Conventional Prostheses versus Sutureless Perceval for Aortic Valve Replacement: A Meta-Analysis.

PURPOSE: Perceval sutureless valves have gained popularity. Whether this implant performs superior to the traditional sutured prosthesis remains unclear. This meta- analysis compared the Perceval implants versus the sutured conventional valves for aortic valve replacement (AVR). METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were accessed: PubMed, Google Scholar, Web of Science, Scopus, and EMBASE. All clinical investigations comparing Perceval versus the conventional prostheses for AVR were considered. RESULTS: The Perceval group demonstrated higher rate of pacemaker implantation (P <0.00001). Aortic cross-clamp (ACC) time (P <0.00001) and cardiopulmonary bypass (CPB) time (P <0.00001) were shorter in the Perceval group. Similarity was found in mean and peak pressure gradient (P = 0.8 and P = 0.2, respectively), mean aortic valve area (P = 0.3), length of intensive care unit (P = 0.4) and hospital stay (P = 0.2), rate of revision (P = 0.11), hemorrhages (P = 0.05), paravalvular leak (P = 0.3), cerebrovascular complication (P = 0.7), and early mortality (P = 0.06). CONCLUSION: Given the shorter ACC time and CPB time, Perceval AVR can be an alternative in high-risk patients. The higher rate of pacemaker implantation following Perceval may limit its routine implantation.

Stent deformation in a sutureless aortic valve bioprosthesis: a pilot observational analysis using imaging and three-dimensional modelling.

OBJECTIVES: The goal of this analysis of the Perceval aortic bioprosthesis was to investigate the ovalization/deformation of the Perceval prosthesis stent after implantation and its propensity for cusp dysfunction, fluttering, fibrosis and blockage. METHODS: Between August 2014 and May 2019, a total of 134 patients (52% female) underwent aortic valve replacement with the Perceval bioprosthesis. We reconstructed three-dimensional models of the Perceval stent using thorax computed tomography scans for 16 patients employing the software Mimics (Materialise NV, Leuven, Belgium) and analysed the ovality of the stents. Radial force (RF) measurements were performed to compare the stiffness of the Perceval bioprosthesis to that of other valves. RESULTS: The three-dimensional reconstructions showed that all Perceval stents exhibited some degree of deformation and ovalization. Ovality in the annulus and commissure section of the Perceval stents ranged from 6.8% to 45% with mean values of 13.6% and 21.9%, respectively. The RF of the Perceval prosthesis was noticeably lower than that of the Edwards Intuity and several transcatheter aortic valve implantation devices. The stent adopted the preoperative shape of the aorta in the 2 patients for whom pre- and postoperative computed tomography data existed. CONCLUSIONS: The Perceval bioprostheses were deformed to different degrees in all analysed cases. The comparably low RFs might be an explanation for the propensity towards this deformation, which can lead to fluttering, a reduction of the cusps' mobility. This condition could potentially result in fibrosis as well as increased transvalvular pressure gradients and might be the cause for the increase in lactate dehydrogenase and the decrease in platelet count.

Evaluation of Left Ventricular Myocardial Work Performance in Patients Undergoing On-Pump and Off-Pump Coronary Artery Bypass Surgery.

PURPOSE: Benefits of off-pump coronary bypass (OPCAB) over on-pump (ONCAB) remain controversial. We aimed to evaluate the early impacts of OPCAB vs ONCAB for varying left ventricular (LV) function baselines by applying the non-invasive myocardial work (MW) analysis, which enables further insights in cardiac mechanics, contractility, and efficacy. METHODS: We retrospectively analyzed 98 patients (55 ONCAB vs 43 OPCAB). Transthoracic echocardiography (TTE) and concurrent arterial blood pressure measurements taken at rest, prior to, and early after surgery were performed. Global myocardial work index (GMWI), global constructive work (GCW), and global work efficiency (GWE), inter alia, were quantified. RESULTS: Preoperatively, OPCAB patients had significantly lower values than ONCAB patients in terms of GMWI (1404.33 ± 585.41 mmHg% vs 1619.07 ± 535.42 mmHg%, p = 0.039), GWE (90% (60%, 96%) vs 93% (74%, 98%), p = 0.028). After surgery, GMWI was reduced in both groups. However, a more significant GMWI impairment occurred early after ONCAB than after OPCAB (-343.14 ± 35.20 mmHg%, p <0.001 vs -224.04 ± 120.91 mmHg%, p = 0.042). CONCLUSION: Despite lower preoperative LV function in OPCAB patients, GMWIs after OPCAB were superior to ONCAB, indicating better preservation of systolic LV function early after OPCAB by means of contractility compared to ONCAB. Further studies should investigate the long-term course of MW response and their clinical impact.

Retrospective Analysis of Air Handling by Contemporary Oxygenators in the Setting of Cardiac Surgery.

PURPOSE: Cardiac surgery with the use of extracorporeal circulation is associated with a significant risk for gaseous microemboli (GME) despite excellent surgical techniques and highest operative standards. GME are associated with postoperative neurocognitive dysfunction and negative clinical outcome. This study determines whether oxygenator design has influence on perioperative outcome after cardiac surgery. METHODS: Three different oxygenator models with integrated arterial filter (HiliteAF 7000, Fusion Affinity, and Synthesis) were retrospectively evaluated in 55 patients undergoing elective cardiac surgery with the use of extracorporeal circulation. The two-channel ultrasound bubble counter BCC200 was used to detect GME in real time. RESULTS: All three oxygenators differ in terms of structural specifications and have different rates of number and volume GME reduction. The Fusion Affinity had the lowest arterial GME volume (1.81 µL ± 0.23 µL), which was statistically significant compared to the Synthesis (3.37 µL ± 0.71 µL, p = 0.014). However, the Synthesis had lower absolute numbers at the venous GME count (31771 µL ± 6579 µL) versus the Fusion Affinity (49304 µL ± 8196 µL). However, with regard to clinical outcome after cardiac surgery (duration of invasive and non-invasive mechanical ventilation, incidence of delirium, stroke, acute renal failure, or new myocardial infarction), we found no differences between groups. CONCLUSION: Despite significant differences in the design specifications, all oxygenators eliminated relevant GME volumes safely.

The flutter-by effect: a comprehensive study of the fluttering cusps of the Perceval heart valve prosthesis.

OBJECTIVES: Sutureless aortic valve prostheses are gaining popularity due to the substantial reduction in cross-clamp time. In this study, we report our observations on the cusp-fluttering phenomenon of the Perceval bioprosthesis (LivaNova, London, UK) using a combination of technical and medical perspectives. METHODS: Between August 2014 and December 2016, a total of 108 patients (69% women) with a mean age of 78 years had aortic valve replacement using the Perceval bioprosthesis (34 combined procedures). All patients underwent transoesophageal echocardiography (TOE) intraoperatively. TOE was performed postoperatively to detect paravalvular leakage and to measure gradients, acceleration time, Doppler velocity indices (Vmax and LVOT/Vmax AV) and effective orifice area indices. In addition, a TOE examination was performed in 21 patients postoperatively. Data were collected retrospectively from our hospital database. RESULTS: The retrospective evaluation of the intraoperative TOE examinations revealed consistent fluttering in all patients with the Perceval bioprosthesis. The echocardiographic postoperative measurements showed a mean effective orifice area index of 0.91 ± 0.12 cm2/m2. The overall mean pressure and peak pressure gradients were in a higher range (13.5 ± 5.1 mmHg and 25.5 ± 8.6 mmHg, respectively), whereas acceleration time (62.8 ± 16.4 ms) and Doppler velocity indices (0.43 ± 0.11) were within the normal range according to the American Society of Echocardiography or european association of echocardiography (EAE) guidelines. The 2-dimensional TOE in Motion Mode (M-Mode) that was performed in patients with elevated lactate dehydrogenase (LDH) levels revealed remarkable fluttering of the cusps of the Perceval bioprosthesis. CONCLUSIONS: In our study cohort, we observed the fluttering phenomenon in all patients who received the Perceval bioprosthesis, which was correlated with elevated LDH levels and higher pressure gradients.

Perioperative onset of acquired von Willebrand syndrome: Comparison between HVAD, HeartMate II and on-pump coronary bypass surgery.

OBJECTIVES: Acquired von Willebrand syndrome (AvWS) is associated with postoperative bleeding complications in patients with continuous flow left ventricular assist devices (CF-LVADs). The aim of this study is to analyze the perioperative vWF profile comparing an axial pump (HMII) to a centrifugal pump (HVAD) regarding the correlation between perioperative occurrence of AvWS, early- and late-postoperative bleeding events. METHODS: From July 2013 until March 2015 blood samples of 33 patients (12 HMII/ 8 HVAD/ 13 controls) were prospectively collected at 12 different time points and analyzed for the vWF antigen (vWF:Ag), its activity (vWF:Ac) and the vWF:Ac/vWF:Ag-ratio (vWF:ratio). The follow up period for postoperative bleeding events was from July 2013 until July 2016. RESULTS: Postoperatively, there was no difference in the vWF-profile between HVAD and HMII groups. However, a subgroup of patients already had significantly lower vWF:ratios preoperatively. Postoperatively, both CF-LVAD groups presented significantly lower vWF:ratios compared to the control group. Bleeding events per patient-year did not differ between the two groups (HMII vs. HVAD: 0.67 vs. 0.85, p = 0.685). We detected a correlation between vWF:ratio <0.7at LVAD-start (r = -0.583, p = 0.006) or at the end of surgery (r = -0.461, p = 0.035) and the occurrence of pericardial tamponade. In the control group, the drop in both vWF:Ag and vWF:Ac recovered immediately postoperatively above preoperative values. CONCLUSION: A subgroup of patients with end-stage heart failure already suffers AvWS preoperatively. In both CF-LVAD groups, AvWS begins immediately after surgery. Intraoperative vWF:ratios <0.7 correlate with higher incidences of pericardial tamponade and re-operation. The presumably dilutive effect of the heart lung machine on vWF vanishes immediately at the end of surgery, possibly as part of an acute-phase response.

Benefits of ultra-fast-track anesthesia in left ventricular assist device implantation: a retrospective, propensity score matched cohort study of a four-year single center experience.

BACKGROUND: The use of left ventricular assist devices (LVADs) has gained significant importance for treatment of end-stage heart failure. Fast-track procedures are well established in cardiac surgery, whereas knowledge of their benefits after LVAD implantation is sparse. We hypothesized that ultra-fast-track anesthesia (UFTA) with in-theater extubation or at a maximum of 4 h. after surgery is feasible in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 3 and 4 patients and might prevent postoperative complications. METHODS: From March, 2010 to March, 2012, 53 LVADs (50 Heart Mate II and 3 Heart Ware) were implanted in patients in our department. UFTA was successfully performed (LVAD ultra ) in 13 patients. After propensity score matching, we compared the LVAD ultra group with a matched group (LVAD match ) receiving conventional anesthesia management. RESULTS: Patients in the LVAD ultra group had significantly lower incidences of pneumonia (p = 0.031), delirium (p = 0.031) and right ventricular failure (RVF) (p = 0.031). They showed a significantly higher cardiac index in the first 12 h. (p = 0.017); a significantly lower central venous pressure during the first 24 h. postoperatively (p = 0.005) and a significantly shorter intensive care unit (ICU) stay (p = 0.016). Kaplan-Meier analysis after four years of follow-up showed no significant difference in survival. CONCLUSION: In this pilot study, we demonstrated the feasibility of ultra-fast-track anesthesia in LVAD implantation in selected patients with INTERMACS level 3-4. Patients had a lower incidence of postoperative complications, better hemodynamic performance, shorter length of ICU stay and lower incidence of RVF after UFTA. Prospective randomized investigations should examine the preservation of right ventricular function in larger numbers and identify appropriate selection criteria.

Fluid Dynamics in Rotary Piston Blood Pumps.

Mechanical circulatory support can maintain a sufficient blood circulation if the native heart is failing. The first implantable devices were displacement pumps with membranes. They were able to provide a sufficient blood flow, yet, were limited because of size and low durability. Rotary pumps have resolved these technical drawbacks, enabled a growing number of mechanical circulatory support therapy and a safer application. However, clinical complications like gastrointestinal bleeding, aortic insufficiency, thromboembolic complications, and impaired renal function are observed with their application. This is traced back to their working principle with attenuated or non-pulsatile flow and high shear stress. Rotary piston pumps potentially merge the benefits of available pump types and seem to avoid their complications. However, a profound assessment and their development requires the knowledge of the flow characteristics. This study aimed at their investigation. A functional model was manufactured and investigated with particle image velocimetry. Furthermore, a fluid-structure interaction computational simulation was established to extend the laboratory capabilities. The numerical results precisely converged with the laboratory measurements. Thus, the in silico model enabled the investigation of relevant areas like gap flows that were hardly feasible with laboratory means. Moreover, an economic method for the investigation of design variations was established.

Percutaneous dilatational tracheostomy following total artificial heart implantation.

Coagulation disorders and an immune-altered state are common among total artificial heart patients. In this context, we sought to evaluate the safety of percutaneous dilatational tracheostomy in cases of prolonged need for mechanical ventilatory support. We retrospectively analysed the charts of 11 total artificial heart patients who received percutaneous dilatational tracheostomy. We focused on early and late complications. We observed no major complications and no procedure-related deaths. Early minor complications included venous oozing (45.4%) and one case of local infection. Late complications, including subglottic stenosis, stomal infection or infections of the lower respiratory tract, were not observed. In conclusion, percutaneous dilatational tracheostomy in total artificial heart patients is safe. Considering the well-known benefits of early tracheotomy over prolonged translaryngeal intubation, we advocate early timing of therapy in cases of prolonged mechanical ventilation.

Video-assisted pericardioscopic surgery for epimyocardial lead implantation.

PURPOSE: Video-assisted pericardioscopic surgery (VAPS) for epimyocardial lead implantation has demonstrated positive acute results concerning the safety and degree of freedom inside the pericardium. We evaluated the employment of a newly developed trocar for pericardioscopy with regard to long-term effects and feasibility of reoperation. DESCRIPTION: Eight adult sheep were divided into three groups. In two animals, VAPS was used exclusively. All other animals received four small-caliber epicardial leads through VAPS. After 6 and 12 months (n = 3 each), reoperation was conducted for reevaluation of entry site, intrapericardial adhesions, lead position, and morphology of the implantation site. EVALUATION: Reentry close to the previous entry site proves unproblematic. Adhesions were mild to moderate in the immediate area of the implanted leads. Throughout the follow-up, pacing parameters were satisfactory. Lead dislodgement occurred in 1 of 24 leads. The deployment of small-caliber flexible endoscopes through the new trocar provided sufficient navigation, stability, and maneuverability. CONCLUSIONS: Reoperation from the same subxiphoid approach proved feasible. Lead removal and reimplantation were feasible at both 6 months and 12 months after initial implantation. The intrapericardial adhesions caused by VAPS alone are mild.

Video-assisted pericardioscopic surgery: refinement of a new technique for implanting epimyocardial pacemaker leads.

OBJECTIVE: Current alternative approaches for pacemaker lead implantation imply the breach of the pleural space. Recently, the feasibility of experimental lead implantation by rigid endoscopy has been described. The use of flexible endoscopes and a standardised application has not been realised yet. Our main goal was to compare rigid and flexible endoscopy and to establish a standardised protocol for the implementation of a closed-chest subxiphoid approach for epimyocardial lead implantation. METHODS: Rigid and flexible endoscopes were used for placement of screw-in pacing leads (4-F). A total of 17 adult pigs (80 kg) were anaesthetised and a 10-mm subxiphoid axial incision performed. The pericardium was opened and entered under endoscopic vision. Epimyocardial electrodes were implanted through the endoscope onto all four chambers. Standard haemodynamic measurements and pacing measurements were carried out. RESULTS: Both methods were deployed in the first three individuals. Superior endorsement of rigid endoscopy, due to better orientation and stability, led to its exclusive deployment in the remaining 14 individuals. Access to the implantation sites was quick (<10 min). A plastic cover had to be applied to reduce arrhythmia (VentricularExtraSystoles(bare): 17 ± 2.2 min(-1) vs VentricularExtraSystoles(cover): 5 ± 1.9 min(-1); n = 4). Measured pacing parameters were comparable with classic endocardial-derived thresholds. Post-mortem examination revealed no relevant damage/injury and/or bleeding in the heart and circumjacent tissue. There was no evidence of injury at the implantation sites and the corresponding pericardium. The electrodes showed excellent anchorage inside the myocardial tissue (penetration depths: 3 ± 0.2mm) and resisted high tractive forces. CONCLUSION: Flexible endoscopy is not suitable for exclusive deployment inside the pericardial space, whereas rigid endoscopy presented itself as a safe, fast and simple approach for epimyocardial lead implantation using an insulating trocar. Without cover, malignant arrhythmia constrains the implementation of video-assisted pericardioscopic surgery (VAPS). Subxiphoid VAPS permits optimal lead positioning under direct vision without fluoroscopy, without the breach of the pleural space and with a short procedural duration (<60 min). Our standardised minimal-invasive approach allows visualisation and intervention, potentially of all intrapericardial structures.

Survival and quality of life in patients with cardiac resynchronization therapy for severe heart failure and in heart transplant recipients within a contemporary heart failure management program.

BACKGROUND: Current treatment of advanced chronic heart failure comprises pharmacologic approaches, multidisciplinary management strategies and device therapy. We sought to compare the outcome after cardiac synchronization therapy (CRT) with the outcome after heart transplantation within a contemporary heart failure management program. METHODS: In a cohort study, survival and quality of life were assessed in 105 patients who had received CRT (53% with defibrillator) for severe heart failure and in 112 heart transplant recipients attending a heart failure clinic at a tertiary hospital. For assessment of health-related quality of life the Medical Outcome Short Form 36 (SF-36) was applied to the survivors. A propensity score for receiving transplantation vs CRT was developed using logistic regression and was incorporated into statistical models. RESULTS: Severity of heart failure before heart transplantation or CRT was similar. Survival was not different between device recipients and transplant recipients by Kaplan-Meier analysis. Cox regression analysis with time-dependent covariates revealed a significant interaction between treatment and time, which favored transplantation late after intervention. There were no significant differences in 7 of 8 subjective measures of health-related quality of life. The score for physical functioning was higher in the transplantation group; this difference remained of borderline significance after multivariate adjustment. CONCLUSIONS: Contemporary management of patients with advanced heart failure including CRT leads to improved survival and quality of life and diminishes the difference in these outcomes between conservative management and heart transplantation within the time-frame studied. Patient selection for heart transplantation requires consideration of these results.

Introduction of a flexible polymeric heart valve prosthesis with special design for aortic position.

OBJECTIVE: Current prosthetic heart valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural valves. Recently a polymeric valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic valve is presented and in vitro and in vivo results are reported. METHODS: The aortic prosthesis (ADIAM lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible prosthesis mimicks the natural aortic valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic valves) and was compared to two different commercial bioprostheses. RESULTS: The polymeric aortic heart valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioprosthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU valves compared to bioprostheses. CONCLUSION: The new flexible polymeric aortic valve prosthesis is superior to current bioprostheses in animal testing.

New flexible polymeric heart valve prostheses for the mitral and aortic positions.

OBJECTIVE: Current prosthetic heart valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared with natural valves. We report in vivo and in vitro results with new polymeric valve prostheses that have a special design for the mitral and aortic positions. The aims are improved durability and elimination of the need for permanent anticoagulation. METHODS: The mitral and aortic prostheses (Adiam Life Science, Erkelenz, Germany) are made entirely of polycarbonate urethane (PCU). The bileaflet asymmetric mitral valve mimics natural, nonaxial inflow, which creates a left ventricular vortex, saving energy for systolic ejection of blood. The trileaflet aortic prosthesis has diminished pressure loss and reduced stress and strain peaks at the commissures. The valves were subjected to long-term in vitro testing and in vivo testing in a growing calf model (20 weeks; 7 mitral and 7 aortic valves) with comparison with 2 commercial bioprostheses (7 mitral, 2 aortic). Two-dimensional echocardiography was performed after implantation and prior to sacrifice with autopsy and valve examination. RESULTS: In vitro durability of the PCU valves was proved up to 20 years. In vivo durability and hemodynamics were superior to those of all bioprostheses. Survival of PCU valves versus bioprostheses was 7 versus 2 mitral valves and 5 versus 0 aortic valves, respectively. Two animals with PCU aortic valves died of pannus overgrowth that caused severe left ventricular outflow tract obstruction without changes in the valves. Degeneration and calcification were mild (mitral) and moderate (aortic) in PCU valves but were severe in biological valves. There was no increased thrombogenicity of the PCU valves compared with bioprostheses. CONCLUSION: The new flexible polymeric aortic and mitral valve prostheses were superior to current bioprostheses in animal testing.