Impact of Different Valve-in-Valve Positions on Functional Results of the New Generation of Balloon-Expandable Transcatheter Heart Valve.

OBJECTIVES: Very precise positioning of the transcatheter heart valve (THV) inside the degenerated SAV is a crucial factor for valve-in-valve (ViV) procedure to achieve optimal hemodynamic results. Therefore, our study aimed to investigate the impact of implantation depth on functional results after ViV procedures in a standardized in vitro setting. METHODS: THV (SAPIEN 3 Ultra 23-mm size) and three SAV models (Magna Ease, Trifecta, and Hancock II-all 21-mm size) were tested at different circulatory conditions in five different positions of the THV (2-6 mm) inside the SAV. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOAmax), and pinwheeling index (PWImean) were analyzed. RESULTS: EOA and MPG of the THV did not differ significantly regarding the position inside the Magna Ease and the Hancock II (p > 0.05). However, EOA differed significantly, depending on the position of the THV inside Trifecta (2 vs. 5 mm; p = 0.021 and 2 vs. 6 mm; p < 0.001). The THV presented the highest EOA (2.047 cm2) and the lowest MPG (5.387 mm Hg) inside the Magna Ease, whereas the lowest EOA (1.335 cm2) and the highest MPG (11.876 mm Hg) were shown inside the Hancock II. Additionally, the highest GOAmax and the lowest PWImean of the THV were noticed inside the Magna Ease. The THV showed lower GOAmax and higher PWImean inside the Trifecta when placed in a deeper position. CONCLUSION: Deep implantation of the SAPIEN 3 Ultra inside the Trifecta correlates with impaired functional results. In contrast, the implantation position of the SAPIEN 3 Ultra inside the Magna Ease and the Hancock II did not have a significant effect on functional results.

Impact of high-pressure balloon aortic valvuloplasty on the hydrodynamic result after a transcatheter valve-in-valve procedure.

OBJECTIVES: The aim of this study was to investigate the degree of functional improvement of a transcatheter heart valve (THV) for valve-in-valve after bioprosthetic valve fracture (BVF) of three small surgical aortic valve bioprostheses (SAVBP) using high-pressure balloon aortic valvuloplasty (HP-BAV) under standardized ex-vivo-conditions. METHODS: A THV 26 mm (Evolut R) and SAVBP 21 mm (Perimount Magna Ease, Trifecta, and Epic supra [n = 4] were used. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOA), minimal internal diameter (MID), and pinwheeling index (PWI) were analyzed before and after HP-BAV of the SAVBP using a noncompliant balloon. Fracturing of the SAVBP was done before implantation of the THV and the balloon pressures at the point of fracture were recorded. RESULTS: The Magna Ease and Epic fractured at balloon pressures of 18 and 8 atm, respectively. The Trifecta did not fracture up to a balloon pressure of 30 atm but was dilated. HP-BAV led to increased THV expansion as evident by straightened coaptation lines of the Evolut R 26 mm with reduced PWI, increased MID, and increased GOA in all 21 mm SAVBP. Evolut R showed significantly lower MPG and higher EOA as ViV in all prostheses after HP-BAV (p < 0.001). MPG and EOA of Evolut R differed regarding the SAVBP. Evolut R presented the lowest MPG and highest EOA in Magna Ease and the highest MPG and lowest EOA in Epic supra. CONCLUSIONS: The degree of function improvement of the same THV as ViV after HP-BAV depends on the surgical valve model. Functional improvement can also be achieved without valve fracture.

4D flow CMR analysis comparing patients with anatomically shaped aortic sinus prostheses, tube prostheses and healthy subjects introducing the wall shear stress gradient: a case control study.

BACKGROUND: Anatomically pre-shaped sinus prostheses (SP) were developed to mimic the aortic sinus with the goal to preserve near physiological hemodynamic conditions after valve-sparing aortic root replacement. Although SP have shown more physiological flow patterns, a comparison to straight tube prosthesis and the analysis of derived quantitative parameters is lacking. Hence, this study sought to analyze differences in aortic wall shear stress (WSS) between anatomically pre-shaped SP, conventional straight tube prostheses (TP), and age-matched healthy subjects) using time-resolved 3-dimensional flow cardiovascular magnetic resonance (4D Flow CMR). Moreover, the WSS gradient was introduced and analyzed regarding its sensitivity to detect changes in hemodynamics and its dependency on the expression of secondary flow patterns. METHODS: Twelve patients with SP (12 male, 62 ± 9yr), eight patients with TP (6 male, 59 ± 9yr), and twelve healthy subjects (2 male, 55 ± 6yr) were examined at 3 T with a 4D Flow CMR sequence in this case control study. Six analysis planes were placed in the thoracic aorta at reproducible landmarks. The following WSS parameters were recorded: WSSavg (spatially averaged over the contour at peak systole), max. WSSseg (maximum segmental WSS), min. WSSseg (minimum segmental WSS) and the WSS Gradient, calculated as max. WSSseg - min. WSSseg. Kruskal-Wallis- and Mann-Whitney-U-Test were used for statistical comparison of groups. Occurrence and expression of secondary flow patterns were evaluated and correlated to WSS values using Spearman's correlation coefficient. RESULTS: In the planes bordering the prosthesis all WSS values were significantly lower in the SP compared to the TP, approaching the physiological optimum of the healthy subjects. The WSS gradient showed significantly different values in the four proximally localized contours when comparing both prostheses with healthy subjects. Strong correlations between an elevated WSS gradient and secondary flow patterns were found in the ascending aorta and the aortic arch. CONCLUSION: Overall, the SP has a positive impact on WSS, most pronounced at the site and adjacent to the prosthesis. The WSS gradient differed most obviously and the correlation of the WSS gradient with the occurrence of secondary flow patterns provides further evidence for linking disturbed flow, which was markedly increased in patients compared to healthy sub jects, to degenerative remodeling of the vascular wall.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

In vitro 4D Flow MRI evaluation of aortic valve replacements reveals disturbed flow distal to biological but not to mechanical valves.

BACKGROUND AND AIM OF THE STUDY: Aortic hemodynamics influence the integrity of the vessel wall and cardiac afterload. The aim of this study was to compare hemodynamics distal to biological (BV) and mechanical aortic valve (MV) replacements by in vitro 4D Flow MRI excluding confounding factors of in-vivo testing potentially influencing hemodynamics. METHODS: Two BV (Perimount MagnaEase [Carpentier-Edwards], Trifecta [Abbott]) and two MV (On-X [CryoLife], prototype trileaflet valve) were scanned in a flexible aortic phantom at 3T using a recommended 4D Flow MR sequence. A triphasic aortic flow profile with blood-mimicking fluid was established. Using GTFlow (Gyrotools), area and velocity of the ejection jet were measured. Presence and extent of sinus vortices and secondary flow patterns were graded on a 0 to 3 scale. RESULTS: A narrow, accelerated central ejection jet (Area = 27 ± 7% of vessel area, Velocity = 166 ± 13 cm/s; measured at sinotubular junction) was observed in BV as compared to MV (Area = 53 ± 13%, Velocity = 109 ± 21 cm/s). As opposed to MV, the jet distal to BV impacted the outer curvature of the ascending aorta and resulted in large secondary flow patterns (BV: n = 4, grades 3, 3, 2, 1; MV: n = 1, grade 1). Sinus vortices only formed distal to MV. Although physiologically configured, they were larger than normal (grade 3). CONCLUSIONS: In contrast to mechanical valves, biological valve replacements induced accelerated and increased flow patterns deviating from physiological ones. While it remains speculative whether this increases the risk of aneurysm formation through wall shear stress changes, findings are contrasted by almost no secondary flow patterns and typical, near-physiological sinus vortex formation distal to mechanical valves.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

BACKGROUND: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. METHODS: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001). RESULTS: There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). CONCLUSION: Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.

Myocardial Tissue Engineering for Regenerative Applications.

PURPOSE OF REVIEW: This review provides an overview of the current state of tissue-engineered heart repair with a special focus on the anticipated modes of action of tissue-engineered therapy candidates and particular implications as to transplant immunology. RECENT FINDINGS: Myocardial tissue engineering technologies have made tremendous advances in recent years. Numerous different strategies are under investigation and have reached different stages on their way to clinical translation. Studies in animal models demonstrated that heart repair requires either remuscularization by delivery of bona fide cardiomyocytes or paracrine support for the activation of endogenous repair mechanisms. Tissue engineering approaches result in enhanced cardiomyocyte retention and sustained remuscularization, but may also be explored for targeted paracrine or mechanical support. Some of the more advanced tissue engineering approaches are already tested clinically; others are at late stages of pre-clinical development. Process optimization towards cGMP compatibility and clinical scalability of contractile engineered human myocardium is an essential step towards clinical translation. Long-term allograft retention can be achieved under immune suppression. HLA matching may be an option to enhance graft retention and reduce the need for comprehensive immune suppression. Tissue-engineered heart repair is entering the clinical stage of the translational pipeline. Like in any effective therapy, side effects must be anticipated and carefully controlled. Allograft implantation under immune suppression is the most likely clinical scenario. Strategies to overcome transplant rejection are evolving and may further boost the clinical acceptance of tissue-engineered heart repair.

Valve-in-valve using an Edwards Sapien XT into a JenaValve in a patient with a low originating left coronary artery and a heavily calcified aorta.

Coronary obstruction during transcatheter aortic valve implantation is a potentially life-threatening complication. Most of the widely used transcatheter heart valves require a certain distance between the basal aortic annular plane and the origins of the coronary arteries. We report the case of a successful valve-in-valve procedure with an Edwards SAPIEN XT valve into a JenaValve as a bail-out procedure in a patient with a low originating left coronary artery and a heavily calcified aorta.

One-Year Clinical Outcome in End-Stage Heart Failure: Comparison of "High Urgent" Listing for Heart Transplantation with Mechanical Circulatory Support Implantation.

BACKGROUND: Heart transplantation (HTx) is still considered the therapeutic gold standard in end-stage heart failure. METHODS: In "high urgent" (HU)-listed patients for HTx (n = 274) and patients receiving left ventricular assist device (LVAD) implants (n = 332), we compared 1-year overall survival (primary endpoint) and 1-year probability of HTx and therapy failure (the need for LVAD implantation in HU-listed patients or the need for HU listing in LVAD patients) (secondary endpoints). RESULTS: In the HU and LVAD group, 1-year survival was 86.8 and 64.7%, respectively (p < 0.001). The propensity score (PS)-adjusted hazard ratio of mortality did not differ between the groups and for the LVAD group (reference = HU group) was = 1.36 (95% confidence interval [CI]: 0.85-2.19; p = 0.198). The PS-adjusted hazard ratio for the failure to receive HTx for the LVAD group (reference = HU group) was = 9.77 (95% CI: 6.00-15.89; p < 0.001). The corresponding hazard ratio for therapy failure for the LVAD group was = 0.16, 95% CI: 0.10-0.27; p < 0.001). CONCLUSION: Despite considerable differences in the probability of HTx and therapy failure, 1-year overall survival was similar in HU and LVAD patients.

Association of pulmonary hypertension with the outcome in patients undergoing edge-to-edge mitral valve repair.

OBJECTIVES: The association of pulmonary hypertension (PH) with the outcome after mitral transcatheter edge-to-edge repair (M-TEER) focusing on the new ESC/ERS guidelines definition for PH. BACKGROUND: PH is frequently found in patients with mitral regurgitation and is associated with lower survival rates. Recent studies were based on echocardiographic parameters, but results based on invasive haemodynamics differentiating distinct types of PH using the new definition for PH are missing. METHODS: 449 consecutive M-TEER-treated patients from December 2009 to February 2015 were included in this retrospective analysis. All patients were stratified by the distinct types of PH (no PH, precapillary PH, isolated postcapillary PH, combined post-PH and precapillary PH) according to the definitions of the ESC/ERS guidelines for the diagnosis of PH from 2015 (meanPA cut-off <25 mm Hg, pulmonary capillary wedge pressure (PCWP) cut-off ≤15 mm Hg, diastolic pulmonary gradient cut-off ≥7 mm Hg or pulmonary vascular resistance (PVR) >3 WU) and 2022 (meanPA cut-off ≤20 mm Hg, PCWP cut-off ≤15 mm Hg, PVR cut-off ≥3 WU). RESULTS: Patients with any type of PH (2015: meanPA cut-off 25 mm Hg; 2022: meanPA cut-off >20 mm Hg) showed a higher risk of death after M-TEER compared with patients with no PH (2015: HR 1.61 (95% CI 1.25 to 2.07); p<0.001 and 2022: HR 2.09 (95% CI 1.54 to 2.83); p<0.001). Based on the new PH definition, each PH subgroup showed a lower survival after M-TEER compared with patients with no PH. Echocardiographic estimated systolic PAP showed a correlation with invasively measured mean pulmonary artery pressure (mPAP) (r=0.29, p<0.001) and systolic pulmonary arterial pressure (r=0.34,p<0.001). Cox-regression analysis showed higher invasive diastolic, systolic and mean pulmonary pressures were associated with higher all-cause mortality (p<0.001). In addition, invasive measured higher right atrial pressure, lower pulmonary arterial compliance, higher PVR and higher wedge pressure were identified as predictors of all-cause mortality after M-TEER. CONCLUSIONS: The new PH definition discriminates PH groups and mortality better than the old definition. The lower threshold of mPAP of 20mmHg improved prognostication in this cohort of patients.

Ex vivo evaluation of 3 different right ventricular outflow tract substitutes.

OBJECTIVES: The Ross procedure represents an excellent treatment option in younger patients with aortic stenosis but is limited by poor availability of homografts. In this study, we investigated the hydrodynamic performance of 3 different types of right ventricular outflow tract replacement with pericardium or synthetic material. METHODS: Three different types of valved conduits were constructed using pericardium and/or synthetic material (Group PEPE: pericardial cusps and pericardial conduit, Group PEPR: pericardial cusps and Dacron conduit, Group PRPR: expanded polytetrafluoroethylene cusps and Dacron conduit). The conduits were designed according to the Ozaki method. Their hydrodynamic performance (effective orifice area, mean pressure gradient and leakage volume) were evaluated in a mock circulation loop at different hydrodynamic conditions. RESULTS: Hydrodynamic assessment showed significantly larger effective orifice area of PEPE and PEPR compared to PRPR under all conditions and there were no significant differences between PEPE and PEPR [for condition 2: PEPE 2.43 (2.35-2.54) cm2, PEPR: 2.42 (2.4-2.5) cm2, PRPR: 2.08 (1.97-2.21) cm2, adjusted pairwise comparisons: PEPE versus PEPR: P = 0.80, PEPE versus PRPR: P < 0.001, PEPR versus PRPR: P < 0.001]. Mean pressure gradient was significantly lower for PEPE and PEPR compared with PRPR, whereas no significant differences were seen between PEPE and PEPR. Leakage volume was significantly lower for PEPE and PEPR compared with PRPR under all conditions while leakage was similar between PEPE and PEPR. CONCLUSIONS: Pulmonary graft reconstruction with pericardium cusps showed superior hydrodynamic performance compared with polytetrafluoroethylene cusps. Our results suggest that it could be considered as an alternative substitute for right ventricular outflow tract replacement during the Ross procedure.

Impact of heart rate, aortic compliance and stroke volume on the aortic regurgitation fraction studied in an ex vivo pig model.

INTRODUCTION: Drug therapy to reduce the regurgitation fraction (RF) of high-grade aortic regurgitation (AR) by increasing heart rate (HR) is generally recommended. However, chronic HR reduction in HFREF patients can significantly improve aortic compliance and thereby potentially decrease RF. To clarify these contrasts, we examined the influence of HR, aortic compliance and stroke volume (SV) on RF in an ex vivo porcine model of severe AR. METHODS: Experiments were performed on porcine ascending aorta with aortic valves (n=12). Compliance was varied by inserting a Dacron graft close to the aortic valve. Both tube systems were connected to a left heart simulator varying HR and SV. AR was accomplished by punching a 0.3 cm2 hole in one aortic cusp. Flow, RF, SV and aortic pressure were measured, aortic compliance with transoesophageal ultrasound probes. RESULTS: Compliance of the aorta was significantly reduced after Dacron graft insertion (0.55%±0.21%/mm Hg vs 0.01%±0.007%/mm Hg, p<0.001, respectively). With increasing HR, RF was significantly reduced in each steady state of the native aorta (HR 40 bpm: 88%±7% vs HR 120 bpm: 42%±10%; p<0.001), but Dacron tube did not affect RF (HR 40 bpm: 87%±8%; p=0.79; HR 120 bpm: 42%±3%; p=0.86). Increasing SV also reduced RF independent of the stiff Dacron graft. CONCLUSION: Aortic compliance did not affect AR in the ex vivo porcine model of AR. RF was significantly reduced with increasing HR and SV. These results affirm that HR lowering and negative inotropic drugs should be avoided to treat severe AR.

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.

Microembolization and myonecrosis during elective percutaneous coronary interventions in diabetic patients: an intracoronary Doppler ultrasound study with 2-year clinical follow-up.

Elevation of cardiac troponin I (cTnI) is a well-known complication after percutaneous coronary interventions (PCI). The aims of this study were to quantify the extent of coronary microembolization during elective PCI, to identify predisposing anatomical and procedural factors, and to evaluate its impact on long-term outcome in diabetic patients with a high cardiovascular risk. 48 patients (pts, median 66.7 years) with type 2 diabetes and coronary artery disease underwent elective PCI with stenting to treat single-vessel lesions. Real-time microembolization during PCI ("HITS") was detected by an intracoronary Doppler guide wire. Peak levels of cTnI were measured within 24 h after PCI. Pts were followed for 2 years to record major cardiac events (MACE: death, myocardial infarction, revascularization of target and non-target vessels). In 47 patients microemboli were detected during PCI. Nineteen patients showed pathologic cTnI elevation (0.13-28.9, median 0.39 µg/l). The amount of HITS correlated with cTnI levels (r = 0.43, p = 0.003), but not with other clinical or angiographic data. Within 2 years MACE were detected in 9 patients, who had significantly more microemboli (15.4 ± 11.8 vs. 28.2 ± 16.0 HITS; p = 0.009, OR 1.07; 95 % CI 1.011-1.13) during PCI. HITS >23, but not cTnI elevation, predicted later MACE (ROC analysis, p = 0.025). A high amount of microembolization during elective PCI in diabetic patients appears to be an indicator of greater atherosclerotic burden and accelerated coronary artery disease progression, associated with acute biomarker elevation and adverse long-term outcomes.

Impact of diabetes mellitus on quality of life in patients with congestive heart failure.

OBJECTIVES: Congestive heart failure (CHF) and diabetes mellitus (DM) are increasing in prevalence. There are conflicting data regarding the crosstalk of DM and CHF with respect to the prognostic impact for the patients. Health-related quality of life (Hr-QoL) has been reported to be useful for risk stratification. The purpose of this study was to investigate the impact of DM on Hr-QoL in a CHF population. METHODS: 325 consecutive patients with CHF were retrospectively analyzed (age 49 ± 12 years, 74.2% male, 18% had diabetes). After a median follow-up time of 7.4 years, we compared Hr-QoL of patients with and without DM. Hr-QoL was assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Kaplan-Meier curves were used to compare survival. RESULTS: The presence of DM reduced Hr-QoL in patients with CHF, indicated by a higher overall MLHFQ score (43.5 vs. 21, P = 0.013). Kaplan-Meier survival curves showed a significant survival difference (P = 0.024). Survival rates of both groups differed significantly after 3 (P = 0.031), 5 (P = 0.006), and 10 years (P = 0.047) favoring the group without DM. CONCLUSIONS: In patients with CHF, the coexistence of DM is associated with a reduced Hr-QoL and a particularly poor long-term survival. Our results indicate that CHF patients with DM are at increased risk.

Functional performance of 8 small surgical aortic valve bioprostheses: an in vitro study.

OBJECTIVES: Selection of a surgical aortic valve (SAV) bioprosthesis model for the treatment of aortic valve disease remains controversial. The aim of this study was to characterize the functional performance of 8 SAV models in a standardized in vitro setting. METHODS: The hydrodynamic performance of 8 SAVs with labelled size 21 mm (Avalus™, Hancock® II, Mosaic® Ultra™, Perimount®, Perimount® Magna Ease, Epic™ Supra, Trifecta™ GT; Freestyle®), was investigated in a pulse duplicator. Transvalvular pressure gradients and effective orifice area (EOA) were recorded. The geometrical orifice area and physical dimensions of the valves were determined, and new functional dimensions were introduced. RESULTS: Mean pressure gradient (MPG) and EOA differed significantly between the analysed SAVs. The Epic presented with the lowest EOA and highest MPG, while the Trifecta showed the highest EOA and the lowest MPG. We introduce a useful way to determine the minimal internal diameter and a new measure termed 'relative orifice area' to characterize a valve's performance. CONCLUSIONS: SAVs showed significant differences in their hydrodynamic performance despite the same label size. This finding was related to the construction of the valves. We introduce a new measure that characterizes the functional performance of a valve model and size for the treatment of an aortic annulus of a specific size. Our data emphasize that SAV selection should carefully be done using an individual patient approach and that future research is necessary to improve the current generation of SAVs.

Ex vivo evaluation of the Ozaki procedure in comparison with the native aortic valve and prosthetic valves.

OBJECTIVES: We investigated the hydrodynamic performance and cusp kinematics of the Ozaki neocuspidized aortic valve in comparison with the native aortic and prosthetic valves in an ex vivo study. METHODS: Native aortic valves of swine hearts were replaced by aortic valve substitutes, and their hydrodynamic performance (effective orifice area and mean pressure gradient) was evaluated in a mock circulation under defined conditions. The following aortic valve substitutes were investigated: native aortic valve, Ozaki valve, Perimount Magna Ease, Trifecta and St. Jude Medical Masters. All prosthetic valves had a labelled size of 21 mm. RESULTS: The Ozaki valve and native aortic valve showed a similar and significantly larger orifice area than all investigated prosthetic valves particularly at high flow rates. There was no significant difference between the Ozaki valve and the native aortic valve. The native aortic valve and Ozaki valve showed a similar increase in orifice area with increasing flow through the valve while prosthetic valves showed a markedly weaker increase. Similarly, the native and Ozaki valve showed a similar increase in mPG with forward flow which was weaker than prosthetic valves. Cusp kinematics were similar between the native and Ozaki valve, whilst prosthetic valves were clearly distinguishable from them. CONCLUSIONS: The Ozaki procedure showed excellent hydrodynamic performance compared to prosthetic valves and showed similar cusp motion characteristics to the native aortic valve. Our results suggest that the Ozaki neocuspidized valve behaves physiologically in many aspects, which may contribute to beneficial clinical outcomes.

Impact of different valve-in-valve positions on the hydrodynamic performance of the newest-generation self-expanding transcatheter heart valve.

OBJECTIVES: Transcatheter aortic valve-in-valve (ViV) procedures are increasingly performed for the treatment of degenerated surgical aortic valves with a high risk for a redo operation. For an optimal functional result, precise positioning of the transcatheter heart valve (THV) inside the SHV is crucial. The aim of this study was to systematically investigate the impact of implantation depth on the functional result after a ViV procedure in a standardized in vitro setting. METHODS: A THV 23 mm (Evolut PRO) and 3 SHV 21 mm (Perimount Magna Ease, Trifecta and Hancock II) were used for hydrodynamic testing with a constant heartbeat 64/min and a range of 55-105 ml of stroke volume in 5 different positions of the THV. The following parameters were analysed: mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area, minimal internal diameter and pin-wheeling index. RESULTS: MPG and EOA differed significantly regarding the position of the THV in the same SHV. The highest EOA and the lowest MPG were recorded for Evolut PRO with significance for both parameters in Hancock II at 4 vs 5 mm (P < 0.001), in Magna Ease at 2 mm (vs 3 mm and vs 6 mm, P < 0.001) and in Trifecta at 4 mm (vs 5 and 6 mm, P < 0.001). Leaflet coadaptation, minimal internal diameter and maximal geometric orifice area of the same TAV differ regarding the position of the TAV. CONCLUSIONS: The optimal position for hydrodynamic performance of the THV as ViV differs among specific SHV models. The findings may be useful for planning a ViV procedure using the Evolut PRO THV.

The figure-of-8 aortic valve suturing technique optimizes the effective orifice area of a small aortic annulus-an ex vivo study.

OBJECTIVES: Surgical aortic valve replacement (SAVR) in small annuli carries an elevated risk for the patient-prosthesis mismatch. In this study, we systematically investigated the influence of different implantation techniques including annular enlargement (AE) on the functional result after SAVR in small annuli using a standardized ex vivo model. METHODS: SAVR using the PERIMOUNT Magna Ease® (PME) 21 mm was performed in small porcine aortic roots using 4 implantation techniques: non-everting pledgeted (NE) suture, single interrupted (SI) suture, continuous suture (CS), figure-of-8 (F8) suture, as well as the PME 23 mm after AE using the Nunez method and the NE suture technique (PME23 AE). The effective orifice area (EOA), mean pressure gradient and leakage volume were evaluated using a mock circulation loop in accordance with ISO regulations. RESULTS: Experiments were conducted on 31 porcine aortic roots. PME21 using F8 and PME23 after AE achieved a significantly larger EOA than using NE. PME23 after AE showed a larger EOA than the PME21 using any suture technique, except the F8 [for stroke volume of 74 ml: PME21 NE: 1.68 (1.63-1.72) cm2, PME21 SI: 1.76 (1.68-1.81) cm2 (P = 0.17), PME21 CS: 1.76 (1.65-1.79) cm2 (P = 0.14), PME21 F8: 1.81 (1.70-1.85) cm2 (P = 0.005); PME23 AE: 1.83 (1.73-1.92) cm2 (P < 0.001)]. SI and CS did not result in larger EOA compared with the NE technique. PME21 using SI had a significantly larger leakage volume than using NE and there was no significant difference between other techniques [for stroke volume of 74 ml: PME21 NE: 3.51 (1.85-4.53) ml/stroke, PME21 SI: 6.00 (4.02-7.06) ml/stroke (P < 0.001), PME21 CS: 4.04 (3.60-4.49) ml/stroke (P = 0.10), PME21 F8: 3.16 (1.99-3.62) ml/stroke (P = 0.74), PME23 NE: 2.89 (2.45-4.72) ml/stroke (P = 0.51)]. CONCLUSIONS: The F8 technique with the PME21 achieved a similar EOA as the 1 size larger PME23 using NE after AE. These results suggest that the F8 technique may be an effective surgical modification to improve the haemodynamic result in a small annulus without additional AE.

Surgical aortic valve replacement in patients aged 50-69 years-insights from the German Aortic Valve Registry (GARY).

OBJECTIVES: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement. METHODS: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention. RESULTS: In total.3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up. CONCLUSIONS: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients.