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Cath lab may be best location for performing transfemoral TAVR
A minimalist strategy of performing transfemoral transcatheter aortic valve replacement in a cath lab yielded improved procedure times and cost and comparable mortality when compared with transfemoral TAVR in a hybrid operating room, concluded recent study findings.
In the study, researchers from Emory University School of Medicine, Atlanta, aimed to further describe differences in outcomes and cost for transfemoral TAVR performed in a cath lab — which they described as the minimalist approach — with the standard approach, or transfemoral TAVR performed in a hybrid operating room. They noted that the minimalist approach does not require general anesthesia, transesophageal echocardiography or a surgical hybrid room.
Eligible participants underwent an elective procedure using the Sapien transcatheter valve (Edwards Lifesciences). There were 142 patients evaluated in the analysis, including 70 patients in the minimalist group and 72 patients in the standard approach group.
At baseline, Society of Thoracic Surgeons scores were 10.6 ± 4.3 for the minimalist group and 11.4 ± 5.8 for the standard group (P=.35).
Successful procedures occurred in all patients who underwent minimalist TAVR, with one intubation. Procedure-related mortality occurred in three patients in the standard TAVR group.
Several measures of duration were shorter in the minimalist TAVR group compared with the standard TAVR group, including:
- Procedure room time, 150 ± 48 min vs. 218 ± 56 min (P<.001);
- Total intensive care unit time, 22 hours vs. 28 hours (P<.001);
- Length of stay from procedure to discharge, 3 days vs. 5 days (P<.001).
The minimalist approach was associated with a cost of $45,485 ± 14,397 compared with $55,377 ± 22,587 in the standard group (P<.001).
Thirty-day mortality rates were 0% for the minimalist approach and 6% for the standard approach (P=.12). Similarly, 30-day stroke/transient ischemic attack rates also were comparable for minimalist vs. standard interventions (4.3% vs. 1.4%; P=.35).
Thirty-day moderate or severe paravulvular leak rates were 3% for minimalist TAVR and 5.8% for standard TAVR (P=.4). Device success rates also were statistically similar (minimalist, 90% vs. standard, 88%; P=.79) at 30 days.
Survival rates were 83% for minimalist TAVR and 82% for standard TAVR at a median follow-up of 435 days (P=.639).
“Our data support [a minimalist] strategy for the treatment of high-risk and inoperable patients with aortic stenosis,” the researchers wrote, adding that the results have important implications for the financial viability of US TAVR programs in the future.
Disclosure: The researchers report financial disclosures with Apica, Bard Medical, Cryolife, Direct Flow Medical, Edwards Lifesciences, InterValve, Maquet, Medtronic, Sorin and St. Jude Medical.
Perspective
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E. Murat Tuzcu, MD
TAVR has come a long way over the last decade or so. Increasing experience and rapid technical developments have made the procedure safer and quicker to perform. Babaliaros and colleagues demonstrate in this study that in a great majority of patients, transfemoral TAVR can be performed in the cath lab with conscious sedation and local anesthesia without transesophageal echocardiogram and then these patients can be cared for on regular cardiology floors rather than the intensive care unit. More and more centers outside of the United States are adopting this approach, which reduces cost substantially. It appears very feasible in the properly selective patients with careful pre-procedure planning. However, the data published are only from 72 patients, thus we need studies that include a larger number of patients to be confident that this approach can be widely applied, particularly in centers that do not have the extensive experience that the Emory group has.
Another point is that performing a procedure in an environment that is not capable of responding to a true emergency with all surgical means, including immediate availability of the cardiopulmonary bypass and the respiratory support, may result in mortality if a patient faces a catastrophic complication such as aortic dissection or annulus rupture. Having said that, I think a substantial number of TAVR procedures can be performed without general anesthesia or transesophageal echocardiogram either in the cath lab or in the hybrid suite, provided that there is capability to handle all complications effectively and emergently.
E. Murat Tuzcu, MD
Cardiology Today’s Intervention Editorial Board member
Disclosures: Tuzcu reports no relevant financial disclosures.
Perspective
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Stephen A. Olenchock, DO, FACC, FACS
The main take away from this paper is that a highly functioning heart valve center with extensive experience treating high-risk aortic stenosis patients can select some appropriate patients who may not need the typical hybrid OR strategy that we’ve employed with open heart procedures. These patients may be able to move along faster with a minimalist, cath lab-based strategy, and there may be cost savings associated with that approach. This savings likely stems from not needing to use a Swan-Ganz catheter and being able to treat patients on more of a fast-track basis with a transfemoral vs. open heart approach. However, these data are observational and from a nonrandomized, retrospective study, so the data should not be seen as conclusive but rather provide impetus for additional randomized studies to more conclusively address these questions.
Within the high-risk TAVR patients, you may be able to find predictors of people who can tolerate not needing extensive monitoring during the procedure. I agree with the researchers in that morbidly obese patients, and those with comorbidities, such as severe lung disease and complex vascular access, as well as those who are mentally challenged and in chronic pain may be best served by the hybrid OR strategy.
In today’s health care environment, where cost plays an increasingly important role, I do believe that the hybrid OR serves an important function. When performing a valve implantation, for example, it needs to be done in a sterile environment and one that is consistent with an operating room, like the hybrid OR. Also, the hybrid OR has an incredible amount of value for a network, because it’s not just transcatheter valves being performed there, but also vascular procedures, neurointerventions, and other surgical and CV interventions. One of the things a hybrid OR does is facilitate cross pollination between specialties, where people bring less invasive procedures, and transcatheter valves are one of those procedures.
Stephen A. Olenchock, DO, FACC, FACS
Chief, Cardiovascular Surgery
St. Luke’s University Health Network, Bethlehem, PA
Clinical Assistant Professor of Surgery
Temple University School of Medicine, Philadelphia
Disclosures: Olenchock reports no relevant financial disclosures.
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