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1.
Cardiovasc Ultrasound ; 10: 11, 2012 Mar 19.
Article in English | MEDLINE | ID: mdl-22429696

ABSTRACT

BACKGROUND: Radiofrequency catheter ablation of atrial fibrillation (AF) has been proved to be effective and to prevent progressive left atrial (LA) remodeling. Cryoballoon catheter ablation (CCA), using a different energy source, was developed to simplify the ablation procedure. Our hypothesis was that successful CCA can also prevent progressive LA remodeling. METHODS: 36 patients selected for their first CCA because of nonvalvular paroxysmal AF had echocardiography before and 3, 6 and 12 months after CCA. LA diameters, volumes (LAV) and LA volume index (LAVI) were evaluated. LA function was assessed by: early diastolic velocities of the mitral annulus (Aa(sept), Aa(lat)), LA filling fraction (LAFF), LA emptying fraction (LAEF) and the systolic fraction of pulmonary venous flow (PVSF). Detailed left ventricular diastolic function assessment was also performed. RESULTS: Excluding recurrences in the first 3-month blanking period, the clinical success rate was 64%. During one-year of follow-up, recurrent atrial arrhythmia was found in 21 patients (58%). In the recurrent group at 12 months after ablation, minimal LAV (38 ± 19 to 44 ± 20 ml; p < 0.05), maximal LAV (73 ± 23 to 81 ± 24 ml; p < 0.05), LAVI (35 ± 10 to 39 ± 11 ml/m2; p = 0.01) and the maximal LA longitudinal diameter (55 ± 5 to 59 ± 6 mm; p < 0.01) had all increased. PVSF (58 ± 9 to 50 ± 10%; p = 0.01) and LAFF (36 ± 7 to 33 ± 8%; p = 0.03) had decreased. In contrast, after successful cryoballoon ablation LA size had not increased and LA function had not declined. In the recurrent group LAEF was significantly lower at baseline and at follow-up visits. CONCLUSIONS: In patients whose paroxysmal atrial fibrillation recurred within one year after cryoballoon catheter ablation left atrial size had increased and left atrial function had declined. In contrast, successful cryoballoon catheter ablation prevented progressive left atrial remodeling.


Subject(s)
Atrial Fibrillation/prevention & control , Atrial Fibrillation/surgery , Catheterization/methods , Cryosurgery/methods , Atrial Fibrillation/diagnostic imaging , Female , Humans , Male , Middle Aged , Secondary Prevention , Treatment Outcome , Ultrasonography
2.
J Heart Valve Dis ; 20(5): 526-30, 2011 Sep.
Article in English | MEDLINE | ID: mdl-22066356

ABSTRACT

Bioprosthetic valve thrombosis is an unexpected complication which has no guidelines for its management. A 70-year-old female presented 10 days after a stroke, three years after having undergone mitral bioprosthetic valve implantation. Both, transthoracic echocardiography and transesophageal echocardiography (TEE) revealed a large mobile, non-obstructive mass attached to the atrial side of the sewing ring of the bioprosthesis. The administration of low-molecular-weight heparin and aspirin resulted only in a reduction of thrombus size, whereas a slow streptokinase infusion resulted in complete disappearance of the thrombus after 16 h. A review of the literature shows that late non-obstructive bioprosthetic valve thrombosis, as diagnosed with TEE, is a rare condition that can be successfully treated either by anticoagulant or thrombolytic therapy. Late bioprosthetic valve thrombosis should be considered as a cause of prosthetic valve dysfunction, and long-term preventive anticoagulant treatment of high-risk patients is warranted. Slow thrombolytic therapy is safe and successful, even for large non-obstructive bioprosthetic thrombi, if there are no contraindications.


Subject(s)
Bioprosthesis/adverse effects , Fibrinolytic Agents/administration & dosage , Heart Valve Prosthesis/adverse effects , Mitral Valve , Streptokinase/administration & dosage , Thrombolytic Therapy , Thrombosis/drug therapy , Acenocoumarol/therapeutic use , Aged , Echocardiography, Transesophageal , Female , Humans , Nadroparin/therapeutic use , Thrombosis/diagnostic imaging , Time Factors
4.
Echocardiography ; 27(3): 230-5, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20486956

ABSTRACT

BACKGROUND: Both systolic and diastolic tissue Doppler (TD) velocities have an important diagnostic and prognostic role in cardiology. We aimed to compare TD velocities between two different echocardiography systems. PATIENTS: Thirty-one consecutive patients (mean age: 65.2 +/- 17.5 years; 12 males) were enrolled. METHODS: Systolic (Sa), early (Ea), and late (Aa) diastolic velocities were measured by TD at the lateral mitral annulus by a Sonos 2000 (Hewlett-Packard, Andover, MA, USA) and a Philips iE33 system. The E/Ea ratio was calculated. RESULTS: Ea, Aa, and Sa velocities were higher when measured by the Sonos system (Ea: 13.2 +/- 4.1 cm/s vs. 8.3 +/- 3.6 cm/s; Aa: 14.8 +/- 3.8 cm/s vs. 9.3 +/- 2.3 cm/s; Sa: 15.2 +/- 3.6 cm/s vs. 8.4 +/- 2.0 cm/s; P < 0.0001 all). A significant correlation was found in Ea and in Ea/Aa (r = 0.84 and r = 0.85 resp; P < 0.0001 for both), and a weaker in Aa (r = 0.43; P = 0.02) between the machines. The Bland-Altman analysis showed broad limits of agreement between the measurements for Ea, Aa, and Sa (mean difference: 4.95 cm/s; 5.52 cm/s; 6.73 cm/s, respectively; limits: 0.64-9.25 cm/s; -1.39-12.39 cm/s; -0.37-13.83 cm/s, respectively). An E/Ea ratio >5.6 by the Sonos system showed 75% sensitivity and 79% specificity for elevated left ventricular filling pressure, defined as E/Ea >10 by the reference Philips system. CONCLUSIONS: Although diastolic TD velocities had excellent correlations between the two machines, there was a systematic overestimation by the Sonos system. Since the limits of agreement do not allow replacing the measurements, we suggest using the same echocardiographic equipment at patient follow-up.


Subject(s)
Echocardiography, Doppler/instrumentation , Echocardiography, Doppler/methods , Adult , Aged , Aged, 80 and over , Blood Flow Velocity , Female , Humans , Male , Middle Aged , ROC Curve
7.
J Heart Valve Dis ; 18(3): 268-75, 2009 May.
Article in English | MEDLINE | ID: mdl-19557981

ABSTRACT

BACKGROUND AND AIM OF THE STUDY: Treatment strategies and guidelines in the management of prosthetic valve thrombosis (PVT) remain controversial. The study aim was to assess the success and complication rate of thrombolytic therapy (TT) by comparing thrombus size, severity of symptoms, type of prosthetic valve, and time since valve implantation. METHODS: Between April 1993 and December 2006, TT was administered for 62 thrombotic events in 55 patients with mitral PVT. Thrombus size was measured by planimetry, and its location and mobility assessed with transesophageal echocardiography (TEE). Continuous thrombolytic treatment in obstructive PVT (OPVT) was monitored using gradient measurement by transthoracic echocardiography every 2-5 h, and by visual assessment with TEE every 24 h. RESULTS: All patients with non-obstructive PVT (NOPVT) were in NYHA class I or II. Among 52 patients with OPVT, eight were in NYHA class I or II, and 44 in NYHA class III-IV (p < 0.0001). The thrombus area (measured with TEE) before thrombolysis was < 0.8 cm2 in 24 cases, > or = 0.8 cm2 in 21 cases, and could not be measured in 17 events. Thrombolysis was successful in 45 events (73%) including all NOPVT. In 13 events (21%) the transvalvular gradient decreased but was not normalized. Thrombolysis failed in four events (6%). Complications of thrombolysis were present in 11 events (18%), and four patients died. There was no significant difference in the outcome of TT regarding the type of artificial valve, NYHA class or thrombus size. In cases of successful thrombolysis, the time since surgery was significantly shorter than in cases of partially successful or failed thrombolysis. CONCLUSIONS: Based on previous data and the present findings, thrombolysis can be considered as first-line treatment in all patients with PVT, independent of the valve type, NYHA functional class, and thrombus size.


Subject(s)
Fibrinolytic Agents/therapeutic use , Heart Valve Prosthesis , Mitral Valve Insufficiency/drug therapy , Thrombolytic Therapy , Thrombosis/drug therapy , Adult , Aged , Echocardiography , Female , Humans , Male , Middle Aged , Mitral Valve Insufficiency/etiology , Predictive Value of Tests , Retrospective Studies , Streptokinase/therapeutic use , Thrombosis/complications , Thrombosis/diagnostic imaging , Treatment Outcome , Urokinase-Type Plasminogen Activator/therapeutic use
8.
Blood Press ; 18(3): 135-41, 2009.
Article in English | MEDLINE | ID: mdl-19484618

ABSTRACT

UNLABELLED: The aim of this study was to assess the different stages of diastolic dysfunction (DD) in elderly, asymptomatic, hypertensive patients with preserved systolic function, and to investigate the role of Tissue Doppler imaging (TDI) and Pulmonary venous (PV) flow added to the routine echocardiographic assessment. Patients. 322 patients (age: 70.8+/-9.1 years) were enrolled. METHODS: Mitral inflow pattern, TDI (Ea: early diastolic velocity) and PV flow was assessed to evaluate diastolic function. Deceleration time of mitral E velocity < 150ms, E/Ea> or =7 and/or S/D< 1 of PV flow indicated elevated filling pressure (EFP). Patients were divided into four groups: no DD, mild DD, moderate DD and severe DD. RESULTS: In 63 cases we found no DD, mild DD was present in 150 cases, moderate DD in 86 cases and severe DD in 23 cases. Compared with patients without DD, the Ea was decreased in mild and moderate DD (14.8+/-2.3 vs 12.2+/-2.4 cm/s, p<0.001; vs 13.3+/-2.6 cm/s, p=0.005). Normal mitral inflow pattern was found in 149 patients, 86 of them had EFP (58%). CONCLUSIONS: One third of elderly hypertensive patients with preserved systolic function had moderate-to-severe asymptomatic DD. More than half of the patients had EFP with normal mitral inflow pattern.


Subject(s)
Echocardiography, Doppler , Aged , Cardiomyopathies/diagnostic imaging , Cardiomyopathies/physiopathology , Diastole , Echocardiography , Female , Humans , Hypertension/diagnostic imaging , Hypertension/physiopathology , Male , Systole
9.
Expert Rev Cardiovasc Ther ; 6(1): 85-93, 2008 Jan.
Article in English | MEDLINE | ID: mdl-18095909

ABSTRACT

Left-sided prosthetic valve thrombosis is a life-threatening complication of the mechanical valves. Prosthetic valve thrombosis has been divided into obstructive forms (OPVT) and nonobstructive forms (NOPVT). Clinical presentation of OPVT is heart failure and systemic embolism of OPVT and NOPVT, but it may be asymptomatic. Transesophageal echocardiography is the technique of choice for diagnosis and treatment guidance. There are three treatment options. Surgery carries a high hospital mortality risk in severely sick patients. Thrombolysis has been successful in 80%, with a mortality of 4%, depending on obstruction and functional class. Embolic complications were 8-10% depending on obstruction, but not on thrombus size. Heparin treatment has been successful only in NOPVT, if thrombus diameter of less than 5 mm. Based on the latest evidence, thrombolysis should be first-line therapy if there are no contraindications, regardless of obstruction and functional class, if thrombus diameter is greater than, or equal to, 5 mm.


Subject(s)
Heart Valve Diseases/diagnosis , Heart Valve Diseases/therapy , Heart Valve Prosthesis , Postoperative Complications/diagnosis , Postoperative Complications/therapy , Thrombolytic Therapy/methods , Thrombosis/diagnosis , Thrombosis/therapy , Anticoagulants/therapeutic use , Combined Modality Therapy , Echocardiography, Transesophageal , Fibrinolytic Agents/therapeutic use , Heart Valve Diseases/etiology , Heparin/therapeutic use , Humans , Postoperative Complications/etiology , Prosthesis Failure , Streptokinase/therapeutic use , Thrombosis/etiology , Treatment Outcome
11.
Angiology ; 58(4): 413-9, 2007.
Article in English | MEDLINE | ID: mdl-17875954

ABSTRACT

Aortic valve calcification (AVC) and carotid artery calcification (CAC) are considered to be markers of generalized atherosclerosis. However, the role of intracardiac calcification (ICC) (valvular and perivalvular calcification) is unclear. The objective of this retrospective study was to analyze the relationship between ICC and CAC, risk factors, and clinical atherosclerotic disease. Risk factors included age, sex, diabetes mellitus, hypercholesterolemia, and hypertension; clinical atherosclerosis comprised stroke, coronary artery disease, and peripheral artery disease. Between January 1, 2001, and January 1, 2004, all consecutive patients were enrolled into the study who underwent both carotid ultrasonography and transthoracic echocardiography examinations within 2 months. Patients with renal failure, substantial aortic stenosis, and carotid artery occlusion were excluded. There were 320 patients (104 men; mean +/- SEM age, 66.6 +/- 0.76 years). Positive results on carotid ultrasonography are defined as any CAC. Patients were categorized as having mild, moderate, or severe CAC. Positive results on transthoracic echocardiography were defined as any ICC; AVC was defined as mitral anulus calcification (MAC) or both. Intracardiac calcification was found in 181 patients, AVC in 51 patients, MAC in 48 patients, and calcification of both structures in 82 patients. Using multiple logistic regression analysis, ICC (odds ratio, 1.9), age (10-year periods) (odds ratio, 2.0), and the presence of peripheral artery disease (odds ratio, 1.7) were independent predictors of CAC. Carotid ultrasonography results were positive in 227 patients. For CAC, the sensitivities of AVC, MAC, both, and any ICC were 52.4%, 52.0%, 33.5%, and 71.2%, respectively, and the specificities were 84.9%, 87.1%, 92.5%, and 78.5%, respectively. The extension of ICC as 0, 1 location (AVC or MAC) , or 2 locations (AVC and MAC) was associated with the severity of CAC (P < .001, tau = 0.42). There was no difference between patients with AVC vs patients with MAC in the presence of different stages of CAC (P = .62). Intracardiac calcification (MAC or AVC) is an independent predictor of CAC as a marker of atherosclerosis, although the lack of ICC does not rule out atherosclerosis. Intracardiac calcification is related to CAC, with high specificity. The extension of ICC is related to the severity of atherosclerosis. Based on our results, antiatherothrombotic therapy should be considered in patients with ICC even before obtaining a positive carotid ultrasonography result.


Subject(s)
Atherosclerosis/complications , Calcinosis/diagnostic imaging , Cardiomyopathies/diagnostic imaging , Carotid Arteries/diagnostic imaging , Aged , Atherosclerosis/diagnostic imaging , Calcinosis/etiology , Cardiomyopathies/etiology , Echocardiography , Female , Humans , Male , Middle Aged , Odds Ratio , Prognosis , Retrospective Studies , Risk Factors , Severity of Illness Index , Ultrasonography, Doppler, Color
12.
Orv Hetil ; 148(5): 217-21, 2007 Feb 04.
Article in Hungarian | MEDLINE | ID: mdl-17344142

ABSTRACT

Brain natriuretic hormone and N-terminal-probrain natriuretic hormone are equally important cardiovascular biomarkers. Moderately increased brain natriuretic hormone level is a reliable predictor of preclinical, asymptomatic left ventricular dysfunction. Low brain natriuretic hormone levels are extensively used to rule out acute heart failure. Increased brain natriuretic hormone is associated to age, left ventricular hypertrophy, left atrial volume, atrial fibrillation, myocardial ischemia, renal failure, pulmonary hypertension, acute pulmonary embolism and progressive aortic stenosis. In chronic heart failure only high brain natriuretic hormone values support the diagnosis. High brain natriuretic hormone level, however, is an important overall cardiovascular prognostic biomarker. In the near future brain natriuretic hormone appears to be an interesting new therapeutic modality.


Subject(s)
Cardiovascular Diseases/diagnosis , Natriuretic Peptide, Brain/blood , Biomarkers/blood , Cardiovascular Diseases/blood , Diagnosis, Differential , Humans , Prognosis
13.
J Heart Valve Dis ; 15(5): 726-9, 2006 Sep.
Article in English | MEDLINE | ID: mdl-17044383

ABSTRACT

Hypereosinophilic syndrome (HES) is defined as a prolonged, unexplained peripheral eosinophilia in a patient presenting with end-organ damage. The heart is frequently involved, resulting in eosinophilic endomyocardial disease, which is characterized by mural thrombus formation and endocardial fibrosis. Thromboembolic complications in HES are mediated by material released from eosinophilic granules. Herein is reported the case of a patient who presented, 15 years after valve replacement with a mechanical prosthesis, with clinical signs of recurrent prosthetic valve thrombosis that was caused by missed hypereosinophilia. The unique feature of the case was that the mitral prosthetic valve obstruction was the result of an eosinophilic thrombus, though no tissue infiltration or inflammation had been detected by random biopsy of the left ventricular myocardium. After nine years of effective treatment of HES there were no cardiac or extracardiac complications.


Subject(s)
Heart Valve Prosthesis/adverse effects , Hypereosinophilic Syndrome/complications , Hypereosinophilic Syndrome/pathology , Mitral Valve Stenosis/surgery , Thrombosis/etiology , Humans , Hypereosinophilic Syndrome/etiology , Male , Middle Aged , Mitral Valve Stenosis/etiology , Recurrence , Rheumatic Heart Disease/complications , Thrombosis/pathology
14.
Eur Heart J ; 27(16): 1947-53, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16774980

ABSTRACT

AIMS: The risk of stroke is greater among women with atrial fibrillation (AF) than men. Warfarin protects against stroke, but treatment-related bleeding occurs more often in women than in men. METHODS AND RESULTS: SPORTIF III (open label, n=3410) and V (double-blind, n=3922) included 2257 women with AF and one or more stroke risk factors randomized to warfarin [target international normalized ratio (INR) 2.0-3.0] or ximelagatran (36 mg twice daily). Primary outcomes were all stroke (ischaemic/haemorrhagic) and systemic embolic event. Women were older, on average, than men, 73.4+/-8.0 vs. 69.8+/-9.0 years (P<0.0001). More women were >75-years old and women had more risk factors than men had (P<0.0001). The INR on warfarin (mean 2.5+/-0.7) was within target range for 67% of follow-up regardless of gender. Women more often developed primary events [2.08%/year, 95% confidence interval (CI) 1.60-2.56%/year vs. 1.44%/year, 95% CI 1.18-1.71%/year in men; P=0.016). Major bleeding rates were similar (P=0.766) but women experienced more overall (major/minor) bleeding (P<0.001). Warfarin was associated with more overall bleeding in both genders and more major bleeding in women than in men (P=0.001). CONCLUSION: When compared with men with AF, women in these studies were older and had more stroke risk factors. Women were more prone to anticoagulant-related bleeding; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Azetidines/administration & dosage , Benzylamines/administration & dosage , Stroke/prevention & control , Warfarin/administration & dosage , Administration, Oral , Age Factors , Aged , Anticoagulants/adverse effects , Azetidines/adverse effects , Benzylamines/adverse effects , Chemical and Drug Induced Liver Injury , Double-Blind Method , Estrogen Replacement Therapy , Female , Hemorrhage/chemically induced , Humans , Male , Risk Factors , Sex Characteristics , Sex Factors , Thromboembolism/prevention & control , Warfarin/adverse effects
16.
J Heart Valve Dis ; 14(5): 567-75, 2005 Sep.
Article in English | MEDLINE | ID: mdl-16245493

ABSTRACT

Prosthetic valve thrombosis (PVT) is a life-threatening disease, for which treatment strategies have been controversial. Herein, existing data on management options are reviewed, and conclusions drawn as to the choice and use of treatment strategies for PVT. The use of transesophageal echocardiography (TEE) allows distinction to be made between obstructive and non-obstructive PVT by the presence or absence of occluder motion limitation. The differentiation of PVT from pannus and vegetation is, however, still limited by TEE. The incidence of PVT has been underestimated by not taking into account a large percentage of non-obstructive PVT. Although the standard treatment for PVT has been surgery, thrombolysis has lower mortality rates, particularly in patients in NYHA functional classes III-IV. The lowest complication rates with thrombolysis have been achieved in patients with non-obstructive PVT. Pregnancy, left atrial appendage thrombi and large PVT are not contraindications to thrombolysis. The third therapeutic option is anticoagulant therapy. The detrimental effect of anticoagulant treatment in obstructive PVT was shown in a prospective study. Non-obstructive thrombi of > 5 mm length have been treated with higher success rates and lower complication rates by thrombolysis than by anticoagulant treatment. In conclusion, all patients with suspected PVT should undergo multiplane TEE. Thrombolysis is the first-line treatment for obstructive PVT, independent of NYHA class and thrombus size if there are no contraindications. Serial TEE studies must be conducted during thrombolysis. Surgery should be reserved for those patients in whom thrombolysis is contraindicated, or has failed. Initial anticoagulant therapy is recommended only for small, non-obstructive PVT if anticoagulation had been subtherapeutic; otherwise, thrombolysis is the treatment of choice if there are no contraindications.


Subject(s)
Heart Valve Diseases/diagnosis , Heart Valve Diseases/therapy , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/instrumentation , Humans , Thrombolytic Therapy
17.
Orv Hetil ; 146(27): 1433-8, 2005 Jul 03.
Article in Hungarian | MEDLINE | ID: mdl-16089103

ABSTRACT

INTRODUCTION: The combined modality treatment used in case of limited stage small cell lung cancer assures the longest disease-free and average survival meanwhile maintaining an acceptable quality of life. OBJECT: The authors examined whether the combined modality treatment in case of limited-stage small cell lung cancer affects the remission positively or not: they presumed that the therapeutic response, early partial or complete clinical and oncological remission develops earlier than in patients treated with chemotherapy. The authors' other presumption was that the early therapeutic response could be the guarantee of the longest possible disease-free and average survival. PATIENTS AND METHOD: Small cell lung cancer (SCLC) was proved in 72 patients (23 women, 49 men, average 53 year-olds) with histological and/or cytological examination. Having examined which stage the patients were in, they proved to be in the limited stage. The patients were divided into two groups at random: cytotoxic chemotherapy containing cisplatin + etoposide was used in 36 cases, meanwhile in the other 36 cases the chemotherapy was completed with early concurrent thoracic radiotherapy. RESULTS: The therapeutic response happened earlier (early remission) in case of patients treated with chemo-radiotherapy than with chemotherapy treatment (average 10.4-12.6 weeks, SD = 1.22-1.99). The result of the "log rank" test showing the difference between the two groups is strongly significant in favor of the chemo-radiotherapy group (p = 0.0001). In patients with early remission receiving chemo-radiotherapy, the thoracic recidives and metastasis developed later (average 74.8 weeks, SD = 44.95), furthermore the average survival also proved to be longer (93.9 weeks, SD = 57.09). The average time until the development of tumor recidives and metastasis in patients belonging to the chemotherapy group was 44.5 weeks (SD = 30.23), and the average survival was 67.4 weeks (SD = 32.77). The result of the "log rank" test proved significant advantage for the chemo-radiotherapy group both for disease-free survival (p = 0.0010) and average survival (p = 0.0079 ). Another positive effect of chemo-radiotherapy was that less thoracic recidives and central nervous system metastasis could be diagnosed. Examination of treatment toxicity showed that one has to count primarily with esophagitis and pneumonitis related to the radiotherapy in patients receiving chemo-radiotherapy.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Small Cell/drug therapy , Carcinoma, Small Cell/radiotherapy , Lung Neoplasms/drug therapy , Lung Neoplasms/radiotherapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Small Cell/mortality , Carcinoma, Small Cell/secondary , Chemotherapy, Adjuvant/adverse effects , Cisplatin/administration & dosage , Disease-Free Survival , Esophagitis/etiology , Etoposide/administration & dosage , Female , Humans , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Male , Middle Aged , Neoplasm Staging , Pneumonia/etiology , Radiotherapy, Adjuvant/adverse effects , Remission Induction , Survival Analysis , Treatment Outcome
18.
J Heart Valve Dis ; 14(1): 1-7, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15700427

ABSTRACT

Major reasons for the considerable heterogeneity among published results of heart valve surgery are inconsistency in follow up techniques, reporting systems and classification of adverse events. The present recommendations are intended to harmonize the presentation of clinical material in order to improve comparison of data from different sources for the analysis of pooled data. The quality of an observational study is largely, if not entirely, due to the follow up technique, which may be graded according to six categories: Self-reporting of adverse events/well-being by the patients may be classified 'excellent'; if the information is gathered and re-checked at short-term intervals. Data obtained from in-hospital or outpatient examinations by qualified examiners at least twice a year or other personal contact through qualified examiners may be regarded as 'sufficient', if the results are re-checked by contacting the treating home physician. All other follow up techniques may be regarded as inappropriate. Consequences of complications are entirely dependent on severity and possible sequelae. It is therefore recommended to grade any reported complication according to its severity by utilizing a score system. Embolisms are best categorized by utilizing the performance status scale. Bleeding events may be categorized according to severity as fatal, major (requiring hospital transmission with transfusion, surgery or with permanently increased disability) or minor (not requiring hospital admission, surgery or transfusion). In some cases it will remain unclear whether an event was primarily embolic or hemorrhagic. These complications should be summarized as 'not categorized'. The reporting of morbid events due to thrombosis, embolism and bleeding should go along with information regarding the quality of antithrombotic management.


Subject(s)
Clinical Trials as Topic/standards , Documentation/standards , Heart Valve Diseases/surgery , Heart Valve Prosthesis/adverse effects , Postoperative Complications , Anticoagulants/therapeutic use , Data Collection/standards , Data Interpretation, Statistical , Health Status , Humans , Patient Selection , Prosthesis Failure
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