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

Jeffrey L. Anderson, MD, FACC, FAHA, Chair , Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect , Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA[§§][1], Lesley H. Curtis, PhD, FAHA, David DeMets, PhD,

/pdf/2014-aha-acc-guideline-for-the-management-of-patients-with-17ab5yki53.pdf

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

Authors/Task Force Members, Alec Vahanian (Chairperson) Paris (France)*, Helmut Baumgartner, Vienna (Austria), Jeroen Bax, Leiden (The Netherlands), Eric Butchart, Cardiff (UK), Robert Dion, Leiden (The Netherlands), Gerasimos Filippatos, Athens (Greece), Frank Flachskampf, Erlangen (Germany), Roger Hall, Norwich (UK), Bernard Iung, Paris (France), Jaroslaw Kasprzak, Lodz (Poland), Patrick Nataf, Paris (France), Pilar Tornos, Barcelona (Spain), Lucia Torracca, Milan (Italy), Arnold Wenink, Leiden (The Netherlands)

Guidelines on the Management of Valvular Heart disease (Version 2012)

Background— Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. Methods and Results— The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81±6 years) in whom surgical ri...

https://www.mc.vanderbilt.edu/root/sbworddocs/res_edu_thoracic/Adult_1_4_06.pdf

Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery

Background— Mitral annuloplasty is the most common surgical procedure performed for ischemic mitral regurgitation (MR). Surgical mitral annuloplasty is limited by morbidity, mortality, and MR recurrence. We evaluated the safety and feasibility of a transvenous catheter-delivered implantable device to provide a percutaneous alternative to surgical mitral annuloplasty. Methods and Results— Five patients with chronic ischemic MR underwent percutaneous transvenous implantation of an annuloplasty device in the coronary sinus. Implantation was successful in 4 patients. Baseline MR in the entire group was grade 3.0±0.7 and was reduced to grade 1.6±1.1 at the last postimplantation visit when the device was intact or the last postprocedural visit in the patient in whom the device was not successfully implanted. Separation of the bridge section of the device occurred in 3 of 4 implanted devices and was detected at 28 to 81 days after implantation. There were no postprocedural device-related complications. Conclusio...

Percutaneous Transvenous Mitral Annuloplasty: Initial Human Experience With Device Implantation in the Coronary Sinus

Background:

Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valve replacement Most are asymptomatic and benign, but some may cause symptoms due to a large regurgitant volume or hemolysis Medical therapy is palliative, while reoperation carries significant morbidity and mortality Percutaneous transcatheter closure techniques, now routinely applied in the management of pathological cardiac and vascular communications, may be adaptable to PVL closure, potentially offer symptomatic relief



Methods:

We reviewed our experience with attempted percutaneous closure of PVLs, using data from medical and procedural records



Results:

Between 2001 and 2004, 14 procedures were performed in 10 patients, all under general anesthesia, with transesophageal and radiographic guidance Mitral (9) and aortic (1) valve replacements were involved, both mechanical and bioprosthetic A variety of devices were used, including atrial septal occluders, patent ductus arteriosus occluders, and coils (all of label use) Six had a single procedure, which was technically successful in four: in two, the PVL could not be crossed Four underwent a second procedure, which was technically successful in three; in one the previously deployed device was dislodged necessitating urgent, but ultimately uneventful, surgical removal and leak repair One patient had transient severe hemolysis, which resolved after 1 week At 1-year follow-up (9/10 pts) three had died, five had sustained symptomatic improvement while 1 patient with a residual leak still required regular blood transfusions



Conclusions:

Percutaneous closure of PVLs is time-consuming but feasible in selected patients, with a reasonable degree of technical and clinical success A second procedure may be necessary and a variety of complications can occur © 2006 Wiley-Liss, Inc

Percutaneous closure of prosthetic paravalvular leaks: case series and review.

Bleeding from gastrointestinal angiodysplasia in patients with aortic stenosis (AS), termed Heyde's syndrome, has been recognized for many years. Intestinal angiodysplasia (IA) and AS are chronic degenerative diseases that are often asymptomatic, with a higher prevalence in the population than is clinically apparent. The incidence of both conditions increases with age, and both are associated with traditional cardiovascular risk factors. Many studies suggest that there is an increased prevalence of IA in AS and vice versa, but there is wide variation between studies. Evidence is mounting that severe AS may cause Type 2 acquired von Willebrand's disease, also termed von Willebrand's syndrome. This involves loss of the large multimers, which are required to maintain hemostasis in high flow conditions, such as occur in angiodysplastic arteriovenous malformations. Heyde's syndrome appears to consist of bleeding from previously latent intestinal angiodysplasia as a result of this acquired hematological defect, which is associated with aortic stenosis. Treatment options include localization of angiodysplastic bleeding points with cauterization, but this is associated with a high recurrence rate. Aortic valve replacement has been shown to improve the hematological abnormalities, and this is paralleled by clinical improvements. Valve replacement appears to offer the best hope of long-term resolution of the bleeding, and should be considered in most cases, particularly in those in whom the AS is symptomatic. In those patients deemed unfit for surgery in whom no bleeding point can be identified, recurrent blood transfusions may offer some symptomatic relief.

Heyde's syndrome: a review.

Friedreich's ataxia is an autosomal recessive neurodegenerative disease. We report the case of a 34-year-old man with Friedreich's ataxia and dilated cardiomyopathy who underwent successful cardiac transplantation. To our knowledge, this is the first reported case of a heart transplantation for Friedreich's ataxia dilated cardiomyopathy.

Mann Chandavimol

Papers

Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery

Percutaneous Transvenous Mitral Annuloplasty: Initial Human Experience With Device Implantation in the Coronary Sinus

Percutaneous closure of prosthetic paravalvular leaks: case series and review.

Heyde's syndrome: a review.

Cardiac transplantation: A temporary solution for Friedreich’s ataxia-induced dilated cardiomyopathy