Methods

All patients treated for native aortic valve disease and aortic bioprosthesis failure with TAVI from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were included in this retrospective analysis. Patients treated with TAVI devices for the management of mitral, tricuspid, and pulmonary valve pathology and pure noncalcific aortic regurgitation were excluded. A dedicated multidisciplinary “Heart Team” consisting of interventional cardiologists, imaging cardiologists, cardiac surgeons, cardiac anesthetists, and general physicians discussed the management of all patients. Although devices changed over time, all patients throughout the study period were deemed to be inoperable or of high surgical risk using a combination of accepted surgical risk scores (EuroSCORE, Society of Thoracic Surgeon risk scores) and clinical judgment to encompass patient factors (e.g., frailty) that are not accounted for by the aforementioned objective assessments, in keeping with current guidelines. All patients provided full informed consent for the procedure, clinical follow-up, data collection, and subsequent analysis.

Before TAVI, all patients underwent multislice computed tomography (MSCT) or coronary angiography to exclude coronary artery disease and invasive or MSCT assessment of the peripheral vasculature. Prosthesis type and sizing was at the operator’s discretion based on the MSCT and/or echocardiographic findings. All procedures were carried out under general anesthesia (GA) or conscious sedation. The transfemoral (TF) route was the default access site, which was performed almost predominantly by a fully percutaneous approach using the femoral crossover technique and suture-mediated closure devices (Prostar and Proglide, Abbott Laboratories, Abbott Park, Illinois). Other access sites (OAS) including transapical, transaortic, and transaxillary were considered if the TF route was contraindicated.

Procedural and inhospital outcomes were prospectively collected in a dedicated TAVI database, and follow-up was conducted either by clinic visits or telephone consultations. Renal failure was defined as patients with chronic kidney disease stage ≥3 (estimated glomerular filtration rate <60 ml/min/1.73 m ² ). All definitions of the clinical end points used were in concordance with the Valve Academic Research Consortium 2 definitions. Other information collected included the severity of aortic regurgitation after TAVI (by aortography or echocardiography), the requirement of PPM implantation, and valve failure.

Continuous variables are presented as the mean ± standard deviation. Normality of each continuous variable was tested with the Kolmogorov–Smirnov test. Differences in continuous variables between groups were compared using the Student t test or Mann–Whitney U test for parametric and nonparametric variables, respectively. Categorical variables are presented as numerical values and percentages and were compared using the Fisher’s exact test. The cumulative incidences of clinical events were estimated on a per-patient basis using Kaplan–Meier analysis, and the significance of differences between curves was assessed with the log-rank test. Cox proportional hazards regression analysis (after exclusion of patients who died in hospital) was performed to identify predictors of long-term all-cause and cardiovascular mortality. For the multivariate analysis, covariates with a p <0.1 on the univariate analysis were included. All reported p values were 2 sided, and values of p <0.05 were regarded as statistically significant. Analyses were performed with SPSS version 21.0 (SPSS Inc., Chicago, Illinois) and GraphPad Prism version 5.0 (GraphPad, San Diego, California).

Results

Eight hundred and twenty-nine consecutive patients who underwent TAVI through the TF (n = 703) and OAS (n = 126) were included. Seven hundred fifty-four patients (91%) were treated for native aortic valve stenosis, 29 (3.5%) for bicuspid valve disease, and 46 (5.5%) for aortic bioprosthesis dysfunction. Demographic data of all patients are summarized in Table 1 . In keeping with the widespread adoption and greater availability of TAVI over time, more recently, there was a trend toward treating younger and lower risk patients ( Figure 1 ; Table 1 ).

Number of procedures and TAVI devices used over study period.

The TF was the default vascular access option when possible and was used in 703 patients (84.8%) with a significant increase in the use of the TF vascular access route in patients treated latterly (first quintile 77.6% vs fifth quintile 88.8%, p = 0.007). For the TF cases, there was a trend away from using GA to using sedation only during the study period, with GA used in 87 patients (12.4%). The different devices used in our center during the study period are summarized in Figure 2 .

Temporal changes in age and risk of patients who underwent TAVI. STS = Society of Thoracic Surgeons.

Procedural outcomes are summarized in Table 2 . Successful implantation of a TAVI device (with any complication adequately managed at the time of the procedure) was achieved in 797 patients (96.1%). Of patients, 86.6% had none or mild (grade I) PVL at the end of the procedure. Nine patients (1.1%) required emergency surgery. Four patients underwent surgery for the management of cardiac tamponade secondary to ventricular perforation, of whom 3 survived. Three patients were treated for aortic dissection after device implantation and 1 patient survived to discharge. Finally, 2 patients required emergency coronary artery bypass grafting for coronary obstruction that was not possible to manage percutaneously and 1 patient survived to hospital discharge.

There were 5 (0.6%) periprocedural deaths. Three patients died after annular rupture and 1 patient from cardiac tamponade likely due to ventricular perforation. The final patient died after balloon aortic valvuloplasty that resulted in severe aortic regurgitation; TAVI device was unable to be delivered, and the patient suffered pulmonary edema and subsequent cardiac arrest and was not successfully resuscitated.

Inhospital outcomes are summarized in Table 3 . Overall inhospital mortality was 3.5% with cardiovascular mortality accounting for approximately half the deaths (1.8%). When comparing the first and the last quintiles of the patient population treated, the length of stay was significantly shorter in the most recently treated patients (9.27 ± 10.1 vs 6.75 ± 8.9 days, p = 0.02, Table 1 ).

The median follow-up for the total study population was 568 days, with the longest follow up of 2,677 days. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years; Figure 3 ). Five-year cardiovascular mortality rates were 2.2% (30 days), 6.3% (1 year), 9.7% (2 years), 12.7% (3 years), 15.8% (4 years), and 21.1% (5 years). The survival probability at 5 years was significantly higher in the TF group compared to the OAS group (log-rank p <0.001, Figure 4 ).

Kaplan–Meier survival curve of total study population.

Kaplan–Meier survival curves of patients who underwent TAVI through the TF route versus other access sites.

After excluding inhospital deaths, when using a multivariate model, diabetes mellitus (hazard ratio [HR] 1.2, 95% confidence interval [CI] 1.02 to 1.40, p = 0.03), baseline dialysis (HR 3.44, 95% CI 1.45 to 8.20, p = 0.01), non-TF vascular access (HR 2.59, 95% CI 1.59 to 4.11, p <0.001), PVL ≥2 (after TAVI; HR 2.30, 95% CI 1.43 to 3.07, p = 0.001), acute kidney injury ≥stage 2 (HR 1.99, 95% CI 1.26 to 3.2, p = 0.003), and inhospital stroke (HR 3.06, 95% CI 1.57 to 16.4, p <0.001) were found to be independent predictors for all-cause mortality ( Table 4 ). Logistic EuroSCORE (HR 1.02, 95% CI 1.01 to 1.04, p <0.001), non-TF vascular access (HR 2.96, 95% CI 1.65 to 5.30, p <0.001), and PVL ≥2 (HR 2.05, 95% CI 1.08 to 3.88, p = 0.03) were identified as independent predictors for cardiovascular mortality ( Table 5 ).

Table 4

Univariate and multivariable analysis for overall long-term mortality

Covariate	Univariate analysis		Multivariable analysis
	HR (95% confidence interval)	P value	HR (95% confidence interval)	P Value
Age	0.99 (0.98-1.01)	0.52
Male gender	0.99 (0.75-1.30)	0.93
Diabetes mellitus	1.17 (1.04-1.32)	0.01	1.20 (1.02-1.40)	0.03
Hypertension	0.96 (0.68-1.33)	0.79
Smoking	1.19 (0.93-1.52)	0.17
Baseline renal failure	1.70 (1.29-2.25)	<0.001	0.86 (0.57-1.28)	0.45
Baseline dialysis	3.19 (1.92-5.34)	<0.001	3.44 (1.45-8.20)	0.01
Pulmonary hypertension	1.44 (1.09-1.89)	0.01	1.30 (0.86-1.83)	0.24
Previous percutaneous coronary intervention	0.80 (0.56-1.14)	0.22
Previous myocardial infarction	1.20 (0.86-1.68)	0.28
Previous coronary artery bypass grafting	0.86 (0.60-1.24)	0.43
Ejection fraction ≤35%	1.45 (1.01-2.07)	0.04	0.94 (0.55-1.59)	0.81
Logistic Euroscore	1.03 (1.02-1.04)	<0.001	1.02 (1.01-1.03)	0.001
Society of Thoracic Surgeons score	1.03 (1.02-1.05)	<0.001	1.02 (0.99-1.04)	0.18
Non transfemoral access site	2.08 (1.51-2.88)	<0.001	2.56 (1.59-4.11)	<0.001
Paravalvular leak ≥2	1.97 (1.39-2.78)	<0.001	2.30 (1.43-3.70)	0.001
Vascular complication	0.83 (0.57-1.20)	0.33
Acute kidney injury: Stage ≥2	1.75 (1.29-2.39)	<0.001	1.99 (1.26-3.2)	0.003
Post-procedure permanent pacemaker implantation	1.39 (0.88-2.19)	0.15
In-hospital stroke	6.49 (2.39-17.6)	<0.001	3.06 (1.57-16.4)	<0.001

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