Taniguchi T, Morimoto T, Shiomi H, Ando K, Kanamori N, Murata K, Kitai T, Kawase Y, Izumi C, Kato T, Ishii K, Nagao K, Nakagawa Y, Toyofuku M, Saito N, Minatoya K, Kimura T; CURRENT AS Registry Investigators.
Sudden Death in Patients With Severe Aortic Stenosis: Observations From the CURRENT AS Registry.
J Am Heart Assoc. 2018 May 18;7(11). doi: 10.1161/JAHA.117.008397. Epub 2018 May 18.
Abstract/Text
BACKGROUND: The annual incidence of sudden death has been reported to be low (<1%/year) in asymptomatic patients with severe aortic stenosis (AS), and there is a paucity of data on the risk factors of sudden death in patients with severe AS.
METHODS AND RESULTS: We evaluated the incidence and risk factors of sudden death during the median follow-up period of 1334 days in the Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis (CURRENT AS) registry enrolling 3815 consecutive patients with severe AS between 2003 and 2011. The mean age was 78 years, and the prevalences of male sex and prior myocardial infarction were 38% and 8%, respectively. Sudden death occurred in 175 patients without aortic valve replacement. The cumulative 5-year incidences of sudden death, censored at aortic valve replacement, which accounted for the competing risk, were 9.2% in symptomatic patients and 7.2% (1.4%/year) in asymptomatic patients (P<0.001). Among 82 asymptomatic patients experiencing sudden death, 54 patients (66%) died abruptly without any preceding symptoms, and 35 (65%) of these sudden deaths occurred within 3 months of the last clinical follow-up visit. Independent risk factors for sudden death were hemodialysis (hazard ratio [HR] 3.63; 95% confidence interval [CI] 2.42-5.43), prior myocardial infarction (HR 2.11; 95% CI 1.28-3.50), body mass index <22 (HR 1.51; 95% CI 1.03-2.21), peak aortic jet velocity ≥5 m/s (HR 1.76; 95% CI 1.12-2.78), and left ventricular ejection fraction <60% (HR 1.52; 95% CI 1.08-2.14).
CONCLUSIONS: The incidence of sudden death in asymptomatic patients with severe AS might be higher than that reported in previous reports. Several baseline clinical and echocardiographic characteristics were associated with increased risk of sudden death.
CLINICAL TRIAL REGISTRATION: URL: www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000012140.
© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
Taniguchi T, Morimoto T, Shiomi H, Ando K, Kanamori N, Murata K, Kitai T, Kawase Y, Izumi C, Miyake M, Mitsuoka H, Kato M, Hirano Y, Matsuda S, Nagao K, Inada T, Murakami T, Takeuchi Y, Yamane K, Toyofuku M, Ishii M, Minamino-Muta E, Kato T, Inoko M, Ikeda T, Komasa A, Ishii K, Hotta K, Higashitani N, Kato Y, Inuzuka Y, Maeda C, Jinnai T, Morikami Y, Sakata R, Kimura T; CURRENT AS Registry Investigators.
Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis.
J Am Coll Cardiol. 2015 Dec 29;66(25):2827-2838. doi: 10.1016/j.jacc.2015.10.001. Epub 2015 Oct 15.
Abstract/Text
BACKGROUND: Current guidelines generally recommend watchful waiting until symptoms emerge for aortic valve replacement (AVR) in asymptomatic patients with severe aortic stenosis (AS).
OBJECTIVES: The study sought to compare the long-term outcomes of initial AVR versus conservative strategies following the diagnosis of asymptomatic severe AS.
METHODS: We used data from a large multicenter registry enrolling 3,815 consecutive patients with severe AS (peak aortic jet velocity >4.0 m/s, or mean aortic pressure gradient >40 mm Hg, or aortic valve area <1.0 cm(2)) between January 2003 and December 2011. Among 1,808 asymptomatic patients, the initial AVR and conservative strategies were chosen in 291 patients, and 1,517 patients, respectively. Median follow-up was 1,361 days with 90% follow-up rate at 2 years. The propensity score-matched cohort of 582 patients (n = 291 in each group) was developed as the main analysis set for the current report.
RESULTS: Baseline characteristics of the propensity score-matched cohort were largely comparable, except for the slightly younger age and the greater AS severity in the initial AVR group. In the conservative group, AVR was performed in 41% of patients during follow-up. The cumulative 5-year incidences of all-cause death and heart failure hospitalization were significantly lower in the initial AVR group than in the conservative group (15.4% vs. 26.4%, p = 0.009; 3.8% vs. 19.9%, p < 0.001, respectively).
CONCLUSIONS: The long-term outcome of asymptomatic patients with severe AS was dismal when managed conservatively in this real-world analysis and might be substantially improved by an initial AVR strategy. (Contemporary Outcomes After Surgery and Medical Treatment in Patients With Severe Aortic Stenosis Registry; UMIN000012140).
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
循環器病の診断と治療に関するガイドライン：弁膜疾患の非薬物治療に関するガイドライン（2012年改訂版）.
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; ACC/AHA Task Force Members.
2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.
Circulation. 2014 Jun 10;129(23):2440-92. doi: 10.1161/CIR.0000000000000029. Epub 2014 Mar 3.
Abstract/Text
日本循環器学会他編：日本循環器学会/日本胸部外科学会/日本血管外科学会/日本心臓血管外科学会合同ガイドライン 2020年改訂版 弁膜症治療のガイドライン [Internet]. 2020. Available from: https://www.j-circ.or.jp/old/guideline/pdf/JCS2020_Izumi_Eishi.pdf
Monin JL, Quéré JP, Monchi M, Petit H, Baleynaud S, Chauvel C, Pop C, Ohlmann P, Lelguen C, Dehant P, Tribouilloy C, Guéret P.
Low-gradient aortic stenosis: operative risk stratification and predictors for long-term outcome: a multicenter study using dobutamine stress hemodynamics.
Circulation. 2003 Jul 22;108(3):319-24. doi: 10.1161/01.CIR.0000079171.43055.46. Epub 2003 Jun 30.
Abstract/Text
BACKGROUND: The prognostic value of dobutamine stress hemodynamic data in the setting of low-gradient aortic stenosis has been addressed in small, single-center studies. Larger studies are needed to define the criteria for selecting the patients who will benefit from valve replacement.
METHODS AND RESULTS: Six centers prospectively enrolled 136 patients with aortic stenosis (96 men; median age, 72 years [range, 65 to 77 years]; median aortic valve area, 0.7 cm2 [range, 0.6 to 0.8]; mean transaortic gradient, 29 mm Hg [range, 23 to 34 mm Hg]; cardiac index, 2.11 L x min(-1) x m(-2) [range, 1.75 to 2.55 L x min(-1) x m(-2)]). Left ventricular contractile reserve on the dobutamine stress Doppler study was present in 92 patients (group I) and absent in 44 patients (group II). Operative mortality was 5% (3 of 64 patients) in group I compared with 32% (10 of 31 patients) in group II (P=0.0002). Predictors for operative mortality were the lack of contractile reserve (odds ratio, 10.9; 95% confidence interval [CI], 2.6 to 43.4; P=0.001) and a mean transaortic gradient < or =20 mm Hg (odds ratio, 4.7; 95% CI, 1.1 to 21.0; P=0.04). Predictors for long-term survival were valve replacement (hazard ratio, 0.30; 95% CI, 0.17 to 0.53; P=0.001) and left ventricular contractile reserve (hazard ratio, 0.40; 95% CI, 0.23 to 0.69; P=0.001).
CONCLUSIONS: In the setting of low-gradient aortic stenosis, surgery seems beneficial for most of the patients with left ventricular contractile reserve. In contrast, the postoperative outcome of patients without reserve is compromised by a high operative mortality. Thus, dobutamine stress Doppler hemodynamics may be factored into the risk-benefit analysis for each patient.
Nakatsuma K, Taniguchi T, Morimoto T, Shiomi H, Ando K, Kanamori N, Murata K, Kitai T, Kawase Y, Izumi C, Miyake M, Mitsuoka H, Kato M, Hirano Y, Matsuda S, Inada T, Nagao K, Mabuchi H, Takeuchi Y, Yamane K, Toyofuku M, Ishii M, Minamino-Muta E, Kato T, Inoko M, Ikeda T, Komasa A, Ishii K, Hotta K, Higashitani N, Kato Y, Inuzuka Y, Maeda C, Jinnai T, Morikami Y, Saito N, Minatoya K, Kimura T; CURRENT AS Registry Investigators.
B-type natriuretic peptide in patients with asymptomatic severe aortic stenosis.
Heart. 2019 Mar;105(5):384-390. doi: 10.1136/heartjnl-2018-313746. Epub 2018 Dec 7.
Abstract/Text
OBJECTIVES: We sought to evaluate the prognostic impact of the B-type natriuretic peptide (BNP) levels in patients with asymptomatic severe aortic stenosis (AS), who were not referred for aortic valve replacement (AVR).
METHODS: We used data from a Japanese multicentre registry, the Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis Registry, which enrolled 3815 consecutive patients with severe AS. Of those, 387 asymptomatic patients who were not referred for AVR without left ventricular dysfunction and very severe AS were subdivided into four groups based on their BNP levels (BNP<100 pg/mL, n=201; 100≤BNP<200 pg/mL, n=94; 200≤BNP<300 pg/mL, n=42 and BNP>300 pg/mL, n=50).
RESULTS: The cumulative 5-year incidence of AS-related events (aortic valve-related death or heart failure hospitalisation) was incrementally higher with increasing BNP level (14.2%, 29.6%, 46.3% and 47.0%, p<0.001). After adjusting for confounders, the risk for AS-related events was incrementally greater with increasing BNP levels (HR: 1.97, 95% CI: 0.97 to 3.98, p=0.06; HR: 3.59, 95% CI: 1.55 to 8.32, p=0.03 and HR: 7.38, 95% CI: 3.21 to 16.9, p<0.001, respectively). Notably, asymptomatic patients with BNPlevels of <100 pg/mL had an event rate of only 2.1% at 1 year.
CONCLUSIONS: Increased BNP level was associated with a higher risk for AS-related adverse events in patients with asymptomatic severe AS with normal left ventricular ejection fraction who were not referred for AVR. Asymptomatic patients with BNP levels of <100 pg/mL had relatively low event rate, who might be safely followed with watchful waiting strategy.
TRAIL REGISTRATION NUMBER: UMIN000012140.
© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
Henri C, Dulgheru R, Magne J, Caballero L, Laaraibi S, Davin L, Kou S, Voilliot D, Nchimi A, Oury C, Pierard LA, Lancellotti P.
Impact of Serial B-Type Natriuretic Peptide Changes for Predicting Outcome in Asymptomatic Patients With Aortic Stenosis.
Can J Cardiol. 2016 Feb;32(2):183-9. doi: 10.1016/j.cjca.2015.06.007. Epub 2015 Jun 18.
Abstract/Text
BACKGROUND: The aim of this study was to determine the impact on the outcome of serial B-type natriuretic peptide (BNP) changes during follow-up in asymptomatic patients with ≥ moderate aortic stenosis (AS) and preserved left ventricular ejection fraction.
METHODS: We prospectively screened 69 patients who underwent comprehensive transthoracic echocardiography, BNP level measurement at baseline and after every 6 or 12 months. Annualized BNP changes were calculated as the difference between the last and baseline BNP measurements divided by the duration of follow-up. The primary endpoint was the occurrence of symptoms, aortic valve replacement, or cardiovascular death.
RESULTS: During a follow-up of 30 ± 19 months, 43 patients experienced a cardiac event. These patients were significantly older (73 ± 9 vs 65 ± 16 years; P = 0.010), had more often dyslipidemia (79% vs 42%; P = 0.038), more severe AS (peak velocity: 3.9 ± 0.6 vs 3.5 ± 0.6 m/s; P = 0.002), larger indexed left atrial area (10.2 ± 2.5 vs 8.7 ± 1.9 cm(2)/m(2); P = 0.006), and a higher increase in annualized BNP (+90 ± 155 vs +7 ± 49 pg/mL/y; P = 0.010). Patients with higher annualized BNP changes (> 20 pg/mL/y) had a significantly lower cardiac event-free survival (1 year: 63 ± 8% vs 97 ± 3%; 3 years: 31 ± 8% vs 68 ± 8%; P < 0.001). Using the multivariate Cox proportional hazards model, higher annualized BNP changes were significantly associated with increased risk of cardiac events (hazard ratio: 2.73, 95% confidence interval: 1.27-5.86; P = 0.010) after adjustment for age, dyslipidemia, and echocardiographic parameters.
CONCLUSIONS: In asymptomatic patients with AS and preserved left ventricular ejection fraction, the use of serial BNP changes may help to anticipate development of class I indication for aortic valve replacement.
Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
日本循環器学会他編：感染性心内膜炎の予防と治療に関するガイドライン（2017年改訂版）.2018.
Reynolds HR, Jagen MA, Tunick PA, Kronzon I.
Sensitivity of transthoracic versus transesophageal echocardiography for the detection of native valve vegetations in the modern era.
J Am Soc Echocardiogr. 2003 Jan;16(1):67-70. doi: 10.1067/mje.2003.43.
Abstract/Text
BACKGROUND: Thirteen years ago, transthoracic echocardiography (TTE) was found to be less sensitive than transesophageal echocardiography (TEE) for native valve vegetations. Since then, harmonic imaging and other advances have improved TTE. How this affects the sensitivity of TTE is unknown.
METHODS: Fifty patients with echocardiography-diagnosed endocarditis had TTE and TEE examinations on high-end machines. These were matched for date of study with 50 patients who had TTE and TEE examinations that were negative for vegetations.
RESULTS: A total of 51 vegetations were seen on TEE. The sensitivity of TTE for vegetations was only 55% (aortic 50% [12/24]; mitral 62% [16/26]; tricuspid 0% [0/1]). Anatomic valvular abnormalities did not alter the sensitivity of TTE (P =.42 for mitral; P =.97 for aortic valves). However, larger vegetations were more likely to be found by TTE.
CONCLUSION: Despite advances in imaging during 12 years, TTE is still insensitive compared with TEE for the detection of native valve vegetations, and fails to demonstrate nearly half of them.
Horstkotte D, Loogen F.
The natural history of aortic valve stenosis.
Eur Heart J. 1988 Apr;9 Suppl E:57-64. doi: 10.1093/eurheartj/9.suppl_e.57.
Abstract/Text
Despite different aetiologies, acquired aortic stenosis is a self-maintaining, slowly progressive process with good long-term prognosis. In 142 patients with mild stenosis, there was clinical progression within 10 years of the initial diagnosis in only 12% of patients. Twenty-five years after the diagnosis had been established, the severity of aortic stenosis was clinically unchanged in 38%, while 25% of patients had moderate stenosis and 35% had undergone valve replacement. Progression of moderate aortic stenosis was more rapid: the average time interval between the manifestation of moderate aortic stenosis and surgery was 13.4 years. Age at the onset of initial symptoms was related to aetiology: 39 +/- 18 years with rheumatic aortic stenoses, 48 +/- 6 years in patients with bicuspid valves who had no history of rheumatic fever, infective endocarditis or myocarditis, and 66 +/- 12 years in degenerative, calcific stenoses of tricuspid aortic valves. Patients with haemodynamically severe stenosis who had refused the recommended operation (n = 55) had an overall poor prognosis: mean survival averaged 23 +/- 5 months and the five-year probability of survival was 18 +/- 7%. All these patients died within 12 years of observation. Mean survival after the occurrence of angina pectoris was 45 +/- 13 months, after syncope 27 +/- 15 months, and after first occurrence of left heart failure 11 +/- 10 months.
Handa N, Miyata H, Motomura N, Nishina T, Takamoto S; Japan Adult Cardiovascular Database Organization.
Procedure- and age-specific risk stratification of single aortic valve replacement in elderly patients based on Japan Adult Cardiovascular Surgery Database.
Circ J. 2012;76(2):356-64. doi: 10.1253/circj.cj-11-0979. Epub 2011 Nov 23.
Abstract/Text
BACKGROUND: Successful introduction of trans-catheter aortic valve implantation for selected patients with critical aortic stenosis has raised the question of how to identify appropriate high-risk candidates.
METHODS AND RESULTS: To assess the risk profile of patients undergoing single aortic valve replacement (sAVR), multiple logistic regression analysis was applied for open sAVR (n = 7,883) registered in the Japan Cardiovascular Surgery Database to predict surgical mortality. Three subgroup analyses stratified by age, <70 years (young), 70-79 years (middle), and ≥80 years (elderly), were also performed. Preoperative patient characteristics indicated increased prevalence of several variables in the elderly subgroup including New York Heart Association (NYHA) class III/IV, 3-vessel coronary artery disease (3VCAD), respiratory insufficiency, and stroke. The following factors, however, were decreased in the elderly subgroup: dialysis, poor heart function, reoperation, renal dysfunction, and emergency surgery. Mortality was 3.0% in all sAVR patients and 5.2% in the elderly subgroup. Multivariate analysis in all patients produced 16 variables as operative risks (P<0.05) including respiratory insufficiency, dialysis, NYHA class III/IV, and reoperation. The analysis in the elderly subgroup produced 9 variables with more pronounced relative risk (RR), which included dialysis (RR = 5.4), respiratory insufficiency (RR = 3.3), preoperative arrhythmia (RR = 3.0), 3VCAD (RR = 3.6), and emergency surgery (RR = 23.1).
CONCLUSIONS: sAVR has produced good surgical results in Japan. Procedure- and age-specific analyses have identified a risk profile that is unique to sAVR patients in the elderly population in Japan.
Cowell SJ, Newby DE, Prescott RJ, Bloomfield P, Reid J, Northridge DB, Boon NA; Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) Investigators.
A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis.
N Engl J Med. 2005 Jun 9;352(23):2389-97. doi: 10.1056/NEJMoa043876.
Abstract/Text
BACKGROUND: Calcific aortic stenosis has many characteristics in common with atherosclerosis, including hypercholesterolemia. We hypothesized that intensive lipid-lowering therapy would halt the progression of calcific aortic stenosis or induce its regression.
METHODS: In this double-blind, placebo-controlled trial, patients with calcific aortic stenosis were randomly assigned to receive either 80 mg of atorvastatin daily or a matched placebo. Aortic-valve stenosis and calcification were assessed with the use of Doppler echocardiography and helical computed tomography, respectively. The primary end points were change in aortic-jet velocity and aortic-valve calcium score.
RESULTS: Seventy-seven patients were assigned to atorvastatin and 78 to placebo, with a median follow-up of 25 months (range, 7 to 36). Serum low-density lipoprotein cholesterol concentrations remained at 130+/-30 mg per deciliter in the placebo group and fell to 63+/-23 mg per deciliter in the atorvastatin group (P<0.001). Increases in aortic-jet velocity were 0.199+/-0.210 m per second per year in the atorvastatin group and 0.203+/-0.208 m per second per year in the placebo group (P=0.95; adjusted mean difference, 0.002; 95 percent confidence interval, -0.066 to 0.070 m per second per year). Progression in valvular calcification was 22.3+/-21.0 percent per year in the atorvastatin group, and 21.7+/-19.8 percent per year in the placebo group (P=0.93; ratio of post-treatment aortic-valve calcium score, 0.998; 95 percent confidence interval, 0.947 to 1.050).
CONCLUSIONS: Intensive lipid-lowering therapy does not halt the progression of calcific aortic stenosis or induce its regression. This study cannot exclude a small reduction in the rate of disease progression or a significant reduction in major clinical end points. Long-term, large-scale, randomized, controlled trials are needed to establish the role of statin therapy in patients with calcific aortic stenosis.
Copyright 2005 Massachusetts Medical Society.
日本循環器学会：弁膜疾患の非薬物治療に関するガイドライン（2012年改訂版）（J）.
Shroyer AL, Coombs LP, Peterson ED, Eiken MC, DeLong ER, Chen A, Ferguson TB Jr, Grover FL, Edwards FH; Society of Thoracic Surgeons.
The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models.
Ann Thorac Surg. 2003 Jun;75(6):1856-64; discussion 1864-5. doi: 10.1016/s0003-4975(03)00179-6.
Abstract/Text
BACKGROUND: Although 30 day risk-adjusted operative mortality (ROM) has been used for quality assessment, it is not sufficient to describe the outcomes after coronary artery bypass grafting (CABG) surgery. Risk-adjusted major morbidity may differentially impact quality of care (as complications occur more frequently than death) and enhance a surgical team's ability to assess their quality. This study identified the preoperative risk factors associated with several complications and a composite outcome (the presence of any major morbidity or 30-day operative mortality or both).
METHODS: For CABG procedures, the 1997 to 1999 Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database was used to develop ROM and risk-adjusted morbidity (ROMB) models. Risk factors were selected using standard STS univariate screening and multivariate logistic regression approaches. Risk model performance was assessed. Across STS participating sites, the association of observed-to-expected (O/E) ratios for ROM and ROMB was evaluated.
RESULTS: The 30-day operative death and major complication rates for STS CABG procedures were 3.05% and 13.40%, respectively (503,478 CABG procedures), including stroke (1.63%), renal failure (3.53%), reoperation (5.17%), prolonged ventilation (5.96%), and sternal infection (0.63%). Risk models were developed (c-indexes for stroke [0.72], renal failure [0.76], reoperation [0.64], prolonged ventilation [0.75], sternal infection [0.66], and the composite endpoint [0.71]). Only a slight correlation was found, however, between ROMB and ROM indicators.
CONCLUSIONS: Used in combination, ROMB and ROM may provide the surgical team with additional information to evaluate the quality of their care as well as valuable insights to allow them to focus on areas for improvement.
Adolf W. Karchmer. Infective endocarditis. In :Braunwald E, Zipes DP, Libby P, editors Heart disease: A Textbookk of Cardiovascular Medicine,8th ed., Philadelphia: WB Saunders; 2008.p1713-1737.
Murdoch DR, Corey GR, Hoen B, Miró JM, Fowler VG Jr, Bayer AS, Karchmer AW, Olaison L, Pappas PA, Moreillon P, Chambers ST, Chu VH, Falcó V, Holland DJ, Jones P, Klein JL, Raymond NJ, Read KM, Tripodi MF, Utili R, Wang A, Woods CW, Cabell CH; International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS) Investigators.
Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study.
Arch Intern Med. 2009 Mar 9;169(5):463-73. doi: 10.1001/archinternmed.2008.603.
Abstract/Text
BACKGROUND: We sought to provide a contemporary picture of the presentation, etiology, and outcome of infective endocarditis (IE) in a large patient cohort from multiple locations worldwide.
METHODS: Prospective cohort study of 2781 adults with definite IE who were admitted to 58 hospitals in 25 countries from June 1, 2000, through September 1, 2005.
RESULTS: The median age of the cohort was 57.9 (interquartile range, 43.2-71.8) years, and 72.1% had native valve IE. Most patients (77.0%) presented early in the disease (<30 days) with few of the classic clinical hallmarks of IE. Recent health care exposure was found in one-quarter of patients. Staphylococcus aureus was the most common pathogen (31.2%). The mitral (41.1%) and aortic (37.6%) valves were infected most commonly. The following complications were common: stroke (16.9%), embolization other than stroke (22.6%), heart failure (32.3%), and intracardiac abscess (14.4%). Surgical therapy was common (48.2%), and in-hospital mortality remained high (17.7%). Prosthetic valve involvement (odds ratio, 1.47; 95% confidence interval, 1.13-1.90), increasing age (1.30; 1.17-1.46 per 10-year interval), pulmonary edema (1.79; 1.39-2.30), S aureus infection (1.54; 1.14-2.08), coagulase-negative staphylococcal infection (1.50; 1.07-2.10), mitral valve vegetation (1.34; 1.06-1.68), and paravalvular complications (2.25; 1.64-3.09) were associated with an increased risk of in-hospital death, whereas viridans streptococcal infection (0.52; 0.33-0.81) and surgery (0.61; 0.44-0.83) were associated with a decreased risk.
CONCLUSIONS: In the early 21st century, IE is more often an acute disease, characterized by a high rate of S aureus infection. Mortality remains relatively high.
日本循環器学会：感染性心内膜炎の予防と治療に関するガイドライン（2008年改訂版）(J).
Otto CM, Mickel MC, Kennedy JW, Alderman EL, Bashore TM, Block PC, Brinker JA, Diver D, Ferguson J, Holmes DR Jr.
Three-year outcome after balloon aortic valvuloplasty. Insights into prognosis of valvular aortic stenosis.
Circulation. 1994 Feb;89(2):642-50. doi: 10.1161/01.cir.89.2.642.
Abstract/Text
BACKGROUND: To identify predictors of long-term outcome after balloon aortic valvuloplasty, we analyzed data on 674 adults (mean age, 78 +/- 9 years; 56% were women) undergoing this procedure at 24 clinical centers who had a mean initial increase in aortic valve area of 0.3 cm2.
METHODS AND RESULTS: Baseline data included clinical, echocardiographic, and catheterization variables. Follow-up data included mortality, cause of death, rehospitalization, 6-month echocardiography, and functional status. Kaplan-Meier curves and log-rank tests were used to evaluate survival in subgroups. Multivariate Cox regression models were used to identify independent predictors of survival. Overall survival was 55% at 1 year, 35% at 2 years, and 23% at 3 years, with the majority of deaths (70%) classified as cardiac by an independent review committee. Rehospitalization was common (64%), although 61% of survivors at 2 years reported improved symptoms. Echocardiography at 6 months (n = 115) showed restenosis from the postprocedural valve area of 0.78 +/- 0.31 cm2 to 0.65 +/- 0.25 cm2 (P < .0001). With stepwise multivariate analysis, sequentially adding clinical, echocardiographic, and catheterization variables, the overall model identified independent predictors of survival as baseline functional status, baseline cardiac output, renal function, cachexia, female gender, left ventricular systolic function, and mitral regurgitation. Baseline and postprocedural variables were examined to identify which subgroup of patients has the best outcome after aortic valvuloplasty. A "lower-risk" subgroup (28% of the study population), defined by normal left ventricular systolic function and mild clinical functional limitation, had a 3-year survival of 36% compared with 17% in the remainder of the study group.
CONCLUSIONS: Long-term survival after balloon aortic valvuloplasty is poor with 1- and 3-year survival rates of 55% and 23%, respectively. Although survivors report fewer symptoms, early restenosis and recurrent hospitalization are common.
O'Keefe JH Jr, Vlietstra RE, Bailey KR, Holmes DR Jr.
Natural history of candidates for balloon aortic valvuloplasty.
Mayo Clin Proc. 1987 Nov;62(11):986-91. doi: 10.1016/s0025-6196(12)65068-x.
Abstract/Text
Recently, balloon aortic valvuloplasty has been proposed for the treatment of severe aortic stenosis in elderly patients when aortic valve replacement has been declined or deferred. The natural history of these patients has not been clearly defined. Therefore, to develop a comparison cohort of patients with unoperated aortic stenosis, we reviewed the records of all Mayo Clinic patients in whom severe aortic stenosis had been diagnosed during the period 1978 through 1985 but no surgical procedure had been performed because the patient declined or the physician deferred this option. Among the 50 patients identified (36 men and 14 women; mean age 77 years, range 60 to 89 years), an operation was declined by 28 and deferred in 22. The diagnosis of aortic stenosis was established clinically by a cardiologist in all 50 patients and independently confirmed by echocardiography, Doppler ultrasonography, or catheterization in 47 of the 50. All patients were symptomatic. Follow-up was complete to September 1986 or death in all 50 patients. Actuarial survival at 1, 2, and 3 years was 57, 37, and 25%, respectively. Survival of age- and sex-matched control subjects was 93, 85, and 77%, respectively (P less than 0.0001 at each 1-year interval). At last follow-up, only 13 of the 50 patients (26%) were alive. A cardiac cause was cited for 36 of the 37 deaths. Because of the poor survival in this group of patients, evaluation of alternative nonsurgical therapeutic modalities such as balloon valvuloplasty is imperative when operative intervention is declined or deferred in elderly patients.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators.
Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Abstract/Text
BACKGROUND: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.
METHODS: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.
RESULTS: A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
CONCLUSIONS: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators.
Transcatheter versus surgical aortic-valve replacement in high-risk patients.
N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
Abstract/Text
BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.
METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.
RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.
CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators.
Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.
N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
Abstract/Text
BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.
METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.
RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.
CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators.
Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.
N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
Abstract/Text
BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.
METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.
RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.
CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
Copyright © 2019 Massachusetts Medical Society.
Søndergaard L, Ihlemann N, Capodanno D, Jørgensen TH, Nissen H, Kjeldsen BJ, Chang Y, Steinbrüchel DA, Olsen PS, Petronio AS, Thyregod HGH.
Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk.
J Am Coll Cardiol. 2019 Feb 12;73(5):546-553. doi: 10.1016/j.jacc.2018.10.083.
Abstract/Text
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.
OBJECTIVES: The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria.
METHODS: In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD.
RESULTS: At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89).
CONCLUSIONS: In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173).
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
