Abstract
Introduction
There is a paucity of data regarding the trends and comparative outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among patients with polyvascular disease (PVD).
Methods
The Nationwide Readmissions Database (2016–2020) was queried for patients undergoing AVR. Propensity score matching was used to compare the outcomes of TAVR versus SAVR among patients with PVD, and for comparing TAVR among those with versus without PVD. The primary outcome was in-hospital mortality.
Results
The final cohort included 545,409 hospitalizations for AVR. During the study years, there was an increase in the utilization of TAVR versus SAVR among patients with PVD. Patients with PVD undergoing TAVR were older and more likely to be women compared with patients with PVD undergoing SAVR. Compared with SAVR, patients with PVD undergoing TAVR had lower odds of in-hospital mortality (adjusted odds ratio (aOR) 0.26; 95% confidence interval (CI) 0.19–0.35), acute myocardial infarction (AMI), ischemic stroke, hemorrhagic stroke, and major bleeding, but higher odds of pacemaker and non-elective 90-day readmissions (aOR 1.13; 95% CI 1.01–1.26). TAVR among patients with versus without PVD showed similar in-hospital mortality (aOR 1.10; 95% CI 0.94–1.20), while there were higher odds of AMI, ischemic stroke, and vascular complications after TAVR in patients with PVD. A higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR more than with TAVR, while a higher burden of atherosclerotic vascular beds conferred a higher risk of ischemic stroke and readmissions after both TAVR and SAVR.
Conclusions
Nationwide data demonstrated that patients with PVD who undergo TAVR were associated with lower in-hospital mortality and major cardiovascular complications compared with those who undergo SAVR. Patients with PVD have similar mortality to those with no PVD undergoing TAVR, but were associated with a higher risk for complications and readmission.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40119-025-00415-7.
Keywords: Aortic stenosis, Aortic valve replacement, Polyvascular disease
Plain Language Summary
The Nationwide Readmissions Database (2016–2020) was queried for patients undergoing aortic valve replacement AVR (n = 545,409). There was an increase in the utilization of transcatheter aortic valve replacement (TAVR) in favor of surgical aortic valve replacement (SAVR) among patients with polyvascular disease. Patients with polyvascular disease undergoing TAVR had lower odds of in-hospital mortality, myocardial infarction, ischemic stroke, hemorrhagic stroke, and major bleeding compared with SAVR, but higher odds of pacemaker and non-elective 90-day readmissions. TAVR among patients with versus without polyvascular disease showed similar in-hospital mortality, while there were higher odds of myocardial infarction, ischemic stroke, and vascular complications after TAVR in patients with polyvascular disease. A higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR than with TAVR.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40119-025-00415-7.
Key Summary Points
| Why carry out this study? |
| There is a paucity of data regarding the trends and comparative outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among patients with polyvascular disease (PVD). |
| Using the NRD (2016–2020), propensity score matching was used to compare the outcomes of TAVR versus SAVR among patients with PVD, and for comparing TAVR among those with versus without PVD. |
| What was learned from the study? |
| Nationwide data demonstrated that patients with PVD who undergo TAVR were associated with lower in-hospital mortality and major cardiovascular complications compared with those who undergo SAVR. Patients with PVD have similar mortality to those with no PVD undergoing TAVR but were associated with a higher risk of complications and readmission. |
| Future studies should explore the long-term outcomes of AVR among patients with PVD. |
Introduction
Aortic stenosis (AS) is a prevalent valvular heart disease, estimated to affect 1.5 million patients in the United States and 12.6 million patients worldwide [1]. The mainstay of treatment for symptomatic AS is either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) [2]. Studies have established a robust correlation between atherosclerotic disease and AS, and both conditions share common risk factors, including aging, smoking, hypertension, and diabetes [3]. The severity and progression of atherosclerotic disease significantly influence the assessment of patients with AS for appropriate AVR modalities [3]. Studies have suggested that patients with prior atherosclerotic cardiovascular disease are at higher procedural risk after AVR [4–6]. Polyvascular disease (PVD) represents a heightened condition of systemic atherosclerotic disease, defined as two or more atherosclerotic vascular beds, including coronary artery disease (CAD), peripheral arterial disease, or cerebrovascular disease [7]. It is hypothesized that many patients with PVD would be considered to be at high surgical risk when evaluated for SAVR, and that the introduction of TAVR could provide an important treatment option for these patients. There is a paucity of data regarding the trends and comparative outcomes of TAVR versus SAVR among patients with PVD. Furthermore, the additive risk of TAVR among patients with PVD compared with those without PVD has not been reported. Patients with PVD are more likely to have prohibitive femoral vascular access and require alternative access TAVR, which may be associated with higher periprocedural risk compared to transfemoral TAVR [8]. Using a large national dataset, we primarily aimed to evaluate the outcomes of TAVR versus SAVR among patients with PVD, and also evaluate the outcomes of TAVR in patients with versus without PVD.
Methods
Data Source
The National Readmission Database (NDR) from years 2016 to 2020 was used for our study. The NRD was developed as a publicly accessible database that compiles all-payer inpatient stays. Agency for Healthcare Research and Quality through the Healthcare and Utilization Project (AHRQ) [9]. The NRD is drawn from geographically dispersed 30 states and accounts for 61.8% of the total U.S. resident population and 60.4% of all U.S. hospitalizations [9]. The NRD includes patient linkage numbers that track sequential visits for a patient within a state and across facilities while adhering to strict privacy guidelines. All discharge records of patients treated in United States community hospitals, except for rehabilitation and long-term acute care facilities, are included in the NRD. National estimates could be derived based on validated discharge weights. This study was deemed exempt from hospital institutional review boards as the NRD is a publicly available database that contains de-identified patient information [9].
Study Population
The NRD database was queried from 2016 to 2020 for patients who underwent TAVR or SAVR using ICD-10 procedural codes (Supplemental Table 1). Patients with a diagnosis of PVD were then identified using ICD-10 diagnostic codes (Supplemental Table 1). PVD was defined as two or more atherosclerotic vascular beds, including CAD, peripheral arterial disease, or cerebrovascular disease. Peripheral arterial disease included patients with lower or upper extremity arterial disease, renovascular disease, or abdominal aortic aneurysm (Supplemental Table 1). The use of ICD codes in identifying patients with prior atherosclerotic disease has been validated to carry high specificity and positive predictive value [10–13]. Patients were excluded if they were missing survival status or had concomitant surgeries, including mitral valve, pulmonic valve, and tricuspid valve surgeries. To avoid capturing patients with moderate AS who underwent SAVR during planned CABG, we excluded patients with combined SAVR and CABG if the principal admission diagnosis was not related to AS. Patients who underwent combined SAVR and TAVR in the index admission were also excluded. Readmissions were evaluated in the study cohort after excluding hospitalized patients in October–December to allow for a 90-day follow-up for the study cohort.
Outcomes
The temporal trends of TAVR or SAVR among patients with PVD were reported. The trends of AVR per number of affected vascular beds were also reported. The primary study outcome was in-hospital mortality after TAVR versus SAVR among patients with PVD.
Other study outcomes included in-hospital mortality after TAVR in patients with versus without PVD. The following outcomes were evaluated after TAVR versus SAVR among patients with PVD, as well as after TAVR among patients with versus without PVD: major bleeding, acute myocardial infarction (AMI), blood transfusion, vascular complications requiring intervention, complete heart block, acute kidney injury (AKI), acute heart failure exacerbation, transient ischemic attack, acute ischemic stroke, hemorrhagic stroke, postoperative hemorrhage, acute deep venous thrombosis or pulmonary embolism, mechanical circulatory support, other bleeding, pericardial complications, discharge to skilled nursing facility, permanent pacemaker implantation (PPM) and palliative care utilization. The evaluated readmissions outcomes included all-cause non-elective 90-day readmission, AMI-related 90-day readmission, percutaneous coronary intervention (PCI) at 90-day readmission, and PPM at 90-day readmission.
The outcomes of TAVR and SAVR procedures among patients with one, two, and three vascular beds were compared with patients with no atherosclerotic vascular disease, including in-hospital mortality, acute ischemic stroke, and 90-day non-elective readmission.
Statistical Analysis
Trend analyses were evaluated using linear or curvilinear regression analyses, depending on the R-squared results for goodness of fit. Propensity score matching was employed when comparing outcomes of patients with PVD undergoing TAVR versus SAVR. The propensity score was calculated using variables derived from the Society of Thoracic Surgery risk score [6], a validated predictor of survival after AVR, including age, sex, chronic kidney disease (stages 3 to 5), congestive heart failure, chronic pulmonary disease, hypertension, diabetes mellitus, cancer, obstructive sleep apnea, smoking, obesity, liver disease, and payer source.
Another propensity score matching model was utilized when comparing outcomes of patients with versus without PVD who underwent TAVR. The propensity score was calculated using variables derived from a validated risk score to predict outcomes after TAVR [14]. The variables included demographics (age, sex), comorbidities (diabetes, chronic kidney disease (stages 3 to 5), chronic pulmonary disease, and obesity), and hospital variables (hospital stratum, bed size, and teaching status). Propensity scores were estimated through the nearest neighbor method using a caliper width of 0.04 and an exact match for the age. The balance of covariate distribution between treatment groups was ascertained by achieved standardized mean differences (SMD) < 0.1.
Multivariable logistic regression analyses were utilized to examine outcomes of TAVR and SAVR procedures among patients with one, two, and three vascular beds compared with patients with no atherosclerotic vascular disease. Multivariable regression analysis was also employed to evaluate the primary study outcome among patients with PVD undergoing TAVR versus SAVR, including the unmatched study cohort. The multivariable models included similar covariates to those utilized in the propensity score matching models. Subgroup analysis was conducted for in-hospital mortality among patients with PVD undergoing TAVR versus SAVR according to revascularization status (i.e., concomitant percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
All analyses were performed using complex survey analyses adjusting for hospital clustering, stratification, and discharge weights according to the recommendations by AHRQ. Percentages were used to describe categorical variables, and the mean ± SD or median (interquartile range [IQR]) was used to describe continuous variables as appropriate. The Pearson X2 test was used for categorical variables. The non-paired t test and Wilcoxon rank-sum test were used as appropriate for continuous variables. The p values and 95% confidence intervals in this report have not been adjusted for multiplicity, which may affect the reproducibility of conclusions drawn from these statistics. Two-sided p values were used with a significance threshold of p < 0.05. Statistical analyses were conducted through STATA, SE version 16.0 (StataCorp, College Station, TX, USA).
Results
Study Population
The study selection process appears in Fig. 1. The initial analysis yielded 631,552 patients. After excluding patients not meeting our selection criteria, the final cohort included 545,409 hospitalizations, of whom 226,053 (41.4%) underwent SAVR and 319,356 (58.6%) underwent TAVR. The SAVR cohort included 18,451 (8.2%) patients with PVD and 207,602 (91.8%) patients without PVD. The TAVR cohort included 42,531 (13.3%) patients with PVD and 276,825 (86.7%) patients without PVD.
Fig. 1.
Study flow diagram outlining the selection process for the final cohort included in the analysis. Starting with a total cohort of 631,552 patients, exclusions were made for missing data, non-aortic valve surgeries (MV, PV, TV), cases with aortic valve disease not as the principal diagnosis, and transcatheter aortic valve replacement (TAVR) procedures converted to surgical aortic valve replacement (SAVR). This resulted in 545,409 patients eligible for analysis, divided into TAVR (n = 319,356) and SAVR (n = 226,053) groups. Further stratification into polyvascular disease (PVD) and non-PVD subgroups was performed, followed by matching within TAVR groups and between TAVR-PVD and SAVR-PVD groups to create comparable cohorts for analysis
Temporal Trends of Aortic Valve Replacement Among Patients with Polyvascular Disease
Among patients with PVD, there was no change in the number of AVR procedures during the study years (58,028 in 2016 vs. 60,815 in 2020, Ptrend = 0.11). There was an increase in the proportion of TAVRs (39.5% in 2016 to 59.9% in 2020, Ptrend < 0.001), and a decline in the proportion of SAVRs (60.5% in 2016 to 40.1% in 2020, Ptrend < 0.001) during the study years (Fig. 2). Trend analyses per number of affected vascular showed no significant temporal changes in the number of AVR procedures among patients with one, two, or three atherosclerotic beds undergoing AVR (Fig. 2).
Fig. 2.
A Temporal trends in admissions for AVR, TAVR, and SAVR among those with PVD. B Temporal trends in admissions for AVR, TAVR, and SAVR according to the number of vascular beds. Panel A illustrates the temporal trends in admissions for aortic valve replacement (AVR), transcatheter aortic valve replacement (TAVR), and surgical aortic valve replacement (SAVR) among patients with peripheral vascular disease (PVD) from 2016 to 2020. Panel B shows the temporal trends in admissions for AVR, TAVR, and SAVR based on the number of affected vascular beds
Baseline Characteristics
The baseline characteristics of patients with PVD undergoing TAVR versus SAVR appear in Table 1. In the unmatched cohort (TAVR [n = 42,5311 vs. SAVR [n = 18,451]), patients with PVD undergoing TAVR were older and more likely to be women compared with those undergoing SAVR. Also, patients undergoing TAVR had a higher burden of comorbidities. After matching (TAVR [n = 12,1411 vs. SAVR [n = 12,020]), the SMD values were < 0.1 for all the covariates. The baseline characteristics of patients with versus without PVD undergoing TAVR are shown in Table 2. In the unmatched cohort (TAVR-PVD [n = 42,5311 vs. TAVR-non PVD [n = 276,825]), patients with PVD undergoing TAVR were less likely to be women and had higher comorbidities compared with those without PVD. After matching (TAVR-PVD [n = 42,5311 vs. TAVR-non PVD [n = 41,982]), the SMD values were < 0.1 for all the covariates.
Table 1.
Baseline characteristics among PVD patients undergoing TAVR versus SAVR
| Unmatched | Matched | ||||
|---|---|---|---|---|---|
| SAVR-PVD (n = 18,451) |
TAVR-PVD (n = 42,531) |
SAVR-PVD (n = 12,020) |
TAVR-PVD (n = 12,141) |
Standardized mean difference | |
| Age, years (mean + SD) | 68.6 + 10.3 | 79.3 + 8.0 | 72.5 + 7.9 | 72.5 + 7.9 | 0.00 |
| Female | 27.2% | 34.9% | 29.0% | 31.6% | 0.05 |
| Chronic kidney disease stage [3–5] | 24.0% | 43.9% | 30.5% | 34.0% | 0.08 |
| Chronic heart failure | 47.3% | 81.9% | 62.9% | 64.0% | 0.02 |
| Chronic pulmonary disease | 26.9% | 33.6% | 30.9% | 33.8% | 0.07 |
| Hypertension | 87.9% | 93.2% | 90.9% | 91.5% | 0.02 |
| Diabetes mellitus | 33.3% | 39.3% | 37.0% | 42.2% | 0.10 |
| Cancer | 4.3% | 5.9% | 5.0% | 5.1% | 0.02 |
| Obstructive sleep apnea | 16.6% | 15.0% | 16.6% | 17.1% | 0.03 |
| Smoking | 52.1% | 49.5% | 52.3% | 54.4% | 0.04 |
| Obesity | 25.9% | 17.5% | 24.1% | 24.8% | 0.02 |
| Liver disease | 4.3% | 3.0% | 4.2% | 4.2% | 0.00 |
| Insurance | – 0.02 | ||||
| Medicare | 68.2% | 90.7% | 80.7% | 83.4% | |
| Medicaid | 5.5% | 1.1% | 3.3% | 2.8% | |
| Private insurance | 22.4% | 5.5% | 13.1% | 10.0% | |
| Self-pay | 1.3% | 0.3% | 0.9% | 0.6% | |
| Number of vascular bed diseases | 2-vessel (86.5%)/3-vessel (13.5%) | 2-vessel (91.0%)/ 3-vessel (9.0%) | 2-vessel (87.3%)/3-vessel (12.7%) | 2-vessel (89.5%)/ 3-vessel (10.5%) | 0.07 |
SD standard deviation, BMI body mass index, SD standard deviation
Table 2.
Baseline characteristics for patients with versus without PVD undergoing TAVR
| Unmatched | Matched | ||||
|---|---|---|---|---|---|
| TAVR-PVD (n = 42,531) |
TAVR- non-PVD (n = 276,825) |
TAVR-PVD (n = 42,531) |
TAVR- non-PVD (n = 41,982) |
Standardized mean difference | |
| Age, years (mean + SD) | 79.3 + 8.0 | 79.1 + 8.6 | 79.3 + 8.0 | 79.3 + 8.0 | 0.00 |
| Female | 34.9% | 45.8% | 34.9% | 41.9% | 0.15 |
| Diabetes mellitus | 39.3% | 37.7% | 39.3% | 38.7% | – 0.02 |
| Chronic kidney disease stage 3 or more | 43.9% | 34.0% | 43.9% | 38.1% | – 0.12 |
| End-stage renal disease | 4.6% | 3.6% | 4.6% | 3.9% | – 0.04 |
| Obesity BMI>40 | 3.7% | 6.8% | 3.7% | 6.0% | 0.11 |
| Chronic pulmonary disease | 33.6% | 26.3% | 33.6% | 30.1% | – 0.07 |
| Number of vascular bed diseases |
0-vessel (61.2%)/ 1-vessel (38.8%) |
2-vessel (86.5%)/ 3-vessel (13.5%) | 0-vessel (60.2%)/ 1-vessel (39.8%) | 2-vessel (86.5%)/ 3-vessel (13.5%) | – 4.1 |
Outcomes of Transcatheter versus Surgical Aortic Valve Replacement Among Patients with Polyvascular Disease
Among the matched cohorts, patients with PVD who underwent TAVR had lower odds of in-hospital mortality compared with patients who underwent SAVR (1.1% vs. 4.0%; OR 0.26; 95% CI 0.19–0.35). Similar results were obtained on a multivariable analysis involving the unmatched study cohort (1.6% vs. 3.4%; OR 0.27; 95% CI 0.22–0.33). Patients with PVD who underwent TAVR versus SAVR had lower major bleeding, acute MI, blood transfusion, acute kidney failure, transient ischemic attack, ischemic stroke, hemorrhagic stroke, postoperative hemorrhage, acute deep venous thrombosis or pulmonary embolism, mechanical circulatory support, other bleeding, pericardial complications, discharge to skilled nursing facility, and palliative care utilization. Patients with PVD undergoing TAVR versus SAVR had higher vascular interventions, complete heart block, acute heart failure exacerbation, and PPM (Fig. 3).
Fig. 3.
Forest plot for adjusted outcomes for TAVR versus SAVR among those with PVD. Adjusted odds ratios comparing various adverse outcomes in transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) patients within the peripheral vascular disease (PVD) cohort. Each point represents the adjusted odds ratio for a specific outcome, with horizontal lines indicating the 95% confidence intervals. Outcomes to the right of the dotted line (OR > 1) indicate a higher likelihood in the TAVR group, while outcomes to the left (OR < 1) indicate a higher likelihood in the SAVR group
Patients with PVD who underwent TAVR had higher unplanned 90-day readmission (20.2% vs. 17.6% aOR 1.13; 95% CI 1.01–1.26), as well as higher readmission-related AMI, PCI, and PPM compared with the patients with PVD who underwent SAVR. Results related to event rates among matched patients with PVD who underwent TAVR and SAVR are presented in Supplemental Table 2. Among patients with PVD, concomitant coronary revascularization occurred in 36.9% of SAVR procedures (i.e., CABG), and 5.1% of TAVR procedures (i.e., PCI). A subgroup analysis suggested an interaction in outcomes of TAVR versus SAVR according to coronary revascularization status (Pinteraction < 0.001). Among those undergoing coronary revascularization, there was no difference in in-hospital mortality between TAVR versus SAVR (aOR 0.84; 95% CI 0.53, 1.31, p = 0.44), while among those not undergoing coronary revascularization, there was lower in-hospital mortality after TAVR versus SAVR (aOR 0.21; 95% CI 0.16, 0.27, p < 0.001).
Outcomes of Transcatheter versus Surgical Aortic Valve Replacement Among Patients without Polyvascular Disease
Among the matched cohort, there were similar odds of in-hospital mortality among those with versus without PVD who underwent TAVR, (1.6% vs. 1.5%, aOR 1.10; 95% CI 0.94–1.20, p = 0.23). TAVR among patients with PVD versus without PVD had similar odds of major bleeding, complete heart block, transient ischemic attack, hemorrhagic stroke, postoperative hemorrhage, acute deep venous thrombosis or pulmonary embolism, pericardial complications, and palliative care utilization. Patients who underwent TAVR with PVD had higher odds of acute MI, blood transfusion, vascular interventions, acute kidney failure, acute HF exacerbation, ischemic stroke, mechanical circulatory support, discharge to skilled nursing facility, and lower odds of PPM implantation compared with patients without PVD (Fig. 4). There were similar odds of unplanned 90-day readmission after TAVR among those with versus without PVD (20.2% vs. 17.6%, aOR 1.14; 95% CI 1.08–1.21), while TAVR among patients with PVD had higher odds of readmission-related AMI and a lower rate of PPM compared to the patients without PVD. Results related to event rates among matched patients with PVD vs. without PVD who underwent TAVR are presented in Supplemental Table 3.
Fig. 4.
Forest plot for adjusted outcomes for TAVR among those with versus without PVD. Adjusted odds ratios comparing various adverse outcomes in transcatheter aortic valve replacement (TAVR) patients with peripheral vascular disease (PVD) to those without PVD. Each point represents the adjusted odds ratio for a specific outcome, with horizontal lines indicating the 95% confidence intervals. Outcomes to the right of the dotted line (OR > 1) are more likely in the TAVR-PVD cohort, while those to the left (OR < 1) are more likely in the non-PVD cohort
Outcomes According to Number of Atherosclerotic Vascular Beds
In Fig. 5, we present the outcomes of TAVR and SAVR procedures per the number of atherosclerotic vascular beds. Compared with patients without any vascular disease, patients with one (aOR 1.43; 95% CI 1.30, − 1.56), two (aOR 1.63; 95% CI 1.39, − 1.90), and three (aOR 1.02; 95% CI 1.01, − 1.022), atherosclerotic vascular beds had higher odds of in-hospital mortality after SAVR. Comparatively, there were increased odds of in-hospital mortality among those with one (aOR 1.20; 95% CI 1.08, − 1.33), two (aOR 1.28; 95% CI 1.09, 1.48), three (aOR 1.18; 95% CI 0.81, − 1.70) atherosclerotic vascular beds after TAVR, albeit the observation for three vascular beds did not reach statistical significance. There was a progressively increased risk of ischemic stroke and 90-day unplanned readmissions after SAVR with increasing an number of affected vascular beds after both TAVR and SAVR.
Fig. 5.
Forest plot for adjusted outcomes after SAVR and TAVR according to the number of vascular beds compared to patients with no PVD. Forest plot illustrating adjusted outcomes following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), categorized by the number of affected vascular beds, compared to patients with no peripheral vascular disease. Panel A shows outcomes for patients who underwent SAVR, while panel B presents outcomes for patients who underwent TAVR
Discussion
In an analysis of 545,409 patients undergoing AVR, we demonstrated the following salient findings: (1) there was an increase in the utilization of TAVR in favor of SAVR among patients with PVD; (2) patients with PVD undergoing TAVR had lower odds of in-hospital mortality, AMI, ischemic stroke, hemorrhagic stroke and major bleeding compared with SAVR, but higher odds of PPM and non-elective 90-day readmissions; (3) TAVR among patients with versus without PVD showed similar in-hospital mortality, while there were higher odds of AMI, ischemic stroke and vascular interventions after TAVR in patients with PVD; (4) a higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR more than with TAVR, while a higher burden of atherosclerotic vascular beds conferred higher risk of ischemic stroke and readmissions after both TAVR or SAVR.
Temporal Trends of TAVR in PVD
Landmark randomized clinical trials evaluating the outcomes of TAVR versus SAVR have not examined the frequency of PVD among their study cohorts [15–20]. Similarly, little is known regarding the differences in the uptake and outcomes TAVR versus SAVR among patients with PVD. The current analysis is the first to report the trend of AVR among patients with PVD. We observed that the number of patients with PVD who are offered AVR has not changed during the study years. A complementary analysis showed similar plateauing in the number of AVRs as per the number of atherosclerotic vascular beds. However, our analysis demonstrated that patients with PVD evaluated for AVR have been increasingly referred towards TAVR, compared with SAVR. In the context of the favorable outcomes observed with TAVR versus SAVR, our analysis demonstrated that the wide adoption of TAVR has provided a safer alternative for treating patients with PVD and severe aortic stenosis.
Outcomes of Transcatheter versus Surgical Aortic Valve Replacement Among Patients with Polyvascular Disease
In the current analysis, we have demonstrated that PVD patients undergoing SAVR had a fourfold higher mortality risk than those undergoing TAVR. Additionally, we reported a novel finding that a higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR than with TAVR. The heightened mortality risk with SAVR in PVD was driven by a higher risk of in-hospital complications such as AMI, stroke, major bleeding, blood transfusions, AKI, and pericardial complications, compared with TAVR in PVD. Specifically, we demonstrated that patients with PVD undergoing SAVR were 2.5- and 3.5-fold more likely to develop ischemic and hemorrhagic strokes, respectively, compared to those undergoing TAVR. Such finding comes in contrast with data on all-comers evaluated for AVR, where recent reports suggest similar short-term risk of stroke after TAVR or SAVR [21].
Outcomes of Transcatheter versus Surgical Aortic valve Replacement Among Patients without Polyvascular Disease
Our analysis demonstrated that PVD itself does not seem to increase mortality risk when comparing patients with PVD undergoing TAVR versus those without PVD. This is dissimilar to the only study to date that evaluated the impact of PVD on TAVR. Yamawaki et al. showed that procedural mortality was 4.5% versus 2.0%, with a higher incidence of cardiovascular death in 2 years up to 2.5-fold in those with PVD versus without [22]. Our analysis includes a much larger sample size and reflects more contemporary practices in TAVR procedure compared with the analysis of Yamawaki et al.’s patients with PVD undergoing TAVR who had higher odds of developing in-hospital complications such as AMI, ischemic stroke, AKI, acute heart failure, and requirement of mechanical circulatory support. These are important findings that are likely related to a higher burden of atherosclerotic disease and traditional cardiac risk factors among patients with PVD. Prior studies have suggested that patients with prior atherosclerotic disease are at higher risk for cerebrovascular complications after TAVR [23].
Concurrent CAD is common in patients with PVD and plays an important role in determining the treatment plan for patients with aortic stenosis. In our analysis, we conducted exploratory subgroup analyses that showed an interaction in the primary study outcome according to the status of coronary revascularization (PCI or CABG). The aforementioned favorable outcome with TAVR versus SAVR in patients with PVD was more prominent among patients who did not receive concurrent coronary revascularization, while this benefit was not demonstrated among those who underwent concurrent coronary revascularization. It is plausible that extensive CAD in patients with PVD would require complex PCI intervention, and the associated risks might mitigate the benefits of TAVR in certain patients with PVD. However, details of coronary revascularization procedures were not present for our analysis, and such a hypothesis could not be verified.
Our results demonstrated that similar to all comers, patients with PVD undergoing SAVR were at lower risk of developing complete heart block and less likely to end up requiring PPM [24]. However, PVD does not appear to increase the risk of PPM in patients undergoing TAVR.
Readmissions After Aortic Valve Replacement in Polyvascular Disease
The current analysis demonstrated that TAVR in patients with PVD appears to be at high risk for readmissions compared with either patients with PVD undergoing SAVR or patients without PVDs undergoing TAVR especially readmissions for AMI requiring PCI. This suggests that patients with PVD are at heightened risk for both short and mid-term outcomes and warrant closer follow-up and prompt management of evolving symptoms. Some of the common risk factors for all-cause readmission following TAVR are diabetes, chronic obstructive pulmonary disease, atrial fibrillation, and chronic kidney disease, which were more prevalent in our TAVR PVD cohort [25, 26]. Future studies should explore other specific causes contributing to the high readmission rate among patients with PVD undergoing TAVR. The role of pursuing aggressive antithrombotic treatment to reduce the occurrence of ischemic outcomes in patients with PVD could be explored in future research, particularly when the risk of bleeding is not a major concern.
Collectively, while TAVR appears safe for patients with PVD, therefore an individualized risk assessment of post-TAVR complications is warranted. Future research should investigate measures to mitigate the risk of ischemic complications and readmissions among patients with PVD. Similarly, further studies are warranted to evaluate the merits of periprocedural coronary revascularization among patients with PVD evaluated for AVR.
Study Limitations
The current analysis has certain limitations. First, due to the administrative nature of the dataset, there is a potential for coding or documentation errors. Nevertheless, the NRD has been previously internally and externally validated [27, 28]. Furthermore, the employed ICD codes to identify the study cohort have been previously validated [10–13]. Second, due to the observational nature of the dataset, there is a potential for allocation bias. However, we have conducted extensive adjustment analyses using multiple propensity score matching analyses, and logistic regression analyses to reduce allocation bias. Third, certain data were irretrievable for our analysis. Clinical data regarding the exact risk assessment of patients in the study, such as the STS risk score and frailty indices, were not available. We reported data regarding vascular interventions among patients undergoing TAVR; however, data were not available to ascertain if these were interventions performed to facilitate TAVR procedure or were complications after the procedure. Furthermore, data regarding the type of endovascular access for transfemoral versus alternate access (TAVR), valvular disease severity, laboratory results, imaging, and procedural details were not retrievable. Also, the NRD database can only capture in-hospital mortality, and longer-term mortality cannot be estimated from the available data. Fourth, in reporting readmission rates, we were unable to adjust for competing risk of mortality among patients who were not readmitted. Fifth, the low event rates for certain outcomes represent a limitation that could yield highly variable odds ratios. Finally, long-term data regarding outcomes of AVR in patients with PVD were unavailable for our analysis.
Conclusions
We presented real-world data from a comprehensive national dataset demonstrating that patients with PVD who undergo TAVR were associated with lower in-hospital mortality and major cardiovascular complications compared with those who undergo SAVR. Furthermore, patients with PVD have similar mortality to those with no PVD undergoing TAVR. Nonetheless, patients with PVD undergoing TAVR were associated with a higher risk for specific complications and readmissions. Further research is needed to explore interventions that could reduce the heightened risk for in-hospital complications and readmissions post-TAVR among patients with PVD.
Supplementary Information
Below is the link to the electronic supplementary material.
Author Contributions
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Abdelrhman Abomoawad, Mamas Mamas, Hani Jneid, Anthony A. Bavry, Dharam J. Kumbhani, Samir Kapadia, Ayman Elbadawi were mainly responsible for study conception and design. Ayman Elbadawi, Abdelrhman Abomoawad, Ramy Sedhom, Harsh Golwala, and Mohamed Abdelazeem performed data collection, acquisition, analysis, and interpretation. All authors shared in drafting the manuscript. Ayman Elbadawi was responsible for the initial critical revision of the manuscript. All authors contributed to a final critical revision of the manuscript for important intellectual content and the final approval of the version to be published.
Funding
No funding or sponsorship was received for this study or publication of this article.
Data Availability
All data generated or analyzed during this study are included in this published article/as supplementary information files.
Declarations
Conflict of Interest
Abdelrhman Abomoawad, MD, Ramy Sedhom, MD, Harsh Golwala, MD, Mohamed Abdelazeem, MD, Mamas Mamas, MD, Hani Jneid, MD, Anthony A. Bavry, MD, Dharam J. Kumbhani, MD/SM, Samir Kapadia, MD, and Ayman Elbadawi, MD/PhD have no conflicts of interest to declare related to this work.
Ethical Approval
This study was deemed exempt from hospital institutional review boards as the NRD is a publicly available database that contains de-identified patient information.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All data generated or analyzed during this study are included in this published article/as supplementary information files.