Background Transcatheter aortic valve implantation has gained widespread acceptance to treat elderly high-risk patients with aortic stenosis. We used a subcutaneous rat model to evaluate whether ...crimping may affect valve long-term durability. Methods Standard Sapien transcatheter valves (Edwards Lifesciences, Irvine, CA) were crimped for different durations (1 hour, 1 day, 1 month) and uncrimped, and leaflet pieces as well as control tissue (Perimount Magna, Edwards) were then implanted subcutaneously in 15 male weanling Sprague-Dawley rats for 12 weeks. Grade of calcification was measured by freeze-dried mass and van Kossa staining. Histologic and electron microscopic examination were performed to investigate potential leaflet-fragmentation caused by crimping. Results There were no differences in calcification among the groups. The calcium carbonate concentrations in all samples ranged from 0.1 to 100 mg/g dry weight. Leaflet morphology, however, differed from no fragmentation (control group) to highly fragmented tissue (1-month crimped). These differences reached statistical significance between crimped and non-crimped leaflets ( p < 0.003). Conclusions Transcatheter valve crimping does not necessarily affect leaflet calcification. However, the structural changes of the leaflets that were caused by crimping may have clinical significance. Duration of crimping should be as short as possible, and very tight crimping to small diameters should be avoided.
Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation ...status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial.
In case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min.
Baseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03).
In case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on "point-of-care" 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality.
German Clinical Trials Register, TRN: DRKS00017367 , date of registration: 05.06.2019, 'retrospectively registered'.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Objective Superior aortic valve hemodynamic performance can accelerate left ventricular mass regression and enhance survival and functional status after surgical aortic valve replacement. This can be ...achieved by rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame, which functionally widens and reshapes the left ventricular outflow tract, to ensure a larger effective orifice area compared with conventional surgical valves. We report the intermediate-term follow-up data from a large series of patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial. Methods In a prospective, multicenter (6 European hospitals), single-arm study, 287 patients with aortic stenosis underwent rapid deployment aortic valve replacement using a stented trileaflet bovine pericardial bioprosthesis. Core laboratory echocardiography was performed at baseline, discharge, and 3 months, 1 year, and 3 years after rapid deployment aortic valve replacement. Results The mean patient age was 75.7 ± 6.7 years (range, 45-93; 49.1% women). The mean aortic valve gradient significantly decreased from discharge to 3 years of follow-up. The mean effective orifice area remained stable from discharge to 3 years. At 1 year, the left ventricular mass index had decreased by 14% ( P < .0001) and at 3 years by 16% ( P < .0001) compared with at discharge. The prevalence of severe patient-prosthesis mismatch was 3% at discharge and remained stable during the follow-up period. Conclusions In a large series of elderly patients with symptomatic severe aortic stenosis, rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame demonstrated excellent hemodynamic performance and significant left ventricular mass regression. With continued follow-up, future studies will establish whether these favorable structural changes correlate with improvement in long-term survival and functional status.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective
Since the beginning of the transcatheter aortic valve implantation (TAVI) era, many prosthetic valves have entered clinical practice. TAVI prostheses differ regarding stent design and some ...may potentially interfere with diagnostic or interventional catheters. The aim of our analysis was to evaluate the feasibility of coronary angiography (CA) or percutaneous coronary intervention (PCI) in patients with prior TAVI.
Methods
From 2011 to 2014, 1,000 patients were treated by TAVI at our center using eight different valve prostheses (Symetis ACURATE TA and ACURATE TF; Medtronic CoreValve and Engager; JenaValve, SJM Portico; Edwards Lifesciences SAPIEN and SAPIEN XT). In this analysis, all patients were included who underwent either CA or PCI after TAVI. CA or PCI were rated as fully feasible when coronary ostia could be fully intubated, partially feasible when coronary arteries could be displayed only unselectively or unfeasible when coronary arteries could not be displayed.
Results
A total of 35 patients underwent CA/PCI after TAVI at our hospital. In all patients with valves implanted in a subcoronary position (SAPIEN
n
= 19; JenaValve
n
= 1), selective intubation was feasible using standard catheters. Out of 15 patients with valve types that are placed over the coronary ostia (CoreValve
n
= 10, ACURATE
n
= 4, Portico
n
= 1), selective intubation of coronary arteries was not possible in 9 cases, even with the use of different diagnostic catheters. Full accessibility was possible only in 3 cases. In 2 cases, display of the right CA was only feasible using unselective aortography. In 1 case, coronary arteries could not be displayed at all immediately after a valve-in-valve procedure.
Conclusion
CA or PCI after TAVI is usually feasible. Devices that are placed in a partially supracoronary position, however, can interfere with diagnostic or guiding catheters and impede straightforward intervention, especially when the prosthesis is not implanted in the correct position.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Objectives A new class of rapid-deployment aortic valves has emerged with the potential to simplify minimally invasive aortic surgery and reduce crossclamp and cardiopulmonary bypass times. We report ...the 1-year clinical outcomes of aortic valve replacement with the EDWARDS INTUITY Valve System (Edwards Lifesciences LLC, Irvine, Calif) in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial. Methods Seventeen surgeons from 6 European centers treated 152 consecutive patients with aortic stenosis requiring valve replacement in a prospective, single-arm trial. A stented trileaflet bovine pericardial bioprosthesis with a balloon-expandable, cloth-covered stent frame at the inflow aspect was implanted in 146 patients (mean age, 75.5 ± 6.7 years; 52.7% were female). Five valve sizes were evaluated (19-27 mm); 58.9% of cases had isolated aortic valve replacement, and 41.1% of cases involved concomitant procedures. Minimally invasive surgical approaches occurred in 48.8% of the isolated aortic valve replacements. Patients were followed at discharge, 3 months, and 1 year postoperatively. Results Implantation success was 96.1% (146/152), early valve-related mortality was 1.4% (2/146), and cumulative survival was 92.5% at a mean follow-up of 9.8 ± 5.1 months. Crossclamp time for isolated aortic valve replacement was 41.1 ± 10.6 minutes. Independent core laboratory–adjudicated mean effective orifice area and aortic valve pressure gradient were 1.7 ± 0.2 cm2 and 8.8 ± 3.0 mm Hg at 3 months, and 1.7 ± 0.2 cm2 and 8.4 ± 3.4 mm Hg at 1 year, respectively. Conclusions Implantation of the EDWARDS INTUITY Valve System is feasible, safe, and efficacious for aortic valve replacement. Aortic crossclamp and cardiopulmonary bypass times were reduced compared with those for conventional aortic valve replacement. Early hemodynamic performance was excellent and remained so up to 1 year.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective Transcatheter aortic valve implantation is an emerging technique for the treatment of aortic valve stenosis in high-risk patients. Detailed knowledge of aortic root anatomy, including ...specific information on the extent of native cusp calcifications, is required. The aim of this study was to evaluate whether echocardiographic assessment of aortic stenosis using a calcification score is useful to predict outcomes of transcatheter aortic valve implantation in elderly high-risk patients. Methods Detailed preoperative digitalized transesophageal echocardiographic images were available from 103 patients treated by transapical transcatheter aortic valve implantation between February 2006 and February 2009. On the basis of a previously published study, an index score was developed to describe the extent of valve calcification ranging from 0 to 8 (normal to diffuse calcification). Results The median age of patients was 82.2 ± 5.9 years. The mean logistic European System for Cardiac Operative Risk Evaluation was 33.0% ± 16.3%. Mild paravalvular leak was present in 43 patients (42.2%), and a moderate paravalvular leak was observed in 5 patients (4.9%). Severe regurgitation was not observed in any patient. Logistic regression analysis revealed that the transcatheter aortic valve implantation echocardiographic calcification score is associated with the presence of moderate paravalvular aortic regurgitation (odds ratio, 8.5; 95% confidence interval, 1.2–58.9; P = .0001) and overall moderate aortic regurgitation (odds ratio, 3.6; 95% confidence interval, 1.2–10.4; P = .0006). Conclusions Transesophageal echocardiography demonstrates detailed anatomic information of the calcification patterns of the aortic valve and root and thus plays an important role in the screening of patients undergoing transcatheter aortic valve implantation. The transcatheter aortic valve implantation echocardiographic calcification score allowed prediction of the risk of postoperative paravalvular and overall aortic regurgitation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Early outcomes after isolated aortic valve replacement with rapid deployment aortic valve Wahlers, Thorsten C.W., MD, PhD; Haverich, Axel, MD; Borger, Michael A., MD, PhD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
06/2016, Volume:
151, Issue:
6
Journal Article
Peer reviewed
Open access
Abstract Objective Minimal access aortic valve replacement is associated with favorable clinical outcomes; however, several meta-analyses have reported significantly longer crossclamp times compared ...with a full sternotomy. We examined the procedural and early safety outcomes after isolated rapid deployment aortic valve replacement by surgical approach in patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial. Methods The Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial was a prospective, multicenter, single-arm study, with successful implants in 287 patients with aortic valve stenosis who underwent rapid deployment aortic valve replacement using the EDWARDS INTUITY Valve System (Edwards Lifesciences, Irvine, Calif). Patients were evaluated perioperatively for procedural times and technical success rates; at discharge, for hospital length of stay; and, at 30 days, for early adverse events. Results A total of 158 patients underwent isolated aortic valve replacement through a full sternotomy (n = 71), upper hemisternotomy (n = 77), or right anterior thoracotomy (n = 10). Mean age at baseline was 75.7 ± 7.2 years. Mean aortic crossclamp and cardiopulmonary bypass times (minutes) were similar for full sternotomy and upper hemisternotomy, 43.5 ± 32.5/71.6 ± 41.8 and 43.1 ± 13.1/69.6 ± 19.1, respectively, and significantly longer for right anterior thoracotomy, 88.3 ± 18.6/122.2 ± 22.1 ( P < .000). Early adverse event rates were similar, and in-hospital mortality rates were low regardless of surgical approach. Conclusions These data suggest that isolated rapid deployment aortic valve replacement through an upper hemisternotomy can lead to shorter crossclamp times than has been reported historically in the literature. This may facilitate minimal access aortic valve replacement by eliminating the issue of prolonged crossclamp times. Further, low in-hospital mortality and new permanent pacemaker implant rates were observed regardless of surgical approach.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Cardiogenic shock (CS) can occur in patients with Takotsubo syndrome (TTS). As TTS has received increasing attention and has been more closely researched, several aspects of the pathogenesis have ...been identified, particularly that an excessive release of catecholamines plays an important role. Nevertheless, evidence on specific therapy concepts is still lacking. As a result, TTS with severe hemodynamic instability and low cardiac output creates unique challenges, and mechanical circulatory support is needed with as few inotropic drugs as possible.
We present a 77-year-old female patient who underwent minimally invasive surgical mitral valve replacement. After an uneventful course, the patient developed acute heart failure eleven days after surgery. Transthoracic echocardiography (TTE) revealed a new onset of TTS. The patient needed left ventricular venting and full haemodynamic flow. We successfully implanted a microaxial left ventricular assist device (Impella 5.5) using the transaxillary approach. The haemodynamic situation stabilised immediately. The patient was weaned and the Impella 5.5 was explanted after five days.
We present the first-in-man implantation of a transaxillary Impella 5.5 in a patient with TTS. The patient benefitted from Impella 5.5 therapy with full haemodynamic support and venting of the left ventricle.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Mitral valve prolapse (MVP) is common among heart valve disease patients, causing severe mitral regurgitation (MR). Although complications such as cardiac arrhythmias and sudden cardiac death are ...rare, the high prevalence of the condition leads to a significant number of such events. Through next-generation gene sequencing approaches, predisposing genetic components have been shown to play a crucial role in the development of MVP. After the discovery of the X-linked inheritance of filamin A, autosomal inherited genes were identified. In addition, the study of sporadic MVP identified several genes, including DZIP1, TNS1, LMCD1, GLIS1, PTPRJ, FLYWCH, and MMP2. The early screening of these genetic predispositions may help to determine the patient population at risk for severe complications of MVP and impact the timing of reconstructive surgery. Surgical mitral valve repair is an effective treatment option for MVP, resulting in excellent short- and long-term outcomes. Repair rates in excess of 95% and low complication rates have been consistently reported for minimally invasive mitral valve repair performed in high-volume centers. We therefore conceptualize a potential preventive surgical strategy for the treatment of MVP in patients with genetic predisposition, which is currently not considered in guideline recommendations. Further genetic studies on MVP pathology and large prospective clinical trials will be required to support such an approach.
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