Waiting is no longer ‘good medicine’: Data shows treating severe AS with TAVR before symptoms appear improves outcomes, reduces costs

“It’s clear that waiting is no longer appropriate,” said Philippe Généreux, MD, EARLY TAVR principal investigator and director of the structural heart program at Morristown Medical Center’s Gagnon Cardiovascular Institute. “AS progresses rapidly and aggressively. The evolution of this disease is unpredictable. Instead of being reactive and waiting for symptoms, we should be proactive and stop them from ever happening.”

Généreux cites the example of knee and hip replacements that have been performed in this manner for years: Do the procedure early to alleviate pain and potentially avoid a nasty fall that puts the patient at risk. He proposes a similar approach should now be applied to TAVR.

“I don’t think waiting until the patient is symptomatic is good medicine,” he said. “Instead of waiting for an emergency, we can plan ahead, select the right technology, do all the testing and get something on the calendar. It’s better to do things in a cautious manner than to wait for something bad to happen.”   

Diving deep into the data

The EARLY TAVR trial enrolled 901 patients ages 65 and older, with approximately 90% confirmed as asymptomatic through a protocol-mandated stress test. For patients unable to perform the stress test, eligibility was confirmed through a detailed physician assessment of medical history. Each patient underwent thorough evaluation to ensure they were suitable for TAVR. All TAVR patients were treated using transfemoral access and a balloon-expandable transcatheter heart valve from Edwards Lifesciences. Patients in the clinical surveillance arm were converted to TAVR with a median conversion time of just 32 days from onset of symptoms or decision to intervene.³

The study’s primary endpoint – a composite of all-cause mortality, stroke or unplanned cardiovascular hospitalizations (including aortic valve intervention/reintervention within 6 months) – occurred in 26.8% of TAVR patients and 45.3% of clinical surveillance patients. This difference was largely driven by a significant reduction in unplanned cardiovascular hospitalization (20.9% for TAVR, 41.7% for clinical surveillance).³ 

In addition to reduced hospitalizations, early intervention had a notable impact on patients’ quality of life (QOL). The patients who received TAVR experienced significantly better outcomes compared to those under clinical surveillance. After two years, 86.6% of the TAVR patients achieved favorable outcomes while just 68% of clinical surveillance patients met the same criteria.³

“It is very hard to deny that early intervention is the best option,” Généreux said. “People will say there was really no difference in mortality, but that is because we were so prompt with treatment. In our case, the workup for these patients had already been completed. However, in a real-world scenario, once patients begin experiencing symptoms, the process of conducting a workup and waiting for scheduling can take several months.” 

Delayed treatment increases the risk of rapid decline 

A significant finding from the EARLY TAVR trial was the frequency with which patients – most of whom were initially deemed asymptomatic through stress testing or detailed physician assessment and showed normal left ventricular (LV) ejection fraction – rapidly progressed to symptomatic severe AS.  Despite meeting clinical criteria for surveillance, the majority ultimately required intervention, underscoring the hidden risk of waiting and the need to reconsider current treatment timelines.³

In fact, over 25% of patients in the clinical surveillance arm were converted to TAVR within six months; that number ballooned to 47% at one year and 71% at two years. Alarmingly, nearly 40% of those patients presented with advanced symptoms such as angina, fatigue, syncope and atrial fibrillation, underscoring just how quickly and unpredictably severe AS can escalate – even in patients initially deemed asymptomatic.³

“The extent of cardiac damage is the strongest predictor of long-term mortality after aortic valve replacement,” Généreux said. “So, we know that we need to prevent cardiac damage, we need to prevent LV damage, we need to prevent left atrial (LA) damage. Preserving the LV and LA like we do with early treatment means better outcomes. On the other hand, exposing the heart to a few more years of damage is going to lead to things like fibrosis, LV hypertrophy, LA dilation, AFib, pulmonary hypertension and eventually stroke.” 

Addressing these issues promptly not only helps avoid unnecessary health challenges³ but also reduces the length of hospitalizations associated with aortic valve replacement procedures, allowing healthcare providers to deliver care in a more streamlined, organized and effective manner.⁶

The cost of waiting

Delaying treatment for aortic stenosis carries both clinical and financial consequences. Medicare data reveals that urgent, emergent and salvage TAVR procedures significantly increase costs –placing strain on healthcare systems and compromising resource allocation and care delivery.An elective TAVR procedure costing $45,686 quickly rises if left untreated. Urgent cases increase the cost by $23,983, emergent by $50,399 and salvage by $96,290.^7,8

The burden also falls on the patient with those undergoing TAVR at the urgent stage suffering higher in-hospital mortality (2.8% vs. 1.5%), longer length of stay (9 days vs. 4) and higher 90-day readmission rates (21% vs. 17%).⁸ 

“There is a significant difference in costs between those coming in with no cardiac damage and coming with extensive cardiac damage,” Généreux said. “You have longer length of stay, patients need to recover more, and then they may be back in the hospital again later because their heart has been more severely damaged. This data demonstrates that patients with delayed TAVR see higher costs, even if their care is covered by Medicare. Treating patients when severe AS is first identified is the most cost-effective strategy for everyone involved.”

Looking to the future

For patients to receive greater access for TAVR evaluation, guidelines and coverage policies will need to change. 

“In spite of how compelling these data are, guidelines will not change overnight,” Généreux explained. “In the meantime, patients will continue missing out on critical care. Lives will be lost. It’s up to us, the cardiologists, to do everything we can to ensure patients who need treatment are being identified as quickly as possible.”

With that mission in mind, Généreux said the undertreatment of severe AS remains a critical failure of modern healthcare systems.⁸

The EARLY TAVR trial points to multiple steps clinicians can take today to start helping more patients:

1. Improve the quality of clinical surveillance. The 32-day conversion timeline Généreux’s team achieved during the trial requires a significant number of resources and may not be possible in most hospital settings. But if care teams work together over time, that rapid conversion rate can be a reality.
2. See that every asymptomatic AS patient undergoes a cardiac stress test. In the EARLY TAVR trial, simple stress tests showed that patients thought to be asymptomatic actually did have symptoms.³
3. Immediately refer AS patients to a care team for evaluation. Every patient with AS, even if asymptomatic, should be referred as soon as possible.
4. Identify opportunities that ensure more AS patients can be evaluated, managed and treated. Once TAVR treatment for asymptomatic patients becomes a guideline-recommended treatment strategy, it will be important for hospitals to have in place the right capabilities and infrastructure.

Généreux concluded, “Waiting on symptoms is a burden. It’s time to move past that. We are using up valuable resources, and we are wasting time – time these patients do not have.”

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References:

1. Madhavan MV, Kodali SK, Thourani VH, Makkar R, Mack MJ, Kapadia S, et al. Outcomes of SAPIEN 3 transcatheter aortic valve replacement compared with surgical valve replacement in intermediate-risk patients. J Am Coll Cardiol. 2023;82(2):109-123.
2. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. JACC. 2021 Feb, 77 (4) e25–e197
3. Généreux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227.
4. P. Généreux, A. Schwartz, J.B. Oldemeyer, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. NEJM. Oct. 28, 2024.
5.  Edwards Lifesciences. Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System: Instructions for Use. Irvine, CA: Edwards Lifesciences LLC; 2025.
6. Généreux P, Pellikka P, Lindman B, Pibarot P, Garcia S. Acute Valve Syndrome and its association with health care cost and resource utilization during and after aortic valve replacement. Presented at: EuroPCR 2025; 2025 May; Paris, France.
7. Optum Medicare Advantage Claims 2016-2022Q3. Procedure costs derived from Biome database (TAVR direct costs reflected)
8. Patel KP, Sawatari H, Chahal A, Vuyisile NT, Somers V, Mullen MJ, Ricci F, Khanji MY. Health Care Resource, Economic, and Readmission Implications After Acute Decompensated Aortic Stenosis-A Nationwide Study. Am J Cardiol. 2023 Oct 1;204:200-206. doi: 10.1016/j.amjcard.2023.07.081. Epub 2023 Aug 4. PMID: 37544145.

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