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.

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.

The American Association for Thoracic Surgery Consensus Guidelines: Reasons and purpose.

The time interval for the doubling of medical knowledge continues to decline. Physicians, patients, administrators, government officials, and payors are struggling to keep up to date with the waves of new information and to integrate the knowledge into new patient treatment protocols, processes, and metrics. Guidelines, Consensus Guidelines, and Consensus Statements, moderated by seasoned content experts, offer one method to rapidly distribute new information in a timely manner and also guide minimal standards of treatment of clinical care pathways as they are developed as part of bundled care programs. These proposed Consensus Guidelines advance The American Association for Thoracic Surgery's mission of leading in cardiothoracic health care, education, innovation, and modeling excellence.

An old mitral homograft in the tricuspid position.

The case is presented of a 55-year-old male implanted with a mitral valve homograft (MVH) in the tricuspid position. The MVH has remained in place for 21 years, but underwent repair during the 13th postoperative year. The explant findings of this surgical anecdote are discussed, with emphasis placed on reoperation and late clinical events. The extreme long-term performance of this MVH was unexpected.

Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years.

OBJECTIVE: The aim of the study was to establish clinical event rates for the On-X bileaflet mechanical heart valve (On-X Life Technologies Inc, Austin, Tex) using an audit of data from the 3 centers within Europe with the longest history of implanting. METHODS: All patients receiving the On-X valve between March 1, 1998, and June 30, 2009, at 3 European centers were studied. Data were collected using questionnaire and telephone surveys augmented by outpatient visits and examination of clinical records. RESULTS: There were 691 patients, with a mean age of 60.3 years, who received 761 valves in total: 407 mitral valve replacements, 214 aortic valve replacements, and 70 aortic + mitral valve replacements (dual valve replacement). Total follow-up was 3595 patient-years, with a mean of 5.2 years (range, 0-12.6 years). Early (≤ 30 days) mortality was 5.4% (mitral valve replacement), 0.9% (aortic valve replacement), and 4.3% (dual valve replacement). Linearized late (>30 days) mortality expressed per patient-year was 3.6% (mitral valve replacement), 2.2% (aortic valve replacement), and 4.1% (dual valve replacement), of which valve-related mortality was 0.5% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.8% (dual valve replacement). Late linearized thromboembolism rates were 1.0% (mitral valve replacement), 0.6% (aortic valve replacement), 1.8% (dual valve replacement). Bleeding rates were 1.0% (mitral valve replacement), 0.4% (aortic valve replacement), and 0.9% (dual valve replacement). Thrombosis rates were 0.1% (mitral valve replacement), 0% (aortic valve replacement), and 0.3% (dual valve replacement). Reoperation rates were 0.6% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.2% (dual valve replacement). CONCLUSIONS: The On-X valve has low adverse clinical event rates in longer-term follow-up (mean 5.2 years and maximum 12.6 years).

Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years.

OBJECTIVE: SYNTAX study compares outcomes of coronary artery bypass grafting with percutaneous coronary intervention in patients with 3-vessel and/or left main disease. Complexity of coronary artery disease was quantified by the SYNTAX score, which combines anatomic characteristics of each significant lesion. This study aims to clarify whether SYNTAX score affects the outcome of bypass grafting as defined by major adverse cerebrovascular and cardiac events (MACCE) and its components over a 2-year follow-up period. METHODS: Of the 3075 patients enrolled in SYNTAX, 1541 underwent coronary artery bypass grafting (897 randomized controlled trial patients, and 644 registry patients). All patients undergoing bypass grafting were stratified according to their SYNTAX score into 3 tertiles: low (0-22), intermediate (22-32), and high (≥33) complexity. Clinical outcomes up to 2 years after allocation were determined for each group and further risk factor analysis was performed. RESULTS: Registry patients had more complex disease than those in the randomized controlled trial (SYNTAX score: registry 37.8 ± 13.3 vs randomized 29.1 ± 11.4; P < .001). At 30 days, overall coronary bypass mortality was 0.9% (registry 0.6% vs randomized 1.2%). MACCE rate at 30 days was 4.4% (registry 3.4% vs randomized 5.2%). SYNTAX score did not significantly affect overall 2-year MACCE rate of 15.6% for low, 14.3% for medium, and 15.4% for high SYNTAX scores. Compared with randomized patients, registry patients had a lower rate of overall MACCE rate (registry 13.0% vs randomized 16.7%; P = .046) and repeat revascularization (4.7% vs 8.6%; P = .003), whereas other event rates were comparable. Risk factor analysis revealed left main disease (P = .049) and incomplete revascularization (P = .005) as predictive for adverse 2-year outcomes. CONCLUSIONS: The outcome of coronary artery bypass grafting was excellent and independent from the SYNTAX score. Incomplete revascularization rather than degree of coronary complexity adversely affects late outcomes of coronary bypass.

Is early antithrombotic therapy necessary after tissue mitral valve replacement?

BACKGROUND AND AIM OF THE STUDY: Patients with prosthetic heart valves have a higher risk of developing valve thrombosis and arterial thromboembolism. Antithrombotic therapy during the early postoperative period after biologic mitral valve replacement (MVR) is controversial. Hence, a retrospective study was conducted to investigate the efficacy of different antithrombotic therapies in patients after MVR with bioprostheses. METHODS: Between January 2000 and January 2006, a total of 99 patients presenting with preoperative sinus rhythm underwent isolated bioprosthetic MVR. Of these patients, 59 (58%) received a bovine pericardial xenograft, and 40 (42%) a porcine bioprosthesis. The postoperative antithrombotic therapy was prescribed according to the surgeon's preference. RESULTS: Fifty-one (51%) patients received acetylsalicylic acid (ASA group, 100 mg/day), 12 (13%) did not receive any specific antithrombotic therapy (NT group), and 36 (36%) received a vitamin K antagonist (VKA group, INR 2-3). The primary endpoints were the rate of cerebral ischemic events, bleeding events, and survival. The mean follow up was 23 months (range: 3-68 months). There were five early deaths (5%), and eight late deaths (8%). There were five episodes of cerebral ischemic events; these included three patients (8.3%) in the VKA group, one patient (2.0%) in ASA group, and one patient (8.3%) in the NT group (p = 0.351). Of these episodes, two occurred between 24 h and three months after surgery. Only one (2.8%) episode of major bleeding occurred (in the VKA group), due to poor anticoagulation management. CONCLUSION: Each of the antithrombotic therapies evaluated appeared to be safe. There was no evidence to suggest that any specific antithrombotic therapy would be superior in preventing valve thrombosis in patients undergoing bioprosthetic MVR.

Heart valve surgery in patients with the antiphospholipid syndrome: analysis of a series of nine cases.

OBJECTIVE: Antiphospholipid syndrome (APS) is a rare coagulation disorder associated with recurrent arterial and venous thrombotic events. Heart valve abnormalities are commonly found in patients with APS. METHODS: From March 1998 to March 2007, nine patients with APS underwent heart valve surgery using cardiopulmonary bypass. We retrospectively reviewed their clinical data, operative and postoperative courses and the long-term results. RESULTS: The mean age was 43.6+/-10.4 years, six were female and three male. Four patients underwent mitral valve replacement, three went through aortic valve replacement, one underwent combined mitral-aortic valve replacement and another aortic valve plasty. The syndrome was primary in seven patients and associated with systemic lupus erythematosus (SLE) in two. Follow-up was 8 days to 8 years (median 66 months). Two patients died in the early postoperative period: both due to an acute cerebrovascular accident. Four patients presented an uneventful late postoperative course. One patient experienced an ischaemic stroke 5 years after mitral valve replacement (MVR) and developed refractory congestive heart failure requiring heart transplantation three years postoperatively. CONCLUSIONS: Heart valve surgery in patients with antiphospholipid syndrome may carry considerable early and late mortality and morbidity. Thrombo-embolic complications are the most common complications. Mechanical prostheses have been used at our Institution in the previous years; however, today, after reviewing our historical results, we reconsider our general strategy and believe that tissue heart valve prostheses are the possible ideal substitutes, minimising the risks of morbidity and mortality due to the hypercoagulable state of APS.

Preoperative risk stratification in infective endocarditis. Does the EuroSCORE model work? Preliminary results.

OBJECTIVE: There is an important role for risk prediction in cardiac surgery. Prediction models are useful in decision making and quality assurance. Patients with infective endocarditis (IE) have a particularly high risk of mortality. The aim was to assess the performance of European System for Cardiac Operative Risk Evaluation (EuroSCORE) in IE. METHODS: The additive and logistic EuroSCORE models were applied to all patients undergoing surgery for IE (Duke criteria) between January 1995 and April 2006 within our prospective institutional database. Observed and predicted mortalities were compared. Model calibration was assessed with the Hosmer-Lemeshow test. Model discrimination was tested by determining the area under the receiver operating characteristic (ROC) curve. RESULTS: One hundred and eighty-one consecutive patients undergoing 191 operations were analyzed. Observed mortality was 28.8%. For the entire cohort the mean additive score was 10.4 (additive predicted mortality of 14.2%). The mean logistic predicted mortality was 27.1%. Discriminative power was good for the additive and the logistic models for the entire series. Area under ROC curve were 0.83 (additive) and 0.84 (logistic) for the entire cohort, 0.81 and 0.81 for the aortic position, 0.91 and 0.92 for the mitral position, 0.81 and 0.81 for the native valve, 0.82 and 0.83 for the prosthetic valves, and 0.81 and 0.51 for the gram-positive microorganisms, respectively. CONCLUSIONS: This initial sample may be small; however, additive and logistic EuroSCORE adequately stratify risk in IE. Logistic EuroSCORE has been calibrated in IE, a special group of very high-risk patients. Further studies with larger sample sizes are required to confirm these initial results.

Degeneration of native and tissue prosthetic valve in aortic position: do statins play an effective role in prevention?

Degenerative aortic valve stenosis is a common disease in western countries. When it becomes severe, it confers significant morbidity and mortality. Aortic stenosis has been recognized as a complex inflammatory and highly regulated process with histological and immunochemical similarities with the process of atherosclerosis. Hypertension, smoking and diabetes mellitus have consistently been linked to the development of aortic stenosis. Endothelial injury or other processes that contribute to coronary disease may play a role in calcific aortic stenosis. Several observational studies suggests that the key factors of aortic stenosis are lipoproteins and that medical therapies with cholesterol lowering drugs may retard its progression. Similarly, it has been suggested that the process of degeneration of the tissue heart valve has been associated with the same risk factors of atherosclerosis and shares many histological and molecular characteristics. Assuming all this concept, and evaluating the results of a retrospective study it has been suggested to use statin also as medical therapy able to prevent tissue valve degeneration. Randomized controlled clinical trials will be needed to demonstrate the role of lipid intervention to prevent the progression of aortic stenosis and the degeneration of tissue heart valves.

Duration of botulinum toxin effect in the treatment of crocodile tears.

PURPOSE: To provide clinical evidence of the duration of botulinum toxin type A (BTX-A) effect when applied in the palpebral lobe of the lacrimal gland in patients with gustatory epiphora. METHODS: Prospective, nonrandomized, nonblinded study. Patients with history of gustatory epiphora were included. A Schirmer test was performed to quantify tearing induced by chewing. Clinical examination included visual acuity, tear-duct syringing, slit lamp examination, corneal staining, and eyelid malpositions. A questionnaire was completed by each patient to asses the severity of hyperlacrimation. A single dose of 2.5 units of BTX-A was injected directly into the lacrimal gland palpebral lobe. Patients were evaluated before and at 1, 4, 12, and 24 weeks after injection. The same person performed the examination and the BTX-A injection. Descriptive statistics, using repeated measures and a paired t test, were used for statistical analysis. RESULTS: Fifteen patients were included. Mean age was 63 years. Before BTX-A injection, mean Schirmer test values were 5.47 mm in the unaffected eyes (NAE) and 12.07 mm in the affected eyes (AE). When comparing Schirmer test values in the AE before and after BTX-A injection, there were statistically significant differences (p < 0.05). Only 2 patients developed mild transitory ptosis. No other complications were noted. CONCLUSIONS: The effect of 2.5 units of BTX-A injected into the lacrimal gland lasted 6 months, a duration similar to that reported for other application sites.

Cryopreserved mitral homograft in the tricuspid position for infective endocarditis: a valve that can be repaired in the long-term (13 years).

Herein is reported the long-term repair of a cryopreserved mitral homograft in the tricuspid position. A 34-year-old HIV-infected patient underwent tricuspid valve replacement in 1991 with a cryopreserved mitral homograft because of infective endocarditis. Chronic tricuspid regurgitation secondary to repeated endocarditis led to reoperation 13 years later. Mitral valve repair was performed with a rigid ring as there was annular dilatation; the valve tissue was intact. One year later, transthoracic echocardiography showed no tricuspid regurgitation. The cryopreserved mitral homograft is a potentially repairable valve in the long-term.

[Mortality and morbidity in HIV-infected patients undergoing coronary artery bypass surgery: a case control study]. / Morbimortalidad en pacientes con infección por el virus de la inmunodeficiencia humana que reciben cirugía de revascularización miocárdica: estudio de casos y controles.

The use of highly active antiretroviral therapy (HAART) in patients with HIV infection has improved survival. This improvement combined with the metabolic effects of treatment has increased cardiovascular risk and the need for cardiac surgery in these patients. We compared morbidity and mortality in HIV-infected patients (cases, n=7) and non-HIV-infected patients (controls, n=21) who underwent isolated coronary artery surgery between 1997 and 2004. The durations of extracorporeal circulation and aortic cross-clamping were shorter in HIV-infected patients (P=.002 and P=.014, respectively). The percentage of patients who experienced complications was similar, at 57.1% in both groups, but there was a slightly higher number of complications per patient in non-HIV-infected individuals. The mean length of total hospitalization was greater in HIV-infected patients (27.1 [13.3] versus 8.8 [5.3] days; P=.003), as was that of postoperative hospitalization (18.2 [15.4] vs 7.9 [4.2] days; P=.08). No HIV-infected patient died or needed a repeat cardiac operation. No progression of the HIV infection was observed. Isolated coronary artery surgery in HIV-infected patients produces good results, and there is no increase in morbidity or mortality. Extracorporeal circulation did not influence disease progression.

Hemolysis in mechanical bileaflet prostheses: experience with the Bicarbon valve.

BACKGROUND: Normal functioning mechanical heart valve prostheses are designed to have a certain degree of intrinsic structural regurgitation as a washout mechanism to avoid prosthetic thrombosis. However, intrinsic regurgitation leads to blood cell trauma and hemolysis. Information on hemolysis associated with mechanical bileaflet prostheses is scarce. This study evaluated factors influencing hemolysis in 197 Bicarbon mechanical bileaflet prostheses implanted in 164 patients. METHODS: Serial office interviews, laboratory studies, and echocardiography evaluations were done in the surviving patients. An assay for measuring lactate dehydrogenase activity was developed, and the presence and severity of subclinical hemolysis was determined using reported criteria and analyzed at 1 and 2 years. RESULTS: Hospital mortality was 5.5%. Follow-up was 98.1% complete. No patient had clinically significant or severe subclinical hemolysis. Serum lactate dehydrogenase levels were significantly higher when a paravalvular leak was documented (282 +/- 85 U/L versus 242 +/- 64 U/L; p = 0.0026). Subclinical hemolysis was significantly more frequent after mitral valve (p = 0.001) and double valve replacement (p = 0.001) than after aortic valve replacement, and was unrelated to prosthetic size or to geometric area index, even in those cases with effective orifice area index equal to or less than 0.85 cm2/m2 (p = 0.298). CONCLUSIONS: Mild subclinical hemolysis is frequently associated with normal functioning Bicarbon heart valves. Subclinical hemolysis was significantly influenced by valve position but not by valve size or effective orifice area index and remained stable through time. The magnitude of hemolysis in Bicarbon prostheses compared favorably with that reported for other bileaflet heart valve prostheses.

Comparative evaluation of small-size Sorin Slimline and St. Jude HP heart valve prostheses.

BACKGROUND: The Sorin Slimline aortic valve prosthesis, a modification of the Sorin Bicarbon valve with increased internal orifice diameter and geometric orifice area, may show improved hemodynamic performance when compared with other previous prosthesis, but so far no comparison study has been reported. METHODS: Between May 1999 and March 2002, 80 patients (31 to 81 years of age; mean, 65 years) with a small aortic annulus were randomized to undergo aortic valve replacement with either the Sorin Slimline (n = 40) or St. Jude High Performance (n = 40) valve prosthesis. Clinical and echocardiographic Doppler follow-up was performed at 3 to 4 weeks, and 6 and 12 months postoperatively. RESULTS: One patient died of non-valve-related causes 9 months after operation. Mean and peak pressure gradients at 6 and 12 months in the Sorin Slimline valve were lower than in the St. Jude High Performance valve for both size 19 and 21 mm. Effective orifice area and effective orifice area index were not significantly different. There was a significant (p = 0.0001) reduction in left ventricular mass and left ventricular mass index between preoperative measurements and at 12 months after surgery for both valves, but there was no difference (p = 0.27) between the Sorin Slimline and St. Jude High Performance valve prosthesis at any other follow-up period. Clinical results showed similarly good results with both valves. CONCLUSIONS: No clinically significant difference in the hemodynamics of both valves was appreciated; patients with a Sorin Slimline valve exhibited statistically significantly lower pressure gradients, but the small differences in effective orifice area and effective orifice area index did not reach significance. A significant left ventricular mass regression was observed with both valve models. Both prostheses provided a satisfactory clinical outcome.

Partial clamping of the brachiocephalic trunk for total ascending aorta replacement without circulatory arrest: early and midterm results.

BACKGROUND: The aim of this study was to evaluate in elective patients the early and midterm results of partial clamping of the brachiocephalic trunk (BCT) for total ascending aorta replacement (TAAR) without circulatory arrest. Contraindications to the procedure were BCT/aortic arch calcifications and chronic aortic dissection. METHODS: The right radial artery was cannulated to monitor the systemic pressure after the BCT was partially clamped. A specially designed clamp was applied obliquely to occlude approximately 50% of the BCT and part of the aortic arch. The distal tip of the clamp was positioned in front of the left subclavian artery. From January 2002 to October 2003, 92 patients underwent TAAR. In 62 patients (67.4%), partial clamping of the BCT was used. Twenty of these patients underwent isolated TAAR, 27 underwent aortic valve replacement and TAAR, 11 had a Bentall operation, and 2 had a Cabrol operation. The aortic valve was spared in the remaining 2 patients. The mean (+/- SD) aortic cross-clamping and cardiopulmonary bypass times were 96 +/- 31 minutes and 116 +/- 43 minutes, respectively. RESULTS: Early mortality was 1.6% (1 patient). No cerebrovascular accidents occurred, demonstrating the safety of the technique. The major complications were acute respiratory insufficiency in 2 cases and acute renal failure in 5. The mean follow-up time was 9.0 +/- 6.5 months. The mean 18- month and event-free survival rate was 96.6% +/- 0.9%. CONCLUSION: Partial clamping of the BCT for TAAR without circulatory arrest provides good early and midterm clinical results. Aortic arch clamping is not associated with cerebrovascular accidents.