Late clinical and echocardiographic results with the Magna Ease© pericardial aortic bioprosthesis.

OBJECTIVES: The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results. METHODS: This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008-2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient-prosthesis mismatch (PPM). RESULTS: Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association class was I or II in 92.1%. Overall survival at 10 years was 56.8 ± 1.8%. Freedom from SVD at 10 was 96.5 ± 0.8% (Kaplan-Meier) and 97.4 ± 0.6% (competing risks) (28 SVD events after 6.9 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (TAVI)); 10-year freedom from reintervention was 97.8 ± 0.6%. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively, without association with late mortality (P = 0.12 for moderate and P = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8 ± 0.5% at 10 years. CONCLUSIONS: In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10-12 years.

Porcine bioprostheses for surgical aortic valve replacement: very long-term performance of a third-generation device.

AIMS: We aimed at investigating the long-term durability of the Epic bioprosthesis for surgical aortic valve replacement (SAVR) in a single-centre series of 888 implantations (2001-2018), expanding previous evaluations with shorter follow-up. METHODS: We retrieved prospectively collected in-hospital data and performed a systematic follow-up focusing on valve-related events (SVD, structural valve deterioration; PPM, patient-prosthesis mismatch; reoperation) (competing risks, CIF and Kaplan--Meier methods). We distinguished between SVD (permanent changes in valve function due to evolutive structural deterioration, ≥10 mmHg average gradient vs. reference echocardiography) and PPM. RESULTS: Average age at SAVR was 75.4 ±â€Š7 years; 855 (96.3%) bioprostheses entered the follow-up and 396 (46.4%) were alive at last assessment. Follow-up was 99.9% complete, median duration was 7.7 years (entire cohort) and 9.9 years (survivors). At 10 years, overall survival was 50% ±â€Š1.9, freedom from SVD was 99.4% ±â€Š0.3 (competing risks) (seven SVD events after 8.1 ±â€Š4.3 years). Freedom from SVD at 15 years was 98.4% ±â€Š0.8 (competing risks). Prevalence of severe PPM was higher in 19 mm (6.5%) and 21 mm (10.2%) size cohorts. PPM (severe or moderate/severe) had no significant impact on overall survival (log-rank P = 0.27 and P = 0.21, respectively). Freedom from any reintervention (reoperation or TAVI Valve-in-Valve) for SVD at 10 years was 99.4% ±â€Š0.3 (competing risks); freedom from any valve-related reintervention was 97.4% ±â€Š0.6 (competing risks). CONCLUSION: The Epic bioprosthesis for SAVR is limited by nonnegligible rates of PPM, which have nonetheless no impact on late survival. This device shows excellent durability and low rates of adverse valve-related events.

Durability of Mitral Valve Replacement With a Third-generation Bioprosthesis.

BACKGROUND: Our aim was to evaluate the durability of a third-generation porcine bioprosthesis (Epic porcine xenograft; Abbott Cardiovascular Inc, St Paul, MN) in the mitral position, according to patients' age at surgery. METHODS: Four hundred eighty-two mitral valve replacements using the Epic valve at a single center were included (2009-2018). Perioperative and early postoperative data were prospectively collected. A systematic follow-up was performed (99% complete, 1609.5 patient-years; average, 3.8 ± 2.5). Standardized definitions of valve-related events were adopted. Mean patient age at mitral valve replacement was 68.1 ± 10.4 years. RESULTS: Operative mortality was 9.3%. There were 5 early valve-related reoperations, mainly due to recurrent infectious endocarditis. Global survival at 8.8 years was 69.5% ± 5%. Nine structural valve deterioration (SVD) events occurred during follow-up (3 receiving reoperations, 4 transcatheter mitral valve replacement valve-in-valve, and 2 medical treatment only). The freedom from SVD at 5 and 10 years was 97.4% ± 1.2% and 89.6% ± 4.4% (actuarial) and 97.8% ± 1% and 91.9% ± 3.3%, respectively (competing risks). After stratification into subgroups by age at surgery (≤59 years, 50.8%; 60-69, 32.8%; ≥70, 16.4%) there was no significant intergroup difference in freedom from SVD (log-rank P = .24). The overall freedom from any reintervention for SVD at 10 years was 90.5% ± 4.4% (actuarial) and 92.7% ± 3.3% (competing risks), with no intergroup difference (log-rank P = .14). The freedom from any valve-related complication at 8.4 years was 83.2% ± 4.5% (actuarial). CONCLUSIONS: The Epic bioprosthesis shows good durability at 5 to 10 years in the mitral position.

Adult cardiac surgery during COVID-19 lockdown: Impact on activity and outcomes in a high-volume centre.

BACKGROUND: The coronavirus disease 2019 (COVID-19) outbreak had a direct impact on adult cardiac surgery activity, which systematically necessitates a postoperative stay in intensive care. AIM: To study the effect of the COVID-19 lockdown on cardiac surgery activity and outcomes, by making a comparison with the corresponding period in 2019. METHODS: This prospective observational cohort study compared adult cardiac surgery activity in our high-volume referral university hospital from 9 March to 10 May 2020 versus 9 March to 10 May 2019. Data were collected in our local certified database and a national database sponsored by the French society of thoracic and cardiovascular surgery. The primary study endpoints were operative mortality and postoperative complications. RESULTS: With 105 interventions in 2020, our activity dropped by 57% compared with the same period in 2019. Patients were at higher risk, with a significantly higher EuroSCORE II score (3.8±4.5% vs. 2.0±1.8%; P<0.001) and higher rates of active endocarditis (7.6% vs. 2.9%; P=0.047) and recent myocardial infarction (9.5% vs. 0%; P<0.001). The weight and priority of the interventions were significantly different in 2020 (P=0.019 and P<0.001, respectively). The rate of acute aortic syndromes was also significantly higher in 2020 (P<0.001). Operative mortality was higher during the lockdown period (5.7% vs. 1.7%; P=0.038). The postoperative course was more complicated in 2020, with more postoperative bleeding (P=0.003), mechanical circulatory support (P=0.032) and prolonged mechanical ventilation (P=0.005). Only two patients (1.8%) developed a positive status for severe acute respiratory syndrome coronavirus 2 after discharge. CONCLUSIONS: Adult cardiac surgery was heavily affected by the COVID-19 lockdown. A further modulation plan is necessary to improve outcomes and reduce postponed operations to decrease operative mortality and morbidity.

Right ventricular load adaptability metrics in patients undergoing left ventricular assist device implantation.

OBJECTIVE: Several right load adaptability metrics have been proposed as predictors of right heart failure (RHF) following left ventricular assist device implantation. This study sought to validate and compare the prognostic value of these indices. METHODS: This retrospective study included 194 patients undergoing continuous-flow left ventricular assist device implantation. The primary end point was unplanned right atrial assist device (RVAD) need within 30 days after left ventricular assist device implantation; the secondary end points included clinical RHF syndrome without RVAD need and the composite of RHF or RVAD need. Load adaptability indices or interventricular ratios were divided into surrogates of ventriculoarterial coupling (RV area change:end-systolic area), indices reflecting adaptation proportionality (Dandel's index = tricuspid regurgitation velocity-time integral normalized for average RV radius in diastole or systole), and simple ratios (eg, pulse pressure:right atrial pressure or right arterial pressure:pulmonary arterial wedge pressure). RESULTS: Mean age was 55 ± 13 years with 77% of men. RHF occurred in 75 patients with 30 patients requiring RVAD implantation. Among right heart metrics, right arterial pressure (normalized odd ratio, 1.62; 95% confidence interval, 1.15-2.38), right arterial pressure:pulmonary arterial wedge pressure (normalized odds ratio, 1.59; 95% confidence interval, 1.08-2.32) and pulse pressure:right arterial pressure < 2.0 (normalized odds ratio, 2.56; 95% confidence interval, 1.16-5.56) were associated with RVAD need (all P values < .02). These 3 metrics significantly added incremental prognostic value to the Interagency Registry for Mechanically Assisted Circulatory Support classification score in a similar range, whereas only RAP was incremental to the Michigan score. Correlates of RHF not requiring RVAD included RV end-systolic area index and the Dandel indices, which provided similar incremental value to the Interagency Registry for Mechanically Assisted Circulatory Support, Michigan, and European Registry for Patients with Mechanical Circulatory Support scores. CONCLUSIONS: Although associated with outcome, right load adaptability indices do not appear to provide strong incremental value when compared with simple metrics.

The Incremental Value of Right Ventricular Size and Strain in the Risk Assessment of Right Heart Failure Post - Left Ventricular Assist Device Implantation.

BACKGROUND: Right heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with high morbidity and mortality. Existing risk scores include semiquantitative evaluation of right ventricular (RV) dysfunction. This study aimed to determine whether quantitative evaluation of both RV size and function improve risk stratification for RHF after LVAD implantation beyond validated scores. METHODS AND RESULTS: From 2009 to 2015, 158 patients who underwent implantation of continuous-flow devices who had complete echocardiographic and hemodynamic data were included. Quantitative RV parameters included RV end-diastolic (RVEDAI) and end-systolic area index, RV free-wall longitudinal strain (RVLS), fractional area change, tricuspid annular plane systolic excursion, and right atrial area and pressure. Independent correlates of early RHF (<30 days) were determined with the use of logistic regression analysis. Mean age was 56 ± 13 years, with 79% male; 49% had INTERMACS profiles ≤2. RHF occurred in 60 patients (38%), with 20 (13%) requiring right ventricular assist device. On multivariate analysis, INTERMACS profiles (adjusted odds ratio 2.38 [95% confidence interval [CI] 1.47-3.85]), RVEDAI (1.61 [1.08-2.32]), and RVLS (2.72 [1.65-4.51]) were independent correlates of RHF (all P < .05). Both RVLS and RVEDAI were incremental to validated risk scores (including the EUROMACS score) for early RHF after LVAD (all P < .01). CONCLUSIONS: RV end-diastolic and strain are complementary prognostic markers of RHF after LVAD implantation.

Conventional aortic valve replacement in 2005 elderly patients: a 32-year experience.

OBJECTIVES: Considering the good immediate results reported for transcatheter aortic valve implantation in high-risk patients, the role of conventional aortic valve replacement (AVR) is being questioned, especially in elderly patients. The aim of this study was to evaluate our long-term results of conventional AVR in octogenarians. METHODS: A total of 2005 patients aged ≥80 years underwent AVR for aortic stenosis in our institution between 1978 and 2011. Of these, 1009 (50%) patients had an associated extracardiac comorbidity and 650 (32%) patients had coronary lesions. Valve replacement was the sole procedure in 1515 (76%) patients, and 396 (19%) patients had concomitant coronary artery bypass grafting. Data were collected at the time of surgery in our database, and regularly updated by mailed questionnaires and telephone contact. RESULTS: Early mortality of isolated AVR was 5.5% for the last 10 years of the series. Significant risk factors were chronic obstructive pulmonary disease, chronic renal failure, advanced cardiac disease [left or right ventricular failure, New York Heart Association (NYHA) Class IV and atrial fibrillation] and coronary disease. Long-term follow-up was 99.5% complete (9 patients lost to follow-up), totalling 8849 patient-years. Nine hundred and one patients died at late follow-up with a median survival of 7.1 years, with 7 patients becoming centenarian. Apart from older age, main late causes of death were cardiovascular (20.5%), neurological deficit (10.2%) and cancer (10.2%). Actuarial survival was 83%, 62.5% and 25% at 2, 5 and 10 years, respectively. This survival compares favourably with that of a French-matched population. Above all, 90% of late survivors reported functional improvement. Univariable and multivariable analysis identified risk factors of late death as male gender, associated comorbidity, renal failure, advanced cardiac disease, atrial fibrillation and impaired ventricular function. Coronary lesions, associated cardiac surgery and small diameter prostheses (19 or 21 mm) did not impair long-term survival. CONCLUSIONS: AVR is effective for all age groups to treat aortic stenosis. Elderly people should not be denied surgery only because of their old age as conventional AVR provides an excellent quality of life and restores life expectancy. Percutaneous valve implantation is to be considered, in cases of non-operable or high-risk patients. However, to date, open-heart surgery remains the treatment of choice for aortic stenosis for the majority of patients.

Incremental Value of Deformation Imaging and Hemodynamics Following Heart Transplantation: Insights From Graft Function Profiling.

OBJECTIVES: This study investigated to define graft dysfunction and to determine its incremental association with long-term outcome after heart transplantation (HT). BACKGROUND: Although graft failure is an established cause of late mortality after HT, few studies have analyzed the prognostic value of graft dysfunction at 1- and 5-year follow-up of HT. METHODS: Patients who underwent HT and completed their first annual evaluation with right heart catheterization and echocardiography at Stanford University between January 1999 and December 2011 were included in the study. Hierarchical clustering was used to identify modules to capture independent features of graft dysfunction at 1 year. The primary endpoint for analysis consisted of the composite of cardiovascular mortality, re-transplantation, or heart failure hospitalization within 5 years of HT. The study further explored whether changes in graft dysfunction between 1 and 5 years were associated with 10-year all-cause mortality. RESULTS: A total of 215 HT recipients were included in the study. Using hierarchical clustering, 3 functional modules were identified; among them, left ventricular global longitudinal strain (LVGLS), stroke volume index, and right atrial pressure (RAP) or pulmonary capillary wedge pressure (PCWP) captured key features of graft function. Graft dysfunction based on pre defined LVGLS in absolute value <14%, stroke volume index <35 ml/m2, RAP >10 mm Hg, or PCWP >15 mm Hg were present in 41%, 36%, and 27%, respectively. The primary endpoint at 5 years occurred in 52 patients (24%), whereas 10-year all-cause mortality occurred in 30 (27%) of 110 patients alive at 5 years. On multivariate analysis, RAP (standardized hazard ratio: 1.63), LVGLS (standardized hazard ratio: 1.39), and a history of hemodynamically compromising rejection within 1 year (hazard ratio: 2.18) were independent predictors of 5-year outcome. RAP at 5 years, as well as change in RAP from 1 to 5 years, was predictive of 10-year all-cause mortality. CONCLUSIONS: RAP and LVGLS at the first annual evaluation provide complementary prognostic information in predicting 5-year outcome after HT.

Load Adaptability in Patients With Pulmonary Arterial Hypertension.

Right ventricular (RV) adaptation to pressure overload is a major prognostic factor in patients with pulmonary arterial hypertension (PAH). The objectives were first to define the relation between RV adaptation and load using allometric modeling, then to compare the prognostic value of different indices of load adaptability in PAH. Both a derivation (n = 85) and a validation cohort (n = 200) were included. Load adaptability was assessed using 3 approaches: (1) surrogates of ventriculo-arterial coupling (e.g., RV area change/end-systolic area), (2) simple ratio of function and load (e.g., tricuspid annular plane systolic excursion/right ventricular systolic pressure), and (3) indices assessing the proportionality of adaptation using allometric pressure-function or size modeling. Proportional hazard modeling was used to compare the hazard ratio for the outcome of death or lung transplantation. The mean age of the derivation cohort was 44 ± 11 years, with 80% female and 74% in New York Heart Association class III or IV. Mean pulmonary vascular resistance index (PVRI) was 24 ± 11 with a wide distribution (1.6 to 57.5 WU/m2). Allometric relations were observed between PVRI and RV fractional area change (R2 = 0.53, p < 0.001) and RV end-systolic area indexed to body surface area right ventricular end-systolic area index (RVESAI) (R2 = 0.29, p < 0.001), allowing the derivation of simple ratiometric load-specific indices of RV adaptation. In right heart parameters, RVESAI was the strongest predictor of outcomes (hazard ratio per SD = 1.93, 95% confidence interval 1.37 to 2.75, p < 0.001). Although RVESAI/PVRI0.35 provided small incremental discrimination on multivariate modeling, none of the load-adaptability indices provided stronger discrimination of outcome than simple RV adaptation metrics in either the derivation or the validation cohort. In conclusion, allometric modeling enables quantification of the proportionality of RV load adaptation but offers small incremental prognostic value to RV end-systolic dimension in PAH.

Right Heart End-Systolic Remodeling Index Strongly Predicts Outcomes in Pulmonary Arterial Hypertension: Comparison With Validated Models.

BACKGROUND: Right ventricular (RV) end-systolic dimensions provide information on both size and function. We investigated whether an internally scaled index of end-systolic dimension is incremental to well-validated prognostic scores in pulmonary arterial hypertension. METHODS AND RESULTS: From 2005 to 2014, 228 patients with pulmonary arterial hypertension were prospectively enrolled. RV end-systolic remodeling index (RVESRI) was defined by lateral length divided by septal height. The incremental values of RV free wall longitudinal strain and RVESRI to risk scores were determined. Mean age was 49±14 years, 78% were female, 33% had connective tissue disease, 52% were in New York Heart Association class ≥III, and mean pulmonary vascular resistance was 11.2±6.4 WU. RVESRI and right atrial area were strongly connected to the other right heart metrics. Three zones of adaptation (adapted, maladapted, and severely maladapted) were identified based on the RVESRI to RV systolic pressure relationship. During a mean follow-up of 3.9±2.4 years, the primary end point of death, transplant, or admission for heart failure was reached in 88 patients. RVESRI was incremental to risk prediction scores in pulmonary arterial hypertension, including the Registry to Evaluate Early and Long-Term PAH Disease Management score, the Pulmonary Hypertension Connection equation, and the Mayo Clinic model. Using multivariable analysis, New York Heart Association class III/IV, RVESRI, and log NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) were retained (χ2, 62.2; P<0.0001). Changes in RVESRI at 1 year (n=203) were predictive of outcome; patients initiated on prostanoid therapy showed the greatest improvement in RVESRI. Among right heart metrics, RVESRI demonstrated the best test-retest characteristics. CONCLUSIONS: RVESRI is a simple reproducible prognostic marker in patients with pulmonary arterial hypertension.

Impact of donor comorbidities on heart transplant outcomes in the modern era.

OBJECTIVES: The use of marginal donors with cardiovascular risk factors is increasing due to organ shortage but remains controversial in heart transplantation (HTx). We sought to investigate post-transplant outcomes in the recent era taking into account donor characteristics. METHODS: We reviewed 261 HTx performed in our hospital between January 1996 and March 2013. Donor characteristics were obtained from the national database. The incidence of primary graft dysfunction (PGD) and cardiac allograft vasculopathy (CAV) and overall survival were compared in 2 groups of HTx recipients: those receiving transplants from 1996 to 2004 (Group A, n = 120) and from 2005 to 2013 (Group B, n = 141). RESULTS: The mean age of the donors was 34 ± 12 years in Group A vs 42 ± 13 years in Group B ( P < 0.001). Donors in Group B had a higher body mass index (23 ± 2 vs 26 ± 5 kg/m 2 , P < 0.001), were more likely to be smokers (29.6% vs 52.9%, P < 0.001) and were more likely to have hypertension (5% vs 13.5%, P = 0.030). There was no difference in survival at 1 and 5 years (79% and 63% in Group A vs 80% and 62% in Group B, respectively; P = 0.551). The rate of PGD was 36% in Group A vs 40% in Group B ( P = 0.092). Freedom from CAV at 5 years was 64% and 61%, respectively ( P = 0.367). Among the characteristics of the donors, only hypertension was associated with reduced survival. CONCLUSIONS: The use of older cardiac donors with more cardiovascular comorbidities in the recent era did not impair the post-transplant outcomes. Donor hypertension was the only determinant of worse survival.

Infective Endocarditis With Paravalvular Extension: 35-Year Experience.

BACKGROUND: We investigated our surgical strategy and clinical results in patients from active infective endocarditis (AIE) complicated by paravalvular involvement to determine the risk factors of early and late death and reoperation. METHODS: From October 1979 to December 2014, 955 patients underwent operations for AIE; among them 207 had AIE with paravalvular extension. The patients were a mean age of 59.9 ± 15.4 years, and 162 (78%) were male. Of these patients, 137 (66%) had isolated aortic valve endocarditis, and 138 (67%) had native valve endocarditis. Follow-up was 99% complete. RESULTS: The operative mortality of the cohort was 16% (n = 34). Abnormal communication, mechanical valve implantation, and renal failure were independent predictors of 30-day death. Survival at 1, 5, 10, and 15 years was 90.3% ± 2.3%, 62.4% ± 3.7%, 49.3% ± 4.1%, and 37.9% ± 4.4%, respectively. Streptococcus endocarditis (all species), complex annular repair, and preoperative heart failure were independent predictors of long-term death. A reoperation was required in 29 patients (14%). Streptococcus pneumoniae endocarditis was the only independent predictor of early reoperation (within 30 days after the operation or during the same hospitalization). Freedom from reoperation at 1, 5, 10, and 15 years was 91.9% ± 2.2%, 89.6% ± 2.6%, 89.6% ± 2.6%, and 87.0% ± 3.5%, respectively. Independent predictors of late reoperation were urgent/emergency operation, prosthetic valve endocarditis, and complex annular repair. CONCLUSIONS: AIE complicated by paravalvular involvement remains a surgical challenge. Valve replacement (particularly using bioprosthesis) associated with ad hoc reconstruction seems to be a reliable option and showed very encouraging results in this context.

Combined Coronary Revascularization: Single-Center 10-Year Experience.

OBJECTIVE: This study aimed to assess the long-term outcome of combined coronary revascularization. METHODS: Between January 2000 and September 2010, 106 consecutive patients underwent combined coronary revascularization, either the same day or staged within 90 days. Percutaneous coronary intervention was always performed before coronary artery bypass grafting. We identified three groups as follows: one-stop combined coronary revascularization (n = 20), percutaneous coronary intervention for acute coronary syndrome before subsequent surgery (n = 39), and percutaneous coronary intervention for stable coronary artery disease before subsequent surgery (n = 47). Off-pump technique was used in all cases. RESULTS: A total of 107 angioplasties were realized (drug-eluting stents, 21; bare metal stents, 114; balloon angioplasty, 4). Percutaneous coronary intervention was mostly performed in the right coronary artery or branches (85%). The mean (SD) number of grafts was 1.9 (0.6), among them 1.8 (0.7) with arterial grafts. A total of 87.7% of the patients underwent exclusive arterial revascularization. There was one reexploration for bleeding and no in-hospital death. Eleven patients died in the follow-up. Repeat percutaneous coronary intervention was necessary for six patients and repeat surgery for one patient. The mean (SD) follow-up was 6.1 (2.7) years. Complete follow-up was obtained in 96.2% of the patients. Freedom from ischemic events (all-cause deaths, angina, acute coronary syndrome, myocardial infarction) was 86.3% (3.7%) at 5 years and 79.7% (5.2%) at 8 years (no difference between groups). Freedom from major adverse cardiac or cerebrovascular events was 88.8% (3.4%) at 5 years and 75.7% (5.2%) at 8 years (no difference between groups). CONCLUSIONS: Combined coronary revascularization increases the use of arterial grafts, with good long-term outcome.

Safety of recombinant factor VIIa in patients under extracorporeal membrane oxygenation.

OBJECTIVES: To address the safety (rate of thromboembolic events and circuit complications) and efficacy (rate of bleeding control) of recombinant activated coagulation factor VII (rFVIIa) to treat severe bleeding refractory to all surgical and medical treatments in patients under veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support. METHODS: In a tertiary referral University Cardiothoracic Surgery Centre including three intensive care units, 30 patients received the rFVIIa during ongoing VA or VV ECMO support (8.6% of ECMO activity from 2005 to 2014; N = 347). Early and late clinical results were analysed (retrospective analysis of prospectively collected data). In a substudy, a case-matching procedure was performed among ECMO patients who received (Group A) or did not receive (Group B) rFVIIa treatment. RESULTS: The mediastinum was the most common site of refractory bleeding (after heart transplantation or other cardiac surgery; 90%); 90% (n = 27) of patients were on VA ECMO and the remainder on VV ECMO. The survival rate at ECMO explantation and at the 30th post-implantation day was 67 and 50%, respectively. The final efficacy rate of rFVIIa in stopping bleeding was 93.3%. The rate of thromboembolic events was 3.3% (1 case) and the rate of circuit change was 16.7% (without instances of overt circuit clotting). After case-matching, Group A comprised 23 patients and Group B included 43 patients. No statistically significant differences were observed among groups in terms of thromboembolic events (P = 0.99), circuit change, ventilation time (P = 0.71), infectious complications (P = 06) and survival at both ECMO explantation and the 30th post-implantation day. Late survival was comparable (Kaplan-Meier analysis; P = 0.42). CONCLUSIONS: In case of life-threatening bleeding refractory to all conventional therapies, rFVIIa presents an acceptable safety profile in patients under ECMO support. No circuit dysfunctions and limited rates of thromboembolism are observed.

Heart transplantation as salvage treatment of intractable infective endocarditis.

This study reports six consecutive patients who underwent heart transplantation as salvage treatment for endocarditis (Duke criteria) with extensive perivalvular lesions and end-stage heart failure. The median age was 45 years (range, 24 to 64), and the aortic valve was affected in all patients. Pathogens were Staphylococcus aureus (n = 2), Streptococcus pneumoniae (n = 2), Streptococcus agalactiae (n = 1), or not documented (n = 1). All patients survived, with no relapse, after a median follow-up of 24.5 months. The 10 patients with heart transplantation for endocarditis previously reported also survived (median follow-up, 27.5 months). Heart transplantation may be considered as salvage treatment in selected patients with intractable infective endocarditis.

Comparison of cardiac allograft vasculopathy in heart and heart-lung transplantations: a 15-year retrospective study.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is a major factor limiting long-term survival after heart transplantation (HTx). Specific determinants of CAV and long-term outcome after CAV occurrence have been poorly investigated after heart-lung transplantation (HLTx). METHODS: Between January 1996 and December 2006, 79 patients underwent HLTx (36.3 ± 12.2 years old; 47% men) and 141 patients underwent HTx (49.2 ± 12.3 years old; 77% men) at two different institutions. CAV grading was reviewed in both groups according to the 2010 standardized nomenclature of the International Society for Heart and Lung Transplantation. The mean post-transplant follow-up was 94 (1 to 181) months. RESULTS: Overall 10-year survival rate was 58% after HTx and 43% after HLTx (p = 0.11). The Grade 1 (or higher) CAV-free survival rate was 95% at 4 years and 69% at 10 years after HLTx, and 77% and 39%, respectively, after HTx (p < 0.01). Mean cyclosporine blood levels were similar between the groups at 3, 6, 12, 24 and 36 months. The main causes of mortality beyond 5 years after HTx and HLTx were malignancies and bronchiolitis obliterans, respectively. By multivariate analysis, recipients who developed >3 acute myocardial rejections during the first year post-transplant were exposed to a higher risk of CAV (95% CI 1.065 to 2.33, p = 0.02). Episodes of acute pulmonary rejection and bronchiolitis obliterans were not associated with an increased risk of CAV (p = 0.52 and p = 0.30). CONCLUSION: HLTx recipients appeared protected from CAV compared with HTx patients in this retrospective study. Repeated acute cardiac rejections were independent predictors of CAV. Unlike bronchiolitis obliterans, CAV had a very low impact on long-term survival after HLTx.