Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Percutaneous ventricular assist device for higher-risk percutaneous coronary intervention in surgically ineligible patients: Indications and outcomes from the OPTIMUM study.

BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

Evaluation of the Effects of an Extubation Protocol With Neostigmine on Duration of Mechanical Ventilation After Cardiac Surgery.

OBJECTIVES: Residual neuromuscular blockade is associated with increased postoperative pulmonary complications. This study aimed to evaluate the effect of an extubation protocol incorporating neuromuscular blockade reversal (NMBR) by train-of-four monitoring on "fast-track" cardiac surgery outcomes. DESIGN: A retrospective cohort study. SETTING: At a university hospital. PARTICIPANTS: Out of 1,843 cardiac surgery patients, from February 2, 2015, to March 31, 2017, 957 (52%) underwent cardiac surgery on or after February 29, 2016. INTERVENTIONS: An extubation protocol, comprised of weaning from mechanical ventilation and NMBR guidelines, was implemented on February 29, 2016. MEASUREMENTS AND MAIN RESULTS: The associations of baseline characteristics with the postoperative duration of mechanical ventilation (primary outcome) and respiratory and/or adverse complications (secondary outcomes) were evaluated using regression and interrupted- time series models. The implementation of an extubation protocol was associated with an 18% decrease in the duration of mechanical ventilation (incident rate ratio [IRR] 0.82, 95% CI 0.72-0.94; p < 0.01), statistically insignificant 26% increase in patients extubated ≤6 hours (odds ratio [OR] 1.26, 95% CI 0.97-1.65; p = 0.09), and 13% shorter intensive care unit length of stay (LOS) (IRR 0.87, 95% CI 0.79-0.97; p < 0.01). Patients undergoing isolated coronary artery bypass graft or isolated valve procedures, on or after February 29, 2016, had decreased extubation times (IRR 0.82, p < 0.01 and IRR 0.80, p = 0.02). The protocol did not have a statistically significant association with hospital LOS (IRR 0.98, p = 0.57) or readmission (OR 1.22, p = 0.33), and differences in the occurrence of pulmonary complications and adverse outcomes between the pre- and postprotocol groups were clinically insignificant. CONCLUSIONS: The application of an extubation protocol incorporating NMBR based on neuromuscular monitoring was associated with a decrease in postoperative duration of mechanical ventilation and facilitated more patients meeting the early extubation benchmark without an increased risk of respiratory complications or adverse outcomes.

Regional geometric differences between regurgitant and non-regurgitant mitral valves in patients with coronary artery disease.

OBJECTIVE: Demonstrate that regional geometric differences exist between regurgitant and non-regurgitant mitral valves (MV's) in patients with coronary artery disease and due to the heterogenous and regional nature of ischemic remodeling in patients with coronary artery disease (CAD), that the available anatomical reserve and likelihood of developing mitral regurgitation (MR) is variable in non-regurgitant MV's in patients with CAD. METHODS: In this retrospective, observational study intraoperative three-dimensional transesophageal echocardiographic data was analyzed in patients undergoing coronary revascularization with MR (IMR group) and without MR (NMR group). Regional geometric differences between both groups were assessed and MV reserve which was defined as the increase in antero-posterior (AP) annular diameter from baseline that would lead to coaptation failure was calculated in three zones of the MV from antero-lateral (zone 1), middle (zone 2), and posteromedial (zone 3). MEASUREMENTS AND MAIN RESULTS: There were 31 patients in the IMR group and 93 patients in the NMR group. Multiple regional geometric differences existed between both groups. Most significantly patients in the NMR group had significantly larger coaptation length and MV reserve than the IMR group in zones 1 (p-value = .005, .049) and 2 (p-value = .00, .00), comparable between the two groups in zone 3 (p-value = .436, .513). Depletion of the MV reserve was associated with posterior displacement of the coaptation point in zones 2 and 3. CONCLUSIONS: There are significant regional geometric differences between regurgitant and non-regurgitant MV's in patients with coronary artery disease. Due to regional variations in available anatomical reserve and the risk of coaptation failure in patients with CAD, absence of MR is not synonymous with normal MV function.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Elective ascending aortic aneurysm repair outcomes in a nationwide US cohort.

OBJECTIVE: To quantify contemporary outcomes following elective ascending aortic aneurysm repair, to determine risk factors for adverse events and to evaluate difference by institutional surgical volume. METHODS: We included all elective hospitalisations of adult patients with an ascending aortic aneurysm who underwent aneurysm repair in the Nationwide Readmissions Database between 2016 and 2019. The primary outcome was a composite of in-hospital mortality, stroke (ischaemic and non-ischaemic) and myocardial infarction (MI). We identified independent predictor of adverse events and investigated outcomes by institutional volume. RESULTS: Among 12 043 patients (mean 62.8 years of age, 28.0% female), MI, stroke or in-hospital death occurred in 598 (4.9%) patients during the index admission (acute stroke: 2.7%, MI: 0.7%, in-hospital death: 2.0%). The strongest predictors of in-hospital death, stroke or MI were chronic weight loss, pulmonary circulation disorder and concomitant descending aortic surgery. Higher procedural volume was associated with a lower incidence of in-hospital death, stroke or MI (OR comparing the highest with the lowest tertile 0.71, 95% CI 0.57 to 0.87; p=0.001) and in-hospital death (OR 0.51, 95% CI 0.37 to 0.72; p<0.001), but no difference in 30-day readmissions. CONCLUSIONS: The overall rate of in-hospital death, stroke and MI is nearly 5% in patients undergoing elective ascending aortic aneurysm repair. Among several predictors, chronic weight loss is associated with the largest increase in the risk of poor outcomes. Higher hospital volume is associated with a lower in-hospital mortality, highlighting the importance to refer patients to high-volume centres while discussing the risks and benefits of proceeding with repair.

Outcomes of Medical Therapy Plus PCI for Multivessel or Left Main CAD Ineligible for Surgery.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used to revascularize patients ineligible for CABG, but few studies describe these patients and their outcomes. OBJECTIVES: This study sought to describe characteristics, utility of risk prediction, and outcomes of patients with left main or multivessel coronary artery disease ineligible for coronary bypass grafting (CABG). METHODS: Patients with complex coronary artery disease ineligible for CABG were enrolled in a prospective registry of medical therapy + PCI. Angiograms were evaluated by an independent core laboratory. Observed-to-expected 30-day mortality ratios were calculated using The Society for Thoracic Surgeons (STS) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) II scores, surgeon-estimated 30-day mortality, and the National Cardiovascular Data Registry (NCDR) CathPCI model. Health status was assessed at baseline, 1 month, and 6 months. RESULTS: A total of 726 patients were enrolled from 22 programs. The mean SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score was 32.4 ± 12.2 before and 15.0 ± 11.7 after PCI. All-cause mortality was 5.6% at 30 days and 12.3% at 6 months. Observed-to-expected mortality ratios were 1.06 (95% CI: 0.71-1.36) with The Society for Thoracic Surgeons score, 0.99 (95% CI: 0.71-1.27) with the EuroSCORE II, 0.59 (95% CI: 0.42-0.77) using cardiac surgeons' estimates, and 4.46 (95% CI: 2.35-7.99) using the NCDR CathPCI score. Health status improved significantly from baseline to 6 months: SAQ summary score (65.9 ± 22.5 vs 86.5 ± 15.1; P < 0.0001), Kansas City Cardiomyopathy Questionnaire summary score (54.1 ± 27.2 vs 82.6 ± 19.7; P < 0.0001). CONCLUSIONS: Patients ineligible for CABG who undergo PCI have complex clinical profiles and high disease burden. Following PCI, short-term mortality is considerably lower than surgeons' estimates, similar to surgical risk model predictions but is over 4-fold higher than estimated by the NCDR CathPCI model. Patients' health status improved significantly through 6 months.

Geometric Indices for Predicting Ischemic Mitral Regurgitation: Correlation of Mitral Valve Coaptation Area With Tenting Height, Tenting Area and Tenting Volume.

OBJECTIVES: Ischemic remodeling of the left ventricle in patients with coronary artery disease (CAD) results in geometric changes of the mitral valve (MV) apparatus, leading to reduced MV leaflet coaptation. Although the calculation of the coaptation area has value in assessing the effects of left ventricular remodeling on the MV, it is difficult and time-consuming to measure. In this study the authors hypothesized that the tenting volume (TV) would have a greater association with coaptation area than tenting height (TH) or tenting area (TA). DESIGN: A retrospective review. SETTING: A single tertiary-care academic hospital. PARTICIPANTS: There were 145 adult patients who underwent coronary artery bypass graft surgery between April 2018 and July 2020. MEASUREMENTS AND MAIN RESULTS: Intraoperative 2- and 3-dimensional transesophageal echocardiographic studies were obtained in the precardiopulmonary bypass period. Offline analysis was used to obtain TH, TA, TV and coaptation area for each patient. Correlation between the coaptation area and the TH, TA, and TV was conducted using Pearson's correlation. The median age of the population was 68.0 years (61.0-73.3), the body mass index was 29.0 kg/m2 (25.7-33.5), and 17.8% were females. Increases in TV were the most reliable predictor of decreases in coaptation area (R2 = 0.75) followed by TA (R2 = 0.48) and TH (R2 = 0.47). CONCLUSION: As a representative of the complete topography of the MV, the authors' study demonstrated that in patients with CAD, TV has a greater negative correlation with coaptation area as compared to TH or TA.

Timing of Blood Transfusions and 30-Day Patient Outcomes After Coronary Artery Bypass Graft Surgery.

OBJECTIVE: Packed red blood cell transfusion during coronary artery bypass graft surgery is known to be associated with adverse outcomes. However, the association of the timing between transfusions in relation to discharge and 30-day postoperative outcomes has not been studied. The study authors investigated the impact of transfusion timing on 30-day surgical outcomes. DESIGN: A retrospective review. SETTING: At a single tertiary-care academic hospital. PARTICIPANTS: A total of 2,481 adult patients underwent primary coronary artery bypass graft surgery between January 2014 and December 2020. MEASUREMENTS AND MAIN RESULTS: The relationship between the timing of packed red blood cell transfusion (intraoperative, postoperative, or both) and 30-day postoperative outcome variables was calculated as an odds ratio. The influence of timing of transfusion on adjusted probability of postoperative complications was plotted against the lowest intraoperative hematocrit. The median age of the population was 67 years (60.0-74.0), body mass index was 28.5 (25.6-32.3) kg/m2, and 497 (20.0%) were female. A total of 1,588 (36%) patients received packed red blood cell transfusions; 182 (7.3%) received intraoperative transfusions, 489 (19.7%) received postoperative transfusions, and 222 (9.0%) received both (intraoperative and postoperative transfusions). Postoperative transfusion was associated with significantly higher odds of readmission (1.83 [1.32-2.54], p = 0.002) and heart failure (1.64 [1.2-2.23], p = 0.008) compared to patients with no transfusions; whereas intraoperative transfusions were not. CONCLUSION: The authors' data suggested that the postoperative timing of transfusion in patients undergoing coronary artery bypass graft surgery may be associated with an increased incidence of 30-day heart failure and readmission. Prospective research is needed to conclusively confirm these findings.

Mitral Regurgitation and Mortality Risk in Medicare Beneficiaries With Heart Failure and Preserved Ejection Fraction.

The association of mitral regurgitation (MR) severity and mortality in heart failure with preserved ejection fraction (HFpEF) is uncertain. We sought to evaluate the relation between MR severity on transthoracic echocardiography (TTE) and subsequent all-cause mortality in Medicare beneficiaries with HFpEF. We linked 57,608 patients referred for TTE at Beth Israel Deaconess Medical Center to Medicare inpatient claims from 2003 to 2017. In those with a history of HF and a physician-reported left ventricular ejection fraction ≥50%, we evaluated the relation of MR severity and time to the primary end point of all-cause mortality using Kaplan-Meier methods. A total of 7,778 individuals (14.5%) met inclusion criteria (mean age 75.5 years ± 11.9, 55.9% female). Over a median follow-up of 8.1 years, 2,016 (25.9%) died at a median (interquartile range) of 1.7 (0.3 to 4.1) years. At 1 year, 15.8% with 3 to 4+ MR had died versus 10.5% with 0 to 2+ MR (hazard ratio 1.54, 95% confidence interval 1.22 to 1.95, p <0.001). After multivariable adjustment, 3 to 4+ MR continued to be associated with increased all-cause mortality (hazard ratio 1.48, 95% confidence interval 1.14 to 1.94, p = 0.004) except in the subset with atrial fibrillation (interaction p = 0.03) or recent (<3 months) HF hospitalization (p = 0.54). In conclusion, in this large, single-institution retrospective study of Medicare beneficiaries with HFpEF who underwent TTE, moderate-to-severe and severe MR were significantly associated with an increased risk of all-cause mortality after multivariable adjustment, except in those with atrial fibrillation or recent HF. Prospective studies are needed to assess the role of MR reduction in mitigating this risk.

Anesthetics to Prevent Lung Injury in Cardiac Surgery: A Randomized Controlled Trial.

OBJECTIVES: To investigate if sevoflurane based anesthesia is superior to propofol in preventing lung inflammation and preventing postoperative pulmonary complications. DESIGN: Randomized controlled trial. SETTING: Single tertiary care university hospital. PARTICIPANTS: Forty adults undergoing cardiac surgery with cardiopulmonary bypass. INTERVENTIONS: Patients were randomized in a 1:1 ratio to anesthetic maintenance with sevoflurane or propofol. MEASUREMENTS AND MAIN RESULTS: Blood and bronchoalveolar lavage fluid was sampled before and after bypass to measure pulmonary inflammation using a biomarker panel. The change in bronchoalveolar lavage concentration of tumor necrosis factor alpha (TNFα) was the primary outcome. Secondary outcomes included lung inflammation defined as changes in other biomarkers and postoperative pulmonary complications. There were no significant differences between groups in the change in bronchoalveolar lavage TNFα concentration (median [IQR] change, 17.24 [1.11-536.77] v 101.51 [1.47-402.84] pg/mL, sevoflurane v propofol, p = 0.31). There was a significantly lower postbypass concentration of plasma interleukin 8 (median [IQR], 53.92 [34.5-55.91] v 66.92 [53.03-94.44] pg/mL, p = 0.04) and a significantly smaller postbypass increase in the plasma receptor for advanced glycosylation end products (median [IQR], 174.59 [73.59-446.06] v 548.22 [193.15-852.39] pg/mL, p = 0.03) in the sevoflurane group compared with propofol. The incidence of postoperative pulmonary complications was 100% in both groups, with high rates of pleural effusion (17/18 [94.44%] v 19/22 [86.36%], p = 0.39) and hypoxemia (16/18 [88.88%] v 22/22 [100%], p = 0.11). CONCLUSIONS: Sevoflurane anesthesia during cardiac surgery did not consistently prevent lung inflammation or prevent postoperative pulmonary complications compared to propofol. There were significantly lower levels of 2 plasma biomarkers specific for lung injury and inflammation in the sevoflurane group.

Three-Dimensional Printing of Patient-Specific Heart Valves: Separating Facts From Fiction and Myth From Reality.

The development of prosthetic heart valves by Dr. Charles Hufnagel in 1952 was a major clinical innovation; however, it was not an ideal solution. Mechanical prosthetic heart valves are rigid, immunogenic, require anticoagulation, do not grow with the patient, and have a finite life.1 An ideal prosthetic valve should overcome all these limitations. Considering the prevalence of valvular heart disorders, there is considerable interest in the creation of patient-specific heart valves. Following the introduction of three-dimensional (3D) printing in 1986 by Chuck Hill, rapid advances in multimodality 3D imaging and modeling have led to a generation of tangible replicas of patient-specific anatomy. The science of organogenesis has gained importance for a multitude of valid reasons: as an alternate source of organs, for realistic drug testing, as an alternative to animal testing, and for transplants that grow with the patient. What scientists imagined to be seemingly impossible in the past now seems just a step away from becoming a reality. However, due to the disruptive nature of this technology, often there are commercially-motivated claims of originality and overstatement of the scope and applicability of 3D printing. It often is difficult to separate fact from fiction and myth from reality. In this manuscript, the authors have reviewed the historic perspective, status of the basic techniques of organogenesis with specific reference to heart valves, and their potential.

Echocardiographic Assessment of the Mitral Valve for Suitability of Repair: An Intraoperative Approach From a Mitral Center.

Intraoperative echocardiography of the mitral valve in the precardiopulmonary bypass period is an integral part of the surgical decision-making process for assessment of suitability for repair. Although there are comprehensive reviews in the literature regarding echocardiographic examination of the mitral valve, the authors present a practical stepwise algorithmic workflow to make objective recommendations. Advances in echocardiography allow for quantitative geometric analyses of the mitral valve, along with precise assessment of the valvular apparatus with three-dimensional echocardiography. In the precardiopulmonary bypass period, echocardiographers are required to diagnose and quantify valvular dysfunction, assess suitability for repair, assist in annuloplasty ring sizing, and determine the success or failure of the surgical procedure. In this manuscript the authors outline an algorithmic approach to intraoperative echocardiography examination using two-dimensional and three-dimensional modalities to objectively analyze mitral valve function and assist in surgical decision-making.