Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.

ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized Clinical Trial.

OBJECTIVES: This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm). BACKGROUND: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. METHODS: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. RESULTS: At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). CONCLUSIONS: Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930).

Alfred Caleb Taylor (1860-1927): X-ray pioneer and martyr.

Alfred Caleb Taylor was the first radiographer at the Peterborough Infirmary and Dispensary from 1896 to 1923. He constructed the first X-ray apparatus and oversaw the development of the X-ray service in Peterborough. He contracted a chronic radiation dermatitis from exposure to X-rays which was a source of considerable suffering for him. When he died in 1927, X-ray dermatitis was considered to have contributed to his death, and he was recognised as an X-ray martyr and a victim of science. In spite of his achievements and his ill-health from working with X-rays, his name is not included on the Martyrs Memorial in Hamburg.

Thomas James Walker (1835-1916): Surgeon and general practitioner.

Thomas James Walker was a surgeon and general practitioner who worked in the city of Peterborough at a time when there were changes and innovations in the practice of medicine. After training in medicine and surgery at Edinburgh University, he qualified in London in 1857. He was a pioneer of laryngoscopy. He played an important role in introducing antiseptic surgery to the Peterborough Infirmary and was instrumental in the development of the operating theatre which opened in 1894. He was a philanthropist and collector of Roman and Saxon artefacts. In 1915, he was recognized as an outstanding member of the Peterborough community when he was offered the Freedom of the City.

Five-year haemodynamic outcomes of the first-generation SAPIEN balloon-expandable transcatheter heart valve.

AIMS: Transcatheter aortic valve implantation (TAVI) has gained rapid acceptance for patients with severe aortic stenosis (AS) at high surgical risk for conventional valve replacement. Although TAVI is now a relatively mature technique, limited data about long-term valvular function are available. Our aim was to report the five-year echocardiographic data evaluating valve performance from three early European feasibility studies designed to assess the safety and effectiveness of the first-generation balloon-expandable transcatheter heart valve (SAPIEN THV). METHODS AND RESULTS: A total of 410 patients were enrolled in the following single-arm, non-randomised, prospective multicentre clinical studies: REVIVE II, TRAVERCE and PARTNER EU. Five-year follow-up was completed in 114 surviving patients. Mean patient age was 82.3±5.6 years; 63.4% were female. The mean logistic EuroSCORE was 28.4±13.3%. NYHA Class III/IV was reported in 92.5%. At five years, the mean effective orifice area (EOA) was 1.6±0.6 cm² (n=34) and the mean gradient was 11.7±5.4 mmHg (n=39). In paired patient data, the difference between discharge and five-year EOA was 0.1±0.7 cm² (p=0.3956) and mean gradient was 2.2±5.7 mmHg (p=0.0900). At discharge and five years, respectively, aortic regurgitation (AR) was evaluated as none/trace in 66.6% (n=162/243) and 55.3% (n=19/38), mild in 28.4% (n=69/243) and 39.5% (n=15/38), and moderate in 4.9% (n=12/243) and 5.3% (n=2/38). No severe AR was reported at follow-up. Valve thrombosis was observed in three patients and occurred within one year. No valve-related explants and no case of structural valve deterioration have been reported. CONCLUSIONS: Long-term echocardiographic outcomes in high-risk patients with severe AS suggest stable haemodynamic function of first-generation balloon-expandable SAPIEN THVs at five years, with no worsening of AR severity over time.

Implementation and consistency of Heart Team decision-making in complex coronary revascularisation.

BACKGROUND: A multidisciplinary team (MDT) approach for decision-making in patients with complex coronary artery disease (CAD) is now a class IC recommendation in the European and American guidelines for myocardial revascularisation. The aim of this study was to evaluate the implementation and consistency of Heart Team HT decision-making in complex coronary revascularisation. METHODS: We prospectively evaluated the data of 399 patients derived from 51 consecutive MDT meetings held in a tertiary cardiac centre. A subset of cases was randomly selected and re-presented with the same clinical data to a panel blinded to the initial outcome, at least 6 months after the initial discussion, in order to evaluate the reproducibility of decision-making. RESULTS: The most common decisions included continued medical management (30%), coronary artery bypass grafting (CABG) (26%) and percutaneous coronary intervention (PCI) (17%). Other decisions, such as further assessment of symptoms or evaluation with further invasive or non-invasive tests were made in 25% of the cases. Decisions were implemented in 93% of the cases. On re-discussion of the same data (n=40) within a median period of 9 months 80% of the initial HT recommendations were successfully reproduced. CONCLUSIONS: The Heart Team is a robust process in the management of patient with complex CAD and decisions are largely reproducible. Although outcomes are successfully implemented in the majority of the cases, it is important that all clinical information is available during discussion and patient preference is taken into account.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.

OBJECTIVES: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. BACKGROUND: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. METHODS: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. RESULTS: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). CONCLUSIONS: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

Impact of left ventricular function and transaortic gradient on outcomes from transcatheter aortic valve implantation: data from the UK TAVI Registry.

AIMS: Aortic valve surgery in the presence of reduced ejection fraction (EF) or low transaortic gradient is associated with adverse outcome. Low gradient (LG) may be associated with reduced EF, known as low EF-low gradient (LEF-LG), or "paradoxically" low with normal EF (P-LG). Our aim was to investigate the impact of EF and transaortic gradient on outcome following transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We retrospectively analysed the UK TAVI Registry from 2007 to 2011 (n=2,535 consecutive patients, mean age 81.3±7.5, logistic EuroSCORE 21.8±14). Thirty-day mortality was 7.8%, low EF (<50%) was present in 39%, low gradient (<64 mmHg) was present in 27%, LEF-LG in 15% and P-LG in 12% of patients, respectively. LEF-LG patients had the highest risk profile vs. the other groups (EuroSCORE 30±16 vs. 20±12, p<0.001). Neither EF nor gradient impacted on procedural outcome or 30-day mortality. Mortality at two years was significantly higher in LEF-LG patients (34.7%), whereas, in patients with low EF/high gradient (27.8%) or normal EF/low gradient (23%), mortality was not significantly different from that of normal EF/high gradient (23%) patients. LEF-LG independently predicted reduced survival, HR 1.7 (1.4-2.1). CONCLUSIONS: Neither low EF nor low gradient affected procedural success or 30-day mortality. Long-term survival was reduced in LEF-LG patients but not in those with low EF and high gradient or P-LG with normal EF.

Percutaneous ventricular restoration (PVR) therapy using the Parachute device in 100 subjects with ischaemic dilated heart failure: one-year primary endpoint results of PARACHUTE III, a European trial.

AIMS: This prospective, non-randomised, observational study conducted in Europe was designed in order to assess the long-term safety and efficacy of the Parachute device in ischaemic heart failure subjects as a result of left ventricle remodelling after anterior wall myocardial infarction. METHODS AND RESULTS: One hundred subjects with New York Heart Association Class II-IV ischaemic heart failure (HF), ejection fraction (EF) between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularised were enrolled. The primary safety endpoint was procedural- or device-related major adverse cardiac cerebral events (MACCE). The secondary safety endpoint was the composite of mortality and morbidity. Secondary efficacy endpoints included haemodynamic measurements determined by echocardiography, LV volume indices, and assessment of functional improvement measured by a standardised six-minute walk test. Of the 100 subjects enrolled, device implantation was successful in 97 (97%) subjects. The one-year rates of the primary and secondary safety endpoints were 7% and 32.3%, respectively. The secondary endpoints, LV volume reduction (p<0.0001) and six-minute walk distance improvement (p<0.01), were achieved. CONCLUSIONS: The favourable outcomes observed in this high-risk population provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for HF subjects.

Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial).

OBJECTIVES: MAVERIC (Mitral Valve Repair Clinical Trial) reports the safety and efficacy of the ARTO system in patients with symptomatic heart failure and functional mitral regurgitation (FMR). BACKGROUND: The ARTO system percutaneously modifies the mitral annulus to improve leaflet coaptation in FMR. METHODS: The MAVERIC trial is a prospective, nonrandomized first-in-human study. Key inclusion criteria were systolic heart failure New York Heart Association functional classes II to IV, FMR grade ≥2+, left ventricular (LV) ejection fraction ≤40%, LV end-diastolic diameter >50 mm and ≤75 mm. Exclusion criteria were clinical variables that precluded feasibility of the ARTO procedure. Primary outcomes were safety (30-day major adverse events) and efficacy (MR reduction, LV volumes, and functional status). RESULTS: Eleven patients received the ARTO system, and there were no procedural adverse events. From baseline to 30 days, there were meaningful improvements. Effective regurgitant orifice area decreased from 30.3 ± 11.1 mm(2) to 13.5 ± 7.1 mm(2) and regurgitant volumes from 45.4 ± 15.0 ml to 19.5 ± 10.2 ml. LV end-systolic volume index improved from 77.5 ± 24.3 ml/m(2) to 68.5 ± 21.4 ml/m(2), and LV end-diastolic volume index 118.7 ± 28.6 ml/m(2) to 103.9 ± 21.2 ml/m(2). Mitral annular anteroposterior diameter decreased from 45.0 ± 3.3 mm to 38.7 ± 3.0 mm. Functional status was 81.8% New York Heart Association functional class III/IV improving to 54.6% functional class I/II. At 30 days, there were 2 adverse events: 1 pericardial effusion requiring surgical drainage; and 1 asymptomatic device dislodgement. CONCLUSIONS: The ARTO system is a novel transcatheter device that can be used safely with meaningful efficacy in the treatment of FMR. (Mitral Valve Repair Clinical Trial [MAVERIC]; NCT02302872).

European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.

OBJECTIVES: The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. BACKGROUND: Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. METHODS: The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. RESULTS: The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. CONCLUSIONS: The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT.

OBJECTIVES: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform. BACKGROUND: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known. METHODS: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography. RESULTS: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR. CONCLUSIONS: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.

Meta-analysis of the impact of mitral regurgitation on outcomes after transcatheter aortic valve implantation.

Significant mitral regurgitation (MR) constitutes an important co-existing valvular heart disease burden in the setting of aortic valve stenosis. There are conflicting reports on the impact of significant MR on outcomes after transcatheter aortic valve implantation (TAVI). We evaluated the impact of MR on outcomes after TAVI by performing a meta-analysis of 8 studies involving 8,927 patients reporting TAVI outcomes based on the presence or absence of moderate-severe MR. Risk ratios (RRs) were calculated using the inverse variance random-effects model. None-mild MR was present in 77.8% and moderate-severe MR in 22.2% of the patients. The presence of moderate-severe MR at baseline was associated with increased mortality at 30 days (RR 1.35, 95% confidence interval [CI] 1.14 to 1.59, p = 0.003) and 1 year (RR 1.24, 95% CI 1.13 to 1.37, p <0.0001). The increased mortality associated with moderate-severe MR was not influenced by the cause of MR (functional or degenerative MR; RR 0.90, 95% CI 0.62 to 1.30, p = 0.56). The severity of MR improved in 61 ± 6.0% of patients after TAVI. Moderate-severe residual MR, compared with none-mild residual MR after TAVI, was associated with significantly increased 1-year mortality (RR 1.48, 95% CI 1.31 to 1.68, p <0.00001). In conclusion, baseline moderate-severe MR and significant residual MR after TAVI are associated with an increase in mortality after TAVI and represent an important group to target with medical or transcatheter therapies in the future.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

AIMS: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. METHODS AND RESULTS: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. CONCLUSIONS: In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

How should I treat dislocation of a TAVI SAPIEN prosthesis into the left ventricle?

BACKGROUND: Despite the technical advancements of the transcatheter aortic valve implantation (TAVI) procedure, valve embolisation into the left ventricle remains a challenging situation requiring expedited management through the Heart Team. INVESTIGATION: The advantages and pitfalls of an interventional transfemoral approach, a transapical extraction of the dislocated prosthesis or the conversion to open heart surgery have to be balanced depending on the overall situation and the specific characteristics of the patient. DIAGNOSIS: A transfemoral approach would be the first choice for most TAVI implanters. We discuss the different options and present an elegant solution solving this challenging situation, leading to a good immediate and long-term outcome. MANAGEMENT: Attempts at pulling the prosthesis out of the ventricle using a balloon remained unsuccessful. After grasping of the prosthesis with a goose-neck snare, the valve was pulled into the annulus. A second SAPIEN XT prosthesis was implanted and fixed the first prosthesis within the annulus. After post-dilatation, there was a good result without relevant gradient and minimal aortic regurgitation.

Successful treatment of failing biological prosthesis because of "Stent creep" with valve-in-valve transcatheter aortic valve implantation.

INTRODUCTION: Stent creep is an uncommon mode of structural deterioration of bioprosthetic heart valves defined by a permanent inward deflection of the stent posts. This may occur because of valve over-sizing and leads to intrinsic valve stenosis. It has been described in older generation of bioprosthesis and was thought not to occur in modern devices. METHODS: We describe three patients who were referred for bioprosthetic valve degeneration with presumed aortic stenosis. Investigations demonstrated mid valvular gradient predominantly because of stent creep. We performed valve-in-valve TAVI with Edward SAPIEN prosthesis. RESULTS: Median age was 84 and logistic EuroSCORE 34.4. All patients had degenerated bioprosthesis with mean implant duration of 5.6 years. Two patients had Carpentier Edwards Perimount prosthesis (19 and 23 mm) and one patient had a Mitroflow (21 mm). Mean gradients were 33, 54, and 22 mm Hg. About 23 mm Edward SAPIEN valve was implanted in all cases with immediate improvement in haemodynamics with mean gradient reduction to 10, 17, and 8 mm Hg, respectively. The mean aortic valve area increased from 0.63 to 1.76cm(2) . There were no serious adverse events. The patients improved from NYHA III/IV to I/II post procedure and remain well at median follow-up of 24-months. DISCUSSION: Stent creep is an uncommon mode of structural deterioration in bioprosthetic heart valves. It has been described in the previous generation of bioprosthesis. It is important to distinguish leaflet dysfunction and stent creep. By forcing the stent posts outwards a balloon expandable TAVI device can be used to treat this condition.