As TAVR Evolves, Local Anesthesia Could Be an Option for Lower-Risk Patients
At experienced centers, TAVR has comparable safety whether performed under conscious sedation or general anesthesia, according to registry study published online March 16, 2015, ahead of print in EuroIntervention.
“Nevertheless, as severe procedural complications are possible, an anesthesiologist should always be present as part of the team,” lead author Cristina Giannini, MD, PhD, of Azienda Ospedaliero-Universitaria Pisana (Pisa, Italy), and colleagues caution.
The researchers looked at 1,316 consecutive patients with severe aortic stenosis (mean age 81.6 years; 53.2% female) who underwent TAVR with the third-generation 18-Fr CoreValve device (Medtronic) at 7 high-volume Italian centers between June 2007 and December 2012. Most patients received the procedure under local anesthesia (73.0%), while the rest had general anesthesia (26.9%).
Baseline characteristics were similar between the groups, but those treated under general anesthesia had higher median logistic EuroSCORE (21% vs 19%; P = .004) and were more likely to have PAD (46.5% vs 23.3%; P < .001).
No Difference in Outcomes
Device success was high and similar in both arms with no difference in prosthesis size. As expected, procedural and fluoroscopy times were longer with general anesthesia, which also was used more often in patients treated with surgical vascular access rather than entirely percutaneous access.
Of the 1,073 patients whose procedures involved femoral access, 80.8% received local anesthesia, whereas conscious sedation was used in only 38.5% of the 242 patients who were treated via the subclavian or aortic approaches.
Rates of valve-in-valve TAVR during the same procedure as well as valve migration did not differ between the study arms, and procedural mortality was low and similar in the general and local anesthesia groups at 2.6% and 1.8%, respectively (P = .46). Four patients in the general anesthesia arm and 3 in the conscious sedation arm required conversion to surgery for uncontrolled pericardial effusion (P = .06).
Greater operator experience was associated with declining use of general anesthesia over the study period (from 65% in the first year to 24% in the sixth year, P < .001 for trend).
There were no between-group differences with regard to in-hospital mortality, stroke, MI, occurrence of new left bundle branch block, or new permanent pacemaker implantation. However, general anesthesia was associated with more stage 3 acute kidney injury, life-threatening bleeding, and major bleeding compared with conscious sedation. Length of stay was also shorter for those receiving local anesthesia (table 1).
Thirty-day and 2-year mortality outcomes were similar between the treatment arms in the overall analysis. In addition, propensity-matched analysis of 255 pairs confirmed the findings.
Downsides to General Anesthesia Uncovered
General anesthesia, Dr. Giannini and colleagues explain, is associated with some disadvantages, including a cardiac depressant effect that can induce cardiovascular instability during the procedure. In particular, hypotension and bradycardia on induction, and the consequent need for vasoconstrictors, can be dangerous in these patients, they add.
“[Local anesthesia] instead avoids hemodynamic uncontrolled changes, is better tolerated by patients with pulmonary insufficiency, and allows instantaneous monitoring of any neurologic change in the patient or pain and discomfort that can be an indication of some complication,” the authors write. “However, the possibility of a switch to full [general anesthesia] must be considered at any moment of the procedure.”
They acknowledge that conscious sedation can prevent the use of procedural TEE but suggest this may not matter because “after the learning curve echocardiographic guidance is not mandatory.”
According to the authors, the numerically higher rates of life-threatening and major bleeding seen with general anesthesia stem from that approach being more often used during the TAVR learning phase when operators were less experienced and peripheral vascular disease was more prevalent.
Simpler Procedures, Better Devices
In an interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), said that, with TAVR, simplification of the procedure and streamlining of devices over time have shifted treatment toward a lower-risk patient population. “These patients are more resilient and have fewer complications,” he said, so conscious sedation is an option.
However, in his experience, Dr. Généreux reported, one-third of patients who receive general anesthesia are typically discharged the day following the procedure. “I like to use light general anesthesia where you can do TEE,” he said. “If a catastrophic complication occurs,… the patient is not awake and you have full control of the situation.”
While acknowledging that patients with a higher comorbidity burden might benefit from conscious sedation, he urged caution, given that “most of the time the complications will occur in these very high risk patients.”
More important than whether local anesthesia is “feasible” is whether it is “optimal,” he added. “The goal is not to say ‘I did local anesthesia’ but rather ‘I did a very good job.’”
Five years from now, “when the device will be so predictable and so small,” conscious sedation will be even more common, he said. “It's going to be like doing a PCI.”
Others Report Changes in Practice
Danny Dvir, MD, of the Centre for Heart Valve Innovation (Vancouver, Canada), emphasized that the “initial TAVR cases performed in France more than a decade ago were performed under local anesthesia only. In fact, one of the objectives with this less-invasive strategy was to allow patients to have aortic valve replacement without general anesthesia.”
He told TCTMD in an email that local anesthesia is preferred for TAVR at his institution. “This is truly a minimalist approach, which is especially beneficial for the frail and high-risk patients,” he said. “However, we must remember that utilizing local anesthesia does not mean that the anesthesiologist is not actively involved in the procedure.”
Similarly, Jeffrey J. Popma, MD, of Beth Israel Deaconess Hospital (Boston, MA), told TCTMD in a telephone interview that while his hospital primarily utilizes general anesthesia for all TAVR procedures, the institutional goal is to move more patients to conscious sedation over the next 6 months. “We're becoming more facile with the TAVR procedure, so we know the predictability, and the outcome has improved substantially over the last year or two,” he said.
However, Dr. Popma explained, those who “would benefit the most are otherwise healthy individuals with large iliofemoral access who have a reasonable baseline sensorium so that when we give them some degree of conscious sedation, they will actually still be able to follow commands and remain very relaxed. That's going to be the majority of patients we’re going to do, particularly as we’re moving to lower French sizes.”
Dr. Dvir suggested that general anesthesia should be used when:
- Patients are unable to lie flat without moving because of communication problems or medical issues
- TEE is important
- Rapid advance support might be needed
All 3 doctors agreed that conscious sedation should not be used when alternative access is necessary but reserved only for patients who can be treated transfemorally. Additionally, only experienced operators should perform TAVR with local anesthesia, Dr. Popma said, adding that “there really can’t be learning curves in the midst of this.”
Petronio AS, Giannini C, De Carlo M, et al. Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry. EuroIntervention. 2015;Epub ahead of print.
- The study was sponsored by Medtronic Italy
- Dr. Giannini reports no relevant conflicts of interest.
- Dr. Généreux reports receiving speakers fees from Edwards Lifesciences.
- Dr. Dvir reports serving as a consultant to Edwards Lifesciences and receiving a research grant and honoraria from Medtronic.
- Dr. Popma reports serving as the principal investigator for the Medtronic CoreValve study and receiving research grants from Boston Scientific and Direct Flow Medical.