Abstract
Background
Temporary use of a percutaneous left ventricular assist device (PLVAD) may be beneficial in patients undergoing high-risk percutaneous coronary intervention (PCI) and those with cardiogenic shock (CS).
Methods
Seventy-four consecutive patients undergoing high-risk PCI and those with CS receiving intraaortic balloon pump (IABP), TandemHeart (TH), or Impella device (IMP) were enrolled. Patient undergoing high-risk PCI ( n =57) and those treated for CS ( n =17) were analyzed as separate cohorts. Patients undergoing IABP-assisted PCI were compared to those undergoing PLVAD (TH and IMP)-assisted PCI. The primary end point was in-hospital major adverse cardiovascular events, and the secondary end point was in-hospital vascular complications.
Results
For the high-risk PCI cohort ( n =57), 22 received PLVAD and 35 received IABP. Patients receiving IABP were younger and less likely to have a prior myocardial infarction (MI) and less likely to be on dialysis compared to those receiving PLVAD support. Patients receiving PLVAD support had a higher baseline Syntax score, had a higher prevalence of unprotected left main disease, underwent treatment of more coronary lesions, received more coronary stents, and more likely received drug-eluting stents compared to those receiving IABP support. The primary and secondary end points were similar between both groups. For the CS cohort ( n =17), 4 received PLVAD and 13 received IABP. Patients receiving PLVAD support were more likely to have a prior MI, had a lower ejection fraction, underwent treatment of more coronary lesions, and received more coronary stents compared to those receiving IABP support. The primary and secondary end points were similar between both groups.
Conclusions
IABP compared with PLVAD use for high-risk PCI and CS is associated with significantly different baseline patient, clinical, procedural, and angiographic characteristics. In-hospital clinical outcome was similar between both groups in both the high-risk PCI and the CS cohorts. When physicians have access to each of these devices, short-term clinical outcome appears to be similar.
1
Introduction
Use of a temporary percutaneous left ventricular assist device (PLVAD) may be beneficial in patients with cardiogenic shock (CS) and those undergoing high-risk percutaneous coronary intervention (PCI) . In the United States, options for PLVAD support include the Impella Device (IMP) (Abiomed, Danvers, MA, USA) and TandemHeart (TH) (Cardiac Assist Inc., Pittsburgh, PA, USA). Randomized studies comparing PLVAD to the intraaortic balloon pump (IABP) show an improvement in hemodynamic parameters with an increase in cardiac index and mean arterial blood pressure and a reduction in pulmonary capillary wedge pressure . However, a recent meta-analysis found no significant improvement in mortality at hospital discharge or at 30 days with use of a PLVAD compared to IABP . Given these issues, indications for PLVAD use remain unclear, and guidelines for elective versus provisional placement are not yet available . Physicians are thus left with clinical judgment and past experience to determine which patients may benefit from a particular device. We therefore sought to evaluate our experience with PLVAD and IABP in a consecutive series of patients undergoing high-risk PCI and those treated for CS.
2
Methods
2.1
Study population
Seventy-four consecutive patients undergoing high-risk PCI and those treated for CS from March 2007 to December 2009 were prospectively enrolled in an observational, nonrandomized study ( Fig. 1 ). Patients undergoing high-risk PCI ( n =57) and those being treated with PCI for CS ( n =17) were analyzed as separate patient cohorts. Patients were then grouped according to the device used for hemodynamic support during PCI. For each patient cohort (high-risk PCI and CS), patients receiving either the IMP or the TH device were considered as the PLVAD group. For the high-risk PCI cohort, 35 received IABP (IABP group, n =35) and 22 received PLVAD (IMP, n =11; TH, n =11; PLVAD group, n =22). For the CS cohort, 13 received IABP and 4 received PLVAD (IMP, n =1; TH, n =3; PLVAD group, n =4).
The study protocol was approved by the institutional review board. Eligible patients included those undergoing placement of IABP, TH, or IMP prior to, during, or immediately following high-risk PCI and those treated with PCI for CS. All three devices were available for use during the study period. High-risk PCI was defined as PCI on an unprotected left main stenosis, PCI on the last remaining conduit vessel, or PCI done in the setting of reduced left ventricular systolic function (ejection fraction <30%).
CS was defined as a cardiac index <2.0 l/m 2 per min, mean arterial pressure <60 mmHg, pulmonary capillary wedge pressure >18 mmHg, and evidence of end-organ hypoperfusion (decreased urine output, altered mental status) or the need for high-dose pressors and/or inotropic support. Use of each device was at the discretion of the treating interventional cardiologist. Patients undergoing IABP or PLVAD for decompensated congestive heart failure or CS not related to an acute coronary syndrome were excluded from the analysis. During the study period, two additional patients underwent placement of right-sided TH support for right heart failure secondary to massive pulmonary embolism and were not included in the analysis.
Data collected consisted of demographics including age, gender, coronary risk factors, medical history, presentation [ST-segment elevation myocardial infarction (STEMI), non-STEMI], and baseline ejection fraction. Angiographic and procedural information included number of diseased vessels, presence of >50% left main stenosis, number of lesions treated, use of drug-eluting stent, use of glycoprotein IIb/IIIa inhibitor, use of Angiomax, use of rotational atherectomy, removal of device immediately post-PCI in the cardiac catheterization laboratory, duration of IABP or PLVAD support (hours), final Thrombolysis in Myocardial Infarction (TIMI) flow, and use of vascular closure device. The Syntax score, a validated anatomic measure of the severity of coronary artery disease burden, was calculated at baseline using the online calculator ( http://www.syntaxscore.com ) . The Society of Thoracic Surgery (STS) score was calculated using an online calculator ( http://209.220.160.181/STSWebRiskCalc261/de.aspx ). The additive European System for Cardiac Operative Risk Evaluation (EuroSCORE), logistic EuroSCORE, and National Cardiovascular Data Registry (NCDR) CathPCI risk score were calculated for each patient to assess overall patient risk . In-hospital clinical events including vascular complications, acute stent thrombosis, recurrent myocardial infarction, repeat target vessel revascularization, major adverse cardiovascular events (MACE), and death were recorded. Vascular complications were defined as need for emergent vascular surgery, limb ischemia, blood transfusion, hematoma >5 cm, pseudoaneurysm, or arterial venous fistula. The primary end point was in-hospital MACE, defined as death, recurrent myocardial infarction, or repeat revascularization. The secondary end point was in-hospital vascular complications.
2.2
Device implantation
The TH device was inserted as previously described . Arterial access was initially obtained with a 6-Fr sheath. In patient without angiographic disease, the ‘Preclose’ technique was used . A 15 -Fr cannula was placed in the femoral/iliac artery over a 0.035-in. Amplatzer guide wire (AGA Medical, Golden Valley, MN, USA). Transeptal puncture was done using either fluoroscopic or intracardiac echocardiographic guidance. The interatrial septum was dilated, and a 21-Fr sheath was placed into the left atrium over a 0.035-in. Amplatzer guide wire (AGA Medical, Golden Valley, MN, USA). The TH system was primed and set to maximum output throughout the procedure. Unfractioned heparin or bivalirudin (Medicines Company, Parsippany, NJ, USA) was given to achieve an activated clotting time (ACT) >250 s. The timing of device explanation was left to the discretion of the treating interventional cardiologist. Following the procedure, in hemodynamically stable patients, both the arterial and venous cannulae were removed in the cardiac catheterization laboratory using the previously placed suture devices or a Femostop device (St. Jude Medical, St. Paul, MN, USA).
The IMP device was placed as previously described . A 6-Fr arterial sheath was placed in the common femoral artery. In patient without angiographic disease, the ‘Preclose’ technique was used . The 6-Fr sheath was exchanged for a 13-Fr sheath, and the IMP device was advanced retrograde across the aortic valve over a .021-in. wire. Unfractioned heparin or bivalirudin (Medicines Company, Parsippany, NJ, USA) was given to achieve an ACT >250 s. Support was increased to achieve the maximal flow rate of 2.5 l/min. The timing of device explanation was left to the discretion of the treating interventional cardiologist. Following the procedure, in hemodynamically stable patients, the arterial sheath was removed in the cardiac catheterization laboratory using the previously placed suture devices or a Femostop device (St. Jude Medical, St. Paul, MN, USA).
2.3
Statistical analysis
Patients undergoing high-risk PCI and those treated with PCI for CS were analyzed as two separate cohorts. For the high-risk PCI cohort ( n =57), those receiving either TH ( n =11) or IMP ( n =11) were considered as the PLVAD group ( n =22) and were compared to the IABP group ( n =35). For the CS cohort ( n =17), those receiving either TH ( n =3) or IMP ( n =1) were considered as the PLVAD group ( n =4) and were compared to the IABP group ( n =13). Continuous variables were presented as mean±standard deviation. Comparison between categorical variables was done using χ 2 test and Student’s t test for differences in continuous variables. A P value of <.05 was considered statistically significant.
2
Methods
2.1
Study population
Seventy-four consecutive patients undergoing high-risk PCI and those treated for CS from March 2007 to December 2009 were prospectively enrolled in an observational, nonrandomized study ( Fig. 1 ). Patients undergoing high-risk PCI ( n =57) and those being treated with PCI for CS ( n =17) were analyzed as separate patient cohorts. Patients were then grouped according to the device used for hemodynamic support during PCI. For each patient cohort (high-risk PCI and CS), patients receiving either the IMP or the TH device were considered as the PLVAD group. For the high-risk PCI cohort, 35 received IABP (IABP group, n =35) and 22 received PLVAD (IMP, n =11; TH, n =11; PLVAD group, n =22). For the CS cohort, 13 received IABP and 4 received PLVAD (IMP, n =1; TH, n =3; PLVAD group, n =4).
The study protocol was approved by the institutional review board. Eligible patients included those undergoing placement of IABP, TH, or IMP prior to, during, or immediately following high-risk PCI and those treated with PCI for CS. All three devices were available for use during the study period. High-risk PCI was defined as PCI on an unprotected left main stenosis, PCI on the last remaining conduit vessel, or PCI done in the setting of reduced left ventricular systolic function (ejection fraction <30%).
CS was defined as a cardiac index <2.0 l/m 2 per min, mean arterial pressure <60 mmHg, pulmonary capillary wedge pressure >18 mmHg, and evidence of end-organ hypoperfusion (decreased urine output, altered mental status) or the need for high-dose pressors and/or inotropic support. Use of each device was at the discretion of the treating interventional cardiologist. Patients undergoing IABP or PLVAD for decompensated congestive heart failure or CS not related to an acute coronary syndrome were excluded from the analysis. During the study period, two additional patients underwent placement of right-sided TH support for right heart failure secondary to massive pulmonary embolism and were not included in the analysis.
Data collected consisted of demographics including age, gender, coronary risk factors, medical history, presentation [ST-segment elevation myocardial infarction (STEMI), non-STEMI], and baseline ejection fraction. Angiographic and procedural information included number of diseased vessels, presence of >50% left main stenosis, number of lesions treated, use of drug-eluting stent, use of glycoprotein IIb/IIIa inhibitor, use of Angiomax, use of rotational atherectomy, removal of device immediately post-PCI in the cardiac catheterization laboratory, duration of IABP or PLVAD support (hours), final Thrombolysis in Myocardial Infarction (TIMI) flow, and use of vascular closure device. The Syntax score, a validated anatomic measure of the severity of coronary artery disease burden, was calculated at baseline using the online calculator ( http://www.syntaxscore.com ) . The Society of Thoracic Surgery (STS) score was calculated using an online calculator ( http://209.220.160.181/STSWebRiskCalc261/de.aspx ). The additive European System for Cardiac Operative Risk Evaluation (EuroSCORE), logistic EuroSCORE, and National Cardiovascular Data Registry (NCDR) CathPCI risk score were calculated for each patient to assess overall patient risk . In-hospital clinical events including vascular complications, acute stent thrombosis, recurrent myocardial infarction, repeat target vessel revascularization, major adverse cardiovascular events (MACE), and death were recorded. Vascular complications were defined as need for emergent vascular surgery, limb ischemia, blood transfusion, hematoma >5 cm, pseudoaneurysm, or arterial venous fistula. The primary end point was in-hospital MACE, defined as death, recurrent myocardial infarction, or repeat revascularization. The secondary end point was in-hospital vascular complications.
2.2
Device implantation
The TH device was inserted as previously described . Arterial access was initially obtained with a 6-Fr sheath. In patient without angiographic disease, the ‘Preclose’ technique was used . A 15 -Fr cannula was placed in the femoral/iliac artery over a 0.035-in. Amplatzer guide wire (AGA Medical, Golden Valley, MN, USA). Transeptal puncture was done using either fluoroscopic or intracardiac echocardiographic guidance. The interatrial septum was dilated, and a 21-Fr sheath was placed into the left atrium over a 0.035-in. Amplatzer guide wire (AGA Medical, Golden Valley, MN, USA). The TH system was primed and set to maximum output throughout the procedure. Unfractioned heparin or bivalirudin (Medicines Company, Parsippany, NJ, USA) was given to achieve an activated clotting time (ACT) >250 s. The timing of device explanation was left to the discretion of the treating interventional cardiologist. Following the procedure, in hemodynamically stable patients, both the arterial and venous cannulae were removed in the cardiac catheterization laboratory using the previously placed suture devices or a Femostop device (St. Jude Medical, St. Paul, MN, USA).
The IMP device was placed as previously described . A 6-Fr arterial sheath was placed in the common femoral artery. In patient without angiographic disease, the ‘Preclose’ technique was used . The 6-Fr sheath was exchanged for a 13-Fr sheath, and the IMP device was advanced retrograde across the aortic valve over a .021-in. wire. Unfractioned heparin or bivalirudin (Medicines Company, Parsippany, NJ, USA) was given to achieve an ACT >250 s. Support was increased to achieve the maximal flow rate of 2.5 l/min. The timing of device explanation was left to the discretion of the treating interventional cardiologist. Following the procedure, in hemodynamically stable patients, the arterial sheath was removed in the cardiac catheterization laboratory using the previously placed suture devices or a Femostop device (St. Jude Medical, St. Paul, MN, USA).
2.3
Statistical analysis
Patients undergoing high-risk PCI and those treated with PCI for CS were analyzed as two separate cohorts. For the high-risk PCI cohort ( n =57), those receiving either TH ( n =11) or IMP ( n =11) were considered as the PLVAD group ( n =22) and were compared to the IABP group ( n =35). For the CS cohort ( n =17), those receiving either TH ( n =3) or IMP ( n =1) were considered as the PLVAD group ( n =4) and were compared to the IABP group ( n =13). Continuous variables were presented as mean±standard deviation. Comparison between categorical variables was done using χ 2 test and Student’s t test for differences in continuous variables. A P value of <.05 was considered statistically significant.
3
Results
3.1
High-risk PCI cohort
Baseline characteristics of patients undergoing high-risk PCI with PLVAD support and IABP support are shown in Table 1 . Patient receiving IABP were younger, were less likely to have a prior myocardial infarction, were less likely to be receiving dialysis, were more likely to present as STEMI, and had a higher ejection fraction at baseline compared to those receiving PLVAD support. The Syntax, STS, and NCDR CathPCI risk scores were higher in the PLVAD group compared to the IABP group. The additive EuroSCORE and logistic EuroSCORE were similar between both groups. Angiographic and procedural characteristics are shown in Table 2 . The mean number of diseased vessels was similar in both groups. Patients receiving PLVAD support had a higher prevalence of unprotected left main disease, underwent treatment of more coronary lesions, had more coronary stents placed, and more likely had a drug-eluting stent placed compared to those receiving IABP support. Patients receiving IABP support more commonly received bivalirudin as the anticoagulant compared to those receiving PLVAD support. Patients receiving PLVAD support more commonly had the device removed immediately following PCI in the cardiac catheterization laboratory, had a shorter duration of device support, and more frequently received a vascular closure device compared to those receiving IABP support.
| Characteristic | High-risk PCI n =57 | CS n =17 | ||||
|---|---|---|---|---|---|---|
| IABP group | PLVAD group | P value | IABP group | PLVAD group | P value | |
| n =35 | n =22 | n =13 | n =4 | |||
| Age a | 57±12 | 68±13 | .001 | 60±9.9 | 69±9.0 | .07 |
| Men, n (%) | 27 (77) | 19 (86) | .39 | 12 (92) | 3 (75) | .35 |
| Hypertension, n (%) | 28 (80) | 19 (86) | .54 | 8 (62) | 2 (50) | .68 |
| Diabetes mellitus, n (%) | 18 (51) | 16 (73) | .11 | 6 (46) | 1 (25) | .52 |
| Hyperlipidemia, n (%) | 26 (74) | 15 (68) | .62 | 8 (62) | 1 (25) | .20 |
| Peripheral vascular disease, n (%) | 2 (6) | 2 (9) | .63 | 4 (31) | 2 (50) | .48 |
| Tobacco use, n (%) | 12 (34) | 13 (59) | .07 | 0 | 0 | – |
| Prior myocardial infarction, n (%) | 8 (23) | 15 (68) | .001 | 2 (15) | 4 (100) | .002 |
| Prior coronary artery bypass, n (%) | 2 (6) | 3 (14) | .30 | 1 (8) | 0 | .33 |
| Prior PCI, n (%) | 8 (23) | 9 (41) | .15 | 2 (15) | 1 (25) | .66 |
| Congestive heart failure, n (%) | 15 (43) | 7 (77) | .40 | 6 (46) | 0 | .91 |
| Dialysis, n (%) | 0 | 4 (18) | .009 | 2 (15) | 0 | .40 |
| Presentation | ||||||
| STEMI, n (%) | 19 (54%) | 0 | <.001 | 11 (85) | 2 (50) | .15 |
| Unstable angina/non-STEMI, n (%) | 12 (34) | 13 (59) | .07 | 2 (15) | 2 (50) | .15 |
| Ejection fraction a | 33±13 | 28±11 | .10 | 30±13 | 13±2.9 | <.01 |
| Syntax score a | 31±12 | 37±11 | .03 | 31±8.4 | 34±1.2 | .29 |
| STS score a | 4.5±8.2 | 11±11 | .01 | 20±13 | 33±21 | .10 |
| Additive EuroSCORE a | 8.3±3.9 | 8.4±3.1 | .46 | 12±3 | 11±6 | .35 |
| Logistic EuroSCORE a | 16±19 | 15±14 | .45 | 26±19 | 30±22 | .38 |
| NCDR CathPCI risk score a | 24±11 | 32±17 | .02 | 63±9.8 | 73±11 | .08 |
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