Complex Double LM and LAD Bifurcation Intervention – April 2019
58 year old female presented with NSTEMI and CCS Class III angina on February 28, 2019 at OSH. A Cardiac Cath on March 12, 2019 revealed 3 V & LM CAD: 90% RCA-RPL, 80% mid RCA, 80% distal left main bifurcation, 80% proximal LAD/D1 bifurcation, 80% proximal LCx with SYNTAX Score of 35 and LVEF 50%. After Heart Team discussion, high-risk staged PCI was decided. Patient underwent successful intervention of RCA using two Promus Premier DES. Patient is now planned for high-risk staged PCI of LM bifurcation and LAD/D1 bifurcation using Impella LV assistance.
QFDA approval aside, where kdo you think Impella shows a clear benefit considering the cost of the device and of the procedure?
A.In my opinion best use of Impella is in pts with complex coronary lesions (high syntax score) and low EF (<35%). It is also clearly indicated in pts with near normal LV function where PCI may potentially cause hemodynamic compromise such as ULM PCI with RCA CTO, PCI of degenerated SVG etc.
QWhat percentage of PCI is it being used for in your institution?
A.Approx 3-4% of our 320PCIs per month (about 12-14) are being done with Impella assist. I also think that appropriate use of Impella should be reserved for maximum 4-5% of PCIs and not to overuse it unnecessarily.
QWhat are your three top indications for the device?
A.Unprotected distal LM bifurcation PCI with normal EF and RCA CTO, 2) Calcified LM bifurcation with EF <35%, 3) Complex 3 V CAD with high syntax score (above 32) with EF <30%.
QPlease provide clarity about the anti-coagulant use with the Impella catheter?
A.We use IV heparin in the Impella flush and use IV heparin as the preferred anticoagulant for PCI with Impella. Bivalirudin can also be used during PCI with Impella assist.
QWe have been watching dozens of cases like today's without Impella as LVEF was near normal. So what changed that we should now use an LV support device that has not been investigated in clinical trials?
A.We certainly need to prove the benefit of Impella in high risk complex PCI with normal LV function in a RCT. One good randomized trial could be stable CAD pts with intermediate to high Syntax score (23+) with normal LV function, comparing Impella assisted complete revascularization PCI versus CABG.
QIn light of today's presentation about strut thickness, do you feel it is the most important attribute in a stent?
A.Strut thickness came to light in 1998 in the ISAR-Stereo trial of Multilink BMS showing lower ISR with strut thickness less then <90 micron. Since then, numerous BMS and DES trials have shown lower ISR with thin struts; that number now is <70micron.
QMore important than the polymer? Or even the drug?
A.I still think most important component of the DES technology is the the antirestenosis drug followed by strut thickness and then lastly the polymer.
QDoes this information about strut thickness (lack of it) support the design and engineering of BVS that have been moving towards thinner struts?
A.That precisely was the reason for Abbott’s BVS failure (140micron thickness). Now newer BVS with 100micron thickness (like MeRas 100 of Meril Lifesciences) are making their way in the BVS technology space.
QRegarding SAFARI, why do you think there was no difference in bleeding in a very large trial?
A.SAFARI trial highlights our improved expertise in both radial and femoral access; later using US guidance or using micro puncture needle liberally.
QWere guidelines too hasty in recommending radial approach for STEMI?
A.Yes ESC guidelines have made Radial PCI as Class I indication in STEMI PCIs in 2017; ACC/AHA has not yet endorsed it as the class I and remains Class IIa. Certainly SAFARI trial results will dampen the enthusiasm of the committee members in the upcoming focused PCI recommendations to make TRI as the Class I for STEMI.