Conscious Sedation Efficient, Safe For TAVI, With Similar Outcomes To General Anesthesia

Minimalist transcatheter aortic valve implantation (M-TAVI) with conscious sedation is more efficient than TAVI with general anesthesia (GA-TAVI) and is associated with similar safety and quality of life outcomes, an observational study suggests.

"These observations are a strong signal that TAVI has quickly evolved to a point where general anesthesia is not necessary for the vast majority of procedures," Dr. Kishore Harjai of Persall Heart Hospital in Wilkes-Barre, PA told Reuters Health by email. "All but 3% of the M-TAVI procedures were completed without conversion to general anesthesia."

"We believe our findings are practice-changing and should be reflected in future guidelines," he said. "A small proportion of patients may not be suitable for M-TAVI and should be considered for general anesthesia from the very beginning of the procedure—for example, patients with severe anxiety, very low pain threshold, or those unable to lay flat."

"Barring such exceptions," he added, "most patients can undergo TAVI with conscious sedation in centers with appropriate experience in percutaneous access and large bore closure."

Dr. Harjai and colleagues analyzed the impact of M-TAVI on procedural efficiency, long-term safety and quality of life in 477 patients with severe aortic stenosis. The mean age was 82; 50% were women and 99%, white; 278 underwent M-TAVI and 199, GA-TAVI. The choice of procedure was left to the discretion of the operating team.

M-TAVI was performed with moderate sedation, transthoracic echocardiographic and percutaneous vascular access. GA-TAVI was performed with GA and transesophageal echocardiography with either surgical femoral cut-down or percutaneous access.

As reported in The American Journal of Cardiology, M-TAVI patients were more likely to have NYHA Class I or II symptoms and less likely to be undergoing valve-in-valve TAVI, or to receive self-expanding valves. All other baseline characteristics were similar between the groups.

As Dr. Harjai noted, M-TAVI was completed without conversion to GA in 97% of patients. M-TAVI was more efficient than GA-TAVI, as indicated by a shorter length of stay (two vs three days); higher likelihood of being discharged home (87% vs 72%); less use of blood transfusions (10% vs 22%), inotropes (13% vs 32%), and contrast volume (50 ml vs 90 ml); less fluoroscopy time (20 min vs 24 min) and less need for >1 valve (0.4% vs 5.5%).

At 1 month, outcomes were similar for death/stroke (4% for M-TAVI vs 6.5% for GA-TAVI) and for a safety composite end-point that included death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding and new pacemaker: 17.6% vs 21.1%.

At a median follow-up of one year, survival curves showed a similar incidence of death/stroke and the safety composite end-point. Quality of life scores were similar at baseline and one month after TAVI.

Further, in multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency.

Dr. Harjai said, "Although not directly estimated in our study, there are likely significant cost savings with M-TAVI...related to earlier release from the hospital, greater likelihood of being discharged home and lower utilization of blood transfusions and inotropic medications."

Dr. Gilbert Tang, director of the structural heart program at the Mount Sinai Health System in New York City, commented in an email to Reuters Health, "Many papers have demonstrated that minimalist TAVR improves procedural efficiency with similar outcomes to GA. Our minimalist TAVR rate at Mount Sinai in 2019 was around 82%."

"We perform GA in patients for multiple reasons, including patient safety, patient preference, patient anatomy, ability to image the heart using cardiac ultrasound, procedural risk, and alternate access other than performing TAVR via a needle stick in the groin," he noted. "Careful patient selection for minimalist vs GA approach in TAVR would confer optimal outcomes."

—Marilynn Larkin

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