Risk Factors of Postoperative Complications in HCM Patients

NCT ID: NCT04275544

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2020-06-30

Brief Summary

Perioperative management may have strong connections with postoperative complications (PCs). However, little is known about the perioperative risk factors of PCs after septal myectomy in hypertrophic obstructive cardiomyopathy (HOCM) patients. This study is designed to assess the in-hospital PCs rate of HOCM patients and to identify perioperative risk factors of PCs in patients who underwent septal myectomy. Retrospective chart review will identify adult HOCM patients who underwent septal myectomy from October 2013 to December 2018 in the investigators' hospital. Patients' data will be collected from electronic medical records. The multivariable logistic regression analysis will be used to determine independent predictors. The predictive ability of individual predictor and different combination of multiple risk factors on PCs will also be calculated.

Detailed Description

This study is a single center retrospective observational study designed to assess the in-hospital PCs rate of HOCM patients and to identify perioperative risk factors of PCs in patients who underwent septal myectomy.

Ethical approval of this study was obtained from the Institutional Review Board of the investigators' hospital (No. KY20192036-C-1). The requirement for written informed consent was waived by the Institutional Review Board, considering the retrospective nature of the study.

Retrospective chart review will identify adult HOCM patients who underwent septal myectomy from October 2013 to December 2018 in the investigators' hospital. The clinical diagnosis of HOCM is made by echocardiography, cardiac magnetic resonance imaging, or computed tomography of a hypertrophied, non-dilated LV, in the absence of cardiac or systemic disease that can aggravate the magnitude of hypertrophy.

Data Collection

The following data will be collected. Data will be obtained from electronic medical records and collected by two trained staff who are unaware of the purpose of the study.

1. Demographic and clinical data included New York Heart Association class, family history of hypertrophic cardiomyopathy (HCM) and sudden death, patient history, symptoms, medications, and comorbidities of these enrolled patients.

2. The following preoperative echocardiographic parameters will be collected : left atrium diameter, left ventricular (LV) ejection fraction (EF), maximal LV wall thickness (defined as the greatest thickness measured at any site within the LV wall), maximal interventricular septal thickness, left ventricular outflow tract diameter (LVOTd) (C-sept distance, the shortest distance from the septum to the coaptation point of the mitral valve), and resting left ventricular outflow tract (LVOT) gradient (measured with continuous-wave Doppler in the apical five-chamber view using the modified Bernoulli equation).

3. Intraoperative data collected include the duration of anaesthesia, surgery, CPB, and cross-clamp; excised LV weight; type of concomitant procedure; lowest body temperature, haematocrit , haemoglobin and highest Lactic acid; perioperative fluid management including the volumes of total fluid intake, total output and intraoperative fluid balance (total intraoperative fluid intake is calculated as the sum of crystalloid, colloid and blood products; total output was calculated as the sum of the volumes of estimated blood loss and urine output; intraoperative fluid balance is calculated by subtracting the total output from the total fluid intake); and blood pressure parameters including the baseline mean arterial pressure and lowest mean arterial pressure, and duration of intraoperative hypotension (intraoperative hypotension is defined as a mean arterial pressure <65 mmHg).

4. Postoperative ventilation hours, lengths of stay in the intensive care unit (ICU) and hospital, blood transfusion in 72 hours after surgery, EF, LVOTd, resting LVOT gradient gradient, and in-hospital PCs will also be obtained. In-hospital PCs include all-cause mortality, heart failure, low cardiac output syndrome, stroke, spinal cord injury, acute respiratory distress syndrome, reintubation, reoperation, permanent implantable cardioverter defibrillator, kidney injury, renal failure, liver injury, and liver failure.

Statistical analysis

Continuous variables will be expressed as mean ± standard deviation (SD) or median (interquartile range). Differences of continuous variables will be analysed by using a parametric unpaired Student's t-test or non-parametric Mann-Whitney U-test, as appropriate. Categorical variables will be described as percentages (%) and compared using the chi-square test or Fisher's exact test. For all analyses, a two-tailed P-value <0.05 will be considered statistically significant. The multivariable model will be used to determine independent predictors by including only variables that are identified by univariable analysis as significant prognosis risk factors with a P-value <0.05. Receiver operating characteristic curve will be used to calculate the cut off values of individual risk factors. The predictive ability of individual predictor and different combination of multiple risk factors on PCs will also be calculated. SPSS software version 22.0 (IBM Corp., Armonk, NY, USA) will be used to analyse the data.

Privacy

All data collected in this study will be stored on computer systems that require user authentication for log on. After data collection is complete, none of this electronic data will be stored with subject-identifying information and will be archived and kept indefinitely.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with PCs

HOCM Patients developing postoperative complications (PCs) following septal myectomy.

PCs include all-cause mortality, heart failure, low cardiac output syndrome, stroke, spinal cord injury, acute respiratory distress syndrome, reintubation, reoperation, permanent implantable cardioverter defibrillator, kidney injury, renal failure, liver injury, and liver failure.

No interventions assigned to this group

Patients without PCs

HOCM Patients do not develope postoperative complications following septal myectomy.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult patients ≥18 years of age who underwent thoracotomy for septal myectomy.

Exclusion Criteria

• Patients with severe liver and renal disease, severe central nervous system disease, malignancy, defibrillators and age under 18 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

chonglei

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hailong Dong, MD, Ph.D

Role: STUDY_DIRECTOR

Director of the Department of Anesthesiology and Perioperative Medicine

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Chong Lei, MD, Ph.D

Role: CONTACT

leichongbb@gmail.com

86-29-84775343

Qianqian Fan, M.D.

Role: CONTACT

qianqianfan0656@163.com

References

Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.

Reference Type: BACKGROUND

PMID: 25173338 (View on PubMed)

Brown ML, Schaff HV. Surgical management of obstructive hypertrophic cardiomyopathy: the gold standard. Expert Rev Cardiovasc Ther. 2008 Jun;6(5):715-22. doi: 10.1586/14779072.6.5.715.

Reference Type: BACKGROUND

PMID: 18510487 (View on PubMed)

Parry DJ, Raskin RE, Poynter JA, Ribero IB, Bajona P, Rakowski H, Woo A, Ralph-Edwards A. Short and medium term outcomes of surgery for patients with hypertrophic obstructive cardiomyopathy. Ann Thorac Surg. 2015 Apr;99(4):1213-9. doi: 10.1016/j.athoracsur.2014.11.020. Epub 2015 Feb 10.

Reference Type: BACKGROUND

PMID: 25678500 (View on PubMed)

Desai MY, Bhonsale A, Smedira NG, Naji P, Thamilarasan M, Lytle BW, Lever HM. Predictors of long-term outcomes in symptomatic hypertrophic obstructive cardiomyopathy patients undergoing surgical relief of left ventricular outflow tract obstruction. Circulation. 2013 Jul 16;128(3):209-16. doi: 10.1161/CIRCULATIONAHA.112.000849. Epub 2013 Jun 14.

Reference Type: BACKGROUND

PMID: 23770748 (View on PubMed)

Woo A, Williams WG, Choi R, Wigle ED, Rozenblyum E, Fedwick K, Siu S, Ralph-Edwards A, Rakowski H. Clinical and echocardiographic determinants of long-term survival after surgical myectomy in obstructive hypertrophic cardiomyopathy. Circulation. 2005 Apr 26;111(16):2033-41. doi: 10.1161/01.CIR.0000162460.36735.71. Epub 2005 Apr 11.

Reference Type: BACKGROUND

PMID: 15824202 (View on PubMed)

Tang B, Song Y, Cui H, Ji K, Zhu C, Zhao S, Huang X, Yu Q, Hu S, Wang S. Prediction of Mid-Term Outcomes in Adult Obstructive Hypertrophic Cardiomyopathy After Surgical Ventricular Septum Myectomy. J Am Coll Cardiol. 2017 Oct 17;70(16):2092-2094. doi: 10.1016/j.jacc.2017.08.032. No abstract available.

Reference Type: BACKGROUND

PMID: 29025563 (View on PubMed)

Fan Q, Lu Z, Wang Y, Wang L, Zhang H, Zheng Z, Dong H, Xiong L, Lei C. Association between postoperative nadir platelet count and postoperative cardiovascular complications following septal myectomy in patients with hypertrophic cardiomyopathy: a retrospective cohort study. BMC Cardiovasc Disord. 2024 Jan 18;24(1):57. doi: 10.1186/s12872-024-03724-2.

Reference Type: DERIVED

PMID: 38238666 (View on PubMed)

Other Identifiers

KY20200121-C-1

Identifier Type: -

Identifier Source: org_study_id