Amyloid Transthyretin Cardiomyopathy in Elderly Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Background The prevalence of calcific aortic stenosis and amyloid transthyretin cardiomyopathy (ATTR-CM) increase with age, and they often coexist. The objective was to determine the prevalence of ATTR-CM in patients with severe aortic stenosis and evaluate differences in presentations and outcomes of patients with concomitant ATTR-CM undergoing transcatheter aortic valve implantation. Methods and Results Prospective screening for ATTR-CM with Technetium99-3,3-diphosphono-1,2-propanodicarboxylic acid bone scintigraphy was performed in 315 patients referred with severe aortic stenosis between August 2019 and August 2021. Myocardial Technetium99-3,3-diphosphono-1,2-propanodicarboxylic acid tracer uptake was detected in 34 patients (10.8%), leading to a diagnosis of ATTR-CM in 30 patients (Perugini ≥2: 9.5%). Age (85.7±4.9 versus 82.8±4.5; P=0.001), male sex (82.4% versus 57.7%; P=0.005), and prior carpal tunnel surgery (17.6% versus 4.3%; P=0.007) were associated with coexisting ATTR-CM, as were ECG (discordant QRS voltage to left ventricular wall thickness [42% versus 12%; P<0.001]), echocardiographic (left ventricular ejection fraction 48.8±12.8 versus 58.4±10.8; P<0.001; left ventricular mass index, 144.4±45.8 versus 117.2±34.4g/m2; P<0.001), and hemodynamic parameters (mean aortic valve gradient, 23.4±12.6 versus 35.5±16.6; P<0.001; mean pulmonary artery pressure, 29.5±9.7 versus 25.8±9.5; P=0.037). Periprocedural (cardiovascular death: hazard ratio [HR], 0.71 [95% CI, 0.04-12.53]; stroke: HR, 0.46 [95% CI, 0.03-7.77]; pacemaker implantation: HR, 1.54 [95% CI, 0.69-3.43]) and 1-year clinical outcomes (cardiovascular death: HR, 1.04 [95% CI, 0.37-2.96]; stroke: HR, 0.34 [95% CI, 0.02-5.63]; pacemaker implantation: HR, 1.50 [95% CI, 0.67-3.34]) were similar between groups. Conclusions Coexisting ATTR-CM was observed in every 10th elderly patient with severe aortic stenosis referred for therapy. While patients with coexisting pathologies differ in clinical presentation and echocardiographic and hemodynamic parameters, peri-interventional risk and early clinical outcomes were comparable up to 1 year after transcatheter aortic valve implantation. REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT04061213.

The impact of sex and gender on aortic events in patients with Marfan syndrome.

OBJECTIVES: The aim of this study was to explore sex and gender differences regarding aortic events in Marfan patients. METHODS: We analysed all data from our connective tissue disorder database. Only patients with Marfan syndrome were included. For analysis, patients were divided by sex. Female patients were further divided into 2 subgroups: with versus without children. Aortic events were defined as Stanford type A aortic dissection (TAAD) or type B aortic dissection (TBAD) or any aortic intervention. RESULTS: A population of 183 Marfan patients was analysed for the purpose of this study. One hundred four (57%) were male and 79 (43%) were female patients. Thirty-seven (47%) of the 79 female patients had at least 1 child. Male patients had a significantly higher probability of experiencing an aortic event (P = 0.015) compared to female patients. However, there was no increased probability for recurrent events in male patients compared to female patients (P = 0.063). Follow-up revealed no sex and gender differences in the occurrence of Stanford TAAD or TBAD between male and female patients (P = 0.324/P = 0.534). While 11% of women with children suffered from peripartum aortic events, 24% experienced Stanford TAAD unrelated to pregnancy. CONCLUSIONS: Male patients have a higher risk of aortic events than female patients. The majority of women were not aware of their Marfan syndrome diagnosis before conceiving. One out of 10 women suffered from peripartum Stanford TAAD or TBAD. Twice as many female patients with children suffered from aortic dissection unrelated to childbirth. There were no sex and gender differences affecting mortality in Marfan patients.

Heart valve sizing and clinical outcomes in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI). BACKGROUND: The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear. METHODS: In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year. RESULTS: Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HRadj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HRadj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HRadj 1.98, 95%CI 1.36-2.87). CONCLUSION: Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.

Discharge Location and Outcomes After Transcatheter Aortic Valve Implantation.

The relation between discharge location and outcomes after transcatheter aortic valve implantation (TAVI) is largely unknown. Thus, the objective of this study was to investigate the impact of discharge location on clinical outcomes after TAVI. Between August 2007 and December 2018, consecutive patients who underwent transfemoral TAVI at Bern University Hospital were grouped according to discharge location. Clinical adverse events were adjudicated according to VARC-2 end point definitions. Of 1,902 eligible patients, 520 (27.3%) were discharged home, 945 (49.7%) were discharged to a rehabilitation clinic and 437 (23.0%) were transferred to another institution. Compared with patients discharged to a rehabilitation facility or another institution, patients discharged home were younger (80.8 ± 6.5 vs 82.9 ± 5.4 and 82.8 ± 6.4 years), less likely female (37.3% vs 59.7% and 54.2%), and at lower risk according to STS-PROM (4.5 ± 3.0% vs 5.5 ± 3.8% and 6.6 ± 4.4%). At 1 year follow-up, patients discharged home had similar rates of all-cause mortality (HRadj 0.82; 95% CI 0.54 to 1.24), cerebrovascular events (HRadj 1.04; 95% CI 0.52 to 2.08) and bleeding complications (HRadj 0.93; 95% CI 0.61 to 1.41) compared with patients discharged to a rehabilitation facility. Patients discharged home or to rehabilitation were at lower risk for death (HRadj 0.37; 95% CI 0.24 to 0.56 and HRadj 0.44; 95% CI 0.32 to 0.60) and bleeding (HRadj 0.48; 95% CI 0.30 to 0.76 and HRadj 0.66; 95% CI 0.45 to 0.96) during the first year after hospital discharge compared with patients transferred to another institution. In conclusion, discharge location is associated with outcomes after TAVI with patients discharged home or to a rehabilitation facility having better clinical outcomes than patients transferred to another institution. Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250.

Long-term outcome of patients with Marfan syndrome with previous aortic surgery but native aortic roots.

OBJECTIVES: The goal of this study was to report the long-term outcomes of patients with Marfan syndrome who had aortic surgery on any aortic segment except for the replacement of the aortic root itself. METHODS: An observational retrospective single-centre study was conducted with 115 Marfan syndrome patients who underwent 189 major aortic interventions from 1995 until 2018. Patients without aortic root replacement were identified and aortic root growth was analysed over time. RESULTS: Eleven of 115 patients (9.5%) did not have aortic root replacement during a follow-up of 10.5 [standard deviation (SD) 5.7] years and a mean age at last follow-up of 53.9 (SD 13.4) years. Patients without root replacement did not suffer less frequently from any type of acute aortic dissection (type A 27% vs 25%, P = 0.999; type B 36% vs 25%, P = 0.474). Patients with native aortic roots did not undergo fewer aortic interventions than those with aortic root replacement [12/11, mean 1.09 (SD 0.54) operations/patient vs 177/104, mean 1.7 (SD 1.3); P = 0.128]. Progression of the aortic root dimension was 0.5 (SD 0.3) mm/year in the group of patients with native aortic roots. CONCLUSIONS: Current data suggest that 10% of patients with Marfan syndrome with previous aortic surgery will be free from aortic root replacement until the sixth decade of life.

Prognostic Relevance of Left Ventricular Myocardial Performance After Transcatheter Aortic Valve Replacement.

BACKGROUND: The left-ventricular myocardial performance index Tei is an echocardiographic parameter that incorporates the information of systolic and diastolic time intervals. While the prognostic value of selected systolic and diastolic parameters is well established after transcatheter aortic valve replacement, the role of Tei has not been evaluated in this setting. METHODS AND RESULTS: Between August 2007 and December 2015, consecutive patients with symptomatic, severe aortic stenosis and transthoracic echocardiography pre- and post-transcatheter aortic valve replacement were considered eligible for this analysis. The primary end point was all-cause mortality at 1 year after transcatheter aortic valve replacement. Of 824 patients with echocardiographic images to calculate Tei, pre-Tei was normal (<0.45) in 639 and high (≥0.45) in 185, whereas post-Tei was normal in 602 and high in 120, respectively. After adjustment for confounding factors, high pre-Tei was associated with an increased risk of all-cause mortality at 30 days (adjusted hazard ratio [HRadj] 3.62; 95% CI, 1.89-6.91) and 1 year (HRadj 2.56; 95% CI, 1.78-3.69). Similarly, post-Tei was associated with an increased risk of mortality between 30 days and 1-year follow-up (HRadj 6.70; 95% CI, 4.22-10.63). At multivariable analysis Tei emerged as an independent predictor of early (pre-Tei index per 0.1-HRadj 1.40; 95% CI, 1.23-1.60) and late mortality (post-Tei index per 0.1-HRadj 1.40; 95% CI, 1.31-1.50), respectively. CONCLUSIONS: The left-ventricular myocardial performance index Tei is associated with impaired clinical outcomes during short- and longer-term follow-up after transcatheter aortic valve replacement. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01368250.

The fate of nonaortic arterial segments in Marfan patients.

OBJECTIVES: The aim of this study was to investigate the fate of nonaortic arterial segments in patients with Marfan syndrome (MFS). METHODS: This was a retrospective analysis of 100 consecutive patients with MFS fulfilling Ghent criteria who underwent 192 interventions on any segment of the arterial tree and were followed over the past 20 years. A review of the available imaging regarding 9 defined regions of interest of the carotid, innominate, subclavian, iliac, and femoral arteries was performed. RESULTS: Mean follow-up interval was 11.6 ± 7.7 years. Of 600 measurements that were performed, 414 (69%) arterial segments showed dilatation above the upper range of normal. There were no significant sex differences. In 100 patients, 66 dissections in nonaortic arterial segments in 33 patients were identified. Nineteen patients with or without previous dissection underwent 34 interventions. Most interventions were performed on the iliac arteries (56%), followed by the subclavian arteries (21%), the intercostal arteries (9%), the carotid arteries (6%), the visceral arteries (6%), and the innominate artery (3%). Most iliac artery interventions (88%) were caused by dilatations due to previous dissections, whereas this was only the case in 17% of interventions on the subclavian arteries. CONCLUSIONS: Most patients with MFS presented with at least 2 dilated nonaortic arterial segments. The current data suggest that 20% of MFS patients will need some form of intervention on nonaortic arterial segments 5 to 6 years after their first aortic intervention, referring to the first aortic dissection of the patient if the patient had a history of dissection. Routine long-term follow-up imaging should include the iliac arteries as well as the supra-aortic branches.

Transcatheter aortic valve thrombosis: incidence, clinical presentation and long-term outcomes.

Aims: To assess the incidence, management and long-term outcomes of transcatheter heart valve thrombosis (THVT). Methods and results: Between August 2007 and February 2016, 1396 patients were included in the Bern TAVI Registry and prospectively followed-up through echocardiographic and clinical evaluation. THVT was suspected in case of: (i) a mean transvalvular pressure gradient greater than 20 mmHg at transthoracic echocardiography, or (ii) an increase of more than 50% of the mean transvalvular pressure gradient compared with previous measurements or (iii) new symptoms or signs of heart failure with the presence of thrombus documented by transoesophageal echocardiography or multi-slice computed tomography. THVT occurred in 10 patients (0.71%) at variable time points after TAVI. Increased transvalvular pressure gradients were recorded in all patients and 7 out of 10 patients were symptomatic. Oral anticoagulant therapy (with vitamin K antagonists or non-Vitamin K antagonists) was initiated in all but two patients and resulted in normalization of transvalvular pressure gradients and amelioration of clinical status within 1 month. At long-term follow-up (between 10 and 25 months after valve thrombosis), echocardiographic findings were stable and no adverse events were reported. Conclusion: THVT is rarely detected at routine clinical and echocardiographic evaluation after TAVI. Oral anticoagulation appears effective to normalize transvalvular gradients in the majority of cases with stable clinical and haemodynamic evolution during long-term follow-up.

Incidence and impact of renal dysfunction on clinical outcomes after transcatheter aortic valve implantation.

BACKGROUND: The impact of baseline renal dysfunction on early and late clinical outcomes after transcatheter aortic valve implantation (TAVI) remains to be defined. METHODS: 927 patients included in the prospective Bern TAVI registry were classified on the basis of the baseline estimated glomerular filtration rate (eGFR), as having none or mild (eGFR ≥60mL/min/1.73m2, n=284, 30.6%), moderate (eGFR between 30 and 59mL/min/1.73m2, n=535, 57.7%) and severe (eGFR <30mL/min/1.73m2, n=108, 11.7%) renal dysfunction. RESULTS: A graded relationship between stages of renal dysfunction and increasing risk profile was observed with higher STS score and lower left ventricular ejection fraction among patients with eGFR<30 (p<0.001 across groups). In patients with none or mild, moderate, and severe renal dysfunction the rate of all-cause mortality was 1.8%, 5.2% and 8.3% at 30-day and 11.0%, 15.0% and 19.5% at 1-year, respectively. After adjusting for relevant confounders, severe renal dysfunction was associated with an increased risk of cardiovascular death (adjusted Hazard Ratio, HRadj, 3.90, 95% Confidence Interval, CI 1.15-13.2) and stage 3 acute kidney injury (HRadj 5.15, 95% CI 1.72-15.5) at 30-day follow-up, however no significant association was found for clinical outcomes at 1-year follow-up. Moreover, moderate and severe renal dysfunction were found to be associated with bleeding at 1-year follow-up (HRadj, 1.36, 95% CI 1.04-1.78 and HRadj 1.49, 95% CI 1.00-2.21, respectively). CONCLUSIONS: Pre-procedural renal dysfunction differentially affects early clinical outcomes, although the magnitude of this association is diluted over time by the overriding effect of underlying risk and comorbidities.

Impact of new technologies and experience on procedural aspects of surgical aortic valve replacement - a process analysis.

BACKGROUND: Surgical aortic valve replacement (SAVR) is the treatment of choice in severe symptomatic aortic valve disease. New techniques and prostheses have been recently developed to facilitate the procedure and reduce aortic cross-clamp time (AOx). The aim of this study was to analyse the different procedural steps in order to identify the most time-consuming part during aortic clamping time and to compare impact of experience on procedural aspects. METHODS: AOx during SAVR was divided into five consecutive steps. Duration of each step was measured. The first procedural step started with clamping of the aorta and ended with the beginning of the second step starting with the resection of the native aortic valve. The third step started with placement of the first valve anchoring suture, the fourth step started with tying of the first suture and the fifth and final step started after the cut of the last suture and ended with removal of the aortic clamp. Surgeons were divided into two groups based on their experience, which in our analysis was defined as a total SAVR experience of more than 100 procedures. RESULTS: From March 2013 to August 2015 57 nonconsecutive patients (33% female; age, median 71.0 years, interquartile range 65.0-76.0) undergoing isolated SAVR for severe aortic valve stenosis in our institution were included in this process analysis. Two different prostheses were implanted. Forty-eight (84%) patients received a tissue valve (Perimount Magna Ease, Edwards Lifesciences, Irvine, USA) and 9 (16%) patients received a mechanical prosthesis (Medtronic AP 360, St-Paul, MN, USA). The mean estimated risk of mortality was 1.1% (0.7-1.6) according to the logistic EUROScore II. Overall duration of AOx was 50.5 ± 13.8 min, with 32.3% (16.4 ± 5.9 min) accounting for placing the sutures into the native annulus and the prosthetic sewing ring and 18.5% (9.2 ± 3.0min) accounting for tying and cutting the sutures. Surgeons with more experience performed 35 operations (61.4%) and needed an average of 44.1 ± 11.5 min versus 60.6 ± 11.0 min (p <0.001) for less experienced surgeons. Surgeons with more experience needed 14.0 ± 5.0 min for the suturing step and 8.4 ± 2.8 min for tying the sutures compared with 20.2 ± 5.2 min and 10.5 ± 3.0 min, respectively, for the less experienced surgeons with (p <0.001 and p = 0.010). CONCLUSION: Placing and tying sutures in the prostheses accounts for over half (50.8%) of AOx during isolated SAVR. Experienced surgeons have significantly reduced AOx. This shortening is equally distributed between all five procedural steps.

Frequency, Timing, and Impact of Access-Site and Non-Access-Site Bleeding on Mortality Among Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to examine the frequency, timing, and association of access-site and non-access-site bleeding with mortality in the setting of transcatheter aortic valve replacement (TAVR) during long-term follow-up. BACKGROUND: Bleeding is frequent and associated with impaired prognosis in patients undergoing TAVR. It is currently unknown whether the site of bleeding differentially influences the outcomes of TAVR patients. METHODS: In total, 926 consecutive patients undergoing TAVR from 2007 through 2014 were evaluated. Bleeding was assessed according to the Valve Academic Research Consortium 2 criteria. The primary outcome of interest was all-cause mortality up to 5 years of follow-up. RESULTS: A total of 285 patients (30.7%) experienced at least 1 (minor, major, or life-threatening) bleeding event up to 5 years. Compared with patients not experiencing bleeding, the adjusted risk for all-cause mortality was significantly increased among patients with access-site (hazard ratio: 1.34; 95% confidence interval: 1.01 to 1.76; p = 0.04) and non-access-site bleeding (hazard ratio: 2.08; 95% confidence interval: 1.60 to 2.71; p < 0.001). However, non-access-site bleeding conferred a significantly higher risk for mortality compared with access-site bleeding (hazard ratio: 1.56; 95% confidence interval: 1.12 to 2.18; p = 0.009). At multivariate analysis, female sex was a significant correlate of access-site bleeding, whereas chronic kidney disease and the Society of Thoracic Surgeons score were significantly associated with non-access-site bleeding. CONCLUSIONS: Among patients with severe aortic stenosis undergoing TAVR, access-site and non-access-site bleeding were independently associated with an increased risk for mortality, with the greatest risk related to non-access-site bleeding during long-term follow-up.

Validation of 3D-reconstructed computed tomography images using OsiriX® software for pre-transcatheter aortic valve implantation aortic annulus sizing.

OBJECTIVES: We report validation of OsiriX® -an image processing freeware-to measure multi-slice computed tomography-derived annulus diameters for preprocedural transcatheter aortic valve implantation planning. METHODS: A total of 137 patients (82 ± 6.5 years, 42.3% male, logistic EuroSCORE 24.1 ± 14.2%) with severe aortic stenosis at high surgical risk underwent transcatheter aortic valve implantation assessment: transoesophageal echocardiography, angiography and multi-slice computed tomography. Retrospectively, 3D multi-slice computed tomography reconstructions were generated using OsiriX and the reliability evaluated regarding inter- and intraobserver variability, intermodality correlation and estimation of the clinical impact on transcatheter aortic valve implantation sizing. RESULTS: Reliability of the novel OsiriX software was high with an interobserver mean difference of 0.6 ± 1.4 mm and intraclass correlation of absolute agreement of 0.84 (95% confidence interval 0.74-0.90). The intermodality accuracy between OsiriX measurements and conventional 2D computed tomography reconstructions, transoesophageal echocardiography and angiography revealed significantly larger sizing with OsiriX, with a mean difference to 2D computed tomography of 0.4 ± 2.2 mm, which would have changed valve sizing in 38% of patients. In 28%, a larger size would have been chosen, and this correlated highly with the occurrence of postoperative severe aortic regurgitation (P < 0.001). CONCLUSIONS: While OsiriX measurements are an accurate and reproducible assessment of the aortic annulus, there are distinct and clinically relevant differences in aortic annulus dimensions between OsiriX measurements and previously standard imaging modalities. Sizing with OsiriX resulted in a larger perimeter compared with conventional 2D imaging. Careful assessment of valve size will take into account multiple imaging modalities.

Rates and predictors of hospital readmission after transcatheter aortic valve implantation.

AIMS: To analyse reasons, timing and predictors of hospital readmissions after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Patients included in the Bern TAVI Registry between August 2007 and June 2014 were analysed. Fine and Gray competing risk regression was used to identify factors predictive of hospital readmission within 1 year after TAVI with bootstrap analysis for internal validation. Of 868 patients alive at discharge, 221 (25.4%) were readmitted within 1 year. Compared with patients not requiring readmission, those with at least one readmission more frequently were male and more often had atrial fibrillation and higher creatinine values (P < 0.05 for all cases). For overall 308 readmissions, cardiovascular causes accounted for 46.1% with heart failure as the most frequent indication; non-cardiovascular readmissions occurred for surgery (11.7%), gastrointestinal disorders (9.7%), malignancy (4.9%), respiratory diseases (4.6%) and chronic kidney failure (2.6%). Male gender (subhazard ratio, SHR, 1.33, 95% confidence intervals, CI, 1.02-1.73, P = 0.035) and stage 3 kidney injury (SHR 2.04, 95% CI 1.12-3.71, P = 0.021) were found independent risk factors for any hospital readmission, whereas previous myocardial infarction (SHR 1.88, 95% CI 1.22-2.90, P = 0.004) and in-hospital life-threatening bleeding (SHR 2.18, 95%CI 1.24-3.85, P = 0.007) were associated with cardiovascular readmissions. The event rate for mortality was significantly increased after readmissions for any cause (RR 4.29, 95% CI 2.86-6.42, P < 0.001). CONCLUSION: Hospital readmission was observed in one out of four patients during the first year after TAVI and was associated with a significant increase in mortality.

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions. METHODS AND RESULTS: Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870). CONCLUSIONS: The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.

Transcarotid aortic valve-in-valve implantation for degenerated stentless aortic root conduits with severe regurgitation: a case series.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is routinely performed via the transfemoral and the transapical route. Subclavian and direct aortic access are described alternatives for TAVI. Recently, the transcarotid approach has been shown to be feasible among patients with limited vascular access and severe native aortic valve stenosis. We aim to investigate the feasibility of transcatheter aortic valve-in-valve implantation via the transcarotid access in patients with severe aortic regurgitation due to degenerated stentless Shelhigh conduits using the 29 mm Medtronic CoreValve bioprosthesis. METHODS: Three patients with complex vascular anatomy undergoing transcatheter valve-in-valve implantation via the transcarotid route were enrolled in the study. The procedure was performed under general anaesthesia using surgical cut-down to facilitate vascular access. Immediate procedural results as well as echocardiographic and clinical outcomes after 30 days and 6 months of the follow-up were recorded and analysed. RESULTS: All three patients underwent unproblematic TAVI and experienced dramatic improvement of symptoms. Mean transvalvular gradient was 3, 6 and 11 mmHg, respectively. Effective orifice area ranged between 1.7 and 2.2 cm(2). Only mild paravalvular regurgitation was detected by echocardiography after 30 days of the follow-up. CONCLUSIONS: The transcarotid approach can be safely performed for valve-in-valve procedures using the Medtronic CoreValve in patients with limited vascular access. It enables accurate positioning and implantation of the prosthesis.

Decision-making in aortic root surgery in Marfan syndrome: bleeding, thromboembolism and risk of reintervention after valve-sparing or mechanical aortic root replacement.

OBJECTIVES: Valve-sparing root replacement (VSRR) is thought to reduce the rate of thromboembolic and bleeding events compared with aortic root replacement using a mechanical aortic root replacement (MRR) with a composite graft by avoiding oral anticoagulation. But as VSRR carries a certain risk for subsequent reinterventions, decision-making in the individual patient can be challenging. METHODS: Of 100 Marfan syndrome (MFS) patients who underwent 169 aortic surgeries and were followed at our institution since 1995, 59 consecutive patients without a history of dissection or prior aortic surgery underwent elective VSRR or MRR and were retrospectively analysed. RESULTS: VSRR was performed in 29 (David n = 24, Yacoub n = 5) and MRR in 30 patients. The mean age was 33 ± 15 years. The mean follow-up after VSRR was 6.5 ± 4 years (180 patient-years) compared with 8.8 ± 9 years (274 patient-years) after MRR. Reoperation rates after root remodelling (Yacoub) were significantly higher than after the reimplantation (David) procedure (60 vs 4.2%, P = 0.01). The need for reinterventions after the reimplantation procedure (0.8% per patient-year) was not significantly higher than after MRR (P = 0.44) but follow-up after VSRR was significantly shorter (P = 0.03). There was neither significant morbidity nor mortality associated with root reoperations. There were no neurological events after VSRR compared with four stroke/intracranial bleeding events in the MRR group (log-rank, P = 0.11), translating into an event rate of 1.46% per patient-year following MRR. CONCLUSION: The calculated annual failure rate after VSRR using the reimplantation technique was lower than the annual risk for thromboembolic or bleeding events. Since the perioperative risk of reinterventions following VSRR is low, patients might benefit from VSRR even if redo surgery may become necessary during follow-up.

Long-term outcome of elderly patients with severe aortic stenosis as a function of treatment modality.

OBJECTIVE: To assess long-term clinical outcomes of consecutive high-risk patients with severe aortic stenosis according to treatment allocation to transcatheter aortic valve implantation (TAVI), surgical aortic valve replacement (SAVR) or medical treatment (MT). METHODS: Patients with severe aortic stenosis were consecutively enrolled into a prospective single centre registry. RESULTS: Among 442 patients (median age 83 years, median STS-score 4.7) allocated to MT (n=78), SAVR (n=107), or TAVI (n=257) all-cause mortality amounted to 81%, 37% and 43% after a median duration of follow-up of 3.9 years (p<0.001). Rates of major adverse cerebro-cardiovascular events were lower in patients undergoing SAVR or TAVI as compared with MT (SAVR vs MT: HR 0.31, 95% CI 0.21 to 0.46) (TAVI vs MT: HR 0.34, 95% CI 0.25 to 0.46), with no significant difference between SAVR and TAVI (HR 0.88, 95% CI 0.62 to 1.25). Whereas SAVR (HR 0.39, 95% CI 0.24 to 0.61), TAVI (HR 0.37, 95% CI 0.26 to 0.52), and female gender (HR 0.72, 95% CI 0.53 to 0.99) were associated with improved survival, body mass index ≤20 kg/m(2) (HR 1.60, 95% CI 1.04 to 2.47), diabetes (HR 1.48, 95% CI 1.03 to 2.12), peripheral vascular disease (HR 2.01, 95% CI 1.44 to 2.81), atrial fibrillation (HR 1.74, 95% CI 1.28 to 2.37) and pulmonary hypertension (HR 1.43, 95% CI 1.03 to 2.00) were identified as independent predictors of mortality. CONCLUSIONS: Among high-risk patients with severe aortic stenosis, long-term clinical outcome through 5 years was comparable between patients allocated to SAVR or TAVI. In contrast, patients with MT had a dismal prognosis.