Reference: Généreux, et al, for the PARTNER Trial Investigators. JACC 2012; 60 (12):1043-62 Original title: Vascular complications after Transcatheter Aortic Valve Replacement: Insights From the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial
The purpose of the study was to investigate the incidence, predictors and vascular complications impact after catheter aortic valve implantation (TAVI) in the PARTNER trial context (Placement of Aortic Transcatheter Valve). This trial’s secondary purpose was defined according to VARC (Valvular Academic Research Consortium)
Increased vascular complication was considered as the presence of any of the following:
Dissection of the aorta;
Injury to the vascular access site, (dissection, stenosis, perforation, rupture, arteriovenous fistula, pseudoaneurysm, hematoma, irreversible nerve injury or compartment syndrome), leading to death or unplanned intervention, (percutaneous or surgical), or irreversible damage of a terminal organ or the requirement of a significant transfusion (> 4U);
Distal embolization, (no brain), from a source requiring vascular surgery or amputation or irreversible organ damage;
Left ventricular perforation.
The following were considered as minor vascular complications:
Injury to the vascular access site that does not lead to death, amputation or irreversible organ damage without intervention and may require a transfusion of up to 2 units.
Distal embolization treated with Embolectomy and / or Thrombectomy without amputation or irreversible organ damage;
Failure of percutaneous closure of the vascular access site requiring intervention (endovascular stent) or surgical correction not associated with death or significant transfusion requirement, (> 4U), or irreversible organ damage.
Results: From the 699 patients who participated in the PARTNER A and 358 from the PARTNER B trials, 419 were included for this analysis treated by a Transfemoral approach. Of these, 64 (15.3%) had major vascular complications and 50 (11.9%) minor vascular complications within 30 days of the procedure. Complications related to the female sex, a lower body surface, presence of diabetes mellitus insulin dependent, introduced a greater diameter relation / external iliac diameter. Furthermore, vascular complications associated with other intercurrences, such as embolization or prosthesis migration using circulatory support and conversion to open surgery. Procedure times and length of stay (6.9 days vs. +2.5. 5.8 +2.3 days, p = 0.006) were longer in the group with vascular complications. Using surgical dissection in the access was more frequent in the group with vascular complications, (85.7% vs. 75.2%, p = 0.07), while percutaneous closure devices were used more frequently in the group without complications, (15.9% vs. 26.5%, p = 0.1).
Both mortality from any cause as well as death from cardiovascular causes, (12.6% vs. 2.8%, p = 0.0003), at 30 days were higher in patients with major vascular complications. This difference remained significant after one year for death from any cause, (39.4% vs. 22.8%, p = 0.001), and death from cardiovascular causes, (27.4% vs. 8.7%, p <0.0001), for groups with increased vascular complications and those without complications respectively. The study concluded that vascular complications were common in the PARTNER trial and mortality increased four times in four days. Predisposing factors are consistent with other reported studies and are consistent with other experiences which require large introducer sets. Although the rate of percutaneous suture use was low, (24.9%), it was associated with better outcomes.
Opinion: The findings of this sub-analysis once again show the importance of access site complications in interventional cardiovascular catheterization. The predisposing factors found are very logical and were expected, smaller vessels and those who are sicker have more complications, in that way women, especially those with very small body surface, represent a challenge for any surgeon. A lower incidence of complications with the use of a percutaneous suture is a fact that deserves to be taken with some caution, since it is well known that learning curve with such devices is independent upon the learning curve of TAVI. Furthermore, this data does not match the 1000 Iberoamerican patients’ record where those exposed to percutaneous access had more complications (Moris Cesar et al. EuroPCR 2012).
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