It can take up to an hour for a cardiologist to implant a pacemaker, but new pacemakers without leads are currently under investigation and will dramatically reduce that time. These new pacemakers even have the potential to reduce the risk of infection. But that’s just one example of the flood of new technologies rushing into the cath lab. Transcatheter aortic valve replacement (TAVR) technology isn’t new to the spotlight, but new indications are gaining a lot of interest.

Subcutaneous implantable cardioverter defibrillators (ICDs) are an exciting, new technology for use with younger patients and may even do away with intravenous ICDs for that population in the near future. But keeping up with all of this new technology has proven to be a challenge for cardiologists. Beyond that, they also have to contend with the changes health care reform is bringing to their practices, and ongoing radiation dose concerns.

HealthCare Business News had the opportunity to speak with Cleveland Clinic, NewYork-Presbyterian/Weill Cornell Medical Center and Duke University Hospital — three of the top cardiology hospitals in the U.S. — about these new technologies as well as the challenges the facilities are facing. The three also offered advice on how smaller hospitals can provide the top quality of care they do.

Technology coming down the pike
The introductions of Medtronic’s CoreValve and Edwards Lifesciences Corporation’s Sapien were the big news stories about a year ago, but the technologies seem to be stepping back to the forefront to address indications within a different patient population. The technology was approved for use in high risk populations, but now it’s being investigated for use in lower-risk populations.

“To date, all the published data for implanted transcatheter aortic valve is positive and promising," says Dr. Harsimran Singh, an interventional cardiologist at NYP/Weill Cornell Medical Center. "As with any newer technology, the million dollar question is whether the durability of transcatheter valves (either Sapien or CoreValve) meets the 10 to 20 year durability of surgically implanted aortic valves. If it does, then TAVR would become an option for even the lowest risk population.”

NYP/Weill Cornell Medical Center is currently involved in the PARTNERS II trial investigating Edwards’ Sapien for the intermediaterisk population. Singh says that so far, the rate of complications and outcomes seem to be equivalent to the rates for the high-risk population.

However, that is only based on a few years of data. The valves usually last between 10 to 20 years, so it will take at least a decade for the question regarding outcomes to be answered. St. Jude Medical’s Nanostim is expected to be the next, hot technology once it receives FDA approval. It is placed directly inside the heart and requires no leads or surgical pocket.

Nanostim is less than a tenth the size of conventional pacemakers and resembles an AAA battery. It consists of a pulse generator that includes a battery and steroid-eluting electrode that transmits pulses to the heart when it detects an issue with the heart’s rhythm.

“There has been a longstanding recognition in our field that the weakest link in a pacemaker has been, for decades, the lead itself,” says Dr. Daniel Cantillon, a cardiologist at Cleveland Clinic. Over four million people worldwide have an implanted pacemaker or other cardiac rhythm management device and more than 700,000 additional patients will receive one every year. Pacemaker complications don’t occur often but when they do, they’re usually caused by the surgical pocket or the leads — about 1 percent of patients have a pocket that becomes infected and about 3 percent have leads that move out of place.

Cleveland Clinic is currently involved in the LEADLESS II trial, required by the FDA, evaluating the effectiveness and safety of Nanostim. The researchers are recruiting appropriate candidates and will have about 670 patients in the U.S. and Canada enrolled. The hospital performed its first implant last February. Cantillon said that traditional pacemakers take him about an hour to implant, but the leadless pacemaker only takes him about 13 minutes.

“[Procedures] that are less invasive and mobilize our patients quicker after surgery are things that benefit both patients and hospital systems,” says Cantillon.

NYP/Weill Cornell Medical Center is also involved in the LEADLESS II trial. Singh said that he believes it’s a fantastic technology when used in the right population — elderly patients and patients with tricuspid valve disease.

For young patients who will require multiple pacemakers throughout their lifetimes, there are still questions regarding how many pacemakers can be put in. For that population, the conventional pacemakers will still be the standard of care.

Duke University Hospital also has experience with Nanostim, but is also involved in a trial investigating Medtronic’s leadless pacemaker called the Micra Transcatheter Pacing System. “We are really enthusiastic about the possibility that it could help reduce the chances of infection from device implantation,” says Dr. Brett D. Atwater, a cardiologist at Duke University Hospital.

There have also been advancements made in the world of ICDs. Previously, patients with sudden cardiac arrest were treated with transvenous ICDs but Boston Scientific received FDA approval in 2012 for its subcutaneous ICD called the S-ICD System, which can treat those patients without touching the heart.

It utilizes a pulse generator like the transvenous ICDs, but it also uses a subcutaneous electrode and analyzes the heart rhythm instead of individual beats. Patients don’t have to undergo vascular surgery to have it implanted and it reduces the potential for systemic infection and complications associated with endovascular lead implantation or extraction. Subcutaneous ICDs are ideal for young patients with an inheritable form of heart disease that renders them vulnerable to sudden cardiac arrest, said Cantillon. Just like the pacemaker, the leads are the weakest link for a defibrillator system since they are susceptible to breaking and other complications.

“When you are dealing with somebody who is young, in their twenties for example, who is looking at a lifelong commitment to device therapy, there is a very significant advantage in taking that hardware out of the vascular space and putting it into the subcutaneous space,” says Cantillon.

Overcoming the challenges
“Structural heart disease in general, is a big growth area for all companies in medicine — we are able to do more and more things in the heart without opening the heart altogether,” says NYP/Weill Cornell’s Singh. “From a technical standpoint, the challenge is learning those skills.” NYP/Weill Cornell Medical Center has a lot of experience with transcatheter valves, but the leadless pacemakers and subcutaneous
ICDs were new to them. After going through a training course, the cardiologists have been making a lot of progress with developing those new skills. “Any surgeon will tell you that the more you do something, the easier it gets,” says Singh.

The cardiologists at Duke University Hospital also needed to go through the training course for the leadless pacemakers. “The leadless pacemaker system is unique — it’s unlike anything we’ve ever done,” says Atwater. “It’s a challenging procedure to get the pacemaker in but once you have the expertise, it can go reasonably fast.”

It’s also a challenge for the other staff members in the cath lab, noted Atwater. When a new procedure is introduced, they have to work on a new type of workflow to ensure that it gets done in a certain time frame that’s reasonable for both the hospital and the patient.

Fluoroscopy, for example, has always been a challenge in the cath lab because of the radiation dose it exposes patients to. “We’re constantly looking for ways to minimize radiation exposure for the patient and for the lab staff, and for the attending physician who is doing the cases,” says Atwater.

To solve that, Duke University Hospital started using non-fluoroscopy 3-D cardiac mapping systems developed by Biosense Webster, St. Jude Medical, and Boston Scientific. Since then, the hospital has seen a dramatic reduction in fluoroscopy exposure and fluoroscopy related complications.

In addition, interventional cardiologists must now have a good understanding of valve disease, cardiac anatomy and physiology and imaging. They are no longer just angioplasty specialists, although it’s still an important bread-and-butter skill.

“The integration of imaging in the cath lab and in the OR is crucial and unless you have trained in it, that is probably one of the biggest limitations,” says Singh. Cardiologists must learn CT, MR, echocardiography, 3-D reconstructions and also holographic imaging to perform better procedures in the cath lab, he added.


Providing that top quality of care
Not every hospital can afford a state-of-theart cath lab or operating room, but there are still ways they can provide top-quality care. “I think it’s fair to say that whether it’s surgery or interventional cardiology, there is a movement to really create these centers of excellence in each specific niche within a specialty,” says Singh. He recommends that instead of trying to do everything that is new and upcoming, hospitals should focus on creating one type of program first and work on the infrastructure.

But these structural procedures are resource intensive and the hospitals need support from the administration, nursing staff, radiology department and surgeons to have a successful program. Cleveland Clinic has an affiliates program that provides consulting services to other hospitals to help them develop their clinical services, including nursing workflows and quality and safety measurements.

Cleveland Clinic produces a recommendations report for all of the hospitals it works with in order to help them improve their cardiovascular program. At the hospitals’ request, Cleveland Clinic can also help them implement the recommendations. “The idea is that we go out to these hospitals, we evaluate their programs, we give them very constructive feedback about their processes and workflow, and safety measures and quality initiatives, and we help them to get better,” says Cantillon.

MedStar Heart Institute recently entered into an alliance with Cleveland Clinic. After several site visits, MedStar began making changes to streamline pre- and post-operative procedures and improve the information management system so it can handle more extensive data collection and outcome measurement.

Duke’s Atwater believes that in order for a hospital to be successful, it must adapt to the changing health care environment. In 2013, Duke joined the CMS Bundled Payments for Care Improvement Initiative to learn more about bundled care and how it affects cardiology.

Atwater is not at liberty to discuss his experience with the initiative, but he did mention that the hospital is starting to focus more on the cost associated with hospital readmission after procedures. “To drive down readmissions we need to drive up the quality of the initial experience for the patient,” he says. “We do our very best to prevent complications associated with the procedures.”

The hospital also takes advantage of the time before the procedure to ensure that the peri-procedural time frame works smoothly for the patient. As a result, the hospital has seen a significant reduction in both the average length of stay and in the readmission rate. That advice applies to every hospital, whether it’s a small, rural hospital or a large hospital like Duke. “We operate in the same payment environment that they do,” says Atwater. “We are looking to try to be as efficient and as slick as possible to make this happen in a cost-effective manner.”