Objectives: The Ross procedure is an attractive method for treating young patients with aortic valve disease, but the optimal surgical technique is still under discussion. This study aimed to evaluate the full-root and graft-inclusion Ross techniques in terms of their hydrodynamic performance ex vivo in a simulated circulation model. Methods: A total of 20 porcine autografts were created using either the full-root (n = 10) or graft-inclusion (n = 10) Ross technique. Hydrodynamic performance, including valvular opening morphology, transvalvular gradients, orifice area, and regurgitation volumes, were assessed under different resting and exercise conditions in an ex vivo mock-up circulation model. Results: Full-root porcine autografts exhibited significantly lower transvalvular pressure gradients and greater orifice areas compared with graft-inclusion autografts (mean pressure gradient: full root 3.6 vs graft inclusion 5.0 mm Hg, P = .007; effective orifice area full root 2.4 vs graft inclusion 2.0 cm2, P = .007). Valvular leakage was comparable between the 2 techniques, but graft inclusion showed a significantly lower valvular closing volume compared with the full-root Ross technique (full root: 7.9 vs graft inclusion: 4.8 mL, P = .002). The differences described were significant under all resting and exercise conditions examined. Conclusions: The full-root technique appears to be advantageous from a hydrodynamic perspective. It revealed lower gradients and greater orifice areas, and the surgical procedure is less complex to perform. However, larger closure volumes may be the reason for dilatation of the neo-aortic root. Therefore, further research on the prevention of neo-aortic root dilatation, focusing on the examination of the closing volume, is needed.
BACKGROUND:Degeneration is an inevitable outcome for bioprosthetic heart valves. In the setting of transcatheter aortic valve (TAV) replacement (TAVR), calcifications and leaflet thickening have implications for feasibility and outcomes of repeat interventions, including leaflet modification techniques. In this study, we aimed to investigate the frequency and pattern of leaflet calcification and thickening in explanted TAVs to inform repeat interventions. METHODS:TAV explants were obtained from the Explanted THV registry and clinical institutions. Micro-computed tomography imaging and histology were used to evaluated TAV calcium volume, distribution, and leaflet thickening. RESULTS:Twenty TAV explants were analyzed: 11 self-expanding CoreValve/Evolut (Medtronic, Dublin, Ireland) TAVs, 8 balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) TAVs, and 1 mechanically-expandable Lotus (Boston Scientific, Marlborough, MA) TAV. Median patient age at explant was 73.0 (interquartile range [IQR], 63.0-81.0) years, with a median time to explant of 3 years and 3 months (IQR, 1 year and 10 months to 4 years and 10 months). Eleven TAVs (55%) had leaflet calcification (median, 77.9; IQR, 24.7-336.1) mm3, and 9 TAVs (45%) had no calcium according to micro-computed tomography. Calcified TAVs had an increased leaflet thickness compared with noncalcific samples (median, 1.02 [IQR, 0.81-1.59] mm vs 0.64 [IQR, 0.47-0.89 mm]; P = 0.006). Leaflet thickness had a positive correlation with implant duration. Calcium distribution was heterogenous within each individual leaflet but also among leaflets of an individual TAV. Calcium pattern appeared to differ between TAV models. CONCLUSIONS:Calcified TAVs tend to have thicker leaflets and calcium distribution appears to vary according to TAV type. These findings might have important clinical implications when considering redo-TAV replacement and leaflet modification techniques.
Objective: Self-expanding (SE) transcatheter aortic prostheses (THV) have been associated with an increased risk of new permanent pacemaker implantation (PPMI), particularly with deeper implantations in the left ventricular outflow tract (LVOT) that result in more atrioventricular conduction system damage, leading to higher rates of post-procedural conduction disturbances (CDs) and subsequently more PPMIs. The cusp-overlap technique (COT) is designed to provide better visualisation of the LVOT during implantation, aiming to achieve a shallower implantation depth (ID) and potentially reduce both post-procedural CDs and PPMIs. This study seeks to compare the traditional three-cusp coplanar view technique (3CT) with the newer COT in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: From March 2018 to April 2020, a total of 586 patients underwent TAVR at the university clinic in Kiel. Among them, 226 patients who received SE prostheses were included in the study. After applying exclusion criteria, a final cohort of 203 patients was analysed. Of these, 106 patients underwent TAVR using the COT, while 97 patients underwent TAVR using the 3CT. The primary endpoints of the study were the occurrence of new CD and PPMI within 30 days post-procedure. Secondary endpoints included various post-TAVR events as defined by the Valve Academic Research Consortium 3 (VARC-3) safety criteria. A specific focus was placed on assessing the risk of high valve implantation according to VARC-3 criteria, specifically paravalvular insufficiency, valve embolisation, and coronary occlusion. Statistical analysis was conducted to compare outcomes between the COT and 3CT groups. Results: Implantation depths were significantly lower in the COT group compared to the 3CT group, with ID values from the NCC and LCC being 2.7 mm (±1.5) and 2.8 mm (±1.5) for the COT, and 5.4 mm (±3) and 6.6 mm (±2.6) for the 3CT (p < 0.001 for both). The incidence of high-grade CD, particularly Atrioventricular Block (AVB) II and III, was significantly higher in the 3CT group (26.8%) compared to the COT group (13.2%) (p = 0.023). The overall 30-day PPMI rate was 18.2% (n = 37), with a significant difference between the COT and 3CT groups (12.2% vs. 24.7%, p = 0.021). The primary indication for PPMI was permanent high-grade AVB occurring during or after TAVR, accounting for 95% of cases. No cases of TAVR embolisation, acute coronary occlusion or related syndromes were observed within the first 30 days post-procedure. There were no significant differences in 30-day mortality or post-procedural paravalvular insufficiency between the groups. In multivariable logistic regression analysis, the COT remained independently associated with lower odds of new post-procedural CD after adjustment for prior right bundle branch block (RBBB), prior first-degree AVB, predilatation, valve size and coronary artery disease (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.24-0.82, p = 0.009). For 30-day PPMI, the cusp-overlap technique demonstrated a borderline association with lower adjusted odds (OR 0.46, 95% CI 0.20-1.02, p = 0.057), while prior RBBB was independently associated with increased PPMI risk (OR 3.54, 95% CI 1.22-10.28, p = 0.020). Conclusions: The COT was associated with shallower implantation depth and lower rates of new post-procedural CD after multivariable adjustment. The association with reduced 30-day PPMI remained directionally consistent but was borderline after adjustment. These findings support the potential value of COT as a procedural strategy to reduce conduction-related complications after TAVR with self-expanding prostheses.
Bioresorbable stents (BRS) have been explored in cardiovascular intervention to provide temporary mechanical support while reducing long-term foreign material. The coronary experience has shown both the potential and the limitations of this strategy. First-generation polymeric stents demonstrated feasibility but were limited by thick struts, insufficient radial strength, delayed healing, and increased scaffold thrombosis. In contrast, metallic bioresorbable platforms improved mechanical performance, but each material system still faces trade-offs between strength, degradation rate, and biological response. Transcatheter pulmonary valve replacement (TPVR) may represent a clinically meaningful setting for renewed BRS development. Patients with congenital heart disease often require repeated pulmonary valve interventions over a lifetime, and permanent metallic frames may increase cumulative implant burden and complicate future treatment. However, TPVR imposes distinct requirements, including large-diameter expansion, stable anchoring, fatigue resistance, controlled degradation, and leaflet-frame integration. This review summarizes the lessons learned from coronary BRS, discusses material considerations for TPVR-oriented stent design, and evaluates current preclinical evidence for bioresorbable and regenerative pulmonary valve platforms. Particular attention is given to magnesium-zinc alloys as a tunable material strategy for future bioresorbable TPVR frames. Although direct evidence for fully bioresorbable metallic TPVR devices remains limited, this approach provides a rational framework for next-generation pulmonary valve intervention.
A tissue-engineered heart valve is a fully functional tissue facilitated through the cultivation of autologous cells on appropriate scaffolds. Scaffold’s surface charge and wettability are the main factors that significantly affect cell adhesion, which is known to be favourable on hydrophilic surfaces. Moreover, biocompatible scaffolds that induce minimal immunogenic response are also essential for successful tissue engineering (TE). However, commonly used biocompatible polymers with preferable bulk properties lack desirable surface properties. For example, poly-ε-caprolactone (PCL), which is widely used as a scaffold in TE, is known for its satisfying structural and mechanical properties, but due to its surface characteristics, cell attachment and, consequently, cell growth on this polymer are limited. In this study, we investigated the possible effect of H2-N2 plasma treatment on the surface wettability of electrospun PCL nanofibres to see the feasibility of improvement in cell adhesion and proliferation. Our results showed an increase in the hydrophilicity of the 650 nm PCL specimens after plasma treatment, which was followed by a significant enhancement in cell attachment without altering PCL mechanical properties. Plasma surface modification is a promising approach that can be used to improve hiMSCs growth without altering the desired bulk properties and fibre morphology of 650 nm PCL specimens.
Severe tricuspid regurgitation (TR) is a prevalent and challenging condition associated with poor survival outcomes and significant morbidity. Medical therapy alone often fails to provide adequate symptom relief, and stand-alone surgical intervention is linked to high mortality rates, making it a less favorable option unless combined with left-sided valve surgery. The advent of transcatheter tricuspid interventions has provided new therapeutic possibilities, particularly for high-risk patients who are ineligible for conventional surgery. However, many patients are still unsuited for transcatheter tricuspid repair or have only limited benefits from such procedures. In this context, Transcatheter tricuspid valve replacement (TTVR) has rapidly emerged as a promising alternative, offering the potential for more effective treatment outcomes. This review explores the latest advancements in TTVR devices, highlights key clinical findings, and discusses the challenges and limitations of this evolving strategy. Additionally, we address patient selection criteria, procedural outcomes, and future directions in the field, emphasizing the potential of TTVR to transform the management of severe TR.
The aim of this study was to systematically compare standard detergents for the generation of Decellularization Vascular Grafts (DVG) in terms of their influence on vascular key characteristics. The most common enzymatic and chemical detergents for decellularization were identified from literature, standardized and included: i) Trypsin, ii) Sodium Dodecyl Sulfate (SDS)- and iii) Triton X-100. All protocols were applied to porcine vessels and the manufactured DVG were analyzed for histological, ultrastructural morphology and biomechanical characteristics. Further, DVG were seeded with Human Umbilical Vein Endothelial Cells (HUVEC) and cultured in a bioreactor to investigate biocompatibility after decellularization. Anti-Coagulation properties were assessed by the Chandler Loop model and a platelet-activation-assay. The Trypsin and SDS treatment were the most effective protocols in terms of tissue clearance but both impaired the ultrastructural integrity of the vessel wall in contrast to the Triton X-100 treatment. Moreover, biomechanical characteristics in the test stand did not differ significantly across the applied protocols but treatment of DVG with Trypsin was associated with a reduced Young's modulus and injuries in the vessel wall in a pulsatil flow model after 30 d. Moreover, coagulation was decreased in the Trypsin-treated group and was slightly increased in the SDS group but no significant difference towards the control group was noted. DVG after Triton X-100 treatment were the only ones capable for successful cell seeding. The here presented experimental data emphasized the main advantages and disadvantages of the most common enzymatic and chemical detergents for the manufacturing of DVG.
Severe tricuspid regurgitation (TR) is a prevalent and challenging condition associated with poor survival outcomes and significant morbidtiy. Medical therapy alone often fails to provide adequate symptom relief, and standalone surgical intervention is liked to high mortality rates, making it a less favorable option unless combined with left-sided valve surgery. The advent of transcatheter tricuspid interventions has provided new therapeutic possi-bilities, particularly for high-risk patients who are ineligible for conventional surgery. However, many patients remain unsuitable for transcatheter tricuspid repair, or achieve only limited benefits from such procedures. In this context, Transcatheter tricuspid valve replacement (TTVR) has rapidly emerged as a promising alternative, offering the po-tential for more effective treatment outcomes. This review explores the latest advance-ments in TTVR devices, highlights key clinical experiences, and discusses the chal-lenges and limitations of this evolving strategy. Additionally, we address patient selec-tion criteria, procedural outcomes, and future directions in the field, emphasizing the potential of TTVR to transform the management of severe TR.
Transcatheter aortic valve implantation (TAVI) is the gold standard therapy for high-risk patients with severe, symptomatic aortic valve stenosis, particularly in patients with impaired left ventricular systolic function or those with previous cardiac surgery. However, TAVI with non-dedicated devices in patients with native severe AR is challenging. Patients frequently have a bicuspid aortic valve, large dimensions of the aortic annulus, and a low aortic valve calcification load. These features increase the risk of significant paravalvular regurgitation and prosthesis migration. We present two cases of severe aortic valve regurgitation due to cusp migration of previously implanted surgical aortic valves and flail cusps. After discussion with the Heart team based on the patient's clinical profile and the high risk of surgical repair, self-expandable-TAVI was performed using the Navitor trans-catheter heart valve in the first case and the Accurate Neo 2 in the second case. During TAVI and before valve release, acute LM coronary artery occlusion was noted. Successful further TAVI implantation and PCI was a lifesaving strategy. The 3-month follow-up was uneventful. Transcatheter valve implantation expands its indications for more complex anatomy, off-label use in severe aortic regurgitation and patient's comorbidity. In the case of flail cusp during TAVI, LM coronary artery obstruction must be considered an expected complication, and LM protection maneuvers should be considered in difficult anatomies.
Abstract Background The prevalence of advanced heart failure (HF) is increasing and prognosis remains poor. Although heart transplantation is still considered to be the gold standard for the treatment of advanced HF in selected patients, its use is limited by organ donor shortage and a growing burden of cormorbidities among potential recipients. The 2021 European Society of Cardiology (ESC) guidelines recommend consideration of long-term mechanical circulatory support with a left ventricular assist device (LVAD) in eligible patients with advanced heart failure (HF) who are refractory to medical/device therapy. Purpose The purpose of this study was to evaluate the national trends of LVAD in Germany. The main hypothesis was that LVAD therapy is still underutilized. Methods From the national database of the German Federal Statistical Office (DESTATIS), we identified all patients who underwent LVAD implantation in Germany between January 2011 and December 2022 (n = 9,232). We compared temporal trends and in-hospital outcomes. Results From 2011 to 2022, number of LVAD implantation was highest in the year 2017 (n = 914) and steadily decreased over the following years (2022: n = 617). Mean age of LVAD recipients was 56.2 years (2011-2015) and increased to 58.4 years (2020-2022). The majority of LVAD recipients are male (84,8 %), and this trend has been stable during the entire time period. In-hospital mortality after LVAD remains high, but has been decreasing (25.8% during 2011-2015 compared to 20.2% during 2020-2022). Conclusion Although LVAD is recommended in eligible patients with advanced HF, our study suggests an underutilization of LVAD in this patient population and especially in female patients.
ObjectivesTo investigate the change in severity of mitral regurgitation (MR) after transcatheter aortic valve replacement (TAVR) and its effect on 5-year mortality.BackgroundThere is inconsistency in literature on pre-existing MR influencing long-term survival in patients who undergo TAVR.MethodsPatients who underwent TAVR at the University Hospital Schleswig-Holstein (USKH) Campus Kiel between March 2009 and February 2018 have been enrolled. Echocardiography determined the degree of MR before and within 7 days after TAVR. Patients were divided into two groups according to their MR at baseline: MR-grade ≤ 2 (non-relevant MR, nr-MR) and baseline MR-grade > 2 (relevant MR, r-MR). Primary endpoint was a composite of MR baseline influence on mortality and MR reduction and its’ impact on mortality.ResultsA total of 820 patients (642 nr-MR and 178 in r-MR) were included in this study. Of these, 167 patients showed an improvement in MR-grade. Thereof 106 (63.5 %) referred to r-MR with a significant decrease in mean MR-grade (p < 0.01). Systolic pulmonary artery pressure (sPAP) (p < 0.01) and NT-proBNP (p = 0.03) decreased in patients who had an improvement. There was no significant difference in 5-year mortality for MR at baseline (p = 0.35) or reduction in mortality for r-MR patients with an MR improvement compared to patients with worsening or equal MR status (p = 0.80).ConclusionIn patients undergoing TAVR, 63.5 % of patients with MR-grade ≥ 2 at baseline showed an improvement of grade of MR after TAVR with reduction of their sPAP and NT-proBNP values but there was no significant difference in mortality.
Background Composite T- grafts between left internal mammary artery ( LIMA) and radial artery (RA) are a common concept in complete arterial myocardial revascularization. The aim of the present study was to investigate whether the use of the great saphenous vein (SV) instead of RA leads to comparably good results in terms of outcome in this context. Methods Patients who underwent myocardial revascularization with a T-graft using RA or a segment of SV to the right coronary artery or circumflex artery between the beginning of 2014 and the end of 2019 at the Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel were included. To minimize surgical variation, only patients were observed by a single senior surgeon in the department. Exclusion criteria were previous cardiac surgery, preoperative extracorporeal circulatory support, off-pump surgery, additional aortocoronary bypasses, and cardiac combination procedures. Results A total of 115 patients were studied. In 55 patients, the T- graft was placed between the LIMA and SV, and in 60 patients, the T-graft was placed between the LIMA and RA. Patients in the SV group were older (70.6 +/- 7.8 vs. 58.5 +/- 10.0 years; p< 0.001), suffered more frequently from non-ST elevation myocardial infarction ( 12.7 vs. 1.7%; p <1/4> 0.027), arterial hypertension (83.6 vs. 61.7%; p 1/4 0.009), and atrial fibrillation (18.2 vs. 1.7%; p 1/4 0.003). They were less likely to be active smokers (16.4 vs. 38.3%; p 1/4 0.009) and less likely to have a history of variceal surgery (0 vs. 15.0%; p 1/4 0.003). Calcification of the ascending aorta was also found more frequently in the saphenous group (18.2 vs. 3.3%, p 1/4 0.009). Operative times and number of distal anastomoses did not differ significantly between the two groups. Postoperative deliriums ( 16.7 vs. 5.0%; p 1/4 0.043) were observed more frequently in venous patients. Wound healing disorders of the leg (11.1 vs. 0%; p 1/4 0.011) did only occur in SV group and wound infections of the arm only in the RA group. Complete follow-up was achieved in 74.8% of cases. Median follow-up was 60.3 (39.6; 73.2) months. Serious adverse cardiac- cerebral events (19.0 vs. 22.7%; p 1/4 0.675) and mortality (14.5 vs. 6.7%; p 1/4 0.167) did not differ significantly between the groups at follow-up. Myocardial infarction (0 vs. 2.5%; p 1/4 1.000) and stroke (0 vs. 7.5%; p 1/4 0.245) were observed exclusively in RA group. Percutaneous coronary intervention was required in single patients of RA group (0 vs. 15.0%; p 1/4 0.028). No patient from either group underwent repeat coronary artery bypass grafting (CABG). The patients of SV group had angiographically competent grafts and open anastomoses. Graft failure was noted in a single patient in RA group, in which case both grafts and native coronary vessels were stented. Kaplan-Meier analysis revealed no significant survival disadvantage for SV group compared with RA group. Conclusion CABG with a composite T- graft between LIMA and a segment of SV may be comparable to bypass surgery with a composite T-graft between LIMA and RA. This might be true in terms of morbidity and mortality over an intermediate-term observation period. The results of our studies give rise to the hypothesis that the decision not to perform aortic bypass anastomosis may be more important than the choice of graft material.
BACKGROUND:The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. OBJECTIVES:The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. METHODS:TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. RESULTS:A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). CONCLUSIONS:TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification.
One of the most important medical interventions for individuals with heart valvular disease is heart valve replacement, which is not without substantial challenges, particularly for pediatric patients. Due to their biological properties and biocompatibility, natural tissue-originated scaffolds derived from human or animal sources are one type of scaffold that is widely used in tissue engineering. However, they are known for their high potential for immunogenicity. Being free of cells and genetic material, decellularized xenografts, consequently, have low immunogenicity and, thus, are expected to be tolerated by the recipient's immune system. The scaffold ultrastructure and ECM composition can be affected by cell removal agents. Therefore, applying an appropriate method that preserves intact the structure of the ECM plays a critical role in the final result. So far, there has not been an effective decellularization technique that preserves the integrity of the heart valve's ultrastructure while securing the least amount of genetic material left. This study demonstrates a new protocol with untraceable cells and residual DNA, thereby maximally reducing any chance of immunogenicity. The mechanical and biochemical properties of the ECM resemble those of native heart valves. Results from this study strongly indicate that different critical factors, such as ionic detergent omission, the substitution of Triton X-100 with Tergitol, and using a lower concentration of trypsin and a higher concentration of DNase and RNase, play a significant role in maintaining intact the ultrastructure and function of the ECM.
Background: TAVI indications expand not only to low-risk patients but also to patients with a more complex anatomy and comorbidities. Transfemoral retrograde access is recognized as the first preferred approach according to the current guidelines. However, this approach is not suitable in up to 10–15% of patients, for whom an alternative non-femoral access route is required. Case Presentation: An 83-year-old male patient with known aortic isthmus stenosis presented with severe symptomatic aortic stenosis. Computed tomography revealed a subtotal isthmus stenosis, directly after left subclavian artery origin, with many collaterals extending toward the axillary and subclavian arteries. Duplex ultrasound verified the proximal diameter of the left brachial artery to be 5.5 mm. A successful surgical cutdown trans-brachial TAVI with an Evolut prosthetic valve with a size of 29 mm was performed. On the fourth postoperative day, the patient was discharged, and the three-month follow-up was uneventful. Conclusion: In patients with aortic isthmus stenosis, the brachial artery could be a feasible alternative, as a less invasive access site, which can be determined after careful assessment of the vessel diameter. More data are required to evaluate the safety and efficacy of this access route and to achieve more technical improvements to increase operator familiarity with it.