Device and procedural innovations have led to improved efficiency with TAVI

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TAVI-procedural-innovation
Rajesh Kharbanda

Caution: This content is only for readers outside of France and Japan. In the US, ACURATE neo is limited by U.S. law to investigational use only. Not available for sale.

Since the first implant 17 years ago, transcatheter aortic valve implantation (TAVI) has become a routine procedure for inoperable and high-risk patients. Furthermore, new procedural and device iterations have led to the development of a “minimalist” TAVI approach, which in turn has led to more and more patients being selected for early discharge. Early discharge has potential benefits for patients and for hospitals.

Writing in the European Heart Journal, Cahill et al report that the evolution of TAVI has led to reductions “in procedural mortality and major complication rates”.1 They add that, along with these reductions, an increasing number of TAVI cases worldwide are now being performed with a minimalist approach using “conscious sedation, local anaesthetic and transthoracic echocardiographic guidance”. According to Rajesh Kharbanda (Department of Cardiology, John Radcliffe Hospital, Oxford, UK), improvements in device and access technologies have helped to drive this move towards a less invasive procedure. He notes: “We are now using much smaller catheters; we insert them percutaneously without the need for a surgeon to cutdown the vessel.”

A minimalist approach has, Cahill et al observe, potential advantages “of reduced procedural time and faster recovery” and, together, these can enable a patient to be discharged early. It could benefit both patients and hospitals. “Early discharge may allow patients to get back to their normal activities as quickly as possible. It may mean less disruption to their general life. Early discharge also has benefits for carers and relatives as it means less disruption for them as well,” Kharbanda says. He adds that, for hospitals, the benefits of early discharge “are clearly financial” because they relate to “better efficiency” and “allow more patients to be treated at the same facility”. In other words, if patients are discharged early, that frees up beds for more patients to be treated.

Data for early discharge

Improved hospital efficiency, however, has not come at the cost of reduced safety for patients. In fact, a recent study found that early discharge was associated with better outcomes than was delayed discharge. Wayangankar et al reviewed data for 24,285 patients who underwent TAVI between 2011 and 2015.2 Of these, 13,389 were discharged early (within 72 hours) and 10,896 were discharged late (after 72 hours). As well as finding that there was a significant decline in the rates of delayed discharge over the study period, the rate of the primary outcome—a composite of death, stroke, myocardial infarction, or bleeding—was significantly higher in the delayed discharge group. The authors report that, even after adjusting for in-hospital complications, delayed discharge was an independent predictor of one-year mortality.

For Kharbanda, though, the lower mortality rate with early discharge is more of an indication of the health of the patients selected for early discharge than a direct result of the early discharge. He states: “At our centre, we use early discharge for patients who are less likely to have problems after the procedure.” Kharbanda’s centre, he adds, selects patients for early discharge when planning the TAVI procedure. “When reviewing if a patient could be discharged early, we look at the complexity of their anatomy and their social factors. If they are independent, have good social support, and their anatomy means that their procedure will not be complex, we might consider putting them on the early discharge pathway,” he explains.

Accurate Neo
ACURATE neo

Devices that enable early discharge

When selecting patients for early discharge, a key consideration is which TAVI device to implant. ACURATE neo (Boston Scientific), Kharbanda says, has several features that may allow an early discharge. He says: “It is compatible with the new 14F iSLEEVE (Boston Scientific) expandable vascular access sheath. That means the hole for the access site is smaller and, thus, the risk of vascular complications is lower. Also, the ACURATE neo system is extremely flexible and so can more easily deal with tortuous anatomy.” Additionally, the valve has a very low gradient, meaning its valve function is—according to Kharbanda— “excellent”. However, the key advantage of the valve is its pacemaker rate, as he says: “It has got the lowest pacemaker rate of any device currently on the market.”

Conduction abnormalities (and consequently, pacemaker implantation) are a barrier to early discharge. Kharbanda explains: “If we put in a valve and the patient develops an abnormal ECG, then we need to monitor them for longer to ensure that this abnormality resolves. But if a patient has a normal ECG, then early discharge becomes easier.”

A study by Kharbanda and his colleagues supports his view that a low pacemaker rate is linked to a higher rate of early discharge.3 They compared procedural outcomes with ACURATE neo (143 patients) with those of an earlier generation self-expanding valve (CoreValve Evolut R, Medtronic; 88 patients). At 30 days, vascular complications, pacemaker implantation, and length of stay were all significantly reduced in the ACURATE neo cohort compared with the CoreValve Evolut R cohort. Specifically, 45% of patients in the ACURATE neo group were discharged within two days vs. 31% of patients in the CoreValve group (p=0.03). “Saying that the [lower] pacemaker rate of ACURATE neo was the only reason for reduced length of stay is difficult, but it was a key contributor to that finding,” Kharbanda comments.

Data from another study showed that also next-day discharge after TAVI with ACURATE neo may be feasible. In a retrospective evaluation, Moriyama et al found that the safety of next-day discharge of TAVI using ACURATE neo was similar to that of SAPIEN 3 with comparable 90-day and one-year outcomes.4

The future of TAVI

Cahill et al believe that the number of TAVI procedures being performed, in part because of the ageing population, may grow “4–10-fold over the next decade”. They add: “Transfemoral delivery and a simplified procedure are increasing availability [of TAVI], but the maintenance of high-quality decision-making, excellent outcomes, and specialist training in a Heart Valve Centre are critical. Meeting the logistic challenge of delivering TAVI care will require a new cadre of structural interventions, derived through cardiological, surgical, or hybrid training routes.”

Looking forward, Kharbanda believes there is need to focus on “achieving a predictable procedure by limiting vascular complications, stroke, paravalvular leak and procedure related pacemaker implantation, and this will enhance efficiency”. He adds: “The continued drive to reduce device calibre, understand the role of cerebral protection devices, and improved valve design will drive procedural improvements.”

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References:

  1. Cahill TJ, Chen M, Hayashida K, et al. Transcatheter aortic valve implantation: current status and future perspectives. Eur Heart J 2018; 39(28): 2625–34.
  2. Wayangankar SA, Elgendy IY, Xiang Q, et al. Length of stay after transfemoral transcatheter aortic valve replacement: An analysis of the society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JACC Cardiovasc Interv 2019; 12(5): 422–30.
  3. Kotronias R, Scarsini R, Rajasundaram S, et al. Routine use of ACURATE neo self-expanding TAVI is associated with improved procedural outcomes and reduced postoperative length of stay: Insights from a single-centre registry. Poster at EuroPCR 2019.
  4. Moriyama N, Vento A, Laine M, et al. Safety of next-day discharge after transfemoral transcatheter aortic valve replacement with a self-expandable versus balloon-expandable valve prosthesis. Circ Cardiovasc Interv 2019; 12(6): e007756.
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