The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

OBJECTIVES: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. METHODS: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. RESULTS: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. CONCLUSIONS: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Valve-in-valve implantation of a novel and small self-expandable transcatheter heart valve in degenerated small surgical bioprostheses: the Hamburg experience.

BACKGROUND: Transcatheter valve-in-valve (VIV) implantation has emerged as a novel treatment option in patients with degenerated aortic bioprostheses and high surgical risk. However, VIV implantation in small aortic bioprostheses using first generation TAVI devices has frequently resulted in high postprocedural gradients and small effective orifice areas. Recently, an updated version of the self-expandable Medtronic CoreValve prosthesis, which is particularly suitable for small aortic annuli, has become available. We report on the feasibility and early results of VIV implantation using this novel device in a series of patients with degenerated small aortic bioprostheses. METHODS AND RESULTS: 16 patients from two Hamburg hospitals (age range 72-92 years) underwent implantation of a 23-mm CoreValve Evolut (Medtronic, Minneapolis, MN, USA) transcatheter heart valve into failing aortic bioprostheses with internal diameters below 21 mm. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team mean (logistic EuroSCORE range 9.0-88%). Implantation was successful without relevant remaining aortic regurgitation or signs of stenosis and a marked reduction in postprocedural gradientswas observed in 14 out of 16 patients. The mean gradient was reduced from from 34 mm Hg (SEM 10 mm Hg) to 14 mm Hg (SEM 6 mm Hg). No major device- or procedure-related adverse events occurred during 30-day follow up and clinical improvement was observed. CONCLUSIONS: Failing aortic bioprostheses with small internal diameters continue to be a challenging pathology for TAVI due to the risk of high residual gradients and small aortic orifice areas. This report provides first evidence that the 23-mm CoreValve Evolut, a novel self-expanding prosthesis, provides an improved treatment option in these specific patients due to its low profile which resulted in promising early results. © 2013 Wiley Periodicals, Inc.

Transcatheter access route options for treatment of degenerated mitral valve prosthesis with a balloon-expandable biological valve.

OBJECTIVES: There is an ongoing discussion if valve-in-valve implantations into failing mitral xenografts should be performed only via a transapical approach. BACKGROUND: In selected high-risk patients, transcatheter valve implantation is an emerging therapy for degenerated mitral xenografts in need of repeated valve replacement. METHODS: Here we describe three different strategies to treat a failing mitral biological prosthesis (Carpentier Edwards S.A.V) by implantation of a SAPIEN-XT valve, which was performed in three different patients. As access site, a transjugular/transseptal approach, a transfemoral/transseptal approach, and a transapical approach were chosen. RESULTS: With all three approaches, valve-in-valve implantation was successfully achieved. The acute hemodynamic effects were excellent and according to VARC there was no adverse event recorded during a 6 months follow-up. CONCLUSIONS: Feasibility of all three approaches is demonstrated and might be taken into consideration for treatment in various patients.

Endovascular repair of ascending aortic aneurysm by transapical approach and periscope technique.

PURPOSE: To demonstrate transapical stent-graft implantation for the treatment of an ascending aortic aneurysm simultaneously using the "periscope" technique for all supra-aortic branches. TECHNIQUE: The treatment plan is demonstrated in a 67-year-old man with prior ascending aortic replacement and known ascending aortic aneurysm who presented with acute severe chest pain. Computed tomographic angiography (CTA) revealed an 11-cm ruptured aneurysm of the ascending aorta distal to the prosthesis. Surgery was impossible due to direct contact of the aneurysm with the sternum. Conventional retrograde stent-graft implantation was infeasible because of a sharp kink of the descending thoracic aorta, so the stent-grafts were implanted via a transapical approach. To provide blood flow to the supra-aortic branches, periscope grafts oriented from the target vessels down the descending thoracic aorta were implanted in all branches before main stent-graft placement. Completion angiography and subsequent CTA documented satisfactory retrograde perfusion of the supra-aortic branches via the periscope grafts. CONCLUSION: A dual approach in terms of transapical stent-graft implantation and the periscope technique for perfusion of the supra-aortic branches may be an option for the treatment of inoperable aneurysms of the ascending aorta.

Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis.

AIMS: To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis. METHODS AND RESULTS: Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%. CONCLUSIONS: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: outcomes according to access route and Mitral Valve Academic Research Consortium (MVARC) criteria.

AIMS: The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria. METHODS AND RESULTS: Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045). CONCLUSIONS: Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

Histology of debris captured by a cerebral protection system during transcatheter valve-in-valve implantation.

OBJECTIVE: Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported. METHODS: Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge. RESULTS: Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56-175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days). CONCLUSIONS: Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV.

Histological Findings and Predictors of Cerebral Debris From Transcatheter Aortic Valve Replacement: The ALSTER Experience.

BACKGROUND: Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined. METHODS AND RESULTS: Embolic debris was analyzed from 322 filters used in a dual-cerebral-filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12-31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032-1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089-2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161). CONCLUSION: This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way.

Severe infective endocarditis after MitraClip implantation treated by cardiac surgery.

AIMS: To report the first described case of a mitral valve infective endocarditis (IE) post MitraClip®. METHODS AND RESULTS: An 88-year-old patient at high surgical risk (log. EuroSCORE 30.4%) underwent a MitraClip procedure for severe eccentric organic mitral regurgitation (MR) due to prolapse with a flail leaflet of the P2 segment (flail gap 6 mm). After one month, the patient was readmitted to our department for fever and recurrence of shortness of breath. An echocardiogram demonstrated severe MR recurrence due to ulceration in the region of the posterior leaflet despite good insertion of both clips, and a large vegetation of 1513 mm within the clip region. Blood cultures were positive for staphylococcus aureus. The patient was treated by cardiac surgery with mitral valve replacement due to IE despite a very high logistic EuroSCORE of 56.8%. Histological and bacteriological analysis of the clip devices confirmed active IE. After cardiac surgery, transthoracic echocardiography showed no mitral regurgitation and a mean gradient across the mitral valve bioprosthesis of about 5 mmHg. The patient was discharged to a rehabilitation department 15 days after cardiac surgery. CONCLUSIONS: Surgical treatment as bail-out therapy for MR recurrence secondary to IE after MitraClip can be successfully carried out despite a high surgical risk.

Targeting systolic anterior motion and left ventricular outflow tract obstruction in hypertrophic obstructed cardiomyopathy with a MitraClip.

AIMS: Hypertrophic obstructive cardiomyopathy (HOCM) with left ventricular outflow tract obstruction frequently involves a systolic anterior motion (SAM) of the anterior mitral leaflet. We hypothesised that SAM could be a new target for MitraClip therapy. METHODS AND RESULTS: Three patients with HOCM were chosen for MitraClip therapy, due to significant SAM with subsequent mitral regurgitation. Invasive haemodynamic studies (right heart catheterisation, simultaneous transaortic pressure recording, and administration of nitroglycerine) were performed before and after MitraClip implantation, and a six-week follow-up was undertaken. MitraClip implantation was successfully performed with significant reduction of mitral regurgitation and SAM in all patients. Basal peak gradients (before clip: 65±25.5 mmHg; after clip: 7.7±5.0 mmHg) as well as provoked pressure gradients (before clip: 145.3±8.1 mmHg; after clip: 23.2±7.6 mmHg) were significantly reduced after MitraClip implantation. Right heart catheterisation data did not reveal major changes. At six-week follow-up, all patients presented in a persistently improved clinical state (NYHA Class I-II) with insignificant residual MR and continuously reduced LVOT gradients. CONCLUSIONS: This is the first catheter-based study targeting primarily a SAM in HOCM to reduce LVOT obstruction. The results prove the concept that SAM is more than an epiphenomenon in HOCM. Thus, SAM-induced obstruction might be a valuable target for the MitraClip.

Corrective Operation in an Intramyocardial Dissecting Hemorrhage After Subacute Anterior Myocardial Infarction.

Intramyocardial dissecting hemorrhage is a very rare and potentially lethal complication of myocardial infarction. The diagnosis is typically made by echocardiography, by cardiac magnetic resonance imaging, at operation, or during postmortem examination. Medical treatment is most often associated with high mortality, and surgical treatment is required. We report a 53-year old man admitted to the urology department with a large left-sided kidney infarction. A subacute myocardial infarction by electrocardiogram, elevated troponin T level, and typical clinical signs of an acute coronary syndrome 5 days and 2 weeks before admission were also evident. Intramyocardial dissecting hemorrhage with an adjacent thrombotic formation was suspected by echocardiography and cardiac computed tomography and confirmed by magnetic resonance imaging. The patient underwent successful surgical correction and was discharged in good clinical condition.

Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients.

BACKGROUND: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population. METHODS: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria. RESULTS: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%). CONCLUSION: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.

Coronary hybrid revascularization from January 1997 to January 2001: a clinical follow-up.

BACKGROUND: Hybrid revascularization (HyR), combining minimally invasive left internal mammary artery (LIMA) bypass grafting to the left anterior descending coronary artery (LAD) and catheter interventional treatment of the remaining coronary lesions, avoids the disadvantages associated with cardiopulmonary bypass (CPB). We investigated the clinical follow-up of 57 patients with multivessel disease undergoing this procedure in the last 4 years. METHODS: Between January 1997 and January 2001, 57 consecutive patients (41 men and 16 women, aged 65.7 +/- 7.9 years) with coronary artery disease (two-vessel, n = 34; three-vessel, n = 23) were treated with off-pump LIMA-to-LAD bypass combined with balloon angioplasty and stenting of the remaining significantly obstructed (> 50%) coronary vessels. Clinical follow-up data included a early postoperative and a 6-month control angiography and a patient interview in January 2001. RESULTS: All patients underwent LIMA-to-LAD bypass-grafting and balloon angioplasty in 72 coronary lesions without procedural-related complications. However, one early LIMA bypass occlusion was documented during coronary angiography. Postoperatively no deterioration of preexistent organ dysfunction was observed in any patient. The mean follow-up was 100.7 +/- 37.9 weeks in 55 of 57 patients (97%). Control angiography 6 months after HyR (n = 34) revealed a patent LIMA bypass in 33 patients and 8 in-stent restenoses (> 50%) in the coronary arteries that were treated interventionally by re-PTCA (n = 6) or by conventional CABG (n = 1). In 1 patient medical treatment resulted in significant reduction of angina so no further intervention was considered necessary. After HyR 1 patient died 18 months later of an intracerebral hemorrhage. All other patients are alive and doing well. CONCLUSIONS: Our results indicate that in selected patients with multivessel disease including left main stem stenosis HyR is an effective and secure procedure with excellent early and good midterm results. Especially elderly patients with severe concomitant diseases appear to benefit from this approach by avoiding CPB.

Off-Pump Arterial Revascularization Using a New Reusable Device for Coronary Occlusion and Local Stabilization.

Abstract Background: Optimal local stabilization, an unobstructed view, and a free field for operation are of most importance during off-pump surgery to facilitate high-quality anastomoses. We report on a new reusable stabilizing platform for complete off-pump coronary revascularization. Methods: From May 2001 until June 2002, 118 consecutive patients (82 men, 36 women) with coronary artery disease (61 with 1-vessel, 42 with 2-vessel, and 15 with 3-vessel disease) and a mean age of 63. 6 +/- 10. 0 years (range, 41-88 years) were scheduled for complete off-pump arterial revascularization. The mean left ventricular ejection fraction was 56. 5% +/- 12. 5%(range, 25%-85%). Exposure of the coronary vessels was facilitated with deep pericardial slings. The target coronary vessel was snared twice with air-cushioned silicone loops and fixed to the platform, which was connected to a flexible steel arm. The platform is available in 3 versions with different connector angles to accommodate various anatomical conditions. Together with its flat design, the platform provides an unobstructed view and a free field of operation. Results: All operations were performed without any intraoperative complications, and all planned bypasses were carried out. The mean number of bypass grafts was 1. 7 +/- 0. 8 (range, 1-5). There was no early (30 days) mortality. The postoperative course was uneventful in all patients except for 1 reexploration for retrosternal bleeding, 10 patients with temporary atrial fibrillation, and 1 patient with reintubation after early extubation in the operating room because of respiratory insufficiency. Patients were discharged from the hospital in good condition 8. 7 +/- 2. 6 days (range, 5-18 days) after surgery. Conclusions: Our data indicate that complete arterial off-pump revascularization can be performed safely and effectively with a new reusable platform that provides excellent stabilization and an unobstructed view to the target coronary vessels.

A steel band in addition to 8 wire cerclages reduces the risk of sternal dehiscence after median sternotomy.

BACKGROUND: Sternal dehiscence after full median sternotomy may result in wound-healing disorders, including osteomyelitis. The consequences are extended hospitalization, plastic surgery, stress for the patient, and increased costs. Stable closure of the median sternotomy plays a crucial role in the avoidance of sternal dehiscence and osteomyelitis. METHODS: All patients who underwent full sternotomy from January 1999 until December 2001 were investigated with respect to the incidence of sternal dehiscence. Since January 2000, patients supposed to be at risk for sternum dehiscence were more frequently treated with an Ethicon steel band at the third intercostal space in addition to standard osteosynthesis with 8 wire cerclages. RESULTS: Since the introduction of this method, the incidences of sternal dehiscence and sternal wound infections decreased from 2.9% and 0.9 %, respectively, in 1999 to 0.3% and 0.2%, respectively, in 2001. This decline resulted in shorter postoperative hospital stays, less stress for the patients, and substantial reductions in postsurgical costs. CONCLUSIONS: A steel band used in addition to standard osteosynthesis with 8 wire cerclages is a safe and effective procedure resulting in a statistically significant decrease in the frequency of sternal dehiscence.

Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up.

OBJECTIVES: The second-generation Jenavalve prosthesis (Jenavalve Technology, Inc., Munich, Germany) is the first transcatheter valve Conformité Européene (CE) marked for treatment of both aortic stenosis (AS) and pure aortic regurgitation (AR). Although the feasibility of the Jenavalve transcatheter aortic valve implantation (TAVI) in patients with pure AR has been described, haemodynamic and follow-up data are lacking. METHODS: We report on a series of 10 transapical Jenavalve implantations for pure AR between December 2012 and September 2013. The patients were determined for TAVI by heart team decision at high surgical risk [log EuroSCORE (European System for Cardiac Operative Risk Evaluation) >20%], frailty or Charlson Comorbidity Index (CCI). Transaortic gradients and right heart haemodynamics were measured invasively before and after TAVI. Ventriculography and transoesophageal echocardiography were used to determine paravalvular regurgitation. All-cause mortality, NYHA functional class and echocardiographic measurements were followed up at 30 days and at 3, 9 and 12 months postoperatively. RESULTS: Overall, mean age was 79 ± 9 years, mean left ventricular ejection fraction 50 ± 17% and mean log EuroSCORE 28.3 ± 17.1%. There were no perioperative complications. Paravalvular regurgitation immediately after implantation was graded none (n = 6), trace (n = 3) or mild (n = 1). Overall 30-day mortality was 30% (3/10). Three patients refused further treatment, such as haemodialysis or treatment of mitral regurgitation. Rate for pacemaker implantation was 2/10 (20%). CONCLUSIONS: Intraprocedural success and haemodynamic data in our cases were good. The mortality in our group highlighted the importance of careful patient selection, especially for this pathology. The Jenavalve prosthesis proved to be suitable for treatment of AR in surgical high-risk patients.

Balloon-expandable valves for degenerated mitral xenografts or failing surgical rings.

AIMS: Transcatheter mitral valve-in-valve implantation (TMViVI) for the treatment of failing mitral xenografts or recurrent mitral regurgitation after surgical ring implantation is an emerging therapy for patients in need of repeated mitral valve surgery. Despite the fact that these procedures have been shown to be feasible and effective, haemodynamic data after TMViVI are still limited in the literature. METHODS AND RESULTS: Twelve patients (logES: 39.2±23.5%) were treated either by transapical (n=7) or transseptal (n=5) TMViVI, as a valve-in-valve (ViV, n=8) or valve-in-ring (ViR, n=4) implantation. Left atrial pressures (LAP), transmitral gradients and right heart haemodynamics (Swan-Ganz catheterisation) were studied before and after TMViVI. Procedural success was 100%, mitral regurgitation after TMViVI was mild in one, trace in five and absent in six patients. Thirty-day mortality was 0%. Left atrial pressures decreased significantly after valve implantation (before LAPmean/v-wave: 24.3/44.1 mmHg; after LAP/v-wave 15.9/22.1 mmHg; p<0.001) and cardiac output increased significantly. Transmitral gradients corresponded to mitral surface areas between 1.7 and 3.5 cm2, and were thus very acceptable in terms of the high surgical risk population. CONCLUSIONS: In conclusion, TMViVI with the balloon-expandable SAPIEN XT valve for ViV or ViR implantation is feasible with promising acute transmitral haemodynamic data. Nevertheless, sustained long-term performance remains to be demonstrated in the future.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.