Single tests of implantable cardioverter defibrillators can be performed in selected patients at a low risk of neuronal damage.

BACKGROUND: Defibrillator testing (DFT) is still used in selected patients to ensure adequate therapy. To do so, ventricular fibrillation is induced and terminated by the implanted cardioverter defibrillator (ICD). Studies have shown increases in neuronal damage markers without a measurable clinical effect in patients after defibrillator threshold testing with multiple shocks. OBJECTIVE: The aim of this study was to measure clinical outcomes, neuronal damage parameters (NSE and S100), and intraoperative cerebral perfusion (Doppler, near infra-red spectroscopy [NIRS]) in patients undergoing single DFT after transvenous ICD implantation and comparing them to untested patients. METHOD: We included 23 patients. Nine underwent surgery with a single DFT, 14 were not tested. Cognitive impairment was tested using the Mini-Mental-Status Test (MMST) and the DEMTECt 24 h prior and postsurgery. We also measured S100 and Neuron-Specific Enolase (NSE) at these timepoints. During surgery we measured medial cerebral artery velocity and cerebral tissue oxygen saturation (rSO2 ). RESULTS: We found no significant differences between the patient groups except for a significant increase in mean arterial blood pressure and an increase in rSO2 after testing. One patient with cerebral vasculopathy had a significant increase in his NSE values without showing clinical symptoms. This patient also had low rSO2 measurements and a decrease in medial cerebral artery velocity after DFT, other than the other patients. CONCLUSION: Single DFT did not lead to signs of neuronal damage or cognitive impairment except in one case with pre-existing cerebral vasculopathy. Therefore, our results support the use of DFT in carefully selected patients.

TAVR outcome after reclassification of aortic valve stenosis by using a hybrid continuity equation that combines computed tomography and echocardiography data.

BACKGROUND: In the continuity equation, assumption of a round-shaped left ventricular outflow tract (LVOT) leads to underestimation of the true aortic valve area in two-dimensional echocardiography. The current study evaluated whether inclusion of the LVOT area, as measured by computed tomography (CT), reclassifies the degree of aortic stenosis (AS) and assessed the impact on patient outcome after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Four hundred and twenty-two patients with indexed aortic valve area index (AVAi) of <0.6 cm2 /m2 , assessed by using the classical continuity equation (mean age: 81.5 ± 6.1 years, 51% female, mean left ventricular ejection fraction: 53.2 ± 13.6%), underwent TAVR and were included. After inclusion of the CT measured LVOT area into the continuity equation, the hybrid AVAi led to a reclassification of 30% (n = 128) of patients from severe to moderate AS. Multivariate predictors for reclassification were male sex, lower mean aortic gradient, and lower annulus/LVOT ratio (all p < .01). Reclassified patients had significantly higher sST2 at baseline and higher NT-proBNP values at baseline and 6 months follow-up compared to non-reclassified patients. Acute kidney injury was experienced more frequently after TAVR by reclassified patients, but no significant mortality difference occurred during 2 years of follow-up. CONCLUSION: The hybrid AVAi reclassifies a significant portion of low-gradient severe AS patients into moderate AS. Reclassified patients showed increased fibrosis and heart failure markers at baseline compared to non-reclassified patients. But reclassification had no significant impact on mortality up to 2 years after TAVR. Routine assessment of hybrid AVAi seems not to improve further risk stratification of TAVR patients.

Surgical Revascularization of Chronically Occluded Coronary Arteries-What You See Is What You Get?

BACKGROUND: Revascularization strategy in coronary artery bypass grafting (CABG) surgery usually depends on coronary dimension and stenosis severity. Little is known about the relation of preoperative evaluation of scarcely or invisibly chronic occluded coronary arteries (chronic total occlusion [CTO]) and revascularization rate or anastomosis quality. We aimed to evaluate the success rates of CTO revascularization in CABG surgery and determine the influence of coronary lumen visibility and collateralization in preoperative angiograms on revascularization rates, bypass blood flow, and target vessel diameter. METHOD: Preoperative coronary angiograms were evaluated for 938 consecutive patients who underwent isolated CABG surgery between 2014 and 2016 and screened for occluded coronary arteries. The occluded vessels were scored for visibility using the Rentrop grading of collateral filling. Intraoperatively, dimensions of the occluded arteries were measured using conventional vessel probes, and anastomosis quality was assessed by transit time flow measurement. RESULTS: A total of 404 (43.1%) patients were identified with at least one CTO. Revascularization rates differed from 96.2% in the left anterior descending artery, to 85.0% in left circumflex artery-dependent vessels, and 78.8% in right coronary artery territory. Coronary visibility and grade of collateralization in the preoperative angiogram had no influence on intraoperatively measured coronary diameter. Bypass blood flow in grafts revascularizing CTOs lacking collateralization were not significantly lower than those grafts leading to CTOs with higher Rentrop scores. CONCLUSION: Preoperative coronary assessment often differs from intraoperative findings. Our study confirms that even patients with scarcely collateralized CTOs and impaired visibility in the coronary angiogram have a high chance of complete revascularization during CABG surgery.

Timely extracorporeal membrane oxygenation assist reduces mortality after bypass surgery in patients with acute myocardial infarction.

BACKGROUND: Patients with acute myocardial infarction (AMI) are at high risk when undergoing emergency coronary artery bypass graft (CABG)-surgery. Their outcome remains poor despite increased use of extracorporeal membrane oxygenation (ECMO). We investigated the impact of timing for perioperative ECMO-support in these patients. METHODS: In this retrospective double-center study, we evaluated 201 patients with AMI undergoing CABG, dividing them into the following groups: No-ECMO (n = 101), preoperative ECMO (pre-ECMO, n = 6), intraoperative ECMO (ECC-ECMO, n = 67), and postoperative ECMO (post-ECMO, n = 27). We evaluated the impact of ECMO timing on postoperative mortality, organ function, and length of stay, comparing these to predicted outcome using different risk-scores. RESULTS: Post-ECMO patients showed lowest 30-day-survival (40.7%), while earlier ECMO-start was associated with better outcome (50.7% in extracorporeal circulation [ECC]-ECMO and 66.7% in pre-ECMO patients). On admission, only pre-ECMO and ECC-ECMO patients showed higher surgery- and intensive-care-unit (ICU)-related risk-scores. In pre- and ECC-ECMO patients, the first significant increase in lactate-levels (>4 mmol/L) was observed preoperatively, while this occurred 1 hour postoperatively in post-ECMO patients. Bilirubin was increased in all patients, decreasing after 3 and 12 days in pre- and ECC-ECMO patients, respectively, but only after 18 days in post-ECMO patients. Multiple ICU risk-scores did not discriminate survival-probability correctly. Only the ECMO-related survival after veno-arterial-ECMO-score correctly predicted the significantly lower survival in post-ECMO patients. CONCLUSION: Our study shows that timely ECMO-support is associated with earlier bilirubin-downtrend and higher survival in patients with AMI after CABG. Lactate-increase greater than 4 mmol/L seems to be a helpful threshold to trigger the timely onset of ECMO-therapy, providing better survival.

Early versus newer generation transcatheter heart valves for transcatheter aortic valve implantation: Echocardiographic and hemodynamic evaluation of an all-comers study cohort using the dimensionless aortic regurgitation index (AR-index).

AIMS: More than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after transcatheter aortic valve implantation (TAVI). "Newer generation" transcatheter heart valves (THVs) including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to improve outcome by reducing the rate of TAVI-related issues such as pAR. Aim was to evaluate and compare the hemodynamic performance with AR index of "early" vs. "newer generation" THVs and its impact on outcome. METHODS AND RESULTS: In 805 patients undergoing TAVI, the degree of pAR was assessed using imaging modalities (angiography, echocardiography) and hemodynamic measurements (aortic regurgitation index, ARI ratio). Severity of pAR and outcome were assessed according to the VARC-2 criteria. 805 patients underwent TAVI with use of the CoreValve (n = 400), SAPIEN XT (n = 48), Direct Flow Medical (n = 38), Evolut R (n = 114), Lotus (n = 104), or SAPIEN 3 (n = 101) prosthesis. TTE post TAVI revealed that a total of 7.3% of the patients showed moderate/severe pAR. The occurrence of greater than mild pAR occurred less frequently in patients treated with "newer generation" THVs (p<0.001): CoreValve (11.3%), SAPIEN XT (12.5%), Direct Flow Medical (5.3%), Evolut R (5.3%), Lotus (0.0%), and SAPIEN 3 (0.0%). The AR index was significantly higher (p<0.001) in patients receiving "newer generation" prostheses compared to those in whom "earlier generation" THVs were used. However, the ARI was only predictive of cumulative all-cause mortality at 1 and 3 years in "early generation", but not in "newer generation" THVs. In the overall cohort, 30-day and 1-year mortality was 4.8% and 20.1%, respectively. In patients treated with "newer generation" devices, the respective mortality rates remained substantially below those of patients treated with "earlier generation" THVs (30-day mortality: 2.5% vs. 6.7%, p< 0.001; 1-year mortality: 11.2% vs. 27.2%, p<0.001). CONCLUSION: TAVI with use of "newer generation" THVs showed significantly reduced pAR and improved outcomes compared to "early generation" devices that could at least in part be explained by more favorable hemodynamics.

Impact of Hemodynamic Support on Outcome in Patients Undergoing High-Risk Percutaneous Coronary Intervention.

The use of left-ventricular (LV) hemodynamic support might facilitate high-risk percutaneous coronary interventions (PCI) in patients with complex coronary artery disease. The impact on outcome is a matter of ongoing debate. We assessed the outcome of high-risk patients who underwent protected PCI in comparison to patients who underwent unprotected high-risk PCI. One hundred and thirty nine patients underwent nonemergent high-risk PCI; 24 (17%) patients underwent protected PCI. To address selection bias, we performed a propensity score matched subanalysis. The primary end point was the occurrence of a major adverse cardiac event during the first year. Patients with protected PCI had a higher logistic EuroSCORE (logES) (protected PCI: 19% vs unprotected PCI: 12%; p = 0.01), a higher SYNTAX score (45 vs 36, p = 0.07), and significantly more often reduced LV function (40% vs 55%; p < 0.001). In protected PCI patients, complete revascularization was more often achieved (87% vs 58%, p = 0.007) without the occurrence of death at 30 days of follow-up (0% vs 4%, p = 0.31). After propensity score matching, patients who underwent protected PCI had a similar 1-year major adverse cardiac event rate compared with patients who underwent unprotected PCI (21% vs 17%, p = 0.67), despite significantly higher procedural complexity for example, more often complex left main bifurcation lesions (71% vs 29%; p = 0.004). In conclusion, 1-year outcome of patients who underwent protected PCI was not different from that in patients with less complex procedures without hemodynamic support, despite more complex coronary anatomy, a higher comorbidity burden, and more often reduced LV function.

Retrograde autologous priming in surgery of thoracic aortic aneurysm.

OBJECTIVES: Surgery of thoracic aortic aneurysm (TAA) is associated with blood loss and coagulopathy and a high need for red blood cell (RBC) volume. Retrograde autologous priming (RAP) decreases haemodilution during cardiopulmonary bypass (CPB). The aim of this study was to show the effect of RAP during surgery of TAA repair on haemodilution, the need for RBC transfusion and the postoperative course compared to conventional CPB (cCPB). METHODS: A retrospective study was performed on 120 patients with TAA. Half of these patients underwent cCPB and the other half received RAP. Statistical analysis was performed using IBM SPSS statistics 23. The χ2 test, the Fisher's exact tests, the independent t-test and the Mann-Whitney U-test were used. Statistical significance was assumed at P-value <0.05. RESULTS: Lower blood product requirements were observed for the RAP group regarding the transfusion of intraoperative RBC (0.87 ± 1.33 vs 1.97 ± 2.43, P = 0.013), postoperative RBC (0.57 ± 1.4 vs 1.32 ± 1.82, P = 0.002) and postoperative fresh frozen plasma (0.52 ± 1.63 vs 1.48 ± 3.32, P = 0.036). The postoperative drainage loss showed significantly lower measurements for the RAP group after 6 h (295.9 ± 342.6 vs 490.6 ± 414.4 ml, P ≤ 0.001), 12 h (450.1 ± 415.5 vs 652.1 ± 463.9 ml, P < 0.001) and 24 h (693.1 ± 483.9 vs 866.4 ± 508.4 ml, P = 0.004). CONCLUSIONS: RAP is a safe and easy method to reduce RBC transfusion in TAA surgery without any adverse effects on the clinical outcome. We were also able to show beneficial effects on fresh frozen plasma requirements and postoperative chest drainage volume. Furthermore, improved microcirculation can be suspected. In consequence, we have implemented RAP as a clinical standard during thoracic aortic surgery.

Safety and Feasibility of Magnetic Resonance Imaging of the Brain at 1.5 Tesla in Patients with Temporary Transmyocardial Pacing Leads.

BACKGROUND: Temporary transmyocardial pacing leads (TTPLs) represent an absolute contraindication to magnetic resonance imaging (MRI). The purpose of this study was to evaluate the safety and feasibility of MRI at 1.5 Tesla (T) using a transmit/receive (T/R) head coil in patients with TTPL. METHODS: TTPLs (220 cm, Osypka TME, Dr. Osypka GmbH, Rheinfelden, Germany) were implanted in a phantom and exposed to conditions of a 1.5 T brain examination using a T/R head coil. Temperature changes at the lead tip were continuously recorded. A total of 28 patients with TTPL and an urgent indication for a brain MRI underwent MRI at 1.5 T with vital sign monitoring. A T/R head coil was used to minimize radiofrequency exposure of the TTPL. Before and immediately after the MRI scan, TTPL lead impedance, pacing capture threshold (PCT), signal slope, and sensing were measured. Serum troponin I was determined before and after MRI to detect thermal myocardial injury. RESULTS: In vitro, the maximum temperature increase from radiofrequency-induced heating of the TTPL tip was < 1°C. In vivo, no complications, such as heating sensations, dizziness, unexpected changes in heart rate or rhythm, or other unusual signs or symptoms were observed. No significant changes in the lead impedance, PCT, signal slope, or sensing were recorded. There were no increases of serum troponin I after the MRI examination. CONCLUSIONS: MRI of the brain may be performed safely at 1.5 T using a T/R head coil in case of an urgent clinical need in patients with TTPL and may be considered a feasible and safe procedure when appropriate precautionary measures are taken.

Impact of Crystalloid or Albumin Priming of the Heart-Lung Machine on Inhospital Outcome after Coronary Artery Bypass Surgery.

BACKGROUND: Crystalloid priming is a cost-effective, free from immunological reactions, and independent from human plasma delivery. However, there is some debate on the negative impact of low plasma colloid pressure and higher incidence of systemic inflammatory response syndrome (SIRS). The aim of the study was to rule out any adverse effects of crystalloid priming on the postoperative outcome. METHODS: We investigated 520 consecutive patients, including emergencies, who had isolated on-pump coronary artery bypass grafting in 2009 by retrospective analysis in our clinic. Crystalloid priming (n = 294) was introduced as an alternative to albumin (n = 226). Reviewing patient charts and IT-based data generated a dataset of perioperative parameters. RESULTS: There were no differences with respect to demographical data and preexisting comorbidities between both groups. Despite equal perfusion times, more volume had to be substituted during extracorporeal circulation following crystalloid priming. However, this did not influence the inhospital outcomes. According to the definition of the "Sepsis-3 Guidelines," the incidence of SIRS was similar. There was no difference in the need for a vasopressor treatment, and only transient higher serum lactate levels were found in the crystalloid group. The incidence of neurologic and organ-related adverse events, as well as 30-day mortality was comparable. CONCLUSION: The use of crystalloid priming is safe in coronary artery bypass grafting surgery in adults. However, there might be a greater need for crystalloid fluids during surgery.

Combination of high-sensitivity C-reactive protein with logistic EuroSCORE improves risk stratification in patients undergoing TAVI.

AIMS: The aim of this study was to assess the clinical value of biomarkers to identify TAVI patients at high risk for adverse outcome, to assess whether these biomarkers provide prognostic information beyond that of established clinical risk scores, and to assess whether a combined multi-marker strategy can improve clinical decision making. METHODS AND RESULTS: In 683 TAVI patients, biomarkers reflecting various pathophysiologic systems were measured before TAVI. The primary endpoint was one-year all-cause mortality. Other outcomes were recorded according to the VARC-2 criteria. Thirty-day and one-year mortality was 2.9% and 12.0%, respectively. Non-survivors at one year had higher risk scores and increased median biomarker levels. Logistic EuroSCORE in combination with hs-CRP had the highest predictive value for 30-day (AUC 0.740 [95% CI: 0.667-0.812], p=0.1117) and one-year mortality (AUC 0.631 [95% CI: 0.569-0.693], p=0.0403). In multivariate regression analysis, logistic EuroSCORE in combination with hs-CRP showed the strongest association with one-year mortality. Combinations of increasing medians of logistic EuroSCORE results and hs-CRP levels allowed the stratification of the TAVI patients into subgroups with one-year mortality rates ranging from 6.6% up to 18.2%. CONCLUSIONS: hs-CRP alongside the logistic EuroSCORE was an independent predictor of one-year all-cause mortality in TAVI patients. A combination of both might help to predict procedural risk and outcome better.

Transcatheter aortic valve implantation versus redo surgery for failing surgical aortic bioprostheses: a multicentre propensity score analysis.

AIMS: Transcatheter aortic valve implantation for a failing surgical bioprosthesis (TAV-in-SAV) has become an alternative for patients at high risk for redo surgical aortic valve replacement (redo-SAVR). Comparisons between these approaches are non-existent. This study aimed to compare clinical and echocardiographic outcomes of patients undergoing TAV-in-SAV versus redo-SAVR after accounting for baseline differences by propensity score matching. METHODS AND RESULTS: Patients from seven centres in Europe and Canada who had undergone either TAV-in-SAV (n=79) or redo-SAVR (n=126) were identified. Significant independent predictors used for propensity scoring were age, NYHA functional class, number of prior cardiac surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using a calliper range of ±0.05, a total of 78 well-matched patient pairs were found. All-cause mortality was similar between groups at 30 days (6.4% redo-SAVR vs. 3.9% TAV-in-SAV; p=0.49) and one year (13.1% redo-SAVR vs. 12.3% TAV-in-SAV; p=0.80). Both groups also showed similar incidences of stroke (0% redo-SAVR vs. 1.3% TAV-in-SAV; p=1.0) and new pacemaker implantation (10.3% redo-SAVR vs. 10.3% TAV-in-SAV; p=1.0). The incidence of acute kidney injury requiring dialysis was numerically lower in the TAV-in-SAV group (11.5% redo-SAVR vs. 3.8% TAV-in-SAV; p=0.13). The TAV-in-SAV group had a significantly shorter median total hospital stay (12 days redo-SAVR vs. 9 days TAV-in-SAV; p=0.001). CONCLUSIONS: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and one-year clinical outcomes.

Periprocedural Myocardial Injury Depends on Transcatheter Heart Valve Type But Does Not Predict Mortality in Patients After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aims of this study were to determine plasma elevations of biomarkers of myocardial injury associated with transfemoral (TF) transcatheter aortic valve replacement (TAVR) and to evaluate their prognostic value. BACKGROUND: Increases in biomarkers of myocardial injury are a common finding after TAVR, but their clinical significance is unclear. METHODS: In 756 consecutive TF TAVR patients, cardiac high-sensitivity troponin I (hsTnI) and creatine kinase MB (CK-MB) levels were measured at pre-defined time points to assess the occurrence of myocardial injury (defined as 15 times the upper reference limit for hsTnI [≥1.5 ng/ml] or 5 times the upper reference limit for CK-MB [≥18 µg/l]) during the first 72 h. The primary endpoint was all-cause mortality at 1 year. RESULTS: After uneventful TF TAVR, hsTnI was elevated in 51.6% and CK-MB in 7.4% of patients, respectively. Myocardial injury was associated with transcatheter heart valve (THV) type: patients who received the LOTUS THV more frequently had myocardial injury compared with those who received other THVs (LOTUS, 81.6%; Direct Flow Medical, 56.4%; CoreValve, 51.2%; Evolut R, 42.7%; SAPIEN XT, 40.4%; SAPIEN 3, 36.6%; p < 0.001). Myocardial injury defined by hsTnI was not associated with adverse outcomes at 30 days (3.1% vs. 2.7%; p = 0.778) or 1 year (16.7% vs. 17.2%; p = 0.841). Likewise, a CK-MB increase was not associated with 30-day mortality (5.5% vs. 2.8%; p = 0.258) or 1-year mortality (16.4% vs. 17.3%; p = 0.856). CONCLUSIONS: Myocardial injury is common following TF TAVR. The extent of cardiac biomarker elevation depends on THV type but is not associated with adverse short- and long-term outcomes after uneventful TAVR.

Impact of coronary artery disease in patients undergoing transfemoral transcatheter aortic valve implantation.

BACKGROUND: The impact of coronary artery disease (CAD) and revascularization on outcome in patients undergoing transcatheter aortic valve implantation (TAVI) has not been fully elucidated so far. OBJECTIVES: To assess whether the degree of CAD influences the prognosis of patients undergoing TAVI. METHODS: Before TAVI, all patients underwent revascularization of the proximal vessels or the left main stem if indicated (stenosis ≥70% or 50%, respectively). In 666 patients, we calculated the baseline (bSS) and residual SYNTAX Score (rSS) prior to TAVI. In patients with revascularization, we determined the SYNTAX Revascularization Index (SRI=(1-(rSS/bSS))∗100). We also assessed the SYNTAX Score II (SS-II), combining anatomical and clinical variables. The primary endpoint was 3-year all-cause mortality. RESULTS: Higher baseline and residual SYNTAX Score were associated with increased 3-year mortality (no CAD 26.2%, low bSS 34.8%, high bSS 46.8%; p=0.001, respectively, no CAD 25.9%, low rSS 31.4%, high rSS 41.5%; p=0.01). The extent of revascularization represented by the SRI was not associated with outcome. The SYNTAX Score II was also associated with increased 3-year mortality. However, baseline and residual SYNTAX Score as well as SYNTAX Score II did not independently predict mortality. CONCLUSION: The anatomic severity of CAD as assessed by the baseline and residual SYNTAX Score is associated with survival after TAVI. Coronary artery disease seems to reflect general comorbidity burden and is associated with a higher risk profile of the patient.

New Mitral Annuloplasty Ring Enables Oversizing of Transcatheter Heart Valve and Prevents Central or Paravalvular Leakage.

Background Transcatheter valve-in-ring strategies have been developed to treat recurrent mitral regurgitation (MR) after failing surgical annuloplasty. However, suboptimal THV expansion with consecutive paravalvular leakage (PVL) is a procedure-immanent issue. Methods A rigid, saddle-shaped ring was cut at four locations. The segments were reconnected with pull-springs, rearranged to the original shape, and covered with a sewing cuff. The length of the annuloplasty ring construct, including extended pull-springs, was defined by the perimeter of an appropriate THV. We deployed a Sapien XT within the new ring, expanded it to its maximum extent, and investigated the geometrical changes. Results Fluoroscopy confirmed oval, saddle-shaped ring before dilation. After THV implantation, the ring segments spread apart and pull-springs were stretched. The extended ring changed its configuration from "oval" to "round" and anchored the THV leaving no paravalvular or central gaps as potential source for PVL. Conclusion We developed an expandable annuloplasty ring that is perfectly concerted to THV implantation. This proof-of-concept study revealed no PVL and good oversizing ability that might impact future annuloplasty ring design. Further studies have to evaluate durability and device safety.

Routine Endovascular Treatment With a Stent Graft for Access-Site and Access-Related Vascular Injury in Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND: Access-site and access-related vascular injury (ASARVI) is still a major limiting factor in transcatheter aortic valve implantation and affects the outcome of patients. Management strategies for ASARVI include manual compression, stent grafts, and vascular surgery. We hypothesized that the standard use of a self-expanding stent graft for the management of ASARVI is feasible and safe. METHODS AND RESULTS: Of 407 patients treated by transfemoral transcatheter aortic valve implantation, 110 experienced ASARVI (27.0%). Of these, 96 (87.3%) were managed by the implantation of a self-expanding nitinol stent graft. In the majority of patients, minor vascular complications triggered the implantation of a stent graft (86.5%), mainly because of bleeding (90.6%) and dissection (5.2%) of the common femoral artery with high rates of primary treatment success (97.9%). Patients receiving stent grafts were more often female (62.2 versus 45.6%, P<0.01), had higher body mass indices (27.8±6.7 versus 25.7±4.7, P=0.01), and suffered more often from diabetes mellitus (34.4 versus 24.5%, P=0.04). Angiographic assessment after a median follow-up of 345 days (interquartile range, 23-745 days) revealed only one patient with moderate, asymptomatic instent-stenosis (1.0%). Compared with a propensity score-matched cohort of patients without ASARVI, stented patients had comparable long-term mortality, despite the occurrence of a vascular complication (1-year mortality: 17.7% versus 26.6%; stent versus matched cohort, respectively; P=0.1). CONCLUSIONS: Routine use of a self-expanding nitinol stent graft in selected patients experiencing ASARVI after transcatheter aortic valve implantation is feasible, safe, and associated with favorable short- and midterm clinical outcome.

New expandable mitral annuloplasty ring facilitates transcatheter mitral valve implantation: proof of concept.

AIMS: Transcatheter mitral valve-in-ring (TMVIR) implantation with transcatheter heart valve (THV) prostheses can be performed in patients with recurrent mitral regurgitation (MR) following annuloplasty. However, an oval configuration and sometimes the rigidity of surgical rings can often lead to suboptimal THV expansion, resulting in considerable paravalvular or central leakage. Therefore, our aim was to develop an annuloplasty ring that fully adjusts to THV implantation. METHODS AND RESULTS: A three-dimensional annuloplasty ring was separated into four pieces at defined locations, the sections were reconnected with heat-shrinkable tubing and rearranged into the original shape. A non-tear stainless steel circular cord of defined length was inserted into the ring's sewing cuff to serve as a limiting structure for THV expansion. We implanted this ring in the mitral position into an isolated pig heart, deployed a THV into the ring, and investigated its function. Fluoroscopy showed that, upon THV deployment, the four breaking points of the ring separated as expected, and the ring expanded in a circular fashion to full expansion of the limiting cord. It securely anchored the THV to the ring, leaving no paravalvular gaps. CONCLUSIONS: We developed an expandable mitral ring to which the THV attached without leakage. This may impact on the future design of annuloplasty rings. Further studies should evaluate the safety of increasing the perimeter of a mitral ring and its durability.

Pre-Procedural Hemodynamic Status Improves the Discriminatory Value of the Aortic Regurgitation Index in Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aims of this study were to increase the discriminatory value of the aortic regurgitation index (ARI) for the assessment of paravalvular regurgitation (PVR) and to further elucidate the association between aortic regurgitation severity and mortality after transcatheter aortic valve replacement (TAVR). BACKGROUND: Hemodynamic parameters such as the ARI complement predominantly angiographically guided TAVR. However, the ARI depends on several baseline and periprocedural characteristics. METHODS: The ARI was prospectively calculated before and after TAVR in 600 patients. The severity of PVR was assessed in all patients by angiography and echocardiography according to a 3-class scheme. To account for pre-procedural hemodynamic status, the ARI ratio was calculated as post- over pre-procedural ARI. RESULTS: Apart from the degree of PVR (ß = -0.396, p < 0.001), pre-procedural hemodynamic status in the form of the ARI before TAVR (ß = 0.227, p < 0.001) was associated with post-procedural ARI in multivariate regression analysis. The ARI ratio increased the specificity of post-procedural ARI alone for the prediction of both more than mild PVR and 1-year mortality from 75.1% to 93.2% and from 75.0% to 93.3%, respectively. Patients with post-procedural ARI values <25 after TAVR had significantly increased 1-year mortality only when the ARI ratio was <0.60 (50.0% vs. 26.3%, p = 0.001). CONCLUSIONS: The ARI ratio integrating pre- and post-procedural hemodynamic status increases the discriminatory value of post-procedural ARI. The ARI ratio, which reflects acute hemodynamic changes after TAVR, is useful to identify patients with negative outcomes.