Next Gen Innovators

Next Gen Innovators

September 07, 2017
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Conscious sedation linked to lower mortality vs. general anesthesia in TAVR

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Jay Giri, MD, MPH
Jay Giri

Transcatheter aortic valve replacement with conscious sedation was linked to shorter length of stay and lower in-hospital and 30-day mortality vs. TAVR with general anesthesia in adjusted and unadjusted analyses, according to new data published in Circulation.

“Many changes to the devices have facilitated more minimally invasive processes of care,” Jay Giri, MD, MPH, from the division of cardiovascular medicine at the hospital of the University of Pennsylvania and Penn Cardiovascular Quality, Outcomes and Evaluative Research Center and a Cardiology Today Next Gen Innovator, told Cardiology Today’s Intervention. “The natural next step for us to investigate is: What about the need for general anesthesia? Should TAVR more closely resemble an open surgical aortic valve replacement or should it more closely resemble a PCI?”

Giri and colleagues used the National Cardiovascular Data Registry (NCDR) Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry to characterize the anesthesia choice and clinical outcomes of U.S. patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014, and June 30, 2015.

Additionally, the researchers performed raw and inverse probability of treatment-weighted analyses comparing general anesthesia with conscious sedation on an intention-to-treat basis for the primary outcome of in-hospital mortality. Secondary outcomes included 30-day mortality, in-hospital and 30-day death/stroke, procedural success, ICU and hospital length of stay and rates of discharge to home.

A post-hoc falsification endpoint analyses was performed in both the unadjusted and adjusted models to evaluate for residual confounding.

Of 10,997 patients, 1,737 (15.8%) were given conscious sedation with a trend of increasing usage during the study period (P for trend < .001).

In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% vs. 98.5%; P = .31).

Compared with general anesthesia, patients in the conscious sedation group were less likely to have in-hospital (1.6% vs. 2.5%; P = .03) and 30-day mortality (2.9% vs. 4.1%; P = .03).

Researchers noted 5.9% of patients who were given conscious sedation were converted to general anesthesia.

After adjustment for 51 covariates, conscious sedation was linked to lower procedural success (97.9% vs. 98.6%; P < .001) and a reduced rate of mortality at the in-hospital (1.5% vs. 2.4%; P < .001) and 30-day (2.3% vs. 4%; P < .001) time points.

Additionally, a link was discovered between conscious sedation and reductions in procedural inotrope requirement, ICU and hospital length of stay (6 vs. 6.5 days; P < .001) and death or stroke at 30 days (4.8% vs. 6.4%; P < .001).

After adjustment, there were no significant differences between groups in the falsification endpoint analyses of vascular complications, bleeding and new pacemaker/defibrillator implantation.

According to Giri, the most important takeaway from the study was the reduced mortality associated with conscious sedation compared with general anesthesia.

“It was a mildly reduced mortality, but the fact that it persisted after rigorous adjustment and in the face of falsification endpoint analyses is quite compelling.  Conscious sedation may be beneficial, not only for health systems moving patients through the system faster and more efficiently, but also for the patients themselves.” – by Dave Quaile

Disclosure: Giri reports he receives research funds from St. Jude Medical.