Early and mid-term outcomes after aortic valve replacement using a novel tissue bioprosthesis: a systematic review.

OBJECTIVES: While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis. METHODS: A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates. RESULTS: A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2-75.1 years. Isolated AVR was performed in 39.0-86.4% of patients. In-hospital or 30-day postoperative mortality was 0-2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0-3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P = 0.98, odds ratio 1.02, 95% confidence interval 0.36-2.83) and stroke (P = 0.98, odds ratio 1.01, 95% confidence interval 0.38-2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis. CONCLUSIONS: Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis.

Case report: A complex case of valve-in-valve TAVI and left bundle branch pacing for severe aortic regurgitation with partially corrected type A aortic dissection and low ejection fraction.

Background: Aortic regurgitation is a major concern following transcatheter aortic valve implantation (TAVI), as even low-grade regurgitation is associated with increased mortality. This is of particular concern to patients with pre-existing aortic disease who are at increased risk of TAVI valve slippage. Furthermore, conduction system disturbances after TAVI, namely left bundle branch block (LBBB), may have an additional detrimental effect on cardiac function. Case presentation: This report documents a successful treatment strategy in a frail patient with a bicuspid aortic valve and aortic disease after valve-sparing surgical repair in 1998, who subsequently developed aortic stenosis and underwent TAVI with an Evolut R self-expanding aortic valve. The progression of aortic disease, aortic root dilatation, and leaflet degeneration over the following years caused aortic regurgitation of the self-expanding aortic valve, resulting in left ventricular dilatation and heart failure along with LBBB and left ventricular (LV) mechanical dyssynchrony. Diagnostic workup of the patient showed persistence of the aneurysm distal to the graft with a dissection spanning the ascending aorta, arch, and terminating proximal to the aortic isthmus. After consideration by the cardiac team, a balloon-expandable valve was chosen for a valve-in-valve (ViV) procedure to provide sufficient radial force to expand the existing valve and correct the regurgitation. Due to the anatomy, a J-wire and pigtail catheter were successfully used for a safe approach and placement of the valve. Following the procedure, intermittent complete atrioventricular block was observed in addition to the pre-existing left bundle branch block, necessitating resynchronization pacing. Due to anatomical considerations, ease of placement, and the expected good level of resynchronization due to the proximal block, we opted for left bundle branch pacing, which showed improvement in left ventricular dyssynchrony and LV function at follow-up. Conclusion: Valve-in-valve implantation of a balloon-expandable Myval TAVI device to treat aortic regurgitation caused by slippage and right leaflet disfunction of slef valve is feasible in challenging anatomical scenarios. Left bundle branch pacing is a viable alternative to correct mechanical dyssynchrony in complex patients with LBBB and anatomical challenges necessitating resynchronization.

Current trends in minimally invasive valve-sparing aortic root replacement-Best available evidence.

BACKGROUND: Valve-sparing aortic root replacement such as the reimplantation (David) procedure is becoming increasingly popular. Despite the fact that the procedure is technically more complex, long-term studies demonstrated that excellent clinical outcomes in selected patients with durable repair are achievable. Benefits of minimal access cardiac surgery have stimulated enthusiasm in the use of this access for valve-sparing aortic root replacement. METHODS: We have reviewed available literature on the topic of valve-sparing aortic root replacement (David procedure) via minimally invasive access through upper hemisternotomy in an attempt to assess current trends and to recognize potential advantages of this technique. Patient selection and preoperative work-up play important role in performing minimally invasive David procedure safely. Surgical technique corresponds to the standard David procedure, with a few exceptions related to the minimal access, and is performed via upper ministernotomy. RESULTS AND CONCLUSION: Evidence from nonrandomized observational and comparative studies demonstrated excellent clinical outcomes of minimally invasive David procedure in selected patients with comparable perioperative mortality and outcomes to the conventional technique. To date, David procedure with a minimal access technique has been performed in carefully selected patients. We believe it could be particularly beneficial to provide younger patients (Marfan syndrome and bicuspid aortic valve) with minimally invasive David procedure as it can allow faster recovery with improved cosmesis with excellent outcomes. A decision to perform minimally invasive David procedure should be individualized to each patient and based on the experience of the team. Further large prospective randomized studies with long-term follow-up are still needed to confirm durability of minimal access technique.

Minimally invasive aortic valve repair using geometric ring annuloplasty.

OBJECTIVES: As aortic valve repair (AVr) for aortic insufficiency (AI) expands, minimally invasive (Mi) approaches are increasingly being applied. Cardiac surgical techniques can be more difficult through small incisions, and this report analyzes medium-term outcomes for MiAVr facilitated by geometric ring annuloplasty. METHODS: Since 2013, 58 patients were selected for AVr through upper sternotomy third-interspace incisions. The average age was 58.9 ± 15.4 (mean ± SD) years, 71% were male, and preoperative AI grade was 3.6 ± 0.8. Sixty-two percent (36/58) had a proximal aortic replacement for ascending aortic aneurysms (n = 26) and/or remodeling grafts for aortic root aneurysms (n = 10). Annuloplasty rings were placed subannularly (69% trileaflet; 31% bicuspid), and leaflet procedures were performed in 70%. The average ring diameter was 21.6 ± 1.4 mm, and the average aortic clamp time was 113 ± 35 min. RESULTS: After repair, AI grade fell to an average of 0.5 ± 0.6 (p < .0001), with a mean valve gradient of 12.5 ± 7.1 mmHg. No operative mortalities or major complications occurred. Three patients required reoperations for bleeding, and two had pacemakers. At an average follow-up of 38 months (maximal 88 months), three late deaths and no valve-related complications were observed. Four patients required reoperative aortic valve replacement over follow-up, and Kaplan-Meier survival and freedom from reoperation both exceeded 80% at 88 months. At the last follow-up, the average AI grade was 0.7 ± 0.7, and the mean valve gradient was 12.7 ± 6.3 mmHg. CONCLUSIONS: Geometric ring annuloplasty was safe and seemed to facilitate performing AVr ± proximal aortic replacement through Mi incisions. Hemodynamic improvements were significant, medium-term clinical outcomes were acceptable, and results could improve further with experience.

Cerebral microemboli in mini-sternotomy compared to mini- thoracotomy for aortic valve replacement: a cross sectional cohort study.

BACKGROUND: Recently adopted mini-thoracotomy approach for surgical aortic valve replacement has shown benefits such as reduced pain and shorter recovery, compared to more conventional mini-sternotomy access. However, whether limited exposure of the heart and ascending aorta resulting from an incision in the second intercostal space may lead to increased intraoperative cerebral embolization and more prominent postoperative neurologic decline, remains inconclusive. The aim of our study was to assess potential neurological complications after two different minimal invasive surgical techniques for aortic valve replacement by measuring cerebral microembolic signal during surgery and by follow-up cognitive evaluation. METHODS: Trans-cranial Doppler was used for microembolic signal detection during aortic valve replacement performed via mini-sternotomy and mini-thoracotomy. Patients were evaluated using Addenbrooke's Cognitive Examination Revised Test before and 30 days after surgical procedure. RESULTS: A total of 60 patients were recruited in the study. In 52 patients, transcranial Doppler was feasible. Of those, 25 underwent mini-sternotomy and 27 had mini-thoracotomy. There were no differences between groups with respect to sex, NYHA class distribution, Euroscore II or aortic valve area. Patients in mini-sternotomy group were younger (60.8 ± 14.4 vs.72 ± 5.84, p = 0.003), heavier (85.2 ± 12.4 vs.72.5 ± 12.9, p = 0.002) and had higher body surface area (1.98 ± 0.167 vs. 1.83 ± 0.178, p = 0.006). Surgery duration was longer in mini-sternotomy group compared to mini-thoracotomy (158 ± 24 vs. 134 ± 30 min, p < 0.001, respectively). There were no differences between groups in microembolic load, length of ICU or total hospital stay. Total microembolic signals count was correlated with cardiopulmonary bypass duration (5.64, 95%CI 0.677-10.60, p = 0.027). Addenbrooke's Cognitive Examination Revised Test score decreased equivalently in both groups (p = 0.630) (MS: 85.2 ± 9.6 vs. 82.9 ± 11.4, p = 0.012; MT: 85.2 ± 9.6 vs. 81.3 ± 8.8, p = 0.001). CONCLUSION: There is no difference in microembolic load between the groups. Total intraoperative microembolic signals count was associated with cardiopulmonary bypass duration. Age, but not micorembolic signals load, was associated with postoperative neurologic decline. TRIAL REGISTRY NUMBER: clinicaltrials.gov , NCT02697786 14.

Minimally invasive aortic valve replacement with sutureless bioprosthesis through right minithoracotomy with completely central cannulation-Early results in 203 patients.

OBJECTIVES: Minimally invasive aortic valve replacement (mini-AVR) might improve clinical outcomes, particularly in high-risk and elderly patients. Sutureless/rapid deployment bioprosthesis can offer advantage of decreasing the cross-clamp time (XCT) and easing the procedure. Our aim was to evaluate the safety and perioperative outcomes of mini-AVR using sutureless bioprothesis via the right minithoracotomy approach with our modified technique of central cannulation. METHODS: We performed a single-center retrospective analysis of 203 patients consecutively undergoing isolated AVR between March 2016 and June 2018 with the right minithoracotomy approach and our modified technique of central cannulation. Aortic valve diseases were stenosis (89.9%), regurgitation (1.6%), and mixed valve disease (8.5%). Patients with concomitant procedures were excluded. Primary endpoints were 30-day and 4-month mortality. RESULTS: Mean age was 76 ± 6.2 years, 63 (31%) patients were 80 years or older. Cardiopulmonary bypass and XCT were 60.5 (39-153) and 35 (24-76) min, respectively. Thirty-day and 4-month mortality were 1% (two patients). We have observed minor paravalvular leak (PVL) which occurred in seven patients (3.4%), and no moderate/severe PVL was found perioperatively. One patient developed moderate/severe PVL during the 4-month follow-up. There was no structural valve degeneration. Two (1%) patients needed conversion to full sternotomy, and two (1%) patients to ministernotomy. CONCLUSIONS: Mini-AVR via the right minithoracotomy approach with central cannulation is an effective and safe procedure and demonstrates excellent early clinical outcomes. This approach can be particularly valuable in higher risk and elderly patients.

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial.

Extracorporeal hemadsorption may reduce inflammatory reaction in cardiopulmonary bypass (CPB) surgery. Glucocorticoids have been used during open-heart surgery for alleviation of systemic inflammation after CPB. We compared intraoperative hemadsorption and methylprednisolone, with usual care, during complex cardiac surgery on CPB, for inflammatory responses, hemodynamics, and perioperative course. Seventy-six patients with prolonged CPB were recruited and randomized, with 60 included in final analysis. Allocation was into three groups: Methylprednisolone (n = 20), Cytosorb (n = 20), and Control group (usual care, n = 20). Proinflammatory (TNF-α, IL-1ß, IL-6, and IL-8) and anti-inflammatory (IL-10) cytokines which complement C5a, CD64, and CD163 expression by immune cells were analyzed within the first five postoperative days, in addition to hemodynamic and clinical outcome parameters. Methylprednisolone group, compared to Cytosorb and Control had significantly lower levels of TNF-α (until the end of surgery, p < 0.001), IL-6 (until 48 h after surgery, p < 0.001), and IL-8 (until 24 h after surgery, p < 0.016). CD64 expression on monocytes was the highest in the Cytosorb group and lasted until the 5th postoperative day (p < 0.016). IL-10 concentration (until the end of surgery) and CD163 expression on monocytes (until 48 h after surgery) were the highest in the Methylprednisolone group (p < 0.016, for all measurements between three groups). No differences between groups in the cardiac index or clinical outcome parameters were found. Methylprednisolone more effectively ameliorates inflammatory responses after CPB surgery compared to hemadsorption and usual care. Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes. Hemadsorption with CytoSorb® was safe and well tolerated. This trial is registered with clinicaltrials.gov (NCT02666703).

Association of biomarker S100B and cerebral oximetry with neurological changes during carotid endarterectomy performed in awake patients.

Background: This study attempted to correlate neurological symptoms in awake patients undergoing carotid endarterectomy (CEA) under local anaesthesia (LA) with serum concentration of S100B protein and measurement of cerebral oximetry with near-infrared spectroscopy (NIRS). Patients and methods: A total of 64 consecutive CEAs in 60 patients operated under LA during an 18-month period were prospectively evaluated. A cerebral oximeter was used to measure cerebral oxygen saturation (rSO2) before and after cross-clamping along with serum concentration of the S100B protein. Selective shunting was performed when neurological changes occurred, regardless of NIRS. Neurological deterioration occurred (neurological symptoms group) in 7 (10.9 %) operations. In 57 (89.1 %) operations, the patients were neurologically stable (no neurological symptoms group). Results: The neurological symptoms that occurred after clamping correlated with an increase in the serum level of S100B (P = .040). The cut-off of 22.5 % of S100B increase was determined to be optimal for identifying patients with neurological symptoms. There was no correlation between rSO2 decline and neurological symptoms (P = .675). Two (3.1 %) perioperative strokes occurred. Conclusions: We found a correlation between neurological symptoms and serum S100B protein increase. However, because of the long evaluation time of serum S100B, this monitoring technique cannot be performed during CEA.

New graft sizing rings for aortic valve reimplantation procedures.

OBJECTIVES: The objective was to design sizing rings that would enable proper sizing of the graft in reimplantation procedures and to perform leaflet repair before graft implantation. METHODS: The rings were designed in Autodesk Fusion 360 (San Rafael, CA, USA) and 3D printed using a commercial online 3D printing service. We designed incomplete rings with a low profile and complete rings with a high profile. The complete rings are best suited for reimplantation procedures, whereas low profile C rings are intended for isolated aortic valve repair, where the ascending aorta is not transected. The rings come in sizes corresponding to Vascutek Gelweave graft sizes (Vascutek Terumo, Renfrewshire, Scotland). The ring internal diameters are 5% larger than the designated ring sizes and account for the 5% stretch of the grafts when pressurized. Blades of the rings are placed at 20° intervals. The slits between the blades are designed in such a way that the commissural U-sutures, when put in place and under tension, will lock the ring in position. RESULTS: The rings were successfully used in 10 of our latest reimplantation procedures. After dissection of the aortic root, the commissures were suspended with U-stitches and then the ring was seated onto them. Complete leaflet repair with plication to achieve adequate effective height was then performed, followed by graft implantation. No additional leaflet repair was needed. CONCLUSIONS: The newly designed sizing rings enable proper sizing of the graft in reimplantation procedures and enable complete leaflet repair before graft implantation.

Coronary Artery Embolism From a Blood Cyst of the Mitral Valve.

Blood cysts are benign, congenital tumours of the heart endothelium, found most commonly on heart valves. Adult cases are rare, since most spontaneously regress with age. However, reports of symptomatic cases with embolic phenomena and valve dysfunction have been described. We present a case of a previously healthy 44-year-old woman with no cardiovascular risk factors who developed acute myocardial infarction caused by coronary artery embolism from a blood cyst of the anterior mitral valve leaflet.

Creatinine, Neutrophil Gelatinase-Associated Lipocalin, and Cystatin C in Determining Acute Kidney Injury After Heart Operations Using Cardiopulmonary Bypass.

Acute kidney injury (AKI) represents frequent complication after cardiac surgery using cardiopulmonary bypass (CPB). In the hope to enhance earlier more reliable characterization of AKI, we tested the utility of neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (CysC) in addition to standard creatinine for early determination of AKI after cardiac surgery using CPB. Forty-one patients met the inclusion criteria. Arterial blood samples collected after induction of general anesthesia were used as baseline, further sampling occurred at CPB termination, 2 h after CPB, on the first and second day after surgery. According to AKIN classification 18 patients (44%) developed AKI (AKI1-2 groups) and 23 (56%) did not (non-AKI group). Groups were similar regarding demographics and operative characteristics. CysC levels differed already preoperatively (non-AKI vs. AKI2; P = 0.045; AKI1 vs. AKI2; P = 0.011), while postoperatively AKI2 group differed on the first day and AKI1 on the second regarding non-AKI group (P = 0.004; P = 0.021, respectively). NGAL and creatinine showed significant difference already 2 h after CPB between groups AKI2 and non-AKI and later on the first postoperative day between groups AKI1 and AKI2 (P = 0.028; P = 0.014, respectively). This study shows similar performance of early plasma creatinine and NGAL in patients with preserved preoperative renal function. It demonstrates that creatinine, as well as NGAL, differentiate subsets of patients developing AKI of clinically more advanced grade early after 2 h, also when used single and uncombined.

Broad-Range 16S rDNA PCR on Heart Valves in Infective Endocarditis.

BACKGROUND AND AIM OF THE STUDY: Infective endocarditis (IE) is diagnosed by blood and/or resected valve cultivation and echocardiographic findings, as defined by the Duke criteria. Unfortunately, cultures may be negative due to prior antibiotic therapy or fastidious or slow-growing microorganisms. The study aim was to investigate the value of the broad-range polymerase chain reaction (PCR) in addition to blood and valve culture for the detection of causative microorganisms. METHODS: Between February 2012 and March 2015, valve samples from 36 patients undergoing cardiac surgery were analyzed; of these patients, 26 had a preoperative diagnosis of IE and 10 served as controls. Multiple blood cultures were obtained from 34 patients before antibiotic therapy was commenced. Valve samples were inoculated on bacteriological media and underwent analysis using broad-range PCR (16S rDNA). RESULTS: IE was confirmed microbiologically in 21 of the 26 patients (80.7%); in 20 cases (76.9%) this was by positive blood cultures and in 16 (61.5%) by positive valves. Valves were positive in 15 blood culturepositive patients, and in one blood-culture negative patient. Broad-range PCR detected a microorganism in valves significantly more frequently (n = 14; 53.8%) compared to valve culture (n = 8; 30.7%) (chisquare 11.5, p <0.001). The predominant microorganisms were Staphylococcus aureus, Streptococcus of the viridans group, coagulasenegative staphylococci and Enterococcus faecalis. Blood, valve cultures and broad-range PCR were negative in five patients (19.3%) with IE, and in all 10 subjects of the control group. CONCLUSIONS: Broad-range PCR on valves was more sensitive than valve culture. However, blood culture, if taken before the start of antibiotic therapy, was the best method for detecting IE.

Restrictive versus Standard Fluid Regimen in Elective Minilaparotomy Abdominal Aortic Repair-Prospective Randomized Controlled Trial.

Objective Elective minilaparotomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal, and central nervous systems, with mortality ranging up to 5%. In our study, we tested the hypothesis that intra- and postoperative intravenous restrictive fluid regimen reduces postoperative morbidity and mortality, and improves the outcome of minilaparotomy AAA repair. Methods From March 2009 to July 2013, 60 patients operated due to AAA were included in a prospective randomized controlled trial (RCT). About the administration of fluid during the operation and in the early postoperative period, all the patients were randomized into two groups: the group of standard fluid administration (S-group, 30 patients) and the group of reduced fluid administration (R-group, 30 patients). The verification of the treatment success was measured by the length of intensive care unit (ICU) stay, duration of hospitalization after the procedure, as well as the number and type of postoperative complications and mortality. This prospective RCT was registered in a publicly accessible database ClinicalTrials.gov with unique Identifier ID: NTC01939652. Results Total fluid administration and administration of blood products were significantly lower in R-group as compared with S-group (2,445.5 mL vs. 3308.7 mL, p = 0.004). Though the number of nonlethal complications was significantly lower in R-group (2 vs. 9 patients, p = 0.042), the difference in lethal complications remained nonsignificant (0 vs. 1 patient, p = ns). The average ICU stay (1.2 vs. 1.97 days, p = 0.003) and duration of postoperative hospital stay (4.33 vs. 6.20 days, p = 0.035 for R-group and S-group, respectively) were found to be significantly shorter in R-group. Conclusion Intra- and postoperative restrictive intravenous fluid regimen in patients undergoing minilaparotomy AAA repair significantly reduces postoperative morbidity, and shortens ICU and overall hospital stay. Even though incidence of lethal complication was lower in R-group, the difference did not reach statistical significance. Therefore, we may assume that this study was probably underpowered to estimate the differences in mortality between R- and S-groups. Further multicentric, sufficiently powered RCTs are needed to confirm these findings and to clarify effect of restrictive fluid management on mortality.