Clinical trial NCT03902717: Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
Official title: An Observational Cohort Study to Investigate Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Surgery
Keywords: Minimally invasive cardiac surgery
Endoscopic coronary artery bypass grafting
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are scheduled to undergo minimally invasive cardiac surgery, open CABG or TAVI

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Quality of Recovery
timeFrame: 2 weeks after surgery
measure: Quality of Recovery
timeFrame: 3 months after surgery
measure: Quality of Recovery
timeFrame: 12 months after surgery
measure: Routine measurements of standard medical practice
timeFrame: 12 months after surgery
measure: Patient satisfaction with respect to surgery
timeFrame: 3 months after surgery
measure: Physical recovery of patients after surgery
timeFrame: 2 weeks after surgery
measure: Physical recovery of patients after surgery
timeFrame: 1 month after surgery
measure: Physical recovery of patients after surgery
timeFrame: 3 months after surgery
measure: Physical recovery of patients after surgery
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
city: Hasselt
country: Belgium
facility: Department of Anesthesiology and Intensive Care
Study officials:
affiliation: Jessa hospital, Hasselt
name: Björn Stessel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezelsoy M, Caynak B, Bayram M, Oral K, Bayramoglu Z, Sagbas E, Aytekin V, Akpinar B. The Comparison between Minimally Invasive Coronary Bypass Grafting Surgery and Conventional Bypass Grafting Surgery in Proximal LAD Lesion. Heart Surg Forum. 2015 Apr 28;18(2):E042-6. doi: 10.1532/hsf.1239.
citation: Diodato M, Chedrawy EG. Coronary artery bypass graft surgery: the past, present, and future of myocardial revascularisation. Surg Res Pract. 2014;2014:726158. doi: 10.1155/2014/726158. Epub 2014 Jan 2.
citation: Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.
citation: Lapierre H, Chan V, Sohmer B, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting via a small thoracotomy versus off-pump: a case-matched study. Eur J Cardiothorac Surg. 2011 Oct;40(4):804-10. doi: 10.1016/j.ejcts.2011.01.066. Epub 2011 Mar 9.
citation: Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
citation: McGinn JT Jr, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual-center experience in 450 consecutive patients. Circulation. 2009 Sep 15;120(11 Suppl):S78-84. doi: 10.1161/CIRCULATIONAHA.108.840041.
citation: Biglioli P, Antona C, Alamanni F, Parolari A, Toscano T, Pompilio G, Polvani G. Minimally invasive direct coronary artery bypass grafting: midterm results and quality of life. Ann Thorac Surg. 2000 Aug;70(2):456-60. doi: 10.1016/s0003-4975(00)01371-0.