[Innovations in cardiology. We are too fast with new methods]. / Innovationen in der Herzmedizin. Wir sind zu schnell mit neuen Methoden.

Cardiology is rapidly developing on many levels. New treatment methods are introduced at ever decreasing intervals. Against the background of economization of other areas in medicine, dangers are lurking here for patients if safety, usefulness and sustainability of the treatment methods cannot be sufficiently proven. The German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) aims to adjust the regulatory framework for the approval of new medical products to the legal requirements of the European Union. With the establishment of the Institute for Quality Assessment and Transparency in Health Care (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen, IQTIG) more precise quality controls should be carried out. Implantation registers will be soon implemented and the routinely performed quality control of different interventions will be coordinated across different healthcare sectors in order to achieve a better understanding of long-term results. Medicine in general and the safety of patients in particular, ultimately benefit from more stringent controls, neutrality and transparency in the assessment of new methods.

[Basic standards for a department of cardiac surgery. Quality requirements for the care of cardiac patients in connection with operations on the heart, the heart vessels and thoracic organ transplantation]. / Basisstandards einer Fachabteilung für Herzchirurgie. Qualitätsanforderungen für die Versorgung von herzkranken Patientinnen und Patienten im Zusammenhang mit Operationen/Eingriffen am Herzen, den herznahen Gefäßen und der thorakalen Organtransplantation.

Current evolutions and substantial amendments of the German health care system in combination with distinguished progress in cardiac surgery over the past years require both a reflection of principles in patient-centered care and an update of basic standard requirements for a department of cardiac surgery in Germany. In due consideration of the data from the voluntary registry of the German Society for Thoracic and Cardiovascular Surgery, this article accurately defines core requirements for a cardiac surgical department (cardiac surgery on-site), subdivided into facilities, staff and processes. If based on these standards, one may anticipate that cardiac surgical care is performed under appropriate conditions leading to an intrinsic benefit for patients.

Ascending-to-descending bypass for simultaneous surgery of aortic coarctation with other cardiac pathologies.

BACKGROUND: The appropriate approach for aortic coarctation associated with other cardiac diseases necessitating surgery is still controversial. The aim of this study was to evaluate the results after simultaneous surgery performed via median sternotomy and consisting of extra-anatomical ascending-to-descending aortic bypass and various other cardiac procedures. METHODS: Between January 1999 and February 2009, 13 consecutive patients with aortic coarctation coexistent with other cardiac diseases necessitating surgery underwent simultaneous surgery via median sternotomy. An extra-anatomical ascending-to-descending aortic bypass for coarctation repair was performed in all patients accompanied by various cardiac procedures (5 aortic root and valve replacement; 2 aortic valve replacement; 2 coronary artery bypass grafting; 2 mitral valve repair; 1 aortic valve replacement and coronary artery bypass grafting; 1 mitral and tricuspid valve repair). There were 3 women and 10 men with a mean age of 52 years (range 25-69). Two patients had recurrent or residual coarctation 37 and 46 years after previous surgical repair, respectively. RESULTS: Early mortality was 0 and there was only 1 late death during the follow-up of up to 11 years. New York Heart Association (NYHA) functional class improved on average from 2.4 to 1.2. At the last follow-up, blood pressure measured at the upper and lower extremities showed no gradient in any patient, indicating a durable function of the extra-anatomical bypass. Only 3 patients were on reduced antihypertensive therapy; 8 patients were on the same medication and 1 patient required increased medication therapy compared with the medication prior to surgery. CONCLUSIONS: Ascending-to-descending bypass can be performed via median sternotomy simultaneously with various cardiac procedures without considerable extension of the procedure. The operative and long-term results are excellent, and this approach can be recommended as the procedure of choice in patients with aortic coarctation and additional cardiac diseases necessitating surgery.

Clinical outcome and quality of life after interventional treatment of left main disease with drug-eluting-stents in comparison to CABG in elderly and younger patients.

INTRODUCTION: The aim of this study was to prospectively assess the clinical outcome and quality of life of elderly patients who underwent either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for treatment of significant left main disease (LMD) compared to a younger patient population. METHODS: Consecutive patients, admitted into our institution between 04/2004 and 12/2007 with LMD and a life expectancy of >1 year were prospectively included and stratified in two groups (either CABG or left main stenting [LMS] with DES) based on the patients' age at inclusion (> or ≤75 years). Rates of death, myocardial infarction (MI), stroke, and target lesion revascularization (TLR) were evaluated over a 12 month follow-up. Six months after the initial procedure, additionally, quality of life was assessed using the SF-36 questionnaire. RESULTS: A total of 300 patients was included; 56 of the 95 PCI patients (59%) were ≤75 years and 39 (44%) >75 years, whereas 155 of 205 patients in the CABG group were ≤75 years (76%), and 50 patients (24%) were >75 years. Mean follow-up was 312 ± 226 days in the PCI and 377 ± 286 in the CABG group. Rates of death and MI were not significantly different between the four groups at the end of follow-up. There was no difference in quality of life after 6 months. CONCLUSION: In this prospective trial, PCI of LM with DES in elderly patients was feasible with a short- and intermediate term outcome comparable to CABG procedure and to a younger patient cohort.

Foreign material reaction to BioGlue® as a possible cause of cardiac tamponade.

We describe the case of a 65-year-old female patient who underwent aortic valve reconstruction for aortic valve stenosis. During the operation, repair of a left ventricular laceration produced by a left ventricular vent was necessary. BioGlue® (CryoLife, Atlanta, GA, USA) and pledgeted sutures were used for repair. Pericardial effusion with signs of cardiac tamponade developed five months later. The patient was treated successfully by the removal of all foreign material and part of the BioGlue®. Microbiological findings were sterile. Histology showed a chronic granulomatous inflammatory response suggesting a foreign material reaction to BioGlue® as the cause of the effusion. Though all visible material was removed, the risk of pericardial effusion still persists as part of the BioGlue® remained within the ventricular wall.

Use of a carotid artery for arterial cannulation: side-related differences.

BACKGROUND: Cannulation of arch arteries (innominate, axillary or carotid) for arterial return during cardiopulmonary bypass is increasingly being used; however, the flow and pressure profile in the cannulated arteries remains unclear. The aim of this study was to evaluate the flow and pressure characteristics of arterial inflow through a carotid artery, especially with regard to operative and technical aspects, clinical outcomes, and side-related differences. METHODS: Between January 2005 and April 2008, 200 consecutive patients underwent elective aortic arch surgery at our facility. One hundred patients were assigned to undergo cannulation of the left and another 100 to undergo cannulation of the right carotid artery. Both groups were similar in terms of age, sex, and type of surgery. In all patients, arterial return was through a side-graft anastomosed to the carotid artery. The arterial line was also used for unilateral cerebral perfusion for brain protection during mild hypothermic circulatory arrest. The flow and pressure profiles in the arterial line and in the carotid artery were evaluated with regard to cardiopulmonary bypass flow rate and side of cannulation. RESULTS: No complications related to the cannulation of a carotid artery were observed. The arterial return was adequate in all patients, regardless of the side being cannulated. Because of low resistance (mean pressure<50 mmHg) in the carotid artery proximal to the inflow side-graft, the flow toward the aortic arch averaged 87+/-2% (range 84.4-92%) of the total flow volume (4.6+/-0.5 L/min), without a significant difference between the sides. However, the perfusion pressure in the arterial line was significantly higher when the left carotid artery was cannulated (216+/-30 mmHg vs. 205+/-30 mmHg; P=0.013). There was also a significant difference in the pressure in the distal carotid arteries, which, compared to the systolic blood pressure prior to cardiopulmonary bypass, increased by 30+/-24 mmHg on the left and decreased by 16+/-21 mmHg on the right (P<0.001). CONCLUSIONS: Both common carotid arteries are suitable for arterial cannulation; however, left-sided cannulation is associated with an increase in the pressure profile. Therefore, if vascular pathology does not dictate cannulation of the left carotid artery, the right carotid artery should be considered the site of choice.

Contained rupture of the aorta in acute Stanford type A aortic dissection causing right ventricular wall dissection.

We describe a rare case of an acute aortic type A dissection after previous aortic valve replacement and coronary artery revascularization complicated by a contained rupture and right ventricular wall dissection. Although preoperatively echocardiography and CT scan described a pericardial hematoma, intraoperatively no intrapericardial hematoma was found; instead an extended right ventricular wall dissection caused by a large thrombus formation within the right ventricular muscle layers was demonstrated. After replacement of the ascending aorta and removal of the thrombus as the sole treatment for right ventricular wall dissection, the two dissected layers of the right ventricular wall were contracting synchronously again.

[Surgical ablation therapy - lessons learned]. / Chirurgische Therapie bei Vorhofflimmern : Vermeidung von Komplikationen.

Atrial fibrillation (AF) is the most frequent sustained arrhythmia affecting more than 5% of the population above 65 years resulting in loss in quality of life and life expectancy. Since the introduction of the MAZE procedure, an increasing number of surgical approaches have been implemented for the treatment of AF. During past years a variety of devices such as application of unipolar and bipolar radiofrequency, cryothermal therapy, microwave, laser and ultrasound have been described. All new methods have undergone thorough evaluations; in that course technical systems have been re-designed and surgical approaches were modified. Before reaching a widespread clinical application a thorough analysis in terms of therapeutic benefit and possible complications is required. Several reports have reported success rates leading to reinstitution of atrial rhythm in 60 to 80% of the patients treated. However, there is no overview on possible complications using surgical ablation therapy. In this report we have focused on different energy sources, time of occurrence of postoperative arrhythmias, patient's symptoms and related diagnostic processes. Various published reports of surgical ablation therapy were evaluated with regard to complications that have occurred. In addition, our own extensive experience was considered as well.

The role of SOAT-1 polymorphisms in cognitive decline and delirium after bypass heart surgery.

BACKGROUND: Cognitive decline (CD) and delirium (PD) are commonly observed complications after bypass heart surgery. In this study we aimed to investigate whether certain genetic factors (alleles of the SOAT-1 gene) play a role in their appearance. PATIENTS AND METHODS: We examined 137 patients receiving coronary bypass surgery with a neuropsychiatric test battery consisting of the Mini Mental State Examination (MMSE), the Brief Psychiatric Rating Scale (BPRS), the Wechsler's Memory Scale-Revised (WMS-R) on admission and one month after surgery, and the Delirium Rating Scale postoperatively, when indicated, and genotyped them in relation to the SOAT-1 genotypes (AA positive group with augmented protection of the nerve cells against stress and the AA negative group--AC and CC subgroups--with diminished protection against stress). RESULTS: We noted a significant decline in test results postoperatively and a high frequency of delirium (29.92% of the patients). None of these complications could be associated to the SOAT-1 genotypes. CONCLUSIONS: Our study confirmed the expected cognitive decline and highly frequent delirium after bypass heart surgery and excluded the possible role of SOAT-1 genotype polymorphisms in their genesis.

Aortic valve leaflet reconstruction after excision of a papillary fibroelastoma using autologous pericardium.

We report on a case of a rare tumor attached to the nodulus arantii of the left coronary cusp in a 56-year-old female patient. She was referred to our institution for a non-ST elevation myocardial infarction after a troponin-positive test. Diagnosis was made by echocardiography and confirmed by surgery. After complete surgical removal of the tumor, we reconstructed the left coronary cusp with autologous pericardium. Aortic valve cusp coaptation could be completely restored. Histology revealed the diagnosis of a papillary fibroelastoma.

Mediastinitis and cardiac surgery--an updated risk factor analysis in 10,373 consecutive adult patients.

BACKGROUND: Deep sternal wound infection (DSWI) remains a serious complication after cardiac surgery. New evolving techniques including the utilization of internal mammary arteries (IMA), beating heart procedures, and minimal invasive surgery (MIC) require an updated risk factor analysis to identify high risk patients in order to improve perioperative treatment. METHODS: 10,373 consecutive patients receiving cardiac surgery between May 1996 and August 1999 were evaluated: 9,303 underwent full sternotomy whereas a minimally invasive (MIC) approach using partial sternotomy or lateral thoracotomy was used in 1,070 patients. DSWI was defined as the evidence of mediastinitis seen at reoperation along with one or more of the following: positive culture of mediastinal fluid, positive blood culture or temperature higher than 38 degrees C and/or leukocytosis. RESULTS: The overall incidence of DSWI in the "full sternotomy" group was 1.44 % (134 of 9,303). Univariate risk factor analysis showed a significant influence of IMA use, ICU / IC treatment > 5 days, postoperative ventilator time > or = 72 h, need for reexploration, diabetes, surgery time > or = 180 min, assist device implantation (including use of IABP), peripheral vascular disease and increased body mass index. Multivariate analysis identified double IMA, ICU treatment > 5 days, single IMA, diabetes, reexploration and increased body mass as significant risk factors. No mediastinitis was observed in the MIC group. CONCLUSION: As DSWI is related to sternotomy, a MIC approach should be considered for patients at high risk for DSWI. IMA takedown as a pedicled graft should be especially avoided in patients with diabetes since the risk for postoperative mediastinitis is unacceptably high in this patient group.

A new intracardiac microaxial pump: first results of a multicenter study.

As coronary artery bypass grafting (CABG) surgery in the beating heart technique is progressing, new devices have been developed to overcome hemodynamic instabilities while tilting the heart for exposure of back wall vessels. A new device for in heart biventricular intracorporeal circulation was applied in 42 patients undergoing CABG surgery (Group 1). The control group consisted of 38 patients operated on using a conventional cardiopulmonary bypass setup (Group 2). The study protocol of the prospective, randomized multicenter study was approved by the local ethics committees. Patients were included following inclusion criteria and patient informed consent. Mean age, procedure time, mean arterial pressure (MAP), and hemolysis by means of plasma free hemoglobin (fHb) were assessed preoperatively, perioperatively, on postoperative Days 1 to 3, at discharge, and at a 3 month follow-up. The mean age was 62.1 (range 59-74) years (Group 1), 62.7 (range 48-72) years (Group 2); procedure time was 112 min +/- 31.9 min (Group 1), 137.4 min +/- 36.2 min (Group 2); and 2.3 +/- 0.6 (Group 1), 2.2 +/- 0.7 (Group 2), vessels were revascularized. The flow on pump was 3.7 (2.5/4.4) L/min (Group 1), 4.9 (3.6/6.2) L/min (Group 2) which resulted in a MAP of 69.8 (4.0/143) mm Hg (Group 1), 58.3 (5.3/94) mm Hg while assessing the vessels of the back wall. Hemolysis defined by fHB was lower than 20 mg/dl at all times pre- and postoperatively. Intraoperative maximum values were up to 100 mg/dl in 4 patients (2 in Group 1 and 2 in Group 2). Body mass index was 26.4 +/- 2.6 (Group 1), 27.9 +/- 3.2. New York Heart Association Class was II to III in both groups. There were no pump related life threatening or severe adverse events. Beating heart procedures with ICC can be reliably and safely achieved. As the device is easy to use, it may deserve a more widespread use in the future.

Computer-enhanced "robotic" cardiac surgery: experience in 148 patients.

OBJECTIVE: A computer-enhanced instrumentation system was used in 148 patients to minimize access in cardiac surgical procedures. METHODS: The da Vinci telemanipulation system (Intuitive Surgical, Mountain View, Calif) provides a high-resolution 3-dimensional videoscopic image and allows remote, tremor-free, and scaled control of endoscopic surgical instruments with 6 degrees of freedom. By April 2000, the system had been used in 131 patients for coronary artery bypass grafting and 17 patients for mitral valve repair. In the coronary bypass group, the system was used in one of three ways: (1) to take down the internal thoracic artery followed by a minimally invasive direct coronary bypass procedure (n = 81); (2) to perform the anastomosis between the internal thoracic artery and the left anterior descending coronary artery in standard-sternotomy coronary bypass (n = 15); or (3) for total endoscopic coronary artery bypass grafting to anastomose the left internal thoracic artery to the left anterior descending on the arrested heart (n = 27) or the beating heart (n = 8). In 17 patients with nonischemic mitral valve insufficiency the mitral valve was repaired. Closed-chest cardiopulmonary bypass with cardioplegic arrest (Port-Access technique; Heartport, Inc, Redwood City, Calif) was used for arrested-heart total endoscopic coronary bypass and mitral valve repair. RESULTS: The da Vinci system allows for precise tissue handling and enables the endoscopic performance of cardiac surgical tasks that require a high degree of dexterity (coronary anastomosis, mitral valve repair). No technical mishaps have occurred. The internal thoracic artery was successfully taken down in 79 of 81 patients in the group undergoing minimally invasive coronary bypass and, after a steep learning curve, is currently performed in less than 40 minutes. The postoperative patency rate is 96.3%. Total endoscopic coronary bypass was completed in 22 of 27 cases with 95.4% patency as demonstrated by angiography at 3 months' follow-up. Closed-chest endoscopic beating-heart bypass grafting was successfully performed in 2 out of 8 patients with the use of a new endoscopic stabilizer. In the group having mitral valve repair, primary endoscopic computer-enhanced repair was successfully completed in 14 of 17 patients; three others had to be changed to a standard endoscopic technique, including 1 who required valve replacement. At 3 months' follow-up, 1 additional patient underwent early reoperation for recurrent mitral insufficiency. Overall early and late mortality in this cohort of 148 patients was 2.0% and was not related to the use of the system. CONCLUSION: In conclusion, computer-enhanced endoscopic cardiac surgery can be performed safely in selected patients. Internal thoracic artery takedown is now routinely performed with good results. Total endoscopic coronary bypass is feasible on the arrested heart but does not offer a major benefit over the minimally invasive direct approach because cardiopulmonary bypass is still required. The early clinical experience with closed-chest beating-heart bypass grafting outlines the limitations of this approach despite some procedural success.

Transmyocardial laser revascularization with the holmium:YAG laser: loss of symptomatic improvement after 2 years.

OBJECTIVE: Whether transmyocardial laser revascularization (TMLR) provides a long-term benefit in terms of relief of angina, improvement of exercise tolerance, left ventricular function, and myocardial perfusion. METHODS: Forty-one patients underwent TMLR using a holmium:YAG-laser, 14 as TMLR alone (group A), 27 with additional aortocoronary bypass grafting (group B). Follow-up was obtained at 6, 12, 18, 24, and 36 months in this prospective study. RESULTS: In group A patients CCS-class improved up to 18 months postoperatively, after 24 and 36 months postoperatively there was absence of a positive effect of TMLR: the CCS-class decreased to 2.4 as compared to 3.5 preoperatively After combined CABG and TMLR (group B) there was a significant decrease in angina at all times. The CCS-functional class in these patients was 1.7 at 36 months as compared to 3.5 preoperatively. There was no significant change in exercise tolerance as compared to preoperatively. Left ventricular ejection fraction did not improve in either of the groups. Thallium scintigraphy indicated no improvement in myocardial perfusion in laser treated areas. The perioperative mortality was 0%, the late mortality rate was 36% in group A and 11% in group B. CONCLUSIONS: In our experience, in the vast majority of patients who are subjected to TMLR alone the benefit of reduction or relief of angina and improvement in quality of life is only temporary. In addition there is no improvement in objective clinical parameters. We believe that TMLR should only be used in patients with severe angina refractory to medical treatment and requiring a symptomatic therapy.

Papillary fibroelastoma of the aortic valve with temporary occlusion of the left coronary ostium.

We report a rare tumor of the aortic valve located at the commissure close to the left coronary ostium in a 71-year old female patient. Due to an intermittent obstruction of the left coronary ostium, the patient became symptomatic and presented with repeated angina and syncope. Diagnosis was made by echocardiography and confirmed by surgery. Complete surgical removal of the tumor was possible, without replacement of the aortic valve. Histology revealed the diagnosis of a papillary fibroelastoma.

[Robotic-guided techniques in heart surgery]. / Robotertechniken in der Herzchirurgie.

The rigid design of conventional endoscopic instruments with limited degrees of freedom has not allowed for endoscopic cardiac surgery. Using a surgical telemanipulation system that is operated from a master console, endoscopic coronary artery bypass grafting and mitral valve repair can be performed with high precision. Closed-chest cardiopulmonary bypass systems that allow cardioplegic cardiac arrest are required. After extensive experimental testing a telemanipulation system was used clinically.

Total endoscopic off-pump coronary artery bypass grafting.

Two cases of totally endoscopic off-pump coronary artery bypass grafting (TECAB) of the left internal thoracic artery to the left anterior descending artery using the da Vincitrade mark telemanipulation system (Intuitive Surgical, Mountain View, CA) are described. A new articulating endoscopic stabilizer with cleats was developed to enable endoscopic anchoring of silastic vessel loops for vascular occlusion. Newly created attachments for irrigation and suction, along with active robotic enhanced assistance by a second surgical console, permitted our group to perform for the first time a truly endoscopic bypass grafting without any thoracotomy.

Functional and morphologic assessment of saphenous veins harvested with minimally invasive techniques using a modified laryngoscope.

BACKGROUND: Minimally invasive saphenous vein harvesting techniques have been shown to reduce postoperative morbidity. Commercially available and often disposable instruments add significant costs to the operation. To lower expenses and to reduce postoperative morbidity, we used an ordinary laryngoscope fitted with a modified # 3 Heine blade for harvesting the greater saphenous vein for coronary artery bypass surgery. OBJECTIVE: To assess the integrity and function of the autologous, undistended, long saphenous vein harvested by a modified laryngoscope. METHODS: Morphology was examined by light and scanning electron microscopy. Endothelial function was assessed by vascular reactivity in an isolated organ bath. Veins, randomly taken and prepared traditionally, served as a control group. Contractile function was measured in response to potassium chloride. Endothelium-dependent relaxation was assessed by use of acetylcholine and calculated as percentage relaxation. RESULTS: There were no significant differences, in response to the constricting or dilating agent, in vein rings taken with the modified laryngoscope compared with the traditional 'open' technique (n = 10, p > 0.05 by ANOVA). Histologic examination by light and scanning electron microscopy showed no significant damage to the endothelial layer. CONCLUSION: Minimally invasive saphenous vein harvesting, using a modified laryngoscope yields morphologically and biologically intact veins.

Prospectively randomized comparison of different mechanical aortic valves.

BACKGROUND: The aim of this prospectively randomized study was to evaluate the hemodynamic and functional outcomes after aortic valve replacement with 3 different bileaflet mechanical valves. METHODS AND RESULTS: Three hundred consecutive patients were randomly assigned to receive ATS (n=100), Carbomedics (n=100), or St Jude Medical Hemodynamic Plus (n=100) mechanical aortic valve replacement. There were no significant differences regarding patient age (average 61+/-8 years), body surface area (1.9+/-0.2 m(2)), left ventricular function (ejection fraction 0.59+/-0.17), and presence of aortic stenosis (90%, 89%, and 91%), respectively. All patients had postoperative as well as 6-month and 1-year follow-ups that included transthoracic echocardiography. Multivariate statistical analysis was performed. Implanted valve sizes were comparable at 24+/-2 (ATS), 23.7+/-1.6 (CM), and 23.6+/-1.9 (SJMHP) mm (NS). At 1-year follow-up, the following incidence of events was noted: death 3/1/1, all non-valve related; stroke 0/1/1; trivial transvalvular incompetence 3/3/2; paravalvular leak 2/3/2; and reoperation 0/1/1, respectively (NS). Transvalvular flow velocities were 2.5/2.6/2.4 m/s postoperatively (P:=0.03) and 2.4/2.4/2.3 m/s at 6-month follow-up, respectively (NS). There was a significant decrease in left ventricular mass for all patients but no significant differences among the groups. CONCLUSIONS: There are no clinically relevant differences among the tested bileaflet aortic valves. Regardless of valve type, there was a low complication rate. On the basis of these findings, all 3 bileaflet prostheses are well suited for aortic valve replacement.