Patient-Specific Computer Simulation of Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Morphology.

BACKGROUND: A patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in tricuspid aortic valve has been developed, which can predict paravalvular regurgitation and conduction disturbance. We wished to validate a patient-specific computer simulation of TAVR in bicuspid aortic valve and to determine whether patient-specific transcatheter heart valve (THV) sizing and positioning might improve clinical outcomes. METHODS: A retrospective study was performed on TAVR in bicuspid aortic valve patients that had both pre- and postprocedural computed tomography imaging. Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis and computational fluid dynamics was performed. The simulation output was compared with postprocedural computed tomography imaging, cineangiography, echocardiography, and electrocardiograms. For each patient, multiple simulations were performed, to identify an optimal THV size and position for the patient's specific anatomic characteristics. RESULTS: A total of 37 patients were included in the study. The simulations accurately predicted the THV frame deformation (minimum-diameter intraclass correlation coefficient, 0.84; maximum-diameter intraclass correlation coefficient, 0.88; perimeter intraclass correlation coefficient, 0.91; area intraclass correlation coefficient, 0.91), more than mild paravalvular regurgitation (area under the receiver operating characteristic curve, 0.86) and major conduction abnormalities (new left bundle branch block or high-degree atrioventricular block; area under the receiver operating characteristic curve, 0.88). When compared with the implanted THV size and implant depth, optimal patient-specific THV sizing and positioning reduced simulation-predicted paravalvular regurgitation and markers of conduction disturbance. CONCLUSIONS: Patient-specific computer simulation of TAVR in bicuspid aortic valve may predict the development of important clinical outcomes, such as paravalvular regurgitation and conduction abnormalities. Patient-specific THV sizing and positioning may improve clinical outcomes of TAVR in bicuspid aortic valve.

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.

Transcatheter valve-in-valve implantation in a degenerated very small Mitroflow prosthesis.

OBJECTIVES: To assess the feasibility and results of 'valve-in-valve' implantation using the 23-mm CoreValve for the treatment of degenerated 19-mm and 21-mm Mitroflow bioprostheses. METHODS: We retrospectively analysed all consecutive patients who underwent transcatheter aortic valve implantation for 19-mm and 21-mm Mitroflow bioprostheses. The height of implantation with respect to the ring of the Mitroflow prosthesis was targeted at -6 mm for the first 3 cases. In the following cases, the target was higher to promote free supra-annular movement of the leaflets. RESULTS: The procedure was successful in 17 of 18 patients (94%). For implantations above the limit of -6 mm, the mean gradient was 10.4 ± 2.6 mmHg compared with 28.1 ± 11.6 mmHg for implantations below the limit of -6 mm (P < 0.01). For patients with severe stenosis as main mechanism of failure of the bioprosthesis, the mean post-procedural gradient was 31.2 ± 11.8 mmHg compared with 12.7 ± 6 mmHg in the absence of severe stenosis (P < 0.01). Patient-prosthesis mismatch (indexed effective orifice area ≤ 0.85 cm2/m2) and severe mismatch (indexed effective orifice area ≤ 0.65 cm2/m2) were present in 83% (15 of 18) and 27% (5 of 18) of patients, respectively. We did not notice any complications following the procedures. Six months after the procedure, functional status was improved in all patients. CONCLUSIONS: Our short series demonstrates the ability to perform transcatheter 'valve-in-valve' implantation in 19-mm and 21-mm Mitroflow prostheses with satisfactory results, but high post-procedural gradients and patient-prosthesis mismatch remain a relatively frequent problem mostly when severe stenosis is the main mechanism of failure. Implantation in a high position is critical to decrease the rate of high postimplantation gradients.

Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis: Insights From the Valve-in-Valve International Data Registry (VIVID).

BACKGROUND: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). METHODS AND RESULTS: Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). CONCLUSIONS: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

OBJECTIVES: The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND: The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS: Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS: A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS: This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

Treatment and clinical outcomes of transcatheter heart valve thrombosis.

BACKGROUND: Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. METHODS AND RESULTS: THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. CONCLUSIONS: THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.

Transcatheter aortic valve implantation in failed bioprosthetic surgical valves.

IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.

Transcatheter aortic valve implantation for severe autograft regurgitation after Ross operation.

The Ross operation is the procedure of choice for aortic valve disease in paediatric patients, because of the potential for growth of the pulmonary autograft and because anticoagulation is not required. However, early and late autograft dilatation and severe aortic regurgitation may occur. Transcatheter aortic valve implantation (TAVI) is an effective procedure for treatment of severe degenerative aortic stenosis in patients deemed inoperable or high surgical risk. Off-label treatment of severe non-calcified aortic regurgitation with transcatheter heart valves has occasionally been reported. We describe the first case of TAVI for severe aortic regurgitation in a young woman 10 years after a Ross operation. The procedure was performed on a compassionate basis after the patient was deemed inoperable because of severe reactive pulmonary hypertension (95/55/68 mmHg; pulmonary resistance 18.3 UR) and haemodynamic compromise. A 29 mm CoreValve (Medtronic, Minneapolis, MN, USA) was implanted. A second prosthesis was deployed "valve-in-valve" for residual severe paravalvular leak, caused by the peculiar post-surgical anatomy of the left ventricular outflow tract. The procedure was successful and the in-hospital course was uncomplicated. During follow-up, pulmonary pressure and resistances were significantly lowered and at four years the patient showed markedly improved exercise tolerance.

Distortion of the CoreValve during transcatheter aortic valve-in-valve implantation due to valve dislocation.

Nowadays transcatheter aortic valve implantation (TAVI) is an accepted alternative to surgical aortic valve replacement for high-risk patients (pts). Successful TAVI procedures for failed aortic surgical bioprosthesis (TAV-in-SAV) have already been reported. In the presented two cases of TAV-in-SAV implantation a strut distortion of the stent was revealed on angiographic imaging and confirmed on control CT scan. In both procedures, a dislocation of the medtronic core valve (MCV) prosthesis during implantation led to valve retrieval, with a necessity of reloading it in the 18F introducer before subsequent implantation of the same valve in correct position.

Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation.

OBJECTIVES: This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable BACKGROUND: Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. METHODS: Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. RESULTS: A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). CONCLUSIONS: This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.

First-in-man assessment of a dedicated guidewire for transcatheter aortic valve implantation.

AIMS: The aim of this study was to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire. METHODS AND RESULTS: From May 2011 to August 2012, 39 consecutive patients referred for TAVI were prospectively enrolled in a first-in-man, open label, non-randomised feasibility study to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire in our institution (mean age 80.4±5.1 years, mean logistic EuroSCORE 26.8±11.7%, n=29 CoreValve transfemoral, n=8 CoreValve direct aortic, n=1 Edwards SAPIEN valve direct aortic, n=1 CoreValve subclavian). The primary safety endpoint was reached successfully with the dedicated TAVI guidewire in all 39 cases with no cases of guidewire displacement from the left ventricle during the procedure. In three cases the wire was repositioned to optimise loop position using a pigtail catheter prior to valve implantation. There were no cases of guidewire-related procedural complications. The mean delivery system tracking time using the guidewire was 1.4±0.6 minutes and the mean deployment time for TAVI was 13.8±7.8 minutes. CONCLUSIONS: This represents the first recorded use of a dedicated TAVI guidewire to treat patients with a transcatheter aortic valve. The wire is easy to place, safe to adjust within the ventricle, and the stiffness of the wire facilitates valve tracking through tortuous anatomy. In this study there were no pericardial complications with the use of this dedicated TAVI guidewire.

Transcatheter aortic valve implantation for severe, non-calcified aortic regurgitation and narrow aortic root: description from a case report of a new approach to potentially avoid coronary artery obstruction.

Transcatheter aortic valve implantation is a possible, although off-label, alternative to conventional aortic valve replacement for high-surgical-risk patients with severe, non-calcified aortic regurgitation (AR). To date, feasibility has only been demonstrated with the Medtronic CoreValve prosthesis (MCV). This prosthesis needs the aortic sinuses to have enough width to avoid coronary obstruction. We report a case of MCV implantation for severe AR where the narrow aortic root theoretically precluded the technique. Good procedural outcome was achieved thanks to a strategy of implantation with planned positioning of the prosthesis leaflets away from the coronary arteries.

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.

Complications at the time of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) improves the prognosis of patients with severe aortic stenosis who are deemed too high risk for surgical valve replacement. However, this evolving technology is associated with a wide range of potential complications--some specific to TAVI, some often fatal. Prevention, early recognition, and effective treatment of these complications will significantly improve the outcome of this procedure and are essential prerequisites before the therapy is extended to lower-risk patient subsets.

Comparison of magnetic resonance imaging of aortic valve stenosis and aortic root to multimodality imaging for selection of transcatheter aortic valve implantation candidates.

The purpose of the present study was to compare the aortic valve area, aortic valve annulus, and aortic root dimensions measured using magnetic resonance imaging (MRI) with catheterization, transthoracic echocardiography (TTE), and transesophageal echocardiography (TEE). An optimal prosthesis--aortic root match is an essential goal when evaluating patients for transcatheter aortic valve implantation. Comparisons between MRI and the other imaging techniques are rare and need validation. In 24 consecutive, high-risk, symptomatic patients with severe aortic stenosis, aortic valve area was prospectively determined using MRI and direct planimetry using three-dimensional TTE and calculated by catheterization using the Gorlin equation and by Doppler echocardiography using the continuity equation. Aortic valve annulus and the aortic root dimensions were prospectively measured using MRI, 2-dimensional TTE, and invasive aortography. In addition, aortic valve annulus was measured using TEE. No differences in aortic valve area were found among MRI, Doppler echocardiography, and 3-dimensional TTE compared with catheterization (p = NS). Invasive angiography underestimated aortic valve annulus compared with MRI (p <0.001), TEE (p <0.001), and 2-dimensional TTE (p <0.001). Two-dimensional TTE tended to underestimate the aortic valve annulus diameters compared to TEE and MRI. In contrast to 2-dimensional TTE, 3 patients had aortic valve annulus beyond the transcatheter aortic valve implantation range using TEE and MRI. In conclusion, MRI planimetry, Doppler, and 3-dimensional TTE provided an accurate estimate of the aortic valve area compared to catheterization. MRI and TEE provided similar and essential assessment of the aortic valve annulus dimensions, especially at the limits of the transcatheter aortic valve implantation range.

Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients.

OBJECTIVE: Trans-catheter aortic valve implantation (TAVI) technology is rapidly evolving, with 412 procedures having been performed at our institution. Herein, we report a complete, prospective analysis of complications occurring during transvascular and trans-apical implantations with two different prostheses. METHODS: Between June 2007 and June 2010, 412 patients (258 female, mean age 80.3±7.2 years, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 20.2%±13.0%) underwent TAVI through either a retrograde (n=252 transfemoral, n=28 transaxillary, and n=5 transaortic) or antegrade (n=127 trans-apical) approach at our institution. The trans-apical access was chosen only in cases where transvascular implantation was not possible. As many as 283 CoreValve and 129 Edwards Sapien prostheses were implanted. RESULTS: Thirty-day survival was 90.9%. Vascular complications occurred in 42 patients (10.2%). In four patients, lethal aortic root (n=3) or abdominal (n=1) aortic rupture occurred. Pericardial effusion developed in 53 patients (12.8%), which resulted in cardiac tamponade in 12 patients (2.9%). Twenty-three patients (5.6%) with valve malplacement were treated interventionally. In five patients (1.2%), emergency institution of cardiopulmonary bypass was required during the procedure for temporary support; all patients survived. Seventeen patients underwent re-intervention on the catheter valve (4.1%). CONCLUSIONS: With growing experience, complications with TAVI may be avoided by proper patient selection and skillful management. Other complications, when they occur, require a specific treatment algorithm to avoid delay in decision making. A considerable number of complications after TAVI require surgical treatment. Therefore, the ideal environment for TAVI procedures is a hybrid operating room, where a multidisciplinary team of surgeons, cardiologists, and anesthesiologists is best fitted to meet the current needs associated with TAVI technology. A reduction in complications was seen after 300 cases. This finding attests to the complexity of the procedure in addition to the experience required to reduce the incidence of complications.

Outcome of patients with aortic stenosis referred to a multidisciplinary meeting for transcatheter valve.

BACKGROUND: Until recently, many elderly patients with symptomatic aortic stenosis and multiple risk factors were untreated due to perceived risks of surgery. With the advent of transcatheter aortic valve implantation there has been a surge in referral for treatment. We present the outcome of patients referred to a multidisciplinary meeting. METHODS: A total of 175 patients were reviewed between January 2008 and March 2010. Patients' characteristics, investigations, and their outcome designated for transcatheter aortic valve implantation, surgical aortic valve replacement, and medical therapy were studied. The decision making process was a combination of known risk factors accounted for in the European system for cardiac operative risk evaluation and factors unaccounted for in traditional scoring systems. RESULTS: Sixty-three patients underwent transcatheter implantation, 74 underwent surgical valve replacement, and 38 were treated medically. There were no deaths at 30 days in the transcatheter or surgical group. There were more strokes (6.3% vs 1.4%, p = 0.057) and pacemaker implantations (25% vs 0, p = 0.0001) in the transcatheter group compared with the surgical group. The patients in the transcatheter group had shorter ventilation and intensive care stays. Similar numbers were discharged home or to their original residence. At median follow-up of 466 days, more patients had paravalvular and central aortic valve regurgitation in the transcatheter group. At one year there were more deaths in the medically managed group (30%), compared with the transcatheter (17%) or surgical groups (4%). CONCLUSIONS: Symptomatic high-risk aortic valve patients have a good outcome after transcatheter aortic valve implantation or surgery. Forty-two percent of patients referred for transcatheter aortic valve implantation had surgery and did well. The medically managed group have a poor outcome.