Minimalist Approach to T-AVR Pichard, L. Satler, R Waksman, I Ben-Dor, G Maluenda, P. Corso, S Boyce, K Kent, W Suddath, N Bernardo, S Goldstein, Z Wang, G Weissman, G Weigold, J Lindsay, J Panza

Gus Pichard, MD Edwards Lifesciences. Proctor St Jude Medical. Speaker Bureau

Percutaneous Aortic Valve without Intubation

Mitral Valvuloplasty with TEE

TEE without Intubation in the Cath Lab. Abstract Presented Sept 2000. 700 procedures Average duration of TEE 60 minutes Procedure well-tolerated No complications related to TEE 5

At the Washington Hospital Center Cath Labs we use TEE for: All mitral valvuloplasties (>1000 patients). All alcohol septal ablations (± 25/year). All ASD/PFO closures until 2008, when TEE was replaced with ICE. Other structural HD (LAA closure, LV parachute, MV clip, VSD closure, etc). Percutaneous aortic valves.

Protocol for TEE in Cath Lab. Standard conscious sedation is initiated (Fentonyl and Versed) by the cath lab nurse. Have never used anesthesiology. TEE probe is introduced as the femoral sheaths are placed. Intervention proceeds under continuous TEE guidance. Patient is awake at end of procedure and is informed about the results of the procedure in the company of his/her family.

Is TEE needed for T-AVR? We always use it (protocol reasons). Probably not needed for valve deployment. Important for analysis of AR post implant. Essential for analysis of complications: - marked hypotension - valve malfunction or malposition.

Conscious Sedation Protocol for TF T-AVR Anesthesiologist assesses patient the day before. Anesthesiologist in the Lab Anesthesia equipment in the Lab Anesthesiologist has the usual set up for cardiac anesthesia: Swan through IJV, radial artery pressure, etc. Anesthesia monitors BP, PAP, 02 and C02, CO. Generous Lidocaine at the access site in the groin.

Drugs used for Conscious Sedation A. Start with VERY light sedation: 1mg versed , 50 mcg Fentonyl while placing A-line, and right IJ Swan. B. Maitenance drugs. 2 protocol options: 1. "Ketaphol" 10mg Ketamine with 200mg (20cc) Propofol. Dose: Propofol 10mcg/kg/min and up to 75 mcg/kg/min. Ketamine adds some analgesia with less respiratory depression than Propofol alone. 2. Dexmetetomidine (Precedex) (sedative used in the ICU with little hemodynamic consequence and minimal respiratory depression). Can be started without any other drugs. Dose: 0.3-0.7mcg/kg/hr with or without a bolus.

Variable Conscious sedation N=70 General anesthesia N=22 P value Age (years) 84.1±5.1 83.7 ± 7.9 0.8 Female 41(58.5%) 14 (63.6 %) 0.3 Society of Thoracic Surgeons score (%) 11.3±3.4 10.9±3.7 0.6 Logistic EuroSCORE 40.1±19.4 28.1±16.1 0.01 High risk surgical 42(60%) 11(50%) 0.7 Non-surgical candidate 28(40%) NYHA class IV 34(48.6%) 12(54.5%) Diabetes 21(30.0%) 7(31.8%) Hypertension 63(90.0%) 21(95.5%) 0.4 Coronary artery disease 39(55.7%) 10(45.5%) Prior myocardial infarction 13(18.6%) 2(9.1%) Prior CABG 23(32.8%) 6(27.2%) COPD 10(14.3%) Renal failure (CrCl <60 ml/min) 26(37.1%) 11(50.0%) Prior CVA/TIA 0.04 Atrial fibrillation 30(42.8%)

Conscious Sedation vs. General Anesthesia Procedure Duration (minutes) ICU Stay (hours) Hospital Stay (days)

Conversion to Intubation 8(11.4%) converted to general anesthesia. 3(4.2%) due to respiratory failure. 2(2.8%) due to hemodynamic compromise. 3(4.2%) retroperitoneal approach was required.

Minimalist Approach: Alain Cribier A. Cribier WHC Intubation No TEE Yes Swan Ganz Radial artery pressure Gradients pre-post Heart-Lung Equipm. in room Vascular Instruments Table Percutaneous Access

Conclusions PHV with TEE guidance is perfectly feasible without intubation. All the side effects of general anesthetics are avoided. No safety concerns. No increased discomfort to the patient. We highly recommend it!

The end

PHV with Concious Sedation and NO intubation 74 year old male PMH: Severe COPD FEV1 - 0.76, 30% predicted PCO2 - 68 mmHg, pO2 50. On Home Oxygen Recurrent GI bleed of unknown origin Diabetic. 262 pounds. Seen by 3 pulmonary specialists and by Cardiac Surgery Not operative candidate Cohort B

PHV on 2/21/08 Surgical access: very deep to reach, took >25 min Tunneled the sheath Dilators went up easy. Same with large sheath. TEE: annulus 23-24 mm 26 mm valve delivered without problems. Excellent position. 1+ AR No intubation, tolerated case very very well. Was talking at the end of the case. Duration: 8 am to 10 am.