Michael Gotzmann

Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry

Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure. # Clinical Perspective {#article-title-38}Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ⩽+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Short-term effects of transcatheter aortic valve implantation on neurohormonal activation, quality of life and 6-minute walk test in severe and symptomatic aortic stenosis

Objective This prospective study aimed to determine to what extent clinical symptoms and neurohumoral activation are improved in patients with severe aortic valve stenosis after transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Methods From June 2008 to June 2009 consecutive patients with symptomatic severe aortic valve stenosis (area<1 cm2), age≥75 years with a logistic EuroSCORE ≥15% or age>60 years plus additional specified risk factors were evaluated for TAVI. Examinations of study patients were performed before and 30 days after TAVI and comprised assessment of quality of life (Minnesota living with heart failure questionnaire, [MLHFQ]) 6-minute walk test, measurement of B-type natriuretic peptide and echocardiography. Aortic valve prosthesis was inserted retrograde using a femoral arterial or a subclavian artery approach. Results In 44 consecutive patients (mean age 79.1±7 years, 50% women, mean left ventricular ejection fraction 55.8±8.5%) TAVI was successfully performed. Follow-up 30 days after TAVI showed a significantly improved quality of life (baseline 44±19.1 vs 28±17.5 MLHFQ Score, p<0.001) and an enhanced distance in the 6-minute walk test (baseline 204±103 vs 266±123 m, p<0.001). B-type natriuretic peptide levels were reduced (baseline 725±837 vs 423±320 pg/ml, p=0.005). Conclusions Our preliminary results show a significant clinical benefit and a reduction of neurohormonal activation in patients with severe and symptomatic aortic valve stenosis early after TAVI.

Long-term outcome of patients with moderate and severe prosthetic aortic valve regurgitation after transcatheter aortic valve implantation.

Recently, moderate and severe postprocedure aortic regurgitations (ARs) have been identified as independent risk factors for short- and midterm mortality after transcatheter aortic valve implantation (TAVI). However, very few data exist on the long-term outcome of postprocedure AR. From 2008 to 2011, 198 consecutive patients with severe aortic stenosis successfully underwent TAVI with the CoreValve prosthesis (Medtronic CV, Minneapolis, Minnesota). After the procedure, patients were subdivided into groups depending on the presence of moderate/severe AR. The primary study end point was death from any cause after TAVI. The secondary end point was defined as cardiovascular death. In study patients (80 ± 6 years old, logistic European System for Cardiac Operative Risk Evaluation 22 ± 16%, left ventricular ejection fraction 53 ± 13%), moderate/severe AR occurred in 28 patients (14%). Despite similar baseline characteristics, patients with moderate/severe AR had higher 30-day and 1-year mortality rates than patients with none/mild AR (21% vs 6%, p = 0.019; 57% vs 16%, p <0.001, respectively). During a mean follow-up of 535 ± 333 days, the primary end point was reached in 54 and the secondary end point in 33 patients. Moderate/severe AR was the strongest independent risk factor of all-cause-mortality (hazard ratio 4.89, 95% confidence interval 2.78 to 8.56, p <0.001) and the strongest independent risk factor of cardiovascular mortality (hazard ratio 7.90, 95% confidence interval 3.95 to 15.81, p <0.001). In conclusion, moderate and severe postprocedure ARs are not uncommon complications after TAVI. Although long-term outcome of patients with none/mild AR is favorable, outcome of patients with moderate/severe AR is dismal.

One-Year Results of Transcatheter Aortic Valve Implantation in Severe Symptomatic Aortic Valve Stenosis

Transcatheter aortic valve implantation (TAVI) is an alternative therapy for symptomatic severe aortic valve stenosis in high-risk patients with several co-morbidities. We evaluated the 1-year effects of TAVI on quality of life, exercise capacity, neurohormonal activation, and myocardial hypertrophy. From June 2008 to October 2009, consecutive patients aged ≥75 years with symptomatic severe aortic valve stenosis (area <1 cm(2)) and a logistic euroSCORE ≥15% or aged >60 years with additional specified risk factors underwent TAVI. An aortic valve prosthesis (CoreValve) was inserted in a retrograde fashion. Examinations were performed before and 30 days and 1 year after TAVI. An assessment of the quality of life (Minnesota Living with Heart Failure Questionnaire), a 6-minute walking test, measurement of B-type natriuretic peptide, and echocardiography were performed. In 51 patients (mean age 78 ± 6.6 years, mean left ventricular ejection fraction 58.4 ± 12.2%), the follow-up examinations were performed after TAVI. The 1-year follow-up visit after TAVI revealed significantly improved quality of life (baseline Minnesota Living with Heart Failure Questionnaire score 39.6 ± 19 vs 26.1 ± 18, p <0.001) and more distance covered in the 6-minute walking test (baseline 185 ± 106 vs 266 ± 118 m, p <0.001). The B-type natriuretic peptide level had decreased (baseline 642 ± 634 vs 323 ± 266 pg/ml, p <0.001), and the left ventricular mass index had decreased (156 ± 45 vs 130 ± 42 g/m(2), p <0.001). The left ventricular diameter and ejection fraction remained unchanged. In conclusion, TAVI leads to significantly reduced neurohormonal activation, regression of myocardial hypertrophy, and lasting enhancement of quality of life and exercise capacity in patients with symptomatic and severe aortic stenosis 1 year after intervention.

Transcatheter aortic valve implantation for treatment of patients with degenerated aortic bioprostheses--valve-in-valve technique.

Background: The management of patients with degeneration of surgical bioprosthetic valve replacement remains a challenge because of the higher risk of re‐do aortic valve replacement. We present a case series of five patients with degenerated aortic bioprostheses treated with transfemoral transcatheter aortic valve implantation (TAVI). Methods: From December 2009 to May 2010, five patients with degenerated aortic valve bioprostheses (aortic valve area < 1 cm2 or severe aortic regurgitation), an excessive operative risk (EuroSCORE ≥ 30%), symptoms of heart failure (NYHA ≥ III) and an internal diameter of bioprosthetic aortic valve 20.5 ± 0.5 mm were included. Procedures were performed without hemodynamic support using femoral arteries. Balloon valvuloplasty with a 20‐mm balloon under rapid pacing was carried out before valve implantation. The 26‐mm CoreValve prosthesis, 18‐F‐generation (Medtronic, Minneapolis, Minnesota) was inserted retrograde under fluoroscopic guidance. Invasive and echocardiographic measurements were done immediately before and after TAVI. Clinical followup and echocardiography were performed after procedure (mean followup 72 days ± 60, range: 176–30 days). Results: In all patients TAVI was successful with immediate decrease of transaortic peak‐to‐peak pressure (P = 0.002). Mild aortic regurgitation occurred in two patients and one patient received a new permanent pacemaker. Major adverse cardiac and cerebrovascular events did not arise. NYHA functional class improved in all patients and left ventricular ejection fraction increased (P = 0.019). Conclusion: Our experiences with the valve‐in‐valve technique using the CoreValve prosthesis suggest that transfemoral TAVI is feasible in high risk patients with degenerated aortic bioprostheses.

Clinical outcome of transcatheter aortic valve implantation in patients with low‐flow, low gradient aortic stenosis

Background: Low‐flow, low‐gradient aortic stenosis is associated with relevant postoperative mortality whereas conservative management results in dismal prognosis. We present the initial experience of low‐flow, low‐gradient aortic stenosis treated with transcatheter aortic valve implantation (TAVI). Methods: From June 2008 to December 2010 167 consecutive patients with native severe aortic stenosis and an excessive operative risk underwent TAVI. Of these, 15 patients presented with low‐flow, low‐gradient aortic stenosis (aortic valve area < 1 cm2, left ventricular (LV) ejection fraction < 40%, aortic mean gradient < 40 mm Hg). The CoreValve prosthesis 18‐F‐generation (Medtronic, Minneapolis, Minnesota) was inserted retrograde. Clinical follow‐up and echocardiography were performed 6 months after procedure. Results: Patients with low‐flow, low‐gradient aortic stenosis (mean LV ejection fraction 32 ± 6%, mean aortic gradient 27 ± 7 mm Hg) had higher all‐cause mortality 6 months after TAVI compared to patients without low‐flow, low‐gradient aortic stenosis (33% vs. 13%, P = 0.037). In the surviving 10 patients with low‐flow, low‐gradient aortic stenosis, LV ejection fraction increased (34 ± 6% before vs. 46 ± 11% 6 months after TAVI, p = 0.005) and more distance covered in the 6‐minute walk test (218 ± 102 meters before vs. 288 ± 129 meters 6 months after TAVI, p = 0.038). Conclusion: Our study suggests that TAVI is feasible in patients with severe co‐morbidities and low‐flow, low‐gradient aortic stenosis. Within the first 6 months after treatment all‐cause mortality was considerable high, but the surviving patients showed symptomatic benefit and significant improvement of myocardial function and exercise capacity.

Heart failure in severe aortic valve stenosis: prognostic impact of left ventricular ejection fraction and mean gradient on outcome after transcatheter aortic valve implantation.

This prospective study aimed to evaluate the prognostic impact of left ventricular ejection fraction (LVEF) and aortic mean gradient patterns on outcome after transcatheter aortic valve implantation (TAVI).

Implantation of the CoreValve self-expanding valve prosthesis via a subclavian artery approach: a case report

an alternative technique for treatment of aortic stenosis in patients with an excessive surgical risk [8]. In 2002, Cribier and coworkers [2] performed the first in man implantation of a bovine pericardial prosthesis in a 57-year-old man with calcified aortic stenosis and cardiogenic shock, using an antegrade transseptal approach. Recently, they summarized their experience in a small series of patients [3]. Of the 36 patients taken to the catheterization laboratory, 27 patients underwent successfully aortic valve implantation [3]. In 23 cases, Cribier’s group used an antegrade, transseptal approach, in four patients a retrograde approach. Although not specifically emphasized by the authors, the differences in their methods are relevant. The antegrade approach demands a transseptal puncture, and the stiff guiding wire that loops from the left atrium to the ascending aorta may cause severe intraprocedural mitral regurgitation. Webb and coworkers reported about their experience in 18 patients with this technique, however, they preferred a retrograde approach for delivery of the Cribier–Edwards valve [9]. They advanced 22 F and 24 F sheaths from the femoral artery to the aorta, and successfully delivered the prosthesis in 14 cases. Of note, iliac injury occurred in two patients requiring surgery. In Germany, a first series of patients was reported by a group from Siegburg [5]. They used a CoreValve self-expanding valve prosthesis, delivered by first (24 F) and second (21 F) generation sheaths via a retrograde approach. Device success and procedural success were achieved in 88% and 84%, respectively. Of note, they discussed the advantages of this approach on account of procedural simplicity, but they also addressed the technical problems tracking a relatively long and high-profile stent valve apparatus through small-diameter, tortuous or heavily atherosclerotic aortas. Most recently in this context, Jilaihawi and coworkers illustrated that Waldemar Bojara Achim Mumme Ulrich Gerckens Michael Lindstaedt Michael Gotzmann Alfried Germing Markus Fritz Werner Pennekamp Andreas Mügge Implantation of the CoreValve self-expanding valve prosthesis via a subclavian artery approach: a case report

Fatal prosthetic valve endocarditis of the CoreValve ReValving System.

Sirs: Since the first human case description in 2005, the CoreValve self-expanding valve prosthesis (Medtronic, Minneapolis, Minnesota) is available for interventional treatment of aortic valve stenosis in patients with high surgical risk [1]. In the last years, an increasing number of patients treated with transcatheter valve implantation (TAVI). We present a case of Staphylococcus lugdunensis prosthetic valve endocarditis of the CoreValve ReValving

Correlation between total atrial conduction time estimated via tissue Doppler imaging (PA-TDI Interval), structural atrial remodeling and new-onset of atrial fibrillation after cardiac surgery.

Recent studies identified total atrial conduction time (TACT) as an independent and powerful predictor of new‐onset atrial fibrillation (AF). The purpose of this study was to assess the association between the degree of atrial fibrosis, TACT, and frequency of postoperative atrial fibrillation (POAF) among patients undergoing cardiac surgery.