Use of the Perclose ProGlide suture-mediated closure strategy to achieve vascular access-site hemostasis after transfemoral TAVR results in fewer major vascular complications than does deployment of the Prostar XL percutaneous surgical closure system, according to an observational study published online August 27, 2015, ahead of print in the European Heart Journal.

For the CONTROL trial, investigators led by Israel M. Barbash, MD, of Sheba Medical Center (Ramat Gan, Israel), analyzed data from 3,138 patients (mean age approximately 81 years) who underwent transfemoral TAVR at 9 international high-volume centers between March 2007 and December 2014 and received either a Prostar XL (n = 1,556) or a Perclose ProGlide (n = 1,582) closure device (both Abbott Vascular). The choice and number of devices used was at the operator’s discretion.

Patients were propensity-score matched to compare devices, creating 472 pairs of patients. Baseline characteristics and the minimal lumen diameter, tortuosity, and degree of calcification were similar between the paired groups. The median sheath size was 18 F in both arms, and an expandable sheath was used in approximately half of each. Both the nonexpanded and the expanded sheath-to-femoral-artery ratios (SFARs) were comparable between groups. Moreover, the proportion of balloon-expandable (mostly Sapien XT; Edwards Lifesciences) and self-expanding (mostly CoreValve; Medtronic) valves implanted were also similar between closure devices.

Fewer Vascular Complications Does Not Translate Into Lower Mortality

The incidence of major vascular complications or in-hospital mortality (primary endpoint) was higher in the Prostar XL group than the ProGlide group, driven by an almost 4-fold increase in major vascular complications. Prostar XL also fared worse in terms of major bleeding, acute kidney injury, and mean length of hospital stay. There were no differences between the devices for MI, stroke, or in-hospital mortality (table 1).

The ProGlide advantage for major vascular complications was maintained across multiple subgroups. While femoral hematomas were more common in the Prostar XL group than the ProGlide group (9.5% vs 1.9%; P = .002), femoral stenosis was more frequent in ProGlide patients (3.4% vs 0.6%; P = .004). However, rates of femoral artery balloon angioplasty were higher in the Prostar XL arm than the ProGlide arm (4.2% vs 1.5%; P = .015), and urgent vascular surgery tended to be more common in the Prostar XL group (2.8% vs 1.1%; P = .077).

Patient sex and Prostar use were independent predictors of both vascular complications and bleeding. Age and nonexpanded SFAR were associated with vascular complications, whereas body mass index, vessel minimal diameter, expanded SFAR, and substantial tortuosity were linked with bleeding.

Analysis of the overall cohort showed a significant decrease in major vascular complications after a center had performed its first 20 cases using ProGlide, indicating the existence of a learning curve for that device. Comparable outcomes before and after the first 20 cases with Prostar XL suggested that it did not entail a learning curve.

Overall, “the ProGlide group demonstrated [a] superior safety profile,” the authors say.

Two previous small, head-to-head comparisons of these devices showed similar results, Dr. Barbash and colleagues note. The current analysis “expands these initial findings and suggests that even with the use of expandable sheaths and smaller delivery systems, there is an increased vascular complications risk with [the] Prostar XL–based vascular closure strategy,” they add.

Differences in Design Key

The enhanced efficacy of the ProGlide compared with the Prostar system may be attributed to “inherent differences in the design and characteristics of the 2 closure devices,” they say. Specifically, the Prostar XL features 4 needles (on each end of 2 sutures), which are delivered simultaneously outward from within the arterial lumen, while the ProGlide delivers only 2 needles (on each end of 1 suture), so typically 2 ProGlide devices are deployed sequentially in a “crosshair approach.” Thus, suboptimal positioning of the Prostar XL device against the arterial wall may result in misdeployment of both sutures, as all needles (and sutures) are deployed at once. Conversely, with a ProGlide approach, each of the 2 sutures is deployed independently, thus reducing the risk of a 2-suture failure.

Furthermore, the investigators say, identification of suture failure or needle “misfiring” in ProGlide can be corrected by adding a third device.

“The higher rates of major vascular complications in the Prostar group contributed to [the] higher incidence of bleeding events and periprocedural acute kidney injury,” the authors observe. Moreover, increased bleeding—with its potential for transfusion and hypotensive episodes—and interventions to treat vascular complications—which require additional contrast dye—raise the likelihood of kidney injury.

Although prior studies have shown a strong correlation between major vascular complications, bleeding, and mortality, no mortality difference between the 2 device groups was seen in the current analysis, Dr. Barbash and colleagues comment. However, the study was underpowered to assess this endpoint, they add.

The authors acknowledge that due to the retrospective nature of the study, certain factors that might have influenced the findings were unavailable, including the number of devices used or supplemental use of Angio-Seal (St. Jude Medical).

Source:

Barbash IM, Barbanti M, Webb J, et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J. 2015;Epub ahead of print.

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