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.

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.

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.

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.

Transcatheter Restoration of the Left Ventricular Outlet in a Patient With an Implanted Apicoaortic Conduit.

We describe the transcatheter management of severe aortic regurgitation in a middle-aged patient with a porcelain aorta who underwent implantation of an apicoaortic valved conduit 12 years ago. Instantaneous relief of heart failure symptoms was achieved by restoring antegrade blood flow to the ascending aorta. (Level of Difficulty: Advanced.).

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.

Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort.

OBJECTIVES: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. BACKGROUND: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. METHODS: The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. RESULTS: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). CONCLUSIONS: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).

Importance of Contrast Aortography With Lotus Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the RESPOND Post-Market Study.

OBJECTIVES: The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). BACKGROUND: Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. METHODS: The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. RESULTS: A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (<6.5 mm: 21% vs. ≥6.5 mm: 41%; p < 0.001). After adjustment for confounders, implantation depth independently predicted need for PPI (odds ratio per 1-mm increment in depth: 1.200; 95% confidence interval: 1.091 to 1.319; p = 0.002). More than trivial PVL was present in 23% by contrast aortography and in 8% by TTE. Implantation depth was not correlated with PVL by contrast aortography or TTE (p = 0.342 and p = 0.149, respectively). PVL grading by contrast aortography and TTE was concordant in 77%. CONCLUSIONS: In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.

Five-year follow-up after transcatheter aortic valve implantation for symptomatic aortic stenosis.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of long-term mortality need to be evaluated to better select patients. Therefore, we aimed to analyse predictors of 5-year mortality after TAVI. METHODS: We analysed data from the German Transcatheter Aortic Valve Interventions-Registry. Each of the 27 participating hospitals agreed to include all consecutive TAVI patients at their institution. Out of 1444 patients treated with TAVI, 1378 patients had a follow-up of at least 4.5 years (completeness 95.4%). Endpoint for this analysis was 5-year survival. Cox regression analysis was used to determine risk factors associated with this endpoint. RESULTS: Patients who died were compared with survivors. The two groups showed multiple differences in patient characteristics, indications for interventions, preinterventional, as well as interventional characteristics and postinterventional events. Calculated 1-year mortality was 21.8% and 5-year mortality 59.1%. A higher logistic EuroScore was associated with a lower 5-year survival, being 45.5% in patients with a logistic EuroScore of <20%, 34.5% in those with 20% to 40% and 28.4% in patients with a logistic EuroScore >40%. Cox proportional hazard analysis revealed the following independent predictors of 5-year mortality: female gender (HR =0.66, 95% CI 0.56 to 0.77, p<0.0001), renal failure (HR=1.43, 95% CI 1.22 to 1.69, p<0.0001), prior mitral regurgitation ≥II° (HR=1.42, 95% CI 1.21 to 1.65, p<0.0001), residual aortic regurgitation ≥II° (HR=1.52, 95% CI 1.24 to 1.85, p<0.0001), atrial fibrillation (HR=1.38, 95% CI 1.18 to 1.64, p=0.0001), low gradient aortic stenosis (HR=1.48, 95% CI 1.19 to 1.84, p=0.0004), prior decompensation (HR=1.32, 95% CI 1.13 to 1.54, p=0.0006), frailty (HR=1.31, 95% CI 1.09 to 1.58, p=0.004), surgical TAVI (HR=1.42, 95% CI 1.12 to 1.80, p=0.004), age (by year) (HR=1.02, 95% CI 1.01 to 1.03, p=0.006), prior myocardial infarction (HR=1.29, 95% CI 1.07 to 1.57, p=0.009), urgent TAVI (HR=1.25, 95% CI 1.04 to 51, p=0.020) and diabetes mellitus (HR=1.20, 95% CI 1.02 to 1.40, p=0.024). CONCLUSIONS: These data from the early TAVI experience show a 5-year mortality of 59.1%. Some of the predictors of 5-year mortality seem to be modifiable, such as residual aortic regurgitation, type of TAVI access route and concomitant mitral regurgitation.

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.

Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study.

BACKGROUND: Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. OBJECTIVE: To report clinical and echocardiographic 3-year results from the ADVANCE study. METHODS: ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years. RESULTS: Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration. CONCLUSIONS: Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.

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.

Four-year experience with the CoreValve transcatheter heart valve.

AIMS: Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis. METHODS AND RESULTS: The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and cardiac survival was 45.3% and 62.6%, respectively, at four years. CONCLUSIONS: The CoreValve bioprosthesis demonstrates long-term durability, stable haemodynamic function, and no evidence of structural deterioration. Most surviving patients continued to have improved NYHA class and QoL at four years.

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

Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score-matching analysis, we analyzed the characteristics and outcomes of patients who underwent TAVI with either GA (n = 245) or non-GA (n = 245) in the fully monitored, international, CoreValve ADVANCE Study. No statistically significant differences existed between the non-GA and GA groups in all-cause mortality (25.4% vs 23.9%, p = 0.78), cardiovascular mortality (16.4% vs 16.6%, p = 0.92), or stroke (5.2% vs 6.9%, p = 0.57) through 2-year follow-up. Major vascular complications were more common in the non-GA group. Total hospital stay was similar between the 2 groups. Conversion from non-GA to GA occurred in 13 patients (5.3%) because of procedural complications in 9 patients and discomfort or restlessness in 4 patients. Most procedural complications were related to valve positioning or vascular issues. Two of the 13 converted patients died during the procedure. Both GA and non-GA are widely used in real-world TAVI practice, and the decision appears to be guided by only a few patient-related factors and dominated by local and national practice. The outcomes of both anesthesia modes are equally good. When conversion from non-GA did occur, the complication requiring GA affected outcomes.

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

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

Nose cone entrapment after transcatheter aortic valve implantation of a CoreValve self-expandable bioprosthesis.

: We describe the first reported case of a nose cone entrapment of the delivering catheter of a CoreValve self-expandable valve, during a transcatheter aortic valve implantation procedure. The complication was successfully treated after snaring the cone and retracting the system within the introducing sheath.

Cardio-anesthesiology considerations for the trans-catheter aortic valve implantation (TAVI) procedure.

Transcatheter aortic valve implantation (TAVI) has become the mainstay for high-risk or inoperable patients with symptomatic aortic valve stenosis, and research regarding the use of transcatheter valves in intermediate or low-risk patients is currently ongoing. The aim of this article is to provide comprehensive insight into the anesthetic management of patients undergoing TAVI and to highlight possible gaps in the current knowledge. One important procedural characteristic that is imperative to consider is the type of anesthesia being used and its possible complications. Increasingly, experienced centers have changed from general anesthesia with endotracheal intubation to local anesthesia with sedation, especially when the transfemoral access route is used for TAVI. There is still debate regarding what type of anesthesia should be used in the procedure, and the lack of randomized data makes it even more challenging for the operators.

One-year outcomes after direct transcatheter aortic valve implantation with a self-expanding bioprosthesis. A two-center international experience.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is considered to be an essential part of the transcatheter aortic valve implantation (TAVI) procedure and is being performed routinely. At present there is insufficient long-term data as to the benefits of routine BAV prior to TAVI. AIM: The aim of this study was to evaluate the safety of direct TAVI and the mortality rate at 1-year in patients undergoing TAVI with or without BAV with a self-expanding bioprosthesis. METHODS: Between January 2008 and September 2013 consecutive patients undergoing TAVI with the Medtronic CoreValve in two experienced centers in Athens, Greece and in Siegburg, Germany were studied. All data were prospectively collected and retrospectively analyzed. Primary endpoint was mortality at 1 year. Procedural data and clinical data (bleeding, vascular complications and echocardiographic parameters) were analyzed. RESULTS: A total of 210 patients undergoing TAVI were evaluated (non-direct=120 patients, direct=90 patients). All-cause mortality at 30 days and at 1 year was similar in both groups (4% in non-direct versus 2% in direct, p=0.6 and 15% in non-direct versus 11% in direct, p=0.5, respectively). Device success rate was similar in both groups (77% in non-direct versus 83% in direct, p=0.2). Major vascular complications were comparable for both groups (5% in non-direct versus 3% in direct, p=0.5). The direct group had less moderate/severe paravalvular leakage than the non-direct group after the device implantation (7% versus 33%, p<0.01). CONCLUSIONS: Performing direct TAVI with the self-expanding bioprosthesis is safe and feasible showing similar mortality rates compared to patients undergoing non-direct TAVI at 30 days and at 1-year.