Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2.

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3-7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm2/m2 vs. 0.95 cm2/m2 vs. 0.92 cm2/m2, p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization.

Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta.

BACKGROUND: Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce. METHODS: A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations. RESULTS: Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( ≥ $\ge $ 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( > $\gt $ mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar. CONCLUSION: Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

BACKGROUND: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. METHODS: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. RESULTS: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). CONCLUSIONS: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis.

BACKGROUND: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. AIMS: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. METHODS: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. RESULTS: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). CONCLUSIONS: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Patients with Porcelain Aorta.

BACKGROUND: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. METHODS: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. RESULTS: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. CONCLUSION: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Small Annuli.

BACKGROUND: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis-patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE neo/neo2 system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce. METHODS: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE neo/neo2 valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label n = 529) and below the recommended sizing range (off-label n = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations. RESULTS: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, p = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, p = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE neo/neo2 S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, p = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, p = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM. CONCLUSIONS: The ACURATE neo/neo2 S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE neo/neo2 system seems to be a reliable option in patients with very small annuli.

Multi-Center Comparison of Two Self-Expanding Transcatheter Heart Valves: A Propensity Matched Analysis.

BACKGROUND: During the last years, several transcatheter aortic heart valves entered the clinical market and are commercially available. The prostheses differ regarding several technical and functional aspects. However, little is known regarding head-to-head comparative data of the ACURATE neo and the PORTICO valve prostheses. OBJECTIVES: The aim of this study was to compare two self-expanding transcatheter aortic heart valves (THV), the ACURATE neo and the PORTICO, with regard to in-hospital and 30-day outcomes, as well as early device failures. METHODS: A total of 1591 consecutive patients with severe native aortic valve stenosis from two centers were included in the analyses and matched by 1:1 nearest neighbor matching to identify one patient treated with PORTICO (n = 344) for each patient treated with ACURATE neo (n = 344). RESULTS: In-hospital complications were comparable between both valves, including any kind of stroke (ACURATE neo = 3.5% vs. PORTICO = 3.8%; p = 1.0), major vascular complications (ACURATE neo = 4.5% vs. PORTICO = 5.4%; p = 0.99) or life-threatening bleeding (ACURATE neo = 1% vs. PORTICO = 2%; p = 0.68). The rate of device failure defined by the VARC-2 criteria were comparable, including elevated gradients and moderate-to-severe paravalvular leakage (ACURATE neo = 7.3% vs. PORTICO = 7.6%; p = 1.0). However, the need for permanent pacemaker implantation (PPI) was significantly more frequent after the use of PORTICO THV (9.5% vs. 18.7%; p = 0.002). CONCLUSIONS: In this two-center case-matched comparison, short-term clinical and hemodynamic outcomes showed comparable results between PORTICO and ACURATE neo prostheses. However, PORTICO was associated with a significant higher incidence of PPI.

Midterm outcomes after transcatheter aortic valve implantation.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. METHODS: A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients' mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). RESULTS: The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. CONCLUSIONS: Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.

Endovascular treatment for nontraumatic rupture of the descending thoracic aorta: long-term results.

BACKGROUND: This study evaluated the long-term results of thoracic endovascular aortic repair (TEVAR) of nontraumatic rupture of the descending thoracic aorta. METHODS: This was a retrospective and observational single-center study. During the 10-year study period, 21 patients (6 males) with an average age of 66.1 ± 12.4 (range 31-81) years underwent emergency TEVAR for nontraumatic rupture of the descending thoracic aorta. The underlying aortic pathologies causing the rupture were degenerative aneurysms in 11 patients, complicated type B dissection in nine, and erosion hemorrhage due to neoplasia in one patient. RESULTS: The 30-day mortality rate was 9.5% (2/21). Two patients died postoperatively: one from a repeat aortic rupture and the other from pneumonia. Two patients underwent early endovascular reintervention. After a median follow-up of 65.6 ± 50.4 (range 1.5-44) months, 10 patients died, resulting in a late mortality of 52.6% (10/19). Six patients (31.5%) developed major complications requiring late reintervention. There was no mortality with reintervention. CONCLUSIONS: Endovascular treatment of the descending thoracic aorta in patients with nontraumatic rupture is a promising treatment option in an emergency setting with a relatively low mortality rate. Despite encouraging early results, TEVAR is associated with a high reintervention rate and poor survival due to nonaortic or procedure-related mortality in the long term.

Secondary interventions after endovascular thoracic aortic repair.

BACKGROUND: Endovascular stent grafting of the descending thoracic aorta has evolved rapidly and is now the standard of care for certain patient subsets. However, the durability of this technique is limited by the development of technique-specific complications at mid-term follow-up. The aim of this study was to evaluate the incidence, techniques, and outcomes of secondary intervention for complications after stent grafting of the descending thoracic aorta. METHODS: Between March 2001 and November 2011, 152 patients underwent endovascular thoracic aortic repair (TEVAR). We identified 19 (12.5%) patients from this cohort who required secondary interventions. RESULTS: The indications for TEVAR were type B aortic dissection in 12 patients, thoracic aortic aneurysm in six patients, and intramural hematoma in one patient. The mean time between TEVAR and secondary intervention was 20.49 ± 24.90 months (range, 1.2-83 months). A secondary endovascular intervention was required in eleven patient, six patients required secondary surgical therapy, and hybrid procedures were performed in two patients. Endoleaks were the most common indication for a secondary intervention. The 30-day mortality rate was 10.5% (2/19). Two perioperative deaths were observed following surgical therapy. During the mean follow-up of 78.06 ± 37.37 months (range, 23-142 months) after TEVAR, four unrelated deaths occurred, two patients were lost to follow-up, and four patients required a further intervention. CONCLUSIONS: Secondary intervention after endovascular stent grafting of the descending thoracic aorta was not infrequently required and can be performed with acceptable risks. However, serial, systematic follow-up is essential to detect late complications and to perform secondary procedures, preferably under elective circumstances.

Sclerostin as a potential novel biomarker for aortic valve calcification: an in-vivo and ex-vivo study.

BACKGROUND AND AIM OF THE STUDY: Sclerostin is a key negative regulator of bone formation. It was hypothesized that sclerostin might also play a potential role in the development of aortic valve calcification (AVC). The study aim was to evaluate serum sclerostin levels in patients with different degrees of AVC compared to a healthy control group, and to investigate local sclerostin expression in explanted calcified and non-calcified aortic valves. METHODS: A prospective cross-sectional study was performed in 115 patients (mean age 74 +/- 7 years) with echocardiographically proven AVC. Sclerostin serum levels were measured using ELISA and compared to values obtained from a healthy control population. For quantification of AVC, all patients of the study cohort underwent non-contrast-enhanced dual-source computed tomography (DSCT). Immunohistochemistry (IHC) staining for sclerostin and mRNA sclerostin expression was analyzed in 10 calcified aortic valves and 10 non-calcified age-matched control valves. RESULTS: Patients with AVC showed significantly higher sclerostin serum levels as compared to healthy controls (0.94 +/- 0.45 versus 0.58 +/- 0.26 ng/ml, p < 0.001). A significant correlation between sclerostin serum levels and Agatston AVC scores as assessed by DSCT was observed (r = 0.62, p < 0.001) in the study cohort. IHC revealed positive sclerostin staining in nine calcified valves, in contrast to negative staining for sclerostin in all non-calcified valves. Quantitative real-time PCR confirmed the increased sclerostin expression on mRNA level, with a significant up-regulation of sclerostin mRNA (fold change 150 +/- 52, p < 0.001) expression being shown in calcified aortic valves compared to non-calcified control valves. Co-staining experiments revealed that sclerostin-expressing cells co-express the major osteogenic transcription factor Runx2 and the extracellular matrix protein osteocalcin. CONCLUSION: Patients with AVC showed increased sclerostin serum levels compared to a healthy reference population, and it was revealed that the severity of AVC may be linked to increased sclerostin serum levels. Moreover, the PCR and staining data demonstrated an increased sclerostin expression in parallel to prototypic markers of osteogenic transdifferentiation, indicating a role of sclerostin in the valvular calcification process.

Two-year mortality after transcatheter aortic valve implantation versus medical therapy for high-surgical risk or inoperable aortic stenosis patients.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for the treatment of high-risk or inoperable patients with symptomatic severe aortic stenosis. The study aim was to compare the two-year mortality of high-risk or inoperable patients treated by TAVI compared to medical therapy, in a single-center setting. METHODS: A total of 135 consecutive patients (58 males, 77 females; mean age 80 +/- 6 years; logistic EuroSCORE 21 +/- 13%) who had undergone TAVI was compared to 135 patients (60 males, 75 females; mean age 79 +/- 3 years; logistic EuroSCORE 21 +/- 19%) who had undergone medical treatment before TAVI became available. The one- and two-year follow up mortalities were recorded for each group. In the TAVI group, the patient characteristics were analyzed for predictors of mortality. RESULTS: Sixteen patients (12%) in the TAVI group and 10 (7%) in the medically treated group died within 30 days of intervention or presentation (p = 0.303). At the one-year follow up, 28 TAVI patients (21%) and 69 medically treated patients (41%) died (p < 0.001). At the two-year follow up, 41 TAVI patients (30%) and 80 medically treated patients (59%) died (p < 0.001). Log-rank analysis demonstrated a significant survival benefit after TAVI compared to medical treatment during the total follow up period. Univariate predictors of death at the two-year follow up included medical therapy, logistic EuroSCORE, and pulmonary hypertension. Medical therapy remained the only independent predictor of two-year mortality in a multivariate analysis (OR 3.343; 95% CI 2.021-6.234, p < 0.001). CONCLUSION: In high-surgical risk or inoperable symptomatic aortic stenosis patients, the one- and two-year follow up mortalities of patients treated with TAVI was significantly lower than after medical therapy. Predictors of mortality, in addition to treatment strategy, were pulmonary hypertension and EuroSCORE.

In vitro assessment of prosthesis type and pressure recovery characteristics: Doppler echocardiography overestimation of bileaflet mechanical and bioprosthetic aortic valve gradients.

OBJECTIVE: Pressure recovery results in Doppler gradients greater than catheter gradients and is well established in association with bileaflet mechanical aortic valves. Because pressure recovery is influenced by orifice geometry, it might manifest differently with various valve prostheses. If true, then the reliability of Doppler echocardiography for the estimation of aortic valve gradients might be different with different prostheses. The purpose of the present study was to test, in an in vitro setting, the degree to which pressure recovery results in Doppler overestimation of gradients for three commonly used aortic valve prostheses. METHODS: Carpentier Edwards Perimount, Medtronic Mosaic, and St. Jude Medical bileaflet prostheses were tested under various flow conditions in a pulsatile mock flow loop with a normal aorta size. Mean pressure gradient was assessed with transducers 1 cm and 10 cm distal to the valve and with Doppler echocardiography. Pressure recovery was defined as the difference between the Doppler gradient and a 10-cm gradient. The percentage of the maximum pressure gradient composed of pressure recovery and the percentage of pressure recovery complete 1 cm distal to the valve were calculated. RESULTS: There was substantial pressure recovery for all valves in all flow states. Pressure recovery was responsible for 50% or more of the Doppler gradients for almost all conditions and was more than 70% complete within 1 cm for almost all conditions. Multivariate analysis found that flow and valve area (but not valve type) were predictors of pressure recovery; that flow was the major predictor of the percentage of Doppler gradient composed of pressure recovery (with minor contributions from the aorta size and prosthesis type); and that valve type and aorta size were the major predictors of the percentage of pressure recovery complete at 1 cm. CONCLUSIONS: In an in vitro model with a normal aorta size, substantial pressure recovery occurred with all three aortic valve prostheses. Although statistically significant differences were found between valve types in the percentage of pressure recovery and percentage of pressure recovery complete at 1 cm, the differences were small and clinically unimportant. Clinically, among patients with an ascending aorta diameter less than 3.0 cm, Doppler echocardiography likely substantially overestimates aortic valve mean gradient, regardless of prosthesis type.

Can cardiac surgery cause hypopituitarism?

Apoplexy of pituitary adenomas with subsequent hypopituitarism is a rare but well recognized complication following cardiac surgery. The nature of cardiac on-pump surgery provides a risk of damage to the pituitary because the vascular supply of the pituitary is not included in the cerebral autoregulation. Thus, pituitary tissue may exhibit an increased susceptibility to hypoperfusion, ischemia or intraoperative embolism. After on-pump procedures, patients often present with physical and psychosocial impairments which resemble symptoms of hypopituitarism. Therefore, we analyzed whether on-pump cardiac surgery may cause pituitary dysfunction also in the absence of pre-existing pituitary disease. Twenty-five patients were examined 3-12 months after on-pump cardiac surgery. Basal hormone levels for all four anterior pituitary hormone axes were measured and a short synacthen test and a growth hormone releasing hormone plus arginine (GHRH-ARG)-test were performed. Quality of life (QoL), depression, subjective distress for a specific life event, sleep quality and fatigue were assessed by means of self-rating questionnaires. Hormonal alterations were only slight and no signs of anterior hypopituitarism were found except for an insufficient growth hormone rise in two overweight patients in the GHRH-ARG-test. Psychosocial impairment was pronounced, including symptoms of moderate to severe depression in 9, reduced mental QoL in 8, dysfunctional coping in 6 and pronounced sleep disturbances in 16 patients. Hormone levels did not correlate with psychosocial impairment. On-pump cardiac surgery did not cause relevant hypopituitarism in our sample of patients and does not serve to explain the psychosocial symptoms of these patients.

Evaluation of aortic root for definition of prosthesis size by magnetic resonance imaging and cardiac computed tomography: implications for transcatheter aortic valve implantation.

BACKGROUND: This study sought to compare cardiac magnetic resonance imaging (CMR) with dual source computed tomography (DSCT) for analysis of aortic root dimensions prior to transcatheter aortic valve implantation (TAVI). In addition, the potential impact of CMR and DSCT measurements on TAVI strategy defined by 2D-transesophageal echocardiography (TEE) was evaluated. METHODS: Aortic root dimensions were measured using CMR and DSCT in 58 patients referred for evaluation of TAVI. The TAVI strategy (choice of prosthesis size and decision to implant) was based on 2D-TEE annulus measurements. RESULTS: CMR and DSCT aortic root measurements showed an overall good correlation (r=0.86, p<0.001 for coronal aortic annulus diameters). There was also a good correlation between TEE and CMR as well as between TEE and DSCT for measurement of sagittal aortic annulus diameters (r=0.69, p<0.001). However, annulus diameters assessed by TEE (22.1±2.3mm) were significantly smaller than coronal aortic annulus diameters assessed by CMR (23.4±1.8mm, p<0.001) or DSCT (23.6±1.8, p<0.001). Regarding TAVI strategy, the agreement between TEE and sagittal CMR (kappa=0.89) as well as sagittal DSCT measurements (kappa=0.87) was statistically perfect. However, decision based on coronal CMR- or MSCT measurements would have modified TAVI strategy as compared to a TEE based choice in a significant number of patients (22% to 24%). CONCLUSION: In patients referred for TAVI, CMR measurements of aortic root dimensions show a good correlation with DSCT measurements and thus CMR may be an alternative 3D-imaging modality. Aortic annulus measurements using TEE, CMR and DSCT were close but not identical and the method used has important potential implications on TAVI strategy.

Incidence and predictors of left bundle branch block after transcatheter aortic valve implantation.

OBJECTIVE: The aim of this study was to evaluate the frequency and predictors of left bundle branch block (LBBB) after Transcatheter Aortic Valve Implantation (TAVI) using CoreValve and Edwards SAPIEN prosthesis. METHODS: 154 consecutive patients (53 male, mean age 81 ± 7 years) with severe symptomatic aortic stenosis underwent TAVI. Transfemoral AVI (CoreValve) was performed in 72 patients (47%). Transapical AVI (Edwards SAPIEN valve) was done with in n=82 patients (53%). Patient characteristics, valvular and left ventricular outflow tract geometry from pre- and postprocedural imaging (computed tomography, transesophageal echocardiography and callipered angiography) and procedural characteristics were evaluated to define predictors of new LBBB after TAVI. PATIENTS: Preprocedural LBBB was present in 15 patients (n=5 CoreValve, n=10 in Edwards SAPIEN). In 40 of 139 patients (29%) a new LBBB was observed after TAVI. The frequency of new LBBB was higher with CoreValve n=27 (38%) than with Edwards SAPIEN implantation n=13 (16%; p=0.006). Patients with new LBBB had larger valve implantation depth into the left ventricular outflow tract (9.0 ± 2.9 vs. 4.4 ± 2.5mm, p<0.001). In 18 of 40 patients (45%) the new LBBB was persistent at 30days. Predictors of new LBBB were prosthesis implantation depth into the left ventricular outflow tract (OR=1.185 95% CI 1.064-1.320 per additional mm implantation depth; p=0.002) and use of CoreValve prosthesis (OR=2.639 95% CI 1.314-5.813; p=0.007). CONCLUSION: TAVI is frequently associated with new LBBB. There is a higher frequency of persistent LBBB with the CoreValve system. Implantation depth is a critical factor for the development of new LBBB.

Thirty-day outcome after transcatheter aortic valve implantation compared with surgical valve replacement in patients with high-risk aortic stenosis: a matched comparison.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative to surgery for the treatment of severe aortic stenosis in high-surgical risk patients. The aim of this study was to compare 30-day mortality of high-risk patients treated by TAVI versus surgical aortic valve replacement. METHODS: A total of 175 patients (60 men; mean age, 80±6 years; Euroscore 21±13%) having undergone TAVI were compared with 175 matched patients (76 men; mean age, 79±3 years; Euroscore 17±9%), which have undergone conventional aortic valve replacement and were deemed to be high-risk patients by the cardiothoracic surgeons. Thirty-day mortality and major adverse events were recorded in both groups. Patients' characteristics were analyzed for predictors of mortality in the TAVI group. RESULTS: Twenty-one patients (12%) in the TAVI group and 13 patients (8%) in the surgical group died within 30 days of the procedure (P=0.165). Two patients (1%) in the TAVI group and one patient (0.5%) in the conventional surgery group had a major stroke (P=1.0). Seven patients (4%) in the TAVI group and 25 patients (14%) in the conventional surgery group required dialysis post procedure (P=0.0013). The average length of stay in the intensive care unit was lower in the TAVI group compared with the conventional surgical group (3.3±3.1 vs. 6.6±10.5 days; P<0.001). Age was the only independent predictor of mortality in the TAVI group (odds ratio=1.009; 95% confidence interval: 1.001-1.018 per additional year; P=0.0186) and in the total study population (odds ratio=1.007; 95% confidence interval: 1.001-1.013 per additional year; P=0.0186). CONCLUSION: In high-surgical risk patients, TAVI can be performed at a mortality risk comparable with conventional surgery with a reduced length of post interventional intensive care unit stay and less need for dialysis.

Aortic valve calcifications on chest films: how much calcium do I need?

OBJECTIVE: Aortic valve calcifications (AVC) as seen on conventional chest films or on CT are associated with aortic valve stenosis (AVS). The absence of AVC on chest films does not exclude high grade AVS. The aim of this study was to analyse if there is a threshold for the detection of AVC from conventional chest films in patients suffering from high grade AVS. METHODS AND RESULTS: The explanted aortic valves of 29 patients (16 male, mean age 72.3 +/- 11.5 years) with high grade AVS were examined by dual-source CT. AVC were quantified using the Agatston AVC score. In all patients conventional chest films obtained the day before surgery were evaluated for the presence of AVC. Results were analysed with students t-test, Spearman's rank correlation and ROC analysis. On conventional chest films AVC were visible in 18 patients. On CT all specimen presented with AVC with an Agatston AVC score ranging from 40.7 to 1870 (mean 991.3 +/- 463.1). In patients with AVC visible on chest films the AVC score was significantly higher (1264.0 +/- 318.2) when compared with patients without visible calcifications (544.9 +/- 274.4; P < 0.0001). There was a strong correlation between the AVC score and the visibility of AVC on chest films (r = 0.781). ROC analysis identified an ideal threshold of 718 for AVC score to separate conventional chest films with and without visible AVC. CONCLUSION: Unlike in coronary calcifications, there is a threshold for identifying AVC from conventional chest films. This finding may be of diagnostic value, as conventional chest films may be used to semiquantitatively evaluate the extent of AVC.