Transcatheter mitral valve repair for inotrope dependent cardiogenic shock - Design and rationale of the CAPITAL MINOS trial.

BACKGROUND: Functional mitral regurgitation (MR) is an important clinical consideration in patients with heart failure. Transcatheter edge-to-edge repair (TEER) has emerged as a useful therapeutic tool for patients with chronic heart failure, however the role of TEER in patients with cardiogenic shock (CS) and MR has not yet been studied in a randomized trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to determine if TEER improves clinical outcomes in the CS population. METHODS AND DESIGN: The CAPITAL MINOS trial is an open-label, multi-center randomized clinical trial comparing TEER to medical therapy in patients with CS and MR. A total of 144 patients with Society for Cardiovascular Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR will be randomized in a 1:1 ratio to TEER or medical therapy alone. The primary outcome will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable left ventricular assist device, or discharge on palliative inotropic therapy. Patients will be followed for the duration of their index hospitalization for the primary outcome. Secondary outcomes include 6 month mortality. IMPLICATIONS: The CAPITAL MINOS trial will determine whether TEER improves outcomes in patients with CS and MR and will be an important step in optimizing treatment for this high-risk patient population.

Impact of sex on outcomes after percutaneous repair of functional mitral valve regurgitation.

BACKGROUND: The role of percutaneous repair of functional mitral regurgitation (MR) is evolving. Left ventricle remodeling is known to be different between men and women; however, outcomes following percutaneous repair of functional MR have not considered the impact of sex. METHODS: Between 2012 and 2018, 175 patients underwent percutaneous repair of functional MR with the Mitra Clip NT/NTR (Abbott) at our institution. Patients were assessed in a dedicated clinic with a follow-up that averaged 0.7 ± 1.2 years and extended to 5.7 years. RESULTS: Men had a larger body surface area than women (p < .001), and were more likely than women to have diabetes preoperatively (p = .02). There were no deaths or instances of single leaflet detachment. Immediate postprocedure MR was ≤2+ in 158 (90%) with a mean trans-mitral valve repair gradient of 3.4 ± 1.0 and 3.5 ± 2.1 mmHg, respectively for women and men (p = .8). One- and 2-year freedom from MR ≥3+ was 86.0 ± 3.5% and 77.6 ± 5.1%, respectively. After adjusting for differences between male and female patients, women were more likely to have recurrent MR ≥3+ (hazard ratio, 4.7; 95% confidence interval, 1.2-18.4; p = .03). Upon adjusted analysis, there was also no association between gender and survival (p = .2). One- and 2-year survival was 69.8 ± 4.3% and 54.3 ± 5.5%, respectively. CONCLUSION: Women are more likely to have recurrent severe MR after percutaneous repair of functional MR. The mechanism for this remains undetermined.

Computational simulation model of transcatheter edge-to-edge mitral valve repair: a proof-of-concept study.

AIMS: As transcatheter mitral valve (MV) interventions are expanding and more device types and sizes become available, a tool supporting operators in pre-procedural planning and the clinical decision-making process is highly desirable. We sought to develop a finite element computational simulation model to predict the results of transcatheter edge-to-edge repair (TEER) interventions. METHODS AND RESULTS: We prospectively enrolled patients with secondary mitral regurgitation (MR) referred for a clinically indicated TEER. The 3D trans-oesophageal echocardiograms performed at the beginning of the procedure were used to perform the simulation. On the 3D dynamic model of the MV that was first obtained, we simulated the clip implantation using the same clip type, size, number, and implantation location that was used during the intervention. The 3D model of the MV obtained after the simulation of the clip implantation was compared with the clinical results obtained at the end of the intervention. We analysed the degree and location of residual MR and the shape and area of the diastolic MV area. We performed computational simulation on five patients. Overall, the simulated models predicted well the degree and location of the residual regurgitant orifice(s) but tended to underestimate the diastolic mitral orifice area. CONCLUSION: In this proof-of-concept study, we present preliminary results on our algorithm simulating clip implantation in five patients with functional MR. We show promising results regarding the feasibility and accuracy in terms of predicting residual MR and the need to improve the estimation of the diastolic MV area.

Left ventricular outflow tract-right atrial fistula following aortic valve replacement.

A 59-year-old male, undergoing outpatient treatment of a sternal wound infection following elective aortic valve replacement surgery, presented with decompensated heart failure. The patient required emergency redo surgery after investigations revealed a left ventricular outflow tract to right atrial fistula due to endocarditis with right ventricular dysfunction. Echocardiography, in particular transesophageal echocardiography, was essential for the diagnosis of this rare event.

Acceptability and response to a postal survey using self-taken samples for HPV vaccine impact monitoring.

OBJECTIVE: To assess the feasibility and acceptance of a postal survey to measure human papillomavirus (HPV) prevalence and monitor vaccine impact, using self-taken specimens from young women who do not attend their first cervical screening appointment. METHODS: Focus groups informed the survey design identifying factors that would influence acceptability. Postal testing kits were sent to a nationally representative sample of unscreened women. Overall response rate, the influence of different specimen types (urine or vaginal swab) and the receipt of a reminder letter on participation were calculated. Specimens were tested anonymously for HPV. Individual test results were not provided. RESULTS: Of 5500 kits sent, 725 were returned (13.2%). Fifty-two women actively opted out. There was a higher return rate for urine kits (13.7% vs 12%) and from those who received a reminder letter (15.5% vs 12.2%). Response was influenced by deprivation (10.3% in the most deprived quintile vs 16.2% in the least). Overall weighted HPV prevalence was 35.9% (40.0% from swab specimens and 31.9% from urine). CONCLUSIONS: Some women were willing to participate in anonymised postal testing. However, the low uptake means that HPV prevalence results are difficult to interpret for ongoing surveillance. Monitoring HPV vaccine impact outwith the cervical screening programme remains challenging.

Frequency and surgical management of complex posterior leaflet prolapse of the mitral valve.

BACKGROUND AND AIM OF THE STUDY: Isolated posterior leaflet prolapse of the mitral valve may present with more complex anatomy than limited middle scallop prolapse (P2). The study aim was to describe the incidence and surgical management of extensive or commissural posterior leaflet prolapse, in addition to long-term outcomes following repair. METHODS: Between October 2001 and May 2008, among 481 patients operated on for mitral valve prolapse, 201 consecutive patients underwent mitral valve repair for isolated posterior leaflet prolapse. Of the latter patients, only 81 (40%) had limited P2 prolapse, while the remaining 120 (60%) showed complex posterior leaflet prolapse, including either extensive (n = 105) or commissural (n = 15) prolapse. Extensive leaflet prolapse was treated with aggressive leaflet resection and sliding plasty, combined with a longitudinal annular plication using polytetrafluoroethylene running sutures. Commissural prolapse was repaired with an edge-to-edge technique or commissuroplasty. The clinical and echocardiographic follow up was complete for all patients, and extended up to 6.8 years (mean 2.4 +/- 1.9 years). RESULTS: There was no hospital mortality. Repair was successful in 200 patients (99%), who showed no or trivial mitral regurgitation (MR) intraoperatively. The five-year freedom from recurrent MR (grade > 1+) was 91.5 +/- 4.2% in patients with isolated P2 prolapse, compared to 98.8 +/- 1.2% in patients with complex posterior leaflet prolapse (p = 0.07). The repair of complex posterior leaflet prolapse was also similar to that of isolated P2 prolapse with regard to five-year freedom from reoperation (98.9 +/- 5.9% versus 100%; p = 0.4), and survival (92.1 +/- 3.3% versus 88.9 +/- 8.0%; p = 0.9). CONCLUSION: In the present series, posterior leaflet prolapse offered more complexity than usually reported, requiring surgical skills beyond simple quadrangular resection. However, the surgical approach, which typically involved extensive leaflet resection and sliding plasty, offered high repair rates and acceptable durability, considering the initial severity of the prolapse anatomy.

Predicting breast cancer risk: implications of a "weak" family history.

Published guidelines adopted in many countries recommend that women whose family history of breast cancer places them at a risk>or=1.7 times that of the age-matched general population, should be considered for inclusion in special surveillance programmes. However validation of risk assessment models has been called for as a matter of urgency. The databases of the four Scottish Familial Breast Cancer clinics and the Scottish Cancer Registry have been searched to identify breast cancers occurring among 1,125 women aged 40-56, with family histories placing them below the "moderate" level of genetic risk. The observed incidence over 6 years was compared with age-specific data for the Scottish population. Our findings confirm that when there are two affected relatives (one first degree) the relative risk (RR) exceeds 1.7 regardless of their ages at diagnosis. When only one (first degree) relative was affected at any age from 40 to 55, the RR does not reach 1.7 if that relative was a mother but exceeds it if the relative was a sister. The probable explanation is that sisters are more likely than mother/daughter pairs to share homozygosity for a risk allele. Surveillance programmes might therefore accommodate sisters of women affected before age 55. Evidence that "low penetrance" alleles contributing to breast cancer risk may be recessive should be taken into account in strategies for identifying them.

Prescribing pressure.

Newly qualified nurses may be able to undertake training to prescribe under Nursing and Midwifery Council proposals (news, 21 June). As a newly qualified nurse, there is so much to learn without having the stress of prescribing. However, for those who want to prescribe, the courses and support should be more accessible.

Aortic Root Rupture during Transcatheter Aortic Valve Implantation in a Patient with Idiopathic Thrombocytopenic Purpura: Utility of Transesophageal Echocardiography in Early Detection and Description of a Semiconservative Surgical Management Approach.

An 87-year-old man with idiopathic thrombocytopenic purpura and platelet count of 56 × 109/L underwent transesophageal echocardiography (TEE)-guided transcatheter aortic valve implantation using a femoral approach. Post valve deployment, a new pericardial effusion was noted which was successfully drained. Despite this, the patient became hypotensive needing vasopressor support with reaccumulation of pericardial fluid. Emergent sternotomy was performed and a perforation of the right ventricular apex was noted which was sealed with a pledgeted suture. Continued bleeding prompted further exploration; the aorta was seen to be mottled in conjunction with clear aortic root hematoma on TEE and a diagnosis of root rupture was made. This was semiconservatively managed without conversion to a full aortic root repair or replacement procedure. Multiple sutures were applied to the periaortic space and the bleeding sealed with use of BioGlue (Cryolife Inc., Kennesaw, GA) and Surgicel (Ethicon Inc., Somerville, NJ). The postoperative course was stable and the patient remained well at 3-month follow-up.

The "hybrid flip-over" technique for anterior leaflet prolapse repair.

Repair of the anterior mitral leaflet or bi-leaflet prolapse is technically more demanding than repair of the posterior mitral leaflet. Although several techniques have been proposed for the repair of anterior mitral leaflet prolapse during bi-leaflet repair, practical challenges remain, including the determination of the appropriate length for artificial chords. Herein we describe a novel and reproducible technique for bi-leaflet mitral valve repair, including those with extensive anterior mitral leaflet prolapse.

Surgery for chronic thromboembolic pulmonary hypertension--inclusive experience from a national referral center.

BACKGROUND: Chronic thromboembolic pulmonary hypertension represents a unique form of pulmonary hypertension amenable to curative intervention with a pulmonary thromboendarterectomy (PTE). Canada's first successful and sustainable program for PTE surgery was established at the University of Ottawa Heart Institute in 1995. Inclusive results from similarly sized programs are not readily available owing to selective reporting, therefore making it difficult to benchmark outcomes. The purpose of this report is to provide a review of the inclusive results from our moderately sized national program for all PTE, with a particular emphasize on the aspects of the learning curve in terms of patient management. METHODS: Since 1995, 180 patients have been referred for consideration of PTE, and 106 patients have undergone surgery with a perioperative 30-day mortality rate of 9.4%. RESULTS: There was a significant improvement in all hemodynamic parameters except right ventricular ejection fraction in nonsurvivors (mean pulmonary artery pressure pre 47 +/- 12 mm Hg versus post 28 +/- 9 mm Hg, p < 0.0001; pulmonary vascular resistance pre 814 +/- 429 dynes x sec(-1) x cm(-5), post 224 +/- 145 dynes x sec(-1) x cm(-5), p < 0.0001; cardiac index pre 2.0 +/- 0.7 L x min(-1) x m(-2), post 3.2 +/- 0.7 L x min(-1) x m(-2), p < 0.0001). A postoperative pulmonary vascular resistance of 500 dynes x sec(-1) x cm(-5) or more was associated with increased perioperative mortality (odds ratio, 12 +/- 8.7; p = 0.001). On average, these procedures were associated with significant resource use involving operating room time (610 +/- 243 minutes), intensive care unit and hospital days (11.2 +/- 13.7 and 19.5 +/- 15.6 days), and ventilation time (7.8 +/- 10.0 days). There was no significant change in hospital or intensive care unit length of stay, or the mortality rate during this first decade. CONCLUSIONS: PTE programs are resource-intensive surgical specialty services that demand excellence in cardiothoracic expertise. The initial decade reflected an expanding referral basis and likely parallel increases in patient complexity and expertise. The current results at a national referral center have emphasized the importance of centralization of resources to optimize patient outcome.

Postoperative pulmonary function in coronary artery bypass graft surgery patients undergoing early tracheal extubation: a comparison between short-term mechanical ventilation and early extubation.

OBJECTIVE: To evaluate the effect of a short period of mechanical ventilation (3 hours) versus immediate extubation (within 1 hour of surgery) on pulmonary function, gas exchange, and pulmonary complications after coronary artery bypass graft (CABG) surgery. DESIGN: Prospective randomized study. SETTING: University teaching hospital. PARTICIPANTS: Thirty-five patients undergoing CABG surgery. INTERVENTIONS: Patients were randomized into 2 groups. Patients in group I were extubated as soon as possible after surgery. Patients in group II were ventilated for a minimum of 3 hours after surgery. Patients in both groups were extubated only after achieving predetermined extubation criteria. Patients who did not meet the criteria for extubation within the predetermined set time limit (90 minutes in group I and 6 hours in group II) were withdrawn from the study. Pulmonary function tests (vital capacity, forced expiratory volume in 1 second, total lung capacity, functional residual capacity), arterial blood gases, and chest radiographs were done preoperatively and postoperatively. Pulmonary complications were recorded. MEASUREMENTS AND MAIN RESULTS: Demographic data were similar between groups. The mean time to extubation in group I was 45.7 plus minus 27.6 minutes and in group II was 201.4 plus minus 21 minutes (p < 0.01). Two patients in group I and 1 patient in group II did not meet the extubation criteria within the predetermined set time limit and were excluded from the study. In both groups, there was a significant decline in pulmonary function but no differences between groups at 24 or 72 hours after surgery. There were no differences between groups in blood gases, atelectasis scores, or pulmonary complications. CONCLUSION: The data suggest that extending mechanical ventilation after CABG surgery does not affect pulmonary function. Provided that routine extubation criteria are met, patients can be safely extubated early (within 1 hour) after major cardiac surgery without concerns of further pulmonary derangement.