Tag: balloon catheter

New Radiation Shielding is a Weight off Cath Lab Shoulders

Radiation warning sign
Photo by Vladyslav Cherkasenko on Unsplash

Testing has shown that a new radiation shielding system offered equivalent radiation protection to the standard lead gowns worn in the catheterisation lab. By using such independent, adjustable shields instead of wearing shielding, the occupational shoulder and back strain inherent to wearing those heavy gowns can be eliminated.

The Rampart shielding system consists of an adjustable stand made of lead equivalent acrylic shielding – was found to block 96% to 98% of radiation scattered to the operator’s head, torso, and waist during an average week of cardiac angiography, according to medical radiation specialist Glenn Ison.

This was equivalent or better than shielding provided by lead gowns and a ceiling-mounted lead shield, Ison said in a presentation at the EuroPCR meeting.

“We found it’s like walking on the moon, doing cases without a lead gown. It’s quite strange,” he remarked.

The researchers had operators wear radiation monitors to measure operator scatter dose to the head, torso, and waist (both under and over their lead gowns) with and without the Rampart.

Dr Ison also pointed out that head and face protection in particular was substantially better with the Rampart shield (radiation exposure -96% vs -70% with standard practice).

Indeed, the shielding of the cumbersome lead gowns — which can weigh up to 13.6kg — only extends to major areas of the torso and waist. Adding on protective glasses and shin guards further adds to this weight.

Ison cited a survey showing that half of interventional cardiologists reported neck or back pain during their careers.

“The ability to maintain protection from scatter radiation whilst lowering or even removing the weight of current lead gowns is a game changer for operators with current back or neck troubles and a way to prevent such problems in the future,” he said. “The longer you’ve been in the game, the more this appeals.”

He added that anaesthetic and nursing staff also had a new highly shielded area to stand in, thanks to the new system.

In response to a panellist question of whether the Rampart would restrict the operator’s arm movements and impede emergency CPR, Ison noted that other companies are working on different shielding types, perhaps some with ceiling-mounted designs making it easier for operators to move around.

“Any benefit to reduce radiation exposure to the operators and staff is an important step forward. The occupational hazards for interventional cardiology are not small, and we need to focus on ways to improve this in the future. To me this is a good step forward,” commented Roxana Mehran, MD, interventional cardiologist at Mount Sinai Health System in New York City.

Ison cautioned that the shield’s effectiveness depends on being correctly positioned. “You must make sure it’s locked in correctly” and test it according to table size and shape, he advised. “Use of real-time audible alarm radiation monitors would be advised.”

Source: MedPage Today

Sweet Success for ‘Chocolate Touch’ Angioplasty Device

Credit: QT Vascular

In patients undergoing angioplasty, a study showed that use of the paclitaxel-coated balloon catheter known as the Chocolate Touch device had better outcomes at compared with those from use of a commercially-available balloon catheter. These findings were presented at the American College of Cardiology’s 71st Annual Scientific Session.

The trial showed noninferiority and an improvement in terms of the proportion of patients with adequate blood flow through the artery without subsequent procedures.

“I’m very excited that we now have a head-to-head comparison of a second-generation vs. first-generation drug-coated balloon and data that we can rely on to make decisions for our patients,” said Mehdi Shishehbor, DO, MPH, PhD, the study’s lead author. “I think that the superiority of Chocolate Touch indicates that as we improve the technologies, there is additional benefit to be gained. For me, this study makes the case that this [Chocolate Touch] will be the device of choice between these two devices for patients who require drug-coated balloon therapy.”

The trial enrolled 313 randomised patients treated for superficial femoral and popliteal artery disease – conditions that involve blocked arteries in the upper leg. All patients underwent balloon angioplasty, a procedure to reopen the artery by threading a tiny device into the blocked area and inflating a small drug-coated balloon that helps prevent reoccurance of the blockage . In half of the patients, a commercially-available Lutonix drug-coated balloon was used, and in the other half the Chocolate Touch balloon was used. The Chocolate Touch device has a constrained balloon, creating characteristic pillows and grooves reminiscent of a chocolate bar.

At 12 months, 78.8% of the patients who received the Chocolate Touch device and 67.7% of those receiving the Lutonix device achieved patency, or blood flow as measured by the peak systolic velocity ratio. No statistical difference in safety was seen between the devices, with a rate of major adverse events of 11.1% in the Chocolate Touch arm and 15.4% in the Lutonix arm. Major adverse events included a composite of death related to the targeted limb, major amputation and revascularidation procedures.

Dr Shishehbor said that estimates of mortality on a cumulative, year-by-year basis are consistently lower in the Chocolate Touch arm as compared to the Lutonix arm. For patients at the three-year follow-up, estimated mortality is 6.8% among patients receiving the Chocolate Touch device, which was also well below the trial’s goal of 13.2%, reinforcing confidence in the device’s safety profile.

“At a minimum, this [Chocolate Touch] device is as safe as the Lutonix, with a trend for lower mortality rates,” Dr Shishehbor said.

The Chocolate Touch device is designed to provide a more even and controlled widening of the artery. This design lets operators use a slightly larger balloon to further widen the artery and provide increased contact between the balloon surface with the paclitaxel coating, Dr Shishehbor said.

Although balloon angioplasty is the preferred treatment for blocked arteries in the leg, many patients experience recurring blockages, requiring additional procedures.

“If we are able to offer patients therapies that can keep the artery open for as long as possible, that will be welcome news,” Dr Shishehbor said. “As we advance our technologies and get more patency, or blood flow, over time, the patients will enjoy that benefit and have a lower likelihood of needing repeat procedures.”

Dr Shishehbor said that the trial paused enrollment for six months in response to industry-wide concerns over the safety of paclitaxel but said that the study ultimately achieved a high follow-up rate of 94%. The trial is also the first to allow combining the drug-coated balloon treatment with atherectomy, in which a blade is used to first remove plaque from the vessel prior to catheter balloon use. Dr Shishehbor said that while only a small number of patients was treated with atherectomy, the patency rate was promising. Future studies could determine whether Chocolate Touch treat longer and more complex blockages.

Source: American College of Cardiology