Staged Intervention of LAD & Diagonal Lesions with Impella Recover 2.5 Assist – June 2011

Case: 88-year old male (with IDDM, CRI, CVA, PVD, COPD) presented on May 10, 2011 with NSTEMI and cardiac cath revealed 3V+LM CAD (SYNTAX Score 44), and severe LV Dysfunction (LVEF 20%). CABG was recommended but declined due to multiple comorbidities. Patient underwent successful PCI (Rota DES) of culprit mid RCA lesion using Xience V DES (4.0x23mm). Now for staged intervention of Calcific LAD & Diagonal lesions with Impella Recover 2.5 Assist Device.

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Q&A

Q While using FFR, how often are you able to downgrade the SYNTAX score? Does that impact your decision regarding PCI and CABG?
A. In our practice at Sinai, FFR is used in about 5% of cases to determine physiological significance of a borderline 50-70% obstructive lesion on angiography. Hence it rarely affects the SYNTAX calculation which is purely angiographic.
Q How much is the learning curve with the Impella device? Should there be mandatory number of proctored cases for using the device?
A. Impella is a fairly simple device to insert with a short learning curve. In my opinion 2 cases should be required for proctoring.
Q What would be your concerns regarding use of the Impella catheter in this 88-year old patient?
A. Most important issue is potential vascular complications in the elderly pts due to calcification and tortuosity.
Q Are you compulsively ruling out LV thrombus, significant aortic valve disease and severe PVD prior to implanting the Impella?
A. Yes as significant aortic valve disease (AVA < 1.3cm2) is relative contraindication with severe PVD and LV thrombus being the absolute contraindication for Impella use.
Q Where do you remove your Impella device and how long after the procedure?
A. We remove Impella in the cath lab after the procedure using Preclose sutures. We have used this technique in all our Impella assisted PCI cases; no pt went out of the cath lab with Impella in place. Usually Impella device time is 40-45 minutes, to perform satisfactory PCI.
Q What is the recommended anti-coagulant strategy with the Impella device?
A. Either IV heparin bolus or Bivalirudin to keep ACT >300sec. Try to minimize the use of GP IIb/IIIa inhibitors in this group of pts due to fear of potential vascular complications.
Q What are some of the innovations that one may expect from the Impella device?
A. They have already made significant changes in the catheter with easy retrograde wire exit port, quick set up kit and improved console display. Others in plan are; better peel away arterial sheath, miniature the catheter size, new position marker for accurate placement, ability to provide CO >2.5L/min.
Q Is the new system significantly more user friendly? How much less preparation time does it need and are those significant reductions to facilitate D2B time STEMI interventions?
A. Now very little preparation is needed and device can be implanted in no time, with set up ready in < 5 minutes. These all work with the D2B time constraints in high risk primary PCI cases.
Q Does propagation of Impella and availability of larger IABP mean gradual extinction of Tandem Heart?
A. Yes. Our lab has not used TandemHeart over two years and don't miss this very complicated device.
Q Do you think the Impella device will have a role to play in structural heart disease management? Do you think the Impella device will have a role to play in structural heart disease management?
A. Only during emergencies and complication of TAVI to provide temporary support especially during coronary occlusion while PCI is being carried out. In other elective high risk structural heart disease cases I don't see the role of Impella.
Q Is it possible to keep cardiac output enough to keep the patient awake, in case of cardiac arrest during Impella-supported PCI?
A. YES while revascularization is being carried out, Impella will provide 2.5L/min output sufficient enough to keep vital organs alive.
Q Did you use Impella during PCI for RCA last time?
A. Yes. 10% of Impella cases have been in RCA alone PCI due severe LV compromise and lesion complexity.
Q Is the aggressive statin pretreatment before the elective PCI helpful for preventing NO-flow/Slow flow after Rotablation? If so, how long the statin should be given before the day of PCI? 5-7 days-pretreatment is enough?
A. High dose statins have been used in PCI (not specifically in Rota cases) and have shown to reduce peri-procedure MACE. They have given statin atleast one day before; especially Atorvastatin 80mg 24hrs before PCI in ARMYDA trial.
Q What is Dr. Sharma's exact definition of vessel diameter on IVUS? External elastic membrane to external elastic membrane? Or Luminal diameter, which is free from plaque near to the lesion?
A. Media to media on IVUS is the vessel diameter as seen by external elastic membrane. I usually use stent 0.5mm less than the size proposed by IVUS. Other way to size the stent, will be to take the average of lumen diameter proximal and distal to the lesion.
Q If the vessel has severely positive remodeling, for example, the outer diameter (adventitia to adventitia) is 4.5mm, but lumen diameter near to the lesion is around 1.75mm, and MLD is 1.3mm, do you still chose 2.0mm burr for Rota?
A. Burr size selection is done visually by angio and not by IVUS. If lumen seems to be >1.75mm in a vessel size >3.5mm, 2.0mm burr will be the choice.

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