Sabine Bleiziffer - Academia.edu (original) (raw)

Papers by Sabine Bleiziffer

Research paper thumbnail of Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study)

The American journal of cardiology, Jan 15, 2016

Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients ... more Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score-matching analysis, we analyzed the characteristics and outcomes of patients who underwent TAVI with either GA (n = 245) or non-GA (n = 245) in the fully monitored, international, CoreValve ADVANCE Study. No statistically significant differences existed between the non-GA and GA groups in all-cause mortality (25.4% vs 23.9%, p = 0.78), cardiovascular mortality (16.4% vs 16.6%, p = 0.92), or stroke (5.2% vs 6.9%, p = 0.57) through 2-year follow-up. Major vascular complications were more common in the non-GA group. Total hospital stay was similar between the 2 groups. Conver...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 2865: Enhanced Left Ventricular Mass Regression Following Aortic Valve Replacement is Associated with Improved Long-Term Survival: A 15-year Study

Circulation, Oct 28, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Hemodynamic characterization of the Sorin Mitroflow pericardial bioprosthesis at rest and exercise

The Journal of Heart Valve Disease, 2009

BACKGROUND AND AIM OF THE STUDY: Although the long-term clinical outcome after aortic valve repla... more BACKGROUND AND AIM OF THE STUDY: Although the long-term clinical outcome after aortic valve replacement (AVR) with the Sorin Mitroflow pericardial bioprosthesis has been well described, few data are available with regards to hemodynamic performance. On the basis of its specialized design, with the pericardium mounted on the outside of the stent, the Mitroflow valve is considered to provide optimal opening and orifice areas.METHODS: Between February 2006 and April 2007, a total of 127 patients (66 females, 61 males; mean age 77.6 +/- 5.2 years) underwent AVR with the Mitroflow valve at the authors' institution. Echocardiography was performed at discharge in 91 patients, while a six-month follow up examination was conducted in 78 (including ergometer hemodynamics in 25 cases).RESULTS: The mean systolic pressure gradient (MPG) ranged from 19.7 +/- 3.3 mmHg (size 19 valve) to 12.4 +/- 2.4 mmHg (size 27 valve), and the mean effective orifice area (EOA) from 0.96 +/- 0.0 cm2 (size 19 valve) to 2.36 +/- 0.4 cm2 (size 27 valve). The incidence of mild-to-moderate and severe prosthesis-patient mismatch (PPM) was 33% and 10% at the six-month follow up. During exercise (25 W-100 W), the MPG increased from 17.1 +/- 3.6 mmHg to 23.6 mmHg in valve sizes 19 to 21, and from 12.2 +/- 3.6 mmHg to 15.9 +/- 2.5 mmHg in valve sizes 23 to 27. The effective orifice fraction (EOF = EOA/annulus area) was 38 +/- 7%.CONCLUSION: The Mitroflow valve exhibits an adequate MPG and EOA, as might be expected for a pericardial bioprosthesis. Of note, the gradient increase during exercise was low, especially for the larger valve sizes. Due to its special design, the Mitroflow prosthesis shows a large opening, as demonstrated by the high EOF. These data relating to the EOA of all prosthesis sizes may help surgeons to select the minimum prosthesis size in order to prevent PPM.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Access and closure of the left ventricular apex: state of play

Journal of thoracic disease, 2015

Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The prefer... more Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The preferred treatment for patients of all age groups is surgical aortic valve replacement. Recently, transcatheter aortic valve implantation (TAVI) has become the standard of care for patients that are deemed to be at high risk for open heart surgery. The most common access route for TAVI is the retrograde transfemoral (TF) approach, followed by the antegrade transapical (TA) approach. Both access routes have distinct indications. While the TF route is least invasive and the access of choice at most centers, the apical route is used complementary in patients with poor femoral access. In addition, the TA approach holds various benefits such as a short distance from the operator to the annulus facilitating exact positioning of the valve and the possibility to accommodate larger sheaths. Furthermore, the TA approach not only provides direct access to the aortic valve but also the mitral valve allow...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Early haemodynamic performance of a latest generation supra-annular aortic bioprosthesis: experience from a large single-centre series

European Journal of Cardio-Thoracic Surgery, 2015

The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet peri... more The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet pericardial valve designed for supra-annular replacement of the aortic valve (AVR). We sought to evaluate the short-term clinical outcome and haemodynamic performance of the Trifecta valve after AVR. A total of 837 patients with severe symptomatic aortic valve stenosis or regurgitation underwent AVR with the SJM Trifecta aortic valve prosthesis between January 2009 and March 2013. All intra- and postoperative data were collected prospectively. At discharge, transthoracic echocardiography was performed. A complete set of echocardiographic data was available in 723 patients. Adjusted mean systolic pressure gradients (MPGs) for valve sizes 19 (n = 37/4.4%), 21 (n = 192/22.9%), 23 (n = 263/31.4%), 25 (n = 202/24.1%), 27 (n = 100/11.9%) and 29 mm (n = 42/5.0%) were 8.6 ± 1.1, 8.7 ± 0.4, 7.2 ± 0.3, 6.2 ± 0.3, 5.6 ± 0.3 and 3.9 ± 0.4 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.5 ± 0.09, 1.6 ± 0.04, 1.9 ± 0.03, 2.0 ± 0.03, 2.2 ± 0.05 and 2.7 ± 0.01 cm(2), respectively. No patient-prosthesis mismatch (PPM) was seen in 71.3% of patients (EOAI >0.85 cm(2)/m(2)). Moderate mismatch (EOAI 0.65-0.85 cm(2)/m(2)) was observed in 23.9% of patients, whereas severe PPM (EOAI <0.65 cm(2)/m(2)) occurred in 4.4% of patients. No malfunction of the prosthesis, endocarditis, valve thrombosis or relevant aortic regurgitation necessitating surgical revision was observed until discharge. The SJM Trifecta valve reveals an excellent early haemodynamic performance with low residual MPGs and a low incidence of PPM. Studies with longitudinal clinical and echocardiographic assessments with longer term follow-up evaluation including a comparison with other contemporary bioprostheses are needed.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study)

The American Journal of Cardiology, 2015

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve... more This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of hemodynamics in patients with a small aortic annulus Influence of completely supra-annular placement of bioprostheses on exercise

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 17855: Prospective Evaluation Of Quality-of-life Among Patients Undergoing Transcatheter Aortic Valve Implantation: 1-year Follow-up Results

Circulation, Nov 23, 2010

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Transcatheter Aortic Valve Implantation in Patients With LV Dysfunction: Impact on Mortality and Predictors of LV Function Recovery

The Journal of Invasive Cardiology, Mar 1, 2014

BACKGROUND: Aortic stenosis patients with left ventricular dysfunction are at increased risk for ... more BACKGROUND: Aortic stenosis patients with left ventricular dysfunction are at increased risk for morbidity and mortality following surgical aortic valve replacement. There are few published data regarding the outcomes of patients with severe aortic stenosis and left ventricular (LV) dysfunction undergoing transcatheter aortic valve implantation (TAVI) and possible predictors of LV recovery.AIMS: To compare the baseline characteristics and outcomes between patients with normal LV function and those with LV dysfunction and to assess the predictors of LV recovery after TAVI.METHODS: We enrolled 505 consecutive patients with severe aortic stenosis who underwent TAVI between November 2007 and January 2010. Patients were stratified according to LV function as follows: normal LV function (ejection fraction [EF] >50%), moderate LV dysfunction (EF 35%-50%) and severe LV dysfunction (EF ≤35%). The baseline characteristics and clinical outcomes, up to 6 months, were subsequently compared among the 3 patient subgroups. Univariable and multivariable logistic regression analyses were used to identify independent predictors of LV recovery.RESULTS: Normal LV function was identified in 324 patients (64%) and LV dysfunction in 181 patients (36%); in those with LV dysfunction, 111 patients (22%) had moderate LV dysfunction and 70 patients (14%) had severe LV dysfunction. As compared to patients with normal LV function, those with severe LV dysfunction were more likely to be male, had higher STS and logistic EuroSCORE, more coronary artery disease/previous coronary artery bypass surgery, higher NT-proBNP levels, lower mean transaortic valve gradients, and smaller aortic valve areas. No significant difference in 30-day mortality was observed between the LV function subgroups. The 6-month mortality, however, was 2-fold higher in patients with severe LV dysfunction (27% vs 15%, respectively; P=.03). Recovery of LVEF to more than 50% was observed in 15% of patients with baseline EF ≤35%. Baseline EF was the strongest independent predictor of LV recovery after TAVI (odds ratio, 85; 95% confidence interval, 19-380; P<.001).CONCLUSIONS: Despite a similar periprocedural outcome, patients with aortic stenosis and severe LV dysfunction exhibit a significantly increased 6-month mortality after TAVI. Survivors with LV dysfunction, however, show a significant potential for LV function recovery.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of A prospective randomized comparison of the Medtronic Advantage Supra® and the St. Jude Medical Regent® mechanical heart valve in the aortic position Is there an additional benefit of supraannnular valve positioning?

Thorac Cardiovasc Surg, 2008

The aim of this prospective randomized trial was to evaluate the impact of complete supraannular ... more The aim of this prospective randomized trial was to evaluate the impact of complete supraannular positioning of mechanical aortic bileaflet valves. Between April of 2004 and November of 2006, 80 patients underwent aortic valve replacement with the complete supraannular Medtronic Advantage Supra (n = 40) (Medtronic Inc, Minneapolis, Minn) or the intra-supraannular St Jude Medical Regent (n = 40) prosthesis (St Jude Medical Inc, St Paul, Minn). Before randomization and valve sizing for both valve types, the aortic tissue annulus diameter was determined by Hegar dilator. Transthoracic echocardiography data were obtained early postoperatively and at 6 months, including stress echocardiography. By grouping the data on the basis of a patient&amp;amp;amp;amp;amp;amp;amp;amp;#39;s tissue annulus diameter, no significant difference of either valve was detected with regard to mean pressure gradient and effective orifice area index at rest. Effective orifice area index ranged from 0.95 +/- 0.32 cm(2)/m(2) to 1.27 +/- 0.33 cm(2)/m(2) in the Advantage Supra group and from 0.98 +/- 0.36 cm(2)/m(2) to 1.26 +/- 0.37 cm(2)/m(2) in the Regent group. During exercise, mean pressure gradients increased from 11.9 +/- 4.9 mm Hg to 19.1 +/- 7.2 mm Hg in the Advantage Supra group and from 9.6 +/- 4.0 to 16.4 mm Hg +/- 7.3 mm Hg in the Regent group. A marked left ventricular mass regression across all annulus sizes was noted in both groups (P &amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Sizing for both valve types showed that in 26.3%, the completely supraannular valve design allows the implantation of a 1 size larger valve in label than the corresponding intra-supraannular valve. By grouping the data on the basis of a patient&amp;amp;amp;amp;amp;amp;amp;amp;#39;s tissue annulus diameter, no significant superiority of either prosthesis was detected with regard to left ventricular mass regression, effective orifice area index, and mean pressure gradient during rest and exercise. We conclude that there is no additional benefit of supraannular valve positioning.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Comparison of bioprostheses in patients with small aortic annulus. Authors' reply

Journal of the American College of Cardiology, 2006

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Rest and Exercise Performance of the Medtronic Advantage Bileaflet Valve in the Aortic Position

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 19599: Survival in High Risk Patients with Severe Aortic Stenosis: Intervention versus Surgery versus Medical Therapy

Circulation, Nov 23, 2010

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 2863: Patient-Prosthesis Mismatch is Associated with Reduced Mid-Term Survival after Aortic Valve Replacement

Circulation, Oct 28, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Hemodynamic performance of the new St. Jude Medical Epic Supra porcine bioprosthesis in comparison to the Medtronic Mosaic on the basis of patient annulus diameter

The Journal of Heart Valve Disease, Aug 1, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Catheter-based aortic valve replacement: Alternative to open surgery on high-risk patients

Zeitschrift Fur Herz Thorax Und Gefabchirurgie, Feb 1, 2009

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Minimal-invasive Venenentnahme als Standardverfahren in der Bypasschirurgie

Zeitschrift Fur Herz Thorax Und Gefasschirurgie, May 15, 2011

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting

Journal of thoracic disease, 2015

Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an incr... more Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac p...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients

Journal of the American College of Cardiology, 2015

Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with sympto... more Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events. This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR. We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist. The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06). Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658).

Bookmarks Related papers MentionsView impact

Research paper thumbnail of TCT-685 Results After Transcatheter Valve-in-Valve Implantation And Redo Aortic Valve Surgery For Failed Aortic Bioprostheses

Journal of the American College of Cardiology, 2015

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study)

The American journal of cardiology, Jan 15, 2016

Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients ... more Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score-matching analysis, we analyzed the characteristics and outcomes of patients who underwent TAVI with either GA (n = 245) or non-GA (n = 245) in the fully monitored, international, CoreValve ADVANCE Study. No statistically significant differences existed between the non-GA and GA groups in all-cause mortality (25.4% vs 23.9%, p = 0.78), cardiovascular mortality (16.4% vs 16.6%, p = 0.92), or stroke (5.2% vs 6.9%, p = 0.57) through 2-year follow-up. Major vascular complications were more common in the non-GA group. Total hospital stay was similar between the 2 groups. Conver...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 2865: Enhanced Left Ventricular Mass Regression Following Aortic Valve Replacement is Associated with Improved Long-Term Survival: A 15-year Study

Circulation, Oct 28, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Hemodynamic characterization of the Sorin Mitroflow pericardial bioprosthesis at rest and exercise

The Journal of Heart Valve Disease, 2009

BACKGROUND AND AIM OF THE STUDY: Although the long-term clinical outcome after aortic valve repla... more BACKGROUND AND AIM OF THE STUDY: Although the long-term clinical outcome after aortic valve replacement (AVR) with the Sorin Mitroflow pericardial bioprosthesis has been well described, few data are available with regards to hemodynamic performance. On the basis of its specialized design, with the pericardium mounted on the outside of the stent, the Mitroflow valve is considered to provide optimal opening and orifice areas.METHODS: Between February 2006 and April 2007, a total of 127 patients (66 females, 61 males; mean age 77.6 +/- 5.2 years) underwent AVR with the Mitroflow valve at the authors' institution. Echocardiography was performed at discharge in 91 patients, while a six-month follow up examination was conducted in 78 (including ergometer hemodynamics in 25 cases).RESULTS: The mean systolic pressure gradient (MPG) ranged from 19.7 +/- 3.3 mmHg (size 19 valve) to 12.4 +/- 2.4 mmHg (size 27 valve), and the mean effective orifice area (EOA) from 0.96 +/- 0.0 cm2 (size 19 valve) to 2.36 +/- 0.4 cm2 (size 27 valve). The incidence of mild-to-moderate and severe prosthesis-patient mismatch (PPM) was 33% and 10% at the six-month follow up. During exercise (25 W-100 W), the MPG increased from 17.1 +/- 3.6 mmHg to 23.6 mmHg in valve sizes 19 to 21, and from 12.2 +/- 3.6 mmHg to 15.9 +/- 2.5 mmHg in valve sizes 23 to 27. The effective orifice fraction (EOF = EOA/annulus area) was 38 +/- 7%.CONCLUSION: The Mitroflow valve exhibits an adequate MPG and EOA, as might be expected for a pericardial bioprosthesis. Of note, the gradient increase during exercise was low, especially for the larger valve sizes. Due to its special design, the Mitroflow prosthesis shows a large opening, as demonstrated by the high EOF. These data relating to the EOA of all prosthesis sizes may help surgeons to select the minimum prosthesis size in order to prevent PPM.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Access and closure of the left ventricular apex: state of play

Journal of thoracic disease, 2015

Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The prefer... more Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The preferred treatment for patients of all age groups is surgical aortic valve replacement. Recently, transcatheter aortic valve implantation (TAVI) has become the standard of care for patients that are deemed to be at high risk for open heart surgery. The most common access route for TAVI is the retrograde transfemoral (TF) approach, followed by the antegrade transapical (TA) approach. Both access routes have distinct indications. While the TF route is least invasive and the access of choice at most centers, the apical route is used complementary in patients with poor femoral access. In addition, the TA approach holds various benefits such as a short distance from the operator to the annulus facilitating exact positioning of the valve and the possibility to accommodate larger sheaths. Furthermore, the TA approach not only provides direct access to the aortic valve but also the mitral valve allow...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Early haemodynamic performance of a latest generation supra-annular aortic bioprosthesis: experience from a large single-centre series

European Journal of Cardio-Thoracic Surgery, 2015

The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet peri... more The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet pericardial valve designed for supra-annular replacement of the aortic valve (AVR). We sought to evaluate the short-term clinical outcome and haemodynamic performance of the Trifecta valve after AVR. A total of 837 patients with severe symptomatic aortic valve stenosis or regurgitation underwent AVR with the SJM Trifecta aortic valve prosthesis between January 2009 and March 2013. All intra- and postoperative data were collected prospectively. At discharge, transthoracic echocardiography was performed. A complete set of echocardiographic data was available in 723 patients. Adjusted mean systolic pressure gradients (MPGs) for valve sizes 19 (n = 37/4.4%), 21 (n = 192/22.9%), 23 (n = 263/31.4%), 25 (n = 202/24.1%), 27 (n = 100/11.9%) and 29 mm (n = 42/5.0%) were 8.6 ± 1.1, 8.7 ± 0.4, 7.2 ± 0.3, 6.2 ± 0.3, 5.6 ± 0.3 and 3.9 ± 0.4 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.5 ± 0.09, 1.6 ± 0.04, 1.9 ± 0.03, 2.0 ± 0.03, 2.2 ± 0.05 and 2.7 ± 0.01 cm(2), respectively. No patient-prosthesis mismatch (PPM) was seen in 71.3% of patients (EOAI &gt;0.85 cm(2)/m(2)). Moderate mismatch (EOAI 0.65-0.85 cm(2)/m(2)) was observed in 23.9% of patients, whereas severe PPM (EOAI &lt;0.65 cm(2)/m(2)) occurred in 4.4% of patients. No malfunction of the prosthesis, endocarditis, valve thrombosis or relevant aortic regurgitation necessitating surgical revision was observed until discharge. The SJM Trifecta valve reveals an excellent early haemodynamic performance with low residual MPGs and a low incidence of PPM. Studies with longitudinal clinical and echocardiographic assessments with longer term follow-up evaluation including a comparison with other contemporary bioprostheses are needed.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study)

The American Journal of Cardiology, 2015

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve... more This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score &gt;7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS &gt;7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p &lt;0.01) and cardiovascular mortality (19.0 vs 30.2, p &lt;0.01) than the STS &gt;7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p &lt;0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS &gt;7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of hemodynamics in patients with a small aortic annulus Influence of completely supra-annular placement of bioprostheses on exercise

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 17855: Prospective Evaluation Of Quality-of-life Among Patients Undergoing Transcatheter Aortic Valve Implantation: 1-year Follow-up Results

Circulation, Nov 23, 2010

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Transcatheter Aortic Valve Implantation in Patients With LV Dysfunction: Impact on Mortality and Predictors of LV Function Recovery

The Journal of Invasive Cardiology, Mar 1, 2014

BACKGROUND: Aortic stenosis patients with left ventricular dysfunction are at increased risk for ... more BACKGROUND: Aortic stenosis patients with left ventricular dysfunction are at increased risk for morbidity and mortality following surgical aortic valve replacement. There are few published data regarding the outcomes of patients with severe aortic stenosis and left ventricular (LV) dysfunction undergoing transcatheter aortic valve implantation (TAVI) and possible predictors of LV recovery.AIMS: To compare the baseline characteristics and outcomes between patients with normal LV function and those with LV dysfunction and to assess the predictors of LV recovery after TAVI.METHODS: We enrolled 505 consecutive patients with severe aortic stenosis who underwent TAVI between November 2007 and January 2010. Patients were stratified according to LV function as follows: normal LV function (ejection fraction [EF] >50%), moderate LV dysfunction (EF 35%-50%) and severe LV dysfunction (EF ≤35%). The baseline characteristics and clinical outcomes, up to 6 months, were subsequently compared among the 3 patient subgroups. Univariable and multivariable logistic regression analyses were used to identify independent predictors of LV recovery.RESULTS: Normal LV function was identified in 324 patients (64%) and LV dysfunction in 181 patients (36%); in those with LV dysfunction, 111 patients (22%) had moderate LV dysfunction and 70 patients (14%) had severe LV dysfunction. As compared to patients with normal LV function, those with severe LV dysfunction were more likely to be male, had higher STS and logistic EuroSCORE, more coronary artery disease/previous coronary artery bypass surgery, higher NT-proBNP levels, lower mean transaortic valve gradients, and smaller aortic valve areas. No significant difference in 30-day mortality was observed between the LV function subgroups. The 6-month mortality, however, was 2-fold higher in patients with severe LV dysfunction (27% vs 15%, respectively; P=.03). Recovery of LVEF to more than 50% was observed in 15% of patients with baseline EF ≤35%. Baseline EF was the strongest independent predictor of LV recovery after TAVI (odds ratio, 85; 95% confidence interval, 19-380; P<.001).CONCLUSIONS: Despite a similar periprocedural outcome, patients with aortic stenosis and severe LV dysfunction exhibit a significantly increased 6-month mortality after TAVI. Survivors with LV dysfunction, however, show a significant potential for LV function recovery.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of A prospective randomized comparison of the Medtronic Advantage Supra® and the St. Jude Medical Regent® mechanical heart valve in the aortic position Is there an additional benefit of supraannnular valve positioning?

Thorac Cardiovasc Surg, 2008

The aim of this prospective randomized trial was to evaluate the impact of complete supraannular ... more The aim of this prospective randomized trial was to evaluate the impact of complete supraannular positioning of mechanical aortic bileaflet valves. Between April of 2004 and November of 2006, 80 patients underwent aortic valve replacement with the complete supraannular Medtronic Advantage Supra (n = 40) (Medtronic Inc, Minneapolis, Minn) or the intra-supraannular St Jude Medical Regent (n = 40) prosthesis (St Jude Medical Inc, St Paul, Minn). Before randomization and valve sizing for both valve types, the aortic tissue annulus diameter was determined by Hegar dilator. Transthoracic echocardiography data were obtained early postoperatively and at 6 months, including stress echocardiography. By grouping the data on the basis of a patient&amp;amp;amp;amp;amp;amp;amp;amp;#39;s tissue annulus diameter, no significant difference of either valve was detected with regard to mean pressure gradient and effective orifice area index at rest. Effective orifice area index ranged from 0.95 +/- 0.32 cm(2)/m(2) to 1.27 +/- 0.33 cm(2)/m(2) in the Advantage Supra group and from 0.98 +/- 0.36 cm(2)/m(2) to 1.26 +/- 0.37 cm(2)/m(2) in the Regent group. During exercise, mean pressure gradients increased from 11.9 +/- 4.9 mm Hg to 19.1 +/- 7.2 mm Hg in the Advantage Supra group and from 9.6 +/- 4.0 to 16.4 mm Hg +/- 7.3 mm Hg in the Regent group. A marked left ventricular mass regression across all annulus sizes was noted in both groups (P &amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Sizing for both valve types showed that in 26.3%, the completely supraannular valve design allows the implantation of a 1 size larger valve in label than the corresponding intra-supraannular valve. By grouping the data on the basis of a patient&amp;amp;amp;amp;amp;amp;amp;amp;#39;s tissue annulus diameter, no significant superiority of either prosthesis was detected with regard to left ventricular mass regression, effective orifice area index, and mean pressure gradient during rest and exercise. We conclude that there is no additional benefit of supraannular valve positioning.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Comparison of bioprostheses in patients with small aortic annulus. Authors' reply

Journal of the American College of Cardiology, 2006

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Rest and Exercise Performance of the Medtronic Advantage Bileaflet Valve in the Aortic Position

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 19599: Survival in High Risk Patients with Severe Aortic Stenosis: Intervention versus Surgery versus Medical Therapy

Circulation, Nov 23, 2010

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Abstract 2863: Patient-Prosthesis Mismatch is Associated with Reduced Mid-Term Survival after Aortic Valve Replacement

Circulation, Oct 28, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Hemodynamic performance of the new St. Jude Medical Epic Supra porcine bioprosthesis in comparison to the Medtronic Mosaic on the basis of patient annulus diameter

The Journal of Heart Valve Disease, Aug 1, 2008

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Catheter-based aortic valve replacement: Alternative to open surgery on high-risk patients

Zeitschrift Fur Herz Thorax Und Gefabchirurgie, Feb 1, 2009

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Minimal-invasive Venenentnahme als Standardverfahren in der Bypasschirurgie

Zeitschrift Fur Herz Thorax Und Gefasschirurgie, May 15, 2011

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting

Journal of thoracic disease, 2015

Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an incr... more Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac p...

Bookmarks Related papers MentionsView impact

Research paper thumbnail of The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients

Journal of the American College of Cardiology, 2015

Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with sympto... more Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events. This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR. We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist. The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06). Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658).

Bookmarks Related papers MentionsView impact

Research paper thumbnail of TCT-685 Results After Transcatheter Valve-in-Valve Implantation And Redo Aortic Valve Surgery For Failed Aortic Bioprostheses

Journal of the American College of Cardiology, 2015

Bookmarks Related papers MentionsView impact