Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI) : Joint Consensus Document of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V. (ALKK) and cooperating Cardiac Surgery Departments.

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4-8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement). The ESC (European Society of Cardiology)/EACTS (European Association for Cardio-Thoracic Surgery) guidelines 2017 and the German DGK (Deutsche Gesellschaft für Kardiologie)/DGTHG (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie) commentary 2018 offer a framework for the selection of the best therapeutic method, but the individual decision is left to the discretion of the heart teams. An interdisciplinary TAVI consensus group of interventional cardiologists of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V.) and cardiac surgeons has developed a detailed consensus on the indications for TF-TAVI to provide an up-to-date, evidence-based, comprehensive decision matrix for daily practice. The matrix of indication criteria includes age, risk scores, contraindications against SAVR (e.g., porcelain aorta), cardiovascular criteria pro TAVI, additional criteria pro TAVI (e.g., frailty, comorbidities, organ dysfunction), contraindications against TAVI (e.g., endocarditis) and cardiovascular criteria pro SAVR (e.g., bicuspid valve anatomy). This interdisciplinary consensus may provide orientation to heart teams for individual TAVI-indication decisions. Future adaptations according to evolving medical evidence are to be expected. Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI).

Mechanical circulatory support and heart transplantation.

Mechanical circulatory support systems are currently in clinical use to keep patients alive with the aim of either cardiac recovery after open heart surgery, myocardial infarction and after heart transplantation with acute graft failure, or as a bridge to transplantation in heart transplant candidates. At the German Heart Institute the "Berlin Heart" mechanical circulatory support system has been used invariably since 1987. Up to 1991 there were 22 patients in the "recovery" group. Four patients could be weaned from the system, but only one patient was discharged from the hospital. In 65 patients mechanical circulatory support systems were implanted as a bridge to transplantation, 39 patients had transplants, and 22 patients left the hospital. Risk factor analysis in the bridging group revealed that previous heart surgery, infective pneumonia, shock-related coagulation disorders, and an age greater than 50 years had an unfavorable influence on patient survival. It is concluded that patients may be kept alive for weeks and months after any kind of cardiogenic shock. Complete cardiac recovery may be achieved in the case of early posttransplant graft failure. Reliable prediction of outcome in the bridge to transplantation group requires further experience.

Recovery of end-organ failure during mechanical circulatory support.

To evaluate organ recovery during mechanical assistance, respiratory, hepatic and renal function parameters of 40 patients who underwent bridge-to-transplant procedures were reviewed retrospectively. Mechanical circulatory support was indicated if the hemodynamic and clinical status deteriorated despite pharmacotherapy with catecholamines, vasodilators, and intravenous use of the phosphodiesterase inhibitor enoximone. Sequelae of cardiogenic shock such as renal, hepatic and respiratory insufficiency were not considered a contraindication for mechanical support. The analysis of preimplant data such as serum creatinine, liver enzymes and pulmonary gas exchange did not identify any predictive indicator of irreversible organ damage. Functional recovery of preexisting respiratory, hepatic and renal dysfunction was found in 91%, 90%, and 85%, respectively. Subsequent transplantation, however, was affected by the number of failing organs prior to mechanical support. Of 17 patients with isolated organ failure prior to assist, 14 (82%) were transplanted. By contrast, 9 (75%) of 12 with combined failure of two organs, and only 6 (54%) of 11 patients with clinical patterns of three failing organ systems received transplants. In all patients who underwent successful transplantation, transplantability was associated with rapid organ recovery within 10 to 15 days after initiating mechanical assistance.

Enoximone in newborns with refractory postoperative low-output states (LOS).

Enoximone was administered to 16 newborns with postoperative, catecholamine-refractory cardiac low-output states in addition to high-dose catecholamine treatment. Haemodynamic changes were assessed at baseline and during treatment. Haemodynamic parameters were improved in 12 newborns ("responders"), 9 of these survived. Three responders died; one from cardiac low-output and 2 from uncorrectable congenital heart disease verified by autopsy. Four newborns did not respond to enoximone therapy ("non-responders") and died. The haemodynamic effects of enoximone were characterized by an increase in cardiac index (+160%, P less than 0.0008), and a fall in right (-26%, P less than 0.0004) and left (-34%, P less than 0.003) atrial pressures. It is concluded that enoximone can be an effective agent in the treatment of cardiac low-output states refractory to high-dose catecholamines in neonates up to 7 months old.

Mechanical circulatory support and heart transplantation. Pre-operative status and outcome.

Between July 1988 and December 1993, 118 patients waiting for heart transplantation underwent mechanical circulatory support by an extracorporeal, pneumatically driven assist device (the Berlin Heart System) to maintain a sufficient circulation and to restore impaired organ function (109 patients requiring a biventricular assist device [BVAD], 9 patients requiring a left ventricular assist device [LVAD]). Before implantation, all patients were in severe cardiogenic shock, despite maximum inotropic support; all had end organ failure. The aim of a retrospective study in 70 patients (for whom pre-operative parameters were available) was to identify patients who would permit from this procedure and could undergo successful transplantation. After a mean bridging time of 34.8 days, 75 (63.5%) patients underwent transplant, and 52 (44.1%) were discharged. Pre-operative coagulation parameters (fibrinogen, antithrombin III, platelet count, and kinetics) were correlated to post-operative blood loss and outcome. Patients who had no or mild coagulation disorders because of a shorter phase of low cardiac output before implantation of the assist device proved to gain faster restitution of organ function and most underwent transplantation. As a result of these observations, implantation of an assist device before shock-induced coagulopathy could occur allowed a greater number of patients to undergo successful bridging and be discharged after heart transplantation.

Effects of the Berlin Heart biventricular assist device on microvascular responses in pre-transplant patients.

Microcirculatory forearm cutaneous blood flow was monitored continuously and noninvasively by laser doppler flow-metry (LDF) in 15 patients treated with the Berlin Heart biventricular assist device system (BVAD) for end-stage heart failure under stable hemodynamic states (BVAD pts, n = 10) and norepinephrine therapy (BVAD nor pts, n = 5). Ten healthy human subjects served as controls (C). Cutaneous blood flow was measured before, during, and after external brachial artery occlusion to evaluate the post-occlusive reactive hyperemia (PORH) as a standardized response. To examine microvascular responses to macrohemodynamic changes, the cardiac output (CO) was decreased by a 20% reduction in BVAD pump rate. No significant differences in baseline LDF measurements (in millivolts) were observed among the three groups (C, 470.7 mV +/- 177.3; BVAD pts, 328.0 mV +/- 122.7; BVAD nor pts, 360.0 mV +/- 160.0). After cuff pressure release (1 min later), a significant (p < 0.004) three-fold to four-fold blood flow increase (PORH) occurred in each group (C, 1113.6 mV +/- 469.2; BVAD pts, 813.0 mV +/- 190.1; BVAD nor pts, 498.0 mV +/- 191.8). The difference in PORH between the BVAD pts and BVAD nor pts was significant (p < 0.01), and the time to peak PORH values was different (p < 0.05) among the three groups (C, 22.2 s +/- 10.7; BVAD pts, 11.3 s +/- 12.5; BVAD nor pts, 7.0 s +/- 5.8). A markedly delayed return to baseline occurred in the BVAD pts. The 20% reduction in BVAD pump rate decreased CO significantly (p < 0.05) and increased (p < 0.01) systemic vascular resistance (SVR).(ABSTRACT TRUNCATED AT 250 WORDS)

Patient selection for mechanical circulatory support as a bridge to cardiac transplantation.

Between 7/87 and 9/90 thirty-four patients underwent total artificial heart (Berlin Heart) (n = 2) or biventricular assist device (Berlin Heart) (n = 32) implantation as a bridge to cardiac transplantation. The time of mechanical support ranged from 2 to 60 days, for a mean of 19.2 days. Twenty-three patients received heart transplants, with 74% 30-day survival and 52% long-term survival. Implantation of a mechanical support system became indicated in those patients whose hemodynamic and clinical condition deteriorated despite treatment with enoximone in addition to maximal sympathomimetic medication. The strategy to administer enoximone routinely was the result of a prospective study on 24 pretransplant patients in whom enoximone therapy reduced the need for mechanical assistance by 62%. At the time of device implantation shock-related organ impairment such as cerebral, renal, hepatic, and respiratory dysfunction was present in 62% of patients. In addition, 7 patients had pneumonia. During mechanical support complete recovery of end-organ failure and resolution of pneumonia was observed in the majority of patients. The results indicate that end-organ dysfunction per se should not be considered a contraindication to mechanical circulatory support as a bridge to cardiac transplantation. However, further clinical investigations are needed to identify predictive indicators of irreversible organ damage.

Skin microcirculation and laser Doppler blood flow in patients supported by the Berlin heart biventricular assist device.

Microcirculatory forearm cutaneous blood flow was monitored continuously and non-invasively by laser-doppler-flowmetry (LDF) in 10 patients treated with the Berlin Heart biventricular assist device (BVAD) system for end-stage heart failure (BVAD-pts). Ten normal human subjects served as controls (C). The cutaneous blood flow was measured before, during, and after external brachial artery occlusion to evaluate the postocclusive reactive hyperemia (PORH) as a standardized response. To examine micro-vasculatory responses to macro-hemodynamic changes the cardiac output (CO) was decreased by reducing the BVAD-pump rate by 20%. No significant differences in base-line LDF measurements were ascertained in the two groups. After sudden cuff pressure release (1 min later) a statistically significant (p less than 0.004) three- to fourfold blood flow increase (PORH) occurred in both groups. The period of the PORH response was altered in all BVAD-pts. The time to peak PORH values were significantly diminished (p less than 0.05) A markedly delayed return to base-line level occurred in the BVAD-pts. The 20% reduction in the BVAD-pump rate significantly decreased CO (p 0.05) and increased systemic vascular resistance (SVR) (p less than 0.01), whereas LDF levels remained unchanged.

[Attempt at classification in patients with peritonitis--evaluation of 53 patients]. / Versuch einer Klassifizierung bei Patienten mit Peritonitis--Auswertung bei 53 Patienten.

Classification is necessary when comparing and judging the results of the treatment of patients with peritonitis. Staging of peritonitis was developed according to interoperative findings. The spreading and age of peritonitis has been considered when contemplating further operative management. In order to judge the general clinical picture, a grading of severity into three groups, using a point scheme, was developed. 22 patients with localised peritonitis in an advanced stage received a closed peritoneal lavage. 31 patients with generalised peritonitis received continual open dorsoventral peritoneal lavage.

[Detectability of pulmonary coin lesions: a comparative assessment of the image quality of a storage phosphor system and a conventional film screen system]. / Erkennbarkeit von Lungenrundherden: Vergleichende Beurteilung der Bildqualität von Speicherleucht-stoffolien mit einem konventionellen Film-Foliensystem.

The object of this study was to compare the prototype of a storage phosphor digital radiography system (Siemens) which allows postprocessing image data adjustment with the stored information, with an optimised conventional film system with respect of image quality and diagnostic accuracy. The test objects were pulmonary coin lesions as the search for primary or secondary lung tumours is one of the most frequent clinical requests and the detectability of coin lesions depends very much on their relative contrast against the surrounding area. In order to achieve reproducible results, an anthropomorphic lung phantom was used. Besides the conventional film radiograms the unprocessed digital radiograms and twelve series with variations of the processing parameters were evaluated. To achieve a homogeneous radiation image an anatomically shaped lead-loaded acrylic glass compensation filter was used. With regard to the true-positive demonstration of coin lesions there were no significant differences between the chosen film system and all digital radiograms. Image processing had no recognisable influence on the demonstration of the findings. Coin lesions of 3 mm diameter were detected only by chance; the detectability of lesions of 5 mm and 10 mm in diameter respectively depended mainly on their localisation. Lesions of 15 mm diameter were detected independent of their localisation. The results indicate that the storage phosphorus radiography system is already comparable to an optimised conventional film system concerning the conspicuity of coin lesions. If the image is homogenised by means of an anatomically shaped lead-loaded acrylic glass compensation filter, selective postprocessing adjustment of the digital radiograms for the evaluation of the mediastinum or the lung parenchyma is unnecessary.

The use of dopexamine after cardiac surgery: acute and long-term effects in patients with impaired cardiac function.

The haemodynamic efficacy of dopexamine, a beta 2-adrenergic agonist with dopaminergic activity, was evaluated during dosetitration and longterm infusion in 20 cardiosurgical patients with low cardiac output following coronary artery bypass grafting and/or valve replacement or repair. After infusion of four doses (1, 2, 4, and 6 micrograms/kg/min), the dose producing the optimal response was administered for up to 36 h. Dopexamine infusion resulted in a dose-dependent significant increase in cardiac index (CI: 2.2-->3.3 L/min/m2) associated with a marked reduction of systemic vascular resistance (SVR: 1820-->1144 dyn.sec.cm-5). Heart rate increased significantly (HR: 89-->117 beats/min), while mean arterial blood pressure remained unchanged (MAP: 94-->89 mmHg). Unwanted effects (tachycardia and hypotension) were chiefly seen at higher doses (-->4 micrograms/kg/min). The beneficial haemodynamic effects were well maintained during the extended infusion period up to 36 hours at a mean dopexamine dose of 2.8 micrograms/kg/min. At these low doses, the positive chronotropic response to the drug remained within the limits of clinical acceptability. During long-term infusion up to 36 hours there was no indication of tolerance or an effect attenuation. It can be concluded that dopexamine acting as "inodilator" with dopaminergic properties is an useful adjunct to the pharmacological spectrum in the management of low-output states following cardiac surgery.

[Enoximone as pharmacologic "bridging" to heart transplantation]. / Enoximon als pharmakologisches "bridging" zur Herztransplantation.

The efficacy of enoximone (EN), a new phosphodiesterase inhibitor, was studied in 24 patients (pts.) with end-stage cardiac disease due to dilative cardiomyopathy (21 pts.) or coronary heart disease (3 pts.). All pts. admitted for urgent transplantation or mechanical circulatory support demonstrated advanced cardiac failure unresponsive to conventional pharmacotherapy. Despite maximal catecholamine and vasodilator therapy the cardiac index averaged 2.08 l/min per m2, the pulmonary capillary wedge pressure (PCWP) 24 mmHg, and the systemic vascular resistance (SVR) 1450 dyn* s* cm-5. In addition to the previous sympathomimetic medication EN was administered as a bolus injection of 1 mg/kg followed by a continuous infusion of 4 to 10 micrograms/kg/min. In all but 4 non-responding pts., who eventually died, clinical and hemodynamic conditions improved significantly within 4 h: CI increased from 2.08 to 3.1 l/min/m2, PCWP dropped from 24 to 17 mmHg, and SVR decreased from 1450 to 950 dyn* s* cm-5 (all p less than 0.05). After initial improvement, 9 pts. experienced acute hemodynamic and clinical deterioration leading to implantation of a biventricular-assist device (Berlin Heart) in 6 pts., while 3 pts. died of irreversible cardiogenic shock. However, of the remaining 15 pts., who demonstrated sustained hemodynamic improvement, 11 could be weaned off their adrenergic medication and remained on oral EN (1.0 to 1.5 mg/kg TID). Three pts. received heart transplants within 8 to 12 weeks; 7 pts. were still on the waiting list at the end of the study, and 1 pt. died after withdrawal of oral EN.2

Effect of antrectomy on small intestinal structure and function in the rat.

Antrectomy reduced the levels of circulating gastrin but did not change jejunal morphology. In vitro and in vivo absorption as well as the activity of some brush border enzymes were increased. The observed alterations are discussed on the basis of antrectomy-induced alterations in the release of gastrointestinal hormones, gastric and pancreatic secretion and gastric emptying.

[Heart transplantation--indications and results]. / Herztransplantation--Indikation und Ergebnisse.

Heart transplantation has become a standard procedure in the treatment for irreversible heart failure. Criteria for both recipients and donors have been extended. One year survival now reaches 81%. In the immediate postoperative course patients are endangered by infection. In the long-term course coronary artery disease of the transplanted heart becomes the most serious problem. Alteration of liver and kidney function due to chronic medication as well as malignancies and hypertension also occur. In case of chronic transplant failure retransplantation may be indicated. Acute cardiac failure before transplantation nowerdays can be treated by mechanical circulatory assist devices.

Haemodynamic effects of different doses of dopexamine hydrochloride in low cardiac output states following cardiac surgery.

We studied the haemodynamic effects of dopexamine hydrochloride, a beta 2-adrenergic agonist with dopaminergic (DA1) activity, in 20 patients with low cardiac output following surgery for coronary artery bypass grafting and/or valve replacement or repair. Following titration of four doses (1, 2, 4 and 6 micrograms.kg-1.min-1), the dose producing the optimal response was infused for up to 48 h (five patients). During the infusion, significant increases in cardiac index and stroke volume were accompanied by significant decreases in systemic vascular resistance. Heart rate increased significantly up to 6 h and thereafter returned to control levels. Mean blood pressure was reduced but did not fall below 60 mmHg. However, in five patients treated for 48 h mean blood pressure had returned to control levels. Unwanted effects (tachycardia and hypotension) were seen chiefly at higher doses, leading us to conclude that infusion rates of 4 micrograms.kg-1.min-1 or less will be useful in the treatment of low cardiac output following cardiac surgery.

[Progress in heart transplantation]. / Fortschritte in der Herztransplantation.

Within the past 10 years, heart transplantation has become established as a standard procedure in heart surgery. Improvements in immunosuppressive therapy and diagnosis of graft rejection have been crucial. The criteria for transplantation have been broadened for recipients as well as for donors. Newborns, pediatric patients, diabetics, and patients with impaired renal function will no longer be excluded from transplantation due to improved postoperative therapy. Furthermore, progress has been made with assisted circulation. Patients with acute heart failure can now be bridged to transplantation.

Clinical use of the Berlin Biventricular Assist Device as a bridge to transplantation.

The Berlin Artificial Heart System/Biventricular Assist Device (BVAD) was used in 38 patients. 1) Twenty-eight patients were awaiting cardiac transplantation (Tx) (age 23-56 yrs). All patients had contraindications not allowing immediate Tx. 2) Five patients were emergency cases not on our Tx list (postcardiotomy cardiac failure, acute myocarditis) (age 28-59). 3) Five patients were post Tx patients with graft failure (age 22-52). Extracorporal circulation was used for implantation of the BVAD. In group 1, 21 of 28 patients (pts) recovered, and all were subsequently transplanted after 6 hours to 39 days, when all organ function was restored. In 7 pts, mechanical circulation was terminated after 1-40 days because of further deterioration. Five of the transplanted pts died, 14 pts survived (greater than 30 days), and 2 pts were just transplanted with satisfactory postoperative courses. Of group 2 and 3 pts, two were successfully weaned. In one patient the allograft recovered after 11 days of support.

Heart transplantation in Berlin--1993 update.

Heart transplantation has become a routine procedure. Surgical techniques have been standardized and triple-drug immunosuppression has proven to be the most effective posttransplantation medical treatment. A shortage of donor organs has remained the major factor inhibiting extensive application of heart transplantation. Improved techniques of organ protection may eventually contribute to an extension of the donor pool. However, it seems to be more important to develop alternative procedures further (artificial heart, xenotransplantation, extended use of conservative surgical or medical treatment). The patient population undergoing heart transplantation will undoubtedly include more older, severely ill, polymorbid patients who are not suitable for alternative procedures. Pediatric heart transplantation may increase in the coming years and mechanical circulatory support will surely gain in importance for both adult and pediatric patients awaiting heart transplantation.

Significance of computed tomography for shock-wave therapy of radiolucent gallbladder stones.

One hundred eleven symptomatic patients (91 women, 20 men) with solitary "radiolucent" stones (proved by a plain radiograph) underwent examination with computed tomography for stone analysis before extracorporeal shock-wave lithotripsy with a second-generation piezoelectric lithoptripter. The aim of the study was to assess the importance of computed tomography as a diagnostic pretreatment procedure compared with the plain abdominal radiograph: computed tomography density values greater than 50 Hounsfield units (HU) were found in 64 of 111 patients with radiolucent stones (58%). Of these 64, 50 patients even had values greater than 90 HU (50/111;45%). The majority of the stones with density values greater than 50 HU had a hyperdense rim (43 of 64) with a mean maximum attenuation of 134 +/- 68 HU. A significantly higher degree of stone disintegration was achieved with stones of group A (less than or equal to 50 HU) than with those in group B (greater than 50 HU and less than or equal to 90 HU) and group C (greater than 90 HU) with respect to the mean maximum fragment size after the first (P less than 0.001) and last (P less than 0.01) lithotripsy and with respect to the total number of shock waves applied (P less than 0.001) and the number of treatments (P less than 0.001). No difference was observed between groups B and C. After all follow-up periods, the rate of complete stone disappearance was higher in group A than in group B (NS for 1, 2, and 4 months of follow-up; P less than 0.01 for month 8; P less than 0.05 for month 12) and group C (P less than 0.05 for 1, 2, and 4 months of follow-up; P less than 0.001 for months 8 and 12). The authors conclude that computed tomographic analysis of gallstones before lithotripsy is more sensitive in detecting nonradiolucent stones than in the plain radiograph. Computed tomographic stone analysis seems to provide a better selection of patients suitable for biliary lithotripsy and could become a standard diagnostic pretreatment procedure to improve stone disintegration and complete stone disappearance after shock-wave lithotripsy and adjuvant chemolitholysis.