Reproducibility of aortic valve calcification scoring with computed tomography - An interplatform analysis.

BACKGROUND: To investigate whether aortic valve calcification (AVC) scoring performed with different workstation platforms generates comparable and thus software-independent results. METHODS: In this IRB-approved retrospective study, we included 100 consecutive patients with symptomatic aortic stenosis undergoing CT prior to transcatheter aortic valve implantation. Two independent observers performed AVC scoring on non-enhanced images with commercially available software platforms of four vendors (GE, Philips, Siemens, 3mensio). Gender-specific Agatston score cut-off values were applied according to current recommendations to assign patients to different likelihood categories of aortic stenosis (unlikely to very likely). Comparative analysis of Agatston scores between the four platforms were performed by using Kruskal-Wallis analysis, Spearman rank correlation, linear regression analysis, and Bland-Altman analysis. Differences in category assignment were compared using Fisher's exact test and Cohen's kappa. RESULTS: For both observers, each workstation platform produced slightly different numeric AVC Agatston scores, however, without statistical significance (p = 0.96 and p = 0.98). Excellent correlation was found between platforms, with r = 0.991-0.996 (Spearman) and r2 = 0.981-0.992 (regression analysis) for both observers. Bland-Altman analyses revealed small mean differences with narrow limits of agreement between platforms (mean differences: 6 ±â€¯128 to 100 ±â€¯179), for inter-observer (mean differences: 1 ±â€¯43 to 12 ±â€¯70), and intra-observer variability (mean differences: 9 ±â€¯42 to 20 ±â€¯96). Observer 1 assigned 11 (kappa: 0.85-0.97) and observer 2 assigned 10 patients (kappa: 0.88-0.95) to different likelihood groups of severe aortic stenosis with at least one platform. Overall, there was no significant difference of likelihood assignment between platforms (p = 0.98 and p = 1.0, respectively). CONCLUSION: While absolute values differ slightly, common commercially available software platforms produce comparable results for AVC scoring, which indicates software-independence of the method.

Early Clinical Experience with Double Ring Implantation for Aortic and Mitral Valve Repair.

Reconstruction of cardiac valves is associated with reduced mortality, including in multiple valve surgery. However, multiple valve repair is still considered a challenge, even with established techniques. Recently, internal aortic ring annuloplasty has been introduced and could simplify multiple valve reconstruction. This study reports early results with double ring aortic and mitral valve repair. Three patients with bivalvular degenerative regurgitation were managed with combined aortic and mitral valve repair using double rings. Mean (±SD) age was 41 ± 21 years, preoperative left ventricular end-diastolic volume was 119 ± 53 mL/m2, and ejection fraction was 0.50 ± 0.07. Mean aortic ring diameter was 21 mm, and mitral rings averaged 32 mm. No operative mortalities or major complications were observed. No valve-related events occurred. Postoperative echo showed complete resolution of mitral and aortic regurgitation. Postoperative left ventricular end-diastolic volume decreased to 98 ± 10 mL/m2; no left ventricular outflow tract obstruction or significant transvalvular gradients were observed. Postoperative cardiac CTs showed an optimal three-dimensional configuration of aortic and mitral annuloplasty devices. This initial series demonstrated the feasibility and safety of combined aortic and mitral repair with double rings. Clinical and hemodynamic results were promising. Increasing application and more clinical experience with combined aortic and mitral double ring repair seems indicated.

The last frontier: transcatheter devices for percutaneous or minimally invasive treatment of chronic heart failure.

Heart failure has a high prevalence in the general population. Morbidity and mortality of heart failure patients remain high, despite improvements in drug therapy, implantable cardioverter-defibrillators and cardiac resynchronisation therapy. New transcatheter implantable devices have been developed to improve the treatment of heart failure. There has been a rapid development of minimally invasive or transcatheter devices used in the treatment of heart failure associated with aortic and mitral valve disease and these devices are being incorporated into routine clinical practice at a fast rate. Several other new transcatheter structural heart interventions for chronic heart failure aimed at a variety of pathophysiologic approaches are currently being developed. In this review, we focus on devices used in the treatment of chronic heart failure by means of left ventricular remodelling, left atrial pressure reduction, tricuspid regurgitation reduction and neuromodulation. The clinical evaluations of these devices are early-stage evaluations of initial feasibility and safety studies and additional clinical evidence needs to be gathered in appropriately designed clinical trials.

Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry

BACKGROUND:Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown.OBJECTIVES:This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR.METHODS:This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up.RESULTS:Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all)...

Transcatheter mitral direct annuloplasty: state of the art.

Transcatheter mitral interventions are emerging as a novel therapy for patients with severe symptomatic mitral regurgitation who are deemed to be high risk or inoperable. Surgical treatment of mitral regurgitation includes a wide spectrum of therapies, ranging from leaflet and annular repair, to mitral valve replacement. Annuloplasty plays a fundamental role in open heart mitral valve repair, since it is associated with longer durability and higher degree of mitral regurgitation reduction. Direct annuloplasty is the interventional methodology most closely reproducing open heart annular repair. We describe the challenges and opportunities of the most promising technologies currently under development which will become available in clinical practice in the next future.

Interventional vs. surgical mitral valve therapy. Which technique for which patient?

Mitral regurgitation (MR) is the most frequent valvular heart disease in developed countries. Surgical repair represents the optimal treatment for severe degenerative MR; however, surgical correction of functional MR is controversial. The Euro Heart Survey showed that up to 50 % of patients with severe MR are today denied surgical treatment. Therefore, new transcatheter techniques have been developed to treat MR with less invasive approaches. Currently, the device with the widest clinical use is the MitraClip System. In this scenario, a multidisciplinary team approach is key in providing optimal individually tailored treatment for patients with MR.

MitraClip Registries: what have we learned recently.

MitraClip therapy is emerging as an alternative treatment for primary and secondary mitral regurgitation in high risk patients. A randomized trial has shown safety in selected patients, with efficacy non inferior to surgery in elderly patients with functional mitral regurgitation. Following commercialization, MitraClip therapy is offered to patients very different from the profile of those enrolled in the randomized trial. Several registries are on the way and provide useful preliminary information related to real-world experience with percutaneous mitral valve repair with the MitraClip system.

The pivotal role of echocardiography in the assessment of multivalvular heart disease.

Multivalvular heart disease (MHD) accounts for approximately 15% of the patients undergoing valve surgery in the EuroHeart Survey and for 8.6% of all valvular surgical interventions. Most clinical studies on valvular heart disease are focused on single-valve disease and very few data stress the difficulties encountered in the diagnostic assessment and clinical decision making of multiple defects, also concerning the reciprocal hemodynamic influence or the overlap of surgical indications. Many fields related to multiple valve disease are not encountered in the European Guidelines on Valvular Heart Disease (ESC) or the American College of Cardiology/American Heart Association (ACC/AHA). Increasing age and new trends of mixed population have newly aroused interest in multivalvular heart disease in the developed countries, still in need of new clinical insights. According to the high comorbidities of candidates, the appropriate diagnostic framework necessary for the correct diagnosis and best clinical outcome may still be challenging. The paper reviews multivalvular heart disease (except congenital heart disease) from aetiology and background definition to surgical outcome, with special emphasis on echocardiographic assessment and clinical interpretation.

Review of the MitraClip clinical evidence.

MitraClip system is the only catheter-based device for percutaneous mitral valve repair available for clinical use, after receipt of the CE Mark in 2008, while it is currently under review for FDA approval in the US. To date, over 3500 MitraClip implants have been performed worldwide, mainly in high risk surgical patients. The aim of this review is to review all the current evidences of the MitraClip therapy in an aim to define its clinical role in the treatment of mitral regurgitation (MR).

Patient selection for MitraClip therapy impaired left ventricular systolic function.

Mitral regurgitation (MR) is a disabling disease associated with poor prognosis and high incidence of clinical events if left untreated. To reduce the invasiveness of the surgical approach, different types of transcatheter procedures are becoming available. The MitraClip procedure (Abbott Vascular Inc. Menlo Park, CA, USA) is yet the only catheter-based procedure available in clinical practice at the moment. The device has been evaluated in a number of preclinical studies, registries and in FDA approved clinical trials. (EVEREST trial, ACCESS-EU trial). Indication and timing of intervention is a crucial step in the diagnostic-therapeutic pathway of patients with mitral regurgitation. The aim of this review is to clarify the potential of MitraClip in clinical practice, particularly focusing on patient selection for this novel therapy. Patient selection and overall decision making is strongly influenced by anatomical and clinical factors. Decision-making in degenerative MR (DMR) vs. functional (FMR) can be quite different. Generally, MitraClip is effective in treating either type II or IIIb dysfunction (at the moment FMR is the main indication for MitraClip in Europe, according to the ACCESS registry data). The relative role of MitraClip and surgery in the management of patients with MR is still unclear. From the global initial experience, MitraClip therapy could be complementary to surgery in those patients at high risk for surgery who have ideal anatomical characteristics for implantation. The procedure is quite predictable in patients with favorable anatomy. In patients with suboptimal anatomy, if the risk of surgery is too high, MitraClip could be still indicated sometimes. Our preliminary experience suggests that in patients with DMR, the EVEREST anatomical criteria are strong predictors of early and mid-term success. According to it, MitraClip therapy is appropriate in those DMR patients with high surgical risk and ideal anatomy for clip implantation according to the EVEREST criteria. In FMR refractory to medical therapy and resynchronization therapy, MitraClip could be considered as first option therapy, particularly in those patients with comorbidities, or advanced age, being the operative risk of surgery above 5% in this population. In the future, novel devices, improved knowledge, more efficient imaging and transcatheter mitral prosthetic valve implantation may expand the indications to those patients currently not treated by MitraClip for anatomical unsuitability, and may improve the results both in term of early efficacy and long term durability.

Percutaneous mitral repair with the MitraClip.

Mitral regurgitation (MR) is associated with poor prognosis and high incidence of clinical events if left untreated. To reduce the invasiveness of the surgical approach, different types of trans-catheter procedures are becoming available. The MitraClip procedure (Abbott Vascular Inc. Menlo Park, CA) is yet the only available at the moment. The procedure is used to treat high risk surgical candidates with either functional or degenerative MR. Recent trials have shown that the procedure is safer than surgery, although less effective. Efficacy of the procedure depends on several factors, including patient selection, anatomy of the valve and the experience of the operators. However, when treating high risk patients a suboptimal repair obtained with low risk can be a acceptable outcome. In the future, novel devices, improved knowledge, more efficient imaging and transcatheter mitral prosthetic valve implantation may expand the indications to those patients currently not treated by MitraClip for anatomical unsuitability, as well as may improve the results both in term of early efficacy and long term durability.

Dosimetric data and radiation risk analysis for new procedures in interventional cardiology.

The purpose of this study was to evaluate radiation doses to the patients and operators during interventional cardiology procedures, with a particular focus on the transcatheter aortic valve implantation (TAVI). Patient doses for 5549 diagnostic and therapeutic procedures and 76 TAVI were examined, as well as occupational doses to Cardiology Department operators. The average patient dose for TAVI was double that of PTCA and six times higher than a simple CA; statistically significant differences were shown in the average patient dose for both transfemoral and transapical access; the measurements show a corresponding increase in the average occupational dose for the cardiologist. Interventional cardiology could increase the collective dose and occupationally exposed worker doses; this increase could be significant if the use of certain procedures is extended to younger people; particular attention in the choice of procedure, optimisation and staff education and organisation is therefore suggested.

Determinants of the degree of functional aortic regurgitation in patients with anatomically normal aortic valve and ascending thoracic aorta aneurysm. Transoesophageal Doppler echocardiography study.

OBJECTIVES: To identify functional aortic regurgitation (FAR) determinants in patients with ascending thoracic aortic aneurysm (ATAA) and surgically confirmed normal aortic valve anatomy. DESIGN: Case-control study. SETTING: Non-invasive Cardiology and Cardiac Surgery Department. PATIENTS: Eighty-nine patients with ATAA and varying degrees of FAR undergoing surgery, 40 age-matched patients with ATAA without aortic regurgitation and 20 normal control subjects. INTERVENTIONS: Doppler and two-dimensional transoesophageal echocardiography. MAIN OUTCOME MEASURES: Vena contracta (VC) of aortic regurgitant jet, diastolic tented area and coaptation height (CH) of aortic valve leaflets, aortic dimension indexes-Valsalva sinus, sinotubular junction (STJ), tubular tract, annulus (A), STJ/A ratio. RESULTS: When VC was used, a wide range of FAR was seen (mean (SD) 5.59 (2.59) mm, ranging from 2 to 13 mm). Of the variables tested, the most strongly associated with FAR severity in multivariate analysis was diastolic leaflet tenting, measured as CH (R(2) = 0.69) (sensitivity 98%, specificity 95% using a cut-off value of CH > or =1.1 cm). In turn, the diastolic leaflet tenting was strongly identified by the STJ/A ratio (sensitivity 87%, specificity 71% using a cut-off value of STJ/A >1.66). CONCLUSION: The diastolic tenting of aortic leaflets is strongly related to FAR severity in patients with ATAA. The mismatch of STJ/A is significantly associated with diastolic leaflet tenting and its correlated valve regurgitation, independently of the actual ATAA dimension. These findings provide new insight into the mechanism of FAR arising from ATAA.

Percutaneous aortic valve implantation: the anesthesiologist perspective.

Percutaneous aortic valve implantation is an emergent technique alternative to surgical aortic valve replacement in high risk patients with aortic stenosis. Percutaneous aortic valve implantation techniques are undergoing rapid development and currently represent a dynamic field of research. Perioperative optimal strategies keep on evolving too. At a review of the literature, only three previous papers on Pubmed focused specifically on anesthesiological challenges of percutaneous aortic valve implantation. In one of them our first 6 months experience was reported. In this new paper we describe the anesthesiological management of percutaneous aortic valve implantation at our Centre, reporting the results of our implantation program from November 2007 to February 2009.

A cardioplegia circuit with versatility: the 'ReVerse' system. How to do it.

Various methods of cardioplegia administration have been used in cardiac surgery: crystalloid, blood and mixed crystalloid/blood. Each of these types of cardioplegia administration typically needs a different circuit. This may correspond to an increase in cost and the time needed to change the circuit if required. When various modifications are performed on the circuit, this also increases the risk of contamination. In order to simplify the management of differing cardioplegia circuits, we devised one circuit for all solutions in all situations by adding one modification. The ReVerse cardioplegia circuit system is a description of a two-pump cardioplegia circuit which is adaptable to either blood or crystalloid cardioplegia. The change from one mode to another requires a manoeuvre of two clamps, allowing the blood solution to travel through shunt tubing into the apposite pumphead. In our experience the versatility of this circuit is a fast, safe method to administrate all types of cardioplegia solution, saving the space taken up by storing multiple circuits.

Flow dynamics of the St Jude Medical Symmetry aortic connector vein graft anastomosis do not contribute to the risk of acute thrombosis.

BACKGROUND: The efficacy of the St Jude Medical Symmetry aortic connector (St Jude Medical, Inc, St Paul, Minn) for coronary artery bypass is currently debated. Potential drawbacks are the biocompatibility of the endoluminal device, the need for graft manipulation during the procedure, and the 90 degrees offset of the vein graft from the ascending aorta, which may induce graft kinking and abnormal fluid dynamics. In this article, a computational approach was designed to investigate the fluid dynamics pattern at the proximal graft. METHODS: Four models of hand-sewn anastomoses and two models of automated anastomoses were constructed; a finite volume technique was used to simulate realistic graft fluid dynamics, including aortic compliance and proper aortic and graft flow rates. The anastomosis geometry performance was analyzed by calculating time-averaged wall shear stress and the oscillating shear index at the toe and heel regions of the proximal graft. RESULTS: Time-averaged wall shear stress was significantly lower in the hand-sewn anastomosis models than in the two models that simulated the use of the aortic connector (0.38 +/- 0.07 Pa vs 1.32 +/- 0.4 Pa). Higher oscillating shear index values were calculated in the hand-sewn anastomosis models (0.15 +/- 0.02 Pa vs 0.06 +/- 0.02 Pa). CONCLUSIONS: Automated anastomosis geometry is associated with less critical fluid dynamics than with conventional hand-sewn anastomosis: the shape of the proximal graft induces more physiological wall shear stresses and less oscillating flow, suggesting a lower risk of atherosclerotic plaque and intimal hyperplasia as compared with conventional anastomosis geometry. Therefore, the reported early thrombosis and late failure of the St Jude Medical aortic connector anastomoses are not related to unfavorable fluid dynamics.

Pulsed tissue Doppler imaging detects early myocardial dysfunction in asymptomatic patients with severe mitral regurgitation.

OBJECTIVE: To assess whether tissue Doppler myocardial imaging (TDI) indices can predict postoperative left ventricular function in patients with mitral regurgitation (MR) after surgical correction. METHODS: 84 patients (mean (SD) age 54.3 (10.8) years) with asymptomatic severe MR, an end systolic diameter < 45 mm, and an ejection fraction (EF) > 60% were subdivided in two groups: 43 patients with a postoperative EF reduction < 10% (group 1) and 41 patients with a postoperative EF reduction > or = 10% (group 2).TDI systolic indices of the lateral annulus were analysed preoperatively to assess myocardial systolic wave (Sm) velocity, myocardial precontraction time (PCTm), myocardial contraction time (CTm), and the PCTm:CTm ratio. RESULTS: Postoperative EF decreased significantly (from 67 (5)% to 60 (5.5)%, p = 0.0001). Group 2 had a higher PCTm, CTm, and PCTm:CTm ratio and a lower Sm velocity than group 1 (PCTm 100.4 (19) ms v 82 (21.8) ms, p = 0.004; CTm 222 (3.1) ms v 215 (2.3) ms, p = 0.01; PCTm:CTm 0.45 (0.08) v 0.38 (0.09), p = 0.001; Sm velocity 10.4 (1.1) cm/s v 13 (1.3) cm/s, p = 0.0001). Multivariate regression analysis showed that the combination of PCTm:CTm ratio > or = 40 ms and Sm velocity < or = 10.5 cm/s was the main independent predictor of postoperative EF reduction > or = 10% (sensitivity 78%, specificity 95%). CONCLUSIONS: TDI systolic indices can predict postoperative left ventricular function in patients with asymptomatic MR undergoing surgical correction.

The "clover technique" as a novel approach for correction of post-traumatic tricuspid regurgitation.

OBJECTIVE: To describe a novel technique, named "clover," to correct complex post-traumatic tricuspid valve lesions. METHODS: Five patients with severe post-traumatic tricuspid insufficiency underwent valve reconstruction with the clover technique, a new surgical approach that consists of stitching together the middle point of the free edges of the tricuspid leaflets, producing a clover-shaped valve. The mechanism of tricuspid regurgitation was complex in all patients, and right ventricular function was always moderately to severely depressed. An echocardiographic study was performed after cardiopulmonary bypass, at discharge, and at follow-up. RESULTS: Cardiopulmonary bypass time was 32 +/- 6.3 minutes and crossclamp time was 23 +/- 7.4. There was no hospital mortality or morbidity. Intraoperative transesophageal and predischarge transthoracic echocardiography showed perfect results in all patients. No late deaths occurred. At the latest follow-up, extending to 14.2 months (mean 11.3; median 12.4), all patients were asymptomatic (New York Heart Association class I) with trivial (2 patients) or no residual regurgitation (3 patients) on 2-dimensional echocardiogram. No transvalvular gradient was revealed in any patient. A significant reduction of the right ventricular end-diastolic dimensions was noted as well (from 54 +/- 7.1 mm to 40 +/- 7.5 mm, P <.001). CONCLUSIONS: In this preliminary experience, the clover technique increased the feasibility of tricuspid valve repair in case of severe traumatic tricuspid valve insufficiency, leading to very satisfactory mid-term results even in the presence of complex lesions or dilatation and deterioration of the right ventricle.

Beating-heart coronary artery bypass graft surgery at San Raffaele Hospital: four years of experience.

OBJECTIVE: To review the database of 1,902 consecutive patients who underwent coronary artery bypass graft (CABG) surgery in the period 1998 through 2001 at this institution, and to compare the preoperative status, anesthetic management, and postoperative outcome of 364 patients with the beating-heart technique with 1,538 patients who underwent the operation on cardiopulmonary bypass. DESIGN: Observational study. SETTING: University hospital. PARTICIPANTS: Consecutive patients (n = 1,902) who underwent CABG surgery in the period 1998 through 2001. MEASUREMENTS AND MAIN RESULTS: Comparison (chi-square test) of the preoperative status shows that surgeons' choice for the beating-heart technique was based on the presence of severe preoperative comorbidities: renal impairment (p < 0.0001), chronic obstructive pulmonary disease (p < 0.04), and low ejection fraction (p < 0.0001). On a multivariate analysis, the beating-heart technique was associated with reduced transfusion needs and duration of mechanical ventilation. CONCLUSION: Beating-heart surgery is gaining popularity as a safe method for myocardial revascularization. Excellent results have been achieved with this technique in this center.

Inaccuracy of four coronary surgery risk-adjusted models to predict mortality in individual patients.

OBJECTIVES: This study was undertaken to evaluate the accuracy of four different risk-adjusted models in predicting mortality in individual patients who are undergoing coronary artery by-pass graft surgery. In the last decade several models to stratify patients before open heart surgery, according to factors affecting mortality, were developed with the aim of retrospectively comparing outcomes of open heart surgery, based on reliable stratification of case-mix, and of prospectively identifying high risk patients as a basis for a meaningful informed consent for patients counseling. METHODS: The pre-operative risk of death was calculated with four different models in 418 consecutive patients who underwent coronary artery by-pass surgery and then compared with the actual outcome. To discriminate patients with favorable and unfavorable outcome, the logistic regression analysis and the areas under the receiver-operating-characteristic curves were applied. The accuracy score was used to evaluate the reliability of each score to predict the individual outcome. RESULTS: Seven deaths (1.7%) were observed within 30 days from the operation, and the overall incidence was similar to that predicted by all models. Only the NBI score was not able to discriminate survivors from patients who will die, and the areas under the curves were 0.596 for the Parsonnet score, 0.861 for the Cleveland Clinic Foundation score, 0.823 for the French score, and 0.806 for the EuroSCORE. The four models were highly accurate (between 0.97 and 0.98) to predict the overall mortality. In seven patients who died the mean predictive scores were very low and ranged between 2.1 and 4.6, but were significantly higher than those of patients who survived (between 1.1 and 2.2). CONCLUSIONS: The four pre-surgical predictive models were similarly able to discriminate favorable vs. unfavorable outcomes and highly accurate to predict overall mortality, but very inaccurate to predict mortality in individual patients.