Case and Plan:
84-year-old female presented with new onset CCS Class III angina with positive SPECT MPI for multivessel ischemia. A Cardiac Cath on January 28, 2020 revealed 3 V CAD: 90% proximal RCA, subtotal large proximal LAD/Diagonal bifurcation lesion, 80% small LCx-OM1, SYNTAX Score of 21 and LVEF of 55%. Patient had a successful intervention of proximal RCA using Promus Premier DES. Patient is now planned for imaging guided staged PCI of LAD and D1 bifurcation using dedicated two stent (mini-crush) technique.
Q&A
Q
What are the major issues causing controversy about Impella?
A.
Two abstract presentations from registry data in AHA 2019 and then print published in Circulation and JAMA have reported higher bleeding and inhospital mortality after Impella vs IABP in STEMI pts especially with Catdiogenic Shock. Cases although not randomized but were propensity matched, consistently showed higher bleeding and mortality with Impella use vs IABP use in these STEMI scenario.
Q
Have you experienced higher bleeding and mortality with Impella?
A.
We ourselves have not observed higher bleeding, vascular complications or mortality after Impella at Mount Sinai Hospital compared to IABP.
Q
For what indications are more data needed?
A.
We have good data for Impella use in high risk PCI (complex CAD and low EF <35%) based on the Protect II trial but do not have any RCT in STEMI pts or Cardiogenic Shock (CS). Two limited trials in CS showed no benefit of Impella over comparative group. Hence we need RCT to prove superiority of Impella over conventional strategy in hemodynamic unstable or cardiogenic Shock STEMI pts.
Q
Was the problem lax approvals that relied on Registries rather than clinical trials?
A.
That is correct that Impella got approval in CS STEMI pts merely based on the prospective registry data but without any positive RCT.
Q
What should the Impella be compared to for these indications?
A.
I recommend Impella in RCT involving adequate number of pts, needs to be compared to IABP or percutaneous LVAD in these STEMI CS pts.
Q
In the case today, how would Orbital atherectomy have fared?
A.
Orbital aterectomy is another viable alternative to RA in today’s case and would have performed well too.
Q
And the laser?
A.
Laser atherectomy is less then ideal in heavily calcified lesions; hence not appropriate.
Q
Which bifurcation technique are you presently using the most?
A.
Minicrush technique using dedicated 2 stents is our most preferred bifurcation technique for both LM and non LM lesions with diseased large SBr (> 2.75mm size). In smaller SBr and non diseased SBr, provisional stent technique is the gold standard. If SBr stent is needed in these pts, then TAP stent technique is preferred via the struts of the MV stent with final KBI.
Q
Where will shockwave find a niche?
A.
Shockwave (IVL) has lot early excitement but we need to wait for the trial data to see its niche. Moderate calcified lesions seems to be the best target for Shockwave therapy.
Q
Can one claim CME for watching your webcast?
A.
We will work with Mount Sinai CME to explore the possibility of getting 1.5 CME credits per episode at nominal fee. We will update our audience in next 1-2 months about this possibility.
