Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p <0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR + PCI group. The propensity score–matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR.
Transcatheter aortic valve replacement (TAVR) in combination with percutaneous coronary intervention (PCI) has now emerged as a less-invasive and feasible therapeutic option for high surgical risk patient population with aortic stenosis (AS) and coronary artery disease (CAD). More than 200,000 TAVR procedures have been performed in >65 countries; nonetheless, there is no consensus on the management of severe CAD in this setting. Several questions regarding the need, safety, and optimal timing of PCI in relation to TAVR are yet to be answered. The aim of this study was to determine the effect of PCI on the outcomes of TAVR when performed during the same hospitalization from the largest publically available inpatient database in the United States.
Methods
Data were collected from the Nationwide Inpatient Sample between the years 2011 and 2013. These data have previously been used to identify, track, and analyze national trends in health care usage, major procedure patterns, access, disparities, trends in hospitalizations, cost, quality, and outcomes. Each hospitalization is deidentified and maintained as a unique entry with a primary discharge diagnosis and up to 24 secondary diagnoses. Demographic details, insurance information, co-morbidities, procedures, hospitalization outcomes, length, and cost of hospital stay are also recorded. All this is assessed on a yearly basis to maintain the validity and accuracy of the data set. We queried Nationwide Inpatient Sample database for the years of 2011 to 2013 using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes for TAVR and percutaneous interventions with stenting. Only patients older than 60 of age years were included and observations with missing information were excluded.
Patient level characteristics such as age, gender, race, co-morbid conditions using Deyo modification of Charlson Comorbidity Index (CCI), median household income according to ZIP code, primary payer, admission type (urgent/emergent vs elective), day of the admission (weekdays vs weekend), and hospital level characteristics such as hospital location (urban/rural), hospital size (small, medium, and large), region (Northeast, Midwest or North Central, South, and West) and teaching status were studied. We defined severity of co-morbid conditions using Deyo modification of CCI. A higher score corresponds to greater burden of co-morbid diseases. Procedural complications were identified by Patient Safety Indicators, version 4.4, March 2012, which have been established by the Agency for Healthcare Research and Quality to monitor preventable adverse events during hospitalization. These indicators are based on International Classification of Diseases, Ninth Revision, Clinical Modification codes and Medicare Severity Diagnosis-Related Groups, and each Patient Safety Indicator has specific inclusion and exclusion criteria.
We used propensity-scoring method to establish matched cohorts to control for imbalances of patients’ and hospitals’ characteristics between the 2 groups (TAVR + PCI vs TAVR on the same hospitalization), which may have influenced outcome. A propensity score was assigned to each hospitalization based on multivariate logistic regression model that examined the impact of different variables (patient demographics, co-morbidities, and hospital characteristics) on the likelihood of treatment assignment. Patients with similar propensity score in the 2 treatment groups were matched using a 1:3 scheme without replacement using greedy algorithm.
Stata IC 11.0 (StataCorp, College Station, Texas) and SAS 9.3 (SAS Institute Inc, Cary, North Carolina) were used for analyses, which accounted for the complex survey design and clustering. For categorical variables such as in-hospital mortality, the chi-square test of trend for proportions was used using the Cochrane Armitage test through the “ptrend” command in Stata. For continuous variables, nonparametric test for trend by Cuzick (which is similar to Wilcoxon rank-sum test) using the “nptrend” command in Stata was used. Differences between categorical variables were tested using the chi-square test, and differences between continuous variables were tested using the Student t test. p Value of less than 0.05 was considered significant.
Results
A total of 22,344 (weighted) TAVRs were identified between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI during the same hospitalization (TAVR + PCI group). The mean (± SD) age was 81.2 ± 0.13 with equal representation from both genders. Most patients were of Caucasian ethnicity and more than 70% of the patients had CCI score of ≥2. Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel and 1.6% had 3-vessel PCI. Of these, 59.8% had 1 and 34.4% had ≥2 stents deployed. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). Table 1 lists and distinguishes the baseline characteristics of the studied population. TAVR + PCI group had a significantly higher number of patients with CAD, acute myocardial infarction, heart failure, emergent admissions, admissions on weekends, use of mechanical support devices, cardiac arrest, cardiogenic shock, and transfemoral TAVRs, whereas TAVR group had a significantly higher percentage of patients with hypertension, obesity, diabetes, renal failure, obstructive pulmonary disease, and transapical TAVRs.
| Variables | TAVR Without PCI | TAVR With PCI | Total | P-Value |
|---|---|---|---|---|
| Total number of cases included in the study (weighted n) | 21,736 (97.3%) | 608 (2.7%) | 22,344 | |
| Age, (years) – mean (std. error) | 81.1 (0.13) | 83.1 (0.58) | 81.2 (0.13) | 0.001 |
| Male | 51.20% | 47.50% | 51.10% | |
| Female | 48.80% | 52.50% | 48.90% | |
| White | 80.30% | 82.10% | 80.30% | |
| Black | 3.30% | 4.10% | 3.30% | |
| Hispanic | 3.60% | 3.30% | 3.60% | |
| Others | 1.30% | 0.80% | 1.30% | |
| Missing | 11.50% | 9.70% | 11.50% | |
| Smoking | 25.30% | 22.00% | 25.30% | 0.06 |
| Dyslipidemia | 62.50% | 58.20% | 62.40% | 0.03 |
| Coronary artery disease | 66.40% | 83.60% | 66.90% | <0.001 |
| Family history of coronary artery disease | 3.00% | 1.60% | 2.90% | 0.056 |
| Prior myocardial infarction | 13.00% | 13.20% | 13.00% | 0.909 |
| Carotid artery disease | 6.60% | 5.80% | 6.60% | 0.415 |
| Heart failure | 70.90% | 80.30% | 71.20% | <0.001 |
| Obesity | 13.70% | 6.50% | 13.50% | <0.001 |
| Hypertension | 78.70% | 72.10% | 78.50% | <0.001 |
| Diabetes mellitus | 33.90% | 26.30% | 33.70% | <0.001 |
| Chronic pulmonary disease | 34.40% | 27.80% | 34.20% | <0.001 |
| Peripheral vascular disease | 29.90% | 32.00% | 30 | 0.274 |
| Fluid-electrolyte abnormalities/renal failure | 52.10% | 45.90% | 51.90% | 0.002 |
| Neurological disorder or paralysis | 7.90% | 5.80% | 7.80% | 0.052 |
| Anemia/coagulopathy | 43.10% | 44.20% | 43.10% | 0.594 |
| Dementia | 7.10% | 10.70% | 7.20% | <0.001 |
| Primary Payer | ||||
| Medicare | 89.60% | 92.60% | 89.70% | <0.001 |
| Medicaid | 1.00% | 0.80% | 1.00% | |
| Private including HMOs & PPOs | 7.30% | 3.30% | 7.20% | |
| No pay/self-pay/others | 2.00% | 3.30% | 2.00% | |
| Median household income category for patients’ zip code | ||||
| 1. 0-25th percentile | 20.60% | 22.10% | 20.60% | 0.01 |
| 2. 26-50th percentile | 23.00% | 18.90% | 22.90% | |
| 3. 51-75th percentile | 25.60% | 30.40% | 25.70% | |
| 4. 76-100th percentile | 29.20% | 26.90% | 29.10% | |
| Hospital bed size depending on location and teaching status | ||||
| Small | 3.60% | 7.40% | 3.70% | <0.001 |
| Medium | 15.00% | 13.20% | 15.00% | |
| Large | 81.40% | 79.50% | 81.30% | |
| Hospital Location and Teaching Status | ||||
| Urban non-teaching or rural | 12.70% | 9.90% | 12.60% | 0.04 |
| Urban teaching | 87.30% | 90.10% | 87.40% | |
| Hospital Region | ||||
| Northeast | 25.90% | 30.20% | 26.00% | <0.001 |
| Midwest | 21.90% | 11.50% | 21.60% | |
| South | 35.30% | 39.40% | 35.40% | |
| West | 17.00% | 18.90% | 17.00% | |
| Admission type | ||||
| Emergency/urgent | 24.00% | 44.90% | 24.60% | <0.001 |
| Elective | 75.90% | 55.10% | 75.30% | |
| Admission day | ||||
| Weekday | 93.50% | 88.70% | 93.30% | <0.001 |
| Weekend | 6.50% | 11.30% | 6.70% | |
| Acute Myocardial Infarction | 2.60% | 16.40% | 3.00% | <0.001 |
| STEMI | 0 | 1.60% | 0.20% | <0.001 |
| Type of access for TAVR | ||||
| Transfemoral/transaortic | 75.90% | 84.50% | 76.20% | <0.001 |
| Transapical | 24.10% | 15.50% | 23.90% | |
| Use of mechanical circulatory support devices | 11.60% | 25.50% | 12.00% | <0.001 |
| Cardiac arrest | 3.50% | 9.00% | 3.70% | <0.001 |
| Ventricular fibrillation | 1.60% | 1.60% | 1.60% | 0.966 |
| Cardiogenic shock | 3.80% | 10.70% | 4.00% | <0.001 |
| Charlson Comorbidity Index (Deyo Modification) | ||||
| Mean (std. error) | 2.58 (0.03) | 2.43 (0.13) | 2.58 (0.02) | 0.237 |
| 0 | 7.90% | 5.80% | 7.80% | 0.052 |
| 1 | 21.60% | 24.60% | 21.70% | |
| ≥2 | 70.50% | 69.70% | 70.50% | |
| Number of vessels on which intervention performed | ||||
| 0 | 100 | 0 | 97.30% | n.a. |
| 1 | 0 | 69.70% | 1.90% | |
| 2 | 0 | 22.20% | 0.60% | |
| 3 | 0 | 1.60% | 0.10% | |
| >=4 | 0 | 0 | 0 | |
| Procedures on bifurcation of vessels | 0 | 3.30% | 0.10% | |
| No information available | 0 | 6.50% | 0.20% | |
| Number of stents placed | ||||
| 0 | 100 | 0 | 97.30% | n.a. |
| 1 | 0 | 59.80% | 1.60% | |
| 2 | 0 | 26.20% | 0.70% | |
| 3 | 0 | 5.80% | 0.20% | |
| >=4 | 0 | 2.50% | 0.10% | |
| No information available | 0 | 5.80% | 0.20% | |
| Types of stents placed | ||||
| Atleast one drug-eluting stent | 0 | 72.10% | 2.00% | n.a. |
| Only bare metal stent | 0 | 28.00% | 0.80% | |
| Use of intravascular ultrasound | 0.40% | 9.00% | 0.60% | <0.001 |
| Use of fractional flow reserve | 0.20% | 3.30% | 0.30% | <0.001 |
| Use of Gp2b3a inhibitors | 0 | 3.30% | 0.50% | <0.001 |
| Disposition | ||||
| Discharge alive to home | 30.10% | 24.70% | 29.90% | <0.001 |
| Transfer to short-term hospital/other facilities/home health care | 65.30% | 64.70% | 65.30% | |
| Discharge alive – others (against medical advice/destination unknown) | 0 | 0 | 0 | |
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