Impact of bleeding after transcatheter aortic valve replacement in patients with chronic kidney disease.

OBJECTIVE: In patients with chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR), this study aims to elucidate (a) the bleeding risks associated with CKD, (b) the association between bleeding and subsequent mortality, and (c) the pattern of antithrombotic therapy prescribed. BACKGROUND: Patients with CKD have a higher risk of bleeding following TAVR. It is unclear whether this risk persists beyond the periprocedural period and whether it negatively impacts mortality. METHODS: A retrospective review was performed on patients who underwent TAVR at Massachusetts General Hospital from 2008 to 2017. CKD was defined as estimated glomerular filtration rate less than 60 ml/min/1.73 m2 . Primary endpoints up to 1-year following TAVR included bleeding, all-cause mortality, and ischemic stroke. Outcomes for patients with and without CKD were compared using log-rank test, and Cox regression with age, sex, and diabetes as covariates. Bleeding was treated as a time-varying covariate, and Cox proportional hazard regression was utilized to model mortality. RESULTS: Of the 773 patients analyzed, 466 (60.3%) had CKD. At 1 year, CKD patients had higher rates of bleeding (9.2 vs. 4.9%, adjusted hazard ratios [aHR] = 1.91, p = .032) and all-cause mortality (13.7 vs. 9.1%, aHR = 1.57, p = .049), but not stroke (3.9 vs. 1.6% aHR = 0.073, p = .094). Bleeding was associated with an increased risk of subsequent mortality (aHR = 2.65, 95% CI: 1.25-5.63, p = .01). There were no differences in the antithrombotic strategy following TAVR between CKD and non-CKD patients. CONCLUSION: CKD is associated with a higher risk of bleeding up to 1 year following TAVR. Long-term bleeding after TAVR is associated with increased subsequent mortality.

Temporal trends in patient referral for Transcatheter aortic valve replacement and reasons for exclusion at a high-volume Center in the United States.

BACKGROUND: Clinical indications for transcatheter aortic valve replacement (TAVR) and elements of the implantation procedure, including delivery system miniaturization and novel access options, have evolved over time. The reasons patients are excluded from TAVR also have changed. The impact of these changes on patient referral for and exclusion from TAVR is unknown. METHODS: We retrospectively analyzed patients referred to our center for TAVR from January 2010 to August 2016 to evaluate reasons for patient exclusion. Patients were divided into three groups based on initial screening date for trends in demographics and exclusion: Group 1, 2010-2012; Group 2, 2012-2014; Group 3, 2014 to August 1, 2016. Annual trends for patient exclusion from TAVR were assessed. RESULTS: One thousand nine hundred fifty-three patients were referred and underwent screening for TAVR. The rates at which patients were referred for TAVR were 23.8, 25.9, and 24.5 per month in groups 1, 2, and 3, respectively. Rate of patient exclusion from TAVR decreased from 68% in Group 1 to 38% in Group 3 (P < .001). The largest percentage of patients (29.4%) were initially excluded from TAVR for cardiac reasons, but this trend has decreased over time. Twenty-five percent are excluded for lack of procedural indication. Exclusion from TAVR for vascular access reasons decreased from 7.9% in 2010 to 1.0% in 2016 (P = .017). CONCLUSIONS: Referral numbers have been robust since TAVR became available. The percentage of patients excluded from TAVR has decreased over time. Patients are most commonly excluded from TAVR for concomitant coronary artery disease (CAD), asymptomatic severe AS, moderate AS, or non-cardiac critical illness. Patients with CAD and those with asymptomatic severe AS or moderate AS should be a focus for continued research in TAVR.

Outcome of implantation of a second self-expanding valve for the treatment of residual significant aortic regurgitation.

BACKGROUND: Residual aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is associated with adverse outcome. We sought to evaluate the efficacy and safety of second CoreValve (CV) implantation to treat residual AR following the initial CV deployment. METHODS AND RESULTS: TAVR patients treated with a second CV due to moderate and above residual AR were compared to single device implantation. Valvular function parameters were compared at baseline, post procedure, and 30 days. Among 172 CV TAVR patients, 11 required a second device (6%) due to significant residual AR. The main differences between the groups were higher rates of low ejection fraction in patients with 2 CV implanted and higher annular diameter (27 [29-25] vs. 25 [26-24] mm, P = 0.03), requiring a larger device. Although two patients in the two CV group had high initial implantation, low implantation was similar between the groups. A second CV achieved adequate reduction in residual AR in six patients (55%), while an additional four patients had moderate residual AR. Only one remained with moderate to severe AR after 30 days follow-up. There were no cases of peri-procedural stroke or mortality. CONCLUSIONS: Second implantation of self-expanding valve can successfully reduce residual significant AR following initial CV implantation and should be considered as therapeutic option for this population. © 2017 Wiley Periodicals, Inc.

Patient- and Process-Related Contributors to the Underuse of Aortic Valve Replacement and Subsequent Mortality in Ambulatory Patients With Severe Aortic Stenosis.

Background Many patients with severe aortic stenosis (AS) and an indication for aortic valve replacement (AVR) do not undergo treatment. The reasons for this have not been well studied in the transcatheter AVR era. We sought to determine how patient- and process-specific factors affected AVR use in patients with severe AS. Methods and Results We identified ambulatory patients from 2016 to 2018 demonstrating severe AS, defined by aortic valve area [Formula: see text]1.0 cm2. Propensity scoring analysis with inverse probability of treatment weighting was used to evaluate associations between predictors and the odds of undergoing AVR at 365 days and subsequent mortality at 730 days. Of 324 patients with an indication for AVR (79.3±9.7 years, 57.4% men), 140 patients (43.2%) did not undergo AVR. The odds of AVR were reduced in patients aged >90 years (odds ratio [OR], 0.24 [95% CI, 0.08-0.69]; P=0.01), greater comorbid conditions (OR, 0.88 per 1-point increase in Combined Comorbidity Index [95% CI, 0.79-0.97]; P=0.01), low-flow, low-gradient AS with preserved left ventricular ejection fraction (OR, 0.11 [95% CI, 0.06-0.21]), and low-gradient AS with reduced left ventricular ejection fraction (OR, 0.18 [95% CI, 0.08-0.40]) and were increased if the transthoracic echocardiogram ordering provider was a cardiologist (OR, 2.46 [95% CI, 1.38-4.38]). Patients who underwent AVR gained an average of 85.8 days of life (95% CI, 40.9-130.6) at 730 days. Conclusions The proportion of ambulatory patients with severe AS and an indication for AVR who do not receive AVR remains significant. Efforts are needed to maximize the recognition of severe AS, especially low-gradient subtypes, and to encourage patient referral to multidisciplinary heart valve teams.

Intraprocedural invasive hemodynamic parameters as predictors of short- and long-term outcomes in patients undergoing transcatheter aortic valve replacement.

OBJECTIVE: Evaluation of invasive hemodynamic parameters as prognostic markers of mortality in patients undergoing TAVR. BACKGROUND: The value of invasive intraprocedural hemodynamic evaluation of patients undergoing transcatheter aortic valve replacement is unclear. METHODS: Consecutive patients who underwent transfemoral TAVR and had complete prospectively collected intraprocedural invasive hemodynamic parameters were retrospectively analyzed. Patients with alternative access, planned general anesthesia, or baseline ≥moderate Tricuspid Regurgitation were excluded. Pre- and post-valve implant parameters included heart rate, systolic and diastolic blood pressures, cardiac output and index, pulmonary arterial systolic and diastolic pressures, transaortic pressure gradient and right atrial pressure. The primary end points were the association of the intraprocedural hemodynamic changes with all-cause mortality at 30days and 1year. Extensive Receiver Operating Characteristic analyses yielded dichotomized threshold of hemodynamic values in association with the binary outcome of mortality. RESULTS: A total of 312 patients (52% male, mean age 83years) were evaluated. A significant association with 30-day and 1-year mortality was found between intraprocedural post-valve implant cardiac index <1.9 vs. ≥1.9L/min/m2 (Log-ranked p=0.0286 and p=0.0432, respectively). Four subgroups with pre- and post-valve implant CI changes (L/min/m2) were compared: [1] pre<1.9, stable_post<1.9; [2] pre<1.9, improved_post≥1.9; [3] pre≥1.9, stable_post≥1.9; and [4] pre≥1.9, worsened_post<1.9. Group 1 (lower CI with no post-valve improvement) had the worst survival, and Group 3 (higher CI and stable post-valve) had the best survival at 1-year follow-up (Log-ranked p=0.0089). CONCLUSIONS: In patients with severe aortic stenosis undergoing TAVR, invasive monitoring can assess for hemodynamic prognostic markers of survival.

Management and Outcome of Residual Aortic Regurgitation After Transcatheter Aortic Valve Implantation.

We aimed to evaluate the success rates of balloon valvuloplasty post-dilation (BVPD) and a second-valve deployment in reducing residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and its impact on outcome. Residual AR immediately post-TAVI in patients with aortic stenosis is a common condition that adversely affects outcome. Patients who underwent TAVI who had more-than-mild residual AR were managed either with medical therapy, re-intervention with BVPD, or a second valve. The clinical impact of these strategies was evaluated, and the anatomical features of patients with successful and unsuccessful intervention were compared. Among 572 patients with TAVI, 110 (19%) had significant residual AR after initial device deployment. Sixty patients were treated by BVPD (n = 49) or second-device deployment (n = 11), whereas 50 patients were treated medically. Successful reduction in residual AR to mild and below was achieved in 56% of the intervention group. Eccentric and calcified annuli were present in patients in whom residual AR remained despite re-intervention (p = 0.004). Interventions to reduce residual AR were independently associated with improved survival compared with conservative medical therapy (hazard ratio 0.45, 95% confidence interval 0.94 to 0.21, p = 0.03). BVPD or a second valve were safe and were not associated with increased rate of periprocedural complications. In conclusion, both BVPD and a second-valve deployment to reduce residual AR post-TAVI are effective and safe. The success rates are inversely correlated with the annulus eccentricity and calcification. These measures should be encouraged to reduce acute residual AR as they are associated with improved long-term survival.

Impact of restrictive versus obstructive pulmonary function patterns on mortality in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Pulmonary function tests to estimate force vital capacity (FVC) and forced expiratory volume in the first second (FEV1) have increasingly been used in patients evaluated for transcatheter aortic valve implantation (TAVI). The impact of obstructive versus restrictive lung disease on mortality remains unclear. The authors sought to identify differences in survival in patients with 2 distinct pulmonary function patterns (obstruction vs. restriction). METHODS: The authors retrospectively analyzed all patients with abnormal FEV1 (lower than 80% of predicted) detected on the pulmonary function tests prior to TAVI from May 2011 to November 2014. Patients were divided into a group with obstructive pattern (FEV1/FVC<70% of predicted) and a group with restrictive pattern (FEV1/FVC>70% of predicted). Cox proportional hazards regression was used to explore the impact of FEV1 on mortality. RESULTS: A total of 94 patients were included in this analysis. Forty-one percent (n=38) had obstructive pattern, and 59% (n=56) had restrictive pattern. FEV1 values were similar between both groups (43±19 vs. 42±26, p=0.89). Both groups had similar rates of in-hospital, 30-day, and 1-year mortality. FEV1 was not a correlate for 1-year mortality. Patients with pulmonary obstructive and restrictive patters had similar rates of mortality. Moreover, FEV1 value is not a correlate for 1-year mortality. CONCLUSION: In the current era, the pattern on pulmonary function tests and FEV1 values should not influence the decision on whom to offer a transcatheter option for their severe valvular disease.