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Papers by Mohamed El-mawardy
Journal of cardiology, Jan 20, 2015
Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TA... more Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TAVI) and has been related to a worse outcome. We investigated the importance of contrast medium composition, either iso-osmolar (IOCM) or low-osmolar (LOCM) and assessed predictors for AKI after TAVI. We assessed AKI in 203 TAVI patients treated mainly with trans-femoral implantation and analgosedation. A total of 100 patients received IOCM and 103 LOCM. AKI was defined according to the Valve Academic Research Consortium. Following TAVI, 39 patients (19.2%) developed AKI; 17.0% of the IOCM and 21.4% of the LOCM group (p=0.43). The only independent predictor for AKI was baseline serum creatinine [odds ratio (OR) 0.26, 95% confidence interval (CI) 0.01-0.64, p=0.002]. Patients with advanced AKI (stages 2 and 3) post-TAVI had significantly higher mortality at 2 years (log rank p<0.001), whereas patients with AKI stage 1 had a similar long-term outcome to non-AKI patients. Following TAVI, ...
JACC: Cardiovascular Interventions, 2014
This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantati... more This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California). AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV. We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score-adjusted models. A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.
JAMA, 2014
Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk pati... more Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed. To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device. The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany. Transfemoral TAVR with a balloon-expandable or self-expandable device. The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications. Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001). Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve. clinicaltrials.gov Identifier: NCT01645202.
Journal of cardiology, Jan 20, 2015
Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TA... more Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TAVI) and has been related to a worse outcome. We investigated the importance of contrast medium composition, either iso-osmolar (IOCM) or low-osmolar (LOCM) and assessed predictors for AKI after TAVI. We assessed AKI in 203 TAVI patients treated mainly with trans-femoral implantation and analgosedation. A total of 100 patients received IOCM and 103 LOCM. AKI was defined according to the Valve Academic Research Consortium. Following TAVI, 39 patients (19.2%) developed AKI; 17.0% of the IOCM and 21.4% of the LOCM group (p=0.43). The only independent predictor for AKI was baseline serum creatinine [odds ratio (OR) 0.26, 95% confidence interval (CI) 0.01-0.64, p=0.002]. Patients with advanced AKI (stages 2 and 3) post-TAVI had significantly higher mortality at 2 years (log rank p<0.001), whereas patients with AKI stage 1 had a similar long-term outcome to non-AKI patients. Following TAVI, ...
JACC: Cardiovascular Interventions, 2014
This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantati... more This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California). AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV. We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score-adjusted models. A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.
JAMA, 2014
Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk pati... more Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed. To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device. The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany. Transfemoral TAVR with a balloon-expandable or self-expandable device. The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications. Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001). Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve. clinicaltrials.gov Identifier: NCT01645202.