New Technology

Successful Pedal Access and Treatment Versatility With the Use of a New Sheath: Halo One™ Thin-Walled Guiding Sheath

Kousta Foteh, MD, Director of Vascular Surgery, Memorial Hermann Northeast Hospital, Humble, Texas

Kousta Foteh, MD, Director of Vascular Surgery, Memorial Hermann Northeast Hospital, Humble, Texas

Can you describe the status of your current peripheral interventional practice? 

With the Covid-19 crisis, obviously we saw a downward trend of cases. The only peripheral intervention we were doing was for patients with rest pain or tissue loss, people who needed urgent intervention. In Texas, they lifted the elective surgery ban almost six weeks ago and there was a backlog of cases as a result, along with new patients. We are coming earlier, staying later, and trying to get through a whole backlog of patients, but it has been rewarding and we have experienced great success. 

Prior to coming in, every patient is screened and tested for Covid. During procedures, we are masking patients (not a N95 mask) and using a nasal cannula for oxygenation. Some patients don’t like the mask and feel like it is suffocating for them. In that scenario, what we usually do is elevate a drape over their face, so if they have to cough or sneeze, or are taking heavy respirations, there is at least something there to prevent droplets from traveling. 

Are you seeing patients at a more advanced state of disease due to the previous halt on elective procedures?

For most of the patients with claudication, we had to delay their procedures until after the Covid-19 crisis, or at least until the surge has passed. What we are mostly seeing now continues to be what I consider very complex peripheral arterial disease (PAD), Rutherford class 4, 5, and 6 patients with advanced tibial-peroneal disease and foot ulcers. We normally see a lot of patients with advanced peripheral vascular disease, multilevel disease, gangrene, and tissue loss. We serve a patient population with a very high incidence of obesity, diabetes, and end-stage renal disease on hemodialysis. If diabetes is mixed into the realm of PAD, as well as kidney failure, it makes treatment even more complicated. Yesterday, for instance, I saw four patients in my office, all who came in with new wounds with abnormal Dopplers and risk factors for PAD. The faster you intervene, the better chance you have to help these patients. 

What is your typical treatment algorithm for such a challenging patient population?

Everything always starts with a good history, a nice conversation with the patient that entails their medical history. Do you smoke? Are you diabetic? Are you dependent on insulin? How well are your blood sugars being controlled? When’s the last time you had labs that were checked? Do you have a primary care provider or cardiologist? Do you have a history of claudication prior to presentation? How long has that wound been here? Do you have neuropathy? Do you have numbness in your feet? We want a good background of what’s going on in order to better understand the disease process. Patients often will present with some sort of imaging. Either their primary care or their podiatrist may have already ordered a duplex ultrasound. I review all the images and if I find abnormalities, if on physical exam I can’t palpate pulses, there is very poor capillary refill, and there is an active wound or an ulcer, then the next step is sending the patient to the cath lab or the OR to do an angiogram. Depending upon where the bulk of the disease is located, I primarily access the pedal vessels first, an approach that cuts down on the incidence of access site complications. I also find that crossing tibial lesions and chronic total occlusions from below, rather than in an antegrade fashion, makes it easier to treat these lesions. Technology now allows us to treat from below as well as cross lesions from below, making a pedal approach a whole lot easier. Our working space is not nearly as gigantic as it was when working from up and over. Pedal access is also a lot easier on me personally. I am not reaching over the table. It is a direct approach. That doesn’t mean that I never access the femoral artery, or go up and over, or even sometimes go antegrade from the femoral, but I prefer to approach from the tibials, because along with the reasons I mentioned, it adds more versatility to procedures. It cuts down on access site complications, bleeding, and retroperitoneal hematomas, and the patients seem to like it much better. The recovery process is a lot faster. They’re up and walking around two hours post procedure, and then at home recuperating for a day. Patients don’t feel that soreness and heavy feeling in their groin post angiogram. Pedal access has done a great deal of good for my patients.

How do you evaluate patients for pedal access? 

Typically, by reviewing the Doppler and evaluating whether the distal posterior tibial, anterior tibial, and/or peroneal arteries are patent, and whether there is enough room to place a sheath. If the patient has advanced imaging like a computed tomography (CT) angiogram or if another physician has previously done an angiogram, I can look at the preoperative imaging to see if that makes them a candidate. The majority of patients, by far, will be a candidate for pedal access, whether it is the anterior tibial, the posterior tibial, or even the peroneal artery. It is very rare that I have been unable to get pedal access, although there have been times when I have been in a case, tried to access the tibial vessels, and simply could not. We then go through a transfemoral approach, and lo and behold, the patient just doesn’t have very good distal vessels. We have to work from above to get down into the foot and fix it that way. But this doesn’t occur very often. Usually a patient will have some sort of runoff to the foot.

You noted technology has advanced to help intervention via pedal access. 

Absolutely. In general, companies are trying to place devices through smaller access, which requires significant innovation. BD has now come out with the Halo One Thin-Walled Guiding Sheath, which makes it possible for stents to be placed through a 5 French (Fr) sheath up to a 7 mm diameter, which is phenomenal, especially for someone like myself who really enjoys going pedal. I can simply upsize to a standard 5 Fr sheath and not worry about going up to a 6 Fr diameter. Previously, I had to upsize my sheaths to at least a 6 Fr sheath in order to place a pedal sheath. I had the privilege of working with BD on the development of the Halo One Guiding Sheath over the last two or three years. The Halo One Guiding Sheath is BD’s answer to the continuous push toward being low profile, while still accommodating the needs of the physician and the patient. The goal is to be able to deliver balloons, catheters, wires, and stents, through a sheath designed to perform like a standard sheath of the same French size, but with a lower profile. 

What do you like about the Halo One Thin-Walled Guiding Sheath?

It is a thin-walled sheath, but what makes it durable is that it has a stainless steel, inner braided lattice that keeps it strong and solid, so we don’t experience that accordion effect when trying to pull out a 5 or 6 Fr balloon. In my experience with the Halo One Guiding Sheath, our equipment has not caught the edges of the sheath and caused it to crimp. The Halo One Guiding Sheath is designed to provide kink resistance. It has a high tensile strength that helps to facilitate crossing lesions and tracking devices over the sheath. Even though it is thin walled, the Halo One Guiding Sheath still provides support when it comes to crossing lesions. It is very radiopaque and most sizes are hydrophilic as well, which makes it easy to insert into the artery. I also really like that BD has a 4 French Halo One Guiding Sheath that goes up to 90 cm. Let’s say you need some extra support in trying to cross a chronic total occlusion (CTO) from below. One of the traditional disadvantages to pedal access is that it usually means a 4 or 5 Fr, 10 cm sheath where the operator is navigating a catheter as well as a wire, and there is not enough support to get that catheter and wire across the CTO. You can use a 4 Fr, 45, 70, or 90 cm length Halo One Guiding Sheath, take it all the way up to the beginning of the lesion, and then take your catheter and wire. It is almost like going antegrade, up and over, but you are coming in from below, with same type of support and rigidity that is necessary to cross some of these very calcified lesions. I used this strategy in one of my patients a few weeks ago with positive results. Typically, once you cross a lesion using a standard 4 Fr 10 cm sheath from below, after the intervention, the catheter has to be advanced all the way back up into the femoral artery and you shoot a picture from the catheter to make sure of your result. With a 4 Fr long-shaft Halo One Guiding Sheath already placed at the start of the occlusion, a retrograde injection can be done without having to place another catheter, increasing efficiency. The Halo One Guiding Sheath offers durability, efficiency, and pushability. I have found it to be easy to insert inside the body. I have used it in both femoral and pedal access. The Halo One Guiding Sheath is in line with my philosophy of keeping access as minimal as possible in order to help prevent complications and increase patient comfort, while still allowing operators to do what is necessary to make the intervention a success and help the patient.

What role does the sheath play regarding access site complications?

Being able to use a 6 Fr sheath with an outer diameter similar to that of a standard 5 French sheath to introduce 6 French devices, for example, does help, but what truly counts is the physician’s use of ultrasound when gaining access. I strongly believe that ultrasound use for access should be standard across the board for all interventionists, whether you are a surgeon, cardiologist, or interventional radiologist. You should not be accessing vessels without the use of ultrasound because you don’t want to stick too high and cause a retroperitoneal hematoma. You really need to understand your anatomy under ultrasound. It should be required of everyone. Obviously, sometimes patients present with very difficult access. Let’s say they’ve had a prior surgery in that area, and there is a lot of scar tissue that makes it very hard to see your vessels, or the vessel is extremely calcified or severely narrowed. In that scenario, you may want to reconsider your alternative sites of access to see if that potential pitfall can be avoided, but sometimes it’s not possible and you still have to press forward. The Halo One Guiding Sheath helps in this process by allowing the access size to be kept minimal while still permitting the use of standard-size interventional tools. You don’t have to go up to a higher size sheath. The operator’s actions and skill level remain key to avoiding access site complications. You have to be comfortable. You have to know what you’re doing. You have to know what you’re looking at. It is going to make your life a whole lot easier if you just use that ultrasound probe to take a good look. It should give you the information you need to make a smart decision.

Can you describe a recent case?

Yes, let me give you some background on the patient. This lady is in her 70s, she is morbidly obese, diabetic, and has kidney failure. The way she presented initially was that her access for her dialysis was too deep; it needed to be elevated. As I was questioning the patient, I asked her if she had a cardiologist. I asked her, did she ever experience any pain in her legs? Since she is a diabetic, does she have any sores, wounds, or ulcers, or neuropathy? I found out that she had significant peripheral vascular disease. Her right common iliac was completely occluded. Her left common iliac had a severe stenosis. The right superficial femoral artery (SFA) had about a 50 to 60% stenosis in the mid segment and her left SFA was occluded. After fixing her fistula, her right common iliac occlusion was opened with a stent, using a brachial approach. I really try to avoid sticking the femorals, especially in obese patients with a large pannus, which can cause problems as far as hemostasis and access site complications. Luckily, there was enough room. There was a little stump of iliac off the aorta that allowed us to place a stent and not have to put in kissing stents. Through the same brachial sheath, we simultaneously fixed the left iliac stenosis as well. The next step was to fix the occluded SFA. Again, this was an obese patient with a recent stent in the iliac artery, a patient where you want to avoid accessing the femoral arteries. We did a pedal access via the posterior tibial artery, starting out with a 4 Fr 10 cm Halo One Guiding Sheath. We advanced the catheter to the area of the occlusion and did an injection that showed the entire SFA was occluded (Figure 1). We didn’t necessarily know where the SFA reconstituted. On the old imaging, the SFA had a little nub coming off the common femoral after we fixed that left iliac, so there was some distance to travel. As you can imagine in a patient who is diabetic and who has kidney failure, the SFA was quite calcified. We were having trouble advancing the catheter and wire (Figure 2). The catheter wire would sort of bounce back as we were trying to advance. We decided to use the 4 Fr 45 cm Halo One Guiding Sheath, which has to be over an .035-inch wire. We advanced an .035-inch wire through our catheter, took out the 4 Fr 10 cm sheath, and then placed the 4 Fr 45 cm sheath up into the popliteal artery, near a distal SFA area where the occlusion started (Figure 3). With this added support, the wire had no trouble crossing the CTO with the catheter piggybacking behind it (Figure 4). We were able to cross the lesion and perform atherectomy, then use a drug-coated balloon. We did an injection that showed a good result without having to put in a stent (Figures 5-6). If we had thought it necessary to put in a stent, I felt very confident that I could take the 4 Fr 45 cm sheath out and place a 5 Fr Halo One Guiding Sheath. I probably would have stayed with a 10 cm sheath and then landed a stent there, but we didn’t have to do that because we stayed luminal, confirming on IVUS. The patient, who is on dialysis, has a hard time lying flat, and also has a history of chronic obstructive pulmonary disease (COPD), was able to remain elevated during the procedure. With the use of pedal access, patients don’t have to lie completely flat and when they go to recovery, they are able to sit up in bed with their legs straight. It adds to the comfort of the recovery, especially for patients with back problems, COPD, or congestive heart failure. The procedure was a success, and having that versatility with the availability of longer size sheaths and lower diameter sheaths allowed for success in this case. Once we revascularized her, the patient felt a huge difference. She had thought her legs hurting her all the time was just arthritis and old age. She was over the moon, excited about the fact that she could walk a lot further. She felt like she had more energy in her legs. The problem really wasn’t arthritis. It was peripheral vascular disease. 

What does it mean to you to have a sheath like the Halo One Guiding Sheath paired with the Lutonix 018 Drug-Coated Balloon?

They pair very well. Lutonix balloons are meant to go through 5 Fr sheaths up to 7 mm. Both pair together well because (A) you don’t have to upsize your sheath, and (B) it keeps the access profile low.

Any final thoughts?

The Halo One Guiding Sheath is an excellent sheath that provides a great deal of versatility. Its ability to allow for the placement of a long segment sheath from below in order to cross lesions is a huge plus and is something that I wasn’t able to do before the Halo One Guiding Sheath was available. It will continue to benefit patients. I urge all physicians who do peripheral work to look into the Halo One Guiding Sheath and see what it can do for them. 

Disclosure: Dr. Kousta Foteh reports a consulting agreement with BD, CSI, and Silk Road Medical.

Dr. Kousta Foteh can be contacted at kfoteh@me.com.

Financial support for this article has been provided by Becton Dickinson and Company.

 

 

The opinions and clinical experiences presented herein reflect those of the author, are for informational purposes only, and may not be representative of what others may experience. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient-specific attributes.

Indications

The Halo One™ Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One™ Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature or the coronary vasculature.

Contraindications

There are no known contraindications for the Halo One™ Thin-Walled Guiding Sheath.

Warnings

  1. Contents supplied STERILE using ethylene oxide (EtO). Non-pyrogenic. Do not re-use, reprocess or re-sterilize. This device is intended for single use only. 
  2. 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.
  3. 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.
  4. Visually inspect the packaging to verify that the sterile barrier is intact. Do not use if the sterile barrier is opened or damaged.
  5. Use the sheath prior to the “Use By” date specified on the package.
  6. Do not advance the guidewire, sheath/dilator, procedural device, or any component if resistance is met, without first determining the cause and taking remedial action. 
  7. Do not use a power injector through the sideport or the three-way stopcock
  8. The Halo One™ Thin-Walled Guiding Sheath has not been evaluated for use in the neurovasculature or the coronary vasculature.
  9. 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.
  10. Only advance or retract the sheath with the dilator inserted and only advance or retract the sheath and dilator while placed over a properly sized guidewire.
  11. Failure to deactivate the procedural device prior to removal through the sheath may cause damage to the sheath and may result in patient injury. 

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions. 

POTENTIAL ADVERSE EFFECTS 

Potential adverse effects that may result from a percutaneous vascular procedure (directly or indirectly associated with the device) may include, but are not limited to:

  • Air embolism 
  • Aneurysm or pseudoaneurysm 
  • Arteriovenous fistula 
  • Compartment Syndrome
  • Death
  • Embolism 
  • Endocarditis 
  • Hematoma 
  • Hemorrhage, including bleeding at the puncture site 
  • Intimal tear 
  • Radial artery occlusion/spasm
  • Sepsis/infection/inflammation 
  • Tissue necrosis
  • Thrombus formation 
  • Vessel spasm, perforation or dissection
  • Potential systemic indirect/inherent adverse effects related to general endovascular procedures may include, but are not limited to:
  • Arrhythmias
  • Drug reactions, allergic reaction to contrast media 
  • Hypotension/hypertension 
  • Pain and tenderness

© 2020 BD. BD, the BD logo, Halo One, and Lutonix are property of Becton, Dickinson and Company or its affiliate. All other trademarks are property of their respective owners.

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