Clinical trial NCT05330260: Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery
Official title: Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery: Evidence for Late Cognitive Decline?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Postoperative Cognitive Dysfunction
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that participated in the NOMICS trail 5 years ago were invited to participate in the FUNOMICS trial.

Brief summary: A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy control group. It is hypothesized that the endo-CABG group will show a stronger postoperative cognitive dysfunction compared to the PCI group and the healthy control group.

Detailed description: Neurologic complications after cardiac surgery are a major cause of morbidity, prolonged hospital stay and increased costings. In selected cases, postoperative neurologic damage leads to permanent disability or decease of the patient. The American College of Cardiology and the American Heart Association classified neurological sequelae after cardiac surgery into type 1 and type 2. Type 1 morbidities are cardiovascular accident (CVA) and transient ischemic attack (TIA) whereas delirium and postoperative cognitive dysfunction (POCD) are classified as type 2 neurologic injury. Reported incidence of TIA/CVA after coronary artery bypass grafting surgery (CABG) is about 1.6-2%. Incidence of delirium and POCD is more difficult to quantify but ranges from 10-20% for delirium and 30-80% for POCD. Exact pathophysiology remains unclear but seems to be a complex interplay between macro- and microembolization, hypoperfusion and systemic inflammation. Also, preoperative neurologic state might play a role in these frequently comorbid cardiac patients. Some recent papers tried to improve neurologic outcomes by surgical, perfusionist or anesthetic adjustments, with limited success.

Literature concerning neurological complications after minimally invasive cardiac surgery (MICS) is scarce. However, this might be of special concern since in MICS, perfusion to the brain is routinely provided via retrograde flow. By consequence, the brain is possibly exposed to aortic atheroma located distal to the cerebral vessels. This is of special interest since embolic phenomena are identified as a trigger for neurologic failure after cardiac surgery. As the practice of MICS is globally expanding, observations on neurologic outcome after MICS are desirable, with screening for short-term as well as long-term complications.

An important reference article concerning late cognitive outcome after CABG surgery prospectively followed a cohort of 102 CABG patients up until five years after surgery. Patients were tested on eight neurocognitive domains at four moments in time: preoperatively, 3 months after surgery, one year after surgery and ultimately five years after surgery. Somewhat surprisingly, at follow-up on one year after surgery, patients performed significantly better at 5/8 cognitive domains without significant worse scores in the remaining domains. The authors note this finding might be attributed to the learning effect. However, on follow-up after five years, a significant decline in several domains was noted, both compared to one year follow-up as to baseline test results. Unfortunately, due to the lack of a (non-surgical) control group, the authors were unable to attribute this finding to CABG surgery itself or to the normal cognitive evolution in this aging, co-morbid population. Therefore, the group performed a nonrandomized longitudinal prospective study between conventional CABG patients, off-pump CABG (OPCAB) patients, nonsurgical coronary artery patients and healthy controls over a six-year follow-up period. They found a larger decline in all three patient groups compared to the healthy control group although none of the groups was substantially worse compared to baseline. As a result, some authors deduct postoperative neurologic decline is more dependent on preoperative patient state rather influenced by procedure-related factors. However, the influence of MICS and retrograde cardiopulmonary bypass (CPB) flow on long-term neurologic decline remains a question.

Between December 2016 and May 2018 the NOMICS trial (Neurologic Outcome after Minimally Invasive Cardiac Surgery) was performed in Jessa Hospitals, Belgium. Three groups were prospectively followed for three months: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy age and gender matched control group. A battery of neurocognitive tests was performed in all patients and control group to establish the incidence of POCD. By performing these tests again five years after baseline, the investigators will be able to screen for late cognitive decline in a MICS population undergone retrograde arterial CPB flow. Also, because of the presence of two control groups, it might be able to discriminate if the earlier established late decline is typical to the surgical population, to the coronary artery disease (CAD) population and/or normal aging effect.

Eligibility criteria: Inclusion Criteria:

* Minimally 18 years old
* Endo-CABG surgery 5 years ago (group 1)
* PCI surgery 5 years ago (group 2)
* Healthy volunteer 5 years ago (group 3)

Exclusion Criteria:

* Medical history of

  * Stroke or POCD
  * Symptomatic carotid disease
  * Dementia
  * Renal dysfunction (GFR \< 30 ml/min)
  * Hepatic dysfunction (Aspartate aminotranspferase (SGOT/AST) or Alanine Amino Transpherase (SGPT/ALT) \> 3x normal limits)
* History of drug, medication or alcohol abuse
* Language barrier or inability to communicate
* Physical abnormality that prevents performing the neurocognitive tests
* Surgical revision or presence of intra-operative major cardiac event (endo-CABG)
* Conversion to cardiac surgery of presence of major cardiac event (PCI)
* Simultaneous valve surgery
* Inability to travel to follow-up moment

Primary outcomes:
measure: The incidence of Late postoperative cognitive dysfunction (LPOCD) at 5 years after surgery
timeFrame: through study completion, 5 year follow up after the previous study
Secondary outcomes:
measure: Comparison of the evolution of LPOCD until five years after the intervention patients (both endo-CABG as PCI) versus five years after baseline for healthy volunteers
timeFrame: through study completion, 5 year follow up after the previous study
measure: Assessment of predictors of poor neurological outcome after Endo-CABG
timeFrame: through study completion, 5 year follow up after the previous study
measure: Assessment of interim medical events: need for additional surgery
timeFrame: through study completion, 5 year follow up after the previous study
measure: Quality of life questionnaire
timeFrame: through study completion, 5 year follow up after the previous study
measure: Patient satisfaction
timeFrame: through study completion, 5 year follow up after the previous study
measure: Interim medical events: brain trauma, dementia, or stroke
timeFrame: through study completion, 5 year follow up after the previous study
measure: Interim medical events: depression
timeFrame: through study completion, 5 year follow up after the previous study
measure: Survival rate 5 years after endo-CABG and PCI
timeFrame: through study completion, 5 year follow up after the previous study
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: