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.

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.

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study.

[Figure: see text].

Excimer Laser Coronary Angioplasty in Coronary Lesions: Use and Safety From the NCDR/CATH PCI Registry.

[Figure: see text].

Sociodemographic differences in utilization and outcomes for temporary cardiovascular mechanical support in the setting of cardiogenic shock.

BACKGROUND: Temporary mechanical circulatory support (MCS) devices are increasingly used in cardiogenic shock, but whether sociodemographic differences by sex, race and/or ethnicity, insurance status, and neighborhood poverty exist in the utilization of these devices is unknown. METHODS: Retrospective cross-sectional study using the National Inpatient Sample for 2012-2017. Logistic regression models were used to examine predictors of use of temporary MCS devices and for in-hospital mortality, clustering by hospital-year. RESULTS: Our study population included 109,327 admissions for cardiogenic shock. Overall, 14.3% of admissions received an intra-aortic balloon pump, 4.2% a percutaneous ventricular assist device, and 1.8% extracorporeal membranous oxygenation (ECMO). After adjusting for age, comorbidities, and hospital characteristics, use of temporary MCS was lower in women compared to men (adjusted odds ratio [aOR] = 0.76, P < .001), Black patients compared to white ones (aOR = 0.73, P < .001), those insured by Medicare (aOR = 0.75, P < .001), Medicaid (aOR = 0.74, P < .001), or uninsured (aOR = 0.90, P = .015) compared to privately insured, and those in the lowest income neighborhoods (aOR = 0.94, P = .003) versus other neighborhoods. Women, admissions covered by Medicare, Medicaid, or uninsured, and those from low-income neighborhoods also had higher mortality rates even after adjustment for MCS implantation. CONCLUSIONS: There are differences in the use of temporary MCS in the setting of cardiogenic shock among specific populations within the United States. The growing use of MCS for treating cardiogenic shock highlights the need to better understand its impact on outcomes.

Clinical and Echocardiographic Features Associated With Improved Survival in Patients With Severe Aortic Stenosis Undergoing Balloon Aortic Valvuloplasty (BAV).

BACKGROUND: Balloon aortic valvuloplasty (BAV) is used in high-risk patients with severe aortic stenosis (AS) when the benefit of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) is unclear. Our objective was to identify clinical or echocardiographic features that identify patients likely to benefit from BAV. METHODS: We studied 141 consecutive patients who underwent BAV from July, 2011 to October, 2017. Clinical characteristics, routine echocardiographic parameters, and speckle tracking imaging of global longitudinal strain (GLS) were assessed before and after BAV. The primary outcome was all-cause mortality as ascertained by the National Death Index. RESULTS: There were 141 patients, median age, 80 years (interquartile range [IQR], 74-87 years) with severe AS (median aortic valve area, 0.66 cm²; IQR, 0.53-0.79 cm²) and median mean gradient of 36 mm Hg (IQR, 27-48 mm Hg) who underwent BAV. The 1-year mortality rate was 52%. Characteristics associated with survival were New York Heart Association class I symptoms, lower brain natriuretic peptide level, higher left ventricular ejection fraction (LVEF) >53%, and higher GLS (>13.2%; absolute values were used for GLS). Landmark analysis at 60 days showed the 47 patients who underwent TAVR/SAVR after BAV had significantly better 1-year survival than those who did not (P<.001). CONCLUSION: A high 1-year mortality rate was observed in severe AS patients selected for BAV. LVEF and left ventricular (LV)-GLS offer similar prognostic value for 1-year mortality; however, LV-GLS may have potentially increased clinical utility, as it provides a clear threshold for predicting poor outcomes compared with LVEF. As patients who undergo TAVR/SAVR have markedly improved mortality, careful consideration should be given to advance definitive valve therapy in carefully selected BAV patients.

Radiation Exposure During Transcatheter Valve Replacement: What Cardiac Surgeons Need to Know.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement expose operators to radiation. These procedures differ primarily in whether they are performed via a transfemoral (TF) or an alternative access (AA) approach. This study compared operator radiation exposure during transcatheter valve implantation when performed via a TF vs an AA approach, when performed in a catheterization lab vs a hybrid operating room (OR), and investigated the potential benefit of disposable shielding. METHODS: Dosimeters were worn during TAVR-TF (n = 50) and TAVR-AA (n = 31) procedures by operators. All TAVR-AA procedures were performed in a hybrid OR and TF procedures were performed in either catheterization labs (n = 16) or a hybrid OR (n = 34). Disposable radiation shielding pads (RADPAD; Worldwide Innovations and Technologies, Inc, Kansas City) or a placebo were added in a randomized, blinded fashion. RESULTS: Team radiation exposure was higher after TAVR-AA vs TAVR-TF (median 15.1 mRad [interquartile range: IQR 8.6, 32.4] vs 5.5 mRad [IQR 2.4, 9.8], P < .001). TAVR-TF procedures required the same amount of fluoroscopy time regardless of where they were performed (20.3 ± 7.4 min in hybrid OR vs 19.0 ± 6.4 min in catheterization lab, P = .55). However, radiation exposure for TAVR-TF remained higher when performed in a hybrid OR (median 9.0 mRad [IQR 4.5, 11.9] vs 2.2 mRad [IQR 1.3, 2.8], P < .001). Radiation exposure was greatest for TAVR-AA (median 15.1 mRad [IQR 8.6, 32.4]). The use of RADPAD did not decrease radiation exposure (median 9.0 mRad [IQR 4.5, 14.7] vs 9.4 mRad [IQR 2.8, 19.5], P = .82). CONCLUSIONS: Procedures performed in the hybrid OR were associated with higher operator radiation exposure. In comparison with the TF approach, AA cases had the highest levels of operator radiation. This is particularly important in cases of transcatheter mitral valve replacement that can only be done via an AA approach. The use of disposable radiation shielding in this series did not attenuate operator radiation exposure. Radiation shielding within hybrid ORs should be scrutinized in an effort to remain on par with that found within catheterization labs.

The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale.

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

Observed to expected 30-day mortality as a benchmark for transcatheter aortic valve replacement.

OBJECTIVE: The observed-to-expected 30-day mortality ratio (O:E ratio) is a standard metric by which transcatheter aortic valve replacement (TAVR) trials have been evaluated. Early TAVR trials consistently demonstrated O:E ratio less than 0.6 after TAVR when based on the Society for Thoracic Surgery Predicted Risk of Mortality (STS-PROM) for surgical aortic valve replacement. Recent published results from the Transcatheter Valve Therapy (TVT) Registry have demonstrated O:E ratios of 1.0. We evaluated our own O:E ratios for TAVR to investigate this discordance. METHODS: Data were collected prospectively for TAVR patients from 2008 through 2015 (N = 546) and were reviewed retrospectively. The observed mortality and STS-PROM were calculated to formulate O:E ratios and were compared over a variety of subgroups. RESULTS: Overall, the O:E ratio for 30-day mortality was 0.4 and significantly less than 1 (P < .001; 95% confidence interval, 0.25-0.63). The O:E ratio relationship remained less than 0.5 for patients with low (STS-PROM < 4), moderate (STS-PROM = 4-8) and high risk (STS-PROM > 8). The O:E ratio was significantly higher for transapical patients (O:E ratio = 0.8) when compared with transfemoral patients (O:E ratio = 0.2). Lastly, O:E ratios for both commercial (O:E ratio = 0.5) and research (O:E ratio = 0.3) patients were similar (P = .337), and both were significantly less than 1 (P = .007 and P < .001, respectively). CONCLUSIONS: The STS-PROM consistently overestimated 30-day mortality after TAVR. Achieving an O:E ratio less than 0.6 may be a realistic goal for all TAVR programs. While an accurate and specific risk calculator for 30-day mortality after TAVR remains to be established, our data suggest that current TVT results are not acceptable for commercial TAVR and that programs with an O:E ratio greater than 0.6, based on the STS-PROM, should reevaluate internal processes to improve their results.

Anesthetic Considerations for the Transcatheter Management of Mitral Valve Disease.

The development of transcatheter interventions to provide a minimally invasive alternative to open surgical repair has revolutionized the care of patients with valvular heart disease. Recently, this technology has been expanded to allow for the treatment of pathology of the mitral valve. This review discusses the anesthetic considerations for patients presenting for transcatheter management of mitral valve disease, including transcatheter mitral valve replacement (TMVR) and transcatheter mitral valve repair (TMVRep). The initial focus is on the current literature on transcatheter interventions for mitral valve pathologies as well as current and developing technology for TMVR and TMVRep. The authors' institutional experience with anesthetic management for the TMVR and TMVRep procedures is described, including potential pitfalls and complications, concluding with a discussion of the role of transesophageal echocardiography in the care of this patient population.

Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients.

OBJECTIVES: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). METHODS: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. RESULTS: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.

Outcomes After the MitraClip Procedure in Patients at Very High Risk for Conventional Mitral Valve Surgery.

OBJECTIVE: Approximately 50% of patients with severe symptomatic mitral regurgitation are deemed too high risk for surgery. The MitraClip procedure is a viable option for this population. Our goal was to assess outcomes and survival of patients who underwent the MitraClip procedure at an institution where mitral valve surgery is routinely performed. METHODS: A retrospective study of patients undergoing the MitraClip procedure was performed. Baseline characteristics, perioperative outcomes, and follow-up echocardiographic and clinical outcomes were examined. Primary end point was survival. Secondary end points included technical failure (residual 3/4+ mitral regurgitation), reoperation, New York Heart Association symptoms, 30-day mortality, and other clinical outcomes. Predictors of mortality were determined using multivariable regression analysis. RESULTS: Fifty consecutive patients underwent the MitraClip procedure during the 4-year period. The average age was 83, the Society of Thoracic Surgeons predicted risk of mortality mean was 9.4%, 88% (44/50) had New York Heart Association III/IV symptoms, 86% (43/50) had 4+ mitral regurgitation, and 72% (36/50) had degenerative mitral disease etiology. Echocardiographic data (median [interquartile range] follow-up = 43 [26-392]) showed that 86% (43/50) of patients had 2+ or less mitral regurgitation. Sixty percent (24/40) had New York Heart Association I/II symptoms at last follow-up. Predictors of mortality were higher Society of Thoracic Surgeons predicted risk of mortality (P = 0.042, hazard ratio = 1.098) and previous cardiac surgery (P = 0.013, hazard ratio = 3.848). Survival at 1 and 2 years was 75% and 63%, respectively. CONCLUSIONS: Many patients with mitral valve regurgitation who are high risk for open surgery can be treated with the MitraClip procedure. In our study, most patients (86%) had a technically successful operation and postoperative outcomes including survival were acceptable.

Reversing the "Risk-Treatment Paradox" of Bleeding in Patients Undergoing Percutaneous Coronary Intervention: Risk-Concordant Use of Bleeding Avoidance Strategies Is Associated With Reduced Bleeding and Lower Costs.

Background Bleeding is a common, morbid, and costly complication of percutaneous coronary intervention. While bleeding avoidance strategies ( BAS ) are effective, they are used paradoxically less in patients at high risk of bleeding. Whether a patient-centered approach to specifically increase the risk-concordant use of BAS and, thus, reverse the risk-treatment paradox is associated with reduced bleeding and costs is unknown. Methods and Results We implemented an intervention to reverse the bleeding risk-treatment paradox at Barnes-Jewish Hospital, St. Louis, MO, and examined: (1) the temporal trends in BAS use and (2) the association of risk-concordant BAS use with bleeding and hospital costs of percutaneous coronary intervention. Among 3519 percutaneous coronary interventions, there was a significantly increasing trend ( P=0.002) in risk-concordant use of BAS . The bleeding incidence was 2% in the risk-concordant group versus 9% in the risk-discordant group (absolute risk difference, 7%; number needed to treat, 14). Risk-concordant BAS use was associated with a 67% (95% confidence interval, 52-78%; P<0.001) reduction in the risk of bleeding and a $4738 (95% confidence interval, 3353-6122; P<0.001) reduction in per-patient percutaneous coronary intervention hospitalization costs (21.6% cost-savings). Conclusions In this study, patient-centered care directly aimed to make treatment-related decisions based on predicted risk of bleeding, led to more risk-concordant use of BAS and reversal of the risk-treatment paradox. This, in turn, was associated with a reduction in bleeding and hospitalization costs. Larger multicentered studies are needed to corroborate these results. As clinical medicine moves toward personalization, both patients and hospitals can benefit from a simple practice change that encourages objectivity and mitigates variability in care.

Acute right ventricular failure and pulseless electrical activity arrest following auto-transfusion of blood.

Air embolism is a rare but potentially catastrophic complication of interventional procedures. The occurrence of acute right ventricular dysfunction during intraoperative auto-transfusion of blood, presumably related to pulmonary embolism of agitated air microbubbles and microthrombi, is less commonly recognized. We report a case of auto-transfusion complicated by acute right ventricular failure and pulseless electrical activity arrest. Auto-transfusion of recovered blood is a practical solution to reduce need for post-procedure allogenic transfusions. Although such interventions are frequently performed without complications, they do have inherent risks that should be readily acknowledged. This case clearly describes a severe complication and sequelae of auto-transfusion. .

Association of Same-Day Discharge After Elective Percutaneous Coronary Intervention in the United States With Costs and Outcomes.

Importance: Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown. Objective: To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers. Design, Setting, and Participants: This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up. Exposures: Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge. Main Outcomes and Measures: Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016. Results: Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates. Conclusions and Relevance: Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.

Etiologies and predictors of 30-day readmissions in patients undergoing percutaneous mechanical circulatory support-assisted percutaneous coronary intervention in the United States: Insights from the Nationwide Readmissions Database.

BACKGROUND: Patients undergoing percutaneous mechanical circulatory support (pMCS)-assisted percutaneous coronary intervention (PCI) represent a high-risk group vulnerable to complications and readmissions. HYPOTHESIS: Thirty-day readmissions after pMCS-assisted PCI are common among patients with comorbidities and account for a significant amount of healthcare spending. METHODS: Patients undergoing PCI and pMCS (Impella, TandemHeart, or intra-aortic balloon pump) for any indication between January 1, 2012, and November 30, 2014, were selected from the Nationwide Readmissions Database. Patients were identified using appropriate ICD-9-CM codes. Clinical risk factors and complications were analyzed for association with 30-day readmission. RESULTS: Our analysis included 29 247 patients, of which 4535 (15.5%) were readmitted within 30 days. On multivariate analysis, age ≥ 65 years, female sex, hypertension, diabetes, chronic lung disease, heart failure, prior implantable cardioverter-defibrillator, liver disease, end-stage renal disease, and length of stay ≥5 days during index hospitalization were independent predictors of 30-day readmission. Cardiac etiologies accounted for ~60% of readmissions, of which systolic or diastolic heart failure (22%), stable coronary artery disease (11.1%), acute coronary syndromes (8.9%), and nonspecific chest pain (4.0%) were the most common causes. In noncardiac causes, sepsis/septic shock (4.6%), hypotension/syncope (3.2%), gastrointestinal bleed (3.1%), and acute kidney injury (2.6%) were among the most common causes of 30-day readmissions. Mean length of stay and cost of readmissions was 4 days and $16 191, respectively. CONCLUSIONS: Thirty-day readmissions after pMCS-assisted PCI are common and are predominantly associated with increased burden of comorbidities. Reducing readmissions for common cardiac etiologies could save substantial healthcare costs.

Novel Patient-Centered Approach to Facilitate Same-Day Discharge in Patients Undergoing Elective Percutaneous Coronary Intervention.

BACKGROUND: Same-day discharge (SDD) after elective percutaneous coronary intervention is safe, less costly, and preferred by patients, but it is usually performed in low-risk patients, if at all. To increase the appropriate use of SDD in more complex patients, we implemented a "patient-centered" protocol based on risk of complications at Barnes-Jewish Hospital. METHODS AND RESULTS: Our objectives were as follows: (1) to evaluate time trends in SDD; (2) to compare (a) mortality, bleeding, and acute kidney injury, (b) patient satisfaction, and (c) hospital costs by SDD versus no SDD (NSDD); and (3) to compare SDD eligibility by our patient-centered approach versus Society for Cardiovascular Angiography and Interventions guidelines. Our patient-centered approach was based on prospectively identifying personalized bleeding, mortality, and acute kidney injury risks, with a personalized safe contrast limit and mitigating those risks. We analyzed Barnes-Jewish Hospital's National Cardiovascular Data Registry CathPCI Registry data from July 1, 2009 to September 30, 2015 (N=1752). SDD increased rapidly from 0% to 77% (P<0.001), independent of radial access. Although SDD patients were comparable to NSDD patients, SDD was not associated with adverse outcomes (0% mortality, 0% bleeds, and 0.4% acute kidney injury). Patient satisfaction was high with SDD. Propensity score-adjusted costs were $7331 lower/SDD patient (P<0.001), saving an estimated $1.8 million annually. Only 16 patients (6.95%) met the eligibility for SDD by Society for Cardiovascular Angiography and Interventions guidelines, implying our patient-centered approach markedly increased SDD eligibility. CONCLUSIONS: With a patient-centered approach, SDD rapidly increased and was safe in 75% of patients undergoing elective percutaneous coronary intervention, despite patient complexity. Patient satisfaction was high, and hospital costs were lower. Patient-centered decision making to facilitate SDD is an important opportunity to improve the value of percutaneous coronary intervention.

Mechanical Circulatory Support in Acute Decompensated Heart Failure and Shock.

An array of interventional therapeutics is available in the modern era, with uses depending on acute or chronic situations. This article focuses on support in acute decompensated heart failure and cardiogenic shock, including intra-aortic balloon pumps, continuous aortic flow augmentation, and extra-corporeal membrane oxygenation.

Left Ventricular Unloading by Impella Device Versus Surgical Vent During Extracorporeal Life Support.

BACKGROUND: Patients supported with extracorporeal life support (ECLS) can experience severe complications from increased left ventricular (LV) afterload. The Impella (Abiomed, Danvers, MA) percutaneous ventricular assist device (PVAD) may offer an attractive option for unloading the LV in these patients. This study describes the efficacy and outcomes of PVAD use during ECLS compared with surgically placed LV vent. METHODS: In this retrospective study, we reviewed patients supported by ECLS with PVAD or surgical LV vent for cardiogenic shock between April 2010 and May 2016. Included were 23 patients with PVADs and 22 with surgical vents. Patients' baseline characteristics, hemodynamic data, and outcomes were collected immediately preceding combined support initiation, at 48 hours, intensive care unit discharge, and 30 days. RESULTS: After 48 hours, pulmonary artery diastolic pressure was significantly reduced in the PVAD (23.3 ± 8.4 vs 15.6 ± 4.2, p = 0.02) and surgical vent groups (20.1 ± 5.9 vs 15.6 ± 5.4, p = 0.01), and radiographic evidence of pulmonary edema was reduced or unchanged in 90% of PVAD patients and in 76% of surgical vent patients. The primary end points of survival to 30 days (43% vs 32%, p = 0.42) and intensive care unit discharge (35% vs 23%, p = 0.37) were not different between the two methods of support. The PVAD and surgical vent groups were also not significantly different in the rate of vascular complications or in the number decannulated from ECLS and transitioned to durable LV assist device. CONCLUSIONS: PVAD use in ECLS patients is an effective means of LV unloading and preventing worsened pulmonary edema, with outcomes and complications that are comparable to surgical LV vent.