Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery: The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial.

BACKGROUND: Prophylactic intra-aortic balloon counterpulsation (IABC) is commonly used in selected patients undergoing coronary artery bypass graft (CABG) surgery, but definitive evidence is lacking. The aim of the multicentre PINBALL Pilot randomised controlled trial (RCT) was to assess the feasibility of performing a definitive trial to address this question. METHODS: Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome were eligible for inclusion if the treating surgical team was uncertain as to the benefit of prophylactic IABC. The primary outcome of feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up. RESULTS: The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants. For 20/24 (83%) participants, preoperative IABC use occurred according to study assignment. Six (6)-month follow-up was available for all enrolled participants, [IABC 1 death (8%) vs. control 1 death (9%), p = 0.95]. CONCLUSION: The PINBALL Pilot recruitment rate was insufficient to demonstrate feasibility of a multicentre RCT of prophylactic IABC in high risk patients undergoing CABG surgery.

Learning curve for cytoreductive surgery and perioperative intraperitoneal chemotherapy for peritoneal surface malignancy--a journey to becoming a Nationally Funded Peritonectomy Center.

BACKGROUND: Cytoreductive surgery (CRS) combined with perioperative intraperitoneal chemotherapy (PIC) for peritoneal surface malignancy is associated with a morbidity rate of 30-50% and a mortality rate of 1-10%. Recently, the St George Hospital in Sydney has been commissioned as the Nationally Funded Center for treatment of peritoneal surface malignancy in Australia. METHODS: The clinical and treatment-related data regarding 140 consecutive patients were prospectively collected. A comparison between the initial 70 patients (Group I) and the subsequent 70 patients (Group II) was performed. Univariate and multivariate analyses were conducted to identify the significant risk factors for moderate to severe morbidity. RESULTS: The hospital mortality was 4%. Sixty-one patients (44%) had moderate morbidity. Twenty-eight patients (20%) experienced severe morbidity. The mean hospital stay was 30 days. Twenty-seven patients (19%) were readmitted after initial discharge for management of delayed complications. The severe morbidity rate reduced from 30% to 10%, and the delayed morbidity rate reduced from 29% to 10%, when comparing Groups I and II. There were also reduced transfusion requirement, duration of operation, and intensive care unit stay. In the multivariate analysis, Group I (vs Group II; P = .005), performing small bowel resection (P = .005), and >4 peritonectomy procedures (vs