October 02, 2015
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Streamlined TAVR Goes Mainstream

Changes in management lead to less time in the hospital, lower costs.

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When transcatheter aortic valve replacement was first performed, patients were treated the same as though they were having major surgery: general anesthesia and transesophageal echocardiography during the procedure, a prolonged ICU stay after the procedure, and a total hospitalization that often exceeded 10 days.

As TAVR has become increasingly more common and new technologies have come into use, interventional cardiologists are now more confident that procedures can be performed with little or no complications. This has led to the adoption of a more minimalist approach, including conscious sedation instead of general anesthesia, greater use of transthoracic echocardiography or other imaging instead of transesophageal echocardiography (TEE), fewer patients needing an ICU stay and more prompt discharge. These factors are also driving down the cost of TAVR.

The average length of stay at many hospitals is now about half of what it used to be, and discharges within 48 hours after TAVR have become common. In fact, at some institutions, discharges within 24 hours are not uncommon. Recently, the first known case report of a same-day discharge after TAVR was published.

Danny Dvir

“A few years ago, we were much more nervous and were keeping patients in the hospital for a much longer period of time,” Danny Dvir, MD, interventional cardiologist at the Center for Heart Valve Innovation, St. Paul’s Hospital, Vancouver, British Columbia, Canada, told Cardiology Today’s Intervention. “The median time of hospitalization after TAVR a couple of years ago was about 1 week. Now, especially with devices that are less prone to conduction defects, leading to a reduced need for a pacemaker after TAVR, we can safely go down to a median length of stay of about 2 days, and in a substantial portion of patients we can discharge the next day.”

Proper Patient Selection Crucial

A successful minimalist approach and prompt discharge requires careful patient selection, experts told Cardiology Today’s Intervention. Especially in the United States, most patients who undergo TAVR are at extreme risk or high risk for surgery, and thus tend to be elderly, frail and have multiple comorbidities.

Howard C. Herrmann

Researchers at the University of Pennsylvania Health System developed a fast-track TAVR program with the following inclusion criteria: identification as a first OR case; simple airway management; no prior severe lung disease; left ventricular ejection fraction > 40%; pulmonary artery systolic pressure < 50 mm Hg; less than grade 2 on the mitral regurgitation scale; normal renal function; Society of Thoracic Surgeons predicted 30-day mortality risk < 8%.

Illustration © Lisa Clark

The criteria “were based on our institution’s experience and our clinical judgment,” Howard C. Herrmann, MD, FACC, MSCAI, professor of medicine at the Perelman School of Medicine at the University of Pennsylvania Health System, health system director for interventional cardiology at the University of Pennsylvania Health System and director of cardiac catheterization labs at the Hospital of the University of Pennsylvania, said in an interview. “Our goal was to identify the patients we thought would be the safest, have the fastest recovery time and the shortest length of stay. We intended to first select a group of low-risk patients to study, not start with the sickest patients and do things to them that would potentially harm their stay.”

In a report published in Catheterization and Cardiovascular Interventions, patients in the fast-track program had a shorter ICU stay (28.4 hours vs. 44.8 hours; P < .0001), shorter postoperative length of stay (4.3 days vs. 7.2 days; P < .0001) and fewer direct costs associated with the procedures ($44,923 vs. $56,339; P < .0001) compared with patients who received standard care,Herrmann and colleagues found. Patients who successfully completed the fast-track program also had a shorter ICU stay (5.8 hours vs. 85.8 hours; P < .0001) and lower costs associated with the procedures ($42,352 vs. $51,467; P = .0033) compared with patients who were enrolled in the fast-track program, but had at least one protocol deviation.

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A key to proper patient selection, Dvir said, is finding patients who have a support system outside of the hospital. “You don’t want to discharge early a patient who doesn’t have a family to support him for at least the first day or two,” he said. “If there is some change ... we need to know about that. We want direct communication with the family to know if something happened.”

Streamlined Screening

Even the screening process before TAVR is being streamlined. Alaide Chieffo, MD, from San Raffaele Scientific Institute, Milan, and colleagues published a study in Catheterization and Cardiovascular Interventions in which patients undergoing TAVR received CTA and invasive coronary angiography if CAD was detected or not evaluable by CTA, or CTA alone if no CAD was confirmed. At 1 year, the risk for MACE was not higher in those who had CTA alone (HR = 0.89; 95% CI, 0.49-1.6).

In an editorial accompanying these data, Dvir noted that the CTA-only approach could enable teams to bypass the step of invasive cath lab assessment before TAVR.

“That group showed that ... an assessment in the cath lab before TAVR is not required in a routine way,” he said. “I tend to believe there is something there. Maybe in the future the patient will have a simple ultrasound echo, afterward they will have the CT, and the next thing will be only a discussion of how to treat the patient. Bringing older patients to the cath lab before the TAVR procedure is not without complications.”

Periprocedural Factors

Before TAVR, two crucial decisions are made that will affect recovery and discharge: Is TEE required to assess the placement of the valve, or can a less-invasive modality such as TTE be used? Is general anesthesia required, or can conscious sedation be used?

At many institutions, these decisions go hand-in-hand: General anesthesia may be used if TEE is needed, but may not be used if it is not needed.

Philippe Généreux

“On about 40% of patients, who are not at extreme risk nor have high-risk anatomical features, we use a pathway of conscious sedation,” Philippe Généreux, MD, interventional cardiologist and director of the structural program at Hôpital du Sacré-Coeur, Montreal, and director of the angiographic core laboratory at the Cardiovascular Research Foundation/Columbia University Medical Center, New York, said in an interview. “The patient is awake and we only use an A-line for monitoring. We don’t have any neck lines. I am able to talk to the patient and reassure him, which is very important. The procedure lasts for 40 minutes if everything is going well. These cases are done by TTE to give a quick look at the moment of deployment.”

As the TAVR patient population has expanded to more patients at the lower end of the high-risk cohort and in the intermediate-risk cohort, it has become possible to use this approach more frequently, Généreux said. “For that class of patient, it is easier to do that approach because the patient is able to communicate and there is not concern about hemodynamic compromise. But if the patient is too high risk, will not cooperate, has very low EF or has the potential for hemodynamic compromise, it will be safer to have the full safety net with full anesthesia and TEE guidance.”

An advantage to minimal anesthesia, is that “once they are free of sedation, they are essentially back to normal. By 2 or 3 hours after the procedure, they are back to reasonable consciousness and cognition, and if they’re OK the next morning and there are no problems with their insertion site, it would be reasonable that they can go home. There’s really not much that can happen thereafter because late complications of TAVR are relatively rare,” Peter C. Block, MD, FACC, MSCAI, professor of medicine/cardiology at Emory University, Atlanta, told Cardiology Today’s Intervention.

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Most institutions have a policy that use of a TEE probe “means putting the patient fully to sleep and intubating the patient for the procedure time, which means it is a much more invasive procedure,” Dvir said. Therefore, he said, TEE is becoming less common in TAVR procedures.

Peter C. Block

“At the beginning, TEE was utilized for sizing and for monitoring complications during the procedure,” he said. “Some centers were also using TEE for positioning of the device. Nowadays, we’ve learned about the importance of CT for sizing in TAVR procedures because of its ability to depict the complex 3-D morphology of the valve and its associated features. So we do not need TEE for sizing. For monitoring complications, the rate of major mechanical complications that you can depict by TEE has become so low that we do not need TEE for that as well.”

It is important, however, that the TAVR team have the ability to convert to TEE mid-procedure if necessary, said Herrmann, a member of the Cardiology Today’s Intervention Editorial Board. “The devices that we use now have such a low rate of significant paravalvular leak that it is becoming less of an issue, but if we see a leak on angiography and can’t determine whether it was paravalvular or central, that is an indication to do TTE. And if we still can’t decide adequately, we might convert over to TEE,” he said. “If there is a real concern about paravalvular leak or the patient is hemodynamically unstable, then we will convert over to general anesthesia and do a TEE immediately.”

Rather than use conscious sedation, Herrmann said his team uses monitored anesthesia care administered by a cardiac anesthesiologist in the hybrid OR setting. “We believe that this gives us the most flexibility and safety, and allows me to concentrate entirely on the TAVR procedure knowing that an expert is managing the patient’s level of sedation and airway,” he said.

Path to Discharge

As general anesthesia has become less common for TAVR, so has the need for a prolonged ICU stay after the procedure. Some institutions now bypass it altogether for lower-risk patients with no complications.

“Most will be perfectly fine in a coronary care unit or a transition unit,” Généreux said. “If the patient comes through with no problems, you observe them for 6 hours in a CCU setting, after which the patient can go to the cardiology ward on telemetry. He doesn’t need the setup with all the bells and alarms and where we often overmedicate the patient. Now, it is very rare that we send patients to the ICU.”

Rebecca Marcantuono

A patient is more likely to need the ICU if he had heart block that required a pacemaker, Herrmann said. “Some patients with temporary pacemakers can go to our floor and do not have to go to the ICU, but sometimes if we are concerned about their rhythm or if they have no underlying escape rhythm, we are more likely to want to monitor them closely in the ICU,” he said.

Rebecca Marcantuono, MSN, CRNP,ACNP-BC, interventional cardiology nurse practitioner at the Hospital of the University of Pennsylvania, told Cardiology Today’s Intervention that when patients bypass the ICU after TAVR and come to the postoperative care unit, they are often quite alert. “Due to the awareness, we try to maintain comfort as a priority and manage their pain as needed,” she said. “It has been my experience that patients are pleased when they come out of the OR. They liken the process to a cardiac catheterization. They feel like they just had a minor procedure, even though we did extensive work on their aortic valve.”

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Patients who do not need the ICU are also more likely to eat and walk promptly, which are requirements for prompt discharge, Généreux said.

“With a dedicated nurse and a dedicated team, you need to quickly prepare the patient for the day after,” if a next-day discharge is the goal, he said. “Six hours after the procedure, you encourage the patient to eat and move and get out of bed. This team is very important to ensure that the patient will not stay in bed and create complications related to increased length of stay, such as infection.”

“Everybody has to be comfortable with discharging the patient, including the patient and the patient’s family,” said Block, a Cardiology Today’s Intervention Editorial Board member. “That is not a minor issue. Many patients need to be carefully watched by family or at an extended care facility if necessary. But on balance, if they’re good enough to have a percutaneous procedure with conscious sedation, we feel that most of these folks really are capable of going home in 1 or 2 days.”

A rare occurrence, but potentially more common in the future, is same-day discharge. Généreux, along with two colleagues, published a case report of a successful same-day patient discharge after TAVR. He said such patients need to be the first case of the day; have good cognitive function; be observed for 10 hours with no problems eating, walking or evidence of rhythm disturbance; and have a valve associated with low rates of AV block. It may even help if the patient already has a pacemaker, he said.

Technology Leading the Way

A major reason the streamlined, minimalist approach is becoming more common is advancements represented by the latest generation of TAVR devices, such as Sapien 3 (Edwards Lifesciences) and Core-Valve Evolut R (Medtronic).

“The lower-profile devices make vascular and bleeding complications less likely, even in the high-risk-access cases,” Généreux said. “With sheaths as low as 14F, it’s a game changer for vascular access. Also helpful is that these devices are associated with a low stroke rate, about 1%, most of which occur around the procedure. It is reassuring to have a very low stroke rate in moderate-risk patients especially.”

Herrmann noted that “the combination of smaller-profile devices, better sealing mechanisms that reduce paravalvular leak, and more predictable results with placement, in the case of Sapien 3, and retrievability, in the case of Evolut R, are making for more predictable, faster and easier procedures. And that should promote the ability to put more patients on our fast track.”

The advent of the newer devices will make same-day discharge easier to achieve, especially as more moderate- and low-risk patients undergo TAVR in the future, Généreux said. “In about 10 years, it will be like PCI, where we are able to achieve same-day discharge in 5% to 10% of patients.” — by Erik Swain

Disclosures: Block reports holding equity in Direct Flow Medical and that his institution is a research site for Edwards Lifesciences. Dvir reports consulting for Edwards Lifesciences and Medtronic. Généreux reports speaking and consulting for Edwards Lifesciences. Herrmann reports receiving consultant honoraria for speaking from Edwards Lifesciences and research funding via his institution from Boston Scientific, Edwards Lifesciences, Medtronic and St. Jude Medical. Marcantuono reports no relevant financial disclosures.