"Like a Patient Etherized Upon a Table"? Not Exactly

In the first randomized trials of transcatheter aortic valve replacement (TAVR) the procedure was mandated to be done in a “hybrid” operating room. Femoral arteries were accessed by cutdown, there was cardiopulmonary bypass standby, both cath lab and operating room teams were present, and patients had general anesthesia (hopefully not ether) making them indeed similar to T.S. Eliot’s shocking image of an evening.¹ TAVR has come a long way since. Operators and hospital administrators have searched for strategies to minimize personnel and TAVR support costs, with the aim of early patient discharge. Marcantuono and colleagues² have published their experience with “fast-track” TAVR. In that study, transfemoral TAVR patients were extubated in the OR, the use of an ICU bed was avoided, and patients were ambulated as soon as possible. Those who completed the fast-track pathway had shorter hospital stays and lower costs than those who received standard care. Though their patients were carefully chosen pre-TAVR, general anesthesia was standard and a hybrid operating room was used.

But if the use of an operating room with its attendant personnel and cost issues is avoided, and hospital stays shortened as well, TAVR cost is vastly lowered. Current technical improvements, mostly evidenced by smaller sheath sizes and more user-friendly devices, have resulted in many centers now performing TAVR in a cath lab with fewer personnel and notably the absence of an anesthesiologist – the so-called “minimalist” strategy.³ From a patient perspective, a minimalist TAVR is quite different. Local anesthesia at the femoral insertion site and conscious sedation of varying amounts are used for comfort reasons and for anxiolysis. Patients are sedated but arousable – not exactly “etherized.” Using a minimalist strategy, as reported by Babaliaros et al,³ many patients do not require an ICU stay, go directly to a monitored floor, and are discharged within a few days, sometimes the next. Infrastructure, material support, and personnel are reduced, resulting in cost savings that may approach $10,000/pt. In a follow-up paper,⁴ Jensen et al point out that there also appears to be little if any learning curve for adopting minimalist TAVR, and many high-volume TAVR centers are turning to this streamlined approach. Although the 2012 American College of Cardiology Foundation/Society of Cardiovascular Angiography & Interventions Expert Consensus Document on Cardiac Catheterization Laboratories update describes the specifications for a hybrid operating room/cath lab, a hybrid operating room is clearly not a prerequisite for a TAVR program any longer, and patients are discharged as soon as safety allows.

In this issue of the Journal of Invasive Cardiology, Piayda⁵ and colleagues from a single German TAVR center describe what might be considered a “next step” – planning and completing TAVR with only local anesthesia. Outcomes were evaluated in terms of additional need for sedation – conscious sedation (for agitation or insufficient local pain relief) or general anesthesia (for complication management or changed access). The study has all the drawbacks of a longitudinal, non-randomized report, but there are a number of interesting outcomes. Some come as a surprise; some not. Despite the use of only local anesthesia, length of stay (LOS) for all groups in the Piayda report is surprisingly long and there is overlap between all three groups. In the Jensen et al study,⁴ LOS was about half as long as in the Piayda report, even though STS scores of patients in the Jensen report were higher and almost all had local anesthesia plus conscious sedation. This may reflect a cultural phenomenon for longer hospital stays in Europe, but raises the question of whether local anesthesia alone in TAVR really makes any difference in reducing cost. Most interesting is that in the Piayda paper the group needing additional conscious sedation had a longer LOS than local anesthesia-alone patients – implying either that in their study the need for conscious sedation was a marker for patients with more risk, or that conscious sedation itself conferred additional need for monitoring (or both). Not surprising is the fact that 22% of the patients could not complete the initial strategy, although only a small minority (3%) fell into the general anesthesia group. 

For me, the “take away” message from the Piayda report is mixed. Certainly TAVR can be done with only local anesthesia. What the paper does not address is whether LOS and ICU time are shortened enough to compete with the already extremely short ICU and LOS times reported from the Emory group in the United States^3,4 in their “minimalist” papers. Only further studies can answer that question. Perhaps the most intriguing finding is that additional conscious sedation, which many would consider to be benign, confers a longer ICU stay. The LOS times in the Piayda report are long in all of their groups, but somehow local anesthesia-only patients did not have a major reduction in LOS (though ICU stays were marginally shorter). The reasons for this are not clear, but if the end-goal of using less anesthesia in patients is to shorten LOS and minimize cost, the Piayda data do not impress. Finally, although TAVR with only local anesthesia can be successful, there are potential drawbacks. Lidocaine infiltration at the femoral insertion site may be locally successful, but will not treat pelvic pain from the straightening of tortuous intrapelvic iliac vessels as straight wires and large sheaths are introduced. Sudden agitation and prolonged pacing runs during valve placement could result in patient movement just as the valve is being deployed, thereby changing fluoroscopic position at a critical moment. Lastly, we have no idea of patient satisfaction with this strategy. 

If a strategy of local anesthesia only is to be considered, further identifiers for selection of the best patients are needed. Patient selection is also critical for any “minimalist” strategy, although the two are likely complementary, not competitive. For now, the Piayda report tells us that more than one-fifth of the patients undergoing TAVR with local anesthesia only will need further sedation. If using local anesthesia only as a first strategy can reduce ICU stay and LOS enough to compete with, or better current minimalist practices in some centers in the United States, such a strategy may well have merit, although we have no hint of that from this paper.

References

1.    Eliot TS. The Love Song of J. Alfred Prufrock. In: Prufrock and Other Observations. 1920.

2.    Marcantuono R, Gutsche J, Burke-Julien M, et al. Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv. 2015;85:648-654.

3.    Babaliaros V, Devireddy C, Lerakis S, et al. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014;7:898-904. Epub 2014 Jul 30. 

4.    Jensen HA, Condado JF, Devireddy C. Minimalist transcatheter aortic valve replacement: the new standard for surgeons and cardiologists using transfemoral access? J Thorac Cardiovasc Surg. 2015;150:833-840. Epub 2015 Jul 30.

5.    Piayda KD, Gafoor S, Bertog S, et al. True first-line local-anesthesia only protocol for transfemoral TAVI. J Invasive Cardiol. 2015;27:501-508.

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From the Department of Medicine, Division of Cardiology, Emory University Hospital, Atlanta, Georgia.

Disclosure: The author has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Block reports no conflicts of interest regarding the content herein.

Address for correspondence: Peter C. Block, MD, FACC, MSCAI, Emory University Hospital, Dept. of Medicine, Division of Cardiology, Atlanta, GA 30322. Email: pblock@emory.edu