Prosthetic Valve Stenosis Research Articles

Left-Sided Prosthetic Valve Dysfunction and Gastrointestinal Bleeding.

Introduction We sought to investigate the association between left-sided prosthetic valve dysfunction and gastrointestinal (GI) bleeding. Methods In a retrospective cohort of patients with left-sided prostheses, we identified those who experienced one or more GI bleeds. The latest or chronologically closest echocardiogram to the GI bleed was analyzed by a blinded investigator for prosthetic valve dysfunction. Results Among 334 unique patients, 166 had aortic prostheses, 127 had mitral prostheses, and 41 had both. A total of 58 (17.4%) subjects had GI bleeding events. Patients in the "GI Bleed" group had higher mean ejection fraction (56±14% vs. 49±15%; P = 0.003) and higher prevalence of hypertension, end-stage renal disease, and liver cirrhosis compared to the "No GI Bleed" group. There was a higher prevalence of moderate or severe prosthetic valve regurgitation in the GI Bleed vs. No GI Bleed group (8.6% vs. 2.2%; P = 0.027). Moderate or severe prosthetic valve regurgitation was independently associated with GI bleeding (odds ratio, 6.18; 95% confidence interval, 1.27-30.05; P = 0.024), after adjusting for ejection fraction, hypertension, end-stage renal disease and liver cirrhosis. Paravalvular regurgitation was associated with a higher incidence of GI bleeding compared to transvalvular regurgitation (35.7% vs. 11.9%; P = 0.044). The prevalence of prosthetic valve stenosis was similar between the GI Bleed and No GI Bleed groups (6.9% vs. 5.8%; P = 0.761). Conclusion In a cohort of patients with predominantly surgically placed prosthetic valves, moderate to severe left-sided prosthetic valve regurgitation was independently associated with GI bleeding.

Prosthetic Mitral Valve Stenosis Caused by Preserved Native Anterior Mitral Valve Leaflet

Prosthetic Mitral Valve Stenosis Caused by Preserved Native Anterior Mitral Valve Leaflet

Easy surgical explantation technique for sutureless Perceval S prosthesis, ‘lasso technique’: a case report

BackgroundDue to structural valve deterioration of sutureless aortic prosthesis, there is a need for explantation of the prothesis. We introduce a surgical technique to explant sutureless aortic prosthesis, which has a self-expanding stent incorporated into the aortic wall.Case presentationAn 82-year-old man who had undergone sutureless aortic valve replacement 6 years previously underwent redo-aortic and mitral valve replacement because of severe prosthetic aortic valve stenosis and mitral regurgitation. The sutureless prosthesis was explanted using ‘lasso technique’. The patient was discharged after 7 days without complications.ConclusionsWe presented a useful technique to explant a sutureless aortic prosthesis.

Comparison of Echocardiographic and Catheter Mean Gradient to Assess Stenosis After Transcatheter Aortic Valve Implantation

Discordance exists between Doppler-derived and left heart catheterization (LHC)-derived mean gradient (MG) in transcatheter aortic valve implantation (TAVI). We compared echocardiographic parameters of prosthetic valve stenosis and LHC-derived MG in new TAVIs. In a retrospective, single-center study, intraoperative transesophageal echocardiogram (TEE)-derived MG, LHC-derived MG, and acceleration time (AT) were obtained before and after TAVI in 362 patients. Discharge MG, AT, and Doppler velocity index (DVI) using transthoracic echocardiogram (TTE) were also obtained. MG ≥10 mm Hg was defined as abnormal. During native valve assessment with pre-TAVI TEE and pre-TAVI LHC, Pearson correlation coefficient revealed a nearly perfect linear relation between both methods' MGs (r=0.97, p <0.0001). Intraoperatively, after TAVI, Spearman correlation coefficient revealed a weak-to-moderate relation between post-TAVI TEE and LHC MGs (r=0.33, p <0.0001). Significant differences were observed in categorizations between post-TAVI TEE MG and post-TAVI AT (McNemar test p=0.0003) and between post-TAVI TEE MG and post-TAVI LHC MG (signed-rank test p <0.0001), with TEE MG more likely to misclassify a patient as abnormal. At discharge, 30% of patients had abnormal TTE MG, whereas 0% and 0.8% of patients had abnormal DVI and AT, respectively. Discharge TTE MG was not associated with death or hospitalization for heart failure at a median follow-up of 862days. Post-TAVI Doppler-derived MG by intraoperative TEE was higher than LHC, despite being virtually identical before implantation. At discharge, patients were more likely to be classified as abnormal using MG than DVI and AT. Elevated MG at discharge was not associated with death or hospitalization for heart failure.

Giant left atrium and Giant Eustachian valve in a patient with stenosis of mitral valve prosthesis

Giant left atrium (LA) is a extremely rare condition due to decline in rheumatic heart disease incidence. Giant Eustachian valve (EV) is an exceptionally rare finding, visualized on echocardiography in only 0.20% in adults. Typically is functionless in adults. We report a giant LA due to prosthetic mitral valve (MV) stenosis, seen on echocardiography, with late stage presentation in a 73-year-old woman. She had a history of MV replacement due to rheumatic MV disease 20-years ago. Echocardiography was suggestive for severe stenosis of MV prosthesis and giant LA with a size of 12.6x13.1cm, while computed tomography scan revealed a LA size of 17 × 11 cm. Giant EV was accidental finding on echocardiogram, that extended from the orifice of the inferior vena cava to the interatrial septum, without clinical significance. The patient was offered to undergo cardiac surgery on many occasions, but she kept refusing surgery. At last she accepted,unfortunately she died before proceeding to surgical intervention. A rheumatic giant LA due to stenosis of MV prosthesis is rarely reported entity in the literature and may be associated with significant morbidity and mortality. Optimal timing for surgery is crucial. Giant EV is rare accidental finding on echocardiography. Pre-operative identification of this structure is important, as it could be mistaken for pathology, ending with unnecessary treatment. This is a first echocardiographic report of coexistence of giant LA and giant EV.

Good response to plasmapheresis and mycophenolate mofetil in a patient with anti-synthetase syndrome associated with peripheral neuritis and severe prosthetic aortic valve stenosis

BackgroundIdiopathic inflammatory myopathies (IIM) are a disease complex that encompasses several distinctly acquired muscle illnesses. Anti-synthetase syndrome is a subset of IIM that is characterized by the presence of antibodies against aminoacyl-tRNA synthetases (ARS). This syndrome has a characteristic phenotype of IIM. Anti-synthetase syndrome was rarely associated with peripheral nerve involvement and endocarditis.Case presentationWe report a 46-year-old female patient with a history of mitral and aortic valve replacement for seven years and on warfarin, presented with symmetrical muscular weakness, generalized edema, progressive dyspnea, dysphagia, fever, fatigue, myalgia, and polyarthralgia. The motor power grading was 2 in proximal muscles of upper limbs and 3 in the distal muscles involving hands and wrists, and it was 0 in proximal muscles in lower limbs and 2 in distal muscles involving ankle and toes movements. Also, her oxygen saturation decreased remarkably. Echocardiography revealed that the patient had severe stenosis (70%) of the prosthetic aortic valve. Electrophysiological studies showed axonal polyneuropathy with average F wave latencies. She was diagnosed with anti-synthetase syndrome for elevated muscle enzymes, interstitial lung disease (ILD), mechanic’s hands, fever, polyarthralgia, and positive anti-Jo-1 antibody. There was a significant improvement with plasmapheresis, mycophenolate mofetil (MMF), and high-dose prednisolone.ConclusionsTo the best of our knowledge, this is a case of anti-synthetase syndrome accompanied by neuropathic involvement and cardiac valve prosthetic stenosis. These were reported as an unusual presentation of the anti-synthetase syndrome. The significant improvement with plasmapheresis gives us a treatment choice for similar critical cases.

Role of myocardial strain and rotation for predicting prosthetic aortic valve stenosis.

Pressure overload due to aortic stenosis leads to subclinical left ventricular (LV) dysfunction and global longitudinal strain (GLS) impairment even if ejection fraction is preserved. However, little is known about LV mechanics in aortic prosthetic valve (APV) stenosis. The study aimed to determine the role of myocardial strain and rotation in predicting prosthetic valve stenosis in mechanical APV patients. 60 patients with mechanical APV and 30 healthy individuals were evaluated. APV patients were analyzed in two groups; aortic valve mean gradient < 20mmHg (27 normal gradient patients) and ≥ 20mmHg (33 high gradient patients). Strain, rotation, and twist values were assessed using the speckle tracking method, and brain natriuretic peptide (BNP) levels were measured. Four-chamber (p < 0.001) and two-chamber (p = 0.008) longitudinal strain (LS) were higher in the control group. GLS was lower in the high gradient group than control and normal gradient groups (p < 0.001, p = 0.022). LS of lateral wall's basal and mid segments were lower in normal and high gradient groups than the control group (p = 0.003, p = 0.008). While basal rotation was lower in the high gradient group than the control group (p = 0.048), there was no difference between the groups in terms of apical rotation, and twist. BNP levels were significantly different between the groups (p = 0.048). No correlation was found between aortic valve mean gradient and GLS, basal rotation, and BNP. In conclusions, LV GLS and basal rotation are depressed in high APV gradient patients; however, these parameters are not independent predictors of gradient increment.

BALLOON VALVULOPLASTY FOR EARLY BIOPROSTHETIC AORTIC VALVE STENOSIS IN SEPTUAGENARIAN - A RAY OF HOPE

Calcic aortic stenosis (AS) remains a major cause of mortality and morbidity in the aging population . Surgical AV Replacement (SAVR) and Transfemoral Aortic Valve Implantation (TAVI) are available treatment options. With improvements in long term patient survival after AVR and increases in overall longevity, more patients are now seen with Prosthetic Aortic Valve failure. The management of patients with stenotic aortic bioprostheses is usually surgical. However, a proportion of such patients are unt for such procedures. The technique of aortic balloon valvuloplasty as an alternative treatment strategy for such patients is explored. We report a case of seventy-three-year-old male with prosthetic aortic valve stenosis treated with balloon valvuloplasty with promising intermediate term outcome and describe the growing valve in valve procedure. Hence this case is reported to enhance our knowledge and potentiate literature regarding the management strategy of prosthetic aortic valve stenosis in old age.

2021 Korean Heart Rhythm Society Guidelines for Stroke Prevention in Atrial Fibrillation

Atrial fibrillation (AF) is a strong risk factor for ischemic stroke and systemic embolism. To prevent thromboembolic events in patients with AF, anticoagulation therapy is essential. The anticoagulant strategy is determined after stroke and bleeding risk assessments using the CHA2DS2-VASc and HAS-BLED scores, respectively; both consider clinical risk factors. Vitamin K antagonists (VKAs) are the sole anticoagulant option in AF patients with a prosthetic mechanical valve or moderate-severe mitral stenosis; in all other AF patients VKA or non-vitamin K antagonist oral anticoagulants are therapeutic options. However, antiplatelet therapy should not be used for stroke prevention in AF patients. Anticoagulation is not needed in AF patients with low stroke risk but strongly recommended in those with a with low bleeding risk. Left atrial appendage (LAA) occlusion offers an alternative in AF patients in whom long-term anticoagulation is contraindicated. Surgical occlusion or the exclusion of LAA can be considered for stroke prevention in AF patients undergoing cardiac surgery. In this article, we review existing data for stroke prevention and suggest optimal strategies to prevent stroke in AF patients.

Comparative analysis of structural valve deterioration and long-term clinical outcomes after bovine pericardial versus porcine bioprosthetic mitral valve replacement

BackgroundThis study aimed to compare long-term outcomes, including durability, after bovine pericardial valve replacement with those after porcine mitral valve replacement (MVR).MethodsWe enrolled 309 patients who underwent MV replacement (mean age: 65.8±11.5 years; 68.9% females) with Carpentier-Edwards PERIMOUNT bovine pericardial valves (bovine MVR group, n=241) or Hancock II porcine bioprosthesis (porcine MVR group, n=68). The mean clinical and echocardiographic follow-up durations were 81.4±60.0 and 57.8±53.3 months, respectively. Structural valve deterioration (SVD) was defined as prosthetic mitral valve (MV) regurgitation or stenosis of greater than moderate degree combined with a motion limitation, tear, or perforation of prosthetic valve leaflet on follow-up echocardiography. Propensity score (PS)-adjusted multivariable analyses were performed.ResultsThirty-day mortality rate was 6.4% (20/309 patients). SVD occurred in 50 patients (33 and 17 patients in the bovine and porcine MV replacement groups, respectively). Cumulative incidences of SVD at 5, 10, and 15 years were 3.2%, 15.9%, and 32.4%, respectively, in the bovine MVR group and 1.9%, 15.3%, and 41.7%, respectively, in the porcine MVR group. Cumulative incidences of SVD in the two groups were not different in competing risk analysis (P=0.23). Other clinical outcomes including overall survival and cumulative incidences of cardiac death and MV-related events were not statistically significantly different between the groups in PS-adjusted multivariable analyses.ConclusionsLong-term clinical outcomes including SVD were not different between the bovine and porcine bioprosthesis MVR groups during average 7 years of clinical follow-up after MVR.

Comparison between two anticoagulant regimens to prevent thrombosis in atrial fibrillation: an analysis mediated by transesophageal echocardiography

Abstract Funding Acknowledgements Type of funding sources: None. Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia causing left atrial appendage thrombosis (LAA-T) which can result in cerebral and systemic embolism. Nowadays, both vitamin K antagonists (VKA) and Direct Oral Anti Coagulants (DOAC) are effective for the prevention of ischaemic stroke in AF. Transesophageal echocardiography (TEE) is the best method to detect LAA-T in AF. However, data on the prevalence of LAA-T are lacking. Purpose. The aim of the study was 1) to evaluate the prevalence of LAA-T in patients affected by AF, receiving different anticoagulation regimens and candidates to cardioversion or catheter ablation 2) to correlate the presence of LAA-T with clinical and echocardiographic data. Methods. This is an observational, single-center study including 796 patients (73% male) with AF. TEE before cardioversion or catheter ablation was performed in all patients. Patients with mechanical prosthetic valve and severe mitral stenosis were excluded. Patients were divided in 2 groups according to anticoagulation regimen: Group 1 including patients on DOAC (dabigatran, rivaroxaban, apixaban, edoxaban) and Group 2 including patients on VKA at therapeutic dose. Results Group 1 included 369 patients (46%), Group 2 427 (54%). Age, CHA2DS2-VASc score, sex and pathology distribution (lone FA, hypertension, valve disease, ischemic cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy) were similar in the 2 groups. The overall prevalence of LAA-T was 43 cases (5%). Similar percentage of LAA-T was found regardless of anticoagulation regimen (Group 1: 16 cases, 4%; Group 2: 27 cases, 6%, p = 0.220). No difference in LAA-T prevalence was detected within Group 1 for different DOACs (p = 0.547). Patients with LAA-T were more frequently older (p = 0.023), female (p = 0.001), with higher CHA2DS2-VASc score (p = 0.002), affected by hypertrophic cardiomyopathy (p = 0.019), valve disease or bioprostetic valve (p = 0.001) regardless of anticoagulation regimen. A total of 697 patients (88%) were scheduled for cardioversion or catheter ablation. Cardioversion was successful in 667 patients (95%) without any ischemic event. Only 1 patient (0.1%) undergoing catheter ablation had a major ischemic event. Conclusions Efficacy of anticoagulation with VKA and DOAC is similar in preventing LAA-T in patients with AF. However, despite optimal adherence to a therapeutic regimen, several clinical factors (age, gender, high CHA2DS2-VASc score, hypertrophic cardiomyopathy and valvular disease) were associated with higher prevalence of LAA-T. TEE guided approach to cardioversion may prevent the risk of embolic events regardless of anticoagulation regimen used.

Simultaneous Aortic Valve-in-Valve and Ascending Stent Grafting for Prosthetic Valve Stenosis and Ascending Flap.

Report on total endovascular repair for a diseased aortic valve and the ascending aorta is few. Therefore, we report a case of prosthetic aortic valve stenosis and internal bovine pericardial flap after ascending aortic replacement complicated by congestive heart failure and hemolysis. Because the patient had high surgical risk and was anatomically suitable to undergo ascending endovascular repair, simultaneous transcatheter aortic valve-in-valve implantation and ascending endografting were performed. Her symptoms of heart failure and hemolysis resolved postoperatively. Thus, a simultaneous transcatheter procedure for a diseased aortic valve and the ascending aorta is a feasible option for appropriately selected patients.

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

Echocardiography-Guided Novel Transcatheter Approach for Frozen Cusp of Mitral Bioprosthesis

A 69-year-old woman with a history of mitral valve (MV) replacement was admitted for acute respiratory failure due to acute infective endocarditis complicated by cardiogenic shock, severe paravalvular mitral regurgitation (MR), severe degenerative mitral prosthetic valve stenosis, severe aortic

OUTCOMES OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PROSTHETIC VALVE STENOSIS

Prosthetic valve stenosis is an important complication in patients with history of prior aortic valve replacement. There is a lack of randomized trials comparing outcomes of subsequent intervention, either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in

P252 Incidental finding of a chronic left ventricular pseudoaneurysm years after surgical aortic valve replacement

Abstract Case presentation A 35-years old female was referred to our outpatient clinic with unclear thoracic pain and dyspnea. Clinical chemistry testing was unremarkable. Electrocardiography (ECG) showed T-wave inversion in the anterior-lateral leads. Chest X-ray displayed an oval bulge on the left border of the heart. The physical exam revealed a systolic murmur on top of the closing click sound of a mechanical aortic valve prothesis which had been implanted nine years ago. Since that time, the patient had not had regular checkups and the actual consultation was motivated by her aggravating symptoms only. Findings. In transthoracic echocardiography, the mechanical aortic valve prothesis exhibited an acceptable peak velocity of 2.7 m/s with a mean gradient of 18 mm Hg and only mild paravalvular regurgitation. The native mitral and tricuspid valves were functionally and morphologically normal. Left and right ventricle were of normal systolic and diastolic function and normal size. No signs of pericardial effusion were detected. However, a big (40x22mm) saccular structure with a narrow (10 mm) neck was visible at the apex of the left ventricle, see left panel of figure. At the neck, a bidirectional flow between the saccular structure and the left ventricle was detected with a peak velocity of 2,5 m/sec indicating the presence of a pseudoaneurysm. Its linings were calcified and free of discernable thrombus formation, although the flow inside was turbulent as evidenced in the contrast echocardiogram, see right panel of figure. Subsequently, CT-imaging confirmed the diagnosis and surgical resection of the pseudoaneurysm was successfully performed 10 days later. The surgeon noted that the walls of the resected cavity contained thrombotic masses despite respective negative findings on CT and echo. The postoperative course was uneventful, and the patient was discharged in good condition with normal left and right ventricular function and no regional left ventricular wall abnormalities. A year later, she was however re-admitted with prosthetic aortic valve stenosis due to thrombus formation on one the leaflets in the second trimester of a pregnancy. Discussion This is an exceptional case of chronic left ventricular pseudoaneurysm following aortic valve replacement. Since the patient had no history of myocardial infarction or of other potential causes that could explain the formation of a pseudoaneurysm, it is likely to be a remnant of venting the left ventricle during the original surgical procedure. The patient had been unattended and asymptomatic for several years which allowed chronification as indicated by the calcifications of the inner linings. Still, immediate surgical repair was mandatory due to the high risk of rupture and thromboembolism. Abstract P252 Figure.

P3780Clinical characteristics and outcomes in Japanese atrial fibrillation patients with valvular heart disease: the Fushimi AF registry

Abstract Background Previous studies have suggested that valvular atrial fibrillation (VAF), defined as atrial fibrillation (AF) patients with prosthetic valve or rheumatic mitral stenosis, increased the risks of thromboembolism. However, clinical characteristics and outcomes of VAF and non-valvular AF (NVAF) patients with other valvular heart disease (VHD) has not been fully described. Method The Fushimi AF Registry was designed to enroll all of the AF patients. In the entire cohort (4,454 patients), follow-up data including echocardiography data were available for 3,566 patients. We compared clinical characteristics and outcomes between 131 VAF patients (3.7%), 583 NVAF with VHD (NVAF-VHD: 16.3%) and 2,852 without VHD (Non-VHD: 80.0%). Result Compared with Non-VHD, patients in VAF and NVAF-VHD were older (VAF vs. NVAF-VHD vs. Non-VHD: 74.3 vs. 76.9 vs. 72.9 years, respectively; p≤0.0001), more often female (56.5% vs. 51.1% vs. 36.9%, p≤0.0001), less in body weight (54.3 vs. 54.7 vs. 60.6 kg, p≤0.0001), more persistent/permanent type (64.1% vs. 65.4% vs. 45.8%, p≤0.0001), more likely to have heart failure (61.8% vs. 53.2% vs. 23.3%, p≤0.0001), had higher CHADS2 score (2.18 vs. 2.49 vs. 1.96, p≤0.0001) and CHA2DS2-VASc score (3.71 vs. 4.02 vs. 3.26, p≤0.0001), and received oral anticoagulant prescription more frequently (78.6% vs. 63.0% vs. 55.6%, p0.0001). NVAF-VHD was more likely to have previous stroke/systemic embolism (SE) than VHD or Non-VHD (14.5% vs. 23.5% vs. 19.6%, p=0.03). VAF or NVAF-VHD had larger left atrium than Non-VHD (50.5 vs. 47.2 vs. 42.4 mm, p&lt;0.0001). Heart rate, diabetes mellitus and previous bleeding were comparable between the groups. During the median follow-up of 1,471 days, the incidence rate of stroke/SE was not significantly different between three groups, however, NVAF-VHD showed modestly higher rate than Non-VHD (1.67 vs. 1.96 vs. 1.28 per 100 person-years, respectively, log rank p=0.054) (Figure). The incidence rates of all-cause death (4.62 vs. 5.74 vs. 3.21, p≤0.0001), cardiac death (1.07 vs. 1.01 vs. 0.44, p=0.0003), and those of hospitalization for heart failure (3.29 vs. 4.41 vs. 1.80, p≤0.0001) were higher in NVAF-VHD and VAF, than Non-VHD. After adjustment by relevant factors including the components of CHA2DS2-VASc score and oral anticoagulant use, NVAF-VHD, but not VAF, was an independent predictor for hospitalization for heart failure. Neither VAF nor NVAF-VHD was predictors for all-cause death, cardiac death or stroke/SE. Figure 1. Incidence of stroke/SE Conclusion As compared with Non-VHD, the risk of stroke/SE in VAF and NVAF-VHD was not particularly high; although NVAF-VHD had modestly higher rate than Non-VHD. VAF and NVAF-VHD were associated with higher incidence rates of all-cause death, cardiac death and hospitalization for heart failure. NVAF-VHD was an independent predictor for hospitalization for heart failure in multivariate analysis. Acknowledgement/Funding Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare and Daiichi Sankyo

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. Boston Scientific (USA).

Pregnancy and transcatheter aortic valve replacement in a severely stenotic Freestyle full aortic root stentless bioprosthesis

Symptomatic degenerative prosthetic aortic valve stenosis during pregnancy represents a significant risk to both mother and fetus, and until recently, surgical aortic valve replacement (SAVR) during pregnancy was often the only choice for women opting to continue pregnancy. However, symptomatic severe stenosis in a pregnant woman with a degenerated full aortic root Freestyle stentless bioprosthesis (FSB) and reimplanted coronary arteries presents additional complexities that require an alternative surgical approach. In this case report, we describe the first successful transcatheter aortic valve replacement (TAVR) in SAVR for a severely stenotic degenerative FSB in a pregnant woman and subsequent delivery of a healthy infant several months later. TAVR in SAVR of a severely stenotic aortic FSB should be considered as a surgical option in symptomatic pregnant women. Short-term and long-term implications for future pregnancy should be discussed by a multidisciplinary team and with the patient.

Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

The Trifecta valve (Abbott, St Paul, MN) has excellent hemodynamic performance with acceptable rates of freedom from structural valve degeneration. However, some recent studies have reported early Trifecta valve failure. Here, we report a case series of seven Trifecta valve failures with a review of the literature. Of 107 implantations of Trifecta bioprostheses between 2012 and 2014, we encountered seven Trifecta valve failures (6.5%). Failure of a 19-mm Trifecta valve occurred in 1 patient, failure of a 21-mm Trifecta valve occurred in 5 patients, and failure of a 23-mm Trifecta valve occurred in 1 patient. The mean duration of valve durability was 51 ± 16 months. The mean effective orifice area index on the first echocardiogram after Trifecta valve implantation was 0.96 ± 0.26. The mode of presentation was prosthetic valve stenosis in 3 patients and severe aortic regurgitation in 4 patients. Six patients underwent redo surgical aortic valve replacement. The common pathologic findings were circumferential pannus formation with noncoronary cusp tear and leaflet calcification. The rates of preoperative end-renal stage disease and postoperative prosthesis-patient mismatch were higher in patients with Trifecta valve failure. The incidence of early Trifecta valve failure was 3.1% at 48 months and 13.1% at 72 months. In our experience, early Trifecta valve failure was caused by cusp tears or leaflet calcification. Patients with end-renal stage disease and prosthesis-patient mismatch should be closely followed. Some patients with cusp tears may require urgent surgery.