PARTNER Analysis: Vascular Complications Common in Transfemoral TAVR

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More than 1 in every 7 patients undergoing transcatheter aortic valve replacement (TAVR) in the PARTNER trial (cohorts A and B) experienced a major vascular complication, confirming the high frequency of such adverse events with the procedure. Results of the study appeared online August 8, 2012, ahead of print in the Journal of the American College of Cardiology.

Researchers led by Martin B. Leon, MD, of Columbia University Medical Center (New York, NY), sought to characterize the incidence and impact of vascular complications by looking at  419 transfemoral TAVR patients from cohort A (operable, high risk; n = 242) and cohort B (inoperable; n = 177) of the PARTNER (Placement of AoRTic traNscathetER valve) trial. The rate of major vascular complications at 30 days was 15.3% (n = 64), mostly consisting of dissection (62.8%), perforation (31.3%) and access site hematoma (22.9%), while minor vascular complications such as access site injury or distal embolization occurred in 50 patients (11.9%).

At 30 days, major vascular complications were associated with increased major bleeding (60.9% vs. 6.8%; P < 0.001), transfusions (40.7% vs. 5.4%; P < 0.001), and renal failure (8.1% vs. 1.7%; P = 0.003). At 1 year, death and cardiovascular death remained increased in patients with major vascular complications (table 1).

Table 1. One-Year Event Rates According to Occurrence of Major Vascular Complications

On multivariable analysis, major vascular complications were an independent predictor of 1-year mortality (HR 2.31; 95% CI 1.20-4.43; P = 0.012) as was renal disease at baseline. Female sex was the strongest independent predictor of major vascular complications within 30 days (HR 2.31; 95% CI 1.08-4.98; P = 0.03).

Minor vascular complications were not associated with poorer outcomes at 1 year with the exception of repeat hospitalizations (31.8% vs. 16.3%; P = 0.004). Interestingly, cohort A patients showed lower overall rates of major and minor vascular complications compared with cohort B patients (23.2% vs. 32.8%; P = 0.03) as well as fewer access-site hematomas (5.1% vs. 12.6%; P = 0.005), with a trend for fewer vascular dissections (10.7% vs. 17.1%; P = 0.07). In addition, the impact of major vascular complications on mortality decreased from cohort B (HR 2.16; 95% CI 1.19-3.93; P = 0.009) to cohort A (HR 1.79; 95% CI 0.90-3.56; P = 0.095).

Patients with major vascular complications were more frequently female, had a lower body surface area, more frequently had insulin-treated diabetes, had smaller vessel diameter, and had higher sheath-to-femoral artery ratio and sheath-to-external iliac artery ratio. Major complications were also associated with higher rates of embolization or migration of the prosthesis, use of hemodynamic support devices, and conversion to open heart surgery.

Patients with major vascular complications also had longer index procedures with more contrast use and longer fluoroscopy times.

“Major [vascular complications] were frequent after [transfemoral]-TAVR in the PARTNER trial using first-generation devices and were associated with a high 1-year mortality,” the authors conclude. “However, the incidence and the impact of major [vascular complications] decreased with lower-risk populations.”

Female Finding Unexpected

According to Dr. Leon, the 15% rate of major vascular complications was anticipated based on previous analyses of cohorts A and B. However, “a new observation was that female gender independent of anything else was a very strong predictor of major vascular complications,” he told TCTMD in an interview.

While smaller vessels in females may contribute to that finding, “when we did risk adjustment to account for smaller vasculature, female gender still came up as an independent predictor,” Dr. Leon said. “So, yes, there may be an element of large sheaths and small vessels, but there’s also probably something associated with the pathophysiology or pathobiology of female vasculature making them more prone to vascular complications.”

According to Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), the study demonstrates the importance of having an experienced heart team ready to deal with vascular complications. “We’re not talking about small hematomas,” he said in a telephone interview with TCTMD. “These procedures have to be done in centers with a high level of experience, because sometimes it’s a vicious cycle. You start with a complication, then severe hemorrhage, then transfusion, then renal failure.”

Study Represents ‘Earliest Experience’

Dr. Rodés-Cabau expressed hope that with smaller sheath introducers and increased experience dealing with vascular complications, “we will be able to reduce their impact.”

Dr. Leon agreed, noting that the situation with vascular complications and TAVR may be different now than when the current analysis was performed. “We’re dealing with the earliest experience, so there are learning-curve issues. We’re dealing with limited alternatives to transfemoral because only a portion of these patients had access to transapical; we’re dealing with a large first-generation device that . . . is certainly not the device that’s available in other parts of the world,” he said. “We expect there would be a change in vascular complications as the device profile [becomes smaller], so we’re dealing with a lot of changing scenarios. Also, 75% of these patients were done with surgical cut down and closure, whereas now the standard for most of these procedures is a fully percutaneous technique.”

Dr. Leon added that with modern techniques, devices, and training, “our hope and expectation is that in the real world the major vascular complication rate can be reduced to 5% or less, but that needs to be borne out in subsequent studies.”

Dr. Rodés-Cabau agreed that vascular complications are probably decreasing, but they are not going away. “You can reduce them with careful evaluation using other approaches in borderline cases, but you will have complications and you have to be ready to deal with them because in many cases they will be life threatening,” he said.

“They are going to happen,” Dr. Leon concurred. “It points out the necessity of an experienced, multidisciplinary team.” In addition, for clinicians early in the learning curve for TAVR procedures, “[they should] take away a healthy respect for the importance of vascular complications, the necessity for meticulous preprocedure screening, and an awareness that they should avoid high-risk patients in their early experience until they gain a comfort level with using these catheters and in treating these kinds of patients,” he added.

Note: Dr. Leon and other coauthors of the study are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

Source:

Généreux P, Webb JG, Svensson LG, et al. Vascular complications after transcatheter aortic valve replacement. Insights from the PARTNER (Placement fo AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012.Epub ahead of print.

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