Intractable coronary fibromuscular dysplasia leading to end-stage heart failure and fatal heart transplantation.

Coronary fibromuscular dysplasia is uncommon, and even rarer its unstable and recurrent course. We present the unique case of a 52-year-old woman who underwent in total 12 coronary angiographies and three percutaneous coronary intervention within 24 months because of repetitive acute coronary syndromes due to refractory spasm, dissection, restenosis all leading to end-stage heart failure, and heart transplantation. The patient died 12 days after the heart transplantation complicated by intraoperative acute thrombotic occlusion of left anterior descending artery of the graft despite normal pretransplant coronary angiography. Autopsy of the recipient heart confirmed coronary fibromuscular dysplasia with massive intimal hyperplasia and restenosis.

Rivaroxaban in patients with mechanical heart valves: A pilot study.

BACKGROUND: Patients with mechanical heart valves are still not eligible for treatment with direct oral anticoagulants (DOAC). We aimed to conduct a proof-of-principle study investigating the anti-Xa inhibitor rivaroxaban as antithrombotic treatment in patients with recent mechanical aortic valve replacement. MATERIALS AND METHODS: Low-risk patients scheduled for elective mechanical aortic valve replacement were treated with rivaroxaban 20 mg once daily (OD) in a prospective cohort study, started on day 3 postoperatively and given for 6 months. The study was registered at ClinicalTrials.gov (#NCT02128841). RESULTS: Ten patients were included (median age, 48; range 39 to 60). Indication was aortic valve stenosis in 6 patients, aortic root aneurysm with severe aortic valve regurgitation in 3 patients, and mixed stenosis/regurgitation in 1 patient. Neither thromboembolic nor bleeding events were observed, and no patient died. Absence of valve thrombosis was demonstrated in all patients. On day 7, median D-dimers were 2723 µg/L (inter-quartile range [IQR] 1672, 5695 µg/L), median TAT levels were 4.5 µg/L (IQR 4.1, 5.6 µg/L); and median peak thrombin generation was 150 nM (IQR 91, 183). On day 90, median D-dimers were 426 µg/L (IQR 278, 569), median TAT levels were 2.7 µg/L (IQR 2.2, 3.1), and median peak thrombin generation were 66 nM (IQR 62, 87). CONCLUSIONS: Rivaroxaban 20 mg OD was safe and effective in a pilot study of 10 low risk patients with mechanical aortic heart valve. Our results justify larger studies investigating the application of anti-Xa inhibitors in patients with mechanical heart valves.

Clinical outcomes in high-risk patients with a severe aortic stenosis: a seven-year follow-up analysis.

INTRODUCTION: The aim of this study was to assess the clinical outcomes of high-risk patients with severe aortic stenosis (AS) allocated to medical treatment (MT), transcatheter aortic valve replacement (TAVR), and surgical aortic valve replacement (SAVR) through extended follow-up. METHODS AND RESULTS: Consecutive patients with severe symptomatic AS included in a prospective single centre registry underwent sweep follow-up between March and August 2016. Clinical outcomes were assessed using a competing risk model. A total of 442 patients (median age 83 years; 52% female) were allocated to MT (n = 78), SAVR (n = 107), or TAVR (n = 257) with a gradient of surgical risk as assessed by logistic EuroSCORE (MT: 27.9 ± 14.5%, TAVR: 24.7 ± 24.9%, SAVR: 12.5 ± 8.2%; p <0.001). Survival after a median duration of follow-up of seven years was 6.4% (MT), 30.4% (TAVR), and 46.7% (SAVR), respectively (p <0.001). One TAVR and one SAVR patient underwent repeat intervention for valvular degeneration between 4.5 and 8.4 years after intervention. Compromised left ventricular function (LVEF <40%) was associated with increased mortality (HR 1.62, 95% CI 1.22–2.15; p <0.0001), whereas female sex was protective (HR 0.68, 95% CI 0.53–0.88; p = 0.0006). CONCLUSION: Both TAVR and SAVR reduced mortality compared to MT throughout a median duration of follow-up of seven years. Repeat interventions for valvular degeneration were rare.

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. METHODS: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). RESULTS: Among 628 patients (mean age 82.4 ±â€¯5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. CONCLUSIONS: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Impact of valvular resistance on aortic regurgitation after transcatheter aortic valve replacement according to the type of prosthesis.

BACKGROUND: The impact of aortic valvular resistance (VR) on the degree of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR) remains unclear. The objective of the study was to investigate the relationship between VR and paravalvular AR after TAVR. METHODS: Between August 2007 and December 2015, 708 TAVR patients had sufficient data to calculate VR before the intervention and were eligible for the present analysis. The patient population was dichotomized according to VR. The association between VR and post-TAVR AR was separately assessed by prosthesis type. RESULTS: Among patients with low VR (LVR; < 238 dynes/cm5), 176 (49.7%) patients were treated with balloon-expandable (BE) valves and 178 (51.3%) patients with self-expandable (SE) transcatheter valves. Among patients with high VR (HVR ≥ 238), 147 (41.5%) and 207 (68.5%) patients received BE and SE, respectively. Baseline characteristics were similar in both groups irrespective of the type of valve. Patients with HVR had a 2.5-fold risk of ≥ moderate post-TAVR AR compared to patients with LVR. Both, HVR (HRadj 2.45, 95% CI 1.33-4.51) and the use of SE (HRadj 3.11, 95% CI 1.66-5.82), emerged as independent predictors of ≥ moderate post-TAVR AR. Moderate or greater post-AR was consistently predicted in patients treated with SE (HRadj 2.42, 95% CI 1.22-4.80) irrespective of the level of VR. CONCLUSIONS: HVR is associated with a nearly 2.5-fold increased risk of moderate or greater post-TAVR AR and is an independent predictor of post-TAVR AR.

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.

Transcatheter aortic valve replacement in patients with concomitant mitral stenosis.

AIMS: Multivalvular disease is of increasing concern in elderly patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present analysis was to investigate the impact of concomitant mitral stenosis (MS) on clinical outcomes in patients undergoing TAVR for severe, symptomatic aortic stenosis (AS). METHODS AND RESULTS: Among 1339 patients undergoing TAVR between August 2007 and December 2015, adequate echocardiographic data for the assessment of severity and aetiology of MS was available in 971 (72.5%) patients. Patients were stratified according to degree and aetiology of concomitant MS. Mitral stenosis was documented in 176 (18.1%) TAVR patients (mean mitral valve area 1.9 ± 0.4 cm2) and considered degenerative in 110 (62.5%) and rheumatic in 66 (37.5%) patients, respectively. Mitral stenosis was categorized as moderate/severe in 28 patients (2.9%). Baseline characteristics were comparable between patients with vs. without MS. At 1 year, patients with MS were at increased risk of cardiovascular death [36 (21.4%) vs. 66 (8.7%); adjusted hazard ratio (HRadj) 3.64, 95% confidence interval (CI) 2.38-5.56] and disabling stroke [12 (7.1%) vs. 23 (3.0%); HRadj 2.98, 95% CI 1.46-6.09] as compared to patients without MS. Differences in cardiovascular death and disabling stroke emerged within 30 days of the index procedure and were largely driven by a difference in patients with rheumatic MS [cardiovascular death: 7 (10.6%) vs. 24 (3.2%), HRadj 4.80, 95% CI 1.98-11.6; disabling stroke: 4 (6.1%) vs. 16 (2.0%), HRadj 4.18, 95% CI 1.34-13.0]. CONCLUSION: Concomitant MS was documented in approximately one-fifth of patients undergoing TAVR for severe, symptomatic AS and associated with a three-fold increased risk of cardiovascular adverse events at 1 year. The difference emerged early and was largely driven by patients with rheumatic MS.

Prognostic Value of Right Ventricular Dysfunction on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of this study was to investigate the association between right ventricular dysfunction (RVD) and cardiovascular death after transcatheter aortic valve replacement (TAVR). BACKGROUND: There is conflicting evidence on the effect of RVD on clinical outcomes after TAVR. METHODS: A total of 1,116 TAVR patients (age 82 ± 6 years; 51% female) who were consecutively enrolled into a prospective registry underwent detailed pre-operative assessment of right ventricular (RV) function and were dichotomized into 2 groups for the purposes of the present retrospective analysis. RVD was assessed using fractional area change (<35%), tricuspid annular plane systolic excursion (<1.7 cm), and systolic movement of the RV lateral wall by tissue Doppler imaging (<9.5 cm/s). RVD was found in 325 (29.1%) patients. The primary outcome was cardiovascular death at 1 year. RESULTS: After adjustment for comorbidities, patients with RVD had a higher risk of cardiovascular death at 1 year compared with patients with normal RV function (20.1% vs. 7.1%; adjusted hazard ratio [HRadj]: 2.94; 95% confidence interval [CI]: 2.02 to 4.27; p < 0.001). The difference emerged within the first 30 days after TAVR (9.0% vs. 2.2%; HRadj: 4.62; 95% CI: 2.51 to 8.50; p < 0.001). Normalization of RV function after TAVR was found in 57.4% of patients with RVD at baseline. There was a gradient of increasing risk of cardiovascular death among patients with normal RV function, RVD recovery (HRadj: 2.16; 95% CI: 1.16 to 4.02), new RVD (HRadj: 3.93; 95% CI: 2.09 to 7.39), and maintained RVD (HRadj: 8.74; 95% CI: 5.33 to 14.3), respectively. CONCLUSIONS: RVD at baseline was associated with a more than 2-fold increased risk of cardiovascular death at 1 year after TAVR, with a gradient of risk according to RVD recovery. (Swiss TAVI Registry; NCT01368250).

The Impact of Left Ventricular Diastolic Dysfunction on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to determine the impact of left ventricular diastolic dysfunction (LVDD) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Left ventricular (LV) hypertrophy in response to afterload increase promotes the development of LVDD and represents an early stage in the progression to valvular heart failure. METHODS: In a consecutive cohort of 777 aortic stenosis patients undergoing TAVR, LVDD was categorized according to the latest guidelines. The primary endpoint was 1-year all-cause mortality. RESULTS: There were 545 (70.1%) patients with LVDD. Ninety-eight (18.0%), 198 (36.3%), and 104 (19.1%) patients were classified as LVDD grades I, II, and III, respectively. In 145 (26.6%) patients, LVDD grade could not be determined because of only 1 or 2 discrepant variables. One-year all-cause mortality was higher in patients with LVDD grades I (16.3%; adjusted hazard ratio [HR]adj: 2.32; 95% confidence interval [CI]: 1.15 to 4.66), II (17.9%; HRadj: 2.58; 95% CI: 1.43 to 4.67), and III (27.6%; HRadj: 4.21; 95% CI: 2.25 to 7.86) than in those with normal diastolic function (6.9%). The difference in clinical outcome emerged within 30 days, was driven by cardiovascular death, and maintained in a sensitivity analysis of patients with normal systolic LV function. Furthermore, LVDD grades I (HRadj: 2.36; 95% CI: 1.17 to 4.74), II (HRadj: 2.58; 95% CI: 1.42 to 4.66), and III (HRadj: 4.41; 95% CI: 2.37 to 8.20) were independent predictors of 1-year mortality. CONCLUSIONS: Advancing stages of LVDD are associated with an incremental risk of all-cause mortality after TAVR, driven by cardiovascular death and taking effect as early as 30 days after the intervention.

Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis.

Aim: Contemporary data comparing early versus newer generation transcatheter heart valve (THV) devices in routine clinical practice are lacking. We sought to compare the safety and efficacy of early versus newer generation THVs in unselected patients undergoing transcatheter aortic valve implantation (TAVI). Methods and results: We performed a propensity score matched analysis of patients undergoing transfemoral TAVI at a single centre with early versus newer generation devices between 2007 and 2016. Patients were matched for balloon-expandable versus self-expandable valves and Society of Thoracic Surgeons score. The primary end point was the Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 days. Among the 391 matched pairs, no differences between early (21.2%) and newer generation (20.8%) THVs regarding the early safety composite end point (HR 0.98, 95% CI 0.72 to 1.33, P=0.88) were observed. The rates of valve embolisation (0.8% vs 4.2%, P=0.005), bleeding events (24.8% vs 32.0%, P=0.028) and moderate-to-severe paravalvular regurgitation (PVR) (3.1% vs 12.1%, P<0.001) were lower among patients receiving newer generation devices. Conversely, patients treated with early generation THVs less frequently experienced annulus rupture (0% vs 2.0%, P=0.008). Conclusion: Newer compared with early generation THV devices were associated with a lower rate of valve embolisation, PVR and bleeding events.

Early Detection of Subclinical Myocardial Damage in Chronic Aortic Regurgitation and Strategies for Timely Treatment of Asymptomatic Patients.

A series of hemodynamic and pathological responses occur in chronic aortic regurgitation, which eventually result in myocardial fibrosis and irreversible left ventricular dysfunction. According to guidelines, valvular surgery is recommended with the development of symptoms, left ventricular systolic dysfunction, or left ventricular dilatation. The optimal timing of surgical intervention has recently been questioned with documentation of irreversible myocardial damage resulting in incomplete left ventricular recovery and adverse clinical outcomes after surgery. Recognizing the shortcomings of the guidelines, we performed a comprehensive review on the novel diagnostic methods that have been shown to improve the detection of subclinical ventricular dysfunction in chronic aortic regurgitation and to improve prediction of outcomes.

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.

Adding vancomycin to perioperative prophylaxis decreases deep sternal wound infections in high-risk cardiac surgery patients.

OBJECTIVES: Perioperative prophylaxis with cephalosporins reduces sternal wound infections (SWIs) after cardiac surgery. However, more than 50% of coagulase-negative staphylococci, an important pathogen, are cephalosporin resistant. The aim of this study was to determine the impact of adjunctive vancomycin on SWIs in high-risk patients. METHODS: We conducted a pre- and postintervention study in an academic hospital. Preintervention (2010-2011), all patients received prophylaxis with 1.5 g of cefuroxime for 48 h. During the intervention period (2012-2013), high-risk patients additionally received 1 g of vancomycin. High-risk status was defined as body mass index ≤18 or ≥ 30 kg/m2, reoperation, renal failure, diabetes mellitus, chronic obstructive pulmonary disease or immunosuppressive medication. Time series analysis was performed to study SWI trends and logistic regression to determine the effect of adding vancomycin adjusting for high-risk status. RESULTS: A total of 3902 consecutive patients (n = 1915 preintervention and n = 1987 postintervention) were included, of which 1493 (38%) patients were high-risk patients. In the high-risk group, 61 of 711 (8.6%) patients had SWI before and 30 of 782 (3.8%) patients after the intervention. Focusing on deep SWI (DSWI), 33 of 711 (4.6%) patients had DSWI before and 13 of 782 (1.7%) patients afterwards; the absolute risk difference of 2.9% yielded a number-needed-to-treat of 34 to prevent 1 DSWI. Corrected for high-risk status, adding vancomycin significantly reduced the overall SWI rate (odds ratio 0.42, 95% confidence interval 0.26-0.67; P < 0.001) and the subset of DSWI (odds ratio 0.30, 95% confidence interval 0.14-0.62; P = 0.001). The rate of SWI in low-risk patients remained unchanged. CONCLUSIONS: Adding vancomycin to standard antibiotic prophylaxis in high-risk patients significantly reduced DSWI after cardiac surgery.

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.

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.

Prognostic impact of invasive haemodynamic measurements in combination with clinical and echocardiographic characteristics on two-year clinical outcomes of patients undergoing transcatheter aortic valve implantation.

AIMS: The aim of the study was to evaluate the prognostic utility of right heart catheterisation (RHC)-derived measures among patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Data of 469 patients included in the Bern TAVI Registry between August 2007 and December 2012 and undergoing preoperative RHC were analysed. The relationship between haemodynamic parameters and survival was evaluated with Cox proportional hazards models. At two-year follow-up, 118 patients had died (25.1%). At multivariable analysis, diabetes (hazard ratio [HR] 1.95, 95% confidence interval [CI]: 1.28-2.96, p=0.001), transapical access (HR 1.66, 95% CI: 1.07-2.56, p=0.02), and moderate or severe mitral regurgitation (HR 1.55, 95% CI: 1.00-2.39, p=0.04) were independent predictors of two-year mortality, whereas no correlation between RHC-derived measures and mortality was found. Furthermore, the addition of haemodynamic variables did not significantly improve the prognostic power of a model incorporating clinical and echocardiographic data (Harrell's C-index: 0.667, 95% CI: 0.615-0.719 vs. 0.662, 95% CI: 0.612-0.713, p=0.47). CONCLUSIONS: On the basis of a comprehensive clinical and echocardiographic evaluation, RHC performed prior to TAVI does not add incremental prognostic value.

The impact of functional vs degenerative mitral regurgitation on clinical outcomes among patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Among patients undergoing transcatheter aortic valve implantation (TAVI), concomitant mitral regurgitation (MR) has been associated with adverse prognosis. We aimed to assess long-term clinical outcomes according to MR etiology. METHODS: In a single-center registry of consecutive patients undergoing TAVI, we investigated the impact of functional (FMR) vs degenerative (DMR) MR on cardiovascular (CV) mortality throughout 2years of follow-up. RESULTS: Among 603 patients (mean age 82.4±5.7years, 55% female) undergoing TAVI, 149 patients had moderate or severe MR (24.7%). Functional MR and DMR were documented in 53 (36%) and 96 (64%) patients, respectively. At 2years, patients with FMR and DMR had higher rates of CV mortality (30.2% vs 32.4%) as compared with patients with no MR (14.6%; FMR vs no MR: hazard ratio [HR] 2.32, 95% CI 1.34-4.02, P=.003; DMR vs no MR: HR 2.56, 95% CI 1.66-3.96, P<.001). In adjusted analyses, DMR was associated with an increased risk of CV mortality throughout the 2-year follow-up (adjusted HR 2.21, 95% CI 1.4-3.49, P=.001) as compared with FMR (adjusted HR 1.13, 95% CI 0.59-2.18, P=.707). Relevant MR was postprocedurally significantly reduced in both the DMR and FMR groups, whereas improvement of a decreased left ventricular ejection fraction was predominantly seen in the FMR group as compared with baseline. CONCLUSION: Patients with severe, symptomatic aortic stenosis undergoing TAVI complicated by moderate or severe MR portend impaired prognosis. Particularly, patients with DMR are at increased risk for CV mortality during long-term follow-up.