Three-dimensional printing creates models for surgical planning of aortic valve replacement after previous coronary bypass grafting.

PURPOSE Resternotomy for aortic valve replacement in patients with previous coronary artery bypass grafting and an internal mammary artery graft may be a surgical problem. Thus, we are exploring the effect of using rapid prototyping techniques for surgical planning and intraoperative orientation during aortic valve replacement after previous coronary artery bypass grafting (CABG). DESCRIPTION As a proof of concept, we studied a patient who had undergone CABG 5 years earlier. At that time the patient received a left internal mammary artery graft to the left anterior descending artery and a venous graft to the right coronary artery. Now the patient required aortic valve replacement due to symptomatic aortic valve stenosis. The left internal mammary artery bypass and the right coronary artery bypass were patent and showed good flow in the angiography. The patient was examined by 128-slice computed tomography. The image data were visualized and reconstructed. Afterwards, a replica showing the anatomic structures was fabricated using a rapid prototyping machine. EVALUATION Using data derived from 128-slice computed tomography angiography linked to proprietary software, we were able to create three-dimensional reconstructions of the vascular anatomy after the previous CABG. The models were sterilized and taken to the operating theatre for orientation during the surgical procedure. CONCLUSIONS Stereolithographic replicas are helpful for choosing treatment strategies in surgical planning and for intraoperative orientation during reoperations of patients with previous CABG.

Short-term Functional and Patient Outcome of the Bi-cruciate Stabilized Total Knee Replacement: Prospective Consecutive Case-series

Background: Total knee replacement is the gold standard treatment for patients suffering from advanced symptomatic knee osteoarthritis. The main goals of knee prosthetics are pain reduction and restoration of knee motion. The new prostheses on the market such as the bi-cruciate stabilized Journey knee implant, promise a reconstruction of total physiological function of the knee with physiological range of motion and therefore high patient satisfaction. Purpose: The aim of this study was to analyze the patient-based Knee Injury and Osteoarthritis Outcome Score (KOOS) outcome after total knee replacement with new physiological bi-cruciate stabilized Journey knee prosthesis. Study Design: Prospective, consecutive case-series. Patients: Ninety nine patients, who received bi-cruciate stabilized Journey total knee prosthesis between January 1st 2006 and May 31st 2012, were included in the study. A single surgeon operated all patients. There were 61.1% females and the overall average age was 68 years (range 41-83 years). Left knee was replaced in 55.6%. Methods: The patients filled in KOO’s questionnaire pre- and 1 year postoperative. Range of motion (ROM) was studied preoperatively and at 1-year follow-ups. The pre- and postoperative KOOS subscores and ROM were compared using the Wilcoxon signed rank test. Results: There are significant improvements of all KOOS subscores. Ninety percent of patients have reached the minimum clinically relevant 10 points in symptoms, 94.5% in pain, 94.5% in activities of daily living, 84.9% in sport and recreation, and 90% in knee related quality of life. Postoperative, the average passive ROM was 131° (range 110-145°) and the average active ROM 122° (range 105-135°). The highest correlation coefficients ROM and the KOOS were observed for the activity and pain subscores. Very low or no correlation was seen for the sport subscore. Conclusions: Bi-cruciate stabilized knee prosthetic offers a solid outcome 1 year postoperative based on the results measured with the KOOS evaluation questionnaire. The Patients showed a generalized improvement in all domains measured in the KOOS of minimally 35, and up to over 52 points, what can be described as statistically significant. Patients described the level of functionality close to double compared to the preoperative status.

State-of-the-art aortic imaging: Part II - applications in transcatheter aortic valve replacement and endovascular aortic aneurysm repair.

Transcatheter aortic valve replacement (TAVR) as well as thoracic and abdominal endovascular aortic repair (TEVAR and EVAR) rely on accurate pre- and postprocedural imaging. This review article discusses the application of imaging, including preprocedural assessment and measurements as well as postprocedural imaging of complications. Furthermore, the exciting perspective of computational fluid dynamics (CFD) based on cross-sectional imaging is presented. TAVR is a minimally invasive alternative for treatment of aortic valve stenosis in patients with high age and multiple comorbidities who cannot undergo traditional open surgical repair. Given the lack of direct visualization during the procedure, pre- and peri-procedural imaging forms an essential part of the intervention. Computed tomography angiography (CTA) is the imaging modality of choice for preprocedural planning. Routine postprocedural follow-up is performed by echocardiography to confirm treatment success and detect complications. EVAR and TEVAR are minimally invasive alternatives to open surgical repair of aortic pathologies. CTA constitutes the preferred imaging modality for both preoperative planning and postoperative follow-up including detection of endoleaks. Magnetic resonance imaging is an excellent alternative to CT for postoperative follow-up, and is especially beneficial for younger patients given the lack of radiation. Ultrasound is applied in screening and postoperative follow-up of abdominal aortic aneurysms, but cross-sectional imaging is required once abnormalities are detected. Contrast-enhanced ultrasound may be as sensitive as CTA in detecting endoleaks.

Total surgical aortic arch replacement as a safe strategy to treat complex multisegmental proximal thoracic aortic pathology.

OBJECTIVE To analyse the results after elective open total aortic arch replacement. METHODS We analysed 39 patients (median age 63 years, median logistic EuroSCORE 18.4) who underwent elective open total arch replacement between 2005 and 2012. RESULTS In-hospital mortality was 5.1% (n = 2) and perioperative neurological injury was 12.8% (n = 5). The indication for surgery was degenerative aneurysmal disease in 59% (n = 23) and late aneurysmal formation following previous surgery of type A aortic dissection in 35.9% (n = 14); 5.1% (n = 2) were due to anastomotical aneurysms after prior ascending repair. Fifty-nine percent (n = 23) of the patients had already undergone previous proximal thoracic aortic surgery. In 30.8% (n = 12) of them, a conventional elephant trunk was added to total arch replacement, in 28.2% (n = 11), root replacement was additionally performed. Median hypothermic circulatory arrest time was 42 min (21-54 min). Selective antegrade cerebral perfusion was used in 95% (n = 37) of patients. Median follow-up was 11 months [interquartile range (IQR) 1-20 months]. There was no late death and no need for reoperation during this period. CONCLUSIONS Open total aortic arch replacement shows very satisfying results. The number of patients undergoing total arch replacement as a redo procedure and as a part of a complex multisegmental aortic pathology is high. Future strategies will have to emphasize neurological protection in extensive simultaneous replacement of the aortic arch and adjacent segments.

Swiss national guideline for reimbursement of enzyme replacement therapy in late-onset Pompe disease.

Glycogen storage disease type II is a rare multi-systemic disorder characterised by an intracellular accumulation of glycogen due a mutation in the acid alpha glucosidase (GAA) gene. The level of residual enzyme activity, the genotype and other yet unknown factors account for the broad variation of the clinical phenotype. The classical infantile form is characterised by severe muscle hypotonia and cardiomyopathy leading to early death. The late-onset form presents as a limb girdle myopathy with or without pulmonary dysfunction. Enzyme replacement therapy (ERT) with recombinant human GAA (rhGAA) in infants is life saving. In contrast, therapeutic efficacy of rhGAA in the late-onset form is modest. High expenses of rhGAA, on-going infusions and poor pharmacokinetic efficacy raised a discussion of the cost effectiveness of ERT in late-onset Pompe disease in Switzerland. This discussion was triggered by a Swiss federal court ruling which confirmed the reluctance of a health care insurer not to reimburse treatment costs in a 67-year-old female suffering from Pompe disease. As a consequence of this judgement ERT was stopped by all insurance companies in late-onset Pompe patients in Switzerland regardless of their clinical condition. Subsequent negotiations lead to the release of a national guideline of the management of late-onset Pompe disease. Initiation and limitation of ERT is outlined in a national Pompe registry. Reimbursement criteria are defined and individual efficacy of ERT with rhGAA is continuously monitored.

Influence of hormone replacement therapy on proteomic pattern in serum of postmenopausal women

OBJECTIVES: Proteomics approaches to cardiovascular biology and disease hold the promise of identifying specific proteins and peptides or modification thereof to assist in the identification of novel biomarkers. METHOD: By using surface-enhanced laser desorption and ionization time of flight mass spectroscopy (SELDI-TOF-MS) serum peptide and protein patterns were detected enabling to discriminate between postmenopausal women with and without hormone replacement therapy (HRT). RESULTS: Serum of 13 HRT and 27 control subjects was analyzed and 42 peptides and proteins could be tentatively identified based on their molecular weight and binding characteristics on the chip surface. By using decision tree-based Biomarker Patternstrade mark Software classification and regression analysis a discriminatory function was developed allowing to distinguish between HRT women and controls correctly and, thus, yielding a sensitivity of 100% and a specificity of 100%. The results show that peptide and protein patterns have the potential to deliver novel biomarkers as well as pinpointing targets for improved treatment. The biomarkers obtained represent a promising tool to discriminate between HRT users and non-users. CONCLUSION: According to a tentative identification of the markers by their molecular weight and binding characteristics, most of them appear to be part of the inflammation induced acute-phase response

Extent and distribution of calcification of both the aortic annulus and the left ventricular outflow tract predict aortic regurgitation after transcatheter aortic valve replacement

Aims: We sought to analyse local distribution of aortic annulus and left ventricular outflow tract (LVOT) calcification in patients undergoing transcatheter aortic valve replacement (TAVR) and its impact on aortic regurgitation (AR) immediately after device placement. Methods and results: A group of 177 patients with severe aortic stenosis undergoing multislice computed tomography of the aortic root followed by TAVR were enrolled in this single-centre study. Annular and LVOT calcifications were assessed per cusp using a semi-quantitative grading system (0: none; 1 [mild]: small, non-protruding calcifications; 2 [moderate]: protruding [>1 mm] or extensive [>50% of cusp sector] calcifications; 3 [severe]: protruding and extensive calcifications). Any calcification of the annulus or LVOT was present in 107 (61%) and 63 (36%) patients, respectively. Prevalence of annulus/LVOT calcifications in the left coronary cusp was 42% and 25%, respectively, in the non-coronary cusp 28% and 13%, in the right coronary cusp 13% and 5%. AR grade 2 to 4 assessed by the method of Sellers immediately after TAVR device implantation was observed in 55 patients (31%). Multivariate regression analysis revealed that the overall annulus calcification (OR [95% CI] 1.48 [1.10-2.00]; p=0.0106), the overall LVOT calcification (1.93 [1.26-2.96]; p=0.0026), any moderate or severe LVOT calcification (5.37 [1.52-18.99]; p=0.0092), and asymmetric LVOT calcification were independent predictors of AR. Conclusions: Calcifications of the aortic annulus and LVOT are frequent in patients undergoing TAVR, and both the distribution and the severity of calcifications appear to be independent predictors of aortic regurgitation after device implantation. - See more at: http://www.pcronline.com/eurointervention/77th_issue/126/#sthash.Hzodgju5.dpuf

Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease.

BACKGROUND Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study

Background Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. Aim To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). Methods This prospective, case–control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. Results Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). Conclusions Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators.

Mid-term results of aortic root replacement using a self-assembled biological composite graft.

OBJECTIVES To report the mid-term results of aortic root replacement using a self-assembled biological composite graft, consisting of a vascular tube graft and a stented tissue valve. METHODS Between January 2005 and December 2011, 201 consecutive patients [median age 66 (interquartile range, IQR, 55-77) years, 31 female patients (15.4%), median logistic EuroSCORE 10 (IQR 6.8-23.2)] underwent aortic root replacement using a stented tissue valve for the following indications: annulo-aortic ectasia or ascending aortic aneurysm with aortic valve disease in 162 (76.8%) patients, active infective endocarditis in 18 (9.0%) and acute aortic dissection Stanford type A in 21 (10.4%). All patients underwent clinical and echocardiographic follow-up. We analysed survival and valve-related events. RESULTS The overall in-hospital mortality rate was 4.5%. One- and 5-year cardiac-related mortality rates were 3 and 6%, and overall survival was 95 ± 1.5 and 75 ± 3.6%, respectively. The rate of freedom from structural valve failure was 99% and 97 ± 0.4% at the 1- and 5-year follow-up, respectively. The incidence rates of prosthetic valve endocarditis were 3 and 4%, respectively. During a median follow-up of 28 (IQR 14-51) months, only 2 (1%) patients required valve-related redo surgery due to prosthetic valvular endocarditis and none suffered from thromboembolic events. One percent of patients showed structural valve deterioration without any clinical symptoms; none of the patients suffered greater than mild aortic regurgitation. CONCLUSIONS Aortic root replacement using a self-assembled biological composite graft is an interesting option. Haemodynamic results are excellent, with freedom from structured valve failure. Need for reoperation is extremely low, but long-term results are necessary to prove the durability of this concept.

Decision-making in aortic root surgery in Marfan syndrome: bleeding, thromboembolism and risk of reintervention after valve-sparing or mechanical aortic root replacement†

OBJECTIVES Valve-sparing root replacement (VSRR) is thought to reduce the rate of thromboembolic and bleeding events compared with aortic root replacement using a mechanical aortic root replacement (MRR) with a composite graft by avoiding oral anticoagulation. But as VSRR carries a certain risk for subsequent reinterventions, decision-making in the individual patient can be challenging. METHODS Of 100 Marfan syndrome (MFS) patients who underwent 169 aortic surgeries and were followed at our institution since 1995, 59 consecutive patients without a history of dissection or prior aortic surgery underwent elective VSRR or MRR and were retrospectively analysed. RESULTS VSRR was performed in 29 (David n = 24, Yacoub n = 5) and MRR in 30 patients. The mean age was 33 ± 15 years. The mean follow-up after VSRR was 6.5 ± 4 years (180 patient-years) compared with 8.8 ± 9 years (274 patient-years) after MRR. Reoperation rates after root remodelling (Yacoub) were significantly higher than after the reimplantation (David) procedure (60 vs 4.2%, P = 0.01). The need for reinterventions after the reimplantation procedure (0.8% per patient-year) was not significantly higher than after MRR (P = 0.44) but follow-up after VSRR was significantly shorter (P = 0.03). There was neither significant morbidity nor mortality associated with root reoperations. There were no neurological events after VSRR compared with four stroke/intracranial bleeding events in the MRR group (log-rank, P = 0.11), translating into an event rate of 1.46% per patient-year following MRR. CONCLUSION The calculated annual failure rate after VSRR using the reimplantation technique was lower than the annual risk for thromboembolic or bleeding events. Since the perioperative risk of reinterventions following VSRR is low, patients might benefit from VSRR even if redo surgery may become necessary during follow-up.

Mitral valve replacement in patients under 65 years of age: mechanical or biological valves?

PURPOSE OF REVIEW There is controversy regarding the optimal choice of prosthetic valves in patients less than 65 years of age requiring mitral valve replacement (MVR). Recently, trends for valve replacement are moving towards biological prosthesis also in younger patients, which is justified by the fact that a later valve-in-valve procedure is feasible in the case of degeneration of the tissue valve. This strategy is increasingly recommended in aortic valve surgery but is questionable for MVR. The purpose of this review is to evaluate current guidelines and analyse evidence for biological MVR in patients under 65 years. RECENT FINDINGS There are differences between guidelines of the American Heart Association and those of the European Society of Cardiology concerning the choice of prostheses in patients undergoing MVR. Although the European Society of Cardiology recommends a mechanical mitral valve in patients under 65 years of age, the American Heart Association does not provide detailed advice for these patients. Mitral valve replacement with biological valves in patients under 65 years is associated with higher rates of reoperation due to structural valve deterioration. In addition, several studies showed a decreased survival after biological MVR. SUMMARY Evidence for biological MVR in patients less than 65 years without comorbidities or contraindication for oral anticoagulation does not exist. Recommendations for patients less than 65 years of age should not be blurred by current 'en-vogue' methods for promising but not yet proven valve-in-valve strategies.

Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials.

BACKGROUND The Perceval (Sorin Group, Milan, Italy) is a self-anchoring sutureless aortic valve prosthesis. We report the short- to midterm results of combined aortic valve replacement (AVR) with concomitant procedures in elderly patients undergoing operation as part of 3 consecutive prospective multicenter European studies. METHODS From April 2007 to February 2013, 243 patients (mean age, 79.7 ± 5.1 years; female patients, 61%; median EuroSCORE, 9%) underwent AVR with concomitant procedures. The concomitant procedures were coronary artery bypass grafting (CABG) (182 cases), septal myectomy (21 cases), CABG + other procedures (18 cases), and 22 other procedures. Primary and secondary end points included implant feasibility and safety (for mortality and morbidity) and efficacy (New York Heart Association [NYHA] class improvement and hemodynamic results) of the prosthesis at the different follow-up periods. Data were expressed as mean ± standard deviation. Kaplan-Meier analysis was performed for survival analysis. RESULTS Mean aortic cross-clamp and extracorporeal circulation (ECC) times were 50.7 ± 22.8 minutes and 78.9 ± 32.3 minutes, respectively. Thirty-day mortality was 2.1%. Mean postoperative gradient and effective orifice area were 10.1 ± 4.7 mm Hg and 1.5 ± 0.4 cm(2) and 8.9 ± 5.6 mm Hg and 1.6 ± 0.4 cm(2), respectively, at 1 year. There were early explantations, 4 of which resulted from paravalvular leaks. One additional valve explantation resulted from aortic root bleeding, probably caused by excessively extensive decalcification. In the late period, there was 1 mild paravalvular leak and no intravalvular insufficiency. No migration, dislodgement, or degeneration of the valve occurred during follow-up. Median follow-up was 444 days. CONCLUSIONS These trials confirm the safety and efficacy of the Perceval sutureless aortic valve, especially in elderly patients requiring AVR + concomitant procedures. In this patient group, sutureless valves may be advantageous compared to transcatheter valve implantations as concomitant procedures other than percutaneous coronary artery angioplasty are not always possible in the latter.