Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS: The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.

Repair of mitral prolapse: comparison of thoracoscopic minimally invasive and conventional approaches.

OBJECTIVES: Surgical repair remains the best treatment for severe primary mitral regurgitation (MR). Minimally invasive mitral valve surgery is being increasingly performed, but there is a lack of solid evidence comparing thoracoscopic with conventional surgery. Our objective was to compare outcomes of both approaches for repair of leaflet prolapse. METHODS: All consecutive patients undergoing surgery for severe MR due to mitral prolapse from 2012 to 2020 were evaluated according to the approach used. Freedom from mortality, reoperation and recurrent severe MR were evaluated by Kaplan-Meier method. Differences in baseline characteristics were adjusted with propensity score-matched analysis (1:1, nearest neighbour). RESULTS: Three hundred patients met inclusion criteria and were divided into thoracoscopic (N = 188) and conventional (sternotomy; N = 112) groups. Unmatched patients in the thoracoscopic group were younger and had lower body mass index, New York Heart Association class and EuroSCORE II preoperatively. After matching, thoracoscopic group presented significantly shorter mechanical ventilation (9 vs 15 h), shorter intensive care unit stay (41 vs 65 h) and higher postoperative haemoglobin levels (11 vs 10.2 mg/dl) despite longer bypass and cross-clamp times (+30 and +17 min). There were no differences in mortality or MR grade at discharge between groups nor differences in survival, repair failures and reinterventions during follow-up. CONCLUSIONS: Minimally invasive mitral repair can be performed in the majority of patients with mitral prolapse, without compromising outcomes, repair rate or durability, while providing shorter mechanical ventilation and intensive care unit stay and less blood loss.

Surgical treatment for chronic thromboembolic pulmonary hypertension: an historical perspective.

Chronic thrombotic occlusion of the pulmonary arteries that results in pulmonary hypertension is now recognized as being relatively common, and surgical treatment of the condition is being increasingly applied throughout the world. However, the condition was not described until 90 years ago, and just 60 years ago less than 200 cases of the syndrome had been reported. At that time the condition was thought to be inoperable. Surgery for the acute phase of pulmonary embolism was attempted beginning 100 years ago, with minimal success until cardiopulmonary bypass was developed and could be used to stabilize the patient during induction of anesthesia and the surgical removal of the embolus. Pulmonary endarterectomy was suggested as a possible surgical approach to the chronic condition in 1956, and the first planned pulmonary endarterectomy was performed in 1957. Over the next thirty years several operations were attempted in Europe and the United States. By 1989 it is likely that fewer than 250 cases of pulmonary endarterectomy had been attempted, with a mortality rate of greater than 20%. Some cases of pulmonary endarterectomy had been carried out successfully at the University of California, San Diego (UCSD), beginning in 1970. The technique of the operation was refined, and in 2003 the results of 1,500 of these operations performed at UCSD were described, with a mortality rate of less than 5%. The good results obtained in San Diego encouraged other groups internationally to start their own programs and the operation is now well established, with good results. The following discourse traces the development of surgery, first for acute pulmonary embolism, and also, growing out of that experience, an operation for chronic pulmonary embolism.

Functional Tricuspid Regurgitation: Behind the Scenes of a Long-Time Neglected Disease.

Severe tricuspid valve regurgitation has been for a long time a neglected valve disease, which has only recently attracted an increasing interest due to the notable negative impact on the prognosis of patients with cardiovascular disease. It is estimated that around 90% of tricuspid regurgitation is diagnosed as "functional" and mostly secondary to a primary left-sided heart disease and, therefore, has been usually interpreted as a benign condition that did not require a surgical management. Nevertheless, the persistence of severe tricuspid regurgitation after left-sided surgical correction of a valve disease, particularly mitral valve surgery, has been associated to adverse outcomes, worsening of the quality of life, and a significant increase in mortality rate. Similar results have been found when the impact of isolated severe tricuspid regurgitation has been studied. Current knowledge is shifting the "functional" categorization toward a more complex and detailed pathophysiological classification, identifying various phenotypes with completely different etiology, natural history and, potentially, an invasive management. The aim of this review is to offer a comprehensive guide for clinicians and surgeons with a systematic description of "functional" tricuspid regurgitation subtypes, an analysis centered on the effectiveness of existing surgical techniques and a focus on the emergent percutaneous procedures. This latter may be an attractive alternative to a standard surgical approach in patients with high-operative risk or isolated tricuspid regurgitation.

Outcomes of vascular allograft transplants in the autonomous community of Catalonia, Spain.

BACKGROUND: The transplantation of tissues is a developing practice. Improving cryopreservation techniques and emerging of new immunobiology concepts have let to establish the transplant of vascular allografts as a suitable alternative. This study aims to expose the Catalan experience in vascular allograft transplantation by disclosing basic data about clinical outcomes. MATERIALS AND METHODS: Data about vascular allografts transplants was gathered from the Registry of Vascular and Valvular Transplantation of Catalonia, Spain. Basic data regards to clinical outcomes are presented. Kaplan-Meier and statistical analysis were performed using SPSS Ver. 20 for Mac (Chicago USA). RESULTS: One hundred and seventy-one adults were transplanted. The overall 5-year SR was 51.5%. Survival (SR) differs with the territory revascularized, ranging from 37.5% to 55.6% at five years. Major adverse limb event-free rate ranges from 13.3% to 50.1% according to the area treated. The Primary patency rate is higher in the supra-inguinal revascularization and lowers when a distal vessel target is treated. CONCLUSION: Only one guideline-supported indication is currently done for allografts, and our results match with this indication. Our results are extensive and susceptible to analysis to address future projects, which are required to reconsider new or specific indications. More studies are needed to clarify the outcomes of arterial allografts.

ANTECEDENTES: El trasplante de tejido es una practica clínica en crecimiento. Las mejoras en técnicas de criopreservación y los nuevos conceptos sobre inmunobiología ha permitido que el trasplante vascular sea una alternativa a considerar. Este estudio expone la experiencia catalana en trasplante de tejido vascular mediante la exposición de datos clínicos. MATERIALES AND MÉTODOS: Los datos sobre trasplantes de aloinjertos vasculares se obtuvieron del Registro de trasplantes vasculares y valvulares de Cataluña, España (ReVAC). Se presentan datos básicos relacionados con los resultados clínicos. Kaplan Meier y el análisis estadístico se realizó con SPSS Ver. 20 para Mac (Chicago EE. UU.). RESULTADOS: 171 adultos fueron trasplantados. La supervivencia a 5 años fue del 51,5%. La supervivencia (SR) difiere con el territorio revascularizado, oscilando entre el 37,5% y el 55,6% a los cinco años. La tasa de sujetos libres de evento mayor en la extremidad (MALE-Free Rate) oscila entre el 13,3% y el 50,1% según la zona tratada. La tasa de permeabilidad primaria es mayor en la revascularización supra-inguinal y menor cuando se trata un vaso diana distal. CONCLUSIÓN: En la actualidad, solo hay una indicación de trasplante de aloinjertos respaldada por las guías clínicas y nuestros resultados coinciden con esta indicación. Nuestros resultados son amplios y susceptibles de análisis para abordar proyectos futuros que se requieren para reconsiderar indicaciones nuevas o específicas. Se necesitan más estudios para aclarar los resultados de los aloinjertos arteriales.

United in earnest: First pilot sites for increased surgical capacity for rheumatic heart disease announced by Cardiac Surgery Intersociety Alliance.

BACKGROUND: Rheumatic heart disease affects more than 33,000,000 individuals, mostly from low- and middle-income countries. The Cape Town Declaration on Access to Cardiac Surgery in the Developing World was published in August 2018, signaling the commitment of the global cardiac surgery and cardiology communities to improving care for rheumatic heart disease patients. METHODS: As the Cape Town Declaration formed the basis for which the Cardiac Surgery Intersociety Alliance was formed, the purpose of this article is to describe the history of the Cardiac Surgery Intersociety Alliance, its formation, ongoing activities, and future directions, including the announcement of selected pilot sites. RESULTS: The Cardiac Surgery Intersociety Alliance is an international alliance consisting of representatives from major cardiothoracic surgical societies and the World Heart Federation. Activities have included meetings at annual conferences, exhibit hall participation for advertisement and recruitment, and publication of selection criteria for cardiac surgery centers to apply for Cardiac Surgery Intersociety Alliance support. Criteria focused on local operating capacity, local championing, governmental and facility support, appropriate identification of a specific gap in care and desire to engage in future research. Eleven applications were received for which three finalist sites were selected and site visits conducted. The two selected sites were Hospital Central Maputo (Mozambique) and King Faisal Hospital Kigali (Rwanda). CONCLUSIONS: Substantial progress has been made since the passing of the Cape Town Declaration and the formation of the Cardiac Surgery Intersociety Alliance, but ongoing efforts with collaboration of all committed parties-cardiac surgery, cardiology, industry, and government-will be necessary to improve access to life-saving cardiac surgery for rheumatic heart disease patients.

United in earnest: first pilot sites for increased surgical capacity for rheumatic heart disease announced by cardiac surgery intersociety alliance.

OBJECTIVES: Rheumatic heart disease (RHD) affects >33 000 000 individuals, mostly from low- and middle-income countries. The Cape Town Declaration on Access to Cardiac Surgery in the Developing World was published in August 2018, signalling the commitment of the global cardiac surgery and cardiology communities to improving care for patients with RHD. METHODS: As the Cape Town Declaration formed the basis for which the Cardiac Surgery Intersociety Alliance (CSIA) was formed, the purpose of this article is to describe the history of the CSIA, its formation, ongoing activities and future directions, including the announcement of selected pilot sites. RESULTS: The CSIA is an international alliance consisting of representatives from major cardiothoracic surgical societies and the World Heart Federation. Activities have included meetings at annual conferences, exhibit hall participation for advertisement and recruitment and publication of selection criteria for cardiac surgery centres to apply for CSIA support. Criteria focused on local operating capacity, local championing, governmental and facility support, appropriate identification of a specific gap in care and desire to engage in future research. Eleven applications were received for which 3 finalist sites were selected and site visits conducted. The 2 selected sites were Hospital Central Maputo (Mozambique) and King Faisal Hospital Kigali (Rwanda). CONCLUSIONS: Substantial progress has been made since the passing of the Cape Town Declaration and the formation of the CSIA, but ongoing efforts with collaboration of all committed parties-cardiac surgery, cardiology, industry and government-will be necessary to improve access to life-saving cardiac surgery for patients with RHD.

United in Earnest: First Pilot Sites for Increased Surgical Capacity for Rheumatic Heart Disease Announced by Cardiac Surgery Intersociety Alliance.

BACKGROUND: Rheumatic heart disease (RHD) affects more than 33,000,000 individuals, mostly from low- and middle-income countries. The Cape Town Declaration On Access to Cardiac Surgery in the Developing World was published in August 2018, signaling the commitment of the global cardiac surgery and cardiology communities to improving care for RHD patients. METHODS: As the Cape Town Declaration formed the basis for which the Cardiac Surgery Intersociety Alliance (CSIA) was formed, the purpose of this article is to describe the history of the CSIA, its formation, ongoing activities, and future directions, including the announcement of selected pilot sites. RESULTS: The CSIA is an international alliance consisting of representatives from major cardiothoracic surgical societies and the World Heart Federation. Activities have included meetings at annual conferences, exhibit hall participation for advertisement and recruitment, and publication of selection criteria for cardiac surgery centers to apply for CSIA support. Criteria focused on local operating capacity, local championing, governmental and facility support, appropriate identification of a specific gap in care, and desire to engage in future research. Eleven applications were received for which three finalist sites were selected and site visits conducted. The two selected sites were Hospital Central Maputo (Mozambique) and King Faisal Hospital Kigali (Rwanda). CONCLUSIONS: Substantial progress has been made since the passing of the Cape Town Declaration and the formation of the CSIA, but ongoing efforts with collaboration of all committed parties-cardiac surgery, cardiology, industry, and government-will be necessary to improve access to life-saving cardiac surgery for RHD patients.

United in earnest: First pilot sites for increased surgical capacity for rheumatic heart disease announced by Cardiac Surgery Intersociety Alliance.

BACKGROUND: Rheumatic heart disease (RHD) affects more than 33,000,000 individuals, mostly from low- and middle-income countries. The Cape Town Declaration On Access to Cardiac Surgery in the Developing World was published in August 2018, signaling the commitment of the global cardiac surgery and cardiology communities to improving care for RHD patients. METHODS: As the Cape Town Declaration formed the basis for which the Cardiac Surgery Intersociety Alliance (CSIA) was formed, the purpose of this article is to describe the history of the CSIA, its formation, ongoing activities, and future directions, including the announcement of selected pilot sites. RESULTS: The CSIA is an international alliance consisting of representatives from major cardiothoracic surgical societies and the World Heart Federation. Activities have included meetings at annual conferences, exhibit hall participation for advertisement and recruitment, and publication of selection criteria for cardiac surgery centers to apply for CSIA support. Criteria focused on local operating capacity, local championing, governmental and facility support, appropriate identification of a specific gap in care, and desire to engage in future research. Eleven applications were received for which three finalist sites were selected and site visits conducted. The two selected sites were Hospital Central Maputo (Mozambique) and King Faisal Hospital Kigali (Rwanda). CONCLUSIONS: Substantial progress has been made since the passing of the Cape Town Declaration and the formation of the CSIA, but ongoing efforts with collaboration of all committed parties-cardiac surgery, cardiology, industry, and government-will be necessary to improve access to life-saving cardiac surgery for RHD patients.

Functional mitral regurgitation.

Dr. O.P. Yadava, Editor-in-Chief, IJTC, and Dr. J.L. Pomar, Former President, EACTS, discuss issues related to secondary mitral regurgitation (MR). Though it is considered a ventricular disease, mitral valve leaflets are not entirely normal. Alignment of subvalvular apparatus plays a more dominant role than annular dilatation. Early repair is preferred.

Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization.

BACKGROUND: Varying definitions of procedural myocardial infarction (PMI) are in widespread use. OBJECTIVES: This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: The pre-specified protocol definition of PMI (PMIProt) required a large elevation of creatine kinase-MB (CK-MB), with identical threshold for both procedures. The Third Universal Definition of MI (types 4a and 5) (PMIUD) required lesser biomarker elevations but with supporting evidence of myocardial ischemia, different after PCI and CABG. For the PMIUD, troponins were used preferentially (available in 49.5% of patients), CK-MB otherwise. The multivariable relationship between each PMI type and 5-year mortality was determined. RESULTS: PMIProt occurred in 34 of 935 (3.6%) patients after PCI and 56 of 923 (6.1%) patients after CABG (difference -2.4%; 95% confidence interval [CI]: -4.4% to -0.5%; p = 0.015). The corresponding rates of PMIUD were 37 (4.0%) and 20 (2.2%), respectively (difference 1.8%; 95% CI: 0.2% to 3.4%; p = 0.025). Both PMIProt and PMIUD were associated with 5-year cardiovascular mortality (adjusted hazard ratio [HR]: 2.18 [95% CI: 1.13 to 4.23] and 2.87 [95% CI: 1.44 to 5.73], respectively). PMIProt was associated with a consistent hazard of cardiovascular mortality after both PCI and CABG (pinteraction = 0.86). Conversely, PMIUD was strongly associated with cardiovascular mortality after CABG (adjusted HR: 11.94; 95% CI: 4.84 to 29.47) but not after PCI (adjusted HR: 1.14; 95% CI: 0.35 to 3.67) (pinteraction = 0.004). Results were similar for all-cause mortality and with varying PMIUD biomarker definitions. Only large biomarker elevations (CK-MB ≥10× upper reference limit and troponin ≥70× upper reference limit) were associated with mortality. CONCLUSIONS: The rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMIProt was associated with similar hazard after PCI and CABG, whereas PMIUD was strongly associated with mortality after CABG but not after PCI. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data.

OBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS: A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0-3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures. CONCLUSIONS: The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.

Registry of Valvular and Vascular Allograft Transplants in the Autonomous Community of Catalonia, Spain (ReVAC): Design of the Registry.

BACKGROUND: In recent years, there have been significant changes in the perception of valvular and vascular allograft transplants. Despite the constant evolution of the field of transplant and the involvement of multiple surgical specialties, there is not an official registry for administrative and clinical control. This study aims to design a registry of vascular and valvular allograft transplantation in Catalonia, Spain (ReVAC). MATERIALS AND METHODS: Three consecutive focal groups were designed. Focal groups established administrative, technical, and clinical requirements of ReVAC. ReVAC included patients with a transplanted cryopreserved vascular segment or cardiac valves that were distributed by Catalan tissue banks to public and private hospitals in Catalonia. Ten hospitals were involved in this study. Data were collected on 380 patients between January 1995 and November 2015. RESULTS: The project resulted in the completion of a growing platform available online. ReVAC was divided into the following 3 levels: patient-related, surgery-related, and transplant-related data. Online access is available through the website of applications of the "Generalitat de Catalunya." CONCLUSION: ReVAC has been useful for administrative and clinical control of transplants in Catalonia. Currently, data related to outcomes of arterial allografts are available, reinforcing the current guideline-supported indications, as well as opening a window for further analysis and guideline creation.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Cryopreserved Allografts for Treatment of Chronic Limb-Threatening Ischemia in Patients Without Autologous Saphenous Veins.

BACKGROUND: Revascularization is the best alternative to reduce symptoms and to improve the limb salvage rate in patients with chronic limb-threatening ischemia (CLI). Alternative grafts as synthetic prostheses and allografts must be considered for patients without a suitable autologous graft. Our aim was to evaluate outcomes of cryopreserved allografts used as a vascular conduit for bypass surgery in the infrainguinal territory. METHODS: A retrospective analysis (January 1995 to January 2014) of the Registry of vascular and valvular allografts transplant in the autonomous community of Catalonia, Spain was performed for identifying patients with CLI who required infrainguinal bypass with cryopreserved arterial allografts. Statistical analysis was performed using SPSS, ver. 20, for Mac (Chicago). RESULTS: A total of 149 patients with CLI (mean age of 70.1 years) were analyzed. One hundred two patients (68.5%) had a grade IV lesion (Fontaine classification). In the overall follow-up, 24.8% of patients required a reintervention. Overall graft occlusion, infection, and dilation rate were 52.3%, 6%, and 5.4% respectively. Overall 30-day mortality was 0.7%. Five-year primary patency rate and limb salvage rate were 38.6% and 50.2%, respectively. Survival rate at 5 years was 54.2%. Major adverse limb event (MALE)-free rate was 21.5% at 5 years. Revascularization to a distal target vessel was an independent positive predictive risk factor for a lower limb salvage rate and lower primary patency rate. Dyslipidemia was related to a lower limb salvage rate and represents a risk factor involved in MALEs. CONCLUSIONS: Although arterial allografts seem to represent a suboptimal alternative, some selected patients could beneficiate from them. Five-year results are disappointing, and more studies are required to know other predictive factors for better selection of patients.

Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes.

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

Global Unmet Needs in Cardiac Surgery.

More than 6 billion people live outside industrialized countries and have insufficient access to cardiac surgery. Given the recently confirmed high prevailing mortality for rheumatic heart disease in many of these countries together with increasing numbers of patients needing interventions for lifestyle diseases due to an accelerating epidemiological transition, a significant need for cardiac surgery could be assumed. Yet, need estimates were largely based on extrapolated screening studies while true service levels remained unknown. A multi-author effort representing 16 high-, middle-, and low-income countries was undertaken to narrow the need assessment for cardiac surgery including rheumatic and lifestyle cardiac diseases as well as congenital heart disease on the basis of existing data deduction. Actual levels of cardiac surgery were determined in each of these countries on the basis of questionnaires, national databases, or annual reports of national societies. Need estimates range from 200 operations per million in low-income countries that are nonendemic for rheumatic heart disease to >1,000 operations per million in high-income countries representing the end of the epidemiological transition. Actually provided levels of cardiac surgery range from 0.5 per million in the assessed low- and lower-middle income countries (average 107 ± 113 per million; representing a population of 1.6 billion) to 500 in the upper-middle-income countries (average 270 ± 163 per million representing a population of 1.9 billion). By combining need estimates with the assessment of de facto provided levels of cardiac surgery, it emerged that a significant degree of underdelivery of often lifesaving open heart surgery does not only prevail in low-income countries but is also disturbingly high in middle-income countries.