Guidelines Vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults 60 Years

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ª 2024 by The Society of Thoracic Surgeons 0003-4975/$36.

00 1
Published by Elsevier Inc. https://doi.org/10.1016/j.athoracsur.2024.07.036

Valve: Research

J. MAXWELL CHAMBERLAIN MEMORIAL PAPER FOR ADULT CARDIAC SURGERY

Guidelines vs Practice: Surgical Versus


Transcatheter Aortic Valve Replacement in
Adults £60 Years
Sundos Alabbadi, PharmD,1 Jad Malas, MD,2 Qiudong Chen, MD,2 Wen Cheng, MD,2
Derrick Y. Tam, MD, PhD,2 Robbin G. Cohen, MD,2 Michael E. Bowdish, MD, MS,2
Natalia Egorova, PhD,1 and Joanna Chikwe, MD2

ABSTRACT

BACKGROUND Consensus guidelines recommend surgical aortic valve replacement (SAVR) over
transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis aged £65 years.
This analysis evaluates clinical practice and outcomes of TAVR and SAVR in patients aged £60 years.

METHODS We identified 2360 patients aged £60 years, including 523 TAVR (22.2%) and 1837 SAVR
(77.8%) procedures, from 2013 through 2021 using the California Department of Health Care Access
and Information database. The median follow-up time was 2.4 years (interquartile range, 1.1-4.5
years) after TAVR and 4.9 years (interquartile range, 2.8-6.9 years) after SAVR. The primary outcome
was 5-year survival. Secondary outcomes included cumulative incidences of reoperation, endo-
carditis, stroke, and heart failure readmissions with death as a competing risk, compared using
propensity score matching.

RESULTS Between 2013 and 2021 TAVR rates in patients aged £60 years increased from 7.2% to 45.7%
(annual increase of 4.7%, P < .001). Mortality at 30 days was similar for SAVR and TAVR (0.2% vs 0.4%,
P [ .20). In 358 propensity-matched pairs, TAVR was associated with an increased hazard of 5-year
mortality (hazard ratio, 2.5; 95% CI, 1.1-3.7; P [ .02). There was no significant difference in the cu-
mulative incidences of reoperation (2.2% vs 3.8%, P [ .25), stroke (1.1% vs 0.8%, P [ .39), endocarditis
(0.8% vs 0.4%, P [ .38), and heart failure readmission (1.9% vs 1.2%, P [ .10).

CONCLUSIONS TAVR use approaches SAVR use in patients aged £60 years in California and is
associated with significantly worse 5-year survival. This may indicate a need for randomized trials to
inform best practice recommendations.
(Ann Thorac Surg 2024;-:---)
ª 2024 by The Society of Thoracic Surgeons. Published by Elsevier Inc.

T ranscatheter aortic valve replacement


(TAVR) is routinely performed in older
and higher-risk adults with severe symp-
tomatic aortic stenosis.1 This is supported by
The Supplemental Material can be viewed in the online version of
this article [https://doi.org/10.1016/j.athoracsur.2024.07.036] on
https://www.annalsthoracicsurgery.org.
results of 7 pivotal randomized controlled trials

Accepted for publication Jul 20, 2024.


Presented as the J. Maxwell Chamberlain Memorial Paper for Adult Cardiac Surgery at the Sixtieth Annual Meeting of The Society of Thoracic Surgeons,
San Antonio, TX, Jan 27-29, 2024.
1
Department of Population Health Science and Policy at Icahn School of Medicine at Mount Sinai, New York, New York; and 2Department of Cardiac
Surgery, Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, California
Address correspondence to Dr Chikwe, Department of Cardiac Surgery, Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S San Vicente Blvd, Ste
A3600, Los Angeles, CA 90048; email: joanna.chikwe@cshs.org.

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comparing TAVR vs surgical aortic valve MATERIAL AND METHODS


replacement (SAVR), initially in prohibitive
surgical risk candidates and then sequentially in DATA SOURCE. The data for this study was extracted
intermediate and low surgical risk patients.2-8 from the California State Patient Discharge Data
Specifically, in 5-year follow-up of The Safety administrative database for the years 2013 to 2021.
and Effectiveness of the SAPIEN 3 Transcatheter These data are provided by the California Depart-
Heart Valve in Low Risk Patients With Aortic Ste- ment of Health Care Access and Information and
nosis (PARTNER-3) trial there was no significant consist of a record of each discharge from a
difference between TAVR and SAVR for death licensed hospital in the state. The data set has
(10% vs 8.2%), stroke (5.8% vs 6.4%), bio- unique patient identifiers that allow the identifi-
prosthetic valve failure (3.3% vs 3.8%), or rehospi- cation of all inpatient and outpatient claims during
talization (13.7% vs 17.4%), respectively.9 the study period for each patient. International
In 4-year follow-up results of the Medtronic Classification of Diseases, Ninth (ICD-9) and Tenth
Evolut Transcatheter Aortic Valve Replacement in Revision (ICD-10) Clinical Modification codes were
Low Risk Patients (Evolut) trial, investigators re- used to identify procedures and outcomes of in-
ported noninferiority of TAVR for the incidence of terest as reported in the Supplemental Table. This
death or disabling stroke (10.7% vs 14.1%; hazard study was approved by the Cedars-Sinai Medical
ratio [HR], 0.75; 95% CI, 0.54-1.00; P ¼ .05) as well Center Institutional Review Board (protocol ID:
as reduced structural valve degeneration in the STUDY00001188, approval date February 19,
TAVR group compared with SAVR based on mean 2021) and the Icahn School of Medicine at Mount
aortic valve gradients and effective orifice areas.10 Sinai Institutional Review Board (protocol ID:
The 10-year follow-up of the randomized Pr02015000525, approval date August 8, 2023),
Nordic Aortic Valve Intervention (NOTION) trial, with a waiver of informed consent.
composed of 280 low-risk patients with severe
STUDY POPULATION. The data set was queried for all
aortic stenosis, demonstrated improved freedom
adult inpatient (age 18-60 years) hospitalizations
from severe structural valve degeneration after
during which TAVR or bioprosthetic SAVR pro-
TAVR (1.5% vs 10.0%; HR, 0.2; 95% CI, 0.04-0.7;
cedures were performed. The following exclusion
P ¼ .02) and similar long-term survival, providing
criteria were applied: patients with isolated aortic
long-term durability evidence for transcatheter
regurgitation, prior aortic valve intervention,
intervention.11
mechanical AVR, concomitant procedures (coro-
These recent favorable results for TAVR sug-
nary artery bypass grafting or percutaneous cor-
gesting similar midterm survival and reduced
onary intervention, other valvular replacements,
rates of structural valve degeneration have pro-
ablations, thoracic aortic intervention), prior
vided further rationale for continued TAVR
thoracic aortic intervention, prior left ventricular
expansion. Although younger patients are most
assist device placement, and patients not residing
likely to be low-risk, <10% of patients included in
in California (Figure 1).
these low-risk trials were aged <65 years, which
limits the generalizability of this evidence to STATISTICAL ANALYSES. Patient characteristics are
younger patients with aortic stenosis. Further- reported as frequencies and percentages for cat-
more, not all young patients with aortic stenosis egorical variables and median with interquartile
are low risk; however, given the importance of range (IQR) for continuous variables. Not nor-
valve durability and long-term survival, surgical mally distributed continuous variables were
options must be considered in these patients. The analyzed using the Wilcoxon nonparametric test,
lack of long-term comparative outcomes data in and categorical variables were compared using
younger patients is reflected in the 2020 American the c2 test. Standardized mean differences are
College of Cardiology/American Heart Association also reported for all variables after propensity
(ACC/AHA) guidelines, which recommend SAVR score matching. Hospital surgical volume was
over TAVR in patients aged 65 with severe calculated as the annual overall hospital volume
symptomatic aortic stenosis and who are not at of AVR procedures regardless of surgical approach
prohibitive risk for surgical intervention.12 This or type of valve used (mechanical or
analysis was therefore designed to address this bioprosthetic).
knowledge gap by evaluating 5-year outcomes of Propensity score matching was performed to
TAVR vs SAVR in adults aged 60 years with se- minimize differences between TAVR and SAVR
vere symptomatic aortic stenosis using a state- groups. A multivariable logistic regression model
wide registry. was fit to estimate a patient’s probability of

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FIGURE 1 Cohort diagram. (CABG, coronary artery bypass grafting; LVAD, left ventricular assist device; PCI, percutaneous
coronary intervention; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.)

undergoing TAVR. The propensity score was in the study), and survival of TAVR vs SAVR,
calculated using the following variables: age, sex, excluding those with ICD-9 and ICD-10 codes
race/ethnicity, insurance type, type of admission, indicating bicuspid aortopathy.
23 comorbidities, the hospital’s annual surgical OUTCOMES. The primary outcome was post-
volume, and the year of surgery. The greedy operative 5-year survival. Long-term survival was
nearest neighbor matching technique with a 1:1 reported as survival probability using the Kaplan-
ratio was used, and propensity score matches Meier estimate. Short-term secondary outcomes
were selected using a caliper width of 0.22 of the included 30-day rates of readmission and
propensity score to match each TAVR patient to a permanent pacemaker implantation. Five-year
SAVR patient. Standardized mean differences secondary outcomes included incidence rates of
were estimated to assess the balance of the infective endocarditis, stroke, reoperation, and
covariates, with a threshold of 10% representing readmission for heart failure analyzed using
good balance and a value of 20% indicating competing risk analysis with death as a
acceptable balance. Subgroup analysis of patients competing risk. Differences in the long-term
without prior history of a permanent pacemaker outcomes were assessed using a marginal Cox
was used to calculate the 30-day incidence of new proportional hazards model with a robust
pacemaker implantation. sandwich estimator covariance matrix to account
Several sensitivity analyses were also per- for institutional clustering and dependence
formed, including the following: survival of TAVR between patients due to matching. The
vs SAVR after United States Food and Drug proportional hazards assumption was examined
Administration approval for low-risk TAVR (2019- using Schoenfeld residuals.
2021), survival of TAVR vs SAVR (including me- In accordance with data use agreements of the
chanical AVRs), 2.5-year survival of TAVR vs SAVR California Department of Health Care Access and
(due to median follow-up time of TAVR patients Information, the exact frequencies and incidence

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FIGURE 2 The trend in transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) procedure rates among
patients aged £60 years who underwent aortic valve replacement in California.

rates with 10 were reported as <10 to maintain of patients included in both TAVR and SAVR
patient confidentiality. Any event of interest with groups are depicted in Supplemental Figure 2.
low counts in both groups was reported as an The trend in median Charlson Comorbidity
absolute risk difference. Index for patients is depicted in Supplemental
The P value for TAVR use was calculated with Figure 3. Patients who underwent TAVR were
the Cochran-Armitage test. Joinpoint regression more likely to have heart failure (73.8% vs
analysis was run to calculate the annual percent 41.0%), atrial fibrillation (21.2% vs 14.0%),
change in the proportion of patients receiving coronary artery disease (71.5% vs 41.7%), chronic
TAVR. The cutoff value for statistical significance obstructive pulmonary disease (39.4% vs 23.9%),
was .05. All statistical analyses were performed chronic kidney disease (44.6% vs 13.4%), and
using SAS 9.4 software (SAS Institute Inc, Cary, dialysis dependency (25.8% vs 3.8%) compared
NC). with those who had SAVR (all P < .001). Patients
receiving TAVR were less likely to undergo
elective procedures (72.1% vs 78.7%, P ¼ .001).
RESULTS
Patients in the TAVR group received care in
PROCEDURAL TRENDS. From 2013 to 2021, 2360 bio- hospitals with higher median annual case
prosthetic AVR procedures were performed in volumes of both SAVR and TAVR (198 cases
patients aged 60 years, of which 1837 (77.8%) [IQR, 111-460 cases] vs 149 cases [IQR, 54-396
were SAVR and 523 (22.2%) were TAVR. Of 97 cases], P < .001).
hospitals offering TAVR in California, 67 (69.1%) The median follow-up time was 4.9 years (IQR,
performed it for patients aged 60 years. The 2.8-6.9 years) for SAVR and 2.4 years (IQR, 1.1-4.5
number of patients who underwent TAVR pro- years) for TAVR. Before propensity score match-
cedures increased from 16 (7.2% of all replace- ing, 30-day mortality for SAVR and TAVR was
ment procedures) in 2013 to 111 (45.7%) in 2021 similar (0.2% vs 0.4%, P ¼ .20). The 30-day overall
(annual percentage change, 4.7%; P < .001) readmission rates were significantly higher among
(Figure 2). The distribution of individual hospital TAVR patients (12.6% vs 8.4%, P ¼ .003). Among
volume and procedure choice is depicted in patients without a history of permanent pace-
Supplemental Figure 1. The total volume of maker placement, 10.5% of TAVR patients needed
TAVR and SAVR in California stratified by age is a new pacemaker within 30 days postoperatively
depicted in Figure 3. compared with 5% of SAVR patients (P < .001).
The unadjusted survival was lower for TAVR
OVERALL COHORT OUTCOMES. The baseline character- compared with SAVR at 5 years (86% vs 98%;
istics of patients who underwent TAVR or SAVR hazard ratio [HR] 6.63; 95% CI, 4.53-9.71; P < .001)
are summarized in Table 1. The age distributions (Figure 4). These results were similar in sensitivity

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FIGURE 3 Overall volume of surgical aortic valve replacement (SAVR), including both bioprosthetic and mechanical, and
transcatheter aortic valve replacement (TAVR) in California between 2013 and 2021, stratified by age. (ACC, American
College of Cardiology; AHA, American Heart Association; FDA, Food and Drug Administration.)

analyses, including those receiving SAVR with a Readmission rates at 30 days were similar be-
mechanical prosthesis, excluding those with tween TAVR and SAVR groups (11.2% vs 10.9%,
bicuspid aortopathy based on ICD-9 and ICD-10 P ¼ .89). There were no differences in the absolute
codes, and among those undergoing TAVR vs risk difference in 30-day mortality or stroke (1
SAVR after Food and Drug Administration event total for each outcome). The 30-day per-
approval for low-risk TAVR in 2019 (Supplemental manent pacemaker rate was not statistically
Figures 4-6). Survival was also improved for SAVR different between TAVR and SAVR groups (7.5%
compared with TAVR at 2.5 years (Supplemental vs 6.1%, P ¼ .46).
Figure 7). The 5-year cumulative incidence of At 5-years, TAVR was associated with a signifi-
reoperation (2.2% vs 3.8%, P ¼ .25), stroke (1.1% vs cantly increased hazard of mortality (11.3% vs
0.8%, P ¼ .39), endocarditis (0.8% vs 0.4%, P ¼ 3.3%; HR, 2.48; 95% CI, 1.13-3.74; P ¼ .02)
.38), and heart failure readmission (1.9% vs 1.2%, (Figure 5). This difference was similar when
P ¼ .10) was similar for SAVR and TAVR, respec- analysis was limited to 2.5-year survival
tively (Supplemental Figure 8). (Supplemental Figure 10). Differences in the
cumulative incidences of secondary outcomes of
PROPENSITY-MATCHED COHORT OUTCOMES. Propensity reintervention (3.3% vs 5.4%), stroke (0.9% vs
score matching yielded 358 pairs of patients who 0.7%), infective endocarditis (0.6% vs 0.4%), and
underwent TAVR or SAVR. The characteristics of readmissions for heart failure (2.2% vs 2.2%)
patients after propensity score matching are were not statistically significant between cohorts
summarized in Table 1. The distribution of (Table 2).
propensity scores before and after matching are
depicted in Supplemental Figure 9. COMMENT
There was no statistically significant risk dif-
ference in 30-day mortality between the 2 groups Our study describes outcomes in young adults
(risk difference, 0.01; 95% CI, 0.002 to 0.01). with severe symptomatic aortic stenosis who

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TABLE 1 Baseline Characteristics of Patients Aged 60 Years Who Had TAVR or SAVR Before and After Propensity Score Matching

Before Propensity Score Matching After Propensity Score Matching


Characteristic TAVR (n ¼ 523) SAVR (n ¼ 1837) P Value TAVR (n ¼ 358) SAVR (n ¼ 358) SMD (%)
Sex <.001 5
Male 331 (63.3) 1303 (70.9) 238 (66.5) 229 (64.0)
Female 192 (36.7) 534 (29.1) 120 (33.5) 129 (36.0)
Age 56 (52-58) 55 (51-58) <.001 56 (52-58) 55 (52-58) 5
Race/ethnicity <.001
White 289 (55.3) 1042 (56.7) 199 (55.6) 206 (57.5) 4
Black 38 (7.3) 72 (3.9) 22 (6.1) 18 (5.0) 5
Hispanic 131 (25.0) 563 (30.6) 90 (25.1) 107 (29.9) 11
Asian 29 (5.5) 82 (4.5) 19 (5.3) 14 (3.9) 6
Other 17 (3.3) 44 (2.4) 14 (3.9) 6 (1.7) 13
Unknown 19 (3.7) 34 (1.9) 14 (3.9) 7 (1.9) 6
Annual hospital volume 198 (111-460) 149 (54-396) <0.001 180 (107-440) 179 (76-484) 4
Insurance status <0.001
Medicare 152 (29.1) 166 (9.0) 64 (17.9) 58 (16.2) 4
Medicaid 105 (20.1) 361 (19.7) 79 (22.1) 73 (20.4) 4
Private insurance 246 (47.0) 1238 (67.4) 197 (55.0) 209 (58.4) 7
Uninsured 2 (0.4) 11 (0.6) 2 (0.6) 2 (0.6) 0
Other insurance 17 (3.3) 61 (3.3) 15 (4.2) 16 (4.5) 2
Elective admission 377 (72.1) 1446 (78.7) .001 258 (72.1) 272 (76.0) 9
Hypertension 454 (86.8) 1366 (74.4) <.001 292 (81.6) 292 (81.6) 0
Heart failure 386 (73.8) 754 (41.0) <.001 218 (60.9) 207 (57.8) 7
Congenital heart disease 5 (1) 12 (0.7) .56 2 (0.6) 2 (0.6) 3
Coronary artery disease 374 (71.5) 766 (41.7) <.001 221 (61.7) 213 (59.5) 5
Hyperlipidemia 408 (78.0) 1099 (59.8) <.001 253 (70.7) 243 (67.9) 6
Cerebrovascular disease 94 (18.0) 112 (6.1) <.001 51 (14.2) 32 (8.9) 17
Peripheral vascular disease 202 (38.6) 339 (18.5) <.001 104 (29.1) 100 (27.9) 3
Coagulopathy 146 (27.9) 220 (12.0) <.001 70 (19.6) 71 (19.8) 1
Atrial fibrillation 111 (21.2) 258 (14.0) <.001 59 (16.5) 57 (15.9) 1
Ventricular arrhythmias 40 (7.6) 65 (3.5) <.001 21 (5.9) 18 (5.0) 4
Diabetes mellitus 285 (54.5) 526 (28.6) <.001 155 (43.3) 153 (42.7) 1
Chronic obstructive pulmonary disease 206 (39.4) 439 (23.9) <.001 109 (30.4) 112 (31.3) 2
Chronic kidney disease 233 (44.6) 247 (13.4) <.001 107 (29.9) 92 (25.7) 10
Dialysis dependency 135 (25.8) 70 (3.8) <.001 43 (12.0) 44 (12.3) 1
Liver disease 199 (38.0) 302 (16.4) <.001 104 (29.1) 94 (26.3) 6
Cancer 140 (26.8) 149 (8.1) <.001 76 (21.2) 71 (19.8) 4
Immobility 52 (9.9) 31 (1.7) <.001 14 (3.9) 12 (3.4) 2
Oxygen dependency 39 (7.5) 25 (1.4) <.001 15 (4.2) 15 (4.2) 0
Tobacco use 258 (49.3) 733 (39.9) <.001 160 (44.7) 151 (42.2) 5
Alcohol use 81 (15.5) 260 (14.2) .44 54 (15.1) 54 (15.1) 0
Drug use 96 (18.4) 225 (12.2) <.001 52 (14.5) 53 (14.8) 1
Charlson Comorbidity Index 3.74 (1.52-7.36) 0.89 (0.02-2.29) <.001 2.74 (1.06-5.87) 2.48 (0.98-5.01) 16

Data are reported as n (%) or median (interquartile range). SAVR, surgical aortic valve replacement; SMD, standardized mean difference; TAVR, transcatheter aortic valve replacement.

were largely excluded from the key random- endocarditis, and stroke were similar between
ized trials of SAVR vs TAVR. ACC/AHA the 2 groups.
consensus guidelines recommend SAVR in Over the study period, a significant increase
adults aged 65 who are not at prohibitive occurred in the proportion of patients undergoing
surgical risk; however, nearly half of all young TAVR. Our results are consistent with findings
adults in California receiving a bioprosthetic provided by Sharma and colleagues1 analyzing
valve underwent TAVR in 2021. Survival at 5 procedural trends in a national cohort of all
years was lower in propensity-matched pa- patients undergoing aortic valve intervention
tients undergoing TAVR. Secondary outcomes captured by the Vizient Clinical Database. In
of readmission for heart failure, reintervention, their analysis, 47.5% of all adults aged 65 with

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FIGURE 4 Survival at 5 years of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic
valve replacement (SAVR) in California in the overall cohort. The shaded areas indicate the 95% CI. (HR, hazard ratio.)

severe aortic stenosis undergoing intervention structural valve degeneration; however, these
received TAVR. These findings suggest that devices have not been studied in detail in younger
patients and providers are increasingly more cohorts at heightened risk for this critical
willing to opt for minimally invasive therapy in complication.15 Given no statistical differences in
the absence of high-quality randomized, long- key secondary outcomes between the 2 groups,
term data. the mechanism by which TAVR was associated
Survival at 5 years after SAVR was 98% in our with increased mortality in patients aged 60
overall study population, consistent with national remains unclear based on our study.
outcomes from the STS database after low-risk Our data suggest that current clinical practice
SAVR published by Thourani and colleagues.13 within California has departed from ACC/AHA
Propensity score matching showed there was a guidelines for aortic valve stenosis management
nearly 2.5-fold increase in the hazard of 5-year in young adults. Although shared decision making
mortality after TAVR. No differences were seen is a quality metric within the Transcatheter Valve
in the cumulative incidences of reintervention, Therapy registry when selecting patients for
stroke, infective endocarditis, or heart failure TAVR, the ACC/AHA may need to consider
readmissions. It is unclear whether structural whether patient preference should be incorpo-
valve degeneration contributed to poorer survival rated into the next iteration of clinical decision-
in the TAVR vs SAVR group given the lack of making guidelines for the choice between TAVR
echocardiographic follow-up data. Several risk and SAVR in patients for whom a bioprosthetic
factors for accelerated structural valve degenera- valve replacement is appropriate. Implementing
tion exist, of which younger age is one of the updated consensus guidelines in the absence of
major risk factors.14 Newer-generation trans- long-term randomized data is particularly chal-
catheter valves have been shown to have reduced lenging. This evidence gap could be addressed

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FIGURE 5 Survival at 5 years of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic
valve replacement (SAVR) in California after propensity score matching. The shaded areas indicate the 95% CI. (HR, hazard
ratio.)

with randomized trials comparing TAVR vs SAVR LIMITATIONS. This is a large multicenter study
in young adults with the newer generation of examining midterm outcomes of TAVR vs SAVR in
transcatheter valve technologies to better inform young adults with severe aortic stenosis. However,
clinical practice. Existing evidence-based data our study has several limitations:
suggests that further expansion of TAVR to young Unmeasured confounders may have contrib-
adults may best be limited to those at particularly uted to the survival differences identified be-
high or prohibitive surgical risk. tween TAVR and SAVR groups.
Given the use of an administrative database,
echocardiographic data are unavailable, and thus,
TABLE 2 Secondary Outcomes of Reintervention, Stroke, Infective
no comments can be made on preoperative ven-
Endocarditis, and Readmission for Heart Failure in Propensity-Matched tricular function and postoperative valve
Patients at 5 Years hemodynamics.
Third, this study excluded patients who un-
Hazard
Outcome TAVR (%) SAVR (%) Ratio (95% CI) derwent the Ross procedure or mechanical AVR.
Reintervention 3.3 (0.1-7.9) 5.4 (2.2-10.6) 0.63 (0.23-1.73) Furthermore, the decrease in overall proced-
Stroke 0.9 (0.2-2.3) 0.7 (0.1-2.4) 1.53 (0.26-9.15) ures performed in 2020 and 2021 may be attrib-
Infective endocarditis 0.6 (0.1-2.9) 0.4 (0.001-2.3) 1.03 (0.06-16.43) uted to the coronavirus disease 2019 pandemic
Readmission for heart failure 2.2 (0.5-6.2) 2.2 (0.5-6.3) 1.36 (0.30-6.07) which could have affected our results, and death
from coronavirus was not able to be identified
Data are summarized as cumulative incidences with 95% CIs. SAVR, surgical aortic valve replacement;
TAVR, transcatheter aortic valve replacement. from the database and thus could not be
excluded.

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2024;-:--- TAVR VS SAVR IN CALIFORNIA ADULTS £60

Fifth, we are unable to account for any primary patients. Randomized clinical trials are warranted to
or secondary outcome data points that occurred better inform practice, and future consensus
outside the California state health system. guidelines may need to incorporate patient
Although we limited our study to patients with preference between transcatheter and open surgical
residence in California throughout the study intervention to better reflect real-world practice.
period, we may be underestimating the total
The data used to produce this publication were provided by the Cali-
number of primary and secondary outcome events.
fornia Department of Health Care Access and Information. However, the
Finally, we are unable to comment on referral conclusions derived, and views expressed herein are those of the au-
patterns of whether patients were first evaluated thors and do not reflect the conclusions or views of the California
Department of Health Care Access and Information. Its employees, of-
by an interventional cardiologist, surgeon, or
ficers, and agents make no representation, warranty, or guarantee as to
multidisciplinary heart team, which may have the accuracy, completeness, currency, or suitability of the information
impacted ultimate procedure choice. provided here.

CONCLUSION. Nearly 50% of patients with severe FUNDING SOURCES


The authors have no funding sources to disclose.
aortic stenosis aged 60 years receiving a bio-
prosthetic valve are undergoing TAVR in California in DISCLOSURES
Dr Joanna Chikwe serves as The Annals of Thoracic Surgery Editor-In-
the current era. TAVR is associated with an increased
Chief. The other authors have no conflicts of interest to disclose.
hazard of 5-year mortality in propensity-matched

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