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Concept: Aortic valve replacement

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OBJECTIVESThe Trifecta valve (St. Jude Medical) was introduced into clinical practice as a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. The present study aims to evaluate the preliminary results with this new bioprosthesis.METHODSSeventy patients underwent aortic valve replacement (AVR) with the Trifecta valve between August 2010 and December 2011. Thirty-three patients were male and 37 were female (52.9%). Mean age was 74.65 ± 7.63 (range 47-90 years). Prevalent cause of AVR was aortic stenosis in 64 (91.43%) patients. The mean preoperative pressure gradient was 50 ± 17 (range 20-84 mmHg), and the mean aortic valve area was 0.77 ± 0.33. Five (7.14%) patients were operated on due to aortic valve endocarditis. One patient was operated on due to isolated, severe aortic insufficiency. All patients were in New York Heart Association functional class III or IV. Twenty-eight (40%) patients underwent concomitant procedures.RESULTSConcomitant procedures were coronary artery bypass grafting (n = 25), mitral valve replacement (n = 1), ablation of atrial fibrillation (n = 1) and septal myomectomy (n = 1). There were no intraoperative deaths. The 30-day in-hospital mortality was 2.85% (2 of 70). One late death occurred during the in-hospital stay due to a multiorgan failure on postoperative day 60. There were 2 (2.85%) perioperative strokes. Mean pressure gradient decreased significantly from a preoperative value of 50 ± 17 mmHg to an intraoperative gradient of 9 ± 4 mmHg (Table 3). The mean gradients were 14, 11, 11, 8 and 6 mmHg for the 19, 21, 23, 25 and 27 mm valve size, respectively. No prosthesis dislocation, endocarditis, valve thrombosis or relevant aortic regurgitation was observed at discharge.CONCLUSIONSThe initial experience with the Trifecta valve bioprosthesis shows excellent outcomes with favourable early haemodynamics. Further studies with longer follow-up are needed to confirm those preliminary results.

Concepts: Cardiology, Heart, Mitral valve prolapse, Aortic valve, Valvular heart disease, Aortic valve stenosis, Aortic valve replacement, Aortic insufficiency

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Reoperation for failing stentless aortic valve replacement is a technically demanding procedure that has traditionally been tackled in one of two ways: either root replacement or the more conservative option of implanting a stented valve within the valve. We sought to determine the relative operative risks, follow-up status and medium to long-term survival of these two methods.

Concepts: Derivative, Left ventricle, Aortic valve, Valve, Valve Corporation, Aortic valve replacement, Aortic insufficiency

28

To evaluate factors associated with aortic enlargement in patients with a bicuspid aortic valve (BAV) and the impact of isolated aortic valve replacement (AVR).

Concepts: Aortic aneurysm, Aortic valve, Aortic valve replacement, Aortic insufficiency, Bicuspid aortic valve

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BACKGROUND: =0.003). Patients with preserved EF had significantly improved 6-month and 8-year survival compared with their reduced EF counterparts.Conclusions-Survival after AVR or AVR+coronary artery bypass grafting was most favorable among patients with preoperative preserved EF. However, patients with mild to moderately depressed EF experienced a substantial survival benefit compared with the natural history of medically treated patients. Furthermore, minor reductions of EF carried equivalent increased risk to those with more compromised function suggesting patients are best served when an AVR is performed before even minor reductions in myocardial function.

Concepts: Myocardial infarction, Cardiology, Heart failure, Ejection fraction, Heart, Aortic valve, Aortic valve replacement, Aortic insufficiency

4

Cardiovascular Magnetic Resonance is often used to evaluate patients after heart valve replacement. This study systematically analyses the influence of heart valve prostheses on phase contrast measurements in a phantom trial.

Concepts: Heart, Nuclear magnetic resonance, Circulatory system, Valvular heart disease, Artificial heart valve, Aortic valve replacement

4

Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve.

Concepts: Clinical trial, Pharmaceutical industry, Clinical research, Aortic valve, Food and Drug Administration, Artificial heart valve, Aortic valve replacement

3

The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of permanent pacemaker (PPM) implantation following transcatheter aortic valve replacement (TAVR).

Concepts: Death, Cardiology, Aortic valve, Artificial pacemaker, Aortic valve replacement

3

IMPORTANCE Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for the treatment of severe, symptomatic aortic stenosis and inoperable status (in 2011) and high-risk but operable status (starting in 2012). A national registry (the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy [STS/ACC TVT] Registry) was initiated to meet a condition for Medicare coverage and also facilitates outcome assessment and comparison with other trials and international registries. OBJECTIVE To report the initial US commercial experience with TAVR. DESIGN, SETTING, AND PARTICIPANTS We obtained results from all eligible US TAVR cases (n=7710) from 224 participating registry hospitals following the Edwards Sapien XT device commercialization (November 2011-May 2013). MAIN OUTCOMES AND MEASURES Primary outcomes included all-cause in-hospital mortality and stroke following TAVR. Secondary analyses included procedural complications and outcomes by clinical indication and access site. Device implantation success was defined as successful vascular access, deployment of a single device in the proper anatomic position, appropriate valve function without either moderate or severe AR, and successful retrieval of the delivery system. Thirty-day outcomes are presented for a representative 3133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting. RESULTS The 7710 patients who underwent TAVR included 1559 (20%) cases that were inoperable and 6151 (80%) cases that were high-risk but operable. The median age was 84 years (interquartile range [IQR], 78-88 years); 3783 patients (49%) were women and the median STS predicted risk of mortality was 7% (IQR, 5%-11%). At baseline, 2176 patients (75%) were either not at all satisfied (1297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2198 (72%) had a 5-m walk time longer than 6 seconds (slow gait speed). The most common vascular access approach was transfemoral (4972 patients [64%]), followed by transapical (2197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7069 patients (92%; 95% CI, 91%-92%). The observed incidence of in-hospital mortality was 5.5% (95% CI, 5.0%-6.1%). Other major complications included stroke (2.0%; 95% CI, 1.7%-2.4%), dialysis-dependent renal failure (1.9%; 95% CI, 1.6%-2.2%), and major vascular injury (6.4%; 95% CI, 5.8%-6.9%). Median hospital stay was 6 days (IQR, 4-10 days), with 4613 (63%) discharged home. Among patients with available follow-up at 30 days (n=3133), the incidence of mortality was 7.6% (95% CI, 6.7%-8.6%) (noncardiovascular cause, 52%); a stroke had occurred in 2.8% (95% CI, 2.3%-3.5%), new dialysis in 2.5% (95% CI, 2.0%-3.1%), and reintervention in 0.5% (95% CI, 0.3%-0.8%). CONCLUSIONS AND RELEVANCE Among patients undergoing TAVR at US centers in the STS/ACC TVT Registry, device implantation success was achieved in 92% of cases, the overall in-hospital mortality rate was 5.5%, and the stroke rate was 2.0%. Although these postmarket US approval findings are comparable with prior published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01737528.

Concepts: Dialysis, Medical terms, Medical statistics, Interquartile range, Aortic valve, Aortic valve replacement, Aortic insufficiency, 22nd century

2

In patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), studies have suggested that reduced left ventricular (LV) ejection fraction (LVEF) and low aortic valve gradient (AVG) are associated with worse long-term outcomes. Because these conditions commonly coexist, the extent to which they are independently associated with outcomes after TAVR is unknown.

Concepts: Cardiology, Ejection fraction, Aortic valve, Aortic valve replacement, Aortic insufficiency

2

Aortic valve replacement for calcific aortic valve stenosis is one of the more common cardiac surgical procedures. However, the underlying pathophysiology of calcific aortic valve stenosis is poorly understood. We therefore investigated the histologic findings of aortic valves excised for calcific aortic valve stenosis and correlated these findings with their associated clinical features.

Concepts: Surgery, Tricuspid valve, Left ventricle, Aortic valve, Aortic valve stenosis, Aortic valve replacement, Aortic insufficiency, Cleveland Clinic