Objectives. To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). Background. The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. Methods. A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. Results. Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). Conclusions. The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.
J INVASIVE CARDIOL 2021 February 18 (Ahead of Issue).
Key words: crossover technique, primary access hemostasis, transcatheter aortic valve replacement, vascular complications
The development of new-generation transcatheter heart valves (THVs), with a significant reduction in sheath-delivery system size, and the increased operator experience with large-bore percutaneous vascular closure techniques, has led to a significant reduction in vascular and bleeding complications following transcatheter aortic valve replacement (TAVR).1,2 Nonetheless, vascular complications (VCs) related to access site remain one of the most important drawbacks of the procedure, especially for transfemoral TAVR.1
The crossover balloon occlusion technique (CBOT) has been proposed to facilitate percutaneous large-sheath access-site closure. Its routine use has been associated with a decrease in the occurrence of major vascular and bleeding complications, as it allows for a prompt diagnosis and treatment.3-5 However, most data supporting the use of the CBOT come from observational studies that included a limited number of patients, mostly treated with-first generation THVs.3-5 Moreover, as TAVR procedures evolve toward a maximal simplification, a simplified version of the traditional CBOT has also been described.6 In this simplified crossover technique (SCT), the over-the-wire balloon is used only if considered necessary (not systematically). Interestingly, the SCT has also been associated with a reduction of major VCs and life-threatening bleeding in a small series of patients.6 Additionally, there are some populations considered at high risk for access-related VCs and percutaneous closure device (PCD) failure, such as obese patients.7,8 In this population, the potential benefit of using a femoral protection through a crossover technique (COT), such as SCT or CBOT, has not been previously elucidated. Thus, the objectives of the present study were: (1) to determine the occurrence of VCs and bleeding complications following TAVR with new-generation devices according to the use of a femoral protection COT (SCT/CBOT); and (2) to evaluate the potential role of the COT in obese TAVR recipients.
The study population included 2214 patients who underwent a full percutaneous transfemoral TAVR procedure between 2013 and 2019 with a new-generation THV at 9 tertiary-care centers in Europe and Canada. A COT for primary access hemostasis was used in 1522 patients (68.7%), with the CBOT performed in 563 patients (25.4%) and the SCT performed in 959 patients (43.3%), whereas simple primary hemostasis without COT was performed in 692 patients (31.3%). The decision of using a COT (CBOT or SCT) was left at the discretion of the heart team responsible for the case. The COTs were performed through a secondary femoral or radial access in 1143 patients (75.1%) and 379 patients (24.9%), respectively. No echo-guided puncture was used in this study. Percutaneous hemostasis after sheath removal was performed mostly with suture-based vascular closure devices (Prostar XL [Abbott Vascular] in 815 patients [36.8%] and Perclose ProGlide [Abbott Vascular] in 1390 patients [62.8%]), which were deployed prior to the introduction of the delivery sheath (the “preclose” technique). In 9 patients (0.4%), femoral hemostasis was performed with the collagen-based Manta percutaneous vascular closure device (Essential Medical). In 157 patients (7.1%), a collagen-based AngioSeal device (Abbott Vascular) was added to the suture-based devices to achieve femoral hemostasis (154 patients who had been treated with Perclose and 3 patients who had been treated with Prostar XL).
Baseline, periprocedural, and 30-day clinical event data were prospectively collected in a dedicated database in each participating center. All events were defined according to the Valve Academic Research Consortium-2 criteria.9 The study was performed in accordance with the institutional review board of participating centers, and all patients provided informed consent for the procedures.
Crossover techniques. The SCT and CBOT performed through the femoral artery and the modified CBOT/SCT through the radial artery have been previously described.3,6,10 Briefly, in our study, the secondary vascular access was mostly cannulated with a 6 Fr introducer sheath (75% of the patients). In both COTs, an exchange-length wire was placed in the femoral artery used as primary access, which was left in place through the duration of the procedure. In the CBOT, once the valve was deployed, the THV sheath or delivery system was retracted until the common iliac artery, and an over-the-wire balloon was advanced up to the iliac vessel. The balloon was then inflated at low pressure to interrupt blood flow, allowing for the removal of the sheath and primary access hemostasis without significant bleeding. Finally, in both SCT and CBOT techniques, an iliofemoral angiography was performed (through the over-the-wire balloon or pigtail catheter) to identify iliofemoral VCs. If no complication was identified, the exchange-length wire was removed safely and secondary access hemostasis was completed (Figure 1).
Statistical analysis. Continuous variables are presented as mean ± standard deviation and categorical variables as count and frequency. Continuous variables were compared using the t-test or Wilcoxon rank-sum test, and categorical variables were compared using the Chi-squared or Fisher’s exact test, as appropriate. The unadjusted analyses were initially performed in the overall study population, according to the use of the COT (vs simple hemostasis, or “no COT”). A propensity-score analysis was performed to adjust for the intergroup clinical differences. A propensity score representing the likelihood of having a crossover was calculated for each patient by the use of multivariable logistic regression analysis that identified variables independently associated with crossover at a P<.20. Continuous variables were checked for the assumption of linearity in the logit and the graphical representations suggested linear relationships. Interactions between variables were allowed only if it was supported clinically and statistically (P<.20). Variables retained in the final model were age, sex, kidney disease, hypertension, peripheral vascular disease, diabetes, valve type, percutaneous vascular closure device, and sheath size. All analyses were performed using a hierarchical method to account for between-center variability. The 30-day clinical outcomes were compared between groups with the use of logistic regression hazard models. The propensity score was then incorporated as an additional variable in the logistic regression models. A subanalysis was done for patients with body mass index (BMI) ≥30 kg/m2 and BMI ≥35 kg/m2. The results were considered significant if P was <.05. All analyses were conducted using the statistical package SAS, version 9.3 (SAS Institute).
The main baseline clinical and procedural characteristics of the overall population and according to the use of a COT are shown in Table 1. The mean age of the study population was 82 ± 8 years, and 52.3% were women. Both COT and no-COT groups had comparable baseline characteristics, with the exception of age (81 ± 8 years in the COT group vs 82 ± 7 years in the no-COT group; P=.03) and baseline kidney disease (69.1% in the COT group vs 62.3% in the no-COT group; P<.01). The overall risk profile of the TAVR recipients was also different between groups (mean STS-PROM scores, 5.8 ± 4.1% vs 5.3 ± 5.2% in the COT group vs the no-COT group, respectively; P=.03).
Thirty-day events of the study population (overall and according to the use of a COT) are shown in Table 2. A major VC related to the primary access was identified in 53 patients (3.5%) in the COT group and 27 patients (3.9%) in the no-COT group (P=.19). Moreover, 178 patients (11.7%) and 41 patients (5.9%) suffered a minor VC in the COT and no-COT groups, respectively (P<.001). Major and minor VCs in each group are depicted in Figure 2. Only 1 patient (0.07% of the population who had a COT) suffered a major VC as a direct consequence of the COT (balloon rupture resulting in femoral thrombosis). Thirty-day events after SCT compared with CBOT are depicted in Table 3. No differences in the rate of vascular complications (major or minor), major/life-threatening bleeding, acute renal injury, or mortality were found between the 2 COT types. PCD failure was identified in 53 patients (2.4% of the overall population, 17.9% of the VCs), and it was the most common cause of major VCs in both groups (28.3% in the COT group vs 40.7% in the no-COT group; P=.26). Although the total number of VCs in the COT group was higher, PCD failure was responsible for a lower proportion of VCs in the COT group compared with the no-COT group (15.3% vs 26.9%, respectively; P=.03).
The treatment of VCs according to the use of a COT is shown in Figure 2. An invasive treatment (surgical or percutaneous) for the management of major VCs was needed in 34 patients (64.2%) in the COT group vs 24 patients (88.9%) in the no-COT group (P=.04). Concerning minor VCs, a total of 63 patients (35.4%) in the COT group underwent an invasive treatment (62 patients percutaneously) vs 11 patients (26.8%) in the no-COT group (all patients treated percutaneously) (P=.40). Major or minor VCs secondary to PCD failure were followed by an invasive treatment in 96.2% of cases (97.1% in the COT group vs 94.4% in the no-COT group; P>.99). In the group of patients who underwent a transradial COT, a percutaneous treatment was needed in 20 patients (5.3% of the patients and 38.5% of the VCs in the transradial COT group). In 8 patients (2.1%), an additional transfemoral COT was performed to allow for stent-graft implantation, while 12 patients (3.2%) underwent percutaneous treatment through the radial artery.
Thirty-day rates of major/life threatening bleeding (3.4% in the COT group vs 2.0% in the no-COT group; P=.33) and overall mortality (2.4% in the COT group vs 2.6% in the no-COT group; P=.23) were comparable between groups, but the rate of acute kidney injury was significantly higher in the COT group (8.9% in the COT group vs 3.9% in the no-COT group; P<.001).
In the group of patients who did not undergo a COT, a total of 569 patients (82.2%) had a final control angiography of the femoral access. Results according the performance of the final angiography showed no differences regarding the rate of major VCs (3.7% for the angiography group vs 2.4% for the no-angiography group; P=.65) or minor VCs (10.2% for the angiography group vs 4.9% for the no-angiography group; P=.06) related to the primary femoral access.
Subanalysis in obese patients. A subanalysis regarding the occurrence of VCs was performed in obese TAVR recipients (defined as BMI ≥30 kg/m2). Obese patients (n = 523; 23.6% of the overall population) showed a tendency toward a lower rate of major VCs when a COT was performed (3.4% in the COT group vs 5.9% in the no-COT group; P=.09). Similarly, in patients who had a BMI ≥35 kg/m2 (n = 164; 7.4% of the overall population), the use of a COT was also associated with a tendency toward a lower rate of major VCs (2.7% in the COT group vs 7.7% in the no-COT group; P=.14) (Figure 3A). On the other hand, the rate of PCD failure was significantly higher in obese patients compared with non-obese patients (4.0% in the BMI ≥30 kg/m2 group vs 1.9% in the BMI <30 kg/m2 group; P<.01). Differences in PCD failure were not sustained if a COT was performed (3.4% in the BMI ≥30 kg/m2 group vs 2.0% in the BMI <30 kg/m2 group; P=.12), but it remained significantly higher in those patients who underwent simple hemostasis without a COT (5.3% in the BMI ≥30 kg/m2 group vs 1.7% in the BMI <30 kg/m2 group; P=.01) (Figure 3B).
To the best our knowledge, this is the largest study to date comparing the outcomes of TAVR procedures with new-generation devices according to the use of a COT (SCT or CBOT) for the protection of the primary femoral access. The main findings of the present study can be summarized as follows: (1) the use of a COT was not associated with a significant reduction in the 30-day rate of major VCs or major/life-threatening bleeding; (2) acute renal failure following TAVR was significantly higher in patients who underwent a COT; and (3) PCD failure rate in obese TAVR recipients was higher compared with non-obese patients, but this rate was comparable among both groups if a COT was performed. Additionally, COT showed a tendency toward a reduction in the rate of major VCs in this high-risk population.
Transfemoral primary access-site hemostasis techniques and vascular closure devices have evolved since the early TAVR experience, and many operators have progressively adopted a fully percutaneous “minimalist approach.”11 Compared with open surgical cutdown, fully percutaneous femoral access using vascular closure devices has been associated with a lower risk of both VCs and in-hospital bleeding events.1,12 Nonetheless, in spite of a significant reduction in VCs and bleeding events over time,1 major/life-threatening bleeding events and major VCs affected more than 5% of patients in trials including intermediate-risk patients.13,14 Consequently, the occurrence of these adverse events poses a major concern, as they are associated with poorer outcomes, including longer hospitalization length, higher 30-day and 1-year mortality rates, increased risk of 1-year rehospitalization, greater cost of care, and poorer quality of life.1,15-18
The CBOT, first described in 2010 by Sharp et al,3 has been proposed as a technique to facilitate percutaneous large-sheath access-site closure. Its safety and feasibility, through both the radial and femoral arteries, has been subsequently demonstrated in small studies that included a limited number of patients treated mostly with first-generation devices.5,10,19 Zaman et al4 found a 4.5-fold reduction in the rate of major VCs associated with the use of the CBOT, and Stortecky et al20 reported a decrease in the rate of major VCs from 12% to 1% after routine implementation of the CBOT. Afterward, a simplified COT was reported by Garcia et al.6 In this study, the over-the-wire balloon was used only if it was required and not as routine strategy.6 Interestingly, the results were similar to those reported in CBOT studies (reduction of major VCs from 18% to 7%). Consequently, a significant proportion of heart teams use the COT (SCT or CBOT) as an all-comers strategy. Nonetheless, while encouraging, the data seem to be too limited to support its routine use in TAVR procedures. Additionally, there is no evidence of the benefit of the COT with the exclusive use of new-generation devices. Unlike previous studies, our study accounted for some elements that are frequently present in contemporaneous procedures, and that have been previously associated with a reduction in the rate of major VCs, independently of the use of the COTs, ie, the use of new-generation devices and lower-profile sheaths, a higher level of operator experience, and lower-risk patient cohort.21 Interestingly, we found that there were no differences in the rate of major VCs and major/life-threatening bleeding rates according to the use of a COT. On the other hand, the rate of minor VCs was higher in the COT group (11.7% vs 5.9% in the no-COT group). This could be explained by the fact that the COT may have been associated with the over-diagnosis and over-treatment of minor VCs. In our study, 36% of the patients who suffered a minor VC in the COT group underwent an invasive treatment (surgical or percutaneous), in comparison with 27% of patients who underwent simple hemostasis (no significant differences between groups). Also, the COT allows for prompt identification and treatment of VCs. Guidewire placement at the beginning of the procedure may prevent delayed treatments as a consequence of difficulties for guidewire advancement once the VC has occurred. Consequently, some potential major VCs could have been converted to minor VCs, as the arterial injury can be immediately treated and its severity reduced6 (Figure 4). Similar findings have been previously reported by Stortecky et al,20 who also noticed an increase in the rate of minor VCs (from 8% to 16%) in parallel with the reduction in major VC rate with the use of the CBOT. Additionally, in our study, major VCs were managed conservatively in 30% of COT patients, in comparison with 11% who did not, also suggesting a potential benefit to the early diagnosis of VCs. Finally, some TAVR operators who do not routinely perform the COT may have used this technique if the patient was deemed at high risk for VCs.
Despite the advantages of the percutaneous approach for transfemoral TAVR procedures, PCD failure has become one of the most frequent causes of major VCs.22 PCD failure rates between 3% and 7.8% have been reported with new-generation THVs.23-26 In our study, PCD failure was identified in 2.4% of patients, accounting for about 33% and 12% of the major and minor VCs, respectively. Interestingly, although the total number of VCs was lower, PCD failure was more frequent in the group of patients who did not undergo the COT, likely due to a delayed diagnosis and treatment of the complication. According to prior studies, PCD failure was associated with an invasive treatment in almost 100% of the cases, underlining the importance of reducing the PCD failure rate.7
Several factors — mainly peripheral vascular disease and obesity — have been associated with an increased risk of PCD failure.7,8 Increased BMI and depth of skin puncture site have been identified as independent predictors of PCD failure, as the presence of thick subcutaneous tissue at the site of puncture may hinder the smooth progression of the knot toward the arterial wound.7 In our study, a BMI ≥30 kg/m2 was associated with a higher risk of PCD failure, especially in those patients who did not undergo a COT. Additionally, obese TAVR recipients who underwent simple hemostasis also showed a tendency toward an increased risk of major VCs (which increased in parallel with the BMI), whereas in those who underwent a COT, the rate of major VCs remained stable independent of BMI. This finding raises the question as to whether the COT should be performed as a routine practice in obese TAVR recipients in order to make a prompt diagnosis and treatment of VCs, which could be otherwise challenging to detect and treat.
Complications directly related to the COT are rare. In our study, only 1 patient (0.07%) experienced a VC related to balloon inflation. Similarly, previous studies reported no cases or isolated cases of VCs related to the COT.3-6 Nonetheless, there are some indirect complications of COT that should be considered. Even though previous studies found no differences in the amount of contrast or the rate of acute kidney injury after performing a COT,4,6 the rate of acute kidney injury following TAVR was higher in patients who underwent a COT in the present study. This increased risk was likely related to the use of a higher amount of contrast, not only to perform the control angiography of the femoral artery after THV sheath removal, but also to either optimize femoral hemostasis or treat vascular complications.
Study limitations. First, this study was subject to the limitations inherent in non-randomized studies with retrospective data analysis. However, a propensity-score analysis was performed to adjust for the intergroup clinical differences, and all complications were prospectively collected and entered into a dedicated database. The lack of some procedural data could also limit the study results. Second, 2 different COTs were used in this study. Despite the lack of previous studies comparing these 2 techniques, both have been associated with similar outcomes when compared to simple hemostasis. Third, no data were collected regarding the procedural time and the amount of contrast used. Fourth, data regarding the calcification degree and disease severity of the femoral arteries were not collected, but all patients were selected as transfemoral candidates by the heart team of each participating center. Fifth, there was no predetermined protocol for the femoral hemostasis technique or the treatment of VCs (medical, percutaneous, or surgical), and femoral access-site management was decided by the operating team.
The present study showed that the COT (SCT or CBOT) in TAVR procedures performed with newer-generation devices was not associated with a significant reduction in major VCs or major/life-threatening bleeding events when used as a routine technique. While the use of COT reduced the number of invasive treatments performed as a consequence of major VCs, the rate of acute kidney injury was higher if the patient had undergone a COT. In obese TAVR recipients, the use of COT was associated with improved procedural outcomes, with lower rates of PCD failure and a tendency toward lower rates of major VCs. Overall, these findings would suggest a tailored strategy for the use of COTs, following a careful risk-benefit assessment in each TAVR candidate. Future randomized studies are warranted.
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From the 1Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada; 2Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France; 3San Raffaele Scientific Institute, Milan, Italy; 4Montefiore Medical Center, New York, New York; 5Hospital Universitario Virgen de la Victoria, Málaga, Spain; 6Cardiovascular Institute. Hospital Clínico San Carlos, IdISSC, Madrid, Spain; 7Groupe Hospitalier Mutualiste de Grenoble, Institut Cardiovasculaire, Grenoble, France; 8Hospital Universitario Central de Asturias, Oviedo, Spain; 9Hospital Universitari Vall d’Hebron, Barcelona, Spain; 10Institut Clínic Cardiovascular, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain; and 11IRCCS Humanitas Research Hospital, Milan, Italy.
Funding: Dr Junquera and Dr. Alperi were supported by a research grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Josep Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Rodés-Cabau has received institutional research grants from Medtronic and Edwards Lifesciences. Dr Latib reports advisory board income from Medtronic and honoraria from Abbott Vascular. Dr Nombela-Franco has served as a proctor for Abbott Vascular. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript accepted July 6, 2020.
Address for correspondence: Josep Rodés-Cabau, MD, Quebec Heart & Lung Institute, Laval University, 2725, Chemin Sainte-Foy, Québec, Canada G1V 4G5. Email: email@example.com