Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return.

BACKGROUND: MitraClip implantation has become the standard transcatheter mitral valve repair (TMVR) technique for severe mitral regurgitation (MR). However, approximately one third of patients have poor outcomes, with MR recurrence at follow-up. The aim of this study was to investigate whether quantitative analysis of mitral valve (MV) geometry on three-dimensional (3D) echocardiography can identify geometric parameters associated with the recurrence of severe functional MR (FMR) versus organic MR (OMR) at 6-month follow-up after TMVR using the MitraClip. METHODS: Sixty-one patients with severe FMR (n = 45) or OMR (n = 16) who underwent transesophageal 3D echocardiography before and 6 months after TMVR were retrospectively analyzed. MV geometry was quantified using 3D echocardiography software. Vena contracta area (VCA) at 6-month follow-up was used to define two outcome groups: patients with good results with VCA < 0.6 cm2 (MR < 0.6) and those with MR recurrence with VCA ≥ 0.6 cm2 (MR ≥ 0.6). RESULTS: MR recurrence was found in 34% of all study patients (21 of 61). In patients with FMR, significant differences between MR < 0.6 and MR ≥ 0.6 were found at baseline for tenting index (1.13 vs 1.23, P = .004), tenting volume (2.8 vs 4.0 ml, P = .04), indexed left ventricular (LV) end-diastolic volume (68.0 vs 99.9 ml/m2, P = .001), and VCA (0.71 vs 1.00 cm2, P = .003); no significant parameters of MR recurrence were found in patients with OMR. Multivariate analysis identified indexed LV end-diastolic volume as the strongest independent determinant of MR recurrence. Receiver operating characteristic analysis identified a tenting index of 1.185 (area under the curve 0.79) and indexed LV end-diastolic volume of 88 ml/m2 (area under the curve 0.76) to best discriminate between MR < 0.6 and MR ≥ 0.6. CONCLUSIONS: MR recurrence after TMVR in patients with FMR is associated with advanced LV dilation and MV tenting before TMVR, which provides clinical implications for a point of no return beyond which progressive LV dilation with MV geometry dilation and tethering cannot be effectively prevented by TMVR. In contrast, no significant determinants of MR recurrence and progressive MV annular dilation could be identified in patients with OMR.

Comparison of Lipoprotein(a)-Levels in Patients ≥70 Years of Age With Versus Without Aortic Valve Stenosis.

Although lipoprotein(a) (Lp[a]) is linked with aortic valve calcification and clinical aortic valve stenosis (AVS) in middle-aged cohorts, patients aged ≥70 years represent a majority of patients with AVS, in which mechanisms leading to AVS may differ. We sought to determine whether Lp(a) distinguishes patients ≥70 years with and without AVS. We matched 484 patients ≥70 years with AVS, scheduled for transcatheter aortic valve implantation with 484 patients without AVS by age group and gender. Lp(a) levels were compared in patients with and without AVS and stratified by presence and absence of clinical coronary artery disease (CAD) manifestation. A total of 968 patients (mean age 80 ± 5 years, 48% women) were included. When comparing patients with and without AVS, no difference in Lp(a) was observed (AVS: 17 [8; 56] mg/dl, no AVS: 18.5 [8.5; 57] mg/dl, p = 0.56). In contrast, patients with clinical CAD manifestation had higher Lp(a) levels than those without clinical CAD manifestation (coronary artery disease: 19 [9; 60] mg/dl, no coronary artery disease 15 [7; 44] mg/dl, p = 0.0006). In regression analysis, no significant association of Lp(a) with AVS was observed in unadjusted (OR [95% CI]: 0.98 [0.91 to 1.06], p = 0.59) and risk factor-adjusted models (0.98 [0.90 to 1.06], p = 0.57). However, Lp(a) was independently associated with clinical CAD manifestation (unadjusted: 1.14 [1.04 to 1.24], p = 0.003, risk factor adjusted: 1.17 [1.07 to 1.27], p = 0.0006). In conclusion, in a large cohort of patients ≥70 years, Lp(a) was associated with clinical CAD manifesation, but not with AVS. Our results suggest that in patients over 70 years, the development of AVS is not influenced by Lp(a).

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. METHODS: A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. RESULTS: The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease (p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase (p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values (p < 0.001), accompanied by a decrease in albumin (p < 0.001). CONCLUSIONS: Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR.

Impact of Preoperative Anemia and Postoperative Hemoglobin Drop on the Incidence of Acute Kidney Injury and In-Hospital Mortality in Patients With Type B Acute Aortic Syndromes Undergoing Thoracic Endovascular Aortic Repair.

BACKGROUND: The impact of preoperative anemia and postoperative hemoglobin (Hb) drop on the incidence of acute kidney injury (AKI) after thoracic endovascular aortic repair (TEVAR) for type B acute aortic syndromes (AAS) as well as their prognostic value is unknown. METHODS: This retrospective study included 144 patients with type B AAS undergoing TEVAR at our center. Preoperative anemia was classified as no/mild (Hb ≥ 12.0 g/dL in men; ≥11.3 g/dL in women), moderate (Hb 10.80-11.99 g/dL in men; 10.23-11.29 g/dL in women), and severe (<10.80 g/dL in men; <10.23 g/dL in women). Postoperative Hb drop was classified as mild (<2 g/dL), moderate (2-4 g/dL), and severe (>4 g/dL). End points of the study were postoperative AKI and in-hospital mortality. RESULTS: Postoperative AKI was higher in the severe and moderate anemia groups than the no/mild anemia group (63.2%, 52.0%, and 31.0%, respectively, P = .01). In-hospital mortality and AKI were higher in patients with severe postoperative Hb drop (40.9% and 86.4%) than patients with moderate (6.9% and 36.2%) and mild (4.7% and 25.0%) postoperative Hb drop (both P < .001). Postoperative Hb drop (odds ratio [OR]:1.67, P = .036), postoperative Hb levels (OR: 0.57, P = .025), and mesenteric ischemia (OR: 4.65, P = .044) were identified as independent predictors of in-hospital mortality. Preoperative Hb (OR: 0.26, P = .001), postoperative Hb drop (OR: 4.34, P < .001), contrast medium (OR: 1.82, P = .004), and diabetes mellitus (OR: 3.79, P = .001) were independent predictors of AKI. At follow-up, anemia and postoperative Hb drop were not associated with increased mortality. CONCLUSION: Preoperative Hb and postoperative Hb drop were significant risk factors for AKI. Postoperative Hb drop and Hb levels predicted in-hospital mortality.

No protection of heart, kidneys and brain by remote ischemic preconditioning before transfemoral transcatheter aortic valve implantation: Interim-analysis of a randomized single-blinded, placebo-controlled, single-center trial.

BACKGROUND: Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI). METHODS: Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299). RESULTS: 100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed. CONCLUSIONS: RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.

Kinetics and Signal Activation Properties of Circulating Factor(s) From Healthy Volunteers Undergoing Remote Ischemic Pre-Conditioning.

Although remote ischemic pre-conditioning (RIPC) reduced infarct size in animal experiments and proof-of-concept clinical trials, recent phase III trials failed to confirm cardioprotection during cardiac surgery. Here, we characterized the kinetic properties of humoral factors that are released after RIPC, as well as the signal transduction pathways that were responsible for cardioprotection in an ex vivo model of global ischemia reperfusion injury. Venous blood from 20 healthy volunteers was collected at baseline and 5 min, 30 min, 1 h, 6 h, and daily from 1 to 7 days after RIPC (3 × 5/5 min upper-limb ischemia/reperfusion). Plasma-dialysates (cut-off: 12 to 14 kDa; dilution: 1:20) were infused into Langendorff-perfused mouse hearts subjected to 20/120 min global ischemia/reperfusion. Infarct size and phosphorylation of signal transducer and activator of transcription (STAT)3, STAT5, extracellular-regulated kinase 1/2 and protein kinase B were determined. In a subgroup of plasma-dialysates, an inhibitor of STAT3 (Stattic) was used in mouse hearts. Perfusion with baseline-dialysate resulted in an infarct size of 39% of ventricular mass (interquartile range: 36% to 42%). Perfusion with dialysates obtained 5 min to 6 days after RIPC significantly reduced infarct size by ∼50% and increased STAT3 phosphorylation beyond that with baseline-dialysate. Inhibition of STAT3 abrogated these effects. These results suggest that RIPC induces the release of cardioprotective, dialyzable factor(s) within 5 min, and that circulate for up to 6 days. STAT3 is activated in murine myocardium by RIPC-induced human humoral factors and is causally involved in cardioprotection.

Early prediction of acute kidney injury after transapical and transaortic aortic valve implantation with urinary G1 cell cycle arrest biomarkers.

BACKGROUND: Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) leading to increased mortality and morbidity. Urinary G1 cell cycle arrest proteins TIMP-2 and IGFBP7 have recently been suggested as sensitive biomarkers for early detection of AKI in critically ill patients. However, the precise role of urinary TIMP-2 and IGFBP7 in patients undergoing TAVI is unknown. METHODS: In a prospective observational trial, 40 patients undergoing TAVI (either transaortic or transapical) were enrolled. Serial measurements of TIMP-2 and IGFBP7 were performed in the early post interventional course. The primary clinical endpoint was the occurrence of AKI stage 2/3 according to the KDIGO classification. RESULTS: Now we show, that ROC analyses of [TIMP-2]*[IGFBP7] on day one after TAVI reveals a sensitivity of 100 % and a specificity of 90 % for predicting AKI 2/3 (AUC 0.971, 95 % CI 0.914-1.0, SE 0.0299, p = 0.001, cut-off 1.03). In contrast, preoperative and postoperative serum creatinine levels as well as glomerular filtration rate (GFR) and perioperative change in GFR did not show any association with the development of AKI. Furthermore, [TIMP-2]*[IGFBP7] remained stable in patients with AKI ≤1, but its levels increased significantly as early as 24 h after TAVI in patients who developed AKI 2/3 in the further course (4.77 ± 3.21 vs. 0.48 ± 0.68, p = 0.022). Mean patients age was 81.2 ± 5.6 years, 16 patients were male (40.0 %). 35 patients underwent transapical and five patients transaortic TAVI. 15 patients (37.5 %) developed any kind of AKI; eight patients (20 %) met the primary endpoint and seven patients required renal replacement therapy (RRT) within 72 h after surgery. CONCLUSION: Early elevation of urinary cell cycle arrest biomarkers after TAVI is associated with the development of postoperative AKI. [TIMP-2]*[IGFBP7] provides an excellent diagnostic accuracy in the prediction of AKI that is superior to that of serum creatinine.

Aspirate from human stented saphenous vein grafts induces epicardial coronary vasoconstriction and impairs perfusion and left ventricular function in rat bioassay hearts with pharmacologically induced endothelial dysfunction.

Stent implantation into aortocoronary saphenous vein grafts (SVG) releases particulate debris and soluble vasoactive mediators, for example, serotonin. We now analyzed effects of the soluble mediators released into the coronary arterial blood during stent implantation on vasomotion of isolated rat epicardial coronary artery segments and on coronary flow and left ventricular developed pressure in isolated perfused rat hearts. Coronary blood was retrieved during percutaneous SVG intervention using a distal occlusion/aspiration protection device in nine symptomatic patients with stable angina pectoris and a flow-limiting SVG stenosis. The blood was separated into particulate debris and plasma. Responses to coronary plasma were determined in isolated rat epicardial coronary arteries and in isolated, constant pressure-perfused rat hearts (±nitric oxide synthase [NOS] inhibition and ±serotonin receptor blockade, respectively). Coronary aspirate plasma taken after stent implantation induced a stronger vasoconstriction of rat epicardial coronary arteries (52 ± 8% of maximal potassium chloride induced vasoconstriction [% KClmax = 100%]) than plasma taken before stent implantation (12 ± 8% of KClmax); NOS inhibition augmented this vasoconstrictor response (to 110 ± 15% and 24 ± 9% of KClmax). Coronary aspirate plasma taken after stent implantation reduced in isolated perfused rat hearts only under NOS inhibition coronary flow by 17 ± 3% and left ventricular developed pressure by 25 ± 4%. Blockade of serotonin receptors abrogated these effects. Coronary aspirate plasma taken after stent implantation induces vasoconstriction in isolated rat epicardial coronary arteries and reduces coronary flow and left ventricular developed pressure in isolated perfused rat hearts with pharmacologically induced endothelial dysfunction.

Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.

AIMS: This study sought to investigate outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (THV) in patients at intermediate risk for surgery. The 30-day results of the transfemoral cohort are reported. METHODS AND RESULTS: The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe, symptomatic aortic stenosis, at intermediate risk for surgery suitable for TAVI via the transfemoral route (TF). Outcomes were adjudicated by a clinical events committee. Echocardiography, computed tomography and electrocardiography exams were analysed in core laboratories. The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8, respectively. A completely percutaneous procedure was performed in 90.1% of patients and conscious sedation and/or local anaesthesia was utilised in 54.5%. Technical success was achieved in 98.0% of patients. At 30 days, mortality was 1.0%, with stroke in 3.0% and a new permanent pacemaker in 4.0% (4.3% of patients without pre-procedural permanent pacemaker). No patients had severe aortic regurgitation after the procedure, only one patient had moderate aortic regurgitation, and 70.8% of patients had no or trace aortic regurgitation. CONCLUSIONS: TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications, including new pacemakers and paravalvular leaks. Although compelling, these initial results are being confirmed in larger global studies before expanding the indications for TAVI in severe aortic stenosis.

Clinical features and prognostic value of stent-graft-induced post-implantation syndrome after thoracic endovascular aortic repair in patients with type B acute aortic syndromes.

OBJECTIVES: The aim of this study was to investigate the incidence, the biomarker profile and the clinical impact of post-implantation syndrome (PIS) after thoracic endovascular aortic repair (TEVAR) for type B acute aortic syndromes (AASs). METHODS: This retrospective study included 133 patients with type B AASs undergoing TEVAR; PIS was defined as fever >38°C, white blood cells (WBCs) >12.0/nl and C-reactive protein (CRP) >10 mg/dl within 72 h after TEVAR, despite negative blood cultures. Fibrinogen (FBG), D-dimer (D-d) and interleukin 6 (IL-6) were also determined. The clinical endpoints were all-cause mortality and a composite of major adverse events (MAEs such as aortic rupture, need for reintervention and all-cause mortality) at follow-up. RESULTS: PIS was diagnosed in 15.8% of patients and was associated with higher peak values of WBC (17.0 ± 5.1 vs 10.6 ± 3.7/nl, P = 0.002), CRP (22.0 ± 5.4 vs 16.8 ± 8.2 mg/dl, P = 0.03), FBG (779 ± 246 vs 639 ± 225 mg/dl, P = 0.046), D-d (1675 ± 605 vs 1048 ± 639 µg/l, P = 0.003) and IL-6 (192 ± 101 vs 84 ± 34 pg/ml, P = 0.03) than non-PIS patients. All-cause mortality did not significantly differ between PIS and non-PIS patients during the index hospitalization (0.0 vs 6.3%; P = 0.60) and at follow-up (18.8 vs 4.9%; P = 0.086). MAEs were more frequent in the PIS than in the non-PIS group (62.5 vs 25.9%; P = 0.004). PIS (hazard ratio [HR] 3.26, P = 0.022), stroke (HR 3.41, P = 0.004), aortic enlargement (HR 6.88, P = 0.001) and partial thrombosis of the false lumen (HR 6.20, P = 0.003) were independent predictors of MAEs. CONCLUSIONS: PIS occurred in 15.8% of patients with AASs without affecting in-hospital outcome. At follow-up, PIS was associated with increased rates of MAEs, but not mortality.

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation.

PURPOSE: Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris. DESCRIPTION: Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally. EVALUATION: New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm(3), p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm(3), p = 0.04). There were no neurologic events after transaortic TAVI. CONCLUSIONS: The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions (ClinicalTrials.gov number, NCT01735513).

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve.

BACKGROUND: We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). METHODS: Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. RESULTS: The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. CONCLUSIONS: The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

Conventional aortic valve replacement or transcatheter aortic valve implantation in patients with previous cardiac surgery.

BACKGROUND: Clinical outcomes were compared among patients with previous cardiac surgery undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR). METHODS: Between 2007 and 2014 a total of 142 consecutive patients with previous cardiac surgery were treated by TAVI either by the transfemoral (n=68) or transapical access (n=74), and 236 patients underwent a surgical redo-AVR. Of these patients, propensity analysis (m:n) matched 62 (group 1, TAVI) and 51 patients (group 2, redo-AVR). A multivariate logistic regression model was constructed. Moreover, mortality was compared between both groups by Cox regression. RESULTS: Both groups differed significantly (p<0.01) in regard to age and preoperative risk scores (EuroSCORE and STS-Score). Thirty-day mortality was 14.5% (9/62) in group 1 and 5.8% (3/51) in group 2 (p=0.23). Risk-adjusted multivariable analysis revealed only the logistic EuroSCORE to be strongly correlated with 30-day mortality (p=0.01). Multivariate analysis showed no difference in 30-day mortality between both groups (p=0.21). Multivariate Cox regression revealed New York Heart Association functional class (p=0.001), logistic EuroSCORE (p=0.01), and STS-Score (p=0.03) to be strongly associated with overall mortality. Moreover, evaluating overall mortality, Cox regression showed no difference between both groups (p=0.36). CONCLUSIONS: The present study shows that in patients with cardiac reoperation, TAVI comes with similar outcomes when compared to surgical AVR. On the other hand, conventional redo-AVR is still a valuable and safe treatment option.

Thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry.

OBJECTIVES: This study analyzed the mechanism and risk factors of thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry (dSINE). BACKGROUND: This late complication of thoracic endovascular aneurysm repair (TEVAR) for aortic dissection is under-recognized but potentially life-threatening. METHODS: In 142 patients who underwent TEVAR with endovascular entry sealing for acute and chronic aortic type B dissection, using commercially available straight (nontapered) stent-grafts, we examined the oversizing rate, the aortic taper ratio, and the need for reintervention. RESULTS: Nine of 142 patients developed thoracic aortic aneurysm expansion due to dSINE after TEVAR. The median follow-up was 47.5 ± 37.4 months. There was a significant difference in the distal stent-aorta angle between the patients with and without dSINE (149.08 ± 15.09° vs. 166.72 ± 12.47°, P < 0.005). Patients with dSINE showed a significantly higher taper ratio of the true lumen of the aorta (40.9 ± 14.13% vs. 25.36 ± 20.2%, P < 0.05). There was also a significant difference in the oversizing of the stent-graft in the distal landing zone (95.88 ± 49.3% vs. 55.94 ± 36.23%, P < 0.01). All patients with dSINE underwent a secondary endograft procedure without any complications or deaths. In 7 cases we used a custom-made, highly tapered stent-graft. CONCLUSIONS: Lifelong follow-up of patients is mandatory after TEVAR. A stent-graft with a tapered design should be used in aortic dissection to avoid oversizing and devastating late complications.

Silent cerebral ischemia after thoracic endovascular aortic repair: a neuroimaging study.

BACKGROUND: The risk of clinically apparent, periprocedural stroke after thoracic endovascular aortic repair (TEVAR) due to dislodgement and embolization of aortic debris from intravascular manipulation of guidewires, catheters, and large-bore delivery systems ranges between 2% and 6% and has been associated with increased postoperative mortality. The rate of clinically silent cerebral ischemia is yet unknown, but may be even higher. METHODS: Nineteen patients (13 male, 6 female) who underwent TEVAR were included into this descriptive study. Periprocedural apparent and silent cerebral ischemia was assessed by daily clinical neurologic assessment and serial cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and 5 days (median, interquartile range: 3.5) after the procedure. RESULTS: The TEVAR was successful in all patients without immediate clinically apparent neurologic deficits. Postinterventional cerebral DW-MRI detected a total of 29 new foci of restricted diffusion in 12 of 19 TEVAR patients (63%). Lesions were usually multiple (1 to 6 lesions per patient) and ranged in size between 15 mm3 and 300 mm3; 16 lesions were found in the left hemisphere, 13 lesions in the right hemisphere. Overstenting of the left subclavian artery was performed in 8 cases, but was not associated with lateralization of lesions. There were no additional apparent neurologic events during the in-hospital period. CONCLUSIONS: Thoracic endovascular aortic repair resulted in a high incidence of new foci of restricted diffusion on cerebral DW-MRI in a pattern suggestive of periprocedural embolization. Although multiple lesions per patients were found, these lesions were not associated with apparent neurologic deficits during the in-hospital period. Further developments in TEVAR should be directed toward reducing the risk of periprocedural cerebral embolization.

Comparison between different risk scoring algorithms on isolated conventional or transcatheter aortic valve replacement.

BACKGROUND: There are a number of scoring systems for risk evaluation in cardiac surgery, the most important of which are the European System for Cardiac Operative Risk Evaluation (EuroSCORE), The Society of Thoracic Surgeons (STS) score, the ACEF score (acronym for age, preoperative creatinine, and ejection fraction), and more recently, the new EuroSCORE-II. The aim of our study was to analyze and compare the predictive value of these scores in patients undergoing aortic valve replacement (AVR) or transcatheter aortic valve replacement (TAVR). METHODS: A total of 1,512 consecutive patients undergoing either conventional AVR (n = 1,066) or TAVR (transfemoral, n = 291; transapical, n = 155) were enrolled. Logistic and additive EuroSCORE of all patients were 13.3% ± 13.2% and 7.8% ± 3.3%, on average. The mean STS score, ACEF score, and EuroSCORE-II were 5.7% ± 5.0%, 1.5% ± 0.7%, and 4.2% ± 4.9%, respectively. RESULTS: Overall mortality at 30 days was 6.3%. The area under the curve (AUC) was 73.8 for the logistic EuroSCORE and 73.5 for the additive EuroSCORE. The STS score gave an AUC of 70.8. The AUCs for the ACEF and EuroSCORE-II were 63.8 and 71.2, respectively. In the transfemoral TAVR group, AUCs were 59.8 and 59.3 for the logistic and additive EuroSCORE, respectively, 63.2 for the STS score, and 55.9 and 55.4 for the ACEF and EuroSCORE-II, respectively. In the transapical TAVR group, AUCs were 88.0 and 82.8 for the logistic and additive EuroSCORE, respectively, 79.0 for the STS score, and 61.7 and 83.7 for the ACEF and EuroSCORE-II, respectively. CONCLUSIONS: Overall, 30-day mortality was best predicted by the STS score. Discrimination threshold predicting mortality was equal between all other risk calculators. Surprisingly, the new EuroSCORE-II was not superior to other models in risk prediction for AVR and TAVR patients.

Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry.

AIMS: Transcatheter aortic valve implantation (TAVI) carries the risk of intraprocedural complications that may ultimately require emergent cardiac surgery (ECS). However, few data exist on the incidence, reasons and outcomes of patients needing ECS during TAVI. We analysed data from 2,307 TAVI patients, prospectively enrolled in the multicentre Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. METHODS AND RESULTS: Twenty-seven (1.2%) of 2,307 patients required ECS. The rates of ECS were similar for patients undergoing transapical TAVI compared with transfemoral TAVI (1.1% vs. 1.2%). The leading causes for ECS were embolisation/migration of the TAVI valve prosthesis (9/27, 33%) and procedure-related aortic injury (n=7, 26%). Thirty-day mortality of ECS was high (51.9%) and showed cause-specific differences, with 100% mortality in patients with aortic rupture or cardiac tamponade, 0% death in those with acute aortic regurgitation and intermediate risk of death or intermediate mortality in those with aortic injury or valve embolisation/migration. CONCLUSIONS: Rates of ECS during TAVI were low (1.2%). Although ECS was performed without time delay, emergent surgery was associated with a 30-day mortality of 52%. Complications with dramatic acute consequences (annular rupture, aortic injury) had higher mortality than those with less acute deterioration (aortic regurgitation). Prevention of complications requiring ECS during TAVI appears to be of critical importance, focusing on less traumatic, more flexible delivery catheter systems and retrievable valves to reduce the risk of aortic injury and valve embolisation, the two most common causes of ECS.

Aspirate from human stented native coronary arteries vs. saphenous vein grafts: more endothelin but less particulate debris.

Stent implantation into atherosclerotic coronary arteries releases particulate debris and soluble substances that contribute to impaired microvascular perfusion. Here we addressed the potential for microvascular obstruction in patients with stenotic native right coronary arteries (nRCA) compared with saphenous vein grafts on right coronary arteries (SVG-RCA). We enrolled symptomatic, male patients with stable angina pectoris and a flow-limiting stenosis in their nRCA or SVG-RCA (n = 18/18). Plaque volume and composition were analyzed using intravascular ultrasound before stent implantation. Coronary aspirate was retrieved during stent implantation under protection with a distal occlusion/aspiration device and divided into particulate debris and plasma. The release of catecholamines, endothelin, serotonin, thromboxane B2, and tumor necrosis factor-α was measured. The response of rat mesenteric arteries with intact (+E) and denuded (-E) endothelium to aspirate plasma (without and with selective endothelin receptor blockade) was normalized to that by potassium chloride (KClmax = 100%). Plaque volume and composition were not different between nRCA and SVG-RCA. There was less particulate debris (65 ± 8 vs. 146 ± 23 mg; P < 0.05) and more endothelin release (5.8 ± 0.8 vs. 1.3 ± 0.7 pg/ml; P < 0.05) in nRCA than in SVG-RCA, whereas the release of the other mediators was not different. Aspirate from nRCA induced stronger vasoconstriction than that from SVG-RCA [nRCA, 78 ± 6% (+E)/84 ± 5% (-E); SVG-RCA, 59 ± 6% (+E)/68 ± 3% (-E); P < 0.05 nRCA vs. SVG-RCA], which was attenuated by a nonspecific endothelin and a specific endothelin receptor A antagonist. Thus coronary aspirate from stented nRCA is characterized by less debris but more endothelin and stronger vasoconstrictor response than that from SVG-RCA.