Preoperative intra-aortic balloon pump in patients with ST-elevation myocardial infarction undergoing urgent cardiac bypass surgery.

BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI), either with or without cardiogenic shock, mechanical circulatory support with an intra-aortic balloon pump (IABP) is not associated with lower mortality. However, in STEMI patients undergoing urgent coronary artery bypass grafting (CABG), preoperative insertion of an IABP has been suggested to reduce mortality. In this study, the effect of preoperative IABP use on mortality in STEMI patients undergoing urgent CABG was investigated. METHODS: All consecutive STEMI patients undergoing urgent CABG in a single centre between 2000 and 2018 were studied. The primary outcome, 30-day mortality, was compared between patients with and without a preoperative IABP. Subgroup analysis and multivariable analysis using a propensity score and inverse probability treatment weighting were performed to adjust for potential confounders. RESULTS: A total of 246 patients were included, of whom 171 (69.5%) received a preoperative IABP (pIABP group) and 75 (30.5%) did not (non-pIABP group). In the pIABP group, more patients suffered from cardiogenic shock, persistent ischaemia and reduced left ventricular function. Unadjusted 30-day mortality was comparable between the pIABP and the non-pIABP group (13.3% vs 12.3%, p = 0.82). However, after correction for confounders and inverse probability treatment weighting preoperative IABP was associated with reduced 30-day mortality (relative risk 0.52, 95% confidence interval 0.30-0.88). CONCLUSION: In patients with STEMI undergoing urgent CABG, preoperative insertion of an IABP is associated with reduced mortality.

Quality assessment of robot assisted thoracic surgical resection of non-small cell lung cancer: nodal upstaging and mediastinal recurrence.

BACKGROUND: Robot assisted thoracic surgery (RATS) is the minimally invasive surgical technique of choice for treatment of patients with non-small cell lung cancer (NSCLC), at the Isala Hospital. The aim of this study is to compare clinical and pathological staging results and mediastinal recurrence after RATS for anatomical resections of lung cancer as surrogate markers for quality of mediastinal lymph node dissection (MLND). METHODS: This single institute retrospective study was conducted in patients who underwent RATS for NSCLC. Excluded were patients with a history of concurrent malignant disease, with other previous neoplasms, with small cell lung cancer (SCLC) and patients in whom the robotic technique was converted to thoracotomy, prior to lymph node dissection. Data were obtained from the hospital database. The difference between clinical and pathological staging was expressed as upstaging and downstaging. Computed Tomography scanning was used for follow-up, and diagnosis of mediastinal recurrence. RESULTS: From November 2011 to May 2016, 227 patients underwent RATS at Isala Hospital Zwolle, the Netherlands. Of those, 130 (mean age, 69.5±9.3 years) met the eligibility criteria. Preoperative mediastinal lymph node staging was done by endoscopic ultrasound/endobronchial ultrasound, by positron emission tomography (PET) or mediastinoscopy. In 14 patients (10.8%) unforeseen N2 disease was found, 6 patients (4.6%) were upstaged from cN0 to pN2 and 8 patients (6.2%) were upstaged from cN1 to pN2. Mediastinal recurrence was detected in 7 patients (5.4%) during a median follow-up of 54 months (range, 1.5-102 months). CONCLUSIONS: In patients with NSCLC, who underwent anatomical resection by means of RATS, an unforeseen N2 disease rate of 10.8% was demonstrated and a mediastinal recurrence rate of 5.4%. It is concluded that robotic surgery provides an accurate lymph node dissection.

Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial.

BACKGROUND: A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. METHODS AND RESULTS: In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%; P=0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17; P=0.046) and had a better knowledge of prosthetic valves (85% versus 68%; P=0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9; P=0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50; P=0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups. CONCLUSIONS: A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being. CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl. Unique identifier: NTR4350.

Use of incisional negative pressure wound therapy on closed median sternal incisions after cardiothoracic surgery: clinical evidence and consensus recommendations.

Negative pressure wound therapy is a concept introduced initially to assist in the treatment of chronic open wounds. Recently, there has been growing interest in using the technique on closed incisions after surgery to prevent potentially severe surgical site infections and other wound complications in high-risk patients. Negative pressure wound therapy uses a negative pressure unit and specific dressings that help to hold the incision edges together, redistribute lateral tension, reduce edema, stimulate perfusion, and protect the surgical site from external infectious sources. Randomized, controlled studies of negative pressure wound therapy for closed incisions in orthopedic settings (which also is a clean surgical procedure in absence of an open fracture) have shown the technology can reduce the risk of wound infection, wound dehiscence, and seroma, and there is accumulating evidence that it also improves wound outcomes after cardiothoracic surgery. Identifying at-risk individuals for whom prophylactic use of negative pressure wound therapy would be most cost-effective remains a challenge; however, several risk-stratification systems have been proposed and should be evaluated more fully. The recent availability of a single-use, closed incision management system offers surgeons a convenient and practical means of delivering negative pressure wound therapy to their high-risk patients, with excellent wound outcomes reported to date. Although larger, randomized, controlled studies will help to clarify the precise role and benefits of such a system in cardiothoracic surgery, limited initial evidence from clinical studies and from the authors' own experiences appears promising. In light of the growing interest in this technology among cardiothoracic surgeons, a consensus meeting, which was attended by a group of international experts, was held to review existing evidence for negative pressure wound therapy in the prevention of wound complications after surgery and to provide recommendations on the optimal use of negative pressure wound therapy on closed median sternal incisions after cardiothoracic surgery.

Can post-sternotomy mediastinitis be prevented by a closed incision management system?

Post-sternotomy mediastinitis is a serious complication after cardiothoracic surgery and contribute significantly to post-operative morbidity, mortality, and healthcare costs. Negative pressure wound therapy is today's golden standard for post-sternotomy mediastinitis treatment. A systematic literature search was conducted at PubMed until October 2012 to analyse whether vacuum-assisted closure technique prevents mediastinitis after clean surgical incisions closure. Today's studies showed reduction of post-sternotomy mediastinitis including a beneficial socio-economic impact. Current studies, however included only high-risk patients, hence furthermore, larger randomised controlled trials are warranted to clarify the benefit for using surgical incision vacuum management systems in the general patient population undergoing sternotomy and clarify risk factor interaction.

Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study.

AIMS: Left ventricular (LV) endocardial pacing may address the limitations in the selection of an LV pacing site and provide improvements in cardiac resynchronization therapy (CRT) effectiveness. We report on the feasibility, the safety, and the short-term outcome of a leadless ultrasound-based technology for LV endocardial resynchronization in heart failure (HF) patients enroled into the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study. METHODS AND RESULTS: Seventeen HF patients were enroled and categorized as: (i) patients in whom attempted coronary sinus lead implantation for CRT had failed (n = 7); (ii) patients with a previously implanted CRT device, not responding to CRT (n = 2); and (iii) patients with previously implanted pacemakers or implantable cardioverter-defibrillator and meeting the standard indications for CRT (n = 8). System implantation was achieved in 13 patients (76.5%); mean R-wave amplitude was 5.6 ± 3.2 mV and the mean pacing threshold was 1.6 ± 1.0 V, respectively. In one patient, no sufficient pacing thresholds were found; in three patients pericardial effusion occurred. Biventricular pacing was recorded in 83% and 92% of the patients at 1 month and 6 months, respectively. QRS duration was shorter during biventricular pacing compared with right ventricular pacing at 1 month (-41 ms; P = 0.0002) and 6 months (-42 ms; P = 0.0011), respectively. At the 6-month follow-up, two-thirds of the patients had at least one functional class change. Left ventricular ejection fraction significantly increased (P < 0.01) by 6 points at the 6-month follow-up. CONCLUSION: The feasibility of providing an endocardial stimulation for CRT with a leadless technology was successfully demonstrated. Despite the promising results for a novel technology, further study is required to definitively conclude the safety and the performance of the system. CLINICAL TRIAL REGISTRATION INFORMATION: NCT01294527.

First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients.

AIMS: The importance of specific-site pacing is increasingly recognized in cardiac resynchronization therapy (CRT). Using current pacing technology, site selection is still largely limited by coronary vein anatomy, whereas left ventricular (LV) endocardial pacing using current lead technology is risky and challenging. To overcome limitations and complications with current LV pacing, the feasibility of a new technology enabling LV endocardial stimulation without the use of a lead is being evaluated in patients. METHODS AND RESULTS: Patients presented in this report are part of the Wireless Stimulation Endocardially for CRT Trial (WiSE-CRT) study investigating the safety and performance of the WiCS(®)-LV system, an implantable cardiac pacing system capable of leadless pacing based on converting ultrasound energy to electrical energy. Three patients are presented: (i) a patient with an existing implantable defibrillator, (ii) a patient with a CRT system whose LV lead does not capture, and (iii) a CRT patient classified as a non-responder. All three patients were successfully treated. Acute electrical pacing thresholds ranged from 0.7 to 1.0 V at 0.5 ms; all patients retained captured at 6 months. Functional New York Heart Association class significantly changed (Pre: III in two patients, and IV in one patient; Post: I in one patient, II in one patient, and II-III in one patient), and LV ejection fraction increased from 23.7 ± 3.4% to 39 ± 6.2% (P < 0.017). CONCLUSION: This report on three first-in-man cases shows that leadless endocardial pacing may be safely applied and effective, conferring short- to-mid-term symptomatic benefits. These promising findings are yet to be substantiated by larger ongoing studies. CLINICAL TRIAL REGISTRATION INFORMATION: http://clinicaltrials.gov/ct2/show/NCT01294527.