Early TAVR Results Match PARTNER Outcomes, But With Fewer Complications

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In-hospital mortality and stroke rates were similar for patients who received the first available device for transcatheter aortic valve replacement (TAVR) whether they were treated as part of the pivotal trial that led to approval or after the device became commercially available, although commercial use was marked by fewer vascular and bleeding complications and shorter length of hospital stay. Results from a single-center study were published online November 11, 2013, ahead of print in the American Journal of Cardiology.

Researchers led by Ron Waksman, MD, of MedStar Washington Hospital Center (Washington, DC), retrospectively compared 69 consecutive patients who underwent TAVR with a commercial Sapien (Edwards Lifesciences, Irvine, CA) valve with 55 TAVR patients treated at the same institution by the same heart team who received the device as part of cohort B of the Placement of AoRTic traNscathetER valves (PARTNER) trial.

All patients had severe, symptomatic aortic stenosis and were considered inoperable. TAVR was performed via the femoral route in all patients. Patients had a mean gradient of 48 mm Hg, mean aortic valve area of 0.66 cm2, and a mean LVEF of 53%. The Partner B cohort had a higher mean STS score (10 vs. 9; P = 0.04) and a lower rate of PAD (19% vs. 44%; P = 0.004). The commercial group included 6% of dialysis-dependent patients, who were excluded from PARTNER.

Compared with patients in the commercial group, PARTNER cohort B patients had similar rates of successful device delivery, but a higher incidence of planned surgical cut down and lower rates of conscious sedation and closure device use.

PARTNER B patients also required less contrast volume (table 1).

Table 1. Procedural Characteristics

 

Variable

Commercial Valve
(n = 69)

PARTNER B
(n = 55)

PValue

Successful Valve Deployment

97%

100%

1.0

Conscious Sedation

83%

66%

0.03

Planned Surgical Cut Down for Access

1.4%

46%

< 0.001

Closure Device

99%

54%

< 0.001

Contrast Volume, mL

110

72

< 0.001


A similar percentage of patients from the commercial group and Cohort B were converted to general anesthesia (16% vs. 25%; P = 0.32) .

Median procedure time was similar between the commercial (80 min) and PARTNER groups (94 min, P = 0.82), as was median fluoroscopic time (19 min in both arms; P = 0.51).

There were no intraprocedural deaths in either group. In addition, in-hospital mortality was similar between the commercial and PARTNER B groups, while rates of major vascular complications and life-threatening or major bleeding were lower in the commercial group, as was the rate of blood transfusion and the median length of hospitalization (table 2).

Table 2. In-hospital Outcomes

 

Variable

Commercial Valve
(n = 69)

PARTNER B
(n = 55)

PValue

Mortality

5.8%

9.1%

0.51

Stroke

7.2%

14.5%

0.19

Major Vascular Complications

7.2%

27%

0.003

Stage 3 Acute Kidney Injury

0

5.9%

0.09

Life-threatening or Major Bleeding

2.9%

16%

0.01

Transfusion

28%

60%

< 0.001

Hospital Length of Stay, days

6

10

0.0002


A key take-away from the lower rates of vascular complications and bleeding in the commercial group, Dr. Waksman and colleagues note, is that they “signify the impact of changes that occurred in terms of operator experience, procedural changes, and patient selection.” Still, in-hospital mortality and stroke rates were high, “which implies the need for future developments and technological advances to further decrease the immediate procedural morbidity and mortality rates for inoperable patients with severe aortic stenosis undergoing TAVR,” they caution.

One of the major refinements to the TAVR procedure, the authors add, is the shift from planned surgical vascular access to a true percutaneous procedure. “The present study demonstrates clear evidence for this dramatic shift in approach to vascular access,” they confirm.

Study Details

The commercial group enrolled patients from April 2012 to February 2013, while the PARTNER B group received treatment from January 2008 to August 2011.

 

 


Source

:
Pendyala LK, Minha S, Barbash IM, et al. Commercial versus PARTNER study experience with the transfemoral Edwards Sapien valve for inoperable patients with severe aortic stenosis. Am J Cardiol. 2013; Epub ahead of print.

 

Disclosure:

  • Dr. Waksman reports no relevant conflicts of interest.

 

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