Supporting patients with heart failure with digital therapeutics-A pilot study in Germany.

Objective: Continuous monitoring and targeted behavioral interventions have been shown to improve health status and quality of life for heart failure patients. Digital therapeutics offer the possibility to make more frequent monitoring and targeted behavioral interventions available for more people. Methods: We conduct a pilot study with 71 patients who were given a smartphone app and wearables for a 3-month period. Clinical indicators as well as patient-reported outcomes were collected at entry and exit examinations. Results: The New York Heart Association class remained stable or improved. Most quantitative outcome measures improved (6-minute walk test distance + 21 m, Kansas City Cardiomyopathy Questionnaire summary score + 6.0 points, European Heard Failure Self-care Behavior Scale summary score + 6.6 points, correct answers in the Atlanta Heart Failure Knowledge Test + 2.1), although the changes were mainly not significantly different from zero. There was no change in EQ-5D weight and 9-item Shared Decision-Making Questionnaire summary score. Conclusions: This before-after comparison shows that an app-based intervention can work as a digital therapeutic for heart failure patients.

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).

[Aortic valve replacement in the elderly]. / Aortenklappenersatz im Alter.

The treatment of severe symptomatic aortic valve stenosis by conventional aortic valve replacement (AVR) or by transcatheter aortic valve implantation (TAVI) has a good perinterventional prognosis even for patients of advanced age. Having a heart team select the best management strategies based on current guidelines for each individual patient is essential for success. Especially in elderly and increasingly multimorbid patients with sometimes severe preconditions, the detection of functional deficits is relevant not only for the mortality but also for perioperative and postoperative complications as well as the functional outcome. Various methods of geriatric assessment are important supplements to standard risk scores. The aim is to implement targeted interventions to minimize the risk factors and to improve the prognosis for elderly patients. The aim of this article is to provide an overview of the current therapy options for aortic valve replacement and to summarize current aspects of treatment options for elderly patients.

First experience with the new Sorin Crown PRT bioprosthetic aortic valve: early postoperative outcome and hemodynamic performance in 90 patients.

AIM: The Crown PRT (The Phospholipid Reduction Treatment) is a new stent bovine bioprosthesis for aortic valve replacement (AVR). Aim of this paper is to report the postoperative clinical and hemodynamic results after ninety consecutive implants. METHODS: After receiving CE mark in July 2014, two European university centers implanted the new Crown PRT (Sorin Group, Burnaby, Canada) for the first time. Up to now, ninety patients underwent aortic valve replacement, in isolated or combined procedures, for aortic stenosis or insufficiency. Intraoperative transesophageal echocardiogram was used to assess the prosthesis's function. In hospital outcomes and echocardiographic parameters were recorded. RESULTS: Age and Log Euroscore were 71.8±7.9 years and 10.2%±4.5 respectively. In-hospital mortality for isolated AVR was 0%; one patient died after a multiple procedure (overall 30-days mortality 1.1%). No adverse device effects were recorded. Intensive Care Unit stay was 2±5.8 days. At discharge, echocardiogram showed no paravalvular leaks and normal postoperative gradients. CONCLUSION: Our starting results showed that the Crown PRT is safe and reliable, with excellent hemodynamic performance. Further clinical results with a larger population and long term follow-up are needed to assess the versatility and the durability of this new device.

Sternal wound dehiscence from intense coughing in a cardiac surgery patient: could it be prevented?

This case report is on a obese patient who underwent a coronary artery bypass. The immediate postoperative phase, on the 8th day, was characterized by sternal dehiscence with diastasis, from intense coughing. At present, for obese patients there are not any guidelines aimed to prevent the sternal diastasis. The use of a sternum support vest after median sternotomy could be a valuable tool in the postoperative care of our patients, in order to avoid chest wall hyperexpansion and to prevent sternal wound dehiscence and diastasis.

Impact of bispectral index monitoring on postoperative delirium in patients undergoing aortic surgery.

BACKGROUND: Bispectral index monitoring can facilitate anesthesia care. We evaluated the association of Bispectral index with postoperative neurological outcome and delirium in patients undergoing aortic surgery. METHODS: From 2006 to 2009, 292 consecutive patients undergoing aortic surgery were retrospectively reviewed. Patients were classified into 5 groups according to Bispectral index reduction: Group I (≤15%), Group II (15-20%), Group III (20-25%), Group IV (25-30%), and Group V (>30%). RESULTS: The number of patients in each group was : 52 (17.8%), Group I; 125 (42.8%), Group II;68 (23.3%), Group III; 33 (11.3%), Group IV; 14 (4.8%), Group V. The incidence of delirium and neurological events was higher in Group IV and Group V(90.9% and 18.2% in Group IV, and 71% and 79% in Group V; both p<0.001). Only Group V showed a longer intensive care unit stay compared to Group I (13.5±10.3 vs 5.4±6.6 days; p=0.002), Group II (7.3±8.6 days, p=0.005) and Group III (6.7±6.5 days, p=0.015). Group V also showed a longer intubation time compared to Group I (228±211 vs 73±112 hours; p=0.008) and Group II (105±177 hours, p=0.002). CONCLUSIONS: Our data suggest a higher incidence of neurological deficits in patients with a Bispectral index reduction of >25% from baseline. Explanations for these findings are speculative with regard to the underlying mechanisms, and larger studies are warranted to clarify these issues.

[Neuropsychological complications after coronary bypass grafting]. / Neuropsychiatrische Komplikationen nach aortokoronarer Bypassoperation.

BACKGROUND: Coronary bypass grafting is more and more performed in elderly, atherosclerotic patients with increased risk of developing postoperative neuropsychological complications. In the present study, we investigated the relative importance of clinical, genetic or metabolic factors with possible impact on any of the primary endpoint encephalopathy, stroke and death after coronary bypass grafting. METHODS: 98 prospective patients (mean age 67.9 years, 23 females, 75 males) underwent conventional elective bypass surgery. All had standardized cardiovascular risk factor assessment, prior stroke, EuroSCORE, a neuropsychologic battery and testing for Apolipoprotein E (APOE) Genotype and Homocysteine. Follow up was possible on 90 patients postoperatively and after 3, 6 and 12 months, monitoring cognitive decline, death or dependency and general health assessment. RESULTS: Early mortality was 3.1 % (3 patients); 3 patients (3.0 %) developed postoperative ischemic stroke and 2 further strokes occurred within the next 3 months. Postoperative encephalopathy occurred in 14 patients (14.3 %). Homocysteine elevation or Apolipoprotein E 4 (APO E 4) did not correlate with immediate postoperative cognitive function. Patients with high EuroSCOREs had significantly lower postoperative Mini-Mental scores. Neither Homocysteine nor presence of an APO E 4 allele was associated with any postoperative endpoint at 3, 6 or 12 months after surgery. The EuroSCORE was modestly associated with postoperative encephalopathy (relative risk 1.3 - 1.5), but not with outcome after one year. Preoperative stroke was highly associated with postoperative ischemic stroke and cognitive decline on follow-up (relative risk 11), but not with postoperative encephalopathy. CONCLUSIONS: Amongst clinical factors, the EuroSCORE may indicate moderate risk increase for acute postoperative encephalopathy. Most strokes occur early after surgery. Patients having suffered stroke prior to cardiac surgery may represent a high-risk group in the acute as well as chronic outcome after cardiac surgery.

The use of preoperative intra-aortic balloon pump in open heart surgery.

AIM: Intra-aortic balloon pump (IABP) therapy before open heart surgery has been suggested for ''high risk'' patients. METHODS: Records from patients undergoing open heart surgery at our institution between June 1999 and February 2002 were reviewed. Indication for IABP insertion was severely impaired left ventricular function, acute myocardial infarction (MI) or unstable angina. RESULTS: Fifty-five patients were included in the study: 41 male, 14 female, age 64+/-9 years. Fifty-one (92.7%) required coronary artery bypass brafting (CABG) alone or as a combined procedure, 2 (3.6%) required mitral valve surgery, and 2 (3.6%) needed more complex cardiac procedures. Thirty-two patients (58%) underwent emergency cardiac surgery and 11 patients (20%) suffered from acute preoperative MI. The overall 30 days mortality was 9%. Mean intensive care unit (ICU) stay was 6+/-8 days. Four patients (7.2%) developed postoperative renal failure requiring temporary hemodialysis. Three patients (5.4%) developed IABP related peripheral vascular complications. CONCLUSIONS: Perioperative morbidity and mortality is increased despite preoperative IABP, particularly in patients with acute MI. In contrast to studies not using this approach, preoperative IABP reduces morbidity and mortality of high risk patients. IABP related complications are low. Our data suggest that high risk patients profit from preoperative IABP therapy, however, prospective studies are needed to confirm these findings.

Impella Recover 100: successful perioperative support for off pump coronary artery bypass grafting surgery in a patient with end-stage ischemic cardiomyopathy.

The authors present the successful use of the Impella recover 100 intracardiac left ventricular assist device in a 55-year old man suffering from end-stage ischemic cardiomyopathy. The pump was implanted preoff pump coronary artery bypass grafting (OPCAB) and it was successfully weaned 5 days postoperatively. In addition, an intra-aortic balloon pump (IABP) was implanted to convert the non-pulsatile flow of the Impella into a pulsatile flow. In this paper benefits and risks of this technique are shown.

Late pulmonary valve replacement after correction of Fallot's tetralogy.

BACKGROUND: The aim of this study was to investigate necessity and outcome of late pulmonary valve replacement (PVR) after repair of tetralogy of Fallot (TOF). METHODS: Hospital records from patients operated on for TOF at our institution between 1960 and 2002 were reviewed and patients were interviewed by questionnaires. RESULTS: Out of 411 long-term survivors after TOF-repair, 47 (11.4 %) patients required reoperation after 13.2 +/- 7.4 years. Preoperative right ventricular (RV) dilatation was present in 36 (76.6 %) patients including 16 (34 %) with impaired RV function. Isolated PVR was performed in 12 patients (25.5 %). Additional procedures were necessary in 35 patients (74.5 %), including closure of residual defects (VSD, n = 11), tricuspid valve replacement (n = 1) and repair (n = 3). Obstructive right ventricular or pulmonary artery lesions (34 patients, 72.3 %) were all surgically addressed. RV pressure decreased from 61.1 +/- 27.7 to 42.9 +/- 13.3 mm Hg (p < 0.01) after PVR. RV size was reduced and RV function improved compared to preoperative values. Early mortality after reoperation was 2.1 % (n = 1) with one patient dying from biventricular failure. There was no late mortality. CONCLUSIONS: PVR after Fallot repair is frequently required because of progressive RV enlargement with dysfunction. It can be performed with relatively low risk, even in the setting of multiple reoperation. Obstructive lesions (RVOTO, PA stenosis) and residual defects are frequently observed in patients needing late PVR and may play a crucial role in the development of RV failure. Timely valve replacement with repair of all obstructive lesions proximal and distal to the implanted valve is the key to preserving RV function.

[Emergency management of an acute rupture of a perforated thoracic aortic aneurysm]. / Notfallmanagement bei akut dissezierendem und gedeckt perforiertem thorakalen Aortenaneurysma.

The emergency medical service was called to a 60-year-old woman with intensive chest pain, signs of shock, dyspnoea, intermittent paraesthesia of the right leg and disturbance of consciousness. With the diagnosis of an acute rupture of an aneurysm of the thoracic aorta, the patient was stabilised with volume, catecholamines, intubation and mechanical ventilation before being rushed to the preinformed department of cardiovascular surgery. The diagnosis was verified by transesophageal echocardiography immediately and the patient underwent surgery 2 h after onset of symptoms. Despite the rupture of the aorta and a short period of cardiac arrest, the patient recovered totally and could be discharged without any residual problems. This case shows that a ruptured thoracic aortic aneurysm can be survived although the overall mortality of this incident is more than 97%. The essentials of a good outcome are: 1. perfectly coordinated rescue operation which means an emergency medical service which includes the rupture of an aortic aneurysm in the differential diagnosis of acute chest pain, 2. an early verification of the diagnosis by means of transesophageal echocardiography which should also be carried out by anaesthesiologists due to its importance in the differential diagnosis in haemodynamic unstable patients.

Aortic valvotomy for congenital valvular aortic stenosis: a 37-year experience.

BACKGROUND: The purpose of the study was to analyze the long-term results of aortic valvotomy and the risk factors associated with reoperation and survival. METHODS: From 1960 to 1977, 116 patients with congenital valvular aortic stenosis underwent isolated aortic valvotomy at a mean age of 13.7 +/- 7.8 years with a mean aortic gradient of 78 +/- 33 mm Hg. Fifteen patients had additional aortic regurgitation, and leaflet calcification was present in another 15 patients. RESULTS: Postoperatively the mean aortic gradient decreased to 19.4 +/- 11.3 mm Hg (p < 0.0001). Early mortality was 2.6%. At a mean follow-up of 23.8 years, 26 late deaths (22.4%) occurred among the 113 early survivors. Actuarial 10-, 20-, 30-, and 37-year survival rates were 94.6%, 79.7%, 76.2%, and 72.5%, respectively. According to multivariate Cox regression analysis, survival was influenced by preoperative New York Heart Association class (p = 0.0418), leaflet calcification (p = 0.0339), date of operation (p = 0.0253), and postoperative endocarditis (p < 0.0001). At a mean interval of 18.3 years, 37 patients required reoperation (31.9%) mainly because of recurrent aortic stenosis. The reoperation rate increased significantly 15 years postoperatively from 0.73%/year to 2.31%/ year (p < 0.0001). In a multivariate risk model, reoperation was influenced by older patient age (p = 0.0032) and the presence of leaflet calcification (p = 0.0289). CONCLUSIONS: AORTIC valvotomy is a simple and effective procedure for congenital aortic stenosis with excellent long-term results. However, the rate of reoperation increases 15 years postoperatively, and clinical follow-up should be intensified. Our results suggest that early repair should be performed and that adequate patient selection is the most important determinant of the longterm results.

Clinical autologous in vitro endothelialization of 153 infrainguinal ePTFE grafts.

BACKGROUND: Over the past 17 years, our group has developed and clinically applied an in vitro endothelialization procedure whereby infrainguinal expanded polytetrafluoroethylene (ePTFE) prostheses are confluently lined with cultured autologous endothelial cells before implantation. After a successful randomized pilot study from 1989 to 1993, the procedure was adopted for routine operations. METHODS: Since June 1993, 153 endothelialized ePTFE grafts were implanted in the infrainguinal position in 136 patients (102 above knee (AK) and 51 below knee (BK), 89 men and 47 women, mean age 64.7+/-9.4 years). Seventeen patients received an endothelialized prosthesis bilaterally. Autologous endothelial cells were harvested from 4- to 5-cm segments of a subcutaneous vein (in 86% the cephalic vein), grown to first-passage mass cultures and confluently lined onto 6- (n = 113) or 7-mm (n = 40) inner diameter (ID) ePTFE grafts, precoated with fibrin glue. The observation period for 6-mm grafts was 7 years, and for 7-mm grafts was 4 years. Patency assessment for Kaplan-Meier survivorship analyses was based on duplex sonography and angiography. RESULTS: Kaplan-Meier survivorship function revealed a primary patency rate of 62.8% after 7 years (SE = 0.05) for all infrainguinal reconstructions (60% AK/70.8% BK). The primary patency for stage II and III patients was 64.4% after 7 years. The more recent group of 7-mm ID grafts showed a primary patency of 83.7% after 4 years. CONCLUSIONS: Our data provide strong evidence that autologous endothelial cell lining distinctly improves the patency of small diameter vascular grafts.

Mitral valve annuloplasty: comparison of the mural annulus shortening suture (MASS) with the Carpentier-Edwards prosthetic ring.

BACKGROUND AND AIM OF THE STUDY: Although mitral annuloplasty is an important element of mitral valve repair, the technique employed remains controversial. In this prospective study, we compared two different annuloplasty techniques with regard to hemodynamic performance. METHODS: Between October 1995 and December 1998, 109 consecutive patients underwent mitral valve repair for mitral regurgitation. One group of patients (n = 55) received a Carpentier-Edwards (CE) ring for annuloplasty, and a second group (n = 54) underwent the mural annulus shortening suture (MASS) to reinforce the posterior circumference of the annulus. All patients were investigated prospectively by Doppler echocardiography before discharge and annually thereafter. The mean follow up was 22.7+/-11.6 months. RESULTS: The early mortality rate was 3.7%, with four early deaths in the CE group, and no early death in the MASS group. There was one late death in each group. One patient in each group required reoperation for severe mitral regurgitation after 19 and 30 months, respectively. Postoperative (12 months) Doppler echocardiography showed mean mitral valve gradients to be significantly lower (1.7+/-0.7 versus 2.7+/-1.7 mmHg; p <0.01) and mitral valve areas significantly larger (3.3+/-1.0 versus 2.6+/-0.7 cm2; p <0.01) in MASS patients compared with CE patients. There was no significant difference in mean postoperative mitral regurgitation between the two groups (0.5+/-0.2 versus 0.4+/-0.2). CONCLUSION: Both annuloplasty techniques showed excellent results; however, hemodynamic performance of MASS was superior to that of the rigid CE ring, while not increasing postoperative mitral regurgitation. Therefore, MASS may be recommended as an alternative to annuloplasty rings, if future long-term follow up studies confirm the durability of the technique.

Clinical autologous in vitro endothelialization of infrainguinal ePTFE grafts in 100 patients: a 9-year experience.

BACKGROUND: Clinical in vitro endothelialization was assessed for its ability to improve the long-term patency of prosthetic femoropopliteal bypass grafts. METHODS: Between June 1989 and May 1998, 100 patients received 113 in vitro endothelialized expanded polytetrafluoroethylene grafts (ePTFE). Bilateral implantations were performed in 13 patients. In phase 1 of the study, 24 patients received 27 endothelialized grafts and 16 patients received 17 untreated grafts. In phase 2, endothelialization was offered to all patients who did not have a suitable saphenous vein available. Phase 2 began in June 1993 and included 76 patients who received 86 endotheliazed ePTFE grafts. In all, 100 patients had autologous endothelial cells harvested from 4- to 5-cm segments of a subcutaneous vein. In phase 1, the external jugular vein was used. In phase 2, the cephalic vein was used. These cells were grown to first-passage mass cultures and were lined confluently onto 6-mm ePTFE grafts, pre-coated with fibrin glue. Patency assessment for Kaplan-Meier survivorship analysis was determined by using duplex sonography and angiography. RESULTS: In phase 1, the Kaplan-Meier method revealed a primary 9-year patency rate for 65% for the endothelialized group, versus 16% for the control group (log-rank test, P = .002; Wilcoxon test, P = .003). In phase 2, the 5-year primary patency rate for all in vitro endothelialized infrainguinal reconstructions was 68% (66% for above-the-knee grafts and 76% for below-the-knee grafts). CONCLUSIONS: Nine years of clinical in vitro endothelialization provided strong evidence that autologous endothelial cell lining improves the patency of small-diameter vascular grafts and that a cell culture-dependent procedure can be used in a clinical routine.