Watching a Procedure Evolve

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL. 66, NO. 25, 2015

ª 2015 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

ISSN 0735-1097/$36.00

AND THE SOCIETY OF THORACIC SURGEONS

http://dx.doi.org/10.1016/j.jacc.2015.11.008

PUBLISHED BY ELSEVIER INC.

EDITORIAL COMMENT

Watching a Procedure Evolve Sequential Findings From the TVT Registry* Michael J. Reardon, MD,y Neal S. Kleiman, MDz

T

ranscatheter aortic valve replacement (TAVR)

TAVR devices (10). The majority of patients receiving

has rapidly expanded in the United States

TAVR are covered by Medicare, and enrollment in the

and worldwide. The approval of the first 2

registry is mandatory for physicians and institutions

TAVR prostheses in the United States is based on

to receive payment for TAVR from CMS. It is thus

data from randomized trials showing survival rates

anticipated that the registry will capture nearly all

superior to conservative medical therapy in nonoper-

commercially funded cases of TAVR and will involve

able patients (1,2) and comparable or superior to surgi-

every

cal aortic valve replacement (SAVR) for patients at

valves, including the authors. The initial in-hospital

high surgical risk (3,4). Data from these trials have

outcomes of the TVT Registry were reported by

now been extended to 5-year outcomes for the

Mack et al. (11) in 2013 and the 1-year outcomes by

PARTNER (Placement of Aortic Transcatheter Valves)

Holmes et al. (12).

trial and 2-year outcomes for the CoreValve trial, and continue to confirm the initial findings (5–8).

U.S.

physician

implanting

transcatheter

SEE PAGE 2813

These trials represent some of the most robust clinical

In this issue of the Journal, Holmes et al. (13) pro-

investigations available in the field of valvular heart

vide further updates of the TVT Registry. The pre-

disease. However, it has long been recognized that

dominant theme of the current report is that the field

observations from clinical trials are not necessarily

of TAVR is exceptionally dynamic. The report cap-

reflective of outcomes and practices in the broader

tures a total of 26,414 TAVR procedures from 348

population, often referred to as “the real world” (9).

centers in 48 states between 2012 and December 31,

The TVT (Transcatheter Valve Therapies) Registry

2014, and thus allows comparison of the first 3 years

was created to address this concern. It arose from a

of commercial TAVR implantation. During this time-

close collaboration between the U.S. Center for

frame, we have seen a dramatic surge in the number

Medicare & Medicaid Services (CMS), the American

of centers implanting transcatheter valves (the num-

College of Cardiology, and the Society of Thoracic

ber of participating sites more than doubled between

Surgeons (STS). Specifically, the goal of the TVT

2012 and 2014), as well as U.S. Food and Drug

Registry was to provide a data repository and

Administration approval of new devices and CMS

reporting structure independent from industry to

approval of new access routes. Patient outcomes

monitor the safety and effectiveness of approved

remain extremely encouraging: the procedural success of device implantation in the proper position is excellent at 97.4%, with 95% of these having a mean

*Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology. From the yDepartment of Cardiovascular Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas; and the zDepartment of

residual gradient <20 mm Hg; mortality (4.4%), myocardial infarction (0.4%), renal injury stage 3 (2.2%), and stroke (2.2%) are low; and conversion to open surgery remains highly unusual at 1.3%.

Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston,

Equally important, the report provides insight into

Texas. Drs. Reardon and Kleiman both serve on the publications committee

how the procedure is evolving. Patient characteristics

for the TVT Registry. Dr. Reardon has served on an advisory board for Medtronic. Dr. Kleiman provides educational services for Medtronic. This

seem to suggest a rightward shift in the selection of

article is copublished in the Journal of the American College of Cardiology

patients for TAVR, such that fewer extremely high-risk

and The Annals of Thoracic Surgery.

and more intermediate- to high-risk patients are

JACC VOL. 66, NO. 25, 2015

Reardon and Kleiman

DECEMBER 29, 2015:2824–6

Sequential Findings From the TVT Registry

undergoing the procedure. There are subtle but sig-

the requisite operator and institutional requirements,

nificant decrements in patient age and baseline risk.

particularly with respect to open surgical volume, to

The median age decreased from 84 to 83 years, and the

develop a TAVR program. Paradoxically, if the current

median STS predicted risk of mortality among enrolled

trials of TAVR in patients at intermediate risk for SAVR,

patients fell from 7.05% to 6.69%, accompanied by a

such as SURTAVI (Surgical Replacement and Trans-

small decrement in the proportion of patients with STS

catheter Aortic Valve Implantation) (NCT01586910)

risk scores $15%. Only about 1 in 5 patients had risk

and PARTNER II (NCT01314313), demonstrate adequate

scores <4%. Noncardiac morbidities, such as the pro-

long-term outcomes for these lower-risk patients

portion on home oxygen, tended to decrease as did

following TAVR, the number of SAVRs will drop and

measures of frailty. Thus, although not completely

meeting the current CMS requirements will become

alleviating early concern about “creep” of the proce-

more difficult. Accordingly, the registry will become

dure into inappropriately low-risk patient pop-

more useful in elucidating the relationship among

ulations, this study shows that the patients remain

operator experience, institutional volume, and the

elderly and at high risk, and are symptomatic and frail.

likelihood of achieving satisfactory clinical outcomes.

These observations suggest that patient selection for

The TVT Registry also can be used with other

TAVR in the United States has remained reasonable,

national registries such as the U.K. Registry (14),

with excellent efficacy and continued safety.

GARY (German Aortic Valve Registry) (15), and France

The observations concerning procedure performance are particularly interesting. Although it is

II Registry (16) to achieve very high-volume data for unusual occurrences with TAVR.

difficult within the registry to distinguish between

Finally, the TVT Registry offers another unique set

overall trends and more conservative practices

of opportunities. TVT played an important role in the

by physicians new to TAVR and to the registry,

acceptance and CMS approval of direct aortic access

several observations are apparent. Over time, TAVR

for TAVR. In Sweden, the TASTE (Thrombus Aspira-

implanters have become more adept at integrating

tion in ST-Elevation Myocardial Infarction in Scandi-

computed tomography angiogram data (used to

navia) investigators demonstrated that simple clinical

assess the aortic annulus in 27.9% in the first cohort

questions concerning currently available therapy,

vs. 51.9% in the second cohort). Notably, the propor-

such as intracoronary thrombectomy during primary

tion of patients receiving moderate sedation rather

percutaneous coronary intervention, can be answered

than general anesthesia rose from 1.6% to 5.1% and

using a randomized trial with data collection per-

the proportion of percutaneous TAVR rose from 21.1%

formed using an existing registry (SCAAR [Swedish

to 40.8%, whereas the proportion of transapical and

Coronary Angiography and Angioplasty Registry])

other nonfemoral access use declined.

(17). Important questions remain to be resolved,

As TAVR enters the mainstream of clinical practice,

particularly in regard to antithrombotic therapies, in

the registry must embrace new challenges, but will

patients who have undergone TAVR. The registry is

also be able to provide new opportunities. First, only

likely to become a useful mechanism to resolve these

the first 3 years of TAVR are currently included in the

questions in a broad national population.

registry. Although 5-year results from the PARTNER trial show no indication of structural valve degener-

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

ation, surgical experience has shown that in many

Michael J. Reardon, Houston Methodist DeBakey

cases, structural valve degeneration can become

Heart & Vascular Center, 6550 Fannin Street, MS

apparent fairly abruptly after this period. Second, the

Smith 1401, Houston, Texas 77030. E-mail: mreardon@

recent National Coverage Decision by CMS specifies

houstonmethodist.org.

REFERENCES 1. Leon MB, Smith CR, Mack M, et al. Trans-

in high-risk patients. N Engl J Med 2011;364:

6. Reardon MJ, Adams DH, Kleiman NS, et al.

catheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–607.

2187–98.

2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol 2015;66:113–21.

2. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014;63:1972–81.

4. Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a selfexpanding prosthesis. N Engl J Med 2014;371: 967–8.

3. Smith CR, Leon MB, Mack MJ, et al. Trans-

5. Yakubov SJ, Adams DH, Watson DR, et al. 2-year outcomes after iliofemoral self-expanding transcatheter aortic valve replacement in patients with severe aortic stenosis deemed extreme risk for

catheter versus surgical aortic-valve replacement

surgery. J Am Coll Cardiol 2015;66:1327–34.

7. Kapadia SR, Leon MB, Makkar RR, et al., for the PARTNER 1 Trial Investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015;385:2485–91. 8. Mack MJ, Leon MB, Smith CR, et al., for the PARTNER 1 Trial Investigators. 5-year outcomes of

2825

2826

Reardon and Kleiman

JACC VOL. 66, NO. 25, 2015

Sequential Findings From the TVT Registry

DECEMBER 29, 2015:2824–6

transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015;385: 2477–84. 9. Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation 2008;118:1294–303. 10. Rumsfeld JS, Holmes DR Jr., Stough WG, et al. Insights from the early experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol Intv 2015;

replacement in the United States. JAMA 2013;310: 2069–77. 12. Holmes DR Jr., Brennan JM, Rumsfeld JS, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA 2015;313: 1019–28. 13. Holmes DR Jr., Nishimura RA, Grover FL, et al., for the STS/ACC TVT Registry. Annual outcomes with transcatheter valve therapy: from the STS/ACC TVT Registry. J Am Coll Cardiol 2015;66: 2813–23.

11. Mack MJ, Brennan JM, Brindis R, et al. Out-

14. Duncan A, Ludman P, Banya W, et al. Longterm outcomes after transcatheter aortic valve replacement in high-risk patients with severe aortic stenosis: the U.K. Transcatheter Aortic Valve Implantation Registry. J Am Coll Cardiol Intv 2015;

comes

8:645–53.

8:377–81.

following

transcatheter

aortic

valve

15. Walther T, Hamm CW, Schuler G, et al. Perioperative results and complications in 15,964 transcatheter aortic valve replacements: prospective data from the GARY Registry. J Am Coll Cardiol 2015;65:2173–80. 16. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in highrisk patients. N Engl J Med 2012;366:1705–15. 17. Lagerqvist B, Fröbert O, Olivecrona GK, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med 2014;371: 1111–20.

KEY WORDS aortic stenosis, aortic valve replacement, transcatheter aortic valve replacement, valvular heart disease, VARC