Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation.

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.

The role of SU-AVR in tomorrow's practice of AVR.

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.

Safety and Tolerability Study of an Intravenously Administered Small Interfering Ribonucleic Acid (siRNA) Post On-Pump Cardiothoracic Surgery in Patients at Risk of Acute Kidney Injury.

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.

No symptomatic intracerebral hemorrhage after cardiac surgery: a 14-year retrospective study.

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.

Permanent pacemaker implantation following cardiac surgery: indications and long-term follow-up.

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. METHODS: We performed a retrospective review of 4,999 patients undergoing surgery between the years 1993 and 2005. Patient age was 64 +/- 12 years, and 71% were males. Coronary bypass was performed in 4,071 (81%), aortic valve replacement in 675 (14%), and mitral valve replacement in 968 (18%) patients. RESULTS: Seventy-two patients (1.4%) required implantation of a permanent pacemaker after surgery. Indications for pacemaker implantation included complete atrioventricular block in 59, symptomatic bradycardia/slow atrial fibrillation in nine, second-degree atrioventricular block in two, and other conduction disturbances in two patients. Predictors for pacemaker requirement by multivariate analysis were left bundle branch block and aortic valve replacement (P < 0.001). Late follow-up was available in 58 patients, at 72 +/- 32 months. Thirty-seven (63%) were pacemaker dependent. Predictors for late pacemaker dependency were third-degree atrioventricular block after surgery and preoperative left bundle branch block (P < 0.001). CONCLUSIONS: Patients at high risk for pacemaker implantation after heart surgery include those with preexisting conduction disturbances, and those undergoing aortic valve replacement. Of those receiving a pacemaker, about one-third will recover at late follow-up. For patients in the high-risk group who are pacemaker dependent after surgery, we recommend implanting a permanent pacemaker at 5 days after surgery, thus enabling early mobilization and early discharge.

Aortic valve replacement: choice between mechanical valves and bioprostheses.

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.

[Permanent pacemaker implantation after heart surgery: incidence and indications].

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.

[Pleural effusion following coronary bypass surgery].

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.

[Surgery for ischemic mitral regurgitation: results and long-term follow-up].

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.

Ozone administration reduces reperfusion injury in an isolated rat heart model.

BACKGROUND: Accumulating clinical experience with ozone administration for conditions associated with ischemia has been encouraging. The aim of our study was to determine the effect of ozone on reperfusion injury in an isolated rat heart model. METHODS: Isolated rat hearts were perfused with modified Krebs-Henseleit buffer solution via ascending aorta cannulation. After 15 minutes, perfusion was stopped and global ischemia was maintained for 30 minutes, following which perfusion was restarted, and continued for 40 minutes. Baseline hemodynamic measurements (heart rate, left ventricular developed pressure (LVDP), dP/dt, and coronary flow) were taken prior to ischemia, and every 10 minutes after reperfusion was started. Eleven hearts were treated with ozone during reperfusion and eight hearts served as controls. In the treatment group, after 5 minutes of reperfusion, ozone was administered in distilled water via a side arm for 5 minutes. RESULTS: Preischemic baseline hemodynamic measurements and coronary flow were similar in the two groups. Hearts treated with ozone during reperfusion exhibited better recovery than did controls. Mean (+/-SE) percent recovery for treatment and control groups, respectively, was: LVDP 69 +/- 2% vs 51 +/- 6% (p = 0.04); dP/dt 68.9 +/- 13.3% vs 53.7 +/- 20.4% (p = 0.05); and LVDPxHR 61.4 +/- 3.3% vs 44.4 +/- 3.5% (p = 0.02). CONCLUSION: In the isolated rat heart model, treatment with ozone during reperfusion enables better recovery than in controls. Although the mechanism by which ozone exerts its beneficial effect is not identified, it is possibly due to reduction in reperfusion injury.

Does mitral valve intervention have an impact on late survival in ischemic cardiomyopathy?

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.

Aortic valve replacement under deep hypothermic circulatory arrest.

BACKGROUND: Aortic valve replacement (AVR) in the presence of a calcified aorta or patent grafts may preclude clamping of the ascending aorta. We employed deep hypothermic circulatory arrest in order to circumvent this problem. METHODS: Between January 1993 and December 2000, 415 patients underwent AVR in our department. Eight of these were operated using deep hypothermic circulatory arrest. There were 5 males, and mean age was 72 years (range 56-81). Indications for using circulatory arrest were reoperation with patent grafts and/or severe calcification of the ascending aorta. In six patients, cardiopulmonary bypass was achieved via femoro-femoral bypass, and in two via aortic-right atrial cannulation. Retrograde cerebral perfusion was employed in five. Mean bypass time was 155 minutes (range 122-187), and mean circulatory arrest time was 38 minutes (range 31-49). RESULTS: There was no operative mortality, and no patient suffered any neurologic sequelae. Echocardiography showed all valves to be functioning well. CONCLUSIONS: AVR under deep hypothermic circulatory arrest can be accomplished with an acceptable degree of safety. It should be considered as an alternative in patients in whom aortic clamping is prohibitive, and might otherwise be considered inoperable. The ability to connect the patient to bypass and the presence of a "window" to allow aortotomy are prerequisites for employing this method.

Does coronary endarterectomy increase the risk of coronary bypass?

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.