• Standalone Cath Lab Does the Trick for TAVR

    Registry data show no advantage for on-site cardiac surgery or hybrid OR

    What the ideal transcatheter aortic valve replacement (TAVR) center should look like remains unclear in the wake of two registry studies: one showing no increase in mortality at cath labs lacking official on-site cardiac surgical backup, another finding hybrid operating rooms (ORs) did not prevent deaths and had higher complication rates.

    Centers in the Austrian Transcatheter Aortic Valve Implantation (TAVI) registry included six hospitals with on-site surgery and three working with cardiac surgeons from other institutions but no cardiac surgery departments of their own, according to the first of the studies in the Nov. 12 issue of JACC: Cardiovascular Interventions.

    Is a Proper Cardiac Surgery Department Necessary?

    Survival rates were similar between groups in the short- to mid-term after propensity score matching 290 patients in TAVR centers with and without on-site cardiac surgery departments, reported the group led by Florian Egger, MD, of the Wilhelminenhospital in Vienna, Austria, with results as follows:

    • Procedural period: 98.6% versus 96.9% (P=0.162)
    • 30 days: 93.8% versus 93.1% (P=0.719)
    • 1 year: 83.4% versus 80.9% (P=0.402)

    “However, prolonged hospital stay and PPM [permanent pacemaker] implantation were still significantly more frequent in hospitals without iOSCS [institutional on-site cardiac surgery],” Egger and co-authors said.

    Although current guidelines recommend TAVR at a hospital with on-site cardiac surgery, an immediate transfer to the operating theater is sometimes impossible because of organizational difficulties, the investigators noted. “Therefore, careful patient selection and close on-site cooperation of interventional cardiologists, cardiac and vascular surgeons, and anesthesiologists might be even more important than the theoretical availability of iOSCS dislocated from the TAVR-performing catheter laboratory.”

    “The biggest concern, however, is regarding patients having access to all therapeutic options,” said Michael Mack, MD, of Baylor Scott & White Health in Dallas, and Lars Svensson, MD, PhD, of Cleveland Clinic, writing in an accompanying editorial.

    “TAVR is more than just a procedure. It is part of a comprehensive treatment program that embraces team-based care by experienced clinicians with shared decision-making and access to all treatment options,” they wrote.

    The registry study included consecutive high-risk and inoperable patients with severe symptomatic aortic stenosis getting transfemoral TAVR (n=1,822), of whom 15.9% got the procedure done at hospitals without cardiac surgery departments.

    Propensity score weighing was performed to account for this group having higher perioperative risk and being older and more likely to have coronary artery disease.

    Even so, the study had the caveats of a limited sample size and voluntary nature of the registry. Moreover, sites did not report with standardized Valve Academic Research Consortium 2 definitions, according to Egger and colleagues.

    “The authors were unable to determine whether any of the nine procedural deaths could possibly have been avoided if on-site surgical rescue was available,” the editorialists commented.

    Mack and Svensson noted that the centers without on-site surgery saw more patients treated with general anesthesia and used more surgical access and transesophageal echocardiography, which may explain some of the higher complication rates for them.

    “The most important concern, however, is that it is difficult to understand what the rationale and justification is for these three additional centers without on-site surgery,” Mack and Svensson wrote. In addition, they noted that Austria is a country of 8.7 million people without long travel distances, making access to TAVR a moot issue. These centers averaged 16 TAVR procedures a year, the editorial pointed out.

    The proliferation of TAVR centers is of concern in the U.S., however, where the Centers for Medicare & Medicaid Services is revisiting the current volume requirements for the initiation and maintenance of these programs.

    Cath labs without institutional on-site surgery were equipped with all necessary infrastructural and personnel requirements to perform bailout cardiac surgery. “With all that equipment and personnel in place, it is hard to understand how this is not ‘on-site cardiac surgery,’” Mack and Svensson wrote.

    Hybrid OR Not Necessarily Better?

    In the second study, hybrid operating rooms (ORs) produced more complications after TAVR, French investigators reportedin the same issue of journal.

    Whereas TAVR complications were similarly rare between cath lab and hybrid ORs, the latter was associated with more major bleeding (6.3% versus 4.8%, P<0.05) and infections (6.1% versus 3.5%, P<0.05) after statistical adjustment, according to data from the FRANCE TAVI registry.

    “We may have expected infectious complications to be lower in the hybrid OR group given strict aseptic measures and specialized ventilation, but this was not the case,” wrote Thierry Lefèvre, MD, of Hopital Privé Jacques Cartier in Massy, and colleagues.

    “Patients in the hybrid OR group were more likely to require antibiotics after the procedure. This was because of pulmonary and urinary complications associated with endotracheal intubation and bladder catheterization, respectively, and to a lesser extent surgical exposure of access site,” the team continued.

    Despite the uptick in complications in the hybrid OR, mortality rates were similar at 1 year (16.2% cath lab versus 15.8% hybrid OR, P=0.91) and 3 years (38.4% versus 36.4%, P=0.49).

    “These findings support the performance of TAVR in either location, which has important implications on healthcare organization and costs,” the authors concluded.

    “In the France TAVI registry, both specialties were involved in the procedure in most cases, regardless of procedure location. This may have contributed to the low procedural complication rates and general success of TAVR in France,” they suggested.

    Unlike these French centers – likely already well experienced by 2013-2015, when the registry data was collected – Japan achieved its sub-2% 30-day mortality rate by relying on having a hybrid OR in every TAVR program, suggested Kentaro Hayashida, MD, PhD, of Keio University School of Medicine in Tokyo, writing in an editorial that accompanied the French study.

    “This fact suggests that a hybrid OR may have played an important role to decrease the mortality of patients who developed severe complications during TAVR in the early learning curve in Japan,” Hayashida wrote.

    In defense of the hybrid OR, the editorialist noted the advantages of an interdisciplinary team, better imaging equipment, increased hygiene level, and full availability of surgical equipment.

    The registry study included 48 French centers performing TAVR (n=12,121) — 62% of cases in a cath lab and the rest in a hybrid OR.

    Patients getting TAVR in the cath lab were older and at higher risk, and also tended to have more comorbidities except for peripheral vascular disease. In turn, cath labs were more likely to employ a more minimalist approach consisting of transfemoral access and local anesthesia, according to Lefèvre’s group.

    Among patients who had annular rupture, conversion to surgery was numerically more common in the hybrid OR (29% versus 13%, P=0.28). This did not translate into better survival rates, however.

    The analysis possibly suffered from unmeasured confounding, Hayashida said, noting the lack of information about percutaneous closure and surgical cutdown for the transfemoral approach.

    Another caveat is the potential site effect given that relatively few centers performed both hybrid OR and cath lab TAVR. This precluded any within-site comparisons, according to the investigators.



    Egger has received speaker honoraria from Medtronic.

    Mack reporting research funding from Edwards Lifesciences.

    Svensson declared no relevant relationships with industry.

    Lefèvre disclosed proctoring for and receiving lecture fees from Edwards Lifesciences and Abbott.

    Hayashida reported being a clinical proctor for Edwards Lifesciences.


    JACC: Cardiovascular Interventions


    Egger F, et al “Impact of on-site cardiac surgery on clinical outcomes after transfemoral transcatheter aortic valve replacement” JACC Cardiovasc Interv 2018; DOI: 10.1016/j.jcin.2018.07.015.


    JACC: Cardiovascular Interventions


    Spaziano M, et al “Transcatheter aortic valve replacement in the catheterization laboratory versus hybrid operating room: insights from the FRANCE TAVI registry” JACC Cardiovasc Interv 2018; DOI: 10.1016/j.jcin.2018.06.043.


    JACC: Cardiovascular Interventions


    Mack MJ, Svensson LG “Transcatheter aortic valve replacement without on-site cardiac surgery: a disappointing step backward!” JACC Cardiovasc Interv 2018; DOI: 10.1016/j.jcin.2018.09.013.


    JACC: Cardiovascular Interventions


    Hayashida K “Hybrid operating rooms for transcatheter aortic valve replacement: a must-have or nice to have?” JACC Cardiovasc Interv 2018; DOI: 10.1016/j.jcin.2018.07.037.


    Read the original article on Medpage Today: Standalone Cath Lab Does the Trick for TAVR

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