Biological Aortic Valve Replacement Research Articles

Mechanical or biological prosthesis for aortic valve replacement in patients aged 45 to 74 years

ObjectiveThe selection of valve prostheses for patients undergoing surgical aortic valve replacement remains controversial. In this study, we compared the long-term outcomes of patients undergoing aortic valve replacement with biological or mechanical aortic valve prostheses. MethodsWe evaluated late results among 5762 patients aged 45 to 74 years who underwent biological or mechanical aortic valve replacement with or without concomitant coronary artery bypass from 1989 to 2019 at 4 medical centers. The Cox proportional hazards model was used to compare late survival; the age-dependent effect of prosthesis type on long-term survival was evaluated by an interaction term between age and prosthesis type. Incidences of stroke, major bleeding, and reoperation on the aortic valve after the index procedure were compared between prosthesis groups. ResultsOverall, 61% (n = 3508) of patients received a bioprosthesis. The 30-day mortality rate was 1.7% (n = 58) in the bioprosthesis group and 1.5% (n = 34) in the mechanical group (P = .75). During a mean follow-up of 9.0 years, the adjusted risk of mortality was higher in the bioprosthesis group (hazard ratio, 1.30, P < .001). The long-term survival benefit associated with mechanical prosthesis persisted until 70 years of age. Bioprosthesis (vs mechanical prosthesis) was associated with a similar risk of stroke (P = .20), lower risk of major bleeding (P < .001), and higher risk of reoperation (P < .001). ConclusionsCompared with bioprostheses, mechanical aortic valves are associated with a lower adjusted risk of long-term mortality in patients aged 70 years or less. Patients aged less than 70 years undergoing surgical aortic valve replacement should be informed of the potential survival benefit of mechanical valve substitutes.

Subclinical valve leaflet thrombosis following bioprosthetic aortic valve replacement.

Subclinical leaflet thrombosis (SLT) is often an incidental finding characterized by a thin layer of thrombus involving one, two or three leaflets, with typical appearance on multi-detector computed tomography (MDCT) of hypo-attenuating defect at the aortic side of the leaflet, also called hypo-attenuating leaflet thickening (HALT). SLT may occur following both transcatheter aortic replacement (TAVR) or biological surgical aortic valve replacement (SAVR). The aim of this review is to present an overview of the current state of knowledge on the incidence, diagnosis, clinical impact, and management of SLT following TAVR or SAVR. SLT occurs in 10-20% of patients following TAVR and is somewhat more frequent than following SAVR (5-15%). SLT may regress spontaneously without treatment in about 50% of the cases but may also progress to clinically significant valve thrombosis in some cases. Oral anticoagulation with vitamin K antagonist is reasonable if SLT is detected by echocardiography and/or MDCT during follow-up and is generally efficient to reverse SLT. SLT is associated with mild increase in the risk of stroke but has no impact on survival. SLT has been linked with accelerated structural valve deterioration and may thus impact valve durability and long-term outcomes. SLT is often an incidental finding on echocardiography or MDCT that occurs in 10-20% of patients following TAVR or 5-15% following biological SAVR and is associated with a mild increase in the risk of thrombo-embolic event with no significant impact on mortality but may be associated with reduced valve durability.

A TAVI VALV IN VALV AT ALMOST 90 YEARS

Abstract Degeneration of the biologic aortic valve prosthesis represents an increasingly important issue. This process often affects frail elderly patients who are not candidates for cardiac re–intervention. TAVI valve–in–valve implantation therefore probably remains the only viable option in such patients.We report the clinical case of Mrs. Luciana F., currently 94 years old, who underwent biological aortic valve replacement in 2016. In charge of the Elderly Patient‘s Heart Failure Outpatient Clinic (SOD Geriatrics–UTIG) since January 2023.At first evaluation,89 years old, widowed, living alone; MMSE 29/30. SPPB 7/12. Totally autonomous in BADL, and partially in IADL.She complained of decreased exercise tolerance (NYHA Class III). No alterations in left ventricular kinetics. Calcified and degenerated aortic valve prosthesis with markedly reduced box opening and severe stenosis (Vel 4.7 m/s; Grad max/med (86/55 mmHg) mild insufficiency. May 2023 access to DEA for syncopal episode, complicated by fall down stairs and head injury; on echocardiogram relief of further degeneration of aortic bioprosthesis (moderate–grade intra–prosthetic insufficiency at 2 jets with PTH 300 msec and severe stenosis, Gmax/Gmed 88/55 mmHg, DVI 0.20 June 2023 worsening of dyspnea that appeared even at rest NYHA IV. At echocolordoppler confirmed severe aortic stenosis severe bioprosthesis degeneration. She was evaluated in Heart Team: low overall risk (MPI 0.31) therefore percutaneous implantation of Medtronic Evolut R aortic bioprosthesis has been performed. At discharge asymptomatic, eupnoic, walking independently without aids for short stretches. At subsequent follow–up.–1 month: substantial clinical well–being in the absence of dyspnea on ordinary exertion (NYHA II), no orthopnea or paroxysmal nocturnal dyspnea; denies angor, heart palp or syncopal episodes. She has resumed household chores and leaves the house almost every day –6 months: clinical stability. She walks long distances every day in the absence of symptomatology. –1 years (turned 90 years old): clinical stability with dyspnea for moderate exertion continues active life. Trans prosthetic gradient max/medium 22/12 mmHg, VD–AD 30 mmHg. In conclusion TAVI procedure on degenerated biological prosthesis should be an option to be considered in the elderly patient selected and evaluated by a multidisciplinary Heart Team to achieve improvement of cardiovascular symptoms and concomitantly recovery of functional autonomy.

Aortic valve hemodynamic characteristics after the Ozaki procedure according to echocardiography: a multicenter retrospective study

Aim. To evaluate the aortic valve (AV) hemodynamic characteristics after the Ozaki procedure according to echocardiography.Material and methods. The retrospective multicenter study included 277 patients with AV defects who were operated on from January 2017 to June 2022 in five centers in Russia. After the Ozaki procedure, the following endpoints were assessed: immediate echocardiographic results (peak AV gradient, mean AV gradient, AV effective orifice area, aortic regurgitation grade), mid-term clinical (three-year survival rate, three-year freedom from reoperation, three-year freedom from grade ≤2 aortic regurgitation) and echocardiographic results (peak and mean AV gradient, AV effective orifice area, aortic regurgitation grade, AV calcification severity). The median follow-up period was 23 (13-32) months. The mean echocardiography follow-up period was 21±10 months.Results. During the treatment, a decrease in the peak AV gradient was observed from 74±30 mm Hg before surgery up to 12 (8-16) mm Hg one week after surgery, which remained in the mid-term period — 12 (9-15) mm Hg. There was also a decrease in the mean gradient from 40 (27-53) mm Hg before surgery up to 6 (4-8) mm Hg one week after surgery. By the mid-term period, the mean gradient was 6 (4-8) mm Hg. The AV effective orifice area increased from 1 (1-1) cm2 to 2 (2-2) cm2 in the mid-term follow-up period. Three-year survival rate was 90,2%, freedom from reoperation was 95%, freedom from grade ³2 aortic regurgitation was 88%, and no patient had AV calcification.Conclusion. The Ozaki procedure in patients with AV defects has good immediate and mid-term hemodynamic parameters according to echocardiography. However, there remains a need for large randomized controlled trials comparing Ozaki procedure with biological AV replacement.

Sutureless Biological Aortic Valve Replacement (Su-AVR) in Redo operations: a retrospective real-world experience report of clinical and echocardiographic outcomes

ObjectiveThis retrospective study aimed to compare the outcomes of sutureless aortic valve replacement (su-AVR) and conventional bioprosthetic sutured AVR (cAVR) in high-risk patients undergoing redo surgery.MethodsA total of 79 patients who underwent redo AVR between 2014 and 2021 were included in the study. Of these, 27 patients underwent su-AVR and 52 underwent cAVR. Patient characteristics and clinical outcomes were analysed using multivariate regression and Kaplan Meier survival test.ResultsThe groups were similar in terms of age, gender, left ventricular function, and number of previous sternotomies. In cases of isolated AVR, su-AVR had significantly lower cross clamp times than cAVR (71 vs. 86 min, p = 0.03). Postoperatively, 4 cAVR patients required pacemaker compared to zero patients in the su-AVR group. There were no significant differences between the two groups in terms of postoperative complications, intrahospital stay (median 9 days, IQR 7–20), or in-hospital mortality (1 su-AVR; 2 cAVR). The long-term survival rate was similar between the su-AVR (90%) and cAVR (92%) groups (log rank p = 0.8). The transvalvular gradients at follow-up were not affected by the type of valve used, regardless of the valve size (coef 2.68, 95%CI -3.14–8.50, p = 0.36).ConclusionThe study suggests that su-AVR is a feasible and safe alternative to cAVR in high-risk patients undergoing redo surgery. The use of su-AVR offers comparable outcomes to cAVR, with reduced cross clamp times and a lower incidence of postoperative pacemaker requirement in isolated AVR cases. The results of this study contribute to the growing body of evidence supporting the use of su-AVR in high-risk patients, highlighting its feasibility and safety in redo surgeries.

Survival and Recurrence of Endocarditis following Mechanical vs. Biological Aortic Valve Replacement for Endocarditis in Patients Aged 40 to 65 Years: Data from the INFECT-Registry.

Infective endocarditis (IE) is a serious disease, and in many cases, surgery is necessary. Whether the type of prosthesis implanted for aortic valve replacement (AVR) for IE impacts patient survival is a matter of debate. The aim of the present study is to quantify differences in long-term survival and recurrence of endocarditis AVR for IE according to prosthesis type among patients aged 40 to 65 years. This was an analysis of the INFECT-REGISTRY. Trends in proportion to the use of mechanical prostheses versus biological ones over time were tested by applying the sieve bootstrapped t-test. Confounders were adjusted using the optimal full-matching propensity score. The difference in overall survival was compared using the Cox model, whereas the differences in recurrence of endocarditis were evaluated using the Gray test. Overall, 4365 patients were diagnosed and operated on for IE from 2000 to 2021. Of these, 549, aged between 40 and 65 years, underwent AVR. A total of 268 (48.8%) received mechanical prostheses, and 281 (51.2%) received biological ones. A significant trend in the reduction of implantation of mechanical vs. biological prostheses was observed during the study period (p < 0.0001). Long-term survival was significantly higher among patients receiving a mechanical prosthesis than those receiving a biological prosthesis (hazard ratio [HR] 0.546, 95% CI: 0.322-0.926, p = 0.025). Mechanical prostheses were associated with significantly less recurrent endocarditis after AVR than biological prostheses (HR 0.268, 95%CI: 0.077-0.933, p = 0.039). The present analysis of the INFECT-REGISTRY shows increased survival and reduced recurrence of endocarditis after a mechanical aortic valve prosthesis implant for IE in middle-aged patients.

Abstract 16917: Ross Procedure versus Biological Aortic Valve Replacement in Adults in a Single Center Setting: A Propensity Score Matched Comparison

Background: Guidelines suggested alternative for middle-aged adults undergoing aortic valve replacement is mechanical prosthesis, followed by the Ross procedure (Ross). However, increasingly more patients receive a biological prosthesis (bio AVR) even in young adult age. Is this practice justified? Objectives: To compare long-term outcomes in a single center after Ross vs bio AVR. Methods: For this retrospective study, we screened 2624 patients 04/2007 - 03/2020. Out of these, 231 received Ross, and 2393 received bio AVR ± CABG or aortic surgery. Exclusion criteria: emergency surgery and concomitant mitral or tricuspid valve surgery. Using 1:1 propensity score 99 matches were paired. Primary end-point was all-cause mortality. Secondary end-point was composite of death, need for repeat intervention, and stroke (MACCE). Median follow-up was 7.5 years (IQR: 4.4 - 10.6 years). Results: Mean age for Ross was 56.2±6.1, and for bio AVR was 56.2±5.9. Actuarial 10-year survival for Ross was 89.3%, but significantly lower for the bio AVR 57.9%. All-cause mortality was significantly lower after the Ross procedure compared to the bio AVR (log rank p&lt;0.001). The MACCE-free survival was significantly better after the Ross procedure (log rank p&lt;0.001). Conclusion: In middle-aged adults undergoing AVR, the Ross procedure was superior over the conventional bio AVR after 10 years F/U. Bio AVR should therefore be avoided in this patient population every time possible. Overall long-term survival after Ross vs bio AVR: MACCE free survival after Ross vs bio AVR:

Clinical Impact of Patient-Prosthesis Mismatch After Aortic Valve Replacement With a Mechanical or Biological Prosthesis.

Patient-prosthesis mismatch (PPM) may impair functional capacity and survival after aortic valve replacement. This study aimed to investigate the impact of PPM on long-term survival and quality of life after mechanical and biological aortic valve replacement. This study included 595 consecutive patients who had undergone isolated aortic valve replacement. Patients were divided into 2 groups according to prosthesis type. The baseline and operative characteristics, survival rates, complications, and quality of life of the groups with and without PPM were compared for up to 6 years. The PPM calculation was performed using the effective orifice area value provided by the manufacturer divided by the patient's body surface area. The moderate to severe PPM rates were 69.8% and 3.7% after biological and mechanical prosthesis implantation, respectively. Mean survival for patients in the biological group who had PPM was statistically significantly shorter (50.2 months [95% CI, 45.2-55.3]) than for patients in the biological group without PPM (60.1 months [95% CI, 55.7-64.4]; P = .04). In the mechanical prosthesis group, there was no difference in mean survival between the subgroup with PPM (66.6 months [95% CI, 58.3-74.9]) and the subgroup without PPM (64.9 months [95% CI, 62.6-67.2]; P = .50). A quality-of-life questionnaire's scores did not differ between the groups. Mismatch is common after biological valve implantation and statistically significantly affects long-term survival and quality of life. If the risk of PPM after implantation of a biological prosthesis is suspected, adopting strategies to avoid PPM at the time of surgery is warranted.

National indication document and aortic valve replacement landscape in the Netherlands.

Based on European guidelines, transcatheter aortic valve implementation (TAVI) could be the therapy of choice in patients with severe aortic stenosis aged ≥ 75years. In the Netherlands, there has been adebate between healthcare providers and the National Health Care Institute regarding reimbursement for TAVI, which resulted in an indication document that defines TAVI patients who are eligible for reimbursement. This document has been effective since 1January 2021. We extracted data from the Netherlands Heart Registry for patients who underwent biological surgical aortic valve replacement (SAVR) or TAVI in the Netherlands from 2018 through 2021. We compared baseline characteristics and variables from the indication document for the subsequent years and age groups. We also analysed the annual SAVR/TAVI ratio. The total number of patients treated with SAVR or TAVI was constant in 2018-2021. Baseline characteristics of patients treated with TAVI did not differ throughout the years. The SAVR/TAVI ratio shifted towards ahigher percentage of TAVI from 2018 to 2019. From 2019 to 2020, the TAVI percentage was constant. Since the implementation of the indication document (in 2021), achange in the SAVR/TAVI ratio was not found either. Since the implementation of the national indication document for AVR in 2021, no major effect was seen for the SAVR versus TAVI landscape in the Netherlands.

A Practical Approach to Systemic Mastocytosis Complications in Cardiac Surgery: A Case Report and Systematic Review of the Literature.

(1) Background: Systemic mastocytosis is a rare, non-curable disease with potential life-threatening complications in patients receiving cardiac surgery. (2) Methods: This systematic review of the literature was prompted by the case of a life-threatening anaphylactic reaction during cardiac surgery related to systemic mastocytosis. The search of all types of studies, using several databases (Pubmed, Scopus and Web of Science), was conducted through September 2022 to identify the relevant studies. (3) Results: Twelve studies were included describing cases of patients undergoing cardiac surgery who were diagnosed with systemic mastocytosis. An adverse effect, namely anaphylaxis, has happened in three cases. Different strategies of premedication, intraoperative and postoperative management were used. In our case, the patient was admitted for elective biological aortic valve replacement due to severe aortic stenosis. Intraoperatively, the patient developed an anaphylactic shock during the administration of protamine after separation from the cardiopulmonary bypass. This anaphylaxis reaction was a complication of the pre-existing systemic mastocytosis and could be successfully managed by the administration of epinephrine, antihistamines and corticosteroids. (4) Conclusions: This systematic literature search and case report highlight the importance of careful preoperative planning, as well as coordination between cardiac surgeons, anesthesiologists and hemato-oncological specialists, in patients with rare but complication-prone diseases such as systemic mastocytosis.

Comparison of hemodynamics in biological surgical aortic valve replacement and transcatheter aortic valve implantation: An in-silico study.

In aortic valve replacement (AVR), the treatment strategy as well as the model and size of the implanted prosthesis have a major impact on the postoperative hemodynamics and thus on the clinical outcome. Preinterventional prediction of the hemodynamics could support the treatment decision. Therefore, we performed paired virtual treatment with transcatheter AVR (TAVI) and biological surgical AVR (SAVR) and compared hemodynamic outcomes using numerical simulations. 10 patients with severe aortic stenosis (AS) undergoing TAVI were virtually treated with both biological SAVR and TAVI to compare post-interventional hemodynamics using numerical simulations of peak-systolic flow. Virtual treatment procedure was done using an in-house developed tool based on position-based dynamics methodology, which was applied to the patient's anatomy including LVOT, aortic root and aorta. Geometries were automatically segmented from dynamic CT-scans and patient-specific flow rates were calculated by volumetric analysis of the left ventricle. Hemodynamics were assessed using the STAR CCM+ software by solving the RANS equations. Virtual treatment with TAVI resulted in realistic hemodynamics comparable to echocardiographic measurements (median difference in transvalvular pressure gradient [TPG]: -0.33 mm Hg). Virtual TAVI and SAVR showed similar hemodynamic functions with a mean TPG with standard deviation of 8.45 ± 4.60 mm Hg in TAVI and 6.66 ± 3.79 mm Hg in SAVR (p=0.03) while max. Wall shear stress being 12.6 ± 4.59 vs. 10.2 ± 4.42 Pa (p=0.001). Using the presented method for virtual treatment of AS, we were able to reliably predict post-interventional hemodynamics. TAVI and SAVR show similar hemodynamics in a pairwise comparison.

Left Atrial Appendage Amputation for Atrial Fibrillation during Aortic Valve Replacement.

Background. Occluding the left atrial appendage (LAA) during cardiac surgery reduces the risk of ischemic stroke; nonetheless, it is currently only softly recommended with “may be considered” by the current guidelines. We aimed to assess thromboembolic risk after LAA amputation in patients with atrial fibrillation (AF) and aortic stenosis undergoing biological aortic valve replacement (AVR) as primary cardiac surgery. Methods. Two cohorts were generated retrospectively: patients with AF undergoing AVR alone or combined with revascularization either with LAA amputation or without. Data were collected from the hospital-specific data system. Follow-up was completed by telephone interview or in person. Thirty-day and follow-up results were compared in patients with vs. without LAA amputation. Results. One hundred and fifty-seven patients were investigated retrospectively, and seventy-four pairs were matched with regard to baseline characteristics. Patients with LAA amputation exhibited a lower incidence of cumulative and late ischemic stroke (6.4% vs. 25%, p = 0.028 and 3.2% vs. 20%, p = 0.008, respectively; hazard ratio 0.30; 95% confidence interval 0.11; 0.84; p = 0.021) during follow-up of 48 months vs. patients without intervention during follow-up of 45 months, p = 0.494. No significant differences were observed in postoperative stroke, 2 (2.7%) vs. 3 (4.1%), p = 1.000, re-exploration for bleeding 3 (4.1%) vs. 6 (8.1), p = 0.494 or late pericardial effusion 2 (2.7%) vs. 3 (4.1%), p = 1.000, in-hospital 2 (2.7%) vs. 4 (5.4%), p = 0.681 and all-cause mortality 15 (23.8%) vs. 9 (15%), p = 0.315 in patients with vs. without LAA amputation, respectively. Conclusions. A combination of leading aortic stenosis and AF in patients undergoing isolated or combined biological AVR represents a subpopulation with excessive thromboembolic risk. Concomitant LAA amputation during cardiac surgery reduces the risk of ischemic stroke without posing an additional periprocedural risk for the patient. Therefore, the minimal invasive approach at the expense of omitting LAA amputation should be discouraged to maximize the clinical benefits of AVR in this setting.

Surgical aortic valve replacement in patients aged 50-69 years-insights from the German Aortic Valve Registry (GARY).

The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement. Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention. In total. Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients.

Mechanical versus bioprosthetic valve for aortic valve replacement: systematic review and meta-analysis of reconstructed individual participant data.

The aim of this study was to compare biological versus mechanical aortic valve replacement. We searched MEDLINE, Scopus and Cochrane Library databases for randomized clinical trials and propensity score-matched studies published by 14 October 2021 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Individual patient data on overall survival were extracted. One- and two-stage survival analyses and random-effects meta-analyses were conducted. A total of 25 studies were identified, incorporating 8721 bioprosthetic and 8962 mechanical valves. In the one-stage meta-analysis, mechanical valves cumulatively demonstrated decreased hazard for mortality [hazard ratio (HR): 0.79, 95% confidence interval (CI): 0.74-0.84, P < 0.0001]. Overall survival was similar between the compared arms for patients <50 years old (HR: 0.88, 95% CI: 0.71-1.1, P = 0.216), increased in the mechanical valve arm for patients 50-70 years old (HR: 0.76, 95% CI: 0.70-0.83, P < 0.0001) and increased in the bioprosthetic arm for patients >70 years old (HR: 1.35, 95% CI: 1.17-1.57, P < 0.0001). Meta-regression analysis revealed that the survival in the 50-70 year-old group was not influenced by the publication year of the individual studies. No statistically significant difference was observed regarding in-hospital mortality, postoperative strokes and postoperative reoperation. All-cause mortality was found decreased in the mechanical group, cardiac mortality was comparable between the 2 groups, major bleeding rates were increased in the mechanical valve group and reoperation rates were increased in the bioprosthetic valve group. Survival rates seem to not be influenced by the type of prosthesis in patients <50 years old. The survival advantage in favour of mechanical valves is observed in patients 50-70 years old, while in patients >70 years old bioprosthetic valves offer better survival outcomes.

Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults

BackgroundThere has recently been renewed interest in the Ross procedure in adults. ObjectivesThe goal of this study was to compare long-term outcomes after the Ross procedure vs biological and mechanical aortic valve replacement (AVR) in adults (aged 18-50 years) undergoing aortic valve surgery. MethodsMandatory California and New York databases were queried between 1997 and 2014. Exclusion criteria included: ≥1 concomitant procedure, reoperations, infective endocarditis, intravenous drug use, hemodialysis, and out-of-state residency. Propensity matching (1:1:1) was used, resulting in 434 patients per group. The primary endpoint was all-cause mortality. Secondary endpoints were stroke, major bleeding, reoperation, and endocarditis. Median follow-up was 12.5 years (IQR: 9.3-15.7 years). ResultsAt 15 years, actuarial survival after the Ross procedure was 93.1% (95% CI: 89.1%-95.7%), similar to that of the age-, sex-, and race-matched U.S. general population. It was significantly lower after biological AVR (HR: 0.42; 95% CI: 0.23-0.075; P = 0.003) and mechanical AVR (HR: 0.45; 95% CI: 0.26-0.79; P = 0.006). At 15 years, the Ross procedure was associated with a lower cumulative risk of reintervention (P = 0.008) and endocarditis (P = 0.01) than biological AVR. In contrast, at 15 years, the Ross procedure was associated with a higher cumulative incidence of reoperation (P < 0.001) but lower risks of stroke (P = 0.03) and major bleeding (P = 0.016) than mechanical AVR. Thirty-day mortality after valve-related complications was lowest after a reintervention. ConclusionsIn young adults, the Ross procedure is associated with better long-term survival and freedom from valve-related complications compared with prosthetic AVR. This confirms the notion that a living valve substitute in the aortic position translates into improved clinically relevant outcomes.

Cardiovascular Interventions in Patients with Hemophilia and Severe Von Willebrand Disease.

The management of cardiovascular interventions in patients with hemophilia and severe von Willebrand disease (VWD) is challenging. The procedure itself as well as the use of anti-platelet drugs and anticoagulants implies a risk of bleeding. On the other hand, factor replacement therapy as well as withdrawal of anti-platelet drugs or anticoagulants may increase the risk of cardiovascular events and thrombosis. Information on the management of such interventions is limited to very few case reports. Here, we report a retrospective analysis of 28 patients with hemophilia A (n=16), hemophilia B (n=4) or VWD (n=8, all with VWF:RCo <30 IU/dl), who underwent a total of 39 cardiovascular interventions including coronary angiography (CA, n=11), percutaneous coronary interventions (PCI, n=18), or cardiac surgery (CS, n=10) including coronary artery bypass grafting (CABG) and heart valve surgery with the use of cardiopulmonary bypass (CPB). Patients had a median age of 66 years (range 47–85) and had a median factor activity of 3 IU/dl (range <1–35). Six patients were on regular prophylaxis prior to the intervention. Patients undergoing CA received replacement therapy for a median of 2 days (range 1–15) with a median starting dose of 36 IU/kg (range 24–67). Minor bleeding at the site of puncture occurred in 5 of 11 patients. Major bleeding or bleeding requiring transfusion did not occur. Patients undergoing PCI received replacement therapy for a median of 4 days (range 1–41) with a starting dose of 40 IU/kg (range 12–63) given before or during the intervention. 12 of 14 patients receiving bare metal stents were on aspirin and clopidogrel for 4 to 6 weeks; 7 of these including all patients with severe hemophilia received prophylactic replacement therapy for the time of dual anti-platelet therapy. Two patients received shorter courses of single anti-platelet agents due to bleeding. Three patients receiving drug-eluting stents were on aspirin and clopidogrel for 8 to 12 weeks; 2 of these also received prophylactic replacement therapy, whereas one patient with mild hemophilia did not. Minor bleeding at the site of puncture occurred in 15 of 18 patients undergoing PCI; major bleeding at the site of puncture occurred in 1 patient and required transfusion. Major bleeding at distant sites occurred in 3 patients with 1 patient requiring transfusion. Two of these three patients received anti-platelet therapy without prophylactic factor replacement. No patient experienced stent thrombosis or other thromboembolic complications. Patients undergoing cardiac surgery received replacement therapy for a median of 23 days (range 11–46) with a median starting dose of 57 IU/kg (range 23–107). Unfractionated heparin was used for anticoagulation during CPB. Minor wound bleeding occurred in 8 of 10 patients. Four patients received transfusions of 2 to 5 units of packed red blood cells. Five of seven patients undergoing CABG received aspirin. One patient with VWD undergoing CABG and biological aortic valve replacement received oral anticoagulation and experienced gross hematuria; he was switched to aspirin after 6 weeks. A patient with mild hemophilia on long-term oral anticoagulation because of atrial fibrillation remained on oral anticoagulants without signs of bleeding. In summary, this is the largest cohort of patients with hemophilia and severe VWD undergoing cardiovascular interventions. Combining replacement therapy with anti-platelet agents or anticoagulants appears to be a safe strategy, despite of frequent minor bleeding. Major bleeding mainly occurred in patients on anti-platelet agents without concomitant prophylactic replacement therapy.

Anticoagulation Therapy After Biologic Aortic Valve Replacement.

Objectives: Thromboembolism prophylaxis after biologic aortic valve replacement (BAVR) is recommended for 3 months postoperatively. We examined the continuation of oral anticoagulation (OAC) treatment and its effect on the long-term prognosis after BAVR.Methods: We used nation-wide register data from 4,079 individuals who underwent BAVR. We examined the association between warfarin and the non-vitamin K antagonist oral anticoagulant use with death, stroke and major bleeding in 2010 – 2016.Results: The risk of stroke was higher (HR 2.39, 95% CI 1.62 – 3.53, p < 0.001) and the risk of death was lower (HR 0.79, 95% CI 0.65 – 0.96, p = 0.016) in OAC-users compared to individuals without OAC. We observed no significant associations between OAC use and bleeding risk.Conclusion: OAC use after BAVR was associated with increased risk of stroke and decreased risk of death. These observational findings warrant validation in randomized controlled trials before any clinical conclusions can be drawn.

Effect of Aortic Valve Type on Patients Who Undergo Type A Aortic Dissection Repair

Aortic valve replacement (AVR) is common in the setting of type A aortic dissection (TAAD) repair. Here, we evaluated the association between prosthesis choice and patient outcomes in an international patient cohort. We reviewed data from the International Registry of Acute Aortic Dissection (IRAD) interventional cohort to examine the relationship between valve choice and short- and mid-term patient outcomes. Between January 1996 and March 2016, 1290 surgically treated patients with TAAD were entered into the IRAD interventional cohort. Of those, 364 patients undergoing TAAD repair underwent aortic valve replacement (AVR; mean age, 57 years). The mechanical valve cohort consisted of 189 patients, of which 151 (79.9%) had a root replacement. The nonmechanical valve cohort consisted of 5 patients who received homografts and 160 patients who received a biologic AVR, with a total of 118 (71.5%) patients who underwent root replacements. The mean follow-up time was 2.92 ± 1.75 years overall (2.46 ± 1.69 years for the mechanical valve cohort and 3.48 ± 1.8 years for the nonmechanical valve cohort). After propensity matching, Kaplan-Meier estimates of 4-year survival rates after surgery were 64.8% in the mechanical valve group compared with 74.7% in the nonmechanical valve group (p = 0.921). A stratified Cox model for 4-year mortality showed no difference in hazard between valve types after adjusting for the propensity score (p = 0.854). A biologic valve is a reasonable option in patients with TAAD who require AVR. Although this option avoids the potential risks of anticoagulation, long-term follow up is necessary to assess the effect of reoperations or transcatheter interventions for structural valve degeneration.

Biological versus mechanical aortic valve replacement in non-elderly patients: a single-centre analysis of clinical outcomes and quality of life.

The aim of this study was to evaluate short- and long-term clinical outcomes, including the perceived health-related quality of life, in patients younger than 65 years having undergone aortic valve replacement either with biological or mechanical valve prostheses. Between 2002 and 2013, 242 consecutive patients <65 years of age underwent isolated aortic valve replacement at our institution, either with biological (n = 134, 55.4%) or mechanical (n = 108, 44.6%) prostheses. Survival, health-related quality of life, short- and long-term clinical outcomes and echocardiographic data were analysed with a retrospective, single-centre study. Propensity matching was performed. No significant difference in survival was found between the 2 groups (mechanical versus biological: 100% vs 96.6% at 1 year, 98.2% vs 93.1% at 5 years and 92.3% vs 83.4% at 10 years after surgery, P = 0.091). For all the interviewed patients (n = 161, 66.5%), perceived quality of life at the latest follow-up was excellent. Need for reoperation was higher in the bioprosthetic group (8% vs 0%, P = 0.995), whereas the rate of major bleedings was higher in the mechanical valve group (3% vs 20%, P = 0.094). The mean and maximum transvalvular pressure gradients were 20.5 ± 9.7 and 37.4 ± 17.5 mmHg in the biological group and 14.8 ± 4.8 and 26.6 ± 9.2 mmHg in the mechanical group (P = 0.014). No significant differences were found between biological and mechanical valves in terms of patients' survival, clinical outcomes and quality of life. Mean and maximum transvalvular pressure gradients were significantly higher in the biological group. The majority of patients would opt for the same prosthesis type, if asked to choose again.

Current trends in aortic valve-preserving surgery.

The natural history of aortic regurgitation is not as benign as once believed, even in asymptomatic patients with preserved left ventricular function. Aortic valve surgery can prolong survival in these patients. However, both mechanical and biological aortic valve replacement have major disadvantages, especially in young patients. Aortic valve-preserving surgery has attracted a great deal of attention because it has a significant survival benefit over replacement. Nonetheless, aortic valve-preserving surgery has not been widely adopted due to the complexity of the technique and assessment (i.e., long learning curve). With recent technical and theoretical advances, aortic valve-preserving surgery has increasingly been performed with better outcomes, and therefore earlier surgical intervention in cases of aortic regurgitation has been considered. Recent advances in aortic valve-preserving surgery include repair-oriented classification of the etiology of aortic regurgitation, objective assessment of the cusp configuration (i.e., effective height and geometric height), use of aortic annuloplasty, introduction of two reproducible valve-sparing root replacement procedures (i.e., aortic valve reimplantation and aortic root remodeling techniques), standardization of aortic valve-preserving surgery, and assessment of cusp configuration with aortoscopy. A number of prospective multicenter studies are currently underway and will clarify the role of aortic valve-preserving surgery in the treatment of aortic regurgitation in the near future.