Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access

Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access Florence Leclercq, MD, PhDa,*, Mariama Akodad, MDa, Jean-Christophe Macia, MDa, Thomas Gandet, MDb, Benoit Lattuca, MDa, Laurent Schmutz, MDc, Richard Gervasoni, MDa, Erika Nogue, MDd, Nicolas Nagot, MDd, Gilles Levy, MDe, Eric Maupas, MDf, Gabriel Robert, MDg, Frederic Targosz, MDh, Hélène Vernhet, MD, PhDi, Guillaume Cayla, MD, PhDc, and Bernard Albat, MD, PhDb Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 – 15 minutes including 13 – 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n [ 26, 6.6%; and n [ 67, 17.2%, respectively) was not related to major or minor VC (p [ 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p [ 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p [ 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;116:1399e1404)

Transcatheter aortic valve implantation (TAVI) is currently a valid option to surgery in patients with severe symptomatic aortic stenosis who are contraindicated or at high risk to surgical replacement.1e6 Although alternative access sites have been developed since the introduction of the technique by Cribier et al in 2001, the transfemoral route remains the

a Department of Cardiology, bDepartment of Cardiovascular Surgery, Department of Medical Information, and iDepartment of Radiology, University Hospital of Montpellier, Montpellier, France; cDepartment of Cardiology, University Hospital of Nimes, Nimes, France; eDepartment of Cardiology, Clinique du Millenaire, Montpellier, France; fDepartment of Cardiology, Clinique des Franciscaines, Nîmes, France; gDepartment of Cardiology, Clinique St. Pierre, Perpignan, France; and hDepartment of Cardiology, General Hospital of Perpignan, Perpignan, France. Manuscript received July 8, 2015; revised manuscript received and accepted August 1, 2015. See page 1403 for disclosure information. *Corresponding author: Tel: þ (33) 467336188; fax: þ33 4 67 33 61 96. E-mail address: [email protected] (F. Leclercq). d

0002-9149/15/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2015.08.003

most widely used for this procedure. Despite an improvement in operator experience, valve technology, and better screening, major vascular complications (VC) remain frequent and may be associated with unfavorable clinical outcomes with significantly higher rate of major bleeding and correlated with 1-year all-cause and cardiac mortality.7e9 According to the Valve Academic Research Consortium 2 (VARC-2) criteria,10 major VC are still reported with an incidence of 3% to 15% of the procedures, the low rates observed usually in registries.4,7e9,11,12 Although percutaneous (PC) closure has been routinely adopted by many centers and performed with a high rate of success after TAVI, the open surgical (OS) access is still widely used, and the superiority of one approach (e.g., surgical cut down) compared with the other (e.g., closure device) still remains a matter of debate. The OS approach may have been viewed as more predictable, offering more direct control during adverse events. Conversely, the PC access is considered as less invasive especially using small diameter sheaths and associated in some studies with significantly lower postprocedural length of stay than the surgical route.13e15 The objective of this study was to evaluate www.ajconline.org

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Table 1 Baseline characteristics of the overall population (n ¼ 396) Female Age, median (years) Body mass index, median (kg/m2) Euroscore, median NYHA class I, II III, IV Hypertension Diabetes mellitus Smoker Coronary artery disease Peripheral arterial disease Atrial fibrillation Left ventricular ejection fraction 30% 30-45% >45% Chronic kidney failure Creatinine (mmol/L) median Hemoglobin (g/dL) median Albumin median (mg/l) Low molecular weight heparin Vitamin K antagonist Antiplatelet therapy Double Simple Direct oral antithrombotic Surgery period <2012 2012

218 85 25.2 15.2

(55.1%) (81-88) (22.8-28.4) (11.0-23.0)

117 268 247 103 6 202 36 150

(30.4%) (69.6%) (62.9%) (26.2%) (1.5%) (51.4%) (9.2%) (38.2%)

30 82 278 31 104 12.2 40 44 42 293 143 150 7

(7.7%) (21.0%) (71.3%) (7.9%) (81-129) (11.3-13.4) (37-43) (11.3%) (10.8%) (75.5%) (36.7%) (38.7%) (1.8%)

159 (40.2%) 237 (59.8%)

Table 2 Major and minor vascular complications (VARC-2 criteria) Vascular Complications False aneurysm Hematoma Fistula Dissection Femoral artery thrombosis Thoracic aortic dissection Total

Major 1 (11.1%) 2 (22.2%) 0 5 (55.6%) 0 1 (11.1%) 9 (2.3%) 25 (6.3%)

Minor 0 (81.25%) (6.25%) (6.25%) (6.25%) 0 16 (4%)

13 1 1 1

incidence of VC in a large population of patients when TAVI is performed with an exclusive femoral OS access and to identify predictive factors of VC using this strategy. Methods This monocentric observational study was conducted in the cardiology department of the Montpellier University Hospital, France, from January 2010 to February 2014. It included 396 consecutive patients who had a transfemoral TAVI procedure using the balloon-expandable Edwards SAPIEN XT bovine pericardial device (Edwards Life Sciences, Irvine, California) or the self-expandable Core Valve porcine pericardial device (Medtronic, Inc., Minneapolis, Minnesota). All patients had severe symptomatic aortic stenosis secondary to degenerative disease confirmed by

transthoracic echocardiography (mean gradient >40 mm Hg and/or valve area <1 cm2) and were not candidate for aortic valve replacement after internal discussions on the therapeutic options within the multidisciplinary heart team. Vascular access was evaluated before the procedure in all patients with multislice computerized tomography angiography of the entire aorta using vascular windows settings (Advantage windows, version 4.6; General Electric Workstation, Milwaukee, Wisconsin). As recommended in the guidelines, in case of circumferential calcification and femoral arterial diameter 6.5 mm, patients were excluded from the femoral approach.16 All procedures were done under general anesthesia. For the SAPIEN XT valve, the sets included the Novaflex delivery system and appropriate introducer sheaths (16Fr to 20Fr). The Medtronic Core Valve (sizes 26 or 29 mm) was delivered through a 30-cmlong 18Fr sheath (Check-Flo Introducer) from Cook Medical (Bloomington, Indiana) with an outer diameter of 7.3 mm (16Fr). All patients received 0.5 mg/kg of heparin at the time of introducing the femoral sheath to achieve an activated clotting time of >250 seconds. A balloon aortic valvuloplasty was systematically performed (balloon size: 20, 23, or 25 mm) before implantation of the prosthesis. We used 2 surgical strategies: before 2012, a conventional surgical approach with femoral artery controlled using vessel loop and arterial repair achieved using arterial crossclamping and interrupted suture, and after 2012, an equivalent of “surgical preclose technique” to avoid arterial cross-clamping and avoid purse string effect.17 For both techniques, the femoral artery was exposed through a transversal groin incision. The anterior wall of the artery was cleaned from surrounding tissues up to a few centimeters. If uneven calcified plaques were found by palpation, a longer part was freed. Then, the most suitable site was chosen. At the end of the procedure, both ends of the sutures were gently pulled to obtain coaptation of the arterial wall and tied. When minimal damage was present, primary transverse closure of the artery was undertaken with polypropylene suture. In situations where arterial damage was more extensive, a pericardial patch or an appropriately sized Dacron graft was used. All patients underwent a controlateral venous and arterial femoral approach using 6Fr sheath to perform angiography, hemodynamic monitoring, and ventricular pacing. We used 6Fr closure devices (angioseal; St. Jude Medical, St. Paul, Minnesota) for the controlateral femoral artery. All procedures were performed in the same site by 6 medical teams including 4 different surgeons and 8 interventional cardiologists. An association of clopidogrel 75 mg and aspirin 75 mg without loading dose was introduced in all patients after the procedure except in those with indication of vitamin K antagonists or direct oral anticoagulant therapy who had only aspirin 75 mg. The vitamin K antagonists were always stopped before the procedure to obtain an INR <2 and reintroduced 1 or 2 days later. The direct anticoagulation therapy was stopped at least 2 days before TAVI. Primary end point concerned incidence and risk factors of VC defined by the modified VARC-2 classification and bleeding complications according to the Bleeding Academic Research Consortium definition.10,18 Secondary end points included total mortality and major events at 1-month and 1-year follow-up

Valvular Heart Disease/Vascular Complications and Surgical Access After TAVI Table 3 Life threatening, major and minor bleeding at 1-month follow-up Life threatening bleeding Pericardial tamponnade Related to annulus rupture Hemorrhagic shock Intracranial During Aortic valve replacement surgery Retroperitoneal hematoma Unknown Hematuria Rectal hemorrage Peri-procedural Total

13 6 1 1

Major bleeding

Table 4 Predictive factors of vascular complications in univariate analysis

Minor bleeding

(3.3%) (1.5%) (0.25%) (0.25%) 1 (0.25%) 1 (0.25%) 1 (0.25%)

15 (3.8%) 31 (7.8%)

3 (0.8%)

1 1 11 13

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(0.25%) (0.25%) (2.8%) (3.3%)

Figure 1. Bleeding complications according to the BARC classification.18 BARC ¼ Bleeding Academic Research Consortium.

(VARC-2 criteria). Patients’ characteristics were presented using median and interquartile range (IQR25e75) for continuous variables and frequencies and proportions for categorical variables. Groups (VC vs no VC) were compared using the Wilcoxon-Mann-Whitney test for continuous variables and the chi-square or Fisher’s test for categorical ones. To determine the relative importance of the covariates on the occurrence of VC, a multivariable analysis using logistic regression was performed. A backward selection of the variables was used, with an alpha-to-exit set at 0.10. Odds ratio (OR) and their 95% confidence intervals were calculated. The goodness-of-fit of the models was assessed using the Hosmer and Lemeshow chi-square test. Statistical analysis was performed using SAS, v.9, statistical software (SAS Institute, Cary, North Carolina). Results The study enrolled 396 patients, including 290 (73.2%) with a SAPIEN XT valve and 106 (26.8%) with a Medtronic Core Valve prosthesis. During the same period, 38 (7.6%) and 60 patients (12.1%) had TAVI through subclavian or transapical access, respectively. Patients’ characteristics are presented in Table 1. The procedure was performed by the right femoral artery for 154 patients (38.9%) and through the left side for 242 of them (61.1%). The median total length of the procedure was 68  19 minutes including

No vascular complications n ¼ 371

Vascular complications n ¼ 25

p

Women 205 (55.3%) 13 (52.0%) Age, median (years) 85.0 (81.0-88.0) 85.0 (83.0-88.0) Body mass index, median 25.1 (22.7-28.4) 25.5 (23.1-29.7) Euroscore, median 15.5 (11.0-23.0) 13.6 (11.89-22.3) NYHA class I, II 110 (30.4%) 7 (30.4%) III, IV 252 (69.6%) 16 (69.6%) Hypertension 231 (62.6%) 16 (66.7%) Diabetes mellitus 92 (24.9%) 11 (47.8%) Smoker 6 (1.6%) 0 Coronary artery disease 191 (51.8%) 11 (45.8%) Peripheral arterial disease 35 (9.5%) 1 (4.2%) Atrial fibrillation 139 (37. 74%) 11 (45.8%) Left ventricular ejection fraction  30% 29 (7.9%) 1 (4.2%) 30-45% 75 (20.5%) 7 (29.2%) 45% 262 (71.6%) 16 (66.7%) Chronic kidney failure 26 (7.0%) 5 (20.8%) Creatinine (mmol/L), median 104.0 (81.0-127.0) 110.0 (73.5-156.0) Hemoglobin (g/dL), median 12.3(11.4-13.4) 11.6 (10.3-12.8) (IQR25-75) Low molecular weight 41 (11.3%) 3 (12.5%) heparin Vitamin K antagonist 39 (10.7%) 3 (12.5%) Antiplatelet therapy 275 (75.6%) 18 (75.0%) DOA 7 (1.9%) 0 Prosthesis Edwards XT 270 (72.8%) 20 (80.0%) Corevalve 101 (27.2%) 5 (20.0%)

0.75 0.27 0.64 0.71 1.00

0.69 0.02 0.53 0.57 0.71 0.43 0.63

0.03 0.53 0.10 0.74 0.73 0.95 0.50 0.43

Table 5 Non vascular complications at the access site Non vascular complications Lymphocele Lymphorrhea Scar dissension Hematoma infection Total

2 2 2 1 7

(28.6%) (28.6%) (28.6%) (14.2%) (1.8%)

13  5 minutes for the surgical access. At 1-month followup (primary end point), VC occurred in 25 patients (6.3%) including 9 (2.3%) with major and 16 (4%) with minor VC. Hematoma and femoral artery dissection were the 2 main complications observed (Table 2). A surgical or a PC management of a VC was requisite for 9 patients (2.3%). Transfusions were required in 54 patients (13.7%), with only 1 unit of red blood cells (RBCs) needed for the vast majority of them (n ¼ 44; 81.5%). Life-threatening and major bleeding concerned 18 patients (4.6%; Table 3, Figure 1). RBC transfusions were inversely correlated to baseline hemoglobin level (11.4  1.6 g/dl in patients with transfusion vs 12.5  1.6 g/dl in those without transfusion, p <0.001). Predictive factors of VC evaluated in univariate analysis are presented in Table 4. In multivariable analysis,

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only diabetes (OR 2.5; 95% confidence interval 1.1 to 6.1, p ¼ 0.034) and chronic kidney failure (OR 3.0; 95% confidence interval 1.0 to 9.0, p ¼ 0.047) were predictive of VC. Non-VC occurring at the access site, considered as specifically related to the use of the surgical approach, concerned 7 patients (1.8%) requiring surgery in 2 of them (Table 5). Other complications occurring at 1-month follow-up (secondary end point) included mainly conduction disorders (n ¼ 78, 19.7%) and required permanent pacing for 47 of them (11.9%) and acute kidney failure (n ¼ 28, 7%). Ischemic stroke occurred in 4 patients (1%), for 3 of them during the inhospital stay. Acute heart failure concerned 10 patients (2.5%). Mortality at 1 month was 6.6% (n ¼ 26) and was related to ventricular arrhythmias associated with left ventricular dysfunction (n ¼ 3, 0.75%), annulus rupture (n ¼ 4, 1%), mesenteric ischemia (n ¼ 1, 0.25%), heart failure (n ¼ 2, 0.5%), septic shock (n ¼ 2, 0.5%), severe aortic regurgitation (n ¼ 2, 0.5%), thoracic dissection (n ¼ 1, 0.25%), or of unclear cause (n ¼ 1, 0.25%). Mortality rate at 1-year follow-up was 17.3% (n ¼ 67), related to cardiovascular cause in 12.6% of patients (n ¼ 49), whereas 2% of the total population (n ¼ 8) was lost at follow-up after index hospitalization. The occurrence of VC was not associated in our study with mortality at 1-month or 1-year follow-up. The need of RBC transfusions was not correlated to 1-month mortality (p ¼ 0.7) but to mortality at 1-year follow-up (p ¼ 0.02). Major VC in the controlateral access site were observed in 5 patients (1.2%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Discussion The main results of this study were (1) in a population of nonselected patients who underwent transfemoral TAVI, the OS approach is associated with a very low rate of major (2.3%) or minor (4%) VC and of life-threatening and major bleeding (4.6%); (2) the occurrence of major vascular events was not correlated with 1-month or 1-year mortality with the OS strategy; (3) in experienced hands, the surgical technique appears simple, fast, and particularly beneficial in patients with high-risk bleeding, like women, or low body mass index (BMI). Chronic renal failure and diabetes remained predictive of VC with this approach. The occurrence of major VC after TAVI is usually associated with unfavorable clinical outcomes and 30-day mortality.7,9,11 First studies that did not use standardized definitions, and concerned first-generation devices, reported a range of VC from 8% to 31%.3,11,19e21 Recent data using the VARC-2 modified criteria10 suggested a decrease in major VC because of the combination of newer device generations, smaller delivery systems, better screening of patients, and increased operator experience.6,13e15,22 The rate of major VC and major bleeding still concerned 4% and 21%, respectively, of the patients with the low-profile new-generation balloon-expandable SAPIEN 3 prosthesis using a quasi-exclusive PC access.22 Our study showed one of the lower rate of major VC (2.3%) reported after TAVI, close to the results of Greason et al (1.8%) using an exclusive OS strategy.12 The OS approach was predominantly used in the first studies of TAVI, but recent data

suggest that a full PC procedure can be performed with a low rate of VC and bleeding events, especially using small diameter sheaths.23,24 In contrast, the OS technique has often been advocated to better control bleeding and VC.12,15,24 Although inhospital access-related events were similar, Nakamura et al, who performed completion iliofemoral angiogram in all patients after closure of the arteriotomy, showed that significant isolated stenosis/dissection at the access site developed more frequently when the access was PC (7.1% vs 0.7%, p ¼ 0.007). In some studies, the OS approach has been independently associated with longer length of stay than the PC access.15,23 Using a technique requiring ultrasound-guided puncture, Togweiller et al13 showed a dramatic decrease in VC (1% vs 8%) with a fully PC procedure with 18Fr to 19Fr sheaths. In our study, the patients were rigorously selected by computed tomographic scan to evaluate arterial diameter, calcifications, and tortuosities, with exclusion for the femoral approach of those with extensive calcifications. The choice of an exclusive surgical technique may have, however, contributed to the low rate of vascular and bleeding complications that we observed. First, the technique of OS providing the opportunity to select simply the optimal location in the artery for cannulation can decrease the risk of femoral dissection.12,15,24 Among major VC, we observed only 5 patients with femoral dissection in our study (1.2%). Second, our results showed that the technique of OS is relatively fast (13  5 minutes) and did not require any technique assistance because direct exploration and tactile feel of the calcium free before puncture are possible.15,24 Third, unlike previous data, neither major VC nor bleeding were associated with mortality at follow-up in our study.7,9 Transfusions, correlated in our study with hemoglobin level at baseline, were associated with mortality at 1-year but not at 1-month follow-up, suggesting that elderly patients with low level of hemoglobin (usually associated with cardiac or kidney failure) were probably at high risk of long-term mortality.25 The OS strategy is, therefore, associated with low rate of VC, but when VC occurred, it may be controlled and repaired more easily and more rapidly than with the PC approach and the prognosis is probably better.15 The low rate of major bleeding observed in our study is probably the result of this better control of VC. Conversely, the PC technique may under-report the prevalence of arterial injury at the site where the sheath enters the artery. Diagnosis of VC may be delayed and complicated with major bleeding which is correlated with morbidity and mortality in all studies.8,26 Fourth, the technique of OS appears to be simple for a vascular surgeon.12,17 Indeed, we did not find effect of learning curve although our results were the same in the early and recent experience. Conversely, the PC technique required more experience and is probably suitable only in high-volume TAVI centers.12,14 Last, similar to the PC approach, the technique of OS allows the patient to stand up the first day after the procedure and the median duration of hospitalization in our study (5 days) compared favorably to recent reports.6,15,22 In the PARTNER (Placement of Aortic TraNscathEteR valve) study, the only identifiable independent predictor of major VC was female gender (relative risk [RR] 2.31). The smaller vessel diameters encountered in women and more complex repair in case of VC may partially

Valvular Heart Disease/Vascular Complications and Surgical Access After TAVI

explain this finding.7,12 Interestingly, in the study of Kadakia et al,15 the increased risk of VC in women was only noted in patients with PC and not in those with OS. This raises the possibility that an OS approach may be preferred in women. Our results are concordant with these findings, whereas neither gender nor low BMI, usually related to female gender, were predictive of VC with the OS approach. Through better exposition of the artery, the surgical approach may probably limit complications and/or facilitated repair in case of complication in patients with high-risk bleeding, like women, or extreme BMI. The combined effect of increased experience paired with smaller sheath size use was highlighted in the study of Togweiller et al13 using PC approach. Conversely, in the study of Greason et al12 using an exclusive OS strategy with relatively large sheath (22Fr to 24Fr), neither calcification nor sheath-to-artery ratio was predictive of VC. We did not evaluate sheath-to-artery ratio in our study, but our results showed that using a rigorous selection of patients with computed tomographic scan, combined using new-generation devices, very low rate of VC and bleeding can be obtained with an exclusive OS strategy. Only chronic renal dysfunction (RR 3.2) and diabetes (RR 2.6) remained related in our study to VC. Previous report showed that low creatinine clearance predicted 30-day allcause mortality, VC, and bleeding after TAVI.6,8,26 Chronic renal dysfunction and diabetes mellitus have been associated with several disorders of primary hemostasis and advanced atherosclerosis that can lead to VC and bleeding.27e29 In these patients, the risk of VC is increased, and the impact of OS strategy compared with the PC approach to minimize the occurrence of vascular injury is not known. The results of our study were limited by its observational and nonrandomized design, and despite adjustment for potential confounders, unmeasured variables may not have been fully controlled. Our population was at intermediate risk, as reflected by the mean logistic Euroscore of 15.2, and this characteristic may influence the incidence of VC. Recent experience with TAVI includes rapidly decreased length of stay, and direct comparison concerning this particular point between PC and OS access is lacking. The monocentric design of the study does not allow to extend these results in nonexperienced surgical centers. Acknowledgment: We thank Valérie Macioce, MD for her help in reading the manuscript and correct English language and Gregory Marin, MD for his assistance for statistical analysis.

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