Sex-related differences among patients undergoing surgical aortic valve replacement-a propensity score matched study.

OBJECTIVES: We investigated the sex-related difference in characteristics and 2-year outcomes after surgical aortic valve replacement (SAVR) by propensity-score matching (PSM). METHODS: Data from 2 prospective registries, the INSPIRIS RESILIA Durability Registry (INDURE) and IMPACT, were merged, resulting in a total of 933 patients: 735 males and 253 females undergoing first-time SAVR. The PSM was performed to assess the impact of sex on the SAVR outcomes, yielding 433 males and 243 females with comparable baseline characteristics. RESULTS: Females had a lower body mass index (median 27.1 vs 28.0 kg/m2; P = 0.008), fewer bicuspid valves (52% vs 59%; P = 0.036), higher EuroSCORE II (mean 2.3 vs 1.8%; P < 0.001) and Society of Thoracic Surgeons score (mean 1.6 vs 0.9%; P < 0.001), were more often in New York Heart Association functional class III/IV (47% vs 30%; P < 0.001) and angina Canadian Cardiovascular Society III/IV (8.2% vs 4.4%; P < 0.001), but had a lower rate of myocardial infarction (1.9% vs 5.2%; P = 0.028) compared to males. These differences vanished after PSM, except for the EuroSCORE II and Society of Thoracic Surgeons scores, which were still significantly higher in females. Furthermore, females required smaller valves (median diameter 23.0 vs 25.0 mm, P < 0.001). There were no differences in the length of hospital stay (median 8 days) or intensive care unit stay (median 24 vs 25 hours) between the 2 sexes. At 2 years, post-SAVR outcomes were comparable between males and females, even after PSM. CONCLUSIONS: Despite females presenting with a significantly higher surgical risk profile, 2-year outcomes following SAVR were comparable between males and females.

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 bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741.

Aortic valve repair versus mechanical valve replacement for root aneurysm: the CAVIAAR multicentric study.

OBJECTIVES: Despite growing evidence that aortic valve repair improves long-term patient outcomes and quality of life, aortic valves are mostly replaced. We evaluate the effect of aortic valve repair versus replacement in patients with dystrophic aortic root aneurysm up to 4 years. METHODS: The multicentric CAVIAAR (Conservation Aortique Valvulaire dans les Insuffisances Aortiques et les Anévrismes de la Racine aortique) prospective cohort study enrolled 261 patients: 130 underwent standardized aortic valve repair (REPAIR) consisting of remodelling root repair with expansible aortic ring annuloplasty, and 131 received mechanical composite valve and graft replacement (REPLACE). Primary outcome was a composite criterion of mortality, reoperation, thromboembolic or major bleeding events, endocarditis or operating site infections, pacemaker implantation and heart failure, analysed with propensity score-weighted Cox model analysis. Secondary outcomes included major adverse valve-related events and components of primary outcome. RESULTS: The mean age was 56.1 years, and valve was bicuspid in 115 patients (44.7%). Up to 4 years, REPAIR did not significantly differ from REPLACE in terms of primary outcome [Hazard Ratio (HR) 0.66 (0.39; 1.12)] but showed significantly less valve-related deaths (HR 0.09 [0.02; 0.34]) and major bleeding events (HR 0.37 [0.16; 0.85]) without an increased risk of valve-related reoperation (HR 2.10 [0.64; 6.96]). When accounting for the occurrence of multiple events in a single patient, the REPAIR group had half the occurrence of major adverse valve-related events (HR 0.51 [0.31; 0.86]). CONCLUSIONS: Although the primary outcome did not significantly differ between the REPAIR and REPLACE groups, the trend is in favour of REPAIR by a significant reduction of valve-related deaths and major bleeding events. Long-term follow-up beyond 4 years is needed to confirm these findings.

Early and long-term results of hypothermic circulatory arrest in aortic surgery: a 20-year single-centre experience.

AIMS: The aim of this study was to document the postoperative outcomes of patients who underwent hypothermic circulatory arrest (HCA), the evolution of HCA management over time and to identify the risks factor for early mortality and postoperative stroke. METHODS: Four hundred and twenty-four patients who underwent aortic surgery with HCA at our institution between January 1995 and June 2016 were consecutively included. RESULTS: The main indications were degenerative aneurysm (254; 59.9%) and acute type A aortic dissection (146; 34.4%). Interventions were performed under deep (18.4 ±â€Š0.9°C; n = 350; 82.5%) or moderate (23.9 ±â€Š1.9°C; n = 74; 17.5%) hypothermia. Antegrade cerebral perfusion (ACP) was employed in 86 (20.3%) cases. The use of moderate hypothermia significantly increased from 2011, to become the preferred strategy in 2016. The in-hospital mortality was 12.5% and the postoperative stroke rate was 7.1%. Kaplan--Meier 5-year survival was 65.7%. Nonelective timing [odds ratio (OR) 4.05; P < 0.001], stroke (OR 3.77' P = 0.032), renal failure (OR 2.49; P = 0.023), redo surgery (2.42; P = 0.049) and CPB time (OR 1.05; P = 0.03) were independent risk factors for in-hospital mortality in multivariate analysis. Femoral cannulation was the only independent risk factor for stroke (OR 3.97; P = 0.002). The level of hypothermia and the use of ACP were not associated with either in-hospital mortality or postoperative stroke. CONCLUSION: HCA might be widely considered to achieve a radical treatment of the aortic disease, provided that hypothermia is maintained below the 24°C safety threshold and ACP is used for HCA exceeding 30 min, to ensure optimal brain, spinal cord and visceral organs protection.

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.

Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry.

BACKGROUND: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. METHODS: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. DISCUSSION: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).

Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves.

BACKGROUND: Aortic valve replacement (AVR) in small aortic roots remains a surgical dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of PPM on outcome and functional class. METHODS: We performed a retrospective analysis of prospectively collected in-hospital data, and a prospective single-center follow-up of 849 patients who received a 19 to 23 mm PMEAV (2008-2014). Concomitant mitral or tricuspid replacement was the exclusion criterion. Early hemodynamic features were prospectively collected; mid-term follow-up was conducted according to current guidelines. RESULTS: Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in 36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-up was 99.9% complete (3.7 ± 2 years). Actuarial freedom from structural valve deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan-Meier's analysis, PPM and age <70 years were associated with SVD. PPM was not associated with worse functional status (New York Heart Association class) or mortality at follow-up. CONCLUSION: This series shows satisfactory clinical outcomes of the PMEAV implanted in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it has limited clinical impact, and it is not associated with mid-term mortality or worse functional class. Few SVD events are evidenced; nonetheless, limited follow-up duration and its methodology need to be considered.

Prognostic impact of blood product transfusion in VA and VV ECMO.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is an accepted and reliable technique to provide temporary circulatory and/or respiratory support. Our objective was to describe the transfusion requirements in ECMO recipients. Secondarily, we addressed the effect of indications for ECMO on transfusion requirements and the baseline factors associated with worse survival. METHODS: We reviewed the prospectively collected data of 509 patients receiving venoarterial (VA) or venovenous (VV) ECMO therapy (2005-2016). Follow-up was prospectively conducted. Data were prospectively entered in the Rennes ECMO database. RESULTS: VA ECMO was employed in 81% of cases; indications were post-cardiotomy myocardial failure in 28% of cases, post-heart transplantation (early graft failure) in 13.2% and cardiogenic shock in 149 (36.4%). VV ECMO was employed in the remaining patients. Average follow-up was 80.25 ± 85.13 days and was 100% complete. In the VA and VV groups, survival at the 30th post-implantation day was 58.3% and 71.1%, respectively, and survival at 6 months was 40.5% and 50.5%, respectively. Platelets and prothrombin time (PT) levels were significantly lower in the VA ECMO group at implantation (p<0.001). VA ECMO patients had a higher rate of thrombotic/haemorrhagic complications (p<0.001) and received both fresh frozen plasma (FFP) (60.5% vs. 31.8% p<0.001) and platelet units (Plt) (61.7% vs. 34.1% p<0.001) more frequently than VV ECMO patients. Post-cardiotomy and post-transplantation patients had significantly higher rates of transfusion of packed red blood cells (pRBC), FFP and Plt than other VA ECMO cases (p<0.001, all). Mortality was equal or greater than 80% among patient subgroups who received more than 19 pRBC, 5 Plt and/or 12 FFP. CONCLUSIONS: An ECMO program is associated with important consumption of blood products. VA ECMO patients have a greater transfusion burden than VV ECMO patients. Mortality is greater in the case of extreme transfusion requirements.

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.

Long-term follow-up of bioprosthetic aortic valve replacement in patients aged ≤60 years.

OBJECTIVE: To address the long-term durability of bioprostheses used for aortic valve replacement (AVR) in adult patients aged ≤60 years at the time of surgery. METHODS: Through a retrospective review of a prospectively collected database, we identified 416 bioprosthetic AVRs performed between 1977 and 2013. A prospective follow-up of valve-related and non-valve-related events was performed. RESULTS: Follow-up was 98.5% complete (2423.1 patient-years; average, 6 ± 5.5 years). At 15 years, overall survival was 62.1 ± 4.4%; freedom from valve-related death was 97.1 ± 1.6%. There were 68 SVD events (11.9 ± 28.8 years after surgery). Freedom from SVD at 15 years was 48.7 ± 5.5% for Kaplan-Meier analysis and 61.4 ± 4.3% for competing-risks analysis. After stratification into age subgroups (<40 years, ≥40 and <50 years, and ≥50 and ≤60 years), we observed no significant difference in freedom from SVD (P = .50). The average delay to SVD was not statistically different among subgroups (P = .30). There were 57 reoperations for SVD (11.8 ± 5.2 years after implantation). The 15 year freedom from reoperation for SVD was 55.4 ± 5.6% by Kaplan-Meier analysis and 67.1 ± 4.2% by competing-risks analysis. After stratification by age, freedom from reoperation for SVD was comparable (P = .13). Freedom from any valve-related complication or death was 42 ± 5% by Kaplan-Meier analysis and 54.4 ± 4.1% by competing-risks analysis. CONCLUSIONS: The lifetime risk of SVD is considerable in patients aged ≤60 years at the time of bioprosthesis implantation. Nonetheless, durability remains consistent during the first decade; additional data are required for the second decade. Patients' information is pivotal for valve choice (competing-risks method).

Clinical outcomes in patients after extracorporeal membrane oxygenation support for post-cardiotomy cardiogenic shock: a single-centre experience of 92 cases.

OBJECTIVES: Post-cardiotomy cardiogenic shock is a major concern in cardiac surgery. We reviewed our experience of extracorporeal membrane oxygenation (ECMO) as temporary circulatory support in post-cardiotomy cardiogenic shock. METHODS: Between January 2005 and December 2014, adult patients implanted with ECMO after cardiac surgical procedures were included. Indications for ECMO were failure to be withdrawn from cardiopulmonary bypass or refractory cardiogenic shock occurring during postoperative Days 1 and 2. Patients' characteristics and outcomes were prospectively collected in a local ECMO database. RESULTS: Ninety-two patients, median age of 63 years (17-83 years), were supported by ECMO following valvular surgery (66%), acute aortic dissection (10%) and coronary artery bypass grafting (9%). A total of 37% were combined surgical procedures, 24% were redo procedures and 33% were emergent procedures. The median duration of ECMO support was 6 days (1-28 days). The weaning rate from mechanical support was 48%. Overall 1-month and 6-month survival rates were, respectively, 42% and 39%. Survivors were younger (57 vs 63 years old, P = 0.02) and had a higher preoperative left ventricular ejection fraction (52.5 vs 44.1%, P = 0.017). There was a trend for lower serum creatinine levels and total bilirubin rates in the survivors' group 24 h after initiation of ECMO (respectively, 162 vs 212 µmol/l, P = 0.06; 25.3 vs 54.2 mg/dl, P = 0.08). Valvular surgery and peak lactic acid serum level were associated with poor outcomes. The mean health-related quality of life EuroQoL scale was 68 ± 16/100 at 2 years. CONCLUSIONS: Refractory cardiogenic shock requiring ECMO was most frequently observed after redo valvular surgery in the present study. The overall 6-month survival rate was 39% after ECMO support for post-cardiotomy cardiogenic shock with acceptable health-related quality of life. Improved kidney and liver functions after 24 h of support were associated with favourable outcomes.

Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement.

OBJECTIVE: To clarify the mid-term durability of the Trifecta bioprosthesis for aortic valve replacement (AVR). METHODS: We retrospectively analyzed the prospectively collected data of 824 consecutive implants of the Trifecta valve at a single institution. A 100% complete follow-up was available (average duration, 2.2 ± 1.3 years; range, 0.03-6.9 years; 1747.6 patient-years). Echocardiography data at discharge were recorded prospectively. RESULTS: Operative mortality was 3.8%; 2.7% in patients receiving isolated AVR. There were 5 valve-related early reoperations, including 1 for infective prosthetic endocarditis and 4 for nonstructural valve dysfunction. The global rate of severe patient-prosthesis mismatch was 1.26%. Overall 5-year survival was 74.9%, and freedom from valve-related death was 97.8%. The majority of deaths attributed to the valve were due to unknown causes. We observed 6 SVD events at 3.4 ± 1.6 years after surgery. At 5 years, the actuarial freedom from SVD was 98% ± 0.9% (n = 6), freedom from reintervention for SVD was 98% ± 0.9% (n = 5, including 2 transcatheter valve-in-valve), and freedom from open reoperation for SVD was 98.9% ± 0.6%. The 5-year freedom from prosthetic endocarditis was 97.7% ± 0.7% (n = 12, 6 requiring reoperation). There was 1 case of late NSVD (5-year freedom, 99.8% ± 0.2%). Freedom from hemorrhagic events was 98.6% ± 0.5% (86% occurring in patients on anticoagulants); there were no thromboembolic events at follow-up. CONCLUSIONS: The Trifecta bioprosthesis is a reliable device for AVR. We confirm excellent immediate hemodynamic properties and a very low rate of patient-prosthesis mismatch. The absolute number of SVD cases observed remains limited; nevertheless, their timing, pathological characteristics, and clinical presentation mandate continued follow-up.

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.

Appraisal of Long-Term Outcomes of Tricuspid Valve Replacement in the Current Perspective.

BACKGROUND: We address the differential long-term results of tricuspid valve replacement and late valve-related events among bioprostheses versus mechanical prostheses. METHODS: In a single-institution investigation, we reviewed the patients' prospectively collected data and performed a clinical follow-up. Both the Kaplan-Meier (actuarial) and the competing risks (actual) methodologies were used. RESULTS: Overall, 188 tricuspid valve replacements were performed during 1971 to 2012. In this complex population (reoperations, 48.1%; associated procedures in 71.3%), operative mortality was 27.6% (significantly declining in recent years). A bioprosthesis was used in 82.4%. Follow-up was 10.2 ± 9.1 years (as long as 37.3 years, or 1,270 patient-years; 91.2% complete). At 15 years, freedom from structural valve deterioration was 93.3% ± 6.4% (competing risks 94.7 ± 5.1%) in the mechanical group and 85.2% ± 5.4% (competing risks 92% ± 2.9%) in the bioprostheses group (p = 0.19). Freedom from any valve-related adverse events was lower among mechanical valves versus bioprostheses (although not statistically significant). Mechanical valves showed significantly lower freedom from thromboembolic events (actuarial 62.3% ± 14.3% versus 97.7% ± 1.6%; competing risks 74.1% ± 10% versus 98% ± 1.4%; p < 0.001) and earlier adverse events (4.9 ± 4.5 versus 11.1 ± 9.4 years) than bioprostheses. There were 11 reoperations for bioprosthetic structural valve deterioration (89.8% and 94.3% actuarial and actual freedom, respectively). CONCLUSIONS: Bioprostheses for tricuspid valve replacement have a very good long-term durability. Mechanical valves display earlier and more severe morbidity at follow-up.

Survival and quality of life after extracorporeal life support for refractory cardiac arrest: A case series.

OBJECTIVES: Extracorporeal life support (ECLS) is an emerging option to treat selected patients with cardiac arrest refractory to cardiopulmonary resuscitation (CPR). Our primary objective was to determine the mortality at 30 days and at hospital discharge among adult patients receiving veno-arterial ECLS for refractory cardiac arrest. Our secondary objectives were to determine the 1-year survival and the health-related quality of life, and to examine factors associated with 30-day mortality. METHODS: In a retrospective, single-center investigation within a tertiary referral center, we analyzed the prospectively collected data of 49 patients rescued from refractory cardiac arrest through emergent implantation of ECLS (E-CPR) (18.1% of our overall ECLS activity, 2005-2013), implanted in-hospital and during ongoing external cardiac massage in all cases. A prospective follow-up with administration of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire was performed. RESULTS: The mean age was 47.6 ± 1.6 years; out-of-hospital cardiac arrest occurred in 12% of cases; average low-flow time was 47.2 ± 33 minutes; causes of cardiac arrest were heart disease (61.2%), trauma (14.3%), respiratory disease (4.1%), sepsis (2%), and miscellaneous (18.4%). PRIMARY OBJECTIVE: Rates of survival at E-CPR explantation and at 30 days were 42.9% and 36.7%, respectively; brain death occurred in 24.5% of cases. SECONDARY OBJECTIVES: Increased simplified acute physiology score; higher serum lactate levels and lower body temperature at the time of implantation were associated with 30-day mortality. Bridge to heart transplantation or implantation of a long-term ventricular assist device was performed in 8.2%. No deaths occurred during the follow-up after discharge (36.7% survival; average follow-up was 15.6 ± 19.2 months). The average Physical Component Summary and Mental Component Summary scores (SF-36 questionnaire) were, respectively, 45.2 ± 6.8 and 48.3 ± 7.7 among survivors. CONCLUSIONS: Extracorporeal cardiopulmonary resuscitation is a viable treatment for selected patients with cardiac arrest refractory to CPR. In our series, approximately one third of rescued patients were alive at 6 months and presented quality-of-life scores comparable to those previously observed in patients treated with ECLS.

Standardized approach to valve repair using an expansible aortic ring versus mechanical Bentall: early outcomes of the CAVIAAR multicentric prospective cohort study.

OBJECTIVE: The study objective was to compare the 30-day outcomes of a standardized aortic valve repair technique (REPAIR group) associating root remodeling with an expansible aortic ring annuloplasty versus mechanical composite valve and graft (CVG group) replacement in treating aortic root aneurysms. METHODS: A total of 261 consecutive patients with aortic root aneurysm were enrolled in this multicentric prospective cohort (131 in the CVG group, 130 in the REPAIR group) in 20 centers. The main end point is a composite criterion including mortality; reoperation; thromboembolic, hemorrhagic, or infectious events; and heart failure. Secondary end points were major adverse valve-related events. Crude and propensity score adjusted estimates are provided. RESULTS: The mean age was 56.1 years, and the valve was bicuspid in 115 patients (44.7%). The median (interquartile range) preoperative aortic insufficiency grade was 2.0 (1.0-3.0) in the REPAIR group and 3.0 (2.0-3.0) in the CVG group (P = .0002). Thirty-day mortality was 3.8% (n = 5) in both groups (P = 1.00). Despite a learning curve and longer crossclamp times for valve repair (147.7 vs 99.8 minutes, P < .0001), the 2 groups did not differ significantly for the main criterion (odds ratio, 1.31; 95% confidence interval, 0.72-2.40; P = .38) or 30-day mortality (odds ratio, 0.99; 95% confidence interval, 0.28-3053; P = .99), with a trend toward more frequent major adverse valve-related events in the CVG group (odds ratio, 2.52; 95% confidence interval, 0.86-7.40; P = .09). At discharge, 121 patients (96.8%) in the REPAIR group had grade 0 or 1 aortic insufficiency. CONCLUSIONS: A new standardized approach to valve repair, combining an expansible aortic annuloplasty ring with the remodeling technique, presented similar 30-day results to mechanical CVG with a trend toward reducing major adverse valve-related events. Analysis of late outcomes is in process for 3- and 10-year follow-ups.