Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model.

BACKGROUND: The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. METHODS: Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. RESULTS: All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves. CONCLUSIONS: The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.

Del Nido versus cold blood cardioplegia in adult patients with impaired ejection fraction undergoing valvular and complex heart surgery.

BACKGROUND: There is sparse evidence on the efficacy of del Nido cardioplegia in high-risk patients with reduced ejection fraction undergoing valvular or complex heart surgery, and further investigation is required. METHODS: An institutional registry was searched for patients who underwent valvular or complex heart surgery and had an ejection fraction <40%. Subjects who received del Nido cardioplegia (DNC) and cold blood cardioplegia (CBC) were selected. Propensity matching was performed with age, gender, and number of conducted procedures as matching criteria. A comparative analysis was performed on primary endpoints of the troponin rise and changes in ejection fraction (EF). A composite endpoint of a troponin rise of ≥20× baseline or fall of EF≥5% was assessed in a multivariate analysis. Other perioperative complications are reported. RESULTS: One hundred patients from the DNC group were matched to the 100 patients in the CBC group. There were no differences between groups at baseline. Postoperatively, lower troponin values were observed in the DNC group at 12 hours (median; IQR: 523.2;349.1-740.4 pg/mL vs. 787.6;443.6-1689.0 pg/mL; P=0.016) and 36 hours (median; IQR: 426.1;337.2-492.1 pg/mL vs. 653.7;398.8-1737.5 pg/mL; P=0.044). Fewer patients in the DNC group had a fall in EF≥5% (7% vs. 16%; P=0.046). The multivariable analysis did not reveal a significant predictor of composite endpoint. CONCLUSIONS: In patients with impaired contractility undergoing valvular and complex procedures, the use of del Nido cardioplegia as an alternative to cold blood cardioplegia is associated with lower troponin release and improved preservation of ejection fraction.

The impact of del Nido cardioplegia solution on blood morphology parameters.

BACKGROUND: Crystalloid cardioplegic solutions are believed to reduce hemoglobin significantly and increase the transfusion rate. However, recent reports indicate that the del Nido cardioplegia may preserve blood morphology parameters. METHODS: In "The del Nido versus cold blood cardioplegia in aortic valve Replacement" trial patients undergoing aortic valve replacement were randomized into the del Nido (DN) or cold blood cardioplegia (CB) group. For the subanalysis, patients who underwent blood transfusions were excluded from the study. Red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count and platelet (PLT) count were measured before the surgery, 24-, 48-, and 96 hours postoperatively. Furthermore, percental variation in first-last measure was compared in groups. In addition, indexed normalized ratio (INR) and activated partial thromboplastin time (aPTT) were compared preoperatively and 24 hours after the surgery. RESULTS: Eighteen (24%) patients from the del Nido group and 22 (29.3%) patients from the CB group received blood product transfusions (p = 0.560) and were excluded from further analysis. As such, 57 patients remained in DN group and 53 patients remained in CB group. No difference was found in RBC, hemoglobin, WBC, and platelet count in time intervals. Percental variation in first-last measure revealed higher fall in RBC (p = 0.0024) and hemoglobin (p = 0.0028) in the CB group. No difference was shown in preoperative and 24-hour postoperative INR and aPTT. CONCLUSIONS: The del Nido cardioplegia does not decrease blood morphology parameters when compared to cold blood cardioplegia and may be used alternatively regardless of bleeding and coagulopathy risk.

Use of del Nido cardioplegia in acute coronary syndrome cases with decreased ejection fraction.

BACKGROUND: There has been increasing interest in using del Nido cardioplegia in adult cardiac surgery. However, there is limited evidence for its efficacy in patients with acute coronary syndrome and reduced ejection fraction. METHODS: This study examined patients with decreased ejection fraction (EF < 40%) who were hospitalized due to acute coronary syndrome and received either del Nido (DN) or cold blood cardioplegia (CB). The patients were matched based on age, gender, myocardial infarction at baseline, and number of conducted surgical procedures. An analysis was conducted on postoperative biomarker release (high-sensitivity troponin T and isoenzyme creatine kinase-MB (CK-MB)), changes in myocardial contractility and perioperative outcomes. RESULTS: 62 pairs of patients with similar baseline characteristics were selected. 51.6% of pairs underwent isolated coronary artery bypass grafting, while 48.4% underwent a complex procedure. Postoperative troponin values did not differ significantly at 12 h (median (IQR): 606.7 (381.4-974.8) pg/mL vs. 552 (231.8-1579.5) pg/mL; p = 0.913), nor did CK-MB (median (IQR): 24.3 (12.6-45.5) ng/mL vs. 23.7 (12.3-49.8) ng/mL; p = 0.972). The postoperative EF was similar between groups (median (IQR): 30% (30-35%) vs. 34% (30-38%); p = 0.323). No difference in perioperative mortality, myocardial infarction, stroke, or composite endpoint was noted. In a multivariate analysis, the cardioplegia protocol did not affect biomarker release or changes in ejection fraction. The first stage of acute kidney injury was more frequent in the CB group (28.5% vs. 9.7%, p = 0.033). CONCLUSIONS: Both del Nido and cold blood cardioplegia provide adequate cardioprotection in patients with acute coronary syndrome with decreased ejection fraction.

Del Nido versus Bretschneider cardioplegic solution in valve replacement for severe aortic stenosis - a case-control pilot study.

Introduction: The adequate protection provided by the del Nido cardioplegia has already been proven in trials comparing the solution with blood cardioplegia. However, evidence regarding comparison to the Bretschneider HTK solution is limited. Aim: To determine the efficacy of the del Nido cardioplegia when compared to Bretschneider HTK solution in patients undergoing aortic valve replacement for severe aortic stenosis. Material and methods: Ten patients undergoing isolated aortic valve replacement for severe aortic stenosis using the del Nido solution (group 1) were case-control matched to patients undergoing aortic valve replacement (AVR) using the Bretschneider solution (group 2). The observation included: cardioplegia dosage, time to cardiac arrest, cross-clamp and extracorporeal circulation time, ventricular fibrillation (VF) after removing the cross-clamp, gasometry parameters, creatinine kinase (MB isoenzyme - CK-MB) at 24 and 48 h following the surgery and troponin (highsensitivity troponin T - hsTnT) at 24 and 48 h. Results: Patients were no different in terms of comorbidities. Higher incidence of VF occurred in group 2 (3 vs. 9, 30% vs. 90%; p = 0.02). Blood sodium measurements after removing the cross-clamp were significantly higher in group 1 (median 137.0 vs. 130.0; p = 0.0004). Biomarker release trended toward lower values in group 1, but not significantly (median troponin at 24 h: 223.1 pg/ml vs. 294.8 pg/ml; p = 0.4 and 48 h: 208.0 pg/ml vs. 242.5 pg/ml; p = 0.7, median CK-MB at 24 h: 16.6 ng/ml vs. 17.3 ng/ml; p = 0.6, and 48 h: 6.7 ng/ml vs. 5.08 ng/ml; p = 0.3). Peak creatinine trended towards lower values in group 2, but not significantly (1.35 mg/dl vs. 1.05 mg/dl; p = 0.09). Conclusions: Both del Nido and Bretschneider cardioplegia provide satisfactory myocardial protection. However, del Nido cardioplegia reduces the incidence of VF after declamping the aorta. Further studies are required.

6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model.

The aim of the study was to evaluate a balloon expandable transcatheter heart valve (THV) system (Myval) at 6-month follow-up in ovine banding model. Eleven THV systems were implanted via carotid approach. There were 2 procedure-related deaths and 2 premature deaths. At 6 months all valves that completed follow-up (n = 7) were functional, with no significant regurgitation, calcification, thrombi, or vegetation. Mean pressure gradient was 21.9 ± 11 mm Hg, maximum velocity = 3.3 ± 1 m/s, and ejection fraction was 53.3 ± 6%. Myval THV showed optimal hemodynamic performance and biocompatibility.

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model.

Objectives: The aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing. Methods: A surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15-16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed. Results: There was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation. Conclusion: This preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted.

Age- and gender-related differences in the del Nido cardioprotection protocol.

BACKGROUND: The evidence regarding the impact of patient's age and gender on del Nido cardioplegia cadio-protection capability in adults is strongly limited. METHODS: A group of 75 patients undergoing aortic valve replacement (AVR) with del Nido cardioplegia was divided into Group 1 (male) and Group 2 (female). Creatine kinase (CK-MB isoenzyme) and high sensitivity troponin T (hs-TnT) values at 24 hours and 48 hours, occurrence of cardiac activity during crossclamp and ventricular fibrillation (VF) during reperfusion were compared. The impact of age on hs-TnT,CK-MB, VF during reperfusion and cardiac activity during crossclamp was investigated using regression models. RESULTS: No difference between the groups was reported in 24-hour CK-MB (median 15.57 ng/mL; IQR 12.13-22.82 ng/mL vs. 13.97; 12.09-17.147 ng/mL; P=0.168), 48-hour CK-MB (6.19; 4.22-7.71 ng/mL vs. 6.07;4.56-7.06 ng/mL; P=0.707), 24-hour hs-TnT (259.2; 172.0-376.9 pg/mL vs. 193.0; 167.8-351 pg/mL.1; P=0.339), 48-hour hs-TnT (169.1; 124.9-293.0 pg/mL vs. 159.2; 123.12-211.77 pg/mL; P=0.673), VF during reperfusion (25% vs. 18,5%; P=0.774) and cardiac activity during arrest (39.6% vs. 37.1%; p= 1.0). Values of CK-MB at 24 hours, hs-TnT at 24 hours and hs-TnT at 48 hours were not dependent on age. The CK-MB at 48 hours was dependent on age (P=0.039). Probit regression failed to reveal the impact of patients' age on postclamp VF occurrence (P=0.11) or electrical activity during arrest (P=0.57). CONCLUSIONS: Considering our study results, it can be hypothesized that the del Nido cardioplegia provides adequate myocardial protection in AVR patients regardless of age and gender.

Long­term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical-risk patients with severe aortic stenosis: a single-center single-valve registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long­term outcomes are still limited. AIMS: The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure­related factors influencing long­term survival. METHODS: Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ­expanding Medtronic valve implantation at American Heart of Poland in Bielsko­Biala were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium­2 (VARC­2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population. RESULTS: The median (interquartile range) follow­up was 3.4 (2.5-4.6) years, and the longest follow­up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow­up. The Kaplan-Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long­term mortality. CONCLUSIONS: TAVI with a self­expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.

The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial.

OBJECTIVES: To compare the cardioprotective efficacy of a solution that requires only a single infusion at the start of the ischemic duration versus a solution that requires multiple infusions. METHODS: Aortic valve replacement was performed for 150 patients, who were randomized into the del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group. The DN cardioplegia was delivered every 90 minutes and the CB cardioplegia was delivered every 20 to 30 minutes, or whenever cardiac activity was observed. The primary endpoints were electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme) at 24 and 48 hours. RESULTS: Electrical activity during crossclamp occurred in 29 (39.7%) patients in the DN group versus 34 (45.3%) patients in the CB group (adjusted P = 1.0). The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41). Troponin values appeared to be lower in the DN group (median, 223.10; interquartile range, 168.35-364.77 pg/mL vs 285.5; 196.20-419.45 pg/mL at 24 hours and 159.60; 125.42-217.20 pg/mL vs 201.60; 160.62-268.45 pg/mL at 48 hours) and CK-MB (median, 14.94; interquartile range, 12.16-20.39 ng/mL vs 17.43; 13.66-22.43 ng/mL at 24 hours and 6.19; 4.41-7.63 ng/mL vs 7.38; 4.74-10.20 ng/mL at 48 hours), but no significance was found. CONCLUSIONS: The del Nido cardioplegia protocol is an acceptable alternative for cold blood cardioplegia in patients undergoing aortic valve replacement.

Peri-procedural hemostasis disorders in surgical and transcatheter aortic valve implantation.

INTRODUCTION: Despite their high effectiveness, surgical aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) are associated with substantial risk of bleeding. Although procedure-related hemostasis disorders might be crucial for safety of both procedures, the amount of data on the peri-procedural status of hemostasis in patients with aortic valve stenosis (AS) subjected to AVR and TAVI is negligible. AIM: To investigate the profile of peri-procedural hemostasis in elderly patients with AS, subjected to aortic valve prosthesis implantation. MATERIAL AND METHODS: We performed a prospective analysis of global hemostasis using ROTEM thromboelastometry and platelet reactivity assessment using impedance aggregometry in 30 consecutive patients ≥ 70 years old subjected to AVR and TAVI. All tests were performed within 24 h before, directly and 24 h after the procedures. RESULTS: Surgical aortic valve replacement was characterized by transient hypofibrinogenemia and von Willebrand factor (vWF) depletion, which quickly recovered within 24 h after AVR. Transcatheter aortic valve implantation was characterized by substantial alteration of platelet function and vWF depletion with significant platelet reactivity impairment and increase in platelet sensitivity to antiplatelet agent, early after the procedure. TAVI-related hemostasis alterations were not recovered at 24 h after the procedure. CONCLUSIONS: Surgical and transcatheter aortic valve replacement procedures are associated with substantial and diverse peri-procedural hemostasis disorders. Since hemostasis disorders related to TAVI are mainly characterized by impaired platelet function, early dual antiplatelet prophylaxis after TAVI requires careful consideration.

State-of-the-art of transcatheter treatment of aortic valve stenosis and the overview of the InFlow project aiming at developing the first Polish TAVI system.

Initial experience of transcatheter aortic valve implantation (TAVI) or replacement (TAVR) has ap-peared as a promising minimally invasive technology for patients disqualified from surgical treatment (SAVR). Safety and efficacy of TAVI has been analyzed and assessed through numerous registries and trials. Furthermore, results obtained from comparative TAVI vs. SAVR trials proved that both treat¬ments can be considered equal in terms of post-procedural mortality and morbidity in high-risk, as well as lower risk patients. However, there are still some issues that have to be addressed, such as higher chance of paravalvular leakage, vascular injuries, conduction disturbances, malpositioning and the yet unmet problem of insufficient biological valves durability. Recent technological developments along with the learning curve of operators prove a great potential for improvement of TAVI and a chance of surpassing SAVR in various groups of patients in the near future. In pursuit of finding new solutions, the CardValve Consortium consisting of leading scientific and research institutions in Poland has been created. Under the name of InFlow and financial support from the National Center for Research and Development, they have started a project with the aim to design, create and implement into clinical practice the first, Polish, low-profile TAVI valve system, utilizing not only biological but also artificial, polymeric-based prosthesis. This review focuses on current developments in TAVI technologies including the InFlow project.

Surgical removal of entrapped guidewire fragment following direct circumflex artery angioplasty and stenting.

We present a case of a 64-year-old man with coronary artery disease, who underwent a percutaneous coronary intervention of the circumflex artery. As the guidewire was being withdrawn from the target vessel, it became entrapped by the structure of the previously implanted stent. Attempts to retrieve the foreign body were unsuccessful. Changes in electrocardiogram were observed during the procedure, and the level of cardiac biomarkers increased within the next 24-hours. The patient was admitted to the Cardiac Surgery Department. Remnants of the foreign body were removed under visual control using extracorporeal circulation, and coronary artery bypass grafting was performed. Treatment options and outcomes are discussed.

Coronary endarterectomy in left anterior descending artery combined with coronary artery bypass grafting - midterm mortality and morbidity.

INTRODUCTION: Completeness of myocardial revascularization is essential in surgical treatment of coronary artery disease. The aim of this study is to determine the effectiveness of coronary endarterectomy as an adjunct to coronary artery bypass grafting (CABG) in the most difficult cases. MATERIAL AND METHODS: Among 1559 patients who had CABG in our department, the cases of 17 who underwent an adjunct left anterior descending endarterectomy were analyzed. All procedures were performed with median sternotomy, extracorporeal circulation and in mild hypothermia (34°C), by the same surgeon. No coronary artery endarterectomy was planned before surgery. RESULTS: There was no infarction or cardiac arrest during hospitalization. Only one patient required mechanical circulatory support (intra-aortic balloon counterpulsation). Each patient was contacted and investigation for major adverse cardiac and cerebrovascular events (MACCE) was performed. Eleven patients (65%) already underwent midterm clinical evaluation. There was no death, myocardial infarction or cerebrovascular incident during the entire period (mean follow-up at 15.3 months). One patient required urgent coronarography due to chest pain. No other patient had chest pain or significant deterioration of ventricular function in echocardiography. CONCLUSIONS: Outcomes and potential indications for performing left anterior descending coronary endarterectomy as an adjunct to CABG are discussed.

Transapical closure of mitral paravalvular leaks with use of amplatzer vascular plug III.

INTRODUCTION: Paravalvular leak (PVL) may complicate cardiac valve replacement surgery. Radical treatment is required if a PVL produces heart failure (HF) symptoms or severe hemolysis. Even though transcatheter PVL closure (TPVLC) has become a valid alternative to reoperation, a number of anatomical conditions may prove technically challenging for transvascular access. We intended to verify the utility of transapical access in such settings. METHODS: We report a prospective series of 7 patients with mitral PVLs who underwent transapical TPVLC. The Heart Team made the choice of treatment and Amplatzer Vascular Plug III devices were used off-label as occluders. RESULTS: Transapical TPVLC enabled excellent sealing of mitral PVL in 6 cases. This resulted in HF symptom reduction and decreased NT-proBNP plasma concentration. No procedure-related complications occurred. CONCLUSIONS: Transapical access seems to be an efficient and safe alternative for transvascular approach for mitral TPVLC, but further technical development is still needed.

Effects of preoperative aspirin in coronary artery bypass grafting: a double-blind, placebo-controlled, randomized trial.

OBJECTIVE: This trial was undertaken to determine the safety and efficacy of preoperative aspirin administration in a contemporary cardiac surgical practice setting. METHODS: This randomized, double-blind, parallel-group, single-center trial involved patients with stable coronary artery disease who were assigned to receive either 300 mg of aspirin or placebo the night before coronary bypass surgery. Using a random digit table, patients were allocated to receive the tablet from 1 of the 40 coded bottles containing either aspirin or placebo. Patients, surgeons, anesthetists, and investigators were all masked to treatment allocation. The primary safety end points were as follows: more than 750 mL of bleeding during the first postoperative 12 hours and more than 1000 mL of total discharge from the chest drains. The secondary efficacy end point was a composite of cardiovascular death, myocardial infarction, or repeat revascularization. RESULTS: A total of 390 patients were allocated to aspirin (387 analyzed) and 399 to placebo (396 analyzed). The follow-up median was 53 months. Fifty-four placebo recipients and 86 aspirin recipients bled more than 750 mL in the first 12 hours (odds ratio [OR], 1.81; 95% confidence interval [CI], 1.25-2.63), while total chest drain discharge was above 1000 mL in 96 placebo and 131 aspirin recipients (OR, 1.60; 95% CI, 1.17-2.18). Preoperative aspirin decreased the long-term hazard of nonfatal coronary event (infarction or repeat revascularization)-hazard ratio (HR), 0.58 (95% CI, 0.33-0.99)--and tended to decrease the hazard of a major cardiac event (cardiovascular death, infarction, or repeat revascularization--HR, 0.65 [95% CI, 0.41-1.03]). CONCLUSIONS: Performing coronary grafts on aspirin is associated with increased postoperative bleeding but may decrease the long-term hazard of coronary events.

[Transapical closure of mitral paravalvular leaks in a patient with haemolytic anaemia and heart failure - a case report]. / Przezkoniuszkowe zamkniecie mitralnychprzecieków okolozastawkowychu pacjenta z hemoliza wewnatrznaczyniowai niewydolnoscia serca.

We present a case of a 72 year-old male who underwent successful closure of two mitral paravalvular leaks with the Amplatzer vascular Plug II using a transapical approach.