Very few things in internal medicine and/or interventional cardiology have been more interesting to me when doing clinical research than analyzing the cost-effectiveness ratio of revascularization techniques or strategies and/or therapy.

Since the times of the randomized clinical trials between angioplastyvs coronary surgery (1) to the rational use of stents (2-3) until the option of using immunosuppressants to prevent restenosis (4-5), the cost-effectiveness ratio has always been studied from 2 different therapeutic positions.

We used to base these different positions (1-4) and we still do today (5) on a similar effectiveness hypothesis of the hard cardiovascular adverse events we wish to compare between both techniques like rate of death, infarction or stroke. In these circumstances both the costs and the cost-effectiveness of each strategy can be analyzed.

To this day, transcatheter aortic valve implantation (TAVI) was and still is the most important therapeutic achievement in our specialty.

First designed for patients contraindicated for surgical aortic valve replacement (SAVR) or with high risk of SAVR related death (6-7), believe it or not, these are the only indications accepted to this day by our country’s social security system.

Over the last few years, the greater knowledge acquired in the implantation technique and the improvements made in the devices used that facilitate the use of percutaneous implants in over 90% of the cases via transfemoral access has brought TAVI indications to study in low and intermediate risk patients.

Therefore, 3 randomized clinical trials have been published to this day between TAVI and SAVR in these clinical circumstances (8-10) together with prospective registries with incredible results like the rates of mortality and incapacitating stroke at the 30-day follow-up in 0 out of 200 patients (11).

Two of these randomized clinical trials were conducted using self-expanding valves (8-9). The remaining one with balloon-expandable valveimplantation (10).

The results from these 3 clinical trials have been exquisitely documented in this issue of RACI by the groups of experts from the Massachussetts General Hospital directed by Dr. Palacios, MD. There is no doubt that the reader will enjoy these results.

The results of the Partner 3, Evolut Low Risk, and NOTION show the advances made with this technique in low or intermediate risk patients.

It is obvious that, as it happens with all randomized clinical trials, these 3 trials had exclusion criteria that should be taken into consideration when indicating SAVR. These exclusion criteria included bicuspid aortic valves, large aortic annulus, impossibility of using femoral access, and young patients with high baseline risk for permanent pacemaker implantation, among other.

Still, when there is a patient eligible for both techniques who meets the inclusion criteria of these studies (9-10) we should not forget that the comparison between SAVR and TAVI brought the following results to light:

Fewer deaths with TAVI compared to SAVR.

Fewer or same incapacitating strokes with TAVI compared to SAVR.

More paravalvular regurgitation and leaks with TAVI compared to SAVR.

Higher rate of permanent pacemaker implantation in some TAVIs when the implants were placed at deep level and not on the aortic annulus.

Similar or less endocarditis compared to SAVR.

Fewer major bleeding or acute kidney injury in TAVI compared to SAVR.

Finally, the cost of TAVI was higher compared to SAVR.

The cost of the device used in TAVI is obviously a preoccupation in Argentina as well as in other regions. The COVID-19 pandemic has exposed the serious problems of healthcare systems even in the most developed countries today.

The rate of permanent pacemaker implantation after TAVI is a complication we should seriously be looking into in patients < 70 patients and low or intermediate risk. As far as I am concerned, the implantation technique depends largely on the type of valve used whether a balloon-expandable or a self-expanding heart valve. As a matter of fact, in our own experience with the Portico self-expanding valve (Abbott/Saint Jude) performing more supra-valvular implantations, the rate of permanent pacemaker implantation in 37 patients was 10.8%.

We have to accept the fact that our country’s social security system has been experiencing serious difficulties making certain devices available due to their disproportionate costs. Also, with weird clinical indications, sometimes. However, this should not worry the patients or the interventional cardiology community in Argentina. It is a matter of discussion for the public and private healthcare systems under the control of the State. They need to solve these problems and make this technique available for all the patients who may need it.

When mortality rate is at stake, the cost-effectiveness ratio becomes insignificant. As we have been seeing in the recent analyses (9-10), the rates of overall mortality, cardiovascular mortality, incapacitating strokes, and acute kidney injury were all higher with SAVR even in the presence of a surgical mortality rate at the 30-day follow-up < 2%.

Public and private healthcare systems together with the Argentinian Ministry of Public Health now have the ball in their court. They need to guarantee that low and intermediate risk patients with aortic valve stenosis will have access to the most suitable therapy in each particular case easily and with lower morbidity and mortality rates.

Alfredo E. Rodríguez MD, PhD, FACC, FSCAI, IAGS
Editor-in-chief of RevistaArgentina de Cardioangiología Intervencionista (RACI)

1. Rodríguez A, Bernardi V, Navia J, et al. Argentine Randomized Study: Coronary Angioplasty with Stenting versusCoronary Bypass Surgery in patients with Multiple-Vessel Disease (ERACI II): 30-day and one-year follow-up results. ERACI II Investigators. J Am Coll Cardiol 2001;37:51-8.

2. Rodríguez AE, Santaera O, Larribau M, et al. Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA. Circulation 1995;91:1397-402.

3. Rodríguez A, Ambrose J. Do we require a cure for “Stentmania.” J Am Coll Cardiol 1996;28:4.

4. Rodríguez AE, Palacios I, Rodríguez-Granillo AM, et al. Comparison of Cost-Effectiveness of Oral Rapamycin Plus Bare-Metal Stents Versus First Generation of Drug-Eluting Stents (from the Randomized Oral Rapamycin in Argentina [ORAR] 3 Trial) Am J Cardiol 2014;113:815e-21.

5. Correa-Sadouet C, Rodríguez-Granillo AM, Gallardo C, et al. Randomized comparison between bare-metal stent plus colchicine versus drug-eluting stent alone in prevention of clinical adverse events after percutaneous coronary intervention. Trial Protocol, Future Cardiol 2020 Nov 11. doi: 10.2217/fca-2020-0161. Online ahead of print.

6. Smith CR, Leon MB, Mack MJ, et al. PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364:2187-98.

7. Adams DH, Popma JJ, Reardon MJ, et al. U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self expanding prosthesis. N Engl J Med 2014;370:1790-8.

8. Thyregod HGH, Steinbrüchel DA, Ihlemann N, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol 2015;65:2184-94.

9. Popma JJ, Deeb M, Yakubo S, et al Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk PatientsN Engl J Med 2019;380(18):1706-15.

10. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380(18):1695-705.

11. Waksman R, Corso PJ, Torguson R, et al. TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial. JACC Cardiovasc Interv 2019;12(10):901-7.

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Percutaneous implantation of aortic valve at low or intermediate risk: when effectiveness trumps cost

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