Streamlining a TAVR Procedure From screening to post TAVR care Hatim Al Lawati

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1 Streamlining a TAVR Procedure From screening to post TAVR care Hatim Al Lawati Consultant Interventional Cardiology Sultan Qaboos University Hospital Muscat Oman

2 Speaker's name: Hatim Al Lawati, SQUH - Oman I do not have any potential conflict of interest

3 TAVR LANDSCAPE: STS SCORE Severe AS, Symptomatic Low Risk <3% Int. Risk STS 3-7% High Risk STS 7-10% Extreme Risk STS >10% On-Going Clinical Trials TAVR Indicated Patient Populations 1. STS Adult Cardiac Database Harvest, Isolated AVR. 2. Bach, et al. JACC. 2007;50(20): Iung B, et al. European Heart Journal. 2003;24: Pellikka et al. Circulation. 2005;111: Charlson, et al. Journal of Heart Valve Disease. 2006;15: Nkomo, et al. Lancet. 2006;368: Lindroos, et al. JACC. 1993;21(5): Mack M, JAMA 2013;310(19): Medtronic Data On File.

4 Agenda Pillars to streamline TAVR: Proper Patients Referrals Screening Optimization TAVR procedure simplification Discharge considerations

5 Proper Patient Referrals Successful programs should employ a multifaceted approach to educate and engage community physicians, using tactics such as valve coordinator outreach, educational sessions, easy-to-use referral guidelines, and dedicated valve center referral lines. Valve centers should also set high service standards to ensure referring physicians will continue to refer. Consistent communication is critical throughout the care continuum, from screening to post-procedure follow-up, so referrers do not feel they have lost control of their patients. In addition to educating referring physicians, TAVR programs can also hardwire identification of patients who would benefit from further evaluation at the valve clinic through echo screening or echo alert protocols to identify patients with severe AS

6 TAVR Screening Optimization Consolidate the screening process as much as possible to optimize patient convenience and expedite time to treatment Develop a one-stop-shop screening approach, in which a patient receives all or nearly all screening and physician consults during one visit at the TAVR clinic, and ideally in one location Dedicate one or two TAVR screening days per week, to ensure physician and lab availability. Situate the clinic rooms in close proximity to diagnostic testing labs (e.g., echo, cath lab) to streamline the process and improve patient convenience.

7 TAVR Procedure Simplification Use of stiff LV wire for pacing instead of the temporary transvenous pacemaker wire Conscious sedation instead of general anesthesia Transthoracic instead of Transesophageal Ultrasound guided access Use of low profile sheaths/delivery systems of TAVR (14 Fr) to minimize vascular complications Use of new closure devices (like MANTA) Management of central lines and pacemaker

8 Alternative to transvenous pacing Use of stiff LV wire for pacing instead of the Temporary transvenous pacemaker wire Set up of the LV pacing system

9 Catheter Cardiovasc Interv 2016; 88: METHODS: A prospective, observational registry study was conducted in three French centers (the GHM and CHU in Grenoble and the Clinique du Tonkin in Lyon) included patients undergoing BAV or TAVR for severe aortic stenosis. The primary objective of the registry was the assessment of the efficiency of left ventricular rapid pacing during BAV or TAVR procedures. The secondary objectives were the assessment of the safety and tolerance of left ventricular rapid pacing during BAV or TAVR, as well as systematic in-hospital follow-up of the registry patients.

10 Description of the Technique Both BAV and TAVR procedures were carried out using standard techniques, but no systematic femoral vein puncture was performed for the RV lead. Rapid ventricular pacing (rate between 160 and 200 bpm) was provided via the back-up guidewire The cathode of an external pacemaker is placed on the external end of the wire using an alligator clamp. The balloon or the TAVR catheter provides the necessary insulation. The anode is placed (also using an alligator clamp) on a small needle piercing the subcutaneous tissue at the site of the anesthetized groin If a complete atrio-ventricular block (AVB) occured during the procedure, immediate stimulation was delivered through the LV guidewire while a venous sheath was inserted for temporary pacing lead placement in the right ventricle and PM implantation was carried out within the next 24 hr., if required.

11 Results 113 consecutive patients underwent 38 BAV and 87 TAVR procedures in three centers using this technique. Left ventricular pacing was successfully implemented in all patients with one for one pacing ( bpm) obtained in each case. A significant reduction in blood pressure was achieved in all cases with a mean systolic pressure during stimulation of 44 mm Hg. No venous vascular complications were observed in the study population.

12 Conscious Sedation vs. General Anesthesia Pros: - Avoids intubation: - Difficulty weaning - Possible trauma - Difficulty with swallowing - Avoids deep sedation - Frequently requires pressors - Confusion - Nausea/vomiting - Delays mobilization Cons: - Less control of patient - May have some local pain - Consider using long acting local anesthetic e.g. Bupivacaine - Without TEE - Typically avoids TEE - Intra-procedural feedback - Added benefit: quicker room turn over time **J Thorac Cardiovasc Surg Oct;150(4): doi: /j.jtcvs Epub 2015 Jul 30

13 Conscious sedation improved outcomes in high risk patients Evaluation of TVT Registry from April 2014-June ,997 patient evaluated 1,737 had conscious sedation (15.8%) Risk of 30-Day Outcomes, Moderate Sedation vs General Anesthesia* 30-day outcomes Moderate sedation (%) General Anesthesia (%) Odd ratio P Mortality <0.001 Mortality or Stroke <0.001 *Adjusted for 51 baseline variables Source: Giri J, SCAI 2016

14 Conscious Sedation: how do you start? Many questions and few answers exist in public domain Sedation Do you include anesthesia? What type of drugs are used? How deep a level of sedation should be taregtted? How do you start this within your institution? Appropriate patient selection Consensus within the Heart Team Training and Education

15 Sedation: One center approach Initially, deep sedation with Propofol You want to have a successful experience for your patient and staff OR staff are not used to having patients feel any pain, get their buy-in first Consider eventual transition to light Propofol + Dexmedetomidine (Precedex ) Identification of pain has allowed us to avoid potential vascular complications Continue to use anesthesia staffing for sedation

16 Transthoracic instead of trans-esophageal echo Questions: How to transition away from TEE? When TTE imaging is poor, how do you evaluate? Utility of TTE: Quantify PVL Evaluate for tamponade Put the probe on up front Can I get good windows? Is there a fat pad or small effusion pre-procedure? Keep in mind that aortography is a much more reliable tool than TTE and primary modality for evaluation of PVL combined with hemodynamics

17 Hemodynamics are your friend! Calculation of the AR index AR Index = (DBP-LVEDP)/SBP x 100 subjects with a AR index >25 had significantly lower mortality Sinning JACC 2012

18 Hemodynamics are your friend! Calculation of the AR index Freedom from all-cause mortality. Kaplan-Meir estimates of cumulative survival according to the degree of peri-ar as assessed by echocardiography (A) and according to the AR index (B). Sinning JACC 2012

19 Ultrasound guided vascular access

20 Ultrasound guided vascular access

21 Ultrasound guided vascular access Conclusions: In this multicenter randomized controlled trial, the US guided puncture reduced the number of attempts, time to access, risk of venipunctures, and vascular complications in femoral arterial access.

22 Ultrasound guided vascular access Common femoral artery placement success US guidance did not demonstrate a significantly superior rate of sheath placement in the common femoral artery in the overall population or the obese or peripheral vascular disease subgroups. US guidance significantly increased common femoral sheath placements in the 31% of patients who had a femoral bifurcation over the femoral head p<0.01

23 Use of low profile sheaths/delivery systems of TAVR to minimize vascular complications

24 Use of new closure devices (e.g. MANTA) It is a new device (CE approved already) and we will need time and experience to reveal if it will contribute to the simplification of the closure in TAVR and thus reduce bleeding/hematoma at the closure site.

25 Invasive lines and pacemaker management Foley catheters: In the case of Trans-femoral TAVR, no need to have a Foley catheter placed in an attempt to reduce urological issues during/after the procedure. Temporary venous pacemaker: For patients with narrow QRS with no changes during the procedure, the guidelines recommend that the temporary pacer should be removed at the end of the procedure.

26 Post-implant Care: pacer guidelines supporting evidence The Electrocardiogram After Transcatheter Aortic Valve Replacement Determines the Risk for Post-Procedural High-Degree AV Block and the Need for Telemetry Monitoring The most important finding of this study is that patients without a left- or right bundle branch block and without firstdegree AVB post-tavr did not develop high-degree AVB during the first 30 days postprocedure. Similarly, patients with atrial fibrillation but no bundle branch block and no bradycardia post-tavr had a very low risk of delayed highdegree AVB. Patients in sinus rhythm without conduction disorders post-tavr did not develop delayed high-degree AVB (0 of 250, 0%) In this study, only patients with QRS duration <120 ms and absence of first-degree AVB did not develop high-degree AVB. Toggweiler, S., et al. JACC: Interventions, 9(12),

27 Consideration for early discharge No ICU stay in transfemoral cases patient transferred from procedure room to ward Stable heart rhythm not requiring pacing within 24h Vital signs stable Effective pain control Ambulates 200 feet or at baseline Groins without bleeding/hematoma Family with appropriate understanding of discharge instructions Plan discharge before admission!

28 Conclusions Streamlining allows for faster, easier and cost effective procedure without impacting the safety and efficacy of TAVR Such methodology requires pre-, peri- and postprocedural planning favoring the trans-femoral (percutaneous) approach Plan to discharge the TAVR patient before admission

29 Streamlining a TAVR Procedure From screening to post TAVR care THANK YOU!

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