Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Virtual support for remote proctoring in TAVR during COVID-19.

OBJECTIVES: The current report describes a single operator's experience of the first use of smartglass technology as a facilitator of virtual support during TAVR proctoring. BACKGROUND: Restricted gatherings and containment measures during the ongoing COVID-19 pandemic have a major impact on daily clinical practice. Interaction between peers is crucial in science, clinical practice, and education. In addition, there is also a growing importance of proctoring in interventional cardiology for structural heart disease. Virtual support may facilitate the wide implementation of remote proctoring. METHODS: A collaboration between a smartglass provider (Rods & Cones) and self-expandable transcatheter aortic heart valve system (Medtronic) was initiated and tested extensively prior to TAVR procedures. Two cases were randomly selected for remote support. The light-weight smartglass consisted of a full HD central camera, a 720p ×5 optical zoom camera, built-in LED light, speaker and earphone jack, and an external visor to project data in a nonobstructive manner in the operators' view. RESULTS: Preprocedural detailed discussion of the cases between the proctor and the operator occurred via teleconferencing. Successful procedural virtual support was determined by the presence of a session coordinator, high quality of the central camera, high-speed and stable wireless internet connection. Limitations were the relative discomfort of the earpieces, discordance between the central and zoom camera and the absence of visual fixation during head motions. CONCLUSION: In a highly complex and demanding context such as TAVR, remote proctoring by means of virtual support is feasible and efficacious.

Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study.

AIMS: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. METHODS AND RESULTS: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). CONCLUSIONS: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

AIMS: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. METHODS AND RESULTS: Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days. CONCLUSION: Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.

Safety and efficacy of a repositionable and fully retrievable aortic valve used in routine clinical practice: the RESPOND Study.

AIMS: RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis. METHODS AND RESULTS: RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6.0 ± 6.9). Repositioning was attempted in 29.2% of patients, with 99% success. The rate of all-cause mortality in the intent-to-treat population at 30 days (primary endpoint) was 2.6% (P < 0.001 vs. pre-specified performance goal). Thirty-day clinical follow-up was completed for 97.3% of patients. Among patients who received a Lotus Valve, the 30-day overall and disabling stroke rates were 3.0% and 2.2%, respectively. The 30-day permanent pacemaker implantation rate was 30.0% in all patients, and 34.6% in pacemaker-naïve patients. Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory. Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge (P < 0.001). Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge (P < 0.001). At hospital discharge, paravalvular leak (PVL) was absent or trace in 92% of patients; no patients had severe PVL, 0.3% of patients exhibited moderate PVL, and 7.7% of patients had mild PVL. Clinical follow-up in RESPOND will extend to 5 years. CONCLUSION: The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov #NCT 02031302.

Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for patients with severe, symptomatic aortic valve stenosis at high surgical risk over the last years. However, besides its minimal invasive character, TAVI still is an invasive procedure usually performed in a population, carrying a substantial risk for vascular complications, like stroke. Stroke is known to be a rare but serious complication of transvascular interventions in clinical practice, which is associated with high morbidity and mortality rates. Despite broad clinical research in many fields of TAVI over the last years, only sparse data still exist on the incidence and clinical risk factors of stroke complicating TAVI in clinical practice today. METHODS: We analyzed data of 1.413 TAVIs, which were enrolled at 30 sites into the prospective and multicenter German TAVI Registry from January 2009 until June 2010. RESULTS: The overall incidence of cerebrovascular events complicating TAVI was 3.2% (n = 45/1.413) in a real-world population today. 40% of all cerebrovascular events were classified as transient ischemic attacks (TIA) with symptoms lasting < 24 hr (18/45) and 60% were classified as stroke with symptoms persisting > 24 hr (27/45). All strokes complicating TAVI of 50% were classified as major strokes leading to notable disability in patients, who survive this complication (Modified Ranking Scale 3-6). In-hospital mortality rate in patients with stroke/TIA was 28.9%, compared to 6.9% in patients without stroke/TIA and 1-year mortality rate 46.7% versus 18.6%, respectively. In multivariate analysis, prior stroke and renal impairment were found as the only independent predictors for stroke complicating TAVI. CONCLUSIONS: Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

AIM: Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. METHODS AND RESULTS: Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. CONCLUSION: The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.

Percutaneous treatment of a post-TAVI ventricular septal defect: a successful combined procedure for an unusual complication.

In this report, we present the successful percutaneous ventricular septal defect (VSD) closure, just 1 week post-transcatheter aortic valve implantation (TAVI). Periprocedurally, after implantation of the 31-mm CoreValve in an intentionally "high" position, we balloon postdilated, with an excellent result. A week post-TAVI, the patient started to deteriorate. Echocardiogram revealed a good working prosthesis; however, a perimembranous VSD was evident, causing significant shunt. We proceeded with interventional treatment of the defect, using an Amplatzer multifenestrated--"Cribriform"--septal occluder. Six months after the combined procedure, the patient showed marked improvement in symptoms and no shunt was observed.

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.

OBJECTIVES: To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry. BACKGROUND: Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations. METHODS: In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed. RESULTS: Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17). CONCLUSIONS: PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry.

BACKGROUND: A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting. METHODS: A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry. RESULTS: Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD (P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI. CONCLUSIONS: In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy.

Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.

AIMS: Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry. METHODS AND RESULTS: Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%. CONCLUSION: In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

Leaflet-splitting device to prevent coronary artery obstruction in valve-in-valve transcatheter aortic valve implantation.

Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement procedures, and current preventive strategies are suboptimal. The novel ShortCut device splits bioprosthetic valve leaflets that are at risk of causing coronary artery obstruction after transcatheter aortic valve implantation, allowing for normal coronary flow. In this video tutorial, we demonstrate a valve-in-valve transcatheter aortic valve implantation using a dedicated leaflet-splitting device for prevention of coronary artery obstruction in transcatheter aortic valve replacement.

Sequential CoreValve implantation for a mal-positioned prosthesis during transcatheter aortic valve implantation.

Transcatheter aortic-valve implantation is rapidly emerging as an effective, safe, and sustainable alternative for a specific subset of high-surgical risk and/or inoperable patients with severe aortic stenosis. However, technical challenges remain for this relatively new procedure, not the least mal-positioning of the transcatheter prosthesis resulting in acute aortic regurgitation. We report a case of deep implantation of a CoreValve prosthesis that was inadvertently pulled out of the aortic annulus during repositioning. The patient received a second sequential CoreValve successfully.

Iatrogenic dissection of the ascending aorta during TAVI sealed with the CoreValve revalving prosthesis.

Transcatheter aortic valve implantation (TAVI) is rapidly becoming an accepted treatment option for a selected group of high risk or inoperable patients with severe aortic stenosis. However, this procedure is not without complications. We report a case of acute type A aortic dissection due to balloon aortic valvuloplasty during TAVI that was successfully sealed by the CoreValve prosthesis, thus avoiding surgical intervention.

Correction of aortic regurgitation after transcatheter aortic valve implantation of the Medtronic CoreValveTM prosthesis due to a too-low implantation, using transcatheter repositioning.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has been introduced for the treatment of severe symptomatic aortic stenosis in patients not suitable for surgical valve replacement. However, a potential problem of TAVI is the development of severe aortic insufficiency after valve implantation due to a too-low implantation of the valve. METHODS: Since August 2008, a total of 33 TAVI procedures using the 18 Fr Medtronic CoreValve ReValving system has been performed at the authors' institution. RESULTS: Severe post-implantation aortic regurgitation occurred in three patients (9%), due to a too-low implantation. Two of these patients underwent a catheter-based repositioning of the valve using a standard snare; the third patient declined any further intervention. Both repositioning procedures were uneventful, with no significant residual regurgitation. CONCLUSION: Severe aortic regurgitation after TAVI with the Medtronic CoreValve system is not uncommon. If the valve is implanted too low, a catheter-based valve repositioning may be the method of choice to resolve the problem.

Transcatheter aortic valve implantation: predictors of procedural success--the Siegburg-Bern experience.

AIMS: The purpose of the present analysis was to identify predictors of procedural success of percutaneous transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We prospectively assessed in-hospital outcome of patients undergoing TAVI at two institutions. We analysed clinical, morphological, and procedural parameters using univariate and multivariate regression models. Between 2005 and 2008, a total of 168 consecutive patients with symptomatic aortic valve stenosis underwent TAVI using the self-expanding CoreValve Revalving prosthesis. Patients (93%) were highly symptomatic with a New York Heart Association grade III/IV and a mean aortic valve area of 0.66 +/- 0.21 cm(2). Acute and in-hospital procedural success rates were 90.5 and 83.9%, respectively, with an in-hospital mortality, myocardial infarction, and stroke rate of 11.9, 1.8, and 3.6%, respectively. Predictors of in-hospital procedural success were type of access (OR 0.33, 95% CI 0.13-0.82, P = 0.017), prior coronary intervention (OR 5.3, 95% CI 1.20-23.41, P = 0.028) and pre-procedural Karnofsky index using univariate regression. Pre-procedural Karnofsky index emerged as the only independent predictor (OR 1.04, 95% CI 1.00-1.08, P = 0.032) in the multivariate analysis. CONCLUSION: Pre-procedural functional performance status predicts the in-hospital outcome after TAVI. Patients with a good functional status are likely to benefit more from TAVI than previously reported high-risk patients.

Transaortic transcatheter aortic valve implantation: a novel approach for the truly "no-access option" patients.

OBJECTIVES: The aim of this study was to test the safety and efficacy of the retrograde, minimally invasive, "transaortic" approach of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis) as an alternative minimally invasive surgical access route. BACKGROUND: TAVI is today recognized as an established percutaneous technique for patients with severe aortic valve stenosis (AS). However, as the number of patients screened for TAVI increases, many are found with absolutely no option for peripheral artery access. METHODS: A new method of TAVI access, described as "transaortic" was performed in two patients A CoreValve prosthesis was implanted via the "transaortic" route. The patients were a 93- and a 84-year-old woman, both with severe PAOD. After a ministernotomy the ascending aorta was directly punctured. At the end, the access site was surgically sutured with the prepositioned sutures. The patients were at all times "off-pump" (beating heart procedure) and without IABP. RESULTS: TAVI was successful in both cases, leading to a fall in the transvalvular gradient and there were no cases of mortality, stroke or myocardial infarction. The patients were extubated directly after the procedure, mobilized after 4 days, and were discharged home after 7 and 9 days. CONCLUSIONS: In the rare occasion, where due to anatomical reasons transfemoral TAVI is not feasible, a minimally invasive "transaortic" approach, as described, provides an alternative option. This is especially true when the transapical route is not suitable (annulus >25 mm or contraindication to lateral thoracotomy).

"Device landing zone" calcification, assessed by MSCT, as a predictive factor for pacemaker implantation after TAVI.

BACKGROUND: After trans-catheter aortic valve implantation (TAVI), the need for postinterventional pacemaker (PM) implantation can occur in as many as 10-50% of cases, but it is not yet clear, how this need can be predicted. The aim of this study was to assess the possible predictive factors of post TAVI PM implantation based on Computed Tomography (CT) measured aortic valve calcification and its distribution. METHODS: We prospectively analyzed 81 consecutive symptomatic patients with severe AS scheduled for TAVI using the CoreValve prosthesis (Medtronic, Minneapolis, USA). In all patients, a native and contrast-enhanced multislice cardiac CT was performed preinterventionally, estimating calcification load of the native valve cusps and of the adjacent outflow tract (so called "device landing zone", DLZ) by the Agatston Score (AgS). Objective, computer-evaluated, preprocedural ECG-analysis was performed with regards to pre-existing conduction abnormalities. Transthoracic echocardiography was performed pre and post TAVI. RESULTS: TAVI was successful in all cases. PM implantation was deemed necessary in altogether 32 patients, out of 67 without a PM pre-TAVI (32/67, 47%). Various parameters were tested as predictors of post TAVI PM in a multivariate logistic regression analysis model. Female sex (P = 0,005) and depressed EF (P = 0,023) showed a significant correlation. PM implantation correlated also to the DLZ calcification, as assessed by CT (P = 0,004). This model leads to an AUC (area under the ROC-receiver operator characteristics-curve) of 0.83. CONCLUSION: Calcium amount in the CoreValve DLZ in combination with clinical data could predict the need for post TAVI PM implantation.