Joelle Kefer

Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

AIMS To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). METHODS AND RESULTS Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. CONCLUSIONS In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

Treatment and Clinical Outcomes of Transcatheter Heart Valve Thrombosis

Background—Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. Methods and Results—THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post–transcatheter aortic valve implantation was 181 days (interquartile range, 45–313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. Conclusions—THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.

Blood Transfusion and the Risk of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Background—Blood transfusion is associated with acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI). We sought to elucidate in more detail the relation between blood transfusion and AKI and its effects on short- and long-term mortality. Methods and Results—Nine hundred ninety-five patients with aortic stenosis underwent TAVI with the Medtronic CoreValve or the Edwards Valve in 7 centers. AKI was defined by the Valve Academic Research Consortium (absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 &mgr;mol/L] or ≥50% increase <72 hours). Logistic and Cox regression was used for predictor and survival analysis. AKI occurred in 20.7% (n=206). The number of units of blood transfusion <24 hours was the strongest predictor of AKI (≥5 units, OR, 4.81 [1.45–15.95], 3–4 units, OR, 3.05 [1.24–7.53], 1–2 units, OR, 1.47 [0.98–2.22]) followed by peripheral vascular disease (OR, 1.48 [1.05–2.10]), history of heart failure (OR, 1.43 [1.01–2.03]), leucocyte count <72 hours after TAVI (OR, 1.05 [1.02–1.09]) and European System for Cardiac Operative Risk Evaluation (EuroSCORE; OR, 1.02 [1.00–1.03]). Potential triggers of blood transfusion such as baseline anemia, bleeding-vascular complications, and perioperative blood loss were not identified as predictors. AKI and life-threatening bleeding were independent predictors of 30-day mortality (OR, 3.15 [1.56–6.38], OR, 6.65 [2.28–19.44], respectively), whereas transfusion (≥3 units), baseline anemia, and AKI predicted mortality beyond 30 days. Conclusions—AKI occurred in 21% of the patients after TAVI. The number of blood transfusions but not the indication of transfusion predicted AKI. AKI was a predictor of both short- and long-term mortality, whereas blood transfusion predicted long-term mortality. These findings indicate that outcome of TAVI may be improved by more restrictive use of blood transfusions.

Incidence, Timing, and Predictors of Valve Hemodynamic Deterioration After Transcatheter Aortic Valve Replacement: Multicenter Registry.

BACKGROUND Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR). OBJECTIVES This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR. METHODS This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment. RESULTS The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD. CONCLUSIONS There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.

Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and trans-apical approaches using Edwards Sapiens valve

OBJECTIVE Cerebral embolization during trans-catheter aortic valve implantation (TAVI) has not been assessed clearly in the literature. Therefore, we compared the rate of cerebral embolisms with diffusion-weighted magnetic resonance imaging (DWI) in transfemoral (TF) and trans-apical (TA) approaches. METHOD Eighty patients benefited from TAVI between January 2008 and June 2010. Out of these, 35 were included in the study. Twenty-one were TF (group 1) and 14 TA (group 2). During the same period, 285 patients benefited from a conventional aortic valve surgery (aortic valve replacement (AVR)). Thirteen of these were also analyzed and considered as the control group (group 3). We systematically performed a DWI the day before the procedure and 48 h after. DWI studies were blindly analyzed by a neuroradiologist, and all patients had a clinical neurological assessment before and after the procedure, according the National Institutes of Health Stroke Scale (NIHSS). RESULTS Thirty-two patients in the TAVI group had new cerebral lesions: 19 in the TF group and 13 in the trans-apical group (p=NS). Mean number of embolic lesions per patient was 6.6 in group I and 6.0 in group II (p=NS). Mean volume of embolic lesions was 475.0 mm³ in group I and 2170.5 mm³ in group II (p=NS). In group III, one patient had one new cerebral lesion (p<0.05 vs TAVI) of 36.5 mm³ (p=NS vs TAVI). All patients were neurologically asymptomatic. CONCLUSIONS The incidence of silent cerebral embolic lesions after TAVI is significantly higher compared with the standard surgical AVR. The number of emboli is similar in the TF and TA groups but the volume tended to be higher in the TA group. However, there is no clinical impact of those lesions.

Direct comparison of whole-heart navigator-gated magnetic resonance coronary angiography and 40- and 64-slice multidetector row computed tomography to detect the coronary artery stenosis in patients scheduled for conventional coronary angiography.

Background—Both whole-heart magnetic resonance coronary angiography (WH-MRCA) and multidetector computed tomography (MDCT) have been proposed for the noninvasive identification of the coronary stenosis. The authors sought to directly compare the diagnostic accuracy of these noninvasive imaging techniques using the invasive quantitative coronary angiography as a reference standard. Methods and Results—Seventy-seven consecutive patients (56 men, 61±14 years) prospectively underwent WH-MRCA and 40- or 64-slice MDCT before the quantitative coronary angiography. Diagnostic accuracy of WH-MRCA and MDCT for the visual identification of >50% diameter stenosis in segments of >1.5 mm size was compared using the quantitative coronary angiography as a reference. According to the quantitative coronary angiography, 49 of 992 coronary segments >1.5 mm diameter had >50% diameter stenosis. MDCT had a higher success rate (100% versus 88%, P<0.001) and enabled identification of more segments (963 versus 726, P<0.001) than did WH-MRCA. On a per-segment basis, WH-MRCA had similar sensitivity (47/49 or 96% versus 48/49 or 98%, P=0.9) but significantly lower specificity (644/943 or 68% versus 863/943 or 92%, P<0.001) and accuracy (691/992 or 70% versus 911/992 or 92%, P<0.001) for the detection of >50% diameter stenosis than did MDCT. On a per-patient basis, the sensitivity was similar (17/17 or 100% versus 16/17 or 94%, P=0.9), but specificity (43/60 or 72% versus 53/60 or 88%, P=0.024) and diagnostic accuracy (60/77 or 78%, versus 69/77 or 90%, P=0.044) of WH-MRCA for the detection of >50% diameter stenosis were significantly lower than of MDCT. Conclusions—Because of the higher success rate and higher number of interpretable segments, 40- or 64-slice MDCT performs better than WH-MRCA.

The Athlete's Heart - Gender Aspects

Background— Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the left coronary system in terms of patency and survival benefit. Several BITA configurations are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is still unidentified. Methods and Results— From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our institution. 481 patients met the inclusion criteria for randomization, and 304 (64%) were randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months and 3 years. Patient telephone interviews were conducted every 3 months and a stress test performed twice yearly under the referring cardiologist’s supervision. Angiographic follow-up was performed 6 months after surgery. The primary and secondary end points were, respectively, major adverse cerebrocardiovascular events (MACCE) and the proportion of ITA grafts that were completely occluded at follow-up angiography. More arterial anastomoses were performed in patients randomized to the Y than the in situ configuration (3.2 versus 2.4; P<0.001). No significant difference between the 2 groups in terms of hospital mortality or morbidity was found. At follow-up, there was no significant difference in any MACCE rate between the 2 groups. 450 out of 464 anastomosis (97%) in the BITA Y group and 287 of 295 (97%) in the BITA in situ group were controlled patent (P=0.99). Conclusion— Excellent patency rates were achieved using both BITA configurations with no significant differences in terms of MACCE up to 19 months postoperatively, but longer-term results remain to be established.BACKGROUND: Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the left coronary system in terms of patency and survival benefit. Several BITA configurations are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is still unidentified. METHODS AND RESULTS: From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our institution. 481 patients met the inclusion criteria for randomization, and 304 (64%) were randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months and 3 years. Patient telephone interviews were conducted every 3 months and a stress test performed twice yearly under the referring cardiologists supervision. Angiographic follow-up was performed 6 months after surgery. The primary and secondary end points were, respectively, major adverse cerebrocardiovascular events (MACCE) and the proportion of ITA grafts that were completely occluded at follow-up angiography. More arterial anastomoses were performed in patients randomized to the Y than the in situ configuration (3.2 versus 2.4; P>0.001). No significant difference between the 2 groups in terms of hospital mortality or morbidity was found. At follow-up, there was no significant difference in any MACCE rate between the 2 groups. 450 out of 464 anastomosis (97%) in the BITA Y group and 287 of 295 (97%) in the BITA in situ group were controlled patent (P=0.99). CONCLUSIONS: Excellent patency rates were achieved using both BITA configurations with no significant differences in terms of MACCE up to 19 months postoperatively, but longer-term results remain to be established.

Acetylcysteine, coronary procedure and prevention of contrast-induced worsening of renal function: which benefit for which patient?

Objectives — This study was designed to determine whether acetylcysteine could provide a protective effect on renal function in a population of patients with normal renal function or mild to moderate chronic renal failure, usually referred for a coronary procedure. Background — Contrast-induced nephropathy is a well-recognized complication of coronary angiography. Recent studies suggest that saline hydration and acetylcysteine reduce the incidence of contrast-induced worsening of renal function in patients with pre-existing chronic renal failure who are undergoing computed tomography examinations. Methods — One hundred eight patients were blindly and randomly assigned to receive either acetylcysteine or placebo before and after administration of contrast agent in association with a moderate hydration protocol. Serum creatinine and urea nitrogen were measured before and 24 hours after coronary procedure. Results — The mean serum creatinine concentration remained unchanged 24 hours after contrast agent administration in both groups: from 1.04 ± 0.26 to 1.03 ± 0.29 mg/dl in the acetylcysteine group and from 1.16 ± 1.1 to 1.06 ± 0.41 mg/dl in the control group (p = 0.29, for the comparison between two groups, NS). We divided the population into 3 subgroups according to their creatinine clearance: no significant change of serum creatinine concentration was observed in patients with normal renal function nor in patients with pre-existing mild to moderate chronic renal failure in both groups. There was no significant difference for the incidence of contrast-induced nephropathy between both groups (2 of the 53 patients in the acetylcysteine group and 3 of the 51 patients in the placebo group, p = 0.98, NS). Conclusions — Our data do not support the systematic use of acetylcysteine before a coronary procedure in patients with normal renal function or mild to moderate chronic renal failure, to prevent contrast-induced nephropathy.

Diagnostic accuracy of 16-slice multidetector-row CT for detection of in-stent restenosis vs detection of stenosis in nonstented coronary arteries.

The purpose of this study was to assess the diagnostic accuracy of 16-slice multidetector-row computed tomography (MDCT) for detecting in-stent restenosis. Fifty patients with 69 previously implanted coronary stents underwent 16-slice MDCT before quantitative coronary angiography (QCA). Diagnostic accuracy of MDCT for detection of in-stent restenosis defined as >50% lumen diameter stenosis (DS) in stented and nonstented coronary segments >1.5-mm diameter was computed using QCA as reference. According to QCA, 18/69 (25%) stented segments had restenosis. In addition, 33/518 (6.4%) nonstented segments had >50% DS. In-stent restenosis was correctly identified on MDCT images in 12/18 stents, and absence of restenosis was correctly identified in 50/51 stents. Stenosis in native coronary arteries was correctly identified in 22/33 segments and correctly excluded in 482/485 segments. Thus, sensitivity (67% vs 67% p=1.0), specificity (98% vs 99%, p=0.96) and overall diagnostic accuracy (90% vs 97%, p=0.68) was similarly high for detecting in-stent restenosis as for detecting stenosis in nonstented coronary segments. MDCT has similarly high diagnostic accuracy for detecting in-stent restenosis as for detecting coronary artery disease in nonstented segments. This suggests that MDCT could be clinically useful for identification of restenosis in patients after coronary stenting.

Prevalence, Factors Associated With, and Prognostic Effects of Preoperative Anemia on Short- and Long-Term Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation

Background—There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI. Methods and Results—Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). The prevalence of preoperative anemia was 57%. Patient-related factors associated with preoperative anemia were (descending order of odds ratio [95% confidence interval]) as follows: anemia-related medication (4.90 [3.08–7.80]), history of heart failure (1.77 [1.43–2.20]), male sex (1.69 [1.32–2.16]), mitral regurgitation grade ≥III (1.61 [1.15–2.25]), history of malignancy (1.44 [1.03–2.09]), and peripheral vascular disease (1.33 [1.04–1.70]). The creatinine clearance was inversely associated with preoperative anemia (odds ratio, 0.92 [0.87–0.97]). In multivariable analyses, preoperative anemia was not associated with 30-day mortality (1.72 [0.96–3.12]; P=0.073) but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60–4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08–3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03–1.14]). Conclusions—Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI.