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Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal

Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 8375878, 4 pages https://doi.org/10.1155/2020/8375878 Research Article Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal 1,2 1 3,4 3 Rajiv Tayal , Michael DiVita, Christoph W. Sossou , Alexis K. Okoh , 5 6 7 1 5 Kelly Stelling, James M. McCabe, Amir Kaki, Najam Wasty, and David A. Baran Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ, USA Division of Cardiology, St. Michael’s Medical Center, Newark, NJ, USA Department of Internal Medicine, Newark Beth Israel Medical Center, Newark, NJ, USA University of Nevada Las Vegas, School of Medicine, Las Vegas, NV, USA Advanced Heart Failure Center, Sentara Heart Hospital, Norfolk, VA, USA Division of Cardiology, University of Washington Medical Center, Seattle, WA, USA Wayne State University School of Medicine, St. John’s Ascension, Detroit, MI, USA Correspondence should be addressed to Rajiv Tayal; rajtayalmd@gmail.com Received 29 April 2020; Accepted 4 July 2020; Published 26 July 2020 Academic Editor: Faisal Latif Copyright © 2020 Rajiv Tayal et al. 'is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. 'e prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. Methods. Data were collected from a prospective internal registry of patients who had a Maquet (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. 'ey were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50–80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Results. 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. 'e median duration of IABP implantation was 12 days (range 1–54 days). Median compression time was 20 minutes (range 5–60 minutes). 'ere were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. Conclusion. Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings. shown the overall prevalence of PAD in patients undergoing 1. Introduction TAVR of about 25%, with outcomes associated with a 'e femoral artery remains the vascular access site of choice traditional femoral approach known to be worse in this for endovascular procedures requiring large bore arterial population [1, 2]. access (LBA) including complex coronary intervention, Percutaneous axillary vascular access has recently re- mechanical circulatory support (MCS), endovascular aortic emerged as an alternative percutaneous access option for aneurysm repairs (EVAR), and transcatheter aortic valve large bore arteriotomies in patients with severe or occlusive replacement (TAVR). Both peripheral vascular disease iliofemoral vascular disease and in fact has now become the (PVD) and coronary artery disease (CAD) have similar risk most utilized alternative access technique in the United factors, and it is common to encounter the challenge of States. However, safe axillary vascular access with effective treating structural or complex coronary disease in patients hemostasis requires special techniques which have not been with significant concomitant PAD. Several studies have well described in the literature. 'e efficacy of manual 2 Journal of Interventional Cardiology hemostasis for axillary vascular access is unknown. 'ere- Baseline characteristics (Table 1) for those patients in whom fore, we sought to investigate the use and outcomes of manual compression was used for hemostasis showed an manual hemostasis in the axillary artery for the removal of average age of 55.9 years (range 21–74 years) and a pre- percutaneously inserted intra-aortic balloon pumps dominance of males (21/29, 72.4). Significant comorbidities (IABPs). included coronary artery disease (3/29, 10.3%), diabetes mellitus (6/29, 20.7%), and chronic kidney disease (11/29, 37.9%). 'e median LVEF by echocardiography was 19% 2. Methods (range 10–55%). 'e average BMI was 29.5 kg/m (range Data were collected from a prospective internal registry of 18–59 kg/m ). All patients ambulated, while the IABP was in patients who had a Maquet (Rastatt, Germany) 8-French place (29/29, 100%). 'e median duration of IABP im- Mega 50 cc IABP placed in the axillary artery position in 46 plantation was 12 days (range 1–54 days). Hemostasis was consecutive patients [3]. A majority of these devices were achieved at bedside in 19/29 patients (65.5%). Median placed for acute decompensated congestive heart failure compression time was 20 minutes (range 5–60 minutes). deemed to require mechanical circulatory support based on hemodynamic indices and used as a bridge to recovery or 3.2. Removal Technique. In each case, the IABP console was destination therapy. 'e registry included comprehensive placed on “standby” mode to fully extract helium from the data related to the insertion and removal of the device. All catheter. Next, the skin site of entry was sterilely scrubbed the devices were inserted in the cardiac catheterization lab with caution, and then sutures holding the catheter were cut using our previously described techniques for percutaneous and removed. Manual pressure was exerted medially to the axillary access and performed using a combination of pal- entry site, and the catheter and any sheath were directly pation, vascular ultrasound, and angiographic visualization removed after initially allowing some bleedback (<10 cc [4]. blood). Pressure was exerted while observing the arterio- Following device insertion, the patients were most fre- tomy site lateral to the compression to assure no bleeding quently supported with 1 : 1 counter pulsation, and, per our was noted. Fifteen minutes of occlusive pressure was applied, group’s standardized strategy, anticoagulated with a 50 U/kg and then progressive reduction of pressure over 5 minutes weight-based bolus of heparin and subsequently started on a until pressure was discontinued. weight-based drip to maintain an activated partial throm- boplastin time (aPTT) of 50–80 seconds for the duration of device of implantation. 3.3. Safety Outcomes. In the 29 patients in whom manual Prior to device removal, all patients were assessed for compression was used to achieve hemostasis of the axillary their ability to tolerate weaning of MCS with trials of 1 : 2 artery, there were no major vascular or bleeding compli- and 1 : 3 augmentation. If weaning was tolerated, 1 : 1 aug- cations as defined by the VARC-2 and BARC-2 criteria, mentation was resumed and anticoagulation discontinued respectively. 'ree (3/29, 10.3%) patients experienced a for 2 hours prior to device removal. aPTTs were not rou- minor vascular complication related to hemostasis, as de- tinely assessed prior to the device removal. Patients were fined by the VARC-2 classification. 'ree (3/29, 10.3%) brought back to the catheterization lab if their ability to patients experienced a BARC-2 type 1 or type 2 bleeding tolerate MCS weaning was uncertain and re-insertion or event. No patients required blood transfusions for bleeding exchange of MCS device was felt to be a possibility. Oth- or intervention by vascular surgery. No brachial nerve plexus erwise, IABPs were removed at bedside in the Cardiac injuries were experienced (Table 2). Additionally, there were Critical Care Unit. no site-related infections or clinically significant cerebro- We analyzed the methods for achieving hemostasis of vascular events following the IABP removal. the axillary artery at time of IABP removal. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research 4. Discussion Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Ad- Despite the use of newer access sites such as the radial artery ditionally, any neurologic complications related to manual or axillary artery, common femoral artery access remains the compression and hemostasis, mainly brachial plexopathies, most commonly used site for access both in the United States were evaluated. and worldwide. 'is is likely due to the familiarity in obtaining access and achieving hemostasis at this site, which is relatively unchanged since percutaneous access of the 3. Results femoral artery was first introduced by Sven Seldinger in 1953 3.1. Study Population. Of the 46 patients who had an IABP [5]. Hemostasis of the femoral artery is predicated on the placed in the axillary artery, manual compression for he- concept of compressibility against the underlying femoral mostasis was used in 29 patients (63%). 'e remaining head. As such, the ideal site for femoral arterial puncture is patients had the catheter removed with a variety of tech- from the lower border of the head of the femur to the niques including closure device (Angio-Seal) or balloon midportion of the femoral head, known as the “target zone” tamponade. No further information is available for these [6]. 'is site insures an area of compressibility with cases. All catheters were placed in the left axillary artery. avoidance of cannulation above the inguinal ligament or Journal of Interventional Cardiology 3 Table 1: Patient characteristics. high complication rate associated with early percutane- ous transaxillary access performed in this manner was Characteristic Manual Hemostasis (N � 29) largely attributable to the convergence of multiple bra- Age–years (range) 55.9 (21–74) chial plexus elements in the area of access, as well as the Male–no. (%) 21 (72.4) presence of the brachial fascial sheath which encompasses Weight–kg (range) 87.5 (40–151.8) the artery, vein, and nerve, wherein even minor bleeding BMI–kg/m (range) 29.5 (18–59) events may lead to a neurovascular compression Non-African American–no. (%) 26 (89.7) syndrome. African American–no. (%) 3 (10.3) Diabetes mellitus–no. (%) 6 (20.7) However, a recent resurgence in interest for percu- Coronary artery disease–no. (%) 3 (10.3) taneous transaxillary access continues to grow with Chronic kidney disease–no. (%) 11 (37.9) outcomes on par with traditional percutaneous femoral LVEF-(%) (range) 19 (10–55) access aside from a few reports citing an elevated risk of Access left axillary artery–no. (%) 29 (100) cerebrovascular accident associated with this approach. Ambulated–no. (%) 29 (100) 'is has, in large part, been due to data suggesting inferior Median duration of 12 (1–54) outcomes with surgical techniques requiring intrathoracic insertion–days (range) access for transcatheter aortic valve replacements Median compression time–min. 20 (5–60) (TAVRs) when transfemoral access is not suitable. (Range) Scha ¨fer et al. were among the first to describe the Removal at bedside–no. (%) 19 (65.5) technique of percutaneous transaxillary artery access for TAVR in a large case series format [9]. As opposed to previous transaxillary access techniques, their technique Table 2: Safety outcomes. utilized an anterior approach through the chest wall, entering the axillary artery in its first segment, or in the Outcome Event (N � 29) proximal 1/3 of the vessel. 'e advantage of this technique VARC-2 major–no. (%) 0 (0) includes, among other aspects, potential compressibility VARC-2 minor–no. (%) 3 (10.3) of the vessel against the second rib for manual hemostasis, BARC-2 type 3–5–no. (%) 0 (0) if needed. As such, Scha ¨fer et al. observed a significantly BARC-2 type 1-2–no. (%) 3 (10.3) Vascular surgery intervention–no. (%) 0 (0) lower complication rate than was reported in the previous Bleeding requiring transfusion–no. (%) 0 (0) studies [10]. Brachial plexus injury–no. (%) 0 (0) In contradistinction to this, our technique for per- Access site infection–no. (%) 0 (0) cutaneous transaxillary access has been directed towards Cerebrovascular accident–no. (%) 0 (0) an access point in the middle third of the vessel, typically referred to as the second portion, due to a well-defined paucity of brachial plexus elements associated with the below the femoral bifurcation which minimizes complica- artery in this area [11]. Access in this area avoids the risk of entering the intrathoracic cavity which may occur tions such as bleeding or hematoma formation. Axillary artery access is not a new concept. It was while targeting the first portion of the vessel and can originally performed by palpation and cannulation of the decrease the risk of additional complications, such as artery along the deltopectoral groove or within the true hemo-or pneumothoraces, and facilitate surgical cut axilla itself, with the arm typically abducted to 90 degrees down and bail out strategies if they were required. or positioned above the patient’s head. Access was ini- Despite a lack of bony structures in this area to which tially performed at this site due to its proximity to the compression of the artery may be secured against, the humeral head after drawing on prior experiences seen findings of our current study, as well as others, suggest with traditional percutaneous femoral artery access. manual compression for hemostasis of the axillary artery to be feasible and safe. It is important to note, however, Additionally, anatomic studies suggested that abduction of the arm draws the axillary artery over the humeral that a lack of bony structures in this area to facilitate manual compression leads to potential displacement of head, creating an additional point of possible compres- sion much like access in the femoral artery. 'is was the vessel when attempting compression. As such, at- described by Rohrer et al. who analyzed axillary artery tention must be paid when securing hand placement and thrombosis in baseball pitchers and found that im- stabilizing the vessel for manual hemostasis. pingement of the third portion of the axillary artery by In many instances, urgency of device implantation or the head of the humerus occurred in athletes, as well as uncertain duration of implantation deters many physi- nonathletes, when the arm was placed in an abducted and cians from placement of vascular closure devices or from externally rotated position, such as would occur with a using well described arteriotomy preclosure techniques. baseball pitcher’s throwing motion [7]. 'is concern becomes further amplified in the cardiac transplantation population as any form of infection or Unfortunately, this technique was found to have an overall complication rate as high as 24%, driven mostly by vascular complication could delay the definitive therapy brachial plexus injury and hematoma formation, which in terms of transplant listing status or potentially increase eventually lead to its abandonment [8]. 'is unacceptably the risk of infection and, in turn, greater morbidity, given 4 Journal of Interventional Cardiology these complex patients require relatively aggressive im- Data Availability munosuppression immediately after transplantation. 'e data supporting the findings of this study are available More interestingly, our data may suggest significant within the article. clinical benefit for the use of percutaneous axillary artery implantation of MCS for prolonged support, given all Conflicts of Interest patients were ambulated and no patients experienced a site-related infection, thus allowing for optimized patient 'e authors declare that they have no conflicts of interest. condition prior to transplantation or insertion of durable LVAD. Moreover, no upper extremity ischemia was ex- References perienced which may relate to the fact that desired access point in the second portion of the axillary artery is [1] D. Mohananey, P. Villablanca, T. Gupta, S. Ranka, N. Bhatia proximal to the subscapularis artery which is known to et al., “Association of peripheral artey disease with in-hospital collateralize the brachial artery. outcomes after endovascular transcatheter aortic valve re- placement,” Catheterization and Cardiovascular Interven- In our study, all 29 patients had successful hemostasis tions, vol. 94, no. 2, pp. 249–255, 2019. of the axillary artery achieved with manual compression. [2] A. C. Fanaroff, P. Manandhar, D. R. Holmes, D. J. Cohen, 'ree minor bleeding complications occurred, mainly J. K. Harrison et al., “Peripheral artery disease and trans- small chest wall hematomas, which resolved without catheter aortic valve outcomes: a report from the society of reintervention or blood transfusion. It should also be thoracic surgeons/American college of cardiology trans- noted that one patient utilized manual compression for catheter therapy registry,” Circulaion Cardiovascular Inter- successful hemostasis after a failed vascular closure de- ventions, vol. 10, no. 10, Article ID e005456, 2017. vice. 'is suggests that manual hemostasis may offer an [3] G. K. Visveswaran, M. Cohen, A. Seliem et al., “A single center alternative to covered stent use as a bailout in certain tertiary care experience utilizing the large volume mega 50 cc settings. Furthermore, manual hemostasis could obviate intra-aortic balloon counterpulsation in contemporary clin- the need for late use of vascular closure devices to achieve ical practice,” Catheterization and Cardiovascular Interven- tions, vol. 90, no. 4, pp. E63–E72, 2017. hemostasis in patients with prolonged device implanta- [4] R. Tayal, C. S. Hirst, A. Garg, and N. K. Kapur, “Deployment tions, thus reducing infection and complication risks. of acute mechanical circulatory support devices via the ax- 'e first limitation of our study is that patients had illary artery,” Expert Review of Cardiovascular 8erapy, vol. 17, axillary artery access performed for the insertion of an no. 5, pp. 353–360, 2019. intra-aortic balloon pump. 'is device requires an 8- [5] S. I. Seldinger, “Catheter replacement of the needle in per- French (Fr) arteriotomy, whether sheathed or sheathless, cutaneous arteriography: a new technique,” Acta Radiologica, and thus not a true “large bore” arteriotomy. 'is limits vol. 39, no. 5, pp. 368–376, 1953. the generalizability of this technique to other endovas- [6] S. Bangalore and D. L. Bhatt, “Right heart catheterization, cular procedures utilizing the axillary artery access point. coronary angiography, and percutaneous coronary inter- However, our experience with manual hemostasis in the vention,” Circulation, vol. 124, no. 17, pp. e147–e156, 2011. IABP population has led us to develop an increased [7] M. J. Rohrer, P. A. Cardullo, A. M. Pappas, D. A. Phillips, and H. B. Wheeler, “Axillary artery compression and thrombosis comfort with utilizing manual compression to facilitate in throwing athletes,” Journal of Vascular Surgery, vol. 11, hemostasis in large bore arteriotomies, even those re- no. 6, pp. 761–769, 1990. quiring 14–16 Fr arteriotomies. A second limitation is the [8] A. F. AbuRahma, P. A. Robinson, J. P. Boland et al., lack of data available with regards to coagulation testing. “Complications of arteriography in a recent series of 707 cases: All patients were maintained on unfractionated heparin factors affecting outcome,” Annals of Vascular Surgery, vol. 7, utilizing a standard weight-based dosing while the IABP no. 2, pp. 122–129, 1993. was in place. Irrespective of aPTT, all IABPs were re- [9] U. Schafer, ¨ Y. Ho, C. Frerker et al., “Direct percutaneous moved after 2 hours of heparin discontinuation. Fortu- access technique for transaxillary transcatheter aortic valve nately, no major bleeding complications were observed. A implantation,” JACC: Cardiovascular Interventions, vol. 5, third limitation is that, in patients who underwent device no. 5, pp. 477–486, 2012. removal at bedside, angiography was not utilized to [10] U. Schafer, F. Deuschl, N. Schofer et al., “Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic confirm the absence of upper extremity embolization or valve implantation using various transcatheter heart valves in thrombosis. 'us, it is possible that vascular events could 100 consecutive patients,” International Journal of Cardiology, have been greater than observed, although clinically this vol. 232, pp. 247–254, 2017. was not the case. Lastly, in contradistinction to recent [11] M. 'awabi, R. Tayal, Z. Khakwani, M. Sinclair, M. Cohen, literature suggesting higher rates of CVA, we had no and N. Wasty, “Suggested bony landmarks for safe axillary events, and this may relate to the size of the device artery access,” 8e Journal of Invasive Cardiology, vol. 30, utilized relative to the vessel size, operator experience, or no. 3, pp. 115–118, 2018. minute differences in procedural technique. In conclusion, manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Further studies may be needed to corroborate these findings, especially in procedures re- quiring larger arteriotomies. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal

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Hindawi Publishing Corporation
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Copyright © 2020 Rajiv Tayal et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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1540-8183
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10.1155/2020/8375878
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Abstract

Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 8375878, 4 pages https://doi.org/10.1155/2020/8375878 Research Article Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal 1,2 1 3,4 3 Rajiv Tayal , Michael DiVita, Christoph W. Sossou , Alexis K. Okoh , 5 6 7 1 5 Kelly Stelling, James M. McCabe, Amir Kaki, Najam Wasty, and David A. Baran Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ, USA Division of Cardiology, St. Michael’s Medical Center, Newark, NJ, USA Department of Internal Medicine, Newark Beth Israel Medical Center, Newark, NJ, USA University of Nevada Las Vegas, School of Medicine, Las Vegas, NV, USA Advanced Heart Failure Center, Sentara Heart Hospital, Norfolk, VA, USA Division of Cardiology, University of Washington Medical Center, Seattle, WA, USA Wayne State University School of Medicine, St. John’s Ascension, Detroit, MI, USA Correspondence should be addressed to Rajiv Tayal; rajtayalmd@gmail.com Received 29 April 2020; Accepted 4 July 2020; Published 26 July 2020 Academic Editor: Faisal Latif Copyright © 2020 Rajiv Tayal et al. 'is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. 'e prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. Methods. Data were collected from a prospective internal registry of patients who had a Maquet (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. 'ey were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50–80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Results. 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. 'e median duration of IABP implantation was 12 days (range 1–54 days). Median compression time was 20 minutes (range 5–60 minutes). 'ere were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. Conclusion. Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings. shown the overall prevalence of PAD in patients undergoing 1. Introduction TAVR of about 25%, with outcomes associated with a 'e femoral artery remains the vascular access site of choice traditional femoral approach known to be worse in this for endovascular procedures requiring large bore arterial population [1, 2]. access (LBA) including complex coronary intervention, Percutaneous axillary vascular access has recently re- mechanical circulatory support (MCS), endovascular aortic emerged as an alternative percutaneous access option for aneurysm repairs (EVAR), and transcatheter aortic valve large bore arteriotomies in patients with severe or occlusive replacement (TAVR). Both peripheral vascular disease iliofemoral vascular disease and in fact has now become the (PVD) and coronary artery disease (CAD) have similar risk most utilized alternative access technique in the United factors, and it is common to encounter the challenge of States. However, safe axillary vascular access with effective treating structural or complex coronary disease in patients hemostasis requires special techniques which have not been with significant concomitant PAD. Several studies have well described in the literature. 'e efficacy of manual 2 Journal of Interventional Cardiology hemostasis for axillary vascular access is unknown. 'ere- Baseline characteristics (Table 1) for those patients in whom fore, we sought to investigate the use and outcomes of manual compression was used for hemostasis showed an manual hemostasis in the axillary artery for the removal of average age of 55.9 years (range 21–74 years) and a pre- percutaneously inserted intra-aortic balloon pumps dominance of males (21/29, 72.4). Significant comorbidities (IABPs). included coronary artery disease (3/29, 10.3%), diabetes mellitus (6/29, 20.7%), and chronic kidney disease (11/29, 37.9%). 'e median LVEF by echocardiography was 19% 2. Methods (range 10–55%). 'e average BMI was 29.5 kg/m (range Data were collected from a prospective internal registry of 18–59 kg/m ). All patients ambulated, while the IABP was in patients who had a Maquet (Rastatt, Germany) 8-French place (29/29, 100%). 'e median duration of IABP im- Mega 50 cc IABP placed in the axillary artery position in 46 plantation was 12 days (range 1–54 days). Hemostasis was consecutive patients [3]. A majority of these devices were achieved at bedside in 19/29 patients (65.5%). Median placed for acute decompensated congestive heart failure compression time was 20 minutes (range 5–60 minutes). deemed to require mechanical circulatory support based on hemodynamic indices and used as a bridge to recovery or 3.2. Removal Technique. In each case, the IABP console was destination therapy. 'e registry included comprehensive placed on “standby” mode to fully extract helium from the data related to the insertion and removal of the device. All catheter. Next, the skin site of entry was sterilely scrubbed the devices were inserted in the cardiac catheterization lab with caution, and then sutures holding the catheter were cut using our previously described techniques for percutaneous and removed. Manual pressure was exerted medially to the axillary access and performed using a combination of pal- entry site, and the catheter and any sheath were directly pation, vascular ultrasound, and angiographic visualization removed after initially allowing some bleedback (<10 cc [4]. blood). Pressure was exerted while observing the arterio- Following device insertion, the patients were most fre- tomy site lateral to the compression to assure no bleeding quently supported with 1 : 1 counter pulsation, and, per our was noted. Fifteen minutes of occlusive pressure was applied, group’s standardized strategy, anticoagulated with a 50 U/kg and then progressive reduction of pressure over 5 minutes weight-based bolus of heparin and subsequently started on a until pressure was discontinued. weight-based drip to maintain an activated partial throm- boplastin time (aPTT) of 50–80 seconds for the duration of device of implantation. 3.3. Safety Outcomes. In the 29 patients in whom manual Prior to device removal, all patients were assessed for compression was used to achieve hemostasis of the axillary their ability to tolerate weaning of MCS with trials of 1 : 2 artery, there were no major vascular or bleeding compli- and 1 : 3 augmentation. If weaning was tolerated, 1 : 1 aug- cations as defined by the VARC-2 and BARC-2 criteria, mentation was resumed and anticoagulation discontinued respectively. 'ree (3/29, 10.3%) patients experienced a for 2 hours prior to device removal. aPTTs were not rou- minor vascular complication related to hemostasis, as de- tinely assessed prior to the device removal. Patients were fined by the VARC-2 classification. 'ree (3/29, 10.3%) brought back to the catheterization lab if their ability to patients experienced a BARC-2 type 1 or type 2 bleeding tolerate MCS weaning was uncertain and re-insertion or event. No patients required blood transfusions for bleeding exchange of MCS device was felt to be a possibility. Oth- or intervention by vascular surgery. No brachial nerve plexus erwise, IABPs were removed at bedside in the Cardiac injuries were experienced (Table 2). Additionally, there were Critical Care Unit. no site-related infections or clinically significant cerebro- We analyzed the methods for achieving hemostasis of vascular events following the IABP removal. the axillary artery at time of IABP removal. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research 4. Discussion Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Ad- Despite the use of newer access sites such as the radial artery ditionally, any neurologic complications related to manual or axillary artery, common femoral artery access remains the compression and hemostasis, mainly brachial plexopathies, most commonly used site for access both in the United States were evaluated. and worldwide. 'is is likely due to the familiarity in obtaining access and achieving hemostasis at this site, which is relatively unchanged since percutaneous access of the 3. Results femoral artery was first introduced by Sven Seldinger in 1953 3.1. Study Population. Of the 46 patients who had an IABP [5]. Hemostasis of the femoral artery is predicated on the placed in the axillary artery, manual compression for he- concept of compressibility against the underlying femoral mostasis was used in 29 patients (63%). 'e remaining head. As such, the ideal site for femoral arterial puncture is patients had the catheter removed with a variety of tech- from the lower border of the head of the femur to the niques including closure device (Angio-Seal) or balloon midportion of the femoral head, known as the “target zone” tamponade. No further information is available for these [6]. 'is site insures an area of compressibility with cases. All catheters were placed in the left axillary artery. avoidance of cannulation above the inguinal ligament or Journal of Interventional Cardiology 3 Table 1: Patient characteristics. high complication rate associated with early percutane- ous transaxillary access performed in this manner was Characteristic Manual Hemostasis (N � 29) largely attributable to the convergence of multiple bra- Age–years (range) 55.9 (21–74) chial plexus elements in the area of access, as well as the Male–no. (%) 21 (72.4) presence of the brachial fascial sheath which encompasses Weight–kg (range) 87.5 (40–151.8) the artery, vein, and nerve, wherein even minor bleeding BMI–kg/m (range) 29.5 (18–59) events may lead to a neurovascular compression Non-African American–no. (%) 26 (89.7) syndrome. African American–no. (%) 3 (10.3) Diabetes mellitus–no. (%) 6 (20.7) However, a recent resurgence in interest for percu- Coronary artery disease–no. (%) 3 (10.3) taneous transaxillary access continues to grow with Chronic kidney disease–no. (%) 11 (37.9) outcomes on par with traditional percutaneous femoral LVEF-(%) (range) 19 (10–55) access aside from a few reports citing an elevated risk of Access left axillary artery–no. (%) 29 (100) cerebrovascular accident associated with this approach. Ambulated–no. (%) 29 (100) 'is has, in large part, been due to data suggesting inferior Median duration of 12 (1–54) outcomes with surgical techniques requiring intrathoracic insertion–days (range) access for transcatheter aortic valve replacements Median compression time–min. 20 (5–60) (TAVRs) when transfemoral access is not suitable. (Range) Scha ¨fer et al. were among the first to describe the Removal at bedside–no. (%) 19 (65.5) technique of percutaneous transaxillary artery access for TAVR in a large case series format [9]. As opposed to previous transaxillary access techniques, their technique Table 2: Safety outcomes. utilized an anterior approach through the chest wall, entering the axillary artery in its first segment, or in the Outcome Event (N � 29) proximal 1/3 of the vessel. 'e advantage of this technique VARC-2 major–no. (%) 0 (0) includes, among other aspects, potential compressibility VARC-2 minor–no. (%) 3 (10.3) of the vessel against the second rib for manual hemostasis, BARC-2 type 3–5–no. (%) 0 (0) if needed. As such, Scha ¨fer et al. observed a significantly BARC-2 type 1-2–no. (%) 3 (10.3) Vascular surgery intervention–no. (%) 0 (0) lower complication rate than was reported in the previous Bleeding requiring transfusion–no. (%) 0 (0) studies [10]. Brachial plexus injury–no. (%) 0 (0) In contradistinction to this, our technique for per- Access site infection–no. (%) 0 (0) cutaneous transaxillary access has been directed towards Cerebrovascular accident–no. (%) 0 (0) an access point in the middle third of the vessel, typically referred to as the second portion, due to a well-defined paucity of brachial plexus elements associated with the below the femoral bifurcation which minimizes complica- artery in this area [11]. Access in this area avoids the risk of entering the intrathoracic cavity which may occur tions such as bleeding or hematoma formation. Axillary artery access is not a new concept. It was while targeting the first portion of the vessel and can originally performed by palpation and cannulation of the decrease the risk of additional complications, such as artery along the deltopectoral groove or within the true hemo-or pneumothoraces, and facilitate surgical cut axilla itself, with the arm typically abducted to 90 degrees down and bail out strategies if they were required. or positioned above the patient’s head. Access was ini- Despite a lack of bony structures in this area to which tially performed at this site due to its proximity to the compression of the artery may be secured against, the humeral head after drawing on prior experiences seen findings of our current study, as well as others, suggest with traditional percutaneous femoral artery access. manual compression for hemostasis of the axillary artery to be feasible and safe. It is important to note, however, Additionally, anatomic studies suggested that abduction of the arm draws the axillary artery over the humeral that a lack of bony structures in this area to facilitate manual compression leads to potential displacement of head, creating an additional point of possible compres- sion much like access in the femoral artery. 'is was the vessel when attempting compression. As such, at- described by Rohrer et al. who analyzed axillary artery tention must be paid when securing hand placement and thrombosis in baseball pitchers and found that im- stabilizing the vessel for manual hemostasis. pingement of the third portion of the axillary artery by In many instances, urgency of device implantation or the head of the humerus occurred in athletes, as well as uncertain duration of implantation deters many physi- nonathletes, when the arm was placed in an abducted and cians from placement of vascular closure devices or from externally rotated position, such as would occur with a using well described arteriotomy preclosure techniques. baseball pitcher’s throwing motion [7]. 'is concern becomes further amplified in the cardiac transplantation population as any form of infection or Unfortunately, this technique was found to have an overall complication rate as high as 24%, driven mostly by vascular complication could delay the definitive therapy brachial plexus injury and hematoma formation, which in terms of transplant listing status or potentially increase eventually lead to its abandonment [8]. 'is unacceptably the risk of infection and, in turn, greater morbidity, given 4 Journal of Interventional Cardiology these complex patients require relatively aggressive im- Data Availability munosuppression immediately after transplantation. 'e data supporting the findings of this study are available More interestingly, our data may suggest significant within the article. clinical benefit for the use of percutaneous axillary artery implantation of MCS for prolonged support, given all Conflicts of Interest patients were ambulated and no patients experienced a site-related infection, thus allowing for optimized patient 'e authors declare that they have no conflicts of interest. condition prior to transplantation or insertion of durable LVAD. Moreover, no upper extremity ischemia was ex- References perienced which may relate to the fact that desired access point in the second portion of the axillary artery is [1] D. Mohananey, P. Villablanca, T. Gupta, S. Ranka, N. Bhatia proximal to the subscapularis artery which is known to et al., “Association of peripheral artey disease with in-hospital collateralize the brachial artery. outcomes after endovascular transcatheter aortic valve re- placement,” Catheterization and Cardiovascular Interven- In our study, all 29 patients had successful hemostasis tions, vol. 94, no. 2, pp. 249–255, 2019. of the axillary artery achieved with manual compression. [2] A. C. Fanaroff, P. Manandhar, D. R. Holmes, D. J. Cohen, 'ree minor bleeding complications occurred, mainly J. K. Harrison et al., “Peripheral artery disease and trans- small chest wall hematomas, which resolved without catheter aortic valve outcomes: a report from the society of reintervention or blood transfusion. It should also be thoracic surgeons/American college of cardiology trans- noted that one patient utilized manual compression for catheter therapy registry,” Circulaion Cardiovascular Inter- successful hemostasis after a failed vascular closure de- ventions, vol. 10, no. 10, Article ID e005456, 2017. vice. 'is suggests that manual hemostasis may offer an [3] G. K. Visveswaran, M. Cohen, A. Seliem et al., “A single center alternative to covered stent use as a bailout in certain tertiary care experience utilizing the large volume mega 50 cc settings. Furthermore, manual hemostasis could obviate intra-aortic balloon counterpulsation in contemporary clin- the need for late use of vascular closure devices to achieve ical practice,” Catheterization and Cardiovascular Interven- tions, vol. 90, no. 4, pp. E63–E72, 2017. hemostasis in patients with prolonged device implanta- [4] R. Tayal, C. S. Hirst, A. Garg, and N. K. Kapur, “Deployment tions, thus reducing infection and complication risks. of acute mechanical circulatory support devices via the ax- 'e first limitation of our study is that patients had illary artery,” Expert Review of Cardiovascular 8erapy, vol. 17, axillary artery access performed for the insertion of an no. 5, pp. 353–360, 2019. intra-aortic balloon pump. 'is device requires an 8- [5] S. I. Seldinger, “Catheter replacement of the needle in per- French (Fr) arteriotomy, whether sheathed or sheathless, cutaneous arteriography: a new technique,” Acta Radiologica, and thus not a true “large bore” arteriotomy. 'is limits vol. 39, no. 5, pp. 368–376, 1953. the generalizability of this technique to other endovas- [6] S. Bangalore and D. L. Bhatt, “Right heart catheterization, cular procedures utilizing the axillary artery access point. coronary angiography, and percutaneous coronary inter- However, our experience with manual hemostasis in the vention,” Circulation, vol. 124, no. 17, pp. e147–e156, 2011. IABP population has led us to develop an increased [7] M. J. Rohrer, P. A. Cardullo, A. M. Pappas, D. A. Phillips, and H. B. Wheeler, “Axillary artery compression and thrombosis comfort with utilizing manual compression to facilitate in throwing athletes,” Journal of Vascular Surgery, vol. 11, hemostasis in large bore arteriotomies, even those re- no. 6, pp. 761–769, 1990. quiring 14–16 Fr arteriotomies. A second limitation is the [8] A. F. AbuRahma, P. A. Robinson, J. P. Boland et al., lack of data available with regards to coagulation testing. “Complications of arteriography in a recent series of 707 cases: All patients were maintained on unfractionated heparin factors affecting outcome,” Annals of Vascular Surgery, vol. 7, utilizing a standard weight-based dosing while the IABP no. 2, pp. 122–129, 1993. was in place. Irrespective of aPTT, all IABPs were re- [9] U. Schafer, ¨ Y. Ho, C. Frerker et al., “Direct percutaneous moved after 2 hours of heparin discontinuation. Fortu- access technique for transaxillary transcatheter aortic valve nately, no major bleeding complications were observed. A implantation,” JACC: Cardiovascular Interventions, vol. 5, third limitation is that, in patients who underwent device no. 5, pp. 477–486, 2012. removal at bedside, angiography was not utilized to [10] U. Schafer, F. Deuschl, N. Schofer et al., “Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic confirm the absence of upper extremity embolization or valve implantation using various transcatheter heart valves in thrombosis. 'us, it is possible that vascular events could 100 consecutive patients,” International Journal of Cardiology, have been greater than observed, although clinically this vol. 232, pp. 247–254, 2017. was not the case. Lastly, in contradistinction to recent [11] M. 'awabi, R. Tayal, Z. Khakwani, M. Sinclair, M. Cohen, literature suggesting higher rates of CVA, we had no and N. Wasty, “Suggested bony landmarks for safe axillary events, and this may relate to the size of the device artery access,” 8e Journal of Invasive Cardiology, vol. 30, utilized relative to the vessel size, operator experience, or no. 3, pp. 115–118, 2018. minute differences in procedural technique. In conclusion, manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Further studies may be needed to corroborate these findings, especially in procedures re- quiring larger arteriotomies.

Journal

Journal of Interventional CardiologyHindawi Publishing Corporation

Published: Jul 26, 2020

References