Risk Factors of Postoperative Complications in HCM Patients

NCT04275544 | Unknown

• 1 other identifier: KY20200121-C-1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

Hypertrophic Obstructive Cardiomyopathy; Risk factor; Postoperative complication

Outcome Measures

Primary Outcomes (1)

• Identify perioperative risk factors of in-hospital postoperative complications (PCs)

  Identify the perioperative risk factors of in-hospital PCs by multivariable logistic regression analysis. 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, blood loss and urine output; and blood pressure parameters including the baseline mean arterial pressure and lowest mean arterial pressure, and duration of intraoperative hypotension (intraoperative hypotension was defined as a mean arterial pressure \<65 mmHg). 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.

  From the surgery start to patient discharge from hospital, normally within 20 days

Secondary Outcomes (1)

• The incidence of in-hospital postoperative complications (PCs)

  From the end of surgery to patient discharged from hospital, normally within 20 days

Other Outcomes (4)

• Hospital-stay

  During patient stay in hospital, normally within 30 days

• ICU-stay

  From the end of surgery to patient discharged from ICU, normally within 10 days

• Postoperative mechanical ventilation

  From the end of surgery to tracheal extubation, normally within 48 hours

Study Arms (2)

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.

Patients without PCs

HOCM Patients do not develope postoperative complications following septal myectomy.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (7)

• 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.

  PMID: 25173338 BACKGROUND

• 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.

  PMID: 18510487 BACKGROUND

• 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.

  PMID: 25678500 BACKGROUND

• 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.

  PMID: 23770748 BACKGROUND

• 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.

  PMID: 15824202 BACKGROUND

• 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.

  PMID: 29025563 BACKGROUND

• 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.

  PMID: 38238666 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Postoperative Complications

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hailong Dong, MD, Ph.D

  Director of the Department of Anesthesiology and Perioperative Medicine

  STUDY DIRECTOR

Central Study Contacts

Chong Lei, MD, Ph.D

CONTACT

86-29-84775343; leichongbb@gmail.com

Qianqian Fan, M.D.

CONTACT

qianqianfan0656@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

CN (1)