V. Voudris MD PhD FESC FACC

Director Interventional Cardiology Division

Chairman Cardiology Department

Onassis Cardiac Surgery Center

A Growing Conundrum; Coronary Access After TAVR Difficulties, Tips and Tricks

Disclosures

Consulting Fees / Honoraria :

Medtronic

➢ Transcatheter Aortic Valve Replacement (TAVR) is now the standard of care for patients who are not surgical candidates, and is comparable to surgical aortic valve replacement (SAVR) in high-and intermediate- risk patients

➢ The prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) is high ➢ in the most recent randomized trials

comparing TAVR to surgery in intermediate-risk patients, >60% have coexisting CAD

TAVR and CAD

The ACTIVATION trial is currently randomizing patients with CAD and severe AS to either pre-TAVR PCI or no pre-TAVR PCI

➢As TAVR indication expands to lower-risk patients who have better long-term prognoses, there will be an increasing need for repeat coronary angiography and percutaneous coronary intervention (PCI) due to progressive CAD and development of acute coronary syndrome

➢However, management of symptomatic CAD after TAVR has not been systematically examined

Coronary Interventions post - TAVR

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CORONARY ACCESS AFTER TAVI

PREVALENCE OF CAD IN TAVR PATIENTS

TAVR Patients with CAD1

40 – 75%

Post-TAVR PCI Rates2,3

3.5 – 5.7%

Median Time to Post-TAVR PCI3

17.7 Months

1.Yudi, et. Al. JACC, 2018.2.Blumenstein et al. Clinical Research in Cardiology, 2015.

3.Allali, et al. Cardiovascular Revasc Med, 2016.

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CORONARY ACCESS AFTER TAVR

Clinical data show that coronary access post-TAVR is technically feasible and highly successful for all valve types

Source TAVIs IncludedAngiography Success Rate

PCI Success Rate

Chetcuti et al., JACC, 2016 169 CoreValve 186/190 (97.9%) 103/113 (91.2%)

Htun et al., Catheter Cardiovasc Inter, 2018 28 CoreValve 71/75 (94.6%) 29/29 (100%)

Zivelonghi et al., Am J Cardiol, 2017 41 Sapien 325 Evolut R

65/66 (98.0%) 17/17 (100%)

Blumenstein et al., Clin Res Cardiol, 2015 19 Sapien 3

10 CoreValve4 Symetis1 Portico1 Jena Valve

34/34 (97.1%) 10/10 (100%)

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CORONARY ACCESS AFTER TAVR

POTENTIAL CHALLENGES TO POST-TAVR CORONARY ACCESS

All commercial trans-catheter aortic valve frames may extend above left coronary ostia in up to 25% patients.1

29 mm Evolut R TAV▪ Annulus Range = 23-26mm

▪ Depth = 3-5mm

26 mm Sapien™* 3 TAV▪ Annulus Range = 23.4-26.4 mm

▪ Depth = 10% of height

25 mm Lotus™* TAV▪ Annulus Range = 23-25mm

▪ Depth = 3.6 mm

Basal plane

20.1 mm

Min 10.4mm

Median 18.4 mm15.9 mm

Max 26.2mm

45.6 mm19 mm

22.5 mm

1.Coronary ostia height measurements are from CoreValve US IDE Trial; Measurements represent the height from the basal plane to the center of the left coronary ostium

IQ Range

To optimize future coronary re-access, implantation depth is critical, especially if the ostia is <10 mm

Because the skirt height of the Evolut-PRO is 13 mm, we need to implant at least 4 mm below the annular plane to ensure the skirt is not overlaying the coronary artery

In this optimal position, it is feasible to engage the coronary artery in a coaxial manner, assuming the native aortic valve leaflets will not interfere with the path to the coronary ostium

If the valve is deployed high, coronary obstruction would not occur due to the narrow waist of the valve and sufficient sinus of Valsalva width

Selective coronary angiography would be difficult in this scenario and would have to occur from a diamond above the ostium, given that the supra-annular valve and its covered segment (e.g., sealing skirt) would be above the level of the ostium

➢ Post-TAVR multidetector computed tomography (CT) can be helpful to determine the anatomy and approach to coronary re-access

➢However, there are several limitations in using this technique ✓ CT cannot be performed in urgent situations✓ it can be a logistical challenge to schedule a CT before an

elective catheterization, especially in terms of the intravenous contrast medium load in patients with renal insufficiency

✓ motion artifact and image quality may limit the ability to visualize leaflet orientation of the transcatheter valve

CT for Coronary Interventions post - TAVR

CT Analysis Post TAVR

CT analysis showed the relationship between skirt height and the coronary ostia, as well as the position of the commissural posts1. the commissural posts were away from the coronary

ostia2. the skirt (13 mm) was well below the left main

coronary artery (23.4 mm from base of the valve)

POST-TAVR CORONARY ACCESSMATERIAL LIST IN CATH LAB

➢J-Tip guidewire

➢Selection of PCI wires

➢Selection of guide catheters

✓Judkins (L & R)

✓Amplatz (L&R), MP, Pigtail, Ikari (R) 1.0/1.5

➢Guide extensions

✓Teleflex GuideLiner™

✓Boston Scientific Guidezilla™

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POST-TAVR CORONARY ACCESSSTEP 1: IDENTIFY CORONARY ORIGINE

▪Identify the coronary take-off points using aortography and a diagnostic pigtail catheter in the outflow portion of frame

▪Identify the frame cells adjacent to the coronary ostia to target when attempting to cannulate the coronaries

▪Recall that the target access zone is located from the waist to node three*

*Assumes implant depth of 3-5mm≈13mm sealing

skirt

Recommended Access Zone

CoreValve Evolut RValves are not shown to scale

20

Post-TAVI Coronary Access | Medtronic

POST-TAVR CORONARY ACCESSSTEP 2: CANNULATE CORONARY OSTIUM

▪Start with a guide catheter, such as a Judkins or an EBU

▪because the frame waist is narrower than the aorta, consider downsizing guide catheter by 0.5 mm

▪Facilitated by using J-wire or angled stiff glide wire to enter the ostia

▪Target the middle of the frame cell co-axial to the take off

▪if difficulty to directly coaxial to the ostium, use another cell

▪Avoid cannulation of the ostia from below the coronary take-off

Coronary Angiography after TAVR

Cannulate left coronary ostium through the middle of valve frame cell at the level of the coronary take-off

Coronary Angiography after TAVR

Cannulate right coronary ostium with a JR 4 catheter

If coronary engagement is unsuccessful try with

✓a non selective placement then engaging with the coronary guidewire

Coronary Interventions post – TAVRStep 2: Unsuccessful Cannulation of Coronary Ostia

Coronary Interventions post – TAVRStep 2: Unsuccessful Cannulation of Coronary Ostia

If coronary engagement is unsuccessful try with✓another guide catheter size

✓an extension catheter when

extra support is needed

or when the distance between

the frame and the coronary

ostia is large

Post-TAVI Coronary AccessStep 3: Perform Intervention

Advance a coronary balloon or stent through the guide catheter to treat the lesion or obstruction

Fluoro image courtesy of F . Ribichini, MD

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POST-TAVR CORONARY ACCESS

STEP 4: CONFIRM PATENCY AND REMOVE CATHETER AND GUIDEWIRE

After performing intervention, confirm patency and disengage guide catheter from ostium and withdraw through frame cell

▪Always remove guide catheter over a wire

▪If there is difficulty removing the guide catheter from ostium, use a balloon to disengage prior to pulling

SAPIEN XT SAPIEN 3

➢The Sapien 3 valve is more likely to extend above the coronary ostia and potentially interfere with coronary access

➢It is well documented that acute coronary obstruction is moreprevalent with balloon-expandable valves

➢Because it does not have a narrowed waist like the self-expanding valve, can extend beyond the STJ, making future coronary access from above the valve more challenging

➢Significant issues with coronary access post-TAVR have not been documented

Balloon Expandable Valve and Coronary Access

Coronary Angiography after Balloon Expandable TAVR

Functional Assessment after Balloon Expandable TAVR

➢Coronary angiography and PCI in post TAVR patients has a high success with both self-expandable and balloon expandable aortic valve devices

➢ Intricate knowledge of the valve design and its relationship with the coronary ostia, sinus of Valsalva, and STJ anatomies can help predict the difficulty in coronary re-access and identify a strategy to manage these patients

Conclusions