Methods

The design and 1-year outcomes of the ADVANCE study have been previously described. Briefly, the ADVANCE study was designed to evaluate the performance of the CoreValve System (Medtronic, Minneapolis, Minnesota) in routine practice at experienced clinical sites. This prospective, fully monitored, observational study was conducted at 44 centers, each of which had performed at least 40 TAVI procedures using the CoreValve system before participating in ADVANCE. Patient eligibility and treatment decisions were determined through the clinical judgment of the local heart teams, which comprised at least 1 interventional cardiologist and 1 cardiothoracic surgeon. Exclusion criteria were limited to participation in another trial that would interfere with routine practice and an unwillingness or inability to provide written informed consent.

For this study, the CoreValve bioprosthesis was available in 2 sizes, 26 and 29 mm, for treatment of native aortic annuli ranging from 20 to 27 mm in diameter. Delivery through all routes was accomplished using an 18Fr catheter. Patient screening before TAVI used a variety of tools, including echocardiography, multislice computed tomography, and angiography. Valve size, delivery route, and other procedural considerations were selected by the local heart team. Likewise, choice of medications administered was based on local hospital-based standard procedures. For the current analysis, patients were categorized into 2 groups, the STS ≤7% and STS >7% groups.

Safety end points including mortality (all-cause and cardiovascular), neurologic events (major and minor stroke and transient ischemic attack), myocardial infarction, bleeding (life-threatening or disabling, major, and minor), vascular complications (major and minor), and acute kidney injury were adjudicated according to the Valve Academic Research Consortium-1 definitions. Death, myocardial infarction, and stroke were reviewed by an independent clinical events committee. For each neurologic event, an independent neurologist reviewed all available patient data, event narratives, and computed tomographic images. The clinical events committee used the neurologist’s assessment along with other patient data to adjudicate the events. A core laboratory (Cardialysis, Rotterdam, The Netherlands) analyzed electrocardiograms, which were collected at baseline, during the procedure, and at 30-day and 1-year follow-up. Transthoracic echocardiography was used to measure post-TAVI aortic regurgitation (AR) at hospital discharge, 30 days, and subsequent yearly follow-up and was characterized at the clinical sites as none, mild, moderate, or severe according to criteria of the European Association of Echocardiography, as previously reported.

The median STS score and interquartile range for each quartile of enrollment are presented. Kruskal-Wallis analysis of ranks was used for comparisons across groups. Categorical variables are reported as counts and percentages with asymptotic 95% confidence intervals (CIs) and were evaluated by the chi-square or Fisher’s exact test. Continuous variables are reported as means and SDs with 95% CIs and were evaluated with t tests. Kaplan-Meier analysis methods were used to calculate outcomes and freedom-from-event curves with comparisons between groups evaluated using the log-rank test.

Cox regression was used to evaluate predictors of 3-year all-cause mortality. Hazard ratios (HRs), 95% CIs, and p values are presented from univariable and multivariable Cox proportional hazards models. For subjects without an event, the date of censoring was the latest date of all follow-up visits (including study exit) and events (including death).

Medical history and characteristics at baseline, including core laboratory electrocardiographic findings, procedural characteristics and complications, and adverse events that occurred during or after the TAVI procedure, were considered as potential predictors. Life-threatening or disabling bleeding was combined with major bleeding to be 1 possible predictor. Minor bleeding, minor vascular complications, and core laboratory–reported sinus rhythm were not considered as potential predictors. With the exception of AR at discharge, adverse events were treated as time-dependent covariates with time to event based on the first occurrence of each event type. Summary statistics for each potential predictor are presented for all patients, censored patients, and patients with an event through 1,095 days. Rare characteristics or events that occurred in ≤5% of the total risk set were excluded from the multivariable selection process. Exclusion criteria for missing data were not applied. Variables with a p value <0.20 from the univariable analyses were included in stepwise selection to determine the final multivariable model within each STS subgroup. The final multivariable model included any predictors with a p value <0.10. All analyses were performed using SAS software (version 9.3; SAS Institute, Cary, North Carolina).

Results

From March 2010 to July 2011, 1,015 patients were enrolled in the ADVANCE study. Of these, 996 patients were treated with the Medtronic CoreValve system and 995 had an STS score available at baseline. Dividing the 995 patients into quartiles according to time of enrollment, the median STS score remained near 5% over the duration of the study ( Figure 1 ). Of the 995 patients, 697 (70.1%) had STS ≤7% and 298 (29.9%) had STS >7%. Baseline characteristics of these 2 cohorts are listed in Table 1 . Many co-morbidities, including diabetes, peripheral vascular disease, and atrial fibrillation, occurred with higher frequency in the STS >7% population.

Median STS score for each enrollment quartile. Error bars represent interquartile range Q1 to Q3. The median STS score remained stable over the enrollment period, March 2010 to July 2011.

The transfemoral approach was used in the vast majority of patients with STS ≤7% ( Table 2 ). Although the transfemoral route was also the most commonly used access route in patients with STS >7%, there was a higher need for alternative access (p <0.001). Other key procedural outcomes are listed in Table 2 .

At 30 days, lower rates of all-cause mortality and stage III acute kidney injury were reported for patients with STS ≤7% compared with those with STS >7% ( Table 3 ). There were no significant between-group differences in cardiovascular mortality, stroke, myocardial infarction, bleeding, and vascular complications rates ( Table 3 ). At 3-year follow-up, the Kaplan-Meier rate of all-cause mortality was 28.6% in patients with STS ≤7%, compared with 45.9% in those with STS >7% ( Figure 2 ). Patients with STS ≤7% also had a lower rate of cardiovascular mortality than those with STS >7% ( Figure 3 ). Rates of major adverse events (stroke, myocardial infarction, bleeding, and emergent reintervention) did not differ significantly between the 2 study groups out to 3 years ( Table 3 ).

Table 3

Outcomes at 30 days, 1 year, and 3 years

Characteristic	Society of Thoracic Surgeons risk score
	30 Days			1 Year			3 Years
	≤7 (n=697)	>7 (n=298)	P †	≤7 (n=697)	>7 (n=298)	P †	≤7 (n=697)	>7 (n=298)	P †
Major adverse cardiovascular and cerebrovascular events ∗	76.6%	11.4%	0.011	17.2%	30.1%	<0.001	33.3%	510.7%	<0.001
All-cause mortality	3.6%	6.7%	0.030	13.9%	26.4%	<0.001	28.6%	45.9%	<0.001
Myocardial infarction ∗	0.3%	0.0%	0.356	0.9%	0.8%	0.852	2.4%	3.4%	0.468
Emergent reintervention	1.3%	1.4%	0.934	1.5%	1.8%	0.729	2.6%	1.8%	0.654
Stroke ∗	2.6%	4.1%	0.216	4.4%	4.6%	0.773	6.6%	6.1%	0.991
Cardiovascular mortality ∗	2.9%	4.7%	0.141	9.0%	18.1%	<0.001	19.0%	30.2%	<0.001
Bleeding ∗	28.9%	29.4%	0.889	31.4%	33.6%	0.618	34.6%	37.4%	0.554
Life-threatening	3.6%	5.1%	0.283	4.4%	6.2%	0.221	5.1%	8.6%	0.081
Major	8.8%	11.8%	0.130	9.6%	15.1%	0.017	11.5%	15.6%	0.062
Minor	18.6%	14.9%	0.150	20.6%	16.3%	0.102	22.2%	18.9%	0.178
Vascular complications ∗	20.7%	20.9%	0.941	22.0%	21.6%	0.952	22.0%	22.1%	0.954
Major	10.6%	11.4%	0.701	11.9%	12.2%	0.836	12.1%	12.7%	0.761
Minor	10.2%	10.1%	0.961	10.4%	10.1%	0.909	10.4%	10.1%	0.909
Stroke or transient ischemic attack ∗	3.0%	4.1%	0.406	5.9%	6.2%	0.787	8.5%	8.2%	0.931
Major	0.9%	2.1%	0.123	2.0%	2.5%	0.524	3.3%	4.0%	0.472
Minor	1.7%	2.1%	0.739	2.4%	2.1%	0.835	3.5%	2.6%	0.610
Transient ischemic attack	0.6%	0.0%	0.192	1.7%	1.6%	0.899	2.1%	2.1%	1.000
Acute kidney injury (stage III)	0.1%	1.0%	0.047	0.3%	1.4%	0.042	0.3%	1.4%	0.042
Permanent pacemaker implantation	26.0%	26.9%	0.729	28.9%	29.7%	0.710	31.3%	31.4%	0.804

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