Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

INTRODUCTION: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

German Experience with a Novel Balloon-Expandable Heart Valve Prosthesis for Transcatheter Aortic Valve Implantation-Outcomes of the MYLAND (MYvaL germAN stuDy) Study.

Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.

Influence of minimal invasive extracorporeal circuits on dialysis dependent patients undergoing cardiac surgery.

INTRODUCTION: Cardiac surgery in patients on chronic renal dialysis is associated with significant morbidity and mortality. Minimally invasive extracorporeal circuits (MiECC) have shown a positive impact on patient outcome in different high-risk populations. This retrospective study compares the outcome of these high-risk patients undergoing heart surgery either with a MiECC or a conventional extracorporeal circulation (CECC). METHODS: This is a single-center experience including 131 consecutive dialysis dependent patients undergoing cardiac surgery between January 2006 and December 2016. A propensity score matching was employed leaving 30 matched cases in each group. RESULTS: After propensity score matching the 30-day mortality was significantly lower in the MiECC group (n = 3 (10%) vs n = 10 (33%) in the CECC group, p = .028). Further, intraoperative transfused units of packed red blood cells were lower in the MiECC group (1.4 ± 1.8 units vs 2.8 ± 1.7, p < .001). CONCLUSIONS: There are evident advantages to using MiECC in dialysis dependent patients, especially regarding mortality. These findings necessitate additional research in MiECC usage in high-risk populations.

Elucidation of the genetic causes of bicuspid aortic valve disease.

AIMS: The present study aims to characterize the genetic risk architecture of bicuspid aortic valve (BAV) disease, the most common congenital heart defect. METHODS AND RESULTS: We carried out a genome-wide association study (GWAS) including 2236 BAV patients and 11 604 controls. This led to the identification of a new risk locus for BAV on chromosome 3q29. The single nucleotide polymorphism rs2550262 was genome-wide significant BAV associated (P = 3.49 × 10-08) and was replicated in an independent case-control sample. The risk locus encodes a deleterious missense variant in MUC4 (p.Ala4821Ser), a gene that is involved in epithelial-to-mesenchymal transformation. Mechanistical studies in zebrafish revealed that loss of Muc4 led to a delay in cardiac valvular development suggesting that loss of MUC4 may also play a role in aortic valve malformation. The GWAS also confirmed previously reported BAV risk loci at PALMD (P = 3.97 × 10-16), GATA4 (P = 1.61 × 10-09), and TEX41 (P = 7.68 × 10-04). In addition, the genetic BAV architecture was examined beyond the single-marker level revealing that a substantial fraction of BAV heritability is polygenic and ∼20% of the observed heritability can be explained by our GWAS data. Furthermore, we used the largest human single-cell atlas for foetal gene expression and show that the transcriptome profile in endothelial cells is a major source contributing to BAV pathology. CONCLUSION: Our study provides a deeper understanding of the genetic risk architecture of BAV formation on the single marker and polygenic level.

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.

Predictors of postoperative atrial fibrillation persisting beyond hospital discharge after coronary artery bypass grafting.

OBJECTIVE: Minimal invasive extracorporeal circuits (MiECC) have been associated with a significant reduction in the incidence of postoperative atrial fibrillation (AF). Nevertheless, AF remains one of the most common complications following elective primary coronary artery bypass grafting (CABG). The aim of this study was to identify the predictors of AF persisting beyond the hospital stay in elective primary CABG patients. METHODS: We conducted a retrospective analysis for the predictors of AF that persisted beyond discharge between all patients who received an elective isolated CABG in our institution between 2009 and 2014. Patients with a positive history for intermittent or persistent AF were excluded from the analysis. Almost all patients were discharged to a rehabilitation facility where they stayed for 3 to 4 weeks postoperatively. At rehab approximately 91% of them received Holter monitoring at least once prior to their discharge. RESULTS: A total of 770 patients were included in the analysis of which 763 patients survived the in-hospital stay. The incidence of AF at hospital discharge was 4.2% (32/763) while that on Holter monitor at Rehab was 1.5% (10/685). Age and the type of extracorporeal circuit (ECC) utilized were the only significant predictors for both AF at discharge (p < 0.01 both) and on Holter monitor in rehab (p < 0.01 and 0.02, respectively). This was also confirmed on multivariate analysis. CONCLUSION: Our findings show that the benefits of MiECC regarding the incidence of postoperative AF persist beyond hospital discharge. They may thus positively influence the outcomes of patients beyond the early postoperative period.

Is aortic valve replacement with a minimally invasive extracorporeal circuit a contemporary option for octogenarians?

OBJECTIVES: Minimally invasive extracorporeal circuits have been introduced to cardiac surgery in an attempt to reduce the negative effects of cardiopulmonary bypass on patient outcome. On the other hand, transcatheter aortic valve replacement (TAVR) provides an excellent option to replace the aortic valve without the need for cardiopulmonary bypass. Several studies have compared TAVR to surgical aortic valve replacement (SAVR) but none have utilized a minimally invasive extracorporeal circuit. METHODS: We retrospectively analysed the results of both procedures among octogenarians operated in our department from 2003 to 2016. Excluded were patients with an active endocarditis, a history of previous cardiac surgery, as well as those who had a minimally invasive surgical approach. This yielded 81 and 142 octogenarians in the SAVR and TAVR groups, respectively. To compensate for a lack of randomization, we performed a propensity score analysis, which yielded 68 patient pairs for the final analysis. RESULTS: The 30-day postoperative mortality was lower in the SAVR group (1.5% vs 5.9%) but not statistically significant (P = 0.4). In contrast, the incidence of postoperative atrial fibrillation was lower in the TAVR group (13% vs 29%) but also non-significant (P = 0.2). Finally, the incidence of paravalvular leakage was in favour of the SAVR group (2.9% vs 52%; P = 0.001) while the transfusion requirement was significantly lower in the TAVR group (29% vs 72%; P < 0.001). CONCLUSIONS: SAVR utilizing a minimally invasive extracorporeal circuit improves the quality of patient care and can offer an alternative to TAVR in octogenarians.

Aortic valve replacement with or without myocardial revascularization in octogenarians. Can minimally invasive extracorporeal circuits improve the outcome?

OBJECTIVE: The positive impact of minimally invasive extracorporeal circuits (MiECC) on patient outcome is expected to be most evident in patients with limited physiologic reserves. Nevertheless, most studies have limited their use to low-risk patients undergoing myocardial revascularization. As such, there is little evidence to their benefit outside this patient population. We, therefore, set out to explore their potential benefit in octogenarians undergoing aortic valve replacement (AVR) with or without concomitant myocardial revascularization. METHODS: Based on the type of the utilized ECC, we performed a retrospective propensity score-matched comparison among all octogenarians (n = 218) who received a primary AVR with or without concomitant coronary artery bypass grafting in our institution between 2003 and 2010. RESULTS: A MiECC was utilized in 32% of the patients. The propensity score matching yielded 52 matched pairs. The 30-day postoperative mortality (2% vs. 10%; p=0.2), the incidence of low cardiac output (0% vs. 6%; p=0.2) and the Intensive Care Unit (ICU) stay (2.5 ± 2.6 vs. 3.8 ± 4.7 days; p=0.06) were all in favour of the MiECC group, but failed to reach statistical significance while the 90-day postoperative mortality did (2% vs. 16%; p=0.02). CONCLUSION: MiECCs have a positive influence on the outcome of octogenarians undergoing AVR with or without concomitant coronary artery bypass grafting. Their use should, therefore, be extended beyond isolated coronary artery bypass graft (CABG) surgery.

Impact of minimally invasive extracorporeal circuits on octogenarians undergoing coronary artery bypass grafting. Have we been looking in the wrong direction?

OBJECTIVES: Minimally invasive extracorporeal circuits (MiECCs) aim at the preservation of physiologic reserves, the impact of which is expected to be most evident in patients in whom these are depleted. In this context, octogenarians present a subpopulation of specific interest. METHODS: Based on the type of the utilized ECC, we performed a retrospective comparison between all octogenarians (n = 324) who received a primary coronary artery bypass in our institution from 2003 until 2010. RESULTS: An MiECC was used in 52% of patients. Preoperative variables showed that the MiECC patients were older (83 ± 2 vs 82 ± 2 years; P = 0.001), had higher incidence of renal dysfunction (8% vs 3%; P = 0.04), moderately reduced left ventricular function (43 vs 33%; P = 0.07) and lower incidence of unstable angina (20% vs 28%; P = 0.06). To overcome these differences, a propensity score matching was performed and yielded 126 matched pairs of patients. The overall transfusion of packed red blood cells (2.3 ± 2.3 vs 3.4 ± 3.2 units per patint; P = <0.001), the rate of low cardiac output (0% vs 6%; P = 0.01) and the 30-day postoperative mortality (2.4% vs 9.5%; P = 0.02) were all in favour of the MiECC group in the matched patient population. CONCLUSIONS: The MiECC concept has shown its benefits regarding both morbidity and mortality in this high-risk patient population. We believe that this beneficial effect finds its reason in a better preservation of physiologic reserves that are essential for a positive outcome in this patient group.

Modular minimal invasive extracorporeal circuits: another step toward universal applicability?

INTRODUCTION: Safety concerns have been one of the main reasons opposing a wider acceptance of minimal invasive extracorporeal circuits (MiECC). Following an extensive experience and a multitude of modifications, we have set out to employ a modular MiECC as a universal extracorporeal circuit. METHODS: A total of 129 cardiac surgical procedures were performed by a single surgeon in 2013. Excluding procedures done under circulatory arrest or with the potential need of such, the MiECC was utilized in almost 90% of surgeries. Of sixty-two (simple procedures) patients who underwent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG + AVR, 82% were non-elective, 10% had a left ventricular ejection fraction (EF) <30% and most had an impaired renal function. Thirty-eight patients had more complex surgeries (complex procedures), 37% of which were urgent, 15% had an EF <30% and the majority had renal dysfunction. RESULTS: The 30-day mortality was 5% in simple procedures and 2.5% in complex procedures. The incidence of postoperative atrial fibrillation was 13% and 16%, respectively. Optimum outcome was defined as a freedom from all complications and blood transfusions and was achieved in 52% and 42%, respectively. CONCLUSIONS: This report shows that modular MiECC can be employed with a high safety margin in cardiac surgery. Furthermore, it emphasizes the impact that minimal invasive philosophy could have in improving patient care.

Open Repair Versus Thoracic Endovascular Aortic Repair in Multiple-Injured Patients: Observations From a Level-1 Trauma Center.

BACKGROUND: Blunt trauma of the thoracic aorta is a rare but potentially life-threatening entity. Intimal tears are a domain of non-operative management, whereas all other types of lesions should be repaired urgently. There is now a clear trend favoring minimally invasive stent grafting over open surgical repair. OBJECTIVES: The aim of the present study was to retrospectively evaluate the mortality and morbidity with either treatment option. Therefore, a retrospective observational study was performed to compare two different treatment methods at two different time periods at one trauma center. PATIENTS AND METHODS: Between 1977 and 2012, all severely injured patients referred to our level 1 trauma center were screened for blunt aortic injuries. We compared baseline characteristics, 30-day and overall mortality, morbidity, duration of intensive care treatment, procedure time, and transfusion of packed red blood between patients who underwent open surgical or stent repair. RESULTS: During the observation period, 45 blunt aortic injuries were recorded. The average Injury Severity Score (ISS) was 41.8 (range 29 - 68). Twenty-five patients underwent Open Repair (OR), and another 20 patients were scheduled to emergency stent grafting. The 30-day mortality in the surgical and stent groups were 5/25 (20%) and 2/20 (10%), respectively. The average time for open surgery was 151 minutes; the mean time for stent grafting was 67 minutes (P = 0.001). Postoperative stay on the intensive care unit was between one and 59 days (median 10) in group one and between four and 50 days in group two (median 26)(P = 0.03). Patients undergoing OR required transfusion of 6.0 units of packed red cells in median; patients undergoing stent grafting required a median of 2.0 units of packed red cells (P < 0.001). In the stent grafting group, 30-day mortality was 10% (2/20). CONCLUSIONS: Due to more sophisticated diagnostic tools and surgical approaches, mortality and morbidity of blunt aortic injuries were significantly reduced over the years compared to thoracic endovascular aortic repair and OR over two different time periods.

Magnetic resonance imaging versus echocardiography to ascertain the regression of left ventricular hypertrophy after bioprosthetic aortic valve replacement: results of the REST study.

OBJECTIVES: To compare the decrease in left ventricular mass index (LVMI) by magnetic resonance imaging (MRI) versus transthoracic echocardiography (TTE) after aortic valve replacement (AVR) for severe aortic stenosis with Epic and Epic Supra stented porcine bioprostheses (St Jude Medical, Inc, St Paul, Minn). METHODS: This prospective multicenter study enrolled 149 patients who underwent AVR between January 2006 and February 2008. TTE and cardiac MRI measurements of LVMI were made at baseline and at 6 months of follow-up and were compared. Changes in mean pressure gradients were examined using TTE. RESULTS: TTE measurements of LVMI were 48% to 63% higher than the MRI measurements. A decrease in LVMI from 137 ± 32 to 95 ± 16 g/m(2) with the Epic and from 139 ± 29 to 104 ± 28 g/m(2) with the Epic Supra valves (P < .0001 for both comparisons) was measured by TTE. Cardiac MRI revealed decreases in LVMI from 84 ± 20 to 64 ± 12 g/m(2) and from 86 ± 27 to 64 ± 17 g/m(2) with the Epic and Epic Supra valves, respectively (P < .0001 for both comparisons). TTE revealed a significant regression of mean pressure gradients from 51.6 ± 15.3 to 15.5 ± 5.2 mm Hg with the Epic and from 46.7 ± 19.4 to 17.9 ± 12.8 mm Hg with the Epic supra (P < .0001 for both comparisons). CONCLUSIONS: A significant decrease in LVMI was measured after AVR with all sizes of both bioprosthetic models. Because of the overestimation of the decrease in LVMI by the Devereux formula, as well as the higher accuracy and reproducibility of cardiac MRI measurements, the latter should be preferred to TTE. An ultimate validation of this thesis could only be done comparing each of these modalities with pathologic examination.

Handling of extensive aneurysm of the aorta with bronchomalacia in a Marfan patient.

Surgical management of extensive aneurysms of the aorta still remains demanding. Herein, we describe the successful treatment of a 59-year-old Marfan patient with extensive aneurysm of the aorta complicated by bronchomalacia.

Sutureless aortic valve replacement with the Trilogy Aortic Valve System: multicenter experience.

OBJECTIVE: To evaluate the modular sutureless Arbor Trilogy Aortic Valve System (Arbor Surgical Technologies, Irvine, Calif), designed for minimally invasive aortic valve replacement. METHODS: In a prospective multicenter study, 32 patients with severe aortic valve stenosis underwent aortic valve replacement with the Trilogy valve between 2006 and 2008. Concomitant coronary artery bypass grafting was performed in 6 patients. Transthoracic echocardiography was performed at baseline, at discharge, at 4 to 6 months, at 11 to 14 months, and annually thereafter. RESULTS: Valve implantation was successful in 30 patients. The procedure was converted to conventional aortic valve replacement in 2 patients. Mean bypass time was 111 ± 42 minutes, and crossclamp time was 70 ± 23 minutes. Valve implantation took 21 ± 7 minutes. The transvalvular gradients at discharge were 10 ± 3 mm Hg (mean) and 20 ± 7 mm Hg (peak), and the effective orifice area was 1.9 ± 0.4 cm(2). At 2-year follow-up, gradients were 7 ± 3 mm Hg (mean) and 14 ± 4 mm Hg (peak), and the effective orifice area was 1.9 ± 0.3 cm(2). There was no intraoperative mortality: Two patients died of causes unrelated to the valve during follow-up. One redo aortic valve replacement was performed at 22 months for prosthetic valve endocarditis. CONCLUSIONS: Sutureless aortic valve replacement is feasible and safe with the Trilogy System. After an initial learning curve, the modular valve design allows a more rapid and simple implantation compared with conventional stented tissue valves. The simplicity may also facilitate a greater adoption of minimally invasive aortic valve replacement by a broader spectrum of surgeons.

Atrioventricular disruption managed by ex-situ repair and autotransplantation.

Atrioventricular groove disruption remains one of the most devastating complications following mitral valve replacement. Herein are described two cases that were successfully managed by ex-situ repair and autotransplantation.