Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery

Completed

• Conditions: Surgery; Cardiac Disease
• Interventions: Procedure: Minimally invasive cardiac surgery

• Registration Number: NCT03902717
• Lead Sponsor: Jessa Hospital

Brief Summary

Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Although retrospective data show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this observational prospective study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures. The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).

Detailed Description

Introduction:

Coronary artery disease is a leading cause of adult mortality worldwide. One of the most commonly performed surgical interventions to treat this vascular disease is a myocardial revascularization, mostly performed via a Coronary Artery Bypass Graft (CABG) (1). Over time, new developments in cardiac surgery have led to the introduction of less invasive and minimally invasive cardiac procedures (2). These minimally invasive cardiac procedures are proven to be safe and feasible (3) and have excellent outcomes (4) (5) (6). More specifically, the short term outcomes include a reduced patient recovery time (5), lower transfusion rates, wound infections, hospitalization time and hospital mortality rate (4), while the long term outcomes comprise a better vessel graft patency (7) (8). Over the past few years, new minimally invasive cardiothoracic surgery techniques have been developed and are currently being implemented at the department of cardiothoracic surgery from the Jessa Hospital (e.g. endo-CABG, VATS Mitral, hybrid revascularization, Yil AVR). These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Also, these techniques allow a coronary revascularization or mitral valve repair or replacement without the use of expensive robotic equipment and exclusion of specific patients based on comorbidities (e.g. elderly patients, diabetic and/or obese patients). Currently, patients undergo cardiothoracic surgery via these techniques and although retrospective data from our hospital show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures.The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).

Outcome measures:

The goal of this study is to assess several patient central outcomes (e.g. quality of recovery measured with quality of life) and clinical outcomes (e.g. mortality rate, serious complications, major cardiac events, time registration in icu and hospital, duration of surgery, occlusion and perfusion time, surgical parameters, revalidation of the patients) after minimally invasive cardiothoracic surgery.

Design:

This study is a single-center prospective observational cohort study in which eligible patients that are treated via minimally invasive cardiac surgery will be included. Inclusion will last for 1 year and patients will be followed-up for 12 months.

Study Procedures:

After signing the informed consent form, the baseline tests will be performed the day before the surgery. On the day of the surgery, several surgical parameters will be measured as well as several parameters that are included in the standard clinical practice. 2 weeks, 1 month, 3 months and 1 year after the surgery, the QoL will be measured. Patient satisfaction will be assessed 3 months after surgery.

Statistical analysis:

Descriptive statistics will be presented as frequencies and percentages of the total amount of patients for categorical variables, while numerical variables will be presented as mean with variances. Results of the different questionnaires will be calculated according to their specific guidelines. The clinical significance of the questionnaires will be calculated via an effect size. A p-value \<0.05 is considered statistical significant, while p\<0.10 is considered a tendency.

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2019-11-25
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• Males and females ≥ 18 years of age

• Patients planned to undergo minimally invasive cardiac surgery by the following techniques:

  • Endo-CABG
  • Hybrid approach
  • VATS Mitral
  • Mini AVR
  • Yil AVR or open CABG or TAVI

Exclusion Criteria

• Patients < 18 years old
• Patients that are not eligible to undergo minimally invasive cardiac surgery
• Patients that participate in other clinical, pharmaceutical or medical devices trials
• Patients that previously had a minimally invasive cardiac surgery and are now scheduled for a revision
• Patients that need a conversion to sternotomy or other non-minimally invasive technique
• Inability to understand and adhere to the study design

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
minimally invasive cardiac surgery	Minimally invasive cardiac surgery	Group of patients that will undergo minimally invasive cardiac surgery

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	1 month after surgery	Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery	12 months after surgery	Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
Patient satisfaction with respect to surgery	3 months after surgery	Patient satisfaction after surgery (assessed via the 7-point likert scale, with 1 being completely dissatisfied and 7 completely satisfied)
Routine measurements of standard medical practice	12 months after surgery	Routine measurements during and after surgery (e.g. amount of blood loss, time of ventilation, time of perfusion, hematology/blood chemistry, registration of mortality rates and complications after surgery, length of stay at the ICU department after surgery, length of stay in the hospital)
Physical recovery of patients after surgery	12 months after surgery	A maximal exercise test will be performed after surgery to asses revalidation of the patients

Trial Locations

Locations (2)

Department of Anesthesiology and Intensive Care; 🇧🇪 Hasselt, Belgium

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium