Author + information
- Received November 7, 2017
- Revision received January 18, 2018
- Accepted January 22, 2018
- Published online March 26, 2018.
- Stephan Ensminger, MD, DPhila,∗ (, )
- Buntaro Fujita, MDa,
- Timm Bauer, MDb,
- Helge Möllmann, MDc,
- Andreas Beckmann, MDd,
- Raffi Bekeredjian, MDe,
- Sabine Bleiziffer, MDf,
- Sandra Landwehr, PhDg,
- Christian W. Hamm, MDh,
- Friedrich W. Mohr, MDi,
- Hugo A. Katus, MDe,
- Wolfgang Harringer, MDj,
- Thomas Walther, MDk,
- Christian Frerker, MDl,
- GARY Executive Board
- aDepartment of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany
- bDepartment of Cardiology, University of Giessen, Giessen, Germany
- cDepartment of Internal Medicine I, St.-Johannes-Hospital, Dortmund, Germany
- dGerman Society of Thoracic, Cardiac and Vascular Surgery, Berlin, Germany
- eDepartment of Cardiology, University of Heidelberg, Heidelberg, Germany
- fClinic for Cardiovascular Surgery, German Heart Center Munich, Munich, Germany
- gBQS Institute for Quality and Patient Safety, Düsseldorf, Germany
- hDepartment of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany
- iDepartment of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany
- jDepartment of Thoracic and Cardiovascular Surgery, Klinikum Braunschweig, Braunschweig, Germany
- kDepartment of Cardiac Surgery, Kerchoff Heart and Thorax Center, Bad Nauheim, Germany
- lDepartment of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany
- ↵∗Address for correspondence:
Dr. Stephan Ensminger, Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Georgstrasse 11, 32545 Bad Oeynhausen, Germany.
Background Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced.
Objectives The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs.
Methods A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other.
Results A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), cardiopulmonary bypass (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and aortic cross clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001), but showed significantly elevated rates of pacemaker implantation (3.7% vs. 8.8%; p < 0.001) and disabling stroke (0.9% vs. 2.2%; p < 0.001), whereas in-hospital mortality was similar (1.7% vs. 2.2%; p = 0.22). These findings persisted after 1:1 propensity score matching. Comparison of the 3 RDVs revealed statistically nonsignificant different pacemaker rates and significantly different post-operative transvalvular gradients.
Conclusions In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827)
- biological aortic valve prosthesis
- German Aortic Valve RegistrY
- rapid deployment heart valve
- surgical aortic valve replacement
- sutureless valve
Surgical aortic valve replacement has been the standard of care for invasive treatment of patients with aortic valve disease for decades. Throughout the past 15 years, transcatheter aortic valve replacement (TAVR) was established and is now recognized as a treatment option in patients who are at high and intermediate surgical risk (1,2). During the same time period, so-called rapid deployment valves (RDVs) (also known as sutureless valves) have been introduced (3). RDVs are made of biological tissue mounted on an atypical stent frame. These valve prostheses are implanted surgically (with cardiopulmonary bypass [CPB] and cardioplegia) after resection of the calcified native aortic valve cusps. Valve implantation is performed without placing circular annular sutures (4). RDVs are equipped with alternative anchoring mechanisms that enable faster implantation through minimally invasive incisions (i.e., ministernotomy or intercostal minithoracotomy). It has been proposed that these valve prostheses may be particularly beneficial in patients who are undergoing combined cardiac surgery, which typically necessitates prolonged aortic cross clamp (X-clamp) times. In the past, 3 RDVs have gained regulatory approval for commercial use: the self-expanding, nitinol-based 3F Enable valve (Medtronic, Dublin, Ireland), the balloon expandable INTUITY valve (Edwards Lifesciences, Irvine, California), and the Perceval sutureless valve (Sorin/LivaNova Group, Saluggia, Italy). Although the self-expanding, nitinol-based valve has been withdrawn from the market, the balloon-expandable and sutureless valves are increasingly being implanted. However, unlike TAVR, treatment with RDVs has so far not been extensively investigated in randomized trials. It is unclear at present whether RDVs can clinically outperform conventional biological valves (CBVs). In addition, specific criteria for the definition of patient groups to be treated with this kind of valve prosthesis have not been elaborated.
GARY (German Aortic Valve Registry) is a prospective, collaborative, multicenter all-comers registry that was initiated to analyze contemporary outcomes after invasive treatment of aortic valve stenosis. Herein, we report the initial nationwide German experience with the 3 previously mentioned RDVs for the treatment of patients with aortic valve stenosis and provide a head-to-head comparison with conventional biological aortic valve prostheses.
GARY is a voluntary, prospective registry that was initiated in 2010 to monitor contemporary outcomes after treatment of aortic valve stenosis in Germany. Consecutive patients of the participating institutions were enrolled if elective or urgent treatment (i.e., balloon valvuloplasty, TAVR, aortic valve reconstruction, or aortic valve replacement) was planned and patients gave written informed consent. Detailed descriptions of GARY have been published previously (5–8).
For the present study, all patients who underwent isolated surgical aortic valve replacement (sAVR) using a xenograft or in combination with coronary artery bypass grafting (CABG) between 2011 and 2015 were identified (Figure 1). Patients who underwent additional procedures (mitral, tricuspid, or pulmonic valve replacement, repair, or valvulotomy; replacement of the ascending aorta; atrial ablation for arrhythmia; and other rare procedures) were excluded. Baseline characteristics, procedural data, and in-hospital outcomes were compared for patients undergoing isolated sAVR and for combined surgery with CABG (sAVR + CABG). In a second step, all RDVs were pooled and were subsequently analyzed according to the implanted RDV type.
Continuous variables are expressed as median (25th to 75th percentile) due to non-normal distribution (as assessed by the Kolmogorov-Smirnov test) and were compared between independent groups using the nonparametric Mann-Whitney U test. Discrete variables are presented as relative and absolute frequencies. The chi-square or Fisher exact tests were applied to test for differences between groups. Patients who underwent isolated sAVR and those who underwent sAVR + CABG were analyzed separately. In both procedure groups, patients who received a CBV were compared with those who received an RDV. To account for differences in baseline characteristics, 1:1 propensity score (PS) matching was performed (Online Appendix). To compare the performance of the 3 RDVs among each other, 1:1:1 PS matching was performed (Online Appendix). A 2-sided p value <0.05 was considered statistically significant. All statistical analyses were performed using IBM SPSS Statistics for Windows, version 19.0 (IBM, Armonk, New York) and RStudio: Integrated Development (R. RStudio, Boston, Massachusetts).
Study population, procedural, and in-hospital outcome: Isolated sAVR
For the isolated sAVR group, 20,937 patients were identified who received a CBV, whereas 1,125 patients were treated with an RDV. Baseline characteristics of these patients are summarized in Table 1. Patients treated with an RDV were significantly older (CBV 72 years [25th to 75th percentile: 66 to 77 years] vs. RDV 75 years [25th to 75th percentile: 71 to 78 years]; p < 0.001), were more often female (40.6% vs. 58.2%; p < 0.001), presented with a higher prevalence of coronary artery disease (21.6% vs. 24.4%; p = 0.02), and more often had a history of PCI (9% vs. 11.2%; p = 0.01), but had less previous cardiac operations (8% vs. 5.7%; p = 0.01). Furthermore, patients who received an RDV more often had an LVEF >50% (76.4% vs. 82.6%; p < 0.001) and higher risk scores. Procedural data are presented in Table 2. RDVs were significantly more often implanted through access sites other than conventional sternotomy (22.4% vs. 58.3%; p < 0.001). Patients treated with an RDV presented with significantly reduced procedure times (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), CPB times (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001) and aortic X-clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001). In 61.9% of RDV patients, the sutureless valve was implanted, whereas 27.9% received the balloon-expandable valve and 10.5% the self-expanding, nitinol-based prosthesis. When comparing the 3 RDVs, we observed a significant decrease of procedure, CPB, and X-clamp times in the following order: self-expanding, nitinol-based valve; the balloon-expandable valve; and the sutureless valve (Figure 2). In-hospital outcomes are shown in Table 3 and Figure 3. In-hospital mortality was similar with both prosthesis types (1.7% vs. 2.2%; p = 0.22). Patients treated with an RDV presented with significantly elevated rates of new pacemaker implantation (3.7% vs. 8.8%; p < 0.001), disabling stroke (0.9% vs. 2.2%; p < 0.001), and residual aortic regurgitation ≥2° (0.4% vs. 1.2%; p < 0.001), whereas the need for transfusion of ≥4 red blood cell units tended to be lower with RDVs (17.1% vs. 15%; p = 0.07).
After PS matching, 1,021 pairs treated with CBVs and RDVs were identified. Baseline characteristics were well balanced after PS matching (Table 1). The procedure time (161 min [25th to 75th percentile: 138 to 195 min] vs. 150 min [25th to 75th percentile: 126 to 177 min]; p < 0.001), CPB time (85 min [25th to 75th percentile: 71 to 105 min] vs. 69 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and X-clamp time (62 min [25th to 75th percentile: 50 to 76 min] vs. 44 min [25th to 75th percentile: 34 to 56 min]; p < 0.001) were significantly shorter for the RDV group in the PS-matched cohorts (Table 2). Regarding in-hospital outcomes, we observed significantly elevated incidences of new pacemaker implantation (4.1% vs. 9.1%; p < 0.001), disabling stroke (1.2% vs. 2.4%; p = 0.04), and elevated mean pressure gradient (MPG) ≥20 mm Hg (9.8% vs. 13.8%; p = 0.03) for RDVs. However, this group presented with significantly lower rates of bleeding requiring transfusion of ≥4 red blood cell units (19.4% vs. 14.5%; p = 0.004) (Table 3, Central illustration).
Study population, procedural, and in-hospital outcome: sAVR + CABG
Of all patients undergoing sAVR + CABG, a total of 14,474 patients received a CBV and 403 patients an RDV. In unmatched analysis, the 2 groups differed significantly in terms of age (74 years [25th to 75th percentile: 70 to 78 years] vs. 76 years [25th to 75th percentile: 72 to 80 years]; p < 0.001), female sex (27.7% vs. 39.2%; p < 0.001), patients on chronic dialysis (1.3% vs. 2.7%; p = 0.01), LVEF distribution (p < 0.05), and risk scores (Online Table 5). Similar to patients who underwent isolated sAVR, the procedure time (223 min [25th to 75th percentile: 185 to 270 min] vs. 210 min [25th to 75th percentile: 177 to 261 min]; p = 0.002), CPB time (116 min [25th to 75th percentile: 94 to 144 min] vs. 103 min [25th to 75th percentile: 80 to 131 min]; p < 0.001), and aortic X-clamp time (83 min [25th to 75th percentile: 67 to 103 min] vs. 70 min [25th to 75th percentile: 52 to 92 min]; p < 0.001) were significantly lower with RDVs compared with CBVs (Online Figure 5, Online Table 6). Patients treated with an RDV showed significantly elevated rates of new pacemaker implantation (3.2% vs. 9.5%; p < 0.001) as well as increased duration of intensive care unit stay (2 days [25th to 75th percentile: 1 to 5 days] vs. 3 days [25th to 75th percentile: 1 to 6 days]; p = 0.001) and hospital stay (11 days [25th to 75th percentile: 8 to 14 days] vs. 12 days [25th to 75th percentile: 9 to 17 days]; p < 0.001) (Online Table 7).
After PS matching, 354 pairs were found for each valve prosthesis type in patients undergoing sAVR + CABG. Baseline characteristics were well balanced in the PS-matched cohorts (Online Table 5). Patients treated with RDVs presented with decreased CPB times (110 min [25th to 75th percentile: 89 to 140 min] vs. 103 min [25th to 75th percentile: 80 to 131 min]; p < 0.001) and aortic X-clamp times (79 min [25th to 75th percentile: 64 to 100 min] vs. 70 min [25th to 75th percentile: 52 to 91 min]; p < 0.001) (Online Table 6). The RDV group presented with significantly elevated rates of new pacemaker implantation (3.8% vs. 9.4%; p = 0.003), and had longer intensive care unit stay (2 days [25th to 75th percentile: 2 to 5 days] vs. 3 days [25th to 75th percentile: 2 to 6 days]; p = 0.01) and hospital stay (10 days [25th to 75th percentile: 8 to 14 days] vs. 12 days [25th to 75th percentile: 9 to 17 days]; p = 0.02) (Online Table 7, Online Figure 6).
Individual performance of the 3 RDVs
Among all patients who received an RDV, the self-expanding, nitinol-based prosthesis was used in 162, the balloon-expandable valve in 466, and the sutureless valve in 900 patients (Table 4). In all 3 RDV groups, the treated patients presented with a similar BMI (p > 0.99), effective orifice area (p = 0.07), and MPG (p = 0.07). The fraction of patients with reduced LVEF <30% differed nonsignificantly between groups (p = 0.21), whereas the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score differed significantly: the self-expanding, nitinol-based valve group presented the lowest and the sutureless valve group the highest STS PROM score (3F Enable 2.4% [25th to 75th percentile: 1.5% to 3.9%] vs. INTUITY 2.5% [25th to 75th percentile: 1.8% to 3.6%] vs. Perceval S 2.7% [25th to 75th percentile: 2% to 4%]; p = 0.01). All 3 RDVs were more often implanted as isolated sAVR than in combination with CABG, and this distribution differed significantly among the RDV types (Table 4). The self-expanding, nitinol-based valve was predominantly implanted through conventional sternotomy, whereas the sutureless valve was more often implanted through alternative access sites. The sutureless valve was more frequently used in larger sizes than the other valves (p < 0.01) (Table 4).
PS matching led to 3 cohorts of 102 patients each. Baseline characteristics were well balanced in the PS-matched cohorts, including effective orifice area, STS PROM score, procedure (i.e., isolated sAVR or sAVR + CABG), surgical access site, and the size of the implanted RDV (Table 5). Patients treated with the sutureless prosthesis presented with the shortest procedure time (3f Enable 177 min [25th to 75th percentile: 145 to 234 min] vs. INTUITY 172 min [25th to 75th percentile: 141 to 209 min] vs. Perceval S 154.5 min [25th to 75th percentile: 130 to 197 min]; p = 0.009), CPB time (86 min [25th to 75th percentile: 68 to 119 min] vs. 81 min [25th to 75th percentile: 64 to 103 min] vs. 74 min [25th to 75th percentile: 58 to 97 min]; p = 0.003), and aortic X-clamp time (54 min [25th to 75th percentile: 42 to 76 min] vs. 50 min [25th to 75th percentile: 41 to 69 min] vs. 47 min [25th to 75th percentile: 36 to 64 min]; p = 0.03) (Table 5). New pacemaker implantation rates were 11.8% vs. 8.1% vs. 13.7%, respectively (p = 0.44). Within the RDV group, Perceval S treatment showed a significantly higher fraction of patients with a post-operative MPG of >20 mm Hg compared with the 3f Enable and INTUITY (8.9% vs. 1.7% vs. 21.1%, respectively; p < 0.001) (Table 5, Figure 3).
In this study, we investigated the early outcome of patients treated with RDVs compared with CBVs for treatment of aortic stenosis in an all-comers population from GARY between 2011 and 2015. Due to differences in baseline characteristics, additional 1:1 PS matching was used for further adjusted comparison. The main findings can be summarized as follows: 1) implantation of RDVs was associated with significantly reduced procedure, CPB, and aortic X-clamp times; 2) patients treated with an RDV presented with significantly elevated rates of new-onset pacemaker implantation and disabling stroke, whereas the need for blood transfusions was lower; and 3) there were differences in post-operative MPGs for the 3 analyzed RDVs (Central Illustration).
Substantial experience with RDVs has been gained over the past decade, and outcomes with the 3 RDVs are well documented in controlled, prospective, single-arm trials (9–14). These studies collectively demonstrate that treatment with RDVs can effectively improve hemodynamics and relieve symptoms in patients with symptomatic and severe aortic stenosis with an acceptable safety profile (15). However, so far there was no compelling evidence comparing the performance of RDVs with CBVs. To fill this knowledge gap, data of the all-comers GARY registry were analyzed. The shorter observed procedural times are in line with previously published studies (9–14). Interestingly, the most commonly implanted RDV had the shortest operating times, indicating that a reduction of these times may be related to operator experience. In addition, RDVs were significantly more often implanted via minimally invasive approaches compared with CBVs. Both of these findings are also stated by an expert panel as the main rationale to recommend RDVs for a variety of patient groups, including redo cases or delicate aortic wall conditions (16). However, data of this GARY analysis demonstrate that a significant reduction of operating times as well as the utilization of minimally invasive approaches may not translate into a beneficial effect on in-hospital mortality. Moreover, neurological events were even elevated in patients undergoing RDV implantation. Whether these observations are also true for specific subgroups remains to be investigated. At this stage, however, it seems unlikely that RDVs are safer than CBVs in the previously mentioned subpopulations. Specifically, in redo cases, full sternotomy is usually indispensable, and the possibility of minimally invasive approaches seems limited. For delicate aortic wall conditions, such as a severely calcified aortic root, the risk for stroke is already elevated; until additional evidence and adequately designed trials are available, such recommendations for potential advantages of RDV need to be interpreted with caution.
Our observation that RDV implantation is associated with an increased risk of stroke compared with CBVs requires attention. The reason for this finding is unclear, but some aspects of RDV implantation may explain this. First, the 3 RDVs are characterized by unique stent frame and leaflet designs. There is limited experience regarding their potential influence on thrombus formation, and hence, risk for stroke. Notably, a recent publication has highlighted the high rate of subclinical leaflet thrombosis after the sutureless valve implantation. Second, it has been recommended to not entirely decalcify the aortic annulus for RDV implantation to prevent inadequate decalcification, which may lead to an uneven surface that, in turn, can lead to paravalvular leakage (PVL). This is in contrast to CBV implantation, where the annulus is usually completely decalcified. It is possible that remaining (or partly mobilized) calcium deposits break off after RDV implantation and lead to stroke. Third, no specific recommendations exist regarding anticoagulation regimen after RDV implantation. However, it is also possible that patients receiving RDVs were more closely monitored, and the increased rate of stroke is the result of reporting bias.
CBVs are characterized by a very long track record of reliability, durability, and consistently low post-operative permanent pacemaker and PVL rates. As RDVs have only been on the market for a limited time, long-term durability data are not available, and a comparison with CBVs seems difficult as a consequence of the specific and unique design of RDVs. Interestingly, PVL rates were similarly low in both groups, but significantly elevated rates of pacemaker implantation were observed with all 3 types of RDVs. This aspect needs attention as it represents a critical point, for example, when a decision is to be made between sAVR and TAVR for an active intermediate-risk patient, as the low pacemaker rate after CBV still represents a strong argument in favor of sAVR. However, the average pacemaker rate reported for RDVs in our study was approximately 9%, and was therefore closer to TAVR than sAVR with CBVs (17–19). The majority of patients currently undergoing sAVR are at intermediate to low surgical risk, with accordingly low expected complication rates. An additional risk for pacemaker implantation in such patients therefore requires justification. Several factors may have contributed to the observed increased pacemaker rates after RDV implantation. In this analysis, the sutureless valve was associated with the highest pacemaker rates (in unmatched analysis) and was also implanted in larger sizes. As a consequence, oversizing may have been one possible explanation. In our view, another relevant factor is the stent material of the RDV, which is self-expanding nitinol (Perceval, 3f Enable) or balloon-expandable stainless steel (INTUITY). Therefore, the results of this analysis are in line with experience from TAVR, where self-expanding nitinol-based valves (CoreValve family) tend to have higher pacemaker rates than balloon-expanding valves made of stainless steel/cobalt-chromium stents (Edwards SAPIEN family). Furthermore, we believe that the design of RDVs is an additional contributing factor, as all 3 valves are equipped with a subvalvular “portion” that may represent an additional risk to injure conduction pathways. This hypothesis is also in line with the TAVR experience, where a higher implantation position of the THV was associated with significantly lower pacemaker rates (20,21).
As a consequence of significantly reduced procedure, CPB, and aortic X-clamp times, RDVs seem to be particularly suitable for patients requiring concomitant surgery, for example, for coronary artery disease as also stated by the expert panel (16). Interestingly, the current GARY analysis could not detect any beneficial effects on in-hospital outcomes in patients undergoing combined sAVR + CABG who were treated with an RDV compared with a CBV, despite significantly decreased procedure times. For this patient cohort, CBV + CABG is currently the standard of care, and future studies (most preferably randomized controlled trials) must investigate if the use of RDVs in complex procedures will translate into a substantial clinical benefit for the patient.
As stated earlier, the 3 RDVs differ considerably in their design, which may be accompanied by different complication profiles. The sutureless valve showed significantly elevated post-operative transvalvular gradients−independent of the implanted valve sizes−compared with the self-expanding, nitinol-based and balloon-expandable valves, which may be related to its design. This finding is in contrast to past studies (including the Perceval S CE mark study and several other single-arm trials with the sutureless valve), where pressure gradients were markedly lower than seen in the current analysis (10,22,23). This discrepancy may be related to the well-known issue that controlled trials often do not reflect real-world clinical practice. However, at this early stage, this finding seems of concern; additional evidence from future studies that also analyze patients outside of controlled trials will be needed to determine if the increased gradients seen in patients treated with the sutureless valve have an effect on long-term outcomes (e.g., durability, survival). Although the reasons for this finding could not be elaborated in this analysis, a recent publication by Dalen et al. (24) showed that 28% of the sutureless valve recipients at a single center presented with reduced leaflet motion, which may explain these findings. Apart from transvalvular gradients, the incidence of pacemaker implantation ranged between 8.1% (INTUITY) and 13.7% (Perceval S) on a significantly higher level compared with CBVs. This is somewhat surprising, as the controlled decalcification and omission of suture placement may in general reduce the risk for conduction disturbances. However, the material and design of each RDV is different, and the TAVR experience has shown that self-expanding valves tend to have higher permanent pacemaker rates (25,26). Although the exact mechanism remains elusive at present, our data clearly demonstrate an increased risk for conduction disturbances with RDVs; this finding will have to be taken into consideration for appropriate patient selection. Finally, there was no statistically significant difference in PVL rates between the 3 RDVs. Therefore, at this stage, CBVs seem to be the safer option for the broad majority of patients who are in need of sAVR. However, we cannot rule out that specific subgroups who will benefit from RDVs may exist. This open question should be addressed in future studies to generate solid data that allow for clear recommendations for the use of RDVs.
First, institutional participation in GARY is voluntary. However, almost all institutions in Germany participate, and therefore allow the registry to generate real-world data. Second, patients treated with RDVs may include patients that were also included in controlled trials.
Shorter operating times with RDV implantation did not translate into improved in-hospital outcomes in >36,000 patients treated with CBVs and RDVs alone or in combination with CABG. The pacemaker rate was increased in all RDVs, and we observed differences in post-operative MPGs between individual RDVs. However, specific subgroups that could benefit from RDV implantation may exist. Future trials should attempt to answer these open questions and identify such patient groups.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: In patients with aortic stenosis undergoing surgical bioprosthetic valve replacement, conventional biological prostheses were associated with better short-term clinical outcomes than rapid deployment valves prostheses.
TRANSLATIONAL OUTLOOK: Randomized trials are needed to confirm these findings and identify specific subgroups of patients who gain more benefit from one type of bioprosthesis or the other.
The authors express their sincere gratitude to Ms. Elke Schäfer for project management.
Funding was obtained from the German Heart Foundation; the Dr. Rolf M. Schwiete Foundation; the German Society of Thoracic, Cardiac and Vascular Surgery; and the German Cardiac Society. Dr. Ensminger has served as a proctor and consultant for Edwards Lifesciences; has served as a proctor and member of the scientific advisory board of JenaValve; and has received travel support from Medtronic. Dr. Bleiziffer has served as a proctor and consultant for Medtronic; and has served as a proctor for Boston Scientific, JenaValve, and Highlife. Dr. Hamm has served on the Advisory Board of Medtronic; and has served as an advisor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Ensminger and Fujita contributed equally to this work and are joint first authors.
- Abbreviations and Acronyms
- coronary artery bypass grafting
- conventional biological valve
- cardiopulmonary bypass
- rapid deployment valve
- transient ischemic attack
- cross clamp
- Received November 7, 2017.
- Revision received January 18, 2018.
- Accepted January 22, 2018.
- 2018 American College of Cardiology Foundation
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