Outcomes and hemodynamics of Enable bioprosthesis in 432 patients: an afterword.

AIMS: To report the largest single-center experience in surgical aortic valve replacement (SAVR) using the Enable sutureless bioprosthesis concerning the clinical outcome and hemodynamic behavior. MATERIAL AND METHODS: From April 2010 to May 2017, a total of 432 patients (36.3% of them women) received the Enable sutureless prosthesis for aortic valve stenosis, regurgitation, and/or endocarditis. The endpoints were overall survival after operation for 30 days and adverse events. RESULTS: No intraoperative complications occurred; intraoperative mortality was 0%. The 30-day mortality rate was 3.5% overall and 0.9% for isolated procedure. No valve-related deaths were observed. There was a need for prosthesis replacement during the early postoperative period in eight patients (1.9%): seven patients (1.6%) had a significant paravalvular leak and one patient (0.2%) developed early postoperative endocarditis. The maximum and mean pressure gradients across the prosthesis were 19.2 ± 7.1 mmHg and 11.1 ± 4.6 mmHg, respectively. A permanent pacemaker was necessary in 6.5% of the patients. CONCLUSIONS: The Enable sutureless prosthesis showed a reliable clinical outcome with low perioperative mortality and morbidity. The hemodynamic performance was satisfactory. Our data confirmed the safety of SAVR using the Enable bioprosthesis. However, a higher rate of pacemaker implantation (6.5%) has to be mentioned.

Stentless Root Replacement versus Tissue Valves in Infective Endocarditis - A Propensity-Score Matched Study.

INTRODUCTION: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. METHODS: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. RESULTS: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). CONCLUSION: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Stentless root replacement versus tissue valves in infective endocarditis - a propensity-score matched study

Abstract Introduction: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. Methods: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. Results: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). Conclusion: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Use of the Medtronic Freestyle for aortic valve infection: A retrospective propensity score matched analysis.

BACKGROUNDS: Aortic valve and prosthetic valve endocarditis present a challenging subgroup of patients at high risk. We analyzed our experience using the Medtronic Freestyle in full root technique for the treatment of these cases over 18-year time period. METHODS: We investigated the endocarditis subgroup from our cohort of 971 patients and compared results against other valve types with propensity score matching implementing nearest neighbor method. T-test, χ2 test, logistic regression, and Cox regression were performed. RESULTS: Fifty-four patients from the Freestyle group (FS) were matched against 54 patients from a cohort of 376 aortic valve/root endocarditis patients treated by other valve types (non-FS). Hospital mortality was 9/54 (16.7%) in the FS vs 13/54 (24.1%) in the non-FS group (P = .33). Variables age (P = .003) and renal impairment (P = .026) had an impact on mortality according to Cox regression analysis for early results. Variables with significant risk for long-term mortality included postoperative renal impairment (P = .0001) and multiorgan failure (P = .0001). Recurrent infection was low (1.8% for FS and 3.7% for non-FS group), and freedom from reoperation was 97.2%. Use of the Medtronic Freestyle was no significant risk factor for long-term mortality. CONCLUSION: The Freestyle stentless xenograft is a viable alternative for treatment of valve/root and prosthetic endocarditis. In our experience, it showed good postoperative performance with low rate of reinfection while having an acceptable operative risk-profile for this high-risk cohort.

Gastrointestinal complications following on-pump cardiac surgery-A propensity matched analysis.

BACKGROUND: Gastrointestinal complications following on-pump cardiac surgery are orphan but serious risk factors for postoperative morbidity and mortality. We aimed to assess incidence, perioperative risk factors, treatment modalities and outcomes. MATERIAL AND METHODS: A university medical center audit comprised 4883 consecutive patients (median age 69 [interquartile range IQR 60-76] years, 33% female, median logistic EuroScore 5 [IQR 3-11]) undergoing all types of cardiac surgery including surgery on the thoracic aorta; patients undergoing repair of congenital heart disease, implantation of assist devices or cardiac transplantation were excluded. Coronary artery disease was the leading indication for on-pump cardiac surgery (60%), patients undergoing cardiac surgery under urgency or emergency setting were included in analysis. We identified a total of 142 patients with gastrointestinal complications. To identify intra- and postoperative predictors for gastrointestinal complications, we applied a 1:1 propensity score matching procedure based on a logistic regression model. RESULTS: Overall, 30-day mortality for the entire cohort was 5.4%; the incidence of gastrointestinal complications was 2.9% and median time to complication 8 days (IQR 4-12). Acute pancreatitis (n = 41), paralytic ileus (n = 14) and acute cholecystitis (n = 18) were the leading pathologies. Mesenteric ischemia and gastrointestinal bleeding accounted for 16 vs. 18 cases, respectively. While 72 patients (51%) could be managed conservatively, 27 patients required endoscopic/radiological (19%) or surgical intervention (43/142 patients, 30%); overall 30-day mortality was 12.1% (p<0.001). Propensity score matching identified prolonged skin-to-skin times (p = 0.026; Odds Ratio OR 1.003, 95% Confidence Interval CI 1.000-1.007) and extended on-pump periods (p = 0.010; OR 1.006, 95%CI 1.001-1.011) as significant perioperative risk factors. COMMENT: Prolonged skin-to-skin times and extended on-pump periods are important perioperative risk factors regardless of preoperative risk factors.

Hospital Results of a Single Center Database for Stentless Xenograft Use in a Full Root Technique in Over 970 Patients.

Our aim was to analyse the hospital outcome for the worldwide largest series of stentless bioroot xenografts (Medtronic Freestyle) as full root replacement in a single centre over a period of 18 years. Retrospective data analysis was performed for the entire cohort of patients undergoing aortic root surgery with the Medtronic Freestyle valve prosthesis. Logistic regression analysis was performed to analyse predictors of in-hospital mortality. 971 patients underwent aortic full root replacement with the Medtronic Freestyle valve in the period from 1999-2017, with an average age of 68.8 ± 10.3y and gender distribution of 608:363 (male:female). Concomitant surgery was performed in 693 patients (71.4%). In-hospital all-comers mortality was 9.8% (95 patients), with the respective highest risk profiles including dissections (6.4%), endocarditis (5.6%) and re-do procedures (12.5%). In-hospital mortality for elective patients was 7.6% while isolated aortic root replacement demonstrated a mortality of 3.6%. Logistic regression analysis demonstrated age (OR 1.05, p = 0.005), dissection (OR 5.78, p < 0.001) and concomitant bypass surgery (OR 2.68, p < 0.001) as preoperative risk factors for the entire cohort. Postoperative analysis demonstrated myocardial infarction (OR 48.6, p < 0.001) and acute kidney injury (OR 20.2, p < 0.001) to be independent risk factors influencing mortality. This analysis presents a work-through of all patients with stentless bioroot treatment without positive selection in a high-volume clinical center with the largest experience world-wide for this form of complex surgery. Isolated aortic root replacement could be performed at acceptable operative risk for this technically-challenging procedure.

Current state of total artificial heart therapy and introduction of the most important total artificial heart systems.

Due to the declining instances of organ donation, total artificial heart (TAH) therapy is of increasing importance for the management of end-stage biventricular heart failure. We introduce the currently most important established and novel TAH systems (SynCardia, CARMAT, ReinHeart, BiVACOR), report clinical outcomes and discuss technical requirements for the successful implementation of TAH therapy as an alternative to cardiac transplantation.

Should heart failure patients be left to fate? Temporary implementation of veno-arterial extracorporeal membrane oxygenation for haemodynamic support during excision of rectal carcinoma in an end-stage biventricular heart failure patient.

Management of end-stage heart failure patients requiring major general surgery is not well defined. Due to poor cardiorespiratory reserve, perioperative morbidity and mortality are excessively high. We report a case of temporary implementation of veno-arterial extracorporeal membrane oxygenation for haemodynamic support during excision of rectal carcinoma in an end-stage heart failure patient and describe perioperative management.

Hyperbaric oxygen in patients with ischemic stroke following cardiac surgery: a retrospective observational trial.

BACKGROUND: Hyperbaric oxygenation (HBO2) involves breathing 100% oxygen under elevated ambient pressure in a hyperbaric chamber, thereby dissolving oxygen in the plasma. This results in an increase of arterial partial pressure of oxygen (pO2). Though well established in experimental studies, HBO2 treatment for ischemic stroke is still under discussion. METHODS: From 2002-2014 HBO2 (2.2 bar, 90 minutes one/day; average number per patient: 4.7) was applied in 49 consecutive patients (32 males, 17 females, mean age: 68.8 years, range 31.2 - 83.9) with acute neurological deficit following cardiac surgery (CABG 15; combined surgery 14; valve surgery 11; aneurysm repair 8; malformation 1). Patients' history including TIA or stroke and carotid artery pathology were documented. Both degree and type of neurological deficit was evaluated by a scoring system (0-4) before and after HBO2 treatment. RESULTS: Before HBO2 therapy, the average motor deficit score was 2.45 and the average speech disorder score was 0.55, as compared with an average motor deficit of 1.12 and an average speech disorder of 0.27 afterward (α=0.0001, α=0.009). The majority of patients had an overall improvement of 2 score-points after HBO2 therapy (n=23 patients). Probit analysis showed that for a 50% response/probability (LC50) of having an overall outcome of ≥2 scoring points, an estimate of 4.3 HBO2 therapy sessions is necessary. CONCLUSIONS: HBO22 therapy was associated with significant improvement in patients with acute neurological deficits due to ischemic stroke following cardiac surgery. Though this fact suggests gas embolism as the most likely cause of stroke in this collective, other underlying pathologies cannot be ruled out. Randomized studies are needed for further evaluation.

Immunosuppressive treatment in fulminant myocarditis and gene expression pattern associated with, but no histological confirmation of giant cell myocarditis.

A healthy woman with acute onset of pulmonary oedema and severely depressed left ventricular function underwent endomyocardial biopsy under the clinical suspicion of fulminant myocarditis. While awaiting the results of biopsy, the situation deteriorated to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and extracorporeal membrane oxygenation was implanted. Finally, immunohistochemistry in biopsy specimen corresponded to fulminant lymphocytic myocarditis, although active myocarditis was excluded. Furthermore, gene expression profiling identified giant cell myocarditis although multinuclear cells were absent. This prompted the start of immunosuppression with cortisone and cyclosporine. The patient fully recovered.

Perceval Sutureless Valve Dysfunction Caused by Valvular Thrombosis.

Until now, to our knowledge no case of bioprosthetic valvular thrombosis after implantation of the sutureless Sorin Perceval valve has been reported. Although sutureless aortic valve replacement has become a powerful tool in our daily practice, recent guidelines from the European Society of Cardiology, the European Association for Cardio-Thoracic Surgery, the American College of Cardiology, and the American Heart Association do not give specific recommendations on postoperative anticoagulation therapy. We report the first case of valve dysfunction resulting from thrombosis 12 months after implantation with a possible link to postoperative cortisole therapy.

Liver failure in total artificial heart therapy.

BACKGROUND: Congestive hepatopathy (CH) and acute liver failure (ALF) are common among biventricular heart failure patients. We sought to evaluate the impact of total artificial heart (TAH) therapy on hepatic function and associated clinical outcomes. METHODS: A total of 31 patients received a Syncardia Total Artificial Heart. Preoperatively 17 patients exhibited normal liver function or mild hepatic derangements that were clinically insignificant and did not qualify as acute or chronic liver failure, 5 patients exhibited ALF and 9 various hepatic derangements owing to CH. Liver associated mortality and postoperative course of liver values were prospectively documented and retrospectively analyzed. RESULTS: Liver associated mortality in normal liver function, ALF and CH cases was 0%, 20% (P=0.03) and 44.4% (P=0.0008) respectively. 1/17 (5.8%) patients with a normal liver function developed an ALF, 4/5 (80%) patients with an ALF experienced a markedly improvement of hepatic function and 6/9 (66.6%) patients with CH a significant deterioration. CONCLUSIONS: TAH therapy results in recovery of hepatic function in ALF cases. Patients with CH prior to surgery form a high risk group with increased liver associated mortality.

Applicability of cardiogoniometry as a non-invasive screening tool for the detection of graft vasculopathy in heart transplant recipients.

Currently available diagnostic modalities for the detection of graft vasculopathy following orthotopic heart transplantation are subject to various restrictions. We hypothesized that cardiogoniometry, a novel non-invasive diagnostic tool for the detection of atherosclerotic coronary vessel disease, is applicable in the graft vasculopathy setting. Cardiogoniometric results were obtained during routine follow-up in 49 consecutive, unselected heart transplant recipients and then retrospectively correlated blindly by an independent reader to recent angiographic findings. Sensitivity of cardiogoniometry was 100%, specificity 62.3%, positive predictive value 68.75%, negative predictive value 100%, negative likelihood ratio 0 and positive likelihood ratio 2.888. Cardiogoniometry is potentially applicable as an easy-to-perform, non-invasive screening tool predominantly for the exclusion but also for the detection of graft vasculopathy in heart transplant recipients.

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches.

OBJECTIVE: To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. METHODS: A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. RESULTS: No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed tomographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. CONCLUSIONS: Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.