Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System.

BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. METHODS: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. RESULTS: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. CONCLUSIONS: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades.

AIMS: Cardiac resynchronization therapy (CRT) upgrades may be less likely to improve following intervention. Leadless left ventricular (LV) endocardial pacing has been used for patients with previously failed CRT or high-risk upgrades. We compared procedural and long-term outcomes in patients undergoing coronary sinus (CS) CRT upgrades with high-risk and previously failed CRT upgrades undergoing LV endocardial upgrades. METHOD AND RESULTS: Prospective consecutive CS upgrades between 2015 and 2019 were compared with those undergoing WiSE-CRT implantation. Cardiac resynchronization therapy response at 6 months was defined as improvement in clinical composite score (CCS) and a reduction in LV end-systolic volume (LVESV) ≥15%. A total of 225 patients were analysed; 121 CS and 104 endocardial upgrades. Patients receiving WiSE-CRT tended to have more comorbidities and were more likely to have previous cardiac surgery (30.9% vs. 16.5%; P = 0.012), hypertension (59.2% vs. 34.7%; P < 0.001), chronic obstructive airways disease (19.4% vs. 9.9%; P = 0.046), and chronic kidney disease (46.4% vs. 21.5%; P < 0.01) but similar LV ejection fraction (30.0 ± 8.3% vs. 29.5 ± 8.6%; P = 0.678). WiSE-CRT upgrades were successful in 97.1% with procedure-related mortality in 1.9%. Coronary sinus upgrades were successful in 97.5% of cases with a 2.5% rate of CS dissection and 5.6% lead malfunction/displacement. At 6 months, 91 WiSE-CRT upgrades and 107 CS upgrades had similar improvements in CCS (76.3% vs. 68.5%; P = 0.210) and reduction in LVESV ≥15% (54.2% vs. 56.3%; P = 0.835). CONCLUSION: Despite prior failed upgrades and high-risk patients with more comorbidities, WiSE-CRT upgrades had high rates of procedural success and similar improvements in CCS and LV remodelling with CS upgrades.

IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe.

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

Impact of selected comorbidities on the presentation and management of aortic stenosis.

BACKGROUND: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. METHODS: Prospective registry of severe patients with AS across 23 centres in nine European countries. RESULTS: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. CONCLUSIONS: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period.

Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation.

Ablation of the left atrium using either radiofrequency (RF) or cryothermal energy is an effective treatment for atrial fibrillation (AF) and is the most frequent type of cardiac ablation procedure performed. Although generally safe, collateral injury to surrounding structures, particularly the esophagus, remains a concern. Cooling or warming the esophagus to counteract the heat from RF ablation, or the cold from cryoablation, is a method that is used to reduce thermal esophageal injury, and there are increasing data to support this approach. This protocol describes the use of a commercially available esophageal temperature management device to cool or warm the esophagus to reduce esophageal injury during left atrial ablation. The temperature management device is powered by standard water-blanket heat exchangers, and is shaped like a standard orogastric tube placed for gastric suctioning and decompression. Water circulates through the device in a closed-loop circuit, transferring heat across the silicone walls of the device, through the esophageal wall. Placement of the device is analogous to the placement of a typical orogastric tube, and temperature is adjusted via the external heat-exchanger console.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement.

OBJECTIVES: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes. METHODS: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure. RESULTS: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%. CONCLUSIONS: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Dual source computed tomography based analysis of stent performance, its association with valvular calcification and residual aortic regurgitation after implantation of a balloon-expandable transcatheter heart valve.

Objectives: The aim of this study was to investigate the mutual influence of valvular calcifications and transcatheter aortic valve stent geometry during and after implantation of a balloon-expandable SAPIEN ® /SAPIEN XT ® prostheses. Aortic valve calcification has been linked with adverse complications after transcatheter aortic valve implantation (TAVI). However, little is known about the fate of the calcifications after TAVI as well as its influence on transcatheter heart valve geometry. Methods: Thirty one patients underwent cardiac dual source computed tomography (DSCT) before and after a TAVI with the Edwards SAPIEN/SAPIEN XT ® prostheses. Detailed DSCT image analysis was performed with Mimics ® and 3Matic ® (both Materialise, Leuven, Belgium). Results: Implanted stents reached an average degree of expansion of 84% and achieved good circularity despite the presence of fairly oval native annuli and a heterogeneous degree of valvular calcification. Both, the degree of stent expansion and the degree of stent eccentricity were inversely related to the degree of oversizing, but independent of the degree of valvular calcification and native annular ovality. Visualization of the position of calcific debris before and after TAVI showed that calcifications were shifted upwards and outwards as a consequence of the implantation procedure. The degree of stent eccentricity was related to residual aortic regurgitation grade ≥2. Conclusions: The SAPIEN ® /SAPIEN XT ® prostheses achieved good degrees of stent expansion and circularity regardless of the morphology of the landing zone. Increased stent ovality was associated with an elevated risk for aortic regurgitation. The total calcification volume, degree of annular ovality and stent expansion were not associated with residual AR.

Prediction of fluoroscopic angulations for transcatheter aortic valve implantation by CT angiography: influence on procedural parameters.

AIMS: Repeated angiograms to achieve an exactly orthogonal visualization of the aortic valve plane can substantially contribute to the total contrast amount required for transcatheter aortic valve implantation (TAVI). We investigated whether pre-procedural identification of an optimal fluoroscopic projection by cardiac computed tomography (CT) can significantly reduce the amount of a procedure-related contrast agent compared with angiographic determination of suitable angulations. METHODS AND RESULTS: Eighty consecutive patients (81 ± 5 years, 55% male) with symptomatic severe aortic valve stenosis and normal renal function who underwent cardiac CT prior to TAVI were prospectively randomized. In 40 patients, a CT-predicted suitable angulation was used for the first aortic angiogram (CT cohort); in the other 40 patients, the first aortogram was acquired at LAO 10°/cranial 10 (angiography cohort). Additional aortograms were performed if no satisfactory view of the aortic valve plane was obtained. The number of aortograms needed to achieve a satisfactory fluoroscopic projection (1.2 ± 0.6 vs. 3.2 ± 1.7; P < 0.001) and the total amount of contrast agent per TAVI procedure were significantly lower in the CT cohort (95 ± 21 vs. 125 ± 36 mL; P < 0.001). Incidence of acute kidney injury was not significantly different. There was no significant difference regarding radiation dose, time of procedure, degree of post-procedural aortic regurgitation, complications and 30-day mortality between the cohorts. CONCLUSION: Pre-procedural identification of a suitable fluoroscopic projection by cardiac CT significantly reduces a procedural contrast agent volume required for TAVI.

Contrast volume reduction using third generation dual source computed tomography for the evaluation of patients prior to transcatheter aortic valve implantation.

OBJECTIVES: Chronic renal failure is common in patients referred for transcatheter aortic valve implantation (TAVI). CT angiography is recommended and provides crucial information prior to TAVI. We evaluated the feasibility of a reduced contrast volume protocol for pre-procedural CT imaging. METHODS: Forty consecutive patients were examined with prospectively ECG-triggered high-pitch spiral acquisition using a novel third-generation dual-source CT system; 38 ml contrast agent was used. Image quality was graded on a visual scale (1-4). Contrast attenuation was measured at the level of the aortic root and at the iliac bifurcation. RESULTS: Mean patient age was 82 ± 6 years (23 males; 58 %). Mean attenuation/average image quality was 285 ± 60 HU/1.5 at the aortic annulus compared to 289 ± 74 HU/1.8 at the iliac bifurcation (p = 0.77/p = 0.29). Mean estimated effective radiation dose was 2.9 ± 0.3 mSv. A repeat acquisition was necessary in one patient due to image quality. Out of the 35 patients who underwent TAVI, 31 (89 %) patients had no or mild aortic regurgitation. Thirty-two (91 %) patients were discharged successfully. CONCLUSION: Pre-procedural CTA with a total of 38 ml contrast volume is feasible and clinically useful, using third-generation dual-source CT, allowing comprehensive imaging for procedural success. KEY POINTS: • Reduction of contrast agent volume is crucial in patients with chronic renal failure. • Novel third-generation computed tomography helps to reduce contrast agent volume. • Pre-procedural CT allows comprehensive imaging for procedural success before heart valve implantation. • A low-contrast CT protocol is feasible for pre-procedural TAVI planning.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.

Marker genes for the metabolic adaptation of Pseudomonas aeruginosa to the hypoxic cystic fibrosis lung environment.

Pseudomonas aeruginosa is the leading pathogen of chronic cystic fibrosis (CF) lung infection. Life-long persistence in the inflamed and ever fluctuating CF lungs results in the selection of a variety of changes in P. aeruginosa physiology. Accumulating evidence suggests that especially metabolic changes support the survival and growth of P. aeruginosa within the hypoxic and nutritious CF mucus. To investigate if metabolic adaptations we described for hypermutable P. aeruginosa from late CF lung disease (Hoboth et al., 2009. J. Infect. Dis., pp. 118-130) may represent specific changes in response to the selective conditions within the oxygen-restricted CF mucus, we determined the expression of a set of genes during aerobic and hypoxic growth in LB and the artificial sputum medium ASM. We further focused on the regulation of the two isocitrate dehydrogenases Icd and Idh. Interestingly, both isoenzymes may replace each other under aerobic and hypoxic conditions. The NADPH- and RpoS-dependent Icd seems to be the leading isoenzyme under prolonged oxygen limitation and stationary growth phase. LacZ reporter analysis revealed that oxygen-restriction increased the expression levels of azu, cbb3-1, cbb3-2, ccpR, icd, idh and oprF gene, whereas himD and nuoA are increasingly expressed only during hypoxic growth in ASM. Overexpression of the anaerobic regulator Anr improved the expression of azu, ccpR, cbb3-2 and icd. In summary, expression of azu, cbb3-1, cbb3-2, ccpR, icd, idh, oprF, himD, and nuoA appeared to be beneficial for the growth of P. aeruginosa under hypoxic conditions indicating these genes may represent marker genes for the metabolic adaptation to the CF lung environment.

Reproducibility of aortic annulus measurements by computed tomography.

OBJECTIVES: To evaluate a systematic approach for measurement of aortic annulus dimensions by cardiac computed tomography. METHODS: CT data sets of 64 patients were evaluated. An oblique cross-section aligned with the aortic root was created by systematically identifying the caudal insertion points of the three aortic cusps and sequentially aligning them in a double oblique plane. Aortic annulus dimensions, distances of coronary ostia and a suitable fluoroscopic projection angle were independently determined by two observers. RESULTS: Interobserver intraclass correlation coefficients (ICC) for aortic annulus diameters were excellent (ICC 0.89-0.93). Agreement for prosthesis size selection was excellent (ĸ = 0.86 for mean, ĸ = 0.84 for area-derived and ĸ = 0.91 for circumference-derived diameter). Mean distances of the left/right coronary ostium were 13.4 ± 2.4/14.4 ± 2.8 mm for observer 1 and 13.2 ± 2.7/13.5 ± 3.2 mm for observer 2 (p = 0.30 and p = 0.0001, respectively; ICC 0.76/0.77 for left/right coronary artery). A difference of less than 10° for fluoroscopic projection angle was achieved in 84.3% of patients. CONCLUSIONS: A systematic approach to generate a double oblique imaging plane exactly aligned with the aortic annulus demonstrates high interobserver and intraobserver agreements for derived measurements which are not influenced by aortic root calcification. KEY POINTS: • Systematic approach to generate a double oblique imaging plane for TAVI evaluation. • This method is straightforward and software independent. • An approach with high reproducibility, not influenced by aortic root calcification.

CT predictors of post-procedural aortic regurgitation in patients referred for transcatheter aortic valve implantation: an analysis of 105 patients.

Cardiac computed tomography (CT) allows accurate and detailed analysis of the anatomy of the aortic root and valve, including quantification of calcium. We evaluated the correlation between different CT parameters and the degree of post-procedural aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using the balloon-expandable Edwards Sapien prosthesis. Pre-intervention contrast-enhanced dual source CT data sets of 105 consecutive patients (48 males, mean age 81 ± 6 years, mean logEuroSCORE 34 ± 13%) with symptomatic severe aortic valve stenosis referred for TAVI using the Edwards Sapien prosthesis (Edwards lifesciences, Inc., CA, USA) were analysed. The degrees of aortic valve commissural calcification and annular calcification were visually assessed on a scale from 0 to 3. Furthermore, the degree of aortic valve calcification as quantified by the Agatston score, aortic annulus eccentricity, aortic diameter at the level of the sinus of valsalva and at the sinotubular junction were assessed. Early post-procedural AR was assessed using aortography. Significant AR was defined as angiographic AR of at least moderate degree (AR ≥ 2). Visual assessment of the degree of aortic annular calcification as well as the Agatston score of aortic valve calcium correlated weakly, yet significantly with the degree of post-procedural AR (r = 0.31 and 0.24, p = 0.001 and 0.013, respectively). Compared to patients with AR < 2, patients with AR ≥ 2 showed more severe calcification of the aortic annulus (mean visual scores 1.9 ± 0.6 vs. 1.5 ± 0.6, p = 0.003) as well as higher aortic valve Agatston scores (1,517 ± 861 vs. 1,062 ± 688, p = 0.005). Visual score for commissural calcification did not differ significantly between both groups (mean scores 2.4 ± 0.5 vs. 2.5 ± 0.5, respectively, p = 0.117). No significant correlation was observed between the degree of AR and commissural calcification, aortic annulus eccentricity index or aortic diameters. The extent of aortic valve annular calcification, but not of commissural calcification, predicts significant post-procedural AR in patients referred for TAVI using the balloon-expandable Edwards Sapiens prosthesis.

A method to determine suitable fluoroscopic projections for transcatheter aortic valve implantation by computed tomography.

BACKGROUND: In transcatheter aortic valve implantation (TAVI), optimal selection of fluoroscopic projections that permit orthogonal visualization of the aortic valve plane is important but may be difficult to achieve. OBJECTIVE: We developed and validated a simple method to predict suitable fluoroscopic projections on the basis of cardiac CT datasets. METHODS: In 75 consecutive patients that underwent TAVI, angulations in which a 35-mm thick maximum intensity projection would render all aortic valve calcium into 1 plane were determined by manual interaction with contrast-enhanced dual-source CT datasets. TAVI operators used the predicted angulation for the first aortic angiogram and performed additional aortic angiograms if no satisfactory view of the aortic valve plane was obtained. Predicted angulations were compared with the angulation used for valve implantation. Radiation exposure and contrast use was compared between patients with accurate prediction of fluoroscopic angulations by CT and patients in whom CT failed to predict a suitable view. RESULTS: The mean difference between the predicted angulation according to CT and the angulation used for implantation was 3 ± 6 degrees. CT predicted a suitable angulation (<5-degree deviation) in 63 of 75 cases (84%). The mean number of aortic angiograms acquired in patients with correct prediction (1.02 ± 0.1) was significantly lower than in patients with incorrect prediction of the implantation angle by CT (3.0 ± 1.7; P < 0.001). Contrast agent required for the entire TAVI procedure was lower in patients with correct prediction (72 ± 36 mL vs 106 ± 39 mL; P = 0.001). CONCLUSION: CT permits prediction of suitable angulations for TAVI in most cases.

Transapical transcatheter aortic valve implantation using the JenaValve™ system: acute and 30-day results of the multicentre CE-mark study.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for conventional heart surgery. The safety and efficacy of transapical aortic valve implantation using the JenaValve™, a second-generation TAVI device, were evaluated. The system consists of a tested porcine root valve mounted on a nitinol stent with feeler-guided positioning and clip fixation on the diseased leaflets. METHODS: This multicentre, prospective, single-arm study, conducted at seven German sites, enrolled 73 patients (mean age 83.1 ± 3.9), European System for Cardiac Operative Risk Evaluation (EuroSCORE) (28.4 ± 6.5%) of whom 67 patients underwent elective TAVI. Three sizes were used for annular diameters up to 23 mm (n = 21), 25 mm (n = 31) and 27 mm (n = 15). Clinical and echocardiographic evaluations were performed at baseline, post-procedure, discharge and 30 days, and also at 3, 6 and 12 months. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints were procedural success, major adverse cardiac and cerebrovascular events and echocardiographic performance. RESULTS: TAVI with the JenaValve™ device was successful in 60 patients (procedural success rate 89.6%). The overall mortality at 30 days was 7.6%. Conversion to surgery was necessary in four patients (6%), two patients underwent valve-in-valve implantations (3%), one patient was withdrawn per protocol after conversion to TAVI using a balloon-expandable valve (1.5%) since the patient did not receive the study device. Perioperative stroke occurred in two cases (3%). Pacemaker implantation for new onset conduction disorders was necessary in six patients (9.1%). No ostial coronary obstructions were seen. Post-procedure TAVI resulted in favourable reduction of mean transvalvular gradients (40.6 ± 15.9 vs. 10.0 ± 7.2 mmHg, P < 0.0001) and increase in valve opening area (0.7 ± 0.2 vs. 1.7 ± 0.6 cm², P < 0.0001). The majority of successfully treated patients revealed no or minimal paravalvular aortic regurgitation (86.4%); none of the patients had severe post-procedural regurgitation (>2+). CONCLUSIONS: Transapical JenaValve™ implantation was safe and effective in the treatment of severe AS in elderly patients at high risk for surgery. Active clip fixation on the native leaflets and anatomically correct feeler-guided positioning led to good functionality and prevented ostial coronary impairment. Implantation without the need for rapid pacing prevented haemodynamic compromise during valve implantation.

Atorvastatin enhances interleukin-10 levels and improves cardiac function in rats after acute myocardial infarction.

LV (left ventricular) remodelling is the basic mechanism of HF (heart failure) following MI (myocardial infarction). Although there is evidence that pro-inflammatory cytokines [including TNF-alpha (tumour necrosis factor-alpha) and IL-6 (interleukin-6)] are involved in the remodelling process, only little is known about the role of anti-inflammatory cytokines, such as IL-10. As accumulating evidence has revealed that statins possess anti-inflammatory properties, the aim of the present study was to elucidate the effect of atorvastatin on the modulation of the anti-inflammatory cytokine IL-10 and its effect on LV function in rats with HF subsequent to MI. Rats with MI, induced by permanent LAD (left anterior descending) branch coronary artery ligation, were treated for 4 weeks with atorvastatin (10 mg x kg(-1) of body weight x day(-1) via oral gavage) starting on the first day after induction of MI. Cardiac function was assessed by echocardiography and cardiac catheterization 4 weeks after MI induction. Membrane-bound and soluble fractions of TNF-alpha, IL-6 and IL-10 protein, the TNF-alpha/IL-10 ratio, serum levels of MCP-1 (monocyte chemoattractant protein-1) as well as myocardial macrophage infiltration were analysed. Treatment with atorvastatin significantly improved post-MI LV function (fractional shortening, +120%; dP/dt(max), +147%; and LV end-diastolic pressure, -27%). Furthermore atorvastatin treatment markedly decreased the levels of TNF-alpha, IL-6 and MCP-1, reduced myocardial infiltration of macrophages and significantly increased myocardial and serum levels of the anti-inflammatory cytokine IL-10. Thus the balance between pro-inflammatory and anti-inflammatory cytokines was shifted in the anti-inflammatory direction, as shown by a significantly decreased TNF-alpha/IL-10 ratio. Atorvastatin ameliorated early LV remodelling and improved LV function in rats with HF subsequent to MI. Our study suggests that the modulation of the balance between pro- and anti-inflammatory cytokines towards the anti-inflammatory cytokine IL-10 is one salutary mechanism underlying how atorvastatin influences post-MI remodelling and thus improves LV function.

Building strong and ready Army families: a multirisk reduction health promotion pilot study.

A quasi-experimental prospective study was conducted to assess the stage of change progression and elimination of unhealthy behaviors among active duty Army soldiers and their spouses (N = 245) before and after attending a community-based wellness program. Significant differences in stage progression between the intervention group and a comparison group was seen in the fitness (p = 0.05) and communication risk categories (p = 0.03) immediately after the intervention; significant differences in stage progression in fitness (p = 0.05) and spirituality (p = 0.005) risk categories 6 months after baseline. There was a significant increase in seat belt use (p = 0.008), a decrease in reported tobacco use (p < 0.05), and a reduction in family stress (p = 0.06) and personal stress (p < 0.02) in the intervention group. Targeting multiple behavior changes and risk reduction in a single intervention program presents several challenges. In this pilot study, there were many positive nonsignificant trends in risk reduction that might translate into significant changes with a larger sample.