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  • Listen to this manuscript’s

    audio summary by

    JACC Editor-in-Chief

    Dr. Valentin Fuster.

    J O U R N A L O F T H E AM E R I C A N C O L L E G E O F C A R D I O L O G Y V O L . 6 7 , N O . 1 2 , 2 0 1 6

    ª 2 0 1 6 B Y T H E AM E R I C A N C O L L E G E O F C A R D I O L O G Y F O UN DA T I O N I S S N 0 7 3 5 - 1 0 9 7 / $ 3 6 . 0 0

    P U B L I S H E D B Y E L S E V I E R h t t p : / / d x . d o i . o r g / 1 0 . 1 0 1 6 / j . j a c c . 2 0 1 6 . 0 1 . 0 5 5

    ORIGINAL INVESTIGATIONS

    Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians?

    Insights From the STS/ACC TVT Registry

    Mani Arsalan, MD,a,b Molly Szerlip, MD,a Sreekanth Vemulapalli, MD,c Elizabeth M. Holper, MD,a

    Suzanne V. Arnold, MD,d Zhuokai Li, PHD,c Michael J. DiMaio, MD,a John S. Rumsfeld, MD,e

    David L. Brown, MD,a Michael J. Mack, MDa

    ABSTRACT

    Fro

    Ins

    Ce

    (ST

    wa

    BACKGROUND Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly

    patients are limited, as they often represent only a small proportion of the trial populations.

    OBJECTIVES The purpose of this study was to compare the outcomes of nonagenarians to younger patients

    undergoing TAVR in current practice.

    METHODS We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter

    Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients $90 years versus

  • ABBR EV I A T I ON S

    AND ACRONYMS

    AS = aortic stenosis

    CI = confidence interval

    IRB = institutional review

    board

    KCCQ-12 = 12-item Kansas City

    Cardiomyopathy Questionnaire

    KCCQ-os = overall summary

    score of the 12-item Kansas City

    Cardiomyopathy Questionnaire

    MI = myocardial infarction

    QOL = quality of life

    TAVR = transcatheter aortic

    valve replacement

    paper repre

    societies id

    received re

    consultant

    member of

    other autho

    Manuscript

    Arsalan et al. J A C C V O L . 6 7 , N O . 1 2 , 2 0 1 6

    TAVR in Nonagenarians M A R C H 2 9 , 2 0 1 6 : 1 3 8 7 – 9 5 1388

    I t is estimated that the number ofpeople age $90 years (nonagenarians)in the United States will quadruple by the year 2050 to reach 8.7 million (1). As such, clinicians are being confronted with an increasing number of nonagenarians with severe aortic stenosis (AS), which significantly reduces quality of life and sur- vival. Due to the morbidity and mortality of surgical aortic valve replacement in patients at advanced age, surgery is often denied to very elderly patients (2,3). Over the last 10 years, transcatheter aortic valve replace- ment (TAVR) has emerged as a viable treat- ment option for patients with severe AS

    who are inoperable or at high surgical risk, prolonging survival and improving quality of life in the majority of patients (4,5). However, the effect of TAVR in no- nagenarians is largely unknown, as they represent only a small fraction of patients enrolled in the pivotal clinical trials. A few small, single-center series have reported outcomes of TAVR in the very elderly and showed acceptable results (6–9). Due to this lack of outcomes data for TAVR in the very elderly, decision-making for TAVR in nonagenarians is complicated. As such, the aim of this study was to compare the procedural, 30-day, and 1-year outcomes of nonagenarians with patients age

  • TABLE 1 Baseline Characteristics of the Study Population

    Nonagenarians (Age $90 yrs) (n ¼ 3,773)

    Others (Age

  • TABLE 2 In-Hospital Outcomes of Nonagenarians and Patients Age

  • FIGURE 1 Adjusted Age Effects on Post-Discharge Outcomes

    0.4 0.6 0.8 1 1.2 1.6 2

    30-Day

    Mortality

    Stroke

    Heart Failure

    Aortic Valve Reintervention

    MI

    1-Year

    Mortality

    Stroke

    Heart Failure

    Aortic Valve Reintervention

    MI

    Adjusted HR (95% CI) p-value

    1.46 (1.25, 1.71)

    1.13 (0.88, 1.47)

    1.35 (1.11, 1.65)

    0.90 (0.44, 1.81)

    1.15 (0.70, 1.90)

  • FIGURE 3 Heart Failure Readmission

    20

    15

    10

    5

    0

    Cu m

    ul at

    iv e

    In ci

    de nc

    e, %

    0 3 6 9 12 Months Since Index Procedure

    No. of events / No. at risk Nonagenarians

    Patients aged < 90 0 / 2628 0 / 12895

    241 / 1825 1054 / 9237

    288 / 1400 1341 / 6914

    324 / 1104 1494 / 5368

    345 / 884 1588 / 4277

    Nonagenarians Patients aged < 90

    Cumulative incidence of heart failure readmission in nonagenarians and patients younger

    than age 90 years.

    FIGURE 4 Mortali

    30

    25

    20

    15

    10

    5

    0

    Cu m

    ul at

    iv e

    In ci

    de nc

    e, %

    No. Nonagenarians

    Patients aged < 90 39 /

    104

    Cumulative incidence

    Arsalan et al. J A C C V O L . 6 7 , N O . 1 2 , 2 0 1 6

    TAVR in Nonagenarians M A R C H 2 9 , 2 0 1 6 : 1 3 8 7 – 9 5 1392

    only provide limited decision-making information on the outcomes of nonagenarians undergoing TAVR (6–9,17). In the largest previous study on TAVR in no- nagenarians (346 nonagenarians of 2,254 enrolled pa- tients; reported from the FRANCE-2 [French National Transcatheter Aortic Valve Implantation Registry]), Yamamoto et al. (18) demonstrated a 30-day mortality of 11.2% in nonagenarians without any significant difference compared with patients age 80 to 84 years

    ty

    0 3 6 9 12 Months Since Index Procedure

    of events / No. at risk 2628

    / 12895 378 / 2020

    1331 / 10080 479 / 1586

    1804 / 7765 526 / 1288

    2093 / 6165 570 / 1054

    2324 / 4989

    Nonagenarians Patients aged < 90

    of mortality in nonagenarians and patients younger than age 90 years.

    or 85 to 89 years (18). We found a lower 30-day mor- tality rate in nonagenarians (8.8%), which may reflect differences in patient selection and improvements in devices and techniques. Although the mortality rate for nonagenarians in our study remained higher than that observed in younger patients (5.9%), this rate may be acceptable, particularly given the QOL benefits observed among surviving nonagenarians. This is further illustrated by the similar observed-to- expected ratios. Of note, the observed nonagenarian mortality rate is not only lower than that previously reported on nonagenarians, but is also comparable to published mortality rates for octogenarians (18,19).

    In regard to long-term survival, the FRANCE-2 data showed a trend toward decreased survival in older patients, but the study did not meet statistical signifi- cance due to the limited number of patients at risk by 1 year (18). The current study confirms a higher mor- tality rate in nonagenarians at 1 year, but due to the high mortality rates in both groups, it is doubtful that themeasureddifference of 2.8% is clinically significant or simply reflects the shorter underlying life expec- tancy of nonagenarians. Some clarity on this issue can be achieved by comparing our 1-year outcomes to the life expectancy of an age-matched general pop- ulation. The younger patient cohort showed a 1-year mortality of 22%, which is significantly higher com- pared with the age-matched general population (6.1% in males and 4.4% in females) (20). In nonagenarians, however, the observed difference between 1-year mortality in TAVR patients (24.8%) and the same- age general population (male 20.5% and female 16.5%) was much smaller (Central Illustration).

    Thus, we confirm the promising results from other reports about TAVR in select nonagenarians, and we additionally show that the difference between out- comes of select nonagenarians and younger patients might not be of major clinical relevance.

    We further describe the outcomes of a very small cohort of patients$100 years of age undergoing TAVR. Overall, 24 centenarians were treated in the TVT reg- istry; thus, this is the largest report on TAVR in this age group. We are aware that our patient cohort (n ¼ 15 with CMS linkage) is too small to give a reliable statement, but nevertheless, the procedural outcomes are encouraging. There was no mortality at 30 days, which is likely indicative of very careful patient selection. The very low 1-year mortality (6.7%) is excellent, especially considering the high 1-year death probability in a 100-year-old patient (36% in males and 31% in females). Of note, Bridges et al. (21), reviewing the STS national database, re- ported that only 5 centenarians underwent cardiac surgery in the United States between 1997 and 2000.

  • TABLE 4 30-Day and 1-Year KCCQ-12 Overall Summary Scores in Nonagenarians and Others Age

  • CENTRAL ILLUSTRATION TAVR in Nonagenarians: Mortality, Stroke, and Quality of Life Compared With Patients

  • PERSPECTIVES

    COMPETENCY IN PATIENT CARE AND PROCEDURAL

    SKILLS: Although 30-day and 1-year mortality rates are higher

    in nonagenarians undergoing TAVR, the absolute and relative

    differences compared with younger patients are clinically modest.

    TRANSLATIONAL OUTLOOK: As the indication for TAVR

    expands to encompass patients at lower risk, more research is

    needed to clarify which patients, regardless of age, benefit most

    from the procedure.

    J A C C V O L . 6 7 , N O . 1 2 , 2 0 1 6 Arsalan et al. M A R C H 2 9 , 2 0 1 6 : 1 3 8 7 – 9 5 TAVR i