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1.
J Thorac Cardiovasc Surg ; 163(1): 140-147.e4, 2022 Jan.
Article En | MEDLINE | ID: mdl-32928549

OBJECTIVE: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival. METHODS: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years. RESULTS: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation. CONCLUSIONS: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates.


Assisted Circulation , Extracorporeal Membrane Oxygenation , Graft Rejection/mortality , Heart Transplantation , Multiple Organ Failure , Postoperative Complications/mortality , Preoperative Care , Assisted Circulation/instrumentation , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Transplantation/methods , Heart Transplantation/mortality , Heart Transplantation/statistics & numerical data , Heart-Assist Devices/classification , Heart-Assist Devices/statistics & numerical data , Humans , Intra-Aortic Balloon Pumping/statistics & numerical data , Male , Middle Aged , Multiple Organ Failure/etiology , Multiple Organ Failure/mortality , Outcome and Process Assessment, Health Care , Preoperative Care/instrumentation , Preoperative Care/methods , Retrospective Studies , Survival Rate , United States , Waiting Lists
5.
J Am Coll Cardiol ; 78(19): 1890-1900, 2021 11 09.
Article En | MEDLINE | ID: mdl-34736565

BACKGROUND: N-terminal pro-B-type natriuretic peptide (NT-proBNP) is frequently used as a valuable prognostic biomarker in cardiac diseases. In children, however, it has not been established because of its strong age dependency. To overcome this obstacle, we recently introduced the zlog value of N-terminal pro-B-type natriuretic peptide (zlog-proBNP) as an age-adjusted reference. OBJECTIVES: This study evaluates the prognostic power of zlog-proBNP for the occurrence of major adverse cardiovascular events (MACE) throughout childhood in patients with congenital heart diseases (CHD). METHODS: A total of 910 children with CHD (median age 5 months; range 0.0-18.0 years) were included. MACE was defined as death, resuscitation, mechanical circulatory support, or hospitalization caused by cardiac decompensation. Because the physiological NT-proBNP concentration decreases significantly during childhood, zlog values were applied for an age-independent evaluation. RESULTS: MACE occurred in 138 children during a median follow-up of 6 months (range 1 day to 7.6 years). High zlog-proBNP values (>+3.0) were most strongly associated with adverse events (n = 93; adjusted HR: 21.1; 95% CI: 2.9-154.2; P < 0.001). Among all evaluated indicators, zlog-proBNP was the best predictor for MACE (adjusted HR: 1.52; 95% CI: 1.31-1.76; P < 0.001) along with age and predictively superior to absolute NT-proBNP values. A cutoff value of +1.96 (age-independent upper limit of the physiological NT-proBNP concentration) achieved a negative predictive value of >96%. CONCLUSIONS: Zlog-proBNP overcomes the strong age dependency of NT-proBNP and is a powerful prognostic marker for age-independent exclusion and prediction of MACE in children with CHD. We therefore expect zlog-proBNP to play a pivotal role in the future management of children with heart diseases.


Heart Defects, Congenital , Heart Failure , Natriuretic Peptide, Brain/blood , Peptide Fragments/blood , Adolescent , Age Factors , Assisted Circulation/statistics & numerical data , Cardiopulmonary Resuscitation/statistics & numerical data , Child , Child Mortality , Female , Follow-Up Studies , Germany/epidemiology , Heart Defects, Congenital/blood , Heart Defects, Congenital/complications , Heart Defects, Congenital/diagnosis , Heart Failure/etiology , Heart Failure/mortality , Heart Failure/therapy , Hospitalization/statistics & numerical data , Humans , Infant , Male , Predictive Value of Tests , Prognosis
6.
Am J Cardiol ; 144: 20-25, 2021 04 01.
Article En | MEDLINE | ID: mdl-33417875

Cardiogenic shock (CS) is associated with high mortality and often requires involvement of a multidisciplinary provider team to deliver timely care. Care coordination is more difficult on weekends, which may lead to a delay in care. We sought to assess the effect of weekend admissions on outcomes in patients admitted with CS. Patients admitted with CS were identified from 2005 to 2014 in the National Inpatient Sample using ICD9 code 785.51. Baseline demographics, in-hospital procedures, and outcomes were obtained and compared by day of admission. A multivariable model was used to assess the impact of weekend admission on in-hospital mortality. A total of 875,054 CS admissions were identified (age 67.4 ± 15.1 years, 40.2% female, 72.1% Caucasian), with 23% of patients being admitted on weekends. Baseline co-morbidities were similar between groups. Weekend admissions were associated with higher in-hospital mortality (40.6% vs 37.5%) and cardiac arrest (20.3% vs 18.1%, p < 0.001 for both) consistently over the study period. Use of temporary and permanent mechanical support devices and heart transplantation were slightly less common for weekend admissions. In a multivariable model adjusting for relevant confounders, weekend admission was associated with a 10% increased mortality in patients with CS. In conclusion, patients with CS admitted on weekends had higher in-hospital mortality and were slightly less likely to receive mechanical support and advanced therapies compared with those admitted on weekdays. Future studies and health system initiatives should focus on rectifying these disparities with around-the-clock multidisciplinary coordinated care for CS.


After-Hours Care/statistics & numerical data , Assisted Circulation/statistics & numerical data , Cardiac Catheterization/statistics & numerical data , Heart Arrest/epidemiology , Hospital Mortality , Myocardial Revascularization/statistics & numerical data , Shock, Cardiogenic/therapy , Aged , Aged, 80 and over , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/therapy , Coronary Artery Bypass/statistics & numerical data , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Transplantation/statistics & numerical data , Heart-Assist Devices/statistics & numerical data , Hospitalization , Humans , Intra-Aortic Balloon Pumping/statistics & numerical data , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/statistics & numerical data , Shock, Cardiogenic/epidemiology
8.
J Cardiovasc Med (Hagerstown) ; 22(5): 388-395, 2021 May 01.
Article En | MEDLINE | ID: mdl-32858640

AIMS: We aimed to describe how treatment of patients in cardiogenic shock bridged to heart transplantation with mechanical circulatory support, using either biventricular assist devices (BVADs) or extracorporeal life support (ECLS), has evolved in the last 20 years in our centre. METHODS: Since 1998, 72 patients with refractory heart failure and indication for heart transplantation have received mechanical circulatory support: 40 had an ECLS system and 32 a BVAD. RESULTS: Early mortality was similar (17.5 vs. 9.4%, P = 0.25) regardless of the type of support. After a median support time of 8 (1-27) vs. 34 (0-385) days (P < 0.01), 70 vs. 65.6% (P = 0.69) of patients underwent transplantation in the two groups. Prior to transplantation, BVAD patients were more stable with lower need for mechanical ventilation (9 vs. 57%, P < 0.01) and dialysis (0 vs. 38%, P < 0.01). Thirty-day mortality after transplantation was similar (18 vs. 14%, P = 0.53). Patients with extracorporeal support had higher rates of renal (P = 0.02) and respiratory failure (P = 0.03), infections (P = 0.02), atrial fibrillation (P = 0.03) and longer ICU stay (P = 0.01). Late survival was similar, while 5-year freedom from coronary vasculopathy was higher in those with BVAD (P = 0.03). CONCLUSION: Although ECLS provides faster and simpler assistance compared with BVADs, no differences in early and medium-term outcomes in the last 20 years were observed in patients with cardiogenic shock. However, BVADs provided longer duration of support, better multiorgan recovery allowing more adequate graft selection, resulting in a lower rate of posttransplant complications.


Assisted Circulation , Extracorporeal Membrane Oxygenation , Heart Failure , Heart Transplantation , Heart-Assist Devices/statistics & numerical data , Postoperative Complications/prevention & control , Shock, Cardiogenic , Assisted Circulation/instrumentation , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Duration of Therapy , Extracorporeal Membrane Oxygenation/instrumentation , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Failure/etiology , Heart Failure/mortality , Heart Failure/physiopathology , Heart Failure/surgery , Heart Transplantation/adverse effects , Heart Transplantation/methods , Humans , Italy/epidemiology , Male , Middle Aged , Mortality , Outcome and Process Assessment, Health Care , Postoperative Complications/etiology , Postoperative Complications/physiopathology , Recovery of Function , Shock, Cardiogenic/complications , Shock, Cardiogenic/therapy
9.
Can J Cardiol ; 36(10): 1587-1591, 2020 10.
Article En | MEDLINE | ID: mdl-32827637

In this prospective cohort study of 250 stable heart failure patients with trimonthly blood sampling, we investigated associations of 17 repeatedly measured cytokines and cytokine receptors with clinical outcome during a median follow-up of 2.2 (25th-75th percentile, 1.4-2.5) years. Sixty-six patients reached the primary end point (composite of cardiovascular mortality, heart failure hospitalization, heart transplantation, left ventricular assist device implantation). Repeatedly measured levels of 8 biomarkers correlated with clinical outcomes independent of clinical characteristics. Rates of change over time (slopes of biomarker evolutions) remained independently associated with outcome for 15 biomarkers. Thus, temporal patterns of cytokines and cytokine receptors, in particular tumour necrosis factor ligand superfamily member 13B and interleukin-1 receptor type 1, might contribute to personalized risk assessment.


Assisted Circulation , B-Cell Activating Factor/blood , Heart Failure , Interleukin-1/blood , Outcome Assessment, Health Care , Receptors, Interleukin-1/blood , Assisted Circulation/instrumentation , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Biomarkers/blood , Cohort Studies , Cytokines/blood , Female , Heart Failure/blood , Heart Failure/mortality , Heart Failure/therapy , Heart Transplantation/methods , Heart Transplantation/statistics & numerical data , Heart-Assist Devices , Humans , Male , Middle Aged , Netherlands/epidemiology , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/statistics & numerical data , Prospective Studies , Receptors, Cytokine/blood , Risk Assessment/methods
10.
J Am Heart Assoc ; 8(24): e014906, 2019 12 17.
Article En | MEDLINE | ID: mdl-31813312

Background Patients undergoing percutaneous coronary intervention (PCI) are older with greater medical comorbidities and anatomical complexity than ever before, resulting in an increased frequency of nonemergent high-risk PCI (HR-PCI). We thus sought to evaluate the temporal trends in performance of HR-PCI and utilization of mechanical circulatory support in the largest integrated healthcare system in the United States. Methods and Results A cohort of high-risk adult patients that underwent nonemergent PCI in the Veterans Affairs Healthcare System between January 2008 and June 2018 were identified by objective clinical, hemodynamic, and anatomic criteria. Temporal trends in the performance of HR-PCI, utilization of mechanical circulatory support, and site-level variation were assessed. Of 111 548 patients assessed during the study period, 554 met 3 high-risk criteria whereas 4414 met at least 2 criteria for HR-PCI. There was a significant linear increase in the proportion of interventions that met 3 (P<0.001) or at least 2 (P<0.001) high-risk criteria over time, with rates approaching 1.9% and 11.2% in the last full calendar year analyzed. A minority of patients who met all high-risk criteria received PCI with mechanical support (15.7%) without a significant increase over time (P=0.193). However, there was significant site-level variation in the probability of performing HR-PCI (4.0-fold higher likelihood) and utilizing mechanical circulatory support (1.9-fold higher likelihood) between high and low utilization sites. Conclusions The proportion of cases categorized as HR-PCI has increased over time, with significant site-level variation in performance. The majority of HR-PCI cases did not utilize mechanical support, highlighting a discrepancy between current recommendations and clinical practice in an integrated healthcare system.


Assisted Circulation/statistics & numerical data , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/trends , Procedures and Techniques Utilization/statistics & numerical data , Veterans Health , Aged , Aged, 80 and over , Cohort Studies , Female , Health Facilities/statistics & numerical data , Humans , Male , Risk Assessment , Time Factors , United States , United States Department of Veterans Affairs
11.
J Interv Cardiol ; 2019: 3276521, 2019.
Article En | MEDLINE | ID: mdl-31772523

Risk-averse behavior has been reported among physicians and facilities treating cardiogenic shock in states with public reporting. Our objective was to evaluate if public reporting leads to a lower use of mechanical circulatory support in cardiogenic shock. We conducted a retrospective study with the use of the National Inpatient Sample from 2005 to 2011. Hospitalizations of patients ≥18 years old with a diagnosis of cardiogenic shock were included. A regional comparison was performed to identify differences between reporting and nonreporting states. The main outcome of interest was the use of mechanical circulatory support. A total of 13043 hospitalizations for cardiogenic shock were identified of which 9664 occurred in reporting and 3379 in nonreporting states (age 69.9 ± 0.4 years, 56.8% men). Use of mechanical circulatory support was 32.8% in this high-risk population. Odds of receiving mechanical circulatory support were lower (OR 0.50; 95% CI 0.43-0.57; p < 0.01) and in-hospital mortality higher (OR 1.19; 95% CI 1.06-1.34; p < 0.01) in reporting states. Use of mechanical circulatory support was also lower in the subgroup of patients with acute myocardial infarction and cardiogenic shock in reporting states (OR 0.61; 95% CI 0.51-0.72; p < 0.01). In conclusion, patients with cardiogenic shock in reporting states are less likely to receive mechanical circulatory support than patients in nonreporting states.


Assisted Circulation/statistics & numerical data , Cardiopulmonary Bypass/statistics & numerical data , Extracorporeal Membrane Oxygenation/statistics & numerical data , Public Reporting of Healthcare Data , Shock, Cardiogenic/therapy , Aged , Female , Hospital Mortality , Hospitalization , Humans , Male , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Retrospective Studies , Shock, Cardiogenic/mortality , United States/epidemiology
12.
Am J Cardiol ; 124(4): 485-490, 2019 08 15.
Article En | MEDLINE | ID: mdl-31213279

Safety-net hospitals (SNHs) are hospitals that serve a higher proportion of patients insured by Medicaid or uninsured and have been reported to have poor outcomes compared with non-SNHs. Procedural and clinical outcomes of ST-segment elevation myocardial infarction complicated by cardiogenic shock (STEMI-CS) at SNHs have not been well described. Nationwide Inpatient Sample from 2005 to 2011 was queried to identify STEMI-CS and age ≥18. SNHs were defined as hospitals with the highest number of inpatient stays that were paid by Medicaid or were uninsured (the top quartile). A total of 23,229 STEMI-CS of which 3,639 (15.7%) were treated at SNHs. Admissions to SNHs were younger (mean age 66.0 vs 67.2, p < 0.001), more likely men (64.0% vs 62.2%, p = 0.04), more frequently ethnic minorities (Black; 11.0% vs 6.0%, Hispanic 20.4% vs 5.8%, p < 0.001), and had higher Elixhauser ≥4 (25.8% vs 21.9%, respectively, p < 0.001). Percutaneous coronary interventions were less performed (60.4% vs 65.8%, p < 0.001) whereas administrations of thrombolysis (2.9% vs 2.1%, p = 0.001) were more frequent at SNHs. Coronary artery bypass and the use of mechanical circulatory support was similar. In-hospital mortality was significantly elevated at SNHs (36.6% vs 32.7%, adjusted odds ratio 1.24, 95% confidence interval 1.10 to 1.39) whereas new dialysis, stroke, and fatal arrhythmias were similar. The median length of stay was similar (6 vs 7 days, p = 0.58) but the median cost was higher (40,175 vs 38,012 US dollars, p = 0.01) at SNHs. SNHs had lower utilization of percutaneous coronary intervention and higher in-hospital mortality compared with non-SNHs in STEMI-CS. Further cause analysis is warranted to improve outcomes of STEMI-CS admitted at SNHs.


Assisted Circulation/statistics & numerical data , Coronary Artery Bypass/statistics & numerical data , Hospital Mortality , Percutaneous Coronary Intervention/statistics & numerical data , ST Elevation Myocardial Infarction/therapy , Shock, Cardiogenic/therapy , Thrombolytic Therapy/statistics & numerical data , Age Distribution , Aged , Aged, 80 and over , Arrhythmias, Cardiac/mortality , Databases, Factual , Ethnicity , Female , Heart-Assist Devices , Humans , Male , Middle Aged , Renal Dialysis/statistics & numerical data , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/epidemiology , Safety-net Providers , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/etiology , Stroke/epidemiology , United States/epidemiology
13.
Am J Cardiol ; 124(4): 505-510, 2019 08 15.
Article En | MEDLINE | ID: mdl-31204034

Cardiogenic shock (CS) is associated with high morbidity and mortality despite recent advances in the temporary mechanical circulatory support (MCS) devices. The current utilization and outcomes of these MCS devices with or without vasopressors compared with conventional medical therapy (no-MCS) in CS remain poorly described. The study population was extracted from the 2014 Nationwide Readmissions Database using International Classification of Diseases, Ninth Revision, Clinical Modification codes for CS, temporary MCS devices, and vasopressor infusion. Study end points included in-hospital all-cause mortality, length of index hospital stay (LOS), the likelihood of receiving invasive treatment, postprocedural bleeding, vascular complications, total hospitalization charges, and discharge disposition. A total of 59,148 discharges with a diagnosis of CS were identified (age 67 years; 38.5% female). Temporary MCS devices were utilized in 22.7%. The use of these devices was associated with lower in-hospital all-cause mortality (33.0% vs 39.7%, p <0.01), increased likelihood of invasive therapy (75.7% vs 26.3%, p <0.01), and increased likelihood of being discharged home (24.8% vs 20.6%, p <0.01). However, the MCS group had longer LOS (16.9 vs 12.1 days, p <0.01), higher vascular complications (2.6% vs 1.4%, p <0.01), bleeding (31.2% vs 16.8%, p <0.01), and total hospitalization charges ($374,574 vs $182,045, p <0.01). In conclusion, the use of the temporary MCS devices for the treatment of CS was associated with lower mortality, increased the likelihood of receiving invasive treatment and the likelihood of being discharged home. However, it was associated with higher in-hospital complications, LOS, and hospitalization charges.


Assisted Circulation/statistics & numerical data , Extracorporeal Membrane Oxygenation/statistics & numerical data , Heart-Assist Devices/statistics & numerical data , Hospital Mortality , Intra-Aortic Balloon Pumping/statistics & numerical data , Shock, Cardiogenic/therapy , Aged , Assisted Circulation/instrumentation , Assisted Circulation/methods , Extracorporeal Membrane Oxygenation/instrumentation , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Intra-Aortic Balloon Pumping/instrumentation , Intra-Aortic Balloon Pumping/methods , Length of Stay/statistics & numerical data , Male , Middle Aged , Myocardial Infarction/complications , Postoperative Complications/epidemiology , Postoperative Hemorrhage/epidemiology , Prosthesis Implantation , Shock, Cardiogenic/etiology , Vasoconstrictor Agents/therapeutic use
14.
J Am Heart Assoc ; 8(13): e012349, 2019 07 02.
Article En | MEDLINE | ID: mdl-31237190

Background Congenital heart disease is common in patients with Trisomy 13 (T13) and Trisomy 18 (T18), but offering cardiac surgery to these patients has been controversial. We describe the landscape of surgical management across the United States, perioperative risk factors, and surgical outcomes in patients with T13 and T18. Methods and Results Patients in the Society of Thoracic Surgeons Congenital Heart Surgery Database with T13 and T18 who underwent cardiac surgery (2010-2017) were included. There were 343 operations (T13: n=73 and T18: n=270) performed on 304 patients. Among 125 hospitals, 87 (70%) performed at least 1 operation and 26 centers (30%) performed ≥5 T13/T18 operations. Operations spanned the full spectrum of complexity with 29% (98/343) being in the highest categories of estimated risk. The operative mortality rate was 15%, with a 56% complication rate. Preoperative mechanical ventilation was associated with an odds ratio of mortality >8 for both patients with T13 and T18 (both P<0.012) while presence of a gastrostomy tube (odds ratio, 0.3; P=0.03) or prior cardiac surgery (odds ratio, 0.2; P=0.02) was associated with better survival in patients with T18 but not patients with T13. Conclusions Data from this nationally representative sample indicate that most centers offer surgical intervention for both patients with T13 and T18, even in highly complex patients. However, the overall mortality rate was high in this select patient cohort. The association of preoperative mechanical ventilation with mortality suggests that this subset of patients with T13 and T18 should perhaps not be considered surgical candidates. This information is valuable to clinicians and families for counseling and deciding what interventions to offer.


Cardiac Surgical Procedures/statistics & numerical data , Heart Defects, Congenital/surgery , Hospital Mortality , Postoperative Complications/epidemiology , Trisomy 13 Syndrome/complications , Trisomy 18 Syndrome/complications , Aortic Coarctation/complications , Aortic Coarctation/surgery , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/therapy , Assisted Circulation/statistics & numerical data , Cardiac Pacing, Artificial , Databases, Factual , Female , Gastrostomy/statistics & numerical data , Heart Arrest/epidemiology , Heart Defects, Congenital/complications , Heart Septal Defects, Atrial/complications , Heart Septal Defects, Atrial/surgery , Heart Septal Defects, Ventricular/complications , Heart Septal Defects, Ventricular/surgery , Humans , Infant , Length of Stay/statistics & numerical data , Male , Patient Selection , Respiration, Artificial/statistics & numerical data , Risk Factors , Tetralogy of Fallot/complications , Tetralogy of Fallot/surgery , Treatment Outcome , United States
15.
J Invasive Cardiol ; 30(3): 81-87, 2018 03.
Article En | MEDLINE | ID: mdl-29493509

OBJECTIVE: To study outcomes with use of percutaneous mechanical circulatory support (MCS) devices in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined characteristics and outcomes of 1598 CTO-PCIs performed from 2012-2017 at 12 high-volume centers. RESULTS: Patient age was 66 ± 10 years; 86% were men. An MCS device was used electively in 69 procedures (4%) and urgently in 22 procedures (1%). The most commonly used elective MCS device was Impella 2.5 or CP (62%). Compared to patients without elective MCS, patients with elective MCS had higher prevalence of prior heart failure (55% vs 29%; P<.001), prior coronary artery bypass graft surgery (49% vs 35%; P=.02), and lower left ventricular ejection fraction (34 ± 14% vs 50 ± 14%; P<.001). MCS patients had a higher prevalence of moderate/ severe calcification (88% vs 55%; P<.001) and higher J-CTO scores (3.1 ± 1.2 vs 2.6 ± 1.2; P<.01), and a greater proportion underwent retrograde crossing attempts (55% vs 39%; P<.01). Despite more complex characteristics in MCS patients, technical success rates (88% vs 87%; P=.70) and procedural success rates (83% vs 87%; P=.32) were similar in the two groups. Use of elective MCS was associated with longer procedure and fluoroscopy times, and higher incidences of in-hospital major adverse cardiovascular events (8.7% vs 2.5%; P<.01) and bleeding (7.3% vs 1.0%; P<.001). CONCLUSION: Elective MCS was used in 4% of patients undergoing CTO-PCI. Despite more complex clinical and angiographic characteristics, elective use of MCS in high-risk patients is associated with similar technical and procedural success rates, but higher risk of complications, compared to cases without elective MCS.


Assisted Circulation , Coronary Occlusion , Hemodynamics , Percutaneous Coronary Intervention , Secondary Prevention , Aged , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Chronic Disease , Coronary Occlusion/diagnosis , Coronary Occlusion/epidemiology , Coronary Occlusion/physiopathology , Coronary Occlusion/surgery , Female , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Registries/statistics & numerical data , Secondary Prevention/methods , Secondary Prevention/statistics & numerical data , Severity of Illness Index , United States/epidemiology
16.
Cochrane Database Syst Rev ; 8: CD011312, 2017 08 02.
Article En | MEDLINE | ID: mdl-28770972

BACKGROUND: Low cardiac output syndrome remains a serious complication, and accounts for substantial morbidity and mortality in the postoperative course of paediatric patients undergoing surgery for congenital heart disease. Standard prophylactic and therapeutic strategies for low cardiac output syndrome are based mainly on catecholamines, which are effective drugs, but have considerable side effects. Levosimendan, a calcium sensitiser, enhances the myocardial function by generating more energy-efficient myocardial contractility than achieved via adrenergic stimulation with catecholamines. Thus potentially, levosimendan is a beneficial alternative to standard medication for the prevention of low cardiac output syndrome in paediatric patients after open heart surgery. OBJECTIVES: To review the efficacy and safety of the postoperative prophylactic use of levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease. SEARCH METHODS: We identified trials via systematic searches of CENTRAL, MEDLINE, Embase, and Web of Science, as well as clinical trial registries, in June 2016. Reference lists from primary studies and review articles were checked for additional references. SELECTION CRITERIA: We only included randomised controlled trials (RCT) in our analysis that compared prophylactic levosimendan with standard medication or placebo, in infants and children up to 18 years of age, who were undergoing surgery for congenital heart disease. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias according to a pre-defined protocol. We obtained additional information from all but one of the study authors of the included studies. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of evidence from the studies that contributed data to the meta-analyses for the prespecified outcomes. We created a 'Summary of findings' table to summarise the results and the quality of evidence for each outcome. MAIN RESULTS: We included five randomised controlled trials with a total of 212 participants in the analyses. All included participants were under five years of age. Using GRADE, we assessed there was low-quality evidence for all analysed outcomes. We assessed high risk of performance and detection bias for two studies due to their unblinded setting. Levosimendan showed no clear effect on risk of mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.12 to 1.82; participants = 123; studies = 3) and no clear effect on low cardiac output syndrome (RR 0.64, 95% CI 0.39 to 1.04; participants = 83; studies = 2) compared to standard treatments. Data on time-to-death were not available from any of the included studies.There was no conclusive evidence on the effect of levosimendan on the secondary outcomes. The length of intensive care unit stays (mean difference (MD) 0.33 days, 95% CI -1.16 to 1.82; participants = 188; studies = 4), length of hospital stays (MD 0.26 days, 95% CI -3.50 to 4.03; participants = 75; studies = 2), duration of mechanical ventilation (MD -0.04 days, 95% CI -0.08 to 0.00; participants = 208; studies = 5), and the risk of mechanical circulatory support or cardiac transplantation (RR 1.49, 95% CI 0.19 to 11.37; participants = 60; studies = 2) did not clearly differ between the groups. Published data about adverse effects of levosimendan were limited. A meta-analysis of hypotension, one of the most feared side effects of levosimendan, was not feasible because of the heterogeneous expression of blood pressure values. AUTHORS' CONCLUSIONS: The current level of evidence is insufficient to judge whether prophylactic levosimendan prevents low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease. So far, no significant differences have been detected between levosimendan and standard inotrope treatments in this setting.The authors evaluated the quality of evidence as low, using the GRADE approach. Reasons for downgrading were serious risk of bias (performance and detection bias due to unblinded setting of two RCTs), serious risk of inconsistency, and serious to very serious risk of imprecision (small number of included patients, low event rates).


Cardiac Output, Low/prevention & control , Cardiotonic Agents/therapeutic use , Heart Defects, Congenital/surgery , Hydrazones/therapeutic use , Postoperative Complications/prevention & control , Pyridazines/therapeutic use , Assisted Circulation/statistics & numerical data , Cardiac Output, Low/etiology , Cardiac Output, Low/mortality , Child, Preschool , Heart Defects, Congenital/mortality , Humans , Infant , Intensive Care Units, Pediatric/statistics & numerical data , Length of Stay/statistics & numerical data , Postoperative Complications/mortality , Randomized Controlled Trials as Topic , Respiration, Artificial/statistics & numerical data , Simendan , Syndrome
17.
Cochrane Database Syst Rev ; 3: CD011312, 2017 Mar 06.
Article En | MEDLINE | ID: mdl-28262914

BACKGROUND: Low cardiac output syndrome remains a serious complication, and accounts for substantial morbidity and mortality in the postoperative course of paediatric patients undergoing surgery for congenital heart disease. Standard prophylactic and therapeutic strategies for low cardiac output syndrome are based mainly on catecholamines, which are effective drugs, but have considerable side effects. Levosimendan, a calcium sensitiser, enhances the myocardial function by generating more energy-efficient myocardial contractility than achieved via adrenergic stimulation with catecholamines. Thus potentially, levosimendan is a beneficial alternative to standard medication for the prevention of low cardiac output syndrome in paediatric patients after open heart surgery. OBJECTIVES: To review the efficacy and safety of the postoperative prophylactic use of levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease. SEARCH METHODS: We identified trials via systematic searches of CENTRAL, MEDLINE, Embase, and Web of Science, as well as clinical trial registries, in June 2016. Reference lists from primary studies and review articles were checked for additional references. SELECTION CRITERIA: We only included randomised controlled trials (RCT) in our analysis that compared prophylactic levosimendan with standard medication or placebo, in infants and children up to 18 years of age, who were undergoing surgery for congenital heart disease. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias according to a pre-defined protocol. We obtained additional information from all but one of the study authors of the included studies. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of evidence from the studies that contributed data to the meta-analyses for the prespecified outcomes. We created a 'Summary of findings' table to summarise the results and the quality of evidence for each outcome. MAIN RESULTS: We included five randomised controlled trials with a total of 212 participants in the analyses. All included participants were under five years of age. Using GRADE, we assessed there was low-quality evidence for all analysed outcomes. We assessed high risk of performance and detection bias for two studies due to their unblinded setting. Levosimendan showed no clear effect on risk of mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.12 to 1.82; participants = 123; studies = 3) and no clear effect on low cardiac output syndrome (RR 0.64, 95% CI 0.39 to 1.04; participants = 83; studies = 2) compared to standard treatments. Data on time-to-death were not available from any of the included studies.There was no conclusive evidence on the effect of levosimendan on the secondary outcomes. The levosimendan groups had shorter length of intensive care unit stays (mean difference (MD) 0.33 days, 95% CI -1.16 to 1.82; participants = 188; studies = 4; I² = 35%), length of hospital stays (0.26 days, 95% CI -3.50 to 4.03; participants = 75; studies = 2), and duration of mechanical ventilation (MD -0.04 days, 95% CI -0.08 to 0.00; participants = 208; studies = 5; I² = 0%). The risk of mechanical circulatory support or cardiac transplantation favoured the levosimendan groups (RR 1.49, 95% CI 0.19 to 11.37; participants = 60; studies = 2). Published data about adverse effects of levosimendan were limited. A meta-analysis of hypotension, one of the most feared side effects of levosimendan, was not feasible because of the heterogeneous expression of blood pressure values. AUTHORS' CONCLUSIONS: The current level of evidence is insufficient to judge whether prophylactic levosimendan prevents low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease. So far, no significant differences have been detected between levosimendan and standard inotrope treatments in this setting.The authors evaluated the quality of evidence as low, using the GRADE approach. Reasons for downgrading were serious risk of bias (performance and detection bias due to unblinded setting of two RCTs), serious risk of inconsistency, and serious to very serious risk of imprecision (small number of included patients, low event rates).


Cardiac Output, Low/prevention & control , Cardiotonic Agents/therapeutic use , Heart Defects, Congenital/surgery , Hydrazones/therapeutic use , Postoperative Complications/prevention & control , Pyridazines/therapeutic use , Assisted Circulation/statistics & numerical data , Cardiac Output, Low/etiology , Cardiac Output, Low/mortality , Coronary Care Units/statistics & numerical data , Heart Defects, Congenital/mortality , Humans , Length of Stay/statistics & numerical data , Postoperative Complications/mortality , Randomized Controlled Trials as Topic , Respiration, Artificial/statistics & numerical data , Simendan
18.
Int J Cardiol ; 224: 114-118, 2016 Dec 01.
Article En | MEDLINE | ID: mdl-27648979

BACKGROUND: Cardiogenic shock (CS) has a poor prognosis. The heterogeneity in the mortality through different subgroups suggests that some factors can be useful to perform risk stratification and guide management. We aimed to find predictors of in-hospital mortality in these patients. METHODS: We analyzed all cases of cardiogenic shock due to medical conditions admitted in our intensive acute cardiovascular care unity from November 2010 till November 2015. Clinical, biochemical and hemodynamic variables were registered, as was the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at 24h of CS diagnosis. From a total of 281 patients, 28 died within the first 24h and were not included in the analysis. RESULTS: A total of 253 patients survived the first 24h, mean age was 68.8±14.4years, and 174 (68.8%) were men. Etiologies: acute coronary syndrome 146 (57.7%), acute heart failure 60 (23.7%), arrhythmias 35 (13.8%), and others 12 (4.8%). A total of 91 patients (36.0%) died during hospitalization. We found the following independent predictors of in-hospital mortality: age (odds ratio [OR] 1.032, 95% confidence interval [CI] 1.003-1.062), blood glucose (OR 1.004, 95% CI 1.001-1.008), heart rate (OR 1.014, 95% CI 1.001-1.028), and INTERMACS profile (OR 0.168, 95% CI 0.107-0.266). CONCLUSIONS: In patients with CS the INTERMACS profile at 24h of diagnosis was associated with higher in-hospital mortality. This and other prognostic variables (age, blood glucose, and heart rate) may be useful for risk stratification and to select appropriate medical or invasive interventions.


Assisted Circulation , Shock, Cardiogenic , Aged , Aged, 80 and over , Assisted Circulation/instrumentation , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Disease Management , Female , Heart-Assist Devices , Hospital Mortality , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Prognosis , Risk Assessment/methods , Shock, Cardiogenic/mortality , Shock, Cardiogenic/therapy , Spain/epidemiology , Survival Analysis , Time Factors
19.
Int J Cardiol ; 222: 247-252, 2016 Nov 01.
Article En | MEDLINE | ID: mdl-27497103

BACKGROUND: Cardiogenic shock remains a clinical challenge with high mortality rate. Mechanical circulatory support (MCS) devices have become an integral component of the therapeutic armamentarium expanding the treatment options for refractory cardiogenic shock (RCS). METHODS: We included all consecutive patients with biventricular unloading with Impella-2.5 and VA-ECMO admitted for RCS between October 2013 and March 2015. Outcome data included survival to discharge, bridging to VAD and 28-day mortality. RESULTS: A total of 17 patients were included. Mean age was 63.3±10.5 and 15 (88%) patients were male. RCS resulted from acute myocardial infarction in 14 (82%), acute myocarditis in 1 (6%) dilated cardiomyopathy in 2 (12%) patients. Mean SAPS II and SOFA score on admission was 74.7±16.86 and 11.16±1.79, respectively. Vasopressor doses and lactate levels were significantly decreased within 72h on biventricular support (p=0.025 for norepinephrine and p=0.005 for lactate). Nine (53%) patients died while on support. Of the remaining 8 patients, 5 (29%) patients were weaned successfully and discharged in cardiac rehabilitation and 3 (18%) patients were successfully bridged to VAD. All 5 patients who were discharged to rehabilitation survived at day 28 after discharge, while 1 of 3 VAD patients died after VAD implantation, corresponding to an overall 28-day survival rate of 41%. CONCLUSIONS: Biventricular support with Impella-2.5 and VA-ECMO in patients with RCS is feasible and led to significant hemodynamic improvement and reduction of lactate levels. Despite high severity scores, ICU- and 28-day mortality rates were better than predicted.


Heart-Assist Devices/statistics & numerical data , Shock, Cardiogenic/mortality , Shock, Cardiogenic/surgery , Ventricular Dysfunction, Left/mortality , Ventricular Dysfunction, Left/surgery , Aged , Assisted Circulation/mortality , Assisted Circulation/statistics & numerical data , Female , Humans , Male , Middle Aged , Retrospective Studies , Shock, Cardiogenic/diagnosis , Survival Rate/trends , Ventricular Dysfunction, Left/diagnosis
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