Mitral valve repair with the edge-to-edge technique: A 20 years single-center experience.

OBJECTIVES: For tailored treatment of primary mitral regurgitation (MR), surgeons developed different repair techniques. One of them, the edge-to-edge repair has recently seen a revival, especially for Barlow's disease. METHODS: This study was designed to assess the outcomes of the edge-to-edge technique in mitral valve (MV) repair. Preoperative, periprocedural, and postoperative data were prospectively collected in a dedicated database and analyzed retrospectively. RESULTS: Between March 1999 and July 2019, a total of 152 patients (mean age: 60 ± 13) received an edge-to-edge repair combined with annuloplasty for degenerative MR at our institution. MR resulted from posterior leaflet prolapse in 23 patients (15.1%), anterior leaflet prolapse in 19 (12.5%), and bileaflet prolapse in 110 (72.4%). Of those who had a bileaflet prolapse, 91 (82.7%) had Barlow's disease. Follow-up was complete in 97.4% (6.4 ± 5.7 years). Echocardiographic assessment was achieved in 85.5% (5.1 ± 5.6 years). Overall survival after 10 years was 73.7 ± 5.0%. Twelve patients required valve-related reoperations due to ring dehiscence (n = 2), leaflet suture dehiscence (n = 2), progression of native valve disease (n = 6), or due to device failure (ring fracture) (n = 2). The cumulative incidence of valve-related reoperation at 10 years was 8.4 ± 3.0% (5.2 ± 4.1% in patients with Barlow's disease). At latest follow-up, echocardiography revealed excellent valve function with no or mild MR in 93 patients (88.6%). The mean gradient was 2.9 ± 1.3 mmHg at discharge and decreased to 2.4 ± 1.3 mmHg. Three patients (2.8%) had more than moderate MR. CONCLUSION: Edge-to-edge MV repair is a simple method with excellent results in terms of valvular function and durability especially in patients with Barlow's disease.

Functional and Degenerative Mitral Regurgitation: One Ring Fits All?

BACKGROUND: Three-dimensional saddle-shaped annuloplasty rings have been shown to create a larger surface of leaflet coaptation in mitral valve repair (MVR) for functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR) which may increase repair durability. For the first time, this study reports mid-term results after MVR for DMR and FMR using a rigid three-dimensional ring (Profile 3D, Medtronic). METHODS: Between June 2009 and June 2012, 369 patients with DMR (n = 326) or FMR (n = 43) underwent MVR (mean age 62.3 ± 12.6 years). A total of 205 patients (55.6%) underwent isolated MVR and 164 patients (44.4%) a combined procedure. Follow-up examinations were performed in 94.9% (mean 4.9 ± 0.9 years). Echocardiographic assessment was complete in 93.2% (mean 4.3 ± 1.2 years). RESULTS: The 30-day mortality was 1.5% (5/326) for DMR (1.5% for isolated and 1.6% for combined procedures) and 9.3% (4/43) for FMR (0% for isolated and 10.5% for combined procedures). Survival at 6 years was 92.1 ± 1.9% for DMR (92.9 ± 2.6% for isolated and 90.7 ± 2.7% for combined procedures) and 66.4 ± 7.9% for FMR (80.0 ± 17.9% for isolated and 63.7 ± 8.9% for combined procedures). Cumulative risk for mitral valve-related reoperation at 6 years was 0% for FMR and 7.1 ± 1.5% for DMR. At echocardiographic follow-up, one patient presented with mitral regurgitation (MR) more than moderate. The only predictor of recurrent MR after MVR for DMR was residual mild MR at discharge. CONCLUSION: Repair of FMR with the three-dimensional Profile 3D annuloplasty ring shows excellent mid-term results with regard to recurrence of MR. In cases of DMR, the results are conforming to the current literature.

Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation.

BACKGROUND: Functional tricuspid regurgitation (FTR) secondary to left-sided heart disease may lead to poor quality of life and reduced long-term survival. This study evaluated clinical and functional outcomes of patients undergoing tricuspid valve (TV) repair using a rigid three-dimensional ring (Contour 3D, Medtronic) concomitant with another procedure. METHODS: From September 2011 to July 2015, 112 patients (mean age 70.9 ± 9.0 years) were enrolled at 10 centers in Europe, Israel, and the United States. Inclusion criteria were FTR ≥ moderate and/or tricuspid annular diameter (TAD) ≥ 40 mm. Echocardiography was planned before surgery and at discharge with echocardiographic and clinical follow-ups performed 6 months postoperatively. RESULTS: Three fourths (74.4%) of patients had higher than moderate TR. Mean TAD was 41.0 ± 7.3 mm; 61.7% of patients were in the New York Heart Association (NYHA) class III/IV. The most common concomitant procedure was mitral valve repair (57 patients, 53.3%). The 30-day mortality rate was 0.9% (n = 1). The mean EuroSCORE II was 8.9 ± 8.4% (median: 5.9%; interquartile range: 3.5-11.5%). The observed to expected ratio (O/E) based on the median was 0.1. Six deaths occurred during follow-up (three cardiac related). Mean implanted ring size was 30.3 ± 2.7. At 6 months, 94.4% of patients showed ≤ mild TR, and 92.0% were in NYHA class I/II (p < 0.001 vs baseline for both). Mean pressure gradient across the TV was 2.0 ± 1.1 mm Hg; leaflet coaptation length was 7.5 ± 3.3 mm. CONCLUSION: The Contour 3D annuloplasty ring used for treatment of FTR substantially reduced TR for up to 6 postoperative months with low mean pressure gradients across the TV and significant improvement in NYHA class. REGISTRATION: www.ClinicalTrials.gov, NCT01532921.

Is a Profiled Annuloplasty Ring Suitable for Repair of Degenerative Mitral Regurgitation? A Single-Center Experience Comprising 200 Patients.

Background Various devices have been proposed for ring annuloplasty in patients with degenerative mitral valve disease. This study reports for the first time midterm results with the rigid three-dimensional Medtronic Profile 3D (Medtronic, Minneapolis, Minnesota, United States) annuloplasty ring. Methods Between June 2009 and June 2011, 200 patients (mean age 61 ± 13 years, 70% male) with severe degenerative mitral regurgitation underwent mitral valve repair using the Medtronic Profile 3D annuloplasty ring. A total of 106 patients (53.0%) underwent isolated mitral valve repair and 94 patients (47.0%) underwent a concomitant procedure such as coronary artery bypass grafting (n = 21), tricuspid valve surgery (n = 49), AF ablation (n = 17), and aortic valve surgery (n = 13). The follow-up is 94.5% complete (mean 2.5 ± 0.5 years). Results Thirty-day mortality was 1.5%. Survival at 3 years was 97.1 ± 1.6% for isolated procedures and 92.4 ± 2.8% for combined procedures (p = 0.137). Freedom from mitral valve-related reoperation at 3 years was 97.1 ± 1.7% for isolated procedures and 95.5 ± 2.2% for combined procedures (p = 0.561). Seven patients (3.5%) required a mitral valve-related reoperation. Two of these reoperations were required for endocarditis, two for ring dehiscence, one for progression of the native disease (flail leaflet), one for leaflet suture dehiscence, and one for persistent systolic anterior motion. Conclusion The three-dimensional Medtronic Profile 3D annuloplasty ring is suitable for mitral valve repair for degenerative diseases. This saddle-shaped annuloplasty device provides excellent early results with a very good functional outcome at midterm either in isolated or combined procedures.

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.

Twenty-Seven-Year Experience With the St. Jude Medical Biocor Bioprosthesis in the Aortic Position.

BACKGROUND: The aim of this study was to evaluate the long-term performance of the St. Jude Medical Biocor porcine stented bioprosthesis in the aortic position. METHODS: From January 1985 to December 1996, 455 patients underwent aortic valve replacement with the St. Jude Medical Biocor prosthesis at the German Heart Center Munich. Mean age at time of operation was 72.5 ± 9 years. In all, 172 patients (37.8%) underwent concomitant coronary artery bypass grafting and 20 patients (4.4%) had had previous cardiac surgery. Event-free rates are given as mean ± SD. Adverse events were recorded according to the guidelines for reporting morbidity and mortality after cardiac valvular operations. RESULTS: Follow-up was complete in 93.4%. Mean follow-up time was 8.4 ± 5.6 years, with a total of 3,834 patient-years and a maximum of 27.4 years. Thirty patients were lost to follow-up after a mean of 9.2 ± 4.1 years. Overall survival rate at 10 and 15 years was 43.3% ± 2.4% and 19.2% ± 2.0%, respectively. Freedom from structural valve deterioration at 10 and 15 years was 92.1% ± 1.7% and 84.8% ± 3.0%, respectively. Freedom from valve-related reoperation at 10 and 15 years was 90.6 ± 1.7% and 86.3 ± 2.5%, respectively. Twenty-four patients needed reoperation for structural valve deterioration, 9 patients for endocarditis, 3 patients for paravalvular leakage, and 2 patients for aortic root aneurysm. At 15 years, freedom from major bleeding was 91.0% ± 2.0% and freedom from thromboembolism was 72.2% ± 2.8%. CONCLUSIONS: This study represents the longest follow-up for the St. Jude Medical Biocor prosthesis and shows an excellent durability with a low incidence of valve-related complications.

Heterotopic Cervical Heart Transplantation in Mice.

The heterotopic cervical heart transplantation in mice is a valuable tool in transplant and cardiovascular research. The cuff technique greatly simplifies this model by avoiding challenging suture anastomoses of small vessels thereby reducing warm ischemia time. In comparison to abdominal graft implantation the cervical model is less invasive and the implanted graft is easily accessible for further follow-up examinations. Anastomoses are performed by pulling the ascending aorta of the graft over the cuff with the recipient's common carotid artery and by pulling the main pulmonary artery over the cuff with the external jugular vein. Selection of appropriate cuff size and complete mobilization of the vessels are important for successful revascularization. Ischemia-reperfusion (I/R) injury can be minimized by perfusing the graft with a cardioplegic solution and by hypothermia. In this article, we provide technical details for a simplified and improved cuff technique, which should allow surgeons with basic microsurgical skills to perform the procedure with a high success rate.

Matched Comparison of Two Different Biological Prostheses for Complete Supra-annular Aortic Valve Replacement.

Objective The aim of this retrospective study was to evaluate the hemodynamic performance of the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St Paul, Minnesota, United States) and the Carpentier-Edwards Perimount Magna Ease (CEPM Ease; Edwards Lifesciences, Irvine, California, United States) bioprostheses early postoperative and at 1 year. Methods From October 2007 to October 2008, a total of 61 consecutive patients underwent aortic valve replacement (AVR) with the CEPM Ease prosthesis. From a prospective cohort of 201 patients (March 2011 to January 2012) who received AVR with the SJM Trifecta valve, a matched group of 51 patients was selected. Matching was conducted 1:1 by ejection fraction, gender, age, and body surface area. A Hegar dilator was used to define the aortic tissue annulus diameter. Data were grouped on the basis of the patient's tissue annulus diameter (≤22 mm; 23-24 mm; ≥25 mm). Results Early postoperative and at 1 year mean pressure gradients (MPGs) in the various groups ranged from 7.2 ± 4.6 to 7.1 ± 2.4 mm Hg and from 10.0 ± 4.3 to 8.0 ± 2.8 mm Hg in the SJM Trifecta group and from 18.0 ± 5.0 to 12.1 ± 3.6 mm Hg and from 17.7 ± 4.5 to 11.8 ± 3.2 mm Hg in the CEPM Ease group, respectively. Likewise, effective orifice areas (EOAs) ranged from 1.7 ± 0.5 to 2.0 ± 0.5 cm(2) and from 1.5 ± 0.3 to 1.7 ± 0.4 cm(2) in the SJM Trifecta group and from 1.3 ± 0.5 to 1.9 ± 0.5 cm(2) and from 1.2 ± 0.3 to 1.8 ± 0.3 cm(2) in the CEPM Ease group, respectively. A marked left ventricular mass (LVM) regression across all annulus sizes was noted in both groups. Severe patient-prosthesis mismatch (PPM) was infrequent overall. Conclusion The SJM Trifecta valve showed lower MPGs early postoperative and at 1 year as well as higher EOA and effective orifice area index early postoperative. No significant differences were detected with regard to LVM regression and PPM.

Do transvalvular pacemaker leads influence functional outcome after tricuspid ring annuloplasty?

OBJECTIVES: The impact of permanent pacemaker (PPM) leads on functional outcome of tricuspid valve (TV) repair has not been clearly demonstrated. Therefore, controversy exists as to whether transvalvular PPM leads should be explanted and replaced by epicardial leads at the time of valve repair. This study evaluates the influence of PPM leads on functional outcome, TV-related reoperations and survival in patients undergoing TV repair for functional tricuspid regurgitation (TR). METHODS: We retrospectively reviewed 415 consecutive patients who underwent TV ring annuloplasty at our institution from July 2007 to February 2013. In 112 patients (27%), a PPM was implanted either pre- or postoperatively. The follow-up is 94% complete (mean: 24.4 months; cumulative total 845 patient-years). RESULTS: The mean age was 70.2 ± 9.8 years and the mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 12.4%. Of note, 76.6% of the patients were in New York Heart Association class III or IV. Echocardiography documented moderate or severe TR in 96.4% of the patients, with a mean annulus diameter of 44.8 ± 5.4 mm. 95.4% of the patients underwent a combined procedure and 16.4% an urgent or emergent operation. The 30-day mortality was 7.5%. The preoperative TR grade was reduced from 2.47 ± 0.52 to 0.70 ± 0.54 (P < 0.001). At hospital discharge, residual ≥II TR was present in 7.1% of the patients. Freedom from recurrent ≥II TR at 5 years was 86.7 ± 3.2%. Upon uni- and multivariate analyses, the presence of a transvalvular PPM was not a risk factor for recurrent ≥II TR and late mortality. Freedom from TV-reoperations was 98.1 ± 0.8% at 5 years without significant difference between groups. CONCLUSION: The presence of a transvalvular PPM lead is not a risk factor for recurrent TR, TV-related reoperations and late mortality in patients undergoing ring annuloplasty for functional TR.

Early experiences with a new three-dimensional annuloplasty ring for the treatment of functional tricuspid regurgitation.

BACKGROUND: Various techniques and devices have been proposed for tricuspid valve (TV) repair in patients with tricuspid regurgitation (TR). However, residual or recurrent TR is not uncommon occurring in 20% to 30% of patients. This study reports first experiences with a new three-dimensional annuloplasty ring. METHODS: We retrospectively reviewed 200 consecutive patients who underwent TV repair for functional TR with the Contour 3D annuloplasty ring (Medtronic, Minneapolis, MN) from December 2010 to February 2013 at our institution. The follow-up is 98% complete (mean 1.0 ± 0.7 years; cumulative total 189 patient-years). RESULTS: Mean age was 70.4 ± 9.1 years and the median logistic European system for cardiac operative risk was 7%. Sixty-nine percent of the patients were in New York Heart Association class III/IV. Echocardiography documented moderate or severe TR in 97.5% of the patients, with a mean annulus diameter of 45.1 ± 4.9 mm; 93.5% of the patients underwent a combined procedure, and 20.5% an urgent or emergent operation. The 30-day mortality was 6%. The preoperative TR grade was reduced from 2.45 ± 0.53 to 0.77 ± 0.54 (p < 0.001). At hospital discharge residual II TR or greater was present in 4.3% of the patients. Freedom from recurrent II TR or greater at 2 years was 90.9% ± 4.2% and freedom from TV-related reoperations at 2 years was 98.5% ± 1.0%. No case of ring dehiscence occurred. Fourteen patients (7%) required a permanent pacemaker implantation for atrioventricular block. CONCLUSIONS: Tricuspid valve repair with the Contour 3D annuloplasty ring can be performed with a low rate of residual TR at hospital discharge, a low reoperation rate, and with an excellent early functional outcome.

Three-dimensional valve repair-the better care? Midterm results of a saddle-shaped, rigid annuloplasty ring in patients with ischemic mitral regurgitation.

OBJECTIVES: Undersized ring annuloplasty is the treatment of choice for functional mitral regurgitation. However, recurrence of mitral regurgitation within the first years is frequent. The aim of this study was to analyze the functional and clinical outcome after mitral valve repair with the 3-dimensional saddle-shaped Edwards GeoForm (Edwards Lifesciences LLC, Irvine, Calif) annuloplasty ring in patients with ischemic mitral regurgitation. METHODS: Between November 2006 and November 2012, 70 patients (mean age, 68 ± 10 years; mean left ventricular ejection fraction, 40% ± 15%) with functional mitral regurgitation due to ischemic cardiomyopathy underwent mitral valve repair with the Edwards GeoForm annuloplasty ring. Concomitant procedures, such as coronary artery bypass grafting (75.7%), tricuspid valve repair (25.7%), aortic valve replacement (8.6%), and the Maze procedure (4.3%), were performed in 92.9% of patients. Follow-up is 97% complete (mean, 3.0 ± 1.7 years). Transthoracic echocardiography was obtained 2.4 ± 1.7 years postoperatively. RESULTS: Thirty-day mortality was 5.9%. Overall survival at 5 years was 71.3% ± 6.9%. At 4 years, overall freedom from recurrence of mitral regurgitation grade 3+ or greater was 92.5% ± 3.6%, and freedom from recurrence of mitral regurgitation grade 2+ or greater was 71.0% ± 8.7%. Three patients required a mitral valve-related reoperation for ring dehiscence. New York Heart Association functional class improved from 3.6 ± 0.6 to 1.6 ± 0.6 during follow-up (P < .05). Mean mitral valve pressure gradient was 3.3 ± 1.8 mm Hg across all ring sizes at the time of follow-up. CONCLUSIONS: Mitral valve repair with the 3-dimensional saddle-shaped Edwards GeoForm annuloplasty ring in case of ischemic mitral regurgitation shows a low rate of recurrent regurgitation at 4 years. Clinically relevant mitral stenosis was not detected. The importance of secure anchoring of the device in the mitral annulus has to be emphasized to prevent ring dehiscence.

Role of metalloproteinases and tissue inhibitors of metalloproteinases during cardiopulmonary bypass in rats.

Matrix metalloproteinases (MMPs) and the tissue inhibitors of matrix metalloproteinases (TIMPs) regulate matrix remodeling in the heart. Changes in synthesis and release of MMPs and TIMPs are observed after extracorporeal circulation (ECC). Thus, MMPs and TIMPs are supposed to be involved in ECC-mediated cardiac dysfunction. The aim was to examine the role of MMPs and TIMPs in ECC-mediated cardiac dysfunction. Extracorporeal circulation was instituted in rats for 60 min at a flow rate of 120 ml/kg/min. Three groups (n = 10) were studied: group CAO: 60 min ECC without aortic cross-clamping, group CAC: 60 min ECC including 30 min aortic cross-clamping (crystalloid Inzolen(®) cardioplegia), and group CAB: 60 min ECC including 30 min aortic cross-clamping (blood cardioplegia). Left ventricular (LV) function was measured with conductance catheter. Matrix metalloproteinase-activity was determined by zymography and TIMP activity was determined by reverse zymography. Gene expression of MMPs and TIMPs was determined by real-time polymerase chain reaction. Sixty minutes after weaning from bypass, there was a preserved LV function in the CAO and CAB group and an impaired LV function in the CAC group. We observed an increased myocardial activity and an increased myocardial messenger RNA expression of MMP-2, MMP-9, TIMP-1, and TIMP-4 in all ECC groups, when compared with sham animals. With regard to enzyme activity, there was an imbalance of MMP/TIMP ratio leading to an increased activity of MMP in the CAC group. In terms of gene expression, there was an imbalance of MMP-2/TIMP-4 ratio leading to an increased expression of MMP-2 in the CAC group. MMP-2 contributes to myocardial reperfusion injury in this in vivo model of ECC with cardioplegic arrest.

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.

Percutaneous cannulation of the femoral vessels for cardiopulmonary bypass.

In case of minimally invasive open heart surgery, access for intrathoracic cannulation is limited and therefore femoral vessel cannulation is necessary. Complications after surgical exposure of the femoral vessels are well known. The authors describe their technique for percutaneous femoral vessel cannulation, which allows a safe establishment of cardiopulmonary bypass, reduces the incidence of groin complications, and offers excellent cosmetic results.

A prospective randomized comparison of the Medtronic Advantage Supra and St Jude Medical Regent mechanical heart valves in the aortic position: is there an additional benefit of supra-annular valve positioning?

OBJECTIVE: The aim of this prospective randomized trial was to evaluate the impact of complete supraannular positioning of mechanical aortic bileaflet valves. METHODS: Between April of 2004 and November of 2006, 80 patients underwent aortic valve replacement with the complete supraannular Medtronic Advantage Supra (n = 40) (Medtronic Inc, Minneapolis, Minn) or the intra-supraannular St Jude Medical Regent (n = 40) prosthesis (St Jude Medical Inc, St Paul, Minn). Before randomization and valve sizing for both valve types, the aortic tissue annulus diameter was determined by Hegar dilator. Transthoracic echocardiography data were obtained early postoperatively and at 6 months, including stress echocardiography. RESULTS: By grouping the data on the basis of a patient's tissue annulus diameter, no significant difference of either valve was detected with regard to mean pressure gradient and effective orifice area index at rest. Effective orifice area index ranged from 0.95 +/- 0.32 cm(2)/m(2) to 1.27 +/- 0.33 cm(2)/m(2) in the Advantage Supra group and from 0.98 +/- 0.36 cm(2)/m(2) to 1.26 +/- 0.37 cm(2)/m(2) in the Regent group. During exercise, mean pressure gradients increased from 11.9 +/- 4.9 mm Hg to 19.1 +/- 7.2 mm Hg in the Advantage Supra group and from 9.6 +/- 4.0 to 16.4 mm Hg +/- 7.3 mm Hg in the Regent group. A marked left ventricular mass regression across all annulus sizes was noted in both groups (P < .001). Sizing for both valve types showed that in 26.3%, the completely supraannular valve design allows the implantation of a 1 size larger valve in label than the corresponding intra-supraannular valve. CONCLUSION: By grouping the data on the basis of a patient's tissue annulus diameter, no significant superiority of either prosthesis was detected with regard to left ventricular mass regression, effective orifice area index, and mean pressure gradient during rest and exercise. We conclude that there is no additional benefit of supraannular valve positioning.

Influence of completely supra-annular placement of bioprostheses on exercise hemodynamics in patients with a small aortic annulus.

OBJECTIVE: Aortic valve replacement in patients with a small aortic annulus is often associated with increased pressure gradients. For this reason, prostheses for completely supra-annular placement have been developed. To evaluate the potential benefit of this design, the present study compared the effectiveness of 1 intra-supra-annular bioprosthesis and 3 completely supra-annular bioprostheses in patients with an aortic annulus diameter of 23 mm or less. METHODS: Between August 2000 and December 2004, each of 192 patients requiring aortic valve replacement with an intraoperatively measured aortic annulus diameter of 23 mm or less received one of the following bioprostheses: the stented bovine Sorin Soprano bioprosthesis (n = 28) (Sorin Group, Saluggia, Italy), the Carpentier-Edwards Perimount bioprosthesis (n = 50) (Edwards Lifesciences, Irvine, Calif), the Carpentier-Edwards Perimount Magna bioprosthesis (n = 70) (Edwards Lifesciences), or the stented porcine Medtronic Mosaic (n = 44) (Medtronic Inc, Minneapolis, Minn) bioprosthesis. After 6 months, hemodynamic data at rest and during exercise were obtained by echocardiography in 142 patients. RESULTS: The pericardial valves showed lower mean systolic pressure gradients, larger effective orifice areas and indices, and superior effective orifice fractions than did the porcine valve (P < .05) (Carpentier-Edwards Perimount: 10.9 +/- 3.6 mm Hg, 1.59 +/- 0.41 cm2, 0.9 +/- 0.25 cm2/m2, 41.9% +/- 9.6%; Carpentier-Edwards Perimount Magna 10.1 +/- 3.8 mm Hg, 1.64 +/- 0.38 cm2, 0.93 +/- 0.22 cm2/m2, 45.1% +/- 10.2%; Sorin Soprano 13.5 +/- 5.0 mm Hg, 1.64 +/- 0.32 cm2, 0.92 +/- 0.15 cm2/m2, 45.8% +/- 9.0%; vs Medtronic Mosaic 15.5 +/- 5.2 mm Hg, 1.31 +/- 0.42 cm2, 0.75 +/- 0.24 cm2/m2, 35.2% +/- 10.0%, respectively). The lowest mean systolic pressure gradients were found after the implantation of the Carpentier-Edwards Perimount Magna. Effective orifice areas, indices, and fractions of the pericardial valves did not show significant differences. CONCLUSIONS: In patients with small aortic roots, transvalvular gradients and effective orifice area showed a tendency to superior results in pericardial valves compared with the porcine bioprosthesis. However, the completely supra-annular design does not necessarily lead to superior hemodynamic results compared with the intra-supra-annular position.

Prediction of valve prosthesis-patient mismatch prior to aortic valve replacement: which is the best method?

BACKGROUND: To predict the occurrence of valve prosthesis-patient mismatch (VP-PM) after aortic valve replacement (AVR), the surgeon needs to estimate the postoperative effective orifice area index (EOAI). AIM: To compare different methods of predicting VP-PM. METHODS: The effective orifice area (EOA) of 383 patients who had undergone AVR between July 2000 and January 2005 with various aortic valve prostheses was obtained echocardiographically 6 months after the operation. We tested the efficacy of (1) EOAI calculated from the echo data obtained in our own laboratory, (2) indexed geometric orifice area, (3) EOAI estimated from charts provided by prosthesis manufacturers (which are based either on in vitro or on echo data) and (4) EOAI estimated from reference echo data published in the literature to predict VP-PM. RESULTS: Sensitivity and specificity to predict VP-PM were 53% and 83% (method 1), 80% and 53% (charts based on echo data, parts of method 3) and 71% and 67% (method 4) using reference data derived from echocardiographic examinations. The sensitivity of method 2 and of charts based on in vitro data (parts of method 3) to predict VP-PM was 0-17%. The incidence of severe VP-PM could be reduced from 8.7% to 0.8% after the introduction of the systematic estimation of the EOAI at the time of operation (p = 0.003, method 1). CONCLUSIONS: The best method of predicting VP-PM is the use of mean (SD) EOAs derived from echocardiographic examinations, whereas the use of in vitro data or the geometric orifice area is unreliable. After the surgeon's anticipation of VP-PM prior to AVR, the incidence of VP-PM could be reduced.

The Toronto root stentless valve in the subcoronary position is hemodynamically superior to the mosaic stented completely supra-annular bioprosthesis.

BACKGROUND AND AIM OF THE STUDY: Stentless valves are considered to exhibit better hemodynamics after aortic valve replacement (AVR) compared to stented valves. However, a new generation of stented bioprostheses for completely supra-annular implantation has been designed to optimize the ratio of the effective orifice area (EOA) of the prosthesis and aortic annulus area. The study aim was to determine whether a stentless valve implanted in the subcoronary technique renders larger orifice areas and lower transvalvular pressure gradients at rest and exercise compared to a completely supra-annular stented device. METHODS: Twenty patients underwent AVR for aortic stenosis with the St. Jude Medical (SJM) Toronto Root stentless porcine bioprosthesis, using a subcoronary implantation technique. Through the authors' institutional database, 20 additional patients were identified who had undergone AVR with the Medtronic Mosaic stented completely supra-annular porcine bioprosthesis. The patient groups were not matched for labeled valve size, but for annulus diameter measured intraoperatively using Hegar's dilators. Hemodynamic performance was assessed by transthoracic echocardiography at discharge (early) and by rest and stress echocardiography at six months postoperatively (mid-term). RESULTS: Transvalvular mean pressure gradients (MPG) at rest were significantly lower in the stentless group, but cardiac output was similar in both groups. Stress echocardiography also revealed significantly lower gradients at 25 W and 50 W exercise in the stentless group. The EOA index (EOAI), grouped by annulus diameter, tended to be larger in the stentless group and showed no severe patient-prosthesis mismatch (PPM; EOAI <0.65 cm2/m2) which, in contrast, occurred in three patients (15%) in the stented group (p = 0.072). CONCLUSION: In summary, the SJM Toronto Root porcine stentless bioprosthesis in the subcoronary position showed lower MPGs and larger EOAs at rest and during exercise compared to the Medtronic Mosaic porcine stented bioprosthesis. Therefore, physically active patients in particular may benefit from use of the stentless valve. Because of its larger EOA, a stentless valve should be implanted if severe PPM is expected.

Hemodynamic evaluation of the Sorin Soprano bioprosthesis in the completely supra-annular aortic position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the clinical and hemodynamic performance of the Sorin Soprano bioprosthesis in the aortic position. METHODS: Rest and stress echocardiography were performed at six months after surgery in 57 patients who underwent aortic valve replacement with the stented Soprano bioprosthesis. The exercise protocol included workloads of 25, 50, 75 and 100 W, each of 2 min duration. RESULTS: Thirty-day mortality was 1.8% (n = 1). Due to malperfusion of the coronary arteries, two Soprano prostheses had to be replaced by a different prosthesis, and one patient received coronary artery bypass grafts. One patient developed bacterial endocarditis of his prosthesis at seven months postoperatively and died as a result of a fulminant sepsis. There were no other prosthesis-related adverse events. Mean pressure gradients (MPG) ranged from 7.8 to 15.9 mmHg, effective orifice areas (EOA) from 1.25 to 2.98 cm2, EOA index (EOAI) from 0.79 to 1.43 cm2/m2, and EOA fraction from 34 to 45%. Stress echocardiography showed no significant increase in MPG up to 50 W, and MPGs did not exceed 35 mmHg at 75 and 100 W. CONCLUSION: Initial hemodynamic results showed low MPGs during rest and exercise. The EOAI was large due to completely supra-annular placement of the Soprano valve. The difficulty of complete supraannular placement is that the prosthesis is positioned relatively high, especially in narrow aortic roots, and this may handicap coronary artery perfusion. Patient selection with suitable aortic root anatomy is crucial to achieve the benefit of completely supra-annular implantation without coronary ostium deterioration.