Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial.

INTRODUCTION: The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice. METHODS: The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612). RESULTS: The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days). CONCLUSIONS: The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.

Incidence, predictors and vascular sequelae of distal limb ischemia in minimally invasive cardiac surgery with femoral artery cannulation: an observational cohort study.

Literature regarding monitoring and consequences of distal limb ischemia due to femoral artery cannulation for Minimally Invasive Cardiac Surgery (MICS) remains limited. The primary objective was to determine its incidence, defined as a ≥ 15% difference in regional Oxygen Saturation (rSO2) lasting ≥ four consecutive minutes between the cannulated and non-cannulated limb. The secondary objectives included: determination of distal limb ischemia, defined as a Tissue Oxygenation Index (TOI) < 50% in the cannulated limb, identification of predictors for distal limb ischemia, determination of a possible association of NIRS-diagnosed ischemia with acute kidney injury, and the need for vascular surgery up to six months after cardiac surgery. A prospective, observational cohort study with blinded rSO2-measurements to prevent intraoperative clinical decision-making. A single-center, community-hospital, clinical study. All consecutive patients ≥ 18 years old, and scheduled for predefined MICS. Patients underwent MICS with bilateral calf muscle rSO2-measurements conducted by Near-Infrared Spectroscopy (NIRS). In total 75/280 patients (26.79%) experienced distal limb ischemia according to the primary objective, while 18/280 patients (6.42%) experienced distal limb ischemia according to the secondary objective. Multivariate logistic regression showed younger age to be an independent predictor for distal limb ischemia (p = 0.003). None of the patients who suffered intraoperative ischemia required vascular surgery within the follow-up period. The incidence of NIRS-diagnosed ischemia varied from 6.4% to 26.8% depending on the used criteria. Short and long-term vascular sequelae, however, are limited and not intraoperative ischemia related. The added value of intraoperative distal limb NIRS monitoring for vascular reasons seems limited. Future research on femoral artery cannulation in MICS should shift focus to other outcome parameters such as acute kidney injury, postoperative pain or paresthesias.

2021 MiECTiS focused update on the 2016 position paper for the use of minimal invasive extracorporeal circulation in cardiac surgery.

The landmark 2016 Minimal Invasive Extracorporeal Technologies International Society (MiECTiS) position paper promoted the creation of a common language between cardiac surgeons, anesthesiologists and perfusionists which led to the development of a stable framework that paved the way for the advancement of minimal invasive perfusion and related technologies. The current expert consensus document offers an update in areas for which new evidence has emerged. In the light of published literature, modular minimal invasive extracorporeal circulation (MiECC) has been established as a safe and effective perfusion technique that increases biocompatibility and ultimately ensures perfusion safety in all adult cardiac surgical procedures, including re-operations, aortic arch and emergency surgery. Moreover, it was recognized that incorporation of MiECC strategies advances minimal invasive cardiac surgery (MICS) by combining reduced surgical trauma with minimal physiologic derangements. Minimal Invasive Extracorporeal Technologies International Society considers MiECC as a physiologically-based multidisciplinary strategy for performing cardiac surgery that is associated with significant evidence-based clinical benefit that has accrued over the years. Widespread adoption of this technology is thus strongly advocated to obtain additional healthcare benefit while advancing patient care.

Neurological outcome after minimally invasive coronary artery bypass surgery (NOMICS): An observational prospective cohort study.

BACKGROUND/OBJECTIVES: Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimally invasive CABG procedure with retrograde arterial perfusion. The main objective of this study is to assess neurocognitive outcome after Endo-CABG. METHODS/DESIGN: In this prospective observational cohort study, patients were categorised into: Endo-CABG (n = 60), a comparative Percutaneous Coronary Intervention (PCI) group (n = 60) and a healthy volunteer group (n = 60). A clinical neurological examination was performed both pre- and postoperatively, delirium was assessed postoperatively. A battery of 6 neurocognitive tests, Quality of life (QoL) and the level of depressive feelings were measured at baseline and after 3 months. Patient Satisfaction after Endo-CABG was assessed at 3-month follow-up. Primary endpoints were incidence of postoperative cognitive dysfunction (POCD), stroke and delirium after Endo-CABG. Secondary endpoints were QOL, patient satisfaction and the incidence of depressive feelings after Endo-CABG. RESULTS: In total, 1 patient after Endo-CABG (1.72%) and 1 patient after PCI (1.67%) suffered from stroke during the 3-month follow-up. POCD in a patient is defined as a Reliable Change Index ≤-1.645 or Z-score ≤-1.645 in at least two tests, and was found in respectively 5 and 6 patients 3 months after Endo-CABG and PCI. Total incidence of POCD/stroke was not different (PCI: n= 7 [15.9%]; Endo-CABG: n= 6 [13.0%], p = 0.732). ICU delirium after Endo-CABG was found in 5 (8.6%) patients. QoL increased significantly three months after Endo-CABG and was comparable with QoL level after PCI and in the control group. Patient satisfaction after Endo-CABG and PCI was comparable. At follow-up, the level of depressive feelings was decreased in all groups. CONCLUSIONS: The incidence of poor neurocognitive outcome, including stroke, POCD and postoperative ICU delirium until three months after Endo-CABG is low and comparable with PCI. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT02979782).

A new viewpoint on endoscopic CABG: technique description and clinical experience.

BACKGROUND: The aim of this paper is to describe a newly developed endoscopic coronary artery bypass graft (Endo-CABG) technique to treat patients with single- and multi-vessel disease and discuss the short-term clinical results in a large patient cohort. This technique avoids a median sternotomy by combining a thoracoscopic technique via three ∼5 mm thoracic ports and a mini-thoracotomy utility 3-4 cm port through the intercostal space. METHODS: From January 2016 to January 2018, data from consecutive patients undergoing an elective Endo-CABG were prospectively entered into a customized database and retrospectively reviewed. Patients scheduled for a combined hybrid intervention were excluded. Conversion rate to sternotomy, incidence of surgical revision and postoperative graft failure, one-month survival, morbidity, and length of stay (LOS) were investigated. Subgroup analyses were performed. RESULTS: A total of 342 patients undergoing an Endo-CABG with one (n = 53) or multiple (n = 289) bypasses were included. No conversion to sternotomy occurred and incidence of surgical revision, graft failure, and 30-day mortality was 7.3%, 1.5%, and 1.8%, respectively. Adverse neurological outcomes were rare: cerebrovascular accident, transient ischemic attack, epilepsy, and postoperative delirium were observed in 0.6%, 0.3%, 0.3%, and 5.3% of patients, respectively. Median intensive care unit and hospital LOS were 2.75 (IQR 1.8 to 3.8) and 8.0 days (IQR 7.0 to 10.0), respectively. Thirty-day mortality in obese patients, diabetics, and octogenarians was 0%, 3.6%, and 5.6%, respectively. EuroSCORE II > 5% was associated with a high 30-day mortality (25%). CONCLUSIONS: Endo-CABG can be considered a safe and effective procedure to treat single- and multi-vessel coronary artery disease. Individual patient selection seems not necessary to apply this technique.

Thoracoscopic retrieval of an atrial appendage occlusion device after embolization into the left ventricular outflow tract and damaging the mitral valve requiring replacement.

Embolization of a percutaneous left atrial appendage occlusion device is a rare, but potentially life-threatening, complication. In this report, we present the case of an embolization of such a device into the left ventricular outflow tract causing extensive damage to the mitral subvalvular apparatus and requiring mitral valve replacement. We also describe the first thoracoscopic removal of such a device from the left ventricular outflow tract.

Neurological outcome after minimal invasive coronary artery surgery (NOMICS): protocol for an observational prospective cohort study.

INTRODUCTION: Adverse neurocognitive outcomes are still an important cause of morbidity and mortality after cardiac surgery. The most common neurocognitive disorders after conventional cardiac surgery are postoperative cognitive dysfunction (POCD), stroke and delirium. Minimal invasive cardiac procedures have recently been introduced into practice. Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimal invasive cardiac procedure based on the conventional CABG procedure. Neurocognitive outcome after minimal invasive cardiac surgery, including Endo-CABG, has never been studied. Therefore, the main objective of this study is to examine neurocognitive outcome after Endo-CABG. METHODS AND ANALYSIS: We will perform a prospective observational cohort study including 150 patients. Patients are categorised into three groups: (1) patients undergoing Endo-CABG, (2) patients undergoing a percutaneous coronary intervention and (3) a healthy volunteer group. All patients in the Endo-CABG group will be treated following a uniform, standardised protocol. To assess neurocognitive outcome after surgery, a battery of six neurocognitive tests will be administered at baseline and at 3-month follow-up. In the Endo-CABG group, a neurological examination will be performed at baseline and postoperatively and delirium will be scored at the intensive care unit. Quality of life (QOL), anxiety and depression will be assessed at baseline and at 3-month follow-up. Satisfaction with Endo-CABG will be assessed at 3-month follow-up. Primary endpoints are the incidence of POCD, stroke and delirium after Endo-CABG. Secondary endpoints are QOL after Endo-CABG, patient satisfaction with Endo-CABG and the incidence of anxiety and depression after Endo-CABG. ETHICS AND DISSEMINATION: The neurological outcome after minimal invasive coronary artery surgery study has received approval of the Jessa Hospital ethics board. It is estimated that the trial will be executed from December 2016 to January 2018, including enrolment and follow-up. Analysis of data, followed by publication of the results, is expected in 2018. TRIAL REGISTRATION NUMBER: NCT02979782.

A comparison between minimized extracorporeal circuits and conventional extracorporeal circuits in patients undergoing aortic valve surgery: is 'minimally invasive extracorporeal circulation' just low prime or closed loop perfusion ?

INTRODUCTION: Even though results have been encouraging, an unequivocal conclusion on the beneficial effect of minimally invasive extracorporeal circulation (MiECC) in patients undergoing aortic valve surgery cannot be derived from previous publications. Long-term outcomes are rarely reported and a significant decrease in operative mortality has not been shown. Most studies have a limited number of patients and are underpowered. They merely report on short-term results of a heterogeneous intraoperative group using different types of ECC system in aortic valve surgery. The aim of the present study was to determine whether MiECC systems are more beneficial than conventional extracorporeal systems (CECC) with regard to mortality, hospital stay and inflammation and with only haemodilution and blood-air interface as differences. METHODS: We retrospectively analysed data regarding mortality, hospital stay and inflammation in patients undergoing isolated aortic valve surgery. Forty patients were divided into two groups based on the type of extracorporeal system used; conventional (n=20) or MiECC (n=20). RESULTS: Perioperative blood product requirements were significantly lower in the MiECC group (MiECC: 0.2±0.5 units vs CECC: 0.9±1.2 units, p=0.004). No differences were seen postoperatively regarding mortality (5% vs 5%, p=0.99), total length of hospital stay (10.6±7.2 days (MiECC) vs 12.1±5.9 days (CECC), p=0.39) or inflammation markers (CRP: MiECC: 7.09±13.62 mg/L vs CECC: 3.4±3.2 mg/L, p=0.89). CONCLUSION: MiECC provides circulatory support that is equally safe and feasible as conventional extracorporeal circuits. No differences in mortality, hospital stay or inflammation markers were observed.

Elective reconstruction of the ascending aorta for aneurysmal disease restores normal life expectancy. An analysis of risk factors for early and late mortality.

OBJECTIVE: We investigated the survival of patients who had undergone elective reconstruction of the ascending aorta for degenerative aneurysms. The long-term survival was compared to an age- and sex-matched case-control population. An analysis of risk factors, influencing survival was made. METHODS AND RESULTS: From May 1998 to January 2012, 72 patients underwent elective reconstruction of the ascending aorta for degenerative disease at the department of Cardiothoracic Surgery of the Jessa Hospital, Hasselt, Belgium. Sixty patients were treated with Bentall procedures, whereas 12 received valve-sparing procedures. The average age of the patient group was 65.5 years (range 24-80), with 64% males. Thirty-day mortality was 9.7% (consistent with calculated Euroscore II: 9.2%). The long-term survival was 80.9% at 3, 5 and 10 years. No deaths occurred between 3 and 10 years postoperatively. In an age- and sex case-matched Belgian population, 3-, 5- and 10-year survival were 95.7%, 94.7% and 85.2%, respectively. Long-term survival was not significantly different between both groups. Poor NYHA class at the time of surgery (P = 0.041) and COPD (P = 0.028) had a significant impact on global survival. Valve-sparing operations provide similar long-term survival, avoiding thrombo-embolic complications. CONCLUSIONS: Reconstruction of the ascending aorta for degenerative aneurysmal disease restores normal life expectancy, compared with an age- and sex-matched case-control population. Early mortality is consistent with the Euroscore II risk calculation. Whereas late survival progressively declines in the average population, it remains constant in the treated group after 3 years. COPD and poor functional class significantly impair survival. Valve-sparing procedures confer a similar long-term survival as valve replacement.