Transradial Crossover Balloon Occlusion Technique for Primary Access Hemostasis During Transcatheter Aortic Valve Replacement: Initial Experience With the Oceanus 140 cm and 200 cm Balloon Catheters

Abstract: Objectives. The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular). Methods. This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded. Results. Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively. Conclusion. In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.

J INVASIVE CARDIOL 2020;32(8):283-288. 

Key words: crossover balloon occlusion technique, radial access, secondary access, transcatheter aortic valve replacement, vascular complications

While the incidence of vascular and bleeding complications following transcatheter aortic valve replacement (TAVR) has progressively decreased over time, it remains one of the most important drawbacks of the procedure.^1,2 The crossover balloon occlusion technique (CBOT) performed through the contralateral femoral artery was first described in 2010 by Sharp et al³ as a technique intended to facilitate primary femoral access hemostasis. Subsequent studies have reported a reduction of vascular and bleeding complications related to the femoral main access following the use of the CBOT.⁴ However, up to 25% of access-site related complications are located at the femoral secondary access,^5-7 and the use of the transradial approach as secondary access has been associated with a significant reduction in vascular complications.^5-7 Buchanan et al⁸ showed the feasibility of using the transradial approach as secondary access (instead of the contralateral femoral artery) for the CBOT. However, the current length of most peripheral balloons (135-150 cm) has been a major limitation for transradial CBOT, with the peripheral balloon not reaching the iliofemoral system in tall patients or in the presence of severe aortoiliofemoral tortuosity. 

The Oceanus balloon dilatation catheter (iVascular) is a new over-the-wire peripheral balloon that is compatible with a 0.035˝ wire, with sizes ranging from 6 to 12 mm, 6 Fr sheath compatible (except the 12 mm balloon, which is 7 Fr sheath compatible), and available in a length up to 200 cm. This increased balloon length should allow the successful performance of the transradial CBOT in all TAVR recipients, regardless of aortoiliofemoral tortuosity and/or the patient’s height. The objective of our study was to determine the feasibility and safety of the modified CBOT through the radial artery with the 140 cm and 200 cm Oceanus 35 balloon catheter.

Methods

A total of 104 patients undergoing TAVR at 11 centers were included. A modified CBOT through the radial artery was performed in all patients. The cases were not preselected, and the selection of the radial artery to perform the modified CBOT was left to the operator’s choice. All events were defined according to the Valve Academic Research Consortium (VARC)-2 criteria.⁹ Vascular complications were classified in relation to the primary or secondary access as major or minor. Bleeding events were classified as related to the primary or secondary access, and as life-threatening, major, or minor. All patients provided informed consent for the procedures.

Transradial CBOT. The modified CBOT through the transradial approach has been previously described in detail.⁸ Briefly, the left radial artery is cannulated with a 6 Fr introducer sheath, and an exchange-length wire is placed in the femoral artery (primary access) through a 120 cm multipurpose diagnostic catheter. Once the wire is correctly placed, the catheter is removed and the wire is maintained in the femoral artery during the entire procedure. Following the removal of the transcatheter heart valve delivery system, an over-the-wire balloon is advanced up to the iliac vessel. The balloon is then inflated at low pressure to interrupt blood flow, allowing for the removal of the sheath and obtaining primary access hemostasis without significant bleeding. Finally, an iliofemoral angiography can be performed through the over-the-wire balloon (only if a 0.025˝/0.018˝/0.014˝ wire was used) to identify iliofemoral vascular complications, and to optimize the femoral lumen at the primary access site if necessary. In our study, the right and left radial approach could be used for the CBOT. Also, the progression of the Oceanus balloon catheter through the subclavian, aortic, and iliofemoral vascular systems was recorded, as well as the ability of the balloon to reach the iliac and femoral arteries, balloon inflation pressure, and vessel occlusion completion. Vascular tortuosity was considered significant if a bend >60º was observed.¹⁰ 

Statistical analysis. Qualitative variables were expressed as absolute numbers (percentages) and quantitative variables are displayed as mean ± standard deviation or median (interquartile range [IQR], 25th-75th percentile) according to variable distribution. All analyses were conducted using the statistical package Stata, version 14 (StataCorp).

Results

The main baseline characteristics of the study population are shown in Table 1. The mean age of the patients was 81 ± 7 years, 43% were women, and the median STS-PROM score was 4.6% (IQR, 2.6%-6.8%). Up to 21% of patients had a height ≥170 cm (up to 186 cm), and a significant aorta and/or iliofemoral tortuosity was observed in 18 patients (17%). 

The main procedural features are shown in Table 2. All TAVR procedures were performed through a transfemoral access (right side in 90% of patients) and a self-expandable valve was implanted in most cases (55%). Hemostasis of the primary access was achieved with the Prostar XL percutaneous vascular surgical system (Abbott Vascular) in 25 patients (24%), the Perclose ProGlide suture-mediated closure system (Abbott Vascular) in 69 patients (66.4%; 2 times in 66 cases; 3 times in 3 cases), and in 9 patients (8.7%) a double system for artery closure with Perclose Proglide (2 times in 6 cases; 3 times in 3 cases) and Angio-Seal (Abbott Vascular) (6 Fr in 4 cases and 8 Fr in 5 cases) was used. The collagen-based Manta vascular closure device (Teleflex) was used in 1 case (1%). The secondary access was the radial artery in all cases (left radial in 74% and right radial in 26%) and a 6 Fr introducer was used in most cases (96%). 

Modified CBOT. The main aspects related to the modified transradial CBOT procedure are shown in Table 2. The 140 cm and 200 cm Oceanus balloons were used in 37.5% and 62.5% of patients, respectively. The balloon reached the femoral artery in all cases, including tall patients with significant vessel tortuosity (Figure 1). The mean balloon size and inflation pressure were 8 ± 1 mm and 6 ± 2 atm, respectively. Appropriate vessel closure during primary access hemostasis was achieved in all patients except 2 (98%). There were no complications directly related to the use of the balloon or the modified CBOT technique.

30-day outcomes. The main 30-day outcomes are shown in Table 3. Bleeding related to the primary access occurred in 7 patients (6.7%) and was classified as minor, major, and life-threatening in 4 patients (3.8%), 2 patients (1.9%), and 1 patient (1.0%), respectively. Vascular complications related to the primary access occurred in 12 patients (11.5%), and were classified as minor and major in 8 patients (7.7%) and 4 patients (3.8%), respectively. Regarding secondary access (radial artery) complications, only 1 case (1.0%) of minor bleeding/minor vascular complication was reported (mild radial hematoma). The overall 30-day mortality rate was 1.9%. 

Discussion

Vascular and bleeding complications in TAVR have been consistently associated with higher short-term and long-term mortality rates, prolonged in-hospital stay, and increased costs.^11-16 Consequently, a lot of effort has been devoted to reduce the size of transcatheter heart valve delivery systems, as well as to improve vascular access and closure techniques.^17,18 Nevertheless, despite significant technological advances and improvements in operator experience, the rates of major vascular and major/life-threatening bleeding complications reported in recent studies with newer-generation transcatheter heart valves were as high as 3%-5% and 11%-12%, respectively.^1,2 

The CBOT has been proposed as a safe and effective technique to facilitate vascular access closure in TAVR recipients.^4,8,19 Additionally, the routine use of the CBOT has been associated with a decrease in the occurrence of major vascular and bleeding complications, as well as with a reduction in the need for blood transfusion after TAVR.⁴ Nonetheless, the CBOT performed through the contralateral femoral artery could be challenging in cases of excessively tortuous vessels or in the presence of narrow iliac carina angles. Also, the use of the femoral artery as secondary access has been associated with a higher rate of vascular/bleeding complications compared with the radial access.^5-7 Consequently, the transradial approach has been proposed to facilitate the CBOT in challenging femoral cases, as well as to potentially reduce the rate of vascular complications associated with the secondary access.^8,20 Nonetheless, some limitations of the modified CBOT have been identified, which could potentially limit its applicability. First, a challenging anatomy of the upper extremity may be found in 3%-7% of cases, which could require reverting to the classical transfemoral CBOT,²¹ particularly in centers with limited experience with the transradial approach. Second, distance from the radial artery to the femoral access site could make standard-length balloon catheters (135-150 cm) insufficient to treat potential complications associated with the TAVR main access (especially in patients with above-average height and a significant aortic or iliofemoral tortuosity). Distance from the left radial access point to the common femoral artery has been estimated at 125 cm (10 cm longer from the right radial artery) in patients shorter than 178 cm,²² and significant vessel tortuosity, frequently present in elderly TAVR recipients, may add several cm to the total vascular length (Figure 2). The Oceanus 35 balloon dilatation catheter offers a catheter length up to 200 cm, so the distance should not be a limitation to perform the modified CBOT in almost any patient. Additionally, it’s the only available 200 cm-long balloon that offers a balloon diameter larger than 8 mm (up to 12 mm), which will allow for a complete iliac or femoral occlusion in most patients. In our study, about one-fourth of the patients had a height >170 cm, and close to one-fifth exhibited a significant aortoiliofemoral tortuosity. The balloon reached the femoral artery in all patients, performing an appropriate vessel closure in 98% of them (a 9-12 mm balloon was used in 39% of the cases). Additionally, the Oceanus balloon dilatation catheter is compatible with a 0.035˝ guidewire, allowing the performance of adequate contrast injections through the balloon without removing the 0.025˝/0.018˝ guidewire placed in the femoral artery at the beginning of the procedure. If a vascular complication is identified at the main access site, there are many devices with longer working lengths that could be used, and successful iliofemoral stent implantations from the radial artery have been previously described.²³ One of the main limitations that could be associated with the modified CBOT is the lack of covered stents that are 6 Fr compatible and long enough to treat an arterial perforation (or other vascular complication) located in the iliac or femoral artery. Nonetheless, if a complication is identified, the transradial crossover balloon could be inflated to stop the bleeding, allowing the safe implantation of a covered stent through the contralateral femoral artery access without significant blood loss. 

The use of the radial artery to perform invasive and complex endovascular procedures is growing. Nowadays, the radial approach is recommended as the first-choice access for coronary interventions due to a reduction in the incidence of vascular and hemorrhagic complications, along with a significant decrease in mortality.^24,25 Additionally, newly developed catheters support peripheral vascular interventions through the radial artery and, similarly to the coronary field, transradial access has been associated with a reduction of vascular and bleeding complications following peripheral interventions.²³ In TAVR procedures, up to 25% of vascular and bleeding complications are related to the femoral secondary access, which may have an impact on patient outcomes.^5-7 In the present registry, only 1 patient (1% of the overall population) experienced a minor adverse event related to the secondary radial access. Similar rates of vascular and bleeding complications associated with transradial secondary access in TAVR procedures have been previously reported, which are significantly lower than those reported for the secondary transfemoral access (0%-1% in the transradial access vs 4%-5% in the transfemoral access).^5-7 

Study limitations. This is a non-randomized study where the use of the modified-CBOT was left to the operator’s discretion. No data were collected regarding the occurrence of radial occlusion. Although this is usually a silent complication with no clinical consequences, future studies will have to evaluate the occurrence of this complication in the TAVR population.

Conclusion

The transradial CBOT was feasible and safe with the use of the 140 and 200 cm Oceanus balloons, regardless of the patient’s height and vessel tortuosity. The use of extra-long peripheral balloons ensured the modified CBOT from the radial artery (secondary access), which could be associated with a lower rate of adverse events at the access site and, consequently, improve TAVR outcomes. Future studies are warranted.

From the ¹Quebec Heart and Lung Institute, Laval University, Quebec City, Canada; ²Heart Institute, Hospital Universitari Germans Trias i Pujol, Department of Medicine, CIBERCV, Autonomous University of Barcelona, Barcelona, Spain; ³Hospital Clinico Universitario de Santiago de Compostela, CIBERCV, Santiago de Compostela, Spain; ⁴Institut Clínic Cardiovascular, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain; ⁵San Raffaele Scientific Institute, Milan, Italy; ⁶Montefiore Medical Center, New York, New York; ⁷Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain; ⁸Hospital Universitario Central de Asturias, Oviedo, Spain; ⁹Hospital Universitari Vall d’Hebron, Barcelona, Spain; ¹⁰Department of Cardiology, Policlínia Guipuzcoa, San Sebastián, Spain; ¹¹Hospital Universitario Virgen de la Victoria, Málaga, Spain; ¹²Hospital Alvaro Cunqueiro, Vigo, Spain; ¹³CIBERCV, Cardiology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; ¹⁴Maria Cecilia GVM Hospital, Cotignola, Italy; and ¹⁵iVascular, Barcelona, Spain. 

Funding: Dr Junquera was supported by a research grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr 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 reports institutional research grants from Edwards Lifesciences and Medtronic. Dr Latib is a consultant for Edwards Lifesciences, Medtronic, and Abbott Vascular. Dr Nombela-Franco is a proctor for Abbott Vascular and reports speaker honoraria from Edwards Lifesciences. Dr Regueiro reports personal fees from Abbott Vascular and Cardiva. Dr Sabaté reports personal fees from Abbott Vascular and iVascular. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted February 5, 2020.

Address for correspondence: Josep Rodés-Cabau, MD, Quebec Heart & Lung Institute, Laval University 2725 Chemin Ste-Foy, G1V 4GS Quebec City, Quebec, Canada. Email: josep.rodes@criucpq.ulaval.ca

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