Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study.
OBJECTIVE
We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry.


METHODS
Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months.


RESULTS
The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 +/- 7% to 41% +/- 13%, P = 0.02).


CONCLUSIONS
Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.
Burzotta
Francesco
F
Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy. f.burzotta@rm.unicatt.it
Paloscia
Leonardo
L
Trani
Carlo
C
Mascellanti
Marco
M
Mongiardo
Rocco
R
Materazzo
Guido
G
Niccoli
Giampaolo
G
Di Marco
Massimo
M
Leone
Antonio Maria
AM
Porto
Italo
I
Mazzari
Mario Attilio
MA
Rebuzzi
Antonio Giuseppe
AG
Schiavoni
Giovanni
G
Crea
Filippo
F
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D004452:Echocardiography; D017558:Elective Surgical Procedures; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006353:Heart-Assist Devices; D006439:Hemodynamics; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012042:Registries; D018570:Risk Assessment; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left