Methods

The Paris–Rotterdam–Milano–Toulouse in Collaboration (PRAGMATIC) initiative is a collaboration of 5 European institutions with established TAVI experience. Baseline patient characteristics, procedural details, and clinical outcome data from a series of 1,230 consecutive patients who underwent TAVI were prospectively collected since the introduction of the respective local TAVI programs covering a period from November 2005 to August 2011: (1) San Raffaele Scientific Institute, Milan, Italy (n = 330); (2) Center Bichat, Paris, France (n = 286); (3) Clinique Pasteur, Toulouse, France (n = 224); (4) Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (n = 206); and (5) Hôpital Rangueil, Toulouse (n = 184). After the VARC consensus document was made public, the proposed end-point definitions were adopted and the respective local databases were modified accordingly. All data were then pooled into a dedicated global multicenter database for retrospective analysis. For assessment of vascular complications, vascular and bleeding complications were analyzed according to VARC end-point definitions. Vascular access origin of bleeding complications was specifically documented.

Patient eligibility for the TAVI procedure in each center has been described previously and is comparable across the 5 centers. All patients consented to the TAVI procedure and use of related data for research and publication purposes in accordance with institutional review board approval. Learning effect was addressed by creating 2 equally sized cohorts: the first cohort consisted of patients treated from November 2005 up to September 2010 and the second cohort from September 2010 until August 2011.

Two TAVI technologies with Conformité Européenne mark approval were used. The Edwards Sapien THV (Edwards Lifesciences, Inc., Irvine, California), which requires the Retroflex delivery catheter and a 22Fr or 24Fr sheath size, was used and since mid-2010 was replaced by the Sapien XT THV, which is refined to an 18Fr- or 19Fr-compatible system using the Novaflex delivery catheter. Apart from 4 cases with the previous Generation 21Fr CoreValve device, the Medtronic CoreValve System (Medtronic, Minneapolis, Minnesota) is 18Fr compatible.

In all patients multimodal imaging was performed to assess anatomic suitability for TAVI and determine the optimal access strategy. The transfemoral approach was the access route of first choice. When transfemoral access was deemed inappropriate according to consensus of the local heart team, a transapical, transaxillary/subclavian, or transaortic approach was considered. For this analysis, only transfemoral cases were included. Surgical and percutaneous access and closure strategies were applied.

Staff members from each participating center were involved with proctoring activities for the Conformité Européenne-marked TAVI technologies, which may underscore the pedigree of the centers involved. Various percutaneous arterial access techniques were applied within and across the different centers. Care was taken to obtain arterial access at the level of the common femoral artery to avoid posterior wall puncture. Arterial closure technique was at the operators’ discretion. Percutaneous closure was performed with 1 or 2 Prostar (Abbott Vascular Devices, Redwood City, California) suture-based closure devices. The cross-over balloon technique during arteriotomy closure was optional. For a surgical access strategy, standard surgical/vascular techniques were applied.

Categorical variables are presented as frequency and percentage and were compared by Pearson chi-square test or Fisher’s exact test, as appropriate. Continuous variables are presented as mean ± SD for a normal distribution or median (interquartile range [IQR]) for a skewed distribution and compared using Student’s t test or Mann–Whitney U test. Normality of distributions was assessed using the Shapiro–Wilks test.

Age, female gender, body mass index, learning effect (defined by the first 1/2 vs the latter 1/2 of the cohort to adjust for changes in procedure over time), sheath size (18Fr/19Fr vs >19 Fr), percutaneous versus surgical access strategy, history of peripheral artery disease, logistic EuroSCORE score, Society of Thoracic Surgeons score, ejection fraction, and glomerular filtration rate were the variables selected to assess as potential predictors for (1) major vascular complications and (2) combined life-threatening and major bleeding complications. Other potential interfering variables such as arterial vessel size, atherosclerotic burden, calcification, and tortuosity were not uniformly quantified and therefore were not analyzed. Variables with a p value <0.10 were entered in the multivariable logistic regression model, taking into account the restricted number of variables to be included in the model. Clinical important variables were forced into the model when not reaching a p value <0.10. A 2-sided alpha level of 0.05 was used for all superiority testing. All statistical analyses were performed with SPSS 17.0 (SPSS, Inc., Chicago, Illinois).

Results

The patient flow chart is depicted in Figure 1 . The study cohort consisted of all 986 patients who were treated through the transfemoral route; 244 patients were excluded because of an alternative access approach. Baseline characteristics are listed in Table 1 . Mean age was 81.4 ± 7.4 years and 53% were men. Calculated operative risk was high. An 18Fr/19Fr sheath was used in 79% of cases (780 patients). Percutaneous access and closure was attempted in 81% of cases. In the patient cohort with >19Fr sheath size, calculated risk scores were significantly higher (median logistic EuroSCORE 23%, IQR 15.5 to 30.5, vs 19.5%, IQR 12.0 to 27.0, p <0.001; Society of Thoracic Surgeons score 9.2%, IQR 5.0 to 13.3, vs 6.7%, IQR 3.5 to 9.9) and proportionally more often a surgical access strategy was chosen (59.7% vs 7.7%, p <0.001), reflecting the previous Edwards TAVI experience before the launch of the Sapien XT system.

Patient study cohort.

Overall incidence of major vascular complications was 14.2% ( Table 2 ). Patients who were treated with the >19Fr sheath had significantly more vascular complications (22% vs 12%, p <0.001) and required more bailout interventions for access-related issues (20% vs 10%, p <0.001) regardless of access strategy ( Figure 2 ). Overall, life-threatening/disabling and major bleeding complications were encountered in 11% and 18% of patients, respectively. The incidence for life-threatening/disabling bleedings but not major bleedings was significantly higher in the patient cohort with >19Fr sheath size regardless of access strategy used ( Figure 2 , Table 2 ). There was no difference in frequency of major vascular complications or life-threatening/disabling bleedings or need for bailout interventions between the percutaneous and surgical access strategies, whereas there were more major and minor bleedings with the percutaneous strategy; in the percutaneous strategy, 64% of major vascular complications and 29% of life-threatening/disabling bleedings were due to closure device failure ( Table 2 , Figures 3 and 4 ).

Major vascular (top) and life-threatening/disabling bleeding (bottom) complications correlated to >19Fr (red bars) and ≤19Fr (blue bars) sheaths and access strategy.

(A) No vascular complication (blue) , major vascular complication (red) , and minor vascular complication (green) with percutaneous access strategy (n = 803). (B) Relative impact of closure (blue) and nonclosure (orange) device-related failures on major vascular complications (n = 111). (C) Relative impact of closure (blue) and nonclosure (orange) device-related failures on minor vascular complications (n = 106).

(A) No access site bleeding complication (blue) and life-threatening (red) , major (green) , and minor (purple) access site bleeding complications with percutaneous access strategy (n = 803). (B) Relative impact of closure (blue) and nonclosure (orange) device-related failures on life-threatening bleeding complication (n = 93). (C) Relative impact of closure (blue) and nonclosure (orange) device-related failures on major bleeding complications (n = 155).

By multivariable logistic regression analysis, female gender and sheath size >19Fr were independent predictors for major vascular complications ( Table 3 ). Female gender, use of >19Fr system, peripheral arterial disease, learning effect, and percutaneous access strategy were independently associated with life-threatening/disabling bleedings ( Table 3 ).

Table 3

Predictors for major vascular complications and life-threatening/disabling bleedings

	Vascular Complications		Life-Threatening/Disabling Bleeding
	Crude OR (95% CI)	Adjusted OR (95% CI)	Crude OR (95% CI)	Adjusted OR (95% CI)
Age	1.00 (0.98–1.03)	1.00 (0.97–1.02)	0.98 (0.96–1.01)	0.96 (0.93–1.00)
Female gender	1.64 (1.14–2.35)	1.63 (1.12–2.36)	1.57 (1.05–2.36)	2.04 (1.31–3.17)
Body mass index	1.001 (0.97–1.05)	1.00 (0.97–1.05)	1.00 (0.96–1.05)	0.99 (0.95–1.04)
Logistic EuroSCORE	—	—	1.02 (1.01–1.03)	1.02 (1.00–1.03)
Society of Thoracic Surgeons/Predicted Risk Of Mortality score	—	—	1.02 (0.99–1.04)	1.02 (0.98–1.05)
Peripheral arterial disease	1.15 (0.72–1.84)	1.29 (0.80–2.09)	2.35 (1.49–3.71)	2.14 (1.27–3.61)
States of Health size >19Fr	2.10 (1.42–3.11)	2.87 (1.68–4.91)	1.70 (1.09–2.66)	1.86 (1.02–3.38)
Learning effect ⁎	0.86 (0.60–1.22)	0.83 (0.54–1.27)	0.50 (0.33–0.76)	0.45 (0.27–0.73)
Percutaneous access strategy	1.17 (0.75–1.83)	0.70 (0.41–1.20)	1.47 (0.82–2.59)	2.39 (1.16–4.89)

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