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J Thorac Cardiovasc Surg 2005;130:693-698
© 2005 The American Association for Thoracic Surgery
Cardiopulmonary Support and Physiology |
a Division of Cardiothoracic Surgery, Department of Surgery, Columbia University, College of Physicians and Surgeons, New York, NY
b Division of Cardiac Surgery, Department of Surgery, Brigham & Women's Hospital, Boston, Mass.
Received for publication December 7, 2004; revisions received March 25, 2005; accepted for publication April 12, 2005. * Address for reprints: Yoshifumi Naka, MD, PhD, Herbert Irving Assistant Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, Columbia University, College of Physicians and Surgeons, 177 Fort Washington Ave, Milstein Hospital, 7GN-435, New York, NY 10032. (Email: yn33{at}columbia.edu).
| Abstract |
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METHODS: Seventy-four patients at 2 institutions underwent LVAD implantation for myocardial infarction and shock over a 12-year period. Twenty-eight underwent direct LVAD placement, and 46 underwent revascularization through coronary artery bypass grafting before LVAD placement. Variables examined included patient demographics, myocardial infarctionLVAD interval, bridge to transplantation, early mortality (
30 days), survival after LVAD placement, and posttransplantation survivals.
RESULTS: There were no differences in demographics between the 2 groups. The group undergoing revascularization before LVAD placement had a lower bridge to transplantation, higher early mortality, and lower overall 6- and 12-month survivals after LVAD placement compared with the group undergoing direct LVAD placement (45.50% vs 70.40%, P = .041; 39.10% vs 14.30%, P = .020; 89.3% and 82.1% vs 54.4% and 52.2%, respectively, P = .006). Posttransplantation survival and LVAD explantation rates were equivalent in both groups.
CONCLUSIONS: Coronary artery bypass grafting before LVAD insertion for cardiogenic shock complicating myocardial infarction adversely affects survival. Confirmation of these findings would require conducting a large, multicenter, randomized clinical trial comparing revascularization versus LVAD support as primary therapy in this setting.
| Introduction |
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Previous studies have reported lower mortality rates for patients with acute MI and CS who subsequently undergo either PCI or CABG procedures compared with rates for patients treated with conventional therapy alone (no revascularization).
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Furthermore, survival seems to be contingent on the success of restoration of blood flow within the infarcted vessel.
3,6,7,9
Short-term survival for these cohorts of patients ranges from 47% to 65%. These results, although satisfactory compared with those of their medically treated counterparts, remain grim. We have considered whether such revascularization strategies alone might be insufficient to reverse the clinical condition of shock in these patients and whether a greater level of cardiac and circulatory support is necessary.
The use of left ventricular assist devices (LVADs) for the treatment of end-stage heart failure is well established, both in terms of bridging patients to cardiac transplantation and providing long-term support as a means of destination therapy.
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Less clearly defined is the role of LVADs in the setting of acute MI complicated by CS. Early reports show modest success with this modality of support, and patients are either weaned from LVADs or effectively bridged to cardiac transplantation.
1115
With improving clinical outcomes of LVADs, their role as primary therapy for acute MI complicated by CS needs to be evaluated.
| Methods |
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Acute MI was defined as that having occurred 3 months or less before LVAD implantation and was manifest by ST-segment elevation of greater than 1 mm on electrocardiography, increased cardiac enzyme levels (creatine kinase MB fraction, troponin, lactic dehydrogenase, and myoglobin), and written documentation of diagnosis by an attending cardiologist. The broad definition of acute MI was established to ensure thorough inclusion and characterization of all patients who received LVADs as a direct result of acute MI and CS. This time interval also accommodated for the additional time that might have elapsed for patients who first underwent revascularization. CS was confirmed by both clinical and hemodynamic criteria and was required to be a direct result of the acute MI. Clinical criteria included systolic blood pressure of less than 90 mm Hg or the need for intravenous vasopressors to maintain a systolic blood pressure of 90 mm Hg or greater, as well as evidence of end-organ hypoperfusion, such as diminished urinary output (<30 mL/h) or cool extremities. Hemodynamic criteria included a documented cardiac index of less than 2.2 L·min1 ·m2 and pulmonary artery diastolic pressure or pulmonary capillary wedge pressure of 15 mm Hg or greater.
Of all the patients who received LVADs at the 2 institutions from October 1991 through December 2003, 74 were identified who had acute anterior wall MI and CS as their primary indication. All patients with diagnoses of chronic congestive heart failure and nonanterior wall MIs were excluded to eliminate alternate possible indications for LVAD support. Six patients received ABIOMED (ABIOMED, Inc, Danvers, Mass) BVS 5000 biventricular support systems, 5 received ABIOMED BVS 5000 LVADs, 1 received a Thoratec (Thoratec Corp, Pleasanton, Calif) paracorporeal LVAD, 9 received HeartMate (Thoratec Corp) implantable pneumatic LVADs, and the remaining 53 received HeartMate vented-electric LVADs. Twenty-eight patients underwent direct LVAD implantation after acute anterior wall MI and CS (LVAD), and 46 underwent attempted revascularization by means of CABG before eventually requiring LVAD support (CABG plus LVAD).
The 2 groups were compared in regard to patient demographics, time interval between diagnosis of acute MI and LVAD insertion (in days), and preoperative intra-aortic balloon pump use. Outcome variables included bridge-to-transplantation rate, LVAD explantation rate, 6- and 12-month survivals after LVAD placement (combined bridge to transplantation, LVAD explantation, and ongoing LVAD support rates), early mortality (
30 day) rate, overall mortality, total hospital length of stay (LOS), intensive care unit (ICU) LOS, and posttransplantation survival.
A second comparison was made between those patients receiving LVADs for 7 days or less (acute) and 7 days or more (subacute) after acute MI and CS, irrespective of revascularization status. Similar preoperative and clinical outcome variables were analyzed.
Data were represented as frequency distributions and simple percentages. Values of continuous variables were expressed as means ± standard deviation. Continuous variables were compared by independent samples t tests, and categorical variables were compared by
2 and Fisher exact tests, where appropriate. Kaplan-Meier analysis was used to calculate long-term survival with a log-rank P value when comparing groups. Actuarial survival was calculated by constructing life tables. All data were analyzed with SPSS version 11.5 software (SPSS, Inc, Chicago, Ill).
| Results |
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30 day) mortality was significantly higher in the CABG plus LVAD group compared with that in the LVAD group (18 [39.1%] patients vs 4 [14.3%] patients, P = .020) and in the acute compared with the subacute MI-LVAD interval groups (18 [38.3%] patients vs 4 [14.8%] patients, P = .033). Overall mortality (early and late) was equivalent between the LVAD and CABG plus LVAD groups (P = .106, Figure 1) but significantly higher in the acute versus subacute MI-LVAD interval group (P = .013, Figure 2).
Duration of LVAD Support
The mean duration of LVAD support for all patients was 75.4 ± 91.3 days. The mean duration of LVAD support up to transplantation, device explantation, or death was 92.5 ± 89.0 days (range, 16407 days), 62.4 ± 98.0 days (range, 483 days), and 56.7 ± 102.3 days (range, 0385 days), respectively.
Hospital and ICU LOS
Total hospital LOS was 60.0 ± 56.2 days in the LVAD group and 39.9 ± 34.8 days in the CABG plus LVAD group (P = .353). Total hospital LOS was significantly greater in the subacute MI-LVAD interval group than in the acute MI-LVAD interval group (59.1 ± 55.9 vs 34.5 ± 32.8 days, P = .022). ICU LOS was similar between the LVAD and CABG plus LVAD groups (14.2 ± 9.8 vs 17.6 ± 14.5 days, P = .480) and between the acute and subacute MI-LVAD interval groups (17.4 ± 21.7 vs 13.9 ± 9.0 days, P = .473).
Posttransplantation Survival
Posttransplantation actuarial survivals at 1, 3, 5, and 7 years in the LVAD and CABG plus LVAD groups were 94.7%, 94.7%, 94.7%, and 94.7% and 79.5%, 74.2%, 67.1%, and 67.1% (P = .066), respectively. Survivals in the acute and subacute MI-LVAD interval groups were 85.4%, 80.0%, 80.0%, and 80.0% and 88.9%, 88.9%, 80.0%, and 80.0% (P = .764), respectively.
| Discussion |
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These survival outcomes prompted the present study, which sought to determine whether LVAD insertion might be considered as primary therapy for acute MI and CS in lieu of revascularization. Numerous design modifications and adjustments in perioperative management have been applied to LVADs as a result of past clinical experience, such that bridge-to-transplantation success rates of 60% to 73% are now commonly reported.
1619
Such improvements in survival with the judicious application of LVADs might similarly translate to the acute MI and CS population.
In this study, patients who had acute anterior wall MI complicated by CS and subsequently underwent direct LVAD implantation had significantly higher 6- and 12-month post-LVAD survivals than those who underwent attempted revascularization with CABG before eventually requiring LVAD support. These findings are curious in light of observations by other studies that patients referred for revascularization, either PCI or CABG, are generally younger and healthier.
2022
They suggest that despite the fact that select patients with acute MI and CS might be clinically stable enough to undergo revascularization by way of CABG, when these patients ultimately require LVAD support, the additional CABG intervention might confer heightened post-LVAD mortality.
The overall 6- and 12-month post-LVAD survivals for the entire LVAD population in this study were 67.6% and 63.5%, respectively. For the CABG plus LVAD group, these rates were 54.4% and 52.2%, respectively. Therefore, even the more ill-fated of the 2 LVAD cohorts, and certainly the LVAD population as a whole, achieved higher survivals than did the early revascularization group in the SHOCK trial (49.7% and 46.7%, respectively). Although this comparison pits the results of an observational study against those of a prospective, randomized clinical trial, the differences in survival are compelling. These findings suggest that the application of LVAD support at any point in the treatment course for acute MI and CS improves survival, regardless of any attempts toward revascularization. The exclusion of revascularization through CABG would seem to heighten survival even further.
The higher early mortality rate in the acute versus subacute MI-LVAD interval group portrays the fact that the acute group represents a sicker cohort of patients. Indeed, it is likely the severity of CS in these patients that prompts immediate LVAD implantation. The greater incidence of early mortality within this group probably represents individuals dying of their illness compounded by surgical intervention rather than the development of complications related to surgical intervention alone.
Posttransplantation survivals between the LVAD and CABG plus LVAD groups and between the acute and subacute MI-LVAD interval groups were equivalent. However, the trend toward lower posttransplantation survival in the CABG plus LVAD group intimates that the post-LVAD systemic milieu in this group might be persistently compromised in such a way that carries into the posttransplantation state.
Although this study suggests that CABG alone confers poorer survival than LVAD as primary therapy for acute MI and CS, the question might arise whether patients might fare best with simultaneous CABG and LVAD. The LVAD can facilitate unloading of the heart in the critical perioperative phase to minimize the work performed by the myocardium. Conversely, the utility of CABG and its associated prolonged operative and cardiopulmonary bypass times is debatable because most of these patients undergo transplantation anyway.
Limitations of the Study
The limitations of this study are those inherent with retrospective analyses. Selection bias is evident because this study fails to account for the probable vast number of patients in similar clinical scenarios who undergo revascularization and require no further intervention. Therefore, the patients in the CABG plus LVAD group likely represent a particularly sick cohort of individuals whose shock was not ameliorated by revascularization alone. Data on the proportion of these patients who presented with failed grafts are lacking.
The definition of acute MI as having occurred 3 months or less before LVAD insertion was established to ensure thorough inclusion of all qualified patients for this study. This broad inclusion interval likely introduces 2 distinct entities of patients with acute MI and CS who might arguably be managed differently. However, it is often difficult to predict and discern truly sick patients from those slightly less sick on the basis of acute MI-LVAD interval alone, and we did not want to exclude from our analysis those requiring later LVAD insertion.
Revascularization by way of PCI is not represented in this study when, in fact, the majority of revascularization efforts are carried out with this approach. CABG often becomes an option only after PCI has failed or is not feasible, again emphasizing the relative sickness of this group of patients. Unfortunately, data reporting the frequency of failed PCI attempts referred for CABG are not available in this study.
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| Footnotes |
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| References |
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