sign in sign up
<<
Home , Interventional radiology

eMedical Research Volume 1 Article ID: 100002

Research Article How Interventional Can Enhance the Performance of a TAVR Team: New Brunswick Centre Experience

Légaré JF1,2,3, Hassan A1,2,3, Yip AM2,3, LeBlanc H3, Macleod JB2,3, O’Brien A1,3, Archer B1,3, Ferguson D1,3, Forgie R1,2,3, Teskey R1,2,3, McGrath B1,2,3 and Paddock V1,2,3 1Dalhousie University (DMNB), New Brunswick, Canada 2Cardiovascular Research New Brunswick, Canada 3The New Brunswick Heart Centre, Saint-John New Brunswick, Canada *Corresponding author: Jean-Francois Legare, The New Brunswick Heart Centre, Saint-John New Brunswick, Canada, Tel: +506-648-6102; Fax: +506-648-6110; E-mail: [email protected] Received: August 02, 2019; Accepted: October 26, 2019; Published: November 03, 2019 Copyright: ©2019 Legare JF et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract Background: Current recommendation describing transcatheter aortic valve (TAVR) heart team remains poorly defined. Methods: The TAVR program at the New Brunswick Heart Centre (NBHC) has included members from interventional , cardiac and . All were assigned complementary roles: (interventional radiology and ), temporary pacing plus valve crossing (interventional cardiology) and valve deployment (all members). Results: 332 TAVR procedures were performed with a mean age of 80+9 years, 40% female, 34% previous heart surgery and 38% peripheral . The median STS score was 5.2 (3-9 IQR) and decreased significantly over time from 7.4 in 2010 to 3.9 in 2017 (p=0.001). The majority of valves implanted were balloon expandable (83%). Transfemoral approach was used in 84% of patients but increased significantly over time (2010: 53%, 2017: 100%, p<0.0001). In 2017, 100% of patients were approached using a percutaneous approach and conscious sedation. Overall in mortality was 1.5% and this did not change over time. Significant access complications were seen in only 1 patient (0.3%) with minor complications limited to 2.7% of patients. Moderate or greater aortic insufficiency post procedure was limited to 2.3% of patients and the permanent pacemaker rate was 10.2%. Conclusion: We demonstrate in the present manuscript how having interventional radiology as part of the TAVR team allowed our program to evolve towards a percutaneous femoral approach in the majority of patients with low rates of vascular and/or access complications.

Keywords: aortic stenosis, TAVR (transcatheter aortic valve replacement), SAVR (surgical aortic valve replacement), outcomes

Introduction The modern treatment of aortic valve disease is rapidly changing. In the past 10 years trans- valve replacement (TAVR) strategies have become common for the treatment of symptomatic severe aortic stenosis and no longer limited to inoperable patients [1-4]. TAVR procedures have been demonstrated to be feasible and safe in patient with severe aortic stenosis and as such now competing with conventional surgery for an increasing number of patients as indications shift towards lower risk patients [5,6].

Page 1 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

These rapid changes in clinical applications of technological and technical advances with available devices have resulted in significant advocacy for collaborative approaches to the decision-making around cardiac care [7]. The Heart Team model of care has therefore been endorsed by major cardiological societies to be the standard of care for the assessment and decision-making around aortic valve disease [8-10]. While the Heart Team model for decision-making in selecting patients for TAVR is a simple concept, there are no clear guidelines on how to assign tasks and responsibilities within a Heart Team particularly at the time of intervention. Most described Heart Teams are composed of only interventional cardiologists and cardiac surgeons but again their exact roles are rarely fully defined. This is particularly important if one where to consider the specific strengths and skills that each of the member of the team brings in ensuring the best possible outcome with TAVR. Vascular access has evolved as a critical component for TAVR feasibility and success. It is currently accepted that the best outcomes are derived from TAVR when performed transfemorally when compared to alternate access sites [11- 13]. Despite excellent outcomes in TAVR there remains significant risk for complications in particular related to the vascular access [14]. Patients with significant peripheral vascular disease (PVD) undergoing TAVR represent more than 30% of patients and may result in important vascular complications often reported in more than 10% of patients [15]. Furthermore, it has been demonstrated that vascular complications affect overall patient outcomes and are associated with poorer survival [16,17]. Given the importance of vascular access we believe that interventional radiologists bring a unique set of expertise to a TAVR heart team based on their expertise in peripheral vascular disease . In the present manuscript we will review the Heart Team from the New Brunswick Heart Centre (NBHC) and how well-defined tasks and collaboration within the heart team and the participation of interventional radiology can potentially enhance a TAVR program. Materials and Methods Heart team composition The TAVR program was initiated at the NBHC in 2010. The Heart Team created to support the TAVR program was composed at the outset from members from interventional cardiology (2 members), cardiac surgery (2 members), interventional radiology (2 members) and cardiac . A nurse coordinator was also assigned to the TAVR program. The coordinator was critical at organizing: patient assessments, meetings for discussion, procedures scheduling and maintaining a comprehensive database for all patients since 2010. Pre-operative assessment Representative members of each group from the Heart Team reviewed individual patient referred for TAVR consideration. Investigations included a thorough clinical assessment with review of echocardiographic findings, cardiac catheterization details, CT angiographic study and assessment. The interventional radiology assessment included a detailed assessment of possible approaches, aortic root measurements, valve sizing and angles predicted for the TAVR intervention. Routine radiologic assessment consists of a gated 4D examination of the heart, followed by a nongated CT angiogram from skull base to thighs. Detailed measurements and 3D reconstructions of access vessels, coronary and of course aortic valve are performed with TeraRecon software. The multiphase nature of the CT acquisition allows cine assessment of valve motion and ventricular function in addition to the usual annular measurements, estimation of calcification and coronary anatomy. An average contrast volume of 120 cc is used. Planning vascular access for various valve systems, temporary pacemaker and diagnostic is a part of every report and printed “TAVI Planning Sheet” which is used at the time of intervention (taped to the image intensifier during the procedure for easy reference).

Page 2 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

All patients were then reviewed by the “Heart Team” group allowing for discussion in a formalized meeting with representative members of the Heart Team present with the nurse coordinator. For each patient a decision was made and included: suitability for TAVR versus surgical aortic valve (SAVR), approach, perceived challenges and timing of intervention. Critical contingency plans are discussed in detail at this stage, for instance: would the patient be a candidate for emergency conversion to SAVR, are there alternate accesses available if the planned approach fails, does the patient have preexisting conduction abnormalities increasing the necessity of permanent pacemaker implantation, and innumerable logistical details. The environment for discussion is open, encourages all members provide their input (perspectives) and all decisions are based on consensus with no predetermined hierarchical structure. Frequently patients are found to have other important findings only tangentially related to the aortic valve, which required further investigation and management prior to TAVR (, , of heart of other regions). The nursing assessment was comprehensive and allowed for not only clinical evaluation but also education of patients in preparation for intervention. The assessment also included functional (DASI), frailty (KATZ) and cognitive (MOCA) assessment that were collected in all patients. Procedural All patients accepted for intervention were admitted the day prior to the cardiac surgery service for final review and anesthesia assessment. All procedures were carried out in the cardiac catheterization laboratory or interventional radiology hybrid suite based on availability or perceived risk for vascular access issues. This means that patients at highest risk of vascular complications are preferentially performed in the interventional radiology hybrid suite to facilitate access to the necessary equipment (balloons, catheters and ) for intervention on the peripheral vasculature. Members from each team were present at all procedures and responsible for specific aspects of the intervention. Patient support: anesthesia team member was responsible for patient monitoring, echocardiography, pacing and cardiorespiratory support. Vascular access: The preferred approach was femoral unless not possible. Alternate approaches used were individualized based on clinical scenario and included: trans-apical, direct aortic and axillary. This task was mainly provided by interventional radiologists unless a surgical cut-down was needed. Percutaneous vascular access for diagnostic catheters, pacing wire and valve was achieved with combined sonographic and fluoroscopic guidance to ensure precise puncture in a plaque free segment of the common femoral . Clinical of fluoroscopic landmarks are inadequate to provide pinpoint accuracy of access, and guided infiltration of local anaesthetic improves pain relief [18]. In selected patients a preliminary /stenting or use of a balloon expandable sheath (SoloPath) was used to facilitate access as identified on the pre-surgical planning meeting. Typically 2 Proglide sutures were placed at the site of access for the large, valve delivery sheath, and the diagnostic and pacing catheter sites were closed with one proglide device and starclose device respectively, at the completion of the procedure. Pacing and valve crossing: Temporary pacing and valve crossing was generally the responsibility of the interventional cardiologist and was performed using well-described techniques under fluoroscopic guidance. Valve preparation and deployment: The interventional radiologist and interventional cardiologists shared valve preparation duties. Valve deployment was shared between interventional cardiology and surgery. Stiff wire manipulation and balloon inflation were taken care of by the interventional radiologist during valve deployment. Rapid pacing was used to achieve minimal pulsatility in the majority of cases. The decision for valve deployment was made collaboratively with any member capable to stop the process if anything was judged to be inappropriate. All cases were carried out with a standby circuit available with on site. Nursing support included representation from all teams including interventional cardiology, interventional radiology and cardiac surgery.

Page 3 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

Post-procedural In the initial experience all patients were transferred to the cardiovascular ICU for a minimum of several hours. This has evolved to now an initial recovery in the cardiac catheterization bay area for a minimum of 40 mins prior to transfer to the cardiac surgery ward for final recovery. Post-operative care was standardized and now emphasized early mobilization and planned discharged the day after intervention. The post-operative care is a shared responsibility between the interventional cardiologist and surgeon involved in the procedure. Data capture and follow-up All patient information, procedural details and outcomes early and late after discharge were collected and maintained in our NBHC-TAVR database. The NBHC-TAVR database is a prospectively collected data registry on all TAVR procedures performed at the NBHC that was mandated by Government and the Institution at the outset of the Program creation. As part of the registry we are mandated to capture not only in-hospital outcome but also yearly follow-up including echocardiography information on all patients undergoing TAVR. The registry currently has follow- up data on all patients since 2010. Routine follow-up was standardized and included discharge echocardiography, 6 week and 3 months follow-up with echo followed by yearly visit with echo. Vascular access complications were defined based on previously published definitions [17]. Briefly major vascular complications included all aortic complications, access site complications resulting in adverse patient outcomes (including major bleeding) or unplanned surgical intervention. All data analysis was carried out using Prism Software version 6©. In brief continuous variables were compared using t-test or ANOVA when appropriate. Categorical variables were compared with chi square analysis and fisher’s exact test. Results During the study period a total of 332 TAVR were attempted and 327 completed as planned (98.5%) (Figure 1). The average age of patients was 80 years, 40% female, 34% previous heart surgery and with an average STS score of 5.2 (Table 1). Overall frailty was noted as a significant reason for undergoing TAVR in 41% of patients, which corresponded to 25% being frail using the Katz index and 67% with a MOCA of less than 26 suggesting some cognitive impairment. During the first 7 years of the program there was a significant evolution of TAVR with respect to patient selection and implantation access route. Major changes can be seen in Table 2. In brief patients overall risk improved over time with STS score ranging from 7.4 in 2010 to 3.9 in 2017. In the first year nearly half of patients were performed using a trans- apical approach while more recently nearly 100% were performed transfemorally (Table 3). Similarly, the femoral approach was initially performed exclusively using a surgical cutdown but has evolved to nearly 100% percutaneous in 2017. All patients were initially performed asleep under full anesthesia to allow transesophageal echocardiography (TEE) but now are performed largely awake with conscious sedation and use transthoracic echocardiography (TTE) rather than TEE.

Figure 1. Figure illustrating all patients in which a TAVR procedure was planned at the NBHC during the study period. CPB- cardiopulmonary bypass, TAVR-transcatheter aortic valve replacement

Page 4 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

Table 1. Baseline characteristics of patients undergoing TAVI April/2010-Dec/2017 at NBHC (n=332) Characteristic (%) All n=332 Age (years), mean ± SD 79.6 ± 9.2 Female, n (%) 132 (39.8) Diabetes 125 (37.7) PVD 128 (38.6) Neurological (dementia, , TIA) 78 (23.5) Carotid disease 108 (32.5) Renal failure (Cr >176 umol/L) 25 (7.5) Pulmonary* 145 (43.7) Previous PCI 91 (27.4) Previous heart surgery 111 (33.4) Previous CABG 90 (27.1) NYHA class III-IV (vs. I-II) 231 (69.6) LVEF, median, IQR 55 (45, 60) MOCA <26 (n=294) 196 (66.7) Duke Activity Index, median, IQR (n=307) 15.70 (13.00, 20.06) METs†, median, IQR (n=307) 4.67 (4.34, 5.21) Frail (Katz ADL<6) 84 (25.3) Log EuroSCORE, median, IQR 5.595 (3.41, 10.78) STS Score, median, IQR 5.15 (3.28, 8.54) Reason for TAVR Excessive risk/frailty 135 (40.7) Comorbidities 101 (30.4) Surgical/Technical 98 (29.5) CABG: Coronary Artery Bypass; COPD: Chronic Pulmonary Disease, NYHA: New York Heart Association; LVEF: Left Ventricular Ejection Fraction; †MET=(0.43*DASI+9.6)/3.5; MOCA: Montreal Cognitive Assessment; PCI: Percutaneous Coronary Intervention; PVD: Peripheral Vascular Disease; STS: Society of Thoracic Surgery; TAVR: Transcatheter Aortic Valve; TIA: Transient Ischemic Attack

Table 2. Baseline characteristics of patients undergoing TAVI April/2010-Dec/2017 at NBHC (n=332) Era All Characteristic (%) 2010-12 2013-14 2015 2016 2017 p-value n=332 n = 64 n = 79 n = 66 n = 65 n = 58 Age (years), mean ± 79.6 ± 9.2 80.6 ± 6.9 80.0 ± 8.5 79.9 ± 7.6 79.6 ± 9.1 77.5 ± 13.1 0.41 SD Female, n (%) 132 (39.8) 33 (51.6) 41 (51.9) 28 (42.4) 20 (30.8) 10 (17.2) 0.0001 Diabetes 125 (37.7) 21 (32.8) 28 (35.4) 30 (45.5) 21 (32.3) 25 (43.1) 0.40 PVD 128 (38.6) 21 (32.8) 24 (30.4) 32 (48.5) 27 (41.5) 24 (41.4) 0.18 Neurological (dementia, stroke, 78 (23.5) 14 (21.9) 20 (25.3) 15 (22.7) 14 (21.5) 15 (25.9) 0.97 TIA) Carotid disease 108 (32.5) 14 (21.9) 27 (34.2) 27 (40.9) 23 (35.4) 17 (29.3) 0.20 Renal failure (Cr >176 25 (7.5) 8 (12.5) 2 (2.5) 4 (6.1) 4 (6.2) 7 (12.1) 0.11 umol/L) Pulmonary* 145 (43.7) 26 (40.6) 39 (49.4) 34 (51.5) 31 (47.7) 15 (25.9) 0.03 Previous PCI 91 (27.4) 6 (9.4) 21 (26.6) 18 (27.3) 25 (38.5) 21 (36.2) 0.002 Previous heart 111 (33.4) 23 (35.9) 25 (31.6) 21 (31.8) 25 (38.5) 17 (29.3) 0.82 surgery Previous CABG 90 (27.1) 22 (34.4) 19 (24.1) 17 (25.8) 19 (29.2) 13 (22.4) 0.57 NYHA class III-IV 231 (69.6) 56 (87.5) 56 (70.9) 50 (75.8) 36 (55.4) 33 (56.9) 0.0002 (vs. I-II) (45, (40, (50, (40, (49, (50, LVEF, median, IQR 55 57.5 60 55 55 55 0.83 60) 65) 65) 60) 60) 60) MOCA <26 (n=294) 196 (66.7) 41 (74.5) 46 (61.3) 36 (59.0) 38 (67.9) 35 (74.5) 0.25 Duke Activity Index, (13.00, (13.00, (13.87, (12.69, (12.69, (13.87, 15.70 15 15.81 15.38 16.56 17.31 0.58 median, IQR (n=307) 20.06) 19.50) 19.89) 17.74) 21.70) 21.08)

Page 5 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

METs†, median, IQR (4.34, (4.34, (4.45, (4.30, (4.30, (4.45, 4.67 4.59 4.69 4.63 4.78 4.87 0.58 (n=307) 5.21) 5.14) 5.19) 4.92) 5.41) 5.33) Frail (Katz ADL<6) 84 (25.3) 45 (70.3) 9 (11.4) 9 (13.6) 11 (16.9) 10 (17.2) <0.0001 Log EuroSCORE, (3.41, (3.57, (3.19, (4.16, (3.32, (2.78, 5.595 6.45 6.09 7.75 5.63 4.21 0.005 median, IQR 10.78) 9.47) 11.17) 14.45) 10.14) 6.00) STS Score, median, (3.28, (4.45, (4.26, (3.50, (2.34, (2.28, 5.15 7.35 6.42 5.78 3.72 3.85 <0.0001 IQR 8.54) 12.70) 9.30) 8.75) 7.10) 5.43) Reason for TAVI Excessive risk/frailty 135 (40.7) 27 (42.2) 36 (45.6) 31 (47.0) 28 (43.1) 13 (22.4) 0.04 Comorbidities 101 (30.4) 31 (48.4) 30 (38.0) 10 (15.2) 11 (16.9) 19 (32.8) <0.0001 Surgical/Technical 98 (29.5) 23 (35.9) 22 (27.8) 21 (31.8) 17 (26.2) 15 (25.9) 0.69 CABG: Coronary Artery Bypass; NYHA: New York Heart Association; LVEF: Left Ventricular Ejection Fraction; MOCA: Montreal Cognitive Assessment; PCI: Percutaneous Coronary Intervention; PVD: Peripheral Vascular Disease; STS: Society of Thoracic Surgery; TAVR: Transcatheter Aortic Valve; TIA: Transient Ischemic Attack *Pulmonary disease included COPD, asthma, pulm htn, FEV1<1, interstitial fibrosis, O2 dependent, pulmonary fibrosis.

Table 3. Procedural details of patients undergoing TAVI April/2010-Dec/2016 at NBHC (n=332) Era All Characteristic (%) 2010-12 2013-14 2015 2016 2017 p-value n = 332 n = 64 n = 79 n = 66 n = 65 n = 58 Location of procedure Cath Lab 263 (79.2) 64 (100.0) 78 (98.7) 46 (69.7) 35 (53.8) 40 (69.0) Hybrid Room 68 (20.5) 0 (0.0) 0 (0.0) 20 (30.3) 30 (46.2) 18 (31.0) <0.0001 Operating room 1 (0.3) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 0 (0.0) Pre-Implantation Balloon 278 (83.7) 51 (79.7) 71 (89.9) 55 (83.3) 52 (80.0) 49 (84.5) 0.46 Valvuloplasty Completed Approach (n=327, not aborted) Femoral 277 (84.7) 32 (54.2) 71 (89.9) 55 (83.3) 61 (93.8) 58 (100.0) Other (transaortic, apical, <0.0001 50 (15.3) 27 (45.8) 8 (10.1) 11 (16.7) 4 (6.2) 0 (0.0) subclavian) Femoral Surgical cut-down (% of 277) 167 (60.3) 32 (100.0) 71 (100.0) 55 (100.0) 7 (11.5) 2 (3.4) <0.0001 Percutaneous 110 (39.7) 0 (0.0) 0 (0.0) 0 (0.0) 54 (88.5) 56 (96.6) Anaesthesia General 272 (81.9) 64 (100.0) 79 (100.0) 66 (100.0) 55 (84.6) 8 (13.8) <0.0001 Local/Conscious 60 (18.1) 0 (0.0) 0 (0.0) 0 (0.0) 10 (15.4) 50 (86.2) Procedure Aborted 5 (1.5) 5 (7.8) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) <0.001 Unable Cross Native Valve 1 (0.3) 0 (0.0) 0 (0.0) 1 (1.5) 0 (0.0) 0 (0.0) 0.76 Converted to Surgery* 4 (1.2) 1 (1.6) 2 (2.5) 0 (0.0) 1 (1.5) 0 (0.0) 0.75 Need for CPB 11 (3.3) 2 (3.1) 4 (5.1) 2 (3.0) 2 (3.1) 1 (1.7) 0.93 Concomitant procedure 21 (6.3) 2 (3.1) 6 (7.6) 6 (9.1) 2 (3.1) 5 (8.6) 0.43 Concomitant PCI 7 (2.1) 1 (1.6) 3 (3.8) 2 (3.0) 0 (0.0) 1 (1.7) 0.63 Concomitant pacemaker 2 (0.6) 0 (0.0) 1 (1.3) 1 (1.5) 0 (0.0) 0 (0.0) 1.00 (planned) Concomitant pacemaker 13 (3.9) 0 (0.0) 3 (3.8) 3 (4.5) 2 (3.1) 5 (8.6) 0.17 (unplanned) Device Type (n=327, not aborted) Edwards Sapien XT 192 (58.7) 59 (100.0) 71 (89.9) 32 (48.5) 30 (46.2) 0 (0.0) St Jude Portico 51 (15.6) 0 (0.0) 8 (10.1) 32 (48.5) 11 (16.9) 0 (0.0) Edwards Sapien 3 77 (23.5) 0 (0.0) 0 (0.0) 0 (0.0) 20 (30.8) 57 (98.3) <0.0001 CoreValve 2 (0.6) 0 (0.0) 0 (0.0) 2 (3.0) 0 (0.0) 0 (0.0) Evolut R 5 (1.5) 0 (0.0) 0 (0.0) 0 (0.0) 4 (6.2) 1 (1.7) CPB: Cardiopulmonary Bypass; PCI: Percutaneous Coronary Intervention

Page 6 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

The majority of the valves implanted were balloon-inflated valves from Edwards (82.2%) compared to self- expanding valves from Medtronic and St. Jude (17.8%). In all cases a surgical team was present with a CPB circuit available in the intervention room. Interventions were performed in the cath lab (79.2%) and interventional radiology hybrid room (20.5%). In our more recent experience where most patients were performed percutaneously the procedure was performed in the interventional hybrid room in 41% of patients. In total CPB was required in 11 patients (3.3%) to support TAVR with 3 patients (0.9%) requiring sternotomy conversion for a major complication namely annular rupture. Access was defined as the site of insertion of the device and included: non-femoral (n=50), femoral cutdown (n=167) and femoral percutaneous (n=110). The incidence of PVD was high (38.6% of patients) and appeared to increase during the 7-year experience. In our more recent experience with an exclusively percutaneous approach one should note that a large number of patients had challenging access vessels simply based on size with 26% <7 mm and 16% <6 mm femoral vessels. In the majority of these patients selective peripheral angioplasty was performed to allow safe sheath insertion and retrieval. Some patients also received peripheral stenting in particular to address bulky calcification of the iliac vessels. There were a total of 10 patients who experienced some access complication (3%) the majority defined as trivial or minor as these did not require surgical intervention or result in adverse patient outcome. A single patient had a major complication involving the cardiac apex and required for the procedure to be aborted given tissue fragility after being repaired on CPB. This means that any vascular complication combining access and annular ruptures occurred in only 3.9% of patients (n=13) with a major vascular complication occurring in 1.2% of patients (n=4) (Table 4).

Table 4. Vascular complications Era All Outcome (%) 2010-12 2013-14 2015 2016 2017 p-value n = 332 n = 64 n = 79 n = 66 n = 65 n = 58 Access complications None 322 -97 63 -98.4 76 -96.2 64 -97 64 -98.5 55 -94.8 Trivial 3 -0.9 0 0 1 -1.3 0 0 0 0 2 -3.4 Minor 6 -1.8 0 0 2 -2.5 2 -3 1 -1.5 1 -1.7 Major 1 -0.3 1 -1.6 0 0 0 0 0 0 0 0

Table 5. Outcomes of patients undergoing TAVI April/2010-Dec/2016 at NBHC (n=332). Era All Outcome (%) 2010-12 2013-14 2015 2016 2017 p-value n=332 n=64 n=79 n=66 n=65 n=58 Pacemaker 34 (10.2) 4 (6.3) 9 (11.4) 6 (9.1) 4 (6.2) 11 (19.0) 0.12 Stroke 11 (3.3) 2 (3.1) 1 (1.3) 4 (6.1) 0 (0.0) 4 (6.9) 0.10 TIA 3 (0.9) 0 (0.0) 0 (0.0) 1 (1.5) 1 (1.5) 1 (1.7) 0.64 In-hospital mortality 5 (1.5) 2 (3.1) 0 (0.0) 0 (0.0) 1 (1.5) 2 (3.4) 0.20 Resulting Total Aortic Regurgitation (n=322)† None 160 (49.7) 15 (26.3) 36 (46.8) 30 (45.5) 41 (64.1) 38 (65.5) Trivial 72 (22.4) 11 (19.3) 18 (23.4) 17 (25.8) 14 (21.9) 12 (20.7) Mild 81 (25.2) 28 (49.1) 23 (29.9) 14 (21.2) 8 (12.5) 8 (13.8) 0.0001 Mild to moderate 3 (0.9) 0 (0.0) 0 (0.0) 2 (3.0) 1 (1.6) 0 (0.0) Moderate 5 (1.6) 3 (5.3) 0 (0.0) 2 (3.0) 0 (0.0) 0 (0.0) Moderate to severe 1 (0.3) 0 (0.0) 0 (0.0) 1 (1.5) 0 (0.0) 0 (0.0) Length of stay, procedure to 4 (3, 5) 5 (4, 5.5) 4 (3, 6) 4 (3, 6) 3 (2, 4) 2 (1, 3) <0.0001 discharge, median (IQR) Discharged 1 day post-TAVR 36 (10.8) 0 (0.0) 0 (0.0) 0 (0.0) 8 (12.3) 28 (48.3) <0.0001 30d mortality 8 (2.4) 3 (4.7) 2 (2.5) 0 (0.0) 1 (1.5) 2 (3.4) 0.48 TIA transient ischemic attack, TAVR transcatether aortic valve †among those not aborted or explanted

Page 7 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

Overall patient outcomes are listed in Table 5. Residual aortic regurgitation (AR) defined as moderate or more was limited to 3.8% of patients with a single patient believed to have moderate to severe AR. Permanent pacemaker were required in 10.2% of patients with 10/34 receiving a permanent pacemaker at the time of the TAVR. The overall in- hospital mortality rate was low at 1.5% and 30-day mortality was 2.4%. The median length of hospitalization post TAVR improved significantly during the study period now being 3 days (IQR 2-4). In 2017, where most patients were performed with conscious sedation and percutaneous approach, single day post TAVR discharge was achieved in 48% of patients. Discussion We demonstrate in the present manuscript the early adoption of the “heart team” concept for the treatment of patients with severe aortic stenosis in which diverse groups of clinicians learned to work together using novel technology. We also highlight how our model TAVR program has evolved significantly over the 7 years by adopting increasingly less invasive approach to patients undergoing TAVR as demonstrated by our adoption of percutaneous approach and conscious sedation. Importantly our experience demonstrates our continued efforts to provide excellent outcomes that compare favorably to other large studies and registries around the world [19]. We report an overall in- hospital mortality rate of 1.5%, which is significantly lower than the predicted mortality based on the well-described STS scoring system. While our overall approach to TAVR is not unique, we argue that our team composition and overall dynamic is unique. There are to the best of our knowledge few centers where interventional radiology plays such a critical role in the Heart Team [20]. Their expertise has been essential in our gradual transition to a nearly 100% percutaneous transfemoral approach. In the last 100 cases there has only been one single patient requiring alternate access (axillary approach) this in spite of 35% of patients with significant known PVD and a significant proportion having small access vessels (26% <7 mm). We also reported a 1.2% major vascular complication rate, which favors favorably to larger series. Infact most reported series suggest that major vascular complications occur in approximately 5% of patients and are likely higher than 10% in patients with PVD where a TF approach is attempted [16,17,21]. One should note that overall vascular issues in our series occurred in significantly fewer patients (<5%) with the majority being minor issues requiring only a percutaneous solution like angioplasty or stenting without affecting patients in terms of bleeding (transfusion) or length of stay in hospital. The definition of vascular complication we used was previously validated [17]. Interventional radiologists have in many institutions been key clinicians involved in the management of peripheral vascular disease and in collaboration with [22]. They have largely been responsible for peripheral interventions and challenging vascular access [22]. This explains at least in part why interventional radiologists have proven to be invaluable members of our TAVR team. This is exemplified by our low (3%) access complication rate and also near complete elimination of the need for alternate access approaches, which typically appear to confer significantly increased risk to TAVR procedures (no alternate access cases in 2017). There are aspects of having the interventional radiologists as part of our team that have impacted each and every patient namely: procedural planning largely based on the CT imaging that included important nuances in terms of likelihood of success with femoral access; planned or possible peripheral vascular interventions needed to allow every patient to be considered for femoral approach; and the interventional radiology hybrid suite facilitating all peripheral interventions when needed. One should also note that the workload on the CT staff and radiologists was not trivial and required cooperation and commitment to optimally plan each patient. This critical planning of vascular access for various valve systems, temporary pacemaker and diagnostic catheters was a routine part of every report and printed “TAVI Planning Sheet” that served as a guide for every intervention.

Page 8 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

Overall, we have developed a system which TAVR procedures are performed in a collaborative manner and where all team members are valued. Critical decisions have not relied on a single individual but instead on overall consensus. We argue that the New Brunswick Heart Centre TAVR Team is an example of a well functioning “Heart Team” and stands in contrast to programs in which outcomes are highly dependent on the team leader rather than a shared responsibility model. Our shared responsibility model promotes respect and understanding of the extensive experience and complementary skills of each member. We argue that our team composition will be particularly critical as TAVR indications are expanding into lower risk patients in which the margin for error or complications will be lower. With time and experience we have adopted increasingly less invasive approaches such as conscious sedation, percutaneous femoral access and avoidance of intensive care unit. While our approach is not universally accepted by all centers performing TAVR it is increasingly being recognized as an approach that is safe in appropriately selected patients [23]. This approach has resulted in significant reduction of hospital resources such as ICU stay and overall length of stay without sacrificing the quality of the care. In fact, recent evidence suggests that it may actually improve patient outcomes [23,24]. One should note that with adoption of a less invasive TAVR approach, governing principles such as readiness for emergency support or sternotomy were not abandoned and remain critical for a small group of patients. In all cases the TAVR team members (cardiology, radiology and surgery) were supported with appropriate resources from nursing and ancillary groups such as x-ray technology and perfusion. We have addressed challenges to scheduling by focusing on patient need and have emphasized flexibility by all members to the benefit of the team as a whole. At present our approach is to limit the impact on the daily activities of the services involved which are surgery, anesthesia, interventional cardiology and interventional radiology. To achieve this, we currently schedule a single TAVR first case in the morning, which can be performed within 60 min (supplemental Table). This allows the operating room, the cath lab and the interventional hybrid room to function normally for the rest of the day with only a slight delay in their activities. One should note that emergent sternotomy and conversion to SAVR was performed in 3 cases due to root rupture with 1 patient achieving a good outcome ultimately. While these critical situations are rare preparedness remains key to achieving some success as demonstrated by others [25]. In summary we demonstrate our approach to the “Heart Team” composition in which all team members have clear dedicated roles and a collaborative responsibility to every patient to ensure the best outcome. In particular we provide evidence that interventional radiologists can add significant value to the team when dealing with vascular access. We argue that there are important qualities and experience that can be gained by someone who does peripheral vascular interventions as part of their daily work, which is difficult to measure or quantify. It is important to note that our study is not without its limitations. In fact, our findings may not be generalizable to other institutions given practice patterns and variable expertise with peripheral intervention unique to each institution. The present study represents a retrospective analysis of a single center experience and did not allow a true comparison that would measure the impact of the addition of interventional radiology to a TAVR team. However, we point out in the present study key features of teamwork that are increasingly being recognized as valuable but have been traditionally difficult to define and implement in medicine [26]. Acknowledgement We acknowledge the work that Dr. Marc Pelletier provided as a founder of the TAVR program at the NBHC and a strong proponent of a diverse collegial TAVR team. He was responsible in part for the early experience (2010-2015). Additional team members from cardiac anesthesia who should be recognized for their contributions include Dr’s A Clarke, J Cloutier and D Hughes.

Page 9 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

Conflict of Interest All author’s state that they have not had financial support or relationships that may pose any conflict of interest regarding the products used in the present manuscript. The work from this manuscript has been presented at the Canadian Cardiovascular Congress with an abstract published in the Canadian Journal of Cardiology in 2018. No other aspects of the manuscript have been published. References 1. Liu Z, Kidney E, Bem D, Bramley G, Bayliss S, et al. (2018) Transcatheter aortic valve implantation for aortic stenosis in high surgical risk patients: A systematic review and meta-analysis. PLoS One 13: e0196877. 2. Siontis GC, Praz F, Pilgrim T, Mavridis D, Verma S, et al. (2016) Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J 37: 3503-3512. 3. Tarantini G, Nai Fovino L, Gersh BJ (2018) Transcatheter aortic valve implantation in lower-risk patients: what is the perspective? Eur Heart J 39: 658-666. 4. Lim GB (2017) Valvular disease: TAVI noninferior to surgery in intermediate-risk patients. Nat Rev Cardiol 14: 255. 5. Thyregod HG, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, et al. (2015) Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis: 1-Year Results from the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol 65: 2184-2194. 6. Cahill TJ, Chen M, Hayashida K, Latib A, Modine T, et al. (2018) Transcatheter aortic valve implantation: current status and future perspectives. Eur Heart J 21: 2625-2634. 7. Merkel S, Eikermann M, Neugebauer EA, von Bandemer S (2015) The transcatheter aortic valve implementation (TAVI)--a qualitative approach to the implementation and diffusion of a minimally invasive surgical procedure. Implement Sci 10: 140. 8. Chelliah R, Showkathali R, Brickham B, Dworakowski R, Alcock E, et al. (2014) 100 Multi-disciplinary : Next Step In “heart Team” Approach For Tavi. BMJ Heart 100: A58-A59. 9. Antonides CFJ, Mack MJ, Kappetein P (2017) Approaches to the Role of The Heart Team in Therapeutic Decision Making for Heart Valve Disease. Structural Heart 1: 249-255. 10. Hong SJ, Hong MK, Ko YG, Choi D, Hong GR (2014) Multidisciplinary Team Approach for Identifying Potential Candidate for Transcatheter Aortic Valve Implantation. Yonsei Med J 55: 1246-1252. 11. Himbert D, Descoutures F, Al-Attar N, Iung B, Ducrocq G, et al. (2009) Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis. J Am Coll Cardiol 54: 303-311. 12. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, et al. (2012) Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 366: 1705-1715. 13. Sawaya FJ, Lefèvre T, Spaziano M, Roy A, Fernandez L, et al. (2016) Transfemoral Transcatheter Aortic Valve Implantation: How Minimalistic Can We Become? J Interv Cardiol 29: 628-631. 14. Kahlert P, Al-Rashid F, Weber M, Wendt D, Heine T, et al. (2009) Vascular access site complications after percutaneous transfemoral aortic valve implantation. Herz 34: 398-408.

Page 10 of 11 Volume 1, Article ID: 100002 Légaré JF, Hassan A, Yip AM, LeBlanc H, Macleod JB, et al. (2019) How Interventional Radiology Can Enhance the Performance of a TAVR Team: New Brunswick Heart Centre Experience. Emed Res 1: 100002.

15. Sinning JM, Horack M, Grube E, Gerckens U, Erbel R, et al. (2012) The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry. Am Heart J 164: 102-110. 16. Kim BG, Ko YG, Hong SJ, Ahn CM, Kim JS, et al. (2018) Impact of peripheral artery disease on early and late outcomes of transcatheter aortic valve implantation in patients with severe aortic valve stenosis. Int J Cardiol 255: 206-211. 17. Mangla A, Gupta S (2012) Vascular complications post-transcatheter aortic valve procedures. Indian Heart J 68: 724-731. 18. Fujihara M, Haramitsu Y, Ohshimo K, Yazu Y, Izumi E, et al. (2017) Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous . Cardiovasc Interv Ther 32: 233-240. 19. Eggebrecht H, Bestehorn M, Haude M, Schmermund A, Bestehorn K, et al. (2016) Outcomes of transfemoral transcatheter aortic valve implantation at with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients. Eur Heart J 37: 2240-228. 20. Kiefer P, Seeburger J, Noack T, Schröter T, Linke A, et al. (2015) The role of the heart team in complicated transcatheter aortic valve implantation: a 7-year single-centre experience. Eur J Cardiothorac Surg 47: 1090-1096. 21. Malyar NM, Kaier K, Freisinger E, Lüders F, Kaleschke G, et al. (2017) Prevalence and impact of critical limb ischaemia on in-hospital outcome in transcatheter aortic valve implantation in Germany. EuroIntervention 13: 1281-1287. 22. Dominguez A, Bahadorani J, Reeves R, Mahmud E, Patel M (2015) Endovascular for critical limb ischemia. Expert Rev Cardiovasc Ther 13: 429-44. 23. Hyman MC, Vemulapalli S, Szeto WY, Stebbins A, Patel PA, et al. (2017) Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation 136: 2132-2140. 24. Toppen W, Johansen D, Sareh S, Fernandez J, Satou N, et al. (2017) Improved costs and outcomes with conscious sedation vs general anesthesia in TAVR patients: Time to wake up? PLoS One 12: e0173777. 25. Eggebrecht H, Vaquerizo B, Moris C, Bossone E, Lämmer J, et al. (2018) Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI). Eur Heart J 39: 676-684. 26. Rosenbaum L (2019) Divided We Fall. N Engl J Med 380: 684-688.

Page 11 of 11 Volume 1, Article ID: 100002