Transcatheter mitral valve repair: where are we?

Mitral valve regurgitation is the second most common form of valve pathology after aortic stenosis needing surgery. While open surgical repair is still the gold standard, innovative interventional approaches have emerged as an alternative treatment option for high-risk patients. While only a few of these new techniques have been approved for the clinical setting, many others are currently under development or in pre-clinical testing. This editorial will attempt to summarize all current transcatheter-based innovations targeting the mitral valve and explore their potential for the future.     

Percutaneous transvenous mitral commissurotomy in rheumatic mitral stenosis with atrial dysfunction. Opening the valve…and a window of opportunity

The International Journal of Cardiovascular Imaging -     

Impact of different annuloplasty rings on geometry of the mitral annulus with fibroelastic deficiency: the significance of aorto–mitral angle

We sought to investigate the impact of full annuloplasty rings versus C-shape bands on mitral annular geometry in the presence of fibroelastic deficiency (FED), as assessed by intraoperative three-dimensional transesophageal echocardiography (3DTEE). We retrospectively selected 65 patients who underwent mitral valve repair for severe mitral regurgitation caused by FED using full rings (the Ring group, n?=?30) and C-shape bands (the Band group, n?=?35). 71 controls without valvular heart disease were also included. Thorough 3DTEE inspections were performed for the entire cohort to measure morphological parameters of mitral annulus before and after surgery. Mid-term repair durability and left atrial diameter were followed up. The preoperative 3DTEE parameters, including annular diameters, area, height and aorto–mitral angle, were significantly larger in the FED groups than normal, and were comparable between two groups using different annuloplasty devices. After repair, the anterior–posterior diameter, annulus circumference and area were significantly larger in the Band group than in the Ring group. The aorto–mitral angle became comparable with normal value in the Ring group (p?=?0.728), but not in the Band group (p?=?0.011). Follow-up echocardiographic data showed a significant correlation between postoperative aorto–mitral angle and reduced left atrial diameter at 50.3 months after surgery (r?=?0.63; p?<?0.001). In conclusion, compared with C-shape bands, full rings may impose less narrowing on aorto–mitral angle, which correlates well with mid-term left atrial reverse remodeling.     

Uncommon delayed and late complications after percutaneous left atrial appendage closure with Amplatzer® Cardiac Plug

Aims

Percutaneous left atrial appendage closure with Amplatzer^® Cardiac Plug (St. Jude Medical Inc.) for the prevention of stroke in patients with atrial fibrillation is rapidly propagating. We sought to provide additional safety data.

Methods and results

We have screened our database of patients having been treated with Amplatzer^® Cardiac Plug and found 3 cases with uncommon complications that have not been reported previously. One patient experienced an embolisation of the occluder about 12 months after implantation that potentially resulted from mismatch of occluder size and landing zone. Another patient developed cardiac tamponade 9 days after implantation. This case of delayed effusion was probably not a result of interventional trauma, but might have been provoked by scratching of the inner pericardial membrane. A third patient developed a large thrombus in the left atrium which was considered to be caused by injury of the endothelial wall during implantation. The first two cases could be treated by a percutaneous procedure, the last case by cardiac surgery without any sequelae.

Conclusions

Complications after left atrial appendage closure not related to a device-related thrombus can occur later after implantation. With appropriate percutaneous or surgical management these complications can be handled without sequelae.     

Evaluation of the comfort of Alphagan® P compared with Alphagan® in irritated eyes

The tolerability of brimonidine tartrate 0.15%--referred to as bromonidine-Purite 0.15% in this study--was compared with brimonidine tartrate 0.2% in irritated eyes of healthy volunteers as well as patients with glaucoma or ocular hypertension (N=20) in a 2-week, single-center, randomized, double-masked, crossover study. Participants were evaluated at days 0, 7, 11, and 15. At day 0, they were exposed to a controlled adverse environment (CAE), in which humidity, temperature, and airflow was regulated, for up to 90 minutes. Participants who reported a sufficient level of bilateral ocular discomfort during exposure to the CAE were enrolled in this study and received 1 drop of brimonidine-Purite 0.15% in 1 eye and 1 drop of brimonidine tartrate 0.2% in the contralateral eye. Immediately following instillation, participants were asked to indicate their preference for either study medication. The study medications were not used between days 0 and 7. From day 7 to 10, participants administered either drug bilaterally. On day 11, the treatment was crossed over, and participants were asked to compare the preferred medication with their previous regimen. They continued to administer the drug bilaterally twice daily until day 15, when the preferred medication was again compared with the previous regimen. Following CAE exposure at visit 1, 70.6% of the participants preferred brimonidine-Purite 0.15% over brimonidine tartrate 0.2% and indicated that it was significantly more comfortable than brimonidine tartrate 0.2% (P=.009). When given brimonidine-Purite 0.15% first before switching to brimonidine tartrate 0.2%, 80% of participants preferred brimonidine-Purite 0.15% (P=.012). When given brimonidine tartrate 0.2% first before switching to brimonidine-Purite 0.15%, 85% preferred brimonidine-Purite 0.15% (P=.001). The results of this study suggest that brimonidine-Purite 0.15% is significantly more comfortable than brimonidine tartrate 0.2% in patients with irritated eyes.     

Clinical experience with the Heartflo™ System in coronary surgery

In coronary artery bypass grafting (CABG), distal graft to coronary anastomoses are currently performed with running sutures or, to a limited extent, interrupted techniques, which are more time‐consuming. The Heartflo? anastomotic device, introduced in 2000, automates the suturing process via simultaneous delivery of ten standard polypropylene sutures through the graft and the coronary vessel wall to construct the anastomosis. Clinical testing was performed after extensive animal studies in several centers in Europe and Canada. After the foot shape of the device had been changed in conjunction with a reduction of its diameter, coronary arteries of 1.5?mm were successfully grafted. During the clinical studies and early follow‐up, no device related injuries were reported. However, as suture management was still time‐consuming with the newest versions of the device, development of automated knot tying systems or – at least – a facilitated suture management is mandatory as the next development step.     

Experience with NORPLANT® in Egypt

Experience with the contraceptive NORPLANT in Egypt dates back to early 1980 when the first multicentre trial was initiated. To date, more than 3000 women have received this contraceptive at the Assiut University Family Clinic alone. Analysis of the overall experience in this clinic has indicated a 5-year cumulative continuation rate of 51 and a pregnancy rate of 1.8 per 100 women.

Clinical pharmacology studies pertaining to the safety of NORPLANT in our community have indicated no deleterious effect on the lipid profile, liver functions and blood coagulation system. Two studies conducted in Egypt have indicated that the initiation of NORPLANT use shortly after delivery does not have any unfavourable effect on lactational performance, or on physical or psychomotor development of the breast-fed infants. This is particularly important in Arab and Moslem cultures where prolonged breast-feeding is emphasized.

A study utilizing focus-group discussion to assess users' attitudes to NORPLANT has indicated the need to improve the informational/educational package given in the service by emphasizing certain cultural considerations.

On the whole, this first implant method has proven to be safe and acceptable in Egypt, where there is a special need for long-term methods for contraception, particularly as sterilization is not socially acceptable.     

Validation of the tablet-based Turkish-PAINReportIt® for lung cancer patients after thoracotomy in Turkey

BackgroundDigital pain assessment is advantageous and timely for healthcare priorities in Turkey. However, a multi-dimensional, tablet-based pain assessment tool is not available in the Turkish language.PurposeTo validate the Turkish-PAINReportIt® as a multi-dimensional measure of post-thoracotomy pain.MethodsIn the first of a two-phased study, 32 Turkish patients (mean age 47.8 ± 15.6 years, 72 % male) participated in individual cognitive interviews as they completed the tablet-based Turkish-PAINReportIt® once during the first four days post-thoracotomy, and 8 clinicians participated in a focus group discussion of implementation barriers. In the second phase, 80 Turkish patients (mean age 59.0 ± 12.7 years, 80 % male) completed the Turkish-PAINReportIt® preoperatively, on postoperative days 1–4, and at the two-week post-operative follow-up visit.ResultsPatients generally interpreted accurately the Turkish-PAINReportIt® instructions and items. We eliminated some items unnecessary for daily assessment based on focus-group suggestions. In the second study phase, pain scores (intensity, quality, pattern) were low pre-thoracotomy for lung cancer and high postoperatively high on day 1, decreasing on days 2, 3 and 4, and back down to pre-surgical levels at 2-weeks. Over time, pain intensity decreased from post-operative day 1 to post-operative day 4 (p < .001) and from post-operative day 1 to post-operative week 2 (p < .001).ConclusionsThe formative research supported proof of concept and informed the longitudinal study. Findings showed strong validity of the Turkish-PAINReportIt® to detect reduced pain over time as healing occurs after thoracotomy.     

Comparison of Two Different Blood Sample Tubes for Platelet Function Analysis with the Multiplate® System

BACKGROUND: For whole blood aggregation on the Multiplate? system, the use of thrombin inhibitor as anticoagulant is recommended. So far sample tubes containing liquid lepirudin were provided (Dynabyte, Munich, Germany). They are not sterile and have to be stored refrigerated. For better handling now also sterile tubes with dried hirudin, storable at room temperature, are also provided (Dynabyte). The aim of this study was to compare the performance of these both sample tubes on the Multiplate system. PATIENTS AND METHODS: Blood was collected from 30 patients, treated with aspirin and/or clopidogrel, in tubes, and ASPItest, ADPtest and TRAPtest were performed. RESULTS: The correlation between both sample tubes was excellent with ASPItest (r(2) = 0.96), good with ADPtest (r(2) = 0.91) and also satisfying with TRAPtest (r(2) = 0.85). CONCLUSION: Both sample tubes are well qualified for platelet function analysis with the Multiplate system. The new sterile sample tube with dried hirudin may be preferred for better handling.     

Biosilicate® and low-level laser therapy improve bone repair in osteoporotic rats

The aim of this study was to investigate the effects of a novel bioactive material (Biosilicate^®) and low‐level laser therapy (LLLT) on bone fracture consolidation in osteoporotic rats. Forty female Wistar rats were submitted to ovariectomy (OVX) to induce osteopenia. Eight weeks after surgery, the animals were randomly divided into four groups of 10 animals each: a bone defect control group (CG); a bone defect filled with Biosilicate group (BG); a bone defect filled with Biosilicate and irradiated with LLLT at 60 J/cm² group (BG60); and a bone defect filled with Biosilicate and irradiated with LLLT at 120 J/cm² group (BG120). Bone defects were surgically performed on both tibias. The size of particle used for Biosilicate was 180–212 µm. Histopathological analysis showed that bone defects were predominantly filled with the biomaterial in specimens treated with Biosilicate. LLLT with either 60 or 120 J/cm² was able to increase collagen, Cbfa‐1, VGEF and COX‐2 expression in the circumjacent cells of the biomaterial. A morphometric analysis revealed that the Biosilicate + laser groups showed a higher amount of newly formed bone. Our results indicate that laser therapy improves bone repair process in contact with Biosilicate as a result of increasing bone formation, as well as COX‐2 and Cbfa‐1 immunoexpression, angiogenesis and collagen deposition in osteoporotic rats. Copyright © 2010 John Wiley & Sons, Ltd.     

Evaluation of the ARKRAY AUTION Eleven® reflectometer in detecting microalbuminuria with AUTION Screen® test strips and proteinuria with AUTION Sticks 10PA® strips

Objective. Albumin/creatinine and protein/creatinine ratios were measured with the ARKRAY AUTION Eleven reflectometer using AUTION Screen and AUTION Sticks 10PA strips, respectively, against quantitative Siemens Advia reference procedures from 368 patient urines, as an evaluation of their applicability for use in points‐of‐care and small laboratories. Material and methods. Direct reflectance measurements were utilized to estimate imprecision, as well as to suggest reclassification of ordinal scale categories into normoalbuminuria, microalbuminuria and macroalbuminuria groups (3.4?g/mol and 34?g/mol cut‐off limits, corresponding to 30?mg/g and 300?mg/g creatinine in conventional units). Results. Analytically, ordinal scale albumin/creatinine ratios agreed in 86?% of cases with those obtained from Advia measurements, resulting in a kappa coefficient of 0.79. Protein/creatinine ratios of the AUTION Sticks 10PA strip were classified into three groups at limits of 11.3?g/mol and 56.6?g/mol (100?mg/g and 500?mg/g in conventional units), with an agreement of 77?% and a kappa coefficient of 0.65 against Advia procedures. To optimize clinical outcomes, cut‐off reflectances of ordinal scale categories of AUTION Eleven were adjusted. The clinical specificity of detecting an increased albumin/creatinine ratio was then increased from 81?% to 95?%, with clinical sensitivity kept at 88?% at the 3.4?g/mol limit of the reference procedure. Clinical specificity of the albuminuria field alone (at a clinical sensitivity of 88?%) was only 73?%. Adjustments to cut‐off reflectances of the reported categories for protein/creatinine ratios increased clinical specificity from 54?% to 94?%, while losing clinical sensitivity from 97?% to 89?% only, with an improved concordance of 83?% and a kappa coefficient of 0.75 against Advia measurements. The combination to creatinine measurements improved clinical specificity compared to 50?% by the protein field alone. In economic terms, it is estimated that population screening for microalbuminuria using the AUTION Eleven reflectometer is cheaper than by quantitative albumin/creatinine measurements alone, based on the incidence of end‐stage renal disease of 90 patients/million/year at the Northern Ostrobothnia Hospital District.