Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test

ABSTRACT Introduction: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. Methods: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. Results: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. Conclusion: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test.

INTRODUCTION: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. METHODS: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. RESULTS: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. CONCLUSION: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Mitral valve-in-valve: defining the indication limits by in vitro hydrodynamic tests in a brazilian transcatheter prosthesis

Abstract Introduction: Reoperations in cardiac surgery represent a clinical challenge, particularly because of the higher rate of perioperative morbidity and mortality. Mitral valve reoperation owing to bioprosthesis dysfunction, transcatheter treatment with a prosthesis implantation over the prosthesis has emerged as an alternative, especially for patients with a previous approach. In this study, we analyzed the hydrodynamic behavior of transcatheter prosthesis implantation in conventional mitral bioprostheses through hydrodynamic tests and produced a recommendation for the size of transcatheter valve most adequate for valve-in-valve procedure. Methods: Mitral bioprostheses were attached to a flow duplicator and different combinations of transcatheter prostheses were implanted inside. The equipment simulates the hydrodynamic behavior of the valves submitted in vitro and determines transvalvular pressures and flow parameters. Results: All tests could be performed. Better hydrodynamic performance occurred for transcatheter prostheses 1 mm smaller than bioprostheses, except for the 27-mm bioprostheses. Effective valve areas (cm²) and transvalvular gradients (mmHg) were, respectively: Bioprosthesis × Inovare: 27 × 28 mm: 1.65 and 5.95/29 × 28 mm and 31 × 30 mm: 2.15 and 3.6. Conclusion: The mitral valve-in-valve implantation proved to be feasible in vitro. The use of 27-mm bioprostheses should be judicious, with preference for a 26-mm transcatheter valve. In the 29 and 31-mm bioprostheses, the implantation was very satisfactory, with good effective valve areas and transvalvular gradients, with preference for smaller transcatheter valves.

Mitral Valve-In-Valve: Defining the Indication Limits by in vitro Hydrodynamic Tests in a Brazilian Transcatheter Prosthesis.

INTRODUCTION: Reoperations in cardiac surgery represent a clinical challenge, particularly because of the higher rate of perioperative morbidity and mortality. Mitral valve reoperation owing to bioprosthesis dysfunction, transcatheter treatment with a prosthesis implantation over the prosthesis has emerged as an alternative, especially for patients with a previous approach. In this study, we analyzed the hydrodynamic behavior of transcatheter prosthesis implantation in conventional mitral bioprostheses through hydrodynamic tests and produced a recommendation for the size of transcatheter valve most adequate for valve-in-valve procedure. METHODS: Mitral bioprostheses were attached to a flow duplicator and different combinations of transcatheter prostheses were implanted inside. The equipment simulates the hydrodynamic behavior of the valves submitted in vitro and determines transvalvular pressures and flow parameters. RESULTS: All tests could be performed. Better hydrodynamic performance occurred for transcatheter prostheses 1 mm smaller than bioprostheses, except for the 27-mm bioprostheses. Effective valve areas (cm²) and transvalvular gradients (mmHg) were, respectively: Bioprosthesis × Inovare: 27 × 28 mm: 1.65 and 5.95/29 × 28 mm and 31 × 30 mm: 2.15 and 3.6. CONCLUSION: The mitral valve-in-valve implantation proved to be feasible in vitro. The use of 27-mm bioprostheses should be judicious, with preference for a 26-mm transcatheter valve. In the 29 and 31-mm bioprostheses, the implantation was very satisfactory, with good effective valve areas and transvalvular gradients, with preference for smaller transcatheter valves.

Percutaneous closure of left ventricular pseudoaneurysm in a patient with concomitant true left ventricular aneurysm.

BACKGROUND: Left ventricular aneurysms (LVA) are serious complications of myocardial infarction, being divided into true and false type. The false one-pseudoaneurysm (PA), is a life-threatening condition that requires urgent treatment due to the high risk of rupture. CASE PRESENTATION: An 84-year-old female presented with progressive heart failure symptoms. Investigation showed a small true LVA and a large PA. Open surgical repair was ruled out as Euroscore and Society of Thoracic Surgeons (STS) score were 42.80% and 39.97%, respectively. After discussion at our Heart Team meeting, percutaneous approach was found to be the best option. Guided by transesophageal echocardiography, we used an interventricular septal defect occluder to close the gap between the LV and the PA. Control ventriculography showed full closure of the gap, with no residual flow to the PA cavity. The patient was discharged from the hospital on the fifth postoperative day and has remained asymptomatic since then. CONCLUSION: Percutaneous approach proved to be a safe and effective modality to treat LV PA. The device implanted achieved the goal of blocking blood flow through the communication between LV and the PA.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Hemodynamic and Imaging Assessment of Transcatheter Aortic Valve Replacement with the Inovare® Proseal using Multislice Computed Tomography.

OBJECTIVE: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). METHODS: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. RESULTS: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. CONCLUSION: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

First-in-Human Endo-Bentall Procedure for Simultaneous Treatment of the Ascending Aorta and Aortic Valve.

We describe the endovascular management of a middle-aged woman who developed a bleeding suprasternal fistula after conventional aortic valve replacement. The patient's condition was considered inoperable. A customized stent attached to a transcatheter valve was successfully used to treat the individual, this being the first-in-human case of the promising Endo-Bentall procedure. (Level of Difficulty: Advanced.).

Hemodynamic and imaging assessment of transcatheter aortic valve replacement with the inovare® proseal using multislice computed tomography

Abstract Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). Methods: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. Results: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. Conclusion: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes.

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

Current generation balloon-expandable transcatheter valve positioning strategies during aortic valve-in-valve procedures and clinical outcomes

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient ($30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth #20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 _ 9.7 years of age, 65.8% male, STS score 8 _ 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 _ 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 _ 2.7% vs. 91.5 _ 3.5%; p » 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p » 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring. (AU)

Mortality prediction after transcatheter treatment of failed bioprosthetic aortic valves utilizing various international scoring systems: Insights from the Valve-in-Valve International Data (VIVID).

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS). OBJECTIVE: The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all-cause mortality after transcatheter aortic valve-in-valve (ViV) implantations, which was not assessed before. METHODS: Using the Valve-in-Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30-day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination. RESULTS: Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30-day mortality with ratios of 0.176 (95% CI 0.138-0.214), 0.342 (95% CI 0.264-0.419), and 0.536 (95% CI 0.421-0.651), respectively. 30-day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698. CONCLUSIONS: All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions.

1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification.

BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Impact of Pre-Existing Prosthesis-Patient Mismatch on Survival Following Aortic Valve-in-Valve Procedures.

OBJECTIVES: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size). BACKGROUND: Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation. METHODS: Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality. RESULTS: Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg). CONCLUSIONS: Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

Objectives: Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. Methods: The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. Results: A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. Conclusions: The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

In vitro evaluation of implantation depth in valve-in-valve using different transcatheter heart valves.

AIMS: Transcatheter heart valve (THV) implantation in failed bioprosthetic valves (valve-in-valve [ViV]) offers an alternative therapy for high-risk patients. Elevated post-procedural gradients are a significant limitation of aortic ViV. Our objective was to assess the relationship between depth of implantation and haemodynamics. METHODS AND RESULTS: Commercially available THVs used for ViV were included in the analysis (CoreValve Evolut, SAPIEN XT and the Portico valve). THVs were implanted in small surgical valves (label size 19 mm) to simulate boundary conditions. Custom-mounted pulse duplicators registered relevant haemodynamic parameters. Twenty-eight experiments were performed (13 CVE, 5 SXT and 10 Portico). Ranges of depth of implantation were: CVE: -1.2 mm to 15.7 mm; SXT: -2.2 mm to 7.5 mm; Portico: 1.4 mm to 12.1 mm. Polynomial regression established a relationship between depth of implantation and valvular mean gradients (CVE: p<0.001; SXT: p=0.01; Portico: p=0.002), as well as with EOA (CVE: p<0.001; SXT: p=0.02; Portico valve: p=0.003). In addition, leaflet coaptation was better in the high implantation experiments for all valves. CONCLUSIONS: The current comprehensive bench testing assessment demonstrates the importance of high device position for the attainment of optimal haemodynamics during aortic ViV procedures.

New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up.

AIMS: Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. METHODS AND RESULTS: Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. CONCLUSIONS: Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.

Ventricular assist device implantation with CentriMag VAS® for biventricular mechanical support.

Despite recent advances in acute heart failure treatment, actual results remain limited in refractory cardiogenic shock. Temporary ventricular assist devices have emerged as an alternative in this serious and challenging medical. The purpose of this communication is to present a case of refractory cardiogenic shock, underwent temporary left ventricular assistance device implantation, progressing to right ventricular failure and conversion to biventricular support.

Off-pump transapical closure of a mitral periprosthetic leak: a new approach to a difficult problem.

A 60-year old male patient with multiple risk factors and two previous interventions over the mitral valve was admitted to the emergency unit with symptoms of cardiac failure. Initial examination revealed a competent mitral bioprosthesis with severe perivalvular mitral insufficiency. Based on previous experiences with transapical procedures, a transapical transcatheter closure of the perivalvular leak was performed. The apex was punctured with a 7 French introducer sheath, and a hydrophilic guidewire was advanced with the aid of a right Judkins catheter and positioned across the defect in the left atrium. Fluoroscopic and tridimensional transoesophageal echocardiography was used to guide the manoeuvre. Next, a long introducer sheath was advanced through the guidewire and positioned inside the left atrium. Two Amplatzer Vascular Plug II (St Jude Medical) were deployed, resulting in a significant reduction in the perivalvular leak. The procedure was considered to be successful. The patient regained consciousness, and the orotracheal tube was removed in the operating theatre. No neurological deficits were detected, and the patient was transferred to the intensive care unit. The patient recovered well and was transferred to the ward after 1 day. Discharge was accomplished after 4 days.

Pulsatile stent graft: a new alternative in chronic ventricular assistance.

OBJECTIVE: Heart failure is currently one of the most common hospitalization causes. Several chronic circulatory assist devices have been tested and are highly complex. The objective is the description of a pulsatile endoprosthesis capable of applying a chronic pulse within the descending aorta, similar to that produced by intra-aortic balloon. METHODS: Pulsatile stents composed of nickel-titanium were built and positioned to engage latex tubes simulating the aorta. Different electric currents were applied to units connected in series in order to cause structure contraction and displacement of a liquid column. There were two sequence tests: first composed of two metallic cages and the second composed of five cages. At first sequence tests was applied a voltage of 16.3 volts and a current of 5 amperes. In the second, voltage of 15 volts and current of 07 amperes. RESULTS: In the first sequence was obtained the pulsatile effect of stent, with contraction of the tube and displacement of the water column sufficient to validate the pulsating effect of the endoprosthesis. The two structures ejected a volume of 2.6 ml per cycle, with a range of 29 mm in height of the column of water equivalent to 8% shrinkage during the pulse. In the second sequence, it reachead a variation of 7.4 mL per cycle. CONCLUSION: The results obtained confirm the stent pulsatile contractility activated by electrical current. The continuity of the study and material improvement are necessary to obtain more efficient model from the point of view of energy and pulse, to allow ejection volumes comparable with the intra-aortic balloons.