Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve: Comparison with Other Self-Expanding Valves and Impact of a Learning Curve in a Single Chinese Center.

Objectives: We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter self-expanding valves and to investigate the impact of the learning curve on post-TAVR AR. Background: Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR. Methods and results: This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of post-procedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves. Conclusion: The Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves.

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

Transcatheter Aortic Valve Replacement vs Surgical Replacement in Patients With Pure Aortic Insufficiency.

OBJECTIVE: To compare the outcomes of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients with pure aortic insufficiency (PAI). BACKGROUND: The treatment of choice for patients with severe symptomatic PAI is SAVR. However, not all patients are candidates for surgery because of comorbidities or are deemed high risk for surgery. As a result, TAVR is being used as an off-label procedure in some patients with PAI. PATIENTS AND METHODS: We analyzed the National Inpatient Sample database from January 1, 2016, to December 31, 2017, using the International Classification of Diseases, 10th Revision. Inclusion criteria were patients with aortic valve insufficiency undergoing either TAVR or SAVR. Patients with concomitant aortic stenosis, or history of infective endocarditis, and those below the age of 18 years were excluded. RESULTS: A total of 14,720 patients with PAI underwent valve replacement. Of those, 6.2% underwent TAVR. The TAVR group was significantly older (median age 78 years vs 64 years; P <.001). There was no evidence of a difference in in-hospital mortality between the 2 groups. However, after adjustment, patients in the TAVR group were associated with favorable outcomes in terms of acute kidney injury, cardiogenic shock, postoperative respiratory complications, and length of stay. On the other hand, those in the SAVR group were less likely to need permanent pacemakers. CONCLUSION: There was no evidence of a significant statistical difference in in-hospital mortality between patients with PAI treated by either SAVR or TAVR, both in unmatched and propensity-matched cohorts. TAVR could be considered for patients with PAI who are not candidates for surgery.

Global, Regional, and National Burden of Calcific Aortic Valve and Degenerative Mitral Valve Diseases, 1990-2017.

BACKGROUND: Nonrheumatic valvular diseases are common; however, no studies have estimated their global or national burden. As part of the Global Burden of Disease Study 2017, mortality, prevalence, and disability-adjusted life-years (DALYs) for calcific aortic valve disease (CAVD), degenerative mitral valve disease, and other nonrheumatic valvular diseases were estimated for 195 countries and territories from 1990 to 2017. METHODS: Vital registration data, epidemiologic survey data, and administrative hospital data were used to estimate disease burden using the Global Burden of Disease Study modeling framework, which ensures comparability across locations. Geospatial statistical methods were used to estimate disease for all countries, because data on nonrheumatic valvular diseases are extremely limited for some regions of the world, such as Sub-Saharan Africa and South Asia. Results accounted for estimated level of disease severity as well as the estimated availability of valve repair or replacement procedures. DALYs and other measures of health-related burden were generated for both sexes and each 5-year age group, location, and year from 1990 to 2017. RESULTS: Globally, CAVD and degenerative mitral valve disease caused 102 700 (95% uncertainty interval [UI], 82 700-107 900) and 35 700 (95% UI, 30 500-42 500) deaths, and 12.6 million (95% UI, 11.4 million-13.8 million) and 18.1 million (95% UI, 17.6 million-18.6 million) prevalent cases existed in 2017, respectively. A total of 2.5 million (95% UI, 2.3 million-2.8 million) DALYs were estimated as caused by nonrheumatic valvular diseases globally, representing 0.10% (95% UI, 0.09%-0.11%) of total lost health from all diseases in 2017. The number of DALYs increased for CAVD and degenerative mitral valve disease between 1990 and 2017 by 101% (95% UI, 79%-117%) and 35% (95% UI, 23%-47%), respectively. There is significant geographic variation in the prevalence, mortality rate, and overall burden of these diseases, with highest age-standardized DALY rates of CAVD estimated for high-income countries. CONCLUSIONS: These global and national estimates demonstrate that CAVD and degenerative mitral valve disease are important causes of disease burden among older adults. Efforts to clarify modifiable risk factors and improve access to valve interventions are necessary if progress is to be made toward reducing, and eventually eliminating, the burden of these highly treatable diseases.

Sex Differences in Phenotypes of Bicuspid Aortic Valve and Aortopathy: Insights From a Large Multicenter, International Registry.

BACKGROUND: This large multicenter, international bicuspid aortic valve (BAV) registry aimed to define the sex differences in prevalence, valve morphology, dysfunction (aortic stenosis/regurgitation), aortopathy, and complications (endocarditis and aortic dissection). METHODS AND RESULTS: Demographic, clinical, and echocardiographic data at first presentation of 1992 patients with BAV (71.5% men) were retrospectively analyzed. BAV morphology and valve function were assessed; aortopathy configuration was defined as isolated dilatation of the sinus of Valsalva or sinotubular junction, isolated dilatation of the ascending aorta distal to the sinotubular junction, or diffuse dilatation of the aortic root and ascending aorta. New cases of endocarditis and aortic dissection were recorded. There were no significant sex differences regarding BAV morphology and frequency of normal valve function. When presenting with moderate/severe aortic valve dysfunction, men had more frequent aortic regurgitation than women (33.8% versus 22.2%, P<0.001), whereas women were more likely to have aortic stenosis (34.5% versus 44.1%, P<0.001). Men had more frequently isolated dilatation of the sinus of Valsalva or sinotubular junction (14.2% versus 6.7%, P<0.001) and diffuse dilatation of the aortic root and ascending aorta (16.2% versus 7.3%, P<0.001) than women. Endocarditis (4.5% versus 2.5%, P=0.037) and aortic dissections (0.5% versus 0%, P<0.001) occurred more frequently in men. CONCLUSIONS: Although there is a male predominance among patients with BAV, men with BAV had more frequently moderate/severe aortic regurgitation at first presentation compared with women, whereas women presented more often with moderate/severe aortic stenosis compared with men. Furthermore, men had more frequent aortopathy than women.

[About the settlement of litigations concerning the harm caused by benfluorex (Mediator®)]. / À propos de l'expertise des dossiers benfluorex (Mediator® et génériques).

Since September 1st 2011, the National Bureau for Compensation of Medical Accidents represents a unique portal for out-of-court settlement of litigations concerning the harm caused by benfluorex. In December 2012, its official record is as follows: 7627 patients files have been received, 1378 have been studied, 797 led to a recommendation, and compensation by the drug company Servier has been recommended for 46 cases. The large number of rejections raises a problem which needs to be examined in the light of the available evidence on benfluorex associated heart valve disease. This evidence concerns both the morphological characteristics of the disease and the epidemiology of its association with benfluorex. More than 90% of emergent double valve disease (aortic and mitral regurgitation), of emergent aortic valve regurgitation, and of prevalent grade 2 aortic valve regurgitation are attributable to benfluorex. The proportion of benfluorex-attributable disease is larger than 75% for prevalent double valve disease, or for prevalent aortic valve regurgitation of any grade. This probabilistic information, derived from the available epidemiological studies, needs to be considered as part of the evidence to establish or refute a causal link between benfluorex and valvular disease for a given patient, particularly if the patient has a low grade valvular insufficiency or no morphological anomaly.

3D color-Doppler echocardiography and chronic aortic regurgitation: a novel approach for severity assessment.

BACKGROUND: 3D echocardiography provides a complete evaluation of the aortic valve and adjacent structures and it improves the assessment of this cardiac region. Three-dimensional color-Doppler echocardiography (3DCDE) evaluation might improve the measurements of the functional regurgitant orifice in patients with Chronic Aortic Regurgitation (CAR). OBJECTIVES: Our aim was to compare the accuracy of current echo-Doppler methods and 3DCDE for the assessment of CAR severity. The reference method used in this work was the CAR severity determined by means of cardiac magnetic resonance (CMR) METHODS: Thirty-two consecutive patients with an established diagnosis of CAR recruited in our institution comprised our study group. CAR severity was determined by conventional Echo-Doppler methods and by 3DCDE and their results were compared with those obtained by means of CMR. RESULTS: Mean age was 63.0 ± 13.5 years. Twenty-two patients (68.8%) were men. Compared with the traditional echo-Doppler methods, 3DCDE evaluation had the best linear association with CMR results (3D vena contracta cross sectional area method: r = 0.88; r square = 0.77; p < 0.001. 3D vena contracta cross sectional area/left ventricular outflow tract cross sectional area method: r = 0.87; r square = 0.75; p < 0.001). The ROC analysis showed an excellent area under curve for detection of severe CAR (3D vena contracta cross sectional area method = 0.97; 3D vena contracta cross sectional area/left ventricular outflow tract cross sectional area method = 0.98). Inter- and intra-observer variability for the 3DCDE evaluation was good (ICC = 0.89 and ICC = 0.91 for inter and intra observer variability respectively). CONCLUSIONS: 3DCDE is an accurate and highly reproducible diagnostic tool for estimating CAR severity. Compared with the traditional echo-Doppler methods, 3DCDE has the best agreement with the CMR determined CAR severity. Thus, 3DCDE is a diagnostic method that may improve the therapeutic management of patients with CAR.

Reoperation after the Ross procedure: incidence, management, and survival.

BACKGROUND: The risk of reoperation on the autograft and homograft is the major long-term drawback of the Ross procedure. The incidence and clinical implications of reoperations after the Ross procedure are reported. METHODS: Between March 1992 and February 2010, 336 consecutive patients had a Ross procedure (mean follow-up, 6.2±4.9 years). Autograft implant technique was freestanding root replacement in 269 patients, subcoronary implantation in 52 patients and a modified root replacement with the autograft included in a Valsalva tube graft in 15. RESULTS: Subsequently, 38 patients (11.3%) underwent reoperations, for autograft dilatation in 23 and a significant autograft insufficiency in 9, at 9.6±3.7 years and 2.6±3.9 years, respectively. Aortic and pulmonary infective endocarditis occurred in 3 patients. Three patients underwent a non valve-related cardiac reoperation. Three patients received a transcatheter pulmonary valve implantation after 12.2±1.7 years. At 15 years, freedoms for autograft and homograft explantation (with 95% confidence interval) were 83.3% (77.4%- to 9.2%) and 92.8% (87.6% to 97.9%), respectively. Native aortic valve regurgitation, indexed aortic annulus diameter exceeding 1.35 cm/m2 and autograft diameter were risk factors for dilated autograft reoperation (hazard ratio, 3.23 [95% confidence interval, 1.19 to 8.81], p=0.02; 3.83 [0.9 to 16.33], p=0.07 and 1.2 per mm [1.01 to 1.41], p=0.03), respectively. CONCLUSIONS: Autograft dilatation was the leading cause of reoperation in patients who underwent root replacement. Long-term follow-up is mandatory to determine whether modifications of the operative technique could limit autograft dilatation.

Cardiac multislice spiral computed tomography as an alternative to coronary angiography in the preoperative assessment of coronary artery disease before aortic valve surgery: a management outcome study.

BACKGROUND: Conventional coronary angiography (CA) is still recommended before valvular surgery. Preliminary studies suggest that multislice spiral computed tomography coronary angiography (MSCT-CA) can be used to rule out coronary artery disease (CAD). AIM: To assess prospectively the safety of ruling out CAD before surgery solely on the basis of normal MSCT-CA in patients with severe aortic valve disease. METHODS: We included all consecutive patients scheduled for aortic valve surgery. We first estimated the calcium score (Agatston score equivalent [ASE]). Patients underwent injected MSCT if the ASE was<1000. CA was cancelled when MSCT-CA quality was sufficient and showed no significant CAD. Our primary endpoint was the occurrence of perioperative myocardial infarction in patients who underwent surgery with no prior CA. RESULTS: Between 1st July 2005 and 30th June 2008, we included 199 patients with severe aortic valve disease: 118 men (59%); mean age 69+/-12 years; 63 patients (32%) underwent CA directly because the ASE was > or =1000. Of 136 patients who underwent MSCT-CA, 106 (78%) had a normal MSCT-CA and underwent aortic valve surgery without prior CA; CA was performed in 30 patients because of abnormal (n=18) or bad quality (n=12) MSCT-CA. One patient of the 106 (0.94%, 95% confidence interval 0.17-5.15) had a perioperative myocardial infarction. CONCLUSIONS: When the ASE is <1000, MSCT is safe and may be recommended instead of CA as a first-line means of ruling out CAD in patients with severe aortic valve disease.

Color Doppler echocardiographic assessment of valvular regurgitation in normal infants.

BACKGROUND/PURPOSE: Despite valvular regurgitation being a common finding in children, its prevalence in infants is unclear. The aim of this study was to determine the presence and severity of valvular regurgitation in normal infants using echocardiographic screening. METHODS: Two-dimensional (2D) color Doppler echocardiography was performed on 420 consecutive infants (aged 1-12 months) with structurally normal hearts. Pulsed, continuous-wave, and color Doppler imaging techniques were used to detect and evaluate regurgitant blood flow at each valve. RESULTS: Valvular regurgitation was present in 258 infants (61.4%). Among these, 41 (15.9%) were found to have a heart murmur. Tricuspid regurgitation was found in 237 (56.4%) infants, pulmonary regurgitation in 71 (16.9%), mitral regurgitation in 51 (12.1%), and aortic regurgitation in nine (2.1%). Regurgitation of one valve occurred in 161 (38.3%) infants, of two valves in 84 (20%), and of three valves in 13 (3.1%). Right-sided regurgitation was significantly more common than left-sided regurgitation (p < 0.05). The degree of regurgitation was trivial or mild in 97.3% of infants and the peak velocities of the regurgitant jets were < or = 2.5 m/sec in all the valves, by Doppler echocardiography. CONCLUSION: The prevalence of inaudible valvular regurgitation is high in infants with structurally normal hearts. Multiple-valve involvement with regurgitation is not uncommon. Mild severity and low velocity on color Doppler, and the structural information provided by 2D imaging strongly suggest that these regurgitant flows are physiologically normal in infancy.

Job matters: differences in risk assessment of percutaneous aortic valve replacement between cardiologists and cardiac surgeons.

BACKGROUND: Percutaneous aortic valve replacement (PAVR) for aortic stenosis is an attractive alternative to operative valve replacement. Several devices are evaluated, but their efficacy and safety are critically discussed. An interdisciplinary approach with collaboration of cardiac surgeons and cardiologists is widely requested. We analyzed how cardiologists and cardiac surgeons assess the possibilities and risks of PAVR and whether there are substantial differences between the judgments of these 2 groups. METHODS AND RESULTS: Fifty-one cardiologists and 54 cardiac surgeons from German hospitals completed an online questionnaire consisting of 11 questions dealing with typical risks and benefits of PAVR. Answers to all questions differed significantly between surgeons and cardiologists. Risks as impaired hemodynamic outcome, paravalvular leakage, or embolic events were deemed higher for PAVR than for an operation from both groups, but cardiologists rated those risks significantly lower than cardiac surgeons (P<0.01 for all questions). A regression analysis with a latent variable approach for possible advantages of PAVR (like minor operative trauma, faster recovery, less pain) showed that the fact of being a cardiologist has a significant impact on the rating of PAVR advantages (r=0.719, P<0.01), whereas personal experience showed no significant effect. CONCLUSIONS: Cardiologists and cardiac surgeons agree on possible risks and advantages of PAVR, but the extent differs significantly between the 2 groups. Cardiologists have a far more optimistic view of PAVR and are likely to favor an interventional approach. More and better evidence based information may help to overcome group related prejudices.

Pattern and severity of rheumatic valvular lesions in children in Khartoum, Sudan.

We determined the pattern and severity of valvular involvement in 100 Sudanese patients with rheumatic heart disease (RHD) in 2 centres in Khartoum in 2003. All the patients underwent history taking, physical examination and Doppler echocardiography. The commonest lesions were mitral regurgitation (84%) and aortic regurgitation (40%). Mitral stenosis alone was uncommon (9%) which could be due to a low detection rate related to the slow stenotic process and the subtle early signs. This, together with the inconsistent history of rheumatic fever, may lead to an underestimate of the prevalence of RHD. There was a strong correlation between severity of the lesion and irregular prophylaxis (P < 0.001).

Intraoperative transesophageal echocardiographic assessment of the effect of protamine on paraprosthetic aortic insufficiency immediately after stentless tissue aortic valve replacement.

Mild paravalvular aortic insufficiency (AI) is common immediately after stentless bioprosthetic aortic valve replacement. Although resolution of paraprosthetic jets with protamine has been described, the predictability of resolution has not been addressed. Intraoperative transesophageal echocardiography was performed before and after protamine administration among 2 groups. The first group (n = 20) was used to define the prevalence and severity of paravalvular AI after stentless tissue AVR, and define a threshold value for jet size associated with resolution with protamine. A second group (n = 18) was used to prospectively test the determined threshold. Paravalvular AI occurred in 13 of 20 (65%) patients. Using a threshold value of 0.3 cm or less jet width, prospective testing revealed positive and negative predictive values for AI resolution with protamine of 93% (14 of 15) and 100% (3 of 3), respectively. Protamine administration is associated with resolution of small AI jets immediately after implantation of a stentless aortic bioprosthesis, with a jet width 0.3 cm or less strongly predictive of resolution.

Serial long-term assessment of the natural history of asymptomatic patients with chronic aortic regurgitation and normal left ventricular systolic function.

BACKGROUND: Many asymptomatic patients with aorta regurgitation and normal left ventricular systolic function remain clinically stable for many years, but others ultimately develop symptoms or left ventricular dysfunction and require operation. To identify indexes of left ventricular function predictive of symptomatic and functional deterioration during the long-term course of asymptomatic patients, we studied 104 asymptomatic patients with chronic severe aortic regurgitation and normal left ventricular ejection fraction at rest. METHODS AND RESULTS: Serial echocardiographic (average, 7.8 per patient) and radionuclide angiographic (average, 5.0 per patient) studies were obtained over a mean follow-up period of 8 years (range, 2-16 years). By Kaplan-Meier life table analysis, 58 +/- 9% of patients remained asymptomatic with normal ejection fraction at 11 years, an average attrition rate of less than 5% per year; two patients died suddenly, four developed asymptomatic left ventricular dysfunction, and 19 underwent operation because symptoms developed. By univariate Cox regression analysis, many variables on initial study were associated with death, ventricular dysfunction, or symptoms, including age, left ventricular end-systolic dimension and end-diastolic dimension, fractional shortening, and both rest and exercise ejection fraction (all p less than 0.001). The average rates of change of rest ejection fraction, fractional shortening, and end-systolic dimension were also associated with death or symptoms by univariate Cox analysis (all p less than 0.01). However, when all variables were included in a multivariate Cox analysis, only age (p less than 0.05), initial end-systolic dimension (p less than 0.001), and rate of change in end-systolic dimension and rest ejection fraction during serial studies (both p less than 0.05) predicted outcome. CONCLUSIONS: Thus, in addition to indexes of left ventricular function determined on initial evaluation, serial long-term changes in systolic function identify patients likely to develop symptoms and require operation. Patients have a higher risk of symptomatic deterioration if there is progressive change in end-systolic dimension or resting ejection fraction during the course of serial studies.