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It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies as they are introduced in the detection, management,

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ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease

Background Many patients with severe aortic stenosis and coexisting conditions are not candi dates 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 com pared 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.)

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Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

A b s t r ac t 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 compli- cations 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 proce- dures 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.)

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Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

Guidelines and Expert Consensus Documents aim to present management recommendations based on all of the relevant evidence on a particular subject in order to help physicians select the best possible management strategies for the individual patient suffering from a specific condition, taking into account the impact on outcome and also the risk–benefit ratio of a particular diagnostic or therapeutic procedure. Numerous studies have demonstrated that patient outcomes improve when guideline recommendations, based on the rigorous assessment of evidence-based research, are applied in clinical practice.

A great number of Guidelines and Expert Consensus Documents have been issued in recent years by the European Society of Cardiology (ESC) and also by other organizations or related societies. The profusion of documents can put at stake the authority and credibility of guidelines, particularly if discrepancies appear between different documents on the same issue, as this can lead to confusion in the minds of physicians. In order to avoid these pitfalls, the ESC and other organizations have issued recommendations for formulating and issuing Guidelines and Expert Consensus Documents. The ESC recommendations for guidelines production can be found on the ESC website.1 It is beyond the scope of this preamble to recall all but the basic rules.

In brief, the ESC appoints experts in the field to carry out a comprehensive review of the literature, with a view to making a critical evaluation of the use of diagnostic and therapeutic procedures and assessing the risk–benefit ratio of the therapies recommended for management and/or prevention of a given condition. Estimates of expected health outcomes are included, where data exist. The strength of evidence for or against particular procedures or treatments is weighed according to predefined scales for grading recommendations and levels of evidence, as outlined in what follows.

The Task Force members of the writing panels, …

Guidelines on the management of valvular heart disease The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology

ACE
: angiotensin-converting enzyme
AF
: atrial fibrillation
aPTT
: activated partial thromboplastin time
AR
: aortic regurgitation
ARB
: angiotensin receptor blockers
AS
: aortic stenosis
AVR
: aortic valve replacement
BNP
: B-type natriuretic peptide
BSA
: body surface area
CABG
: coronary artery bypass grafting
CAD
: coronary artery disease
CMR
: cardiac magnetic resonance
CPG
: Committee for Practice Guidelines
CRT
: cardiac resynchronization therapy
CT
: computed tomography
EACTS
: European Association for Cardio-Thoracic Surgery
ECG
: electrocardiogram
EF
: ejection fraction
EROA
: effective regurgitant orifice area
ESC
: European Society of Cardiology
EVEREST
: (Endovascular Valve Edge-to-Edge REpair STudy)
HF
: heart failure
INR
: international normalized ratio
LA
: left atrial
LMWH
: low molecular weight heparin
LV
: left ventricular
LVEF
: left ventricular ejection fraction
LVEDD
: left ventricular end-diastolic diameter
LVESD
: left ventricular end-systolic diameter
MR
: mitral regurgitation
MS
: mitral stenosis
MSCT
: multi-slice computed tomography
NYHA
: New York Heart Association
PISA
: proximal isovelocity surface area
PMC
: percutaneous mitral commissurotomy
PVL
: paravalvular leak
RV
: right ventricular
rtPA
: recombinant tissue plasminogen activator
SVD
: structural valve deterioration
STS
: Society of Thoracic Surgeons
TAPSE
: tricuspid annular plane systolic excursion
TAVI
: transcatheter aortic valve implantation
TOE
: transoesophageal echocardiography
TR
: tricuspid regurgitation
TS
: tricuspid stenosis
TTE
: transthoracic echocardiography
UFH
: unfractionated heparin
VHD
: valvular heart disease
3DE
: three-dimensional echocardiography

Guidelines summarize and evaluate all evidence available, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well …

Guidelines on the management of valvular heart disease (version 2012)

Aims To analyse decision-making in elderly patients with severe, symptomatic aortic stenosis (AS).

Methods and results In the Euro Heart Survey on valvular heart disease, 216 patients aged ≥75 had severe AS (valve area ≤0.6 cm2/m2 body surface area or mean gradient ≥50 mmHg) and angina or New York Heart Association class III or IV. Patient characteristics were analysed according to the decision to operate or not. A decision not to operate was taken in 72 patients (33%). In multivariable analysis, left ventricular (LV) ejection fraction [OR=2.27, 95% CI (1.32–3.97) for ejection fraction 30–50, OR=5.15, 95% CI (1.73–15.35) for ejection fraction ≤30 vs. >50%, P =0.003] and age [OR=1.84, 95% CI (1.18–2.89) for 80–85 years, OR=3.38, 95% CI (1.38–8.27) for ≥85 vs. 75–80 years, P =0.008] were significantly associated with the decision not to operate; however, the Charlson comorbidity index was not [OR=1.72, 95% CI (0.83–3.50), P =0.14 for index ≥2 vs. <2]. Neurological dysfunction was the only comorbidity significantly linked with the decision not to operate.

Conclusion Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.

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Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?

Background Doppler pressure half-time (PHT) is widely used for mitral valve area (MVA) assessment but its accuracy has not been fully evaluated before and after percutaneous mitral commissurotomy (PMC) in a large series of patients. Methods In 120 patients with severe mitral stenosis, MVA PHT was prospectively evaluated before and 24 to 48 hours after PMC and compared with 2-dimensional planimetry (MVA 2D ) as a reference method. Results After PMC, MVA 2D significantly increased (1.81 ± 0.30 vs 1.03 ± 0.23 cm 2 , P P 2D ≥ 1.5 cm 2 ) was observed in 107 patients (89%). Before PMC, correlation between MVA PHT and MVA 2D was only fair overall ( r = 0.52, P r = 0.16, P = .37) and in patients in atrial fibrillation ( r = 0.38, P PHT (1.62 ± 0.39 cm 2 ) was significantly lower than MVA 2D ( P r = 0.30, P = .0004; mean difference 0.33 ± 0.30 cm 2 ) and in all subgroups ( r Conclusion For MVA assessment, the PHT method should be used cautiously even before PMC, especially in older patients or those in atrial fibrillation. After PMC, it does not provide an accurate MVA evaluation but can still be used as a semiquantitative method: a PHT less than 130 milliseconds is associated with a good valve opening, which can be useful in difficult cases.

Echocardiographic Evaluation of the Mitral Valve Area Before and After Percutaneous Mitral Commissurotomy: The Pressure Half-time Method Revisited

Aim: One limitation for a wider use of the proximal isovelocity surface area method (PISA) for the evaluation of the mitral valve area (MVA) in patients with mitral stenosis (MS) is the requirement of an angle correction factor (angle a between the mitral leaflets) which cannot be obtained using the machine's built-in software and requires a manual measurement. The aim of the present study was to evaluate if the use of afi xed angle could provide an acceptable MVA estimation. Methods and results: In 48 patients (53 � 14 years, 75% female and 32% atrial fibril- lation), MVA was prospectively measured by planimetry (MVA2D) and PISA (PISAmes). The angle a was manually measured on paper prints using a protractor. MVA2D was 1.38 � 0.56 cm 2 (0.5e2.40). PISAmes (a ¼ 104 � 13 � inter-quartiles 90e115) was 1.34 � 0.64 cm 2 (0.31e2.95) and did not differ from and correlated well with MVA2D (P ¼ 0.25; r ¼ 0.93, P 0.35 and r > 0.90, P < 0.0001). Conclusion: The angle formed by the mitral leaflet only slightly changes in between patients and use of a fixed angle value of 100 � provides an accurate estimation of the MVA by the PISA method in patients with MS. This simplification would facilitate and extend the use of the PISA as an additional method for the assessment of MS severity in routine practice.

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Evaluation of mitral valve area by the proximal isovelocity surface area method in mitral stenosis: Could it be simplified?

Pacemaker (PM) induced tricuspid regurgitation (TR) is a common echocardiographic finding. Although mild or moderate TR is frequently observed, severe TR is rare. We report the exceptional observation of a severe TR due to leaflet malcoaptation occurring late after PM implantation and in the following weeks after an aortic valve replacement. Our hypothesis is that the aortic valve surgery has been responsible for conformational changes between cardiac cavities, tricuspid valve and PM leads resulting in a severe TR.

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Agnès Cachier

Papers

Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?

Echocardiographic Evaluation of the Mitral Valve Area Before and After Percutaneous Mitral Commissurotomy: The Pressure Half-time Method Revisited

Evaluation of mitral valve area by the proximal isovelocity surface area method in mitral stenosis: Could it be simplified?

An unusual cause of pacemaker-induced severe tricuspid regurgitation

Actual management of patients with asymptomatic aortic valve disease: how practice fits with guidelines.