NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

RATIONALE: Postconditioning at the time of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction may reduce infarct size and improve myocardial salvage. However, clinical trials have shown inconsistent benefit. OBJECTIVE: We performed the first National Heart, Lung, and Blood Institute-sponsored trial of postconditioning in the United States using strict enrollment criteria to optimize the early benefits of postconditioning and assess its long-term effects on left ventricular (LV) function. METHODS AND RESULTS: We randomized 122 ST-segment-elevation myocardial infarction patients to postconditioning (4, 30 seconds PTCA [percutaneous transluminal coronary angioplasty] inflations/deflations)+PCI (n=65) versus routine PCI (n=57). All subjects had an occluded major epicardial artery (thrombolysis in myocardial infarction=0) with ischemic times between 1 and 6 hours with no evidence of preinfarction angina or collateral blood flow. Cardiac magnetic resonance imaging measured at 2 days post-PCI showed no difference between the postconditioning group and control in regards to infarct size (22.5±14.5 versus 24.0±18.5 g), myocardial salvage index (30.3±15.6% versus 31.5±23.6%), or mean LV ejection fraction. Magnetic resonance imaging at 12 months showed a significant recovery of LV ejection fraction in both groups (61.0±11.4% and 61.4±9.1%; P<0.01). Subjects randomized to postconditioning experienced more favorable remodeling over 1 year (LV end-diastolic volume =157±34 to 150±38 mL) compared with the control group (157±40 to 165±45 mL; P<0.03) and reduced microvascular obstruction ( P=0.05) on baseline magnetic resonance imaging and significantly less adverse LV remodeling compared with control subjects with microvascular obstruction ( P<0.05). No significant adverse events were associated with the postconditioning protocol and all patients but one (hemorrhagic stroke) survived through 1 year of follow-up. CONCLUSIONS: We found no early benefit of postconditioning on infarct size, myocardial salvage index, and LV function compared with routine PCI. However, postconditioning was associated with improved LV remodeling at 1 year of follow-up, especially in subjects with microvascular obstruction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01324453.

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

Laparoscopic pancreatoduodenectomy with open or laparoscopic reconstruction during the learning curve: a multicenter propensity score matched study.

BACKGROUND: Laparoscopic pancreatoduodenectomy with open reconstruction (LPD-OR) has been suggested to lower the rate of postoperative pancreatic fistula reported after laparoscopic pancreatoduodenectomy with laparoscopic reconstruction (LPD). Propensity score matched studies are, lacking. METHODS: This is a multicenter prospective cohort study including patients from 7 Dutch centers between 2014-2018. Patients undergoing LPD-OR were matched LPD patients in a 1:1 ratio based on propensity scores. Main outcomes were postoperative pancreatic fistulas (POPF) grade B/C and Clavien-Dindo grade ≥3 complications. RESULTS: A total of 172 patients were included, involving the first procedure for all centers. All 56 patients after LPD-OR could be matched to a patient undergoing LPD. With LPD-OR, the unplanned conversion rate was 21% vs. 9% with LPD (P < 0.001). Median blood loss (300 vs. 400 mL, P = 0.85), operative time (401 vs. 378 min, P = 0.62) and hospital stay (10 vs. 12 days, P = 0.31) were comparable for LPD-OR vs. LPD, as were Clavien-Dindo grade ≥3 complications (38% vs. 52%, P = 0.13), POPF grade B/C (23% vs. 21%, P = 0.82), and 90-day mortality (4% vs. 4%, P > 0.99). CONCLUSION: In this propensity matched cohort performed early in the learning curve, no benefit was found for LPD-OR, as compared to LPD.

Impact of sleep deprivation on the outcomes of percutaneous coronary intervention.

OBJECTIVES: This study sought to compare the clinical outcomes of percutaneous coronary interventions (PCIs) performed by sleep deprived and non-sleep deprived operators. BACKGROUND: Interventional cardiologists are at risk for sleep deprivation as they often have to perform emergent procedures at night, but the effects of sleep deprivation on clinical outcomes have received limited study. METHODS: We examined the frequency, clinical characteristics, and outcomes of daytime PCIs performed by sleep deprived and non-sleep deprived operators at a tertiary medical center. Operators were considered sleep deprived when performing a daytime (7 am-11:59 pm) procedure preceded by a nighttime (12 am-6:59 am) procedure on the same date. RESULTS: Of the 12,680 daytime PCIs performed from 6/29/09 to 12/30/2016, 367 (2.9%) were performed by sleep deprived operators. Patients undergoing PCI performed by a sleep deprived operator were more likely to be younger, white, and to present with ST-elevation acute myocardial infarction (STEMI). The incidence of in-hospital death (1.1% vs. 1.3%, P = 1.0) and bleeding within 72 hr (3.9% vs. 2.9%, P = 0.29) were similar for procedures performed by sleep-deprived and non-sleep deprived operators. When the sleep deprived group was further stratified based on degree of sleep deprivation or length of sleep interruption, differences in mortality and total bleeding remained non-significant. CONCLUSIONS: In this large single center study, operator sleep deprivation did not appear to adversely impact PCI outcomes.

Meta-analysis of the impact of successful chronic total occlusion percutaneous coronary intervention on left ventricular systolic function and reverse remodeling.

BACKGROUND: We sought to examine the impact of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on left ventricular (LV) function. METHODS: We performed a systematic review and meta-analysis of studies published between January 1980 and November 2017 on the impact of successful CTO PCI on LV function. RESULTS: A total of 34 observational studies including 2735 patients were included in the meta-analysis. Over a weighted mean follow-up of 7.9 months, successful CTO PCI was associated with an increase in LV ejection fraction by 3.8% (95%CI 3.0-4.7, P < 0.0001, I2 = 45%). In secondary analysis of 15 studies (1248 patients) that defined CTOs as occlusions of at least 3-month duration and reported follow-up of at least 3-months after the procedure, successful CTO PCI was associated with improvement in LV ejection fraction by 4.3% (95%CI [3.1, 5.6], P < 0.0001). In the 10 studies (502 patients) that reported LV end-systolic volume, successful CTO PCI was associated with a decrease in LV end-systolic volume by 4 mL, (95%CI -6.0 to -2.1, P < 0.0001, I2 = 0%). LV end-diastolic volume was reported in 9 studies with 403 patients and did not significantly change after successful CTO PCI (-2.3 mL, 95%CI -5.7 to 1.2 mL, P = 0.19, I2 = 0%). CONCLUSIONS: Successful CTO PCI is associated with a statistically significant improvement in LV ejection fraction and decrease in LV end-systolic volume, that may reflect a beneficial effect of CTO recanalization on LV remodeling. The clinical implications of these findings warrant further investigation.

Single center cost analysis of single-port and conventional laparoscopic surgical treatment in colorectal malignant diseases.

BACKGROUND AND PURPOSE: Single-port laparoscopy (SPL) is a relatively new technique, used in various procedures. There is limited knowledge about the cost effectiveness and the learning curve of this technique. The primary aim of this study was to compare hospital costs between SPL and conventional laparoscopic resections (CLR) for colorectal cancer; the secondary aim was to identify a learning curve of SPL. METHODS: All elective colorectal cancer SPL and CLR performed in a major teaching hospital between 2011 and 2012 that were registered in the Dutch Surgical Colorectal Audit were included (n = 267). The economic evaluation was conducted from a hospital perspective, and costs were calculated using time-driven activity-based costing methodology up to 90 days after discharge. When looking at SPL only, the introduction year (2011) was compared to the next year (2012). RESULTS: SPL (n = 78) was associated with lower mortality, lower reintervention rates, and more complications as compared to CLR (n = 189); however, none of these differences were statistically significant. A significant shorter operating time was seen in the SPL. Total costs were higher for SPL group as compared to CLR; however, this difference was not statistically significant. For the SPL group, most clinical outcomes improved between 2011 and 2012; moreover, total hospital costs for SPL in 2012 became comparable to CLR. CONCLUSION: No significant differences in financial outcomes between SPL and CLR were identified. After the introduction period, SPL showed similar results as compared to CLR. Conclusions are based on a small single-port group and the conclusions of this manuscript should be an impetus for further research.

Acute laparoscopic and open sigmoidectomy for perforated diverticulitis: a propensity score-matched cohort.

BACKGROUND: Hartmann's procedure for perforated diverticulitis can be characterised by high morbidity and mortality rates. While the scientific community focuses on laparoscopic lavage as an alternative for laparotomy, the option of laparoscopic sigmoidectomy seems overlooked. We compared morbidity and hospital stay following acute laparoscopic sigmoidectomy (LS) and open sigmoidectomy (OS) for perforated diverticulitis. METHODS: This retrospective cohort parallel to the Ladies trial included patients from 28 Dutch academic or teaching hospitals between July 2010 and July 2014. Patients with LS were matched 1:2 to OS using the propensity score for age, gender, previous laparotomy, CRP level, gastrointestinal surgeon, and Hinchey classification. RESULTS: The propensity-matched cohort consisted of 39 patients with LS and 78 patients with OS, selected from a sample of 307 consecutive patients with purulent or faecal perforated diverticulitis. In both groups, 66 % of the patients had Hartmann's procedure and 34 % had primary anastomosis. The hospital stay was shorter following LS (LS 7 vs OS 9 days; P = 0.016), and the postoperative morbidity rate was lower following LS (LS 44 % vs OS 66 %; P = 0.016). Mortality was low in both groups (LS 3 % vs OS 4 %; P = 0.685). The stoma reversal rate after Hartmann's procedure was higher following laparoscopy, with a probability of being stoma-free at 12 months of 88 and 62 % in the laparoscopic and open groups, respectively (P = 0.019). After primary anastomosis, the probability of reversal was 100 % in both groups. CONCLUSIONS: In this propensity score-matched cohort, laparoscopic sigmoidectomy is superior to open sigmoidectomy for perforated diverticulitis with regard to postoperative morbidity and hospital stay.

Use of a multi-instrument access device in abdominoperineal resections.

BACKGROUND: Laparoscopic colorectal surgery results in less post-operative pain, faster recovery, shorter length of stay and reduced morbidity compared with open procedures. Less or minimally invasive techniques have been developed to further minimise surgical trauma and to decrease the size and number of incisions. This study describes the safety and feasibility of using an umbilical multi-instrument access (MIA) port (Olympus TriPort+) device with the placement of just one 12-mm suprapubic trocar in laparoscopic (double-port) abdominoperineal resections (APRs) in rectal cancer patients. PATIENTS AND METHODS: The study included 20 patients undergoing double-port APRs for rectal cancer between June 2011 and August 2013. Preoperative data were gathered in a prospective database, and post-operative data were collected retrospectively. RESULTS: The 20 patients (30% female) had a median age of 67 years (range 46-80 years), and their median body mass index (BMI) was 26 kg/m2 (range 20-31 kg/m2). An additional third trocar was placed in 2 patients. No laparoscopic procedures were converted to an open procedure. Median operating time was 195 min (range 115-306 min). A radical resection (R0 resection) was achieved in all patients, with a median of 14 lymph nodes harvested. Median length of stay was 8 days (range 5-43 days). CONCLUSION: Laparoscopic APR using a MIA trocar is a feasible and safe procedure. A MIA port might be of benefit as an extra option in the toolbox of the laparoscopic surgeon to further minimise surgical trauma.

New generation drug-eluting stents for ST-elevation myocardial infarction: a new paradigm for safety.

OBJECTIVES: The objective of this study is to compare the long-term safety of new generation drug-eluting stents (DES) with early generation DES and bare metal stents (BMS) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Early generation DES for STEMI have reduced target vessel revascularization, but have more very late ST compared with BMS raising concerns about their safety. New compared with early generation DES have lower rates of ST, but there are limited data in STEMI patients. METHODS: From 2003 to 2011, 3,464 STEMI patients were treated with BMS (n = 1,187), early generation DES (n = 1,525), or new generation DES (n = 752) and were followed for 1-9 years. RESULTS: Patients with new generation DES were younger, had less cardiogenic shock, and less prior infarction versus BMS, and more hypertension versus early generation DES. At 2 years, new generation DES had lower mortality (4.0% vs. 12.4%, P < 0.001), similar reinfarction (4.4% vs. 5.1%, P = 0.35), and less ST (1.4% vs. 3.8%, P = 0.031) versus BMS; and similar mortality (4.0% vs. 5.8%, P = 0.23), similar reinfarction (4.4% vs. 5.2%, P = 0.64), and trends for less ST (1.4% vs. 3.3%, P = 0.17) versus early generation DES. By Cox multivariable analyses, BMS had more ST than new generation DES (HR [95% CI] = 1.93 [1.01-3.66], P = 0.045). CONCLUSIONS: New generation DES in STEMI patients have less ST compared to BMS and trends for less ST compared to early generation DES. These data suggest a new safety paradigm and should encourage the use of new generation DES in most STEMI patients treated with primary percutaneous coronary intervention (PCI).

Causes of delay and associated mortality in patients transferred with ST-segment-elevation myocardial infarction.

BACKGROUND: Regional ST-segment-elevation myocardial infarction systems are being developed to improve timely access to primary percutaneous coronary intervention (PCI). System delays may diminish the mortality benefit achieved with primary PCI in ST-segment-elevation myocardial infarction patients, but the specific reasons for and clinical impact of delays in patients transferred for PCI are unknown. METHODS AND RESULTS: This was a prospective, observational study of 2034 patients transferred for primary PCI at a single center as part of a regional ST-segment-elevation myocardial infarction system from March 2003 to December 2009. Despite long-distance transfers, 30.4% of patients (n=613) were treated in ≤ 90 minutes and 65.7% (n=1324) were treated in ≤ 120 minutes. Delays occurred most frequently at the referral hospital (64.0%, n=1298), followed by the PCI center (15.7%, n=317) and transport (12.6%, n=255). For the referral hospital, the most common reasons for delay were awaiting transport (26.4%, n=535) and emergency department delays (14.3%, n=289). Diagnostic dilemmas (median, 95.5 minutes; 25th and 75th percentiles, 72-127 minutes) and nondiagnostic initial ECGs (81 minutes; 64-110.5 minutes) led to delays of the greatest magnitude. Delays caused by cardiac arrest and/or cardiogenic shock had the highest in-hospital mortality (30.6%), in contrast with nondiagnostic initial ECGs, which, despite long treatment delays, did not affect mortality (0%). Significant variation in both the magnitude and clinical impact of delays also occurred during the transport and PCI center segments. CONCLUSIONS: Treatment delays occur even in efficient systems for ST-segment-elevation myocardial infarction care. The clinical impact of specific delays in interhospital transfer for PCI varies according to the cause of the delay.

The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute⊕ Study.

BACKGROUND: The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing negative for lymph node metastases (i.e. pN0) will subsequently develop locoregional and/or systemic metastases within 5 years. The presence of occult nodal isolated tumor cells (ITCs) and/or micrometastases (MMs) at the time of resection predisposes CC patients to high risk for disease recurrence. These pN0(micro+) patients harbouring occult micrometastases may benefit from adjuvant treatment. The purpose of the present study is to delineate the subset of pN0 patients with micrometastases (pN0(micro+)) and evaluate the benefits from adjuvant chemotherapy in pN0(micro+) CC patients. METHODS/DESIGN: EnRoute+ is an open label, multicenter, randomized controlled clinical trial. All CC patients (age above 18 years) without synchronous locoregional lymph node and/or systemic metastases (clinical stage I-II disease) and operated upon with curative intent are eligible for inclusion. All resected specimens of patients are subject to an ex vivo sentinel lymph node mapping procedure (SLNM) following curative resection. The investigation for micrometastases in pN0 patients is done by extended serial sectioning and immunohistochemistry for pan-cytokeratin in sentinel lymph nodes which are tumour negative upon standard pathological examination. Patients with ITC/MM-positive sentinel lymph nodes (pN0(micro+)) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS). DISCUSSION: The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0(micro+) CC patients by reducing disease recurrence by adjuvant chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01097265.

Clopidogrel pretreatment in ST-elevation myocardial infarction patients transferred for percutaneous coronary intervention.

BACKGROUND: Pretreatment with clopidogrel reduces ischemic complications before percutaneous coronary intervention (PCI). Limited data exist regarding the effect of pretreatment for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. METHODS: Prospective data were analyzed from a regional STEMI system using rapid transfer for primary PCI in 30 community hospitals. Zone 1 community hospitals are <60 miles and Zone 2 hospitals are 60 to 210 miles away from the PCI hospital. Compared with 63 minutes in the PCI hospital, median door-to-balloon times were 94 minutes in Zone 1 and 123 minutes in Zone 2 hospitals. All patients received aspirin, unfractionated heparin, and clopidogrel 600 mg in the emergency department of the presenting hospital within 15 minutes of diagnosis. RESULTS: From April 2003 through December 2008, 2,014 consecutive STEMI patients were pretreated with clopidogrel before PCI, with a median (25th-75th percentile) duration from pretreatment to PCI of 75 (58-93) minutes. Patients with longer pretreatment duration had significantly reduced reinfarction/reischemia at 30 days (Zone 1: 0.85%, Zone 2: 0.9%) compared with nontransferred patients (3.2%, P = .001) as well as reduced stent thrombosis (Zone 1: 0.6%, Zone 2: 0.6% vs Abbott Northwestern: 2.0%; P = .04). Similarly, pretreatment duration of >60 minutes before PCI had reduced 30-day reinfarction/reischemia (1.0% vs 2.9%, P = .003). There were no significant differences in mortality or major bleeding. CONCLUSION: ST-segment elevation myocardial infarction patients undergoing primary PCI in a regional STEMI network who received earlier pretreatment with a 600-mg loading dose of clopidogrel had less ischemic complications without increased bleeding or mortality.

Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial.

BACKGROUND: Laparoscopic pancreatoduodenectomy may improve postoperative recovery compared with open pancreatoduodenectomy. However, there are concerns that the extensive learning curve of this complex procedure could increase the risk of complications. We aimed to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatoduodenectomy. METHODS: This multicentre, patient-blinded, parallel-group, randomised controlled phase 2/3 trial was performed in four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation. Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement, were randomly assigned (1:1) to undergo either laparoscopic or open pancreatoduodenectomy using a central web-based system. Randomisation was stratified for annual case volume and preoperative estimated risk of pancreatic fistula. Patients were blinded to treatment allocation. Analysis was done according to the intention-to-treat principle. The main objective of the phase 2 part of the trial was to assess the safety of laparoscopic pancreatoduodenectomy (complications and mortality), and the primary outcome of phase 3 was time to functional recovery in days, defined as all of the following: adequate pain control with only oral analgesia; independent mobility; ability to maintain more than 50% of the daily required caloric intake; no need for intravenous fluid administration; and no signs of infection (temperature <38·5°C). This trial is registered with Trialregister.nl, number NTR5689. FINDINGS: Between May 13 and Dec 20, 2016, 42 patients were randomised in the phase 2 part of the trial. Two patients did not receive surgery and were excluded from analyses in accordance with the study protocol. Three (15%) of 20 patients died within 90 days after laparoscopic pancreatoduodenectomy, compared with none of 20 patients after open pancreatoduodenectomy. Based on safety data from the phase 2 part of the trial, the data and safety monitoring board and protocol committee agreed to proceed with phase 3. Between Jan 31 and Nov 14, 2017, 63 additional patients were randomised in phase 3 of the trial. Four patients did not receive surgery and were excluded from analyses in accordance with the study protocol. After randomisation of 105 patients (combining patients from both phase 2 and phase 3), of whom 99 underwent surgery, the trial was prematurely terminated by the data and safety monitoring board because of a difference in 90-day complication-related mortality (five [10%] of 50 patients in the laparoscopic pancreatoduodenectomy group vs one [2%] of 49 in the open pancreatoduodenectomy group; risk ratio [RR] 4·90 [95% CI 0·59-40·44]; p=0·20). Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80). Clavien-Dindo grade III or higher complications (25 [50%] of 50 patients after laparoscopic pancreatoduodenectomy vs 19 [39%] of 49 after open pancreatoduodenectomy; RR 1·29 [95% CI 0·82-2·02]; p=0·26) and grade B/C postoperative pancreatic fistulas (14 [28%] vs 12 [24%]; RR 1·14 [95% CI 0·59-2·22]; p=0·69) were comparable between groups. INTERPRETATION: Although not statistically significant, laparoscopic pancreatoduodenectomy was associated with more complication-related deaths than was open pancreatoduodenectomy, and there was no difference between groups in time to functional recovery. These safety concerns were unexpected and worrisome, especially in the setting of trained surgeons working in centres performing 20 or more pancreatoduodenectomies annually. Experience, learning curve, and annual volume might have influenced the outcomes; future research should focus on these issues. FUNDING: Grant for investigator-initiated studies by Johnson & Johnson Medical Limited.

Prevalence, Trends, and Outcomes of Higher-Risk Percutaneous Coronary Interventions Among Patients Without Acute Coronary Syndromes.

BACKGROUND/PURPOSE: Patients and lesions at a higher procedural risk for percutaneous coronary intervention (PCI) are an understudied population. We examined the frequency, clinical characteristics, and outcomes of higher risk and non-higher risk PCIs at a large tertiary center. METHODS/MATERIALS: The following procedures were considered higher risk: unprotected left main PCI, chronic total occlusion PCI, PCI requiring atherectomy, multivessel PCI, bifurcation PCI, PCI in prior coronary artery bypass graft surgery (CABG) patients, pre-PCI left ventricular ejection fraction ≤30%, or use of hemodynamic support. RESULTS: Of the 1975 PCIs performed from 6/29/09 to 12/30/2016 in patients without acute coronary syndromes, 1230 (62%) were higher risk. Patients undergoing higher risk PCI were more likely to have a history of CABG, myocardial infarction, PCI, cerebrovascular disease, peripheral arterial disease, or congestive heart failure. Higher risk PCIs required more stents (2.0 vs. 1.0, p < 0.001), and had longer median fluoroscopy times (17.3 vs. 8.5 min, p < 0.001) and higher median contrast doses (160 vs. 120 mL, p < 0.001). In higher risk PCIs, the risks for technical failure and periprocedural complications were 2.9 (95% CI 1.2-7.4) times and 2.2 (95% CI 0.9-5.4) times higher as compared with non-higher risk PCI procedures. CONCLUSIONS: In summary, over half of the PCIs performed in non-acute coronary syndrome patients were higher risk and were associated with lower odds of technical success and higher periprocedural complication rates as compared with non-higher risk PCIs. SUMMARY: We examined the frequency, clinical characteristics, and outcomes of higher risk and non-higher risk PCIs at a large tertiary center. Higher risk PCI was associated with lower odds of technical and procedural success and higher odds of procedural complications as compared with non-higher risk PCI. However, the risk/benefit ratio may still be favorable for many of these higher-risk patients and should be estimated on a case by case basis.

Sleep Deprivation in Cardiology: A Multidisciplinary Survey.

BACKGROUND: The burden and impact of sleep deprivation in cardiology has received limited study. METHODS: A multidisciplinary, online survey on sleep health patterns and sleep deprivation involving 44 closed-ended questions was distributed via email list to cardiovascular workers. RESULTS: The survey was circulated among 6683 individuals, of whom 481 (7.2%) completed the survey; 80% of the respondents were men and 70% were interventional cardiologists. Nearly all (91%) had call responsibilities, with 43% doing ≥7 call-nights per month. Sleep disorders were reported in 25%, with 25% using sleep-inducing medications (8.4% at least once per week). The main factors diminishing the quality and/or quantity of sleep were related to work (66%), family and/or personal activities (56%), and staying up late at night writing or studying (48%). Sleep deprivation was associated with difficulty concentrating (58%), lack of motivation (56%), and irritability (68%). Work performance was felt to be hindered by 46% of participants and 8.6% reported an adverse event such as a complication and/ or negative patient outcome likely related to sleep deprivation. Many (56.5%) felt burnout and 85% opined that policies should exist allowing sleep-deprived individuals to go home early post call. CONCLUSIONS: Our survey provides insights into sleep health patterns among cardiovascular workers and potential factors contributing to sleep deprivation. Sleep deprivation may impact performance, with 8.6% of respondents describing sleep-deprivation related adverse events. Further study is required to both identify measures to attenuate the burden and better understand the impact of sleep deprivation on both health-care personnel and patient outcomes.

A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is superior to fibrinolysis when performed in a timely manner in high-volume centers. Recent European trials suggest that transfer for PCI also may be superior to fibrinolysis and increase access to PCI. In the United States, transfer times are consistently long; therefore, many believe a transfer for PCI strategy for STEMI is not practical. METHODS AND RESULTS: We developed a standardized PCI-based treatment system for STEMI patients from 30 hospitals up to 210 miles from a PCI center. From March 2003 to November 2006, 1345 consecutive STEMI patients were treated, including 1048 patients transferred from non-PCI hospitals. The median first door-to-balloon time for patients <60 miles (zone 1) and 60 to 210 miles (zone 2) from the PCI center was 95 minutes (25th and 75th percentiles, 82 and 116 minutes) and 120 minutes (25th and 75th percentiles, 100 and 145 minutes), respectively. Despite the high-risk unselected patient population (cardiogenic shock, 12.3%; cardiac arrest, 10.8%; and elderly [> or =80 years of age], 14.6%), in-hospital mortality was 4.2%, and median length of stay was 3 days. CONCLUSIONS: Rapid transfer of STEMI patients from community hospitals up to 210 miles from a PCI center is safe and feasible using a standardized protocol with an integrated transfer system.

Outcomes of Extracorporeal Membrane Oxygenation Support for Complex High-Risk Elective Percutaneous Coronary Interventions: A Single-Center Experience and Review of the Literature.

OBJECTIVES: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is most commonly used in patients with cardiac arrest and cardiogenic shock. There are limited data on the use of VA-ECMO for elective, high-risk percutaneous coronary intervention (PCI). We examined the in-hospital and mid-term clinical outcomes in patients undergoing complex, high-risk PCI with VA-ECMO support. METHODS: . We conducted a retrospective review of ECMO-supported elective high-risk PCIs performed at our institution between May 2012 and May 2017. The electronic medical records and angiograms were individually reviewed. We assessed the in-hospital and mid-term major adverse cardiovascular and cerebrovascular event (MACCE) rates, and reviewed bleeding and vascular complications. RESULTS: Five patients underwent elective high-risk PCI with ECMO support. Mean age was 66.8 ± 8.6 years and all patients were men. The mean ejection fraction was 26.6 ± 18.0%. Most procedures were unprotected left main PCIs. All PCIs were successful; 1 patient required femoral artery surgical repair. The mean hospital stay post procedure was 6.4 ± 2.0 days. ECMO was successfully weaned in all cases, and the duration of ECMO was <24 hours in 4 cases. There was no occurrence of in-hospital and 1-year MACCE. CONCLUSION: ECMO can be successfully used for hemodynamic support during elective high-risk PCI.

Estrogen receptor beta protects the murine heart against left ventricular hypertrophy.

BACKGROUND: Left ventricular hypertrophy (LVH) displays significant gender-based differences. 17beta-estradiol (E2) plays an important role in this process because it can attenuate pressure overload hypertrophy via 2 distinct estrogen receptors (ERs): ERalpha and ERbeta. However, which ER is critically involved in the modulation of LVH is poorly understood. We therefore used ERalpha-deficient (ERalpha-/-) and ERbeta-deficient (ERbeta-/-) mice to analyze the respective ER-mediated effects. METHODS AND RESULTS: Respective ER-deficient female mice were ovariectomized and were given E2 or placebo subcutaneously using 60-day release pellets. After 2 weeks, they underwent transverse aortic constriction (TAC) or sham operation. In ERalpha-/- animals, TAC led to a significant increase in ventricular mass compared with sham operation. E2 treatment reduced TAC induced cardiac hypertrophy significantly in wild-type (WT) and ERalpha-/- mice but not in ERbeta-/- mice. Biochemical analysis showed that E2 blocked the increased phosphorylation of p38-mitogen-activated protein kinase observed in TAC-treated ERalpha-/- mice. Moreover, E2 led to an increase of ventricular atrial natriuretic factor expression in WT and ERalpha-/- mice. CONCLUSIONS: These findings demonstrate that E2, through ERbeta-mediated mechanisms, protects the murine heart against LVH.

Contemporary Arterial Access in the Cardiac Catheterization Laboratory.

Obtaining femoral and radial arterial access in the cardiac catheterization laboratory using state-of-the-art techniques is essential to optimize outcomes, patient satisfaction, and procedural efficiency. Although transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, femoral access remains necessary for numerous procedures, many requiring large-bore access, including complex high-risk coronary interventions, structural procedures, and procedures involving mechanical circulatory support. For femoral access, contemporary access techniques should combine the use of fluoroscopy, ultrasound, micropuncture needle, femoral angiography, and vascular closure devices, when feasible. For radial access, ultrasound may reveal important anatomic features and expedite access. Despite randomized controlled trials supporting use of routine ultrasound guidance for femoral and/or radial arterial access, ultrasound remains underused in cardiac catheterization laboratories. This article reviews contemporary techniques to achieve optimal arterial access in the cardiac catheterization laboratory.

Calcineurin Abeta gene targeting predisposes the myocardium to acute ischemia-induced apoptosis and dysfunction.

Cardiovascular disease is the leading cause of mortality and morbidity within the industrialized nations of the world, with coronary heart disease (CHD) accounting for as much as 66% of these deaths. Acute myocardial infarction is a typical sequelae associated with long-standing coronary heart disease resulting in large scale loss of ventricular myocardium through both apoptotic and necrotic cell death. In this study, we investigated the role that the calcium calmodulin-activated protein phosphatase calcineurin (PP2B) plays in modulating cardiac apoptosis after acute ischemia-reperfusion injury to the heart. Calcineurin Abeta gene-targeted mice showed a greater loss of viable myocardium, enhanced DNA laddering and TUNEL, and a greater loss in functional performance compared with strain-matched wild-type control mice after ischemia-reperfusion injury. RNA expression profiling was performed to uncover potential mechanisms associated with this loss of cardioprotection. Interestingly, calcineurin Abeta-/- hearts were characterized by a generalized downregulation in gene expression representing approximately 6% of all genes surveyed. Consistent with this observation, nuclear factor of activated T cells (NFAT)-luciferase reporter transgenic mice showed reduced expression in calcineurin Abeta-/- hearts at baseline and after ischemia-reperfusion injury. Finally, expression of an activated NFAT mutant protected cardiac myocytes from apoptotic stimuli, whereas directed inhibition of NFAT augmented cell death. These results represent the first genetic loss-of-function data showing a prosurvival role for calcineurin-NFAT signaling in the heart.