Early haemodynamic performance of a latest generation supra-annular aortic bioprosthesis: experience from a large single-centre series.

OBJECTIVES: The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet pericardial valve designed for supra-annular replacement of the aortic valve (AVR). We sought to evaluate the short-term clinical outcome and haemodynamic performance of the Trifecta valve after AVR. METHODS: A total of 837 patients with severe symptomatic aortic valve stenosis or regurgitation underwent AVR with the SJM Trifecta aortic valve prosthesis between January 2009 and March 2013. All intra- and postoperative data were collected prospectively. At discharge, transthoracic echocardiography was performed. A complete set of echocardiographic data was available in 723 patients. RESULTS: Adjusted mean systolic pressure gradients (MPGs) for valve sizes 19 (n = 37/4.4%), 21 (n = 192/22.9%), 23 (n = 263/31.4%), 25 (n = 202/24.1%), 27 (n = 100/11.9%) and 29 mm (n = 42/5.0%) were 8.6 ± 1.1, 8.7 ± 0.4, 7.2 ± 0.3, 6.2 ± 0.3, 5.6 ± 0.3 and 3.9 ± 0.4 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.5 ± 0.09, 1.6 ± 0.04, 1.9 ± 0.03, 2.0 ± 0.03, 2.2 ± 0.05 and 2.7 ± 0.01 cm(2), respectively. No patient-prosthesis mismatch (PPM) was seen in 71.3% of patients (EOAI >0.85 cm(2)/m(2)). Moderate mismatch (EOAI 0.65-0.85 cm(2)/m(2)) was observed in 23.9% of patients, whereas severe PPM (EOAI <0.65 cm(2)/m(2)) occurred in 4.4% of patients. No malfunction of the prosthesis, endocarditis, valve thrombosis or relevant aortic regurgitation necessitating surgical revision was observed until discharge. CONCLUSIONS: The SJM Trifecta valve reveals an excellent early haemodynamic performance with low residual MPGs and a low incidence of PPM. Studies with longitudinal clinical and echocardiographic assessments with longer term follow-up evaluation including a comparison with other contemporary bioprostheses are needed.

Early results of a novel technique for ring-reinforced aortic valve and root restoration.

OBJECTIVES: Surgery for aortic root aneurysm without valve stenosis is increasingly being transformed from the Bentall procedure to valve-sparing aortic root remodelling or reimplantation. In this report, a new repair option is explored, with full functional 'restoration' of the aortic root complex using a geometric annuloplasty ring, leaflet repair, and sinus/ascending aortic replacement with a Valsalva graft. METHODS: The geometric annuloplasty ring restores elliptical annular shape and size in patients with tri-leaflet aortic insufficiency (AI). The ring mounts the three valve commissures on 10° outwardly flaring posts, and facilitates required leaflet procedures. In clinical application, the device has been effective in achieving stable AI reduction with low valve gradients. In this report, 6 patients with aortic root aneurysms and moderate/severe AI were managed with valve repair using the annuloplasty device and leaflet reconstruction, and then concomitant sinus and ascending aortic graft replacement with coronary implantation. RESULTS: In the 6 initial root aneurysm patients, there were no in-hospital mortalities, procedural conversions, or valve-related complications. Preoperative AI grade was 2-4 and fell to 0-1 postoperatively. Post-repair mean systolic gradients ranged from 7 to 12 mmHg, and all patients had stable intermediate-term valve function. CONCLUSIONS: Aortic root restoration using a geometric annuloplasty ring and Valsalva graft may be the most physiological method of aortic valve repair and root replacement. Even with severe leaflet derangements, valve sparing can be achieved with good competence and potentially stable long-term results. This technique could assist in extending valve sparing into most categories of aortic root disease. CLINICAL TRIALS: Patients were managed as part of a Phase I (ClinicalTrials.gov Identifier: NCT01400841), supported by BioStable Science and Engineering (BSE), Austin, TX, USA; www.biostable-s-e.com.

Early results after implantation of a new geometric annuloplasty ring for aortic valve repair.

BACKGROUND: Aortic valve repair is associated with fewer long-term valve-related complications as compared with valve replacement, and repair is being performed increasingly. A current problem is the lack of a geometric annuloplasty ring to facilitate reconstruction. This paper describes the first clinical application of such a device designed to permanently restore physiologic annular size and geometry during aortic valve repair. METHODS: Based on mathematical studies of human cadaver valves, as well as computed tomography angiographic analyses of awake patients with normal valves, a three-dimensional annuloplasty ring has been developed, consisting of low-profile, one-piece titanium construction and Dacron cloth covering. The ring design incorporates 2:3 elliptical base geometry and 10-degree outwardly flaring subcommissural posts. RESULTS: Appropriately sized rings were implanted in 5 patients with severe aortic insufficiency due to annular dilation and anatomic leaflet defects. The rings restored annular geometry and facilitated leaflet repairs in all patients. Each recovered excellent valve function with minimal residual leak. All patients convalesced uneventfully, were discharged within 7 days after surgery, and continue with stable valve function as long as 6 months after implantation. CONCLUSIONS: Initial clinical application of a geometric aortic annuloplasty ring was associated with excellent device performance and perhaps better repairs. Further clinical series and patient follow-up should identify potential benefits of the device, including improved applicability and stability of aortic valve repair.

Valve-sparing root replacement in children with aortic root aneurysm: mid-term results.

OBJECTIVES: We aimed at evaluating the results of aortic valve-sparing root replacement (AVSRR) in children with aortic root aneurysm (ARA) due to genetic disorders in terms of mortality, reoperation and recurrent aortic valve regurgitation (AVR). METHODS: Thirteen patients (mean age 9.7 ± 6.5 years, 10 months-18 years) underwent AVSRR for ARA between 2002 and 2011. Six of the 13 patients had Marfan syndrome, 3 Loeys-Dietz syndrome (LDS), 2 bicuspid aortic valve syndrome and 2 an unspecified connective tissue disorder. AVR was graded as none/trace, mild and severe in 5, 7 and 1 patient, respectively. The mean pre-operative root diameter was 45 ± 10 mm (mean Z-score 10.3 ± 2.0). Remodelling of the aortic root was performed in 4 patients, reimplantation of the aortic valve in 9 and a concomitant cusp repair in 4. The diameter of the prostheses used for root replacement varied from 22 to 30 mm (mean Z-score = 2.3 ± 3). The follow-up was 100% complete with a mean follow-up time of 3.7 years. RESULTS: There was no operative mortality. One patient with LDS died 2.5 years after the operation due to spontaneous rupture of the descending aorta. Root re-replacement with mechanical conduit was necessary in 1 patient for severe recurrent AVR 8 days after remodelling of the aortic root. At final follow-up, AVR was graded as none/trace and mild in all patients. Eleven patients presented in New York Heart Association functional Class I and 1 in Class II. CONCLUSIONS: In paediatric patients with ARA, valve-sparing root replacement can be performed with low operative risk and excellent mid-term valve durability. Hence, prosthetic valve-related morbidity may be avoided. Due to the large diameters of the aortic root and the ascending aorta, the size of the implanted root prostheses will not limit later growth of the native aorta.

One-year results of health-related quality of life among patients undergoing transcatheter aortic valve implantation.

Recently, it has been demonstrated that transcatheter aortic valve implantation (TAVI) can result in significant improvement in patients' quality of life (QOL) in the short term. At present, however, little is known about the long-term improvements in QOL after TAVI. Thus, our aim was to prospectively assess the 1-year QOL outcome of patients undergoing TAVI. We performed a prospective analysis of 186 patients with symptomatic severe aortic valve stenosis ineligible for conventional aortic valve replacement, who underwent TAVI with either the Medtronic CoreValve or Edwards Sapien device. A total of 106 patients completed the 1-year follow-up protocol. The QOL was measured using the Medical Outcomes Study 36-item short-form health survey questionnaire at baseline and at 3 months and 1 year of follow-up. At 1 year of follow-up, significant improvements in the Medical Outcomes Study 36-item short-form health survey questionnaire scores for physical functioning (baseline 34.6 ± 2.3 vs 1 year of follow-up 45.6 ± 2.7; p <0.001), role physical (20 ± 3.0 vs 34.2 ± 4.4; p <0.001), bodily pain (59.9 ± 3 vs 70 ± 2.7; p <0.01), general health (47.3 ± 1.5 vs 55.2 ± 2.1, p <0.001), vitality (35.9 ± 2 vs 48.5 ± 2; p <0.001), and mental health (62.2 ± 2.2 vs 67.3 ± 1.8; p <0.05) were observed compared to baseline. No significant improvement could be detected for social functioning (75.4 ± 2.5 vs 76.5 ± 2.6; p = 0.79) and role emotional (61.1 ± 4.3 vs 66.5 ± 4.7; p = 0.29). At 1 year of follow-up, the various physical and mental scores were comparable to an age-matched standard population. In conclusion, the present study has demonstrated that TAVI can improve the QOL status of high-surgical risk patients with severe aortic valve stenosis that can be maintained for ≤1 year postproceduraly in survivors. Although the mental subscales improved slightly, the mental component summary score failed to reach statistical significance in our study population.

Long-term performance of the Hancock bioprosthetic valved conduit in the aortic root position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess long-term morbidity and mortality with special regard to prosthesis durability after aortic root replacement with the Hancock bioprosthetic porcine conduit. METHODS: Between 1975 and 2004, a total of 81 patients (55 males, 26 females; mean age 58 +/- 18 years) underwent aortic root replacement with the Hancock conduit for aortic dissection (n = 22; 27%), ascending aortic aneurysm (n = 57; 70%), or porcelain aorta (n = 2; 3%). Twenty-five patients (31%) underwent an emergency operation, 12 (15%) presented with Marfan syndrome, and eight (10%) had undergone previous cardiac surgery. Concomitant procedures were performed in 26 cases (32%). The follow up was 98% complete; the mean follow up was 4.8 +/- 4.0 years (range: 1 day to 16.7 years), and the cumulative follow up was 403 patient-years. Actuarial event-free rates were calculated, and valve-related complications classified according to guidelines for reporting morbidity and mortality after cardiac valvular operations. RESULTS: There were seven (9%) operative deaths and four (5%) in-hospital deaths. Actuarial survival rates at five and 10 years (excluding operative deaths) were 77.0 +/- 5.3% and 54.0 +/- 7.5%, respectively. Actuarial freedom from aortic valve reoperation at five and 10 years was 98 +/- 1.6% and 64 +/- 10.2%, from structural valve deterioration 88.1 +/- 4.7% and 49.9 +/- 9.6%, from thromboembolic events 87.4 +/- 4.6% and 75.1 +/- 9.5%, and from major bleeding events 90.2 +/- 3.9% and 75.4 +/- 8.1%, respectively. Among redo procedures, the stentless Hancock valve could be excised without separating the synthetic graft from the left ventricular outflow tract, and a stented valve prosthesis thus implanted. Hence, it was possible to avoid a second Bentall operation. CONCLUSION: The long-term survival rates after aortic root replacement with the bioprosthetic Hancock conduit were reasonable for this demanding patient cohort. However, the durability of the prosthesis was inferior to that reported for the stented Hancock valve substitute. The key benefit of this bioprosthetic valved conduit was the simplified redo procedure.

Are bicuspid aortic valves a limitation for aortic valve repair?

OBJECTIVE: To compare the mid-term results after aortic valve (AV) repair in bicuspid AVs with those in tricuspid AVs. METHODS: Between 2000 and 2010, 100 patients (mean age 47.2 years) underwent AV repair procedures for insufficient bicuspid AV (n=43) and tricuspid AV (n=57). Aortic regurgitation (AR) more than moderate was present in 31/43 and 21/57 patients in the bicuspid AV and the tricuspid AV group, respectively. Concomitant root replacement by either the reimplantation or the remodeling technique was performed in 42 patients (bicuspid AV 17/43, tricuspid AV 25/57). All patients were prospectively studied with postoperative and further annual clinical assessment and echocardiography. Follow-up was 99% complete with a mean follow-up time of 22 months. RESULTS: Three patients died during the initial hospitalization, all due to postoperative cardiac failure. Overall actuarial 3 years' survival was 93±4.2% without significant differences between the two groups. Overall actuarial 3 years' freedom from AV-related reoperation was 86±5.1% without significant differences between the groups (85±9.7% for bicuspid AV, 86±6.0% for tricuspid AV; log-rank test: p=0.98). Overall actuarial 3 years' freedom from recurrent AR≥moderate was 100% and AR>trace was 71.3±8.2% without significant differences between the groups (76.5±11.7% for bicuspid AV, 71.4±9.4 for tricuspid AV; log-rank test: p=0.97). CONCLUSIONS: The mid-term outcome in terms of survival, freedom from reoperation or recurrent AR is similar for both groups of patients after AV repair procedures. Therefore, we advocate valve repair also in patients presenting with an insufficient bicuspid AV.

Twenty years of cardiac surgery in patients aged 80 years and older: risks and benefits.

BACKGROUND: Patients aged 80 years and older who require cardiac surgical procedures are an increasing population and usually present with considerable comorbidity. Detailed operative risk stratification versus long-term survival and quality of life after surgery is mandatory. METHODS: A retrospective analysis was performed on 1,003 patients aged 82.3 years (range, 80 to 94 years) who underwent aortic valve replacement (n = 303), coronary artery bypass grafting (n = 403), or aortic valve replacement with coronary artery bypass grafting (n = 297) between 1987 and 2006. Preoperative data, operative outcome, long-term survival, and predictors for early and late mortality were analyzed. Furthermore, the Short Form 36 Health Status questionnaire was used to evaluate the quality of life. RESULTS: Overall in-hospital mortality was 7.1%. Overall actuarial survival at 1, 5, and 10 years was 81.6% ± 1.2%, 60.4% ± 1.9%, and 23.3% ± 2.6% (mean survival time, 6.25 ± 0.2 years) and showed no significant difference compared with an age- and sex-matched general population. Multivariate analysis showed that preoperative creatinine concentration greater than 1.3 mg/dL (p < 0.001), preoperative atrial fibrillation (p < 0.005), and postoperative prolonged ventilation (p < 0.001) were independent predictors for poor long-term survival. The physical health summarized score of the Short Form 36 Health Status questionnaire was significantly increased in the study population compared with a German standard population aged 80 years and older (p < 0.05). CONCLUSIONS: Despite an increased operative mortality, octogenarians showed a considerable quality of life and an excellent long-term survival. To further improve surgical outcome in octogenarians, patient selection should be done with consideration of the identified independent preoperative risk factors.

LIFEBRIDGE B2T--a new portable cardiopulmonary bypass system.

The LIFEBRIDGE B2T is a new portable cardiopulmonary bypass (CPB) system designed for temporary circulatory support. The LIFEBRIDGE B2T consists of a disposable patient unit with a CPB circuit, a control, and a base unit. The system weighs 20 kg. We used the LIFEBRIDGE B2T in four patients for circulatory support in beating heart coronary artery bypass graft for complete revascularization. The LIFEBRIDGE B2T was connected via femoral cannulation. Concentrations of free hemoglobin (fHb), interleukin (IL)-6, and -8 were measured. For venous blood drainage, 22-24 Fr cannulae and for arterial cannulation, 16-20 Fr cannulae were used. Average extracorporeal circulation (ECC) time was 61 +/- 18 minutes. During circulatory support, the system delivered an arterial blood flow between 3.1 and 4.1 L/min. The negative pressure at the venous drainage was between -79 and -45 mm Hg. During circulatory support, fHb concentration increased from 5.8 +/- 1.7 mg/dL to a maximum of 10.2 +/- 6.2 mg/dL. Also, IL-6 and -8 increased from 2.1 +/- 0.06 to 503.3 +/- 400.7 U/L and 5.9 +/- 0.9 to 66.5 +/- 46.8 U/L, respectively. The LIFEBRIDGE B2T is a new portable and safe circulatory support system. Connected via femoral cannulation, the system provides adequate arterial blood flow and an acceptable negative pressure at the venous cannula. The fHb concentration showed only a moderate increase during ECC.

The complete supraannular concept: in vivo hemodynamics of bovine and porcine aortic bioprostheses.

BACKGROUND: Complete supraannular placement of an aortic bioprosthesis is one approach to optimize the hemodynamic result of an aortic valve replacement. It is achieved with the combination of a special valve design and the supraannular sewing technique with noneverted mattress sutures. We evaluated 5 bioprostheses designed for complete supraannular placement to assess potential hemodynamic differences caused by factors (eg, valve material) other than implantation position. METHODS AND RESULTS: In 336 patients (mean age, 72.0+/-7.1 years; 143 women), hemodynamics including mean pressure gradients, effective orifice areas, and indices and incidence of patient-prosthesis mismatch were evaluated 6 months after surgery. Annulus diameter was measured during surgery. Patients received the Carpentier Edwards Perimount Magna (Magna, n=169), the Medtronic Mosaic (Mosaic, n=46), the Mosaic Ultra (Ultra, n=17), the SJM Epic Supra (Epic, n=46), and the Sorin Soprano (Soprano, n=58). For small annulus sizes (<23 mm), the mean pressure gradients of the Magna (11.82+/-4.8 mm Hg) were significantly lower than the Mosaic (16.04+/-6.1 mm Hg) and the Ultra (22.0+/-4.1 mm Hg), and the Soprano (13.3+/-5.2 mm Hg) was hemodynamically superior to the Ultra. For medium (23 to 24 mm) and large (>24 mm) annulus sizes, the mean pressure gradients of the Magna were lower than the Epic (10.0+/-3.5 mm Hg versus 14.9+/-6.4 mm Hg; 9.9+/-4.0 mm Hg versus 18.6+/-12.7 mm Hg). Furthermore, in patients with large annulus size, the mean pressure gradients of the Soprano (11.4+/-3.8 mm Hg) were lower compared with the Epic (18.5+/-12.7 mm Hg). Severe patient-prosthesis mismatch was observed more frequently in patients with the Mosaic (12/46; 26.1%) and the Ultra (3/17; 17.6%) prostheses. CONCLUSIONS: Complete supraannular placement cannot prevent high pressure gradients or patient-prosthesis mismatch thoroughly, but the choice of a bovine prosthesis can optimize hemodynamic performance.

Hemodynamic characterization of the Sorin Mitroflow pericardial bioprosthesis at rest and exercise.

BACKGROUND AND AIM OF THE STUDY: Although the long-term clinical outcome after aortic valve replacement (AVR) with the Sorin Mitroflow pericardial bioprosthesis has been well described, few data are available with regards to hemodynamic performance. On the basis of its specialized design, with the pericardium mounted on the outside of the stent, the Mitroflow valve is considered to provide optimal opening and orifice areas. METHODS: Between February 2006 and April 2007, a total of 127 patients (66 females, 61 males; mean age 77.6 +/- 5.2 years) underwent AVR with the Mitroflow valve at the authors' institution. Echocardiography was performed at discharge in 91 patients, while a six-month follow up examination was conducted in 78 (including ergometer hemodynamics in 25 cases). RESULTS: The mean systolic pressure gradient (MPG) ranged from 19.7 +/- 3.3 mmHg (size 19 valve) to 12.4 +/- 2.4 mmHg (size 27 valve), and the mean effective orifice area (EOA) from 0.96 +/- 0.0 cm2 (size 19 valve) to 2.36 +/- 0.4 cm2 (size 27 valve). The incidence of mild-to-moderate and severe prosthesis-patient mismatch (PPM) was 33% and 10% at the six-month follow up. During exercise (25 W-100 W), the MPG increased from 17.1 +/- 3.6 mmHg to 23.6 mmHg in valve sizes 19 to 21, and from 12.2 +/- 3.6 mmHg to 15.9 +/- 2.5 mmHg in valve sizes 23 to 27. The effective orifice fraction (EOF = EOA/annulus area) was 38 +/- 7%. CONCLUSION: The Mitroflow valve exhibits an adequate MPG and EOA, as might be expected for a pericardial bioprosthesis. Of note, the gradient increase during exercise was low, especially for the larger valve sizes. Due to its special design, the Mitroflow prosthesis shows a large opening, as demonstrated by the high EOF. These data relating to the EOA of all prosthesis sizes may help surgeons to select the minimum prosthesis size in order to prevent PPM.