Treatment Of Aortic Valve Stenosis Research Articles

Health-related quality of life after minimal-invasive treatment of aortic valve stenosis in the elderly.

Although transfemoral transcatheter aortic valve implantation (TF-TAVI) offers superior early outcome over open surgical aortic valve replacement (SAVR) in the elderly, a comparison of TF-TAVI with surgery performed through partial upper mini sternotomy (PUMS) hasn't yet been validated. The aim of the present study is to evaluate the clinical outcome and quality of life of patients subjected to TF-TAVI and open surgical aortic valve replacement through partial upper mini sternotomy (PUMS-SAVR). Baseline, procedural and post-treatment data of 197 consecutive patients: 137 TF-TAVI and 60 PUMS-SAVR treated at Philipps University of Marburg, were retrospectively collected. The propensity score method was used to create two groups in a 1:1 fashion. Questionnaire assessment (SF36_LQ) of quality of life of the matched patients was carried out at the ambulant routine control presentation. A competing risk regression model is used to evaluate the impact of the clinical outcome on health-related quality of life (HrQoL). After propensity matching, TF-TAVI remained associated with lower procedural time (136±50 vs. 298±36 min, P<0.01), intensive care unit stay (2.68±2.70 vs. 4.29±2.43 days, P<0.01), transfusion of packed red cell units (0.46±2.05 vs. 1.60±2.00 U, P=0.02) and higher heart block (42.86% vs. 0%, P<0.01) and permanent pacemaker implantation rates (14.29% vs. 0%, P=0.05) compared to PUMS-SAVR. TF-TAVI is associated with less complains, superior HrQoL (excellent 40% and very good 60% vs. very good 100% in PUMS). Partial sternotomy is the main predictor of the inferior HrQoL, with the regression coefficient of -1.11 (95% confidential interval, -1.503 to -0.726; R2=0.324, P<0.0001). Transfusion (P=0.26), paravalvular leakage (0.618), pacemaker implantation (P=0.19) and delirium (P=0.92) did not influence HrQoL after the minimal-invasive treatment of aortic valve stenosis in elderly patients. Although PUMS-SAVR offers better technical outcomes with less permanent pacemaker implantation and less paravalvular leakage than TF-TAVI, it is still associated with more need for transfusion, longer ventilation-and intensive care unit-times, and prolonged hospital stay. In the elderly, PUMS-SAVR achieves inferior quality of life compared to TF-TAVI. Partial sternotomy reveals as the strongest risk factor of perceived health-level post-treatment. It remains to be revealed whether fast-track open heart surgery that maintains a fully intact sternum and allows immediate postoperative extubation-as performed through video-assisted mini-thoracotomy or thoracoscopic robotic procedures with percutaneous cannulation - should be favored against PUMS-SAVR.

Cerebral Embolic Protection Devices for Transcatheter Aortic Valve Replacement: Review of the Literature and Future Perspectives.

Transcatheter aortic valve replacement (TAVR) has been a revolutionary therapy in the treatment of aortic valve stenosis. The risk of stroke associated with TAVR has decreased significantly since its introduction; however, it remains a devastating complication when it does occur. Many of the strokes associated with TAVR occur peri-procedurally and are thought to be due to embolic debris entering the cerebrovascular circulation. A number of different cerebral embolic protection devices (CEPD) have been developed and are in various stages of testing and use. The results from clinical trials evaluating the role for CEPD to reduce the risk of stroke have been mixed. As a result, their uptake has been very heterogeneous. This review provides a summary of the diverse CEPD devices available for use and outlines the clinical evidence available to date.

Update on the treatment of aortic valve stenosis in symptomatic and asymptomatic patients

Aortic valve stenosis is one of the most frequent valvular heart diseases requiring treatment in industrialized countries. The symptom onset is associated with asignificantly increased mortality, so that there is aclear indication for treatment in patients with severe, symptomatic aortic valve stenosis; however, data on the optimal treatment of patients with asymptomatic aortic valve stenosis are scarce. Smaller studies in the field of cardiac surgery suggest that early surgical valve replacement is superior to aconservative approach. For this reason, the results of additional adequately powered randomized trials are awaited with great interest. In this year numerous long-term results from randomized comparisons of the two available treatment options (surgical versus transcatheter aortic valve replacement) were published, which will further guide the heart team to find the best treatment approach for each individual.

Balloon-expandable transcatheter heart valves for treatment of aortic valve stenosis in patients with large aortic annuli: Evaluation of deployment balloon overfilling strategies.

Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.

Surgical vs. transcatheter aortic valve replacement in patients over 75 years with aortic stenosis: sociodemographic profile, clinical characteristics, quality of life and functionality.

Aortic valve stenosis (AVS) affects 25% of the population over 65 years. At present, there is no curative medical treatment for AVS and therefore the surgical approach, consisting of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), is the treatment of choice. The aim of this study was to analyze the sociodemographic and clinical characteristics, quality of life and functionality of a sample of patients with AVS over 75 years of age, who underwent TAVR or SAVR, applying standard clinical practice. A prospective multicenter observational study was conducted in two hospitals of the Spanish National Health System. Data were collected at baseline, 1, 6 months and 1 year. In total, 227 participants were included, with a mean age of 80.6 [SD 4.1]. Statistically significant differences were found in terms of quality of life, which was higher at 1 year in patients who underwent SAVR. In terms of functionality, SAVR patients obtained a better score (p < 0.01). However, patients who underwent TAVR began with a worse baseline situation and managed to increase their quality of life and functionality after 1 year of follow-up. The individualized choice of TAVR or SAVR in patients with AVS improves patients' quality of life and function. Moreover, the TAVR procedure in patients with a worse baseline situation and a high surgical risk achieved a similar increase in quality of life and functionality compared to patients undergoing SAVR with a better baseline situation.

Transcatheter Aortic Valve Implantation by Intercostal Access: Initial Experience with a No-Touch Technique.

Transcatheter aortic valve implantation (TAVI) is now a well-established therapeutic option in an elderly high-risk patient cohort with aortic valve disease. Although most commonly performed via a transfemoral route, alternative approaches for TAVI are constantly being improved. Instead of the classical mini-sternotomy, it is possible to achieve a transaortic access via a right anterior mini-thoracotomy in the second intercostal space. We describe our experience with this sternum- and rib-sparing technique in comparison to the classical transaortic approach. Our retrospective study includes 173 patients who were treated in our institution between January 2017 and April 2020 with transaortic TAVI via either upper mini-sternotomy or intercostal thoracotomy. The primary endpoint was 30-day mortality, and secondary endpoints were defined as major postoperative complications that included admission to the intensive care unit and overall hospital stay, according to the Valve Academic Research Consortium 3. Eighty-two patients were treated with TAo-TAVI by upper mini-sternotomy, while 91 patients received the intercostal approach. Both groups were comparable in age (mean age: 82 years) and in the proportion of female patients. The intercostal group had a higher rate of peripheral artery disease (41% vs. 22%, p = 0.008) and coronary artery disease (71% vs. 40%, p < 0.001) with a history of percutaneous coronary intervention or coronary artery bypass grafting, resulting in significantly higher preinterventional risk evaluation (EuroScore II 8% in the intercostal vs. 4% in the TAo group, p = 0.005). Successful device implantation and a reduction of the transvalvular gradient were achieved in all cases with a significantly lower rate of trace to mild paravalvular leakage in the intercostal group (12% vs. 33%, p < 0.001). The intercostal group required significantly fewer blood transfusions (0 vs. 2 units, p = 0.001) and tended to require less reoperation (7% vs. 15%, p = 0.084). Hospital stays (9 vs. 12 d, p = 0.011) were also shorter in the intercostal group. Short- and long-term survival in the follow-up showed comparable results between the two approaches (30-day, 6-month- and 2-year mortality: 7%, 23% and 36% in the intercostal vs. 9%, 26% and 33% in the TAo group) with acute kidney injury (AKI) and reintubation being independent risk factors for mortality. Transaortic TAVI via an intercostal access offers a safe and effective treatment of aortic valve stenosis.

The sutureless aortic valve: a story of continuing improvements.

In light of all evolutions in transcatheter treatment of aortic valve stenosis, also the world of surgical aortic valve replacement (AVR) has to keep evolving, with improvements in outcome for the patient as the most important objective. One of the possible ways to facilitate surgery and improve the overall result is to make the surgical procedure faster, easier and less invasive. Sutureless valve technology was introduced in surgical AVR to reach these goals [1]. The fact that we are able now to implant a tissue valve without any suture saves time and avoids unneeded manipulation in the aortic root. A quick implantation makes cross-clamp time, cardiopulmonary bypass time and overall procedure time significantly shorter. Some still argue whether this is relevant in a straightforward case of isolated valve replacement. But in many patients, like in more complex cases, more fragile patients, in minimal access surgery and in combined cases (CABG, multiple valves, etc.), taking off 20–30 min in cross-clamp and overall procedure time, can only be beneficial to the patient. It also opens doors to enhanced recovery and fast-track protocols. Next to the speed of implantation, the sutureless valve technology like Perceval also allows to position a valve with only minimal manipulation in the aorta. The absence of any need for stitching and knotting does not only provide an elegant bail-out scenario in complex cases but also—much more importantly—significantly facilitates minimal access surgery in single AVR. And still, the surgical field still needs a big push towards minimally invasive procedures for isolated AVR.

Engineering Lipid Spherulites for the Sustained Release of Highly Dosed Small Hydrophilic Compounds.

Currently, there is a lack of parenteral sustained release formulations for the delivery of highly dosed small hydrophilic drugs. Therefore, parenteral lipid spherulites are engineered capable of entrapping large amounts of such compounds and spontaneously releasing them in a sustained fashion. A library of spherulites is prepared with a simple green process, using phosphatidylcholine (PC) and/or phosphatidylethanolamine (PE), nonionic surfactants and water. The vesicle formulations exhibiting appropriate size distribution and morphology are selected and loaded with 4,6-di-O-(methoxy-diethyleneglycol)-myo-inositol-1,2,3,5-tetrakis(phosphate), ((OEG2 )2 -IP4), an inositol phosphate derivative currently under clinical evaluation for the treatment of aortic valve stenosis. The loading efficiency of spherulites is up to 12.5-fold higher than that of liposomes produced with the same materials. While the PC-containing vesicles showed high stability, the PE spherulites gradually lost their multilayer organization upon dilution, triggering the active pharmaceutical ingredient (API) release over time. In vitro experiments and pharmacokinetic studies in rats demonstrated the ability of PE spherulites to increase the systemic exposure of (OEG2 )2 -IP4 up to 3.1-fold after subcutaneous injection, and to completely release their payload within 3-4 d. In conclusion, PE spherulites represent a promising lipid platform for the extravascular parenteral administration of highly dosed small hydrophilic drugs.

Abstract 13862: Trends in Complication Rates Post-Transcatheter Aortic Valve Replacement

Introduction: Transcatheter Aortic Valve Replacement (TAVR) is a mainstay of treatment for aortic valve stenosis for patients. It is unclear if this has resulted in a significant change in post-procedural complications over time. Hypothesis: We hypothesised a reduction in major complication rates across our study period given the improvement in delivery systems. Methods: This is a nationwide temporal trends study utilizing the 2016-2019 National In Patient Sample (NIS) registry. Patients who underwent TAVR including those with major procedural complications (i.e: need for transfusion or permanent pacemaker implantation [PPMI]) were identified. The trends in overall complication rate and individual complication rates between 2016 to 2019 were analysed. Multivariate model was built to predict the factors influencing complications. Results: Between 2016-2019, 217,110 patients underwent TAVR of which 12.6% had atleast one major complication. Proportion of complications decreased significantly across the study period(see Fig 1). Overall, females had a 10% higher complication rate (aOR 1.1, p=0.002) mainly driven by bleeding with over a 50% need for transfusion (aOR 1.57, p&lt;0.001) while having a 12% lower risk of PPMI (aOR 0.88, p=0.001). The Northeast region had a significantly higher complication rate driven by higher bleeding, with PPMI rate not differing geographically. Charlson comorbidity index (CCI) score was predictive of higher bleeding with a score of &gt;3 having over a threefold risk (aOR 3.4, p&lt;0.001). Conclusions: Our study shows that although there is a reduction in complication rate post-TAVR, the changes are uneven across different complications and population groups. More than 10% of patients were still experiencing a complication as recently as 2019. This could be a reflection of moving towards lower risk population, recent improvements in valve profile and implantation technique and a better understanding of predictors of PPMI.

From an Unfolding Emergency Treatment to a Universal Shift in Therapy: The History and Evolution of the Catheter-Based Treatment of Aortic Valve Stenosis

Aortic valve stenosis (AVS) is the most frequent valvular heart disease in industrialized countries, presenting with very high mortality if left untreated. While drug treatment can sometimes alleviate symptoms, it fails to stop progression or cure the underlying disease. Until the first decade of this millennium, surgical aortic valve replacement (SAVR) remained the only available therapy option with a positive impact on mortality and morbidity. Even though several studies reported highly positive effects of SAVR regarding the improved quality of life and better physical performance, SAVR remained an intervention that, due to its remarkable complexity and the need for heart-lung machine and cardioplegia, was limited by the patients’ comorbid profile. While unsatisfying hemodynamic results after transcatheter aortic balloon valvuloplasty in high-risk surgical patients limited its adoption as an alternative treatment, it provided the impetus for further interventional approaches to the therapy of AVS. This review considers the invention and development of transcatheter aortic valve implantation (TAVI), which established itself as a catheter-based, minimally invasive procedure over the past decade, and has become an equivalent treatment method for high-risk surgical patients. For that matter, early TAVI concepts, their amendments, and the associated pioneers are recognized for paving the way to a revolutionary diversification in AVS treatment.

Rapid deployment bioprostesis for aortic valve stenosis: single center short and long-term outcomes

Abstract Background Despite recent advances, surgical aortic valve replacement (SAVR) remains the gold standard for most of the patients with aortic valve stenosis. The ageing population, with increased comorbidities and the rising of minimally invasive techniques, led to the development of new prosthetic devices of easier and faster implantation. Purpose This study aimed to analyse short and long-term outcomes of SAVR with rapid-deployment (RD) aortic bioprosthesis for isolated aortic valve stenosis Method Singe center, retrospective longitudinal cohort study of patients with isolated aortic valve stenosis who underwent elective aortic valve replacement using RD devices between 2014 and December 2021. Continuous variables are presented with median (IQR) and were analyzed using Mann-Whitney test. Categorical variables are presented in percentage or frequency and were analyzed using chi-square test. Kaplan-Meyer survival curve was constructed base on collected data from national registry. Results A RD device was implanted in 358 patients with a median age of 75,8 years and Euroscore II of 2,3. Median cross clamp and extracorporeal circulation time were 27,4 and 36,7 min, respectively. No significant paravalvular leaks. Intensive care unit (ICU) length of stay was 3 days with acute renal lesion (any stage-53,2%; Dialysis-2,5%), need for hemodynamic support (63,1%) and new onset atrial fibrillation (33,6%) being the most frequent post-operative complications. Stroke occurred in 0,6% of cases and mortality was 1,1%. Pacemaker implementation rate of 11%. The mean follow-up time was 6,7 years with 90% 5-years survival rate. Mean gradients of 11,2±4,8 mmHg at 6 months Conclusion Surgical treatment of aortic valve stenosis using RD devices is safe, with a low mortality rate. ICU length of stay and hospital length of stay are reduced. Follow-up shows an excellent long-term survival and hemodynamic performance. Funding Acknowledgement Type of funding sources: None.

Abstract P3059: Hydrogen Sulfide Inhibits Aortic Valve Fibrosis, Inflammation And Calcification By Inducing Pro-autophagy Effect In Human Valvular Interstitial Cells

Background: As of now, there is no pharmacological treatment for aortic valve stenosis (AS) except for valve replacement. In the previously studied proteomics analysis, we demonstrated that the expression of sulfide:quinone oxidoreductase (SQOR) was significantly lower in aortic valve interstitial cells (VICs) isolated from AS patients than those of normal patients. However, the role of SQOR in AS pathophysiology has not been clarified yet. Methods: To elucidate the cellular mechanism of SQOR and hydrogen sulfide (H2S) as therapeutic aspects in AS, we studied the effects of NaHS (H2S-releasing compound) on diseased aortic VICs using real-time PCR and western blots. Results: NaHS treatment led to increased SQOR expression in diseased aortic VICs and induced an increase of the Nrf2-target genes, especially NQO1. It showed that the effects of NaHS decreased not only fibrosis and inflammation markers (MMP9, TNF-α, IL6) but also calcification markers (ALP, osteocalcin, RUNX2, COL1A1). In addition, AMPK and Beclin-1 significantly increased by NaHS while Akt and mTOR decreased which is expected to have pro-autophagy effect. Conclusion: H2S releasing compound enhances the expression of SQOR and activates AMPK/mTOR mediated pro-autophagy function resulting in inhibition of fibrosis, inflammation and calcification in human VICs. Therefore, H2S can be a potential therapeutic target in AS.

Balloon aortic valvuloplasty in degenerative aortic stenosis

Balloon valvuloplasty of the aortic valve (BAV) in aortic stenosis has been practiced for over 35 years. The initial enthusiasm caused by the excellent immediate hemodynamic effect of the procedure disappears due to the rapid restenosis of the aortic valve after intervention. The results of modern methods for defi nitive treatment of aortic valve stenosis &amp;ndash; AVR and TAVI are excellent, thanks to which they are fi rmly rooted in treatment guidelines. However, BAV has its indications in symptomatic patients who are not suitable for defi nitive interventions. This publication discusses current indications for BAV, the main stages of the procedure, possible complications, and treatment outcomes.

Evolving Indications of Transcatheter Aortic Valve Replacement-Where Are We Now, and Where Are We Going.

Indications for transcatheter aortic valve replacement (TAVR) have steadily increased over the last decade since the first trials including inoperable or very high risk patients. Thus, TAVR is now the most common treatment of aortic valve stenosis in elderly patients (vs. surgical aortic valve replacement -SAVR-). In this review, we summarize the current indications of TAVR and explore future directions in which TAVR indications can expand.

Current-Era Outcomes of Balloon Aortic Valvotomy in Neonates and Infants

BackgroundThe optimal initial treatment pathway for aortic valve stenosis remains debated. ObjectivesThe objective of this study was to review current outcomes of balloon aortic valvotomy (BAV) in neonates and infants. MethodsNeonates and infants with a biventricular circulation treated with BAV between 2004 and 2019 were reviewed. ResultsOne hundred thirty-nine infants (48% neonates) with median (Q1, Q3) age of 33(7, 84) days and weight 4.0 (3.4, 5.1) kg were followed up for 7.1 (3.3, 11.0) years. BAV reduced peak-to-peak gradient from mean (SD) 52 (16) mmHg to 18 (12) mmHg; P < 0.001. Aortic regurgitation (AI) increased with time after BAV. Three children died during follow-up. Fifty-one reinterventions (26 BAV, 19 aortic valve replacements [AVRs], and 6 surgical valvotomies) were performed on 40 children. Freedom from AVR (95% CI) was 96% (93%-99%) at 1, 91% (86%-96%) at 5, and 86% (79%-93%) at 10 years. The predictors of AVR were a unicommissural valve (hazard ratio [HR] [95% CI]: 3.7 [1.4-9.6]; P = 0.007) and moderate to severe AI after index BAV (HR [95% CI]: 3.3 [1.1-9.7]; P = 0.029). Freedom from reintervention was 84% (78%-90%) at 1, 76% (69%-83%) at 5, and 69% (60-78%) at 10 years. Main predictors of reintervention were age below 1 month (HR [95% CI]: 2.1 [1.1-4.1]; P = 0.032) and postdilation peak-to-peak gradient (per 10-mmHg increase; HR [95% CI]: 1.36 [1.02-1.79]; P = 0.032). ConclusionsBAV is a safe and effective treatment for aortic valve stenosis in neonates and infants. Outcomes are competitive with contemporary published data on aortic valve repair in relation to mortality, gradient relief, long-term AVR, and reintervention rates. In the absence of significant AI, surgery can be reserved for those with gradients resistant to valve dilation.

An study on the influence of collagen fiber directions in TAVs performance using FEM

Transcatheter Aortic Valve Implantation (TAVI) or Replacement (TAVR) is a promising treatment for aortic valve stenosis, consisting of a procedure to replace a damaged native aortic valve by a bioprosthetic one. This replacement valve control the flow of blood using leaflets that are similar to the ones of a native aortic valve. Commonly manufactured using bovine or porcine pericardium, it is a tissue histologically composed of collagen fibers embedded into a nearly-isotropic matrix, where their distribution makes the pericardium behave as an anisotropic hyperelastic material. Because of such complicated behavior, bioprosthetic pericardium valves are, as expected, sensitive to the distribution and orientation of these fibers in such device.Therefore, the objective of this work is a thorough systematic study on the influence of these fibers’ distribution. First, a Finite Element model of a bioprosthetic valve is generated; then, a material routine to accurately describe the behavior of pericardium is implemented in a commercial software package; in addition, a dedicated algorithm to specify the direction of fibers is developed. Finally, a systematic study on the influence that fiber orientations have on the overall behavior of the TAV is performed.As a result of this study, two extreme behaviors are highlighted depending on the preferential orientation of collagen fibers; namely, one with fibers in circumferential direction and the opposite with fibers in an axial orientation. Then, it is concluded that the behavior of fibers in circumferential direction is very sensitive to small variations of the orientation angle, whereas such orientation is not as determining when the aim is to achieve a behavior near to the one corresponding with axial orientation.

Novel self-expanding ALLEGRA transcatheter aortic valve for native aortic stenosis and degenerated bioprosthesis.

To investigate the safety and efficacy of the ALLEGRA valve in routine use. The ALLEGRA aortic valve is a self-expanding transcatheter heart valve (THV) with bovine pericardial tissue and was CE approved in March 2017. Its unique design was developed to provide low prosthesis gradients. We analyzed patients receiving an ALLEGRA THV between May 2017 and March 2021 at our center for treatment of aortic valve stenosis or degenerated valve prosthesis. Hemodynamic results and clinical outcome according to the Valve Academic Research Consortium-2 consensus criteria were evaluated at discharge and three months post transcatheter aortic valve replacement (TAVR) procedure. 93 patients with a mean age of 82.5 ± 4.8 years and a median EuroScore II of 4.7 ± 3.4 were treated, 15 of them were valve-in-valve procedures. Implantation was successful in 97.8% (91/93) and VARC-2 defined device success was achieved in 94.6% (88/93). In-hospital all-cause mortality was 2.2% (2/93). Life-threatening bleeding, major vascular complications and strokes were 3.2% (3/93), 2.2% (2/93) and 3.2% (3/93), respectively. Paravalvular leakage was none to trace in 60.4%, mild in 38.5% and moderate in 1.1%. Permanent pacemaker implantation in pacemaker naive patients was necessary in 9.5% (8/84). Mean gradient at discharge was 8.2 ± 4.3 mmHg for all patients; 7.1 ± 2.6 mmHg in patients treated for stenosis of the native aortic valve and 13.8 ± 6.3 mmHg in patients treated valve-in-valve. The ALLEGRA THV provides excellent hemodynamic results and a good safety profile with a low complication rate.

Pushing the limits for interventional treatment of aortic valve stenosis.

As we approach 20years of clinical experience with transcatheter aortic valve replacement (TAVR), avast portfolio of high-quality clinical data has accumulated, confirming the safety and efficacy of TAVR across the entire spectrum of surgical risk. Although many aspects of this innovative therapy have been thoroughly studied, several challenges remain. As TAVR is expanding to include younger low-risk patients, with longer life expectancy, one major unsolved issue is represented by transcatheter heart valve (THV) durability, since robust THV durability data are currently limited to approximately 5-6years. Additionally, steric interactions between THV components and coronary ostia may render coronary access particularly difficult, and thus personalized decisions regarding THV type and implanting techniques are of paramount importance to secure future coronary access. Since bicuspid aortic valve (BAV) stenosis may be associated with unfavorable anatomic factors, it has represented an exclusion criterion in major randomized TAVR trials. Albeit promising data are available from multicenter registries, results of specifically designed randomized trials are eagerly needed to inform use of TAVR for BAV stenosis. Although valve-in-valve (ViV) TAVR has emerged as an effective treatment option for degenerated aortic bioprostheses, ViV procedures are associated with specific risks, which mandated the development of specific techniques aimed at reducing the occurrence of periprocedural adverse events. Despite the transfemoral approach represents the access of choice for TAVR, asignificant proportion of patients have significant peripheral artery disease and alternative vascular access routes have been increasingly evaluated with encouraging data regarding their safety and feasibility.

Clinical outcomes after implantation of a sutureless aortic bioprosthesis with concomitant mitral valve surgery: the SURE-AVR registry

BackgroundEarly treatment of aortic valve stenosis is recommended in eligible symptomatic patients with severe aortic valve stenosis who would otherwise have a poor prognosis. The sutureless aortic valve bioprosthesis offers an alternative to standard aortic valve replacement with a sutured valve, but limited data are available in patients who have undergone multiple valve procedures involving the new, sutureless technology. We sought to investigate outcomes in high operative risk patients with previous or concomitant valve surgery who were implanted with a sutureless valve.MethodsSURE-AVR is an ongoing, prospective, multinational registry of patients undergoing aortic valve replacement. In-hospital and post-discharge outcomes up to 5 years were collected.ResultsThe study population comprised 78 patients (mean ± SD: age 73.6 ± 7.6 years, logistic EuroSCORE 18.0 ± 17.5) enrolled at 13 sites who presented for concomitant or previous mitral valve repair (n = 45) or replacement (n = 33), with or without additional concomitant procedures, and were implanted with a sutureless valve. Mean ± SD overall aortic cross-clamp time was 109 ± 41 min and cardiopulmonary bypass time was 152 ± 49 min. Mean ± SD aortic pressure gradients decreased from 37.6 ± 17.7 mmHg preoperatively to 13.0 ± 5.7 mmHg at hospital discharge, and peak aortic pressure gradient from 61.5 ± 28.7 to 23.4 ± 10.6 mmHg. Early events included 1 death, 1 transient ischaemic attack, and 1 bleed (all 1.3%); a permanent pacemaker implantation was required in 6 patients (7.7%), and 2 reoperations (not valve related) (2.6%) took place. Over a median follow-up of 55.5 months (Q1 13.4, Q3 68.6), 12 patients died (6 cardiovascular and 6 non-cardiovascular, both 2.1% per patient-year). Five-year survival was 81.3%. Late paravalvular leak occurred in 2 patients (0.7% per patient-year) and permanent pacemaker implantation was required in 3 patients (0.1% per patient-year). There was no apparent rise in mean or peak aortic pressure gradient over the study.ConclusionsThese results suggest that the sutureless implant is a technically feasible procedure during mitral surgery and is associated with good clinical outcomes.

Rapid Deployment vs Conventional Valves for Aortic Valve Replacement. Short- and Mid-term Outcomes. A Propensity Score Matching Comparison.

Objectives: Rapid deployment Aortic valves have become an alternative for aortic valve stenosis treatment in recent years. Edwards Intuity was developed over Perimount Edwards Magna Ease design, with the addition of an infraannular ballon-expandable frame. So, we could hypothesize that outcomes should be similar between both protheses. Very few studies have compared these kinds of protheses. We communicate our experience with these prostheses. Methods: Retrospective observational study of 392 patients who receive aortic valve replacement in a single institution (175 Magna Ease, 117 Intuity). After adjustment through Propensity Score Matching (PSM), we obtained 65 couples of patients with equality in baseline characteristics. Results: Baseline values showed some differences between Intuity and Magna groups on terms of age (74.93 vs 73.21; p < 0.001), endocarditis (0 vs 8.1%; p < 0.001), diabetes (51 vs 30.3%; p < 0.001), Euroscore I (5.92 vs 6.82; p < 0.001), dyslipedemia (63.2% vs 47.3%; p < 0.005), previous cardiac surgery (0 vs 8.1%; p < 0.001) and combined cardiac procedure (12.8% vs 35.5%; p < 0.001). All baseline values were balanced after the employment of PSM. CBP (61.05± 17.18 vs 79.43± 21.78) and cross-clamp (42.38±11.44 vs 66.95± 17.05) times were lower in Intuity group (p < 0.001). There weren’t differences in terms of morbi-mortality. Incidence of new onset left bundle branch block was higher in Intuity group (26.2% vs 7.7%; p < 0.001). Intuity prostheses showed an higher incidence of postoperative paravalvular leak (12.3% vs 6.2%; p = 0.022) and lower 2-year transvalvular mean gradients (8.47 ± 2.81 vs 16.50 ± 5.21; p < 0.001). Conclusions: Our findings suggest that Intuity implants are related with better hemodynamics and surgical times than Magna prostheses. These outcomes enhance our knowledge on aortic prothesis profiles. Further randomized investigations are needed to estimate real differences between prostheses.