Abstract Objectives This study sought to examine whether imaging of the atrioventricular (AV) membranous septum (MS) by computed tomography (CT) can be used to identify patient-specific anatomic risk ...of high-degree AV block and permanent pacemaker (PPM) implantation before transcatheter aortic valve implantation (TAVI) with self-expandable valves. Background MS length represents an anatomic surrogate of the distance between the aortic annulus and the bundle of His and may therefore be inversely related to the risk of conduction system abnormalities after TAVI. Methods Seventy-three consecutive patients with severe aortic stenosis underwent contrast-enhanced CT before TAVI. The aortic annulus, aortic valve, and AV junction were assessed, and MS length was measured in the coronal view. Results In 13 patients (18%), high-degree AV block developed, and 21 patients (29%) received a PPM. Multivariable logistic regression analysis revealed MS length as the most powerful pre -procedural independent predictor of high-degree AV block (odds ratio OR: 1.35, 95% confidence interval CI: 1.1 to 1.7, p = 0.01) and PPM implantation (OR: 1.43, 95% CI: 1.1 to 1.8, p = 0.002). When taking into account pre- and post -procedural parameters, the difference between MS length and implantation depth emerged as the most powerful independent predictor of high-degree AV block (OR: 1.4, 95% CI: 1.2 to 1.7, p < 0.001), whereas the difference between MS length and implantation depth and calcification in the basal septum were the most powerful independent predictors of PPM implantation (OR: 1.39, 95% CI: 1.2 to 1.7, p < 0.001 and OR: 4.9, 95% CI: 1.2 to 20.5, p = 0.03; respectively). Conclusions Short MS, insufficient difference between MS length and implantation depth, and the presence of calcification in the basal septum, factors that may all facilitate mechanical compression of the conduction tissue by the implanted valve, predict conduction abnormalities after TAVI with self-expandable valves. CT assessment of membranous septal anatomy provides unique pre-procedural information about the patient-specific propensity for the risk of AV block.
Abstract Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR ...prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients undergoing TAVR distinguished by renal function. Baseline characteristics, procedural data and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel and Japan. Data was analyzed according to renal function. Patients (n=1204) were divided into 4 groups according to pre-TAVR estimated glomerular filtration rate (eGFR): group I (eGFR >60) n=288 (female 45%), group II (eGFR 31-60) n=452 (female 61%), group III (eGFR ≤30) n=398 (female 61%) and group IV (dialysis) n=66 (female 31%). Mean Society of Thoracic Surgeons (STS) score was higher in patients with lower pre-procedural eGFR. All-cause mortality at 1-year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, 24.2% for group I, II, III and IV; respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31-60, was associated with increased risk of death (OR 3), bleeding (OR 5.2) and device implantation failure (HR 2.28). For each 10-mL/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p<0.001), cardiovascular death (14%; p=0.018), major bleeding 35% (p<0.001), and transcatheter valve failure (16%; p=0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion among patients undergoing TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality.
Background Patients undergoing transcatheter aortic valve replacement (TAVR) are at increased risk for acute kidney injury (AKI). The Valve Academic Research Consortium (VARC) recently published ...criteria for AKI after TAVR. We aimed to identify predictors, assess the prognostic impact of AKI after TAVR, and compare various criteria for AKI. Methods Patients with aortic stenosis undergoing TAVR were retrospectively analyzed for periprocedural AKI (<72 hours) according to the VARC definition (increase in serum creatinine ≥0.3 mg/dL or ≥1.5× baseline) or according to the modified Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria (decrease of >25% in estimated glomerular filtration rate at 48 hours). Results Acute kidney injury, according to the VARC definition, occurred in 24 (14.6%) of 165 patients after TAVR. Acute kidney injury, according to RIFLE criteria, occurred in 19 patients (11.5%). Men (63% vs 38%, P = .03) and patients receiving blood transfusion (63% vs 39%, P = .04) were more likely to develop AKI. In multivariable analysis, only blood transfusion emerged as a predictor for AKI (odds ratio 3.74, 95% CI 1.36-10.3). Patients who developed AKI had higher in-hospital (21% vs 4%, P = .007) and 30-day mortality (29% vs 7%, P = .004) as compared with patients without AKI. Conclusion Acute kidney injury is a frequent complication of TAVR. Even a small increase (0.3 mg/dL) in baseline creatinine post-TAVR is associated with worse outcome. The poor prognosis of these patients should encourage improvement in patient selection and careful management for prevention of this complication.
Objectives The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Background Outcomes of patients with ...CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. Methods All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Results Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test <50 m; hazard ratio: 1.67, p = 0.0009) and oxygen-dependency (hazard ratio: 1.44, p = 0.02). Although CLD patients undergoing TAVR have worse outcomes than patients without CLD, TAVR is better in these patients than standard therapy and is similar to SAVR. Conclusions Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )
The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe ...and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 ± 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AKI) stage ≥2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro–brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased pro-BNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction <30% (OR 6.7, 95% CI 3.5 to 12.7), and periprocedural acute myocardial infarction (OR 6.5, 95% CI 2.3 to 18.1) represented the predictors of midterm mortality. In conclusion, in this large meta-analysis of patients undergoing TAVI, we found that high pro-BNP levels and postprocedural AKI were the strongest independent predictors of both 30-day and 1-year mortality. These findings may contribute to a better understanding of the risk assessment process of patients undergoing TAVI.
Limited amount of data suggest that patients with aortic stenosis and pulmonary hypertension (PH) who undergo transcatheter aortic valve replacement (TAVR) experience decrease in PH postprocedure. ...Inconsistent use of systolic pulmonary artery pressure cut-off values in previous studies limits our ability to draw meaningful conclusions regarding the prognostic role of PH in assessment of TAVR candidates. A total of 415 consecutive patients who underwent TAVR were included in the present study. Two groups were compared based on receiver-operating characteristics curve analysis for the best SPAP value to predict outcome, yielding 2 study groups of no/mild PH (≤50 mm Hg; n = 172, 41%) versus moderate/severe PH (>50 mm Hg; n = 243, 59%). Demographics and co-morbidities were comparable between the 2 groups; however, right-sided cardiac failure (35% vs 19.8%, p = 0.02) and mitral regurgitation (18.4% vs 8.6%, p = 0.007) were more frequent in patients with moderate/severe PH. Procedural characteristics and complications were comparable between the groups. Although there was an early overall decrease in SPAP postprocedure, only 26% of moderate/severe patients with PH experienced a significant decrease in SPAP (>10 mm Hg). The 30-day (14.5% vs 7.4%, p = 0.02) and 1-year mortality (30.8% vs 21%, p = 0.02) was higher in moderate/severe patients with PH. In multivariate analysis, systolic pulmonary artery pressure and chronic lung disease were identified as independent predictors for mortality at 1 year. PH is a frequent co-morbidity in patients with severe aortic stenosis who underwent TAVR. Significantly elevated pulmonary artery pressures at baseline may serve as a poor prognostic factor when performing preprocedural assessment of the patients.
The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary ...artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.
Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by ...TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio HR 1.9, 95% confidence interval CI 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome compared with high-risk patients.
The incidence and prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR) have not been consistently studied. We aimed to assess the incidence and extent of ...myocardial injury after TAVR performed using transfemoral and transapical approaches. The clinical data from patients with aortic stenosis who underwent TAVR were retrospectively analyzed. The myocardial necrosis markers cardiac troponin I and creatine kinase (CK)-MB were assessed during hospitalization. Of the 150 TAVR patients, 95% and 50% had an abnormally elevated cardiac troponin I and CK-MB level, respectively. The transapical patients had significantly greater elevations of both cardiac troponin I (13.8 ± 14.0 vs 2.5 ± 5.8 ng/ml, p <0.001) and CK-MB (28.4 ± 24.2 vs 7.4 ± 8.6 ng/ml, p ≤0.001). On receiver operating curve analysis, postprocedural CK-MB (twofold increase) had high predictive power for 30-day mortality (area under the curve 0.85, p <0.001). Patients with high CK-MB levels had greater rates of postprocedural kidney injury (22% vs 6%, p = 0.026), in-hospital (22% vs 0%, p <0.001), 30-day (27% vs 1.5%, p <0.001), and 1-year mortality (41% vs 18%, p = 0.01). Baseline renal failure and no β-blocker treatment on admission were independent predictors of an elevated postprocedural CK-MB level. In conclusion, a cardiac biomarker increase after TAVR was common and more frequent among transapical access patients. A twofold increase (>7 ng/ml) in CK-MB after transfemoral TAVR was a surrogate for poor long-term outcomes.
Abstract Background Coronary CT has become the foremost noninvasive imaging modality for detecting coronary stenoses in patients with suspected coronary artery disease. Nevertheless, little is known ...about its performance in patients undergoing transcatheter aortic valve replacement (TAVR). Objective This study investigates the diagnostic performance of coronary CT angiography in patients referred for TAVR. Methods One hundred and fifteen consecutive patients with severe aortic stenosis underwent CT angiography with retrospective electrocardiography triggered acquisition and an iterative reconstruction algorithm, of whom 23 (20%) had prior coronary artery bypass graft (CABG) surgery. Diagnostic accuracy of CT for detecting significant coronary stenosis (≥50% luminal diameter stenosis in segments ≥2 mm) in the left main, proximal, or middle segments of coronary arteries and bypass grafts was compared with that of invasive coronary angiography. Results In the overall study population, the sensitivity, specificity, and positive and negative predictive value of CT angiography for the detection of coronary segment or bypass graft lesions were 96% (47 of 49), 73% (48 of 66), 72% (47 of 65), and 96% (48 of 50), respectively. The per-patient diagnostic yield of CT angiography was consistent among patients without prior CABG (93% 28 of 30, 73% 45 of 62, 62% 28 of 45, and 96% 45 of 47, respectively) and among patients with prior CABG (100% 19 of 19, 75% 3 of 4, 95% 19 of 20, and 100% 3 of 3, respectively). Conclusion Among patients referred for TAVR, coronary CT angiography with retrospective gating and iterative reconstruction may allow detection of significant stenosis in the proximal or middle segments of coronary arteries and could permit the evaluation of patients after bypass grafts.
PDF
