[Tracheostoma valves and their associated risks]. / Tracheostomaventile und ihre Risiken.

Tracheostoma valves have proven to be very effective for voice restoration in patients with a tracheotomy or laryngectomy. Nevertheless, in recent years there have been a number of reports about life-threatening incidents with tracheostoma valves. An analysis of these incidents and the commercially available tracheostoma valves, their functions and limitations enables typical risk situations to be derived. The most reported incidents were caused by inadvertently filling the cuff of the tracheostomy tube while the tracheostoma valve was in place and by confusing a heat and moisture exchanger (HME) filter with a tracheostoma valve. These mistakes caused a complete obstruction of the expiratory airway leading to a barotrauma of the lungs with pneumothorax and asphyxia. Another typical risk in mechanically ventilated patients is insufficient monitoring during the use of the tracheostoma valve. Clear marking of tracheostoma valves and a specific training of hospital personnel with respect to the typical risks of tracheostoma valves could effectively reduce the associated dangers.

Surgery of benign thyroid disease by ENT/head and neck surgeons and general surgeons: 233 cases of vocal fold paralysis in 3509 patients.

PURPOSE: Thyroid surgery is mainly performed by general surgeons (GS). The aim of this study is to evaluate the safety and efficiency of thyroid surgery by ENT/head and neck surgeons (ENT), especially regarding the incidence of vocal fold palsy (VFP). METHODS: We retrospectively analysed 3509 patients (69.0% female) who underwent surgery for benign thyroid diseases (56.8% nodular goitre, 18.6% inactive nodes, 14.0% thyroid autonomy, 7.0% Graves' disease). Operations were mainly performed with intraoperative neuromonitoring by GS (n = 1933) or physicians trained for head and neck surgery (n = 1576). 18.7% of the procedures were carried out by residents in training. RESULTS: VFP occurred in 233 subjects (6.6%); 6.2% in females and 7.6% in males. A lower rate (p < 0.001) was observed in operations performed by ENT (4.7%) than by GS (8.2%). No increased incidence of VFP was seen for surgeries performed by physicians in training (6.2%, n = 657). Prevalence of VFP was not different for minimally invasive (6.3%, n = 950) and conventional surgery (6.8%, n = 2559), but higher in total (7.2%, n = 1916) than in subtotal thyroidectomy (5.0%, n = 997). Postoperative haemorrhage (5.6 vs. 1.9%) and hypocalcaemia < 2.0 mmol/l (32.8 vs. 22.0%) were documented more frequently in patients with VFP, also substitution therapy with calcium (23.2 vs. 14.7%) and dihydrotachysterol (8.1 vs. 3.7%) had to be applied more frequently. CONCLUSION: Thyroid surgery performed by surgeons specifically trained for ENT/head and neck surgery is safe and has a significantly reduced rate of VFP. VFP is associated with other complications (postoperative haemorrhaging, hypocalcaemia).

Are modern voice prostheses better? A lifetime comparison of 749 voice prostheses.

The aim of the study was to compare device life of more recent indwelling voice prostheses Provox Vega and Blom-Singer Dual Valve to device life of well-known standard devices (Provox 2, Blom-Singer Classic). In a prospective, non-randomised study, device life of Blom-Singer Classic, Blom-Singer Dual Valve, Provox2, Provox Vega and Provox ActiValve voice prostheses was recorded in a group of 102 laryngectomised patients. In total 749 voice prosthesis were included. Average overall life time was 108 days, median 74 days. The prosthesis with the longest dwell time was the Provox ActiValve (median 291 days). Provox Vega had longer device life compared with Provox2 (median 92 days vs 66 days; p = 0.006) and compared with Blom-Singer Classic (median 92 days vs 69 days; p = 0.004). In conclusion, device lifetimes of Provox Vega and ActiValve were better than those of Provox2 and the Blom-Singer Classic. New voice prostheses, with a defined valve opening pressure (Provox Vega, Provox ActiValve, Blom-Singer Dual Valve) had longer lifetimes than prostheses without a defined opening pressure (Blom-Singer Classic and Provox 2).

[The custom-fit voice prosthesis, for treatment of periprothetic leakage after tracheoesophageal voice restoration]. / Die Custom-fit-Stimmprothese. Zur Therapie der periprothetischen Leckage bei Stimmprothesenträgern.

BACKGROUND: Leakage around an indwelling voice prosthesis is detected during 13% up to 27% of all replacement procedures of voice prosthesis and causes serious complications in further voice restoration of the laryngectomee. Lots of therapeutic options to stop periprothetic leakage have been described (Injection of Bioplastique, autologous fat or collagen, suture techniques, spacer therapy) without convincing success rates. METHODS: Custom-fit voice prostheses are ordinary indwelling voice prostheses (Blom-Singer low pressure Indwelling 20 fr) with enlarged flanges and reduced shaft length that are individually sized for the shunt of the laryngectomee. Especially enlarging the esophageal flange provides a tight sealing of leakage around the prosthesis. PATIENTS: In a one year lasting clinical trial 692 voice prostheses were changed. In 77 cases periprothetic leakage was detected and fistulas were fitted with individually sized voice prostheses. RESULTS: In 76 cases total control of leakage was achieved without any specific complications taking place. Moreover two types of leaking tracheoesophageal fistulas were distinguished, a dilated-atrophic and an infected-necrotic type. 57% of the fistulas were dilated-atrophic type and 43% of the fistulas were classified infected-necrotic type. Infected-necrotic fistulas needed enlarged flanges tracheal an esophageal for tight sealing in 91% of the cases whereas dilated-atrophic fistulas needed double flanges only in 45%. 70% of infected-necrotic type fistulas needed only one singular history of a custom-fit prosthesis and could be changed back to ordinary indwelling prostheses after healing had taken place. CONCLUSIONS: As the insertion of a modified prosthesis is only slightly more effort than an ordinary voice prosthesis insertion, the success rate is high und complications are rare we recommend the custom-fit voice prosthesis for treatment of periprothetic leakage.

[Clinical use of a voice prosthesis with a flap valve containing silver oxide (Blom-Singer Advantage), biofilm formation, in-situ lifetime and indication]. / Klinische Anwendung einer Stimmprothese mit silberoxidhaltigem Ventil (Blom-Singer Advantage)--Biofilmresistenz, Prothesenverweildauer und Indikation.

BACKGROUND: Fungal growth and the resulting leakage through an indwelling voice prosthesis remains the most frequent reason of prosthesis failure and renewal. In some patients leakage caused by fungal growth occurs in very short intervals (below 12 weeks in-situ lifetime) and causes frequent treatments and high costs. METHODS: The Blom-Singer(R) Advantage voice prosthesis is a new prosthesis type with a modified flange design, a flap valve containing 7 % silver oxide in the silicon matrix and is expected to be resistant against biofilm formation and fungal growth. PATIENTS: In a clinical trial we used the Blom-Singer(R) Advantage prosthesis in 33 patients with short in-situ lifetimes of their voice prosthesis and analysed the effects on in-situ lifetime and complications statistically. RESULTS: The clinical use of the Blom-Singer(R) Advantage prosthesis was similar to other types of indwelling voice prosthesis (Provox(R) II, Blom-Singer Indwelling(R)) and did not cause any special problems. Prosthesis specific side effects (i. e. allergy against silver oxide) did not occur. Statistical analysis of the aquired data showed an interindividually changing, but significantly longer in-situ lifetime for the Blom-Singer(R) Advantage prosthesis. The mean device lifetime increased from 36 days (median 36 days) to a mean lifetime of 110 days (median 87 days) with the use of the Blom-Singer(R) Advantage prosthesis. CONCLUSIONS: Using a voice prosthesis with a valve containing silver oxide can normalize and even increase the in-situ lifetime in patients with frequent changing procedures caused by fungal growth on the valve. Therefore we recommend the use of this type of voice prosthesis for those patients as reduction of costs and effort results.

[Quantification of tricuspid insufficiency--comparison of Doppler echocardiography and radionuclide ventriculography]. / Schweregradbestimmung der Trikuspidalinsuffizienz--Vergleich von Dopplerechokardiographie und Radionuklidventrikulographie.

In 40 patients (pts) (ages 34-83 years) the severity of tricuspid regurgitation (TR) was graded by pulsed Doppler echocardiographic determination of regurgitant jet extension. Mild TR was assessed in seven pts (group I), mode-rate TR in 20 pts (group II), and severe TR in 13 pts (group III). The enddiastolic diameter of the left ventricle as measured by M-mode-echocardiography was 55 +/- 16 mm in group I, 48 +/- 6 mm in group II, and 50 +/- 10 mm in group III. The regurgitant index (RI), i.e., the ratio of left-to-right-ventricular stroke counts (normal range 0.89-1.97) and the time-activity curve over the liver area were measured by equilibrium radionuclide ventriculography (RNV). The RI differed significantly between group I (1.6 +/- 0.5), II (1.0 +/- 0.3), and III (0.8 +/- 0.3) (p less than 0.01). An RI-value below 0.89 as an index of right-ventricular volume overload was found in 14% (group I), 45%, (group II) and 77% (group III). The time-activity curve over the liver area, as graded by count variation in phase with the right atrium from 1 (no count variation) to 4 (typical count variation) showed all grades in groups I and II, but only grade 2 to 4 in group III. The RI resp. the time-activity curve over the liver is a sensitive parameter for the detection of moderate to severe TR. If TR is ascertained, severe regurgitation can be differentiated from mild regurgitation by RNV-derived RI as an index of right-ventricular volume overload.

[The role of radionuclide ventriculograms in determining the indications for valve replacement in chronic aortic valve insufficiency]. / Die Rolle des Radionuklid-ventrikulogramms für die Indikationsstellung zum Klappenersatz bei der chronischen Aortenklappeninsuffizienz.

Timing of aortic valve replacement (AVR) in chronic aortic regurgitation (AR) remains a difficult problem in clinical practice. Radionuclide ventriculography (RNV) yields information on the extent of valvular regurgitation, the enlargement and the systolic function of the left ventricle. A "well-timed" AVR is defined by 1) postoperative improvement of clinical symptoms, decrease in left ventricular end-diastolic volume (EDV) and normalization of ejection fraction (EF) as well as by 2) greater improvement under surgical therapy as compared to conservative management. In "too early" AVR the latter condition is not fulfilled, while in "too late" AVR the first condition is not accomplished. In this study 54 patients with chronic aortic incompetence were evaluated by RNV to see whether these three groups ("too early", "well timed", "too late" AVR, resp.) can be separated by the relation between EDV and regurgitant volume (RV), the level of the EDV and the clinical status. The examination was based on pre- and postoperative RNV studies as well as on follow-up studies. A good postoperative result can be expected in cases with a preoperative EDV/RV-ratio similar to that observed in 30 patients with AR in whom AVR was not indicated. In contrast, in the majority of those cases with an EDV/RV-ratio exceeding this normal range the postoperative outcome will be unsatisfactory. If the EDV/RV-ratio is normal, AVR should be performed in cases with an EDV exceeding 400 ml, while in cases with an EDV between 300-400 ml AVR is only indicated in the presence of additional symptoms (NYHA greater than or equal to II).(ABSTRACT TRUNCATED AT 250 WORDS)

Timing of valve replacement in chronic aortic regurgitation. A pathophysiological approach.

Timing of valve replacement (AVR) in chronic aortic regurgitation remains a difficult problem in clinical practice. When the disease takes a favorable natural course, this may be attributed to excellent compensatory mechanisms - especially an increase in left ventricular end-diastolic volume (LVEDV) in relation to regurgitant volume (RV) - whereas a rapid clinical and hemodynamic deterioration may usually be ascribed to a vicious circle consisting in a marked increase in afterload leading to an increase in LVEDV and so on. 54 patients with aortic regurgitation underwent pre- and postoperative as well as long-term follow-up radionuclide ventriculographic (RNV) studies in order to determine LVEDV and RV and to measure left ventricular ejection fraction (LVEF). These measures were expected to provide information on 'physiologic' LVEDV elevation in relation to RV. Our results indicate that if LVEDV exceeds 300-400 ml there may be an increase in afterload for LV. Factors counteracting this increased afterload (LV hypertrophy, increased diastolic stretching) will eventually preserve LVEF and keep LVEDV/RV within the normal range, but are accompanied by an elevation of LV filling pressure leading to dyspnea on exertion. With an LVEDV exceeding 400-500 ml these factors generally cannot prevent the initiation of the above mentioned vicious circle. Hence, in these severely symptomatic cases LVEDV/RV exceeds the normal range and LVEF becomes markedly depressed. An unfavorable postoperative result must be expected in these patients, while the postoperative result will be good in cases with an LVEDV/RV within the normal range. Hence, we conclude that AVR should ideally be performed in those patients with an EDV exceeding 300 ml, who still have an LVEDV/RV within the normal range, but who show clinical symptoms and/or an only moderately depressed LVEF, indicating that the limits of the compensatory mechanism are reached. The indications for AVR in other conditions characterized by the clinical status, the level of the LVEDV and LVEDV/RV are discussed.

[Stress testing of long-term type I diabetic patients with radionuclide ventriculography]. / Belastungsuntersuchung bei langjährigem Typ-I-Diabetes mit der Radionuklidventrikulographie.

Left ventricular function was assessed by means of radionuclide ventriculography in 42 patients with long-standing (13 +/- 5 yrs) insulin-dependent diabetes mellitus and in eleven healthy age matched control subjects. Only diabetics were included in the study without diabetes related cardiac risk factors such as hypertension and CAD in order to evaluate diabetes specific changes of cardiac function. No differences were seen between diabetics and controls concerning heart rate and functional parameters of left ventricle in systole and diastole. The rapid filling period was not prolonged. According to our radionuclide data there is no evidence of diabetes related impairment of ventricular function in young patients with long-standing type-1-diabetes mellitus.

Differentiation between infarction and cardiomyopathy in left bundle branch block by parametric radionuclide imaging.

In LBBB the diagnosis of the underlying disease, i.e. infarction (MI) or cardiomyopathy (CMP), is still a challenge. In this study, the usefulness of radionuclide ventriculography (RNV) for solving this problem noninvasively was tested. The hypothesis was that quantitation of the space-time sequence of left ventricular (LV) contraction by Fourier analysis may differentiate among MI, CMP, and LBBB-specific wall motion abnormalities (WMA). Forty-seven patients (pts) with LBBB were divided into 3 groups: 1) 20 pts with MI, 2) 7 pts with CMP, 3) 20 pts without MI or CMP. Regional parametric amplitude and phase data of eight LV sectors were calculated and expressed in standard deviation units (SDU) of normal. Out of the many regional data only the values of the mean amplitude and the standard deviation of the mean phase shift showed high discriminative power for separating the three groups, with an average squared canonic correlation of 0.5 and a Wilks lambda of 0.22, respectively. In other words, 17 of 20 pts in group 1, 6 of 7 pts in group 2, and 19 of 20 pts in group 3 were truly diagnosed by RNV alone. Such a separation also seems reasonable physiologically, since the mean amplitude reflects global left ventricular function and standard deviation of phase is a measure of time homogeneity of contraction. Furthermore, there was a significant septal phase delay of -4.92 +/- 5.3 SDU in 15 pts with septal MI compared to group 3 pts, who had a subtle premature septal motion of +0.75 +/- 2.64 SDU, whereas the septal amplitude was not different and slightly decreased in both.(ABSTRACT TRUNCATED AT 250 WORDS)

Relation of pressure and flow of pulmonary circulation in patients with chronic obstructive pulmonary disease.

A series of 31 patients with various degrees of chronic obstructive pulmonary disease underwent right heart catheterization using flow-directed thermodilution catheters. Both rest and supine exercise values were obtained. The patients were divided into two groups on the basis of their reduction in forced expiratory volume in 1 s (FEV1). In patients with FEV1 values of greater than or equal to 1,300 ml (group 1), the arterial oxygen partial pressure (PaO2) did not significantly change with exercise, while in patients with FEV1 of less than or equal to 1,200 ml (group 2) PaO2 significantly (p less than 0.05) fell in response to exercise. In group 2, a significant increase of total pulmonary resistance (TPR) with exercise was found (p less than 0.01). Pulmonary vascular resistance (PVR) remained unchanged in both subgroups. It is suggested that the value of PVR for subgroup 2 is artificially low because an important variable, namely pulmonary artery wedge pressure, is influenced by alveolar pressure in patients with an uneven distribution of perfusion and ventilation at pulmonary venous pressures lower than alveolar pressure. The steeper slope of the pressure-flow relationship in these patients is probably due to an increased vascular tone caused by chronic hypoxia at rest and further fall of PaO2 and rise of arterial CO2 partial pressure in response to exercise.

[Radionuclide ventriculography--a noninvasive method of diagnosis and quantification of tricuspid valve insufficiency]. / Die Radionuklidventrikulographie--eine nichtinvasive Methode zur Diagnose und Quantifizierung der Trikuspidalklappeninsuffizienz.

The diagnosis of tricuspid regurgitation (TR) is difficult to make by simple clinical methods or by invasive techniques. Contrast echocardiography and Doppler echocardiography have improved diagnostic results, but a golden standard is still not available. Radionuclide ventriculography (RNV) is a well-established method for the detection and quantification of a volume load on the left ventricle: the regurgitation fraction can simply be derived from the regurgitant index as the ratio of enddiastolic-endsystolic count-rate differences between the left and right ventricle. In left heart valvular regurgitation a regurgitant index exceeding the upper normal limit can be expected. This study was performed to evaluate the diagnostic accuracy of an abnormally low regurgitant index in detecting TR, which is accompanied by an isolated volume load on the right ventricle. A series of 33 patients with TR on physical examination and cardiac catheterization underwent RNV and was compared with 48 patients with right ventricular enlargement or pressure load on the right ventricle. In addition, the specificity of the method was evaluated in 470 consecutive patients with various forms of heart disease. In 18 out of 20 subjects with isolated TR a regurgitant index below the lower normal limit was found. The remaining 2 cases with minor TR had a regurgitant index within the normal range, which is 0.89 to 1.97 in this laboratory. In patients with additional volume load on the left ventricle, the sensitivity of the method was found to be low, as could be expected from the principle of the method. The time-activity curve over the liver was usually in phase with that recorded over the atria in subjects with TR. Therefore, the additional examination of a region of interest over the liver was particularly useful in these patients with concomitant aortic or mitral valve regurgitation. None of the 48 patients with right ventricular enlargement or pressure load on the right ventricle had a falsely positive result. A total of 17 out of 470 consecutive patients had a regurgitant index below the normal range; left ventricular function was severely impaired in 9 of these patients. The remaining subjects had a regurgitant index slightly below the lower normal limit. In conclusion, RNV has a high sensitivity in the diagnosis of TR in patients without left heart valvular regurgitation and a high specificity in patients without severely impaired left ventricular function and without left-to-right shunt through an atrial septal defect.(ABSTRACT TRUNCATED AT 400 WORDS)

Radionuclide ventriculography and hemodynamic evaluation by right heart catheterization with exercise for assessing the functional significance of coronary artery stenoses. A comparative study.

A series of 13 patients with significant coronary stenoses but without prior myocardial infarction were simultaneously studied by right heart catheterization and radionuclide ventriculography to determine the extent to which abnormal responses in left ventricular ejection fraction and wall motion to maximum exercise are paralleled by abnormal left ventricular filling pressures. The correlations of the filling pressure as evaluated by the diastolic pulmonary artery pressure with both the exercise ejection fraction and the rest-to-exercise change in ejection fraction were high (r = -0.89, P less than 0.01 and r = -0.76, P less than 0.01, respectively). In addition, the filling-pressure response to stress separated the patients into distinct radionuclide categories. All the 7 patients with grossly abnormal filling pressures (P greater than or equal to 30 mmHg) developed regional wall motion abnormalities with exercise as evaluated by visual interpretation or quantitative phase analysis. These patients also had a decrease in ejection fraction from rest to exercise ranging from -9% to -32% together with an exercise ejection fraction below 50%. Conversely, these abnormalities were never found in patients with filling pressures below this threshold level. The data suggest that radionuclide ventriculography and measurement of left ventricular filling pressure with exercise yield corresponding results when assessing the functional significance of coronary stenoses in normotensive patients without prior myocardial infarction and normal global left ventricular function at rest.

Haemodynamic response to exercise in patients with chest pain and normal coronary angiograms.

A series of 42 patients with chest pain but normal coronary angiograms and normal haemodynamics at rest were prospectively classified as typical angina (group 1, N = 9) or atypical angina (group 2, N = 16) or non-anginal chest pain (group 3, N = 17). All patients underwent radionuclide ventriculography and measurement of pulmonary artery pressure at rest and during maximum exercise. Comparison of data during exercise revealed significantly higher (P less than 0.025) left ventricular filing pressures as reflected by the diastolic pulmonary artery pressure in group 1 (29 +/- 5 mmHg) than in both group 2 (22 +/- 6 mmHg) and group 3 (22 +/- 5 mmHg). The rest-to-exercise change in left ventricular ejection fraction was variable and not significant in group 1 (62 +/- 6% vs 63 +/- 14%). By contrast, both group 2 and group 3 had significant increases (63 +/- 6% vs 69 +/- 10%, P less than 0.02 and 63 +/- 5% vs 68 +/- 5%, P less than 0.01). The classification as 'typical angina' was predictive of an abnormal (greater than 25 mmHg) filling-pressure response to stress. The positive and negative predictive values were 78% and 70%, respectively. The clinical classification was not a predictor of an abnormal (delta less than 5%) ejection-fraction response. No correlation between radionuclide and filling-pressure data could be established. The data suggest that the majority of patients assigned to group 1 manifested an impaired left ventricular function with exercise. This was primarily related to abnormalities in diastolic filling while the systolic performance was not consistently depressed.

Interactions of vasodilators with calcium entry- and beta-blockers in patients with coronary heart disease.

Combinations of antianginal drugs may be used for an additive effect against angina, but also to off-set unwanted effects of one drug with another, either by direct effects or by a reduction of dosage of each drug. Based on earlier studies with separate drugs we have now examined the effect of 150 mg bupranolol combined with 40 mg isosorbide dinitrate (ISDN) in one retarded tablet, given twice daily. 22 patients with CHD entered the study, 11 of those with and 11 without signs of ischemia during exercise. In an acute radionuclide ventriculographic (RNV) study 2 h after the tablet, ejection fraction (EF) during exercise increased only in patients with exercise ischemia (+6%, p less than 0.001). In the other patients EF did not change. After 21 days of treatment echocardiographically determined end-systolic and end-diastolic diameters decreased, resulting in an increase of shortening fraction by 15.6% (p less than 0.05). Heart rate, systolic and diastolic pressure and ST-segment depression decreased significantly. In another acute RNV study the effect of a venous vasodilator, molsidomine 4 mg s.l., was examined after nifedipine 10 mg s.l. in 19 patients with CHD, 9 with and 10 without exercise ischemia. Differences between drugs were most prominent during exercise. In the nonischemic group EF rose by 6.6% after nifedipine (n.s.) and by 14% after molsidomine (p less than 0.01 against control). In the group with ischemia EF rose by 12.6% after nifedipine and by 17.4% after additional molsidomine, significant against control (p less than 0.01) as well as against nifedipine (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Limitations of radionuclide ventriculography in the non-invasive diagnosis of coronary artery disease. A correlation with right heart haemodynamic values during exercise.

A consecutive series of 56 patients with chest pain but no evidence of previous myocardial infarction was prospectively studied by radionuclide ventriculography to determine the value of global and regional radionuclide indices in detecting coronary artery disease. The results were correlated with the clinical judgment of chest pain, the results of the exercise electrocardiogram, and the right heart haemodynamic measurements during exercise. As a result of the criteria for entry, the study group was representative of the population seen in such a clinical setting. Only 25% of patients had coronary artery disease. The predictive power of radionuclide ventriculography was limited. The conventionally used criterion that normal subjects have an increase in left ventricular ejection fraction of at least 5% with exercise provided only 78% sensitivity and 57% specificity. Fourier analysis and visual interpretation of radionuclide studies wrongly diagnosed three out of 10 patients with extensive disease requiring surgery. These results suggest that radionuclide ventriculography is of limited value in the non-invasive diagnosis of coronary artery disease.