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Based on a voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (DGTHG) in 1980, a well-defined but limited dataset of all cardiac and vascular surgery procedures performed in 77 German heart surgery departments is reported annually. For the year 2023, a total of 168,841 procedures were submitted to the registry. Of these operations, 100,606 are defined as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 28,996 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 2.8:1) was 97.6%; 97.7% for the 39,859 isolated heart valve procedures (23,727 transcatheter interventions included); and 99.2% for 19,699 pacemaker/implantable cardioverter defibrillator procedures. Concerning short and long-term mechanical circulatory support, a total of 2,982 extracorporeal life support/extracorporeal membrane oxygenation implantations and 772 ventricular assist device implantations (left/right ventricular assist device, BVAD, total artificial heart) were reported. In 2023, 324 isolated heart transplantations, 248 isolated lung transplantations, and 2 combined heart-lung transplantations were performed. This annually updated registry of the DGTHG represents nonrisk adjusted voluntary public reporting and encompasses acute data for nearly all heart surgical procedures in Germany. It constitutes trends in heart medicine and represents a basis for quality management (e.g., benchmark) for all participating institutions.
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Procedimientos Quirúrgicos Cardíacos , Sistema de Registros , Humanos , Alemania , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Procedimientos Quirúrgicos Cardíacos/tendencias , Resultado del Tratamiento , Factores de Tiempo , Sociedades Médicas , Mortalidad Hospitalaria , Factores de Riesgo , Indicadores de Calidad de la Atención de Salud/tendencias , Masculino , Persona de Mediana Edad , Femenino , Anciano , Adulto , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Cardiopatías/cirugía , Cardiopatías/mortalidad , Evaluación de Procesos y Resultados en Atención de Salud/tendencias , Cirugía Torácica/tendencias , AdolescenteRESUMEN
BACKGROUND: The German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease is a voluntary registry initiated by the German Society for Thoracic and Cardiovascular Surgery and the German Society for Pediatric Cardiology and Congenital Heart Defects. Since 2012, the registry collects data for the assessment of treatment and outcomes of surgical and interventional procedures in patients with congenital heart disease (CHD) of all age groups. METHODS: This real-world, prospective all-comers registry collects clinical and procedural characteristics, adverse events (AEs), mortality, and medium-term outcomes (up to 90 days) of patients undergoing surgical and interventional. A unique pseudonymous personal identifier (PID) allows longitudinal data acquisition in case of further invasive treatment in any participating German heart center. Prior to evaluation, all data sets are monitored for data completeness and integrity. Evaluation includes risk stratification of interventional and surgical procedures and classification of AEs. Each year's data are summarized in annual reports containing detailed information on the entire cohort, all subgroups, and 15 index procedures. In addition, each participating center receives an institutional benchmark report for comparison with the national results. This paper presents a comprehensive summary of the annual report 2021. RESULTS: In 2021, a total of 5,439 patients were included by 22 participating centers. In total, 3,721 surgical, 3,413 interventional, and 34 hybrid procedures were performed during 6,122 hospital stays. 2,220 cases (36.3%) could be allocated to the 15 index procedures. The mean unadjusted in-hospital mortality ranged from 0.4% among interventional and 2% among surgical cases up to 6.2 % in cases with multiple procedures. In-hospital mortality among index procedures accounted for 2.3% in total cavopulmonary connection, 20.3% in Norwood procedures, and 0.4% following interventional closure of patent ductus arteriosus. For the remaining seven surgical and five interventional index procedures, no in-hospital deaths were recorded. The 10-year longitudinal evaluation of 1,795 patients after tetralogy of Fallot repair revealed repeat interventional or surgical procedures in 21% of the patients. Over the same period, 31.1% of 2,037 patients, following initial treatment of native coarctation, required at least one additional hospital admission, 39.4% after initial interventional, and 21.3% after initial surgical therapy. CONCLUSION: The annual report 2021 of the German Registry for Cardiac Operations and Interventions in CHD shows continuously good results in accordance with previous data of the registry. Compared to international registries on CHD, it can be ascertained that in Germany invasive treatment of CHD is offered on a high medical level with excellent quality. The proven fact that patients with various malformations like tetralogy of Fallot and coarctation of the aorta require repeat procedures during follow-up confirms the urgent requirement for longitudinal assessment of all patients presenting with complex lesions.
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Procedimientos Quirúrgicos Cardíacos , Cardiopatías Congénitas , Complicaciones Posoperatorias , Sistema de Registros , Humanos , Cardiopatías Congénitas/cirugía , Cardiopatías Congénitas/mortalidad , Alemania , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Resultado del Tratamiento , Lactante , Factores de Tiempo , Preescolar , Niño , Factores de Riesgo , Recién Nacido , Adolescente , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Masculino , Estudios Prospectivos , Femenino , Benchmarking , Adulto Joven , Medición de Riesgo , Indicadores de Calidad de la Atención de Salud , Informes Anuales como Asunto , Mortalidad Hospitalaria , Evaluación de Procesos y Resultados en Atención de Salud , AdultoRESUMEN
BACKGROUND: In patients not suitable for transfemoral transcatheter aortic valve implantation (TAVI), several access strategies can be chosen. AIM: To evaluate the use and patient outcomes of transaxillary (TAx), transapical (TA), and transaortic (TAo) as alternative access for TAVI in Germany; to further evaluate surgical cutdown vs. percutaneous TAx access. METHODS: All patients entered the German Aortic Valve Registry (GARY) between 2011 and 2019 who underwent non-transfemoral TAVI were included in this analysis. Patients with TA, TAo, or TAx TAVI were compared using a weighted propensity score model. Furthermore, a subgroup analysis was performed for TAx regarding the percutaneous or surgical cutdown approach. RESULTS: Overall, 9686 patients received a non-transfemoral access. A total of 8918 patients (92.1%) underwent TA, 398 (4.1%) TAo, and 370 (3.8%) TAx approaches. Within the TAx subgroup, 141 patients (38.1%) received subclavian cutdown, while 200 (54.1%) underwent a percutaneous approach. The TA patients had a significantly lower 30-day survival than TAx patients (TA 90.92% vs. TAx 95.59%, p = 0.006; TAo 92.22% vs. TAx 95.59%, p = 0.102). Comparing percutaneous and cutdown TAx approaches, no significant differences were seen. However, more vascular complications occurred (TA 1.8%, TAo 2.4%, TAx 12.2%; p < .001), and the hospital length of stay was shorter (TA 12.9 days, TAo 14.1 days, TAx 12 days; p < .001) after TAx access. CONCLUSION: It may be reasonable to consider TAx access first in patients not suitable for TF-TAVI, because the 30-day survival was higher compared with TA access and the 1-year survival was higher compared with TAo access. It remains important for the heart teams to offer alternative access modalities for patients not amenable to the standard TF-TAVI approaches.
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BACKGROUND: Various second-generation transcatheter heart valve (THV) prostheses with high clinical efficacy and safety are available, but there is limited large-scale data available comparing their hemodynamic performance and clinical implications. OBJECTIVE: To compare the hemodynamic performance and short-term clinical outcome of four second-generation THV prostheses. METHODS: 24,124 patients out of the German Aortic Valve Registry who underwent transfemoral transcatheter aortic valve implantation (TAVI) (Evolut™ R n = 7028, Acurate neo™ n = 2922, Portico n = 878 and Sapien 3 n = 13,296) were included in this analysis. Propensity-score weighted analysis was performed to control for differences in age, left ventricular function, STS score and sex. Primary endpoint was survival at one-year, secondary endpoints were 30 days survival, pre-discharge transvalvular gradients, paravalvular leakage and peri-procedural complications. RESULTS: Thirty-day and one-year survival were not significantly different between the four patient groups. Transvalvular gradients in Evolut™ R and Acurate neo™ were significantly lower as compared to Portico and Sapien 3 at hospital discharge. This difference exists across all annulus sizes. Paravalvular leakage ≥ II occurred significantly less often in the Sapien 3 group (1.2%, p < 0.0001). Rate of severe procedural complications was low and comparable in all groups. Permanent pacemaker implantation rate at one year was lowest in the ACUARATE neo group (13.0%) and highest in the Evolut™ R group (21.9%). CONCLUSION: Albeit comparable short-term clinical outcomes there are certain differences regarding hemodynamic performance and permanent pacemaker implantation rate between currently available THV prostheses which should be considered for individual prosthesis selection.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Diseño de Prótesis , Resultado del Tratamiento , Sistema de RegistrosRESUMEN
BACKGROUND: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of nonelderly adults with aortic regurgitation. We aimed to determine the 1-year outcome after AV repair vs surgical AV replacement (sAVR) using real-world data from the German Aortic Valve Registry. METHODS: A total of 8076 aortic regurgitation patients (mean age, 59.1 ± 15.0 years; 76% men; mean The Society of Thoracic Surgeons score, 1.3 ± 1.1), who underwent AV surgical procedures between 2011 and 2015, were identified from German Aortic Valve Registry. The AV was repaired in 2327 patients (29%), and the remaining 5749 patients (71%) underwent sAVR. A weighted propensity score model, including the variables of age, sex, and The Society of Thoracic Surgeons score, was used to correct for baseline differences between AV repair and sAVR cohorts. The primary end point was 1-year survival after AV repair vs sAVR. Secondary end points were freedom from cardiac events and AV reinterventions. RESULTS: Survival at 1 year was 97.7% (95% CI, 97.0%-98.5%) in the AV repair cohort vs 96.4% (95% CI, 95.9%-96.9%) in the propensity score-weighted sAVR cohort (log-rank P < .001). Cox regression revealed a significant advantage of AV repair vs sAVR (hazard ratio, 0.68; 95% CI, 0.51-0.90; P < .0001) on 1-year survival, which was independent of age. Cardiac event-free survival at 1 year was 85.7% (95% CI, 483.8%-87.7%) in the AV repair group vs 81.7% (95% CI, 80.7%-82.9%) in the sAVR group (log-rank P < .001). AV reintervention was required in 38 AV repair patients (1.6%) compared with 1.6% in the sAVR cohort (P = .59). CONCLUSIONS: AV repair surgery, whenever intraoperatively feasible, is associated with a significantly better 1-year survival and 1-year cardiac event-free survival compared with sAVR.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Adulto , Persona de Mediana Edad , Anciano , Femenino , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de Riesgo , Sistema de RegistrosRESUMEN
BACKGROUND: Making the right decision in stressful situations is required for goal-oriented action in cardiac surgery. Current labor laws prevent residents to be subjected to situations that test their stress tolerance. These situations often occur only later in the career. We simulated such conditions in a structured non-stop 36-hour cardiac surgical training course and assessed the participant's performance. METHODS: Fourteen advanced residents/junior staff surgeons were selected. The course was conducted in collaboration with the national antiterror police forces that provided coaching for teamplay, leadership, and responsibility awareness. The candidates attended graded and evaluated workshops/lectures and performed academic and surgical tasks. Psychological and surgical skill assessments were conducted at times 0, 12, 24, 36 hours. RESULTS: Progressive reductions in individual motivation, associated with increased stress and irritability levels, worsening mood, and fatigue were observed. Long- and short-term memory functions were unaffected and practical surgical performance even increased over time. CONCLUSION: Among the candidates, 36 hours of sleep deprivation did not lead to relevant changes in the skills required from a cardiac surgeon in daily life. Importantly, group dynamics substantially improved during the course, suggesting advances in the perception of responsibility and teamwork.
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Cirugía General , Internado y Residencia , Cirujanos , Humanos , Resultado del Tratamiento , Estrés Psicológico/diagnóstico , Estrés Psicológico/prevención & control , Percepción , Competencia Clínica , Cirugía General/educaciónRESUMEN
OBJECTIVE: After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population. METHODS: The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint 'cardiac and cerebrovascular events' containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. RESULTS: Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups. CONCLUSIONS: This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Prospectivos , Anticoagulantes/efectos adversos , Válvula Aórtica/cirugía , Fibrinolíticos , Vitamina K , Resultado del Tratamiento , Factores de RiesgoRESUMEN
Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS/DGTHG) in 1980, well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2022 are analyzed. Under the decreasing interference of the worldwide coronavirus disease 2019 pandemic, a total of 162,167 procedures were submitted to the registry. A total of 93,913 of these operations are summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 27,994 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.2:1) was 97.5%. For the 38,492 isolated heart valve procedures (20,272 transcatheter interventions included) it was 96.9%, and for the registered pacemaker/implantable cardioverter-defibrillator procedures (19,531) 99.1%, respectively. Concerning short- and long-term circulatory support, a total of 2,737 extracorporeal life support/extracorporeal membrane oxygenation implantations, respectively 672 assist device implantations (L-/ R-/ BVAD, TAH) were registered. In 2022, 356 isolated heart transplantations, 228 isolated lung transplantations, and 5 combined heart-lung transplantations were performed. This annually updated registry of the GSTCVS/DGTHG represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine, and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is always available.
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COVID-19 , Procedimientos Quirúrgicos Cardíacos , Humanos , Sociedades Médicas , Resultado del Tratamiento , Indicadores de Calidad de la Atención de Salud , Factores de Tiempo , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Sistema de Registros , Alemania/epidemiologíaRESUMEN
Aims: Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Methods and results: Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). Conclusion: TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.
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In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.
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Oxigenación por Membrana Extracorpórea , Choque , Humanos , Sociedades Científicas , Circulación Extracorporea , Sociedades Médicas , AlemaniaRESUMEN
BACKGROUND AND AIMS: Currently, it is unclear whether transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI; d-TAVI) or with preimplantation balloon valvuloplasty (b-TAVI) provides similar clinical safety and efficacy. Therefore, we analyzed patients undergoing d-TAVI or b-TAVI for severe aortic stenosis (AS) with either self-expanding or balloon-expandable transcatheter heart valves (THVs) from the German Aortic Valve Registry (GARY). METHODS: Between 2011 and 2017, a total of 44,783 TAVI patients were collected, with 25,717 (57.4%) receiving a balloon-expandable THV and 19,066 (42.6%) receiving a self-expanding THV. A propensity-score weighted model was used to compare d-TAVI vs b-TAVI regarding differences in outcome. RESULTS: B-TAVI was performed in 71% and d-TAVI was performed in 29% of patients. In the investigated time interval, frequency of b-TAVI declined from 88.4% to 58.2%, accompanied by a constant rate of postdilation. After propensity weighting of patients receiving balloon-expandable THV, d-TAVI vs b-TAVI was associated with more frequent postoperative transvalvular mean pressure gradients (mPG) >15 mm Hg (20.7% vs 18.4%; P<.001), similar rates of paravalvular leakage (PVL) ≥ moderate (18.0% vs 16.9%; P=.08), fewer postdilations (13.4% vs 15.5%; P<.001), and fewer complications (permanent pacemaker implantation, 10.2% vs 11.9% [P=.01]; vascular complications, 1.9% vs 2.6% [P<.01]; pericardial tamponade, 0.5% vs 0.9% [P<.01]; and stroke, 0.9% vs 1.3% [P=.02]). In patients receiving self-expanding THVs, d-TAVI vs b-TAVI was associated with more frequent postimplantation mean PG ≥ 15 mm Hg (12.7% vs 10.4%; P<.01), higher rates of PVL ≥ moderate (24.8% vs 16.5%; P<.001), and similar complication rates including permanent pacemaker implantation. CONCLUSIONS: The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.
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Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugíaRESUMEN
OBJECTIVES: We aimed to develop and validate an effective prediction model for 1-year mortality risk in elective transfemoral transcatheter aortic valve replacement (TAVR), ie, the TAVR-Risk (TARI) model. BACKGROUND: TAVR is the primary treatment for patients with symptomatic severe aortic valve stenosis; however, risk assessment tools for longer-term outcomes after TAVR remain scarce. METHODS: This retrospective cohort study used logistic regression to test univariate and multivariate associations. The German Aortic Valve Registry (GARY) was the derivation (n = 20,704) and the Swedish SWEDEHEART TAVR Registry (SWENTRY) was the validation cohort (n = 3982). The main outcome was the area under the curve (AUC) in the prediction of 1-year mortality. The final model included 12 parameters that were associated with 1-year mortality in a multivariate analysis. RESULTS: The TARI model (AUC, 0.66; 95% confidence interval [CI] 0.65-0.67) performed better as compared with the Society of Thoracic Surgeons (STS) score (AUC, 0.63; 95% CI, 0.62-0.64; P<.001) and logistic EuroSCORE I (AUC, 0.60; 95% CI, 0.59-0.61; P<.001) in the GARY derivation cohort, and discriminated the risk for 1-year mortality better than logistic EuroSCORE I in the SWENTRY validation cohort (AUC, 0.62; 95% CI, 0.60-0.64 vs AUC, 0.59; 95% CI, 0.57-0.61; P=.04). CONCLUSIONS: This novel TARI score provides a relatively easy-to-use risk model and offers a superior prediction for 1-year mortality in European TAVR patients.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/cirugía , Estudios Retrospectivos , Estenosis de la Válvula Aórtica/cirugía , Factores de Riesgo , Medición de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The annual report of the German Quality Assurance of Congenital Heart Disease displays a broad overview on outcome of interventional and surgical treatment with respect to patient's age and risk categorization. Particular features of the German all-comers registry are the inclusion of all interventional and surgical procedures, the possibility to record repeated treatments with distinct individual patient assignment, and to record various procedures within one case. METHODS: International Pediatric and Congenital Cardiac Code terminology for diagnoses and procedures as well as classified adverse events, also recording of demographic data, key procedural performance indicators, and key quality indicators (mortality, adverse event rates). Surgical and interventional adverse events were classified according to the Society of Thoracic Surgeons and to the Congenital Heart Disease Adjustment for Risk Method of the congenital cardiac catheterization project on outcomes. Annual analysis of all cases and additional long-term evaluation of patients after repair of Fallot and primary treatment of native coarctation of the aorta were performed. RESULTS: In 2020, 5,532 patients with 6,051 cases (hospital stays) with 6,986 procedures were treated in 23 German institutions. Cases dispense on 618 newborns (10.2%), 1,532 infants (25.3%), 3,077 children (50.9%), and 824 adults (13.6%). Freedom from adverse events was 94.5% in 2,795 interventional cases, 67.9% in 2,887 surgical cases, and 42.9% in 336 cases with multiple procedures (without considering the 33 hybrid interventions). In-hospital mortality was 0.5% in interventional, 1.6% in surgical, and 5.7% in cases with multiple treatments. Long-term observation of 1,632 patient after repair of Fallot depicts the impact of previous palliation in 18% of the patients on the rate of 20.8% redo cases. Differentiated analysis of 1,864 patients with native coarctation picture clear differences of patient, age, and procedure selection and outcome. The overall redo procedure rate in this patient population is high with 30.8%. CONCLUSION: Improvement in quality of care requires detailed analysis of risks, performance indicators, and outcomes. The high necessity of redo procedures in patients with complex congenital heart disease underlines the imperative need of long-term observations.
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Procedimientos Quirúrgicos Cardíacos , Cardiopatías Congénitas , Adulto , Coartación Aórtica/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Niño , Alemania , Cardiopatías Congénitas/cirugía , Humanos , Lactante , Recién Nacido , Sistema de Registros , Resultado del TratamientoRESUMEN
OBJECTIVE: We compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15-60 ml/min/1.73 m2) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4-8). BACKGROUND: According to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD). METHODS: Data from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis. RESULTS: One-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan-Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR (p < 0.0001); however, a probable need for chronic dialysis was rare and similar in both groups. CONCLUSION: Both TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Infarto del Miocardio , Insuficiencia Renal Crónica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Factores de Riesgo , Sistema de Registros , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/epidemiología , Infarto del Miocardio/etiología , Resultado del TratamientoRESUMEN
Background: For documentation of COVID-19 pandemic-related changes in cardiac surgery in Germany, the German Society for Thoracic and Cardiovascular Surgery carried out a structured survey. Methods: From 79 German institutions for cardiac surgery, 53 took part in the survey. The cut-off date before the pandemic was taken as 1 January 2020 and 30 April 2021 as the cut-off date for data recruitment. At this point of time, the third wave of the pandemic in Germany had already ebbed away and the return to routine surgery seemed to be foreseeable. Results: On 1 January 2020, in 53 German cardiac surgery departments 800 intensive care beds were allocated. In April 2021, this capacity was reduced by 25.6% to 595 beds. Accordingly, the number of operating rooms for cardiac surgery procedures was reduced from 207 to 152 (-26.9%) during the first two lockdowns. During the COVID-19 pandemic, hospital facilities were restructured: 50.9% of participants delegated medical personnel, and 75.5% had to transfer nursing personnel to special COVID-19 facilities in their hospitals. Conclusion: From the start of the COVID-19 pandemic until the end of the third wave during April 2021, cardiac surgery in Germany changed profoundly, leading to a substantial reduction of intensive care beds and operating rooms for patients requiring cardiac surgery.
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BACKGROUND: Patients with severe aortic stenosis (AS) frequently presented mitral regurgitation (MR), which may interfere with the standard echocardiographic measurements of mean pressure gradient (MPG), flow velocity, and aortic valve area (AVA). AIMS: Herein we investigated the prevalence and severity of MR in patients with severe AS and its role on the accuracy of the standard echocardiographic parameters of AS quantification. METHODS: Of all patients with severe AS undergoing transcatheter or surgical aortic valve replacement enrolled in the German Aortic Registry from 2011 to 2017, 119,641 were included in this study. The population was divided based on the values of left ventricular ejection fraction ([LVEF] > 50%, LVEF 31-50%, and LVEF ≤ 30%] and AVA (0.80 to ≤ 1.00 cm2, 0.60 to < 0.80 cm2, 0.40 to < 0.60 cm2, and 0.20 to < 0.40 cm2). RESULTS: Overall, 77,890 (65%) patients with mild to-moderate and 4262 (4%) with severe MR were compared with 37,489 (31%) patients without MR. Patients with mild-to-moderate and severe MR presented significantly lower mPG (ΔmPG [95%CI] - 1.694 mmHg [- 2.123 to - 1.265], p < 0.0001 and - 6.954 mmHg [- 7.725 to - 6.183], p < 0.0001, respectively), that increased with LVEF impairment. Conversely, AVA did not differ (severe versus no MR: ΔAVA [95%CI]: - 0.007cm2 [- 0.023 to 0.009], p = 0.973). Increasing MR severity was associated with significant mPG reduction throughout all AVA strata, causing a low-gradient pattern, that manifested since the early stages of severe AS (LVEF > 50%: AVA 0.80 to 1.00 cm2; LVEF 31-50%: AVA 0.60 to 0.80 cm2). CONCLUSIONS: In patients with severe AS, concomitant MR is common, contributes to the onset of a low-gradient AS pattern, and affects the diagnostic accuracy of flow-dependent AVA measurements. In this setting, a multimodality, AVA-centric approach should be implemented. In patients with severe aortic stenosis, concomitant mitral regurgitation contributes to the onset of a low-gradient pattern, warranting a multimodality, and AVA-centric diagnostic approach.
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Estenosis de la Válvula Aórtica , Insuficiencia de la Válvula Mitral , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/epidemiología , Insuficiencia de la Válvula Mitral/complicaciones , Volumen Sistólico , Función Ventricular Izquierda , Índice de Severidad de la Enfermedad , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/epidemiología , Sistema de Registros , Estudios RetrospectivosRESUMEN
The evolution and progress in cardiovascular medicine and substantial changes in the German health care system require both a reflection of the principles of patient-centered care in general and an update of the criteria that define a department of cardiac surgery in Germany. This position paper lists the core requirements for a cardiac surgical department with regard to infrastructure, facilities, necessary staff, and standard of care (processes). This standard may be used by hospitals and health care providers to ensure the safety and quality of cardiac surgical departments in Germany.
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Procedimientos Quirúrgicos Cardíacos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Atención a la Salud , Alemania , Humanos , Resultado del TratamientoRESUMEN
Based on a longtime voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) in 1980, well-defined data of all cardiac, thoracic and vascular surgery procedures performed in 78 German heart surgery departments during the year 2021 are analyzed. Under more than extraordinary conditions of the further ongoing worldwide coronavirus disease 2019 (COVID-19) pandemic, a total of 161,261 procedures were submitted to the registry. In total, 92,838 of these operations are summarized as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 27,947 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 3.2:1) was 97.3%. For the 36,714 isolated heart valve procedures (19,242 transcatheter interventions included) it was 96.7 and 99.0% for the registered pacemaker and International Classification of Diseases (ICD) procedures (19,490), respectively. Concerning short- and long-term circulatory support, a total of 3,404 ECLS/ECMO implantations and 750 assist device implantations (L-/ R-/ BVAD, TAH), respectively were registered. In 2021 329 isolated heart transplantations, 254 isolated lung transplantations, and one combined heart-lung transplantations were performed.This annually updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, constitutes advancements in heart medicine and represents a basis for quality management for all participating institutions. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is up to date, appropriate, and nationwide patient treatment is guaranteed all the time.
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COVID-19 , Procedimientos Quirúrgicos Cardíacos , Cirugía Torácica , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Alemania/epidemiología , Mortalidad Hospitalaria , Humanos , Indicadores de Calidad de la Atención de Salud , Sistema de Registros , Sociedades Médicas , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of young patients with aortic regurgitation (AR) and/or aortic root aneurysm. We aimed to determine the clinical outcome following AV repair/AV-sparing root surgery using real-world data from the German Aortic Valve Registry. METHODS: A total of 2327 patients with AR (mean age 55.2 ± 15.0 years, 76% men), who underwent AV repair/AV-sparing root surgery between 2011 and 2015 (i.e. 5% of 42 868 AV surgery patients enrolled in the German Aortic Valve Registry during the same period) were included. Study cohort was subdivided according to the technique of AV repair: isolated AV repair without root surgery (group I) (n = 914), AV-sparing root surgery (i.e. reimplantation or remodelling) without cusp repair (group II) (n = 1077) and AV-sparing root surgery (i.e. reimplantation or remodelling) with simultaneous cusp repair (group III) (n = 336). Primary end point was 1-year survival after AV repair/AV-sparing root surgery. Secondary end points were freedom from cardiac adverse events and freedom from AV reinterventions at 1-year follow-up. RESULTS: Thirty-day mortality was 19 (0.8%) in the whole study cohort without significant differences in the 3 subgroups [4 (0.4%) patients in group I vs 14 (1.3%) patients in group II vs 1 (0.3%) patient in group III (P = 0.054)]. Postoperatively, 1445 (74%) patients had no residual AR, 474 (24%) patients had mild AR and 40 (2%) patients had moderate/severe AR at the time of hospital discharge. One-year survival (95% confidence interval) was 97.7% (97.1-98.3) in the whole study cohort and without significant difference among the 3 subgroups. One-year cardiac adverse event-free survival (95% confidence interval) was 85.7% (84.2-87.1) and was similar in all 3 study groups in propensity score-weighted analysis. A total of 38 (1.6%) patients required AV reintervention during a 1-year follow-up, without significant difference among subgroups (P = 0.11). CONCLUSIONS: AV repair/AV-sparing root surgery is performed in 5% of patients requiring AV surgery in Germany. Our data demonstrate very satisfactory periprocedural and 1-year survival and cardiac event-free survival after AV repair surgery. Implementation of specific surgical techniques during the index procedure seems to result in comparable outcomes.