Summary
Background
The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial.
Aim
To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty.
Methods
We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification ≥ 3) and vascular access complications.
Results
We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10–3.09; P = 0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs.
Conclusions
Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.
Résumé
Contexte
L’intérêt des dispositifs de fermeture vasculaire pour prévenir les complications vasculaires après intervention percutanée fémorale reste controversé. Ceux-ci ont par ailleurs été évalués essentiellement après angioplastie coronaire.
Objectif
Évaluer l’efficacité des dispositifs de fermeture percutanée à base de collagène pour prévenir les complications vasculaires après valvuloplastie aortique au ballon.
Méthodes
Il s’agit d’une étude prospective menée entre 2009 et 2012, incluant 180 patients consécutifs qui bénéficient d’une valvuloplastie aortique au ballon par voie fémorale rétrograde pour sténose aortique serrée. Dans le groupe 1 ( n = 75), un dispositif de fermeture percutané de taille 8F (Angio-Seal™ ; Saint-Jude Medical, Inc.) est utilisé au niveau de l’abord vasculaire fémoral ; dans le groupe 2 ( n = 105), une compression fémorale manuelle ou mécanique est réalisée (FemoStop™, RADI Medical Systems, Inc.). L’héparine n’est pas utilisée pendant la procédure. Les complications intra-hospitalières majeures, les complications vasculaires et les évènements hémorragiques graves (≥ BARC classe 3) sont évaluées.
Résultats
La valvuloplastie aortique est faite essentiellement en « pont » avant TAVI ou en traitement palliatif ( n = 130 ; 72 %). Les deux groupes ont des caractéristiques cliniques similaires : âge moyen 84 ans, antécédent d’artériopathie périphérique et index de masse corporelle. Des complications vasculaires ou hémorragiques sont observées parmi 11,1 % des patients et sont significativement plus fréquentes dans le groupe 1 (RR 2,60, 95 % CI 1,10–3,09 ; p = 0,05). Ces résultats sont observés dans tous les sous-groupes prédéfinis. La durée de l’hospitalisation n’est pas différente entre les 2 groupes ( p = 0,3).
Conclusions
Cette étude montre des résultats défavorables en termes de complications vasculaires et hémorragiques des dispositifs de fermeture percutanée utilisés après valvuloplastie aortique réalisée avec de petits désilets et sans héparine. L’utilisation systématique de ces dispositifs chez des patients âgés avec athérosclérose fémorale fréquente apparaît discutable.
Introduction
A resurgence of balloon aortic valvuloplasty (BAV) has taken place during the past decade, alongside a rapid expansion in the population of elderly patients with severe aortic stenosis and significant co-morbidities and the development of percutaneous valve replacement therapies .
Whereas the complications of BAV have been markedly reduced by improvements in techniques and materials, the main risks of the procedure remain (i.e. complications at the femoral entry site, with a high risk of bleeding, the need for blood transfusion or vascular lesions, which can affect up to 10% of patients) . Reducing vascular and bleeding events has become an important goal in interventional cardiology, because they are associated with mortality, morbidity and prolonged hospitalization .
Vascular closure devices (VCDs), which are frequently used to obtain rapid femoral haemostasis and patient deambulation, are controversial with regard to their ability to prevent femoral vascular access complications. The use of these devices in the particular setting of BAV has only been evaluated in small and retrospective series . This question is of major concern, because BAV needs large French size arterial puncture and is usually performed in elderly patients, who often have advanced lower limb atherosclerosis, which may increase the risk of vascular complications.
The objective of this prospective study was to compare VCDs with manual or mechanical compression in terms of the occurrence of femoral vascular access and bleeding events.
Methods
Patient population
All patients who were referred to the Department of Cardiology at the University Hospital of Montpellier, France for BAV between 2008 and 2012 were included in this prospective study. All the patients had severe symptomatic aortic stenosis secondary to degenerative disease, confirmed by transthoracic echocardiography (mean gradient > 40 mmHg and/or S < 1 cm 2 ), and were not candidates for aortic valve replacement. The logistic euroSCORE (European System for Cardiac Operative Risk Evaluation) was calculated for all patients . Patients with significant (> 2) aortic regurgitation and lack of femoral vascular access were excluded. For all patients, there was discussion of the therapeutic options for treating aortic stenosis, including an assessment of the risks of BAV and of surgical aortic valve replacement. Patients were referred for BAV for palliation of heart failure symptoms, treatment of cardiogenic shock or as a bridge to transcatheter aortic valve implantation (TAVI), surgical aortic valve replacement or non-cardiac surgery. Anticoagulation therapy with vitamin K antagonists was withdrawn before BAV, and the procedure was performed when the international normalized ratio was < 2. Platelet anti-aggregation therapy was continued.
Balloon aortic valvuloplasty procedure
The BAV procedure was performed by the same operating team of three experienced interventional cardiologists according to the standard technique via the retrograde femoral approach, using 8F or 9F sheaths. The aortic valve was crossed under fluoroscopic guidance with a 0.034-inch straight guidewire through an Amplatz catheter (Boston Scientific, Marlborough, MA, USA). The aortic valve gradient was measured from simultaneous pressure recordings from the left ventricle and the descending aorta through the sheath. An Amplatz 0.038-inch Stiff™ guidewire (Boston Scientific) is shaped to have a curved tip; it was advanced into the left ventricle through the Amplatz catheter and left in place while the Amplatz catheter was removed under fluoroscopic guidance. BAV was performed by using 20F, 22F or 23F non-compliant dilatation balloons catheters (Tyshak™; B. Braun Interventional Systems, Inc., Bethlehem, PA, USA). To stabilize the balloon position across the valve, the heart was paced at a high rate (180–200 beats/min) through the use of a temporary pacemaker positioned in the right ventricle through the femoral vein. The goal was to obtain a mean pressure gradient < 20 mmHg or a decrease in the initial gradient of 50%. If this goal was not achieved and no procedural complications occurred, the procedure could be repeated using a larger balloon catheter, but without exceeding a balloon/ring ratio of > 1.2.
Patients were divided into two groups according to femoral puncture site haemostasis method. Group 1 consisted of patients who had femoral closure with a collagen plug-based VCD (8F Angio-Seal™; St. Jude Medical, Inc., St. Paul, MN, USA); group 2 included those who had manual compression of the femoral puncture site, aided or not by a compression device (FemoStop™; RADI Medical Systems, Inc., Uppsala, Sweden). The three interventional cardiologists had experience with the device, as they had used it for several years for femoral intervention, with sheath sizes between 6F and 9F. The choice of whether or not to use a VCD during the procedure was left at the discretion of the interventional cardiologist. In accordance with recent reports, we did not use heparin during the procedure . We recommended that all patients remained in an elongated position until the day after the procedure; however, patients with devices without vascular complications could sit in the bed after 2 hours. A pressure bandage was applied in all patients in the manual compression group, but not in the VCD group without bleeding or vascular complications.
Clinical endpoints
Clinical events were evaluated during the hospital stay and at 1-month follow-up, and were compared between the two groups of patients. Our primary combined endpoint was evaluation of severe vascular and bleeding complications. Severe vascular complications included femoral pseudoaneurysm or arteriovenous fistulae requiring surgery or endovascular intervention, acute limb ischaemia and groin infection. Severe bleeding events were defined as a score ≥ 3 according to the Bleeding Academic Research Consortium classification .
Our secondary endpoint was all adverse events, including death, heart failure, significant aortic regurgitation, myocardial infarction (defined as a rise in troponin greater than 3 times the 99th percentile of the upper reference limit), stroke, mesenteric ischaemia or systemic embolism. We also evaluated duration of hospital stay in the two groups.
Statistical analysis
Patient characteristics are presented using medians and 25–75% interquartile ranges or means ± standard deviations for continuous variables and frequencies and proportions for categorical variables. The two groups were compared using the Kruskall–Wallis test for continuous variables and the Chi 2 or Fisher’s test for categorical variables. Relative risks (RRs) and their 95% confidence intervals (CIs) were calculated between the two groups. A multivariable analysis of the factors associated with severe complications was carried out using logistic regression, using a backward selection of the variables. The α-to-enter and α-to-exit were set at 0.20 and 0.15, respectively. Odds ratios (ORs) with 95% CIs were calculated. The statistical bilateral significance threshold was set at 5%. Statistical analyses were performed using SAS version 9.1 (SAS Institute, Cary, NC, USA).
Results
Patient population
Between 2008 and 2012, 180 consecutive patients underwent BAV (six repeat procedures, four second repeat procedures), including 75 patients (41.7%) with femoral closure obtained with a VCD (group 1) and 105 patients (58.3%) who had manual or mechanical compression of the femoral puncture site (group 2).
The baseline characteristics of the patients ( Table 1 ) were identical between the two groups: same median age (84 years), prevalence of peripheral vascular disease (overall n = 47; 26%), body mass index (mean 27 kg/m 2 ) and existence of previous platelet anti-aggregation therapy (overall n = 100; 55%). The main indications for BAV were palliative procedure or bridge to TAVI ( n = 130; 72%); other indications were bridge to surgery ( n = 35; 19%) and cardiogenic shock ( n = 15; 8%). A good haemodynamic result with a decrease in initial gradient of at least 50% was obtained in all patients.
| Group 1 (VCD) ( n = 75) | Group 2 (no VCD) ( n = 105) | P | |
|---|---|---|---|
| Age (years) | 84 (78–87) | 84 (80–89) | 0.37 |
| Men | 38 (50.6) | 46 (43.8) | 0.58 |
| Diabetes | 21 (28.0) | 24 (22.8) | 0.55 |
| BMI (kg/m 2 ) | 27 ± 4 | 25 ± 4 | 0.60 |
| LVEF | 0.92 | ||
| > 45% | 42 (56.0) | 58 (55.2) | |
| 35–35% | 15 (20.0) | 17 (16.1) | |
| 25–35% | 10 (13.3) | 15 (14.2) | |
| < 25% | 8 (10.6) | 15 (14.2) | |
| NYHA functional class | 0.12 | ||
| I or II | 14 (18.6) | 21 (20.0) | |
| III | 27 (36.0) | 40 (38.1) | |
| IV | 34 (45.3) | 45 (42.8) | |
| Peripheral vascular disease | 21 (28.0) | 26 (24.7) | 0.79 |
| Coronary artery disease | 45 (60.0) | 50 (47.6) | 0.17 |
| Platelet anti-aggregation therapy | 48 (64.0) | 52 (49.5) | 0.55 |
| Creatinine clearance < 30 mL/min a | 10 (13.3) | 12 (11.4) | 0.60 |
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