Abstract Background Functional tricuspid regurgitation (FTR) secondary to left-sided heart disease may lead to poor quality of life and reduced long-term survival. This study evaluated clinical and functional outcomes of patients undergoing tricuspid valve (TV) repair using a rigid three-dimensional ring (Contour 3D, Medtronic) concomitant with another procedure. Methods From September 2011 to July 2015, 112 patients (mean age 70.9 ± 9.0 years) were enrolled at 10 centers in Europe, Israel, and the United States. Inclusion criteria were FTR ≥ moderate and/or tricuspid annular diameter (TAD) ≥ 40 mm. Echocardiography was planned before surgery and at discharge with echocardiographic and clinical follow-ups performed 6 months postoperatively. Results Three fourths (74.4%) of patients had higher than moderate TR. Mean TAD was 41.0 ± 7.3 mm; 61.7% of patients were in the New York Heart Association (NYHA) class III/IV. The most common concomitant procedure was mitral valve repair (57 patients, 53.3%). The 30-day mortality rate was 0.9% (n = 1). The mean EuroSCORE II was 8.9 ± 8.4% (median: 5.9%; interquartile range: 3.5–11.5%). The observed to expected ratio (O/E) based on the median was 0.1. Six deaths occurred during follow-up (three cardiac related). Mean implanted ring size was 30.3 ± 2.7. At 6 months, 94.4% of patients showed ≤ mild TR, and 92.0% were in NYHA class I/II (p < 0.001 vs baseline for both). Mean pressure gradient across the TV was 2.0 ± 1.1 mm Hg; leaflet coaptation length was 7.5 ± 3.3 mm. Conclusion The Contour 3D annuloplasty ring used for treatment of FTR substantially reduced TR for up to 6 postoperative months with low mean pressure gradients across the TV and significant improvement in NYHA class. Registration www.ClinicalTrials.gov, NCT01532921.

Conventional aortic valve replacement (C-AVR) is the golden standard in the treatment of severe aortic stenosis (AS). Despite its tremendous success there are many problems associated with the procedure. A large segment of the AS population is not suitable for surgery because of the excessive risk. Over the few last years, transcatheter aortic valve implantation and the use of sutureless valves are new technologies that aim to replace the C-AVR. In this review we compare the three therapeutic modalities in treating severe AS. Based on accumulated data we aspire to describe the clinical landscape of AVR in the near future. We will try to delineate how sutureless valves will be used in treating severe AS.

Introduction: Patients undergoing on-pump cardiac surgery are at an increased risk of acute kidney injury. QPI-1002, a small interfering ribonucleic acid, is under clinical development for the prevention of acute kidney injury. The safety, tolerability, and pharmacokinetics of QPI-1002 was evaluated in this first-in-man, Phase 1 study of a small, interfering ribonucleic acid in patients at risk of acute kidney injury after on-pump cardiac surgery.Methods: In this phase 1 randomized, placebo-controlled dose-escalation study, a single i.v. dose of QPI-1002 was administered in subjects undergoing on-pump cardiac surgery. Subjects received placebo (n = 4), or QPI-1002 in increasing doses of 0.5 mg/kg (n = 3), 1.5 mg/kg (n = 3), 5 mg/kg (n = 3), and 10 mg/kg (n = 3).Results: A total of 16 subjects were enrolled in the study. The average maximum concentration and area under the curve from the time of dosing to the last measurable concentration of QPI-1002 were generally dose proportional, indicating that exposure increased with increasing dose. The average mean residence time (mean residence time to the last measurable concentration) was 10 to 13 minutes in all 4 drug-dosing cohorts. Adverse events occurred at a similar rate in all study groups. Of the total 109 reported adverse events, the events were distributed as 26 in the placebo group and 21, 19, 24, and 19 in the QPI-1002 0.5, 1.5, 5.0, and 10.0 mg/kg groups, respectively. Eight of the 16 subjects experienced at least 1 serious adverse event: 4 (100%) in the placebo group and 4 (33.3%) in the combined QPI-1002 cohorts.Discussion: QPI-1002 was rapidly eliminated from plasma. QPI-1002 was safe and well tolerated across all dose groups. Overall, no dose-limiting toxicities or safety signals were observed in the study. Further development of QPI-1002 for prophylaxis of acute kidney injury is warranted.

Background: In the presence of new neurological findings occurring after cardiac surgery, the clinical question is whether to exclude symptomatic intracerebral hemorrhage (ICH), particularly in the context of routine postoperative anticoagulation treatment. Methods: This is a retrospective 14-year study including 5,275 patients who underwent cardiovascular surgery. The control cohort included all patients with acute cerebrovascular accidents hospitalized in 2 general hospitals in Jerusalem during a 2-month period in 2007 (part of a national survey). Results: After cardiac surgery, 78 patients developed ischemic strokes, mostly of large-vessel etiology. These ischemic strokes occurred more often in patients who underwent combined operations (22/647 = 3.4% vs. 45/3,489 = 1.3%; p = 0.0004). ICH was found in 6% of all acute cerebrovascular accidents in the general survey, but was absent after cardiac surgery (5 vs. 0; p = 0.02). Conclusions:Despite hypertension as a main risk factor and the administration of postoperative anticoagulation, we found that symptomatic ICH did not occur after cardiac surgery.

Background: Conduction disturbances requiring permanent pacemaker implantation after heart surgery occur in about 1.5% of patients. Early pacemaker implantation may reduce morbidity and postoperative hospital stay. We reviewed our experience with patients undergoing surgery to try and identify predictors for pacemaker requirements and patients who will remain pacemaker dependent.

BACKGROUND:The choice between a mechanical or bioprosthetic valve replacement device is not always clear, although patient age is most often the determining factor. We reviewed our experience with patients undergoing aortic valve replacement (AVR) in order to assess and compare long-term outcomes between patients receiving a mechanical valve and those receiving a bioprosthesis.METHODS:Three hundred fifty-two patients underwent AVR with or without coronary artery bypass between 1993 and 2004: 189 received a mechanical valve and 163 a bioprosthesis. Events included: late mortality, thrombo-embolic events, stroke, bleeding events, valve thrombosis, endocarditis, reoperation, and coronary catheterization.RESULTS:Patients in the bioprosthesis group were older (71 +/- 11 vs. 65 +/- 13) than in the mechanical group (p < 0.0001). There was no difference in operative mortality (6.8%) or morbidity. Follow-up (61 +/- 40 months) was available in 87%. For mechanical valves and bioprostheses, respectively: 3-, 5-, and 10-year survival was 92%, 86%, and 69% versus 90%, 86%, and 71% (p = n.s.); and event-free survival was 79%, 68%, and 41% versus 79%, 68%, and 44% (p = n.s.). Five patients (3%) in each group required re-replacement of their aortic valve (p = n.s.). Coronary artery disease requiring bypass surgery did not affect long-term survival. Age at operation and renal failure were the only predictors for late mortality.CONCLUSIONS:Survival and event-free survival are similar for patients receiving a mechanical or biological aortic valve substitute. Selection of a valve replacement device should be based on life expectancy, patient preference, ability to take anticoagulants, lifestyle, risk of bleeding, and risk of reoperation. Patient age alone should not be the determining factor.

BACKGROUND:New conduction disturbances requiring pacemaker implantation occur in about 1-3% of patients undergoing heart surgery. We reviewed our experience with patients undergoing heart surgery between the years 1993-2005 in order to identify predictors for pacemaker requirement.METHODS:There were 4999 patients aged 64 +/- 12 years. Coronary bypass was performed in 3448 (69%), valve surgery in 831 (17%), combined procedures in 623 (12%), and other procedures in 97 (2%).RESULTS:Overall, 72 (1.4%) patients required pacemaker implantation for the following indications: complete atrioventricular block (AVB) in 59, second degree AVB in 2, severe bradycardia (< 40 beats/min) in 9, first degree AVB with left bundle branch block (LBBB) in 1, and bifascicular block in 1. For patients undergoing aortic valve replacement, the incidence of pacemaker implantation was 5%. Multivariate analysis identified the following predictors for pacemaker implantation: LBBB, aortic valve replacement, and elevated CPK-MB levels after surgery.CONCLUSIONS:Patients undergoing heart surgery will require a permanent pacemaker in about 1.4% of cases. Based upon the recognition of predictors for pacemaker requirement, we recommend early implantation in order to enable early mobilization and shorter hospital stay.

BACKGROUND:The natural history of patients with ischemic mitral regurgitation (IMR) shows a poor prognosis. The surgical risk in these patients is high, but affords improved survival. We examined long-term results after coronary bypass and mitral repair for patients with IMR.METHODS:There were 122 patients operated on between the years 1993-2004. Patient age was 65 +/- 10 years, and 89 (73%) were male. Fifty-one (42%) were in NYHA class IV (mean NYHA class 3.1 +/- 1); 77 (63%) had pre-operative LV function grade 3-4 (mean LV grade 2.8 +/- 1); 103 (84%) had MR grade 4 (mean MR grade 3.8 +/- 0.4). All patients received mitral valve annuloplasty with a flexible ring (size 26 +/- 1 mm). Number of bypass grafts performed was 2.5 +/- 0.9.RESULTS:Operative mortality was 7% (9 patients). Operative survivors (n = 113) were followed for a mean interval of 34 months (range 2-91). NYHA class was 2.2 +/- 1. In 65 patients (58%) LV function was grade 1-2. Mean MR was 1.6 +/- 1 for the whole group, and 28 (25%) remained with MR grade 3-4. Late mortality was 18% (21 patients) 33 +/- 20 months after surgery (range 2-62). Predictors for late mortality were poor LV function, NYHA class IV, and age > 70 years (p < 0.0001). Overall, residual MR did not emerge as a predictor for late mortality.CONCLUSIONS:Surgery for patients with IMR can be performed with an acceptable risk. In our patient group, LV function is the major determinant for late survival, overshadowing the effect of residual MR.

BACKGROUND Pleural effusion is a common finding after coronary artery bypass surgery (CABG). We sought to determine the incidence and patient characteristics predictive of its appearance, in addition to the effect of post-operative treatment with enoxaparin. METHODS We retrospectively examined 893 patients undergoing CABG: 520 consecutive patients did not receive enoxaparin, and 373 patients received it. All early (up to 10 days) peri-operative chest radiograms were examined and graded by the amount of pleural effusion: (i) small--obliteration of the costophrenic angle; (ii) moderate-- < 50% of lung field; (iii) large-- > 50% of lung field. Patient characteristics as well as operative and post-operative parameters were analyzed in order to identify predictors for pleural effusion. RESULTS Pleural effusion was small in 415 patients (46%), moderate in 346 (39%) and large in 132 (15%). Older age, female gender and congestive heart failure were found to be predictors for pleural effusion by multi-variate analysis (p <0.05). Routine use of enoxaparin was not found to be associated with pleural effusion after CABG. CONCLUSIONS Over 50% of patients will develop a significant pleural effusion following CABG. Prophylactic treatment with enoxaparin does not increase the risk for pleural effusion.

Mechanical occlusion devices are used mainly for the closure of septal defects or patent ductus. There have been some reports of their use for the closure of paravalvular leaks after valve replacement. The potential for leaflet obstruction of a mechanical mitral prosthesis has so far been unrecognized. This is the first report of this potential complication. A 74-year-old woman underwent coronary bypass and aortic valve replacement with a mechanical device 13 years ago. Two years before the current admission, she underwent a second operation to replace her mitral valve because of heart failure secondary to severe mitral incompetence. Her valve was replaced with a St Jude 25-mm valve (St Jude Medical, St Paul, Minn). Shortly thereafter, shortness of breath developed in the patient, and a severe paravalvular leak was seen on the mitral prosthesis. She then underwent attempted closure of the paravalvular leak with percutaneous insertion of an Amplatzer occlusion device (AGA Medical Corporation, Golden Valley, Minn). Her condition continued to deteriorate, hemolytic anemia developed, and severe mitral regurgitation persisted (seen on echocardiography as an eccentric jet). Fluoroscopy (Figure 1) showed that 1 of the valve leaflets, adjacent to the device, was immobile. She was then referred to our department for repeat mitral valve replacement. The occlusion device was found to impinge on the posterior leaflet, restricting it in a closed position (Figure 2). The mitral valve was replaced with a bioprosthesis. The operation and immediate postoperative course were uneventful; however, on the day after surgery massive bleeding developed from the mediastinal drains. Emergency exploration was undertaken in the intensive care unit, which revealed bleeding from the area of the inferoposterior left ventricular wall, suggestive of atrioventricular rupture. The patient could not be resuscitated, and she died. Reexamination of the angiogram revealed a relatively large distance between the original mitral prosthesis and the calcified mitral annulus. This indicates that atrioventricular disruption may have been present before surgery but was contained because of adhesions; however, we could not be certain that the device directly contributed to the catastrophic event.Figure 2Explanted prosthetic valve with the occlusion device. The valve leaflet adjacent to the device was immobilized in the closed position.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Percutaneous insertion of occluding devices is used mainly for closure of intracardiac defects. Transcatheter closure of paravalvular leaks was first reported by Hourihan and colleagues1Hourihan M. Perry S.B. Mandell V.S. Keane J.F. Rome J.J. Bittl J.A. et al.Transcatheter umbrella closure of valvular and paravalvular leaks.J Am Coll Cardiol. 1992; 20: 1371-1377Abstract Full Text PDF PubMed Scopus (184) Google Scholar in 1992. There have been other reports of the use of occlusion devices in the mitral position2Kort H.W. Sharkey A.M. Balzer D.T. Novel use of the Amplatzer duct occluder to close perivalvular leak involving a prosthetic mitral valve.Catheter Cardiovasc Interv. 2004; 61: 548-551Crossref PubMed Scopus (53) Google Scholar and aortic position.3Webb J.G. Pate G.E. Munt B.I. Percutaneous closure of an aortic prosthetic paravalvular leak with an Amplatzer duct occluder.Catheter Cardiovasc Interv. 2005; 65: 69-72Crossref PubMed Scopus (64) Google Scholar Pate and colleagues4Pate G.E. Thompson C.R. Munt B.I. Webb J.G. Techniques for percutaneous closure of prosthetic paravalvular leaks.Catheter Cardiovasc Interv. 2006; 67: 158-166Crossref PubMed Scopus (51) Google Scholar summarized the techniques and considerations of percutaneous device use for closure of prosthetic valve leaks. In their article they mention a number of potential device-related complications, such as valve dehiscence, device embolization, infection, wire trauma, valve leaflet damage, impingement of valve leaflet motion, and hemolysis. Hussain and colleagues5Hussain S.T. Devagourou V. Kumar A.S. Management of mitral paravalvular leak: therapy or misadventure?.J Thorac Cardiovasc Surg. 2003; 126: 879-880Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar reported a case of attempted repair of paravalvular prosthetic mitral leak with an Amplatzer device (AGA Medical Corporation). The patient continued to demonstrate congestive heart failure and hemolysis secondary to persistent paravalvular leak and required surgery to remove the old prosthesis and the device. Our patient presented with severe congestive heart failure and hemolysis. The intention of avoiding surgery was not realized. Furthermore, she underwent surgery in a compromised clinical state. Current devices are not geometrically adapted to the anatomy of paravalvular leaks. A device may successfully repair a small leak but also propagate valve dehiscence. We believe that paravalvular leaks are best treated with reoperation. At this time, the use of percutaneous occlusion devices for closure of paravalvular leaks should be limited to those patients who are not surgical candidates. To our knowledge, our case is the first report of a device impinging on the valve leaflet.

BACKGROUND:Ischemic mitral regurgitation is associated with reduced survival after coronary artery bypass surgery.OBJECTIVES:To compare long-term survival among patients undergoing coronary surgery for reduced left ventricular function and severe ischemic MR in whom the valve was repaired, replaced, or no intervention was performed.METHODS:Eighty patients with severe left ventricular dysfunction and severe MR underwent coronary bypass surgery. The mean age of the patients was 65 years (range 42-82), and 63 (79%) were male. Sixty-three (79%) were in preoperative NYHA functional class III-IV (mean NYHA 3.3), and 26 (32%) were operated on an urgent/emergent basis. Coronary artery bypass surgery was performed in all patients. The mitral valve was repaired in 38 and replaced in 14, and in 28 there was no intervention. The clinical profile was similar in the three groups, although patients undergoing repair were slightly younger.RESULTS:Operative mortality was 15% (8%, 14%, and 25% for the repair, replacement and no intervention respectively; not significant). Long-term follow up was 100% complete, for a mean of 38 months (range 2-92). Twenty-nine patients (57%) were in NYHA I-II (mean NYHA 2.3). Among the surgery survivors, late survival was improved in the repair group compared to the other groups (P < 0.05). Predictors for late mortality were non-repair of the mitral valve, residual MR, and stroke (P = 0.005).CONCLUSIONS:Patients with severe ischemic cardiomyopathy and severe MR undergoing coronary bypass surgery should have a mitral procedure at the time of surgery. Mitral valve repair offers a survival advantage as compared to replacement or no intervention on the valve. Patients with residual MR had the worst results.

BACKGROUND:With increased incidence of angioplasty and stent implantation, patients referred for coronary bypass (CABG) typically have more advanced and diffuse coronary disease. Thus, more patients may require endarterectomy in order to achieve complete revascularization. We compared our results in patients undergoing CABG with or without coronary endarterectomy.METHODS:Between 1993 and 1999, 2372 patients underwent isolated CABG in our department. A retrospective analysis was performed to compare patients requiring coronary endarterectomy of the LAD (group 1, n = 88), endarterectomy of arteries other than the LAD (group 2, n = 143), to those not requiring endarterectomy (group 3, n = 2071). Patients undergoing CABG without the use of cardiopulmonary bypass were excluded. Group 1 had a higher incidence of proximal LAD stenosis (p = 0.001) than group 3, while group 2 had a higher incidence of peripheral vascular disease (p = 0.02), preoperative MI (p = 0.03) and LV dysfunction (p = 0.001).RESULTS:Operative mortality was 10% in group 1 (p < 0.001) and 4% in group 2 (p = NS) compared to 3% in group 3. Incidence of perioperative MI was 12% in group 1 (p = 0.001) and 8% in group 2 (p = 0.001) compared to 2% in group 3.CONCLUSIONS:Patients requiring endarterectomy of the LAD are at increased risk of operative mortality. This was not true for patients requiring endarterectomy of arteries other than the LAD. In both groups there was an increased risk of perioperative myocardial infarction.