The Carpentier-Edwards pericardial valve was designed to minimize structural valve deterioration. Excellent durability and low incidence of valve-related complications have been reported. The ...objective of the present study was to analyze clinical results after 25 years of experience with this valve implanted in the aortic position. The effect of patient age at the time of surgery was also evaluated.
This is a retrospective cohort study of 2,405 patients from November 1981 to March 2011. Primary outcomes of interest were survival and freedom from major adverse effects such as thromboembolic, endocarditis, and reoperation.
Sixty percent were male, with a mean age of 71 ± 9 years old. Actuarial survival rates including early deaths averaged 78% ± 2%, 55% ± 2%, and 16 % ± 2% after 5, 10, and 20 years of follow-up, respectively. The freedom rate of valve reoperation for prosthesis dysfunction and all other causes averaged 98 % ± 0.2%, 96% ± 1%, and 67% ± 4% at 5, 10, and 20 years. Patients younger than 60 years of age had a 15-year survival averaging 54% ± 5% compared with patients aged between 60 and 70 years of age averaging 46% ± 3% and with patients older than 70 years of age averaging 28% ± 3% (p = 0.001). Survival at 5, 10, and 20 years for patients who had concomitant CABG coronary artery bypass grafting were 78% ± 1%, 55% ± 2%, and 9% ± 3% compared with no concomitant CABG (84% ± 1%, 62% ± 2%, and 22% ± 3% (p < 0.001)).
Carpentier-Edwards pericardial valve implantation in the aortic position is secure and durable. The effects of age influence reoperation rate and survival as well as a concomitant coronary artery bypass procedure.
The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in ...improved kidney function by alleviating cardiorenal syndrome.
The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality.
Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed.
At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival.
In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR.
Display omitted
This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age ...groups.
Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail.
The study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis.
These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001).
This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.
Display omitted
Abstract Background Neutrophil-lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) mark systemic inflammation. Patients with high NLR and PLR have worse cardiovascular disease and outcomes. We ...assessed the role of these ratios in predicting outcomes after transcatheter aortic valve replacement (TAVR). Methods The association between NLR and PLR with baseline characteristics, 30-day outcomes, and 1-year readmission/survival was determined in patients that underwent TAVR between 2007 and 2014 and had baseline complete blood count with differential. A subgroup analysis determined the association between change in NLR and PLR (discharge-baseline) and 1-year outcomes. Results In 520 patients that underwent TAVR, a higher NLR (p = 0.01) and PLR (p = 0.02) were associated with a higher STS-PROM score, and with increased occurrence of the 30-day early-safety outcome (by VARC-2), even after adjusting for STS-PROM score, valve generation (Sapien vs. Sapien XT), and access (transfemoral vs. non-transfemoral) (NLR: OR 1.29, 95% CI 1.04–1.61; PLR: OR 1.27, 95% CI 1.01–1.60) but not with 1-year readmission or survival. In our subgroup analysis (N = 294), change in PLR was not associated with the 1-year outcomes but a high change in NLR was associated with worse 1-year survival/readmission and 1-year survival, even after adjusting for STS-PROM score, valve generation and access (HR 1.22, 95% CI 1.04–1.44 and HR 1.26, 95% CI 0.99–1.6, respectively). Conclusions NLR and PLR correlate with surgical risk. An elevated NLR and PLR were associated with the occurrence of 30-day adverse outcomes, similar to the STS-PROM score. A high variation of NLR from baseline to discharge may help stratify patients that underwent TAVR in addition to traditional risk factors.
Although preoperative renal dysfunction (RD) is associated with increased mortality and morbidity after surgical aortic valve replacement, its impact on clinical outcomes after transcatheter aortic ...valve replacement (TAVR) is less defined.
TAVR patients in the PARTNER (Placement of Aortic Transcatheter Valves) trial with a calculable glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation were included. Patients were divided into three groups: GFR >60 mL/min (none/mild RD), GFR 31 to 60 mL/min (moderate RD), and GFR ≤30 mL/min (severe RD). Operative characteristics and clinical outcomes were analyzed. Cox regression models were used to determine multivariable predictors of 1-year all-cause mortality.
A total of 2,531 inoperable or high surgical risk patients from the PARTNER trial and continued access registries had a calculable GFR level: 767 (30%) had normal renal function or mild RD, 1,473 (58%) had moderate RD, and 291 (12%) presented with severe RD. The mean Society of Thoracic Surgeons Predicted Risk of Mortality for the cohort was 11.5%, and it was highest in those with severe RD (13.8%). Patients with severe RD were more often women with a higher prevalence of diabetes. Patients with severe RD had the highest incidence of 30-day and 1-year all-cause mortality and rehospitalization. The 30-day rate of death from any cause was 10.7% in the severe RD group versus 6.0% in the moderate and mild RD groups (p = 0.01). The 1-year rate of death from any cause was 34.4% in the severe RD group versus 21.5% in the moderate RD and 20.8% in the none/mild RD groups (adjusted hazard ratio HR 2.24, p < 0.0001 for severe versus none/mild; adjusted HR 1.14, p = 0.24 for severe versus moderate). Other significant predictors of 1-year all-cause mortality included lower body mass index, frailty, the transapical approach, a lower ejection fraction, oxygen-dependent chronic obstructive pulmonary disease, liver disease, and male sex.
Preoperative severe RD is a significant predictor for 1-year mortality in TAVR patients. Careful risk stratification by the heart team is required in patients with severe preprocedural RD.
Abstract Objectives Sutureless aortic valves are deemed suitable for patients considered at high risk for surgery. The objective of this study is to evaluate the perioperative results of implanting a ...sutureless valve in elderly persons, compared with a stented biological valve in the aortic position. Methods Between 2011 and 2015, 76 patients underwent aortic valve replacement with the Perceval prosthesis (Sorin Group, Saluggia, Italy). The group was compared with 319 consecutive patients who received aortic valve replacement with the stented valve in that same period. Results The mean age of patients was 83 ± 2 years in the Perceval group and 83 ± 3 years in the stented valve group ( P = .3). Preoperative demographics were similar in both groups. Median cardiopulmonary bypass and crossclamp times were lower in the Perceval group than in the stented valve group ( P < .001). Mortality was 5% in the Perceval group and 6% in the stented valve group ( P = .8). There were more pacemaker implantations in the Perceval group than in the stented valve group (17% vs 8%; P = .02). A subgroup analysis of patients who underwent aortic valve replacement and concomitant procedures showed the same results as the entire cohort. Conclusions Aortic valve replacement with a sutureless prosthesis resulted in shorter aortic crossclamp and bypass times compared with a stented biological prosthesis. The reduced cardiopulmonary bypass and aortic crossclamp times obtained using the Perceval prosthesis did not translate into perioperative gains in our population of elderly patients.
With improved durability of contemporary bioprostheses, surgeons are now recommending biologic valves in younger patients. However, long-term outcomes of patients younger than 60 years old undergoing ...biologic aortic valve implantation are not well known.
From November 1991 to March 2011, 144 patients less than 60 years old underwent aortic valve replacement (AVR) with Carpentier-Edwards pericardial valves (Edwards Lifesciences, Irvine, CA). Mean follow-up was 10±4 years. Outcomes were reported according to published guidelines.
Seventy-five percent of patients were male, with a mean age of 51±9 years. Actuarial survival rates including early deaths were 89%±3%, 79%±4%, and 57%±6% after 5, 10, and 15 years of follow-up, respectively. Survival of patients was comparatively lower than a gender- and age-matched general population at all time points. The freedom from major adverse cardiac events (myocardial infarction, heart failure, hemorrhage, thromboembolic event, and endocarditis) was 89%±3%, 87%±3%, and 75%±6% at 5, 10, and 15 years after surgery. The freedom rate from prosthetic valve dysfunction was 97%±2%, 84%±4%, and 57%±6% at 5, 10, and 15 years after surgery. Patients with a diagnosis of structural valve deterioration (29 of 37, 78%) underwent reoperation 11±5 years after the initial valve replacement with no perioperative mortality.
In patients younger than 60 years undergoing AVR, the Carpentier-Edwards Perimount bioprosthesis provided satisfactory clinical outcomes. However, late survival was inferior to an age- and gender-matched population. Structural valve deterioration and the need for reintervention were common late after implantation, but reoperation for prosthetic valve dysfunction was associated with a very low risk of mortality.
The effect of frailty on outcomes after transcatheter aortic valve replacement (TAVR) remains incompletely understood. The objective of this study was to evaluate the performance of four commonly ...used frailty markers as predictors of early and late outcomes among patients undergoing TAVR.
A review was performed of 361 high- and extreme-risk patients undergoing TAVR from 2011 to 2015. Four frailty variables were assessed: serum albumin (g/dL), 5-m walk (seconds), grip strength (kg), and Katz index of independence in activities of daily living. Logistic regression was used to examine the association between the frailty indicators and 30-day composite of mortality, stroke, new heart block requiring permanent pacemaker, major or life-threatening bleeding, acute renal failure, major vascular complication, and 30-day readmission rate. Minimum distance to the perfect point (0, 1) was performed to delineate a cutoff point for each frailty indicator, and risk models were compared using receiver-operating characteristics curves.
The composite of outcomes occurred in 28% of patients. Serum albumin, activities of daily living, and 5-m walk were independent predictors for 30-day composite outcomes, but only albumin was predictive of 30-day mortality. A new frailty model (four frailty indicators, age, and sex) to predict 30-day mortality was created and compared with The Society of Thoracic Surgeons predicted risk of mortality. Better discrimination was found with the new frailty model (area under the curve 0.74 versus 0.58). New individual frailty variable cutoff values were found to predict our composite of events.
Among high- and extreme-risk patients undergoing TAVR, our new frailty model was more discriminative of 30-day mortality than The Society of Thoracic Surgeons predicted risk of mortality. New cutoff values for frailty indicators were identified and will require further validation.
Data is controversial regarding the existence of an “obesity paradox” in patients undergoing Transcatheter Aortic Valve Replacement (TAVR). We sought to investigate the prognostic value of the body ...mass index (BMI) on outcomes following TAVR.
This is an observational, single-center study involving all patients who underwent TAVR from 2009 to 2019. BMI was calculated in all patients before TAVR. The cohort was subdivided into four groups: underweight (<20 kg/m2), normal weight (≥20 to <25 kg/m2), overweight (≥25 to <30 kg/m2) and obese (≥30 kg/m2). The main endpoint was all-cause 30-day and one-year mortality.
A total of 412 patients (mean age 79.6 ± 7.8 years, mean STS score 5.3 ± 3.6) were included. Patients were grouped as follows: underweight (n = 35, 8.5%), normal weight (n = 121, 29.4%), overweight (n = 140, 34%) and obese (n = 116, 28.1%). Obese patients were younger, included more females and had lower STS score than the rest of the cohort whereas underweight patients were older, had higher STS score, more chronic kidney disease, more left ventricular dysfunction and more often underwent non-transfemoral TAVR. BMI predicted 30-day survival (AUC:0.692 95%CI 0.522–0.862; p = 0.030) with an optimal cut-off of 24.4 (sensitivity = 66.6%, specificity = 63.6%). On multivariate analysis, higher BMI trended toward lower 30-day mortality (HR = 0.87 95%CI 0.75–1.01; p = 0.071).
Thirty-day mortality was higher in the underweight group (8.3%) in comparison with other BMI subgroups (normal weight 2.5%, overweight 1.4%, obese 0.9%; p = 0.045). However, no significant difference was found after adjustment of confounders (all p = NS). BMI did not predict one-year mortality. No significant difference in one-year survival was observed between the four BMI subgroups (log rank p = 0.925).
BMI could represent an interesting prognostic tool for short-term mortality in patients undergoing TAVR. BMI < 20 kg/m2 was associated with higher 30-day mortality. Symptoms improved similarly in obese patients compared to lower BMI patients. For 30-day survivors, no evidence of the existence of an obesity paradox was observed in this cohort.
PDF
