Transfemoral TAVR with the low-profile Sapien 3 device results in low death and stroke rates at 30 days in patients at intermediate-to-high surgical risk, according to a study published in the December 2, 2014, issue of the Journal of the American College of Cardiology.

Results were previously presented at EuroPCR 2014 in Paris, France.

John Webb, MD, of St. Paul’s Hospital (Vancouver, Canada), and colleagues treated 150 patients (mean age 84 years; 54% female) who had symptomatic, severe aortic stenosis with the Sapien 3 transcatheter heart valve (Edwards Lifesciences) using transfemoral (n = 96) or alternative access (transaortic/transapical; n = 54) at 16 European and Canadian sites. The first 50 patients were at high surgical risk (STS score ≥ 8 or EuroSCORE ≥ 15), while the following 100 patients were at intermediate-to-high risk (STS score ≥ 4 or EuroSCORE ≥ 10). 

Patients who underwent TAVR via transaortic/transapical access had higher mean logistic EuroSCORE (P = .0215) at baseline. The group also had greater prevalence of moderate-to-severe mitral regurgitation (P = .0018), peripheral vascular disease (P = .0032), and MI (P = .0142) as well as trends toward more CAD, A-fib, and CABG compared with the transfemoral group.

Early Results Promising 

At 30 days, the rates of all-cause mortality (primary endpoint), stroke, and complications were low overall (table 1). Patients treated using alternative access were more likely to die than those receiving transfemoral access (P = .03).

No occurrences of disabling stroke, coronary obstruction, device embolization, or rehospitalization were reported.

TEE showed an overall reduction in mean gradient (45.2 ± 14.5 to 10.6 ± 4.7 mm Hg) and an increase in valve area (0.6 ± 0.2 to 1.5 ± 0.4 cm²) at 30 days. Paravalvular regurgitation was absent or trace in 74.3% of patients, mild in 22.1%, and moderate in 3.5%, with no cases of severe leak at follow-up. 

Quality of life improvements were documented by both visual analogue and 6-minute walking tests. Also, only 6.6% of patients remained NYHA functional class ≥ 3 at 30 days compared with 88.1% at baseline.

‘New Standard’ for TAVR Devices 

The mortality rate of those who received transfemoral TAVR is “among the lowest ever reported in a large multicenter series,” according to the study authors. Furthermore, they say the overall stroke rate “compares favorably” with that of the PARTNER II trial (4.3%).

In an editorial accompanying the study, Howard C. Herrmann, MD, of the University of Pennsylvania (Philadelphia, PA), states that transfemoral access should be the default strategy in most patients implanted with smaller devices, given the increasing use of femoral closure devices, monitored anesthesia, and the learning curve with alternative access. 

Sapien 3, Dr. Herrmann says, “has set a new standard for the worst complications of TAVR, creating hunger for this and other new prostheses.”

Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview that Sapien 3 “is unique” in that it has a low-profile and allows for quick, “stable deployment without the need for… repositioning.” Multiple attempts to reposition, he continued, can cause stroke. 

Other new-generation devices, such as the Lotus (Boston Scientific) and Direct Flow valves (Direct Flow Medical), have been associated with similar reductions in aortic regurgitation, Josep Rodés-Cabau, MD, of the Quebec Heart and Lung Institute (Quebec City, Canada), told TCTMD in an email.

Higher Pacemaker Rate Remains Drawback 

The need for pacemaker implantation seems to be the only complication that occurs more often with Sapien 3 than with the prior-generation Sapien XT (Edwards Lifesciences), Dr. Rodés-Cabau said. Both he and Dr. Généreux suggested that the difference could be due to early experience with the Sapien 3.

The new valve is longer and can “move up a bit,” Dr. Généreux said. “In the beginning, maybe the operators were implanting the valve a bit too low, and in the second half of the study, the recommendation was to place the valve a little bit higher, to aim for about 70% aorta and 30% ventricular.” This shift in technique, he continued, could decrease the pacemaker rate. 

TAVR in Low-Risk Patients?

Even with new-generation devices, “[r]esidual paravalvular leaks remain one of the major drawbacks of TAVR technology,” explained Dr. Rodés-Cabau. “The Sapien 3 system is associated with a major improvement in the rate of paravalvular leaks, and this is of major importance in order to expand the technology towards the treatment of lower risk patients.” 

Dr. Généreux said that “from a mechanical point of view, if you can decrease the profile even more, and we can help decrease manipulation of the valve even more, this device is pretty close to [being able to be] used in lower-risk patients.” Meanwhile, he added, “we are ready to be working on the minutia, the fine-tuning of the technique.”

Yet Dr. Rodés-Cabau emphasized that randomized trials are needed before extending use of Sapien 3 to lower-risk patients.
  

1. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-2243.

2. Herrmann HC. New transcatheter aortic valve prosthesis sets a new standard [editorial]. J Am Coll Cardiol. 2014;64:2244-2245.

Disclosures:

• Dr. Webb reports receiving consulting fees from Edwards Lifesciences.
• Dr. Herrmann reports receiving grant support from Boston Scientific, Edwards Lifesciences, Medtronic, and St. Jude Medical and honoraria from Edwards Lifesciences and Siemens; and owning equity in Microinterventional Devices.
• Dr. Généreux reports receiving speaker fees from Abbott and Edwards Lifesciences.
• Dr. Rodés-Cabau reports receiving research grant support from Edwards Lifesciences.

Related Stories:

• New Iteration of Sapien Device Associated with Low Rates of Early Mortality, Stroke
• Sapien 3 Ups Need for Pacemaker Compared With Its Predecessor, But Reduces Moderate-Severe Paravalvular Leak
• New Devices May Help Overcome the Issue of Paravalvular Regurgitation After TAVR