No data exist on the impact of vascular complications related to the secondary access site in transcatheter aortic valve implantation (TAVI). The objectives of this nonrandomized study were to determine the rate of vascular complications related to the secondary access site in TAVI procedures and to evaluate the clinical impact of using the radial versus femoral approach as a secondary access in such procedures. A total of 462 consecutive patients (mean age 79 ± 9 years, 50% men) who underwent TAVI were included. The femoral approach (FA) was used as the secondary access (for the insertion of a 5F pigtail catheter) in 335 patients and the radial approach (RA) in 127 patients. Thirty-day events were prospectively collected. There were no baseline differences between groups, except for a higher prevalence of women and peripheral disease in the FA group (p <0.05 for both). A total of 74 vascular access site complications occurred in 70 patients (15%), and 23% of them (29% in the FA group) were related to the secondary access. The use of FA as secondary access was associated with a higher rate of vascular complications (5.0% vs 0% in the RA group, p = 0.005, adjusted p = 0.014). All major vascular complications related to the secondary access occurred in the FA group (3% vs 0% in the RA group, p = 0.040, adjusted p = 0.049), and this translated into a higher rate of major and/or life-threatening bleeding events related to the secondary access in the FA group (3% vs 0% in the RA group, p = 0.040, adjusted p = 0.049). In conclusion, about 1/4 of vascular access site complications in TAVI are related to the secondary access. The use of the RA as a secondary access was associated with a major reduction in vascular complications. These results highlight the impact of secondary access vascular complications in TAVI procedures and support the use of the RA as the preferred secondary access.
Highlights
- 1.
This is the first report on vascular complications related to the secondary access in transcatheter aortic valve implantation (TAVI) interventions.
- 2.
One fourth of vascular complications in TAVI are related to the secondary access, and this rate increased up to about 1/3 when the femoral approach was used as secondary access.
- 3.
The use of the radial approach as secondary access was associated with a reduction in vascular complications and major and/or life-threatening bleeding complications.
- 4.
The results of the present study support the use of the radial approach as the first-option secondary access in TAVI procedures.
The radial access is a well known alternative to the femoral access in coronary procedures. Several studies have shown a major reduction in vascular complications associated with the radial approach (RA), and this access has been adopted as the primary choice over femoral access in many interventional cardiology laboratories worldwide. However, data on the use of the RA in transcatheter aortic valve implantation (TAVI) procedures have been limited to their use as a modified crossover technique for the percutaneous closure management of the primary femoral access. This study determines the rate of vascular and bleeding complications related to the secondary access in TAVI and evaluates the impact of using the RA versus femoral approach (FA) as a secondary access in the TAVI procedures.
Methods
A total of 462 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI in our center from 2007 to 2014 were included. From May 2007 to January 2013, the transfemoral approach was selected as the secondary access. No ultrasound or angiographic guidance or iterative micropuncture was used for the transfemoral puncture. The right RA was the first-choice secondary access as of January 2013 in transfemoral-TAVI cases, and it was also used occasionally (depending on the physician responsible for the procedure) in nontransfemoral TAVI cases. In all cases, a 5F sheath (Terumo Medical Corporation, Somerset, New Jersey) was used for the secondary access and a 5F pigtail catheter inserted through it. The radial access was initially attempted as a secondary access in 132 patients. Lack of radial pulse was observed in 2 of these patients and failure to obtain radial access occurred in 3 patients, leading to the use of the FA as a secondary access in these 5 patients. This led to a final study population of 335 patients in the FA group and 127 patients in the RA group for whom the femoral and radial accesses were used as secondary access, respectively. Hemostasis of the primary femoral access at the end of the procedure was obtained by surgical cutdown in all transfemoral-TAVI cases. Iliofemoral angiography was not systematically performed at the end of the procedure. Hemostasis of the secondary femoral access was obtained by manual compression in 114 cases (87%) and a percutaneous closure device was used in 17 cases (13%; ProGlide [Abbott Vascular, Santa Clara, California] in 10 cases and Angio-Seal [St Jude Medical, Inc., Minneapolis, Minnesota] in 7 cases). Hemostasis of the radial access was obtained by mechanical compression either with the Zoom device (Zoom Co. Medica, Piedmont, Quebec, Canada) or the BENGAL device (Benrikal Services, St-Bruno, Quebec, Canada) in all cases.
Details about patient selection and TAVI procedures have been given elsewhere. Heparin (100 U/kg) was administered after obtaining the accesses and adjusted for an activated clotting time of ≥300 seconds. The patients received aspirin (80 mg) before the procedure and clopidogrel (300 mg before the procedure followed by 75 mg/day). No clopidogrel was administered before the transapical TAVi procedures. All periprocedural and 30-day events were prospectively collected and entered in a dedicated database. All events were defined according to the Valve Academic Research Consortium (VARC)-2 criteria. Major and minor vascular complications were classified as related to the primary or secondary access. Major and/or life-threatening bleeding events were also classified as related to the primary access, secondary access, or unrelated to vascular access.
Continuous variables are presented as mean ± SD for variables following normal distribution, whereas nominal variables are presented in absolute and percentage values (%). Group comparisons were tested for differences with the Student t test or Wilcoxon test for continuous variables, and the chi-square test or Fisher’s exact test was used for categorical variables. Logistic regression analysis and Cochran-Mantel-Haenszel tests were used to examine gender- and peripheral disease–adjusted differences between groups. The results were considered significant with p values <0.05. All analyses were conducted using the statistical package SAS version 9.3 (SAS Institute, Cary, NC).
Results
Baseline and procedural characteristics of the study population, overall and according to the secondary access, are listed in Table 1 . Baseline and procedural characteristics of the patients who underwent the TAVI procedure by transfemoral approach are listed in Table 2 .
| Variable | Study Population (n=462) | Secondary Access | p value | |
|---|---|---|---|---|
| Femoral (n=335) | Radial (n=127) | |||
| Age (years) | 79.1±8.6 | 79±8 | 80±9 | 0.267 |
| Men | 228 (50%) | 151 (45%) | 77 (61%) | 0.002 |
| Body mass index (kg/m 2 ) | 26.8±5.1 | 26.6±4.9 | 27.3±5.7 | 0.248 |
| Diabetes mellitus | 157 (34%) | 118 (35%) | 39 (31%) | 0.381 |
| Hypertension | 402 (87%) | 296 (88%) | 106 (84%) | 0.166 |
| Coronary artery disease ∗ | 303 (66%) | 223 (67%) | 80 (63%) | 0.511 |
| Previous atrial fibrillation | 83 (18%) | 58 (17%) | 25 (20%) | 0.588 |
| Prior coronary bypass | 171 (37%) | 129 (39%) | 42 (33%) | 0.331 |
| Prior cerebrovascular disease | 85 (18%) | 65 (19%) | 20 (16%) | 0.421 |
| Peripheral vascular disease | 162 (35%) | 132 (40%) | 30 (24%) | 0.002 |
| eGFR<60 ml/min/m 2 | 255 (55%) | 190 (57%) | 65 (51%) | 0.296 |
| Chronic obstructive pulmonary disease | 129 (28%) | 97 (29%) | 32 (25%) | 0.486 |
| STS-PROM score | 7.2±4.6 | 7.1±4.5 | 7.2±5.0 | 0.802 |
| Procedural characteristics | ||||
| Approach | ||||
| Transfemoral | 221 (48%) | 103 (31%) | 118 (93%) | <0.001 |
| Transapical | 203 (44%) | 195 (58%) | 8 (6%) | |
| Transaortic | 37 (8%) | 36 (11%) | 1 (1%) | |
| Subclavian | 1 (0.2%) | 1 (0.3%) | 0 (0) | |
| Prosthesis type | ||||
| Balloon-expandable | 432 (94%) | 320 (96%) | 112 (88%) | 0.004 |
| Self-expandable | 24 (5%) | 11 (3%) | 13 (10%) | |
| Sheath size (transfemoral TAVI) | ||||
| >18F | 298 (65%) | 259 (77%) | 39 (31%) | <0.001 |
| ≤18F | 154 (34%) | 69 (21%) | 85 (67%) | |
| Procedural success | 439 (95%) | 321 (96%) | 118 (93%) | 0.333 |
∗ Coronary artery disease defined as presence of untreated coronary stenosis ≥50% or previous coronary revascularization (percutaneous coronary intervention, coronary artery bypass grafting).
| Variables | Study Population (n=221) | Secondary Access | p value | |
|---|---|---|---|---|
| Femoral (n=103) | Radial (n=118) | |||
| Age (years) | 80±9 | 80±10 | 80±9 | 0.979 |
| Men | 118 (54%) | 48 (47%) | 70 (60%) | 0.057 |
| Body mass index (kg/m 2 ) | 27.1±5.3 | 26.8±5.1 | 27.3±5.5 | 0.507 |
| Diabetes mellitus | 70 (32%) | 34 (33%) | 36 (31%) | 0.772 |
| Hypertension | 182 (82%) | 85 (83%) | 97 (82%) | 1.00 |
| Coronary artery disease | 135 (61%) | 63 (61%) | 72 (61%) | 1.00 |
| Previous atrial fibrillation | 41 (19%) | 18 (18%) | 23 (20%) | 0.732 |
| Prior coronary bypass | 69 (31%) | 32 (31%) | 37 (31%) | 1.00 |
| Prior cerebrovascular disease | 31 (14%) | 14 (14%) | 17 (15%) | 0.849 |
| eGFR<60 ml/min/m 2 | 118 (53%) | 58 (56%) | 60 (51%) | 0.422 |
| Chronic obstructive pulmonary disease | 46 (21%) | 19 (19%) | 27 (23%) | 0.622 |
| STS-PROM score | 7.0±4.9 | 7.1±4.9 | 6.9±4.9 | 0.779 |
| Procedural characteristics | ||||
| Prosthesis type | ||||
| Balloon-expandable | 197 (89%) | 94 (91%) | 103 (87%) | 0.230 |
| Self-expandable | 19 (9%) | 6 (6%) | 13 (11%) | |
| Sheath size (TAVI) | ||||
| >18F | 64 (30%) | 33 (32%) | 31 (27%) | 0.370 |
| ≤18F | 152 (69%) | 67 (65%) | 85 (73%) | |
| Procedural success | 204 (92%) | 95 (92%) | 109 (93%) | 0.801 |
Thirty-day events, overall and according to the secondary access, are listed in Table 3 . A total of 70 patients (15%) had a total of 74 vascular access site complications (4 patients had vascular complications related to both primary and secondary accesses) and were classified as major and minor in 31 (42%) and 43 (58%) of the cases, respectively. Of these, 17 vascular complications (23% of total vascular complications) were related to the secondary access and were classified as major and minor in 11 and 6 patients, respectively ( Figure 1 ). All major vascular complications related to the secondary access occurred in the FA group (p = 0.040 vs the RA group, adjusted p = 0.049). In the FA group, 29% of the vascular complications were related to the secondary access, 39% of the major vascular complications and 20% of the minor vascular complications ( Figure 2 ). In the RA group, all vascular complications were related to the primary access ( Figure 3 ). A total 84 of major and/or life-threatening bleeding events occurred overall, and 43 of them (51%) were related to vascular access site complications. Of these, 11 bleeding events were related to a vascular complication of the secondary access (13% of total bleeding events, 26% of bleeding events related to access site), all of them in the FA group (p = 0.040 vs RA group, adjusted p = 0.049).
| Variable | Study Population (n=462) | Secondary Access | p value | Adjusted p value ∗ | |
|---|---|---|---|---|---|
| Femoral (n=335) | Radial (n=127) | ||||
| Myocardial infarction | 12 (3%) | 10 (3%) | 2 (2%) | 0.524 | 0.704 |
| Stroke | 13 (3%) | 12 (4%) | 1 (1%) | 0.124 | 0.204 |
| Vascular complications | 85 (18%) | 63 (19%) | 22 (17%) | 0.789 | 0.606 |
| Related to access | 70 (15%) | 54 (16%) | 16 (13%) | 0.386 | 0.270 |
| Related to primary access | 57 (12%) | 41 (12%) | 16 (13%) | 1.00 | 0.893 |
| Related to secondary access | 17 (4%) | 17 (5%) | 0 | 0.005 | 0.014 |
| Non-related to access | 15 (3%) | 9 (3%) | 6 (5%) | 0.256 | 0.272 |
| Major vascular complications | 46 (10%) | 37 (11%) | 9 (7%) | 0.228 | 0.285 |
| Related to access | 31 (7%) | 28 (8%) | 3 (2%) | 0.021 | 0.046 |
| Related to primary access | 20 (4%) | 17 (5%) | 3 (2%) | 0.305 | 0.266 |
| Related to secondary access | 11 (2%) | 11 (3%) | 0 | 0.040 | 0.049 |
| Non-related to access | 15 (3%) | 9 (3%) | 6 (5%) | 0.256 | 0.272 |
| Minor vascular complications | 41 (9%) | 28 (8%) | 13 (10%) | 0.583 | 0.840 |
| Related to access | 41 (9%) | 28 (8%) | 13 (10%) | 0.583 | 0.840 |
| Related to primary access | 37 (8%) | 24 (7%) | 13 (10%) | 0.336 | 0.514 |
| Related to secondary access | 6 (1%) | 6 (2%) | 0 | 0.195 | 0.148 |
| Non-related to access | 0 | 0 | 0 | – | – |
| Major/life threatening bleeding | 84 (18%) | 74 (22%) | 10 (8%) | <0.0001 | 0.002 |
| Related to access | 43 (9%) | 41 (12%) | 2 (2%) | <0.0001 | 0.004 |
| Related to primary access | 32 (7%) | 30 (9%) | 2 (2%) | 0.004 | 0.016 |
| Related to secondary access | 11 (2%) | 11 (3%) | 0 | 0.040 | 0.049 |
| Non-related to access | 41 (9%) | 33 (10%) | 8 (6%) | 0.274 | 0.335 |
| 30-day mortality | 33 (7%) | 27 (8%) | 6 (5%) | 0.408 | 0.291 |
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