September 2021 | Issue 91
10 Advertorial
Issue 91 | September 2021
Advertorial 11
THIS ADVERTORIAL IS SPONSORED BY BD
Treating the dysfunctional vascular access: The expert’s low-pressure, low-dose approach Panagiotis M Kitrou (Patras University Hospital, Patras, Greece) advocates a lowpressure, low-dose approach in order to address stenosis—the main culprit behind vascular access dysfunction.1 While high-pressure balloon angioplasty is currently considered the gold standard of treatment, the assistant professor of interventional radiology highlights associated issues of vascular wall trauma and restenosis. In the following case report, Kitrou proposes vessel preparation with the low-pressure Ultrascore™ focused force percutaneous transluminal angioplasty (PTA) balloon (BD) followed by angioplasty with the low-dose Lutonix™ 035 drug-coated balloon (DCB) PTA catheter (BD) as a way of addressing these two key issues and still successfully treating a dysfunctional vascular access.
A
s described by the latest Kidney Disease Outcomes Quality Initiative (KDOQI), a preferred way to treat a stenosis within the vascular access circuit, on a baseline level, is highpressure balloon angioplasty.2 However, as high pressures are frequently needed, up to 40atm, the vascular wall is traumatised due to barotrauma. This leads to a healing process which, at the same time, causes vessel restenosis. As an opinion, there are two key elements in this Sisyphean cycle of events. The first is to achieve an immediate lumen gain provoking the least trauma possible and the other is to slow down the inevitable process of restenosis. The scoring balloon is a relatively new technology proposed to treat vascular access stenosis at low pressures, an example of which is the Ultrascore focused force PTA balloon. The theory behind the technology is that when the balloon is inflated, it
pushes the wires against the vascular wall creating “cracks” in the stenotic tissue. In the case of vascular access stenosis, this could be very helpful confronting the fibrous part of the lesion. However, it should be noted there is inadequate evidence in the current KDOQI Guidelines to make a recommendation on the use of scoring balloons. Slowing down the process of restenosis is proposed to be achieved with the use of DCBs using paclitaxel
A final angiogram showed neither signs of residual stenosis nor significant flaps after scoring angioplasty.”
as the drug of choice.3 The Lutonix 035 DCB PTA catheter is a low-dose (2μg/mm2) paclitaxel-coated device. It has been investigated in several studies for the treatment of the dysfunctional vascular access. The Lutonix Panagiotis M Kitrou Global AV registry, a multicentre, single-arm study by Karnabatidis et al, recruited 320 subjects from Europe and Asia, who underwent DCB angioplasty in 392 treatment areas. Access and lesion characteristics reflected real-world scenarios encountered by physicians in their everyday practice. The study included both arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) in a 3:1 proportion. The study demonstrated a target lesion primary patency of 73.9% at six months.4
Case
The patient was a 52-year-old male on dialysis with a radiocephalic AVF for three years. He had recurrent stenosis that was treated with high-pressure balloons three times in the previous six months. Ultrasound examination revealed no significant stenosis in the upper part of the AVF, but a significant stenosis at the outflow region near the anastomosis and at the area of the anastomosis were observed (Figure 1). Volume flow measurements were 604.4ml/min at the level of the brachial artery and 259.5ml/min at the level of the radial artery. Access was gained from the cannulation zone, above the level of stenosis, in a retrograde approach and an angiogram was performed (Figure 2). Anastomosis was negotiated with a 0.018” wire and a 4Fr angled catheter. For vessel preparation a 4x40mm Ultrascore focused force PTA balloon at the level of the anastomosis and a 7x60mm for the level of the outflow vein were used. Balloons were gradually inflated at the nominal pressure (6atm) for two minutes (Figure 3). Following scoring balloon angioplasty, the Lutonix 035 DCB PTA
Figure 2. Initial angiogram Figure 3. Angioplasty with the Ultrascore focused force PTA balloon at the level of the anastomosis (a) and outflow vein (b)
Figure 4. Lutonix 035 PTA DCB catheters used in the outflow vein stenosis and the anastomosis (a.b.c.). An image overlay shows sufficient overlap of devices and treated areas to avoid geographic miss (d).
Continued overleaf
Figure 1. Ultrasonographic evaluation of vascular access and correlation with the anatomy. From bottom to top: stenosis at the anastomosis; stenosis at the segment following the anastomosis; segment without significant stenosis at the level of the cannulation zone.
Above: Ultrascore Focused Force PTA balloon
September 2021 | Issue 91
12 Advertorial THIS ADVERTORIAL IS SPONSORED BY BD catheters were used as an adjunctive treatment. It is of utmost importance to secure full coverage of the treated area with a DCB to avoid geographic miss. In cases where more than one balloon is needed, balloons should overlap to a minimum of 5mm for the same reason. In the current case three DCBs were used (8x60mm, 7x40mm, and 5x40mm) to treat both lesions. As it appears in Figure 4, the whole treated areas were covered and sufficient overlap between the devices was performed. A final angiogram showed neither signs of residual stenosis nor significant flaps after scoring angioplasty. An interesting finding is the so-called “contrastdiluted phenomenon”. When comparing the initial with the final angiogram, contrast density is lower in the final angiogram (Figure 5). This could be because blood flow is higher in the latter case thus increasing the volume of blood mixed with contrast, which is also an indirect sign of successful angioplasty. Post-intervention ultrasound showed a volume flow of 1,030ml/min in the brachial artery providing an increase of 70.4% (Figure 6) while clinical examination revealed a palpable thrill.
Figure 5. Initial and final angiograms (left and right respectively)
Panagiotis M Kitrou is an assistant professor of interventional radiology at Patras University Hospital in Patras, Greece. References 1. D iskin CJ. Novel insights into the pathobiology of the vascular access— do they translate into improved care? Blood Purif 2010;29(2):216–29. 2. L ok CE, Huber TS, Lee T, et al. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis 2020;75(4 Suppl 2):S1– S164. 3. K itrou PM, Katsanos K, Spyridonidis I, et al. Use of drug-coated balloons in dysfunctional arteriovenous dialysis access treatment: the effect of consecutive treatments on lesion patency. J Vasc Interv Radiol 2019;30(2):212–6. 4. K arnabatidis D, Kitrou PM, Ponce P, et al. A multicenter global registry of paclitaxel drug-coated balloon in dysfunctional arteriovenous fistulae and grafts: 6-month results. J Vasc Interv Radiol 2021;32(3):360–8 e2.
DISCLAIMER
Ultrascore™ Focused Force PTA Balloon INDICATIONS FOR USE:
The ULTRASCORE™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature. CONTRAINDICATIONS:
The ULTRASCORE™ Focused Force PTA Balloon is contraindicated: • Where there is the inability to cross the target lesion with a guidewire • For use in the coronary or neuro vasculature WARNINGS:
1) Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. Use the catheter prior to the “Use By” date specified on the package label. 2) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 4) To reduce the potential for vessel damage or difficulty in deflating, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis. 5) When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip or catheter breakage, catheter kink, or balloon separation. 6) Do not exceed the RBP recommended for this device. Balloon rupture or difficulty in deflation may occur if the RBP rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. 7) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
Figure 6. Volume flow increased by 70.4% following treatment. a. Volume flow prior to the treatment (604.4ml/ min). b. Post-treatment volume flow (1,030ml/min).
PRECAUTIONS:
1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The ULTRASCORE™ Focused Force PTA Balloon should only be used by physicians experienced in the performance of percutaneous transluminal angioplasty. 3) It is recommended to consider the use of anti-coagulants, anti-platelet agents, and/or vasodilators in conformance with the accepted standard of practice or institutional guidelines surrounding peripheral endovascular procedures. 4) For ULTRASCORE™ .014” guidewire sizes only, in order to activate the hydrophilic coating, wet the ULTRASCORE™ balloon and catheter with sterile saline or wipe the balloon catheter with sterile saline saturated gauze immediately prior to its insertion in the body. Do not wipe the balloon catheter with dry gauze. 5) The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label. 6) Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution). Never use air or other gaseous medium to inflate the balloon. 7) The ULTRASCORE™ Focused Force PTA Balloon should be used with caution for procedures involving calcified lesions, stents or synthetic vascular grafts due to the abrasive nature of these lesions. 8) Fully evacuate the balloon prior to withdrawing the system. Larger sizes of ULTRASCORE™ Focused Force PTA Balloons may exhibit slower deflation times. 9) If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast medium is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. 10) If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. 11) Do not continue to use the balloon catheter if the shaft has been bent or kinked. 12) For ULTRASCORE™ .014” guidewire sizes only, prior to re-insertion through the introducer sheath, re-activate the hydrophilic coating, and clean the balloon catheter by wiping the balloon catheter with sterile saline saturated gauze and rinsing with sterile saline. Do not wipe the balloon catheter with dry gauze. 13) GEOALIGN™ Marking System is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion and prior to balloon deployment. POTENTIAL ADVERSE REACTIONS:
The complications that may result from a peripheral balloon dilatation procedure include: • Additional intervention • Allergic reaction to drugs or contrast medium • Aneurysm or pseudoaneurysm • Arrhythmias • Embolization • Hematoma • Hemorrhage, including bleeding at the puncture site • Hypotension/hypertension • Inflammation • Occlusion • Pain or tenderness • Pneumothorax or hemothorax • Sepsis/ infection • Shock • Short term hemodynamic deterioration • Stroke • Thrombosis • Vessel dissection, perforation, rupture, or spasm.
Lutonix™ 035 Drug Coated Balloon PTA Catheter INDICATIONS FOR USE:
The Lutonix® 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix® 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis. CONTRAINDICATIONS:
The Lutonix® Catheter is contraindicated for use in: 1) Patients who cannot receive recommended anti-platelet and/ or anticoagulant therapy. 2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. 3) Pediatric patients. The safety and effectiveness of the Lutonix® Catheter in pediatric patients has not been established. 4) Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system. 5) This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds. WARNINGS:
1) Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use. 2) Do not use if product damage is evident. 3) Do not use after the “Use By” date. 4 )The Lutonix® Catheter is for use in one patient only; do not reuse in another patient, reprocess or resterilize. Risks of reuse in another patient, reprocessing, or resterilization include: Compromising the structural integrity of the device and/ or device failure which, in turn, may result in patient injury, illness or death. Creating a risk of device contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to patient injury, illness or death. 5) Do not exceed the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended. 6) Use the recommended balloon inflation medium of contrast and sterile saline (≤ 50% contrast). Never use air or any gaseous medium to inflate the balloon. 7) The safety and effectiveness of the Lutonix® Catheter have not been established for treatment in cerebral, carotid, coronary, renal vasculature or mesenteric arteries. PRECAUTIONS: General Precautions: 1) The safety and
effectiveness of using more than a maximum drug coating quantity of approximately 7.6 mg paclitaxel in a patient has not been clinically evaluated. 2) The Lutonix® Catheter should only be used by physicians trained in percutaneous interventional procedures. 3) Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents. Use in Conjunction with Other Procedures:The safety and effectiveness of the Lutonix® Catheter used in conjunction with other drug eluting stents or drug coated balloons in
the same procedure or following treatment failure has not been evaluated. Device Handling Precautions: 1) Do not immerse the Lutonix® Catheter in a saline bath. Replace any device where the balloon has come into contact with fluids prior to use. 2) The coated balloon portion should be handled with dry sterile gloves whenever possible prior to use. 3) The balloon protector should stay in place during preparation of the Lutonix® Catheter and not be removed until just prior to placing over guidewire. 4) If difficulty is encountered while removing the balloon protector, a new Lutonix® Catheter should be utilized. Removing the balloon protector by force can cause a kink in the catheter shaft and lumen constriction may occur, affecting inflation/deflation of the balloon. Device Use/Procedure Precautions: 1) The Lutonix® Catheter should always be manipulated with adequate visualization technique when in the body. 2) Appropriate vessel preparation, such as predilatation, is recommended to achieve optimal DCB results. Successful pre-dilation is defined as of ≤ 30% residual stenosis. 3) Always advance and retrieve the Lutonix® Catheter under negative pressure. 4) After insertion, do not over-tighten the hemostatic adaptor (if used) around the Lutonix® Catheter shaft as lumen constriction may occur, affecting inflation/deflation of the balloon. 5) To ensure therapeutic drug delivery: Never inflate the Lutonix® Drug Coated Balloon prior to reaching the target lesion. The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. ≤ 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to vessel ratio of ≥ 1:1). If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires replacement with a new unit. 1) Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may remain inflated as long as is required by the standard of care to achieve a good angioplasty outcome 2) Do not continue to use the Lutonix® Catheter if the shaft has been bent or kinked. 3) Whenever possible, the Lutonix® Catheter should be the final treatment of the vessel; however, post-dilatation is allowed with another PTA catheter or the previously used Lutonix® catheter. Best outcomes are obtained when the final % diameter stenosis is 0 – 20%.Pre- and Post-Procedure Antiplatelet Regimen If applicable, dual antiplatelet therapy should be administered according to current medical standards pre-procedure and for a minimum of 4 weeks after the intervention. Prolonged antiplatelet therapy can be given at the discretion of the physician Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions. © 2020 BD. BD, the BD logo, GeoAlign and Lutonix are trademarks of Becton, Dickinson and Company or an affiliate. All other trademarks are the property of their respective owners. All Rights Reserved.
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