Aortic Bioprosthesis Research Articles

TCTAP A-162 Late Recoil of Balloon-expandable Transcatheter Aortic Bioprosthesis: Insights from the OCEAN-TAVI Registry

TCTAP A-162 Late Recoil of Balloon-expandable Transcatheter Aortic Bioprosthesis: Insights from the OCEAN-TAVI Registry

A rare case report of early bioprosthetic valve thrombosis presenting with acute heart failure salvaged by thrombectomy

BackgroundBioprosthetic valve thrombosis is previously considered as an extremely rare complication which hasn’t been systemically recognized and understood.Case presentationHerein, we present an unusual case of a patient manifesting with acute heart failure, secondary to thrombus formation in a porcine aortic bioprosthesis which was implanted 11 months prior to hospitalization. Due to the patient’s poor heart function and intraoperative findings, thrombectomy was performed. For our best knowledge, cases of early bioprosthetic valve thrombosis presenting with acute heart failure have seldomly been reported.ConclusionOur study reviews predisposing factors, typical echocardiographic features and treatment for bioprosthetic valve thrombosis and it should be considered as a reason for bioprosthetic malfunction. A combination of clinical and echocardiographic features can help for diagnosis preoperatively. In some certain circumstances, early reoperation can be avoided if anticoagulant therapy works.

SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve.

The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used.

Sutureless aortic bioprosthesis.

Aortic valve replacement (AVR) is the treatment of choice for aortic valve disease, with excellent results reported in the short- and long-term follow-up. Due to the increasing number of patient comorbidities and older age, various technical alternatives have been developed such as transcatheter aortic valve implantation and, more recently, sutureless valve bioprostheses. For patients with very high surgical risk, transcatheter implantation is becoming the top therapeutic option. However, the percutaneous technique still has major disadvantages including those related to implantation without excision of the diseased native valve without direct view of the annulus, which increases the probability of developing perivalvular leaks and a high percentage of atrioventricular block. Due to the need for aggressive crimping of pericardial layers, there is uncertainty about their long-term durability. A new technique for AVR using sutureless bioprosthesis has recently been developed. The main advantages of this technique are the excellent haemodynamic performance and fast deployment under direct view, thereby avoiding the knotting of surgical stitches, which is especially advantageous in more technically demanding procedures (e.g. minimally invasive surgery, calcified aortic root and reoperations). The good clinical results of these valves have been supported by scientific evidence, making it a feasible option for patients who are candidates for AVR using biologic prosthesis, especially for those with mid-high surgical risk for standard AVR and percutaneous transcatheter valve implantation. In this article, we review the latest evidence on these new prostheses, including their advantages and possible disadvantages.

Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses: Insights from the PARTNER II Valve-in-Valve Registry on Utilizing Baseline Computed-Tomographic Assessment

ABSTRACTBackground: Residual stenosis is a major limitation of transcatheter aortic valve replacement inside failed surgical bioprostheses (valve-in-valve). Our aim was to evaluate whether pre-procedure CT assessment could identify cases at risk for having residual stenosis after the procedure.Methods: Patients with failed surgical aortic bioprostheses were prospectively enrolled in the multicenter PARTNER II valve-in-valve registry. Core-lab assessment of echocardiographic and CT findings were utilized.Results: A total of 84 patients that underwent pre-procedural CT were included in the current analysis with a median age of 79.9 ± 9.6 years with 65.5% being male. CT average annulus internal area was 331.64 ± 73.52mm2. Post SAPIEN XT implantation mean gradient was 17.95 ± 7.59 mmHg and average aortic valve area was 1.06 ± 0.35 cm2. Small internal annular area per CT was significantly associated with increased gradients in intermediate/large surgical valves (true ID > 20 mm, p = 0.01). ROC curve for the evaluation of predictability of CT measured area on post-procedural gradients in intermediate/large surgical valves was high (AUC 0.81). Cutoff of 329 mm2 had negative predictive value of 95%.Conclusions: CT-derived annulus area in cases with intermediate and large surgical valves can identify cases at risk for poor hemodynamics after valve-in-valve and influence clinical decision making.

Effect of transcatheter aortic valve size and position on valve-in-valve hemodynamics: An in vitro study

ObjectiveTranscatheter heart valve implantation in failed aortic bioprostheses (valve-in-valve [ViV]) is an increasingly used therapeutic option for high-risk patients. However, high postprocedural gradients are a significant limitation of aortic ViV. Our objective was to evaluate Medtronic CoreValve Evolut R ViV hemodynamics in relation to the degree of device oversizing and depth of implantation. MethodsEvolut R devices of 23 and 26 mm were implanted within 21-, 23-, and 25-mm Hancock II bioprostheses. Small and gradual changes in implantation depth were attempted. Hemodynamic testing was performed in a pulse duplicator under ISO-5840 standard. ResultsA total of 47 bench-testing experiments were performed. The mean gradient of the 26-mm Evolut R in 23- and 25-mm Hancock II was lower than 23-mm Evolut R (P < .001). However, the mean gradient of 26-mm Evolut R in 21-mm Hancock II bioprostheses R (ranging from 21.30 ± 0.23 to 24.30 ± 0.22 mm Hg) was worse than 23-mm Evolut R (ranging from 15.94 ± 0.18 to 20.35 ± 0.16 mm Hg, P < .001). Furthermore, our results suggest that supra-annular implantation of 23-mm and 26-mm Evolut R devices within the bioprostheses can lead to lower gradient and improved leaflet coaptation. Regardless of implantation depth, superior transvalvular gradient is expected with 26-mm Evolut R than 23-mm Evolut R in a nonstenotic Hancock II with a true internal diameter > 17.5 mm. ConclusionsThe current comprehensive bench-testing assessment demonstrates the importance of both transcatheter heart valve size and device position for the attainment of optimal hemodynamics during ViV procedures. Additional in vitro testing may be required to develop hemodynamics-based guidelines for device sizing in ViV procedures in degenerated surgical bioprostheses.

Hemodynamic Follow-up after Valve-in-Valve TAVI for Failed Aortic Bioprosthesis

Hemodynamic Follow-up after Valve-in-Valve TAVI for Failed Aortic Bioprosthesis

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters’ Registry

ObjectivesThe authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BackgroundThe Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. MethodsClinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. ResultsA total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. ConclusionsThis registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

CRT-800.12 Effect Of Transcatheter Aortic Valve Size And Position On Valve-in-valve Hemodynamics: An In-vitro Study

Transcatheter heart valve implantation in failed aortic bioprostheses (valve-in-valve,ViV) is an increasingly used therapeutic option for high-risk patients. However, high post-procedural gradients are a significant limitation of aortic ViV. Our Objective was to evaluate Medtronic CoreValve® Evolut

Evaluation of Hemodynamic Performance of Aortic Valve Bioprostheses in a Model of Oversizing

The risk of patient-prosthesis mismatch drives most surgeons to select the largest bioprosthesis possible during aortic valve replacement, but interactions between the native aortic annulus and valve prosthesis remain poorly defined. We examined the hemodynamic and functional consequences of oversizing contemporary bioprostheses in an invitro model. Three sizes each (21, 23, and 25 mm) of 5 aortic bioprostheses (Magna, Edwards Lifesciences, Irvine, CA; Trifecta and Epic, St. Jude, St. Paul, MN; and Mosaic and Hancock II, Medtronic, Minneapolis, MN) were tested on a mock annulus in a pulsatile aortic simulator. After the annulus was sized to match each valve, the annulus was decreased by 3 mm and then by 6 mm to simulate oversizing. We measured the effective orifice area and the mean pressure gradient. Changes in prosthetic leaflet behavior and geometric orifice area wereassessed with slow-motion video. Statistical analysis used mixed-effects models for repeated-measures data, allowing comparison within and between groups. For each valve model and size, oversizing resulted in decreased effective orifice areas and geometric orifice areas and increased pressure gradients. This was more pronounced with smaller valve sizes and higher flow rates but varied between valve types. Slow-motion imaging revealed this change in geometric orifice area was a result of an inward shift of the valve leaflet hinge point. Bioprosthetic oversizing impairs hemodynamic performance of aortic valve bioprostheses. The magnitude of this effect varies by valve model and size. Clinically, these data suggest that during aortic valve replacement, placing a valve whose internal orifice closely matches the aortic annulus will provide the optimal hemodynamic performance.

Formation of Infectious Coronary Artery Aneurysms After Percutaneous Coronary Intervention in a Patient With Acute Myocardial Infarction Due to Septic Embolism

A 68-year-old man, who underwent aortic valve replacement (biological valve, Carpentier-Edwards PERIMOUNT Magna Aortic Bioprosthesis 21 mm, Edwards Lifesciences, Irvine, California) for aortic valve regurgitation without coronary artery disease 5 months previous, was admitted to our institution due

Coronary Procedures After TAVI With the Self-Expanding Aortic Bioprosthesis Medtronic CoreValve™, Not an Easy Matter.

To evaluate the feasibility of coronary procedures after transcatheter aortic valve implantation (TAVI) with the CoreValve™ device. Due to its design, CoreValve™ prosthesis may interfere with coronary procedures. Data on this issue are sparse. Between 2007 and 2015, 550 patients underwent CoreValve™ TAVI in our hospital. Among them, 16 underwent coronary angiogram after TAVI and were included in our retrospective study. For each patient, we compared the characteristics of coronary angiograms performed before and after TAVI. Coronary angiogram was deemed successful in 9 patients. The mean number of different catheters used in attempts to cannulate the coronary arteries was 3.6 ± 1.4 and the rate of selective intubation was low. Fluoroscopy time (13.2 ± 5.8 vs. 7.2 ± 4.6 min, P = 0.003), dose area product (5,347 ± 4,919 vs. 3,433 ± 3,420 cGy/m2 , P = 0.004), and contrast volume (157.7 ± 69.6 vs. 108.3 ± 42.6 mL, P = 0.006) were more important in coronary angiograms performed after CoreValve™ implantation. Percutaneous coronary intervention was successfully performed in 6 out of 7 patients who required it. Coronary procedures after CoreValve™ TAVI are feasible, but challenging. This problem is currently rare but will be more common as the indications of TAVI are expanded to younger patients with longer life expectancies. Recommendations for post-TAVI coronary procedures are needed, particularly for centers unfamiliar with the management of post-TAVI patients.

Acute embolisation of Watchman plug onto aortic bioprosthesis followed by successful percutaneous removal.

Acute embolisation of Watchman plug onto aortic bioprosthesis followed by successful percutaneous removal.

Successful Management of Refractory Prosthetic Vessel Infection, Prosthetic Valve Endocarditis and Mediastinitis: Report of a Case-Late Timing Caused Repeated Surgery

The patient was diagnosed with anuloaortic ectasia with localized dissection in the right Valsalva sinus. He underwent aortic root replacement with mechanical valve. But, he was re-admitted for mediastinitis. Although his serum (CRP) level was normalized for one month, his body temperature suddenly rose to 40°C. An emergency operation was performed including re-sternotomy, drainage, and irrigation. However, a proximal anastomotic site ruptured and he went into shock. Following cardiopulmonary bypass, we performed a second aortic root replacement. Therefore, the patient was operated for sternum debridement and to wrap the prosthetic vessel into an omental pedicle. Nine days after the last intervention, bleeding from the chest wound suddenly appeared and he went into shock. He was transported to the operating room to initiate cardiopulmonary bypass. During circulatory arrest, laceration was detected at the same annular position. Deep into the left ventricle, we made interrupted sutures in the left cardiac muscle. Next, we implanted a Freestyle aortic root bioprosthesis using the full root technique. After removing all former implants, another prosthetic vessel was anastomosed between the Freestyle conduit and the distal aorta, and wrapped with omental pedicle. After three weeks, his serum CRP level was normal. He remained free of infection for at least three years.

Balloon Post-Dilation Following Implantation of a Self-Expanding Transcatheter Aortic Valve Bioprosthesis

ObjectivesThis study sought to explore the impact of balloon post-dilation (BPD) on outcomes in the CoreValve US Clinical Trials. BackgroundBPD following transcatheter aortic valve replacement (TAVR) has been used in selected cases to optimize hemodynamic results. MethodsProcedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. “Best practice” guidelines recommended BPD for treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual aortic regurgitation (AR). ResultsProcedural BPD was performed in 782 patients (22%) patients. The most common (58.1%) indication was greater than or equal to moderate AR following valve deployment. Greater baseline aortic valve gradients (p < 0.001), higher grades of baseline AR (p < 0.001), larger annular diameters (p < 0.001), and lower device to annular ratios (p < 0.001) were more common in patients who underwent BPD. BPD was performed less often with the 26-mm valve (17.9%) compared to the 31 mm (38.1%) (p < 0.05). BPD reduced moderate or severe AR by 75.6% from 58.1% to 14.2%. Thirty-day and 1-year clinical events were similar in the 2 groups, although acute kidney injury was more common in patients undergoing BPD (p = 0.026). In-hospital major adverse cardiovascular and cerebrovascular event rates were 9.3% in the BPD group versus 7.5% for others (p = NS). There was no increase in neurological events. ConclusionsBPD of the self-expanding bioprosthesis was performed in 22% of patients in the CoreValve US Clinical Trials most commonly to reduce the degree of residual AR. BPD was effective in acutely improving valve performance without an associated increase in neurologic events. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement; NCT01531374)

391 - Evaluation of automatic software to select aortic bioprosthesis before transcatheter aortic valve implantation

391 - Evaluation of automatic software to select aortic bioprosthesis before transcatheter aortic valve implantation

740 - Coronary procedures in patients treated by TAVI with the self-expanding aortic bioprosthesis Medtronic CoreValve ©, not an easy matter

740 - Coronary procedures in patients treated by TAVI with the self-expanding aortic bioprosthesis Medtronic CoreValve ©, not an easy matter

Reducing Prosthesis-Patient Mismatch With Edwards Magna Prosthesis for Aortic Valve Replacement.

Prosthesis-patient mismatch (PPM) is associated with increased mid-term and long-term mortality rates after aortic valve replacement (AVR). This study aimed to evaluate the efficacy of the Carpentier-Edwards Perimount Magna and Magna Ease (CEPMs) aortic bioprostheses to reduce the incidence of PPM.Methods and Results:Altogether, 282 consecutive patients (113 women, mean age 69.9±9.9 years) underwent AVR with a CEPMs between 2008 and 2015. They were divided into 3 groups based on the risk of PPM as a result of their body surface area and aortic annular diameter (BSA/AnnD ratio): low-risk (LR) group: 0.64±0.05 m2/cm (n=94); medium-risk (MR) group: 0.73±0.02 m2/cm (n=94); high-risk (HR) group: 0.83±0.05 m2/cm (n=94). The 30-day mortality rate was 0.4%. The 5-year actuarial survival rates were 93.2%, 92.3%, and 94.8% for groups LR, MR, and HR, respectively. No explants as a result of structural valve deterioration occurred. No patients showed severe PPM, defined as a measured effective orifice area index (EOAI) <0.65 cm2/m2. Although there were significant (P<0.05) differences in EOAI (0.98±0.2, 0.90±0.21, and 0.88±0.1 cm2/m2among the LR, MR, and HR groups, respectively), the corresponding transvalvular mean pressure gradients (13.0±5.5, 12.3±4.0, 12.7±5.3 mmHg) and regression rates of the left ventricular mass (29.8%, 28.7%, 28.9%) were similar among groups. CEPMs provide low surgical risk and reduce the risks of PPM, even in HR patients, with excellent hemodynamics.

Perceval S and Coronary Artery Bypass Grafting, Contradiction or Full Harmony?

Background / Study Objective: Coronary artery disease is very common in patients who are referred to aortic valve replacement. Concomitant coronary artery bypass grafting (CABG) procedure does not necessarily contradict with the use of last generation sutureless bioprostheses, but, publications about this combined approach are very limited. The objective of this study is to describe the results of aortic valve replacement plus CABG using Perceval S aortic sutureless bioprostheses in our Center. Methods: From our database we retrospectively described the outcomes of 42 patients who underwent aortic valve replacement with a last generation sutureless bioprostheses (Perceval S) plus CABG at the same procedure. We used a combination of arterials (left internal mammary artery (LIMA), right internal mammary artery (RIMA) and radial artery) and saphenous vein for the coronary artery bypass grafting. Most of the patients received 1 bypass (range: 1-3). Mean age: 78,19 ± 5,1. Male 64,3%, female 35,7%. Cardiovascular risk factors: Hypertension 97,6%; Diabetes 38,1%, Dyslipidemia 69%, peripheral vascular disease 38,2%, prior stroke 9,5%, chronic renal failure 40,5%, obstructive pulmonary disease 21,4% of the patients. Mean Logistic EuroScoreI/II: 16,68/10,73% (expected mortality). Results and Conclusions: Excellent results were achieved in patients undergoing aortic valve replacement with Perceval S sutureless bioprostheses and concomitant coronary artery bypass grafting. Although high aortotomy is needed for Perceval S implantation, is possible to perform proximal anastomosis for saphenous grafts properly. Perceval S is a feasible alternative for patients with aortic valve stenosis and coronary artery disease, with shorter cross-clamp and extracorporeal circulation times and low rate of complications.

Early clinical outcomes of a novel self-expanding transapical transcatheter aortic valve bioprosthesis

ObjectiveCoronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland). MethodsBetween May 2014 and April 2015, 30 consecutive patients (aged 85 ± 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 ± 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n = 14), peripheral vascular disease in 43% (n = 13), and porcelain aorta in 30% (n = 9). The mean left and right coronary heights were 10.8 ± 1.5 mm and 16.4 ± 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 ± 0.8. ResultsAll 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n = 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 ± 17 and 84 ± 31 mm Hg to 14 ± 7 and 28 ± 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n = 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively. ConclusionsThe Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction.