Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants.

AIM: To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6-2.1 for aortic valve replacement (AVR) and 2.0-2.5 for mitral valve replacement (MVR) or double valve replacement (DVR). METHODS AND RESULTS: In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8-2.8; MVR/DVR: 2.5-3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6-2.1; MVR/DVR: 2.0-2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups. FINDINGS: Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively (P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively (P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102-0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070-0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473-5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62-13.60; P = 0.004) for the VLT group. CONCLUSION: Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients.

EuroSCORE-predicted mortality and surgical judgment for interventional aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) is used as an alternative to conventional surgery in high-risk patients. The EuroSCORE quantifies the risk, and patients are selected for this procedure if their predicted mortality is high. The study aim was to evaluate the risk discrimination and calibration of the EuroSCORE, as well as the surgical judgment that is used when selecting the aortic valve replacement (AVR) approach. METHODS: Between 2003 and 2006, a total of 2757 patients underwent isolated, open AVR. The EuroSCORE was compared to the observed in-hospital mortality. A survey among surgeons assessed the relevance of patient-specific factors towards the approach of TAVI versus open AVR. RESULTS: Survivors of AVR had a lower additive EuroSCORE than non-survivors (7.2 +/- 3.34 versus 12.0 +/- 3.34; p < 0.001). The EuroSCORE demonstrated reasonable risk stratification (c-statistic 0.843, p < 0.001). However, none of the 67 non-survivors was correctly predicted (Hosmer-Lemeshow test; p < 0.001), and most patients with a high EuroSCORE survived AVR. The actual mortality was 2.8% as compared to a EuroSCORE-predicted mortality of 12.5 +/- 14.2% (p < 0.001). This poor calibration was worse with higher EuroSCOREs (Cusum test; p < 0.001). Surgeons identified a porcelain aorta as the only factor that warranted TAVI. Most EuroSCORE variables had either no relevance for treatment selection, or prompted open AVR. CONCLUSION: Patient selection for TAVI cannot be based on the EuroSCORE, because it lacks discrimination and center-specific calibration. Thus, individual, surgical judgment that weighs institutional expertise for high-risk patients against a possible reduction of mortality by using interventional techniques, is recommended.

Acute Left Main Stent Thrombosis Diagnosed by Transesophageal Echocardiography.

(Echocardiography, ****;**:E1-E2).

Circulating calcitriol concentrations and total mortality.

BACKGROUND: Evidence is accumulating that vitamin D supplementation of patients with low 25-hydroxyvitamin D concentrations is associated with lower cardiovascular morbidity and total mortality during long-term follow-up. Little is known, however, about the effect of low concentrations of the vitamin D hormone calcitriol on total mortality. We therefore evaluated the predictive value of circulating calcitriol for midterm mortality in patients of a specialized heart center. METHODS: This prospective cohort study included 510 patients, 67.7% with heart failure (two-thirds in end stage), 64.3% hypertension, 33.7% coronary heart disease, 20.2% diabetes, and 17.3% renal failure. We followed the patients for up to 1 year after blood collection. For data analysis, the study cohort was stratified into quintiles of circulating calcitriol concentrations. RESULTS: Patients in the lowest calcitriol quintile were more likely to have coronary heart disease, heart failure, hypertension, diabetes, and renal failure compared to other patients. They also had low 25-hydroxyvitamin D concentrations and high concentrations of creatinine, C-reactive protein, and tumor necrosis factor alpha. Eighty-two patients (16.0%) died during follow-up. Probability of 1-year survival was 66.7% in the lowest calcitriol quintile, 82.2% in the second quintile, 86.7% in the intermediate quintile, 88.8% in the fourth quintile, and 96.1% in the highest quintile (P < 0.001). Discrimination between survivors and nonsurvivors was best when a cutoff value of 25 ng/L was applied (area under the ROC curve 0.72; 95% CI 0.66-0.78). CONCLUSIONS: Decreased calcitriol levels are linked to excess midterm mortality in patients of a specialized heart center.

International normalized ratio patient self-management for mechanical valves: is it safe enough?

PURPOSE OF REVIEW: People with mechanical heart valve replacement depend on lifelong anticoagulation. Since a few years, patients can control this themselves with the assistance of a portable anticoagulation monitor. If the patient performs the complete self-testing and self-adjustment by himself, the method is called self-management. Recently completed studies concerning international normalized ratio (INR) self-management in mechanical heart valve patients are reviewed in this article. RECENT FINDINGS: Large randomized prospective studies have demonstrated that the INR self-management concept results in well-trained patients with a high percentage of their measured INR values lying within the predetermined therapeutic range, thus resulting in a low rate of complications such as bleeding and thromboembolism. The reduced anticoagulation level resulted in fewer grade III bleeding complications (which means there is a need for surgery or endoscopy, in-hospital treatment or permanent damage) without increasing thromboembolic event rates. SUMMARY: The concept of INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. Data of the Early Self-Controlled Anticoagulation Trial (ESCAT II) study demonstrate that low-dose INR self-management does not increase the risk of thromboembolic events compared with conventional-dose INR self-management.

Are sounds from mechanical heart valves equal for different valve types?

BACKGROUND AND AIM OF THE STUDY: The closing 'click' sounds from mechanical heart valve prostheses are often clearly audible for patients and their relatives. These sounds have been recognized as a disturbing factor causing sleeping disturbances or social embarrassment, which patients must endure for the rest of their lives. The study aim was to determine whether the intensity of the transmitted sounds varies according to the type of valve implanted. METHODS: Closing sounds were measured from 15 patients with ATS valves, 29 with Medtronic-Hall valves, and 40 with St. Jude Medical (SJM) valve prostheses; all prostheses were implanted in the aortic position. The sounds were recorded by a microphone placed 5 cm above the chest of the patient when placed in a supine position in a bioacoustical laboratory. The mean sound pressure levels (SPLs) from the valves were measured in dB(A). RESULTS: The mean SPL values were 43 +/- 5 dB(A) for ATS valves, 41 +/- 4 dB(A) for Medtronic-Hall valves and 40 +/- 4 dB(A) for SJM valves (p < 0.05, ATS versus SJM). CONCLUSION: The study results showed a statistically significant difference in SPLs among the three investigated mechanical heart valve prostheses. The highest levels were in the ATS valves, and the lowest in the SJM valves. These objectively measured SPLs must be correlated with the sound as perceived by the patient in order to determine the annoyance that they cause.

Antithrombotic therapy after bioprosthetic aortic valve replacement: ACTION Registry survey results.

AIMS: A variety of antithrombotic regimens have been described for the early postoperative period after bioprosthetic aortic valve replacement (AVR). This study reviews antithrombotic practice for patients undergoing bioprosthetic AVR with or without coronary artery bypass graft (CABG) amongst the centers participating in the ACTION (Anticoagulation Treatment Influence on Postoperative Patients) Registry. METHODS AND RESULTS: An antithrombotic therapy questionnaire was answered by the 49 centers participating in the ACTION Registry located in Europe, Middle East, Canada and Asia. The 43% of centers prescribe vitamin K antagonist (VKA), 20% prescribe VKA and acetyl salicylic acid (ASA), 33% prescribe only ASA and 4% do not prescribe any therapy after bioprosthetic AVR. For patients undergoing bioprosthetic AVR and CABG 39% of the centers prescribe VKA and ASA, 37% prescribe VKA and 24% prescribe ASA. After the first three postoperative months following bioprosthetic AVR, 61% of the centers prescribe only ASA, while 39% do not prescribe any therapy. Patients with bioprosthetic AVR and CABG receive ASA in 90% centers, in 2% centers VKA and ASA, and 8% centers do not prescribe any antithrombotic. CONCLUSION: This study demonstrates that, despite guidelines published by several professional societies, medical practice for the prevention of thrombotic events early after bioprosthetic AVR varies widely among cardiac surgical centers.

Hemodynamic performance of the Medtronic ADVANTAGE prosthetic heart valve in the aortic position: echocardiographic evaluation at one year.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the echocardiographic Doppler-derived hemodynamic results at one-year follow up at a single center for patients receiving the Medtronic ADVANTAGE aortic prosthetic heart valve. This study was part of a multi-center, prospective clinical evaluation of the ADVANTAGE bileaflet mechanical heart valve. METHODS: Echocardiographic data were obtained one year postoperatively from 40 patients who underwent aortic valve replacement between November 1999 and March 2000. Data collected were in accordance with the Food and Drug Administration guidelines for clinical trials. RESULTS: The in-vivo mean pressure gradients for valves implanted in the aortic position ranged from 11.2 mmHg for size 21 valves to 6.1 mmHg for size 29 valves, and the corresponding in-vivo effective orifice area ranged from 1.5 to 3.6 cm2. CONCLUSION: Early results of the study showed hemodynamic performance of the ADVANTAGE aortic valve to be comparable with that of other bileaflet valves in current clinical use.

Does the noise of mechanical heart valve prostheses affect quality of life as measured by the SF-36 questionnaire?

OBJECTIVE: The closure clicks of mechanical heart valve prostheses' leaflets are quite often clearly audible. The study describes the effects of subjective valve sound perception on the patients' quality of life and analyses factors that might contribute to valve noise-related discomfort. METHODS: We included 556 patients who received a mechanical valve prosthesis and participated in the study in our institution from 1994 to 1998. All compiled the standardised questionnaire Short-Form-36 Health Survey (SF-36) and indicated their subjective disturbance grade pre- and postoperatively, then every 6 months up to 2 years. A series of factors was scanned for correlation with unpleasant noise perception. RESULTS: Two years after the operation, only 5.8% classified their valve sounds as 'quite' or 'very much' disturbing. Age <60 years and being female were statistically significant factors for persisting unease caused by valve sounds. Without one of these factors, severe disturbance chance was 1.5%. As expected, quality of life improved after surgery. Patients disturbed seriously by valve noise showed significantly lower mean life quality values on each SF-36 scale. CONCLUSION: Patients (94.2%) with mechanical heart valve replacement have no persistent complaints about the valve noise. The grade of annoyance by valve noise is paralleled by lower average quality of life. Age under 60 years or being female increases the probability of severe disturbance due to mechanical valve sounds. It remains unclear whether the disturbing noise is reason or consequence of lower quality of life.

Paraprosthetic leak closure 28 years after mitral caged-ball Starr-Edwards implantation.

In this case report, we present a patient 28 years after mitral valve replacement with the Starr-Edwards prosthesis complicated by periprosthetic leak with severe aortic stenosis and moderate tricuspid regurgitation. We successfully repaired the periprosthetic regurgitation in a patient with extensive mitral annular calcification, without replacement of the valve. No apparent structural deterioration on the caged-ball valve was found. Moreover, aortic valve replacement and tricuspid annuloplasty were performed. One month after reoperation, the patient remained stable with improved clinical status and without any evidence for further paravalvular leak.

Thrombosis of the ascending aorta during mechanical circulatory support in a patient with cardiogenic shock.

Cardiogenic shock after percutaneous coronary intervention (PCI) is a life-threatening complication and is most often related to abrupt vessel closure. We present the case of a patient who developed cardiogenic shock after PCI and was supported with intra-aortic balloon counterpulsation and the Levitronix CentriMag short-term mechanical circulatory support. He was evaluated for implantation of a ventricular assist device as bridge-to-transplantation. Preoperative transesophageal echocardiography revealed a massive thrombus of the aortic root and ascending aorta despite optimal anticoagulation regimen. The patient succumbed due to multiorgan failure.

Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement.

BACKGROUND: Self-management improves oral anticoagulation control. Here we provide data of a preplanned interim analysis of very low-dose early self-controlled anticoagulation. METHODS: In a prospective, randomized, multicenter trial, 1,137 patients performed low-dose international normalized ratio (INR) self-management with a target INR range of 1.8. to 2.8 for aortic valve replacement recipients and 2.5 to 3.5 for mitral or double valve replacement recipients for the first six postoperative months. Thereafter, 379 patients continued to achieve the aforementioned INR target range (LOW group), whereas the INR target value was set at 2.0 (range, 1.6 to 2.1) for the remaining patients with aortic valve replacement and 2.3 (range, 2.0 to 2.5) for the remaining patients with mitral valve or double valve replacement. One half of this latter group had to check their INR values once a week (VL1 group) the other half twice a week (VL2 group). Patients were followed up for 24 months. RESULTS: Beyond study month six, the incidence of thromboembolic events that required hospital admission was 0.58%, 0.0%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.368). The incidence of bleeding events per patient-year was 1.16%, 1.07%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.665). Mortality rate did not differ among study groups. CONCLUSIONS: Data demonstrate the efficacy and safety of very low-dose INR self-management.

Vitamin D supplementation enhances the beneficial effects of weight loss on cardiovascular disease risk markers.

BACKGROUND: High blood concentrations of parathyroid hormone and low concentrations of the vitamin D metabolites 25-hydroxyvitamin D [25(OH)D] and calcitriol are considered new cardiovascular disease risk markers. However, there is also evidence that calcitriol increases lipogenesis and decreases lipolysis. OBJECTIVE: We investigated the effect of vitamin D on weight loss and traditional and nontraditional cardiovascular disease risk markers in overweight subjects. DESIGN: Healthy overweight subjects (n = 200) with mean 25(OH)D concentrations of 30 nmol/L (12 ng/mL) received vitamin D (83 microg/d) or placebo in a double-blind manner for 12 mo while participating in a weight-reduction program. RESULTS: Weight loss was not affected significantly by vitamin D supplementation (-5.7 +/- 5.8 kg) or placebo (-6.4 +/- 5.6 kg). However, mean 25(OH)D and calcitriol concentrations increased by 55.5 nmol/L and 40.0 pmol/L, respectively, in the vitamin D group but by only 11.8 nmol/L and 9.3 pmol/L, respectively, in the placebo group (P < 0.001), whereas a more pronounced decrease occurred in the vitamin D group than in the placebo group in blood concentrations of parathyroid hormone (-26.5% compared with -18.7%; P = 0.014), triglycerides (-13.5% compared with +3.0%; P < 0.001), and the inflammation marker tumor necrosis factor-alpha (-10.2% compared with -3.2%; P = 0.049). The beneficial biochemical effects were independent of the loss in body weight, fat mass, and sex. However, compared with placebo, vitamin D supplementation also increased LDL-cholesterol concentrations (+5.4% compared with -2.5%; P < 0.001). CONCLUSIONS: The results indicate that a vitamin D supplement of 83 microg/d does not adversely affect weight loss and is able to significantly improve several cardiovascular disease risk markers in overweight subjects with inadequate vitamin D status participating in a weight-reduction program. This trial was registered at clinicaltrials.gov as NCT00493012.

International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement.

BACKGROUND: Although prosthetic valves are durable and easy to implant, the need for lifetime warfarin-based anticoagulation restricts their exclusive usage. We investigated if anticoagulation self-management improves outcome in a single-center series. METHODS: Between 1994 and 1998, 765 patients with prosthetic valve replacements were prospectively enrolled and randomized to receive conventional anticoagulation management by their primary physician (group 1, n = 295) or to pursue anticoagulation self-management (group 2, n = 470). A study head office was implemented to coordinate and monitor anticoagulation protocols, international normalized ratios (INR), and adverse events. Patients were instructed on how to obtain and test their own blood samples and to adjust warfarin dosages according to the measured INR (target range, 2.5 to 4). RESULTS: Mean INR values were slightly yet significantly smaller in group 1 than in group 2 (2.8 +/- 0.7 vs 3.0 +/- .6, p < 0.001). Moreover, INR values of patients with conventional INR management were frequently measured outside the INR target range, whereas those with anticoagulation self-management mostly remained within the range (35% vs 21%, p < 0.001). In addition, the scatter of INR values was smaller if self-managed. Freedom from thromboembolism at 3, 12, and 24 months, respectively, was 99%, 95%, and 91% in group 1 compared with 99%, 98%, and 96% in group 2 (p = 0.008). Bleeding events were similar in both groups. Time-related multivariate analysis identified INR self-management and higher INR as independent predictors for better outcome. CONCLUSIONS: Anticoagulation self-management can improve INR profiles up to 2 years after prosthetic valve replacement and reduce adverse events. Current indications of prosthetic rather than biologic valve implantations may be extended if the benefit of INR self-management is shown by future studies with longer follow-up.

Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement.

BACKGROUND: The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical heart valve replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known. METHODS: Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival. RESULTS: In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group. CONCLUSIONS: Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic valves.

Noninvasive echocardiographic estimation of pulmonary wedge pressure in candidates for and recipients of heart transplantation.

OBJECTIVE: We assessed the value of deceleration time (dt) of diastolic wave of pulmonary venous flow (PVF) (PVF_dt) as noninvasive estimation of pulmonary wedge pressure (PWP) in candidates for and recipients of heart transplantation. METHODS: We prospectively recruited 51 patients with end-stage congestive heart failure (group A) and 49 recipients of heart transplantation (group B). PWP and PVF_dt were measured using a Swan-Ganz catheter and Doppler echocardiography, respectively. We performed regression analyses to assess interrelationships. Moreover, we used the area under the receiver operating characteristic curve to assess how clearly PVF_dt could discriminate between normal and elevated PWP values. RESULTS: In both study groups, PWP was inversely associated with PVF_dt (R(2) = 0.785 and 0.797, respectively, P < .001). A cut-off value of less than 187 milliseconds was predictive of an elevated PWP value (> or =12 mm Hg) in both study groups. Specificity and sensitivity were between 90% and 100%, respectively, in both study groups. The area under the receiver operating characteristic curve was 0.961 (0.908-1.013; P < .001) for group A and 0.998 (0.992-1.04; P < .001) for group B. CONCLUSION: In recipients of heart transplantation and patients with end-stage congestive heart failure, the noninvasive measuring of PVF_dt distinguishes between normal and elevated PWP values.