Guidelines Vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults 60 Years
Guidelines Vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults 60 Years
Guidelines Vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults 60 Years
00 1
Published by Elsevier Inc. https://doi.org/10.1016/j.athoracsur.2024.07.036
Valve: Research
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.
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
2 J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL Ann Thorac Surg
TAVR VS SAVR IN CALIFORNIA ADULTS £60 2024;-:---
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
Ann Thorac Surg J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL 3
2024;-:--- TAVR VS SAVR IN CALIFORNIA ADULTS £60
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
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
4 J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL Ann Thorac Surg
TAVR VS SAVR IN CALIFORNIA ADULTS £60 2024;-:---
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
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
Ann Thorac Surg J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL 5
2024;-:--- TAVR VS SAVR IN CALIFORNIA ADULTS £60
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
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
6 J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL Ann Thorac Surg
TAVR VS SAVR IN CALIFORNIA ADULTS £60 2024;-:---
TABLE 1 Baseline Characteristics of Patients Aged 60 Years Who Had TAVR or SAVR Before and After Propensity Score Matching
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
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
Ann Thorac Surg J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL 7
2024;-:--- TAVR VS SAVR IN CALIFORNIA ADULTS £60
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
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
8 J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL Ann Thorac Surg
TAVR VS SAVR IN CALIFORNIA ADULTS £60 2024;-:---
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.
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.
Ann Thorac Surg J. MAXWELL CHAMBERLAIN MEMORIAL PAPER ALABBADI ET AL 9
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.
REFERENCES
1. Sharma T, Krishnan AM, Lahoud R, et al. National trends in TAVR and 9. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve
SAVR for patients with severe isolated aortic stenosis. J Am Coll Cardiol. replacement in low-risk patients at five years. N Engl J Med. 2023;389:
2022;80:2054-2056. 1949-1960.
2. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve 10. Forrest JK, Deeb GM, Yakubov SJ, et al. 4-year outcomes of patients
replacement with a self-expanding prosthesis. N Engl J Med. 2014;370: with aortic stenosis in the Evolut low risk trial. J Am Coll Cardiol. 2023;82:
1790-1798. 2163-2165.
3. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve im-
11. Thyregod HGH, Jørgensen TH, Ihlemann N, et al. Transcatheter or
plantation for aortic stenosis in patients who cannot undergo surgery.
surgical aortic valve implantation: 10-year outcomes of the NOTION trial.
N Engl J Med. 2010;363:1597-1607.
Eur Heart J. 2024;45:1116-1124.
4. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-
valve replacement in intermediate-risk patients. N Engl J Med. 2016;374: 12. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline
1609-1620. for the Management of Patients With Valvular Heart Disease: a report
of the American College of Cardiology/American Heart Association
5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143:
replacement with a balloon-expandable valve in low-risk patients. e72-e227.
N Engl J Med. 2019;380:1695-1705.
13. Thourani VH, Habib R, Szeto WY, et al. Survival after surgical aortic
6. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve
valve replacement in low-risk patients: a contemporary trial benchmark.
replacement with a self-expanding valve in low-risk patients. N Engl J
Ann Thorac Surg. 2024;117:106-112.
Med. 2019;380:1706-1715.
7. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or trans- 14. Dvir D, Bourguignon T, Otto CM, et al. Standardized definition of
catheter aortic-valve replacement in intermediate-risk patients. N Engl J structural valve degeneration for surgical and transcatheter bio-
Med. 2017;376:1321-1331. prosthetic aortic valves. Circulation. 2018;137:388-399.
8. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic- 15. Belle EV, Delhaye C, Vincent F. Structural valve deterioration at 5
valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198. years of TAVR versus SAVR. J Am Coll Cardiol. 2020;76:1844-1847.
Downloaded for CBS LMU (cbslmu@yahoo.com) at R4L.Bangladesh [CK] from ClinicalKey.com by Elsevier on November
05, 2024. For personal use only. No other uses without permission. Copyright ©2024. Elsevier Inc. All rights reserved.