Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Transesophageal Echocardiographic Screening for Structural Heart Interventions.

PURPOSE OF REVIEW: Percutaneous structural interventions have provided patients with an effective therapeutic option, and its growth has been aided by echocardiography. We describe the vital role that transesophageal echocardiography (TEE) plays in screening patients prior to their procedure. RECENT FINDINGS: A multimodality imaging approach is employed by the valve team, but TEE plays a unique role in diagnosis and planning. Utilization of all TEE views and features such as biplane, 3D imaging, and multiplanar reconstruction ensures accurate assessment of the structural lesion of interest. The role of TEE remains essential in the planning of structural interventions, and these studies should be performed in a systematic and comprehensive manner.

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Bacterial endocarditis with AACEK (HACEK) organisms.

INTRODUCTION: Gram-negative organisms of the AACEK group, formerly known as HACEK, rarely cause endocarditis. CASE SERIES: We present three cases of bacterial endocarditis, involving native and prosthetic valves, caused by AACEK organisms. In two patients, Cardiobacterium hominis was the responsible organism, and in a third, Aggregatibacter aphrophilus was implicated. A dental source of infection was identified in two patients, and in all three patients, the presentation of endocarditis was subacute. DISCUSSION: This case series highlights the indolent nature of infection with the AACEK organisms. It also demonstrates the crucial role of multimodality imaging, especially transesophageal echocardiography, in the diagnosis of AACEk endocarditis of both native and prosthetic valves, and in delineating the extent of abscess in those with prosthetic valve infection.

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.

BACKGROUND: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. RESULTS: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. CONCLUSIONS: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial.

BACKGROUND: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. METHODS: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. RESULTS: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT01586910.

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Preprocedural P2Y12 inhibition and decrease in platelet count following transcatheter aortic valve replacement.

BACKGROUND: Thrombocytopenia after transcatheter aortic valve replacement (TAVR) is associated with adverse clinical outcomes. Whether preprocedural P2Y12 inhibition prevents postprocedural thrombocytopenia is uncertain. METHODS: This retrospective analysis identified consecutive patients (n = 266) undergoing TAVR between November 2016 and July 2017. Preprocedure clopidogrel load ≥300 mg or maintenance P2Y12 inhibitor therapy defined preprocedural P2Y12 inhibition. Patients who did not consent for the registry (n = 8), with baseline severe thrombocytopenia (<90 × 103 platelets/µL; n = 14), or without baseline platelet count (n = 4) were excluded. The primary outcome was proportion of patients who developed >20% decrease in platelet count from baseline to day 1 post-TAVR. RESULTS: Patients with (n = 134) versus without (n = 106) preprocedural P2Y12 inhibition had no differences in platelet count at baseline. Patients with preprocedural P2Y12 inhibition had a significantly lower proportion of the primary outcome (34.3% vs. 57.5%, p = .001) and a lower absolute decrease in platelet count (32.8 × 103 vs. 45.8 × 103 platelet/µL, p = .01). Of patients without baseline thrombocytopenia (n = 198), a numerically lower rate of patients with versus without preprocedural P2Y12 inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). CONCLUSION: Patients who received preprocedural P2Y12 inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.

Factors predicting persistence of AV nodal block in post-TAVR patients following permanent pacemaker implantation.

INTRODUCTION: A common complication of transcatheter aortic valve repair (TAVR) is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE: To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS: Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS: Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR right bundle branch block was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; P = .01). Device-dependence was associated with AVBIII as the first postprocedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; P < .0001), earlier implantation (median 1d, IQR: 0-1.5d vs 2d, IQR: 1.0-4.0d, P = .0004), and a shorter duration of hospitalization (median 3d, IQR: 2-3.5d vs 4d, IQR: 2-5.75d, P = .03). Pacemaker dependence was also associated with a higher prosthesis-to left ventricular outflow tract (LVOT) diameter (1.45 ± 0.11 vs 1.39 ± 0.07; P = .02) and the lack of prior aortic valvuloplasty (5 of 39, 13% vs 8 of 22, 36%; RR 0.35; P = .03). CONCLUSIONS: In patients receiving a PPM following self-expanding TAVR, a long-term pacing requirement can be predicted from the timing of AV block, existing conduction-system disease, larger prosthesis-to-LVOT diameter, and the lack of aortic valvuloplasty.

Klippel-Feil syndrome: A very unusual cause of severe aortic regurgitation visualized by multimodality imaging.

A 51-year-old man with Klippel-Feil syndrome (KFS) and immunodeficiency syndrome, status postintravenous immunoglobulin therapy, presented with shortness of breath. He was found to have severe aortic regurgitation in the setting of a trileaflet aortic valve with thickened leaflets and mild prolapse of the right coronary cusp with left ventricular dilation and borderline left ventricular ejection fraction. Although various cardiac anomalies have been described in KPS, otherwise unexplained severe aortic regurgitation has not been previously reported to the best of our knowledge. The patient underwent an uncomplicated surgical aortic valve replacement with a 25-mm Medtronic Avalus pericardial tissue valve resulting in symptomatic improvement. Intra-operative management and transesophageal echocardiography can be particularly challenging in KFS patients. We describe the first reported case of severe aortic regurgitation in KPS, review the cardiac anomalies associated with the syndrome, and highlight the clinical challenges in intra-operative management of these patients.

Operational and Institutional Recommendations and Requirements for TAVR: A Review of Expert Consensus and the Impact on Health Care Policy.

When transcatheter aortic valve replacement (TAVR) was first approved for use in the United States in 2012, multiple leading surgical and cardiology societies were tasked with creating recommendations and requirements for operators and institutions starting and maintaining TAVR programs. Creation of this consensus document was challenging due to limited experience with this new technology, and a lack of robust centralized data that could be used to validate outcome measures and create benchmarks for self-assessment and improvement. Despite these limitations, this document provided government agencies a framework for regulation that ultimately determined requirements for Medicare payment for TAVR and therefore greatly determined how and where care was delivered for patients with aortic stenosis. After the proliferation of TAVR institutions throughout the US and with data from more than 100,000 cases in the STS/ACC Transcatheter Valve Therapies TM Registry, leaders of the same societies reconvened in 2018 to update their consensus document. The new recommendations include suggested personnel, facilities, training, and assessment of outcomes and competencies required to run a safe and efficient TAVR program. This article seeks to detail the changes from the original consensus document with a particular focus on issues relevant to cardiac anesthesiologists as well as important healthcare policy ramifications for patients and providers in the United States.

Outcomes after transcatheter aortic valve replacement in patients with low versus high gradient severe aortic stenosis in the setting of preserved left ventricular ejection fraction.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for low gradient (LG) severe aortic stenosis (AS) with preserved left ventricular ejection fraction (LVEF) remains an area of clinical uncertainty. METHODS: Retrospective review identified 422 patients who underwent TAVR between September 4, 2014 and July 1, 2016. Procedural indication other than severe AS (n = 22) or LVEF <50% (n = 98) were excluded. Outcomes were defined by valve academic research consortium two criteria when applicable and compared between LG (peak velocity <4.0 m/s and mean gradient <40 mmHg; n = 73) and high gradient (HG) (n = 229) groups. The LG group was further categorized as low stroke volume index (SVI) (n = 41) or normal SVI (n = 32). Median follow-up was 747 days [interquartile range 220-1013]. RESULTS: Baseline thirty-day mortality risk (LG 6.2% [3.8-8.1] vs HG 5.7% [4.1-7.4], P = 0.43) did not differ between groups. Short-term outcomes, including procedural success rate (86.1% vs 88.8%, P = 0.53), peri-procedural complications (intra-procedural heart block: 6.8% vs 7.9%, P = 0.99; permanent pacemaker placement: 11.0% vs 13.6%, P = 0.69; moderate paravalvular regurgitation: 2.7% vs 1.3%, P = 0.60), and all-cause in-hospital mortality (2.7% vs 0.9%, P = 0.25) did not differ between LG and HG groups. On long-term follow-up, all-cause mortality also did not differ between LG and HG groups (6.8% vs 10.0%, plog-rank = 0.33) or between the LG low SVI (9.8%), LG normal SVI (3.1%), and HG (10.0%) groups (plog-rank = 0.39). CONCLUSION: Patients with preserved LVEF undergoing TAVR for severe AS with LG, including LG with low SVI, have no significant difference in adverse outcomes when compared to patients with HG.

3D transesophageal echocardiography and radiography of mitral valve prostheses and repairs.

This paper provides a comprehensive overview of 3D transesophageal echocardiography still images and movies of mechanical mitral valves, mitral bioprostheses, and mitral valve repairs. Alongside these visual descriptions, the historical overview of surgical and percutaneous mitral valve intervention is described with the special emphasis on the incremental value of 3D transesophageal echocardiography (3DTEE). For each mitral valve intervention, 2D echocardiography, chest x-ray, and fluoroscopy images corresponding to 3DTEE are given. In addition, key references on echocardiographic imaging of individual valves and procedures are enumerated in accompanying figures and tables.

Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.

BACKGROUND: Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting. OBJECTIVE: To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial. DESIGN: Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894). SETTING: 25 hospitals in the United States, Canada, and Germany. PATIENTS: High-risk and inoperable patients (1220 women and 1339 men). INTERVENTION: TAVR. MEASUREMENTS: Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters. RESULTS: At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001). LIMITATION: Secondary analysis that included nonrandomized trial data. CONCLUSION: Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. PRIMARY FUNDING SOURCE: Edwards Lifesciences.

Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy.

BACKGROUND: The higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching. METHODS AND RESULTS: From April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P<0.0001), and slower recovery (New York Heart Association class I, 31% versus 38% at 30 days, equalizing by 6 months at 51% versus 47%); stroke risk was similar (3.4% versus 3.3% at 30 days and 6.0% versus 6.7% at 3 years); mortality was elevated for the first 6 postprocedural months (19% versus 12%; P=0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P=0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P<0.0001). CONCLUSIONS: The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial.

BACKGROUND: Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients. METHODS: We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1:1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with ClinicalTrials.gov, number NCT00530894. FINDINGS: We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 71·8% in the TAVR group versus 93·6% in the standard treatment group (hazard ratio 0·50, 95% CI 0·39-0·65; p<0·0001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1·52 cm(2) at 5 years, mean gradient 10·6 mm Hg at 5 years), with no evidence of structural valve deterioration. INTERPRETATION: TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities. FUNDING: Edwards Lifesciences.

Robotic Transcatheter Mitral Valve Replacement Using the Sapien XT in the Setting of Severe Mitral Annular Calcification.

We describe the use of the Sapien XT, placed in the mitral position using a totally endoscopic robotic approach in a 76-year-old man with extensive circumferential mitral calcifications and severe stenosis. The patient was at high risk for traditional open surgery and a large mitral valve annulus prevented safe transcatheter deployment due to size mismatch. Our novel approach offered a minimally invasive technique for native mitral valve replacement in a high-risk patient with anatomical constraints prohibitive to conventional approaches. doi: 10.1111/jocs.12737 (J Card Surg 2016;31:303-305).

Short-term outcomes in adult cardiac surgery in the use of del Nido cardioplegia solution.

OBJECTIVES: Del Nido cardioplegia in adult cardiac surgery has not been studied although it has been in common use as a "single" dose cardioplegia in pediatric heart surgery. We retrospectively assessed the short-term (in-hospital) clinical outcomes of patients undergoing aortic valve replacement (AVR) using del Nido cardioplegia solution, comparing it to conventional multi-dose whole blood cardioplegia. METHODS: We switched our cardioplegia protocol from conventional whole blood cardioplegia exclusively to del Nido solution in May 2011. In 2011, 240 consecutive patients underwent isolated AVR. One hundred and seventy-eight of them were operated on with the use of del Nido cardioplegia (del Nido group) and whole blood cardioplegia (conventional group) was used in the other 62 patients. Isolated AVR was chosen as a cohort because of its relative simplicity and the similarity of surgical techniques among surgeons. Propensity-score matching identified 54 matched pairs for analysis. RESULTS: The retrograde cardioplegia technique was used in 19 cases (35.2%) in the del Nido group and 52 cases (96.3%) in the conventional group (p<0.001). Mean cardiopulmonary bypass time and mean aortic cross-clamp time were significantly shorter in the del Nido group compared to the conventional group: 71 ± 16 min vs. 84 ± 28 min (p<0.01), 52 ± 14 min vs. 60 ± 16 min (p<0.01), respectively. Postoperative inotropic support was required in 11 patients (20.4 %) in the del Nido group and 13 patients (24.1 %) in the conventional group (p=0.82) with no statistical difference. No patient required a postoperative intra-aortic balloon pump and in-hospital mortality was 0% in both groups. There was no significant difference in postoperative complications between the two groups. CONCLUSIONS: Short-term outcomes in adult cardiac surgery using del Nido solution were acceptable and comparable to conventional multi-dose whole blood cardioplegia. The del Nido cardioplegia technique was associated with shortened cross-clamp times and less frequent utilization of the retrograde cardioplegia delivery technique.

Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.

BACKGROUND: The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown. METHODS AND RESULTS: In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial. CONCLUSIONS: TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Two-year outcomes after transcatheter or surgical aortic-valve replacement.

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).