First-in-man prolonged pressure-controlled intermittent coronary sinus occlusion to treat

refractory left ventricular dysfunction and ischemia

Francesco Giannini MD1, Marco Ancona MD1, Federico Pappalardo MD3, Luca

Ferri MD1, Richard J. Jabbour MD1, Andrea Aurelio MD1, Antonio Mangieri

MD1, Damiano Regazzoli MD1, Matteo Montorfano MD1, Michele De Bonis MD2,

Alberto Zangrillo MD3, Ottavio Alfieri MD2, Antonio Colombo MD1, Azeem

Latib MD1

1Interventional Cardiology Unit, 2Cardiac Surgery Unit and 3Department of Cardiothoracic

Anaesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy

Disclosure Statement of Financial Interest

Speaker's name: Francesco Giannini

I do not have any potential conflict of interest

Clinical Scenario

• Patient Demographic: Male, 32-year-old

• Severe Aortic Regurgitation:

Bicuspid aortic valve

Normal ascending aorta

Dilated left ventricle; EF 48%

• Aortic valve repair: Free margin plication +

subvalvular annuloplasty

• Five hours after surgery:

Ventricular fibrillation

Cardiogenic shock

Treatment

• Peripheral VA-ECMO

• IAOBP

Emergency re-sternotomy

Coronary Angiography

Spasm on mid LAD and RCA

TT Echocardiography

Clinical Scenario

• 1st Post operative (PO) day:

Impella placement due to poor LV unload

IAOBP removed

• 1st to 15th PO day:

Full mechanical support with VA-ECMO and

Impella

No LV function recovery

ECG: diffuse ST-segment depression

• 15th PO day: Repeated coronary angiography

Coronary Angiography - 15th PO day

Persistence of spasm on LAD

Baseline After nitrate

Spasm on RCA resolved

TT Echocardiography – 15th PO day

What shall we do?

• Full mechanical support (ECMO + Impella)

since 15 days

• Persistence of refractory LV dysfunction:

Diffuse ST-segment depression

• PICSO?

Percutaneous Intermittent Coronary Sinus

Occlusion (PICSO)

Van de Hoef TP et al.; EuroIntervention. 2015 May 19;11(1):37-44

• Prepare RAMSES study: 30 STEMI patients

• Primary end-point

Safety and feasibility of 90 minutes of PICSO treatment after pPCI

CMR-defined infarct size at 2-5 days and 4 months post pPCI for

PICSO-treated versus matched control patients

Percutaneous Intermittent Coronary Sinus

Occlusion (PICSO)

- PICSO Impulse Catheter

- PICSO Impulse Console

Percutaneous Intermittent Coronary Sinus

Occlusion (PICSO)

Intermittent occlusion of the coronary sinus

increases coronary sinus pressure which

translates into an increase in (arterial) wedge

pressure over the ischemic area

This leads to:

I. Redistribution of venous blood to the

border zone of the deprived

myocardium1

II. Enhanced washout of deleterious

agents from the microcirculation2

III. Induction and expression of VEGF in

the ischemic myocardium from the

venous endothelium3,4

1. Ido A, et al., Am J Physiol Heart Circ Physiol 280:1361-1367, 2001 2. Ikeoka et al.Jpn Circ J Oct;54(10):1258-73, 19903. Weigel G, et al., J Thorac urg 2007;133 4. Mohl W, et al., Nat Clin Pract Cardiovasc Med 2008;5:528-05. Mohl W, et al., Am J Cardiol 1984 Mar 15;53(7):923-8

PICSO: Novel Indication

Prolonged PICSO treatment

PICSO placed on 16th day

PICSO results

Recovery of normal LV function the day after PICSO

Prolonged PICSO therapy (17th – 20th PO day)

- PICSO quantity: 24829 mmHh

20th PO day: weaning from ventricular assistance device

- Sepsis and Respiratory failure

Conclusions

• Standard PICSO treatment:

To reduce the extend of myocardial necrosis in

STEMI patients

Maximum 90 minutes

• Novel application: prolonged PICSO therapy

To treat refractory LV dysfunction and ongoing

ischemia

Efficacy probable related to redistribution of

venous blood and improvement in

microvascular perfusion

Thank for your attention