TAVR is not PCI, say experts. While complications needing bailout are rare with TAVR, when they occur they tend to be deadly.
The need for emergent cardiac surgery resulting from complications during transcatheter aortic valve replacement is a “rare event” but “highly consequential” when it is required, according to a large analysis of patients treated at European centers.
Emergent surgery for complications such as left ventricle guidewire perforation, annular rupture, valve embolization/migration, and aortic dissection was required in just 0.76% of TAVR-treated patients. Of these, more than one-third died within 72 hours and 46% died in-hospital.
“Although half of the patients with such complications proceeding to [emergent cardiac surgery] were salvaged acutely, mid-term outcomes were bleak,” Holger Eggebrecht, MD (Cardiovascular Center Bethanien, Frankfurt, Germany), and colleagues report in their study published online recently in the European Heart Journal. Prevention of complications needing emergent surgery remains the most important strategy for improving clinical outcomes of TAVR patients, they add.
Speaking with TCTMD, Tamim Nazif, MD (Columbia University Medical Center, New York, NY), said the study is a reminder that while TAVR is a less invasive procedure than surgery and is increasingly performed via a minimalist approach to expedite recovery and discharge, it does carry risk. “People tend to lose sight of that with the evolution in the field, but this is a sobering reminder that it’s a major cardiac procedure that comes with some degree of risk,” he commented.
That said, Nazif also found the results reassuring, particularly since they are in line with what has been observed in randomized clinical trials, such as PARTNER 2Aand the SAPIEN 3 registry. “It’s comforting that the real-world experience seems to be mimicking the trial experience,” he said.
Rodrigo Bagur, MD, PhD (Western University, London, Canada), who also was not involved in the study, pointed out that while the overall rate of emergency cardiac surgery is “quite low,” an additional 60 patients were considered for emergency surgery but did not undergo any procedure. The outcome of these patients is unknown, but “likely may have been fatal,” said Bagur.
“The bottom line is that even though TAVI teams and operators became more and more proficient in different aspects of the procedure, there are still procedural-related complications that can occur and perhaps might not be absolutely predictable and/or avoidable,” he said.
Large Registry of European Centers
The new analysis from the European Registry on Emergent Cardiac Surgery During TAVI (EuRECS-TAVI) is based on 27,760 patients undergoing transfemoral interventions at 79 centers between 2013 and 2016. The mean age of TAVR patients was 82.4 years, and the mean logistic EuroSCORE was 17.1% (mean STS risk score was 5.8%). Less than one-quarter of patients were considered to be at high risk for surgery.
In total, 212 patients required emergency surgery for complications, the most frequent being left ventricular guidewire perforation (28.3%) and annular rupture (21.2%). More than 90% of the complications manifested acutely during the TAVR procedure, report investigators. Cardiac surgery was performed most frequently on the TAVR table in a hybrid catheterization lab (61.1%), while the remainder were transferred to the operating room.
Overall, 24.2% of those requiring emergency surgery died the day of the operation and 34.6% died within 72 hours. The in-hospital and 1-year mortality rate was 46.0% and 78.2%, respectively. In-hospital mortality was highest for patients needing surgery for annular rupture (62.2%), coronary obstruction (54.5%), aortic dissection (52.0%), and left ventricle guidewire perforation (50.8%).
Bagur pointed out that the rate of emergency surgery declined over time, which might be related to more systematic use of preprocedural CT planning. This allows physicians to select an appropriate valve type and choose how aggressive to be with pre- and postdilatation. He said the rate of left ventricle perforations seems high and deserves attention to reduce the risk, such as being more careful in shaping the wire or using preshaped guidewires.
The EuRECS data showed no significant difference between low- and high-volume hospitals with respect to the incidence of emergency surgery during TAVR and in-hospital mortality following the operation. Nazif said he was surprised by those findings, noting that a previous analysis of the Society of Thoracic Surgeons/American College of Cardiology TVT Registry did show that higher-volume centers had better clinical outcomes than low-volume institutions, including lower in-hospital mortality.
Is Surgical Backup Necessary? Yes, Say Experts
In an editorial, Craig Smith, MD (Columbia University Medical Center), writes that these latest results raise the question of whether TAVR should be restricted to centers that have on-site cardiac surgery. For Smith, a cardiac surgeon, it is “grossly obvious” that only centers with surgical backup perform TAVR, but he acknowledges that restricting the procedure to such centers is subject to intense debate.
“Opponents of restriction rely on two primary arguments—access and an analogy to PCI. The problem with ‘access’ is that it can have many different meanings,” writes Smith. “It becomes synonymous with ‘convenience’ when argued to be a patient’s ‘right’ to a TAVI program in every local hospital. The results from EuRECS suggest that patients under that scenario would be acquiring, along with convenience, access to unjustifiable risk.”
In the United States, the Centers for Medicare & Medicaid Services (CMS) has placed conditions on reimbursement, stating TAVR should take place in a facility using a heart team approach, which includes interventionalists and surgeons experienced in both procedures. CMS also requires that TAVR be performed at a hospital with on-site surgical backup. In Europe, there are centers where TAVR is performed without the surgical safety net.
For Nazif, the EuRECS analysis reinforces the need for a surgical presence at TAVR centers, particularly as physicians move into treating intermediate- and low-risk patients where a preventable mortality risk is not acceptable.
To TCTMD, Bagur pointed out that TAVR requires a team approach. Even if transfemoral TAVR is performed by interventional cardiologists, “it is important to rely on the rapid availability of our cardiac surgeons that were part of the clinical decision-making process.” He noted that performing TAVR in centers without surgical backup seems quite courageous but may result in some centers, including low-volume centers and/or those with insufficient training, “being unable to properly handle critical complications, such as saving 40% to 50% of lives as shown in the paper.”
In his editorial, Smith stresses that TAVR is not PCI, a procedure that has been shown to be acceptably safe in centers without surgical backup. Although the frequency of emergent surgery during PCI is in the range of 0.2% to 0.6%, complications are less lethal than in TAVR, where structural heart device complications are so challenging, writes Smith.
Nazif agreed. “These are very severe complications that carry very severe mortality rates,” he said. “We need to take TAVI seriously—it’s not the same as PCI. It should be done at experienced centers with surgical backup.”
- Eggebrecht H, Vaquerizo B, Moris C, et al. Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI). Eur Heart J. 2017;Epub ahead of print.
- Smith CR. Emergent cardiac surgery following TAVI: implications for the future. Eur Heart J. 2018;Epub ahead of print.
- Eggebrecht, Smith, Nazif, and Bagur report having no relevant conflicts of interest.