Clinical trial NCT04275544: Risk Factors of Postoperative Complications in HCM Patients
Official title: Perioperative Risk Factors of Postoperative Complications in Hypertrophic Obstructive Cardiomyopathy Patients Undergoing Septal Myectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Hypertrophic Obstructive Cardiomyopathy
Risk factor
Postoperative complication
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed clinical diagnosis of HOCM were referred for surgical septal myectomy in a tertiary hospital in China

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.

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

Primary outcomes:
measure: Identify perioperative risk factors of in-hospital postoperative complications (PCs)
timeFrame: From the surgery start to patient discharge from hospital, normally within 20 days
Secondary outcomes:
measure: The incidence of in-hospital postoperative complications (PCs)
timeFrame: From the end of surgery to patient discharged from hospital, normally within 20 days
Other outcomes:
measure: Hospital-stay
timeFrame: During patient stay in hospital, normally within 30 days
measure: ICU-stay
timeFrame: From the end of surgery to patient discharged from ICU, normally within 10 days
measure: Postoperative mechanical ventilation
timeFrame: From the end of surgery to tracheal extubation, normally within 48 hours
measure: Postoperative hospital stay
timeFrame: From the end of surgery to patient discharged from hospital, normally within 20 days
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Director of the Department of Anesthesiology and Perioperative Medicine
name: Hailong Dong, MD, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
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citation: 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.
citation: 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.