A team at Penn Medicine has performed a retrospective analysis that appears to substantiate the safety of conscious sedation by comparison to general anesthesia in patients having transcatheter aortic valve replacement (TAVR). Their findings, published in Circulation in September 2017, indicate that versus general anesthesia, TAVR with conscious sedation results in a shorter length of stay and lower in-hospital and 30-day mortality. The study thus validates the previously limited evidence for the safety and efficacy of conscious sedation in TAVR. The full report is available here.
TAVR was developed for patients with symptomatic severe aortic stenosis at prohibitive surgical risk, but with continuing technical and procedural innovation is considered a viable option for patients at intermediate and high surgical risk, as well.  Many of the advances associated with TAVR have involved a lessening of the physical and hemodynamic stresses of the procedure, including the intensity of anesthetic support.
General anesthesia is a leading cause of post-operative cognitive dysfunction in the elderly, who comprise the majority of patients in the TAVR population. Conscious sedation, a combination of anesthetics and sedatives, has been used with increasing frequency for TAVR in the United States in recent years. However, with the exception of scattered single-institution reports, limited evidence is available to define the safety and efficacy of the practice.
To address this discrepancy, the Penn team turned to the NCDR® STS/ACC TVT Registry* which collects information on demographics, comorbidities, peri-procedural details, in-hospital and 30-day clinical outcomes with participation mandated for all U.S. TAVR implanters by the Centers for Medicare & Medicaid Services National Coverage Determinations.
The anesthesia choice and clinical outcomes of 10,997 patients at 314 hospitals who had elective percutaneous transfemoral TAVR between April 1, 2014 and June 30, 2015 were collected from the Registry database. A variety of analyses were then performed to compare general anesthesia patients with conscious sedation patients on an intention-to-treat basis for the primary outcome of in-hospital mortality, and for secondary outcomes, including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, ICU and hospital length of stay, and rates of discharge to home.
* The National Cardiovascular Data Registry (NCDR®) Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Registry.
Conclusions - Overall, conscious sedation was used in 15.8% of TAVR cases during the time period studied, with a significant trend of increasing usage (11% - 20%) in this timeframe. While intraprocedural success with conscious sedation and general anesthesia was similar, patients who underwent TAVR with conscious sedation had a reduced rate of mortality at the in-hospital and 30-day time points. Conscious sedation was also associated with reductions in ICU and hospital length of stay and combined 30-day death/stroke rates.
Mr. R, an 82-year-old male, was referred to the Penn Medicine Heart and Vascular Center by his primary care physician after an episode of syncope during light yard work. During his evaluation, he reported several previous episodes of light-headedness, mild chest pain and breathlessness during exertion, all of which he attributed to a combination of age and his daily drug regimen, which included diltiazem 120 mg and losartan 100 mg for atrial flutter and hypertension. Mr. R was otherwise healthy with no history of kidney disease, diabetes or blood disorders.
On physical examination, Mr. R was found to have a prominent systolic murmur at the second right intercostal space radiating to the carotid arteries. A subsequent Doppler echo found an aortic valve area of 0.68 cm2 and left ventricular ejection fraction of 47%. After consideration of his age and circumstances, a consultation was planned for Mr. R with the TAVR team and an anesthesiologist at the Heart and Vascular Center. At this meeting, it was determined that Mr. R was at intermediate risk for a traditional surgical aortic valve replacement. He was offered the option of a TAVR and was deemed a good candidate for monitored anesthesia care, a form of conscious sedation in which sedatives are administered by a trained anesthesia provider who actively manages sedation and is prepared to convert to general anesthesia, if necessary.
Mr. R’s procedure took place in the hybrid operating room at the Hospital of the University of Pennsylvania. Prior to his procedure, a vertical drape was placed at the level of Mr. R’s shoulders. He was then administered a combination of sedatives and anesthetics that caused him to fall into a light sleep. Local anesthetics were then administered at the access to his right femoral artery, and a sheath introduced and advanced to the thoracic aorta.
A guide wire was then threaded into the heart with the artificial valve advanced over it and across the aortic valve. The heart was then paced to prevent ejection of the new valve, and the valve was deployed successfully within the native aortic valve. A post-placement angiogram then confirmed that the valve was in place with excellent results and minimal paravalvular aortic insufficiency. A transthoracic echocardiogram was performed confirming these results. All equipment and sheaths were removed from the femoral vascular sites with two suture-based closure devices used to achieve hemostasis, completing the fully percutaneous procedure.
Mr. R was fully conscious by the time he was moved to the recovery room. He remained in the hospital for 36 hours, after which he was discharged to home. At his six-month follow-up examination, his ejection fraction had improved to 62%, and he reported a significantly increased capacity for exercise.
Penn Heart and Vascular Center
Perelman Center for Advanced Medicine
East Pavilion, 2nd Floor
3400 Civic Center Boulevard
Philadelphia, PA 19104
Penn Presbyterian Medical Center
Heart & Vascular Pavilion
2nd Floor, Suite 2A
51 N. 39th Street
Philadelphia, PA 19104
Published on: December 11, 2017
1. Thourani VH, Kodali S, Makkar RR, Herrmann HC, et al. Lancet 2016;387:2218-2225.
About the Heart Valve Disease Program at Penn Heart and Vascular
As the largest program of its kind in the region, the Heart Valve Disease Program at Penn Medicine offers a varied spectrum of advanced procedures for patients with mitral, aortic, pulmonic and tricuspid valve disease. A focal point for research and surgical excellence, the Program pioneered many advances in minimally invasive surgery, valve repair, hybrid and robotic therapies for valve replacement, and high-risk catheter-based treatment options, including transcatheter aortic valve replacement (TAVR). The Program faculty comprises experts in diagnostic cardiac imaging, interventional cardiology, cardiology and cardiovascular surgery who collaborate to select the best type of heart valve and procedure for every patient.
To make a referral to the TAVR Program, please call 215.662.4387or email TAVR@uphs.upenn.edu.
Penn Faculty Team
Co-Director, Transcatheter Valve Program
Director, Cardiac Transplantation and Mechanical Circulatory Support Program
Director, Minimally Invasive and Robotic Cardiac Surgery Program
Co-Director, Transcatheter Valve Program
Director, Thoracic Aortic Surgery Program
Vice Chief, Division of Cardiovascular Surgery
Director, Thoracic Aortic Surgery Research Program
Director, Peripheral Intervention
Director, Cardiac Catheterization Laboratories, Hospital of the University of Pennsylvania
Health System Director for Interventional Cardiology
Co-Director, Transcatheter Aortic Valve Replacement Program, Penn Presbyterian Medical Center
Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center
Surgical Director, Transcatheter Cardio-Aortic Therapies
Vice Chief of Clinical Operations and Quality, Division of Cardiovascular Surgery
Program Director, Cardiothoracic Surgery