Patients with poor left ventricular (LV) function and complex coronary anatomy (such as multivessel disease, left main disease, and last remaining vessel) may be unsuitable for surgical revascularization due to high risk for periprocedural complications [
Recent meta-analysis by Pasceri et al. suggests improved outcomes following complete revascularization in patients with multivessel disease [
This is a retrospective study using a prospectively maintained database: data of all consecutive patients undergoing elective Impella-protected PCI from April 2007 to December 2016 in two high-volume (>1000 PCI per year) Italian cardiac catheterization laboratories. Patients with cardiogenic shock and acute myocardial infarction within 24 hours were excluded. According to the hospital practice at the two centers, the need for Impella-protected high-risk PCI was assessed based on collegial heart-team discussion in which the potential benefit of myocardial revascularization was agreed and surgical revascularization was considered not feasible. Coronary stenosis ≥70% was considered significant (≥50% in case of left main coronary artery lesion) by visual assessment on angiogram. Alternatively, it was assessed by guided by fractional flow reserve (FFR) or by stress test imaging. All patients provided written consent to undergo PCI with Impella support after detailed explanation of the procedural features. Clinical data, operative risk score (EuroSCORE I), and procedural data were prospectively collected. Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) score before and after the procedure was calculated for all patients without previous coronary surgery. For the present study, an interventional cardiology fellow (blinded to patient’s clinical presentation and outcome) graded the myocardium at jeopardy before and after PCI using the British Cardiovascular Intervention Society (BCIS) Jeopardy Score (JS) algorithm [
The Impella 2.5 or Impella CP (after its release in Italy) heart pumps were used and implantation was performed through percutaneous trans-femoral approach. All patients received iliac-femoral artery axis assessment by ultrasonography and/or peripheral angiography during a pre-PCI work-up. All femoral punctures were fluoroscopy-guided. Prior to Impella sheath placement, peripheral angiography (through the radial or contralateral femoral access selected for PCI) was performed to confirm the suitability of iliac-femoral arterial axis anatomy. Accordingly, when atherosclerotic burden or tortuosity was high, the contralateral iliac-femoral axis was assessed and the most favorable side was chosen for Impella implantation. The presence of atherosclerotic disease of the iliac-femoral axis with nonsignificant (<50% diameter) stenosis was not considered an exclusion criterion. No failure of device implantation was reported due to the screening process including systematic iliac-femoral axis assessment.
After femoral artery stick, a 6-8 Fr sheath was inserted. Then, “pre-closure” technique with suture-based hemostatic devices was used. The “pre-closure” technique was performed with (according to operator’s yield) the Prostar XL10F or Perclose ProGlide devices (Abbott Vascular Devices, Redwood City, CA, USA) and consisted of the suture deployment before introduction of the (13 Fr or 14 Fr) Impella 2.5 or CP sheath. After the procedure, Impella was removed and the sutures were tied by pushing down knot(s) in order to achieve percutaneous hemostasis. Of note, when using ProGlide, a double ProGlide pre-closure technique was adopted, based on sequential insertion of two ProGlide devices rotated in opposite sides 30-45°, to create an interrupted X-figure closure [
PCI was performed by the radial or (in patients with unsuitable radial accesses) by contralateral femoral approach using 6-8 Fr guiding catheters. Selection of guidewires, balloons, and stents was based operator’s choice. Drug-eluting stent implantation was the main PCI technique and debulking with Rotablator was the main adjunctive device used for severely calcified coronary segments. At the end of PCI, Impella speed was gradually decreased and patient’s hemodynamic condition was evaluated. In case of hemodynamic stability, Impella was immediately removed. In the case of mechanical hemostasis failures, manual compression followed by compressive bandage was adopted. Of note, access-artery angiography to confirm hemostasis and to rule-out vascular complications was systematically performed. In all patients, heparin was administered (initial weight-adjusted intravenous bolus then further boluses administered in order to keep the activated clotting time between 250 and 300s) and double antiplatelet therapy was started before PCI initiation and recommended for 12 months. Blood samples were obtained at 6 and 24 h after the procedure to measure hemoglobin and creatinine levels. Additional laboratory exams were performed if clinically indicated. The occurrence of any complication during the hospital stay was prospectively recorded into the catheterization laboratory database.
For the present study, clinical records were carefully evaluated and clinical follow-up was obtained by reviewing the outpatient visit reports or by telephone interview. Access site or bleeding complications were classified according to the Valve Academic Research Consortium (VARC) and the Bleeding Academic Research Consortium (BARC) criteria [
Echocardiographic assessment of the LV ejection fraction (LVEF), aortic valve, and the presence of intraventricular thrombus was systematically performed before the procedure. After the index hospitalization, clinical follow-up (with echocardiographic examination) was systematically recommended. Echocardiographic assessment of LV function was performed according to the biplane method of disk summation (modified Simpson’s rule) [
Continuous variables are presented as mean with standard deviation (SD) and categorical variables as numbers and percentages. The continuous variables related to LVEF and BCIS-JS RI were categorised in tertiles. Comparisons of continuous variables across different groups were performed using Student t test or ANOVA test (as appropriate). Categorical variables were evaluated using
From April 2007 to December 2016, a total of 86 patients (mean age 72±10 years, 91.8% men) underwent Impella protected high-risk PCI at two high volume Italian centers and were included in the present analysis. Baseline characteristics of patients are listed in Table
Baseline characteristics of study population.
Present Study | PROTECT II | EUROpella | USpella | |
---|---|---|---|---|
Number of enrolling centres | 2 | 112 | 10 | 18 |
Number of enrolled patients | 86 | 225 | 144 | 175 |
Age (years), mean±SD | 72±10 | 68±11 | 72±10 | 70±10 |
Gender, males/females | 79/7 | 180/45 | 117/27 | 74/101 |
| ||||
Hypertension | 67 (78) | / | 97 (67) | / |
Dyslipidemia | 53 (62) | / | 93 (65) | / |
Diabetes | 38 (44) | 117 (52) | 62 (43) | 82 (47) |
Smoking | 16 (19) | / | 61 (42) | / |
Family history of CAD | 16 (19) | / | / | / |
Renal Failure° | 27 (31) | 102 (23) | 41 (28) | 58 (33) |
| ||||
Prior MI | 30 (35) | / | 76 (53) | 98 (56) |
Prior PCI | 14 (16) | / | / | 84 (48) |
Prior CABG | 19 (22) | 85 (38) | 42 (29) | 49 (28) |
| ||||
STEMI | 13 (15) | / | / | / |
NSTEMI | 50 (58) | 55 (37) | / | / |
SA | 23 (27) | 93 (63) | / | / |
| 60 (70) | 151 (67) | / | 115 (66) |
| 31±9 | 23±6 | / | 31±17 |
| 67 (78) | 216 (100) | 92 (64)† | 121 (69) |
| 9±3 | 9±6 | 8±3 | / |
Lower Tertile (3-7) | 30 (35) | |||
Mid Tertile 2 (8-10) | 30 (35) | |||
Higher Tertile 3 (11-20) | 26 (30) | |||
| 86 (100) | 144 (64) | 62 (43) | 98 (56) |
| ||||
Multivessel disease, n (%) | 86 (100) | / | 118 (82) | 155 (89) |
Left main disease, n (%) | 38 (44) | 18 (8) | 76 (53) § | 89(51) |
Syntax Score | 31±10 | 30±13 | / | 37±16 |
BCIS-JS | 10±2 | / | / | / |
† LVEF <40%
‡ On the basis of heart-team discussion.
§PCI on left main coronary artery.
° Abnormalities of kidney function (decreased glomerular filtration rate <60 ml/min/1.73m2) or kidney structure (e.g., kidney transplantation).
CAD=coronary artery disease; MI=myocardial infarction; PCI=percutaneous coronary intervention; CABG=coronary artery bypass graft; STEMI=ST elevation myocardial infarction; NSTEMI=non-ST elevation myocardial infarction; SA= stable angina; NYHA=New York Heart Association; LVEF=left ventricular ejection fraction; BCIS-JS= The British Cardiovascular Intervention Society myocardial Jeopardy Score.
Seventy-four patients (86%) received hemodynamic support with Impella 2.5 and 12 patients (14%) with Impella CP (Table
Procedural characteristics.
CHARACTERISTICS | N=86 (%) |
---|---|
| |
Radial | 66 (77) |
Femoral | 20 (23) |
| |
One-vessel PCI | 23 (27) |
Two-vessel PCI | 39 (45) |
Three-vessel PCI | 24 (28) |
PCI on bifurcation | 52 (60) |
PCI with Rotablator | 13 (15) |
At least one DES implanted | 83 (96) |
| |
Syntax Score | 12±8. |
BCIS-JS | 3± |
| 0.7±0.2 |
Lower Tertile (0.20-0.50) | 28 (33) |
Mid Tertile (0.51-0.80) | 29 (34) |
Higher Tertile (0.81-1.00) | 29 (34) |
| |
2.5 | 74 (86) |
CP | 12 (14) |
| 104 (55-3151) |
| |
Double Perclose | 54 (63) |
Prostar | 10 (12) |
Manual compression | 22 (25) |
° value expressed as median with range.
PCI= percutaneous coronary intervention; DES=drug eluting stent; BCIS-JS= the British Cardiovascular Intervention Society myocardial Jeopardy Score.
Bleeding and vascular complications occurred in 14% and 2%, respectively (Table
Periprocedural bleeding and vascular complications.
COMPLICATION | N=86 (%) |
---|---|
| |
Type I | 6 (7) |
Type II | 2 (2) |
Type III | 4 (5) |
Type IV | 0 |
Type V | 0 |
| 2 (2) |
Major vascular complication | 0 |
Minor vascular complication | 2 |
Percutaneous closure device failure | 0 |
BARC= Bleeding Academic Research Consortium; VARC= Valve Academic Research Consortium; see text for detailed description of complications.
In our study the median value for the duration of Impella support was 104 minutes (range 55-3151) and Impella malfunctions were not reported. Further insights into procedural hemodynamic behavior and Impella pump performance were available only in 37 patients [
Seventy-nine patients (92%) underwent echocardiography at mean follow-up of 6 months (range 1-12 months) and significant improvement in LVEF was observed (31±9% at baseline to 39±9%, p < 0.001). Of the 79 patients, 27.9% presented with pre-PCI LVEF ≤ 25%, 50% with LVEF of 26-34%, and 22.1% with LVEF of 35-50%. After PCI, only 9.3% had LVEF ≤ 25%, and 23.3% had LVEF of 26-34%. Patients had significant improvement in LVEF post-Impella-protected PCI with 67.4% having LVEF of 35-50% (Figure
Among the different preprocedural and procedural factors, pre-PCI LVEF (p < 0.001) and BCIS-JS revascularization index (p < 0.001) significantly influenced “indexed” LVEF variation. In particular, significantly higher indexed LVEF variation was observed in patients with higher BCIS-JS revascularization index (p = 0.002) (Figure
The rate of major adverse cardiac and cerebrovascular events (MACCE) during mean follow-up of 14 months was 24% (Table
Clinical outcome at longest follow-up.
ADVERSE EVENT | Present Study | PROTECT II | EUROpella | USpella |
---|---|---|---|---|
MACCE | 21 (24) | 90 (41) § | 17 (12) | |
Re-PCI | 12 (14) | 8 (4) | / | 1 (1) |
CABG | 1 (1) | 2 (1) | 0 | † |
AMI | 6 (7) | 27 (12) | 0 | 2 (1) |
Stroke | 0 | 2 (1) | 1 (1) | 1 (1) |
| 9 (10) | 27 (12) | 8 (6) | 7 (4) |
° Data at longest follow up available in the intention-to-treat population
§ Composite rate of intra- and postprocedural major adverse events (MAEs) at discharge or 30-day follow-up, whichever was longer. The composite primary end point components included all-cause death, Q-wave or non–Q wave
MI, stroke, or transient ischemic attack, any repeat revascularization procedure, need for a cardiac or a vascular operation, acute renal insufficiency, severe intraprocedural hypotension requiring therapy, cardiopulmonary resuscitation or ventricular tachycardia requiring cardioversion, aortic insufficiency, and angiographic failure of PCI.
† Includes PCI or CABG revascularization.
MACCE=major adverse cardiac and cerebrovascular events; PCI= percutaneous coronary intervention; CABG=coronary artery bypass grafting; AMI=acute myocardial infarction
In the multivariate analysis including all the main baseline characteristics, EuroSCORE I > 11 (HR 311.8, 95% CI 10.9 to 8952, and p = 0.001) and BCIS-JS revascularization index of ≤ 0.8 (HR 0.11, 95% CI 0.01 to 0.92, and p = 0.042) were the only independent predictors of mortality (Table
Multivariate analysis for independent predictors of mortality.
P-value | Adjusted HR (95% CI) | |
---|---|---|
| ||
mid tertile vs. lower tertile | 0.053 | 31.4 (1.0-1036.8) |
higher tertile vs. lower tertile | 0.001 | 311.8 (10.9-8952.0) |
| ||
mid tertile vs. lower tertile | 0.490 | 0.38 (0.03-5.83) |
higher tertile vs. lower tertile | 0.042 | 0.11 (0.01-0.92) |
Other variables this model controlled for: age, gender, diabetes, renal failure, prior MI, prior CABG, NSTEMI, and SA.
MI= myocardial infarction; PCI= percutaneous coronary intervention; CABG=coronary artery bypass grafting; NSTEMI=non ST elevation myocardial infarction; SA= stable angina; NYHA=New York Heart Association; BCIS-JS= the British Cardiovascular Intervention Society myocardial Jeopardy Score.
In this large cohort of patients treated by IMP-protected PCI in two experienced Italian centers we found that: Impella-protected PCI in CHIP is associated with LVEF recovery and very promising survival rates the extent of the coronary revascularization achieved during IMP-protected PCI in CHIP is associated with LVEF recovery and survival.
Collectively, the results of our study suggest that Impella-protected PCI is an attractive revascularization strategy in CHIP, leading to favorable outcomes.
All the patients in our study had multivessel disease, were deemed to be ineligible for surgery, and had higher prevalence of left main disease as compared to the patients randomized in the PROTECT-II trial (Table
The present study assessed the extent of revascularization using the BCIS-JS, which takes into account the entire myocardial area at risk [
More complete revascularization with Impella-protected PCI resulted in improvement in cardiac function with about 70% of CHIP having LVEF ≥ 35%. Moreover, BCIS-JS derived RI significantly influenced “indexed” LVEF variation. This is a novel finding as previous studies of Impella in high risk PCI have inferred more complete revascularization based on reduced need for repeat revascularization [
Previous studies have documented the safety of Impella use in high-risk PCI at 30 and 90 days [
Our results demonstrate that protected PCI with Impella 2.5 in CHIP yields acceptable complication rates with a MACCE rate of 24% at longest follow-up of 14 months. Furthermore, periprocedural adverse events occurred less frequently given the uniform adoption of best practices including careful iliac-femoral axis selection, meticulous femoral puncture, high radial access use for PCI, early pump removal with angiographic hemostasis check, use of suture-based devices preclosure technique, and endovascular management of vascular complications.
Currently, the role of Impella in the setting of high-risk procedures has been addressed in expert consensus documents [
Indeed, more data about Impella supported PCI in the setting of high-risk patients are needed. However, this study provides evidence supporting the use of Impella in CHIP.
Given the observational and retrospective nature of our study, the findings should be considered hypothesis generating. Randomized trials are required to fully validate the findings and establish causality. This is a study from two centers in Italy with unique geographic and demographic characteristics and therefore results may not be generalizable.
Impella-protected PCI in CHIP is associated with LVEF improvement. A more complete myocardial revascularization was associated with LVEF improvement and better survival.
The clinical and procedural data used to support the findings of this study are included within the article.
Dr. Burzotta discloses to have been involved in advisory board meetings or having received speaker’s fees from Medtronic, St Jude Medical, Abiomed, Biotronic. Dr. Trani discloses to have been involved in advisory board meetings or having received speaker’s fees from St Jude Medical, Abiomed, Biotronic. Dr. Aurigemma has been involved in advisory board activities by Biotronic. The remaining authors have nothing to disclose.