Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis.

BACKGROUND: The Carpentier-Edwards Perimount Magna Ease prosthesis (PME) represents the latest generation of stented bioprostheses used for surgical aortic valve replacement (SAVR). The aim of our study was to evaluate the long-term clinical outcome and hemodynamic performance of the prosthesis with a focus on the incidence and course of structural valve deterioration (SVD) by serial echocardiographic examinations. METHODS: SAVR with the PME was performed in 58 consecutive patients between 2007 and 2008. Transthoracic echocardiography was performed preoperatively, at discharge and annually during a 10-year follow-up at the German Heart Center Munich. RESULTS: Mean age at surgery was 62±14 years. At discharge (n=57), the overall mean pressure gradient (MPG) and effective orifice area (EOA) were 15.8±4.1 mmHg and 1.8±0.4 cm2, respectively. Moderate patient-prosthesis mismatch (PPM) was present in 18 patients (32%) and severe PPM in 6 patients (11%) at discharge. Ten years following SAVR (n=33), the overall MPG was 16.6±7.3 mmHg and EOA was 1.3±0.4 cm2.Thirty-day and late mortality was 2% (n=1) and 21% (n=12), respectively. Survival at 1, 5, and 10 years was 94.7%±3.3%, 91.1%±4.1%, and 77.3%±5.9%, respectively. Freedom from reoperation at 10 years was 88.8%±4.7%. Ten years after PME implantation the cumulative incidence of any SVD, severe SVD, and bioprosthetic valve failure (BVF) was 25%±6%, 14%±5%, and 16%±5%, respectively. CONCLUSIONS: The PME shows an excellent hemodynamic performance over the course of 10 years with development of clinically relevant SVD as late as 6 years post implant, and a 10-year incidence of severe SVD of 14%.

Mitral Valve Repair in Children Below Age 10 Years: Trouble or Success?

BACKGROUND: Mitral valve (MV) repair in children is challenging because of the broad spectrum of lesions and anticipated patient growth. The purpose of the study was to evaluate the outcome of MV repair in children below 10 years of age. METHODS: We reviewed all MV repair procedures performed in children below 10 years of age. Endpoints of the study were survival after MV repair and cumulative incidence of reoperation. RESULTS: MV repair was performed in 40 patients with congenital MV disease (MVD) and in 10 patients with acquired MVD. Median age at time of repair for congenital MVD was 1.2 years (range, 14 days to 9.8 years) and for acquired MVD 1.9 years (range, 10 days to 9.9 years). Indication for MV repair was mitral regurgitation in 31 congenital MVD patients (77.5%) and in all acquired MVD patients. In patients with congenital MVD operative mortality was 5% and late mortality was 10%. No deaths occurred in patients with acquired MVD. Patients with congenital mitral regurgitation showed a better, yet not significant, 6-year survival than patients with congenital mitral stenosis (85.3% ± 8.2% vs 60% ± 18.2%, P = .1). In patients with congenital MVD cumulative incidence of reoperation at 6 years was 38.6% ± 8.3%. CONCLUSIONS: In children below 10 years of age, MV repair is an effective treatment option for MVD. However it often just delays the time to valve replacement.

Dexmedetomidine versus propofol-opioid for sedation in transcatheter aortic valve implantation patients: a retrospective analysis of periprocedural gas exchange and hemodynamic support.

PURPOSE: Different sedation regimens have been described for use during transfemoral transcatheter aortic valve implantation (tf-TAVI) for treatment in patients with severe aortic stenosis. The purpose of this study was to compare dexmedetomidine (DEX) with a combination of propofol-opioid (PO) with respect to periprocedural gas exchange and hemodynamic support. METHODS: Data from a cohort of patients sedated with either DEX or PO for tf-TAVI were retrospectively analyzed from a prospectively maintained TAVI registry. Operative risk was determined from comorbidities and risk scores. Periprocedural partial pressure of carbon dioxide (PaCO2) was chosen as the primary endpoint. Other differences in gas exchange, need for catecholamine therapy, the frequency of conversion to general anesthesia, and need for sedative "rescue therapy" (in DEX patients) were secondary endpoints. Inverse probability of treatment weighting (IPTW) was used for analysis to minimize any selection bias. RESULTS: Of the 297 patients (140 PO, 157 DEX) included, the median [interquartile range] periprocedural PaCO2 values of DEX patients were significantly lower than in PO patients (40 [36-45] mmHg vs 44 [40-49] mmHg, respectively; median difference -4 mmHg; 95% confidence interval, -5 to -3 mmHg; P < 0.001). Hypercapnia (PaCO2 > 45 mmHg) was significantly less frequent in DEX patients compared with the PO group (25% vs 42%, respectively; P = 0.005). Vasopressor support was more frequent in the PO group compared with DEX (68% vs 25%, respectively; P < 0.001). Conversion to general anesthesia was not different between groups (9%, PO vs 3%, DEX; P = 0.051). Additional sedatives/opioids were required in 25 (16%) of the DEX patients. CONCLUSIONS: In sedated TAVI patients, DEX was associated with lower PaCO2 values and reduced requirements for vasopressor support, making it a promising alternative to PO for sedation during TAVI. TRIAL REGISTRATION: www.ClinicalTrials.gov (NCT01390675). Registered 11 July 2011.

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.

In-vivo bacterial adherence to intracardiac prosthetic materials: a new experimental model.

BACKGROUND AND AIM OF THE STUDY: Bacterial colonization of inert artificial materials is a critical variable in the appearance of foreign body-centered infections. Hence, a new experimental endocarditis model was evaluated that enables quantitative in-vivo testing of bacterial adherence to prosthetic materials. METHODS: In 53 rabbits, different patches of either Dacron (DAC; n = 16), glutaraldehyde-fixed pericardium (GAP; n = 18) or cryopreserved allograft (AG; n = 19) were threaded onto a Prolene suture and led through a stitch incision at the left atrium to the ventricle, perforating the mitral valve and leaving the heart at the outside of the left ventricle. The patch became caught in the valve tissue, creating mitral insufficiency. At 6 h after surgery, 6 x 10(6) colony-forming units (CFU) of Staphylococcus aureus were administered intravenously. Postmortem examination and further analysis were carried out 48 h after bacterial inoculation. RESULTS: Ten animals (two DAC, four GAP, four AG) died and were excluded. Subsequently, sterile patches were found in 6/14 animals of the DAC group, in 9/14 of the GAP group, and in 9/15 of the AG group. The mean numbers of cultured organisms in the remaining patches were 2.3 x 10(6) + 7.6 x 10(6)/mg (DAC), 1.8 x 10(4)+/-6.7 x 10(4)/mg (GAP) and 4.9 x 10(5)+/-1.0 x 10(6) CFU/mg (AG). Differences in the number of CFU were not significant for all groups. CONCLUSION: The above-described model allows reliable quantitative in-vivo testing of bacterial adherence to different prosthetic materials within a short time period. The results suggest that, with regard to avoiding the development of bacterial endocarditis, biomaterials have no advantage over Dacron.