A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

BACKGROUND: In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS: We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS: This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS: Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Risk factors and mortality associated with permanent pacemaker after surgical or transcatheter aortic valve replacement: Early versus late implantation.

INTRODUCTION: Inflation of transcatheter aortic valve replacement (TAVR) procedures compared to surgical aortic valve replacement (SAVR) has increased the number of patients requiring a postprocedure permanent pacemaker (PPM). We investigate the impact of PPM on mid-term mortality comparing SAVR versus TAVR procedures and risk factors for early and late (>14 days) need of PPM. METHODS: We conducted a retrospective, single-center evaluation of 903 patients that underwent either SAVR or TAVR procedures at the Yale New Haven Hospital from 2012 to 2017. Patients were stratified into PPM and non-PPM groups. We performed Kaplan-Meier and Cox proportional hazard analysis to characterize mid-term mortality. Further subgroup analysis was performed to identify risk factors for early and late PPM implantation in the TAVR cohort. RESULTS: There was no correlation between PPM implantation and mid-term mortality in both SAVR (hazard ratio [HR] = 0.69; confidence interval [CI] = 0.21-2.30; p = .56) and TAVR (HR = 0.70; CI = 0.42-1.17; p = .18) patients. The presence of the right bundle branch block (Odds ratio = 24.07; 95% CI = 2.34-247.64, p = .007) was associated with higher odds of early PPM requirement after TAVR procedures. CONCLUSION: PPM placement after SAVR or TAVR procedures is not associated with increased mid-term mortality. In-depth characterization of risk factors for early and late PPM implantation will require further analysis in the growing TAVR patient population.

An unbelievable ordeal: The experiences of adult survivors treated with extracorporeal membrane oxygenation.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a rescue treatment option for adult patients with severe cardiac dysfunction or respiratory failure. While short-term patient outcomes, such as in-hospital mortality and complications, have been widely described, little is known about the illness or recovery experience from the perspectives of survivors. Subjective reports of health are important indicators of the full, long-term impact of critical illness and treatment with ECMO on survivors' lives. OBJECTIVE: The objective of this study was to describe the experiences and needs of adults treated with ECMO, from onset of illness symptoms through the process of survivorship. METHODS: This study was guided by the qualitative method of interpretive description. We conducted in-depth, semistructured interviews with 16 adult survivors of ECMO who were treated at two participating regional ECMO centres in the northeast United States. Additional data were collected from demographic questionnaires, field notes, memos, and medical record review. Development of interview guides and data analysis were informed by the Family Management Style Framework. Qualitative data were analysed using thematic analysis techniques. RESULTS: The sample (n = 16) included 75% male participants; ages ranged from 23 to 65 years. Duration from hospital discharge to interviews ranged from 11 to 90 (M = 54; standard deviation = 28) months. Survivors progressed through three stages: Trauma and Vulnerability, Resiliency and Recovery, and Survivorship. Participants described short- and long-term impacts of the ECMO experience: all experienced physical challenges, two-thirds had at least one psychological or cognitive difficulty, and 25% were unable to return to work. All were deeply influenced by their own specific contexts, family support, and interactions with healthcare providers. CONCLUSIONS: The ECMO experience is traumatic and complex. Recovery requires considerable time, perseverance, and support. Long-term sequelae include impairments in cognitive, mental, emotional, physical, and social health. Survivors could likely benefit from specialised posthospital health services that include integrated, comprehensive follow-up care.

Trends in volume and risk profiles of patients undergoing isolated surgical and transcatheter aortic valve replacement.

BACKGROUND: Recent reports describe increases in the case volume of surgical aortic valve replacement (SAVR) after centers establish a transcatheter aortic valve replacement (TAVR) program. We investigate contemporary temporal trends in SAVR and TAVR case volumes and risk profiles at a high volume academic medical center. METHODS: We conducted a retrospective, descriptive evaluation of consecutive patients who underwent TAVR (n = 538) or SAVR (n = 657) in 2011-2016. The STS predicted risk of mortality (PROM) for isolated SAVR was used to calculate PROM for both SAVR and TAVR patients. Patients were stratified based on STS PROM as follows: low risk (<4%), intermediate risk (4-8%), and high risk (≥8%). Temporal changes in patient risk-profile were characterized descriptively. RESULTS: Median STS PROM for the study period was 6.3% and 2.0% for TAVR and SAVR cohorts, respectively (P < 0.001). Since 2011, TAVR volume consistently increased, while SAVR volume increased initially, peaking in 2013 and steadily declined. The STS PROM for SAVR remained stable during the entire study period, while that for TAVR showed a steady decline. The proportions of intermediate and low STS PROM patients undergoing TAVR increased. Proportions of each risk category in SAVR cohort remained stable over time. CONCLUSIONS: SAVR volume increased initially but declined eventually following the implementation of TAVR program. The distribution of the STS PROM in TAVR cohort changed dramatically with increasing proportion of patients in lower risk categories. These findings suggest the converging patient populations in TAVR and SAVR, which may be associated with the decline in the overall SAVR volume.

Ventricular septal rupture complicating acute myocardial infarction: Incidence, treatment, and outcomes among medicare beneficiaries 1999-2014.

OBJECTIVES: The present study was designed to assess whether the incidence and outcomes of VSR-AMI have changed in the era of timely primary PCI. BACKGROUND: Ventricular septal rupture (VSR) is a rare but frequently fatal complication of acute myocardial infarction (AMI). METHODS: We conducted a retrospective cohort study of all Medicare fee-for-service beneficiaries from 1999 to 2014 to examine trends in the incidence, surgical and percutaneous repair, and 30-day and 1-year mortality of VSR-AMI. RESULTS: The annual incidence of VSR-AMI hospitalization declined by 41.6% from 197 patients per 100,000 AMIs in 1999 to 115 patients per 100,000 AMIs in 2014 (P < 0.001). The 30-day VSR-AMI repair rate decreased from 49.9% in 1999 to 33.3% in 2014 (P < 0.001). In 2014, 82.9% of repairs were performed surgically and 17.1% percutaneously. VSR-AMI mortality rates were high (60.2% at 30 days; 68.5% at 1 year) and changed minimally over the study period with adjusted 30-day mortality per year Odds Ratio (OR) 0.99 (95% confidence interval [CI] 0.98-1.01) and adjusted 1-year mortality per year OR 0.98 (95% CI 0.97-1.00). Across the 16 years of data, unadjusted mortality rates were lower in patients undergoing repair than in unrepaired patients at 30 days (mean 51.7% and 65.7%, P ≤ 0.01) and 1 year (mean 62.0% and 72.8%, P < 0.01). CONCLUSIONS: In the era of increased timely primary PCI, the incidence of VSR-AMI hospitalization declined but its associated mortality rate remained high. Rates of VSR repair decreased from 1999 to 2014 despite increased use of percutaneous repair.

Spontaneous rupture of the ascending aorta.

BACKGROUND: Nontraumatic, spontaneous rupture of the ascending aorta is rare and the etiology is largely unknown. METHODS: We reviewed seven patients from our institution, with no known aortic disease or hereditary connective tissue disorder that presented with spontaneous ascending aortic rupture from 2012 to 2017. RESULTS: Most patients presented with non-radiating chest pain along with hypertension (71.4%). The mean ascending aortic diameter at rupture was 4.60 ± 0.62 cm. The median door-to-operating room time was 2.58 h, resulting from effective implementation of an aortic emergency protocol. There were no operative mortalities. CONCLUSIONS: In patients with ascending aortic rupture, aortic diameter may not always correlate with the risk of rupture. Rapid diagnosis combined with a multidisciplinary approach is vital for the successful management of these high-risk patients.

The Impact of Donor and Recipient Renal Dysfunction on Cardiac Allograft Survival: Insights Into Reno-Cardiac Interactions.

BACKGROUND: Renal dysfunction (RD) is a potent risk factor for death in patients with cardiovascular disease. This relationship may be causal; experimentally induced RD produces findings such as myocardial necrosis and apoptosis in animals. Cardiac transplantation provides an opportunity to investigate this hypothesis in humans. METHODS AND RESULTS: Cardiac transplantations from the United Network for Organ Sharing registry were studied (n = 23,056). RD was defined as an estimated glomerular filtration rate <60 mL/min/1.73 m(2). RD was present in 17.9% of donors and 39.4% of recipients. Unlike multiple donor characteristics, such as older age, hypertension, or diabetes, donor RD was not associated with recipient death or retransplantation (age-adjusted hazard ratio [HR] = 1.00, 95% confidence interval [CI] 0.94-1.07, P = .92). Moreover, in recipients with RD the highest risk for death or retransplantation occurred immediately posttransplant (0-30 day HR = 1.8, 95% CI 1.54-2.02, P < .001) with subsequent attenuation of the risk over time (30-365 day HR = 0.92, 95% CI 0.77-1.09, P = .33). CONCLUSIONS: The risk for adverse recipient outcomes associated with RD does not appear to be transferrable from donor to recipient via the cardiac allograft, and the risk associated with recipient RD is greatest immediately following transplant. These observations suggest that the risk for adverse outcomes associated with RD is likely primarily driven by nonmyocardial factors.

Heart transplant outcomes in recipients of Centers for Disease Control (CDC) high risk donors.

BACKGROUND: A lack of donor hearts remains a major limitation of heart transplantation. Hearts from Centers for Disease Control (CDC) high-risk donors can be utilized with specific recipient consent. However, outcomes of heart transplantation with CDC high-risk donors are not well known. We sought to define outcomes, including posttransplant hepatitis and human immunodeficiency virus (HIV) status, in recipients of CDC high-risk donor hearts at our institution. METHODS: All heart transplant recipients from August 2010 to December 2014 (n = 74) were reviewed. Comparison of 1) CDC high-risk donor (HRD) versus 2) standard-risk donor (SRD) groups were performed using chi-squared tests for nominal data and Wilcoxon two-sample tests for continuous variables. Survival was estimated with Kaplan-Meier curves. RESULTS: Of 74 heart transplant recipients reviewed, 66 (89%) received a SRD heart and eight (11%) received a CDC HRD heart. We found no significant differences in recipient age, sex, waiting list 1A status, pretransplant left ventricular assist device (LVAD) support, cytomegalovirus (CMV) status, and graft ischemia times (p = NS) between the HRD and SRD groups. All of the eight HRD were seronegative at the time of transplant. Postoperatively, there was no significant difference in rejection rates at six and 12 months posttransplant. Importantly, no HRD recipients acquired hepatitis or HIV. Survival in HRD versus SRD recipients was not significantly different by Kaplan-Meier analysis (log rank p = 0.644) at five years posttransplant. CONCLUSION: Heart transplants that were seronegative at the time of transplant had similar posttransplant graft function, rejection rates, and five-year posttransplant survival versus recipients of SRD hearts. At our institution, no cases of hepatitis or HIV occurred in HRD recipients in early follow-up.

Principles of HeartMate II implantation to avoid pump malposition and migration.

Proper left ventricular assist device (LVAD) insertion will help maximize LVAD flow and may reduce adverse events such as right heart failure and pump thrombosis. Although no standardized insertion technique has been universally accepted, the goals are: unobstructed inflow cannula, unobstructed outflow graft with avoidance of right ventricular compression, and prevention of pump migration. To achieve these objectives for the HeartMate II LVAD, we delineate four principles: proper pump pocket creation, optimized positioning of inflow cannula and outflow graft, proper pump position in the body, and fixation. These basic principles are easy to implement and have been beneficial in our patients, assuring long-term unobstructed LVAD flow.

Surgical management of tricuspid valve endocarditis in systemically infected patients.

BACKGROUND AND AIM OF THE STUDY: Isolated bacterial tricuspid valve (TV) endocarditis is usually managed medically. Whilst the indications and optimal timing for surgical treatment of the condition have not been clearly defined, it is hypothesized that early surgery in patients who are bacteremic and/or have evidence of systemic seeding is superior to medical treatment. METHODS: All cases of isolated TV endocarditis reported between 2006 and 2011 at the authors' institution were reviewed. Patients with bacteremia and/or systemic seeding who were treated surgically after short-term medical therapy were compared to an equivalent group of patients who remained under long-term medical treatment only. RESULTS: A total of 45 patients with isolated TV endocarditis showed evidence of bacteremia and/or systemic seeding. Of these patients, 10 (22.2%) were treated surgically with valve repair or replacement, and 35 (77.8%) received long-term medical therapy only. The 30-day and one-year survival rates in both groups were comparable (100% versus 88.6%, p = 0.27). Patients treated surgically had clear blood cultures sooner (2.0 versus 6.7 days, p = 0.04), defervesced earlier (0 versus 9.0 days, p = 0.02), and demonstrated a complete resolution of TV vegetations (100% versus 30.0%, p = 0.003). Change in creatinine clearance (+22.1 versus +11.6 ml/min, p = 0.40) and durations of vasopressor support (6.8 versus 8.9 h, p = 0.86), mechanical ventilation (8.5 versus 32.2 h, p = 0.44), ICU stay (148.1 versus 53.8 h, p = 0.14) and total hospital stay (32.1 versus 24.6 days, p = 0.22) were not different between groups. Long-term echocardiogram surveillance demonstrated a higher prevalence of moderate-severe tricuspid regurgitation in the medically treated patients (75.0 versus 0.0%, p < 0.001). None of the patients treated surgically was readmitted with prosthetic valve endocarditis. CONCLUSION: Early surgery is warranted in patients with isolated TV endocarditis who are bacteremic and/or systemically infected despite optimal medical therapy.

Right atrial approach for surgical repair of post infarction ventricular septal defect and acute tricuspid regurgitation with cardiogenic shock.

A complex case of inferior wall infarction with ventricular septal defect and severe tricuspid valve regurgitation due to acute papillary muscle rupture in a 65 year-old male is described. This constellation of pathological lesions and the surgical approach to the repair have not been previously described.

Cardiac transplantation can be safely performed with low donor-to-recipient body weight ratios.

BACKGROUND: United Network for Organ Sharing adult heart transplant criteria recommend against using same-sex donors with a donor-recipient body weight ratio <0.7. The same criteria recommend against a female donor to male recipient body weight ratio <0.9. We attempted to determine if transplantation with low donor-recipient body weight ratios can be safely performed. METHODS AND RESULTS: Transplants with same-sex donor-recipient body weight ratio <0.7 and female donor-male recipient body weight ratio <0.9 were compared with age- and sex-matched control subjects with ideally matched donor weights. Of the 123 patients undergoing transplantation, 23 met low donor-recipient body weight ratio criteria. This cohort was compared with 22 ideally weight-matched patients. There was no difference in survival at 1, 5, and 10 years (P = .68). Freedom from rejection (52.2 vs 50.0%; P = 1.0), creatinine clearance change (-1.3 vs 5.7 mL/min; P = .88), duration of inotropic support (191.5 vs 208.8 h; P = .65), and duration of mechanical ventilation (156.3 vs 84.5 h; P = .52) were similar. Intensive care (290.5 vs 368.6 h; P = .71) and hospital length of stay (35.4 vs 36.7 d; P = .94) were not different. CONCLUSIONS: Accepted donor-recipient weight match criteria may be extended to increase the donor pool.

The Impact of Sex on Strength Training in Adults With Cardiovascular Disease.

Cardiovascular disease (CVD) is the leading killer of American males and females. Outcomes of treatment for CVD have historically been worse in females than in males. The inability to recover, may be, at least in part, due to lower levels of skeletal muscle mass in females; which is made worse with the onset of menopause and especially when a catabolic event like surgery and / or illness occurs. We theorize that while regaining cardiorespiratory fitness (CRF) after treatment for CVD is very important, it is only part of what is required for complete recovery. Regaining strength and muscle mass is just as important for healthy physiologic aging and recovery from illness. We outline a simply strategy for helping males and females train for strength while recovering from CVD.

Clinical Profile and Sex-Specific Recovery With Cardiac Rehabilitation After Coronary Artery Bypass Grafting Surgery.

BACKGROUND: Cardiac rehabilitation (CR) improves major adverse cardiac outcomes in patients recovering from myocardial infarction. CR influences outcomes through attenuation of cardiac risk factors, lifestyle changes, and biological effects on endothelial function. The clinical profile and sex-specific outcomes with CR after coronary artery bypass grafting (CABG) is less well defined. METHODS: This retrospective cohort study of consecutive patients undergoing elective or urgent CABG was performed between 2014 and 2016 at a single site. Patients requiring concomitant procedures were excluded. Patients received referral to a 12-week, 36-session CR program standardized through the health care system and tracked via electronic health records. Clinical data and complications during hospitalization were abstracted from Society of Thoracic Surgeons (STS) registry and matched with 12-months outcomes from electronic health records. Primary composite outcomes were mortality and STS-defined complications within 12 months after CABG. Kaplan-Meier plots for mortality were generated from conditional 6-month survival data. FINDINGS: Of 756 patients undergoing CABG, 420 met the eligibility criteria (mean age, 66 years). Women (18%) had a similar cardiac risk profile to men except for a higher hemoglobin A1c level and lower hematocrit before surgery. Women had similar extent of revascularization to men but had higher rates of intraoperative (30% vs 8%; p < 0.001) and postoperative blood transfusions (43% vs 29%; p = 0.014) compared with men. Only 66% of women qualified for direct discharge to home compared with 85% of men (p = 0.0003). Twelve-month mortality was 1.3% and 2%, respectively (p > 0.05). Half of the cohort got referred for CR, and 32% of men and 23% of women underwent CR. Twelve-month composite outcomes did not differ by referral to cardiac rehabilitation (odds ratio = 0.77; 95% CI, 0.36-1.64) or engagement with CR (odds ratio = 0.67; 95% CI -0.05 to 0.086), adjusting for age, sex, body mass index, and diabetes. Kaplan-Meier analysis found no significant difference in survival between those who did and did not undergo CR. Men experienced increases in metabolic equivalents (38%, P = 0.014), grip strength (11%, P < 0.0001), and sense of physical well-being (40.9%, P < 0.0001), whereas women experienced increases in aerobic exercise duration (15.5%, P = 0.02) and a trend in improved sense for physical well-being (93.3%, P = 0.06). IMPLICATIONS: Sex differences exist with CR after CABG. Future studies should confirm these findings in larger cohorts and corroborate the effect on endothelial function and other biological markers.

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

OBJECTIVES: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis. BACKGROUND: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%. METHODS: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs. RESULTS: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001). CONCLUSIONS: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Mesenchymal stem cells modified with Akt prevent remodeling and restore performance of infarcted hearts.

Transplantation of adult bone marrow-derived mesenchymal stem cells has been proposed as a strategy for cardiac repair following myocardial damage. However, poor cell viability associated with transplantation has limited the reparative capacity of these cells in vivo. In this study, we genetically engineered rat mesenchymal stem cells using ex vivo retroviral transduction to overexpress the prosurvival gene Akt1 (encoding the Akt protein). Transplantation of 5 x 10(6) cells overexpressing Akt into the ischemic rat myocardium inhibited the process of cardiac remodeling by reducing intramyocardial inflammation, collagen deposition and cardiac myocyte hypertrophy, regenerated 80-90% of lost myocardial volume, and completely normalized systolic and diastolic cardiac function. These observed effects were dose (cell number) dependent. Mesenchymal stem cells transduced with Akt1 restored fourfold greater myocardial volume than equal numbers of cells transduced with the reporter gene lacZ. Thus, mesenchymal stem cells genetically enhanced with Akt1 can repair infarcted myocardium, prevent remodeling and nearly normalize cardiac performance.

Percutaneous Coronary Intervention with Stenting versus Coronary Artery Bypass Grafting in Stable Coronary Artery Disease.

The debate over coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with stent placement for the treatment of stable multivessel coronary artery disease (CAD) continues in spite of numerous studies investigating the issue. This paper reviews the most recent randomized control trials (RCT) and meta-analyses of pooled RCT data to help address this issue. General trends demonstrated that CABG was superior in all-cause mortality and fulfilling the need for repeat revascularization. These advantages tended to be more pronounced in multivessel CAD and diabetes, and less so in left main CAD. PCI showed a consistently lower rate of cerebrovascular events. CABG continues to offer significant advantages over PCI, even as drug-eluting stent technology continues to evolve. The ideal endpoint for comparing PCI and CABG remains to be determined. Furthermore, additional research is required to further refine patient selection criteria for each intervention.

Aortic remodeling and competitive flow after surgical treatment of aortic dissection.

Aortic remodeling after dissection is poorly understood and remains a focus of current research. In the present report, we have described the cases of two patients with acute lower extremity ischemia related to malperfusion from aortic dissection treated with extra-anatomic axillobifemoral bypass. During long-term follow-up, aortic remodeling led to reinstitution of flow through the native aorta. This resulted in competitive flow, leading to complete thrombosis of the extra-anatomic conduits. These cases highlight the occurrence of spontaneous aortic recanalization and subsequent competitive flow, two vascular phenomena that are not well understood but can significantly affect patient outcomes.

Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis.

Importance: The outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion. Objective: To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk. Design, Setting, and Participants: The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement. Interventions: Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements. Main Outcomes and Measures: The prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure. Results: A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak. Conclusions and Relevance: Transcatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate. Trial Registration: ClinicalTrials.gov Identifier: NCT03635424.

Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study.

BACKGROUND: Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. METHODS: The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. RESULTS: At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction. Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm2, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. CONCLUSION: Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.