Patrice Wendling

May 31, 2016

PARIS, FRANCE — Rates of major complications and in-hospital mortality are similar when patients undergo transcatheter aortic-valve replacement (TAVR) at hospitals with or without on-site cardiac surgical backup, according to German quality-assurance registry data[1].

Despite concerns that the TAVR indication would be applied too liberally, patients treated at hospitals without cardiac surgery (CS) departments were older, had more comorbidities, and were at higher operative risk. TAVR procedures also declined 19% over the study period at non-CS hospitals, while increasing 41% at hospitals with on-site CS departments.

"Close cooperation in the heart team is the key for a successful TAVI program," but lack of a CS department on site "should not be regarded as a contraindication for TAVI," study author Dr Holger Eggebrecht (Cardiovascular Center Bethanien, Frankfurt, Germany) said during a hot-line session at EuroPCR 2016. The research was also published online in the European Heart Journal.

He observed that the absence of an on-site CS department and heart team is an absolute contraindication in the 2012 European Society of Cardiology (ESC) guidelines and has sparked discussions across Germany as TAVR has become increasingly safe and more mainstream. In 2014, the German Cardiac Society updated its position paper on transfemoral TAVR in support of TAVR at hospitals without on-site CS if they had a contractual agreement with an external CS department and joint interdisciplinary decision making for patient selection. Germany's ruling authority, the federal joint committee, however, went with the 2012 ESC guidelines and gave non-CS hospitals that already perform TAVI a 1-year transition period to establish on-site CS.

The present analysis looked at the complete 2013 and 2014 data sets (17919 patients) in the German Quality Assurance Registry on Aortic Valve Replacement (AQUA), including 1332 patients treated at 22 hospitals without a CS department and 16,587 patients treated at 75 hospitals with on-site CS. All hospitals had heart teams, and non-CS hospitals had internal cardiologists and access to an external CS team.

Procedures took longer in hospitals without cardiac surgical backup than those with CS (110.3 vs 79.3 min; P<0.001), perhaps because surgeons were not as experienced, but fluoroscopy times were nearly identical (18.9 and 19.9 min; P=0.273), "which shows that maybe the procedure itself was similar in both institutions," Eggebrecht said.

Rates of major intraprocedural complications were very low and similar at hospitals with and without CS departments, with the exception of aortic regurgitation grade 2 or higher, which occurred more often at non-CS hospitals (2.1% vs 1%; P<0.001).

The rate of in-hospital death was 3.8% for patients undergoing TAVR at hospitals without CS and 4.2% for those at hospitals with CS (P=0.396).

The investigators also looked at in-hospital deaths for the composite of intraprocedural complications likely to benefit from bailout surgery (device malposition, embolization, annular rupture, aortic dissection, coronary obstruction, and pericardial tamponade) and again found no between-group difference (37.0% vs 33.7%; P=0.771).

A matched-pair analysis performed in 550 patient-pairs also confirmed that non-CS and CS hospitals had similar rates of intraprocedural complications (9.2% vs 10.3%; P=0.543; odds ratio [OR] 0.884) and in-hospital death (1.8% vs 2.9%; P=0.234; OR 0.618).

Panelist Dr Kentaro Hayashida (Keio University, Tokyo, Japan) told heartwire from Medscape that the data were striking but, "Personally, I like having a surgical department for the safety of the patient, even though the incidence of hard events is really low. If the mortality rate were to decrease to the level of PCI, maybe we can do it, but the mortality rate is still 2% or so."

During a discussion of the data, several panel members struggled with the benefit of performing TAVR when the cardiac surgeon or rescue equipment may be 10 km away, describing this as a "logistic nightmare."

Eggebrecht said that internal cardiologists at his center are supported by visiting cardiac surgeons who are at the table and that a heart–lung machine is set up should a severe complication arise, although he reiterated that the rate of such complications was very low. "Our data clearly show that you can construct a successful heart team even though you don't have a cardiac-surgery department."

Still, the panel expressed doubt that the results can be considered equal to those reported for TAVR from studies performed at hospitals with an on-site CS department given that this was a self-reported registry and it was argued, "in some instances outcomes are underreported."

Eggebrecht countered that participation in the AQUA registry is mandatory. "Underreporting would also be considered for institutions that have a cardiac-surgery department on site. Why would they be the honest ones and the other one not be the honest ones? That is too easy."

Dr Ariel Finkelstein (Tel-Aviv Medical Center, Israel) told the audience that Israel is going through the same process right now and that he was "amazed at the results" because centers without CS on site are likely to have started performing TAVR much later or be low-volume and may still be early in the learning curve. "And still this is definitely not inferior. How do you explain this?"

Eggebrecht said that not all centers without on-site CS departments started TAVR late, but added, "I have some doubts that we can extrapolate these data and say it is safe also for low-volume beginner centers. I would be cautious about this."

The study was supported in part by a grant from the German Cardiac Society. Eggebrecht reports no relevant financial relationships.

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