HRS: Implantation complications happen, here's how to avoid them

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DENVER—With the need for cardiac device implantation on the rise, operators must be aware of complications and the proper techniques to avoid them, said Steve L. Higgins, MD, of Cardiac Arrhythmia Associates in La Jolla, Calif., during a presentation at the 31st annual Heart Rhythm Society scientific sessions this morning in Denver.

To provide advice to prevent complications during defibrillator implantation, Higgins performed a meta-analysis of data to pinpoint risk of complications and techniques to prevent them.

“Every area of medicine shows that volume and experience reduce complications,” Higgins said. “You need to have higher volume centers and you need to be trained with a high-volume implanter.”

Higgins said that training programs must equally teach ablation skills as well as device implantation skills. Currently, training programs “are heavily weighed on one or the other.”

As much as politics might be involved, due to pushes from referring physicians, it is important to avoid and discourage low-volume implants, he said.

Examining complication rates is difficult because of the variance of reporting data, but complications are common, he said. Patients who undergo a device implantation have a one in 250 chance of dying on the table. “This can be prioritized depending on the patient’s risk, but that is indeed a risk of this surgery.”

Additionally, cardiac arrest, hematomas, lead complications and generator complications are all significant risk factors for implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) patients.

For rates of device related hematoma, Higgins found that the likelihood of patients having a hematoma who are prescribed low molecular weight heparin (LMWH) post-op is 12 percent, for patients on Coumadin, it is only a 3 percent risk.

While Higgins said that Coumadin is essentially safe when administered alone, as well as aspirin, using duel anti-platelet therapy of aspirin and clopidogrel (Plavix) holds a 25 percent risk of hematoma.

“Don’t be afraid of Coumadin,” said Higgins. Operators and staff must be re-educated and should try and operate on patients on Coumadin rather than LMWH, he recommended.

Additionally, use of topical thrombin, while controversial, may be helpful in preventing risk of hematoma is selected patients, he said. While only one industry study has been performed, that research showed patients who underwent topical thrombin had a 50 percent decrease in pocket hematomas compared to those in the control group, 11.7 percent versus 22.5 percent, respectively.

The technique is used most frequently in patients who are on anti-platelet therapy or who have pocket bleeding.

Additionally, Higgins said that while placing chest tubes or thoracic vents in the electrophysiology (EP) lab is not taught in training, “it’s something you should learn. It’s a very easy thing to do and a great way to evacuate pneumothorax.”

On another note, Higgins said that “ICD generator changes is talked about much less than it should be and is a huge percentage of a practice—over 5 percent.”

Higgins said that it is pertinent that the operator is aware and prepared for lead revisions and it is also beneficial to prep both sides of the chest before surgery, visually inspect the lead and take the time to check and recheck setscrews and electrograms.

Lastly, facilities should implement EP emergency courses, which teach team building and help prevent complications. “It’s extremely helpful to talk about what you would do in rare situations,” he said.

He offered that the meetings should talk about how to deal with cardiac arrest, hypothermia, emergency thoracotomy, and pericardiocentesis protocols.

“What would you do to save a patient’s life? You must think about this in advance,” he said.

“Clearly there are patients who die who could have lived very easily. You need to understand what to do and how to deal with these scenarios and how to prevent them," concluded Higgins.