the principles of shared decision-making emphasized in current guidelines. This evolving landscape suggests that while TAVR can be considered as a first-line option for some younger patients, caution is warranted due to uncertainties regarding long-term durability and lifetime management in this population.

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