Christian Felix

Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry

Background Percutaneous mitral valve repair (MVR) using the MitraClip system has become a valid alternative for patients with severe mitral regurgitation (MR) and high operative risk. Objective To identify clinical and periprocedural factors that may have an impact on clinical outcome. Design Multi-centre longitudinal cohort study. Setting Tertiary referral centres. Patients Here we report on the first 100 consecutive patients treated with percutaneous MVR in Switzerland between March 2009 and April 2011. All of them had moderate–severe (3+) or severe (4+) MR, and 62% had functional MR. 82% of the patients were in New York Heart Association (NYHA) class III/IV, mean left ventricular ejection fraction was 48% and the median European System for Cardiac Operative Risk Evaluation was 16.9%. Interventions MitraClip implantation performed under echocardiographic and fluoroscopic guidance in general anaesthesia. Main outcome measures Clinical, echocardiographic and procedural data were prospectively collected. Results Acute procedural success (APS, defined as successful clip implantation with residual MR grade ≤2+) was achieved in 85% of patients. Overall survival at 6 and 12 months was 89.9% (95% CI 81.8 to 94.6) and 84.6% (95% CI 74.7 to 91.0), respectively. Univariate Cox regression analysis identified APS (p=0.0069) and discharge MR grade (p=0.03) as significant predictors of survival. Conclusions In our consecutive cohort of patients, APS was achieved in 85%. APS and residual discharge MR grade are important predictors of mid-term survival after percutaneous MVR.

Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes

Background Percutaneous mitral valve repair (MVR) using the Evalve MitraClip has been recently introduced as a potential alternative to surgical MVR. Objective To assess immediate haemodynamic changes after percutaneous MVR using right heart catheterisation. Design Single-centre longitudinal cohort study. Setting Tertiary referral centre. Patients Fifty consecutive non-surgical patients (age 74±14 years, EuroSCORE 26±14) with moderate to severe (3+) and severe (4+) mitral regurgitation (MR) due to functional (56%), degenerative (30%) or mixed (14%) disease were selected. Interventions MitraClip implantation was performed under general anaesthesia with fluoroscopy and echocardiographic guidance. Haemodynamic variables were obtained before and after MVR using standard right heart catheterisation and oximetry. Main outcome measures Haemodynamic changes immediately before and after MVR. Results Acute procedural success (reduction in MR to grade 2+ or less) was achieved in 46 (92%) patients. Mitral valve clipping reduced mean pulmonary capillary wedge pressure (mPCWP) (from 17±7 to 12±5 mm Hg), PCWP v-wave (from 24±11 to 16±7 mm Hg) and mean pulmonary artery pressure (mPAP) (from 29±12 to 24±6 mm Hg), and increased the cardiac index (CI) (from 3.1±1.0 to 3.9±1.1 l/min/m2) (all p<0.05). On Cox univariate regression analysis, mPCWP, PCWP v-wave- and mPAP-changes were associated with death, open-heart surgery for MR and/or hospitalisation for heart failure on follow-up. Conclusion In a heterogeneous population with predominantly functional MR, percutaneous MVR with the Evalve MitraClip system lowers mPCWP, PCWP v-wave and mPAP by 20%, 20% and 8%, respectively, and increases the CI by 32%.

Real-Time Left Ventricular Pressure-Volume Loops During Percutaneous Mitral Valve Repair With the MitraClip System

Background— Percutaneous mitral valve repair with the MitraClip device has emerged as an alternative to surgery for treating severe mitral regurgitation. However, its effects on left ventricular loading conditions and contractility have not been investigated yet. Methods and Results— Pressure-volume loops were recorded throughout the MitraClip procedure using conductance catheter in 33 patients (mean age, 78±10 years) with functional (45%), degenerative (48%), or mixed (6%) mitral regurgitation. Percutaneous mitral valve repair increased end-systolic wall stress (WSES; from [median] 184 mm Hg [interquartile range (IQR), 140–200 mm Hg] to 209 mm Hg [IQR, 176–232 mm Hg]; P=0.001) and decreased end-diastolic WS (WSED; from 48 mm Hg [IQR, 28–58 mm Hg] to 34 mm Hg [IQR, 21–46 mm Hg]; P=0.005), whereas the end-systolic pressure-volume relationship was not significantly affected. Conversely, cardiac index increased (from 2.6 L·min−1·m−2 [IQR, 2.2–3.0 L·min−1·m−2] to 3.2 L·min−1·m−2 [IQR, 2.6–3.8 L·min−1·m−2]; P<0.001) and mean pulmonary capillary wedge pressure decreased (from 15 mm Hg [IQR, 12–20 mm Hg] to 12 mm Hg [IQR, 10–13 mm Hg]; P<0.001). Although changes in WSES were not correlated with changes in cardiac index, changes in WSED correlated significantly with changes in mean pulmonary capillary wedge pressure (r=0.63, P<0.001). Total mechanical energy assessed by the pressure-volume area remained unchanged, resulting in a more favorable index of forward output (cardiac index) to mechanical energy (pressure-volume area) after mitral valve repair. On follow-up (153±94 days), New York Heart Association functional class was reduced from 2.9±0.6 to 1.9±0.5 (P<0.001) at 3 months, and echocardiographic follow-up documented a stepwise reduction in end-diastolic volume (from 147 mL [IQR, 95–191 mL] to 127 mL [IQR, 82–202 mL]; P=0.036). Conclusions— Percutaneous mitral valve repair improves hemodynamic profiles and induces reverse left ventricular remodeling by reducing left ventricular preload while preserving contractility. In nonsurgical candidates with compromised left ventricular function, MitraClip therapy could be considered an alternative to surgical mitral valve repair.

How good patient blood management leads to excellent outcomes in Jehovah's witness patients undergoing cardiac surgery

OBJECTIVES The refusal of blood products makes open-heart surgery in Jehovahs witnesses (JW) an ethical challenge. We demonstrate how patient blood management strategies lead to excellent surgical outcomes. METHODS From 2003 to 2008, 16 JW underwent cardiac surgery at our institution. Only senior surgeons performed coronary revascularization (n=6), valve (n=6), combined (n=1) and aortic surgery (n=3) of which two patients presented with acute type-A dissection. Off-pump surgery remained the method of choice for patients requiring a bypass procedure (n=5). Preoperative hematocrit (Hk) and hemoglobin (Hb) were 42.8±4.7% and 14.5±2 g/dl. In three patients with an Hb<12 g/dl, preoperative hematological stimulating treatment was implemented. RESULTS All patients survived, no major complications occurred and no blood transfusion was administered. The Cell Saver® system (transfused volume: 474±101 ml) and synthetic plasma substitutes [Ringers Lactate: 873±367 ml and hydroxyethyl starch (HES) 6%: 700±388 ml] were used routinely as well as hemostaticas, such as bone wax, and fibrin glue. The decrease of Hk and Hb appeared to be the lowest after off-pump surgery when compared to all other procedures requiring cardiopulmonary bypass (CPB) (25±9% vs. 33±6%; P=0.01 and 22±9% vs. 31±6%; P=0.04). Similarly, the decrease of platelets was significantly lower (20±12% vs. 43±14%; P=0.01). In the follow-up period (52±34 months), one patient died due to a non-cardiac reason, whereas all others were alive, in good clinical condition and did not have major adverse cardiac events (MACE) or recurrent symptoms requiring re-intervention. CONCLUSION Patient blood management leads to excellent short- and long-term outcomes in JW. Combined efforts in regard to preoperative hematological parameter optimization, effective volume management and meticulous surgical techniques make this possible but raise the cautionary note why this is only possible in JW patients.

Strategies to reduce the use of blood products: a European perspective.

Purpose of review Anemia is the most common hematologic problem preoperatively. In itself it compromises the outcome of surgical patients, and additionally results in more frequent allogeneic red blood cell (RBC) transfusions which again independently compromise patient outcome. In elective cardiac surgery as well as in other surgical specialties the use of a patient blood management program will minimize the exposure to blood products, lead to a cost reduction and improve patients outcome. The aim of this review is to discuss the rationale for patient blood management, explain patient blood management in detail including modern and future transfusion strategies. Recent findings The risk for allergenic RBC transfusions is increased by preoperative anemia. The adverse outcome in recipients of RBC transfusions has recently been shown to be caused rather than only associated with RBC transfusions. In Jehovahs witnesses undergoing cardiac surgery patient blood management programs have been established effectively, demonstrating that it is possible to correct preoperative anemia and avoid RBC transfusions resulting in better outcomes. Summary Patient blood management strategies are based on an interdisciplinary multimodal approach including early preoperative recognition and treatment of anemic patients, surgical efforts to minimize blood loss, optimal perfusion strategies to reduce hemodilution and continuous assessment of the bleeding and coagulation status of patients as well as a restrictive volume management. This allows specific and goal-directed treatment of patients, preventing anemia in elective patients, optimizing patients coagulation status early, minimizing exposure to blood products, reducing costs and improving patients outcome.

Safety and feasibility of novel technology fusing echocardiography and fluoroscopy images during MitraClip interventions.

AIMS The EchoNavigator (EN) software (Philips Healthcare, Best, The Netherlands) enables real-time fusion of echocardiography and fluoroscopy by co-registration of the echocardiography probe on the x-ray image. We aimed to evaluate the feasibility and safety of this novel software during MitraClip procedures. METHODS AND RESULTS Twenty-one patients were treated with the support of EchoNavigator software (EN+ patients). The primary (safety) endpoint was the total radiation dose. Secondary endpoints were fluoroscopy and total procedure time. The measurements were compared to those of 21 patients treated immediately before the installation of EchoNavigator (EN- patients). More MitraClips (45 vs. 36) were implanted in the EN+ group, mirroring more complex interventions in this group. In EN+ patients, radiation dose (Gy/cm2) was similar compared to EN- patients (146.5±123.6 vs.146.8±134.1, p=0.9). Total procedure time (minutes) was similar in the EN+ group compared to EN- patients (136.2±50.2 vs. 125.7±51.2, p=0.5). The main benefit of the EchoNavigator is the automated real-time fusion of echocardiography and fluoroscopy, leading to easier catheter manipulation. CONCLUSIONS The use of EchoNavigator software was feasible and safe in all study patients. Further studies are necessary to confirm the benefits of using this software.

Assessment of mitral valve area during percutaneous mitral valve repair using the MitraClip system: comparison of different echocardiographic methods.

Background—Quantification of the mitral valve area (MVA) is important to guide percutaneous mitral valve repair using the MitraClip system. However, little is known about how to best assess MVA in this specific situation. Methods and Results—Immediately before and after MitraClip implantation, comprehensive 3-dimensional (3D) transesophageal echocardiography data were acquired for MVA assessment by the pressure half-time method and by two 3D quantification methods (mitral valve quantification software and 3D quantification software). In addition, transmitral gradients by continuous-wave Doppler (dPmeanCW) were measured to indirectly assess MVA. Data are given as median (interquartile range). Thirty-three patients (39% women) with a median age of 77.1 years (12.4 years) were studied. Before intervention, the median MVAs by the pressure half-time method, mitral valve quantification software, and 3D quantification software were 4.4 cm2 (2.0 cm2), 4.7 cm2 (2.4 cm2), and 6.2 cm2 (2.4 cm2), respectively (P<0.001). After intervention, MVA was reduced to 1.9 cm2 (0.7 cm2), 2.1 cm2 (1.1 cm2), and 2.8 cm2 (1.1 cm2), respectively (P=0.001). The median values for dPmeanCW before and after intervention were 1.0 mm Hg (1.0 mm Hg) and 3.0 mm Hg (3.0 mm Hg; P<0.001), respectively. At discharge, the median dPmeanCW was 4.0 mm Hg (3.0 mm Hg). In multivariate regression analyses including body surface area, the 3 different MVA methods, and dPmeanCW, a post-dPmeanCW ≥5 mm Hg was the best independent predictor of an elevated transmitral gradient at discharge. Conclusions—Transmitral gradients by continuous-wave Doppler are quick, feasible in all patients, and superior to direct peri-interventional assessment of MVA. A postinterventional transmitral gradient by continuous-wave Doppler of ≥5 mm Hg best predicted elevated transmitral gradients at discharge.

Integrated x-ray and echocardiography imaging for structural heart interventions.

Treatment of structural heart disease (SHD) represents a growing need and, with increasing device availability, an increasing number of SHD can be and will be treated percutaneously. However, interventional treatment of SHD is challenging. Long procedure times and steep learning curves are recognised obstacles. The main difficulties arise, however, from the inability to visualise simultaneously the anatomy and the devices using a single imaging technology. In fact, the majority of percutaneous interventions in SHD are guided by fluoroscopy. On the other hand, a multitude of imaging technologies are presently available to guide the interventionalist. Of these technologies, transoesophageal echocardiography (TEE), and particularly 3-D TEE, is rapidly becoming the imaging modality of choice for many of these procedures because it provides critical insights into soft tissue anatomy. However, adequate visualisation and appreciation of the relationships between the cardiac structures and the devices using various imaging modalities remain a challenge. Hence, the interaction between the operator and imager is a crucial factor in attaining procedural success. Innovative technology that fuses live 3-D TEE with live x-ray in an intuitive way could have an important added value. This new imaging technology seeks to improve the communication between the echocardiographer and the interventionalist, to increase the confidence and anatomical awareness, to assist in guidance, and to increase procedural efficiency.

Severe cardiomyopathy following treatment with the tumour necrosis factor-α inhibitor adalimumab for Crohn's disease

Adalimumab belongs to the group of tumour necrosis factor‐α inhibitors and has been approved for the treatment Crohns Disease since 2007. Herein we report a severe adverse reaction to adalimumab in a 25‐year‐old female patient. One week after the initial‐dose of adalimumab (160 mg), which was initiated due to an acute exacerbation of Crohns disease, the patient developed a fulminant cardiomyopathy. In severe cardiogenic shock, the patient required an extracorporeal membrane‐oxygenation system for 8 days until cardiac recovery.

Percutaneous double valve intervention

An 81-year-old woman was referred for NSTEMI complicated by cardiogenic shock. Urgent invasive assessment revealed a subtotal left anterior descending artery (LAD) stenosis, severe aortic stenosis (mean gradient 60 mmHg, aortic valve area 0.5 cm2), decreased left ventricular (LV) function [left ventricular ejection fraction (LVEF) 49%], grade 3+ mitral regurgitation (MR), and severe pulmonary hypertension. In view of her critical situation, acute LAD–percutaneous coronary intervention and aortic valvuloplasty were performed with …