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Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry

Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients... Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 5243913, 10 pages https://doi.org/10.1155/2019/5243913 Research Article Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry 1,2 1,2 3 3 Francesco Burzotta , Giulio Russo, Flavio Ribichini , Anna Piccoli, 1,2 1,2 1,2 3 Domenico D’Amario , Lazzaro Paraggio, Leonardo Previ, Gabriele Pesarini, 1,2 1,2 1,2 1,2 Italo Porto, Antonio Maria Leone, Giampaolo Niccoli, Cristina Aurigemma, 1,2 1,2 1,2 Diana Verdirosi, Filippo Crea, and Carlo Trani Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy Universita` Cattolica del Sacro Cuore, Roma, Italy Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy Correspondence should be addressed to Francesco Burzotta; francescoburzotta@gmail.com Received 26 November 2018; Revised 11 March 2019; Accepted 25 March 2019; Published 9 April 2019 Academic Editor: Vasileios Panoulas Copyright © 2019 Francesco Burzotta et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objective. To investigate the eeff ct of extent of revascularization in complex high-risk indicated patients (CHIP) undergoing Impella-protected percutaneous coronary intervention (PCI). Background. Complete revascularization has been shown to be associated with improved outcomes. However, the impact of more complete revascularization during Impella-protected PCI in CHIP has not been reported. Methods. A total of 86 CHIP undergoing elective PCI with Impella 2.5 or Impella CP between April 2007 and December 2016 from 2 high volume Italian centers were included. Baseline, procedural, and clinical outcomes data were collected retrospectively. Completeness of coronary revascularization was assessed using the British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) derived revascularization index (RI). eTh primary end-point was all-cause mortality. A multivariate regression model was used to identify independent predictors of mortality. Results. All patients had multivessel disease and were considered unsuitable for surgery. At baseline, 44% had left main disease, 78% had LVEF ≤ 35%, and mean BCIS-JS score was 10±2. The mean BCIS-JS derived RI was 0.7 ±0.2 and procedural complications were uncommon. At 14-month follow-up, all- cause mortality was 10.5%. At follow-up, 67.4% of CHIP had LVEF≥ 35% compared to 22.1% before Impella protected-PCI. Higher BCIS-JS RI was significantly associated with LVEF improvement (p=0.002). BCIS-JS RI of ≤ 0.8 (HR 0.11, 95% CI 0.01- 0.92, and p = 0.042) was an independent predictor of mortality. Conclusions. ese Th results support the practice of percutaneous Impella use for protected PCI in CHIP. A more complete revascularization was associated with significant LVEF improvement and survival. 1. Introduction commonly referred to as complex high-risk indicated patients (CHIP) [2]. The use of percutaneous left ventricular assist Patients with poor left ventricular (LV) function and complex devices may minimize the risk of hemodynamic compromise coronary anatomy (such as multivessel disease, left main during such high risk PCI and allow complete revascular- disease, and last remaining vessel) may be unsuitable for ization, thus improving outcomes. The feasibility, safety, and surgical revascularization due to high risk for periprocedural hemodynamic eeff cts of Impella devices during high-risk PCI complications [1]. Percutaneous coronary intervention (PCI) have been demonstrated in the PROTECT-I and PROTECT- is an alternative revascularization strategy in such patients, II trials and in multiple real-world studies [3–8]. 2 Journal of Interventional Cardiology Recent meta-analysis by Pasceri et al. suggests improved favorablesidewas chosen for Impella implantation. The pres- outcomes following complete revascularization in patients ence of atherosclerotic disease of the iliac-femoral axis with with multivessel disease [9]. Importantly, studies suggest nonsignificant ( <50% diameter) stenosis was not considered the possibility of complete revascularization during Impella- an exclusion criterion. No failure of device implantation was protected PCI, resulting in reduced need for repeat revas- reported due to the screening process including systematic cularizations [10]. The purpose of the present study was to iliac-femoral axis assessment. investigate the effect of extent of revascularization, as assessed After femoral artery stick, a 6-8 Fr sheath was inserted. using the BCIS-JS, in CHIP undergoing Impella-protected Then, “pre-closure” technique with suture-based hemostatic PCI in an all comers cohort from two high volume Italian devices was used. The “pre-closure” technique was performed centers. with (according to operator’s yield) the Prostar XL10F or Perclose ProGlide devices (Abbott Vascular Devices, Red- wood City, CA, USA) and consisted of the suture deployment 2. Methods before introduction of the (13 Fr or 14 Fr) Impella 2.5 or CP sheath. After the procedure, Impella was removed and the .. Study Population. This is a retrospective study using a sutures were tied by pushing down knot(s) in order to achieve prospectively maintained database: data of all consecutive percutaneous hemostasis. Of note, when using ProGlide, a patients undergoing elective Impella-protected PCI from double ProGlide pre-closure technique was adopted, based April 2007 to December 2016 in two high-volume (>1000 PCI on sequential insertion of two ProGlide devices rotated in per year) Italian cardiac catheterization laboratories. Patients opposite sides 30-45 , to create an interrupted X-figure clo- with cardiogenic shock and acute myocardial infarction sure [13]. After dedicated sheath insertion, a 6 Fr diagnostic within 24 hours were excluded. According to the hospital catheter (Judkins right or pigtail) was advanced into the practice at the two centers, the need for Impella-protected LV and used to place the 300 cm extra-support guidewire high-risk PCI was assessed based on collegial heart-team into the LV. Then, the Impella catheter was advanced over discussion in which the potential benefit of myocardial the guidewire through the aortic valve into the LV. Impella revascularization was agreed and surgical revascularization was then activated aer ft removal of the guidewire and LV was considered not feasible. Coronary stenosis ≥70% was assistance maintained throughout the procedure. Our center considered significant ( ≥50% in case of left main coro- started using the pre-closure technique before 2007 and nary artery lesion) by visual assessment on angiogram. gaining since then experience in the management of vascular Alternatively, it was assessed by guided by fractional ow fl access with largeboredevices resulting inlow vascular reserve (FFR) or by stress test imaging. All patients provided complication rate (2%) in our registry. Our experience with written consent to undergo PCI with Impella support aer ft double pre-closure system using Perclose has already been detailed explanation of the procedural features. Clinical reported elsewhere [14]. In more recent years, our puncture data, operative risk score (EuroSCORE I), and procedural technique has undergone further improvements by combin- data were prospectively collected. Synergy between Percu- ing angiographic and ultrasound guidance [15, 16]. taneous Coronary Intervention with TAXUS and Cardiac PCI was performed by the radial or (in patients with Surgery (SYNTAX) score before and aeft r the procedure unsuitable radial accesses) by contralateral femoral approach was calculated for all patients without previous coronary using 6-8 Fr guiding catheters. Selection of guidewires, surgery. For the present study, an interventional cardiology balloons, and stents was based operator’s choice. Drug- fellow (blinded to patient’s clinical presentation and outcome) eluting stent implantation was the main PCI technique and graded the myocardium at jeopardy before and after PCI debulking with Rotablator was the main adjunctive device using the British Cardiovascular Intervention Society (BCIS) used for severely calcified coronary segments. At the end Jeopardy Score (JS) algorithm [11]. Extent of revascularization of PCI, Impella speed was gradually decreased and patient’s was assessed using the BCIS-JS revascularization index (RI): hemodynamic condition was evaluated. In case of hemody- (BCIS-JS -BCIS-JS )/ BCIS-JS as previously reported pre post pre namic stability, Impella was immediately removed. In the [12]. Two examples of BCIS-JS RI calculations are provided case of mechanical hemostasis failures, manual compression in Figures 1(a) and 1(b). followed by compressive bandage was adopted. Of note, access-artery angiography to confirm hemostasis and to rule- .. Impella-Protected PCI. The Impella 2.5 or Impella CP out vascular complications was systematically performed. (after its release in Italy) heart pumps were used and implan- In all patients, heparin was administered (initial weight- adjusted intravenous bolus then further boluses administered tation was performed through percutaneous trans-femoral approach. All patients received iliac-femoral artery axis in order to keep the activated clotting time between 250 assessment by ultrasonography and/or peripheral angiog- and 300s) and double antiplatelet therapy was started before raphy during a pre-PCI work-up. All femoral punctures PCI initiation and recommended for 12 months. Blood were u fl oroscopy-guided. Prior to Impella sheath placement, samples were obtained at 6 and 24 h after the procedure to measure hemoglobin and creatinine levels. Additional peripheral angiography (through the radial or contralateral femoral access selected for PCI) was performed to confirm laboratory exams were performed if clinically indicated. The the suitability of iliac-femoral arterial axis anatomy. Accord- occurrence of any complication during the hospital stay was prospectively recorded into the catheterization laboratory ingly, when atherosclerotic burden or tortuosity was high, the contralateral iliac-femoral axis was assessed and the most database. Journal of Interventional Cardiology 3 PRE POST CX Dominant RCA Dominant LM = 12 LM = 8 Prox LAD = 6 Prox LAD = 6 Prox CX = 6 Prox CX = 2 Diag= 2 Diag= 2 OM = 2 OM = 2 Dist CX = 2 Dist CX = 0 Mid/dist LAD = 2 Mid/dist LAD = 2 RCA = 0 RCA = 4 PDA= 2 BCIS-JR = 12 BCIS-JR = 4 Pre-PCI LVEF= 31% LVEF at follow-up =25% 12 - 4 BCIS-JR Revasc. Index = = 0.67 (a) PRE POST CX Dominant RCA Dominant LM = 8 LM = 12 Prox LAD = 6 Prox LAD = 6 Prox CX = 6 Prox CX = 2 Diag= 2 Diag= 2 OM = 2 Dist CX = 2 OM = 2 Dist CX = 0 Mid/dist LAD = 2 Mid/dist LAD = 2 RCA = 0 RCA = 4 PDA= 2 BCIS-JR = 12 BCIS-JR = 0 Pre-PCI LVEF= 18% LVEF at follow-up =45% 12 - 0 BCIS-JR Revasc. Index = = 1.00 (b) Figure 1: British-Cardiovascular-Intervention-Society jeopardy-score (BCIS-JS) calculation examples in a patient with complete (a) and in a patient with incomplete (b) myocardial revascularization. Patient in (a) showed a significant improvement of left ventricular function, while patient in (b) died after 6 months of follow-up. Arrows indicate significant coronary stenosis. PCI=percutaneous coronary intervention and LVEF=left ventricular ejection fraction. .. Procedural and Clinical Outcome Assessment. For the definition of myocardial infarction [19]. Stroke was defined present study, clinical records were carefully evaluated and as any new, permanent, global, or focal neurological deficit clinical follow-up was obtained by reviewing the outpatient ascertained by a standard neurological examination, lasting longer than 24 hours or less if evidence of cerebral infarction visit reports or by telephone interview. Access site or bleed- was obtained by imaging. In our study renal failure was ing complications were classified according to the Valve defined per the Kidney Disease Improving Global Outcomes Academic Research Consortium (VARC) and the Bleeding (KDIGO) guidelines as any abnormality of kidney function Academic Research Consortium (BARC) criteria [17, 18]. (decreased glomerular filtration rate <60 ml/min/1.73m )or The primary study end-point was all-cause mortality. Major kidney structure (e.g., kidney transplantation). adverse cardiac and cerebrovascular events (MACCE) were den fi ed as the composite of death and/or acute myocardial infarction (AMI) or target vessel revascularization (either .. Le Ventricular Function. Echocardiographic assess- percutaneous or surgical) or stroke. AMI during follow- ment of the LV ejection fraction (LVEF), aortic valve, and up wasdenfi ed asthe rise andfall ofcardiac enzymes thepresenceofintraventricular thrombus was systematically (usually serum high-sensitivity Troponin I) in the presence performed before the procedure. After the index hospital- of electrocardiogram signs or symptoms compatible with ization, clinical follow-up (with echocardiographic examina- myocardial ischemia, as described in the third universal tion) was systematically recommended. Echocardiographic 4 Journal of Interventional Cardiology assessment of LV function was performed according to the access. Thirty-vfi e (41%) patients underwent left main PCI biplane method of disk summation (modified Simpson’s and almost three-quarters of patients were treated on at rule) [20]. Changes in LVEF between baseline and post- least two vessels including bifurcations and diffusely diseased PCI (at the longest available echocardiographic examination) vessels (Table 2). Thirteen patients (15%) received rotational were estimated by calculating the “indexed” LVEF variation, atherectomy for heavily calciefi d lesions. At least one drug calculated as (LVEF -LVEF )/LVEF . eluting stent was implanted in 83 (96%) patients, and the pre-PCI post-PCI pre-PCI remaining 3 (4%) patients received bare metal stents due to concerns regarding their tolerance for prolonged dual .. Statistical Analysis. Continuous variables are presented antiplatelet therapy. Both SYNTAX score and BCIS-JS were as mean with standard deviation (SD) and categorical vari- significantly reduced after PCI compared to baseline (from ables as numbers and percentages. The continuous variables 31±10 to 12±9and from 10±2to3±3 respectively, p< 0.001 related to LVEF and BCIS-JS RI were categorised in ter- for both). Patients had complete revascularization as sug- tiles. Comparisons of continuous variables across dieff rent gested by mean BCIS-JS revascularization index of 0.7±0.2. groups were performed using Student t test or ANOVA test Successful hemostasis was achieved by insertion of double (as appropriate). Categorical variables were evaluated using 2 preimplanted Perclose ProGlide in 63%, Prostar XL in 12%, 휒 test or Fisher’s exact test, as appropriate. Comparisons and manual compression in 25%. between pre-PCI and post-PCI data were performed using Bleeding and vascular complications occurred in 14% paired t-test. A Cox regression analysis was performed to and 2%, respectively (Table 3). There were 6 cases of minor identify the independent predictors of mortality among the hematomas that required no specific intervention (BARC main baseline characteristics (age, gender, diabetes, renal Type I), 2 patients required bail-out balloon peripheral angio- failure, prior myocardial infarction, prior PCI, prior cardiac plasty to facilitate hemostasis by manual-compression (BARC surgery, clinical presentation, advanced New York Heart Type II), and 4 patients had decrease in hemoglobin by>3 Association class, EuroSCORE, and BCIS-JS RI). Adjusted g/dL with three of them requiring blood transfusion (BARC hazard ratios (HR) with associated 95% confidence interval Type III). Two minor vascular complications occurred. One (CI) were calculated for the significant mortality predictors patient had distal embolization few hours after PCI (acute and corresponding adjusted survival curves were deter- lower limb ischemia plus occlusion of lower limb arteries mined. A 2-tailed, p-value<0.05 was established as the level of based on ultrasound examination) and was successfully statistical significance. All statistical analyses were performed managed by urgent peripheral angioplasty on tibial-peroneal using SPSS software v22.0 (IBM Corporation, Armonk, New arteries. The other case was an access site vascular injury York). consisting of angiographically documented common femoral artery occlusion after Impella 2.5 pump removal. Since the 3. Results patient was asymptomatic, and collateral branches provided full distal supply (probably due to pre-existing superficial .. Patient Population. From April 2007 to December 2016, a femoral artery disease), a conservative management was total of 86 patients (mean age 72±10 years, 91.8% men) under- selected, and the clinical course was uneventful. No other went Impella protected high-risk PCI at two high volume Ital- main procedure-related complication was noticed and a total ian centers and were included in the present analysis. Baseline of 94% of patients were discharged alive (see below for death characteristics of patients are listed in Table 1. Patients were reports). highly symptomatic with New York Heart Association class In our study the median value for the duration of Impella III or IV in 69.7%. They had high prevalence of hyperten- support was 104 minutes (range 55-3151) and Impella mal- sion (78%), dyslipidemia (62%), diabetes (44%), previous functions were not reported. Further insights into procedural myocardial infarction (35%), and previous coronary bypass hemodynamic behavior and Impella pump performance were grafting surgery (22%). About 58% of patients were admitted available only in 37 patients [21]. for a non-ST elevation myocardial infarction (NSTEMI). About 78% had LVEF< 35% (mean 31±9%). All patients had multivessel disease and 44% had left main disease. The mean .. Le Ventricular Function. Seventy-nine patients (92%) SYNTAX score was 31±10 and mean EuroSCORE I was 9±3. underwent echocardiography at mean follow-up of 6 months The extent of jeopardized myocardium was large with mean (range 1-12 months) and signicfi ant improvement in LVEF pre-PCI BCIS-JS of 10 (score range: 0-12). All patients were was observed (31±9% at baseline to 39±9%, p< 0.001). Of deemed unsuitable for surgery on the basis of heart-team the 79 patients, 27.9% presented with pre-PCI LVEF≤ 25%, discussion. The baseline characteristics of the present study 50% with LVEF of 26-34%, and 22.1% with LVEF of 35-50%. cohort were listed alongside previously published clinical After PCI, only 9.3% had LVEF ≤ 25%, and 23.3% had LVEF of studies: PROTECT II trial, Europella, and USpella registries 26-34%. Patients had significant improvement in LVEF post- [4–6] (Table 1). Impella-protected PCI with 67.4% having LVEF of 35-50% (Figure 2). .. Procedural and Safety Outcomes. Seventy-four patients Among the different preprocedural and procedural fac- (86%) received hemodynamic support with Impella 2.5 and tors, pre-PCI LVEF (p< 0.001) and BCIS-JS revascularization index (p< 0.001) significantly influenced “indexed” LVEF 12 patients (14%) with Impella CP (Table 2). In majority of patients (77%), PCI was performed via the radial artery variation. In particular, significantly higher indexed LVEF Journal of Interventional Cardiology 5 Table 1: 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 Cardiovascular Risk Factors, n(%) 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) Past Cardiac History, n(%) Prior MI 30 (35) / 76 (53) 98 (56) Prior PCI 14 (16) / / 84 (48) Prior CABG 19 (22) 85 (38) 42 (29) 49 (28) Clinical presentation, n(%) STEMI 13 (15) / / / NSTEMI 50 (58) 55 (37) / / SA 23 (27) 93 (63) / / NYHA III-IV, n(%) 60 (70) 151 (67) / 115 (66) LVEF, mean±SD (%) 31±923±6/ 31±17 LVEF≤%, n(%) 67 (78) 216 (100) 92 (64)† 121 (69) EuroSCORE, mean±SD 9±39±68±3/ Lower Tertile (3-7) 30 (35) Mid Tertile 2 (8-10) 30 (35) Higher Tertile 3 (11-20) 26 (30) Unsuitable for surgery‡,n (%) 86 (100) 144 (64) 62 (43) 98 (56) Angiographic characteristics 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/ / / ∗ Randomized Impella arm. † 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. variation was observed in patients with higher BCIS-JS one patient (exhibiting persistent electrical instability) died revascularization index (p = 0.002) (Figure 3). during ventricular tachycardia ablation attempt. Among the remaining four patients who died aer ft 30 days, one had fatal stent thrombosis at 6-months, and three had progressive .. Clinical Outcome and Its Determinants. The rate of major congestive heart failure. Repeat PCI was performed in 12 adverse cardiac and cerebrovascular events (MACCE) during patients (14%) and CABG in 1 patient (1%). AMI occurred mean follow-up of 14 months was 24% (Table 4). A total of in 6 patients (7%) and no case of stroke was reported. nine deaths (10.5%) occurred during the study. In particular, In the multivariate analysis including all the main base- one death occurred few hours after procedure due to acute bare metal stent thrombosis. Four deaths occurred within 30 line characteristics, EuroSCORE I> 11 (HR 311.8, 95% CI 10.9 days from the index procedure: three patients died of pro- to 8952, and p = 0.001) and BCIS-JS revascularization index gressive respiratory failure in the presence of refractory heart of≤ 0.8 (HR 0.11, 95% CI 0.01 to 0.92, and p = 0.042) were failure and severe chronic obstructive pulmonary disease and the only independent predictors of mortality (Table 5). No 6 Journal of Interventional Cardiology Table 2: Procedural characteristics. CHARACTERISTICS N=86 (%) Approach for PCI Radial 66 (77) Femoral 20 (23) Number of treated vessels 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) Post-PCI Angiographic scores Syntax Score 12±8.7 BCIS-JS 3±3 BCIS-JS Revascularization Index, mean±SD 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) Impella pump 2.5 74 (86) CP 12 (14) Impella support duration,min∘ 104 (55-3151) Haemostasis technique Double Perclose 54 (63) Prostar 10 (12) Manual compression 22 (25) p<0.001 as compared with baseline values. ∘ value expressed as median with range. PCI= percutaneous coronary intervention; DES=drug eluting stent; BCIS-JS= the British Cardiovascular Intervention Society myocardial Jeopardy Score. Table 3: Periprocedural bleeding and vascular complications. COMPLICATION N=86 (%) Bleedings (BARC criteria)  () Type I 6(7) Type II 2(2) Type III 4(5) Type IV 0 Type V 0 Vascular complications (VARC criteria) 2(2) Major vascular complication 0 Minorvascularcomplication 2 Percutaneous closure device failure 0 BARC= Bleeding Academic Research Consortium; VARC= Valve Academic Research Consortium; see text for detailed description of complications. significant association was found with residual Syntax Score. 4. Discussion Based on Kaplan-Meier analysis, patients with more complete In this large cohort of patients treated by IMP-protected PCI revascularization of angiographically significant stenosis (RI in two experienced Italian centers we found that: > 0.8 to 1.0) had a survival advantage, both early after PCI and in the longer term, compared to those with less revascularization (RI 0.2 to 0.5 or 0.51 to 0.80; p = 0.049) (1) Impella-protected PCI in CHIP is associated with (Figure 4). LVEF recovery and very promising survival rates Journal of Interventional Cardiology 7 p ≤ 0.001 205% 22.1% Increase in patients with LVEF 35-50% at follow-up 67.4% 50.0% 23.3% 27.9% 9.3% LVEF Pre-PCI LVEF at follow-up LVEF 35-50% LVEF 26-34% LVEF ≤25% Figure 2: Le ventricular ejection fraction improvement during the follow-up aer IMP-protected PCI. eTh figure shows the comparison of left ventricular ejection fraction impairment between pre-PCI and follow-up assessment. LVEF=left ventricular ejection fraction and PCI=percutaneous coronary intervention. p=0.002 p=0.049 2.0 1.00 1.5 0.99 1.0 0.98 0.5 0.0 0.97 −0.5 Lower BCIS-JS Mid BCIS-JS Higher BCIS-JS 0.96 Revascularization Revascularization Revascularization Index Tertile Index Tertile Index Tertile 0.95 (0.20-0.50) (0.51-0.80) (0.81-1.00) Figure 3: Le ventricular ejection fraction improvement according 0.94 to revascularization extent. eTh figure shows the left ventricular improvement in patients stratified according to revascularization 0 3 6 9 12 15 18 extent as evaluated by the British Cardiovascular Intervention Months from intervention Society Jeopardy Score (BCIS-JS) tertiles. LVEF=left ventricular BCIS-JS RI higher tertile (0.81- 1.00) ejection fraction. BCIS-JS RI mid tertile (0.51- 0.80) BCIS-JS RI lower tertile (0.20 -0.50) Figure 4: Survival curves according to revascularization extent.The (2) the extent of the coronary revascularization achieved figure shows the adjusted survival curves in the study population during IMP-protected PCI in CHIP is associated with stratified according to British Cardiovascular Intervention Society LVEF recovery and survival. Jeopardy Score (BCIS-JS) revascularization index tertiles. RI= revas- cularization index. 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, higher complexity and mortality of patients in routine clinical were deemed to be ineligible for surgery, and had higher practice. The study by Waldo et al. suggested that surgical prevalence of left main disease as compared to the patients ineligibility is common and associated with higher mor- randomized in the PROTECT-II trial (Table 1), reflecting tality among patients with multivessel or left main disease Indexed LVEF % of patients Survival 8 Journal of Interventional Cardiology Table 4: Clinical outcome at longest follow-up. Present PROTECT EUROpella USpella ADVERSE EVENT Study II N=144 (%)∘ N=175 (%)∘ N=86 (%) N=225∗ (%)∘ 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) All-cause death 9 (10) 27 (12) 8 (6) 7 (4) Randomized Impella arm ∘ 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 primar y 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 insufficien cy, 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=acu te myocardial infarction Table 5: Multivariate analysis for independent predictors of mortality. P-value Adjusted HR (95% CI) EuroSCORE 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) BCIS-JS Revascularization Index 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. undergoing nonemergent PCI [22]. Despite the high risk was slightly different from that presented in this study: they of mortality, the survival rate in our study was favor- hada lowerbaseline Syntax Score andonly a minority of able at 90% likely due to more complete revascularization patients presented with reduced LV function. While Syntax with Impella-protected PCI. In fact, BCIS-JS derived RI Score remains the main tool for risk assessment according to was an independent predictor of mortality in multivariate coronary anatomy complexity our results suggest that BCIS- analysis. JS score and the BCIS-JS derived RI might provide a better risk evaluation in the work-up of CHIP. The present study assessed the extent of revascularization using the BCIS-JS, which takes into account the entire More complete revascularization with Impella-protected PCI resulted in improvement in cardiac function with about myocardial area at risk [12]. The mean BCIS-JS-derived RI 70% of CHIP having LVEF≥ 35%. Moreover, BCIS-JS derived of 0.7 demonstrates the utility of Impella-protected PCI RI significantly influenced “indexed” LVEF variation. This is in achieving more complete revascularization. The n fi ding a novel finding as previous studies of Impella in high risk of higher survival with higher RI is in line with previous study demonstrating survival benefit following complete PCI have inferred more complete revascularization based on reduced need for repeat revascularization [4, 10]. As revascularization and the prognostic value of BCIS-JS in demonstrated in previous studies with STEMI and mul- predicting mortality in high-risk PCI [12]. Complete revas- cularization during Impella-protected PCI is likely due to tivessel disease, complete revascularization was associated with improved survival outcomes and complications [9, 24], the greater hemodynamic stability provided by Impella, thus although our patient population included 58% with non- allowing operators to perform more vigorous procedures including rotational atherectomy for heavily calcified lesions STEMI. [4]. Gen ´ er ´ eux et al. [23] had previously shown that higher Previous studies have documented the safety of Impella residual Syntax Score was associated with poor short- and usein high-risk PCIat 30and 90 days [4,25].A substudy of the PROTECT II trial [26] focused on patients with three- long-term prognosis in patients with moderate/high risk acute coronary syndrome. However, their study population vessel coronary artery disease and reduced LV function, Journal of Interventional Cardiology 9 showing improved outcomes when Impella 2.5 was used as Data Availability LV support device, compared to intra-aortic balloon pump The clinical and procedural data used to support the findings (IABP). The composite endpoint of major cardiac events was of this study are included within the article. significantly lower in the Impella group compared to IABP group (32.9% vs 42.4% at 30 days and 39.5% vs 51.0% aer ft 90 days of follow-up). However, all-cause death rates, for Conflicts of Interest which the study was not powered, were similar between the two groups. Moreover, data regarding Impella supported PCI Dr. Burzotta discloses to have been involved in advisory in patients undergoing unprotected left main (LM) revascu- board meetings or having received speaker’s fees from larization have been extrapolated from the USpella registry Medtronic, St Jude Medical, Abiomed, Biotronic. Dr. Trani [27] demonstrating its feasibility and safety. Although the discloses to have been involved in advisory board meetings analysis was mainly based on patients undergoing LM PCI, or having received speaker’s fees from St Jude Medical, they achieved nearly complete revascularization with low Abiomed, Biotronic. Dr. Aurigemma has been involved in procedural risk. advisory board activities by Biotronic. The remaining authors have nothing to disclose. 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. 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Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry

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Copyright © 2019 Francesco Burzotta et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 5243913, 10 pages https://doi.org/10.1155/2019/5243913 Research Article Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry 1,2 1,2 3 3 Francesco Burzotta , Giulio Russo, Flavio Ribichini , Anna Piccoli, 1,2 1,2 1,2 3 Domenico D’Amario , Lazzaro Paraggio, Leonardo Previ, Gabriele Pesarini, 1,2 1,2 1,2 1,2 Italo Porto, Antonio Maria Leone, Giampaolo Niccoli, Cristina Aurigemma, 1,2 1,2 1,2 Diana Verdirosi, Filippo Crea, and Carlo Trani Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy Universita` Cattolica del Sacro Cuore, Roma, Italy Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy Correspondence should be addressed to Francesco Burzotta; francescoburzotta@gmail.com Received 26 November 2018; Revised 11 March 2019; Accepted 25 March 2019; Published 9 April 2019 Academic Editor: Vasileios Panoulas Copyright © 2019 Francesco Burzotta et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objective. To investigate the eeff ct of extent of revascularization in complex high-risk indicated patients (CHIP) undergoing Impella-protected percutaneous coronary intervention (PCI). Background. Complete revascularization has been shown to be associated with improved outcomes. However, the impact of more complete revascularization during Impella-protected PCI in CHIP has not been reported. Methods. A total of 86 CHIP undergoing elective PCI with Impella 2.5 or Impella CP between April 2007 and December 2016 from 2 high volume Italian centers were included. Baseline, procedural, and clinical outcomes data were collected retrospectively. Completeness of coronary revascularization was assessed using the British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) derived revascularization index (RI). eTh primary end-point was all-cause mortality. A multivariate regression model was used to identify independent predictors of mortality. Results. All patients had multivessel disease and were considered unsuitable for surgery. At baseline, 44% had left main disease, 78% had LVEF ≤ 35%, and mean BCIS-JS score was 10±2. The mean BCIS-JS derived RI was 0.7 ±0.2 and procedural complications were uncommon. At 14-month follow-up, all- cause mortality was 10.5%. At follow-up, 67.4% of CHIP had LVEF≥ 35% compared to 22.1% before Impella protected-PCI. Higher BCIS-JS RI was significantly associated with LVEF improvement (p=0.002). BCIS-JS RI of ≤ 0.8 (HR 0.11, 95% CI 0.01- 0.92, and p = 0.042) was an independent predictor of mortality. Conclusions. ese Th results support the practice of percutaneous Impella use for protected PCI in CHIP. A more complete revascularization was associated with significant LVEF improvement and survival. 1. Introduction commonly referred to as complex high-risk indicated patients (CHIP) [2]. The use of percutaneous left ventricular assist Patients with poor left ventricular (LV) function and complex devices may minimize the risk of hemodynamic compromise coronary anatomy (such as multivessel disease, left main during such high risk PCI and allow complete revascular- disease, and last remaining vessel) may be unsuitable for ization, thus improving outcomes. The feasibility, safety, and surgical revascularization due to high risk for periprocedural hemodynamic eeff cts of Impella devices during high-risk PCI complications [1]. Percutaneous coronary intervention (PCI) have been demonstrated in the PROTECT-I and PROTECT- is an alternative revascularization strategy in such patients, II trials and in multiple real-world studies [3–8]. 2 Journal of Interventional Cardiology Recent meta-analysis by Pasceri et al. suggests improved favorablesidewas chosen for Impella implantation. The pres- outcomes following complete revascularization in patients ence of atherosclerotic disease of the iliac-femoral axis with with multivessel disease [9]. Importantly, studies suggest nonsignificant ( <50% diameter) stenosis was not considered the possibility of complete revascularization during Impella- an exclusion criterion. No failure of device implantation was protected PCI, resulting in reduced need for repeat revas- reported due to the screening process including systematic cularizations [10]. The purpose of the present study was to iliac-femoral axis assessment. investigate the effect of extent of revascularization, as assessed After femoral artery stick, a 6-8 Fr sheath was inserted. using the BCIS-JS, in CHIP undergoing Impella-protected Then, “pre-closure” technique with suture-based hemostatic PCI in an all comers cohort from two high volume Italian devices was used. The “pre-closure” technique was performed centers. with (according to operator’s yield) the Prostar XL10F or Perclose ProGlide devices (Abbott Vascular Devices, Red- wood City, CA, USA) and consisted of the suture deployment 2. Methods before introduction of the (13 Fr or 14 Fr) Impella 2.5 or CP sheath. After the procedure, Impella was removed and the .. Study Population. This is a retrospective study using a sutures were tied by pushing down knot(s) in order to achieve prospectively maintained database: data of all consecutive percutaneous hemostasis. Of note, when using ProGlide, a patients undergoing elective Impella-protected PCI from double ProGlide pre-closure technique was adopted, based April 2007 to December 2016 in two high-volume (>1000 PCI on sequential insertion of two ProGlide devices rotated in per year) Italian cardiac catheterization laboratories. Patients opposite sides 30-45 , to create an interrupted X-figure clo- with cardiogenic shock and acute myocardial infarction sure [13]. After dedicated sheath insertion, a 6 Fr diagnostic within 24 hours were excluded. According to the hospital catheter (Judkins right or pigtail) was advanced into the practice at the two centers, the need for Impella-protected LV and used to place the 300 cm extra-support guidewire high-risk PCI was assessed based on collegial heart-team into the LV. Then, the Impella catheter was advanced over discussion in which the potential benefit of myocardial the guidewire through the aortic valve into the LV. Impella revascularization was agreed and surgical revascularization was then activated aer ft removal of the guidewire and LV was considered not feasible. Coronary stenosis ≥70% was assistance maintained throughout the procedure. Our center considered significant ( ≥50% in case of left main coro- started using the pre-closure technique before 2007 and nary artery lesion) by visual assessment on angiogram. gaining since then experience in the management of vascular Alternatively, it was assessed by guided by fractional ow fl access with largeboredevices resulting inlow vascular reserve (FFR) or by stress test imaging. All patients provided complication rate (2%) in our registry. Our experience with written consent to undergo PCI with Impella support aer ft double pre-closure system using Perclose has already been detailed explanation of the procedural features. Clinical reported elsewhere [14]. In more recent years, our puncture data, operative risk score (EuroSCORE I), and procedural technique has undergone further improvements by combin- data were prospectively collected. Synergy between Percu- ing angiographic and ultrasound guidance [15, 16]. taneous Coronary Intervention with TAXUS and Cardiac PCI was performed by the radial or (in patients with Surgery (SYNTAX) score before and aeft r the procedure unsuitable radial accesses) by contralateral femoral approach was calculated for all patients without previous coronary using 6-8 Fr guiding catheters. Selection of guidewires, surgery. For the present study, an interventional cardiology balloons, and stents was based operator’s choice. Drug- fellow (blinded to patient’s clinical presentation and outcome) eluting stent implantation was the main PCI technique and graded the myocardium at jeopardy before and after PCI debulking with Rotablator was the main adjunctive device using the British Cardiovascular Intervention Society (BCIS) used for severely calcified coronary segments. At the end Jeopardy Score (JS) algorithm [11]. Extent of revascularization of PCI, Impella speed was gradually decreased and patient’s was assessed using the BCIS-JS revascularization index (RI): hemodynamic condition was evaluated. In case of hemody- (BCIS-JS -BCIS-JS )/ BCIS-JS as previously reported pre post pre namic stability, Impella was immediately removed. In the [12]. Two examples of BCIS-JS RI calculations are provided case of mechanical hemostasis failures, manual compression in Figures 1(a) and 1(b). followed by compressive bandage was adopted. Of note, access-artery angiography to confirm hemostasis and to rule- .. Impella-Protected PCI. The Impella 2.5 or Impella CP out vascular complications was systematically performed. (after its release in Italy) heart pumps were used and implan- In all patients, heparin was administered (initial weight- adjusted intravenous bolus then further boluses administered tation was performed through percutaneous trans-femoral approach. All patients received iliac-femoral artery axis in order to keep the activated clotting time between 250 assessment by ultrasonography and/or peripheral angiog- and 300s) and double antiplatelet therapy was started before raphy during a pre-PCI work-up. All femoral punctures PCI initiation and recommended for 12 months. Blood were u fl oroscopy-guided. Prior to Impella sheath placement, samples were obtained at 6 and 24 h after the procedure to measure hemoglobin and creatinine levels. Additional peripheral angiography (through the radial or contralateral femoral access selected for PCI) was performed to confirm laboratory exams were performed if clinically indicated. The the suitability of iliac-femoral arterial axis anatomy. Accord- occurrence of any complication during the hospital stay was prospectively recorded into the catheterization laboratory ingly, when atherosclerotic burden or tortuosity was high, the contralateral iliac-femoral axis was assessed and the most database. Journal of Interventional Cardiology 3 PRE POST CX Dominant RCA Dominant LM = 12 LM = 8 Prox LAD = 6 Prox LAD = 6 Prox CX = 6 Prox CX = 2 Diag= 2 Diag= 2 OM = 2 OM = 2 Dist CX = 2 Dist CX = 0 Mid/dist LAD = 2 Mid/dist LAD = 2 RCA = 0 RCA = 4 PDA= 2 BCIS-JR = 12 BCIS-JR = 4 Pre-PCI LVEF= 31% LVEF at follow-up =25% 12 - 4 BCIS-JR Revasc. Index = = 0.67 (a) PRE POST CX Dominant RCA Dominant LM = 8 LM = 12 Prox LAD = 6 Prox LAD = 6 Prox CX = 6 Prox CX = 2 Diag= 2 Diag= 2 OM = 2 Dist CX = 2 OM = 2 Dist CX = 0 Mid/dist LAD = 2 Mid/dist LAD = 2 RCA = 0 RCA = 4 PDA= 2 BCIS-JR = 12 BCIS-JR = 0 Pre-PCI LVEF= 18% LVEF at follow-up =45% 12 - 0 BCIS-JR Revasc. Index = = 1.00 (b) Figure 1: British-Cardiovascular-Intervention-Society jeopardy-score (BCIS-JS) calculation examples in a patient with complete (a) and in a patient with incomplete (b) myocardial revascularization. Patient in (a) showed a significant improvement of left ventricular function, while patient in (b) died after 6 months of follow-up. Arrows indicate significant coronary stenosis. PCI=percutaneous coronary intervention and LVEF=left ventricular ejection fraction. .. Procedural and Clinical Outcome Assessment. For the definition of myocardial infarction [19]. Stroke was defined present study, clinical records were carefully evaluated and as any new, permanent, global, or focal neurological deficit clinical follow-up was obtained by reviewing the outpatient ascertained by a standard neurological examination, lasting longer than 24 hours or less if evidence of cerebral infarction visit reports or by telephone interview. Access site or bleed- was obtained by imaging. In our study renal failure was ing complications were classified according to the Valve defined per the Kidney Disease Improving Global Outcomes Academic Research Consortium (VARC) and the Bleeding (KDIGO) guidelines as any abnormality of kidney function Academic Research Consortium (BARC) criteria [17, 18]. (decreased glomerular filtration rate <60 ml/min/1.73m )or The primary study end-point was all-cause mortality. Major kidney structure (e.g., kidney transplantation). adverse cardiac and cerebrovascular events (MACCE) were den fi ed as the composite of death and/or acute myocardial infarction (AMI) or target vessel revascularization (either .. Le Ventricular Function. Echocardiographic assess- percutaneous or surgical) or stroke. AMI during follow- ment of the LV ejection fraction (LVEF), aortic valve, and up wasdenfi ed asthe rise andfall ofcardiac enzymes thepresenceofintraventricular thrombus was systematically (usually serum high-sensitivity Troponin I) in the presence performed before the procedure. After the index hospital- of electrocardiogram signs or symptoms compatible with ization, clinical follow-up (with echocardiographic examina- myocardial ischemia, as described in the third universal tion) was systematically recommended. Echocardiographic 4 Journal of Interventional Cardiology assessment of LV function was performed according to the access. Thirty-vfi e (41%) patients underwent left main PCI biplane method of disk summation (modified Simpson’s and almost three-quarters of patients were treated on at rule) [20]. Changes in LVEF between baseline and post- least two vessels including bifurcations and diffusely diseased PCI (at the longest available echocardiographic examination) vessels (Table 2). Thirteen patients (15%) received rotational were estimated by calculating the “indexed” LVEF variation, atherectomy for heavily calciefi d lesions. At least one drug calculated as (LVEF -LVEF )/LVEF . eluting stent was implanted in 83 (96%) patients, and the pre-PCI post-PCI pre-PCI remaining 3 (4%) patients received bare metal stents due to concerns regarding their tolerance for prolonged dual .. Statistical Analysis. Continuous variables are presented antiplatelet therapy. Both SYNTAX score and BCIS-JS were as mean with standard deviation (SD) and categorical vari- significantly reduced after PCI compared to baseline (from ables as numbers and percentages. The continuous variables 31±10 to 12±9and from 10±2to3±3 respectively, p< 0.001 related to LVEF and BCIS-JS RI were categorised in ter- for both). Patients had complete revascularization as sug- tiles. Comparisons of continuous variables across dieff rent gested by mean BCIS-JS revascularization index of 0.7±0.2. groups were performed using Student t test or ANOVA test Successful hemostasis was achieved by insertion of double (as appropriate). Categorical variables were evaluated using 2 preimplanted Perclose ProGlide in 63%, Prostar XL in 12%, 휒 test or Fisher’s exact test, as appropriate. Comparisons and manual compression in 25%. between pre-PCI and post-PCI data were performed using Bleeding and vascular complications occurred in 14% paired t-test. A Cox regression analysis was performed to and 2%, respectively (Table 3). There were 6 cases of minor identify the independent predictors of mortality among the hematomas that required no specific intervention (BARC main baseline characteristics (age, gender, diabetes, renal Type I), 2 patients required bail-out balloon peripheral angio- failure, prior myocardial infarction, prior PCI, prior cardiac plasty to facilitate hemostasis by manual-compression (BARC surgery, clinical presentation, advanced New York Heart Type II), and 4 patients had decrease in hemoglobin by>3 Association class, EuroSCORE, and BCIS-JS RI). Adjusted g/dL with three of them requiring blood transfusion (BARC hazard ratios (HR) with associated 95% confidence interval Type III). Two minor vascular complications occurred. One (CI) were calculated for the significant mortality predictors patient had distal embolization few hours after PCI (acute and corresponding adjusted survival curves were deter- lower limb ischemia plus occlusion of lower limb arteries mined. A 2-tailed, p-value<0.05 was established as the level of based on ultrasound examination) and was successfully statistical significance. All statistical analyses were performed managed by urgent peripheral angioplasty on tibial-peroneal using SPSS software v22.0 (IBM Corporation, Armonk, New arteries. The other case was an access site vascular injury York). consisting of angiographically documented common femoral artery occlusion after Impella 2.5 pump removal. Since the 3. Results patient was asymptomatic, and collateral branches provided full distal supply (probably due to pre-existing superficial .. Patient Population. From April 2007 to December 2016, a femoral artery disease), a conservative management was total of 86 patients (mean age 72±10 years, 91.8% men) under- selected, and the clinical course was uneventful. No other went Impella protected high-risk PCI at two high volume Ital- main procedure-related complication was noticed and a total ian centers and were included in the present analysis. Baseline of 94% of patients were discharged alive (see below for death characteristics of patients are listed in Table 1. Patients were reports). highly symptomatic with New York Heart Association class In our study the median value for the duration of Impella III or IV in 69.7%. They had high prevalence of hyperten- support was 104 minutes (range 55-3151) and Impella mal- sion (78%), dyslipidemia (62%), diabetes (44%), previous functions were not reported. Further insights into procedural myocardial infarction (35%), and previous coronary bypass hemodynamic behavior and Impella pump performance were grafting surgery (22%). About 58% of patients were admitted available only in 37 patients [21]. for a non-ST elevation myocardial infarction (NSTEMI). About 78% had LVEF< 35% (mean 31±9%). All patients had multivessel disease and 44% had left main disease. The mean .. Le Ventricular Function. Seventy-nine patients (92%) SYNTAX score was 31±10 and mean EuroSCORE I was 9±3. underwent echocardiography at mean follow-up of 6 months The extent of jeopardized myocardium was large with mean (range 1-12 months) and signicfi ant improvement in LVEF pre-PCI BCIS-JS of 10 (score range: 0-12). All patients were was observed (31±9% at baseline to 39±9%, p< 0.001). Of deemed unsuitable for surgery on the basis of heart-team the 79 patients, 27.9% presented with pre-PCI LVEF≤ 25%, discussion. The baseline characteristics of the present study 50% with LVEF of 26-34%, and 22.1% with LVEF of 35-50%. cohort were listed alongside previously published clinical After PCI, only 9.3% had LVEF ≤ 25%, and 23.3% had LVEF of studies: PROTECT II trial, Europella, and USpella registries 26-34%. Patients had significant improvement in LVEF post- [4–6] (Table 1). Impella-protected PCI with 67.4% having LVEF of 35-50% (Figure 2). .. Procedural and Safety Outcomes. Seventy-four patients Among the different preprocedural and procedural fac- (86%) received hemodynamic support with Impella 2.5 and tors, pre-PCI LVEF (p< 0.001) and BCIS-JS revascularization index (p< 0.001) significantly influenced “indexed” LVEF 12 patients (14%) with Impella CP (Table 2). In majority of patients (77%), PCI was performed via the radial artery variation. In particular, significantly higher indexed LVEF Journal of Interventional Cardiology 5 Table 1: 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 Cardiovascular Risk Factors, n(%) 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) Past Cardiac History, n(%) Prior MI 30 (35) / 76 (53) 98 (56) Prior PCI 14 (16) / / 84 (48) Prior CABG 19 (22) 85 (38) 42 (29) 49 (28) Clinical presentation, n(%) STEMI 13 (15) / / / NSTEMI 50 (58) 55 (37) / / SA 23 (27) 93 (63) / / NYHA III-IV, n(%) 60 (70) 151 (67) / 115 (66) LVEF, mean±SD (%) 31±923±6/ 31±17 LVEF≤%, n(%) 67 (78) 216 (100) 92 (64)† 121 (69) EuroSCORE, mean±SD 9±39±68±3/ Lower Tertile (3-7) 30 (35) Mid Tertile 2 (8-10) 30 (35) Higher Tertile 3 (11-20) 26 (30) Unsuitable for surgery‡,n (%) 86 (100) 144 (64) 62 (43) 98 (56) Angiographic characteristics 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/ / / ∗ Randomized Impella arm. † 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. variation was observed in patients with higher BCIS-JS one patient (exhibiting persistent electrical instability) died revascularization index (p = 0.002) (Figure 3). during ventricular tachycardia ablation attempt. Among the remaining four patients who died aer ft 30 days, one had fatal stent thrombosis at 6-months, and three had progressive .. Clinical Outcome and Its Determinants. The rate of major congestive heart failure. Repeat PCI was performed in 12 adverse cardiac and cerebrovascular events (MACCE) during patients (14%) and CABG in 1 patient (1%). AMI occurred mean follow-up of 14 months was 24% (Table 4). A total of in 6 patients (7%) and no case of stroke was reported. nine deaths (10.5%) occurred during the study. In particular, In the multivariate analysis including all the main base- one death occurred few hours after procedure due to acute bare metal stent thrombosis. Four deaths occurred within 30 line characteristics, EuroSCORE I> 11 (HR 311.8, 95% CI 10.9 days from the index procedure: three patients died of pro- to 8952, and p = 0.001) and BCIS-JS revascularization index gressive respiratory failure in the presence of refractory heart of≤ 0.8 (HR 0.11, 95% CI 0.01 to 0.92, and p = 0.042) were failure and severe chronic obstructive pulmonary disease and the only independent predictors of mortality (Table 5). No 6 Journal of Interventional Cardiology Table 2: Procedural characteristics. CHARACTERISTICS N=86 (%) Approach for PCI Radial 66 (77) Femoral 20 (23) Number of treated vessels 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) Post-PCI Angiographic scores Syntax Score 12±8.7 BCIS-JS 3±3 BCIS-JS Revascularization Index, mean±SD 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) Impella pump 2.5 74 (86) CP 12 (14) Impella support duration,min∘ 104 (55-3151) Haemostasis technique Double Perclose 54 (63) Prostar 10 (12) Manual compression 22 (25) p<0.001 as compared with baseline values. ∘ value expressed as median with range. PCI= percutaneous coronary intervention; DES=drug eluting stent; BCIS-JS= the British Cardiovascular Intervention Society myocardial Jeopardy Score. Table 3: Periprocedural bleeding and vascular complications. COMPLICATION N=86 (%) Bleedings (BARC criteria)  () Type I 6(7) Type II 2(2) Type III 4(5) Type IV 0 Type V 0 Vascular complications (VARC criteria) 2(2) Major vascular complication 0 Minorvascularcomplication 2 Percutaneous closure device failure 0 BARC= Bleeding Academic Research Consortium; VARC= Valve Academic Research Consortium; see text for detailed description of complications. significant association was found with residual Syntax Score. 4. Discussion Based on Kaplan-Meier analysis, patients with more complete In this large cohort of patients treated by IMP-protected PCI revascularization of angiographically significant stenosis (RI in two experienced Italian centers we found that: > 0.8 to 1.0) had a survival advantage, both early after PCI and in the longer term, compared to those with less revascularization (RI 0.2 to 0.5 or 0.51 to 0.80; p = 0.049) (1) Impella-protected PCI in CHIP is associated with (Figure 4). LVEF recovery and very promising survival rates Journal of Interventional Cardiology 7 p ≤ 0.001 205% 22.1% Increase in patients with LVEF 35-50% at follow-up 67.4% 50.0% 23.3% 27.9% 9.3% LVEF Pre-PCI LVEF at follow-up LVEF 35-50% LVEF 26-34% LVEF ≤25% Figure 2: Le ventricular ejection fraction improvement during the follow-up aer IMP-protected PCI. eTh figure shows the comparison of left ventricular ejection fraction impairment between pre-PCI and follow-up assessment. LVEF=left ventricular ejection fraction and PCI=percutaneous coronary intervention. p=0.002 p=0.049 2.0 1.00 1.5 0.99 1.0 0.98 0.5 0.0 0.97 −0.5 Lower BCIS-JS Mid BCIS-JS Higher BCIS-JS 0.96 Revascularization Revascularization Revascularization Index Tertile Index Tertile Index Tertile 0.95 (0.20-0.50) (0.51-0.80) (0.81-1.00) Figure 3: Le ventricular ejection fraction improvement according 0.94 to revascularization extent. eTh figure shows the left ventricular improvement in patients stratified according to revascularization 0 3 6 9 12 15 18 extent as evaluated by the British Cardiovascular Intervention Months from intervention Society Jeopardy Score (BCIS-JS) tertiles. LVEF=left ventricular BCIS-JS RI higher tertile (0.81- 1.00) ejection fraction. BCIS-JS RI mid tertile (0.51- 0.80) BCIS-JS RI lower tertile (0.20 -0.50) Figure 4: Survival curves according to revascularization extent.The (2) the extent of the coronary revascularization achieved figure shows the adjusted survival curves in the study population during IMP-protected PCI in CHIP is associated with stratified according to British Cardiovascular Intervention Society LVEF recovery and survival. Jeopardy Score (BCIS-JS) revascularization index tertiles. RI= revas- cularization index. 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, higher complexity and mortality of patients in routine clinical were deemed to be ineligible for surgery, and had higher practice. The study by Waldo et al. suggested that surgical prevalence of left main disease as compared to the patients ineligibility is common and associated with higher mor- randomized in the PROTECT-II trial (Table 1), reflecting tality among patients with multivessel or left main disease Indexed LVEF % of patients Survival 8 Journal of Interventional Cardiology Table 4: Clinical outcome at longest follow-up. Present PROTECT EUROpella USpella ADVERSE EVENT Study II N=144 (%)∘ N=175 (%)∘ N=86 (%) N=225∗ (%)∘ 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) All-cause death 9 (10) 27 (12) 8 (6) 7 (4) Randomized Impella arm ∘ 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 primar y 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 insufficien cy, 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=acu te myocardial infarction Table 5: Multivariate analysis for independent predictors of mortality. P-value Adjusted HR (95% CI) EuroSCORE 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) BCIS-JS Revascularization Index 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. undergoing nonemergent PCI [22]. Despite the high risk was slightly different from that presented in this study: they of mortality, the survival rate in our study was favor- hada lowerbaseline Syntax Score andonly a minority of able at 90% likely due to more complete revascularization patients presented with reduced LV function. While Syntax with Impella-protected PCI. In fact, BCIS-JS derived RI Score remains the main tool for risk assessment according to was an independent predictor of mortality in multivariate coronary anatomy complexity our results suggest that BCIS- analysis. JS score and the BCIS-JS derived RI might provide a better risk evaluation in the work-up of CHIP. The present study assessed the extent of revascularization using the BCIS-JS, which takes into account the entire More complete revascularization with Impella-protected PCI resulted in improvement in cardiac function with about myocardial area at risk [12]. The mean BCIS-JS-derived RI 70% of CHIP having LVEF≥ 35%. Moreover, BCIS-JS derived of 0.7 demonstrates the utility of Impella-protected PCI RI significantly influenced “indexed” LVEF variation. This is in achieving more complete revascularization. The n fi ding a novel finding as previous studies of Impella in high risk of higher survival with higher RI is in line with previous study demonstrating survival benefit following complete PCI have inferred more complete revascularization based on reduced need for repeat revascularization [4, 10]. As revascularization and the prognostic value of BCIS-JS in demonstrated in previous studies with STEMI and mul- predicting mortality in high-risk PCI [12]. Complete revas- cularization during Impella-protected PCI is likely due to tivessel disease, complete revascularization was associated with improved survival outcomes and complications [9, 24], the greater hemodynamic stability provided by Impella, thus although our patient population included 58% with non- allowing operators to perform more vigorous procedures including rotational atherectomy for heavily calcified lesions STEMI. [4]. Gen ´ er ´ eux et al. [23] had previously shown that higher Previous studies have documented the safety of Impella residual Syntax Score was associated with poor short- and usein high-risk PCIat 30and 90 days [4,25].A substudy of the PROTECT II trial [26] focused on patients with three- long-term prognosis in patients with moderate/high risk acute coronary syndrome. However, their study population vessel coronary artery disease and reduced LV function, Journal of Interventional Cardiology 9 showing improved outcomes when Impella 2.5 was used as Data Availability LV support device, compared to intra-aortic balloon pump The clinical and procedural data used to support the findings (IABP). The composite endpoint of major cardiac events was of this study are included within the article. significantly lower in the Impella group compared to IABP group (32.9% vs 42.4% at 30 days and 39.5% vs 51.0% aer ft 90 days of follow-up). However, all-cause death rates, for Conflicts of Interest which the study was not powered, were similar between the two groups. Moreover, data regarding Impella supported PCI Dr. Burzotta discloses to have been involved in advisory in patients undergoing unprotected left main (LM) revascu- board meetings or having received speaker’s fees from larization have been extrapolated from the USpella registry Medtronic, St Jude Medical, Abiomed, Biotronic. Dr. Trani [27] demonstrating its feasibility and safety. Although the discloses to have been involved in advisory board meetings analysis was mainly based on patients undergoing LM PCI, or having received speaker’s fees from St Jude Medical, they achieved nearly complete revascularization with low Abiomed, Biotronic. Dr. Aurigemma has been involved in procedural risk. advisory board activities by Biotronic. The remaining authors have nothing to disclose. 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. 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