An analytical, mathematical annuloplasty ring curvature model for planning of valve-in-ring transcatheter mitral valve replacement.

Objectives: An increasing number of high-risk patients with previous mitral valve annuloplasty require transcatheter mitral valve replacement due to recurrent regurgitation. Annulus dilation with a transcatheter balloon is often performed before valve-in-ring transcatheter mitral valve replacement, which is believed to reduce misalignment and paravalvular leakage, yet little evidence exists to support this practice. Our objective was to generate intuitive annuloplasty ring analyses for improved valve-in-ring transcatheter mitral valve replacement planning. Methods: We generated a mathematical model that calculates image-tracked differential ring curvature to build quantifications for improved planning for valve-in-ring procedures. Carpentier-Edwards Physio M24 and M30 (n = 2 each), Physio II M24 and M26 (n = 3 each), LivaNova AnnuloFlex M26 (n = 2), and Edwards Geoform M28 (n = 2) rings were tested with a 30-mm Toray Inoue balloon inflated to maximum rated pressures. Results: Curvature variance reduces with larger ring sizes, indicating that larger rings are initially more circular than smaller ones. Evaluated semi-rigid and rigid rings showed little to no difference between pre- and post-dilation states. Annuloflex rings (flexible band) showed a postdilation variance reduction of 32.83% (P < .001) followed by an increase after 10 minutes of relaxation that was still reduced by 19.62% relative to the initial state (P < .001). Conclusions: We discovered that balloon dilation does not significantly deform evaluated semi-rigid or rigid rings at maximum rated balloon pressures. This may mean that dilation for these conditions before valve-in-ring transcatheter mitral valve replacement is unnecessary. Our mathematical approach creates a foundation for extended classification of this practice, providing meaningful quantification of ring geometry.

Early- and mid-term outcomes following redo surgical aortic valve replacement in patients with previous transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to analyse the early- and mid-term outcomes after redo surgical aortic valve replacement (SAVR) in patients with previous transcatheter aortic valve implantation (TAVI). METHODS: Retrospective single-centre analysis of early- and mid-term outcomes following redo SAVR in patients with previous TAVI between 2013 and 2020. Primary outcomes were in-hospital mortality and mid-term survival. RESULTS: During the study period, a total of 5756 patients underwent TAVI. Among them, 28 (0.5%) patients required redo SAVR after TAVI. During periods 2013-2016 and 2017-2020, 4/2184 (0.2%) patients and 24/3572 (0.7%) patients required SAVR after TAVI, respectively. The median logistic EuroSCORE was significantly higher at the time of SAVR than at the time of the index TAVI (5.9% vs 11.6%; P < 0.001). The median elapsed time between TAVI and redo SAVR was 7 months (3.5-14 months). Infective endocarditis (IE) was the most frequent indication for surgery [19 (67.8%) patients]. A total of 11 (39.3%) patients underwent isolated SAVR and 17 (60.7%) SAVR + additional cardiac surgical procedures. The overall in-hospital mortality was 14.3% (4/28). In-hospital mortality was 15.8% (3/19) among IE patients and 11.1% (1/9) among non-IE patients (P = 0.7). Overall estimated survival was 66.5%, 59.9% and 48.0% at 12, 18 and 24 months, respectively. Patients with IE showed a trend towards a lower estimated mid-term survival compared to non-IE patients [41.6% (95% confidence interval: 22.0-78.0%) vs 58.3% (95% confidence interval: 30.0-100%) survival at 24 months (P = 0.3)]. CONCLUSIONS: SAVR can be successfully performed in patients with prior TAVI despite the increased surgical risk and technical difficulty. IE is associated with decreased mid-term survival.

The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. METHODS: The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. RESULTS: The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. CONCLUSIONS: One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve.

Management of aortic root in type A dissection: Bentall approach.

BACKGROUND: We analyzed the results of the modified Bentall procedure in a high-risk group of patients presenting with acute type A aortic dissection (ATAAD). METHODS: ATAAD patients undergoing a modified Bentall between 1996 and 2018 (n = 314) were analyzed. Mechanical composite conduits were used in 45%, and biological ones using either a bioprosthesis implanted into an aortic graft (33%) or xeno-/homograft root conduits (22%) in the rest. Preoperative malperfusion was present in 34% of patients and cardiopulmonary resuscitation required in 9%. RESULTS: Concomitant arch procedures consisted of hemiarch in 56% and total arch/elephant trunk in 34%, while concomitant coronary artery surgery was required in 20%. The average cross-clamp and cardiopulmonary bypass times were 126 ± 43 and 210 ± 76 min, respectively, while the average circulatory arrest times were 29 ± 17 min. A total of 69 patients (22%) suffered permanent neurologic deficit, while myocardial infarction occurred in 18 cases (6%) and low cardiac output syndrome in 47 (15%). The in-hospital mortality rate was 17% due to intractable low cardiac output syndrome (n = 29), major brain injury (n = 16), multiorgan failure (n = 6), and sepsis (n = 2). The independent predictors of in-hospital mortality were critical preoperative state (odds ratio [OR], 5.6; p < .001), coronary malperfusion (OR, 3.6; p = .002), coronary artery disease (OR, 2.6; p = .033), and prior cerebrovascular accident (OR, 5.6; p = .002). CONCLUSIONS: The modified Bentall operation, along with necessary concomitant procedures, can be performed with good early results in high-risk ATAAD patients presenting.

Loop neochord versus leaflet resection techniques for minimally invasive mitral valve repair: long-term results.

OBJECTIVES: Non-leaflet resection techniques including loop chordal replacement are being used with increasing frequency, but the long-term results of these techniques are still unknown. The aim of this study was to compare the long-term results of loop neochord replacement with leaflet resection techniques in patients undergoing minimally invasive mitral valve (MV) repair for MV prolapse. METHODS: Between 1999 and 2014, 2134 consecutive MV prolapse patients underwent minimally invasive MV repair with isolated loop (n = 1751; 82.1%) or resection techniques (n = 383, 17.9%) at our institution. Follow-up data were available for 86% of patients with a mean follow-up time of 6.1 ± 4.3 years. RESULTS: The 30-day mortality was 0.8% for all patients (loop: 0.7%, resection: 1.6%; P = 0.09). Leaflet resection was associated with more moderate or more mitral regurgitation on predischarge echocardiography (P = 0.003). The 1-, 5- and 10-year survival rates were 98 ± 1%, 95 ± 1% and 86 ± 2% for the loop technique versus 97 ± 1%, 92 ± 1% and 81 ± 2% for resection patients, respectively (P = 0.003). Significant predictors for late mortality were MV repair technique (P = 0.004), left ventricular ejection fraction (P < 0.001), age (P < 0.001) and myocardial infarction (P < 0.001). Freedom from MV reoperation at 1, 5 and 10 years was 98 ± 1%, 97 ± 1%, 97 ± 1% and 97 ± 1%, 97 ± 1%, 96 ± 1% for patients operated on with the loop technique and leaflet resection (P = 0.4). CONCLUSIONS: In our patient cohort, MV repair with loop chordal replacement is associated with less early recurrent mitral regurgitation and very good long-term results when compared to classical leaflet resection techniques for MV prolapse and is therefore an excellent option for such patients.

Five-year outcomes following complex reconstructive surgery for infective endocarditis involving the intervalvular fibrous body.

OBJECTIVES: Destruction of the intervalvular fibrous body (IFB) due to infective endocarditis (IE) warrants a complex operation involving radical debridement of all infected tissue, followed by double valve replacement (aortic and mitral valve replacement) with patch reconstruction of the IFB. This study assesses the 5-year outcomes in patients undergoing this complex procedure for treatment of double valve IE with IFB involvement. METHODS: A total of 127 consecutive patients underwent double valve replacement with reconstruction of the IFB for active complex IE between January 1999 and December 2018. Primary outcomes were 3-year and 5-year survival, as well as 5-year freedom from reoperation. RESULTS: Patients' mean age was 65.3 ± 12.9 years. Preoperative cardiogenic shock and sepsis were present in 17.3% and 18.9%, respectively. The majority of patients (81.3%) had undergone previous cardiac surgery. Overall, 30-day and 90-day mortality rates were 28.3% and 37.0%, respectively. The 3- and 5-year survival rates for all patients were 45.3 ± 5.1% and 41.8 ± 5.8%, and for those who survived the first 90 postoperative days 75.8 ± 6.1% and 70.0 ± 8.0%, respectively. The overall 5-year freedom from reoperation was 85.1 ± 5.7%. Preoperative predictors for 30-day mortality were Staphylococcus aureus [odds ratio (OR) 1.65; P = 0.04] and left ventricular ejection fraction (LVEF) <35% (OR 12.06; P = 0.03), for 90-day mortality acute kidney injury requiring dialysis (OR 6.2; P = 0.02) and LVEF <35% (OR 9.66; P = 0.03) and for long-term mortality cardiogenic shock (hazard ratio 2.46; P = 0.01). CONCLUSIONS: Double valve replacement with reconstruction of the IFB in patients with complex IE is a challenging operation associated with high morbidity and mortality, particularly in the first 90 days after surgery. Survival and freedom from reoperation rates are acceptable thereafter, particularly considering the severity of disease and complex surgery.

Changes in dynamic mitral valve geometry during percutaneous edge-edge mitral valve repair with the MitraClip system.

BACKGROUND: The aim of this study was to quantify the acute dynamic changes of mitral valve (MV) geometry throughout the cardiac cycle-during percutaneous MV repair with the MitraClip system by 3-dimensional transesophageal echocardiography (3D TEE). METHODS: The MV was imaged throughout the cardiac cycle (CC) before and after the MitraClip procedure using 3D TEE in 28 patients (mean age, 77 ± 8 years) with functional mitral regurgitation (FMR). Dynamic changes in the MV annulus geometry and anatomical MV orifice area (AMVOA) were quantified using a novel semi-automated software. RESULTS: Percutaneous MV repair decreased anterior-posterior diameter by up to 9% (at 50% of CC; from 34.5 to 31.9 mm; p < 0.001) throughout the CC and increased the diastolic lateral-medial diameter by up to 7% (at 60% of the CC; from 39.7 to 42.3 mm; p < 0.001), whereas the annular circumference and area were not significantly affected. Annulus sphericity index was reduced up to 13% (at 50% of the CC; from 0.89 to 0.78, p < 0.001). The AMVOA also decreased during systole, the maximum decrease being from 0.6 to 0.2 mm2 (at 0% of CC; p = 0.007), and during diastole the maximum decrease being from 4.6 to 1.6 cm2 (at 50% of CC; p < 0.001). CONCLUSIONS: Percutaneous MV repair reduces the MR by an improved coaptation of MV leaflets joint with a simultaneous indirect reduction of anterior-posterior diameter. Further, the MitraClip procedure leads to a reduction of AMVOA of more than 60% during diastole.

Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes.

OBJECTIVES: We assessed the safety and efficacy of a novel low-profile, 22-Fr transapical delivery system together with the ACURATE neo™ resheathable transcatheter heart valve. METHODS: This prospective, single-arm, multicentre study enrolled 60 patients with severe symptomatic aortic stenosis and high surgical risk ineligible for transfemoral access. Primary end points were 6-month mortality and procedural success. RESULTS: The mean age of patients was 79.8 ± 4.7 years, and the patients had severe comorbidities including coronary artery disease (71.7%), diabetes (38.3%), atrial fibrillation (30.0%) and chronic obstructive pulmonary disease (21.7%); logistic EuroSCORE-I, -II and the Society of Thoracic Surgeons (STS) scores were 20.9 ± 8.9%, 6.1 ± 5.0% and 4.3 ± 2.9%, respectively. A non-rib spreading approach using soft tissue retractors only was used in 88.3% of patients (n = 53). Resheathing and repositioning of transcatheter heart valve were performed in 6.7% of cases (n = 4); the device implantation time was 3 ± 2 min. Apical access site complications occurred in 1.7% (n = 1). Procedural success was 98.3% (n = 59), and procedural success in the absence of major adverse cardiac and cerebrovascular events at 30 days was 90.0% (n = 54). At 30 days, cardiovascular and overall mortality were 8.3% (n = 5), stroke rate was 1.7% (n = 1), and 17.2% of patients (n = 10) received a permanent pacemaker implant. No paravalvular leakage ≥2+ was observed, and the mean transvalvular gradient was 5.9 ± 2.7 mmHg. At 6 months, survival was 84.3% with sustained haemodynamic results. CONCLUSIONS: This study indicates safety and efficacy of transapical aortic valve implantation using a novel low-profile delivery system. High procedural success, short implantation times and a low rate of apical access site complications underline the favourable safety profile and ease of use. Clinical trial registration: ClinicalTrials.gov: NCT02950428.

Suprasternal Transcatheter Aortic Valve Replacement in Patients With Marginal Femoral Access.

OBJECTIVE: Recently, the PARTNER 2A trial reported results of transcatheter aortic valve replacement versus surgical aortic valve replacement in 2032 intermediate-risk patients at 2 years. Two hundred thirty-six patients (24%) required an access route other than transfemoral. Compared with transfemoral and surgical aortic valve replacement, nontransfemoral transcatheter aortic valve replacement was associated with a numerically higher rate of death and disabling stroke at 30 days. This underscores the need for a better alternative surgical approach for patients with marginal femoral access. We reviewed our multicenter experience with minimally invasive suprasternal transcatheter aortic valve replacement. METHODS: Consecutive patients with symptomatic severe aortic stenosis at high or intermediate risk for surgical aortic valve replacement underwent suprasternal transcatheter aortic valve replacement. A commercially available transcatheter heart valve was deployed under fluoroscopic guidance through the innominate artery or ascending aorta. Using a 3-cm skin incision just above the sternal notch, the Aegis Transit System (Aegis Surgical Ltd, Galway, Ireland) provided illuminated access to the mediastinum without bone disruption. Through a purse-string suture placed in the innominate artery or ascending aorta, transcatheter aortic valve replacement proceeded similarly to the direct aortic approach. RESULTS: Thirty patients at six medical centers successfully underwent suprasternal transcatheter aortic valve replacement. Implanted valves included 2 CoreValve and 12 Evolut-R (Medtronic, Inc, Minneapolis, MN USA), as well as 10 SAPIEN 3 and 6 SAPIEN XT (Edwards Lifesciences, Corp, Irvine, CA USA) with sizes ranging from 23 to 31 mm. Median procedure time was 90 minutes and median hospital stay was 4 days. Postoperatively, new permanent pacemaker (n = 3) was the most common Vascular Academic Research Consortium 2 complication. CONCLUSIONS: These data demonstrate the early clinical feasibility of suprasternal transcatheter aortic valve replacement. Key advantages of this approach include direct access to the innominate artery and ascending aorta, precise sheath control, and confident arterial closure. Additional experience is warranted to confirm these favorable results.

Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve.

OBJECTIVE: We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. METHODS: A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). RESULTS: Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). CONCLUSIONS: Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family.

OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system. BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances. METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria. RESULTS: A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24). CONCLUSIONS: Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries.

OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

Outcomes of Dialysis-Dependent Patients After Cardiac Operations in a Single-Center Experience of 483 Patients.

BACKGROUND: The aim of this study was to determine the preoperative predictors of in-hospital and medium-term mortality in patients with dialysis-dependent chronic renal failure (DD CRF) undergoing cardiac operations. METHODS: Between January 1996 and June 2014, 483 consecutive patients with DD CRF underwent cardiac surgical procedures. The mean age was 65 ± 11 years, and 32. 3% were women. Isolated coronary artery bypass grafting (CABG) or isolated valve operations were performed in 39.8% and 32.3%, of patients, respectively. Combined surgical procedures (CABG with valve operations) were necessary in 20.3% of patients. Endocarditis was an indication for surgical intervention in 11% of patients. Urgent or emergent operations were performed in 49.3% of patients. RESULTS: The in-hospital mortality was 15.3%. Postoperative respiratory failure, gastrointestinal complications, low cardiac output, stroke, and sepsis occurred in 25.7%, 12.4%, 11.8%, 5.6%, and 5.2% of patients, respectively. The independent predictors of in-hospital mortality were combined mitral and aortic valve pathologic conditions (odds ratio [OR], 3.7, 95% CI, 1. 5-9; p = 0.003), chronic obstructive pulmonary disease (OR, 2.6; 95% CI, 1.1-5.9; p = 0. 03), peripheral vascular disease (OR, 2.3; 95% CI, 1.04-4; p = 0.003), left ventricular ejection fraction (LVEF) <30% (OR, 2.9; 95% CI, 1.3-6. 4; p = 0.008), and active endocarditis (OR, 2.2; 95% CI, 1.04-4.6; p = 0.04). The estimated 2-, 4-, and 6-year survival was 50.1% ± 2%, 34.3% ± 2%, and 20.3% ± 2%, respectively. Previous cerebrovascular accident, active endocarditis, previous cardiac operations, and combined aortic/mitral valve pathologic conditions were independent predictors of medium-term mortality. CONCLUSIONS: Patients with DD CRF undergoing cardiac operations have high perioperative and medium-term mortality, particularly in the presence of combined aortic and mitral valve pathologic conditions, active endocarditis, and poor left ventricular function.

Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

OBJECTIVES: This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). BACKGROUND: Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. METHODS: In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. RESULTS: Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. CONCLUSIONS: TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.

Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial.

IMPORTANCE: Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by diffusion-weighted magnetic resonance imaging (DWMRI). OBJECTIVE: To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014. INTERVENTIONS: TAVI with or without a cerebral protection device (filter system). MAIN OUTCOMES AND MEASURES: The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories. RESULTS: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00]; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95% CI, 91-406]; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy. CONCLUSIONS AND RELEVANCE: Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01833052.

Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial.

OBJECTIVES: Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis. METHODS: A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory. RESULTS: Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm2; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027). CONCLUSIONS: MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.

Symetis valve implantation in failing freestyle with close proximity between coronary Ostia and annulus.

Transcatheter treatment of patients with degenerated aortic valve stentless prosthesis and low proximal coronary ostia to the aortic annulus remain a challenge because of the elevated risk for coronary obstruction. Newer generation transcatheter aortic valve devices that engage and pull the aortic valve calcium towards the aortic annulus may be beneficial in these patients. We present a case of successful treatment of a degenerated tubular stentless prosthesis with low coronary ostia with a Symetis Acurate TA prosthesis.