Research Spotlight

Baran, D. A., C. L. Grines, S. Bailey, D. Burkhoff, S. A. Hall, T. D. Henry, S. M. Hollenberg, N. K. Kapur, W. O’Neill, J. P. Ornato, K. Stelling, H. Thiele, S. van Diepen and S. S. Naidu (2019). “SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019.” Catheter Cardiovasc Interv 94(1): 29-37.

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BACKGROUND: The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It is clear that there are varying degrees of cardiogenic shock but there is no robust classification scheme to categorize this disease state. METHODS: A multidisciplinary group of experts convened by the Society for Cardiovascular Angiography and Interventions was assembled to derive a proposed classification schema for cardiogenic shock. Representatives from cardiology (interventional, advanced heart failure, noninvasive), emergency medicine, critical care, and cardiac nursing all collaborated to develop the proposed schema. RESULTS: A system describing stages of cardiogenic shock from A to E was developed. Stage A is “at risk” for cardiogenic shock, stage B is “beginning” shock, stage C is “classic” cardiogenic shock, stage D is “deteriorating”, and E is “extremis”. The difference between stages B and C is the presence of hypoperfusion which is present in stages C and higher. Stage D implies that the initial set of interventions chosen have not restored stability and adequate perfusion despite at least 30 minutes of observation and stage E is the patient in extremis, highly unstable, often with cardiovascular collapse. CONCLUSION: This proposed classification system is simple, clinically applicable across the care spectrum from pre-hospital providers to intensive care staff but will require future validation studies to assess its utility and potential prognostic implications.

Badhwar, V., M. Alkhouli, M. J. Mack, V. H. Thourani and G. Ailawadi (2019). “A pathoanatomic approach to secondary functional mitral regurgitation: Evaluating the evidence.” J Thorac Cardiovasc Surg 158(1): 76-81.

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As evidence to support transcatheter and surgical management of functional secondary mitral regurgitation evolves, targeting therapy to pathoanatomic grade may improve outcomes and the evidence . . . Surgical repair indeed has its niche role in pathoanatomically suitable disease and MV replacement has its place for symptom resolution, although randomized investigation has not been performed to clearly identify survival benefit. Transcatheter repair will clearly have an expanding role in SMR, but successes in some patients and failures in others highlight the need for clarity in how to identify the ideal patients to receive optimal benefit from this modality. Transcatheter MV replacement is undergoing active investigation, but anatomic limitations of LV outflow tract obstruction and annular size may limit its widespread application. Due to the spectrum of structural cardiac disease that accompanies SMR, not all patients can be managed in the same manner and therapy should be tailored . . . In light of the accumulated knowledge from the surgical and transcatheter literature, a simplified pathoanatomic classification scheme of SMR that incorporates the key categories of annular dilatation, LV dysfunction/dilatation and leaflet tethering is proposed. This scoring system may aid in assessing SMR features in outpatient clinics and echocardiography laboratories ( Table 2 ) and assist in tailoring the pathoanatomy to possible therapeutic options based on comorbid risk. This intuitive schema may be useful for future prospective investigation as well as for retrospective examination of both the MITRA-FR echocardiograms as well as the COAPT trial core lab echocardiograms to ascertain if this simple categorization predicts short- and long-term success in transcatheter MV repair. (Excerpts from text, p. 76, 79-80; no abstract available.)

Al-Temimi, M. H., B. Chandrasekaran, J. Agapian, W. R. Peters, Jr. and K. O. Wells (2019). “Robotic versus laparoscopic elective colectomy for left side diverticulitis: a propensity score-matched analysis of the NSQIP database.” Int J Colorectal Dis Jun 23. [Epub ahead of print].

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PURPOSE: Robotic surgery might have an advantage over conventional laparoscopy for colonic diverticulitis. We intend to compare both approaches in the elective management of left side diverticulitis. METHODS: The National Surgical Quality Improvement Program (NSQIP) database (2012-2014) was surveyed for patients undergoing elective left/sigmoid colectomy for diverticulitis. Patient demographics, co-morbidities, disease complexity, and intraoperative details were matched on propensity scores derived from logistic regression model. RESULTS: We identified 441 robotic and 6584 laparoscopic cases. Mean age was 56.8 years. Mean BMI was 29.5, and 46.5% of patients were males. Low preoperative albumin (< 3.5 mg/dl, 11.1% vs. 6.8%, p = 0.003), splenectomy (0.45% vs. 0.05%, p = 0.002), and enterotomy repair (1.1% vs. 0.4%, p = 0.029) were higher in the robotic group than the laparoscopic group. Hand assistance (35.8% vs. 42.9%, p = 0.003), splenic flexure takedown (41.5% vs. 49.2%, p = 0.002), and ureteric stent placement (18.6% vs. 23.5%, p = 0.017) were less common in the robotic group than the laparoscopic group. Case-matched analysis showed that robotic surgery was associated with shorter hospital stay (3.89 +/- 2.18 days vs. 4.75 +/- 3.25 days, p < 0.001), lower conversion rate (7.5% vs. 14.3%, p = 0.001), and longer operative time (219.2 +/- 95.6 min vs. 188.8 +/- 82.3 min, p < 0.001) than laparoscopic surgery. Robotic approach was associated with lower overall morbidity in multivariate analysis (OR = 0.72, 95% CI = 0.55-0.96), but not in case-matched analysis (14.4% vs. 19.2%, p = 0.058). CONCLUSIONS: Robotic surgery is associated with shorter hospital stay and lower conversion rate and may offer lower overall morbidity than laparoscopy after elective left side colectomy for diverticulitis. Controlled prospective studies are needed to confirm these findings.

Afzal, A., K. M. Tecson, A. K. Jamil, J. Felius, P. S. Garcha, S. A. Hall and S. A. Carey (2019). “The Effect of Obstructive Sleep Apnea on 3-Year Outcomes in Patients Who Underwent Orthotopic Heart Transplantation.” Am J Cardiol 124(1): 51-54.

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Despite the well-known association between obstructive sleep apnea (OSA) and cardiovascular disease, there is a paucity of data regarding OSA in orthotopic heart transplant (OHT) recipients and its effect on clinical outcomes. Hence, we sought to determine the association between OSA, as detected by polysomnography, and late graft dysfunction (LGD) after OHT. In this retrospective review of consecutive OHT recipients from 2012 to 2014 at our center, we examined LGD, i.e., graft failure >1 year after OHT, through competing risks analysis. Due to small sample size and event counts, as well as preliminary testing which revealed statistically similar demographics and outcomes, we pooled patients who had treated OSA with those who had no OSA. Of 146 patients, 29 (20%) had untreated OSA, i.e., OSA without use of continuous positive airway pressure therapy, at the time of transplantation. Patients with untreated OSA were significantly older, heavier, and more likely to have baseline hypertension than those with treated/no OSA. Although there were no differences between groups in regard to short-term complications of acute kidney injury, cardiac allograft vasculopathy, or primary graft dysfunction, there were significant differences in the occurrence of LGD. Those with untreated OSA were at 3 times the risk of developing LGD than those with treated/no OSA (hazard ratio 3.2; 95% confidence interval 1.3 to 7.9; p=0.01). Because OSA is a common co-morbidity of OHT patients and because patients with untreated OSA have an elevated risk of LGD, screening for and treating OSA should occur during the OHT selection period.

Tarakji, K. G., S. Mittal, C. Kennergren, R. Corey, J. E. Poole, E. Schloss, J. Gallastegui, R. A. Pickett, R. Evonich, F. Philippon, J. M. McComb, S. F. Roark, D. Sorrentino, D. Sholevar, E. Cronin, B. Berman, D. Riggio, M. Biffi, H. Khan, M. T. Silver, J. Collier, Z. Eldadah, D. J. Wright, J. D. Lande, D. R. Lexcen, A. Cheng and B. L. Wilkoff (2019). “Antibacterial Envelope to Prevent Cardiac Implantable Device Infection.” N Engl J Med 380(20): 1895-1905.

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BACKGROUND: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections. METHODS: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months. RESULTS: A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (+/-SD) duration of follow-up was 20.7+/-8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98). CONCLUSIONS: Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.).