Heart Valve Patients Research Articles

INFLUENCE OF SECONDARY HYPERPARATHYROIDISM ON THE CALCIFICATION OF HEART VALVES IN PATIENTS WITH CHRONIC KIDNEY DISEASE VD STAGE

The aim of this work was to study the relationship of elevated levels of parathyroid hormone (PTH) with cardiovascular changes (calcification of the heart valves) and to identify possible risk factors of calcification in the group of patients receiving renal replacement therapy.
 Materials and methods. The study included 96 patients with ESRD: 1-st group receives the treatment of peritoneal dialysis (PD) (45 patients), 2-nd group haemodialysis (HD) (51 patients). In serum determined concentration of calcium, phosphorus, PTH. All patients underwent echocardiographic examination.
 Results. The prevalence of secondary hyperparathyroidism in PD-patients reached 72%, in HD-patients 83%. Calcification of heart valves in both groups occurred in patients with high PTH level (greater than 400 PG/ml). Patients in both groups were significantly more frequent in the combined mitrale-aortic calcification. Isolated mitral calcification was detected more often aortic. Predictors of progression of calcification of heart valves in patients on PD is the age, in patients on HD - level average BP and the duration of dialysis therapy.
 Conclusions. Echocardiological data and clinical and laboratory examination of patients with ESRD allowed us to estimate the prevalence and structure of mitrale-aortic calcification and its relationship with secondary hyperparathyroidism.

Periodontal microbiota and microorganisms isolated from heart valves in patients undergoing valve replacement surgery in a clinic in Cali, Colombia

Periodontitis is an infectious disease that affects the support tissue of the teeth and it is associated with different systemic diseases, including cardiovascular disease. Microbiological studies facilitate the detection of microorganisms from subgingival and cardiovascular samples. To describe the cultivable periodontal microbiota and the presence of microorganisms in heart valves from patients undergoing valve replacement surgery in a clinic in Cali. We analyzed 30 subgingival and valvular tissue samples by means of two-phase culture medium, supplemented blood agar and trypticase soy agar with antibiotics. Conventional PCR was performed on samples of valve tissue. The periodontal pathogens isolated from periodontal pockets were: Fusobacterium nucleatum (50%), Prevotella intermedia/ nigrescens (40%), Campylobacter rectus (40%), Eikenella corrodens (36.7%), Gram negative enteric bacilli (36.7%), Porphyromonas gingivalis (33.3%), and Eubacterium spp. (33.3%). The pathogens isolated from the aortic valve were Propionibacterium acnes (12%), Gram negative enteric bacilli (8%), Bacteroides merdae (4%), and Clostridium bifermentans (4%), and from the mitral valve we isolated P. acnes and Clostridium beijerinckii. Conventional PCR did not return positive results for oral pathogens and bacterial DNA was detected only in two samples. Periodontal microbiota of patients undergoing surgery for heart valve replacement consisted of species of Gram-negative bacteria that have been associated with infections in extraoral tissues. However, there is no evidence of the presence of periodontal pathogens in valve tissue, because even though there were valve and subgingival samples positive for Gram-negative enteric bacilli, it is not possible to maintain they corresponded to the same phylogenetic origin.

Prophylactic doses of low-molecular weight heparin as periprocedural bridging therapy in mechanical heart valve patients

BackgroundMechanical heart valve (MHV) patients undergoing invasive procedures necessitating an interruption of their lifelong anticoagulant therapy, often require bridging with low-molecular weight heparin (LMWH) or unfractionated heparin. The aim of this study was to assess whether bridging MHV patients with prophylactic doses of LMWH undergoing invasive, elective procedures is a safe and effective method. MethodThis observational cohort study included all MHV patients on vitamin K anticoagulant therapy in Malmö, registered and monitored via AuriculA (the Swedish national quality registry for atrial fibrillation and anticoagulation), between 1/1/2008 and 31/12/2011. Inclusion criteria were periprocedural bridging therapies conducted via AuriculA. Primary endpoints were mortality, thromboembolic (TE) events or major bleedings (MBE) within 30 days of bridging. ResultsDuring the study period, 210 patients had undergone 434 bridging therapies managed via AuriculA; 203 due to subtherapeutic INR-values were excluded. The remaining 231 periprocedural bridging therapies were included. All were bridged with prophylactic doses of LMWH. When comparing patients with aortic and/or mitral valve replacements undergoing low- or high-risk interventions, only number of days bridged for a low-risk intervention differed significantly. Patients with a mitral or mitral and aortic valve replacement were bridged for a longer period (p=0.023). No TE events, 1 death (0.4%) and 3 MBEs (1.3%) occurred related to periprocedural bridging. ConclusionOur study shows a low rate of MBEs, deaths and no TE events when bridging MHV patients undergoing invasive, elective procedures with prophylactic doses of LMWH.

Surgical management of nonbacterial thrombotic endocarditis in malignancy

BackgroundNonbacterial thrombotic endocarditis is commonly seen on heart valves in patients with malignant or collagen diseases. The natural prognosis of nonbacterial thrombotic endocarditis is reported to be poor due to underlying malignancy. Surgical indications and appropriate timing for surgery for nonbacterial thrombotic endocarditis and underlying malignancy have not been formally studied.Case presentationThe case was a 45-year-old woman who presented with a history of systemic embolization associated with occult malignancy. A preoperative transesophageal echocardiogram showed multiple mobile vegetations on the aortic and mitral valves. She underwent valve surgery to prevent recurrent embolization. Based on the histopathologic findings, she was diagnosed with nonbacterial thrombotic endocarditis. She subsequently underwent surgery for occult malignancy, which was diagnosed as endometrioid adenocarcinoma.ConclusionsAlthough surgical indications for nonbacterial thrombotic endocarditis remain unclear, valve replacement or repair and multidisciplinary treatment including surgical intervention are essential to prevent recurrent embolization in patients with nonbacterial thrombotic endocarditis associated with malignancy.

Anticoagulant bridging in left-sided mechanical heart valve patients

BackgroundIn preparation for an invasive procedure with a high bleeding risk, patients with a mechanical heart valve temporarily have to discontinue their anticoagulant therapy and are usually bridged with either intravenous unfractionated heparin (UFH) or subcutaneous low-molecular-weight heparin (LMWH). In this study we retrospectively analyzed the safety of UFH versus LMWH as bridging strategy in left-sided mechanical heart valve patients. MethodsWe performed a retrospective multicenter study in four surgical centers in The Netherlands. Patients with a mechanical heart valve implantation bridged from January 2010 until January 2015 were included. The cumulative incidence of adverse events in the 30days following the procedure was recorded. Main outcomes were major bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria, symptomatic thromboembolism, and mortality. ResultsIn total, 238 (174 aortic, 42 mitral, 22 aortic+mitral) bridging episodes were included. The incidence of major bleeding was 16 (19%) events in the UFH group versus 29 (19%) events in the LMWH group (p=0.97). Incidences of thromboembolism were 2 (2.4%) versus 1 (0.6%). The incidence of death was 1 (1.2%) patient in the UFH group versus 3 (1.9%) patients in the LMWH group. More than 50% of all bleeding complications were categorized as a major bleeding. ConclusionsBridging anticoagulation in patients with aortic and mitral mechanical valves is associated with considerable risk, but no difference was apparent between UFH and LMWH strategy. The rate of thromboembolism and death was low with either strategy and the vast majority of adverse events were bleedings.

Тактические подходы к протезированию клапанов сердца у больных с поражением коронарных и каротидных артерий

Атеросклеротическое поражение коронарных и брахиоцефальных артерий (БЦА) нередко составляет сопутствующую патологию у пациентов — кандидатов на хирургическую коррекцию клапанного аппарата сердца и могут быть причиной таких периоперационных осложнений, как инфаркт миокарда и/или инсульт. Тактика хирургического лечения сочетанных поражений сонных и коронарных артерий (каротидной эндартерэктомии и коронарного шунтирования) разработана и широко представлена в литературе. В то же время стратегия комплексного вмешательства на клапанах сердца, сонных артериях и коронарных сосудах остается недостаточно изученной и представляет значительный научный и практический интерес по следующим направлениям: предоперационная диагностика основного заболевания и сочетанной патологии, включая скрининговое ультразвуковое дуплексное сканирование БЦА, а также определение тактических подходов в выполнении хирургического лечения на основании установленных факторов хирургического риска. Кроме того, в последние годы в литературе широко обсуждаются вопросы реваскуляризации сонных артерий с помощью эндоваскулярных методов, являющихся менее инвазивными, то есть альтернативой, и характеризующихся меньшей частотой развития инсульта. Цель публикации — представить системный обзор вопросов оптимизации тактических подходов хирургического лечения пациентов с пороками клапанов сердца и сопутствующим атеросклеротическим поражением брахиоцефальных и коронарных артерий.

Increased intracellular calcium and decreased deformability of erythrocytes from prosthetic heart valve patients

Increased intracellular calcium and decreased deformability of erythrocytes from prosthetic heart valve patients

Timing of vitamin K antagonist re-initiation following intracranial hemorrhage in mechanical heart valves: Systematic review and meta-analysis

BackgroundWhile evidence supports resumption of vitamin K antagonists (VKAs) among mechanical heart valve (MHV) patients presenting with anticoagulant-associated intracranial hemorrhage (ICH), ideal timing of resumption is uncertain. ObjectiveTo determine the optimal timing of VKA re-initiation and its associated clinical outcomes. MethodsWe performed a systematic review and a meta-analysis of studies published from January 1950 to August 2015. We extracted data on the location of initial ICH, use of cranial surgery, presence of atrial fibrillation, MHV type and position, number of MHVs, and timing of VKA resumption. Outcomes including valve thrombosis, thromboembolic events or ICH recurrence were recorded. Meta-regression analysis was conducting with controlling for covariates. We calculated absolute risks, and assessed the effect of anticoagulant resumption timing on ICH recurrence. Results23 case-series and case-reports were identified. Overall ICH recurrence was 13% (95% confidence interval [CI], 7%–25%), while valve thrombosis and ischemic strokes occurred at 7% (95% CI, 3%–17%) and 12% (95% CI, 5%–23%) respectively. A trend towards lower ICH recurrence was observed with delayed VKA resumption (slope estimate −0.2154, p=0.10). Recurrence rate ranged from 50% with VKA resumption at 3days to 0% with resumption at 16days. ConclusionAmong patients with MHV, there is inadequate data to suggest an optimal timing of VKA re-initiation following an ICH, though delayed restart appears to be protective against recurrence but is associated with higher risk of thrombosis. Our analysis suggests 4–7days might be an ideal time with least risk of thrombosis or ICH recurrence.

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.

Computer-Assisted Transcatheter Heart Valve Implantation in Valve-in-Valve Procedures.

Valve-in-valve (ViV) procedures are increasingly being considered as an alternative to redo surgery for the treatment of degenerated bioprosthetic heart valves in patients with excessive reoperative risk. The objective of our study was to evaluate the feasibility of computer guidance in transcatheter heart valve (THV) implantation during ViV procedures. Preprocedural electrocardiogram-gated computed tomography-scan images were processed using semiautomatic segmentation of the degenerated bioprosthesis' radiopaque landmarks and of the ascending aorta. Virtual three-dimensional (3D) reconstructions were created. A virtual plane was subsequently added to the 3D reconstructions, indicating the optimal landing plane of the THV inside the tissue valve. Within a hybrid operating theater, a 3D/2D registration was used to superimpose the 3D reconstructions, while dynamic tracking was allowed to maintain the superimposition onto the fluoroscopic images. The THV was afterward implanted according to the optimal landing plane. Projection of the ascending aorta and the coronary arteries was used to assess the risk of coronary ostia obstruction. Between January 2014 and October 2014, nine patients underwent aortic ViV procedures in our institution. Among those nine patients, five procedures were retrospectively evaluated as a validation step using the proposed method. The mean (SD) superimposition error was 1.1 (0.75) mm. Subsequently, two live cases were prospectively carried out using our approach, successfully implanting the THV inside the degenerated tissue valve. Our study demonstrates the feasibility of a computer-guided implantation of THV in ViV procedures. Moreover, it suggests that augmented reality may increase the reliability of THV implantation inside degenerated bioprostheses through better reproducibility.

Abstract 19831: Pre-clinical in vivo Evaluation of Cormatrix as Right-sided Valved Conduit

Introduction: Although not FDA approved for heart valve repair, decellularized porcine small intestinal submucosa (Cormatrix) is currently used in quite a lot of institutes to reconstruct heart valves in patients. Recently, surgeons experienced clinical failures using Cormatrix as a patch in heart valve repair and words of caution were raised. The aim of this study was to pre-clinically evaluate CorMatrix as right-sided heart valved conduit in a xenogeneic animal model. Methods: CorMatrix was used as valved conduit in the right ventricular outflow tract in sheep (n=10) and lambs (n=10). Valved conduits were home-made and explanted after 1 month, 3 months or 6 months. Valve function was assessed by echocardiography directly after implantation and prior to termination. Explants were analyzed using histology, scanning electron microscopy, mechanical testing, biochemical analysis and immunohistochemistry. Results: All valved conduits were successfully implanted. 5 sheep and 2 lambs did not survive until planned follow-up. Diseased animals died due to valve failure after 1 or 2 months. Valve leaflets where thickened with signs of a massive inflammatory response. 5 sheep (1 month n=3, 3 months n=1 and 6 months n=1) and 8 lambs (1 month n=3, 3 months n=3, 6 months n=2) survived until planned follow up. In these animals, on echocardiography a well functioning valve with no signs of stenosis or insufficiency was seen. However all explants showed only limited signs of cellular infiltration or neotissue formation. Conclusions: In the chronic sheep and lamb model, 13 out of 20 CorMatrix pulmonary valved conduits were intact and showed good functionality, although only limited signs of tissue remodeling. However, 7 out of 20 valves failed owing to a massive inflammatory response. Further analysis is needed to understand the disturbing dichotomous outcome before clinical application can be advised

Self-Management of Anticoagulant Therapy in Mechanical Heart Valve Patients: A Matched Cohort Study

Patient-self-management (PSM) of oral anticoagulant therapy with vitamin K antagonists for mechanical heart valves has demonstrated efficacy in randomized controlled trials. However, the effectiveness of PSM in clinical practice has only been investigated in small trials. Our aim was to evaluate the effectiveness of PSM of oral anticoagulant therapy in mechanical heart valve patients. We conducted a matched cohort study: cases were patients with a mechanical heart valve performing PSM affiliated with Aarhus University Hospital or Aalborg University Hospital, Denmark, in the period 1996 to 2012 (n = 615). Prospectively registered patient data were obtained from databases at two hospitals, and cross linkage between these databases and national patient registries provided detailed information on comorbidities and events. Control patients were matched (on sex, date of birth, year of first valve surgery, and grouped valve position) in a ratio of 5:1 (n = 3,075) with patients receiving conventional management who were randomly selected within the match group. The effectiveness and safety was estimated using major bleeding and thromboembolic events and death as outcomes. We observed low event rates in the PSM group. After 5 years, PSM was associated with a lower risk of all-cause mortality compared with conventional management (adjusted hazard ratio of 0.49, 95% confidence interval: 0.34 to 0.71). The hazard ratios for thromboembolism and major bleeding were 0.91 (95% confidence interval: 0.66 to 1.24) and 0.83 (95% confidence interval: 0.56 to 1.22). Owing to superior clinical effectiveness, self-managed oral anticoagulant therapy may potentially improve the standard of care for patients with mechanical heart valves.

Physiologic determinants of exercise capacity in patients with different types of right-sided regurgitant lesions: Ebstein's malformation with tricuspid regurgitation and repaired tetralogy of Fallot with pulmonary regurgitation

BackgroundExercise capacity relates to right ventricular (RV) volume overload in congenital heart disease and may improve after surgery. We herewith investigate the relation between exercise capacity, cardiac index, and RV volume overload due to tricuspid regurgitation (TR) in Ebstein's malformation and pulmonary regurgitation (PR) after repair of tetralogy of Fallot (rToF). MethodsWe measured cardiac index and tricuspid/pulmonary regurgitant fraction by cardiovascular magnetic resonance in patients with Ebstein's malformation (n=40) or rTOF (n=53) with at least moderate TR/PR and 24 healthy controls. Exercise tolerance was determined by peak oxygen consumption (peak VO2) during cardiopulmonary exercise testing. ResultsTR and PR fraction were similar in Ebstein and rTOF patients (43±17% versus 39±12%, respectively). Cardiac index was reduced in Ebstein (2.7±0.6L/min/m2 compared to controls 3.5±0.9L/min/m2, p<0.001) but not in rToF patients (3.2±0.5L/min/m2). Multiple regression analysis revealed a significant correlation between peak VO2 and cardiac index in Ebstein. Furthermore, peak VO2 correlated with peak heart rate in both groups but not with regurgitation fraction. ConclusionsDespite comparable amounts of regurgitation from a right sided heart valve in patients with Ebstein and rToF, reduction of cardiac index was observed only in the former group. Greater physiologic complexity and adverse ventricular interaction with chronotropic incompetence in Ebstein's malformation may account for this.

European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.

The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p< 0.0001), renal insufficiency (HR: 1.53; p< 0.0001), liver disease (HR: 1.67; p=0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p= 0.0019), porcelain aorta (HR: 1.47; p= 0.0352), and atrial fibrillation (HR: 1.41; p= 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).

Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report.

Transcatheter aortic valve implantation (TAVI) has become an effective treatment option for high-risk or inoperable patients with aortic stenosis. However, experience with TAVI for non-calcified aortic regurgitation is still limited. The new J-Valve(™) system is a new second-generation TAVI device that is designed for transapical implantation. It is characterized by three U-shaped, anatomically oriented devices-'graspers' that could facilitate intuitive 'self-positioning' valve implantation and provide extra-radial fixation by embracing the native valve leaflets. Here, we reported the initial experience of TAVI in high-risk patients with pure aortic regurgitation using the J-Valve(™) system.

Xeno-immunogenicity of ice-free cryopreserved porcine leaflets

BackgroundUndesirable processes of inflammation, calcification, or immune-mediated reactions are limiting factors in long-term survival of heart valves in patients. In this study, we target the modulatory effects of ice-free cryopreservation (IFC) of xenogeneic heart valve leaflet matrices, without decellularization, on the adaptive human immune responses in vitro. MethodsWe tested porcine leaflet matrices from fresh untreated, conventionally cryopreserved (CFC), and IFC pulmonary valves by culturing them with human blood mononuclear cells for 5 d in vitro. No other tissue treatment protocols to modify possible immune responses were used. Matrices alone or in addition with a low-dose second stimulus were analyzed for induction of proliferation and cytokine release by flow cytometry-based techniques. Evaluation of the α-Gal epitope expression was performed by immunohistochemistry with fluorochrome-labeled B4 isolectin. ResultsNone of the tested leaflet treatment groups directly triggered the proliferation of immune cells. But when tested in combination with a second trigger by anti-CD3, IFC valves showed significantly reduced proliferation of T cells, especially effector memory T cells, in comparison with fresh or CFC tissue. Moreover, the cytokine levels for interferon-γ (IFNγ), tumor necrosis factor α, and interleukin-10 were reduced for the IFC-treated group being significantly different compared with the CFC group. However, no difference between treatment groups in the expression of the α-Gal antigen was observed. ConclusionsIFC of xenogeneic tissue might be an appropriate treatment method or processing step to prevent responses of the adaptive immune system.

PROSTHESIS-PATIENT MISMATCH IN VALVULAR HEART DISEASE: AN EVALUATION OF ECHOCARDIOGRAPHIC FINDINGS

Guidelines for reporting echocardiographic studies in prosthetic heart valve patients have recently been published. Prothesis-patient mismatch (PPM) was first described in 1978 and is present when the effective orifice area (EOA) of an implanted surgical prosthetic valve is too small in relation to a patient’s body surface area (BSA). PPM remains a common occurrence and has been reported in the literature in up to 20-70% of AVR patients. This is concerning, since undersized prostheses relative to body size may result in higher transprosthetic gradients, worse hemodynamic function and adverse patient outcomes. We examined reporting trends in patients with prosthetic aortic and mitral valves at London Health Sciences Centre (LHSC)and St Joseph's Health Care, with particular focus on PPM in these patient populations. Patients with prosthetic aortic valve replacement (AVR) and/or mitral valve replacement (MVR) undergoing echocardiography between September 2003 and August 2013 were identified. Studies with complete patient data for whom PPM could be measured were included for further analysis. PPM was defined as EOA/BSA ≤ 0.85 cm2/m2 in the aortic position (0.65-0.85 cm2/m2 moderate, <0.65 cm2/m2 severe), and as ≤ 1.3 cm2/m2 in the mitral position. Demographic and echocardiographic parameters were evaluated. Overall 8901 studies from 3378 patients were identified (61% male; mean age 68 ± 13 years). Echocardiographic studies (mean 2.6 studies/patient) were performed in patients with AVR (6290, 71%), MVR (1904, 21%) or both (707, 8%). Complete data sets were obtained for 2391 AVR studies. PPM was present in 44% of AVR studies (severe in 3%). AVR patients with PPM were older at the time of valve replacement (71 vs. 63 years) and at follow-up (73 vs. 65 years), had greater body weight (86 vs. 81kg), larger BSA (1.97 vs. 1.92kg/m2), smaller left ventricular dimensions (47 vs. 49mm), LVOT (19 vs. 20mm) and aortic roots (30 vs. 32mm), with higher transprosthetic gradients (34 vs. 26mmHg) and lower Doppler velocity index (0.41 vs. 0.44) in comparison to patients without PPM (p<0.001 for all). PPM was more common in females (48% vs. 41%, p=0.002), in those with bioprosthetic AVR (56% vs. 9%, p<0.001), with concurrent CABG (52% vs. 39%, p<0.001) and without concurrent aortic root enlargement surgery (46% vs. 32%, p<0.001). The presence of PPM in AVR patients in our study population was common. Our data analysis identified patient subsets with a higher prevalence of PPM, which co-localized with indices of impaired cardiac performance.

Outcomes and total costs of outpatient vs. inpatient peri-procedural anticoagulation management of mechanical prosthetic heart valve patients

Background/objectivesThe most cost-effective periprocedural management of patients with mechanical heart valves (MHV) is uncertain. The objective was to compare the effectiveness, safety and costs for inpatient intravenous unfractionated heparin (IVUH) vs. outpatient low molecular weight heparin (LMWH) “bridging” as periprocedural anticoagulation management for MHV patients. MethodsIn a case-cohort study, Olmsted County, MN residents with MHV who received outpatient periprocedural LMWH management (cases) over the 11-year period, 1997–2007, were matched to residents with MHV who received inpatient IVUH periprocedural management on valve location and type, and on procedure type. Patients were followed for 3months following hospitalization to identify thromboembolism (TE) and major bleeding. Total costs from 30days before to 90days after the procedure were determined from the Olmsted County Healthcare Expenditure and Utilization Database. Outcomes were compared using survival analysis and costs were compared using the Wilcoxon rank sum. Results149 cases (100 aortic, 29 mitral, 20 both; 64% bileaflet) were compared to 149 cohort members (100 aortic, 29 mitral, 20 both; 75% bileaflet). While the 3-month cumulative incidence of TE did not differ significantly among cases (2.7%) and cohort members (4.7%; p=0.36), major bleeding was significantly lower in cases (5.4% vs. 15.4%; p<0.005). Total costs were significantly higher for cohort members ($50,984 vs. $39,347; p=0.002) due to higher inpatient costs ($47,729 vs. $34,860; p=0.0002). ConclusionsOutpatient bridging LMWH therapy is equally effective, but safer and less costly than inpatient IVUH as periprocedural anticoagulation management for MHV patients.

Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study

Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the 'Médiator scandal'. To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex. Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts. Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients (P=0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P=0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P=0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort. Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.

Transapical Implantation of a Second-Generation Transcatheter Heart Valve in Patients With Noncalcified Aortic Regurgitation

This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results.